국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Nonacog gamma 200 IU/mL equivalent to 1000 IU/vial;
Takeda New Zealand Limited
Nonacog gamma 200 IU/mL (equivalent to 1000 IU/vial)
200 IU/mL
Powder for injection
Active: Nonacog gamma 200 IU/mL equivalent to 1000 IU/vial Excipient: Calcium chloride dihydrate Histidine Mannitol Polysorbate 80 Sodium chloride Sucrose Water for injection
General sale
Baxalta Manufacturing Sarl
· Routine prophylaxis of bleeding episodes in patients with haemophilia B · Treatment & prevention of bleeding episodes in patients with haemophilia B (congenital factor IX deficiency) · Peri-operative management in patients with haemophilia B
Package - Contents - Shelf Life: Combination pack, 1 vial active + 1 vial diluent - 1000 U - 36 months from date of manufacture stored at or below 30°C. do not freeze 3 hours reconstituted stored at or below 30°C. do not refrigerate or freeze - Vial, glass, diluent - 5 mL - - Vial, glass, active component - 1000 U -
2013-03-28
RIXUBIS 1 RIXUBIS ® _nonacog gamma (rch) (recombinant coagulation factor IX), 250, 500, 1000, 2000, 3000 IU /vial _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RIXUBIS. It does not contain all of the available information. All medicines have risks and benefits. Your doctor has weighed the risks of using your medicine against the benefit that it will have for you. It does not take the place of talking to your doctor or pharmacist. IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Please read this leaflet carefully before using your medicine as it contains information about your medicine. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT RIXUBIS IS RIXUBIS, nonacog gamma (rch) is a coagulation factor IX product that is produced by recombinant technology. Mammalian cells, which have the DNA for human coagulation factor IX put in them, are grown in large amounts in cell culture laboratories. These cells make recombinant human factor IX, which is released into cell culture media and then very highly purified. The recombinant factor IX does not contain any human blood, preservatives, or added animal or human components. WHAT RIXUBIS IS USED FOR People with haemophilia B (Christmas disease) are deficient in coagulation factor IX. RIXUBIS works by replacing factor IX to enable blood to clot. Your medicine is used to prevent and control bleeding in people with haemophilia B. Your doctor may give you RIXUBIS when you have surgery. Your medicine can reduce the number of bleeding episodes when used regularly (prophylaxis). BEFORE YOU USE RIXUBIS To make sure that your medicine is suitable for you, it is important to tell your doctor or pharmacist if any of the points below apply to you. If there is anything you do not understand, ask your doctor or pharmacist to explain. Do not use RIXUBIS if you: • are allergic to hamsters. • are allergic to any ingredients in RIXUBIS (see "What is in RIXUBIS?"). _WHAT S 전체 문서 읽기
NEW ZEALAND DATA SHEET RIXUBIS Data Sheet V0.1 CCDS22820150519 Page 1 1 RIXUBIS (50 IU/mL, 100 IU/mL, 200 IU/mL, 400 IU/mL and 600 IU/mL powder for injection) RIXUBIS is available in the following strengths: 50 IU/mL equivalent to 250 IU, 100 IU/mL equivalent to 500 IU, 200 IU/mL equivalent to 1000 IU, 400 IU/mL equivalent to 2000 IU, 600 IU/mL equivalent to 3000 IU. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Nonacog gamma (rch), Recombinant Coagulation Factor IX (rFIX). The product concentration differs for each strength, as every strength is reconstituted with the accompanying 5 mL of water for injections. The specific activity of rFIX is ≥ 200 IU factor IX per mg. Unit Formulation: after reconstitution with water for injections to 5mL RIXUBIS 250 IU 500 IU 1000 IU 2000 IU 3000 IU Active ingredient: Nonacog gamma [Recombinant Coagulation FIX (rch)] 250 IU 500 IU 1000 IU 2000 IU 3000 IU Approximate Product Concentration: (IU rFIX per mL of reconstituted solution) _ _ 50 IU/mL 100 IU/mL 200 IU/mL 400 IU/mL 600 IU/mL For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. White, lyophilised powder and diluent for solution, for intravenous administration. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications RIXUBIS is indicated for: • Routine prophylaxis of bleeding episodes in patients with haemophilia B • Treatment and prevention of bleeding episodes in patients with haemophilia B (congenital factor IX deficiency) • Peri-operative management in patients with haemophilia B. 4.2 Dose and method of administration _General _ Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. NEW ZEALAND DATA SHEET RIXUBIS Data Sheet V0.1 CCDS22820150519 Page 2 It is recommended that prescribed doses of RIXUBIS are expressed as ‘International Units’ (written in full) of factor IX. Patients and their caregivers should be adequately trained in the correct administration technique before 전체 문서 읽기