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SAP AT GLANCE

Founded in 2011, Satya Abadi Pharma (Sapharma) is a pharmaceutical company that is growing in marketing quality pharmaceutical products and medical devices. In just 6 years, Sapharma has become one of the leading companies in plasma protein therapy in Indonesia

In an effort to provide wider services to the community, Sapharma also provides supplement products and traditional medicines.

Investment in human resources, of course, plays an important role in determining the achievement of our company's targets and ideas

SAP AT GLANCE

Founded in 2011, Satya Abadi Pharma (Sapharma) is a pharmaceutical company that is growing in marketing quality pharmaceutical products and medical devices. In just 6 years, Sapharma has become one of the leading companies in plasma protein therapy in Indonesia

In an effort to provide wider services to the community, Sapharma also provides supplement products and traditional medicines.

Investment in human resources, of course, plays an important role in determining the achievement of our company's targets and ideas

Latest Articles

Sapharma | 7 Jun 2022

Octanate®: over 20 years of clinical experience in overcoming challenges in haemophilia A treatment

Abstract Treatment of haemophilia A with FVIII replacement has evolved over the past decades to adapt to the needs of patients. Octanate®, a plasma-derived, double virus-inactivated, von Willebrand factor (VWF)-containing FVIII concentrate, has been used in clinics worldwide for over 20 years. First licensed in 1998 in Germany, Octanate® is approved in over 80 countries for the prevention and treatment of bleeding and for surgical prophylaxis in patients with haemophilia A, and in over 40 countries for immune tolerance induction (ITI). The manufacturing process for Octanate® was developed to ensure high viral safety and effectively eliminates both enveloped and nonenveloped viruses. Over the past 20 years, the excellent safety and efficacy of Octanate® have been demonstrated in pivotal clinical trials in adult and paediatric previously treated patients (PTPs) for on-demand treatment, prophylaxis and as surgical cover. Importantly, Octanate® has displayed low immunogenicity in previously untreated patients (PUPs), with only 9.8% of PUPs developing FVIII inhibitors. Octanate® has also shown to be highly effective in inhibitor elimination when used as ITI therapy. In a population of patients with high risk of ITI failure, success was achieved in 79.2% of patients (70.8% complete success), even when using exceptionally stringent success criteria. No relapses were observed. Here we present an overview of the clinical data with Octanate® that support its use in a range of patient populations and clinical indications. Keywords: haemophilia A, immune tolerance induction, Octanate® Introduction Haemophilia A is a bleeding disorder characterized by a deficiency of coagulation factor VIII (FVIII), and the natural approach to haemophilia management is replacement of the missing FVIII. Historically, FVIII replacement therapy required administration of whole fresh blood, fresh or frozen plasma or cryoprecipitate. In the 1970s, freeze-dried concentrates of coagulation factors from human plasma became commercially available, which represented the start of a new era of haemophilia therapy. The availability of factor concentrates dramatically increased access to replacement therapy, made home-based therapy feasible and resulted in improvements in life expectancy and quality of life for patients with haemophilia.1 Development of the solvent/detergent (S/D) viral inactivation method revolutionized the production of FVIII concentrates. This innovative approach, which inactivates lipid-enveloped viruses, was first employed on an industrial scale in the production of plasma-derived biopharmaceuticals by Octapharma in 1986. Subsequently, Octapharma further optimized the manufacture of their FVIII concentrates and included a second virus inactivation step of terminal dry-heat treatment in the production of Octanate®. Octanate® is a native, human, highly purified plasma-derived (pd) FVIII/von Willebrand factor (VWF) concentrate that combines VWF ristocetin cofactor activity (VWF:RCo) and FVIII activity (FVIII:C) in a ratio of ~0.4. FVIII binding to its natural stabilizer VWF may decrease FVIII immunogenicity due to epitope masking and protection of FVIII from endocytosis by antigen-presenting cells.2,3 Binding of FVIII to VWF also prolongs FVIII half-life by preventing its proteolytic degradation. Octanate® is derived from plasma from carefully selected donors and collected at highly regulated blood and plasma collection centres. Each individual donation undergoes virus testing for human immunodeficiency virus (HIV), hepatitis A, B and C viruses (HAV, HBV and HCV), and parvovirus B19. Only donations that are free from viruses are released for production. In addition to the extensive viral inactivation steps during its purification, the final Octanate® product meets the European Medicines Agency standards for virus safety. Over the 20 years since Octanate® was first marketed in Germany in 1998, a wealth of data has been accumulated in clinical studies and in routine clinical practice demonstrating the efficacy and safety of Octanate® in previously treated patients (PTPs) with or without inhibitors, and previously untreated patients (PUPs). Since its development, over 12 billion IU of Octanate® have been infused worldwide. Today, Octanate® is approved in over 80 countries for the treatment and prevention of bleeding, including surgical prophylaxis, in patients with haemophilia A, and in more than 40 countries for immune tolerance induction (ITI). Clinical development of Octanate®: the clinical trial programme An extensive phase III programme was undertaken to investigate the efficacy, safety and pharmacokinetics of Octanate® in a variety of clinical settings. Six prospective, open-label, noncontrolled, pivotal studies were conducted in accordance with good clinical practice guidelines. Five of these studies recruited a total of 86 PTPs (children, adolescents and adults) and one study was conducted in 51 PUPs (Table 1). Baseline demographics and clinical characteristics of the pooled PTP population and the PUPs are shown in Table 2. At the time the pivotal studies were started (late 1990s and early 2000s), severe haemophilia A was defined as FVIII activity (FVIII:C) <2%. The definition of severe haemophilia was later revised to FVIII:C <1%. Even so, 97% of PTPs in the pivotal studies had a basal FVIII:C of ⩽1%. In study AVI-403, 92% of the PUPs had FVIII:C <1%. Three studies assessed the pharmacokinetic properties of Octanate® as a primary objective; data are summarised in Table 3. The mean half-life of Octanate® after a single administration of an average dose of 40 IU/kg in PTPs ⩾ 12 years of age was between 11.1 and 14.3 h,6 and the mean recovery of Octanate® was in agreement with expected recovery values for FVIII (2.0–2.5% per IU/kg).7 Mean recovery of Octanate® in children under 6 years of age was analysed as a secondary objective in one PTP study and was slightly lower than that in adolescents and adults, as expected due to higher plasma volumes per unit weight in children. All six studies assessed the efficacy, safety and immunogenicity of Octanate® treatment, either prophylactically or on-demand, with immunogenicity being the primary endpoint in two PTP studies and the PUP study. Octanate® is effective for the treatment and prevention of bleeding in PTPs The efficacy of Octanate® in the treatment of bleeding episodes across the five PTP studies was assessed in a pooled analysis, based on the following objective criteria: percentage of bleeds treated successfully (see Figure 1 footnote for criteria), and percentage of bleeds with adequate treatment duration [defined as ⩽2 treatment days for bleeding episodes (⩽7 days for GI bleeding episodes)]. Across the five studies, 76 of the 77 patients experienced 1875 bleeding episodes. The success rate for Octanate® treatment for all bleeding episodes was 92.7% [95% confidence interval (CI): 91.5%, 93.9%] and percentage of bleedings with adequate treatment duration was 94.7% (95% CI: 93.6%, 95.6%). The percentage of bleeding episodes treated for ⩽2 days was 90.8%. When only those bleeding episodes that were treated successfully were taken into consideration, the percentage of bleeds treated in ⩽2 days was 97.9% (Figure 1). The mean (SD) dose per day for successfully treated bleeds was 22.84 (8.96) IU/kg. In three studies, including a paediatric study, (AVI-402, -406, -408), the efficacy of individual prophylactic infusions of Octanate® was rated by the investigator. A total of 443 prophylactic infusions in 32 patients were rated for efficacy and 100% of these were rated as ‘excellent’. For long-term prophylaxis against bleeding in patients with severe haemophilia A, doses of 20–40 IU/kg at intervals of 2–3 days are recommended.10 Dosing of Octanate® can also be personalized based on a patient’s pharmacokinetic profile. The Web-Accessible Population Pharmacokinetic Service (WAPPS-Hemo; www.wapps-hemo.org), led by McMaster University, Hamilton, Ontario, Canada,11,12 allows the estimation of pharmacokinetics and the optimization of dosing regimens for individual patients based on only a few sampling time points. Importantly, for patients on Octanate®, an Octanate®-specific population pharmacokinetic model is available in WAPPS. Octanate® is effective in major and minor surgeries The efficacy of Octanate® as surgical prophylaxis was assessed in 19 surgical procedures in the 14 adult or adolescent patients in the AVI-401/402 surgery study. The patients were aged 11–38 years, and all but one were receiving FVIII therapy on-demand at study entry. All patients had a basal FVIII:C of <1% and >100 previous exposure days (EDs) to FVIII, except one patient with a basal FVIII:C of 2% and 50 previous EDs. Of the 19 surgical procedures, 6 were classified as major (total hip replacement, arthrodesis of knee, arthroplasty of both knees, total elbow replacement, cholecystectomy and a correction of a talipes equinovarus), 5 as intermediate (1 elongation of Achilles tendon, 2 needle liver biopsies and 2 follow-up procedures for removal of orthopaedic devices), and 8 as minor (7 dental extractions and 1 extraction of an ingrown toenail). Continuous infusion was administered in 6 procedures (5 of the major surgeries and 1 of the follow-up procedures). Haemostatic effect was assessed as ‘excellent’ or ‘good’ in all 18 evaluated procedures except one (94.4%) due to rebleed at the operation site (elbow replacement). For one procedure (arthrodesis of the knee), an efficacy assessment was not possible due to continued bleeding in the postoperative phase, which was due to an open vessel and was not related to the haemostatic efficacy of Octanate®. The mean (SD) duration of treatment for all procedures was 7.2 (7.1) days (range 1–20 days). Patients received a mean total dose of 18,251.5 IU (range 1000–63,000 IU) of Octanate® and a mean dose of 44.6 IU/kg (range 28.6–68.3 IU/kg) per ED. One additional surgical procedure was performed in a 2-year-old PTP in the AVI-408 study. The patient underwent a surgical intervention for a thoracotomy and haematoma evacuation. The patient received 7000 IU (approximately 535 IU/kg) Octanate® as bolus injections over 8 EDs, from 3 days prior to the intervention until 4 days after the end of surgery [1000 IU on day 1, 500 IU on days 2 and 3, 2000 IU on day 4 (day of surgery), 1000 IU on days 5 and 6, and 500 IU on days 7 and 8]. Treatment was assessed as effective in terms of haemostasis and was well tolerated. No major bleeding occurred intra- or postoperatively. In summary, Octanate® provides effective cover during surgery, regardless of surgery type and severity. Octanate® displays low immunogenicity and excellent efficacy in PUPs The development of allo-antibodies that neutralize exogenous FVIII, commonly referred to as FVIII inhibitors, remains a major complication of FVIII therapy in the current treatment era. PUPs with severe haemophilia A are at greatest risk of inhibitor development, with approximately 35% developing inhibitors, usually within the first 50 EDs,13–16 whereas an estimated 1% of PTPs develop inhibitors.17 FVIII inhibitor development is thought to be dependent on a number of patient- and treatment-related factors; however, none of these definitively predict inhibitor development, making it difficult to assign risk to individual patients and posing challenges in prevention of inhibitor development.18,19 One recognised risk factor for inhibitors is the type of F8 gene mutation, with mutations that results in the complete absence of