Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Factor IX 500 [iU] (50 IU/mL when reconstituted with 10 ml water for injections)
CSL Behring (NZ) Ltd
Factor IX 500 IU (50 IU/mL when reconstituted with 10 ml water for injections)
50 IU/mL
Injection with diluent
Active: Factor IX 500 [iU] (50 IU/mL when reconstituted with 10 ml water for injections) Excipient: Antithrombin III Chloride Citric acid monohydrate Heparin Phosphorus Plasma protein fraction Sodium Water for injection
Combination pack, Vial + Diluent, 50 IU
General sale
General sale
CSL Behring (Australia) Pty Ltd
MonoFIX®-VF is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia B. MonoFIX®-VF is not indicated for the treatment of factor II, VII or X deficiencies because it does not contain therapeutic levels of these coagulation factors. MonoFIX®-VF is not indicated for the treatment of haemophilia A patients with factor VIII inhibitors.
Package - Contents - Shelf Life: Combination pack, Vial + Diluent - 50 IU - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, diluent - 10 mL - 60 months from date of manufacture stored at or below 25°C - Vial, glass, lyophilised powder - 50 IU - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1998-03-06
Medsafe Logo INFORMATION FOR CONSUMERS Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search Consumer Medicine Information MonoFIX ® -VF Human coagulation factor IX, freeze-dried. What is in this leaflet This leaflet answers some common questions about MonoFIX ® -VF. It does not contain complete information about MonoFIX ® -VF. It does not take the place of talking to your doctor. If you have any concerns about using this product, please talk to your doctor. Follow your doctor's advice, even if it is different from what this leaflet says. Please read this leaflet carefully and keep it for future reference. However, the information in this leaflet is subject to change. Please check with your haemophilia treatment centre if there is any new information about this medicine that you should know since you were last treated with this medicine. What MonoFIX ® -VF is used for MonoFIX ® -VF contains purified and concentrated factor IX, a protein which is essential for normal blood clotting. MonoFIX ® -VF is used in patients with haemophilia B or Christmas disease, a bleeding disorder, in which there are reduced levels of the clotting factor. Also, it is available for use in surgery. Individuals with factor IX levels lower than normal have difficulty in forming blood clots, with these clots often taking longer to be made than normal. Sometimes the individual may bleed unexpectedly into their joints, muscles or internal organs. Ask your haemophilia treatment centre if you have any questions about why MonoFIX ® -VF has been prescribed for you. Before your doctor gives you MonoFIX ® -VF SPECIAL WARNING This product is made from human blood. When products are made from human blood and injected into This product is made from Прочитайте повний документ
NEW ZEALAND DATA SHEET MonoFIX®-VF NZ DS 5.00 Page 1 of 13 1 PRODUCT NAME MonoFIX ® -VF 500 IU powder and diluent (10 mL) for solution for injection MonoFIX ® -VF 500 IU powder and diluent (5 mL) for solution for injection MonoFIX ® -VF 1000 IU powder and diluent (10 mL) for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MonoFIX ® -VF is a sterile freeze-dried powder containing purified human coagulation factor IX. MonoFIX ® -VF is manufactured from human plasma donated by New Zealand’s voluntary and non-remunerated donors. The factor IX in MonoFIX ® -VF is purified using ion-exchange and heparin affinity chromatography to remove other vitamin K-dependent factors such as factors II, VII and X. MonoFIX ® -VF is presented in two different concentrations (strengths): 50 IU/mL and 100 IU/mL, and in three different presentations as detailed in TABLE 1 . TABLE 1: MONOFIX ® -VF PRESENTATIONS PRESENTATION 500 IU (50 IU FACTOR IX/ML) 500 IU (100 IU FACTOR IX/ML) 1000 IU (100 IU FACTOR IX/ML) ACTIVE INGREDIENT IU/VIAL (NOMINAL) Factor IX 500 500 1000 RECONSTITUTION VOLUME (ML) 10 5 10 CONCENTRATION 50 IU/ML 100 IU/ML 100 IU/ML PLASMA PROTEINS (MG/ML) ≤ 2 ≤ 4 ≤ 4 Not all registered presentations may be supplied. EXCIPIENTS WITH KNOWN EFFECT MonoFIX ® -VF contains 28 mg (1.2 mmol) sodium in each 500 IU vial and 56 mg (2.4 mmol) sodium in each 1000 IU vial. MonoFIX ® -VF contains 50–140 IU heparin in each 500 IU vial and 100–280 IU heparin in each 1000 IU vial. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and diluent for solution for injection Powder: white Diluent (Water for Injections): clear, colourless. NEW ZEALAND DATA SHEET MonoFIX®-VF NZ DS 5.00 Page 2 of 13 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MonoFIX ® -VF is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia B. MonoFIX ® -VF is not indicated for the treatment of factor II, VII or X deficiencies because it does not Прочитайте повний документ