OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU

WELLCHEM PHARMACEUTICALS PTE LTD

WELLCHEM PHARMACEUTICALS PTE LTD

Therapeutic

Prescription Only

INJECTION, POWDER, FOR SOLUTION

**4.2 Posology and method of administration** **Posology** Only general dosage guidelines are given below. Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders. The dosage and duration of the substitution therapy depend on the severity of the disorder, on the location and extent of the bleeding and on the patient’s clinical condition. The amount and the frequency of administration should be calculated on an individual patient basis. Dosage intervals must be adapted to the different circulating half-life of the different coagulation factors in the prothrombin complex (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Individual dosage requirements can only be identified on the basis of regular determinations of the individual plasma levels of the coagulation factors of interest, or on global tests of the prothrombin complex levels (prothrombin time, INR), and continuous monitoring of the clinical condition of the patient. In case of major surgical interventions precise monitoring of the substitution therapy by means of coagulation assays is essential (specific coagulation factor assays and/or global tests for prothrombin complex levels). **Bleeding and perioperative prophylaxis of bleeding during vitamin K antagonist treatment:** The dose will depend on the INR before treatment and the targeted INR. In the following table approximate doses (ml/kg body weight of the reconstituted product) required for normalisation of INR (≤ 1.2 within 1 hour) at different initial INR levels are given.  The single dose should not exceed 3.000 international units (120 ml Octaplex). The INR should be monitored after each dose. The correction of the vitamin K antagonist induced impairment of haemostasis persists for approximately 6–8 hours. However, the effects of vitamin K, if administered simultaneously, are usually achieved within 4–6 hours. Thus, repeated treatment with human prothrombin complex is not usually required when vitamin K has been administered. As these recommendations are empirical and recovery and the duration of effect may vary, monitoring of INR during treatment is mandatory. **Method of administration** Dissolve the product as described at 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Octaplex should be administered intravenously. The infusion should start at a speed of 1 ml per minute, followed by 2–3 ml per minute, using an aseptic technique.