MENOPUR 1200 IU Powder and Solvent for Solution for Injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Menotrophin

Tersedia dari:

PCO Manufacturing Ltd.

Kode ATC:

G03GA02

INN (Nama Internasional):

Menotrophin

Bentuk farmasi:

Powder and solvent for solution for injection

Area terapi:

human menopausal gonadotrophin

Tanggal Otorisasi:

2022-05-27

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
MENOPUR
® 1200 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
included any possible side effects not
listed in the leaflet.
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 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.
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 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 egg might
dev

Karakteristik produk

Health Products Regulatory Authority
27 May 2022
CRN00CV36
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MENOPUR 1200 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 1200 IU and luteinizing
hormone activity LH 1200 IU.
After reconstitution, 1 ml of the reconstituted solution contains 600
IU of highly purified menotrophin.
Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in
postmenopausal urine, is present in MENOPUR and
is the main contributor of the LH activity.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
_Product imported from the Czech Republic and Greece:_
_ _
Appearance of powder: white to off-white lyophilisation cake
Appearance of solvent: clear colourless solution.
4 CLINICAL PARTICULARS
As per PA1009/015/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1009/015/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Powder
Lactose monohydrate
Polysorbate 20
Sodium phosphate dibasic heptahydrate (for pH adjustment)
Phosphoric acid (concentrated) (for pH adjustment)
Solvent
Metacresol
Water for Injections
6.2 INCOMPATIBILITIES
MENOPUR should not be administered in the same injection with other
products.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
27 May 2022
CRN00CV36
Page 2 of 3
After reconstitution, the solution may be stored for a maximum of 28
days at not more than 25 °C. Do not freeze.
The patient should write the date of first preparation of MENOPUR on
the outer carton.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
For storage conditions after reconstitution of the medicinal pro