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

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

bosentan monohydrate, Quantity: 129.083 mg

Dostupné z:

Sun Pharma ANZ Pty Ltd

INN (Medzinárodný Name):

bosentan monohydrate

Forma lieku:

Tablet, film coated

Zloženie:

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

Spôsob podávania:

Oral

Počet v balení:

56, 60

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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

Prehľad produktov:

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

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2016-07-11