Orgalutran solution for s/c injection

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

ganirelix (ganirelix acetate)

Διαθέσιμο από:

N.V. Organon

Φαρμακολογική κατηγορία (ATC):

H01CC01

INN (Διεθνής Όνομα):

ganirelix (ganirelix acetate)

Δοσολογία:

0,25mg/0,5ml

Φαρμακοτεχνική μορφή:

solution for s/c injection

Μονάδες σε πακέτο:

(5) pre-filled syringes 0,5ml

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2021-05-21

Αρχείο Π.Χ.Π.

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:
Active ingredient: ganirelix acetate 0.25 mg in 0.5 ml aqueous
solution.
Excipients: mannitol, glacial acetic acid 99%, sodium hydroxide and/or
glacial acetic acid, water for
injections.
Excipient with known effect:
This medicinal product contains less than 1 mmol sodium (23 mg) per
injection, i.e. essentially
‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colorless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The prevention of premature luteinizing hormone (LH) surges in women
undergoing controlled ovarian
hypestimulation (COH) for assisted reproduction techniques (ART).
In clinical trials Orgalutran was used with recombinant 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 patients
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 in general on
day 5 or day 6 of FSH administration or on
day 5 or day 6 following the administration of corifollitropin alfa.
In high responders an early LH rise may be
prevented by starting Orgalutran treatment on day 5. The start of
Orgalutran may be delayed in absence of
follicular growth.
Orgalutran and FSH should be administered approximately at the same
time. However, the preparations should
not be mixed and different injection sites are to be used.
FSH dose adjustments should be based on the number and size of growing
follicles, rather than on the amount
of circulating oestradiol. (see S