ROXALEM rivaroxaban 15 mg film-coated tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

rivaroxaban, Quantity: 15 mg

Disponível em:

Alembic Pharmaceuticals Australia Pty Ltd

Forma farmacêutica:

Tablet, film coated

Composição:

Excipient Ingredients: hypromellose; magnesium stearate; lactose monohydrate; microcrystalline cellulose; poloxamer; croscarmellose sodium; titanium dioxide; macrogol 8000; iron oxide red; iron oxide black

Via de administração:

Oral

Unidades em pacote:

28 tablets, 42 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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)

Resumo do produto:

Visual Identification: Round shaped, light brown to brown, film-coated biconvex tablets debossed with 15 on one side and I on the other side. Approximately 6 mm in diameter and 3 mm in thickness.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 6 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Registered

Data de autorização:

2023-10-03