Pergoveris 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 vials and (3) solvent in vials 1ml, (10) glass vials and (10) solvent in vials 1ml

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2023-04-21

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
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 adaptation should
p