ORGALUTRAN ganirelix 250 microgram/0.5mL (as acetate) injection prefilled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ganirelix, Quantity: 0.5 mg/mL

Available from:

ORGANON PHARMA PTY LTD

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: mannitol; acetic acid; sodium hydroxide; water for injections

Administration route:

Subcutaneous

Units in package:

1 syringe, 5 syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques.

Product summary:

Visual Identification: Clear, colourelss solution in a clear glass syringe fitted with a stainless steel needle fitted with a natural rubber shield.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2001-03-19

Patient Information leaflet

ORGALUTRAN
®
_Ganirelix (as acetate) 250 micrograms in 0.5 millilitres_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Orgalutran.
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 taking Orgalutran
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 LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ORGALUTRAN IS
USED FOR
Orgalutran is used together with
other medications to regulate
hormone response in women
undergoing Assisted Reproductive
Technology such as in vitro
fertilisation (IVF).
Orgalutran works by preventing
women from ovulating (releasing an
egg from the ovary) too soon during
stimulation of their ovaries to
produce a mature egg.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
No effects on ability to drive and use
machines have been observed.
Orgalutran is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
ORGALUTRAN
_WHEN YOU MUST NOT USE IT_
DO NOT USE ORGALUTRAN IF:
•
you are allergic (hypersensitive)
to ganirelix or to any other
components of Orgalutran,
including the ingredients listed at
the end of this leaflet and/or dry
natural rubber/latex
•
you are allergic to any other
similar medicines
•
you are pregnant
•
you are breastfeeding
•
you have moderate to severe
kidney or liver disease
•
the solution is not clear and
colourless
•
the expiry date on the pack has
passed
•
the package shows any signs of
tampering
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START USING ORGALUTRAN, TALK
TO YOUR DOCTOR.
_BEFORE YOU START TO USE IT_
TELL YOUR DOCTOR IF :
•
you have allergies to any other
medicines, substances such as
foods, preservatives or dyes
•
you are currently experiencing
allergic sy

Summary of Product characteristics

Orgalutran PI A190620 v7.0 (CCDS-MK8761-INJ-122018)
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION
ORGALUTRAN
®
(GANIRELIX ACETATE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Ganirelix acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ORGALUTRAN 250 ΜG GANIRELIX (AS ACETATE) /0.5 ML SOLUTION FOR
INJECTION
Orgalutran contains the synthetic decapeptide ganirelix (INN) as its
acetate salt, with high
antagonistic activity to the naturally occurring gonadotropin
releasing hormone (GnRH).
Each prefilled syringe contains 250 µg ganirelix (as acetate) in 0.5
mL.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Orgalutran (ganirelix acetate) is presented as a sterile, ready for
use, clear and colourless
aqueous solution intended for subcutaneous administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prevention of premature luteinisation and ovulation in
patients undergoing controlled
ovarian stimulation, followed by oocyte pick up and assisted
reproductive techniques.
4.2
DOSE AND METHOD OF ADMINISTRATION
Orgalutran should only be prescribed by a specialist experienced in
the treatment of fertility.
DOSAGE
Orgalutran is used to prevent premature LH surges in patients
undergoing COH. Controlled
ovarian hyperstimulation with FSH may start at day 2 or 3 of menses.
Orgalutran (0.25 mg)
should be injected subcutaneously once daily, starting from day 5 or
day 6 of FSH
administration depending on the level of ovarian response. Orgalutran
should not be mixed
with FSH but both preparations should be administered approximately at
the same time.
Daily treatment with Orgalutran should be continued up to the day that
sufficient follicles of
adequate size are present. Final maturation of follicles can be
induced by administering
hCG. Because of the half life of ganirelix, the time between two
Orgalutran injections and
Orgalutran PI A190620 v7.0 (CCDS-MK8761-INJ-122018)
Page 2 of 9
between the last Orgalutran injection and the hCG injection should n