Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
voriconazole, Quantity: 50 mg
Sandoz Pty Ltd
Voriconazole
Tablet, film coated
Excipient Ingredients: povidone; croscarmellose sodium; lactose monohydrate; magnesium stearate; pregelatinised maize starch; titanium dioxide; hypromellose; triacetin
Oral
56
(S4) Prescription Only Medicine
Voriconazole Sandoz 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: White to off-white, round, biconvex, film coated tablets with '50' debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-03-17
Voriconazole Sandoz® 1 VORICONAZOLE SANDOZ® 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 VORICONAZOLE SANDOZ? Voriconazole Sandoz contains the active ingredient voriconazole. Voriconazole Sandoz is used to treat fungal and yeast infections. For more information, see Section 1. Why am I using Voriconazole Sandoz? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE VORICONAZOLE SANDOZ? Do not use if you have ever had an allergic reaction to voriconazole 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. VORICONAZOLE SANDOZ 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 Voriconazole Sandoz? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Voriconazole Sandoz 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 VORICONAZOLE SANDOZ? • Your doctor will prescribe the amount required of Voriconazole Sandoz based on your weight. More instructions can be found in Section 4. How do I use Voriconazole Sandoz? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING VORICONAZOLE SANDOZ? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Voriconazole Sandoz. • Avoid going out in the sun for long periods of time while you are taking Voriconazole Sandoz. Voriconazole Sandoz 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 সম্পূর্ণ নথি পড়ুন
220906-voriconazole-sandoz-pi Page 1 of 36 AUSTRALIAN PRODUCT INFORMATION VORICONAZOLE SANDOZ ® (VORICONAZOLE) FILM-COATED TABLETS 1. NAME OF THE MEDICINE Voriconazole 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Voriconazole Sandoz 50 mg film-coated tablet contains 50 mg of voriconazole. Each Voriconazole Sandoz 200 mg film-coated tablet contains 200 mg of voriconazole. _Not all strengths may be marketed. _ _Excipient with known effect:_ Each tablet contains sugars as lactose. _ _ For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Voriconazole Sandoz 50 mg tablets - White to off-white, round, biconvex, film coated tablets with ‘50’ debossed on one side and plain on other side. Voriconazole Sandoz 200 mg tablets - White to off-white, biconvex, capsule shaped film coated tablets with ‘200’ debossed on one side and plain on other side 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Voriconazole Sandoz 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. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE This brand is only available as tablets and therefore only indicated for adults and children 12 ye সম্পূর্ণ নথি পড়ুন