Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
voriconazole
Hikma Farmaceutica (Portugal) S.A.
J02AC03
voriconazole
Antimycotics for systemic use
Bacterial Infections and Mycoses; Aspergillosis; Candidiasis
Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:treatment of invasive aspergillosis;treatment of candidaemia in non-neutropenic patients;treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections.Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT)recipients.
Revision: 12
Authorised
2015-05-27
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER VORICONAZOLE HIKMA 200 MG POWDER FOR SOLUTION FOR INFUSION voriconazole 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,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 signs of illness 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 Voriconazole Hikma is and what it is used for 2. What you need to know before you take Voriconazole Hikma 3. How to take Voriconazole Hikma 4. Possible side effects 5. How to store Voriconazole Hikma 6. Contents of the pack and other information 1. WHAT VORICONAZOLE HIKMA IS AND WHAT IT IS USED FOR Voriconazole Hikma contains the active substance voriconazole. Voriconazole Hikma is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections. It is used for the treatment of patients (adults and children over the age of 2) with: • invasive aspergillosis (a type of fungal infection due to _Aspergillus sp._ ), • candidaemia (another type of fungal infection due to _Candida sp._ ) in non-neutropenic patients (patients without abnormally low white blood cell count), • serious invasive _Candida sp. _ infections when the fungus is resistant to fluconazole (another antifungal medicine), • serious fungal infections caused by _Scedosporium sp._ or _Fusarium sp._ (two different species of fungi). Voriconazole Hikma is intended for patients with worsening, possibly life-threatening, fungal infections. Prevention of fungal infections in high risk bone marrow transplant recipients. This medicinal product should only be used under the supervision of a doctor. 2. WH Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Voriconazole Hikma 200 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 200 mg of voriconazole. After reconstitution each ml contains 10 mg of voriconazole. Once reconstituted further dilution is required before administration. Excipient with known effect Each vial contains 217.6 mg sodium. Each vial contains 3,200 mg cyclodextrin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion (powder for infusion) White to off-white lyophilised cake. pH of the reconstituted solution is 4.0 to 7.0. Osmolality: 500± 50 mOsm/kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: • Treatment of invasive aspergillosis. • Treatment of candidaemia in non-neutropenic patients • Treatment of fluconazole-resistant serious invasive _Candida_ infections (including _C. krusei_ ). • Treatment of serious fungal infections caused by _Scedosporium_ spp. and _Fusarium_ spp. Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.4). 3 It is recommended that voriconazole is administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours. _ _ Treatment _Adults _ Voriconazole Hikma 200 mg powder for solution for infusion is for intravenous use only. Oral dosage forms of voriconazole are available from other manufacturers. Therapy must be initiated with the specified loading dose regimen of either in Przeczytaj cały dokument