Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
voriconazole, Quantity: 200 mg
Alphapharm Pty Ltd
Voriconazole
Tablet, film coated
Excipient Ingredients: lactose monohydrate; croscarmellose sodium; pregelatinised maize starch; povidone; magnesium stearate; titanium dioxide; hypromellose; triacetin
Oral
10, 20, 2, 56, 100, 50, 30, 14, 28
(S4) Prescription Only Medicine
VTTACK is indicated for treatment of the following fungal infections: Invasive aspergillosis. Serious Candida infections (including C. krusei), including oesophageal and systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). Serious fungal infections caused by Scedosporium spp and Fusarium spp. Other serious fungal infections, in patients intolerant of, or refractory to, other therapy. Prophylaxis in patients who are at high risk of developing invasive fungal infections. The indication is based on studies including patients undergoing haematopoietic stem cell transplantation. This brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. For dosing requirements for populations who require intravenous or oral suspension treatment see DOSAGE and ADMINISTRATION
Visual Identification: A white to off-white film-coated, capsule shaped, bivonvex tablet debossed with M164 on one side of the tablet and blank on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-09-09
VTTACK ® V T T A C K CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING VTTACK? VTTACK contains the active ingredient voriconazole. VTTACK is used to treat fungal and yeast infections. For more information, see Section 1. Why am I using VTTACK? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE VTTACK? Do not use if you have ever had an allergic reaction to voriconazole, any similar medicines, or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. VTTACK should NOT be used during pregnancy or breastfeeding, unless indicated by your doctor. Effective contraception should be used in women of childbearing potential. For more information, see Section 2. What should I know before I use VTTACK? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with VTTACK and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE VTTACK? • Your doctor will prescribe the amount required of VTTACK based on your weight. More instructions can be found in Section 4. How do I use VTTACK? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING VTTACK? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that you are using VTTACK. • Avoid going out in the sun for long periods of time while you are taking VTTACK. VTTACK can cause sensitivity to sunlight. • Make sure you follow your doctor's instructions and keep all appointments, including blood tests. • If you are about to have any blood tests, tell your doctor that you are taking this medicine. THINGS YOU SHOULD NOT DO • Do not stop taking your medicine or lower the dosage without checking with your doctor. • If you do not complete the full course prescribed by your doct Læs hele dokumentet
AUSTRALIAN PRODUCT INFORMATION VTTACK ® _Voriconazole Film-coated Tablets _ 1 NAME OF THE MEDICINE Voriconazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Voriconazole, a broad-spectrum, triazole antifungal agent, is available as film-coated tablets for oral administration. Each film-coated tablet contains 50 mg or 200 mg of voriconazole as the active ingredient. Excipients with known effect: Sugars as lactose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM VTTACK 50 mg : 50 mg film-coated tablets are a white to off-white film-coated, oval, biconvex tablet debossed with “ V26 ” on one side of the tablet and blank on the other side. VTTACK 200 mg : 200 mg film-coated tablets are a white to off-white film-coated, capsule shaped, biconvex tablet debossed with “ M164 ” on one side of the tablet and blank on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VTTACK is indicated for treatment of the following fungal infections: Invasive aspergillosis. Serious _Candida _ infections (including _C. krusei_ ), including oesophageal and systemic _Candida _ infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). Serious fungal infections caused by _Scedosporium _ spp and _Fusarium _ spp. Other serious fungal infections, in patients intolerant of, or refractory to, other therapy. Prophylaxis in patients who are at high risk of developing invasive fungal infections. The indication is based on studies including patients undergoing haematopoietic stem cell transplantation. This brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. For dosing requirements for populations who require intravenous or oral suspension treatment (see SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION ). VTTACK ® – PRODUCT INFORMATION 2 4.2 DOSE AND METHOD OF ADMINISTRATION This product is only registered in tablet dosage form and therefore only indicated for adults and children 12 years Læs hele dokumentet