Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
Octocog alfa, Quantity: 500 IU
Takeda Pharmaceuticals Australia Pty Ltd
Octocog alfa
Diluent, not applicable
Excipient Ingredients: water for injections
Intravenous
1 vial with advate (octocog alfa (rch)) 500 IU powder and 1 vial of diluent (WFI) with a drug delivery system (Baxject II or Baxject III))
exempt from scheduling - Appendix A; prescription medicine
Advate is indicated or use in haemophilia A for prevention and control of haermorrhagic episodes. Patients with haemophilia A may be treated with Advate as perioperative management. Advate is not indicated in von Wllebrand's disease
Visual Identification: clear colourless liquid with no particulate matter; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2005-04-04
ADVATE ® _(WITH BAXJECT II)_ _Octocog alfa_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START USING ADVATE. This leaflet answers some common questions about ADVATE. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using ADVATE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may wish to read it again. Information in this leaflet is subject to change over time. Ask your doctor or visit the Health Authority website (in Australia: www.ebs.tga.gov.au; in New Zealand: www.medsafe.govt.nz) for the latest Consumer Medicine Information. WHAT IS ADVATE USED FOR ADVATE belongs to the group of medicines called blood coagulation factor VIII. It is used for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ADVATE does not contain von Willebrand factor and is therefore not suitable for use in von Willebrand's disease. ADVATE contains the active ingredient octocog alfa, which is a human recombinant coagulation factor VIII produced by recombinant DNA technology. _HOW DOES ADVATE WORK_ Under normal physiological condition, factor VIII is essential for blood clotting and maintenance of a bleeding episode. Individuals with haemophilia A disease, which is a hereditary disorder of blood coagulation have a low level of factor VIII in their blood circulation. As a result of factor VIII deficiency, the individual with this disease may have a heavy bleeding into joints, muscles or internal organs either spontaneously or as a result of accidental or surgical trauma. ADVATE is similar to and works in the same way as plasma-derived factor VIII. As such, it can be used as a replacement therapy to correct the factor VIII deficiency in patients with haemophilia A. BEFORE YOU Lire le document complet
ADVATE PI V1.0 7OCT2020 (CCDS 7.0) 1 of 21 AUSTRALIAN PRODUCT INFORMATION ADVATE ® (OCTOCOG ALFA) 1 NAME OF THE MEDICINE Octocog alfa. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ADVATE 250, 500, 1000, 1500, 2000, 3000, 4000 International Units (IU). ADVATE contains nominally 250, 500, 1000, 1500, 2000, 3000 or 4000 IU octocog alfa [recombinant coagulation factor VIII (recombinant FVIII)]. The product contains approximately 40 to 960 IU per mL octocog alfa when reconstituted with either 5 mL or 2 mL sterile water for injections. ADVATE is available in the following strengths with 5 mL diluent of water for injections: 250, 500, 1000, 1500, 2000, 3000 or 4000 IU. ADVATE is available in the following strengths with 2 mL diluent of water for injections: 250, 500, 1000, 1500 IU. Each ADVATE vial is labelled with the strength expressed in IU per vial. Octocog alfa, recombinant antihaemophilic factor VIII Plasma/Albumin-Free Method (rAHF-PFM), is produced from a genetically engineered Chinese Hamster Ovary (CHO) cell-line under conditions which are free from the use of animal derived protein. Trehalose, a disaccharide of two glucose molecules linked by an α, α, glucopyranose of glycoside bond has been used as a stabiliser in the formulation, instead of human albumin. The active ingredient, octocog alfa, has been manufactured by a method that is free from the use of animal or human derived proteins. This manufacturing process provides a low risk of transmission of blood-borne viruses derived from exogenous human and animal origins. The molecular integrity and biological activity of rAHF-PFM is indistinguishable from that of the first generation of rAHF. They differ on the culture media used during the manufacturing process and the cell lines. In the first generation of rAHF production, the cell lines are grown in a culture medium containing animal/human derived proteins, whereas in the rAHF-PFM production, the cell lines are adapted to grow without using animal/human components. The CHO cells transfected with factor VI Lire le document complet