functional FVIII (null mutations) conferring the greatest risk for inhibitor development.20–22 Intron-22 and intron-1 inversions and large deletions have been associated with a high risk of inhibitor development, while small insertions and deletions and splice site mutations are usually associated with lower risk.22 Another risk factor, which has been a topic of much debate and research in the last decade, is the type of FVIII concentrate, plasma-derived or recombinant, used in the early treatment of patients. While some studies and meta-analyses reported an increased inhibitor risk with recombinant FVIII (rFVIII) derived from hamster cell lines compared with pdFVIII,16,18,23–27 others found no difference in the risk.13,15,19,28,29 The immunogenicity profile of Octanate® was evaluated in a prospective, open-label, noncontrolled, multinational, multicentre study (AVI-403) in PUPs treated with Octanate®.30 The study included patients who had received no previous treatment with FVIII-containing products and no inhibitor activity [<0.6 Bethesda units (BU)/mL], with ages ranging from 0.01 to 5.6 years. The primary endpoint of the study was the immunogenicity of Octanate® during prophylactic or on-demand treatment over a total of 100 EDs or 5 years, whichever came first. Frequent inhibitor testing was performed at baseline, every 3 or 4 EDs until 20 EDs, and thereafter either every 10th ED or every 3 months, whichever came first. Efficacy in the prevention and treatment of bleeds and in surgical prophylaxis, virus safety and tolerability were examined as secondary endpoints. A total of 51 PUPs were treated with Octanate®, of whom 80.4% had an identified high-risk/null F8 mutation (including intron 22 inversions, nonsense/stop/splice site mutations and large deletions). At the end of the study, 46 (90.2%) patients had >50 EDs, 2 (3.9%) had 20–49 EDs, and 3 (5.9%) had <20 EDs. FVIII inhibitors were detected in 5 of 51 (9.8%) patients; 4 (7.8%) had high-titre inhibitors (> 5 BU/mL) and 1 had a low-titre inhibitor (Table 4). Two of the patients with inhibitors had transient inhibitors that disappeared during regular Octanate® treatment without a change in dose or treatment frequency and were not considered clinically relevant. Of note, no FVIII inhibitors developed in PUPs after major surgeries. All patients who developed inhibitors had high-risk/null F8 mutations: either intron 22 inversions (4 patients) or large deletions (1 patient), and all were treated on-demand. No inhibitors developed in patients with non-null F8 mutations or in patients on prophylaxis. Of the 51 PUPs in the study, 4 had a baseline FVIII:C level ⩾ 1%, and 2 patients who did not develop inhibitors had not had 20 EDs, the time by which most inhibitors occur. Excluding these patients, and thus applying more stringent criteria, the incidence of inhibitors was 11.1% (5/45) for all inhibitors and 8.9% (4/45) for high-titre inhibitors. Previously reported FVIII inhibitor incidences from five large epidemiological studies in PUPs treated with pdFVIII concentrates ranged from 20% to 33% for all inhibitors, and 12% to 24% for high-responding inhibitors.19 A recent prospective, randomized, controlled trial, SIPPET, showed a cumulative inhibitor incidence of 44.5% in PUPs and minimally treated patients treated with rFVIII, compared with 26.8% in patients treated with pdFVIII/VWF.14 The inhibitor rate observed in the AVI-403 was lower than that observed with pdFVIII/VWF in the SIPPET study, despite there being similar percentages of patients with the null F8 gene mutations in the Octanate® study (80.4%) as in the SIPPET study (86.3% in the pdFVIII/VWF group and 82.1% in the rFVIII group). In the SIPPET study, no inhibitors developed in 16 PUPs with non-null mutations in the F8 gene following treatment with pdFVIII/VWF concentrates, whereas 27 inhibitors developed in 101 (26.7%) PUPs with null mutations.31 The same pattern was observed in the Octanate® PUP study, in that none of the PUPs who developed inhibitors had a non-null F8 gene mutation. In addition to the low immunogenicity, Octanate® demonstrated excellent efficacy in PUPs, consistent with its performance in PTP studies. The haemostatic efficacy of Octanate® was overwhelmingly rated as ‘excellent’ (99.7% of 4716 administrations with available efficacy ratings) (Table 5), and the vast majority of bleeds (95.5%) resolved with 1 or 2 days of treatment. Efficacy of all 201 infusions administered for 23 surgical procedures was rated as ‘excellent’. Octanate® is successful in ITI therapy in patients with inhibitors If inhibitors develop, patients become resistant to FVIII replacement therapy and haemostasis during bleeding episodes and surgical procedures is difficult to establish. This increases the risk of unmanageable bleeding, thereby putting patients in potentially life-threatening situations, and of associated morbidity, such as severe arthropathy and subsequent disability. ITI is the only proven strategy for FVIII inhibitor eradication. Several ITI protocols are currently in use,32–35 and there is no consensus on the optimal protocol or FVIII concentrate to be used. Octanate® is one of the FVIII products being evaluated in the ongoing, investigator-initiated, international, open-label, uncontrolled, Observational Immune Tolerance Induction (ObsITI) study. The ObsITI study applies three stringent ITI success criteria to define the efficacy of ITI: inhibitor titre <0.6 BU/mL; FVIII recovery ⩾80% of the predefined reference value of 1.5%/IU per kg body weight within 1 h postinjection; and FVIII half-life ⩾7 h. ‘Complete success’ requires achievement of all three criteria, ‘partial success’ requires achievement of two, and ‘partial response’ requires achievement of one of the three criteria. ITI is considered to have failed if no criteria are met within the 36-month observation period.36 Interim data from the prospective arm of the ObsITI study have been reported for a largely poor prognosis cohort of 48 patients who received ITI with Octanate®, administered mainly according to the Bonn protocol.36 This cohort included both children and adult patients (age range 0.8–28.1 years); 31.3% had failed a previous ITI attempt and underwent rescue ITI in the study. Of the 48 patients, 42 (87.5%) had high-titre inhibitors and 6 (12.5%) had low-titre inhibitors. A total of 40 patients (83.3%) had at least one risk factor historically associated with a poor ITI prognosis. Following ITI with Octanate®, a persistent negative inhibitor titre was achieved in 38 out of 48 patients (79.2%), FVIII recovery was normalized in 37 patients (77.1%), and half-life was ⩾7 h in 34 patients (70.8%) (Figure 2). The median time to achievement of these success criteria was short, namely 3.94, 5.26 and 10.86 months, respectively. Complete ITI success was achieved in 34 (70.8%) patients; three had partial success (6.3%), and one (2.1%) a partial response. ITI was unsuccessful in 10 patients (20.8%). All six patients with low-titre inhibitors and 28 of 42 (66.7%) of those with high-titre inhibitors achieved complete success. Furthermore, 22 of 35 patients (62.9%) with high-titre inhibitors and ⩾1 poor prognosis factor achieved complete success. Complete success rate was 60% (9/15 patients) in those with prior ITI treatment (rescue ITI) versus 75.8% (25/33 patients) in those without prior ITI (primary ITI). The study also showed that eradication of inhibitors translated into a clinical benefit: a statistically significant reduction of 86% in mean monthly bleeding rate was observed following elimination of inhibitors. In the 12 months of follow up, none of the 26 patients who achieved complete success and resumed FVIII prophylaxis had a relapse, showing that ITI with Octanate® has a long-lasting tolerizing effect. The tolerization rate observed in ObsITI is in line with previously published rates for pdFVIII/VWF concentrates in ITI, which range from 64% to 94%.37–42 Much lower success rates of approximately 35% were observed after rFVIII concentrates without VWF became available and were used for ITI,43–46 supporting the favourable effect of VWF in terms of decreasing FVIII immunogenicity. Recently, a complete success rate of 55% was reported in the retrospective Grifols-ITI study analysing ITI success using a pdFVIII/VWF concentrate in a cohort of 60 patients with severe haemophilia and high-titre inhibitors, largely at high risk of ITI failure.46 The time to reach success criteria with Octanate®, particular negative inhibitor titres, was short. In ObsITI, negative inhibitor titre and complete success were achieved with Octanate® in a median of 3.94 months and 10.86 months, respectively.36 In the International ITI study of 115 patients with a good ITI risk profile and mostly treated with rFVIII products (102 patients, 90%), median time to negative inhibitor titre and complete success were 4.6–9.9 months and 10.6–15.5 months (depending on the dose regimen), respectively.47 A retrospective chart review of rFVIIIFc (Eloctate®) reported 4 of 7 primary ITI patients achieved negative inhibitor titres in a median of approximately 6 months and complete success in a median of 8 months.48 The authors speculated that rFVIIIFc may have properties that uniquely promote tolerization but prospective data are needed before definitive conclusions can be drawn.48 Overall, the ObsITI study showed successful management of patients with inhibitors using Octanate®, and based on these data, Octanate® was approved for ITI in haemophilia A patients with inhibitors. It is important to consider that future ITI protocols might also include nonfactor therapies.49 The recently started investigator-initiated, international, low-interventional MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A (MOTIVATE) study will evaluate different approaches in the management of patients with haemophilia A and inhibitors, including the combination of various FVIII concentrates (among them Octanate®) and emicizumab. Safety profile of Octanate® The safety profile of Octanate® in the PTP studies was consistent with other pdFVIII products, with Octanate® being well tolerated and few adverse events (AEs) reported. During 2613 EDs in 85 patients across the five PTP studies, there were a total of 35 AEs, of which 9 were classified as serious and 5 as treatment related. The 5 AEs considered treatment related were malaise in one patient; thrombophlebitis at the infusion site in a surgical patient who had been receiving continuous infusion for 8 days; development of antibodies to parvovirus B19 in two children without any clinical symptoms; and development of a low-titre inhibitor in a surgical patient. A causal relationship between the low-titre inhibitor and Octanate® treatment could not be determined, as the patient had frequently received an alternative FVIII product around the time of inhibitor development. Therefore, no cases of confirmed inhibitor development were reported in PTPs. A total of 21 AEs were considered probably or possibly related to Octanate® in the PUP study: the 5 cases of inhibitor development described above and 16 asymptomatic parvovirus B19 seroconversions. As parvovirus B19 infection is ubiquitous in the general population, it is likely that the 16 children, as well as the 2 PTPs, were exposed through channels other than Octanate® treatment. In the ObsITI study, Octanate® for ITI was well tolerated, with only one adverse drug reaction reported (dermatitis allergica). Between August 1998 and November 2017, approximately 9.5 million IU of Octanate® were sold worldwide. Assuming a mean daily dose of 2000 IU, this corresponds to approximately 4.7 million EDs. Inhibitor development (1 report per 677,732 EDs) and hypersensitivity (1 report per 237,206 EDs) were very rare (<1/10,000), and there were no cases of drug-related thromboembolism. Conclusions Over the past 20 years, the safety and efficacy of Octanate® in the prevention and treatment of bleeding in patients with severe haemophilia A have been demonstrated consistently in clinical studies. Available data support the use of Octanate® in the treatment of haemophilia A in a variety of populations, including previously treated adults, adolescents and children, as well as PUPs. The low immunogenicity of Octanate® is particularly important for the high-risk previously untreated population. Successful ITI with octanate® was seen in the investigator-initiated ObsITI study, demonstrating the utility of Octanate® in patients who develop inhibitors and have a poor prognosis for ITI success. These clinical trial data are supported by the wealth of clinical experience with Octanate®, which continues to meet the needs of haemophilia A patients for an effective human pdFVIII concentrate with proven low immunogenicity.
Sapharma | 7 Jun 2022

