Ülke: Singapur
Dil: İngilizce
Kaynak: HSA (Health Sciences Authority)
EDOXABAN TOSILATE eqv. EDOXABAN
A. MENARINI SINGAPORE PTE. LTD.
B01AF03
TABLET, FILM COATED
EDOXABAN TOSILATE eqv. EDOXABAN 60 mg
ORAL
Prescription Only
Daiichi Sankyo Europe GmbH (Bulk manufacturer & primary packager)
ACTIVE
2020-12-18
1 LIXIANA SINGAPORE PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Lixiana 15 mg film-coated tablets Lixiana 30 mg film-coated tablets Lixiana 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lixiana 15 mg film-coated tablets Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate). Lixiana 30 mg film-coated tablets Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate). Lixiana 60 mg film-coated tablets Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Lixiana 15 mg film-coated tablets: Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”. Lixiana 30 mg film-coated tablets: Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with “DSC L30”. Lixiana 60 mg film-coated tablets: Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lixiana is indicated in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Lixiana is indicated in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Prevention of stroke and systemic embolism _ The recommended dose is 60 mg edoxaban once daily. Therapy with edoxaban in NVAF patients should be continued long term. 2 _Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE) _ The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days (see section 5.1). Edoxaban and initial parenteral anticoagulant should not be admin Belgenin tamamını okuyun