Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
efmoroctocog alfa, Quantity: 750 IU
Sanofi-Aventis Australia Pty Ltd
efmoroctocog alfa
Drug delivery system
Excipient Ingredients:
Intravenous
1s (vial + diluent)
exempt from scheduling - Appendix A; prescription medicine
ELOCTATE is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia A (congenital factor VIII deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis). ELOCTATE does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease.
Visual Identification: ; Container Type: Multiple containers; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2014-06-27
ELOCTATE ® 1 ELOCTATE ® _Efmoroctocog alfa (recombinant coagulation factor VIII Fc fusion protein) 250, 500, 750, 1000, 1500, _ _2000, 3000 IU/vial _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ELOCTATE. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. This leaflet was last updated on the date at the end of this leaflet. SPEAK TO YOUR DOCTOR OR YOUR HAEMOPHILIA TREATMENT CENTRE TO OBTAIN THE MOST UP TO DATE INFORMATION ON THIS MEDICINE. You can also download the most up to date leaflet from www.medicines.org.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using ELOCTATE against the benefits they expect it will have for you. If you have any concerns about using this medicine, ask your doctor. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ELOCTATE IS USED FOR ELOCTATE is used for the management of haemophilia A (congenital factor VIII deficiency). ELOCTATE is used to: control and prevent bleeding episodes routinely prevent and reduce the frequency of bleeding episodes reduce bleeding before, during, and after surgery. Eloctate does not contain von Willebrand factor and therefore is not suitable for use in Von Willebrand’s disease. People with haemophilia A lack sufficient factor VIII to control bleeding. ELOCTATE works by replacing factor VIII to enable blood to clot. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. It is available only with a doctor's prescription. DO NOT GIVE THIS MEDICINE TO ANYONE ELSE. It may harm them, even if their symptoms are the same as yours. BEFORE YOU USE ELOCTATE _WHEN YOU MUST NOT USE IT _ DO NOT USE ELOCTATE IF YOU HAVE AN ALLERGY TO: ELOCTATE or other factor VIII replacement factors any of the ingredients listed at the end of this leafl Прочитајте комплетан документ
elo-ccdsv12-piv10-03mar22 Page 1 of 32 AUSTRALIAN PRODUCT INFORMATION – ELOCTATE (EFMOROCTOCOG ALFA) (RHU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Efmoroctocog alfa 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-use vial contains nominally 250, 500, 750, 1000, 1500, 2000, or 3000 International Units (IU) of efmoroctocog alfa. Each pre-filled syringe contains 3 mL of solvent. Efmoroctocog alfa is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line, which has been extensively characterised. The HEK cell line expresses efmoroctocog alfa into a defined cell culture medium that does not contain any proteins derived from animal or human sources. The purification process utilises a series of chromatography and multiple viral clearance steps. The viral clearance steps include affinity chromatography, 15nm virus-retaining nano-filtration step, and detergent viral inactivation. No human or animal derived additives are used in the purification and formulation processes. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. ELOCTATE is formulated as a sterile, preservative-free, non-pyrogenic, lyophilised, white to off- white powder to cake, for intravenous (IV) administration in a single-use vial. The liquid diluent (sterile water for injections) is in a pre-filled syringe. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ELOCTATE is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia A (congenital factor VIII deficiency) for: • Control and prevention of bleeding episodes. elo-ccdsv12-piv10-03mar22 Page 2 of 32 • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. • Perioperative management (surgical prophylaxis). ELOCTATE does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand’s disease. 4.2 DOSE AND METHOD OF ADMINISTRATION For Intravenous Us Прочитајте комплетан документ