Pregnyl 5000IU powder lyophilized for solution for i/m and s/c injection

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

gonadotrophin chorionic

Предлага се от:

N.V. Organon

АТС код:

G03GA01

INN (Международно Name):

gonadotrophin chorionic

дозиране:

5000IU

Лекарствена форма:

powder lyophilized for solution for i/m and s/c injection

Броя в опаковка:

ampoule 2ml and 1ml solvent in ampoule

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2015-08-03

Данни за продукта

Translation of Dutch Summary of Product Characteristics
RA 2400 NL S3 (ref 2.0) English
PREGNYL 1500 and 5000
powder and solvent for solution for injection
20111005/Pregnyl SPC
Page 1 of 8
1. NAME OF THE MEDICINAL PRODUCT
Pregnyl
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _chorionic gonadotropin 1500_ _or
5000 International Units_ _(I.U.) in 1 ampoule._ _
_Excipients: _ carmellose sodium, mannitol,
disodium hydrogen phosphate, sodium
dihydrogen phosphate.
3. PHARMACEUTICAL FORM
Lyophilizate for solution for intramuscular and subcutaneous
injections.
White lyophilizate or lyophilized powder. The solvent: colorless,
clear solution.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
_In the female: _
• Ovulation induction in subfertility due to anovulation or impaired
follicle-ripening.
• Preparation of follicles for puncture in controlled ovarian
hyperstimulation programs (for medically
assisted reproductive techniques).
• Luteal phase support in women undergoing controlled ovarian
hyperstimulation (in medically
assisted reproductive programs) using GnRH analogs or after ovulation
induction in cases of infertility
due to anovulation in the absence of endogenous estrogenous activity
(WHO group I).
_In the male: _
• Hypogonadotropic hypogonadism
• Subfertility associated with idiopathic dysspermias.
• Delayed puberty associated with insufficient gonadotropic
pituitary function.
• Cryptorchidism, not due to anatomical obstruction.
4.2
POSOLOGY AND METHOD OF
ADMINISTRATION
_Dosage in the female: _
•
Ovulation induction associated with subfertility due to anovulation or
impaired follicle ripening
Usually, one injection of 5000-10000 I.U. Pregnyl
®
to complete treatment with an FSH preparation.
•
Preparation of follicles for puncture in controlled ovarian
hyperstimulation programs
Usually one injection of 5000 or 10000 I.U. Pregnyl® following
treatment with a FSH preparation.
•
Luteal phase support, as part of controlled ovarian
hyperstimulationprograms:
Two to three repeat