GENRX BOSENTAN bosentan (as monohydrate) 62.5mg tablets bottle

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
26-11-2017

Toimeaine:

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

Saadav alates:

Arrotex Pharmaceuticals Pty Ltd

INN (Rahvusvaheline Nimetus):

bosentan monohydrate

Ravimvorm:

Tablet, film coated

Koostis:

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

Manustamisviis:

Oral

Ühikuid pakis:

60

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

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.

Toote kokkuvõte:

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

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2016-02-25