Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FOLLITROPIN ALFA
MERCK SDN. BHD.
FOLLITROPIN ALFA
1Units Units; 5Units Units; 10Units Units
Merck Serono S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 GONAL-F ® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Follitropin alfa (450 IU/0.75 ml, 75 IU/ml) WHAT IS IN THIS LEAFLET 1. What Gonal-F is used for 2. How Gonal-F works 3. Before you use Gonal-F 4. How to use Gonal-F 5. While you are using Gonal-F 6. Side effects 7. Storage and Disposal of Gonal-F 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT GONAL-F IS USED FOR Gonal-F can be used to bring about the development of follicles (each follicle contains one egg) 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 fertilization (IVF). HOW GONAL-F WORKS 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. BEFORE YOU USE GONAL-F _- When you must not use it _ Do not use Gonal-F if you have a history of allergy to any of the ingredients listed at the end of this leaflet. Do not use Gonal-F if you have tumours of the hypothalamus or pituitary gland (both are part of the brain). Do not use Gonal-F if you: • are pregnant • are breastfeeding • have enlarged ovaries • have an unexplained ovarian cyst • have unexplained vaginal or uterine bleeding • have cancer of the ovaries, uterus or breasts • ovaries have failed • have fibroids in your uterus or malformations of sexual organs which would make pregnancy impossible • have testicular insufficiency _ _ _- Before you start to use it _ Your doctor will assess you and your partner's fertility. This may include tests for other medical conditions, which may interfere with your ability to become pregnant. If necessary, other medical conditions may be treated before s সম্পূর্ণ নথি পড়ুন
page 1 Stimulation of multifollicular development in women • undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra- fallopian transfer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with GONAL-f should be initiated under the supervision of a physician experienced in the treatment of fertility disorders. Posology The dose recommendations given for GONAL-f are those in use for urinary FSH. Clinical assessment of GONAL-f indicates that its daily doses, regimens of administration, and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products. It is advised to adhere to the recommended starting doses indicated below. Comparative clinical studies have shown that on average patients require a lower cumulative dose and shorter treatment duration with GONAL-f compared with urinary FSH. Therefore, it is considered appropriate to give a lower total dose of GONAL-f than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation. See section 5.1. _Women with anovulation (including polycystic ovarian _ _syndrome)_ GONAL-f may be given as a course of daily injections. In menstruating women treatment should commence within the first 7 days of the menstrual cycle. A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response. Treatment should be tailored to the individual patient’s response as assessed by measuring follicle size by ultrasound and/or oestrogen secretion. The maximal daily dose is usually not higher than 225 IU FSH. If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should undergo further evaluation after which she may recommence treatment a সম্পূর্ণ নথি পড়ুন