GYNOGEN HP 75 IU Powder and Solvent for Solution for Injection (Menotrophin for Injection BP 75 IU Vial)

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

MENOTROPHIN

Available from:

Haczen Sdn Bhd

INN (International Name):

MENOTROPHIN

Units in package:

1 Vials; 1 Ampoules

Manufactured by:

Sanzyme Ltd

Summary of Product characteristics

GYNOGEN HP therapy should start within the initial 7 days of the
menstrual cycle. The recommended initial dose of GYNOGEN HP is 75-
150 IU daily, which should be maintained for at least 7 days. Based on
clinical monitoring (including ovarian ultrasound alone or in
combination
with measurement of oestradiol levels) subsequent dosing should be
adjusted according to individual patient response. Adjustments in dose
should not be made more frequently than every 7 days. The
recommended dose increment is 37.5 IU per adjustment, and should not
exceed 75 IU. The maximum daily dose should not be higher than 225 IU.
If a patient fails to respond adequately after 4 weeks of treatment,
that
cycle should be abandoned and the patient should recommence
treatment at a higher starting dose than in the abandoned cycle.
WOMEN WITH ANOVULATION (INCLUDING PCOD): The object of GYNOGEN
HP therapy is to develop a single Graafian follicle from which the
oocyte
will be liberated after the administration of human chorionic
gonadotrophin (hCG).
·
Pregnancy and lactation.
·
Gynaecological haemorrhage of unknown aetiology.
·
Ovarian cysts or enlarged ovaries not due to polycystic ovarian
disease.
In the following situations treatment outcome is unlikely to be
favourable,
and therefore GYNOGEN HP should not be administered:
Before starting treatment, the couple's infertility should be assessed
as
WARNINGS & PRECAUTIONS
GYNOGEN HP is a potent gonadotropic substance capable of causing
mild to severe adverse reactions, and should only be used by
physicians
who are thoroughly familiar with infertility problems and their
management.
There is considerable inter-patient variability in response to
menotrophin
administration, with a poor response to menotrophin in some patients.
The lowest effective dose in relation to the treatment objective
should be
used.The first injection of GYNOGEN HP should be performed under
direct medical supervision.
·
Malformation of sexual organs incompatible with pregnancy.
When an optimal response is obtained, a single