País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SEMAGLUTIDE
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
SEMAGLUTIDE
1 Units
NOVO NORDISK A/S
OZEMPIC ® SOLUTION FOR INJECTION IN PRE-FILLED PEN Semaglutide 1.34 mg/ml (0.25, 0.5 mg/dose, 1 mg/dose) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 WHAT IS IN THIS LEAFLET 1. What Ozempic ® is used for 2. How Ozempic ® works 3. Before you use Ozempic ® 4. How to use Ozempic ® 5. While you are using it 6. Side effects 7. Storage and disposal of Ozempic ® 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT OZEMPIC ® IS USED FOR Ozempic ® is used to treat adults (aged 18 years and older) with type 2 diabetes when diet and exercise is not enough: ► on its own – when you cannot use metformin (another diabetes medicine) or ► with other medicines for diabetes – when they are not enough to control your blood sugar levels. These may be medicines you take by mouth or inject such as insulin. Prevention of cardiovascular events Ozempic ® is indicated to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease or at high risk for heart disease. It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse. 2. HOW OZEMPIC ® WORKS Ozempic ® contains the active substance semaglutide. It helps your body reduce your blood sugar level only when blood sugar is too high and can help prevent heart disease. 3. BEFORE YOU USE OZEMPIC ® - _WHEN YOU MUST NOT USE IT_ If you are allergic to semaglutide or any of the other ingredients of this medicine. - _BEFORE YOU START TO USE IT_ Talk to your doctor, pharmacist or nurse before using Ozempic ® . WARNINGS AND PRECAUTIONS This medicine is not the same as insulin and you should not use it if: ► you have type 1 diabetes – a condition where your body does not produce any insulin ► you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or Leer el documento completo
1 Ozempic ® Professional leaflet_EN-Jun-2023 Based on EU text: 20230124_EN_A0Z0000000A9001_OZE_13-3 1. NAME OF THE MEDICINAL PRODUCT OZEMPIC ® 1.34 mg/ml (0.25 mg, 0.5 mg/dose) Solution for injection in pre-filled pen OZEMPIC ® 1.34 mg/ml (1 mg/dose) Solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Ozempic_ _®_ _1.34 mg/ml (0.25 mg, 0.5 mg/dose) Solution for injection in pre-filled pen_ One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 2 mg semaglutide* in 1.5 ml solution. _Ozempic_ _®_ _1.34 mg/ml (1 mg/dose) Solution for injection in pre-filled pen_ One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 4 mg semaglutide* in 3 ml solution. Each dose contains 1 mg of semaglutide in 0.74 ml solution. *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 or almost colourless, isotonic solution; pH=7.4. 4.1 THERAPEUTIC INDICATIONS Ozempic ® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. Prevention of cardiovascular events: Ozempic ® is indicated to reduce the risk of major adverse cardiovascular events (MACE), composed of cardiovascular (CV) death, non-fatal myocardial infarction and non-fatal stroke, in adults with type 2 diabetes who have established CV disease or are at high risk for CV disease. For trial results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1 _._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The starting dose is 0.25 mg semaglutide once w Leer el documento completo