Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
Leuprorelin acetate
Hospira Australia Pty Ltd
Medicine Registered
ELIGARD ® 1 Eligard ® Leuprorelin (LOO-pro-rel-in) 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 being given Eligard ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. 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. 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 h Прочитайте повний документ
Product Information Version 11.0 1 ELIGARD ® NAME OF THE MEDICINE Leuprorelin acetate CAS: 74381-53-6 DESCRIPTION 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. The chemical name is 5-oxo-L-prolyl-L-histidyl- L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt). COMPOSITION Eligard ® is available in a single use kit. The kit consists of a two-syringe mixing system, a 20-gauge half-inch needle (for Eligard ® 1 month and Eligard ® 3 month) or a 20-gauge 5/8- inch needle (for Eligard ® 4 month) or a 18-gauge 5/8-inch needle (for Eligard ® 6 month), a silicone desiccant pouch to control moisture uptake, and package insert for constitution and administration procedures. Each syringe is individually packaged. One contains the Atrigel ® Delivery System and the other contains leuprorelin acetate. Eligard ® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. Eligard ® is administered subcutaneously where it forms a solid drug delivery depot. Product Information Version 11.0 2 The Atrigel ® Delivery System is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable polyglactin. The polymer is dissolved in a biocompatible solvent, _N_-methyl-2-pyrrolidone. The polyglactin mixture and volume differ with each Прочитайте повний документ