Menopur Multidose Powder and Solvent for Solution for Injection 1200IU

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MENOTROPHIN, HIGHLY PURIFIED

Available from:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC code:

G03G A02

Dosage:

1200 IU

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

MENOTROPHIN, HIGHLY PURIFIED 1200 IU/vial

Administration route:

SUBCUTANEOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Ferring GmbH (Powder & Solvent)

Authorization status:

ACTIVE

Authorization date:

2013-06-17

Patient Information leaflet

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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

Summary of Product characteristics

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