Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEUPRORELIN ACETATE
GP-PHARM, S.A.
L02AE; L02AE02
LEUPRORELIN ACETATE
22.5 milligram(s)
Pdr+Solv for PR for Susp for Inj
Intramuscular injection
Kit including: 1 vial, 1 prefilled syringe, 1 sterile needle
Product subject to prescription which may not be renewed (A)
GP-PHARM, S.A.
Endocrine therapy. Hormones and related agents. Gonadotropin-releasing hormones
Gonadotropin releasing hormone analogues; leuprorelin
It is indicated for palliative treatment of hormone dependent advanced prostate cancer.
Not marketed
2015-06-19
LUTRATE DEPOT 22.5 MG MODULE 1 SECTION 1.3.1 PAGE 1/11 Lut(3m)-ie-pl-v03-Var PRAC-clean-Ago2018 PACKAGE LEAFLET: INFORMATION FOR THE USER LEUPRORELIN 3-MONTH DEPOT 22.5 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION leuprorelin acetate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Leuprorelin 3-month Depot is and what it is used for 2. What you need to know before you use Leuprorelin 3-month Depot 3. How to use Leuprorelin 3-month Depot 4. Possible side effects 5. How to store Leuprorelin 3-month Depot 6. Contents of the pack and other information 1. WHAT LEUPRORELIN 3-MONTH DEPOT IS AND WHAT IT IS USED FOR _ _ Leuprorelin 3-month Depot is a vial containing a white powder, which is made into a suspension for injection into a muscle. Leuprorelin 3-month Depot contains the active ingredient leuprorelin (also called LEUPROLIDE), which belongs to a group of medicines called luteinizing hormone releasing hormone (LHRH) agonists (medicines that reduce testosterone – a sex hormone). Your doctor has prescribed Leuprorelin 3-month Depot for_ _palliative treatment of advanced prostate cancer. LUTRATE DEPOT 22.5 MG MODULE 1 SECTION 1.3.1 PAGE 2/11 Lut(3m)-ie-pl-v03-Var PRAC-clean-Ago2018 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LEUPRORELIN 3-MONTH DEPOT DO NOT USE LEUPRORELIN 3-MONTH DEPOT: - if you are allergic (hypersensitive) to LHRH, LHRH agonists or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty of Read the complete document
Health Products Regulatory Authority 24 January 2019 CRN008VHS Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Leuprorelin 3-month Depot 22.5mg Powder and Solvent for Prolonged-release Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 22.5 mg of leuprorelin acetate (equivalent to 21.42 mg leuprorelin free base). 1 mL of reconstituted suspension contains 11.25 mg of leuprorelin acetate. _Excipients with known effect:_ Each vial contains from 1.6 to 2.7 mg (<1 mmol) of sodium (as carmellose sodium). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for prolonged-release suspension for injection. Powder: white to off-white powder. Solvent: clear, colorless and particle free solution (pH 5.0 – 7.0). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Leuprorelin 3-month Depot is indicated for palliative treatment of hormone dependent advanced prostate cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual recommended dose of Leuprorelin 3-month Depot is 22.5 mg presented as a three months depot injection and administered as a single intramuscular injection every three months. Leuprorelin 3-month Depot must be administered under direction of healthcare professional having the appropriate expertise for monitoring the response to treatment. The dose of Leuprorelin 3-month Depot 22.5 mg allowing the continuous release of leuprorelin acetate over a three month period is incorporated in a depot formulation. The lyophilized powder should be reconstituted and administered as a single Health Products Regulatory Authority 24 January 2019 CRN008VHS Page 2 of 17 intramuscular injection every three months. Intraarterial or intravenous administration must be avoided. The vial of Leuprorelin 3-month Depot microsphere powder should be reconstituted immediately prior to administration by intramuscular injection. As with other drugs administered regularly by injection, the injection site should be varied periodi Read the complete document