Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SEMAGLUTIDE
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
SEMAGLUTIDE
4 Pre-Filled Syringes
Novo Nordisk Pharmaceutical Industries, LP
_ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WEGOVY ® SOLUTION FOR INJECTION IN PRE-FILLED PEN Semaglutide (0.25 mg/0.5 mL (0.25mg/does), 0.5 mg/0.5 mL (0.5mg/does), 1 mg/0.5 mL (1mg/does), 1.7 mg/0.75 mL (1.7mg/dose), 2.4 mg/0.75 mL (2.4mg/does)) 1 WHAT IS IN THIS LEAFLET 1. What Wegovy ® is used for 2. How Wegovy ® works 3. Before you use Wegovy ® 4. How to use Wegovy ® 5. While you are using it 6. Side effects 7. Storage and disposal of Wegovy ® 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT WEGOVY ® IS USED FOR Wegovy ® is used together with diet and physical activity for weight loss and to help keep the weight under control. It is used in adults, who have • a BMI of 30 kg/m² or greater (obesity) or • a BMI of at least 27 kg/m² but less than 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’ or a history of heart attack, stroke or blood vessel problems). BMI (Body Mass Index) is a measure of your weight in relation to your height. 2. HOW WEGOVY ® WORKS Wegovy ® is a medicine for weight loss and weight maintenance that contains the active substance semaglutide. It is similar to a natural hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. It works by acting on targets (receptors) in the brain that control your appetite, causing you to feel fuller and less hungry and experience less craving for food. This will help you eat less food and reduce your body weight. 3. BEFORE YOU USE WEGOVY ® _- WHEN YU MUST NOT USE IT _ DO NOT USE WEGOVY ® • if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 8). _- BEFORE YOU START TO USE IT _ WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Wegovy ® . The use of Wegovy ® is not recommended if you: • use other Citiți documentul complet
Wegovy ® Professional leaflet EN-Jan-2022_8-9570-00-001-1 Based on EU text: 20211111_EN_06614_WEG_0-7 1 Wegovy ® 0.25 mg/0.5 mL (0.25 mg/dose) Solution for injection in pre-filled pen Wegovy ® 0.5 mg/0.5 mL (0.5 mg/dose) Solution for injection in pre-filled pen Wegovy ® 1 mg/0.5 mL (1 mg/dose) Solution for injection in pre-filled pen Wegovy ® 1.7 mg/0.75 mL (1.7 mg/dose) Solution for injection in pre-filled pen Wegovy ® 2.4 mg/0.75 mL (2.4 mg/dose) Solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Wegovy ® 0.25 mg solution for injection Each single-use pre-filled pen contains 0.25 mg semaglutide* in 0.5 mL solution. One mL of solution contains 0.5 mg of semaglutide*. Wegovy ® 0.5 mg solution for injection Each single-use pre-filled pen contains 0.5 mg semaglutide* in 0.5 mL solution. One mL of solution contains 1 mg of semaglutide*. Wegovy ® 1 mg solution for injection Each single-use pre-filled pen contains 1 mg semaglutide* in 0.5 mL solution. One mL of solution contains 2 mg of semaglutide*. Wegovy ® 1.7 mg solution for injection Each single-use pre-filled pen contains 1.7 mg semaglutide* in 0.75 mL solution. One mL of solution contains 2.27 mg of semaglutide*. Wegovy ® 2.4 mg solution for injection Each single-use pre-filled pen contains 2.4 mg semaglutide* in 0.75 mL solution. One mL of solution contains 3.2 mg of semaglutide*. *human glucagon-like peptide-1 (GLP-1) analogue produced in _Saccharomyces cerevisiae _ cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Clear and colourless isotonic solution; pH=7.4. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Wegovy ® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of Wegovy ® Professional leaflet EN-Jan-2022_8-9570-00-001-1 Based on EU text: 20211111_EN_06614_WEG_ Citiți documentul complet