Are Collagen Supplements Beneficial For Arthritis Patients?

Collagen is a protein that is found in many parts of the body, including the cartilage between bones. Since collagen is made up of amino acids, the building blocks of protein, it has been hypothesized that the body can use the amino acids in collagen supplements to protect and rebuild joint cartilage that has been damaged by osteoarthritis (OA) and rheumatoid arthritis (RA). The research on the effectiveness of collagen in these conditions is mixed but shows promise. What Is Collagen? Collagen is known as the most abundant protein in the body. It is the main component of the body’s connective tissues and can be found in skin, bones, cartilage, tendons, and teeth. Tough bundles of collagen, called collagen fibers, support most of the body’s tissues and can be found inside and outside cells. The word "collagen" comes from the Greek word for glue because it acts as a glue between cells and provides structure to the body's organs. For this reason, a drop in collagen levels in the body will cause the skin to lose its shape. Many people therefore take collagen supplements to preserve their skin health. Similarly, low collagen levels can loosen cartilage and tendons, making them more vulnerable to injuries. Types of Collagen Natural Collagen There are 16 types of collagen, with the most common types in the body being:3 Type I: Found in skin, tendons, internal organs, and the non-mineral parts of the bone Type II: Found in cartilage, allowing cartilage to be springy and cushioning the stress on joints Type III: Found in the liver, bone marrow, and lymphoid These three types of collagen make up 80% to 90% of the collagen in the body. Collagen Supplements Collagen supplements also come in three types: Gelatin Hydrolyzed Undenatured Gelatin and hydrolyzed collagen have been broken down from large proteins to smaller bits.3 When collagen is boiled for a long time, it turns into gelatin. Collagen can be further predigested into its basic amino acids and is called collagen hydrolysate, hydrolyzed gelatin, collagen peptides, or hydrolyzed collagen. Undenatured collagen is not broken down into smaller proteins or amino acids. Undenatured type II collagen (UC-II) is not intended to be used by the body as a collagen rebuilder. Health Benefits of Collagen for Arthritis Collagen type II is most often used to treat pain in osteoarthritis and rheumatoid arthritis. It is usually taken from chickens. It is said to work by causing the body to produce substances that fight inflammation, but this has not been proven. Chicken collagen contains the chemicals chondroitin and glucosamine, which may help rebuild cartilage. However, studies on supplementing with chondroitin and glucosamine have been mixed, and there is no convincing information on the efficacy of these two chemicals on OA.5   Uses in Osteoarthritis Osteoarthritis (OA), also known as degenerative joint disease, is one of the most common forms of arthritis, affecting more than 32.5 million adults.6 It occurs when the cartilage that protects the joints wears down over time. It is said that collagen supplements may help in rebuilding joints and reduce inflammation in osteoarthritis, but clinical evidence is mixed. One study showed that when patients with knee osteoarthritis were given acetaminophen and collagen, significant improvements in their joint pain, function, and quality of life were reported.7 This was, however, a small study and included only 39 subjects. A systematic review focusing on osteoarthritis and cartilage repair found that collagen hydrolysate and undenatured collagen showed some potential as an option for managing osteoarthritis, but further investigation is needed before any definite conclusion on their effectiveness can be made.8 Uses in Rheumatoid Arthritis Rheumatoid arthritis (RA) happens when the body’s immune system attacks healthy cells by mistake, causing painful swelling mainly in the hand, wrist, and knee joints. In RA, the lining of the joint becomes inflamed, damaging the joint tissue. Research studying the use of collagen supplements in RA has yielded mixed results as well. A study that looked at both OA and RA noted that reports of positive results with oral collagen in RA remain controversial, particularly when compared with conventional therapies such as methotrexate, a drug designed to slow down the progression of RA.9 Research into oral collagen for OA in the form of UC-II and partially denatured collagen has shown promise as a pain reliever for those suffering from OA. However, there are still not enough large and long-term studies to verify the effectiveness of collagen in these conditions. Overall, oral collagen supplementation has achieved some positive results against RA in preclinical and clinical studies. Possible Side Effects Side effects vary depending on which type of collagen supplement you take, but they are generally minor overall. Possible side effects include: Upset stomach Diarrhea Rashes, or skin reactions Nausea Constipation Heartburn Headache People with allergies to fish, shellfish, chicken, or egg should avoid taking collagen supplements since many of them contain these ingredients. Collagen supplements haven't been tested for safety, so people who are pregnant or breastfeeding should avoid using these products when possible. Doses and Preparation The best dosage for collagen supplements has not yet been established, but studies have used daily doses of between 1 g and 10 g of collagen hydrolysate and 0.1 mg to 1 mg of chicken or bovine type II collagen.10 UC-II should be taken in very small doses, usually 20 mg to 40 mg per day, while gelatin and hydrolyzed collagen should be taken in higher doses, 10 gm per day.3 Collagen supplements come in powder, capsules, drink mixes, concentrated elixirs, gummies, and chewable tablets. What to Look For Unlike prescription and over-the-counter medications, the Food and Drug Administration (FDA) does not approve dietary supplements like collagen for safety and ability to produce results. Organizations do exist that oversee nutritional supplements like collagen, however. Look for seals of approval from U.S. Pharmacopeia (USP), ConsumerLab, or NSF International to be sure the products are manufactured properly.3 The USP Dietary Supplement Verification Program gives a USP verified mark to products that met the program's strict testing and evaluation criteria.11 If you are looking for collagen that is easy to take, look for hydrolyzed collagen powder. It usually has no flavor or color, unless it is added, and dissolves easily in beverages, smoothies, soups, and sauces. Powdered collagen can be added to drinks or food. It mixes best with cold liquids but can be added to warm or hot liquids as well, although it will need more mixing if added to hot liquids. A Word From Verywell Even though collagen is considered a natural supplement, always tell your healthcare provider if you are taking collagen or any other dietary supplements. Collagen has been shown to be helpful for some people in reducing the symptoms of OA and RA. However, more research is needed for collagen to verify its effectiveness and ensure its safety in different people. That said, collagen supplements usually cause very mild effects. It's still important to watch out for side effects and let your healthcare provider know if you experience any changes to your health while on collagen supplements.
Sapharma | 7 Jun 2022

