Menopur

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

menotropin

Beschikbaar vanaf:

Ferring GmbH

INN (Algemene Internationale Benaming):

menotropin

Dosering:

75IU

farmaceutische vorm:

powder lyophilized for solution for injection

Prescription-type:

Prescription

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MENOPUR
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: 1 injection bottle with powder contains highly
purified menotrophin
(human menopausal gonadotrophin, HMG) corresponding to FSH 75 IU and
LH 75
IU.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Appearance of powder: white to off-white lyophilisation cake.
Appearance of solvent: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MENOPUR is indicated for the treatment of female infertility in the
following clinical
situations:
•
Anovulation [including polycystic ovarian disease (PCOD)] in women who
have been
unresponsive to treatment with clomiphene citrate.
•
Controlled ovarian hyperstimulation to induce the development of
multiple follicles
for assisted reproductive technologies (ART) [e.g.: in vitro
fertilisation/embryo
transfer (IVF/ET), gamete intra-Follopian transfer (GIFT) and
intracytoplasmic
sperm injection (ICSI)]
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
MENOPUR is intended for subcutaneous (s.c.) or intramuscular (i.m.)
injection after
reconstitution with the solvent provided. The powder should be
reconstituted immediately
prior to use. Up to 3 injection bottles of MENOPUR may be dissolved in
1 ml of the
solvent provided. The solution should not be used if it contains
particles or if it is not
clear.
DOSAGE
Dosage regimens described below are identical for subcutaneous and
intramuscular
administration.
There are great inter- and intraindividual variations in the response
of the ovaries to
exogenous gonadotrophins. This makes it impossible to set a uniform
dosage scheme.
The dosage should, therefore, be adjusted individually depending on
the ovarian
response. MENOPUR can be given alone or in combination with a
gonadotrophin-
SPC MENOPUR Germany 2008 English (Menogon HP for AM).doc
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releasing hormone (GnRH) agonist or antagonist. Recommendati