Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
corifollitropin alfa
N.V. Organon
G03GA09
corifollitropin alfa
100mcg/0,5ml
solution for injection
(1) pre-filled syringe 0,5ml and needle
Prescription
Registered
2021-10-08
1 1. NAME OF THE MEDICINAL PRODUCT ELONVA ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 100 or 150 micrograms of corifollitropin alfa in a 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 (23 mg) sodium per injection, i.e., essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for subcutaneous injection. Сlear aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 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 “Therapeutic indications”, “Precautions for use” and “Pharmacodynamic properties”) Прочитать полный документ