Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
leuprorelin acetate, Quantity: 45 mg
Abbvie Pty Ltd
leuprorelin acetate
Injection
Excipient Ingredients: mannitol; polylactic acid; stearic acid; glacial acetic acid; carmellose sodium; polysorbate 80; water for injections
Intramuscular
1 prefilled dual chamber syringe
(S4) Prescription Only Medicine
Lucrin Depot is indicated for the palliative treatment of metastatic or locally advanced prostate cancer.
Visual Identification: White, lyophilised powder which, when reconstituted, becomes a milky suspension; Container Type: Syringe; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-05-12
LUCRIN ® L U C R I N ® C M I - V E R S I O N 1 5 - 0 1 J u l y 2 0 2 1 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING LUCRIN? Lucrin contains the active ingredient leuprorelin acetate. Lucrin is used to treat prostate cancer in men and precocious (unusually early) puberty in children. For more information, see Section 1. Why am I using Lucrin? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LUCRIN? Check the list of ingredients at the end of the CMI. Do not use Lucrin if you have ever had an allergic reaction to any of them. Talk to your doctor before you use this medicine if he/she is not aware that you have any other medical conditions, take any other medicines or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Lucrin? in the full CMI. 3. WHAT IF I AM USING OTHER MEDICINES? Some medicines may interfere with Lucrin and affect how it works or Lucrin may interfere with other medicines and affect how they work. A list of these medicines is in Section 3. What if I am using other medicines? in the full CMI. 4. HOW DO I USE LUCRIN? • Lucrin Injection is given by your doctor or nurse. • The Lucrin dose and how frequently it is given is based on your doctor's assessment. More instructions can be found in Section 4. How do I use Lucrin? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LUCRIN? THINGS YOU SHOULD DO • Keep all your appointments, including those for blood tests or bone density checks. • Remind any doctor or dentist you visit that you are using Lucrin. THINGS YOU SHOULD NOT DO • Do not miss a scheduled injection. DRIVING OR USING MACHINES • It is unlikely that Lucrin will affect your ability to drive or use machines. DRINKING ALCOHOL • There is no information on the use of Lucrin with alcohol. LOOKING AFTER YOUR MEDICINE • Store Lucrin in a cool dry place away f Läs hela dokumentet
LUCRIN PDS PI Version 16 24 August 2021 Page 1 of 37 AUSTRALIAN PI – LUCRIN DEPOT ® AND LUCRIN DEPOT ® PAEDIATRIC (LEUPRORELIN ACETATE) PREFILLED DUAL-CHAMBER SYRINGE (PDS) INJECTION 1 NAME OF THE MEDICINE Leuprorelin acetate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LUCRIN DEPOT 1-MONTH 7.5 MG PDS INJECTION: each prefilled dual chamber syringe contains 7.5 mg leuprorelin acetate in the front chamber and 1 mL of diluent in the rear chamber. LUCRIN DEPOT 3-MONTH 22.5 MG PDS INJECTION: each prefilled dual chamber syringe contains 22.5 mg leuprorelin acetate in the front chamber and 1.5 mL of diluent in the rear chamber. LUCRIN DEPOT 4-MONTH 30 MG PDS INJECTION: each prefilled dual chamber syringe contains 30 mg leuprorelin acetate in the front chamber and 1.5 mL of diluent in the rear chamber. LUCRIN DEPOT 6-MONTH 45 MG PDS INJECTION: each prefilled dual chamber syringe contains 45 mg leuprorelin acetate in the front chamber and 1.5 mL of diluent in the rear chamber. LUCRIN DEPOT PAEDIATRIC 30 MG PDS INJECTION: each prefilled dual chamber syringe contains 30 mg leuprorelin acetate in the front chamber and 1.5 mL of diluent in the rear chamber. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Prefilled dual chamber syringe consisting of powder for injection and diluent. POWDER FOR INJECTION White lyophilised powder once reconstituted becomes a milky suspension. DILUENT Clear colourless solution. LUCRIN PDS PI Version 16 24 August 2021 Page 2 of 37 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LUCRIN Depot PDS injection is indicated for: • The palliative treatment of metastatic or locally advanced prostate cancer LUCRIN Depot Paediatric 3-Month 30mg PDS injection is indicated for: • The treatment of children with central precocious puberty (CPP). 4.2 DOSE AND METHOD OF ADMINISTRATION Overall treatment with LUCRIN must be done under the supervision of a physician; however, administration of the drug product may be done by a healthcare professional experienced in Läs hela dokumentet