البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
CORIFOLLITROPIN ALFA
ORGANON PHARMA ISRAEL LTD., ISRAEL
G03GA09
SOLUTION FOR INJECTION
CORIFOLLITROPIN ALFA 150 MCG / 0.5 ML
S.C
Required
ORGANON LLC, USA
CORIFOLLITROPIN ALFA
CORIFOLLITROPIN ALFA
Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.
2016-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine can be sold under doctor's prescription only ELONVA ® 100 MCG/0.5 ML SOLUTION FOR INJECTION ELONVA ® 150 MCG/0.5 ML SOLUTION FOR INJECTION Each syringe contains: Each syringe contains: Corifollitropin alfa 100 mcg/0.5 mL solution Corifollitropin alfa 150 mcg/0.5 mL solution For a list of inactive ingredients see section 6.1 "WHAT ELONVA CONTAINS". READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • This leaflet contains concise information about ELONVA. If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. 1. WHAT ELONVA IS AND WHAT IT IS USED FOR? 1.1 WHAT IS ELONVA? THERAPEUTIC GROUP: ELONVA contains the active ingredient corifollitropin alfa and belongs to the group of medicines called gonadotropic hormones. Gonadotropic hormones play an important role in human fertility and reproduction. One of these gonadotropic hormones is Follicle-Stimulating Hormone (FSH), which is needed in women for the growth and development of follicles (small round sacs in your ovaries that contain the eggs). 1.2 WHAT IS ELONVA USED FOR? ELONVA causes the growth and development of several follicles at the same time by a controlled stimulation of the ovaries in women having infertility treatment. ELONVA is used to help achieve pregnancy in women having infertility treatment, such as _in vitro _fertilisation (IVF). IVF involves collecting the eggs from the ovary, fertilising them in the laboratory, and transferring the embryos into the uterus a few days later. 2. BEFORE YOU USE ELONVA 2.1 DO NOT USE ELONVA IF YOU: _-_ _ _ are allergic (hypersensitive) to corifollitropin alfa or any of the other ingredients of this medicine (listed in section 6) _-_ _ _ have cancer of the ovary, breast, uterus, or brain (pituitary gland or hypothalamus) _-_ _ _ hav اقرأ الوثيقة كاملة
1 1. NAME OF THE MEDICINAL PRODUCT ELONVA ® 100 MCG /0.5 ML ELONVA ® 150 MCG /0.5 ML 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 100 or 150 micrograms of corifollitropin alfa* in 0.5 mL solution for injection. *corifollitropin alfa is a glycoprotein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Excipient(s) with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say, essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear and colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Elonva is indicated for Controlled Ovarian Stimulation (COS) in combination with a Gonadotropin Releasing Hormone (GnRH) antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Elonva should be initiated under the supervision of a physician experienced in the treatment of fertility problems. _Posology _ In the treatment of women of reproductive age, the dose of Elonva is based on weight and age. _-_ _ _ A single 100-microgram dose is recommended in women who weigh less than or equal to 60 kilograms and who are 36 years of age or younger. _-_ _ _ A single 150-microgram dose is recommended in women: - who weigh more than 60 kilograms, regardless of age. - who weigh 50 kilograms or more and who are older than 36 years of age. Women older than 36 years of age who weighed less than 50 kilograms were not studied. 2 Body Weight Less than 50 kg 50 – 60 kg More than 60 kg Age 36 years or younger 100 micrograms 100 micrograms 150 micrograms Older than 36 years Not studied. 150 micrograms 150 micrograms The recommended doses of Elonva have only been established in a treatment cycle with a GnRH antagonist that was administered from stimulation day 5 or day 6 onwards (see also sections 4.1 اقرأ الوثيقة كاملة