BOSENTAN AMNEAL bosentan (as monohydrate) 125 mg film-coated tablet bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

bosentan monohydrate, Quantity: 129.082 mg

Dostupné z:

Amneal Pharma Australia Pty Ltd

INN (Medzinárodný Name):

bosentan monohydrate

Forma lieku:

Tablet, film coated

Zloženie:

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

Spôsob podávania:

Oral

Počet v balení:

60

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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

Prehľad produktov:

Visual Identification: Orange, oval, biconvex, film coated tablets, debossed with AN on one side and 874 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2017-08-22