MENOPUR SOLUTION FOR INJECTION IN PRE-FILLED PEN 600 IU0.96 ML

Valsts: Singapūra

Valoda: angļu

Klimata pārmaiņas: HSA (Health Sciences Authority)

Aktīvā sastāvdaļa:

Menotrophin Highly Purified

Pieejams no:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATĶ kods:

G03GA02

Zāļu forma:

INJECTION, SOLUTION

Kompozīcija:

Menotrophin Highly Purified 600 IU

Ievadīšanas:

SUBCUTANEOUS

Receptes veids:

Prescription Only

Ražojis:

Rechon Life Science AB (Bulk Production and Primary Packaging)

Autorizācija statuss:

ACTIVE

Autorizācija datums:

2023-02-20

Produkta apraksts

MENOPPFP600,1200-I-SG-01.02
1.
NAME OF THE MEDICINAL PRODUCT
MENOPUR
®
SOLUTION FOR INJECTION IN PRE-FILLED PEN 600 IU/ 0.96 ML
MENOPUR
®
SOLUTION FOR INJECTION IN PRE-FILLED PEN 1200 IU/ 1.92 ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MENOPUR
®
solution for injection in pre-filled pen 600 IU/ 0.96 ml :
One pre-filled multidose pen delivers highly purified menotrophin
(human menopausal gonadotrophin, HMG)
corresponding to follicle stimulating hormone activity FSH 600 IU and
luteinizing hormone activity LH 600 IU in
0.96 mL solution.
MENOPUR
®
solution for injection in pre-filled pen 1200 IU/ 1.92 ml:
One pre-filled multidose pen delivers highly purified menotrophin
(human menopausal gonadotrophin, HMG)
corresponding to follicle stimulating hormone activity FSH 1200 IU and
luteinizing hormone activity LH 1200 IU in
1.92 mL solution.
One mL of solution contains 625 IU FSH activity and 625 IU LH
activity.
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 the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen (injection).
Clear solution.
4.
CLINICAL PARTICULARS
4.1 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with MENOPUR
®
should be initiated under the supervision of a physician experienced
in the treatment
of fe