Menopur

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Menotrophin 600 [iU]

から入手可能:

Pharmaco (NZ) Ltd

投薬量:

600 IU

医薬品形態:

Powder for injection with diluent

構図:

Active: Menotrophin 600 [iU] Excipient: Dibasic sodium phosphate heptahydrate Lactose monohydrate Phosphoric acid Polysorbate 20 Metacresol Nitrogen Water for injection

処方タイプ:

Prescription

適応症:

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) (eg, in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)).

製品概要:

Package - Contents - Shelf Life: Combination pack, Type I vial, prefilled solvent syringe, reconstitution needle - 600 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days reconstituted stored at or below 25°C - Syringe, glass, Type I prefilled solvent syringe - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I vial containing powder for injection - 600 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

承認日:

2017-07-27

情報リーフレット

MENOPUR
®
1
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 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/EF
(in vitro fertilisation/embryo transfer)
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
The active ingredient in this
preparation is extracted from human
urine. Th

製品の特徴

NEW ZEALAND DATA SHEET
MENOPUR 600IU and 1200IU Version 04
August 2022
Page 1 of 12
MENOPUR 600IU and 1200IU
powder and solvent for solution for injection
Menotrophin HP
1 PRODUCT NAME
MENOPUR 600IU and 1200IU powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
MENOPUR 600 IU (600 IU/mL after reconstitution): Each vial with powder
contains highly purified
menotrophin (human menopausal gonadotrophin, hMG) corresponding to
follicle stimulating
hormone (FSH) activity 600 IU and luteinising hormone (LH) activity
600 IU.
MENOPUR 1200 IU (600 IU/mL after reconstitution): Each vial with
powder contains highly purified
menotrophin (human menopausal gonadotrophin, hMG) corresponding to
follicle stimulating
hormone (FSH) FSH 1200 IU and luteinising hormone (LH) LH 1200 IU.
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 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
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)).
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.
_DOSAGE _
There are great inter-individual variations in the response of the
ovaries to exogenous
gonadotrophins. This mak