Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Voriconazole
Aspire Pharma Ltd
J02AC03
Voriconazole
200mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100; GTIN: 5060209731490
PACKAGE LEAFLET: INFORMATION FOR THE USER VORICONAZOLE 50 MG FILM-COATED TABLETS VORICONAZOLE 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 is and what it is used for 2. What you need to know before you take Voriconazole 3. How to take Voriconazole 4. Possible side effects 5. How to store Voriconazole 6. Contents of the pack and other information 1. WHAT VORICONAZOLE IS AND WHAT IT IS USED FOR Voriconazole contains the active substance voriconazole. Voriconazole 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 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 taken under the supervision of a doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VORICONAZOLE DO Przeczytaj cały dokument
OBJECT 1 VORICONAZOLE 200MG FILM-COATED TABLETS Summary of Product Characteristics Updated 04-May-2018 | Aspire Pharma Ltd 1. Name of the medicinal product Voriconazole 200 mg film-coated tablets 2. Qualitative and quantitative composition Each tablet contains 200 mg voriconazole. Excipient with known effect Each tablet contains 232.68 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film coated tablet White to off-white, oval biconvex film coated tablets, with code V200 on one side, 15.7 ±0.2 mm in length and 7.9 ±0.2 mm in width. 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). Voriconazole is also available as 50 mg film-coated tablets and 200 mg powder for solution for infusion. Treatment _Adults_ Therapy must be initiated with the specified loading dose regimen of either intravenous or oral Voriconazole 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. Detailed information on dosage reco Przeczytaj cały dokument