Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
APIXABAN
NOVUGEN PHARMA SDN. BHD.
APIXABAN
3x10 Tablets; 6x10 Tablets; 10x10 Tablets; 2x10 Tablets; 1x10 Tablets
NOVUGEN PHARMA SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ APEXIB FILM COATED TABLETS Apixaban (2.5mg, 5mg) 1 WHAT IS IN THIS LEAFLET 1. What Apexib is used for 2. How Apexib works 3. Before you use Apexib 4. How to use Apexib 5. While you are using Apexib 6. Side effects 7. Storage and Disposal of Apexib 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT APEXIB IS USED FOR Apexib 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: o previous stroke condition or transient ischaemic attack (TIA) (mini stroke); o age ≥75 years o high blood pressure (hypertension) o high blood sugar levels (diabetes mellitus) o 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 APEXIB WORKS The active substance in Apexib is apixaban. It helps to prevent blood clot formation by inhibiting Factor Xa, which is an important component of blood clotting. BEFORE YOU USE APEXIB − _When you must not use it _ Do not take Apexib 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 connection between arteries and Citiți documentul complet
APEXIB 2.5MG FILM COATED TABLETS APEXIB 5MG FILM COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Apexib 2.5mg Film Coated Tablets Apexib 5 mg Film Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION APEXIB 2.5MG FILM COATED TABLETS : Each tablet contains 2.5mg Apixaban. APEXIB 5MG FILM COATED TABLETS : Each tablet contains 5mg Apixaban. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. APEXIB 2.5MG FILM COATED TABLETS : Yellow, round shaped film-coated tablet, debossed with “E2” on one side and plain on other side. APEXIB 5MG FILM COATED TABLETS : Pink, oval shaped, biconvex film-coated tablet with bevelled edges, debossed with “E1” on one side and plain on other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION FOR 2.5MG Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. FOR 2.5MG AND 5MG 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 Apexib is 2.5mg 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 du Citiți documentul complet