Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LIRAGLUTIDE
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
LIRAGLUTIDE
3ml mL
NOVO NORDISK A/S
VICTOZA ® _Consumer Medication Information Leaflet (RiMUP) _ Liraglutide (6 mg/ml) ________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Victoza ® is used for 2. How Victoza ® works 3. Before you use Victoza ® 4. How to use Victoza ® 5. While you are using it 6. Side effects 7. Storage and Disposal of Victoza ® 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT VICTOZA ® IS USED FOR Victoza ® is used with other medicines for diabetes when they are not enough to control your blood sugar levels. These may include: - oral antidiabetics (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter 2 inhibitor (SGLT2i) and/or insulin. 2. HOW VICTOZA ® WORKS Victoza contains the active substance liraglutide. It helps your body reduce your blood sugar level only when blood sugar is too high. It also slows food passage through your stomach and can help prevent heart disease. 3. BEFORE YOU USE VICTOZA ® _- WHEN YOU MUST NOT USE IT _ If you are allergic to liraglutide or any of the other ingredients of this medicine (listed in section 8, Product Description). CHILDREN AND ADOLESCENTS Victoza ® can be used in adolescents and children aged 10 years and above. No data are available in children below 10 years of age. _- BEFORE YOU START TO USE IT _ Talk to your doctor, pharmacist or nurse: - Before using Victoza ® . - If you have or have had a disease of the pancreas. This medicine should not be used if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar and increase in effort to breathe). It is not an insulin and should therefore not be used as a substitute for insulin. The use of Victoza ® is not recommended if you are on dialysis. The use of Victoza ® is not recommended if you have severe liver disease. The use of Victoza ® is not recommended if you have severe heart failure. Thi Διαβάστε το πλήρες έγγραφο
Victoza ® _Professional leaflet_STF-Oct-2020 1 NAME OF THE MEDICINAL PRODUCT VICTOZA ® 6 mg/ml Solution for injection in pre-filled pen QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 6 mg of liraglutide*. One pre-filled pen contains 18 mg liraglutide in 3 ml. * human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in _Saccharomyces cerevisiae._ For the full list of excipients, see _Pharmaceutical particulars._ PHARMACEUTICAL FORM Solution for injection. Clear and colourless or almost colourless, isotonic solution; pH=8.15. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Victoza ® is indicated for the treatment of adults, adolescents and children aged 10 years and above with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or insulin when these, together with diet and exercise, do not provide adequate glycaemic control (see sections _Special warnings and precautions for use_ and _Pharmacodynamic properties _ for available data on the different combinations). Prevention of cardiovascular events: Victoza ® 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. POSOLOGY AND METHOD OF ADMINISTRATION Posology To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily. After at least one week, the dose should be increased to 1.2 mg. Some patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg and based on clinical response, after at least one week, the dose can be increased to 1.8 mg to further improve glycaemic control. Daily doses higher than 1.8 mg are not recommended. When Victoza ® is added to a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia (s Διαβάστε το πλήρες έγγραφο