Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VORICONAZOLE
ACCORD HEALTHCARE SDN.BHD.
VORICONAZOLE
10 (1x10) Tablets
INTAS PHARMACEUTICALS LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ VORITROP Voriconazole Tablets (50 mg and 200 mg) 1 WHAT IS IN THIS LEAFLET 1. What VORITROP tablets are used for 2. How VORITROP tablets works 3. Before you use VORITROP tablets. 4. How to use VORITROP tablets 5. While you are using VORITROP tablets. 6. Side effects 7. Storage and disposal of VORITROP tablets. 8. Product description. 9. Manufacturer and Product registration holder. 10. Date of revision. 11. Serial No. WHAT VORITROP TABLETS ARE USED FOR: 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), - Serios Candida infections including infection in the esophagus, - Serious invasive Candida sp.infections when the fungus is resistant to fluconazole (another Anti-fungal 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 breakthrough fungal infections in febrile high- risk neutropenic patients. Prevention of fungal infections in high risk bone marrow transplant in patients ≥12 years old.. HOW VORITROP TABLETS WORKS VORITROP contains the active substance voriconazole. Voriconazole is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections. BEFORE YOU USE VORITROP TABLETS - _When you must not take it_ Voriconazole must not be taken during pregnancy or breastfeeding, unless indicated by your doctor. Effective contraception must be used in women of childbearing potential. Contact your doctor immediately if you become pregnant while taking Voriconazole. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for a Přečtěte si celý dokument
Interaction table Interactions between voriconazole and other medicinal products are listed in the table below (once daily as “QD”, twice daily as “BID”, three times daily as “TID” and not determined as “ND”). The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80- 125% range. The asterisk (*) indicates a two-way interaction. AUCτ, AUCt and AUC0-∞ represent area under the curve over a dosing interval, from time zero to the time with detectable measurement and from time zero to infinity, respectively. The interactions in the table are presented in the following order: contraindications, those requiring dose adjustment and careful clinical and/or biological monitoring, and finally those that have no significant pharmacokinetic interaction but may be of clinical interest in this therapeutic field. 10. FERTILITY, PREGNANCY AND LACTATION Pregnancy There are no adequate data from the use of voriconazole in pregnant women. The potential risk for humans is unknown. Voriconazole must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus. Women of child-bearing potential Women of child-bearing potential must always use effective contraception during treatment. Breast-feeding The excretion of voriconazole into breast milk has not been investigated. Breast-feeding must be stopped on initiation of treatment with Voriconazole. 11. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Voriconazole has moderate influence on the ability to drive and use machines. It may cause transient and reversible changes to vision, including blurring, altered/enhanced visual perception and/or photophobia. Patients must avoid potentially hazardous tasks, such as driving or operating machinery while experiencing these symptoms. 12. UNDESIRABLE EFFECTS Summary of safety profile The most commonly reported adverse reactions were visual impairment, pyrex Přečtěte si celý dokument