Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
INSULIN GLARGINE
BIOCON SDN BHD
INSULIN GLARGINE
3 ml; 3 ml; 3 ml
BIOCON BIOLOGICS INDIA LIMITED
_Consumer Medication Information Leaflet _ BASALOG ONE ® Insulin Glargine Injection (rDNA Origin) 100 IU/mL 1 | P a g e WHAT IS IN THIS LEAFLET: 1) What BASALOG ONE ® is used for 2) How BASALOG ONE ® works 3) Before you use BASALOG ONE ® 4) How to use BASALOG ONE ® 5) While you are using BASALOG ONE ® 6) Side effects 7) Storage and Disposal of BASALOG ONE ® 8) Product description 9) Manufacturer and Product Registration Holder 10) Date of Revision 11) Serial number 1) WHAT BASALOG ONE ® IS USED FOR BASALOG ONE ® (insulin glargine [recombinant DNA origin]) is long- acting insulin in a pre-filled disposable pen. Because BASALOG ONE ® is made by recombinant DNA (rDNA) technology and is chemically different from the insulin made by the human body; it is called an insulin analogue. BASALOG ONE ® 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 ONE ® 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 ONE ® _When you must not use it _ • If you are allergic (hypersensitive) to insulin glargine or any of the other ingredients of BASALOG ONE ® (see section 8 for a full list of ingredients). Watch out for the signs of allergy in section 6 (side e Izlasiet visu dokumentu