PERGOVERIS

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

FOLLITROPIN ALFA; LUTROPIN ALFA

Dostupné s:

MERCK SERONO LTD

ATC kód:

G03GA05

Léková forma:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Složení:

FOLLITROPIN ALFA 150 IU; LUTROPIN ALFA 75 IU

Podání:

S.C

Druh předpisu:

Required

Výrobce:

MERCK SERONO S.A., SWITZERLAND

Terapeutické skupiny:

FOLLITROPIN ALFA

Terapeutické oblasti:

FOLLITROPIN ALFA

Terapeutické indikace:

Pergoveris is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/l.

Datum autorizace:

2015-12-31

Charakteristika produktu

1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
P
ERGOVERIS
®
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 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
2 of 11
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 ada