Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
eftrenonacog alfa, Quantity: 500 IU
Sanofi-Aventis Australia Pty Ltd
eftrenonacog alfa
Drug delivery system
Excipient Ingredients:
Intravenous
1s (vial + diluent)
exempt from scheduling - Appendix A; prescription medicine
ALPROLIX is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia B (congenital factor IX deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)
Visual Identification: ; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2014-05-01
ALPROLIX ® A l p r o l i x ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING ALPROLIX? ALPROLIX contains the active ingredient eftrenonacog alfa (recombinant coagulation factor IX fusion protein). ALPROLIX is used for the management of haemophilia B (congenital factor IX deficiency). For more information, see Section 1. Why am I using ALPROLIX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ALPROLIX? Do not use if you have ever had an allergic reaction to ALPROLIX or other factor IX replacement factors, or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, USE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use ALPROLIX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Tell your doctor or Haemophilia Treatment Centre if you are taking or using any other medicines including any that you get without a prescription from your pharmacy, supermarket, or health food shop. For more information see Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ALPROLIX? • Your doctor will decide how much ALPROLIX you use. This will depend on your individual need for replacement factor IX therapy. Your doctor may change the dose you use during your treatment. • ALPROLIX is given by slow injection directly into your veins. • ALPROLIX comes in a vial of sterile powder to cake and a pre-filled syringe containing solvent, also known as diluent. These need to be mixed before use. More instructions can be found in Section 4. How do I use ALPROLIX? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ALPROLIX? THINGS YOU SHOULD DO • Tell your doctor immediately if bleeding is not controlled after using ALPROLIX. • If you become pregnant while on treatment with ALPROLIX, immediately te Прочитайте повний документ
alp-ccdsv14-piv11-04nov21 Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION – ALPROLIX (EFTRENONACOG ALFA) (RHU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Eftrenonacog alfa 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-use vial contains nominally 250, 500, 1000, 2000, 3000 or 4000 International Units (IU) of eftrenonacog alfa. Each pre-filled syringe contains 5 mL of solvent. Eftrenonacog 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 eftrenonacog alfa into a defined cell culture medium that does not contain any proteins derived from animal or human sources. Eftrenonacog alfa is purified by a series of chromatography steps that does not require use of a monoclonal antibody. The process includes multiple viral clearance steps including 15nm virus-retaining nano-filtration. No human or animal additives are used in the cell culture, 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. ALPROLIX 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 sodium chloride solution 0.325%) is in a pre-filled syringe. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALPROLIX is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia B (congenital factor IX deficiency) for: • Control and prevention of bleeding episodes alp-ccdsv14-piv11-04nov21 Page 2 of 28 • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes • Perioperative management (surgical prophylaxis) 4.2 DOSE AND METHOD OF ADMINISTRATION For Intravenous Use Only After Reconstitution. Treatment should be initiated and supervised by qualified healthcare professionals experienced in the d Прочитайте повний документ