What is hemophilia?

Hemophilia is an inherited bleeding disorder. With this condition, the blood does not clot as it should, which can result in spontaneous bleeding and bruising after surgery or other injuries. According to the Centers for Disease Control and Prevention (CDC)Trusted Source, proteins called clotting factors work with platelets to stop bleeding at the site of an injury. People with the most common types of hemophilia produce lower amounts of either factor VIII or factor IX. This means that the person tends to bleed for a longer time after an injury and is more susceptible to internal bleeding.  The CDC also states that the exact number of people living with hemophilia is not known. Estimates suggest that as many as 33,000Trusted Source males were living with the condition in the United States from 2012 to 2018. Causes of hemophilia   Hemophilia is typically an inherited disorder, which means that a person is born with the condition. The CDCTrusted Source states that hemophilia is a sex-linked recessive condition. Hemophilia tends to occur in males. The reason for this has to do with inherited genes. Males inherit one X chromosome from the female parent and one Y chromosome from the male parent. Females have two X chromosomes, inheriting one from each parent. The genetic change that causes hemophilia is a recessive change in the X chromosome. Males have one copy of the genes in the X chromosome, and females have two copies. As a result, males have a 50%Trusted Source chance of developing hemophilia if their biological mother is a carrier of the gene. If they inherit the affected X chromosome, they have hemophilia. Females can also inherit hemophilia. However, this is rare. For females to inherit hemophilia, the affected gene is in both X chromosomes, or the affected gene is in one X chromosome, and inactive or missing in the other. Females with one altered gene can be carriers and pass the condition to any children they may have. In some cases, a person may spontaneously develop a gene mutation that causes hemophilia. In these cases, the person does not have a family history of the condition, and the biological mother is not a carrier. Rarely, a person may develop acquired hemophilia. They typically have no family or personal history of hemophilia. Instead, acquired hemophilia is an autoimmune condition where the body’s immune system starts to attack the clotting factors found in the blood.   Von Willebrand disease Another genetic disorder that causes frequent bleeding is von Willebrand disease (vWD). It causes bleeding episodes such as nosebleeds, bleeding gums, and excessive menstrual periods. According to the CDCTrusted Source, vWD affects around 1% of the American population. The condition affects every sex equally. However, females are more likely to develop symptoms. This is because people with a menstrual cycle may notice heavier or abnormal bleeding during menstrual periods, childbirth, or post-childbirth.   Types of hemophilia   There are two major types of hemophilia — type A and type B. Both A and B can be: Mild: Approximately 25% of cases are mild. A person with mild hemophilia has factor levels of 6–30%. Moderate: Approximately 15% of cases a moderate, and a person with moderate hemophilia will have factor levels of 1–5%. Severe: Approximately 60% of cases are severe, and people with severe hemophilia will have factor levels of less than 1%. Hemophilia A occurs due to a lack of clotting factor VIII. This type of hemophilia is four times more common than hemophilia B. Of those, more than half of people with hemophilia A have the severe form. Hemophilia B, colloquially known as Christmas disease, happens due to a lack of clotting factor IX. Hemophilia B occurs in around 1 in every 25,000 males born worldwide.   Symptoms of hemophilia Common signs of hemophilia include: bruising hematomas, which is when there is bleeding into the muscle or soft tissues bleeding from the mouth and gums bleeding after a circumcision blood in the stool blood in the urine nosebleeds that are frequent and difficult to stop bleeding after vaccinations or other injections bleeding into the joints According to the National Organization for Rare Disorders, the severity of hemophilia can also affect symptoms. In mild cases, a person will most likely experience: spontaneous nose bleeds bleeding from the mouth or gums easy bruising or hematomas excessive bleeding following dental or other surgical procedures or injury Symptoms for people living with the mild form may not show until adulthood. In moderate cases of hemophilia, a person may experience: easy and excessive bruising excessive bleeding following surgeries or trauma Doctors can often diagnose moderate cases by the time the person is 5 or 6. In severe cases of hemophilia, a person may experience spontaneous bleeding, often in the muscles or joints. This can lead to pain and swelling. Without treatment, it can result in arthritis in the affected joints. Doctors can often diagnose severe cases when the person is an infant.   Diagnosing hemophilia Diagnosis of hemophilia involves: a review of symptoms a clinical evaluation a review of personal medical history blood tests and other diagnostic testing If a person has bleeding problems, or if a doctor suspects hemophilia, a physician will ask about the person’s family and personal medical history. A doctor will then perform a physical examination. Blood tests can provide information about how long it takes for the blood to clot, the levels of clotting factors, and which clotting factors, if any, are missing. Blood test results can also help to identify the type of hemophilia and its severity.   Treatment for hemophilia Though no cure exists for hemophilia, doctors can successfully treat the condition. Treatment focuses on replacing the missing protein and preventing complications. It involves giving or replacing the clotting factors that are too low or missing. Scientists can derive clotting factor treatments for replacement therapy from human blood or synthetically produce a form in a laboratory. Synthetically produced factors are called recombinant clotting factors. Doctors often consider recombinant clotting factors as their first treatment choice because they further reduce the risk of transmitting infections that can be present in human blood. However, modern screening techniques have decreased the likelihood of disease transmission from human samples. There are two main forms of replacement therapy: Prophylactic therapy: Some patients will need regular replacement therapy in order to prevent bleeding. This is called prophylactic therapy. Doctors typically recommend regular treatment for people with severe forms of Hemophilia A. Demand therapy: This will stop the bleeding on-demand. People living with mild hemophilia may only need demand therapy, which is a treatment that doctors provide only after bleeding begins and remains uncontrollable. Other treatment options In 2018, the Food and Drug AdministrationTrusted Source approved a medication called emicizumab-kxwh. This is intended to reduce or prevent the frequency of bleeding episodes in those with hemophilia A, with or without factor VIII inhibitors. A doctor can administer this medication as an injection under the skin. Initially, a person will receive a dose of 3 mg/kg once a week for 4 weeks. After that, they can receive maintenance injections every 1–4 weeks, depending on the dosage. Other hemophilia A treatments include desmopressin, a manufactured hormone that stimulates the release of stored factor VIII, and antifibrinolytic medications, which prevent clots from breaking down. Doctors may prescribe one of several medications for people living with hemophilia B that replace Factor IX, such as Rixubis or Rebinyn. Treatment complications Complications from treatment of hemophilia may occur. They can include developing antibodies to treatments and viral infections from human clotting factors. Treatment can also cause blood clots. Getting treatment as soon as possible is important to help reduce the risk of damage to joints, muscles, and other body parts.   Living with hemophilia A person can take several steps to help reduce the risk of excessive bleeding and to protect their joints. These include: regular low impact exercise or non contact sports avoiding certain medications, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), and blood thinners, such as heparin practicing good dental hygiene As preventive treatment, a person should follow the doctor’s recommendations regarding when to get injections of clotting factor VIII or IX. The CDC recommends regular testing for blood-borne infections, such as HIV and hepatitis. They also recommend getting vaccinations for hepatitis A and B. People with hemophilia who receive donated blood products may be at risk of contracting these conditions. Hemophilia Treatment Centers (HTCs) are available for support. A CDC study of 3,000 people with hemophilia found that those who used an HTC were 40% less likely to die of a complication related to their condition. To protect against injuries that can cause bleeding, a person can wear protective gear. They should also take extra precautions, such as consulting a physician, when participating in sports or high impact activities.   Bleeding after vaccinations People living with hemophilia may experience bleeding following a shot. However, this should not stop someone from getting vaccinated. Prior to getting a vaccination, a person should consider getting a dose of factor replacement. Following a shot, they should plan to spend about 10 minutes applying pressure to the area. Several factors can affect a person’s safety when getting a shot. A person should speak with a doctor before getting any vaccination to avoid possible complications. Summary Hemophilia is an inherited bleeding disorder associated with excessive bruising, nose bleeds, and spontaneous bleeding in severe cases. The condition typically affects males since the mutation occurs on the X chromosome and males have only one copy of it. A person living with hemophilia can take typically manage the condition with factor replacement therapy and lifestyle changes.
Sapharma | 4 Mar 2022

