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
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.