Menopur 1200 IU solution for injection in a pre-filled pen

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Dostupné z:

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

ATC kód:

G03GA02

INN (Medzinárodný Name):

MENOTROPHIN 1200 IU

Forma lieku:

SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Zloženie:

MENOTROPHIN 1200 IU

Typ predpisu:

POM

Terapeutické oblasti:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Prehľad produktov:

Licence number in the source country: NOT APPLICAPABLE

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2023-02-24

Príbalový leták

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MENOPUR 600 IU SOLUTION FOR INJECTION IN PRE-FILLED PEN
MENOPUR 1200 IU SOLUTION FOR INJECTION IN PRE-FILLED PEN
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 pharmacist.
-
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 pharmacist. 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.
Contents of the pack and other information
1.
WHAT MENOPUR IS AND WHAT IT IS USED FOR
MENOPUR comes as a solution for injection in a pre‑filled pen. The
injection is given under your
skin
(‘sub-cutaneous’ injection) – usually in the tummy.
MENOPUR contains ‘menotrophin’, which is a mixture of two natural
hormones called:
•
follicle stimulating hormone (FSH) and
•
luteinizing hormone (LH).
These hormones help reproductive organs to work normally. The FSH and
LH hormones in
menotrophin are obtained from the urine of women who have passed the
menopause.
WHAT MENOPUR IS USED FOR
MENOPUR is used to treat women who cannot become pregnant. It is used
for:
•
women whose ovaries do not produce eggs. This includes women with
‘polycystic ovarian disease’
(‘PCOD’). MENOPUR is used when women have already had a medicine
called ‘clomiphene
citrate’, but this medicine has not helped.
•
women in ‘assisted reproductive technology’
programmes. This includes:
o ‘In vitro fertilisation’ (IVF) or ‘embryo transfer’ (ET)
o ‘Gamete intra-fallopian transfer’ (GIFT)
o ‘Intracytoplasmic sperm

Súhrn charakteristických

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Menopur 1200 IU solution for injection in a pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled multidose pen delivers highly purified menotrophin
(human menopausal gonadotrophin,
HMG) corresponding to follicle stimulating hormone activity FSH 1200
IU and luteinizing hormone
activity LH 1200 IU in 1.92 mL solution.
One mL of solution contains 625 IU FSH activity and 625 IU LH
activity.
Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in
postmenopausal urine, is
present in Menopur and is the main contributor of the LH 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
Solution for injection in pre-filled pen (injection).
Clear 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
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 antagonist.
Recommendations about dosage and
duration of treatment may change dependi