ITRACONAZOLE GXP itraconazole 100 mg capsule blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

itraconazole, Quantity: 100 mg

Disponibil de la:

Arrotex Pharmaceuticals Pty Ltd

INN (nume internaţional):

Itraconazole

Forma farmaceutică:

Capsule

Compoziție:

Excipient Ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Calea de administrare:

Oral

Unități în pachet:

60 capsules, 6 capsules, 4 capsules, 15 capsules, 28 capsules

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

ITRACONAZOLE GXP is indicated for use in adults for the treatment of: ? Superficial dermatomycoses not responding to topical treatment. ? Fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. ? Pityriasis versicolor not responding to any other treatment. ? Vulvovaginal candidiasis not responding to topical treatment. ? Oral candidiasis in immunocompromised patients. ? Onychomycosis caused by dermatophytes. ? Systemic mycoses: - Systemic aspergillosis, histoplasmosis, sporotrichosis. - Treatment and maintenance therapy in AIDS patients with disseminated or chronic pulmonary histoplasmosis infection. - Treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - Treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

Rezumat produs:

Visual Identification: Size 0el hard gelatin white opaque capsules filled with off-white to cream colored pellets and imprinting with ITR on cap and 100 on body; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2016-08-09