देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
Factor IX, Quantity: 1000 IU
CSL Behring Australia Pty Ltd
Factor IX
Injection, powder for
Excipient Ingredients: phosphate; Plasma proteins; Antithrombin III; heparin sodium; sodium; citrate; chloride
Intravenous
Glass vial containing 1000 IU factor IX supplied with 1 x 10 mL diluent vial
Not scheduled. Not considered by committee
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 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.
Visual Identification: A white powder plug or friable solid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2005-05-31
MonoFIX-VF AU CMI 3.00 Page 1 of 6 MONOFIX ® -VF_ _ Human coagulation factor IX. CONSUMER MEDICINE INFORMATION 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 MEDICINE, 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. 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. 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 YOU ARE GIVEN MONOFIX ® -VF TELL YOUR DOCTOR IF YOU: • have allergies to any medicines • are taking or using any other medicines. These include medicines bought from pharmacies, supermarkets and health food stores. • have any other medical conditions • are pregnant or breast-feeding • become pregnant during your treatment. If you want further information, consult your doctor or haemophilia treatment centre. ABOUT BLOOD PRODUCTS MonoFIX ® -VF is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. W पूरा दस्तावेज़ पढ़ें
MonoFIX-VF AU PI 4.00 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION MONOFIX ® -VF (HUMAN COAGULATION FACTOR IX) 1 NAME OF THE MEDICINE Human coagulation factor IX. 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 collected by Australian Red Cross Lifeblood. 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 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 (FACTOR IX) 50 IU/ML 100 IU/ML 100 IU/ML Not all registered presentations may be supplied. For the full list of excipients, see section 6.1: List of excipients. 3 PHARMACEUTICAL FORM Powder and diluent for solution for injection Powder: white Diluent (Water for Injections): clear, colourless MonoFIX-VF AU PI 4.00 Page 2 of 13 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 contain therapeutic levels of these coagulation factors. MonoFIX ® -VF is not indicated for the treatment of haemophilia A patients with factor VIII inhibitors. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The dosage recommendations in TABLE 2 are a general guideline for therapy. The exact loading and maintenance doses and dosing intervals should be based on the patient ’ s clinical condition and response to therapy. Laboratory tests should be performed to पूरा दस्तावेज़ पढ़ें