Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Voriconazole 200mg
Neo Health (NZ) Limited
Voriconazole 200 mg
200 mg
Powder for injection
Active: Voriconazole 200mg Excipient: Hydrochloric acid Hydroxypropyl-beta-cyclodextrin Sodium chloride Water for injection
Prescription
Dishman Pharmaceuticals & Chemicals Ltd
Voriconazole 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.
Package - Contents - Shelf Life: Vial, glass, Type I sealed with rubber stopper and aluminium cap with plastic flip-off seal - 1 dose units - 30 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2016-09-07
Voriconazole CMI New Zealand 1 VORICONAZOLE IV INJECTION _Voriconazole (vori-con-a-zole) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about voriconazole. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking voriconazole against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE TAKING VORICONAZOLE AND KEEP THIS LEAFLET. You may need to read it again. WHAT VORICONAZOLE IS USED FOR Voriconazole is used to treat fungal and yeast infections such as: • invasive aspergillosis (as-pur-ji-losis), a fungal infection caused by a fungus called _Aspergillus _ (as-pur-jilus), which usually begins in the respiratorytract (in the nose, sinuses or lungs). Aspergillus is harmless in most healthy people; however, in people with poor immune systems (such as people who have had organ transplants and people with cancer or HIV/AIDS) invasive aspergillosis can be serious and spread to other tissues and organs • serious _Candida _ (can-did-da) infections, including _Candida_ infections of the food pipe and those that have spread into the blood stream or to other parts of the body • serious fungal infections caused by _Scedosporium _ (ski-doe- sporerium) species and _Fusarium _ (fewsaa-rium) species • other serious fungal infections in patients who do not respond to, or cannot tolerate, other antifungal medicines. This medicine belongs to a group of medicines called triazole antifungals. This medicine works by preventing the growth of fungal and yeast organisms causing your infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s p Baca dokumen lengkap
Page 1 of 32 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Voriconazole (Neo Health) 200mg powder for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IV powder for injection Each vial contains 200mg of voriconazole The lyophilised powder contents of the Voriconazole 200 mg vials are intended for reconstitution with 19 mL Water for Injections to produce a solution containing 10 mg/mL voriconazole and 120mg/ml hydroxypropyl beta cyclodextrine (HP-β-CD) and 11.87mg/ml of sodium chloride. The resulting solution is further diluted prior to administration as an intravenous infusion (see SECTION 6.6 ) For full list of excipients, see SECTION 6.1 3. PHARMACEUTICAL FORM Powder for Injection White to off white lyophilized powder containing nominally 200mg voriconazole in a 30ml Type 1 clear glass vial. Voriconazole is intended for administration by intravenous infusion. It is a single dose, unpreserved product. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Voriconazole 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. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE _USE IN 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. Page 2 of 32 Intravenous administration is not recommended for the treatment of oesophageal candidiasis; dosage recommendations for oesophageal candidiasis are provided in the following table. DETAILED INFORMATION ON DOSAG Baca dokumen lengkap