Pergoveris 150IU+75IU powder lyophilized for solution for s/c injection

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

follitropin alfa, lutropin alfa

제공처:

Merck Serono S.p.A.

ATC 코드:

G03GA30

INN (국제 이름):

follitropin alfa, lutropin alfa

복용량:

150IU+75IU

약제 형태:

powder lyophilized for solution for s/c injection

패키지 단위:

(1) glass vial and (1) solvent in vial 1ml, (3) glass vial and (3) solvent in vial 1ml, (10) glass vial and (10) solvent in vial

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2018-06-29

제품 특성 요약

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 adaptatio