Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
VORICONAZOLE
Apotex Europe B.V.
J02AC03
VORICONAZOLE
200 Milligram
Film Coated Tablet
oral use
14, 20, 28, 30, 56 and 100 tablets.
Product subject to prescription which may not be renewed (A)
Apotex Research Private Limited
Antimycotics for systemic use, triazole derivatives
voriconazole
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 candidemia 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 Apotex 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
Not Marketed
2015-10-23
VORICONAZOLE APOTEX 50 MG, 200 MG FILM-COATED TABLETS MODULE 1.3 Product Information Version: 2017-06-09 MODULE 1.3.1 Package Leaflet Replaces: 2016-02 1 PACKAGE LEAFLET: INFORMATION FOR THE USER VORICONAZOLE APOTEX 50 MG FILM-COATED TABLETS VORICONAZOLE APOTEX 200 MG FILM-COATED TABLETS 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 Apotex is and what it is used for 2. What you need to know before you take Voriconazole Apotex 3. How to take Voriconazole Apotex 4. Possible side effects 5. How to store Voriconazole Apotex 6. Content of the pack and other information 1. WHAT VORICONAZOLE APOTEX IS AND WHAT IT IS USED FOR Voriconazole Apotex contains the active substance voriconazole. Voriconazole Apotex 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 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 Apotex is intended for patients with worsening, possibly life-threatening, fungal i Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Voriconzaole Apotex 200mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg voriconazole Excipient(s) with known effect: Voriconazole Apotex 200 mg film-coated tablets: Each tablet contains 364.00 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White coloured, modified oval-shaped, bi-convex film-coated tablet (size: 15.50 x 7.90 mm), engraved “APO” on one side and “VOR 200” on the other side. 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 candidemia 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 Apotex 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). Voriconazole Apotex is available as 50 mg film-coated tablets and 200 mg film-coated tablets. Treatment _Adults _ Therapy must be initiated with the specified loading dose regimen of either intravenous or oral Voriconazole Apotex 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 clinically indicated. H E A L T H P R O D U C T S R E G U L A T O R Y Citiți documentul complet