Država: Izrael
Jezik: angleščina
Source: Ministry of Health
VORICONAZOLE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
J02AC03
FILM COATED TABLETS
VORICONAZOLE 50 MG
PER OS
Required
R - PHARM GERMANY GMBH
VORICONAZOLE
VORICONAZOLE
Treatment of:- invasive aspergillosis,- fluconazole-resistant serious invasive Candida infections (including C. krusei) - serious fungal infections caused by scedosporium spp. and fusarium spp.- Vfend should be administered primarily to immunocompromised patients with progressive possibly life-threatening infections. - Treatment of candidemia in non neutropenic patients.- Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
2012-10-31
Vfend POS; Film-Coated Tablets PIL CC 17 August 2023 English 2023-0084997 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only VFEND ® 50 MG FILM-COATED TABLETS VFEND ® 200 MG FILM-COATED TABLETS VFEND ® 40 MG/ML POWDER FOR ORAL SUSPENSION FILM-COATED TABLETS: VORICONAZOLE 50 MG, 200 MG EACH ML OF RECONSTITUTED SUSPENSION CONTAINS: VORICONAZOLE 40 MG Inactive ingredients and allergens: see section 2 under “Important information about some of this medicine’s ingredients” and section 6 “Further information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? VFEND is a broad-spectrum antifungal preparation intended for the treatment of: • invasive aspergillosis (a fungal infection caused by _Aspergillus sp._) • _Candida_ infections in the blood system (candidemia) in non-neutropenic patients • invasive infections of _Candida_ that are resistant to fluconazole (another antifungal medicine), including _C. krusei_ • severe fungal infections caused by _Scedosporium _and _Fusarium_ type of fungi. VFEND is intended for patients with severe, possibly life-threatening, fungal infections. VFEND is intended for the prevention of invasive fungal infections in high-risk bone marrow transplant recipients. THERAPEUTIC GROUP: Antifungal from the triazole group. It works by killing or stopping the growth of different fungi that cause infections. 2. BEFORE USING THIS MEDICINE Vfend POS; Film-Coated Tablets PIL CC 17 August 2023 English 2023-0084997 2 DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the additional ingredients Preberite celoten dokument
VFEND IV, POS & Film-Coated Tablets LPD CC 07 January 2024 2022-0080286; 2023-0084030 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT VFEND ® 200 mg Powder for Solution for Infusion VFEND ® 50 mg Film-Coated Tablets VFEND ® 200 mg Film-Coated Tablets VFEND ® 40 mg/mL Powder for Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _VFEND Powder for solution for infusion: _ Each vial contains 200 mg of voriconazole. After reconstitution, each ml contains 10 mg of voriconazole. Once reconstituted further dilution is required before administration. Excipients with known effect Each vial contains 221 mg sodium. Each vial contains 3,200 mg cyclodextrin. _VFEND Film-coated tablets: _ Each tablet contains 50 mg or 200 mg voriconazole. Excipient with known effect Each 50 or 200 mg tablet contains 62.5 or 250.0 mg lactose monohydrate respectively. _VFEND Powder for oral suspension: _ Each ml of oral suspension contains 40 mg of voriconazole when reconstituted with water. Each bottle contains 3 g of voriconazole. Excipient with known effect: Each ml of suspension contains 0.54 g sucrose. Each ml of suspension contains 2.40 mg sodium benzoate. FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1. 3. PHARMACEUTICAL FORM _VFEND Powder for solution for infusion: _ Powder for solution for infusion is a white lyophilised powder containing nominally 200 mg voriconazole presented in a 30 ml clear glass vial. _VFEND Film-coated tablets: _ VFEND 50 mg film-coated tablets are white to off-white, round tablets, debossed “Pfizer” on one side and “VOR50” on the reverse. VFEND 200 mg film-coated tablets are white to off-white, capsule-shaped tablets, debossed “Pfizer” on one side and “VOR200” on the reverse. _VFEND Powder for oral suspension: _ Powder for oral suspension is a white to off-white powder providing a white to off-white opaque fluid containing undissolved solids when constituted. VFEND IV, POS & Film-Coated Tablets LPD CC 07 January 2024 2022-0080286; 2023-0084030 2 4. CLINICAL PART Preberite celoten dokument