Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Eftrenonacog alfa 500 [iU];
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Eftrenonacog alfa 500 IU
500 IU
Powder for infusion
Active: Eftrenonacog alfa 500 [iU] Excipient: Histidine Mannitol Polysorbate 20 Sucrose Sodium chloride Water for injection
General sale
Biogen Inc
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)
Package - Contents - Shelf Life: Combination pack, vial + syringe + plunger rod + vial adaptor, with or without ancillary pack (infusion set etc) - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 months from date of manufacture stored at or below 30°C protect from light 6 hours reconstituted stored at or below 30°C - Syringe, glass, Diluent - 1 dose units - - Vial, glass, single dose, Active, Type 1 glass with teflon coated butyl rubber stopper - 1 dose units -
2014-11-10
ALPROLIX® 1 ALPROLIX® 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 tell your Lugege kogu dokumenti
alp-ccdsv14-dsv9-20jun22 Page 1 of 31 NEW ZEALAND DATA SHEET 1 ALPROLIX (POWDER FOR INFUSION) ALPROLIX 250 International Units (IU), Powder for infusion ALPROLIX 500 IU, Powder for infusion ALPROLIX 1000 IU, Powder for infusion ALPROLIX, 2000 IU, Powder for infusion ALPROLIX, 3000 IU, Powder for infusion ALPROLIX, 4000 IU, Powder for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Alprolix 250 IU: Each single-use vial contains nominally 250 IU of eftrenonacog alfa (rhu). After reconstitution, each mL of solution for injection contains 50 IU of eftrenonacog alfa (rhu 1 ). Alprolix 500 IU: Each single-use vial contains nominally 500 IU of eftrenonacog alfa (rhu). After reconstitution, each mL of solution for injection contains 100 IU of eftrenonacog alfa (rhu 1 ). Alprolix 1000 IU: Each single-use vial contains nominally 1000 IU of eftrenonacog alfa (rhu). After reconstitution, each mL of solution for injection contains 200 IU of eftrenonacog alfa (rhu 1 ). Alprolix 2000 IU: Each single-use vial contains nominally 2000 IU of eftrenonacog alfa (rhu). After reconstitution, each mL of solution for injection contains 400 IU of eftrenonacog alfa (rhu 1 ). Alprolix 3000 IU: Each single-use vial contains nominally 3000 IU of eftrenonacog alfa (rhu). After reconstitution, each mL of solution for injection contains 600 IU of eftrenonacog alfa (rhu 1 ). Alprolix 4000 IU: Each single-use vial contains nominally 4000 IU of eftrenonacog alfa (rhu). After reconstitution, each mL of solution for injection contains 800 IU of eftrenonacog alfa (rhu 1 ). For the full list of excipients, see _Section 6.1 LIST OF EXCIPIENTS_. 3 PHARMACEUTICAL FORM Powder for infusion 1 rhu: Produced in human embryonic kidney (HEK) 293H cells by recombinant DNA technology. alp-ccdsv14-dsv9-20jun22 Page 2 of 31 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 is in a pre-filled syringe. 4 CLINICAL PARTICU Lugege kogu dokumenti