GANIRELIX THERAMEX 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, Quantity: 0.25 mg

Available from:

Theramex Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous

Units in package:

5 prefilled syringes, 1 prefilled syringe

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: GANIRELIX THERAMEX (ganirelix as acetate) is presented as a sterile, ready for use, clear and colourless aqueous solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-12-20

Patient Information leaflet

GANIRELIX THERAMEX
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING GANIRELIX THERAMEX?
Ganirelix Theramex contains the active ingredient ganirelix (as
acetate). Ganirelix Theramex is used together with other medications
to regulate hormone response in women undergoing Assisted Reproductive
Technology such as in vitro fertilisation (IVF).
For more information, see Section 1. Why am I using Ganirelix
Theramex? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GANIRELIX THERAMEX?
Do not use if you have ever had an allergic reaction to ganirelix or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Ganirelix Theramex? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ganirelix Theramex and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE GANIRELIX THERAMEX?
•
Treatment with Ganirelix Theramex should be started under the
supervision of a fertility specialist
•
Ganirelix Theramex is given as a subcutaneous (under the skin)
injection in the thigh or stomach
•
The usual dose is the contents of one pre-filled syringe of Ganirelix
Theramex once a day on specific days of the menstrual
cycle.
More instructions can be found in Section 4. How do I use Ganirelix
Theramex? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GANIRELIX THERAMEX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
Ganirelix Theramex.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine without telling your doctor.
•
Do not change the dose unless

Summary of Product characteristics

GANIRELIX THERAMEX ganirelix (as acetate) 250 µg/0.5 mL solution for
injection
Theramex Australia Pty Ltd
Version 1.0
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AUSTRALIAN PRODUCT INFORMATION
GANIRELIX THERAMEX (GANIRELIX (AS ACETATE)) 250 ΜG/0.5 ML SOLUTION
FOR INJECTION
1
NAME OF THE MEDICINE
Ganirelix (as acetate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
GANIRELIX THERAMEX 250 μg ganirelix (as acetate)/0.5 mL solution for
injection
GANIRELIX THERAMEX 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 THERAMEX (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 THERAMEX should only be prescribed by a specialist
experienced in the treatment
of fertility.
DOSAGE
GANIRELIX THERAMEX 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 THERAMEX (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
THERAMEX should not be mixed with FSH but both preparations should be
administered
approximately at the same time. Daily treatment with GANIRELIX
THERAMEX 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
betwe