MENOPUR Multidose Powder and Solvent for Solution for Injection 600 IU

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

MENOTROPHIN, HIGHLY PURIFIED

Tersedia dari:

FERRING PHARMACEUTICALS PRIVATE LIMITED

Kode ATC:

G03G A02

Dosis:

600 IU

Bentuk farmasi:

INJECTION, POWDER, FOR SOLUTION

Komposisi:

MENOTROPHIN, HIGHLY PURIFIED 600 IU/vial

Rute administrasi :

SUBCUTANEOUS, INTRAMUSCULAR

Jenis Resep:

Prescription Only

Diproduksi oleh:

Ferring GmbH (Powder & Solvent)

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

2013-06-17

Selebaran informasi

 
MENOPUR
®
 MULTIDOSE 600 IU AND 1200 IU 

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 DOSAGE FORM 
Powder and solvent for solution for injection 

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. 

DOSAGE AND ADMINISTRATION 
Treatment with MENOPUR
®
 should be initiated under the supervision of a physician experienced in the tre

Karakteristik produk

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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