Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Leuprorelin acetate
Astellas Pharma Co. Ltd
L02AE; L02AE02
Leuprorelin acetate
45 milligram(s)
Powder and solvent for solution for injection
Product subject to prescription which may not be renewed (A)
Gonadotropin releasing hormone analogues; leuprorelin
Marketed
2007-10-26
PACKAGE LEAFLET: INFORMATION FOR THE USER ELIGARD 45 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION LEUPRORELIN ACETATE. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What ELIGARD is and what it is used for 2. What you need to know before you use ELIGARD 3. How to use ELIGARD 4. Possible side effects 5. How to store ELIGARD 6. Contents of the pack and other information 1. WHAT ELIGARD IS AND WHAT IT IS USED FOR The active substance of ELIGARD belongs to the group of so-called gonadotropin releasing hormones. These medicines are used to decrease the production of certain sex hormones (testosterone). ELIGARD is used to treat hormone dependent metastatic PROSTATE CANCER in adult men and for the treatment of high-risk non-metastatic hormone dependent prostate cancer in combination with radiotherapy._ _ 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ELIGARD DO NOT USE ELIGARD If you are a WOMAN OR A CHILD If you are HYPERSENSITIVE (ALLERGIC) to the active substance leuprorelin acetate, products with an activity comparable to the naturally occurring hormone gonadotropin, or to any of the other ingredients of ELIGARD (listed in section 6). Following SURGICAL REMOVAL OF YOUR TESTES, as in that case ELIGARD does not lead to a further decrease in serum testosterone levels. As the only treatment if you suffer from symptoms related to pressure on the spinal cord or tumour in the spinal column. In this case, ELIGARD may only be used in combination with other medicinal products for prostate cance Lestu allt skjalið
Health Products Regulatory Authority 08 September 2020 CRN008RD8 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ELIGARD 45 mg powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prefilled syringe with powder for solution for injection contains 45 mg leuprorelin acetate, equivalent to 41.7 mg leuprorelin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder (Syringe B): Pre-filled syringe with a white to off-white powder. Solvent (Syringe A): Pre-filled syringe with a clear, colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ELIGARD 45 mg is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adult Males ELIGARD 45 mg should be administered under the direction of a healthcare professional having available the appropriate expertise for monitoring the response to treatment. ELIGARD 45 mg is administered as a single subcutaneous injection every six months _. _ The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate over a six-month period. As a rule, therapy of advanced prostate cancer with ELIGARD 45 mg entails long-term treatment and therapy should not be discontinued when remission or improvement occurs. ELIGARD 45 mg may be used as neoadjuvant or adjuvant therapy in combination with radiotherapy in high-risk localised and locally advanced prostate cancer. Response to ELIGARD 45 mg should be monitored by clinical parameters and by measuring prostate specific antigen (PSA) serum levels. Clinical studies have shown that testosterone levels increased during the first 3 days of treatment in the majority of non-orchiectomised patients and then decreased to below medical Lestu allt skjalið