Frequent consumption of turmeric, this is the impact on your body!

Turmeric itself is one of the herbal plants that can be used as a cooking spice, because this plant is included in the spice category which is quite popular in Central America to Asia, including Indonesia. It's not just a flavoring for food. It turns out that turmeric can also be used as natural medicines. Turmeric itself has a dark color because it contains curcumin. It is an active ingredient that has an anti-inflammatory effect, besides that turmeric can also increase endurance and prevent various diseases, one of which is ulcers and flatulence. According to the University of Maryland medical center, curcumin has also been shown to have antioxidant properties that can fight free radicals and thus prevent various chronic diseases. 1. Treating ulcers Turmeric has long been believed to be used as a natural remedy for digestive disorders. So when ulcer symptoms come, turmeric is always the first choice to relieve the pain. According to research from the journal Pharmacognosy Reviews looked at the effects of curcumin to treat inflammation caused by wounds and protect the stomach from these irritants by increasing the production of mucus in the stomach wall. 2. Overcome Bloated Stomach Too often passing gas (farting) is a sign that your digestion is not doing well, these symptoms can be a sign that you have flatulence. The curcumin in turmeric can help the muscles of the digestive organs to move smoothly as they should to reduce gas pressure in the stomach. Turmeric also helps the stomach stop producing excess acid that causes flatulence. 3. Treat nausea Turmeric mixed with black pepper is believed to relieve nausea, a study in the journal Food in 2017 proved that the addition of black pepper helps the benefits of yellow spice feel more leverage. After consumption, the curcumin content in turmeric is slowly absorbed into the bloodstream, this makes you lose the efficacy of turmeric itself. The study showed that piperine in black pepper can increase the absorption of curcumin up to 2,000 percent faster into the blood. In addition to consuming turmeric to treat ulcers, now there are herbal medicines that are practical and have better properties for treating ulcers and flatulence, ALBUSE is an herbal medicine to relieve symptoms of stomach acid, flatulence, nausea, vomiting and hot throat, and prevent recurrence. Curcumin itself is a pure extract of turmeric without the content of essential oils, the combination of curcuminoids with honey has a better effectiveness to treat digestive disorders than giving turmeric or honey alone. According to the Andalas Health Journal, in 2018 the combination of curcuminoids with honey had a better effectiveness in reducing gastric ulcers due to aspirin or pain relievers. In addition, the benefits of consuming Albuse can protect the stomach lining from inflammation/damage due to NSAIDs, unhealthy food & drinks, & H. pylori bacterial infection, reducing pain, bloating and excessive gas in the stomach. Albuse itself is already available in e-commerce such as Shopee and Tokopedia.

Course Calendar

Journal Articles

Nutrition and Health | 29 Mar 2022

The Association between Eating Behavior and Various Health Parameters: A Matched Sample Study

Bonforce | 29 Mar 2022

The use of collagen hydrolysates and native collagen in Osteoarthritis

Bonforce | 29 Mar 2022

Anti-inflammatory activity of mangostins from Garcinia mangostana

Albunorm | 29 Mar 2022

Serum albumin is a predictor of bronchiectasis

Albunorm | 29 Mar 2022

Human albumin in the management of complications of liver cirrhosis

Albuforce | 29 Mar 2022

Effect of snakehead fish extract on total antioxidant status in acute ischemic stroke patients with a history of hypertension.

Albuforce | 29 Mar 2022

Medical nutritional therapy in infected bronchiectasis with impending respiratory failure

Buragel | 29 Mar 2022

Role of honey in wound dressing in diabetic foot ulcer

Buragel | 29 Mar 2022

Effects of Topical Honey Wound Bandages on Decubitus Ulcers

Octaplex | 29 Mar 2022

A Comparison of Prothrombin Complex Concentrate and Recombinant Activated Factor VII for the Management of Bleeding With Cardiac Surgery

Octaplex | 29 Mar 2022

Effectiveness of prothrombin complex concentrate for the treatment of bleeding: A systematic review and meta-analysis

Octanate - Octanine | 29 Mar 2022

The factor VIII protein and its function

Octanate - Octanine | 29 Mar 2022

WFH Guidelines for the Management of Hemophilia, 3rd edition

Osforce | 29 Mar 2022

Calcium and/or Vitamin D Supplementation for the Prevention of Fragility Fractures: Who Needs It?

Osforce | 29 Mar 2022

Evolving role of vitamin K2-7(Menaquinone) in Osteoporosis & cardiovascular health

Scanlux | 29 Mar 2022

Intravenous iodinated contrast media and metformin: interactions and precautions

Scanlux | 29 Mar 2022

Metformin and intravenous contrast

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Our Product

Salaam Hand sanitizer

SALAAM Hand Sanitizer is a hand sanitizer that contains several natural ingredients, namely Morus alba leaf extract and Phellodendron amurense bark extract, which have been scientifically proven in several studies conducted at leading medical institutions as strong natural ingredients to ward off viruses. It has been proven effective against the H1N1 virus.

The combination with the active ingredient in the form of 0.1% Benzethonium Chloride adds to its effectiveness against bacteria and fungi. In addition, the addition of Aloevera in the composition of the ingredients makes SALAAM Hand Sanitizer moist on the skin.

SALAAM Hand Sanitizer is scented with gravity, making the sensation of a fresh scent on the hands.

Packaging:

Spray Bottle 60 ml

How to use:

Spray SALAAM Hand Sanitizer on the hands, then smooth it out until it dries and no need to rinse.

Attention:

1. For external use only.

2. Avoid contact with eyes. In case of contact with eyes, rinse immediately with running water.

3. If irritation occurs, discontinue use and consult a doctor.

4. Store in a cool and dry place.
MedicsBLU

medicsBLU® OraLightStick® - Mouth and Throat Cleanser

A potential and innovative product in the form of an LED stick to Clean the Mouth and Throat Area. With UV-free technology, providing an effective product that can reduce viruses, bacteria and fungi* resulting in a clean and fresh mouth sensation. Regular use of medicsBLU® OraLightStick® will protect you and your family in just 15 minutes.

Benefit

1.    Chemical Free, Reduces viruses, bacteria and fungi.

2.    Clean the Mouth and Throat Area.

3.    As an alternative to mouthwash.

4.    Reduces viruses, bacteria, and fungi.

5.    For a clean and fresh taste sensation in the mouth area.

6.    For prevention, use every day for 15 minutes. As for intensive use, it can be used 2-4 times a day, with a duration of 15 minutes once used, for 2-4 days in a row.

