Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RIVAROXABAN
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
RIVAROXABAN
10 Tablets; 30 Tablets
DR. REDDY'S LABORATORIES LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ Page 1 RIVAXORED (RIVAROXABAN TABLETS 10MG) _RIVAROXABAN _(10MG) WHAT IS IN THIS LEAFLET 1. What Rivaxored is used for 2. How Rivaxored works 3. Before you use Rivaxored 4. How to use Rivaxored 5. While you are using it 6. Side effects 7. Storage and Disposal of Rivaxored 8. Product Description 9. Manufacturer & Product Registration Holder 10. Date of revision 11. Serial Number WHAT RIVAXORED IS USED FOR Rivaxored contains the active substance rivaroxaban and is used in adults to - prevent blood clots in the veins after a hip or knee replacement operation. Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots. HOW RIVAXORED WORKS Rivaxored belongs to a group of medicines called antithrombotic agents. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots. BEFORE YOU USE RIVAXORED - _When you must not use it _ Do not take Rivaxored - if you are allergic to rivaroxaban or any of the other ingredients of this medicine - if you are bleeding excessively - if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes) - if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open - if you have a liver disease which leads to an increased risk of bleeding - if you are pregnant or breast-feeding Do not take Rivaxored and tell your doctor if any of these apply to you. - _Before you start to use it _ _Warnings and precautions _ Talk to your doctor or pharmacist before taking Rivaxored. _Take special care with Rivaxored _ - if you have an increased risk of bleeding, as could be the case in situations such as: ▪ moderate or severe kidney disease, since y Прочитайте повний документ
PACK INSERT Page 1 of 14 RIVAXORED (RIVAROXABAN TABLETS 10MG) 1. NAME OF THE MEDICINAL PRODUCT RIVAXORED (Rivaroxaban Tablets 10mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg rivaroxaban. Excipients: Each 10 mg film-coated tablet contains lactose monohydrate, see section 4.4. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Light Pink colored, round biconvex film coated tablets, engraved with ‘10’ on one side and plain on other side. 4. CLINICAL INFORMATION 4.1 THERAPEUTIC INDICATIONS Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken 6 to 10 hours after surgery, provided that haemostasis has been established. The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery. •For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended. •For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended. If a dose is missed the patient should take Rivaxored immediately and then continue the following day with once daily intake as before. Converting from Vitamin K Antagonists (VKA) to Rivaxored When converting patients from VKAs to Rivaxored, International Normalized Ratio (INR) values will be falsely elevated after the intake of Rivaxored. The INR is not valid to measure the anticoagulant activity of Rivaxored, and therefore should not be used (see section 4.5). Converting from Rivaxored to Vitamin K antagonists (VKA) There is a potential for inadequate anticoagulation during the transition from Rivaxored to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Rivaxored can contribute to an elevated INR. In patient Прочитайте повний документ