Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
Apixaban
PFIZER PRIVATE LIMITED
B01AF02
5mg
TABLET, FILM COATED
Apixaban 5mg
ORAL
Prescription Only
Bristol-Myers Squibb Manufacturing Company Unlimited Company
ACTIVE
2013-09-11
ELIQUIS 5 MG FILM-COATED TABLETS Table of Content _Please click on either of the following links to access the required information: _ PRESCRIBING INFORMATION PATIENT INFORMATION LEAFLET Page 1 of 25 1. NAME OF THE MEDICINAL PRODUCT ELIQUIS 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg apixaban. Excipient(s) with known effect Each 5 mg film-coated tablet contains 102.9 mg lactose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Pink, oval shaped, biconvex film-coated tablets with “894” debossed on one side and “5” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and 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 in patients with non-valvular atrial fibrillation (NVAF)_ The recommended dose of apixaban is 5 mg taken orally twice daily. _Dose reduction_ The recommended dose of apixaban is 2.5 mg taken orally twice daily in patients with NVAF and at least two of the following characteristics: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L). Therapy should be continued long term. _Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt)_ The recommended dose of apixaban for the treatment of acute DVT and treatment of PE is 10 mg taken orally twice daily for the first 7 days followed by 5 mg taken orally twice daily. As per available medical guidelines, short duration of treatment (at least 3 months Lees het volledige document
1. NAME OF THE MEDICINAL PRODUCT ELIQUIS 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg apixaban. Excipient(s) with known effect Each 5 mg film-coated tablet contains 102.9 mg lactose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Pink, oval shaped, biconvex film-coated tablets with “894” debossed on one side and “5” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and 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 in patients with non-valvular atrial fibrillation (NVAF)_ The recommended dose of apixaban is 5 mg taken orally twice daily. _Dose reduction_ The recommended dose of apixaban is 2.5 mg taken orally twice daily in patients with NVAF and at least two of the following characteristics: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L). Therapy should be continued long term. _Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt)_ The recommended dose of apixaban for the treatment of acute DVT and treatment of PE is 10 mg taken orally twice daily for the first 7 days followed by 5 mg taken orally twice daily. As per available medical guidelines, short duration of treatment (at least 3 months) should be based on transient risk factors (e.g., recent surgery, trauma, immobilisation). The recommended dose of apixaban for the prevention of recurrent DVT and PE is 2.5 mg taken orally twice dai Lees het volledige document