Land: Singapore
Sprog: engelsk
Kilde: HSA (Health Sciences Authority)
Apixaban
PFIZER PRIVATE LIMITED
B01AF02
2.5mg
TABLET, FILM COATED
Apixaban 2.5mg
ORAL
Prescription Only
Bristol-Myers Squibb Manufacturing Company Unlimited Company
ACTIVE
2012-12-24
ELIQUIS 2.5 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 27 1. NAME OF THE MEDICINAL PRODUCT ELIQUIS 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg apixaban. Excipient(s) with known effect Each 2.5 mg film-coated tablet contains 51.4 mg lactose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Yellow, round, biconvex film-coated tablets with “893” debossed on one side and 2½ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. 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 VTE (VTEp): elective hip or knee replacement surgery_ The recommended dose of apixaban is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery. Physicians may consider the potential benefits of earlier anticoagulation for VTE prophylaxis as well as the risks of post-surgical bleeding in deciding on the time of administration within this time window. _In patients undergoing hip replacement surgery_ The recommended duration of treatment is 32 to 38 days. _In patients undergoing knee replacement surgery_ The recommended duration of treatment is 10 to 14 days. Page 2 of 27 _Prevention of stroke and systemic embolism Læs hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT ELIQUIS 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg apixaban. Excipient(s) with known effect Each 2.5 mg film-coated tablet contains 51.4 mg lactose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Yellow, round, biconvex film-coated tablets with “893” debossed on one side and 2½ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. 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 VTE (VTEp): elective hip or knee replacement surgery_ The recommended dose of apixaban is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery. Physicians may consider the potential benefits of earlier anticoagulation for VTE prophylaxis as well as the risks of post-surgical bleeding in deciding on the time of administration within this time window. _In patients undergoing hip replacement surgery_ The recommended duration of treatment is 32 to 38 days. _In patients undergoing knee replacement surgery_ The recommended duration of treatment is 10 to 14 days. _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 pa Læs hele dokumentet