Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Follitropin beta
Merck Sharp & Dohme Ltd
G03GA06
Follitropin beta
200unit/1ml
Solution for injection
Intramuscular; Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 06050100; GTIN: 5013257001497
PACKAGE LEAFLET: INFORMATION FOR THE USER PUREGON® 50 IU/0.5 ML_ _SOLUTION FOR INJECTION PUREGON® 75 IU/0.5 ML_ _SOLUTION FOR INJECTION PUREGON® 100 IU/0.5 ML SOLUTION FOR INJECTION PUREGON® 150 IU/0.5 ML_ _SOLUTION FOR INJECTION PUREGON® 200 IU/0.5 ML SOLUTION FOR INJECTION PUREGON® 225 IU/0.5 ML SOLUTION FOR INJECTION FOLLITROPIN BETA 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT PUREGON IS AND WHAT IT IS USED FOR Puregon solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH). FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction. In women, FSH is needed for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain the egg cells. In men, FSH is needed for the production of sperm. Puregon is used to treat infertility in any of the following situations: WOMEN In women who do not ovulate and do not respond to treatment with clomifene citrate, Puregon can be used to cause ovulation. In women undergoing assisted reproduction techniques, including _in vitro_ fertilisation (IVF) and other methods, Puregon can bring about the development of multiple follicles. MEN In men who are infertile due to lowered hormone levels, Puregon can be used for the production of sperm. 1. WHAT PUREGON IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PUREGON 3. HOW TO USE PUREGON 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PUREGON 6. CONTENTS OF TH Olvassa el a teljes dokumentumot
OBJECT 1 PUREGON 50 IU/0.5 ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 08-Jun-2016 | Merck Sharp & Dohme Limited 1. Name of the medicinal product Puregon® 50 IU/0.5 mL solution for injection Puregon® 75 IU/0.5 mL solution for injection Puregon® 100 IU/0.5 mL solution for injection Puregon® 150 IU/0.5 mL solution for injection Puregon® 200 IU/0.5 mL solution for injection Puregon® 225 IU/0.5 mL solution for injection 2. Qualitative and quantitative composition Puregon 50 IU/0.5 mL solution for injection One vial contains 50 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. This corresponds to a strength of 100 IU/mL. One vial contains 5 microgram of protein (specific _in vivo_ bioactivity equal to approximately 10,000 IU FSH / mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line. Puregon 75 IU/0.5 mL solution for injection One vial contains 75 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. This corresponds to a strength of 150 IU/mL. One vial contains 7.5 microgram of protein (specific _in vivo_ bioactivity equal to approximately 10,000 IU FSH / mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line. Puregon 100 IU/0.5 mL solution for injection One vial contains 100 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. This corresponds to a strength of 200 IU/mL. One vial contains 10 microgram of protein (specific _in vivo_ bioactivity equal to approximately 10,000 IU FSH / mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line. Puregon 150 IU/0.5 mL solution for injection One vial contains 150 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. This corres Olvassa el a teljes dokumentumot