IntravenousTreatment and prophylaxis of haemorrhageAdult: 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.
|
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.
|
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.
|
|
|
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.
|
Description: 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.
Pharmacokinetics:
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.
|
|
|
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. https://online.lexi.com. Accessed 14/06/2018. Buckingham R (ed). Factor IX. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/06/2018. Joint Formulary Committee. Dried Prothrombin Complex. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/06/2018. Kcentra (CSL Behring GmbH). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 14/06/2018.
|
Sign Out
