Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ENOXAPARIN SODIUM
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
ENOXAPARIN SODIUM
2 Units; 6 Units; 10 Units; 12 Units
Rovi Pharma Industrial Services S.A
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ ENOXAPARIN _®_ SANDOZ _ _ Enoxaparin Sodium 20mg (2,000/0.2ml) – 40mg (4,000/0.4ml) – 60mg (6,000/0.6ml) 1 WHAT IS IN THIS LEAFLET 1. What Enoxaparin Sandoz is used for 2. How Enoxaparin Sandoz works 3. Before you use Enoxaparin Sandoz 4. How to use Enoxaparin Sandoz 5. While you are using it 6. Side effects 7. Storage and Disposal of Enoxaparin Sandoz 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ENOXAPARIN SANDOZ IS USED FOR The name of your medicine is Enoxaparin Sandoz 20 mg (2,000 IU) solution for injection in pre-filled syringe. Enoxaparin Sandoz contains a medicine called enoxaparin sodium. This belongs to a group of medicines called low molecular weight heparins. Enoxaparin Sandoz can be used to: • Treat blood clots that are in your blood (deep vein thrombosis with or without pulmonary embolism). • Stop blood clots forming in your blood in the following situations: - After an operation or long periods of bed rest due to illness. - Unstable angina (where not enough blood gets to your heart). - After you have had a heart attack. • Stop blood clots forming in the tubes of your dialysis machine (used for people with kidney problems). HOW ENOXAPARIN SANDOZ WORKS Enoxaparin Sandoz works in two ways: 1) Stopping existing blood clots from getting any bigger. This helps your body to break them down and stop them causing you harm. 2) Stopping blood clots forming in your blood. BEFORE YOU USE ENOXAPARIN SANDOZ _- When you must not use it _ _ _ Do not use Enoxaparin Sandoz: -if you are allergic to enoxaparin sodium. Signs of an allergic reaction _ _ include: a rash, swallowing or breathing problems, swelling of your _ _ lips, face, throat or tongue, _ _ - if you are allergic to heparin or other low molecular weight heparins, - if you have an acute infection in your heart, - if you are having severe bleedings or if you suffer from conditions in which the risk for severe bleeding is increased: - if you ha Baca dokumen lengkap
1. NAME OF THE MEDICINAL PRODUCT Enoxaparin Sandoz 2,000 IU (20 mg) /0.2 mL Solution for Injection in Pre-filled Syringe Enoxaparin Sandoz 4,000 IU (40 mg) /0.4 mL Solution for Injection in Pre-filled Syringe Enoxaparin Sandoz 6,000 IU (60 mg) /0.6 mL Solution for Injection in Pre-filled Syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2,000 IU (20 mg) /0.2 mL Each prefilled syringe contains enoxaparin sodium 2,000 IU anti-Xa activity (equivalent to 20 mg) in 0.2 mL water for injections. 4,000 IU (40 mg) /0.4 mL Each prefilled syringe contains enoxaparin sodium 4,000 IU anti-Xa activity (equivalent to 40 mg) in 0.4 mL water for injections. 6,000 IU (60 mg) /0.6 mL Each prefilled syringe contains enoxaparin sodium 6,000 IU anti-Xa activity (equivalent to 60 mg) in 0.6 mL water for injections. For the full list of excipients, see section 6.1. Enoxaparin sodium is a biological substance obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Enoxaparin Sandoz has been developed as a similar biological medicinal product to Clexane and has been shown to have a comparable quality, safety and efficacy profile to Clexane. Therefore, interchangeability with the reference product is possible, as long as this is in agreement with the treating physician. However, automatic substitution (i.e the practice by which a different product to that specified on the prescription is dispensed to the patient without the prior informed consent of the treating physician) and active substance- based prescription cannot apply to biologicals, including biosimilars. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe (injection). Clear, colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Enoxaparin Sandoz is indicated in adults for: • Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. • Prevention of thrombus forma Baca dokumen lengkap