PERGOVERIS PRE-FILLED PEN

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

FOLLITROPIN ALFA; LUTROPIN ALFA

Dostupné z:

MERCK SERONO LTD

ATC kód:

G03GA05

Forma lieku:

SOLUTION FOR INJECTION

Zloženie:

LUTROPIN ALFA 150 IU / 0.48 ML; FOLLITROPIN ALFA 300 IU / 0.48 ML

Spôsob podávania:

S.C

Typ predpisu:

Required

Výrobca:

MERCK EUROPE B.V., THE NETHERLANDS

Terapeutické oblasti:

FOLLITROPIN ALFA

Terapeutické indikácie:

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

Dátum Autorizácia:

2023-05-31

Príbalový leták

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
PERGOVERIS
®
Pre-filled pen
Solution for Subcutaneous Injection
Active ingredients:
Follitropin Alfa (r-hFSH)
Lutropin Alfa (r-hLH)
Provided in three volumes:
Pergoveris (300 IU* r-hFSH + 150 IU r-hLH)/0.48 mL
Pergoveris (450 IU r-hFSH + 225 IU r-hLH)/0.72 mL
Pergoveris (900 IU r-hFSH + 450 IU r-hLH)/1.44 mL
(*IU – international units)
Inactive and allergenic ingredients in the preparation – see section
6.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the doctor or
pharmacist. Keep this leaflet; you may need to read it again.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar.
The medicine is not intended for girls and adolescent girls below the
age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR
The medicine is intended for stimulation of follicles and their
maturation in the ovaries in
adult women with severe gonadotropin hormone deficiency (FSH and LH).
In clinical trials, patients were defined by levels of LH (the
luteinizing hormone) in the blood,
below 1.2 international units per liter.
Therapeutic
group:
Gonadotropin
hormones
that
are
involved
in
regulating
the
reproductive system.
The medicine contains 2 active ingredients called Follitropin Alfa and
Lutropin Alfa. Both
ingredients belong to a group of hormones called gonadotropins that
are involved in
regulation of the reproductive system.
The active ingredients in the medicine are copies of the natural
hormones, FSH and LH in
the body:
FSH, follicle stimulating hormone - stimulates maturation of eggs.
LH, luteinizing hormone - stimulates release of the eggs.
The medicine allows women with low levels of FSH and LH to develop a
follicle. The injection
of another hormone - hu

Súhrn charakteristických

1
PRESCRIBING INFORMATION
PERGOVERIS
® PRE-FILLED PEN
1.
NAME OF THE MEDICINAL PRODUCT
Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in
pre-filled pen
Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in
pre-filled pen
Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PERGOVERIS (300 IU + 150 IU)/0.48 ML:
Each multidose pre-filled pen contains 300 IU (equivalent to 22
micrograms) of follitropin alfa*
(r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa*
(r-hLH) in 0.48 mL solution.
PERGOVERIS (450 IU + 225 IU)/0.72 ML:
Each multidose pre-filled pen contains 450 IU (equivalent to 33
micrograms) of follitropin alfa*
(r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa*
(r-hLH) in 0.72 mL solution.
PERGOVERIS (900 IU + 450 IU)/1.44 ML:
Each multidose pre-filled pen contains 900 IU (equivalent to 66
micrograms) of follitropin alfa*
(r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa*
(r-hLH) in 1.44 mL solution.
*recombinant human follitropin alfa and recombinant human lutropin
alfa are produced in Chinese
hamster ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to slightly yellow solution.
The pH of the solution is 6.5 to 7.5, its osmolality is 250 to 400
mOsm/kg.
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 disorders.
Posology
In LH and FSH deficient women (hypogonadotrophic hypogonadism), the
objective of Pergoveris
therapy is to develop a single mature Graafian follicle from