MENOPUR gonadotrophin

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

human menopausal gonadotrophin, Quantity: 1200 IU

Prieinama:

Ferring Pharmaceuticals Pty Ltd

INN (Tarptautinis Pavadinimas):

human menopausal gonadotrophin

Vaisto forma:

Injection, solvent for

Sudėtis:

Excipient Ingredients: water for injections; metacresol

Vartojimo būdas:

Subcutaneous

Vienetai pakuotėje:

1 (1 vial, 2 prefilled syringes with solvent for reconstitution, 1 needle for reconstitution)

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

MENOPUR is indicated for the treatment of infertility in the following clinical situations:,Anovulatory infertility, 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)).

Produkto santrauka:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorizacija statusas:

Licence status A

Leidimo data:

2011-09-13

Pakuotės lapelis

MENOPUR
®
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
_Human menopausal gonadotrophin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Menopur.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Menopur
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MENOPUR IS USED
FOR
Menopur contains highly purified
human menopausal gonadotrophin
(hMG), also known as menotrophin,
as the active ingredient. It is obtained
from the urine of post-menopausal
women.
hMG is a mixture of three hormones
with follicle stimulating hormone
(FSH) activity and luteinising
hormone (LH) activity found
naturally in humans.
Menopur belongs to a class of
medicines called gonadotrophins.
Menopur is used to treat infertility
(reproduction related conditions) in
women.
Menopur is used in women who are
not ovulating (not producing eggs). It
helps women become pregnant by
stimulating the ovarian follicles to
release an egg.
Menopur is also used to stimulate the
ovarian follicles in women
undergoing Assisted Reproductive
Technology (ART) such as IVF/ET
(in vitro fertilisation/embryo
transfer), GIFT (gamete intra-
fallopian transfer) and ICSI
(intracytoplasmic sperm injection) to
help them become pregnant.
Your doctor will be able to talk to
you about your specific fertility
problem.
Menopur is given only by or under
the supervision of your doctor.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU USE
MENOPUR

Prekės savybės

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#24207-v16C
AUSTRALIAN PI - MENOPUR
® (HUMAN MENOPAUSAL
GONADOTROPHIN) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
1 NAME OF THE MEDICINE
Human menopausal gonadotrophin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
MENOPUR 600 IU (600 IU/mL after reconstitution)
MENOPUR 1200 IU (600 IU/mL after reconstitution)
MENOPUR 600 IU: each vial with powder contains highly purified
menotrophin (human
menopausal gonadotrophin,
hMG)
corresponding to follicle stimulating
hormone
activity FSH 600 IU and luteinising hormone activity LH 600 IU.
MENOPUR 1200 IU: each vial with powder contains highly purified
menotrophin
(human
menopausal
gonadotrophin,
hMG)
corresponding
to
follicle
stimulating
hormone activity FSH 1200 IU and luteinising hormone activity LH 1200
IU.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
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
MENOPUR is indicated for the treatment of infertility in the following
clinical situations:
Anovulatory infertility, 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)).
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of
14
#24207-v16C
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.
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 dependi