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

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

bosentan monohydrate, Quantity: 129.083 mg

Dostopno od:

Sun Pharma ANZ Pty Ltd

INN (mednarodno ime):

bosentan monohydrate

Farmacevtska oblika:

Tablet, film coated

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

56, 60

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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

Povzetek izdelek:

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

Status dovoljenje:

Licence status A

Datum dovoljenje:

2016-07-11