Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Voriconazole 200mg
Max Health Limited
Voriconazole 200 mg
200 mg
Powder for infusion
Active: Voriconazole 200mg Excipient: Hydrochloric acid Hydroxypropyl-beta-cyclodextrin Sodium chloride
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 (25 mL capacity), with chlorobutyl stopper, aluminium cap and plastic flip-off seal - 1 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2016-05-17
Page 1 of 37 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Voriconazole 200 mg Powder for Infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 200 mg of voriconazole. After reconstitution, each ml contains 10 mg of voriconazole. Once reconstituted further dilution is required before administration. Excipient with known effect: each vial contains 88.74 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for infusion. White to off-white lyophilised powder. pH: 5.0 – 7.0 Osmolality: 530 mOsm/Kg ± 10% 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 Therapy must be initiated with the specified loading dose regimen 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 Pharmacokinetic properties) switching between intravenous and oral administration is appropriate when clinically indicated. Intravenous administration is not recommended for the treatment of oesophageal candidiasis. Page 2 of 37 DETAILED INFORMATION ON DOSAGE RECOMMENDATIONS: INTRAVENOUS ORAL PATIENTS 40 KG OR ABOVE PATIENTS 40 KG OR ABOVE SERIOUS INVASIVE _CANDIDA _INFECTIONS Loading dose regimen (first 24 hours) 6 mg/kg every 12 hours (for the first 24 hours) 400 mg or 10 mL every 12 hours (for the first 24 hours) 200 mg or 5 mL every 12 hours (for the first 24 hours) Maintenance dose (after first 24 hours) 3 mg/kg every 12 hours 200 mg or 5 mL twice daily 100 mg or 2.5 mL twice daily OESOPHAGEAL CANDIDIASIS Прочитать полный документ