MENOPUR multidose 600IU Powder and Solvent for Solution for Injection

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MENOTROPHIN, HIGHLY PURIFIED

Boleh didapati daripada:

Ferring Sdn. Bhd.

INN (Nama Antarabangsa):

MENOTROPHIN, HIGHLY PURIFIED

Unit dalam pakej:

1 Units

Dikeluarkan oleh:

FERRING GMBH

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
MENOPUR
® MULTIDOSE 600IU
MENOPUR
® MULTIDOSE 1200IU
Powder and solvent for solution for injection
Menotrophin HP 600IU and 1200IU
1
READ
THE
ENTIRE
LEAFLET
CAREFULLY
BEFORE USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR
YOU.
-
Keep this leaflet. You may need to
read it again.
-
If you have any further questions,
ask your doctor or nurse.
-
This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same
as yours.
-
If you get any side effects talk to
your doctor or nurse. This includes
any possible side effects not listed
in the leaflet
WHAT IS IN THIS LEAFLET
:
1.
What MENOPUR
®
is and what it is
used for
2.
What you need to know before you use
MENOPUR
®
3.
How to use MENOPUR
®
4.
Possible side effects
5.
How to store MENOPUR
®
6.
Content
of
the
pack
and
other
information
1. WHAT MENOPUR
® IS AND WHAT
IT IS USED FOR
MENOPUR
®
is
provided
as
a
powder
which must be mixed with liquid (solvent)
before it is used. It is given as an injection
under the skin.
MENOPUR
®
contains
two
hormones
called follicle stimulating hormone (FSH)
and luteinizing hormone (LH). FSH and
LH are natural hormones produced in both
males
and
females.
They
help
the
reproductive
organs
to
work
normally.
The
FSH
and
LH
in
MENOPUR
®
are
obtained
from
the
urine
of
postmenopausal
women.
The
active
ingredient is highly purified, and is known
as menotrophin.
MENOPUR
®
is
used
to
treat
female
infertility in the following situations:
i.
Anovulation,
including
polycystic
ovarian
disease
(PCOD),
in
women who have been unresponsive to
treatment with clomiphene citrate.
ii.
Women
in
Assisted
Reproductive
Technology,
(ART)
programmes
(including
in
vitro
fertilization
/
embryo
transfer
[IVF/ET],
gamete
intra-fallopian
transfer
[GIFT]
and
intracytoplasmic
sperm
injection
[ICSI]). MENOPUR
®
helps the ovaries
to develop many egg sacs (follicles)
where an egg might develop (multiple
follicular developments).
2

Ciri produk

Proposed packaging material
Code (61,62) -I-MY -06.01 Size
Submission ☐NDA ☐Renewal ☒Variation change detail no.: 125375 remove of alcohol swab Code of p revious version (61,62) -I-MY -05.01 Change s 125375 Remove of alcohol swab ☐CCDS version:
☐Core PIL version:
☐SPC country/version/date:
☐LAC no.:
Name & Date JIW O, 18-MAY -2017
MENOPUR
® multidose 600 IU and 1200 IU
Powder and Solvent for Solution for Injection
COMPOSITION
MENOPUR
® multidose 600 IU: Each vial with powder contains highly purified menotrophin (human menopausal
gonadotrophin, HMG) corresponding to follicle stimulating hormone activity FSH 600 IU and luteinizing hormone
activity LH 600 IU.
MENOPUR
® multidose 1200 IU: Each vial with powder contains highly purified menotrophin (human menopausal
gonadotrophin, HMG) corresponding to follicle stimulating hormone activity FSH 1200 IU and luteinizing hormone
activity LH 1200 IU.
Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in postmenopausal urine, is present in
MENOPUR and is the main contributor of the LH activity.
List of excipients:
Powder: lactose monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate , phosphoric acid (concentrated)
Solvent: m etacresol, water for injection
PHARMACEUTICAL DOSAGE FORM
Powder and solvent for solution for injection
INDICATIONS
MENOPUR
® is indicated for the treatment of infertility in the following clinical situation s:
Anovulation, including polycystic ovarian disease (PCOD), in women who have been unresponsive to treatment with
clomiphene citrate.
Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive
technologies (ART) (e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra -fallopian transfer (GIFT) and
int racytoplasmic sperm injection (ICSI).
DOSAGE AND ADMINISTRATION
Treatment with MENOPUR
® should be initiated under the supervision of a physician experienced in the treatment of
fertility problems.
Method of administration
MENOPUR ® 600IU AN