País: Suècia
Idioma: suec
Font: Läkemedelsverket (Medical Products Agency)
buserelinacetat
Orifarm AB
L02AE01
buserelin acetate
9,45 mg
Implantat
buserelinacetat 9,9 mg Aktiv substans
Apotek
Receptbelagt
Buserelin
Avregistrerad
2014-01-09
PACKAGE LEAFLET: INFORMATION FOR THE USER SUPREFACT DEPOT 9.45 MG IMPLANT BUSERELIN 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 or pharmacist. 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 Suprefact Depot is and what it is used for 2. What you need to know before you use Suprefact Depot 3. How to use Suprefact Depot 4. Possible side effects 5. How to store Suprefact Depot 6. Contents of the pack and other information 1. WHAT SUPREFACT DEPOT IS AND WHAT IT IS USED FOR WHAT SUPREFACT DEPOT IS Suprefact Depot contains a medicine called buserelin. Buserelin is similar to a natural hormone released by the brain. It belongs to a group of medicines called ‘luteinizing-hormone-releasing hormones analogues’ ( LHRH analogues) . HOW SUPREFACT DEPOT WORKS It works by lowering the amount of hormones which promote prostate tumour growth. Prostate is a gland that lies underneath the bladder of men. WHAT SUPREFACT DEPOT IS USED FOR Suprefact Depot is used to treat advanced prostate cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SUPREFACT DEPOT DO NOT USE SUPREFACT DEPOT : If you are allergic to buserelin, to other LHRH analogues (e.g. leuprolide, goserelin, triptorelin) or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before starting treatment with Suprefact Depot. 1 WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING SUPREFACT DEPOT : If you have had your testicles removed. If your cancer has spread (metastatic Llegiu el document complet
1 NAME OF THE MEDICINAL PRODUCT Suprefact Depot 9.45 mg implant 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe with three identical rod-shaped implants contains, as active ingredient, 9.9 mg buserelin acetate, equivalent to 9.45 mg buserelin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Implants Each implant consists of three creamy-coloured rod-shaped implant. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Suprefact Depot is indicated in adults for the treatment of advanced hormone-dependent prostatic carcinoma. However, Suprefact Depot is not indicated after bilateral orchiectomy as there would be no further reduction in testosterone levels. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Suprefact Depot is intended for the long-term treatment of advanced prostatic carcinoma. _Paediatric population_ Suprefact Depot should not be used in children. The safety and efficacy of Suprefact Depot in children has not been established. Method of administration The contents of the syringe (three implant rods, equivalent to 9.45 mg buserelin) are injected subcutaneously into the abdominal wall every three months (see section 6.6). The three month interval between injections may, however, occasionally be extended by up to three weeks. Before injection, a local anaesthetic may be given. It is recommended that administration of an anti-androgen is started as adjunctive therapy about 5 days before starting Suprefact Depot (see also section 4.4). 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance , LHRH analogues or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE It is recommended that administration of an anti-androgen is started as adjunctive therapy about 5 days before starting Suprefact Depot. This supplementary treatment must be continued in parallel with buserelin therapy for 3 – 4 weeks. After this time testosterone levels have usually fallen into the desired range in response to buserelin. In patients with kn Llegiu el document complet