Pergoveris solution for injection in pre-filled pen

국가: 말레이시아

언어: 영어

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

유효 성분:

Follitropin Alfa; LUTROPIN ALFA

제공처:

MERCK SDN. BHD.

INN (International Name):

Follitropin Alfa; LUTROPIN ALFA

패키지 단위:

0.48 ml; 0.72 ml; 1.44 ml

Manufactured by:

Merck Serono S.p.A.

환자 정보 전단

_Consumer Medication Information Leaflet (RiMUP) _
1
PERGOVERIS
® SOLUTION FOR INJECTION IN
PRE-FILLED PEN
Follitropin alfa and Lutropin alfa (45.5mcg/13.75mcg/ml)
WHAT IS IN THIS LEAFLET
1.
What Pergoveris is used for
2.
How Pergoveris works
3.
Before you use Pergoveris
4.
How to use Pergoveris
5.
While you are using Pergoveris
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. 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
(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 that would
make a normal pregnancy
impossible, such as an early
menopause, malformed sex organs
or benign tumours of the womb
Do not use this medicine if any of the
above apply to you. If you are not
sure, talk to you

제품 특성 요약

1.
NAME OF THE MEDICINAL PRODUCT
Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
*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 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to slightly yellow solution.
The pH of the solution is 6.5 – 7.5, its osmolality is 250 – 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.
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.
Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in
pre-filled pen
Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in
pre-filled pen
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.
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.
A treatment regimen commence