ROXALEM rivaroxaban 2.5 mg film-coated tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
03-10-2023

Aktivna sestavina:

rivaroxaban, Quantity: 2.5 mg

Dostopno od:

Alembic Pharmaceuticals Australia Pty Ltd

Farmacevtska oblika:

Tablet, film coated

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

60 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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)

Povzetek izdelek:

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

Status dovoljenje:

Registered

Datum dovoljenje:

2023-10-03