Puregon

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Follitropin beta 833 IU/mL;  

Available from:

Organon (New Zealand) Limited

INN (International Name):

Follitropin beta 833 IU/mL

Dosage:

833 IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Follitropin beta 833 IU/mL   Excipient: Benzyl alcohol Hydrochloric acid As 0.1N solution to adjust to pH 7.0 Methionine Polysorbate 20 Sodium citrate dihydrate Sodium hydroxide As 0.1N solution to adjust to pH 7.0 Sucrose Water for injection

Units in package:

Cartridge, glass, 225IU in 0.27mL, 150 IU

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

NV Organon

Therapeutic indications:

In the female: - Anovulatory infertility - Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programmes [e.g. in vitro fertilisation and related procedures].

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, 225IU in 0.27mL - 150 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 months from date of manufacture stored at or below 25°C protect from light 28 days opened stored at or below 25°C protect from light - Cartridge, glass, 400IU in 0.48mL, includes 6 needles - 300 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 months from date of manufacture stored at or below 25°C protect from light 28 days opened stored at or below 25°C protect from light - Cartridge, glass, 700IU in 0.84mL, includes 6 needles - 600 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 months from date of manufacture stored at or below 25°C protect from light 28 days opened stored at or below 25°C protect from light - Cartridge, glass, 1025IU in 1.23mL, includes 9 needles - 900 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 months from date of manufacture stored at or below 25°C protect from light 28 days opened stored at or below 25°C protect from light

Authorization date:

1999-04-30

Patient Information leaflet

PUREGON
®
1
PUREGON
®
_follitropin beta [rch] _
NEW ZEALAND 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 caus

Summary of Product characteristics

Page 1 of 13
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
PUREGON 150 IU, 300 IU, 600 IU, 900 IU Solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
150 IU cartridge: a clear, colourless, aqueous solution containing 833
IU FSH (follitropin beta)
per mL.
Total volume = 0.270 mL
300 IU cartridge: a clear, colourless, aqueous solution containing 833
IU FSH (follitropin beta)
per mL.
Total volume 0.480 mL (= 437 IU)
600 IU cartridge: a clear, colourless aqueous solution containing 833
IU FSH (follitropin beta)
per mL.
Total volume 0.840 mL (= 737 IU)
900 IU cartridge: a clear, colourless, aqueous solution containing 833
IU FSH (follitropin beta)
per mL.
Total volume = 1.230 mL
Cartridges contain 833 IU of FSH activity per mL aqueous solution.
Cartridges with a net dose
of 150 IU contain a minimum of 225 IU in 0.270 mL; those of 300 IU
contain a minimum of 400
IU
in
0.480
mL;
those
of
600
IU
contain
a
minimum
of
700
IU
in
0.840 mL; those of 900 IU contain a minimum of 1,025 IU in 1.230 mL.
PUREGON cartridges contain the active substance follitropin beta
(recombinant follicle-
stimulating hormone, FSH produced by genetic engineering of a Chinese
hamster ovary
(CHO) cell line, in a concentration of 833 IU/mL aqueous solution.
This strength corresponds
to 83.3 mcg of protein/mL (specific _ in vivo_ bioactivity equal to
approximately 10,000 IU
FSH/mg protein). One cartridge contains a net total dose of 150 IU,
300 IU, 600 IU or 900 IU.
Total dosings are limited to 3 (150 IU cartridge), 6 (300 or 600 IU
cartridges), or 9 (900 IU
cartridge).
Excipients with known effect:
–
benzyl alcohol
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
In cartridges, designed to be used in conjunction with a pen injector.
Page 2 of 13
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the female
•
Anovulatory infertility
•
Controlled ovarian hyperstimulation to induce the development of
multiple follicles in
medically assisted repro