Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Efmoroctocog alfa 250 [iU];
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Efmoroctocog alfa 250 IU
250 IU
Powder for infusion
Active: Efmoroctocog alfa 250 [iU] Excipient: Calcium chloride dihydrate Histidine Polysorbate 20 Sodium chloride Sucrose Water for injection
General sale
Biogen Inc
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.
Package - Contents - Shelf Life: Combination pack, 1 vial + 1 syringe + 1 vial adapter, with or without ancillary pack - 250 IU - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours reconstituted stored at or below 30°C protect from light 6 months from date of manufacture stored at or below 30°C protect from light. single period, no return to refrigeration - Syringe, glass, diluent - 3 mL - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months from date of manufacture stored at or below 30°C - Vial, glass, active component - 250 IU - 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. single period, no return to refrigeration
2014-12-12
ELOCTATE® 1 ELOCTATE ® 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 ELOCTATE? ELOCTATE contains the active ingredient efmoroctocog alfa. Efmoroctocog alfa is a factor VIII protein necessary for forming clots in the blood and helps to control or prevent bleeding. ELOCTATE is used for the management of haemophilia A (congenital factor VIII deficiency). For more information, see Section 1. Why am I using ELOCTATE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ELOCTATE? Do not use if you have ever had an allergic reaction to ELOCTATE, efmoroctocog alfa or other factor VIII 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, TAKE 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 ELOCTATE? in the full CMI. 3. WHAT IF I AM TAKING OR USING 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 or using other medicines? in the full CMI. 4. HOW DO I USE ELOCTATE? • Your doctor will decide what dose you will receive. Do not use more than the recommended dose. • ELOCTATE is administered by slow injection directly into your vein. • ELOCATE comes in a vial of sterile powder to cake and a pre-filled syringe containing solvent. These need to be mixed before use. MORE INSTRUCTIONS AND HOW TO USE ELOCTATE CAN BE FOUND IN SECTION 4. How do I use ELOCTATE? IN THE FULL CMI. 5. WHAT SHOULD I KNOW WHILE USING ELOCTATE? THINGS YOU SHOULD DO • Tell your doctor immediately if bleeding is not controlled after using ELOCTATE. • Tell your doctor immediately if you become pregna Прочитать полный документ
ELOCTATE New Zealand Data Sheet eloctate-ccdsv12-dsv9-30oct23 Page 1 of 35 NEW ZEALAND DATA SHEET 1 ELOCTATE (POWDER FOR INFUSION) Eloctate 250 International Units (IU) powder for infusion Eloctate 500 IU powder for infusion Eloctate 1000 IU powder for infusion Eloctate 2000 IU powder for infusion Eloctate 3000 IU powder for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-use vial contains nominally 250, 500, 1000, 2000, or 3000 International Units (IU) of efmoroctocog alfa (rhu). 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 for infusion. ELOCTATE is formulated as a sterile, non-pyrogenic, preservative-free, lyophilised, white to off-white powder to cake for intravenous (IV) administration in a single-use vial. The liquid diluent, sterilised water for injections (sWFI) 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. • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ELOCTATE New Zealand Data Sheet eloctate-ccdsv12-dsv9-30oct23 Page 2 of 35 • Perioperative management (surgical prophylaxis). ELOCTATE does not contain von Прочитать полный документ