Prothrombin complex concentrate, Human


Concise Prescribing Info
Indications/Uses
Treatment and prophylaxis of haemorrhage.
Dosage/Direction for Use
Adult : IV 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).
Dosage Details
Intravenous
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).
Reconstitution
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.
Contraindications
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
MonitoringParameters
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.
Action
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.
Storage
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.
Disclaimer: This information is independently developed by MIMS based on Prothrombin complex concentrate, Human from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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