Cetrotide 0.25 mg powder and solvent for solution for injection

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CETRORELIX

Boleh didapati daripada:

MERCK SDN. BHD.

INN (Nama Antarabangsa):

CETRORELIX

Unit dalam pakej:

1vial Vials; 7vial Vials

Dikeluarkan oleh:

FAREVA PAU 2

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
CETROTIDE INJECTION
Cetrorelix Acetate (0.25mg)
WHAT IS IN THIS LEAFLET
1.
What Cetrotide is used for
2.
How Cetrotide works
3.
Before you use Cetrotide
4.
How to use Cetrotide
5.
While you are using Cetrotide
6.
Side Effects
7.
Storage and Disposal of Cetrotide
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CETROTIDE IS USED FOR
Cetrotide is used to prevent premature
ovulation (the release of an egg from
the ovary) in women undergoing an
assisted reproduction cycle, such as in
vitro fertilization (IVF).
Ovulation that is too early, before the
egg has fully matured, is undesirable
during hormone treatment for ovarian
stimulation, because only mature egg
cells are suitable for fertilization.
HOW CETROTIDE WORKS
The active substance in Cetrotide,
cetrorelix, blocks the effects of a
natural hormone called luteinising-
hormone-releasing hormone (LHRH).
LHRH controls the production and
release of another hormone called
luteinising hormone (LH), which
causes ovulation during the menstrual
cycle. During fertility treatment,
ovarian stimulation is normally used
to make the ovaries produce more
eggs. By blocking the effect of LHRH,
Cetrotide stops the production of LH,
and therefore prevents premature
ovulation, which can result in the
release of eggs that are immature and
unsuitable for use in techniques such
as in vitro fertilisation (IVF).
BEFORE YOU USE CETROTIDE
-
_When you must not take it _
Do not use Cetrotide if you have an
allergy to:
•
Cetrorelix acetate
•
Mannitol
•
Exogenous peptide hormones
(medicines similar to Cetrotide).
Symptoms of an allergic reaction 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 Cetrotide if you are or
have any of the following conditions:
•
severe kidney disease
•
you are pregnant or suspect that you
might be pregnant
•
breastfee

Ciri produk

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 0.25 mg cetrorelix (as acetate). After
reconstitution with the solvent provided,
each ml of the solution contains 0.25 mg cetrorelix.
For a full list of excipients, see List of Excipients.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of the powder: white lyophilisate.
Appearance of the solvent: clear and colourless solution.
The pH of the reconstituted solution is 4.0 – 6.0.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Prevention of premature ovulation in patients undergoing a controlled
ovarian stimulation,
followed by oocyte pick-up and assisted reproductive techniques.
In clinical trials Cetrotide® 0.25 mg was used with human menopausal
gonadotropin (HMG),
however, limited experience with recombinant follicle-stimulating
hormone (FSH) suggested
similar efficacy.
POSOLOGY AND METHOD OF ADMINISTRATION
Cetrotide® 0.25 mg should only be prescribed by a specialist
experienced in this field.
Posology
The first administration of Cetrotide® should be performed under the
supervision of a physician
and under conditions where treatment of possible
allergic/pseudo-allergic reactions (including
life-threatening anaphylaxis) is immediately available. The following
injections may be self-
administered as long as the patient is made aware of the signs and
symptoms that may indicate
hypersensitivity, the consequences of such a reaction and the need for
immediate medical
intervention.
The contents of 1 vial (0.25 mg cetrorelix) are to be administered
once daily, at 24 h intervals,
either in the morning or in the evening. Following the first
administration, it is advised that the
patient be kept under medical supervision for 30 minutes to ensure
there is no allergic/pseudo-
allergic reaction to the injection. Facilities for the treatment of
such reactions should be
immediately available.
_Elderly _
There is no relevant use of Cetrotide in the geriatric population.
_Paediatric population _
There is no relevant use of Cetrotide in the