7.    Easy to use either at home or when you are on vacation.

8.    Safe to use for all family members over the age of 6 years.

Usage Procedure

1.    Charge the medicsBLU® OraLightStick® device using the tools provided in the kit.

2.    Once the battery is fully charged insert the replaceable silicone* into the medicsBLU® OraLightStick®

3.    Activate/turn on the medicsBLU® OraLightStick®, by pressing the button on the bottom.

4.    Once on, put the medicsBLU® OraLightStick® in your mouth. For prevention, use every day for 15 minutes. As for intensive use, it can be used 2-4 times a day, with a duration of 15 minutes once used, for 2-4 days in a row.

Note: After intensive use is complete, perform the preventive procedure of 15 minutes every day.

PAKET PENGIRIMAN

•    1 medicsBLU® OraLightStick®

•    3 replaceable silicone mouthpieces (Can be washed with boiling water)

•    High-quality medicsBLU® box

•    USB-C Charging Cable.

•    Instructions for Use and Cleaning.

OTHER INFORMATION

1.    2 Years Warranty.

2.    Can be used for 3 family members (there are 3 replaceable silicones).

3.    Not recommended for children under 6 years.

4.    Effectiveness of killing bacteria up to 99.9% (Microbial Laboratory Results-Spain)

5.    Free of UV Rays.

6.   Designed in Germany.
Conax

CONAX is able to increase the quality and quantity of sexual activity because it uses white ginseng which is known to contain Aphrodisiac or stimulant substances. Because it uses herbal ingredients, CONAX has no side effects when taking this herbal supplement.

Ingredients: Dextrose Monohydrate, Maltodextrin, Coffee Extract, Fructose, Vegetable Creamer (contains milk protein), Blueberry Powder, Mint Powder, Grape Powder, Inulin, Tomato Extract, Ginsen Extract.

* Contains allergens (milk protein)

Availability Form: Powder in sachet

Packaging: 1 Box contains 5 Sachets @ 3 grams.

Advantages:

1.    Helps increase desire, arousal and orgasm by increasing the levels of Dopamine (DA) and Acetylcholine (Ach) in the brain and modulating Gamma-aminobutryc acid (GABA) in the nervous system of the brain.

2.    Plays a role in the regulation of nerve cells related to sexual libido.

3.    Increases the secretion of Luteinizing Hormone (LH) which is produced by the anterior pituitary gland and causes an increase in testosterone levels.

4.    Hardens maximally and lasts a long time.

5.    Has the ability to increase the level of spermatogenesis (the process of sperm formation and maturation in men) through increasing the expression of GDNF (Glial cell Derived Neurotrophic Factor) in Sertoli cells and activating the testicular responsive element CREM (CAMP Responsive Element Modulator). Where one of the parameters determining sperm quality is sperm motility as seen from the number of sperm that move progressively and correctly to reach the ovum for the fertilization process.

6.    Ginsenosides have been shown in vitro to improve sperm directional motility and human sperm development.

 

How to use:

Dissolved in 150 ml of plain water (room temperature) and drink immediately.

Warning:

1.    Do not take more than the recommended dose.

2.    It is recommended to consume 2-3 hours before sexual activity.

3.    Caution should be exercised in its use in pregnant, lactating women and children.

4.    Prolonged use (more than 3 weeks). In order to stop taking ginseng with an interval of 2-3 weeks.
Albuse

Albuse is a herbal product that contains an effective combination of curcuminoids and honey. Curcuminoids and honey are also known to have many beneficial properties in them.

Composition: Has 3 components that work synergistically as a therapy for acute and chronic digestive disorders:

- Curcumin <77%>

- Demethoxycurcumin (DMC) <17%>

- Bisedemethoxycurcumin (BDMC) <3%>

Availability Form: Solution with orange flavor

Packaging: 115 ml bottle

Advantages:

1.    Protects from inflammation/damage due to consumption of unhealthy food and drink, as well as bacterial infection, Helicobacter pylori

2.    Reduces pain, bloating and excessive gas in the stomach

3.    Accelerate the healing of gastric ulcers and prevent the change of normal cells into cancer cells in chronic gastritis patients

4.    Prevent the occurrence of GERD and damage to the lining of the esophagus due to GERD.

5.    Honey protects the lining of the stomach wall so that it can help treat gastric ulcers due to the use of non-steroidal anti-inflammatory drugs (NSAIDs).

6.    Honey has the same effectiveness as chemical drugs (cimetidine) for the treatment of ulcers.

7.    The reactions and effects are fast, so the benefits can be felt within 10-15 minutes after consumption. Effective for curing acute indigestion.

8.    The solution for chronic indigestion because it is an Esophageal Gastroprotector so that it can help prevent the recurrence of indigestion.

9.    Free of essential oils, thus minimizing the potential for bile disorders

 

How to use:

1.    1 tbsp Albuse is mixed with 50 ml of room temperature water and stirred until homogeneous or 1 tbsp Albuse can be drunk directly 1-3 times a day.
Acetium

Acetium products focus on reducing smoking addiction slowly. The way Acetium works is by sucking the product while smoking. Using Acetium regularly will increase the percentage of cure from smoking dependence.

Ingredients: Contains L-cysteine, a natural amino acid that is 90% effective at binding acetaldehyde from saliva during smoking.

Dosage Form: Tablet

Packaging: 3 Strips (30 tablets)

Advantages:

1. Smoking cessation solution for those of you who want to quit smoking fast

2. Reduces nicotine withdrawal syndrome such as restlessness, irritability and shaking

3. Reducing addiction to nicotine, in order to quit smoking.

4. Makes the body healthier and free of nicotine.

5. Removes 90% of carcinogenic acetaldehyde from cigarette smoke

 

How to use:

1. When you smoke, put this tablet/candy in your mouth

2. Then suck the tablet/candy while smoking

3. Do it repeatedly until the smoking activity is gone

Rules of Use:

-   1 or 2 lozenges in smoking
Bonforce

Helps overcome cartilage problems and restore its function.

Bonforce with the main content of Collagen type II, is the most collagen found in joints with the addition of mangosteen peel extract which has anti-inflammatory properties. So Bonforce is the right choice to help maintain healthy joints.

Composition: Each sachet of Bonforce contains Hydrolyzed Collagen Type II 1000 mg and Alpha, gamma mangosteen 300 mg

Availability/Packaging: 1 Box contains 10 sachets @ 3.5 grams

Uses: Reduces inflammation and pain, Protects cartilage, Lubricates and cushions cartilage

Suggestion for use: 1-2 times a day 1 sachet after meals

How to use: Dissolve in 150 ml of room temperature water

Contraindications:-

Side effects: -

Storage: Store in a dry place at a temperature below 25ºC, protected from direct sunlight.
img1-scanlux-370-50ml
Scanlux® 370 50ml

Scanlux is a non-ionic iodinated X-Ray contrast medium, which is water soluble.

Ingredients: Iopamidol 755 mg/ml

Dosage Form: Injection

Packaging: 50 ml and 100 ml

Indication

Neuroradiologi : myeloradiculography, cisternography dan ventriculography.

Angiography : cerebral arteriography, coronary arteriography, thorax aortography, abdominal aortography, angiocardiography, visceral arteriography selective, peripheral arteriography, venography, digital subtraction angiography (DSA), DSA cerebral artery, DSA peripheral artery, DSA abdominal artery

Urography : intravenous urography

Contrast enhancement on CT scanning, arthrography, fistulography

Contraindications: Iopamidol is strictly contraindicated in patients with manifest hyperthyroidism or hypersensitivity to the iopamidol group.

Special warnings and cautions : Patients w/ severe hepatic or renal impairment, hepatorenal syndrome, monoclonal gammopathy.

Scanlux® 370 can only be used for appropriate clinical indications, taking into account the risk factors in the patient to be examined. Adequate hydration should be provided before and after contrast media administration; If necessary, give intravenous infusion fluids until all the contrast media has been excreted. Especially for patients with kidney dysfunction, diabetes mellitus, multiple myeloma, hyperuricemia, infants, children and elderly patients

Dosage: Individually, depending on various factors including age, weight, heart and kidney function, general state of health, clinical objectives, examination method and examination area. The total dose should not be > 1.5 g of iodine/kgBW/day for each examination

Side Effects: Headache, nausea, burning sensation, dizziness, flushing, vomiting, pain at the injection site, chest pain. If side effects occur, talk to your doctor or nurse
img1-scanlux-370-100ml
Scanlux® 370 100ml

Scanlux is a non-ionic iodinated X-Ray contrast medium, which is water soluble.

Ingredients: Iopamidol 755 mg/ml

Dosage Form: Injection

Packaging: 50 ml and 100 ml

Indication

Neuroradiologi : myeloradiculography, cisternography dan ventriculography.

