VORICONAZOLE-GX voriconazole 200mg tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
26-11-2017

Aktivna sestavina:

voriconazole, Quantity: 200 mg

Dostopno od:

Medis Pharma Pty Ltd

INN (mednarodno ime):

Voriconazole

Farmacevtska oblika:

Tablet, film coated

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

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

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

Visual Identification: white, oval biconvex tablets, debossed 'VC200' 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

Status dovoljenje:

Licence status A

Datum dovoljenje:

2015-02-02