Menopur 75 IU powder and solvent for solution for injection

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

थमां उपलब्ध:

Ferring Ireland Limited United Drug House, Magna Drive Magna Business Park, Citywest Road Dublin 24 , Ireland

ए.टी.सी कोड:

G03GA02

INN (इंटरनेशनल नाम):

MENOTROPHIN 75 IU

फार्मास्यूटिकल फॉर्म:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

रचना:

MENOTROPHIN 75 IU

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

उत्पाद समीक्षा:

Licence number in the source country: NOT APPLICAPABLE

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2023-02-24

सूचना पत्रक

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MENOPUR 75 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Menotrophin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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 this leaflet. See section 4.
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 or in the muscle.
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 two
situations:
i. Women who cannot become pregnant because their ovaries do not
produce eggs (including polycystic
ovarian disease). Menopur is used in women who have already been given
a medicine called clomiphene
citrate to treat their infertility, but this medicine has not helped.
ii. Women in assisted reproductive technology programmes (ART)
(including
_in vitro_
fertilisation/embryo
transfer [IVF/ET], gamete intra-fallopian transfer [GIFT] and
intracytoplasmic sperm injection [ICSI]).
Menopur helps the ovaries to de

उत्पाद विशेषताएं

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SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Menopur 75 IU powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial with powder contains highly purified menotrophin (human
menopausal gonadotrophin, HMG)
corresponding to follicle stimulating hormone activity FSH 75 IU and
luteinizing hormone activity LH 75
IU.
Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in
postmenopausal urine, is present
in Menopur and contributes to the overall luteinizing hormone
activity.
The active ingredient in Menopur is obtained from the urine of
postmenopausal women.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of powder: white to off-white lyophilisation cake
Appearance of solvent: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Menopur is indicated for the treatment of infertility in the following
clinical situations:
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 intracytoplasmic sperm injection (ICSI)).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Menopur should be initiated under the supervision of a
physician experienced in the
treatment of fertility problems.
POSOLOGY
Dosage regimens described below are identical for S.C. and I.M.
administration.
There are great inter-individual variations in the response of the
ovaries to exogenous gonadotrophins. This
makes it impossible to set a uniform dosage scheme. The dosage should,
therefore, be adjusted individually
depending on the ovarian response. Menopur can be given alone or in
combination with a gonadotrophin-
releasing hormone (GnRH) agonist or a