Angiography : cerebral arteriography, coronary arteriography, thorax aortography, abdominal aortography, angiocardiography, visceral arteriography selective, peripheral arteriography, venography, digital subtraction angiography (DSA), DSA cerebral artery, DSA peripheral artery, DSA abdominal artery

Urography : intravenous urography

Contrast enhancement on CT scanning, arthrography, fistulography

Contraindications: Iopamidol is strictly contraindicated in patients with manifest hyperthyroidism or hypersensitivity to the iopamidol group.

Special warnings and cautions : Patients w/ severe hepatic or renal impairment, hepatorenal syndrome, monoclonal gammopathy.

Scanlux® 370 can only be used for appropriate clinical indications, taking into account the risk factors in the patient to be examined. Adequate hydration should be provided before and after contrast media administration; If necessary, give intravenous infusion fluids until all the contrast media has been excreted. Especially for patients with kidney dysfunction, diabetes mellitus, multiple myeloma, hyperuricemia, infants, children and elderly patients

Dosage: Individually, depending on various factors including age, weight, heart and kidney function, general state of health, clinical objectives, examination method and examination area. The total dose should not be > 1.5 g of iodine/kgBW/day for each examination

Side Effects: Headache, nausea, burning sensation, dizziness, flushing, vomiting, pain at the injection site, chest pain. If side effects occur, talk to your doctor or nurse
img1-scanlux-300-50ml
Scanlux® 300 50ml

Scanlux is a non-ionic iodinated X-Ray contrast medium, which is water soluble.

Ingredients: Iopamidol 612 mg/ml

Dosage Form: Injection

Packaging: 50 ml and 100 ml

Indication

Neuroradiologi : myeloradiculography, cisternography dan ventriculography.

Angiography : cerebral arteriography, coronary arteriography, thorax aortography, abdominal aortography, angiocardiography, visceral arteriography selective, peripheral arteriography, venography, digital subtraction angiography (DSA), DSA cerebral artery, DSA peripheral artery, DSA abdominal artery

Urography : intravenous urography

Contrast enhancement on CT scanning, arthrography, fistulography

Special warnings and cautions : Patients w/ severe hepatic or renal impairment, hepatorenal syndrome, monoclonal gammopathy.

Scanlux® 300 can only be used for appropriate clinical indications, taking into account the risk factors in the patient to be examined. Adequate hydration should be provided before and after contrast media administration; If necessary, give intravenous infusion fluids until all the contrast media has been excreted. Especially for patients with kidney dysfunction, diabetes mellitus, multiple myeloma, hyperuricemia, infants, children and elderly patients

Dosage: Individual, depending on various factors including age, weight, heart and kidney function, general state of health, clinical goals, examination method and examination area. The total dose should not be > 1.5 g of iodine/kgBW/day for each examination

Side Effects: Headache, nausea, burning sensation, dizziness, flushing, vomiting, pain at the injection site, chest pain. If side effects occur, talk to your doctor or nurse
img1-scanlux-300-100ml
Scanlux® 300 100ml

Scanlux is a non-ionic iodinated X-Ray contrast medium, which is water soluble.

Ingredients: Iopamidol 612 mg/ml

Dosage Form: Injection

Packaging: 50 ml and 100 ml

Indication

Neuroradiology: myeloradiculopathy, cisternography and ventriculography.

Angiography : cerebral arteriography, coronary arteriography, thorax aortography, abdominal aortography, angiocardiography, visceral arteriography selective, peripheral arteriography, venography, digital subtraction angiography (DSA), DSA cerebral artery, DSA peripheral artery, DSA abdominal artery

Urography : intravenous urography

Contrast enhancement on CT scanning, arthrography, fistulography

Contraindications: Iopamidol is strictly contraindicated in patients with manifest hyperthyroidism or hypersensitivity to the iopamidol group.

Special warnings and cautions : Patients w/ severe hepatic or renal impairment, hepatorenal syndrome, monoclonal gammopathy.

Scanlux® 300 can only be used for appropriate clinical indications, taking into account the risk factors in the patient to be examined. Adequate hydration should be provided before and after contrast media administration; If necessary, give intravenous infusion fluids until all the contrast media has been excreted. Especially for patients with kidney dysfunction, diabetes mellitus, multiple myeloma, hyperuricemia, infants, children and elderly patients

Dosage: Individual, depending on various factors including age, weight, heart and kidney function, general state of health, clinical goals, examination method and examination area. The total dose should not be > 1.5 g of iodine/kgBW/day for each examination

Side Effects: Headache, nausea, burning sensation, dizziness, flushing, vomiting, pain at the injection site, chest pain. If side effects occur, talk to your doctor or nurse
img1-osforce
Osforce

Helps maintain bone health and prevent osteoporosis

Is a complete supplement with a composition suitable for maintaining bone health, consisting of Calcium (Hydroxyapatite) 1000 mg, Vit D3 800 iu and Vit K2 90 mcg.

With the addition of this vitamin K2, the absorption of calcium in the bones will be maximized.

Composition:

Each Osforce sachet contains:

  • Marine Calcium 1000 mg

  • Vitamin D3 800 iu

  • Vitamin K2 (Menaquinone-7) 90 mcg

Availability/Packaging: 1 sachet @ 3 gram Box isi 15 

Advantages :

  1. Increase bone density

  2. Reducing the risk of fracture due to Osteoporosis

Suggestion for use: 1x a day 1 sachet after meals

How to use: Dissolve in 150 ml of room temperature water

Contraindications:-

Side effects: -

Storage: Store in a dry place at a temperature below 25 degrees C, protected from direct sunlight.
img1-octaplex500-iu
OCTAPLEX® 500 IU

Physiological functions of coagulation factors II, VII, IX and X, especially their effect on stopping medical bleeding due to acquired or inherited deficiency of blood coagulation factors.

Composition: OCTAPLEX® 500 IU/20 ml

    Active ingredients     

    Amount / Vial (IU)     

    Amount IU/ml     

  Human factor II  

              280-760

              14-38

  Human factor VII  

              180-480

                9-24

  Human factor IX  

                  500

                25

  Human factor X  

                360-600

              18-30

        Protein C

                260-620

              13-31

        Protein S

                240-640

              12-32

Availability: OCTAPLEX® 500 IU / 20 ml. Available in powder and solvent form.

The powder is bluish-white in color, while the solvent is clear and colorless.

Pharmacology: OCTAPLEX belongs to the group: anti-hemorrhagic (anti-bleeding), blood clotting factors II, VII, IX and X. Factor VII is a zymogen of active factor VII which is a blood coagulation factor from the extrinsic pathway. The binding of tissue factor and factor VIIa (active factor VII) will activate factors X and IX to form factors Xa and IXa so that the activation continues until factor II becomes active and turns into thrombin. Thrombin then converts fibrinogen to fibrin and a blood clot is formed.

Indication :

  1. Management of bleeding and prevention of bleeding in acquired coagulation factor deficiency, eg when rapid correction is required as in cases of deficiency caused by vitamin K antagonists or in cases of vitamin K antagonist overdose..

  2. Management of bleeding and perioperative prophylaxis in congenital deficiency of several vitamin K dependent coagulation factors (factors II and X) when pure specific coagulant factor products are not available.

Contraindications: Hypersensitivity to the active substance of the product or known allergy to heparin or heparin induced thrombocytopenia.

Dosage and How to use

The dose and duration of therapy depend on the severity, location and clinical condition of the patient. The dose interval given should pay attention to the calculation of the half-life of each clotting factor contained in OCTAPLEX

Bleeding and prevention of bleeding in the case of therapy using vitamin K antagonists, the dose will refer to the INR value before therapy and the INR target to be achieved. The following table reference can be used (ml/kg of mixed OCTAPLEX BW) to normalize the INR value (≤ 1.2 in 1 hour):

ReferenceINR

2 – 2,5

2,5 – 3

  1. – 3,5

>3,5

Dosage requirement

(ml OCTAPLEX/Kg BB)

0,9 – 1,3

1,3 – 1,6

1,6 – 1,9

>1,9

In one administration should not exceed 3,000 IU (120 ml OCTAPLEX).

Giving OCTAPLEX can be combined with vitamin K injection which will work in the next 4-6 hours to improve the INR value.

OCTAPLEX is given intravenously, with an initial rate of 1 ml/min then it can be increased to 2-3 ml/min.

Warning and Caution: If an allergic or anaphylactic type reaction occurs, the infusion should be stopped immediately and appropriate management given

Side effects:

  • Allergic or anaphylactic reactions (rare)

  • Fever (rare)

  • Headache (rare)

 

Medicine Mixing Way:

  • Warm the solvent and concentrate to room temperature before use.

  • Remove the cap on the vial of concentrate and solvent, then clean with an alcohol swab.

  • Open the plastic cover on the 2-way needle (make sure the needle does not come into contact with other objects), insert the short needle into the solvent vial (the blue cap is inserted into the solvent vial).

