IntravenousReplacement therapy in haemophilia BAdult: Dosage and duration is individualised based on preparation used, severity of factor IX deficiency, extent and location of bleeding, and patient’s clinical status. Dose may be titrated as needed based on clinical response. Suggested target factor IX concentrations: Mild to moderate haemorrhage: Increase to 20-40% of normal. More serious haemorrhage or minor surgery: Increase to 30-60% of normal. Severe haemorrhage or major surgery: Increase to 60-100% of normal. Refer to detailed product guideline.
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Refer to individual product labelling for specific details.
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Hypersensitivity to factor IX complex, history of heparin-induced thrombocytopaenia, heparin allergy (Bebulin).
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Patient with risk for thromboembolic complications [e.g. fibrinolysis, thrombosis, disseminated intravascular coagulation (DIC), undergoing or underwent surgery], risk of transmitting infectious agents (e.g. risk of variant Creutzfeldt-Jakob disease (vCJD), Creutzfeldt-Jakob disease (CJD) and parvovirus B19 infections). Hepatic impairment. Pregnancy.
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Significant: Antibody formation.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain.
General disorders and administration site conditions: Pyrexia, chills, lethargy.
Nervous system disorders: Headache, dizziness, somnolence.
Skin and subcutaneous tissue disorders: Erythema.
Vascular disorders: Flushing.
Potentially Fatal: Serious thromboembolic complications (e.g. venous thrombosis, DIC, stroke, MI, pulmonary embolism), hypersensitivity (e.g. anaphylaxis, urticaria, angioedema, dyspnoea, hypotension, tachycardia).
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Monitor factor IX plasma levels, prothrombin time, partial thromboplastin time; signs and symptoms of hypersensitivity, thromboembolic complications, development of inhibitors.
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Description: Factor IX complex is a mixture of vitamin K-dependent clotting factors II, IX, X and low, non-therapeutic levels of factor VII. It increases the plasma levels of factor IX in patients with haemophilia B (factor IX deficiency) thereby, temporarily correcting the deficiency and restoring haemostasis.
Synonym: 3-factor prothrombin complex concentrate.
Pharmacokinetics:
Excretion: Elimination half-life: Approx 19-25 hours (factor IX).
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Bebulin: Store between 2-8°C. Profilnine: Store below 25°C.
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B02BD04 - coagulation factor IX ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
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. Factor IX (Human), Factor IX Complex (Human). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 08/06/2018. Anon. Factor IX Complex (Human) [(Factors II, IX, X)]. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/06/2018. Bebulin (Baxalta Incorporated). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/06/2018. Buckingham R (ed). Factor IX. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/06/2018. Profilnine (Grifols USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/06/2018.
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