LIXIANA FILM-COATED TABLET 60 MG

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

EDOXABAN TOSILATE eqv. EDOXABAN

Tersedia dari:

A. MENARINI SINGAPORE PTE. LTD.

Kode ATC:

B01AF03

Bentuk farmasi:

TABLET, FILM COATED

Komposisi:

EDOXABAN TOSILATE eqv. EDOXABAN 60 mg

Rute administrasi :

ORAL

Jenis Resep:

Prescription Only

Diproduksi oleh:

Daiichi Sankyo Europe GmbH (Bulk manufacturer & primary packager)

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

2020-12-18

Karakteristik produk

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