BOSENTAN RAN bosentan (as monohydrate) 125 mg film-coated tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

bosentan monohydrate, Quantity: 129.083 mg

Disponible desde:

Sun Pharma ANZ Pty Ltd

Designación común internacional (DCI):

bosentan monohydrate

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: pregelatinised maize starch; magnesium stearate; maize starch; povidone; sodium starch glycollate type A; glycerol dibehenate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose

Vía de administración:

Oral

Unidades en paquete:

56, 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: The 125mg film-coated tablets are light peach to peach colored, oval shaped, biconvex & debossed with '125' on one side & plain on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Licence status A

Fecha de autorización:

2016-07-11