VORICONAZOLE-GX voriconazole 50mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

voriconazole, Quantity: 50 mg

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Voriconazole

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; magnesium stearate; povidone; titanium dioxide; hypromellose; triacetin; macrogol 3350

Administration route:

Oral

Units in package:

2, 56, 10, 14, 28, 20, 30, 100, 50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VORICONAZOLE-GX 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.

Product summary:

Visual Identification: white, round biconvex tablets, debossed 'VC50' on one side and plain on the reverse'; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-02-02