Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FONDAPARINUX SODIUM
Aspen Medical Products Malaysia Sdn Bhd
FONDAPARINUX SODIUM
0.4ml 2Units mL; 0.6ml 2Units mL; 0.6ml 10 Units mL; 0.4ml 10 Units mL
Aspen Notre Dame De Bondeville
_Consumer Medication Information Leaflet (RiMUP)_ _ _ ARIXTRA 12.5 MG/ML SOLUTION FOR INJECTION Fondaparinux sodium (12.5 mg/ ml) 1 WHAT IS IN THIS LEAFLET 1. What ARIXTRA is used for 2. How ARIXTRA works 3. Before you use ARIXTRA 4. How to use ARIXTRA 5. While you are using it 6. Side Effects 7. Storage and Disposal of ARIXTRA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ARIXTRA IS USED FOR Arixtra is used to: prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery treat blood clots in blood vessels that are deep in the legs (deep vein thrombosis) or lungs (pulmonary thrombosis) HOW ARIXTRA WORKS Arixtra is a medicine that helps to prevent blood clots from forming in the blood vessels (_thromboses_), or treats blood clots if they have already formed (_an antithrombotic _ _agent_). It does this by stopping a clotting factor called Xa (“ten-A”) from working in the blood. BEFORE YOU USE ARIXTRA - _When you must not use it_ Do not use Arixtra: if you are allergic (_hypersensitive_) to fondaparinux sodium or to any of the other ingredients of Arixtra if you are bleeding excessively if you have a bacterial heart infection if you have severe kidney impairment Check with your doctor if you think any of these may apply to you. Arixtra should not be prescribed to pregnant women unless clearly necessary. If you are pregnant, or think you could be, tell your doctor. Breast-feeding is not recommended during treatment with Arixtra. - _Before you start to use it_ Before you are given Arixtra your doctor needs to know: if you have a risk of uncontrolled bleeding (_haemorrhage_) including: - stomach ulcer - bleeding disorders - recent bleeding in the brain (_intracranial bleeding_) - recent surgery on the brain, spine or eye if you have had blood clotting problems, or a reduction in the number of cells necessary for clotting after previous trea Soma hati kamili
CO NFIDENTIAL 1 ARIXTRA 5MG/0.4ML ARIXTRA 7.5MG/0.6ML Fondaparinux sodium QUALITATIVE AND Q UANTITATIVE CO MPOSITION Sterile, pr eservative- free, clear and colourless t o slightly yellow, injectable solution, i n a single dose pre- filled syringe. Each syringe contains 5.0 mg o f fondaparinux so dium in 0.4 ml solution for injection. Each syringe contains 7.5 mg o f fondaparinux so dium in 0.6 ml solution for injection. PHARMACEUTICAL FORM Injectabl e solution f or subcutaneous use . CLINICAL PARTICULARS Indications Treatment o f a cute De ep Vein Thrombosis (DVT). Treatment of acute Pulmonary E mbolism (PE). Dosage and Administration Method of a dministration Subcutaneous a dministration The sites of administration shoul d alternate between the left an d the right anterolateral and l eft and right posterolateral abdominal w all. To avoid the l oss of medicinal pr oduct when using t he pre-filled syringe do not ex pel the ai r bubble from t he syringe before the injection. The whole lengt h of the needle should be Soma hati kamili