GENRX BOSENTAN bosentan (as monohydrate) 62.5mg tablets bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

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

Tilgængelig fra:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

bosentan monohydrate

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

60

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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.

Produkt oversigt:

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

Autorisation status:

Licence status A

Autorisation dato:

2016-02-25