Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
WARFARIN SODIUM
ORION PHARMA (MY) SDN. BHD.
WARFARIN SODIUM
100 Tablets
ORION CORP
_CONSUMER_ _ _ _MEDICATION_ _ _ _INFORMATION_ _ _ _LEAFLET_ _ _ _(RIMUP)_ _ _ ORFARIN TABLET Warfarin Sodium (3mg and 5mg) 1 WHAT IS IN THIS LEAFLET 1. What Orfarin is used for 2. How Orfarin works 3. Before you use Orfarin 4. How to use Orfarin 5. While you are using it 6. Side effects 7. Storage and Disposal of Orfarin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ORFARIN IS USED FOR Orfarin tablets are used to prevent thromboembolism (blood clots) or to treat thromboembolism or its complications. Orfarin tablets reduce the tendency of blood to form clots. Your doctor will explain to you, what disease is treated or prevented by this medicine. Most commonly, this medicine is used to: • prevent and treat deep venous thrombosis of the lower limbs (blood clots in the blood vessels of lower limbs) and pulmonary embolism (blood clots in the blood vessels of the lung) • prevent formation of blood clots during rapid and irregular heart beating • prevent formation or reoccurrence of blood clots after heart attack • prevent formation of blood clots after heart valve replacement. HOW ORFARIN WORKS Orfarin belongs to a group of medicine called anticoagulants. These medicines increase the time it takes for your blood to clot. BEFORE YOU USE ORFARIN - _When you must not use it _ DO NOT USE ORFARIN IF YOU: • are in the first trimester and last four weeks of pregnancy. • suffer from a bleeding tendency (haemophilia, von Willebrand disease, deficiency of blood platelets (thrombocytopenia) or platelet function deficit) • suffer from severe liver insufficiency or liver cirrhosis • suffer from untreated high blood pressure • have had recent intracranial bleeding • have tendency to frequent falls due to neurological or other health- related conditions • have had the surgery of the central nervous system or the eye recently or if you may undergo such surgery in the near future • suffer from endocarditis (inflammation of the inner layer of the heart, the endoc Lesen Sie das vollständige Dokument
1. NAME OF THE MEDICINAL PRODUCT ORFARIN TABLET 3MG ORFARIN 5MG TABLET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Warfarin sodium 3 mg/tablet Warfarin sodium 5 mg/tablet Excipients: Orfarin (3 mg) tablet contains lactose monohydrate equivalent to 85.1 mg lactose. Orfarin (5 mg) tablet contains lactose monohydrate equivalent to 84.6 mg lactose. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ORFARIN TABLET 3MG: Light blue or light blue may be spotted, flat bevelled edged and scored uncoated tablets with a diameter of 7 mm and code ORN 17. ORFARIN 5MG TABLET: Pink or pink may be spotted, , flat bevelled edged and scored uncoated tablets with a diameter of 7 mm and code ORN 18. 4. CLINICAL PARTICULARS 4.1. INDICATIONS Treatment and prevention of deep venous thrombosis and pulmonary embolism. Prevention of thromboembolic complications (stroke or systemic embolism) after myocardial infarct. Prevention of thromboembolic complications(stroke or systemic embolism) in patients with atrial fibrillation, cardiac valvular disease or prosthetic heart valves. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The target INR range of oral anticoagulant therapy: Prophylaxis of thromboembolic complications in patients with prosthetic heart valves: INR 2.5-3.5 Other indications: INR 2.0-3.0 Adults: Patients in normal weight and the spontaneous INR under 1.2 are administered 10 mg of warfarin on three consecutive days. The dosing is continued according to the table below, based on the INR-measured on the fourth day. In open care and for patients with inherited protein C or protein S deficiency the recommended initial dose is 5 mg of warfarin (*) in three days. The dosing is continued according to the table below, based on the INR-measured on the fourth day. For elderly patients, for those small in size, for those with the spontaneous INR over 1.2, or for those who have a disease (see Special warnings and special precautions for use) or medication (see Interaction with other medicinal products and other forms of intera Lesen Sie das vollständige Dokument