Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
rivaroxaban, Quantity: 10 mg
Bayer Australia Ltd
Rivaroxaban
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; hypromellose; lactose monohydrate; iron oxide red; titanium dioxide; macrogol 3350; magnesium stearate
Oral
15 tablets, 100 tablets, 3 tablets (physician sample pack), 10 tablets, 30 tablets
(S4) Prescription Only Medicine
XARELTO 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,XARELTO, 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).
Visual Identification: Light red, round, biconvex, film-coated tablets marked with the BAYER-cross on one side and 10 and a triangle on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2008-11-24
XARELTO CMI XV2.0 1 XARELTO ® (ZA·REL·TOE) _rivaroxaban _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about XARELTO. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking XARELTO against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT XARELTO IS USED FOR The active substance is rivaroxaban. It belongs to a group of medicines called _anticoagulants_ . It works by inhibiting the blood clotting protein called Factor Xa, thus reducing the tendency of blood to form clots. XARELTO has been prescribed to you for one of the following uses: - Prevention of blood clots in your veins after a hip or knee replacement operation because after an operation you are at an increased risk of getting blood clots - Prevention of blood clots in your brain (stroke) and/or other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation - Treatment of blood clots in the veins of your legs (deep vein thrombosis, DVT) and clots in your lung (pulmonary embolism, PE) and to prevent blood clots from re-occurring in your legs and/or lungs. XARELTO 2.5 mg tablets twice daily along with aspirin 100 mg once daily, has been prescribed to you for: - prevention of major heart related events (stroke, heart attack and death from heart related conditions) if you have poor blood flow in the blood vessels of your heart (coronary artery disease or CAD) and/or arms and legs (peripheral artery disease or PAD). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed XARELTO for another reason. XARELTO is a prescription medicine. It should only be used in adults under medical supe Perskaitykite visą dokumentą
XARELTO PI XV3.0; CCDS 16 Page 1 of 50 AUSTRALIAN PRODUCT INFORMATION XARELTO ® (RIVAROXABAN) 1. NAME OF THE MEDICINE XARELTO ® (rivaroxaban) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of XARELTO - 2.5 mg contains 2.5 mg of rivaroxaban - 10 mg contains 10 mg of rivaroxaban - 15 mg contains 15 mg of rivaroxaban - 20 mg contains 20 mg of rivaroxaban _Excipient with known effect _ Each film-coated tablet of XARELTO - 2.5 mg contains 35.70 mg lactose (as monohydrate) - 10 mg contains 27.90 mg lactose (as monohydrate) - 15 mg contains 25.40 mg lactose (as monohydrate) - 20 mg contains 22.90 mg lactose (as monohydrate) See Information about excipients For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Film-coated (immediate release) tablet. XARELTO 2.5 mg – Light yellow, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "2.5" and a triangle on the other side. XARELTO 10 mg – Light red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "10" and a triangle on the other side. XARELTO 15 mg – Red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER cross on one side and “15” and a triangle on the other side. XARELTO 20 mg – Brown-red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “20” and a triangle on the other side. XARELTO PI XV3.0; CCDS 16 Page 2 of 50 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS XARELTO 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 Perskaitykite visą dokumentą