GONAL-F FOR INJECTION 75 iu (5.5 mcg)vial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FOLLITROPIN ALFA

Available from:

MERCK PTE. LTD.

ATC code:

G03GA05

Dosage:

5.5 mcg/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

FOLLITROPIN ALFA 75IU (5.5mcg) /vial

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Merck Serono SA

Authorization status:

ACTIVE

Authorization date:

2003-10-22

Patient Information leaflet

 
1 
1. NAME OF THE MEDICINAL PRODUCT 

GONAL-f™ 75 IU (5.5 micrograms), powder and solvent for solution
for injection. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each vial contains 5.5 micrograms of follitropin alfa* equivalent
to 75 IU. Each ml of the 
reconstituted solution contains 75 IU. 
* recombinant human follicle stimulating hormone (r-hFSH) produced in
Chinese Hamster Ovary 
(CHO) cells by recombinant DNA technology. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Powder and solvent for solution for injection. 

Appearance of the powder: white lyophilised pellet. 
Appearance of the solvent: clear colourless solution. 
The pH of the reconstituted solution is 6.5-7.5. 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

In adult women 
• 
Anovulation (including polycystic ovarian syndrome ) in women who
have been unresponsive 
to treatment with clomiphene citrate. 

• 
Stimulation of multifollicular development in women  undergoing
superovulation for assisted 
reproductive technologies (ART) such as _in vitro_ fertilisation
(IVF), gamete intra-fallopian 
transfer  and zygote intra-fallopian transfer . 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

Treatment with GONAL-f™ should be initiated under the supervision of
a physician experienced in 
the treatment of fertility disorders. 
_ _
_Posology _

The dose recommendations given for GONAL-f™ are those in use for
urinary FSH. Clinical 
assessment of GONAL-f™ indicates that its daily doses, regimens
of administration, and treatment 
monitoring procedures should not be different from those
currently used for urinary FSH-containing 
medicinal products. It is advised to adhere to the recommended
starting doses indicated below. 
Comparative clinical studies have shown that on average patients
require a lower cumulative dose and 
shorter treatment duration with GONAL-f
TM
 compared with urinary FSH. Therefo

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
GONAL-f™ 75 IU (5.5 micrograms), powder and solvent for solution for
injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 5.5 micrograms of follitropin alfa* equivalent to
75 IU. Each ml of the
reconstituted solution contains 75 IU.
* recombinant human follicle stimulating hormone (r-hFSH) produced in
Chinese Hamster Ovary
(CHO) cells by recombinant DNA technology.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of the powder: white lyophilised pellet.
Appearance of the solvent: clear colourless solution.
The pH of the reconstituted solution is 6.5-7.5.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adult women
•
Anovulation (including polycystic ovarian syndrome) in women who have
been unresponsive to
treatment with clomiphene citrate.
•
Stimulation of multifollicular development in women undergoing
superovulation for assisted
reproductive technologies (ART) such as
_in vitro_
fertilisation (IVF), gamete intra-fallopian
transfer and zygote intra-fallopian transfer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with GONAL-f™ should be initiated under the supervision of
a physician experienced in
the treatment of fertility disorders.
_ _
_Posology _
The dose
recommendations
given
for
GONAL-f™
are those
in
use for
urinary
FSH. Clinical
assessment of GONAL-f™ indicates that its daily doses, regimens of
administration, and treatment
monitoring procedures should not be different from those currently
used for urinary FSH-containing
medicinal products. It is advised to adhere to the recommended
starting doses indicated below.
Comparative clinical studies have shown that on average patients
require a lower cumulative dose and
shorter treatment duration with GONAL-f
TM
compared with urinary FSH. Therefore, it is considered
appropriate to give a lower total dose of GONAL-f
TM
than generally used for urinary FSH, not only in
order to optimise follicular developmen