Land: Bretland
Tungumál: enska
Heimild: myHealthbox
human coagulation factor VIII, Willebrand factor (VWF:RCo)
Octapharma Limited
B02BD02
human coagulation factor VIII, Willebrand factor (VWF:RCo)
500IU, 60IU
Powder and solvent for solution for injection
intravenous route
one 100IU/ml vial
POM - Prescription Only Medicine
Octapharma Pharmazeutika Produktionsges.m.b.H
antihemorrhagics: blood coagulation factor VIII
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)
Authorised
2014-11-13
bleeding may continue. In such RARE cases, it is recommended that a specialised haemophilia centre be contacted immediately. You should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.Inhibitors may increase the risk of suffering severe allergic reactions (anaphylactic shock). If you suffer an allergic reaction, you should be tested for the presence of an inhibitor. For information on viral safety see section 2. (Take special care with Octanate LV - Information about the blood and plasma used for Octanate LV). Reporting of suspected adverse reactions If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra. gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE OCTANATE LV Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vials in the outer carton in order to protect from light. Use the reconstituted solution immediately and for single use only. Do not use this medicine if you notice cloudy or incompletely dissolved solutions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT OCTANATE LV CONTAINS The ACTIVE SUBSTANCE is the human blood coagulation factor VIII. Volume and concentrations Octanate LV ® powder vial size (IU FVIII) Solvent vial size (to be added to Octanate LV ® powder vial) (ml) Nominal concentration of reconstituted solution (IU FVIII/ml) 500 Lestu allt skjalið
octanateLV Summary of Product Characteristics Updated 18Aug2015 | Octapharma Limited 1. Name of the medicinal product Octanate LV 100 IU/ml Octanate LV 200 IU/ml Powder and solvent for solution for injection 2. Qualitative and quantitative composition Octanate LV 100 IU/ml contains nominally 500 IU human coagulation factor VIII per vial. The product contains approximately 100 IU* per ml human coagulation factor VIII when reconstituted with 5 ml of solvent. Produced from the plasma of human donors. The product contains approximately ≤ 60 IU per ml von Willebrand factor (VWF:RCo). Octanate LV 200 IU/ml contains nominally 1000 IU human coagulation factor VIII per vial. The product contains approximately 200 IU* per ml human coagulation factor VIII when reconstituted with 5 ml of solvent. Produced from the plasma of human donors. The product contains approximately ≤ 120 IU per ml von Willebrand factor (VWF:RCo). Excipient with known effect: Sodium up to 1.75 mmol (40 mg) per dose Sodium concentration after reconstitution: 250 – 350 mmol/l For the full list of excipients, see section 6.1. * The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The mean specific activity of Octanate LV is ≥ 100 IU/mg protein. 3. Pharmaceutical form Powder and solvent for solution for injection. The powder is white or pale yellow, also appearing as a friable solid. The solvent is a clear, colourless liquid. 4. Clinical particulars 4.1 Therapeutic indications Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand's disease. 4.2 Posology and method of administration Tre Lestu allt skjalið