Country: Malta
Bahasa: Inggeris
Sumber: Malta Medicines Authority
VORICONAZOLE
Vocate Pharmaceuticals S.A 150, Gounari str, 166 74 Glyfada, Athens, Greece
J02AC03
VORICONAZOLE 200 mg
POWDER FOR SOLUTION FOR INFUSION
VORICONAZOLE 200 mg
POM
ANTIMYCOTICS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-07-29
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER VORICONAZOLE VOCATE 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 Vocate is and what it is used for 2. What you need to know before you take Voriconazole Vocate 3. How to use Voriconazole Vocate 4. Possible side effects 5. How to store Voriconazole Vocate 6. Content of the pack and other information 1. WHAT VORICONAZOLE VOCATE IS AND WHAT IT IS USED FOR Voriconazole Vocate contains the active substance voriconazole. Voriconazole Vocate 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: • candidaemia (another type of fungal infection due to _Candida sp_ ) in non-neutropenic patients (patients without abnormally low white blood cells 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 Vocate is intended for patients with worsening, possibly life-threatening, fungal infections. Prevention of fungal infections in high risk bone marrow transplant recipients. This product should only be used under the supervision of a doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VORICONAZOLE VOCATE DO NOT TAKE VORICONAZOLE VOCATE: - Baca dokumen lengkap
Page 1 of 34 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 34 1. NAME OF THE MEDICINAL PRODUCT Voriconazole Vocate 200 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 200mg of voriconazole. After reconstitution each ml contains 10mg of voriconazole. Once reconstituted further dilution is required before administration. Excipient with known effect Each vial contains 220.8 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion white to off-white lyophilizate. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Voriconazole Vocate is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: -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 Vocate 200 mg powder for solution for infusion 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). Page 3 of 34 It is recommended that Voriconazole Vocate is administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours. Treatment _Adults _ Therapy must be initiated with the specified loading dose regimen of either intravenous or oral Voriconazole Vocate to achieve plasma concentrations on Day 1 that are close to steady state. On the basis of the high oral bioavailability (96%; see section 5.2), switching between intravenous and oral administration is appropriate when cl Baca dokumen lengkap