IntravenousTreatment and prophylaxis of haemorrhageAdult: In patients with acquired deficiency of the prothrombin complex coagulation factors (e.g. deficiency caused by treatment with vitamin K antagonists, in cases of vitamin K antagonists overdose where rapid correction of deficiency is required) or for those with congenital deficiency of any of the vitamin K dependent coagulation factors when purified specific coagulation factor products are unavailable: Dosage is individualised and adjusted according to the severity of disorder, extent and location of bleeding, patient condition, and type of preparation used. Required dose is calculated based on the regular determinations of the individual plasma levels of the coagulation factors of interest or on global test of the prothrombin complex levels (e.g. INR, Quick's test). Treatment and dosing recommendations may vary among individual products and between countries. Refer to specific product or local treatment guidelines for further information.
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Instructions for reconstitution may vary among individual products and between countries (refer to specific product guidelines).
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Hypersensitivity (e.g. anaphylaxis or severe systemic reaction) to prothrombin complex concentrate or any component of the formulation. Disseminated intravascular coagulation, history of heparin-induced thrombocytopenia; IgA deficiency with known antibodies against IgA. Contraindications may vary among individual products and between countries (refer to specific product guidelines).
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Patient with hypercoagulopathy, history of CHD or MI; at risk of thromboembolic phenomena, disseminated intravascular coagulation or simultaneous inhibitor deficiency. Hepatic impairment. Pregnancy and lactation.
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Significant: Hypersensitivity reactions (including flushing, urticaria, tachycardia, anxiety, angioedema, wheezing, nausea, vomiting, hypotension, tachypnoea, dyspnoea, pulmonary oedema, bronchospasm); disseminated intravascular coagulation; risk of transmitting infectious agents.
Gastrointestinal disorders: Abdominal pain, diarrhoea.
General disorders and administration site conditions: Asthenia.
Investigations: Increased body temperature.
Nervous system disorders: Headache, insomnia.
Potentially Fatal: Arterial thromboembolic events (e.g. acute MI, arterial thrombosis); venous thromboembolic events (e.g. pulmonary embolism, venous thrombosis).
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Obtain INR at baseline and 30 minutes after therapy. Monitor cardiac and CNS function during and after therapy; Hb, haematocrit; bleeding control. Assess for signs of thromboembolism.
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Description:
Mechanism of Action: Prothrombin complex concentrate, human is composed of the vitamin K- dependent coagulation factors II, VII, IX and X, which is known as the prothrombin complex, and the antithrombic protein C and protein S. It rapidly increases the plasma levels of the vitamin K-dependent coagulation factors, thereby temporarily correcting the coagulation defect.
Onset: Significant INR decline: Within 30 minutes.
Pharmacokinetics:
Excretion: Elimination half-life: 48-60 hours (factor II); 1.5-6 hours (factor VII); 20-24 hours (factor IX); 24-48 hours (factor X); 1.5-6 hours; 24-48 hours (protein S).
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Store between 2-25°C. Do not freeze. Protect from light. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).
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B02BD01 - coagulation factor IX, II, VII and X in combination ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
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Anon. Prothrombin Complex Concentrate (Human). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 14/02/2024. Balfaxar Powder, for Solution (Octapharma USA Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 14/02/2024. Beriplex P/N 250 IU, Powder and Solvent for Solution for Injection (CSL Behring GmbH). MHRA. https://products.mhra.gov.uk. Accessed 03/05/2023. Joint Formulary Committee. Dried Prothrombin Complex. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/05/2023. Kcentra (CSL Behring GmbH). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 14/02/2024. Octaplex 500 IU Powder and Solvent for Solution for Infusion (Octapharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 14/02/2024.
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