GENRX BOSENTAN bosentan (as monohydrate) 62.5mg tablets bottle

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Kauptu það núna

Opinber matsskýrsla Opinber matsskýrsla (PAR)
26-11-2017

Virkt innihaldsefni:

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

Fáanlegur frá:

Arrotex Pharmaceuticals Pty Ltd

INN (Alþjóðlegt nafn):

bosentan monohydrate

Lyfjaform:

Tablet, film coated

Samsetning:

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

Stjórnsýsluleið:

Oral

Einingar í pakka:

60

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

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.

Vörulýsing:

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

Leyfisstaða:

Licence status A

Leyfisdagur:

2016-02-25