Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Apixaban
PFIZER (MALAYSIA) SDN. BHD.
Apixaban
2 x 10 tablet Tablets; 6 x 10 tablet Tablets
PFIZER IRELAND PHARMACEUTICALS
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ELIQUIS ® FILM COATED TABLETS Apixaban (2.5 mg, 5 mg) 1 WHAT IS IN THIS LEAFLET 1. What ELIQUIS is used for 2. How ELIQUIS works 3. Before you use ELIQUIS 4. How to use ELIQUIS 5. While you are using it 6. Side effects 7. Storage and Disposal of ELIQUIS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT ELIQUIS IS USED FOR ELIQUIS is used to - prevent blood clots in veins (venous thromboembolic events (VTE)) after a hip or knee replacement surgery. - prevent stroke and blood clots in adult patients with a condition called non-valvular atrial fibrillation, which is a type of irregular heart rhythm with one or more risk factors, such as: previous stroke condition or transient ischaemic attack (TIA) (mini stroke); age ≥ 75 years high blood pressure (hypertension) high blood sugar levels (diabetes mellitus) symptomatic heart failure (NYHA Class ≥ II). - treat blood clots occurring in deep veins (Deep Vein Thrombosis [DVT]) and clots in your lungs (Pulmonary Embolism [PE]) and also to prevent these from recurring. HOW ELIQUIS WORKS The active substance in Eliquis is apixaban. It helps to prevent blood clot formation by inhibiting Factor Xa, which is an important component of blood clotting. BEFORE YOU USE ELIQUIS - _When you must not use it_ Do not take ELIQUIS if - you are allergic to Apixaban or to any of the other ingredients listed at the end of this leaflet - you have an injury to a body organ or any internal bleeding - you have liver disease associated with a bleeding disorder called coagulopathy and an increased risk of bleeding - you have any condition or injury to a body organ that could lead to significant bleeding (such as ulcers in stomach; cancerous growth; recent brain or spinal injury; recent brain, spinal or eye surgery; bleeding in the brain; abnormal, enlarged veins in the tube that connects the throat and stomach (esophagus); an abnormal conne Baca dokumen lengkap
Pfizer Confidential 1. NAME OF THE MEDICINAL PRODUCT Eliquis 2.5 mg film-coated tablets. Eliquis 5 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.5 MG Each film-coated tablet contains 2.5 mg Apixaban. Excipients with known effect: Each 2.5 mg film-coated tablet contains 51.4 mg lactose (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 5 MG Each film-coated tablet contains 5.0 mg Apixaban. Excipients with known effect: Each 5 mg film-coated tablet contains 102.9 mg lactose (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM 2.5 MG Yellow, round, biconvex film-coated tablets (diameter of 5.95 mm) with “893” debossed on one side and “2½” on the other side. 5 MG Pink, oval shaped, biconvex film-coated tablets (9.73 mm x 5.16 mm) with “894” debossed on one side and “5” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION FOR 2.5 MG Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. FOR 2.5 MG AND 5 MG 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). Pfizer Confidential 1 Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE) 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 Eliquis 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 Baca dokumen lengkap