Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Follitropin alfa, Quantity: 225 IU
Gedeon Richter Australia Pty Ltd
Follitropin alfa
Injection, solution
Excipient Ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; Trypsin
Subcutaneous
10, 5, 1
(S4) Prescription Only Medicine
In adult women:,- Afolia is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated,- Controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies,- Afolia in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/L.,In adult men:,- Afolia is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.
Visual Identification: Clear colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-11-27
Consumer Medicine Information Afolia Gedeon Richter November 2022 1 AFOLIA® _Recombinant human follicle stimulating hormone (follitropin alfa [rch]) _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Afolia. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Afolia against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS INFORMATION WITH YOUR MEDICINE. You may need to read it again later. WHAT IS AFOLIA USED FOR Afolia contains follitropin alfa, which is similar to follicle stimulating hormone (FSH) found naturally in humans. Afolia belongs to a class of hormones called gonadotrophins. FSH is necessary for the growth and development of egg cells (follicles) in women, and sperm production in men. Afolia is an approved biosimilar to the reference product Gonal-f®. Comparability in safety, efficacy and quality between Afolia and Gonal-f® have been established. IN WOMEN Afolia can be used to bring about the development of follicles in women who are not ovulating and who have not responded to treatment with clomiphene citrate. Afolia is also used to stimulate the development of several follicles in women undergoing assisted reproductive technologies (ART) such as _in _ _vitro _fertilisation (IVF). Afolia can be used together with another hormone called Luteinising Hormone (LH) to stimulate development of follicles in women who have been shown to produce very low levels of some of the hormones involved in the natural reproductive cycle. IN MEN Afolia is used in combination with human chorionic gonadotrophin (hCG) to stimulate the production of sperm. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AFOLIA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Afolia is availa Læs hele dokumentet
GEDEON RICHTER AUSTR 262645, AUSTR 262646, AUSTR 262647, AUSTR 262648, AUSTR 262649 Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION AFOLIA (FOLLITROPIN ALFA (RCH)) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE follitropin alfa, (rch) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AFOLIA is a biosimilar medicinal product, i.e. a medicine that has been demonstrated to be similar in quality, safety and efficacy to the reference medicinal product GONAL-f®. AFOLIA contains the active ingredient follitropin alfa (rch). This is produced by a Chinese Hamster Ovary cell line transfected with the human FSH subunit genes (i.e. by recombinant DNA technology). Clear glass cartridges containing AFOLIA solution for injection are designed for subcutaneous injection pre-assembled in a disposable pen. AFOLIA is available as solution for injection, containing follitropin alfa (rch) 75 IU/0.125 mL (5.5 micrograms/0.125 mL), 150 IU/0.25 mL (11 micrograms/0.25 mL), 225 IU/0.375 mL (16.5 micrograms/0.375 mL), 300 IU/0.5 mL (22 micrograms/0.5 mL) or 450 IU/0.75 mL (33 micrograms/0.75 mL) in pre-filled pens. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM AFOLIA is a clear, colourless solution for injection for subcutaneous injection pre-assembled in a disposable pen. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adult women: • AFOLIA is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated. • Controlled ovarian hyperstimulation in women undergoing assisted reproductive Technologies • AFOLIA in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/l. In adult men: • AFOLIA is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonado Læs hele dokumentet