Nazione: Indonesia
Lingua: indonesiano
Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
APIXABAN
PFIZER INDONESIA - Indonesia
APIXABAN
5.00 MG
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT
PFIZER IRELAND PHARMACEUTICALS - Ireland
2021-04-22
Generic Name: Apixaban Trade Name: ELIQUIS CDS Effective Date: April 19, 2019 Supersedes: July 21, 2017 Approved by BPOM: 2020-0060265, 2020-0060262; 2020-0060155 Page 1 of 43 PT PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Apixaban Trade Name: ELIQUIS CDS Effective Date: April 19, 2019 Supersedes: July 21, 2017 1. NAME OF THE MEDICINAL PRODUCT ELIQUIS 2.5 mg film-coated tablets. ELIQUIS 5.0 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg and 5.0 mg apixaban, respectively. 3. PHARMACEUTICAL FORM 2.5 mg: Yellow, round, biconvex film-coated tablets debossed with “893” on one side and “2½” on the other side. 5.0 mg: Pink, oval shaped, biconvex film-coated tablets debossed with “894” on one side and “5” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of VTE: elective hip or knee replacement surgery Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke: non-valvular atrial fibrillation ELIQUIS is indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation with one or more risk factors, including patients unsuitable for warfarin/Vitamin K antagonist therapy (VKA). Treatment of VTE ELIQUIS is indicated for: - Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). - Prevention of recurrent DVT and PE. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ELIQUIS can be taken with or without food. DISETUJUI OLEH BPOM : 31/03/2021 EREG100241VR12000460 EREG100241VR12000461 EREG100241VR12000462 Generic Name: Apixaban Trade Name: ELIQUIS CDS Effective Date: April 19, 2019 Supersedes: July 21, 2017 Approved by BPOM: 2020-0060265, 2020-0060262; 2020-0060155 Page 2 of 43 If a dose is missed, the patient should take ELIQUIS immediately and then continue with twice daily intake as before. Posology Prevention of VTE: elective hip or knee replacement surgery: The recommended dose of ELIQUIS Leggi il documento completo