ROXALEM rivaroxaban 15 mg film-coated tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

rivaroxaban, Quantity: 15 mg

Διαθέσιμο από:

Alembic Pharmaceuticals Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

28 tablets, 42 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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)

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2023-10-03