Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
cidofovir
Gilead Sciences International Limited
J05AB12
cidofovir
Antivirals for systemic use
Cytomegalovirus Retinitis
Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable.,
Revision: 21
Withdrawn
1997-04-23
19 B. PACKAGE LEAFLET Medicinal product no longer authorised 20 PACKAGE LEAFLET: INFORMATION FOR THE USER VISTIDE 75 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Cidofovir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Vistide is and what it is used for 2. Before you use Vistide 3. How to use Vistide 4. Possible side effects 5. How to store Vistide 6. Further information 1. WHAT VISTIDE IS AND WHAT IT IS USED FOR VISTIDE IS USED TO TREAT AN EYE INFECTION CALLED CMV RETINITIS IN PATIENTS WITH AIDS (ACQUIRED IMMUNODEFICIENCY SYNDROME). Vistide will not cure CMV retinitis but may improve your condition by delaying progression of the disease. The safety and efficacy of Vistide has not been demonstrated in diseases other than CMV retinitis in patients with AIDS. Vistide must be administered by a healthcare professional (doctor or nurse) in a hospital setting. WHAT IS CMV RETINITIS? CMV retinitis is an eye infection caused by a virus named cytomegalovirus (CMV). CMV attacks the retina of the eye and may cause loss of vision, and eventually lead to blindness. Patients with AIDS are at high risk of developing CMV retinitis or other forms of CMV disease such as colitis (an inflammatory bowel disease). Treatment for CMV retinitis is necessary to reduce the potential for blindness. Vistide is an antiviral medicine which blocks the replication of CMV by interfering with viral DNA production. 2. BEFORE YOU USE VISTIDE DO NOT USE VISTIDE • IF YOU ARE ALLERGIC _(HYPERSENSITIVE)_ to cidofovir or any of the other ingredients of Vistide. • IF YOU HAVE EVER HAD KIDNEY DISEASE. • IF Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Vistide 75 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 75 mg cidofovir anhydrous. Each vial contains 375 mg/5 ml cidofovir anhydrous as the active substance. Excipients: Each vial contains approximately 2.5 mmol (or 57 mg) sodium per vial (5 ml) as a constituent of the excipients. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear solution. The formulation is adjusted to pH 7.4. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vistide is indicated for the treatment of CMV retinitis in adults with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The therapy should be prescribed by a physician experienced in the management of HIV infection. Before each administration of Vistide, serum creatinine and urine protein levels should be investigated. Vistide must be administered with oral probenecid and intravenous saline as described below (see section 4.4 for appropriate recommendations, and under section 6.6 for information on obtaining probenecid). Posology _Adults:_ Induction treatment. The recommended dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once weekly for two consecutive weeks. Maintenance treatment. Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once every two weeks. Suspension of maintenance treatment with cidofovir should be considered in accordance with local recommendations for the management of HIV infected patients. _Elderly population:_ The safety and efficacy of Vistide have not been e Lesen Sie das vollständige Dokument