Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
APIXABAN
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
APIXABAN
60 Tablets; 20 Tablets
Sandoz Private Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ HEMAPIX FILM COATED TABLET _ _ Apixaban (2.5mg and 5mg) 1 WHAT IS IN THIS LEAFLET 1. What Hemapix is used for 2. How Hemapix works 3. Before you use Hemapix 4. How to use Hemapix 5. While you are using it 6. Side effects 7. Storage & Disposal of Hemapix 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT HEMAPIX IS USED FOR Hemapix 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 HEMAPIX WORKS The active substance in Hemapix is apixaban. It helps to prevent blood clot formation by inhibiting Factor Xa, which is an important component of blood clotting. BEFORE YOU USE HEMAPIX _- When you must not use it _ Do not take Hemapix 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 increase 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 connection between arter Aqra d-dokument sħiħ
Page 1 of 14 PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Hemapix Film Coated Tablet 2.5mg Hemapix Film Coated Tablet 5mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hemapix Film Coated Tablet 2.5mg Each film coated tablet contains 2.5mg of apixaban. Hemapix Film Coated Tablet 5mg Each film coated tablet contains 5mg of apixaban. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. Hemapix Film Coated Tablet 2.5mg Yellow, round, biconvex, film coated tablet, debossed AX on one side and 2.5 on the opposite side Hemapix Film Coated Tablet 5mg Pink, oval, biconvex, film coated tablet, debossed AX on one side and 5 on the opposite side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults 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 Hemapix 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 14 PREVENTION OF ST Aqra d-dokument sħiħ