Pergoveris

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktív összetevők:

follitropin alfa, lutropin alfa

Beszerezhető a:

Merck Serono S.p.A.

INN (nemzetközi neve):

follitropin alfa, lutropin alfa

Adagolás:

150IU+75IU

Gyógyszerészeti forma:

powder lyophilized for solution for s/c injection

Recept típusa:

Prescription

Termékjellemzők

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pergoveris 150 IU/75 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 150 IU (equivalent to 11 micrograms) of follitropin
alfa* (r-hFSH) and 75 IU
(equivalent to 3 micrograms) of lutropin alfa* (r-hLH).
After reconstitution, each ml of the solution contains 150 IU r-hFSH
and 75 IU r-hLH per milliliter.
_ _
* produced in genetically engineered Chinese hamster Ovary (CHO)
cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: white to off-white lyophilised pellet.
Solvent: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pergoveris is indicated for the stimulation of follicular development
in adult women with severe LH
and FSH deficiency.
In clinical trials, these patients were defined by an endogenous serum
LH level < 1.2 IU/l.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Pergoveris should be initiated under the supervision of
a physician experienced in the
treatment of fertility problems.
Posology
In LH and FSH deficient women (hypogonadotrophic hypogonadism), the
objective of Pergoveris
therapy is to develop a single mature Graafian follicle from which the
oocyte will be liberated after the
administration of human chorionic gonadotrophin (hCG). Pergoveris
should be given as a course of
daily injections. Since these patients are amenorrhoeic and have low
endogenous oestrogen secretion,
treatment can commence at any time.
Treatment should be tailored to the individual patient’s response as
assessed by measuring follicle size
by ultrasound and oestrogen response. A recommended regimen commences
with one vial of
Pergoveris daily. If less than one vial of Pergoveris daily is used,
the follicular response may be
unsatisfactory because the amount of lutropin alfa may be insufficient
(see section 5.1).
If an FSH dose increase is deemed appropriate, dose adapt