Orgalutran

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

ganirelix (ganirelix acetate)

Disponible depuis:

Organon (Ireland) Ltd.

DCI (Dénomination commune internationale):

ganirelix (ganirelix acetate)

Dosage:

0,25mg/0,5ml

forme pharmaceutique:

solution for s/c injection

Type d'ordonnance:

Prescription

Résumé des caractéristiques du produit

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Orgalutran 0.25 mg/0.5 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 ml
aqueous solution. The active substance
ganirelix (INN) is a synthetic decapeptide with high antagonistic
activity to the naturally occurring
gonadotrophin releasing hormone (GnRH). The amino acids at positions
1, 2, 3, 6, 8 and 10 of the
natural GnRH decapeptide have been substituted resulting in
N-Ac-D-Nal(2)
1
, D-pClPhe
2
, D-Pal(3)
3
,
D-hArg(Et2)
6
, L-hArg(Et2)
8
, D-Ala
10
]-GnRH with a molecular weight of 1570.4.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The prevention of premature luteinising hormone (LH) surges in women
undergoing controlled
ovarian hyperstimulation (COH) for assisted reproduction techniques
(ART).
In clinical studies Orgalutran was used with recombinant human
follicle stimulating hormone (FSH)
or corifollitropin alfa, the sustained follicle stimulant.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Orgalutran should only be prescribed by a specialist experienced in
the treatment of infertility.
Posology
Orgalutran is used to prevent premature LH surges in women undergoing
COH. Controlled ovarian
hyperstimulation with FSH or corifollitropin alfa may start at day 2
or 3 of menses. Orgalutran
(0.25 mg) should be injected subcutaneously once daily, starting on
day 5 or day 6 of FSH
administration or on day 5 or day 6 following the administration of
corifollitropin alfa. The starting
day of Orgalutran is depending on the ovarian response, i.e. the
number and size of growing follicles
and/or the amount of circulating oestradiol. The start of Orgalutran
may be delayed in absence of
follicular growth, although clinical experience is based on starting
Orgalutran on day 5 or day 6 of
stimulation.
Orgalutran and FSH should be ad