  • A long needle on the opposite side (transparent color cap), is inserted into the concentrate vial. The vacuum condition in the concentrate will draw the liquid into the concentrate vial.

  • Stir gently (forming a figure 8) until the concentrate is completely mixed.

  • Hold the transparent cap firmly, then rotate the blue cap so that the cap and vial containing solvent separate from the concentrate cap.

  • Insert the syringe into the transparent cap, then suck the liquid into the syringe.

  • OCTAPLEX is ready to be infused into patients using an infusion set.
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OCTANINE® F 500 IU

Composition: Human Coagulation Factor XI 500 IU

Availability: Dus, 1 vial serbuk injeksi @ 500 iu, 1 vial pelarut @ 5 ml + 1 disposable syringe + 1 double ended needle + 1 filter needle + 1 infusion set + 2 alcohol swabs

Pharmacology: Factor IX is a protein needed for blood coagulation process and maintain blood haemostasis derived from human plasma or recombinant. Working together with active factor VIII increases the conversion of factor X to activated factor X (Factor Xa). Factor Xa converts prothrombin to thrombin, converts fibrinogen to fibrin, is responsible for the process of blood clotting.

Indications: Treatment and prevention of bleeding in patients with hemophilia B (congenital factor IX deficiency)

Contraindications: Hypersensitivity to the active ingredients and/or additives in Octanine® preparations, heparin-induced thrombocytopenia (HIT Type II)

Dosage and How to use

The required dose is determined by the following formula:

Units required = body weight (Kg) x desired increase in factor IX activity (%) (IU/dl) x 0.8

For long-term prophylaxis against bleeding in patients with severe hemophilia B, the usual dose is 20 to 40 IU of factor IX per kg of body weight at intervals of 3 to 4 days.

Side Effects: The following side effects have been observed with preparations containing factor IX: Hypersensitivity or allergic reaction, rarely; severe anaphylaxis in association with formation of anti-factor IX antibodies. In rare cases, increase in body temperature, formation of inhibitors to factor IX.

Administration of low-purity factor IX preparations creates a potential risk of thromboembolic episodes (myocardial infarction, disseminated intravascular coagulation, venous thrombosis, pulmonary embolism). However, such side effects are extremely rare with highly purified factor IX preparations, such as Octanine®

There have been reports of the development of nephrotic syndrome when immune tolerance was attempted in hemophilia B patients with anti-factor IX antibodies and a history of allergic reactions. Because of the presence of heparin, heparin-induced thrombocytopenia (HIT type II) may occur although this is extremely rare, with platelet counts markedly below 100,000 per ul or rapid declines to less than 50% of baseline values.

In patients without prior heparin hypersensitivity, the onset of a decrease in the platelet count usually occurs within 6-14 days of starting treatment. In patients with heparin hypersensitivity, this decrease may occur within hours. In this case, the administration of Octanine® should be discontinued immediately. Patients should be advised not to use drugs containing heparin in the future.

Drug Interaction with other preparations: Not known

Incompatibility: Octanine® should not be mixed with other products

Storage Period and Method: 2 years. Store at 2⁰ - 25⁰ C. Do not freeze. Protect from light.
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OCTANATE®

Octanate is a medicinal preparation used for hemophilia patients. Octanine contains the active substance Antihemophilic factor VIII (human), an essential blood clotting protein

Composition: Human Coagulation Factor VIII 250 IU/500 IU/1000 IU

Availability:

Dus, 1 vial serbuk injeksi @ 250 iu / @ 500 iu + dus, 1 vial pelarut @ 5 ml + 1 disposable syringe + 1 double ended needle + 1 filter needle + 1 infusion set + 2 alcohol swabs

Dus, 1 vial serbuk injeksi @ 1000 iu + dus, 1 vial pelarut @ 10 ml + 1 disposable syringe + 1 double ended needle + 1 filter needle + 1 infusion set + 2 alcohol swabs

Pharmacology: Factor VIII is a protein needed in the process of blood coagulation and maintain blood haemostasis derived from human plasma or recombinants. It acts as a cofactor in the activation of factor IX, which increases the conversion of factor X to activated factor X (Factor Xa). Factor Xa converts prothrombin to thrombin, converts fibrinogen to fibrin, which is responsible for the process of blood clotting.

Indication: Treatment and prophylaxis of bleeding in patients with hemophilia type A (Congenital factor VIII deficiency).

Contraindications: Hypersensitivity to the active ingredient in the Octanate® preparation or to any of the excipients.

Dosage and Administration: The dose and duration of therapy depend on the severity of factor VIII deficiency on the site and extent of bleeding, and also on the patient's condition. The unit number for factor VIII given is based on the International Unit (IU) standard rules that have been set by the World Health Organization (WHO) for factor VIII products. Factor VIII activity in plasma, expressed as a percentage (relative to normal humans) or in International Units/IU (relative to international standards for factor VIII plasma products).

One International Unit (IU) of factor VIII activity is equal to the amount of factor VIII in 1 ml of normal human plasma. The calculation of the dose required for factor VIII is based on empirical findings which state that 1 IU of factor VIII per kg body weight can increase plasma factor VIII activity by 1.5% to 2% of normal.

The required dose is determined by the following formula:

Units required = body weight (Kg) x desired increase in factor VIII activity (%) (IU/dl) x 0.5 The amount and frequency of administration should always be adjusted to the clinical effectiveness of each individual patient. In case of bleeding/hemorrhagic events, factor VIII activity should not be less than the plasma activity level (in % under normal conditions) over the appropriate period.

During treatment, proper determination of factor VIII levels is recommended to guide the dose to be administered and the frequency for repeated infusions. In the case of major surgical intervention in particular, proper monitoring of substitution therapy via coagulation analysis (plasma factor VIII activity) is necessary. Individual patients may vary in their response to factor VIII, achieve different rates of recovery in vivo and exhibit different half-lives.

For long-term prophylaxis against bleeding in patients with severe hemophilia A, the usual dose is 20 to 40 IU of factor VIII per kg body weight at 2 to 3 day intervals.

Warnings and Cautions: As with intravenous protein products, allergic-type hypersensitivity reactions are possible. The product contains traces of human protein in addition to factor VIII. Patients should be informed of the early signs of a hypersensitivity reaction including hives, generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis. If these symptoms occur, they should be advised to stop using the product immediately and contact their doctor.

Side Effects: Hypersensitivity or allergic reaction (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, itching, hypotension, lethargy, nausea, restlessness, tachycardia, chest tightness, tingling, vomiting, wheezing) in some cases progress to severe anaphylaxis, including shock.

Drug Interaction with other preparations: Not known

Inkompatibilitas: OCTANATE®  should not be mixed with other products

Storage Period and Method: 2 years. Store at 2⁰C - 25⁰C. Don't freeze. Protect from light.
Albuforce Sachet

Albuforce is an Enteral Nutrition high in protein, dietary fiber, zinc, and calcium sourced from Ophiocephalus striatus (Channa striata) extract to help maintain a healthy body.

Ingredients: Skimmed Milk Powder, Fish Extract (27.27%), Whey Protein Isolate, Synthetic Flavor (vanilla, grape, cream), Vegetable Stabilizer, Anti-caking Tricalcium Phosphate, Sucralose Artificial Sweetener, Zinc Picolinate

Preparation: Sachet

Indications: Help maintain a healthy body by meeting the body's nutritional intake of Protein, Fiber, Zinc and Calcium

Contraindications: Patients with hypersensitivity to the components of the supplement therein 

Side Effects: There have never been any side effects from using this product

Storage: Store in a dry place at a temperature below 30o C, protected from direct sunlight
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ALBUNORM 20% & 25%

Composition : Human Albumin, 250 g/L (ALBUNORM 25%)

Availability : ALBUNORM 25%: botol 50 & 100 mL

Farmakologi: The physiological function of albumin is related to blood oncotic pressure and transport function. Albumin maintains the balance of circulating blood volume and transport of hormones, enzymes, drugs, and toxins

Indications: Restore and maintain circulating blood volume when fluid depletion (hypovolemia) occurs and colloids are required.

Contraindications: Hypersensitivity to albumin preparations or other additives

Dosage and Administration: The albumin concentration, dose, and infusion rate should be adjusted to the individual needs of the patient

Warnings and Cautions: If an allergic or anaphylactic reaction occurs, the infusion should be stopped immediately and appropriate treatment given. ALBUNORM should be used with caution in patients who are at risk for hypervolemia and/or hemodilution. Examples of these conditions are: decompensated cardiac insufficiency, hypertension, esophageal varices, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and post-renal anuria.

Side Effects: Headache, flushing, allergic reactions, nausea, etc.

Drug Interactions: No specific interactions of human albumin with other medicinal products are known.