Држава: Израел
Језик: Енглески
Извор: Ministry of Health
CHORIOGONADOTROPIN ALFA
MERCK SERONO LTD
G03GA08
SOLUTION FOR INJECTION
CHORIOGONADOTROPIN ALFA 250 MCG / 0.5 ML
S.C
Required
MERCK SERONO S.P.A., ITALY
CHORIOGONADOTROPIN ALFA
CHORIOGONADOTROPIN ALFA
- For women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilization (IVF) : Ovitrelle is administered to trigger final follicular maturation AND luteinisation AFTER stimulation of follicular growth. - Anovulatory OR oligo-ovulatory women: Ovitrelle is administered to trigger ovulation AND luteinisation in Anovulatory OR oligo-ovulatory patients AFTER stimulation of follicular growth.
2020-03-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only Ovitrelle ® 250 micrograms Solution for subcutaneous injection Pre-filled syringe Pre-filled pen The active ingredient and its quantity: Choriogonadotropin alfa 250 mcg/0.5 ml equivalent to 6500 IU Inactive ingredients — see section 6. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Keep this leaflet at hand; you may need to read it again. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. If you experience any side effects, speak to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. 1. WHAT IS THE MEDICINE INTENDED FOR Ovitrelle contains a medicine called choriogonadotropin alfa, which is produced by recombinant DNA technology. Choriogonadotropin alfa is similar to a hormone naturally found in the body called chorionic gonadotropin, which is associated with the reproductive system and fertility. Ovitrelle is used together with other medicines: • To help develop and ripen several follicles in women undergoing fertility treatment such as in vitro fertilization (IVF). Other medicines will be given first to bring about the development of several follicles. • To help release an egg from the ovary in women who do not ovulate, or women who ovulate infrequently. Other medicines will be given first to develop and ripen the follicles. Therapeutic group: Gonadotropin hormones. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • you are sensitive (allergic) to the active ingredient choriogonadotropin alfa, or to any of the ingredients of the medicine (see section 6). • you have a tumor in the hypothalamus or pituitary gland (both are parts of the brain). • y Прочитајте комплетан документ
PRESCRIBING INFORMATION OVITRELLE ® 250 MCG 1. NAME OF THE MEDICINAL PRODUCT OVITRELLE ® 250 micrograms/0.5 ml, solution for injection in a pre-filled syringe OVITRELLE ® 250 micrograms/0.5 ml, solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 250 micrograms Choriogonadotropin alfa* (equivalent to approximately 6,500 IU) in 0.5 ml solution. Each pre-filled pen contains 250 micrograms Choriogonadotropin alfa* (equivalent to approximately 6,500 IU). * recombinant human chorionic gonadotropin, r-hCG produced in Chinese hamster ovary (CHO) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. Solution for injection in pre-filled pen. Clear, colourless to slightly yellow solution. The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ovitrelle ® is indicated in the treatment of: (i)_ _ Adult Women undergoing superovulation prior to assisted reproductive technologies (ART)_ _ such as _in vitro_ fertilisation (IVF):_ _Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth, (ii) Anovulatory or oligo-ovulatory adult women:_ _Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory women after stimulation of follicular growth. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Ovitrelle should be performed under the supervision of a physician experienced in the treatment of fertility problems. Posology The maximum dose is 250 micrograms. The following dose regimen should be used: • Women undergoing superovulation prior to assisted reproductive technologies (ART) such as _in vitro_ fertilisation (IVF): One pre-filled syringe/pen of Ovitrelle (250 micrograms) is administered 24 to 48 hours after the last administration of a follicle stimulation hormone (FSH) or human menopausa Прочитајте комплетан документ