Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin Glargine
BIOCON SDN BHD
Insulin Glargine
3ml mL; 5ml mL; 10ml mL; 3ml mL
BIOCON BIOLOGICS INDIA LIMITED
_Consumer Medication Information Leaflet _ BASALOG ® Insulin Glargine Injection (rDNA origin) 100 IU/mL 1 | P a g e WHAT IS IN THIS LEAFLET: 1) What BASALOG ® is used for 2) How BASALOG ® works 3) Before you use BASALOG ® 4) How to use BASALOG ® 5) While you are using BASALOG ® 6) Side effects 7) Storage and Disposal of BASALOG ® 8) Product description 9) Manufacturer and Product Registration Holder 10) Date of Revision 11) Serial Number 1) WHAT BASALOG ® IS USED FOR BASALOG ® (insulin glargine [recombinant DNA origin]) is long-acting insulin. Because BASALOG ® is made by recombinant DNA (rDNA) technology and is chemically different from the insulin made by the human body; it is called an insulin analog. BASALOG ® is used to reduce high blood sugar in adults, adolescents and children of 2 years or above with diabetes mellitus. Diabetes mellitus is a condition in which a person has high blood sugar, either because the pancreas does not produce enough insulin or the cells do not respond to the insulin that is produced. Extra insulin is therefore needed to lower your blood sugar level after the injection. Insulin glargine has a long and steady blood-sugar-lowering action. 2) HOW BASALOG ® WORKS Insulin glargine is a human insulin analogue designed to have low solubility at a neutral pH. It is completely soluble at the acidic pH of the injection solution (pH 4). After injection into subcutaneous tissue, the acidic solution is neutralised leading to formation of micro-precipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/time profile with a prolonged duration of action. 3) BEFORE YOU USE BASALOG ® _When you must not use it _ • If you are allergic (hypersensitive) to insulin glargine or any of the other ingredients of BASALOG ® (see section 8 for a full list of ingredients). Watch out for the signs of allergy in section 6 (side effects) or ask your doctor for clarification. • If you experience symptoms of low blood Läs hela dokumentet