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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.


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