Menopur

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Menotrophin 75 [iU] equivalent to 75 IU FSH & 75 IU LH

Available from:

Pharmaco (NZ) Ltd

INN (International Name):

Menotrophin 75 IU (equivalent to 75 IU FSH & 75 IU LH)

Dosage:

75 IU

Pharmaceutical form:

Powder for injection with diluent

Composition:

Active: Menotrophin 75 [iU] equivalent to 75 IU FSH & 75 IU LH Excipient: Hydrochloric acid Lactose monohydrate Polysorbate 20 Sodium hydroxide Hydrochloric acid Sodium chloride Water for injection

Units in package:

Ampoule, glass, Diluent, 1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Instituto Massone SA

Therapeutic indications:

MENOPUR is indicated for the treatment of infertility in anovulation, including polycystic ovarian disease (PCOD), in women who have been unresponsive to treatment with clomiphene citrate.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Diluent - 1 mL -   - Combination pack, (powder + diluent) - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Combination pack, (powder + diluent) - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, Active - 75 IU -  

Authorization date:

2006-08-18

Patient Information leaflet

MENOPUR
®
_Menotrophin HP_
75 IU powder and solvent for 
solution for injection
CONSUMER MEDICINE INFORMATION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START USING THIS MEDICINE.
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. Do not pass it on to others. It may harm them, 
even if their symptoms are the same as yours. 
If any of the side effects gets serious, or if you 
notice any side effects not listed in this leaflet, 
please tell your doctor or nurse.
WHAT IS IN THIS LEAFLET
1. What MENOPUR is and what it is used for
2. Before you take MENOPUR
3. How to take MENOPUR
4. Possible side effects
5. How to store MENOPUR
6. Further information
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 is obtained from the 
urine of postmenopausal women. It is highly 
purified, and is then 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 reproduction programmes 
(ART) (including _in vitro_ fertilisation/embryo 
transfer [IVF/ET], gamete intra-fallopian 
transfer [GIFT] and intracytoplasmic sperm 
injection [ICSI]). MENOPUR helps the ovaries 
develop many egg sacs (follicles) where 
an

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Menopur 75IU V004
Aug 2022
Page 1 of 9
MENOPUR® 75IU
Menotrophin HP
1 PRODUCT NAME
MENOPUR, powder and solvent for solution for injection, 75 IU
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 luteinising hormone
activity LH 75 IU.
Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in
post-menopausal urine, is
present in MENOPUR and is the main contributor of the LH activity.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
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 hyper-stimulation 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 intra-cytoplasmic sperm injection
(ICSI)).
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with MENOPUR should be initiated under the supervision of a
physician experienced in the
treatment of fertility problems.
MENOPUR is intended for subcutaneous (S.C.) or intramuscular (I.M.)
injection after reconstitution
with the solvent provided. Vigorous shaking should be avoided. The
powder should be reconstituted
immediately prior to use. In order to avoid the injection of large
volumes up to 3 vials of the powder
may be dissolved in I mL of the solvent provided. The solution should
not be used if it contains particles
or if it is not clear (see section 6.6).
_DOSAGE _
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
gonadotroph