Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Follitropin alfa 300 [iU] (22 mcg)
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Follitropin alfa 300 IU (22 mcg)
600 IU/mL
Solution for injection
Active: Follitropin alfa 300 [iU] (22 mcg) Excipient: Dibasic sodium phosphate dihydrate Methionine Monobasic sodium phosphate dihydrate Phosphoric acid Poloxamer Sucrose Water for injection
Prescription
Polymun Scientific Immunobiologische Forschung GmbH
In adult men: Bemfola is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.
Package - Contents - Shelf Life: Cartridge, glass, in prefilled pen - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months not refrigerated stored at or below 25°C - Cartridge, glass, in prefilled pen - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months not refrigerated stored at or below 25°C - Cartridge, glass, in prefilled pen - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months not refrigerated stored at or below 25°C
2016-02-11
Consumer Medicine Information Bemfola Gedeon Richter May 2022 1 BEMFOLA® _Recombinant human follicle stimulating hormone (follitropin alfa [rch]) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bemfola. 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 Bemfola 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 BEMFOLA USED FOR Bemfola contains follitropin alfa, which is similar to follicle stimulating hormone (FSH) found naturally in humans. Bemfola 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. Bemfola is an approved biosimilar to the reference product Gonal-f®. Comparability in safety, efficacy and quality between Bemfola and Gonal-f® have been established. IN WOMEN Bemfola 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. Bemfola is also used to stimulate the development of several follicles in women undergoing assisted reproductive technologies (ART) such as _in vitro_ fertilisation (IVF). Bemfola 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 Bemfola 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 BEMFOLA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Bemfola is ava Lue koko asiakirja
New Zealand Data Sheet Bemfola, Recombinant human follicle stimulating hormone (follitropin alfa (rch)) GEDEON RICHTER BEMFOLA DS–May 2022 Page 1 of 16 DATA SHEET BEMFOLA (FOLLITROPIN ALFA (RCH)) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE BEMFOLA Solution for Injection follitropin alfa (rch) 600IU/mL (75 IU/0.125 mL) cartridge in a pre- filled pen; BEMFOLA Solution for Injection follitropin alfa (rch) 600IU/mL (150 IU/0.25 mL) cartridge in a pre- filled pen; BEMFOLA Solution for Injection follitropin alfa (rch) 600IU/mL (225 IU/0.375 mL) cartridge in a pre- flled pen; BEMFOLA Solution for Injection follitropin alfa (rch) 600IU/mL (300 IU/0.5 mL) cartridge in a pre- filled pen; BEMFOLA Solution for Injection follitropin alfa (rch) 600IU/mL (450 IU/0.75 mL) cartridge in a pre- filled pen. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ BEMFOLA 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®. The prescribing physician should be involved in any decision regarding interchangeability with other products. Additional information is available on the following website (http://www.medsafe.govt.nz/profs/RIss/Biosimilars.asp). Data comparing BEMFOLA to GONAL-f can be found in “Clinical Trials” section of this datasheet. BEMFOLA 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 BEMFOLA solution for injection are designed for subcutaneous injection pre-assembled in a disposable pen. BEMFOLA is available as solution for injection, containing follitropin alfa (rch) 600IU/mL in the following presentations: 75 IU/0.125 mL (5.5 micrograms/0.125mL), 150 IU/0.25 mL (11 micrograms/0.25mL), 225 IU/0.375 mL (16.5 micrograms/0.375mL), 300 IU/0.5 mL (22 micrograms/0.5mL) or 450 IU/0.75 mL (33 micrograms/0.75mL) in pre-filled pens. EXCIPIENT Lue koko asiakirja