Pergoveris

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

follitropin alfa, lutropin alfa

MAH:

Merck Europe B.V. 

ATC_code:

G03GA30

INN:

follitropin alfa, lutropin alfa

therapeutic_group:

Sex hormones and modulators of the genital system,

therapeutic_area:

Infertility, Female

therapeutic_indication:

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

leaflet_short:

Revision: 15

authorization_status:

Authorised

authorization_date:

2007-06-25

PIL

60
B. PACKAGE LEAFLET
61
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERGOVERIS 150
IU/75
IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
follitropin alfa/lutropin alfa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pergoveris is and what it is used for
2.
What you need to know before you use Pergoveris
3.
How to use Pergoveris
4.
Possible side effects
5.
How to store Pergoveris
6.
Contents of the pack and other information
1.
WHAT PERGOVERIS IS AND WHAT IT IS USED FOR
WHAT PERGOVERIS IS
Pergoveris contains two different active substances called
“follitropin alfa” and “lutropin alfa”. Both
belong to the family of hormones called “gonadotropins”, which are
involved in reproduction and
fertility.
WHAT PERGOVERIS IS USED FOR
This medicine is used to stimulate the development of follicles (each
containing an egg) in your
ovaries. This is to help you get pregnant. It is for use in adult
women (18 years old or above) who have
low levels (severe deficiency) of “follicle stimulating hormone”
(FSH) and “luteinising hormone”
(LH). These women are usually infertile.
HOW PERGOVERIS WORKS
The active substances in Pergoveris are copies of the natural hormones
FSH and LH. In your body:
•
FSH stimulates the production of eggs
•
LH stimulates the release of the eggs.
By replacing the missing hormones, Pergoveris allows women with low
levels of FSH and LH to
develop a follicle. This will then release an egg, after an injection
of the hormone “human chorionic
gonadotropin (hC

SPC

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.
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, the objective of Pergoveris therapy is
to promote follicular
development followed by final maturation after the administration of
human chorionic gonadotropin
(hCG). Pergoveris should be given as a course of daily injections. If
the patient is amenorrhoeic and
has low endogenous oestrogen secretion, treatment can commence at any
time.
A recommended regimen commences with one vial of Pergoveris daily. If
less than one vial daily is
used, the follicular response may be unsatisfactory because the amount
of lutropin alfa may be
insufficient (see section 5.1).
Treatment should be tailored to the individual patient’s response as
assessed by measuring follicle size
by ultrasound and oestrogen response.
If an FSH dose increase is deemed appropriate, dose adaptation should
preferably be after 7 to 14 day
intervals and preferably by 37.5 to 75 IU increments using a licensed
follitropin alfa preparation. It
may be acceptable to