Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
leuprorelin acetate, Quantity: 22.5 mg
Mundipharma Pty Ltd
Injection, modified release
Excipient Ingredients: N-methyl-2-pyrrolidone; polyglactin
Subcutaneous
1 injection, containing syringe A & syringe B.
(S4) Prescription Only Medicine
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.
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
Licence status A
2003-11-26
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 Read the complete document
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 Read the complete document