Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
FOLLITROPIN BETA
ORGANON PHARMA ISRAEL LTD., ISRAEL
G03GA06
SOLUTION FOR INJECTION
FOLLITROPIN BETA 833 IU / 1 ML
S.C
Required
ORGANON LLC, USA
FOLLITROPIN BETA
FOLLITROPIN BETA
Puregon is indicated for the treatment of female infertility in the following clinical situations: Anovulation (including polycystic ovarian disease, PCOD) in women who have beenunresponsive to treatment with clomiphene citrate. Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [ e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. In the male : Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
2014-02-28
[Organon] Proprietary PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine can be sold under doctor's prescription only PUREGON ® SOLUTION FOR INJECTION 150 IU, 300 IU, 600 IU, 900 IU Solution for Injection Each cartridge contains: Follitropin beta 150 IU/ 0.18 ml Follitropin beta 300 IU/ 0.36 ml Follitropin beta 600 IU/ 0.72 ml Follitropin beta 900 IU/ 1.08 ml For a list of inactive ingredients see section 6.1 "What PUREGON contains". Read all of this leaflet carefully before you start using this medicine. • This leaflet contains concise information about PUREGON. If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. • PUREGON is not intended for use in children. • PUREGON is not intended for pregnant women. 1. WHAT IS THE MEDICINE INTENDED FOR? 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. Therapeutic group: Gonadotrophins (sex hormones). PUREGON solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH). FSH belongs to the group of gonadotrophins (sex hormones), 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. 2. BEFORE YOU TAKE PUREGON 2.1 Do not use PUREGON if you: − are hypersensitive (allergic) to folli Przeczytaj cały dokument
[Organon] Proprietary 1. NAME OF THE MEDICINAL PRODUCT Puregon solution for injection 150 IU/0.18 mL, 300 IU/0.36 mL, 600 IU/0.72 mL or 900 IU/1.08 mL. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains a net total dose of 150 IU, 300 IU, 600 IU or 900 IU recombinant follicle-stimulating hormone (FSH) in 0.18, 0.36, 0.72 or 1.08 ml aqueous solution. The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 833 IU/mL aqueous solution. This strength corresponds to 83.3 microgram of protein / ml (specific _in vivo_ bioactivity equal to approximately 10,000 IU FSH / mg protein). Excipient(s) with known effect: This medicinal product contains 10 mg of benzyl alcohol per mL. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless solution. In cartridges, designed to be used in conjunction with a pen injector. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications _In the female: _ Puregon is indicated for the treatment of female infertility in the following clinical situations: • Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate. • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. _in vitro_ fertilisation/embryo transfer (IVF/ET), gamete intra- fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. _ _ _In the male _ • Deficient spermatogenesis due to hypogonadotrophic hypogonadism. 4.2 Posology and method of administration Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems. The first injection of Puregon should be performed under direct medical supervision. Posology _ _ _Dosage in the female _ There are great inter- and intra-individual variations in the response of the o Przeczytaj cały dokument