Puregon

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

follitropin beta (recombinant)

Доступна с:

Organon (Ireland) Ltd.

ИНН (Международная Имя):

follitropin beta (recombinant)

дозировка:

600IU/0,72ml

Фармацевтическая форма:

solution for s/c injection

Тип рецепта:

Prescription

Характеристики продукта

S-CCDS-MK8328-SOI-082013A
1
SUMMARY OF PRODUCT CHARACTERISTICS FOR ARMENIA
PUREGON
®
1.
NAME OF THE MEDICINAL PRODUCT
PUREGON 150 IU/0.18 mL, 300 IU/0.36 mL, 600 IU/0.72 mL or 900 IU/1.08
mL solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One cartridge contains a net total dose of 150 IU, 300 IU, 600 IU or
900 IU recombinant
follicle-stimulating hormone (FSH) activity in 0.18, 0.36, 0.72 or
1.08 mL aqueous solution.
The solution for injection contains the active substance follitropin
beta, produced by genetic
engineering of a Chinese hamster ovary (CHO) cell line, in a
concentration of 833 IU/mL
aqueous solution. This strength corresponds to 83.3 microgram of
protein/mL (specific in
vivo bioactivity equal to approximately 10 000 IU FSH/mg protein).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colorless solution.
In cartridges, designed to be used in conjunction with a pen injector.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_In the female _
Puregon is indicated for the treatment of female infertility in the
following clinical situations
•
Anovulation (including polycystic ovarian syndrome, PCOS) in women who
have been
unresponsive to treatment with clomifene citrate.
•
Controlled ovarian hyperstimulation to induce the development of
multiple follicles in
medically assisted reproduction programs [e.g. _in vitro_
fertilization/embryo transfer (IVF/ET),
gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm
injection (ICSI)].
_In the male _
S-CCDS-MK8328-SOI-082013A
2
•
Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Puregon should be initiated under the supervision of a
physician
experienced in the treatment of fertility problems.
The first injection of Puregon should be performed under direct
medical supervision.
_Posology _
When using the pen injector, it should be realized that the pen is a
precision device that
accurately delivers the