Elonva

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

corifollitropin alfa

Доступна с:

Organon (Ireland) Ltd.

ИНН (Международная Имя):

corifollitropin alfa

дозировка:

150mcg/0,5ml

Фармацевтическая форма:

solution for injection

Тип рецепта:

Prescription

Характеристики продукта

14
1.
NAME OF THE MEDICINAL PRODUCT
Elonva 150 micrograms solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 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 (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 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.
15
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, 4.4,
and 5.1).
Stimulat