Menotrophin Ferring 1200 IU solution for injection in a pre-filled pen

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Menotrophin

Beschikbaar vanaf:

Ferring Ireland Ltd

ATC-code:

G03GA02

INN (Algemene Internationale Benaming):

Menotrophin

farmaceutische vorm:

Solution for injection in pre-filled pen

Therapeutisch gebied:

human menopausal gonadotrophin

Autorisatie-status:

Not marketed

Autorisatie datum:

2022-11-04

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MENOTROPHIN FERRING 600 IU SOLUTION FOR INJECTION IN A PRE-FILLED PEN
MENOTROPHIN FERRING 1200 IU SOLUTION FOR INJECTION IN A 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 Menotrophin Ferring is and what it is used for
2.
What you need to know before you use Menotrophin Ferring
3.
How to use Menotrophin Ferring
4.
Possible side effects
5.
How to store Menotrophin Ferring
6.
Contents of the pack and other information
1.
WHAT MENOTROPHIN FERRING IS AND WHAT IT IS USED FOR
Menotrophin Ferring 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.
Menotrophin Ferring 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 MENOTROPHIN FERRING IS USED FOR
Menotrophin Ferring 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’). Menotrophin Ferring 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

Productkenmerken

Health Products Regulatory Authority
07 November 2022
CRN00CSPH
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Menotrophin Ferring 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 Menotrophin
Ferring and is the main contributor of the LH activity.
The active ingredient in Menotrophin Ferring 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
Menotrophin Ferring 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 Menotrophin Ferring 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. Menotrophin Ferring can be given alone or in combination
with a gona