Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Follitropin beta, Quantity: 833 IU/mL
ORGANON PHARMA PTY LTD
Injection, solution
Excipient Ingredients: sucrose; sodium citrate dihydrate; polysorbate 20; benzyl alcohol; methionine; hydrochloric acid; sodium hydroxide; water for injections
Subcutaneous
1 x cartridge
(S4) Prescription Only Medicine
In the female: Anovulatory infertility and; Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in vitro fertilisation and related procedures). In the male: For the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Visual Identification: Clear colourless aqueous solution in glass cartridge; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2022-10-28
RECAGON _follitropin beta[rch]_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RECAGON. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using RECAGON against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS INFORMATION WITH YOUR MEDICINE. YOU MAY WISH TO READ IT AGAIN. WHAT RECAGON IS USED FOR RECAGON 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. FSH is needed in women 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. RECAGON is used to treat infertility in any of the following situations: WOMEN: • RECAGON can be used to cause ovulation in women who have not responded to treatment with clomiphene citrate. • RECAGON can be used to bring about the development of multiple follicles in women undergoing assisted reproduction technologies (ART) such as in vitro fertilisation (IVF). MEN: RECAGON can be used for the production of sperm in men who are infertile due to a hormonal deficiency. RECAGON is not addictive. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU USE RECAGON _WHEN YOU MUST NOT USE IT_ DO NOT USE RECAGON IF YOU: • are allergic (hypersensitive) to follitropin beta or to any of the ingredients in RECAGON listed at the end of this leaflet • have a tumour of the ovary, breast, uterus, testis, or brain (pituitary gland or hypothalamus) • are pregnant or think you may be pregnant • have heavy or irregular vaginal bleeding where the cause is not known • suffer from p Aqra d-dokument sħiħ
Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION RECAGON TM FOLLITROPIN BETA (RCH) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Follitropin beta. [Recombinant human follicle-stimulating hormone (recFSH)] 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains either 0.480 mL equal to a net dose of 300 IU follitropin bets (rch), 0.840 mL equal to a net dose of 600 IU follitropin beta (rch) or 1.230 mL equal to a net dose of 900 IU follitropin beta (rch). Follitropin beta (rch) is produced by recombinant-DNA technology in a Chinese hamster ovary cell line transfected with the human FSH subunit genes. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IN THE FEMALE: Anovulatory infertility and; Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. _in vitro_ fertilisation and related procedures). IN THE MALE: For the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with RECAGON should be initiated under the supervision of a physician experienced in the treatment of fertility problems. DOSAGE IN THE FEMALE: ANOVULATION / DEFECTIVE FOLLICLE RIPENING AND/OR CORPUS LUTEUM INSUFFICIENCY There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. This requires ultrasound assessment of follicular development. The concurrent determination of serum oestradiol levels may also be useful. Page 2 of 13 A sequential treatment scheme is recommended starting with daily administration of 50 IU RECAGON. The starting dose is maintained for at least seven days. If there is no ovarian response, the daily dose is then gradually increased u Aqra d-dokument sħiħ