ORGALUTRAN 0.25MG0.5ML (SOLUTION FOR INJECTION)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GANIRELIX

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

GANIRELIX

Unit dalam pakej:

0.5ml1Units mL; 0.5ml5Units mL

Dikeluarkan oleh:

VETTER PHARMA-FERTIGUNG GMBH & CO KG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ORGALUTRAN
® (SOLUTION FOR INJECTION)
Ganirelix acetate (0.25mg/0.5ml)
Copyright 2021 Organon group of companies. All rights reserved.
1
WHAT IS IN THIS LEAFLET
1.
What ORGALUTRAN is used
for
2.
How ORGALUTRAN works
3.
Before you use ORGALUTRAN
4.
How to use ORGALUTRAN
5.
While you are using
ORGALUTRAN
6.
Side effects
7.
Storage and Disposal of
ORGALUTRAN
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial number
WHAT ORGALUTRAN IS USED FOR
Orgalutran is used together with
other medications to regulate
hormone response in women
undergoing Assisted Reproductive
Technology such as
_in vitro _
fertilisation (IVF).
HOW ORGALUTRAN WORKS
Orgalutran works by preventing
women from ovulating (releasing an
egg from the ovary) too soon during
stimulation of their ovaries to
produce a mature egg.
BEFORE YOU USE ORGALUTRAN
_-When you must not use it _
_ _
You should not take
ORGALUTRAN
if:
•
you are allergic (hypersensitive)
to ganirelix;
•
you are allergic to any
components of
ORGALUTRAN, including dry
natural rubber/latex;
•
you are hypersensitive to
gonadotrophin releasing
hormone (GnRH) or a GnRH
analogue;
•
you are pregnant or breast-
feeding;
•
you have moderate or severe
impairment of kidney or liver
function.
If any of these conditions apply to
you, please tell your doctor before
starting to use this medicine.
_-Before you start to use it _
_ _
TAKE SPECIAL CARE WITH
ORGALUTRAN
•
If you have an active
allergic condition, please
tell your doctor.
•
Cases of allergic reactions,
both generalized and local,
including hives (urticaria),
swelling of the face, lips,
tongue and/or throat that
may cause difficulty in
breathing or swallowing
(angioedema and/or
anaphylaxis) have been
reported, as early as with
the first dose. (See also
Side effects.) If you have
an allergic reaction, stop
taking Orgalutran and seek
immediate medical
assistance.
•
If your weight is less than
50 kg or more than 90 kg.
•
The need

Ciri produk

Copyright 2021 Organon group of companies. All rights reserved.
LPC-OG-8761-INJ-082020
ORGALUTRAN 0.25 MG/0.5 ML
solution for injection
1.
NAME OF THE MEDICINAL PRODUCT
Orgalutran 0.25 mg/0.5 ml solution for injection
2.
QUALITATIVE
AND
QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 0.25 mg of ganirelix (INN) in 0.5 ml
aqueous solution. The
active substance ganirelix is a synthetic decapeptide with high
antagonistic activity to the
naturally occurring gonadotrophin releasing hormone (GnRH). The amino
acids at positions
1, 2, 3, 6, 8 and 10 of the natural GnRH decapeptide have been
substituted resulting in N-
Ac-D-Nal(2)
1
,
D-pClPhe
2
,
D-Pal(3)
3
,
D-hArg(Et2)
6
,
L-hArg(Et2)
8
,
D-Ala
10
]-GnRH
with
a
molecular weight of 1570.4.
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colorless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The
prevention
of
premature
luteinizing
hormone
(LH)
surges
in
women
undergoing
controlled ovarian hyperstimulation (COH) for assisted reproduction
techniques (ART).
In clinical trials Orgalutran was used with recombinant follicle
stimulating hormone (FSH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Copyright 2021 Organon group of companies. All rights reserved.
Orgalutran should only be prescribed by a specialist experienced in
the treatment of
infertility.
Posology
Orgalutran is used to prevent premature LH surges in patients
undergoing COH. Controlled
ovarian hyperstimulation with FSH may start at day 2 or 3 of menses.
Orgalutran (0.25 mg)
should
be
injected
subcutaneously
once
daily,
starting
in
general
on
day
6
of
FSH
administration. In high responders an early LH rise may be prevented
by starting Orgalutran
treatment on day 5. The start of Orgalutran may be delayed in absence
of follicular growth.
Orgalutran and FSH should be administered approximately at the same
time. However, the
preparations should not be mixed and different injection sites are to
be used.
FSH dose adjustments should be based