Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
water for injections, Quantity: 5.4 mL
Takeda Pharmaceuticals Australia Pty Ltd
Injection, solution
Excipient Ingredients:
Intravenous
1 vial of drug powder (rurioctocog alfa pegol) and 1 vial of diluent (WFI) with 1 reconstitution system (Baxject II or Baxject III)
exempt from scheduling - Appendix A; prescription medicine
ADYNOVATE is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia A (congenital factor VIII deficiency) patients for:,? Control and prevention of bleeding episodes,? Routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? Perioperative management (surgical prophylaxis),ADYNOVATE is not indicated for the treatment of von Willebrand disease.
Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2019-01-29
ADYNOVATE _Rurioctocog alfa pegol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START USING ADYNOVATE. This leaflet answers some common questions about ADYNOVATE. 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 ADYNOVATE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may wish to read it again. WHAT IS ADYNOVATE USED FOR ADYNOVATE 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). ADYNOVATE does not contain von Willebrand factor and is therefore not suitable for use in von Willebrand's disease. ADYNOVATE contains the active substance rurioctocog alfa pegol, PEGylated human recombinant coagulation factor VIII. The human coagulation factor VIII is produced by recombinant DNA technology and has been modified chemically to prolong its duration of action. _HOW DOES ADYNOVATE_ _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. ADYNOVATE is similar to plasma- derived factor VIII. As it works in the same way, it can be used as a replacement therapy in patients with haemophilia A. BEFORE YOU ARE GIVEN ADYNOVATE _ADYNOVATE SHOULD NOT BE_ _GIVEN TO YOU IF:_ • you are allergic (hypersensitive) to mouse, hamster proteins or any other ing Lue koko asiakirja
ADYNOVATE PI V2.0 CCDS 6.0 Page 1 AUSTRALIAN PRODUCT INFORMATION ADYNOVATE ® (RURIOCTOCOG ALFA PEGOL) 1 NAME OF THE MEDICINE Rurioctocog alfa pegol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ADYNOVATE 250, 500, 750, 1000, 1500, 2000 and 3000 International Units (IU). ADYNOVATE [rurioctocog alfa pegol, Recombinant Coagulation Factor VIII (rch), PEGylated] is supplied in single-use vials containing nominal potencies of 250, 500, 750, 1000, 1500, 2000 or 3000 IU per vial with a diluent vial containing sterile water for injections for reconstitution to 2 mL or 5 mL. The 5 mL diluent of water for injections is available for ADYNOVATE 250, 500, 750, 1000, 1500, 2000 or 3000 IU. The 2 mL diluent of water for injections is available for ADYNOVATE 250, 500, 750, 1000 or 1500 IU. The amounts of the inactive ingredients are constant in all strengths. Excipient(s) with known effect Each vial of ADYNOVATE contains 0.45 mmol (10 mg) sodium, see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Powder for injection with diluent. ADYNOVATE is formulated as a sterile, non-pyrogenic, white to off-white, lyophilised powder for intravenous injection after reconstitution with water for injections. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADYNOVATE is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia A (congenital factor VIII deficiency) patients for: • Control and prevention of bleeding episodes • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes • Perioperative management (surgical prophylaxis) ADYNOVATE is not indicated for the treatment of von Willebrand disease. ADYNOVATE PI V2.0 CCDS 6.0 Page 2 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with ADYNOVATE should be under the supervision of a physician experienced in the treatment of haemophilia. TREATMENT MONITORING During the course of treatment, appropriate determination of factor VIII levels (by one-stage clotting Lue koko asiakirja