ROXALEM rivaroxaban 2.5 mg film-coated tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

rivaroxaban, Quantity: 2.5 mg

Disponibil de la:

Alembic Pharmaceuticals Australia Pty Ltd

Forma farmaceutică:

Tablet, film coated

Compoziție:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; hypromellose; sodium lauryl sulfate; magnesium stearate; lactose monohydrate; titanium dioxide; iron oxide yellow; macrogol 6000; iron oxide red; quinoline yellow aluminium lake

Calea de administrare:

Oral

Unități în pachet:

60 tablets

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Rivaroxaban is indicated for:,? Prevention of venous thromboembolism (VTE) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks),? Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke,? Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and PE,Rivaroxaban, in combination with aspirin, is indicated for:,? The prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD)

Rezumat produs:

Visual Identification: Round shaped, yellow film-coated biconvex tablets debossed with 09 on one side and L on the other side. Approximately 4 mm in diameter and 2 mm in thickness.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2023-10-03