ELIGARD leuprorelin acetate 45 mg modified release injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

leuprorelin acetate, Quantity: 45 mg

Available from:

Mundipharma Pty Ltd

INN (International Name):

leuprorelin acetate

Pharmaceutical form:

Injection, modified release

Composition:

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

Administration route:

Subcutaneous

Units in package:

1 Injection: the product is presented in a pack containing both Syringe A (Atrigel Delivery System) and Syringe B (leuprorelin acetate)

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.,Central precocious puberty (CPP),ELIGARD 45mg 6 month is indicated for the treatment of children 2 years of age and older with central precocious puberty (CPP).

Product summary:

Visual Identification: Colourless to pale yellow, clear, viscous solution. May contain air bubbles but is substantially free of 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:

Licence status A

Authorization date:

2005-09-16

Patient Information leaflet

ELIGARD
®
_Leuprorelin acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ELIGARD. 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 ELIGARD
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ELIGARD IS
USED FOR
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. This
medicine is similar to a hormone
called gonadotrophin releasing
hormone, which is normally released
from the brain.
When it is given regularly to males,
this medicine works by reducing the
amount of testosterone produced.
This inhibits the growth of prostate
cancers which rely on testosterone to
grow.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
ELIGARD
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN ELIGARD
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
leuprorelin
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines (such
as goserelin).
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT USE ELIGARD FOLLOWING
SURGICAL REMOVAL OF YOUR TESTES, AS
IN THAT CASE ELIGARD DOES NOT
LEAD TO FURTHER DECREASE IN SERUM
TESTOSTERONE LEVELS.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU ARE PREGNANT OR
PLAN TO BECOME PREGNANT OR ARE
BRE

Summary of Product characteristics

ELIGARD
®
MODIFIED RELEASE INJECTION SYRINGE
Page 1 of 20
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)
dissolved in 258.5 mg N-methyl-2-pyrrolidone and 211.5 mg polyglactin.
The approximate
weight of the administered formulation is 500 mg. It is designed to
deliver 30 mg of leuprorelin
acetate at a controlled rate over a 4 month therapeutic period.
ELIGARD 6 month c