PUREGON SOLUTION FOR INJECTION 300 iu0.36 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FOLLITROPIN BETA

Available from:

ORGANON SINGAPORE PTE. LTD.

ATC code:

G03GA06

Dosage:

833IU/ml

Pharmaceutical form:

INJECTION

Composition:

FOLLITROPIN BETA 833IU/ml

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

VETTER PHARMA-FERTIGUNG GMBH & CO KG

Authorization status:

ACTIVE

Authorization date:

2003-02-06

Patient Information leaflet

 
S-CCDS-MK8328-SOi-082013 

Puregon® 
solution for injection 
follitropin beta 

1.  NAME OF THE MEDICINAL PRODUCT 
Puregon

150 IU/0.18 mL, 300 IU/0.36 mL, 600 IU/0.72 mL
or 900 IU/1.08 mL 
solution for injection. 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

One cartridge contains a net total dose of 150 IU, 300 IU,
600 IU or 900 IU 
recombinant follicle-stimulating hormone
(FSH) activity in 0.18, 0.36, 0.72 or 
1.08 mL aqueous solution. 

The solution for injection contains the active substance
recombinant follicle-
stimulating hormone (FSH) (follitropin beta), in a
concentration of 833 IU/mL 
aqueous solution. This strength corresponds to 83.3 microgram of protein/mL 
(specific in vivo
 bioactivity equal to approximately 10 000 IU FSH/mg
protein).  

For a full list of excipients, see section 6.1. 

3.  PHARMACEUTICAL FORM 

Solution for injection. 
Clear and colourless solution. 
In cartridges, designed to be used in conjunction with a pen
injector. 

4.  CLINICAL PARTICULARS 

4.1 Therapeutic indications 

In the female 
Puregon

is indicated for the treatment of female infertility in the
following clinical 
situations 
•

Anovulation (including polycystic ovarian syndrome (PCOS) in
women who 
have been unresponsive to treatment with clomifene citrate. 
•

Controlled ovarian hyperstimulation to induce the
development of multiple 
follicles in medically assisted reproduction programs [e.g. 
in vitro 
fertilization/embryo transfer (IVF/ET), gamete intra-fallopian
transfer (GIFT) 
and intracytoplasmic sperm injection (ICSI)]. 

In the male 
•

Deficient spermatogenesis due to hypogonadotrophic hypogonadism. 

4.2 Posology and method of administration 

Treatment with Puregon

should be initiated under the supervision of a physician 
experienced in the treatment of fertility problems.�

Summary of Product characteristics

S-CCDS-OG8328-SOi-082023
Puregon®
solution for injection
follitropin beta
1. NAME OF THE MEDICINAL PRODUCT
Puregon
150 IU/0.18 mL,
300 IU/0.36 mL,
600 IU/0.72 mL
or
900 IU/1.08 mL
solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One cartridge contains a net total dose of 150 IU, 300 IU, 600 IU or
900 IU
recombinant follicle-stimulating hormone (FSH) activity in 0.18, 0.36,
0.72 or
1.08 mL aqueous solution.
The
solution
for
injection
contains
the active
substance
recombinant
follicle-
stimulating hormone (FSH) (follitropin beta), in a concentration of
833 IU/mL
aqueous solution. This strength corresponds to 83.3 microgram of
protein/mL
(specific
in vivo
bioactivity equal to approximately 10 000 IU FSH/mg protein).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear and colorless solution.
In cartridges, designed to be used in conjunction with a pen injector.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
In the female
Puregon is indicated for the treatment of female infertility in the
following clinical
situations:
•
Anovulation (including polycystic ovarian syndrome, PCOS) in women who
have been unresponsive to treatment with clomifene citrate.
•
Controlled ovarian hyperstimulation to induce the development of
multiple
follicles
in
medically
assisted
reproduction
programs
[e.g.,
in
vitro
fertilization/embryo transfer (IVF/ET), gamete intra-fallopian
transfer (GIFT)
and intracytoplasmic sperm injection (ICSI)].
In the male
•
Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
4.2 Posology and method of administration
Treatment with Puregon should be initiated under the supervision of a
physician
experienced in the treatment of fertility problems.
The first injection of Puregon should be performed under direct
medical supervision.
Posology
When using the pen injector, it should be realized that the pen is a
precision device
that accurately delivers the dose to which it is set. It was shown
that on average an
18% higher amou