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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

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):

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.