Pergoveris 150IU75IU powder and solvent for solution for injection

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Follitropin Alfa; LUTROPIN ALFA

Boleh didapati daripada:

MERCK SDN. BHD.

INN (Nama Antarabangsa):

Follitropin Alfa; LUTROPIN ALFA

Unit dalam pakej:

10Units Units; 1Units Units

Dikeluarkan oleh:

Merck Serono S.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
PERGOVERIS POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
Follitropin alfa and Lutropin alfa (150IU, 75IU)
WHAT IS IN THIS LEAFLET
1.
What Pergoveris Powder and
Solvent for Solution for Injection
is used for
2.
How Pergoveris Powder and
Solvent for Solution for Injection
works
3.
Before you use Pergoveris
Powder and Solvent for Solution
for Injection
4.
How to use Pergoveris Powder
and Solvent for Solution for
Injection
5.
While you are using Pergoveris
Powder and Solvent for Solution
for Injection
6.
Side effects
7.
Storage and Disposal of
Pergoveris
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT PERGOVERIS IS USED FOR
This medicine is used to stimulate the
development of follicles (each
containing an egg) in your ovaries 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
(hCG)”. This helps the women to
become pregnant.
BEFORE YOU USE PERGOVERIS
-
_When you must not use it _
•
If you are allergic to follicle
stimulating hormone (FSH),
luteinising hormone (LH) or any of
the other ingredients of this
medicine
•
If you have a brain tumour (in your
hypothalamus or pituitary gland)
•
If you have large ovaries or sacs of
fluid within your ovaries (ovarian
cysts) of unknown origin
•
If you have unexplained vaginal
bleeding
•
If you have cancer in your ovaries,
womb or breasts
•
If you have a condition th

Ciri produk

NAME OF THE MEDICINAL PRODUCT
Pergoveris 150 IU/75 IU powder and solvent for solution for injection
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).
The reconstituted solution contains 150 IU r-hFSH and 75 IU r-hLH per
milliliter. Follitropin alfa and
lutropin alfa are produced in genetically engineered Chinese Hamster
Ovary (CHO) cells.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: white to off-white lyophilised pellet.
Solvent: clear colourless solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Pergoveris is indicated for the stimulation of follicular development
in adult women with severe LH and
FSH deficiency.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Pergoveris should be initiated under the supervision of
a physician experienced in the
treatment of fertility disorders.
Pergoveris is intended for subcutaneous administration. The powder
should be reconstituted immediately
prior to use with the solvent provided.
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 on pharmacodynamic properties).
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