Puregon

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Follitropin beta

Available from:

Merck Sharp & Dohme Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

PUREGON
®

_follitropin beta[rch]_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Puregon.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Puregon
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION WITH YOUR
MEDICINE. YOU MAY WISH TO READ IT
AGAIN.

WHAT PUREGON IS USED
FOR
Puregon solution for injection
contains follitropin beta, a hormone
known as follicle stimulating
hormone (FSH).
FSH belongs to the group of
gonadotrophins, which play an
important role in human fertility and
reproduction. FSH is needed in
women for the growth and
development of follicles in the
ovaries. Follicles are small round
sacs that contain the egg cells.
In men, FSH is needed for the
production of sperm.
Puregon is used to treat infertility in
any of the following situations:

WOMEN:
•
Puregon can be used to cause
ovulation in women who have not
responded to treatment with
clomiphene citrate.
•
Puregon can be used to bring
about the development of
multiple follicles in women
undergoing assisted reproduction
technologies (ART) such as in
vitro fertilisation (IVF).

MEN:
Puregon can be used for the
production of sperm in men who are
infertile due to a hormonal
deficiency.
Puregon is not addictive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU USE
PUREGON
_WHEN YOU MUST NOT USE IT_
DO NOT USE PUREGON IF YOU:
•
are allergic (hypersensitive) to
follitropin beta or to any of the
ingredients in Puregon listed at
the end of this leaflet.
•
have a tumour of the ovary,
breast, uterus, testis, or brain
(pituitary gland or hypothalamus)
•
are pregnant or breast feeding
•
have heavy or irregular vaginal
bleeding where the cause is not
known

Summary of Product characteristics

 
A111129    RA 2540 OS S7 (Ref 4.0)  

1 

P
RODUCT 
I
NFORMATION

PUREGON


(I) 
NAME OF THE MEDICINE 

PUREGON

  CONTAINS  _FOLLITROPIN  BETA.    _[_Recombinant human
follicle-stimulating hormone _
_(recFSH)_] 

(II) 
DESCRIPTION 

Packs of clear glass cartridges containing Puregon solution
for injection, designed for sub-cutaneous 
injection using a pen injector.  

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Puregon

 contains the active ingredient, follitropin beta
rch. This is produced by a Chinese hamster ovary 
cell line transfected with the human
FSH subunit genes (i.e., by recombinant-DNA technology).  
One cartridge contains either 0.270 mL equal to a net dose of 150
IU, 0.480 mL equal to a net dose of 300 
IU, 0.840 mL equal to a net dose of 600 IU or 1.230 mL equal to
a net dose of 900 IU. 

LIST OF EXCIPIENTS 
Puregon solution also
contains sucrose, sodium citrate, methionine, polysorbate 20 and
benzyl alcohol in 
water for injections. The pH may have been adjusted with
sodium hydroxide and/or hydrochloric acid. 

(III)  PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 

Pharmacotherapeutic group: gonadotrophins; ATC code: G03G A06. 

Puregon

 contains follitropin beta, a recombinant human
FSH. FSH is indispensable in normal gamete 
growth and maturation, and gonadal steroid production. 

IN THE FEMALE: The amount of FSH is critical for the
onset and duration of follicular development, and 
consequently for the timing and number of follicles reaching
maturity. Puregon

 can thus be used to 
stimulate follicular development and steroid production in selected
cases of disturbed gonadal function. 

Furthermore Puregon

 can be used to promote multiple follicular development in
medically assisted 
reproduction programs [e.g. in vitro fertilisation/embryo
transfer