国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
epoetin theta
Teva GmbH
B03XA01
epoetin theta
Other antianemic preparations
Kidney Failure, Chronic; Anemia; Cancer
Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Revision: 15
Authorised
2009-10-23
54 B. PACKAGE LEAFLET 55 PACKAGE LEAFLET: INFORMATION FOR THE USER BIOPOIN 1,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE BIOPOIN 2,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE BIOPOIN 3,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE BIOPOIN 4,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE BIOPOIN 5,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE BIOPOIN 10,000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE BIOPOIN 20,000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE BIOPOIN 30,000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE epoetin theta READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Biopoin is and what it is used for 2. What you need to know before you use Biopoin 3. How to use Biopoin 4. Possible side effects 5. How to store Biopoin 6. Contents of the pack and other information 7. Information for injecting yourself 1. WHAT BIOPOIN IS AND WHAT IT IS USED FOR WHAT BIOPOIN IS Biopoin contains the active substance epoetin theta, which is almost identical to erythropoietin, a natural hormone produced by your body. Epoetin theta is a protein produced by biotechnology. It works in exactly the same way as erythropoietin. Erythropoietin is produced in your kidneys and stimulates your bone marrow to produce red blood cells. Red blood cells are very important for distributing oxygen within your body. WHAT BIOPOIN IS USED FOR Biopoin is used for the treatment of anaemia accompanied by symptoms (for example 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 1,000 international units (IU) (8.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 IU (16.7 µg) epoetin theta per ml. Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 2,000 international units (IU) (16.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 µg) epoetin theta per ml. Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 3,000 international units (IU) (25 µg) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 µg) epoetin theta per ml. Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 4,000 international units (IU) (33.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 IU (66.7 µg) epoetin theta per ml. Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 5,000 international units (IU) (41.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml. Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 10,000 international units (IU) (8 完全なドキュメントを読む