PUREGON follitropin beta (rch) 300 IU solution for injection cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Follitropin beta, Quantity: 833 IU/mL

Available from:

ORGANON PHARMA PTY LTD

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sucrose; sodium citrate dihydrate; polysorbate 20; benzyl alcohol; methionine; hydrochloric acid; sodium hydroxide; water for injections

Administration route:

Subcutaneous

Units in package:

1 x cartridge

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

In the female: Anovulatory infertility and; Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in vitro fertilisation and related procedures). In the male: For the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism.

Product summary:

Visual Identification: Clear colourless aqueous solution in glass cartridge; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2001-11-15

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 think you may be
pregnant
•
have heavy or irregular vaginal
bleeding where the cause is not
known
•
suffer fro

Summary of Product characteristics

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
PUREGON

FOLLITROPIN BETA (RCH)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Follitropin beta. [Recombinant human follicle-stimulating hormone
(recFSH)]
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One cartridge contains either 0.270 mL equal to a net dose of 150 IU*
follitropin beta (rch),
0.480 mL equal to a net dose of 300 IU follitropin bets (rch), 0.840
mL equal to a net dose of
600 IU follitropin beta (rch) or 1.230 mL equal to a net dose of 900
IU follitropin beta (rch).
Follitropin beta (rch) is produced by recombinant-DNA technology in a
Chinese hamster ovary
cell line transfected with the human FSH subunit genes.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IN THE FEMALE:
Anovulatory infertility and;
Controlled ovarian hyperstimulation to induce the development of
multiple follicles in medically
assisted reproduction programs (e.g. _in vitro_ fertilisation and
related procedures).
IN THE MALE:
For the treatment of deficient spermatogenesis due to
hypogonadotrophic hypogonadism.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment
with
PUREGON
should
be
initiated
under
the
supervision
of
a
physician
experienced in the treatment of fertility problems.
DOSAGE IN THE FEMALE:
ANOVULATION / DEFECTIVE FOLLICLE RIPENING AND/OR CORPUS LUTEUM
INSUFFICIENCY
There are great inter- and intra-individual variations in the response
of the ovaries to
exogenous gonadotrophins. This makes it impossible to set a uniform
dosage scheme. The
dosage should, therefore, be adjusted individually depending on the
ovarian response. This
requires ultrasound assessment of follicular development. The
concurrent determination of
serum oestradiol levels may also be useful.
Page 2 of 14
A sequential treatment scheme is recommended starting with daily
administration of 50 IU
PUREGON. The starting dose is maintained for at least seven days. If
there is