Prothrombin complex concentrate, Human

Generic Medicine Info
Indications and Dosage
Treatment and prophylaxis of haemorrhage
Adult: In patients with acquired coagulation factor deficiency: ≤100 kg: 25-50 IU/kg via slow injection not more than 8 mL/min; >100 kg: Max: 2,500-5,000 IU. Dosage is individualised based on INR level prior to treatment and the target INR (refer to detailed product guideline). In patients with congenital coagulation factor deficiency: Calculate required dosage based on severity of coagulation disorder, location and extent of haemorrhage and patient’s clinical condition following specific formula (refer to detailed product guideline).
Reconstitute vial labelled as 500 IU or 1,000 IU with 20 mL or 40 mL sterile water for inj respectively, to a final concentration between 20-31 IU/mL. Gently swirl or rotate the vial to dissolve. Do not shake or agitate.
Hypersensitivity to prothrombin complex and heparin. Active thrombosis, disseminated intravascular coagulation (DIC), history of heparin-induced thrombocytopenia (HIT), and immunoglobulin A (IgA) deficiency within the past 3 months.
Special Precautions
Patient with history of thromboembolic events (e.g. CHD, CVA, MI, TIA, unstable angina pectoris, severe peripheral vascular disease); simultaneous inhibitor deficiency, high risk of virus transmission. Hepatic impairment. Neonates, children. Pregnancy and lactation.
Adverse Reactions
Significant: Anaphylactic reactions, hypotension, thromboembolic events (e.g. stroke, pulmonary embolism, DVT), increased body temperature. Rarely, anaphylaxis.
Blood and lymphatic system disorders: Anaemia.
Gastrointestinal disorders: Nausea, vomiting.
Musculoskeletal and connective tissue disorders: Chills.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Urticaria.
IV/Parenteral: C
Monitoring Parameters
Closely monitor vital signs, cardiac, and CNS status before and during the infusion. Assess prothrombin time/INR, aPTT, and clotting factor assays prior to, during, and after therapy. Watch out for signs and symptoms of thromboembolic events and excessive bleeding.
Mechanism of Action: Prothrombin concentrate complex (PCC) is a factor IX preparation from human plasma containing variable amount of factor II, VII and X. It rapidly increases the plasma levels of the vitamin K-dependent coagulation factors and temporarily correct the coagulation defect in patient with deficiency of these factors.
Onset: Significant decline in INR: Within 10 minutes.
Duration: Approx 6-8 hours.
Excretion: Elimination half-life: Factor II: 48-60 hours; factor VII: 1.5-6 hours; factor IX: 20-24 hours; factor X: 24-48 hours; protein C: 1.5-6 hours; protein S: 24-48 hours.
Store between 2-25°C. Do not freeze. Protect from light.
MIMS Class
ATC Classification
B02BD01 - coagulation factor IX, II, VII and X in combination ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Anon. Prothrombin Complex Concentrate (Human). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 14/06/2018.

Buckingham R (ed). Factor IX. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 14/06/2018.

Joint Formulary Committee. Dried Prothrombin Complex. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. Accessed 14/06/2018.

Kcentra (CSL Behring GmbH). DailyMed. Source: U.S. National Library of Medicine. Accessed 14/06/2018.

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