ELIGARD leuprorelin acetate 30mg modified release injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

leuprorelin acetate, Quantity: 30 mg

Available from:

Mundipharma Pty Ltd

Pharmaceutical form:

Injection, modified release

Composition:

Excipient Ingredients: N-methyl-2-pyrrolidone; polyglactin

Administration route:

Subcutaneous

Units in package:

1 injection, containing syringe A & syringe B.

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prostate cancer,ELIGARD 7.5mg 1 month, ELIGARD 22.5mg 3 month, ELIGARD 30mg 4 month and ELIGARD 45mg 6 month are indicated for the:,? Palliative treatment of advanced prostate cancer.,? Treatment of high-risk localised and locally advanced hormone-dependent prostate cancer in combination with radiotherapy.

Product summary:

Visual Identification: Colourless to pale yellow clear viscous solution. May contain air bubbles but if free from visible particles and foreign matter.; Container Type: Syringe; Container Material: Plastic; Container Life Time: 2 Years; Container Temperature: Store below 8 degrees Celsius (refrigerate); Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2003-11-26

Patient Information leaflet

ELIGARD®
1
This medicine is subject to additional monitoring due to approval of
an extension of indications. This will allow quick
identification of new safety information. You can help by reporting
any side effects you may get. You can report side effects to
your doctor, or directly at www.tga.gov.au/reporting-problems.
ELIGARD
®
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 BEING GIVEN ELIGARD?
ELIGARD contains the active ingredient leuprorelin acetate. ELIGARD is
used to reduce the symptoms of advanced cancer of the
prostate gland, or to treat high-risk localised prostate cancer in
combination with radiotherapy. ELIGARD is also used to treat
early puberty in children 2 years of age and older (central precocious
puberty).
For more information, see Section 1. Why am I being given
ELIGARD? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE AM I GIVEN ELIGARD?
Do not use ELIGARD if you have ever had an allergic reaction to
leuprorelin acetate 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
am I given ELIGARD? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ELIGARD 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 AM I GIVEN ELIGARD?
•
Your doctor will decide what dose of ELIGARD you will receive.
•
ELIGARD should only be given to you by a doctor or nurse.
More instructions can be found in Section 4. How am I given
ELIGARD? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN ELIGARD?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using ELIGARD.
•
Keep all of your doctor's appointments so that your pro

Summary of Product characteristics

ELIGARD
®
MODIFIED RELEASE INJECTION SYRINGE
Page 1 of 24
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
ELIGARD
® (LEUPRORELIN ACETATE) MODIFIED RELEASE INJECTION
SYRINGE
1
NAME OF THE MEDICINE
Leuprorelin acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ELIGARD is a sterile polymeric matrix formulation of leuprorelin
acetate for subcutaneous
injection. It is designed to deliver leuprorelin acetate at a
controlled rate over a therapeutic
period.
Leuprorelin acetate is a synthetic nonapeptide analogue of naturally
occurring gonadotropin
releasing hormone (GnRH or LH-RH) that, when given continuously,
inhibits pituitary
gonadotropin secretion and suppresses testicular steroidogenesis. The
analogue possesses
greater potency than the natural hormone.
ELIGARD 1 month contains 10.6 mg of lyophilised leuprorelin acetate.
ELIGARD 1 month
delivers 7.5 mg of leuprorelin acetate (equivalent to approximately
7.0 mg leuprorelin free
base) dissolved in 160 mg N-methyl-2-pyrrolidone and 82.5 mg
polyglactin. The approximate
weight of the administered formulation is 250 mg. It is designed to
deliver 7.5 mg of
leuprorelin acetate at a controlled rate over a 1 month therapeutic
period.
ELIGARD 3 month contains 29.2 mg lyophilised leuprorelin acetate.
ELIGARD 3 month delivers
22.5 mg of leuprorelin acetate (equivalent to approximately 21 mg
leuprorelin free base)
dissolved in 193.9 mg N-methyl-2-pyrrolidone and 158.6 mg polyglactin.
The approximate
weight of the administered formulation is 375 mg. It is designed to
deliver 22.5 mg of
leuprorelin acetate at a controlled rate over a 3 month therapeutic
period.
ELIGARD 4 month contains 37.2 mg lyophilised leuprorelin acetate.
ELIGARD 4 month delivers
30 mg of leuprorelin acetate (equivalent to approximately 28 mg
leuprorelin free base)
dissolve