Menotrophin Ferring 75 IU powder and solvent for solution for injection.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Menotrophin

Available from:

Ferring Ireland Ltd

ATC code:

G03GA02

INN (International Name):

Menotrophin

Pharmaceutical form:

Powder and solvent for solution for injection

Therapeutic area:

human menopausal gonadotrophin

Authorization status:

Not marketed

Authorization date:

2022-10-21

Patient Information leaflet

1
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
MENOTROPHIN FERRING 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 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.
Content of the pack and other information
1.
WHAT MENOTROPHIN FERRING IS AND WHAT IT IS USED FOR
MENOTROPHIN FERRING 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.
MENOTROPHIN FERRING 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
MENOTROPHIN FERRING are
obtained from the urine of postmenopausal women. The active ingredient
is highly purified, and is known
as menotrophin.
MENOTROPHIN FERRING 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). MENOTROPHIN FERRING 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

Summary of Product characteristics

Health Products Regulatory Authority
25 October 2022
CRN00CSJR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Menotrophin Ferring 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 Menotrophin
Ferring and contributes to the overall luteinizing hormone 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
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
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
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