GENRX BOSENTAN bosentan (as monohydrate) 62.5mg tablets bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

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Ingredientes activos:

bosentan monohydrate, Quantity: 64.542 mg (Equivalent: bosentan, Qty 62.5 mg)

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

Designación común internacional (DCI):

bosentan monohydrate

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: silicon dioxide; methylcellulose; crospovidone; poloxamer; macrogol 8000; titanium dioxide; iron oxide red; hyprolose; hypromellose; magnesium stearate; iron oxide yellow

Vía de administración:

Oral

Unidades en paquete:

60

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Bosentan is indicated for the treatment of: ? idiopathic pulmonary arterial hypertension; ? familial pulmonary arterial hypertension; ? pulmonary arterial hypertension associated with scleroderma; or ? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger?s physiology,in patients with WHO Functional Class II, III or IV symptoms.

Resumen del producto:

Visual Identification: Orange-white coloured, round shaped, biconvex film coated tablet, engraved "APO" on one side and "62.5" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Estado de Autorización:

Licence status A

Fecha de autorización:

2016-02-25