GANIRELIX SUN ganirelix (as acetate) 250 microgram/0.5 mL solution for injection prefilled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ganirelix acetate, Quantity: 0.269 mg (Equivalent: ganirelix, Qty 0.25 mg)

Available from:

Sun Pharma ANZ Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous

Units in package:

1 or 5 prefilled 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 colorless solution free from visible particulate matter filled in 1 mL prefilled syringe; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-11-02

Patient Information leaflet

GANIRELIX SUN
GANIRELIX SUN
_Ganirelix (as acetate) 250 micrograms in 0.5 millilitres_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ganirelix SUN.
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 Ganirelix SUN
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 GANIRELIX SUN IS
USED FOR
Ganirelix SUN is used together with
other
medications
to
regulate
hormone
response
in
women
undergoing
Assisted
Reproductive
Technology
such
as
in
vitro
fertilisation (IVF).
Ganirelix SUN 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.
Ganirelix SUN is not addictive.
This medicine is available only with
a doctor's prescription.
_____________________________
BEFORE YOU USE
GANIRELIX SUN
_WHEN YOU MUST NOT USE IT_
_ _
DO NOT USE GANIRELIX SUN IF:
•
you are allergic (hypersensitive)
to
ganirelix
or
to
any
other
components of Ganirelix SUN,
including the ingredients listed at
the end of this leaflet and 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 GANIRELIX SUN,
TALK TO YOUR DOCTOR.
_BEFORE YOU START TO USE IT_
TELL YOUR DOCTOR IF:
•
you have allergies to any other
medicines, or substances such
as fo

Summary of Product characteristics

GANIRELIX SUN v2
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
GANIRELIX SUN (GANIRELIX ACETATE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Ganirelix acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
GANIRELIX SUN 250 ΜG GANIRELIX (AS ACETATE) /0.5 ML SOLUTION FOR
INJECTION
GANIRELIX SUN 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.
GANIRELIX SUN (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
GANIRELIX SUN should only be prescribed by a specialist experienced in
the treatment of
fertility.
DOSAGE
GANIRELIX SUN is used to prevent premature LH surges in patients
undergoing Controlled
ovarian hyperstimulation (COH). COH with FSH may start at day 2 or 3
of menses.
GANIRELIX SUN (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. GANIRELIX
SUN
should
not
be
mixed
with
FSH
but
both
preparations
should
be administered
GANIRELIX SUN v2
Page 2 of 11
approximately at the same time. Daily treatment with GANIRELIX SUN
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
GANIRELIX SUN injections and between the last GANIRELIX SUN injection
and the hCG
injection should not exceed 30 hrs, as otherwise a