Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
Follitropin alfa, Quantity: 600 IU/mL
Merck Healthcare Pty Ltd
Follitropin alfa
Injection, solution
Excipient Ingredients: methionine; phosphoric acid; dibasic sodium phosphate dihydrate; water for injections; sucrose; poloxamer; sodium hydroxide; metacresol; monobasic sodium phosphate monohydrate
Subcutaneous
1 cartridge + 8 needles
(S4) Prescription Only Medicine
The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated. For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies. GONAL-f 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: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2003-12-01
GONAL-F ® _(follitropin alfa [rch]) solution for injection_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GONAL-f. 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 GONAL-f 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 GONAL-F USED FOR GONAL-f contains follitropin alfa, which is similar to follicle stimulating hormone (FSH) found naturally in humans. GONAL-f 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. IN WOMEN GONAL-f 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. GONAL-f is also used to stimulate the development of several follicles in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF). IN MEN GONAL-f 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 GONAL-F HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. GONAL-f is available only on a doctor's prescription. GONAL-f is not habit-forming. BEFORE YOU ARE GIVEN GONAL-F _WHEN YOU MUST NOT USE_ _GONAL-F_ DO NOT USE GONAL-F IF YOU HAVE A HISTORY OF ALLERGY TO ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT USE GONAL-F IF YOU HAVE TUMOURS OF TH Lugege kogu dokumenti
Version: A015-1219 1 Supersedes: A014-0219 AUSTRALIAN PRODUCT INFORMATION – GONAL-F ® (FOLLITROPIN ALFA (RCH)) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Follitropin alfa (rch) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION GONAL-f is produced by a Chinese Hamster Ovary cell line transfected with the human FSH subunit genes (i.e. by recombinant DNA technology). Each cartridge contains the active ingredient follitropin alfa (rch) (recombinant human follicle stimulating hormone) 300 IU/0.5 mL, 450 IU/0.75 mL or 900 IU/1.5 mL. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection in a cartridge pre-assembled in a pen. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 1. The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated. 2. For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies. 3. GONAL-f is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective. 4.2 D OSE AND METHOD OF ADMINISTRATION Treatment with GONAL-f should be initiated under the supervision of a physician experienced in the treatment of fertility disorders. GONAL-f should be administered subcutaneously. The injection site should be alternated daily to prevent lipoatrophy. Self-administration of GONAL-f should only be performed by patients who are well motivated, adequately trained and who have access to expert advice. Each GONAL- f pen is for individual patient use only. WOMEN WITH ANOVULATORY INFERTILITY (WHO GROUP II) The objective of GONAL-f therapy is to develop a single mature Graafian follicle from which the ovum will be liberated after the administration of hCG. GONAL-f may be given as a course of daily injections. In menstruating patients, treatment should commence within the first 7 days of the menstrual cycle. Treatment should be tailo Lugege kogu dokumenti