Țară: Singapore
Limbă: engleză
Sursă: HSA (Health Sciences Authority)
rivaroxaban micronized
BAYER (SOUTH EAST ASIA) PTE LTD
BO1AX06
2.5mg
TABLET, FILM COATED
rivaroxaban micronized 2.5mg
ORAL
Prescription Only
Bayer AG
ACTIVE
2013-12-06
1. NAME OF THE MEDICINAL PRODUCT Xarelto 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION XARELTO 2.5 MG 1 film-coated tablet contains 2.5 mg rivaroxaban. Each 2.5 mg film-coated tablet contains 35.70 mg lactose monohydrate (= 33.92 mg lactose) per tablet. For a full list of excipient(s) see section ’List of excipients_ _ 3. PHARMACEUTICAL FORM XARELTO 2.5 MG Film-coated, round, biconvex, light yellow immediate release tablets of 6 mm diameter and 9 mm radius of curvature for oral use. Bayer-cross on the bottom side and 2.5 and a triangle on the top side. 4. CLINICAL PARTICULARS 4.1 INDICATIONS Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of cardiovascular death in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections ‘Contraindications’, ‘Special warnings and precautions for use’ and ‘Pharmcodynamic properties’) 4.2 DOSAGE AND METHOD OF ADMINISTRATION 4.2.1 METHOD OF ADMINISTRATION Oral use 4.2.2 RECOMMENDED USUAL DOSE The recommended dose is 2.5 mg twice daily. Patients should also take a daily dose of 75-100 mg ASA or a daily dose 75-100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine. 4.2.3 DURATION OF TREATMENT Treatment should be regularly evaluated in the individual patient weighing the risk for ischaemic events against the bleeding risks. Extension of treatment beyond 12 months should be done one an individual patient basis as experience up to 24 months is limited (see section ‘Pharmcodynamic properties’) 4.2 Citiți documentul complet
Xarelto 2.5mg_CCDS 17_Oct 2022 1. NAME OF THE MEDICINAL PRODUCT Xarelto 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION XARELTO 2.5 MG 1 film-coated tablet contains 2.5 mg rivaroxaban. Each 2.5 mg film-coated tablet contains 35.70 mg lactose monohydrate (= 33.92 mg lactose) per tablet. For a full list of excipient(s) see section ‘List of excipients’. _ _ 3. PHARMACEUTICAL FORM XARELTO 2.5 MG Film-coated, round, biconvex, light yellow immediate release tablets of 6 mm diameter and 9 mm radius of curvature for oral use. Bayer-cross on the bottom side and 2.5 and a triangle on the top side. 4. CLINICAL PARTICULARS 4.1 INDICATIONS Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of cardiovascular death in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections ‘Contraindications’, ‘Special warnings and precautions for use’ and ‘Pharmacodynamic properties’) XARELTO, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI) and stroke) in adult patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD) at high risk of ischemic events. 4.2 DOSAGE AND METHOD OF ADMINISTRATION 4.2.1 METHOD OF ADMINISTRATION Oral use 4.2.2 RECOMMENDED USUAL DOSE ACS Xarelto 2.5mg_CCDS 17_Oct 2022 The recommended vascular protection regimen is one tablet of 2.5 mg Xarelto twice daily. Patients should also take a daily dose of 75-100 mg ASA or a daily dose 75-100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine. CAD or PAD The recommended vascular protection regimen for patients with CAD or PAD is one tablet of 2.5 mg Xarelto twice daily in combination with a daily dose of 75-100 mg ASA. 4.2.3 DURATION OF TREATMENT Treatment should be regularly evaluated in the individual patient weighing the risk for Citiți documentul complet