OVIDREL 250MCG0.5ML SOLUTION FOR INJECTION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Choriogonadotropin Alfa

Boleh didapati daripada:

MERCK SDN. BHD.

INN (Nama Antarabangsa):

Choriogonadotropin Alfa

Unit dalam pakej:

0.5ml1 mL

Dikeluarkan oleh:

Merck Serono S.p.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
OVIDREL
® SOLUTION FOR INJECTION
Choriogonadotropin alfa (250mcg/0.5ml)
WHAT IS IN THIS LEAFLET
1.
What Ovidrel is used for
2.
How Ovidrel works
3.
Before you use Ovidrel
4.
How to use Ovidrel
5.
While you are using Ovidrel
6.
Side effects
7.
Storage and Disposal of Ovidrel
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT OVIDREL IS USED FOR
Ovidrel is used in women undergoing
assisted reproductive techniques such
as in vitro fertilization (IVF). Other
medicines are given first to bring
about the growth and development of
several follicles to produce eggs.
Follicles are the structures in your
ovaries that contain the egg.
Ovidrel is then used to ripen (mature)
these follicles. Ovidrel is also used in
women who do not produce eggs
(anovulation), or who produce too few
eggs (oligoovulation). It is used to
trigger the release of eggs (ovulation),
after other medicines have been used
to develop the follicles.
Your doctor may prescribe Ovidrel for
another reason. Ask your doctor if you
have any questions about why Ovidrel
has been prescribed for you. Ovidrel is
not addictive. This medicine is
available only with a doctor's
prescription.
HOW OVIDREL WORKS
Ovidrel belongs to a family of
hormones known as gonadotrophins,
which are involved in the normal
control of reproduction.
The active substance of Ovidrel is
choriogonadotropin alfa that is
produced in mammalian cells
modified by recombinant DNA
technology.
BEFORE YOU USE OVIDREL_ _
_- When you must not use it _
Do not use Ovidrel if:
• you have a history of allergy to
choriogonadotropin alfa, or a
similar medicine, or any other
inactive ingredients (listed at the
end of this leaflet).
Symptoms of an allergic reaction to
Ovidrel may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
_ _
Do not use Ovidrel if you have, or
have had, any of the following
medic

Ciri produk

250 MICROGRAMS/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
OR PRE-FILLED PEN
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 250 micrograms choriogonadotropin
alfa* (equivalent to approximately
6,500 IU) in 0.5 mL solution.
* recombinant human chorionic gonadotropin, r-hCG produced in Chinese
hamster ovary (CHO) cells by
recombinant DNA technology
For the full list of excipients, see section 6.1
PHARMACEUTICAL FORM
Solution for injection
Clear, colorless to slightly yellowish solution.
The pH of the solution is 7.0 ±0.3, its osmolality 250-400 mOsm/kg.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Ovidrel® is indicated in the treatment of
•
Adult women undergoing superovulation prior to assisted reproductive
technologies (ART) such
as in vitro fertilization (IVF): Ovidrel® is administered to trigger
final follicular maturation and
luteinisation after stimulation of follicular growth,
•
Anovulatory or oligo-ovulatory women: Ovidrel® is administered to
trigger ovulation and
luteinisation in anovulatory or oligo-ovulatory patients after
stimulation of follicular growth
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Ovidrel® should be performed under the supervision of
a physician experienced in the
treatment of fertility problems.
Posology
The maximum dose is 250 micrograms. The following dosing regimen
should be used:
•
Women undergoing superovulation prior to assist reproductive
technologies (ART) such as in
vitro fertilization (IVF):
One pre-filled syringe or prefilled pen of Ovidrel® (250 micrograms)
is administered 24 to 48
hours after the last administration of a follicle stimulating horming
(FSH) or human menopausal
gonadotropin (hMG) preparation, i.e. when optimal stimulation of
follicular growth is achieved,
•
Anovulatory or oligo-ovulatory women:
One pre-filled syringe or prefilled pen of Ovidrel® (250 micrograms)
is administered 24 to 48
hours after optimal stimulation of follicular growth is achieved. The
patient is recommended to
have coitus on the