Menopur Multidose Powder and Solvent for Solution for Injection 1200IU

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

MENOTROPHIN, HIGHLY PURIFIED

Dostopno od:

FERRING PHARMACEUTICALS PRIVATE LIMITED

Koda artikla:

G03G A02

Odmerek:

1200 IU

Farmacevtska oblika:

INJECTION, POWDER, FOR SOLUTION

Sestava:

MENOTROPHIN, HIGHLY PURIFIED 1200 IU/vial

Pot uporabe:

SUBCUTANEOUS, INTRAMUSCULAR

Tip zastaranja:

Prescription Only

Izdeluje:

Ferring GmbH (Powder & Solvent)

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2013-06-17

Navodilo za uporabo

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MENOPUR
®
multidose 600 IU and 1200 IU
QUALITATIVE AND QUANTITATIVE COMPOSITION
MENOPUR
®
multidose 600 IU: Each vial with powder contains highly purified
menotrophin
(human menopausal gonadotrophin, HMG) corresponding to follicle
stimulating hormone
activity FSH 600 IU and luteinizing hormone activity LH 600 IU.
MENOPUR
®
multidose 1200 IU: 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.
Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in
postmenopausal
urine, is present in MENOPUR
®
and is the main contributor of the LH activity.
List of excipients:
Powder: lactose monohydrate, polysorbate 20, sodium phosphate dibasic
heptahydrate,
phosphoric acid (concentrated)
Solvent: metacresol, water for injection
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Appearance of powder: white to off‑white lyophilisation cake.
Appearance of solvent: clear colourless solution.
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 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).
Sterility in females with hypo‑ or normogonadotropic ovarian
insufficiency: Stimulation
of follicular growth.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with MENOPUR
®
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

Lastnosti izdelka

MENOP600,1200-I-SG-04.02
MENOPUR
®
MULTIDOSE 600 IU AND 1200 IU
QUALITATIVE AND QUANTITATIVE COMPOSITION
MENOPUR
®
multidose 600 IU: Each vial with powder contains highly purified
menotrophin (human menopausal
gonadotrophin, HMG) corresponding to follicle stimulating hormone
activity FSH 600 IU and luteinizing hormone
activity LH 600 IU.
MENOPUR
®
multidose 1200 IU: 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.
Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in
postmenopausal urine, is present in
MENOPUR
®
and is the main contributor of the LH activity.
List of excipients:
Powder: lactose monohydrate, polysorbate 20, sodium phosphate dibasic
heptahydrate, phosphoric acid (concentrated)
Solvent: metacresol, water for injection
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Appearance of powder: white to off-white lyophilisation cake.
Appearance of solvent: clear colourless solution.
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 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).
Sterility in females with hypo- or normogonadotropic ovarian
insufficiency: Stimulation of follicular growth.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with MENOPUR
®
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 respon