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OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU [SIN14933P]
Active ingredients: OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU
Last updated 26 October 2025
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Product Info
OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU
[SIN14933P]
Product information
Active Ingredient and Strength | FACTOR II - 280 - 760 INTERNATIONAL UNITS/VIAL |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Manufacturer and Country | OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M.B.H.(POWDER) - AUSTRIA |
Registration Number | SIN14933P |
Licence Holder | WELLCHEM PHARMACEUTICALS PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | B02BD01 |
4.1 Therapeutic indications
Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.
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.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Known allergy to heparin or history of heparin induced thrombocytopenia.
Individuals who have IgA deficiency with known antibodies against IgA.