Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin Glargine__
SM PHARMACEUTICALS SDN. BHD.
Insulin Glargine__
1x3ml Pieces; 5x3ml Pieces
WOCKHARDT LIMITED (BIOTECH PARK)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ GLARITUS 100 IU/ML SOLUTION FOR INJECTION GLARITUS 100 IU/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN Each ml contains Insulin Glargine 100IU _____________________________________________________________________________________________________________________ _______________________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. WHAT GLARITUS IS USED FOR 2.HOW GLARITUS WORKS 3.BEFORE YOU USE GLARITUS 4.HOW TO USE GLARITUS 5.WHILE YOU ARE USING GLARITUS 6.SIDE EFFECTS 7. STORAGE AND DISPOSAL OF GLARITUS 8.PRODUCT DESCRIPTION 9.MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10.DATE OF REVISION WHAT GLARITUS USED FOR The treatment of type 1 or type 2 diabetes mellitus patients who require insulin for the control of hyperglycaemia . HOW GLARITUS WORKS After injection into the subcutaneous tissue, te acidic solution is neutralised,leading to formation of microprecipptates from which small amounts of insulin glargine are continuously released, providing a smooth,peakles,predictable time/concentration profile and a prolonged duration of action. This allows once daily dosing to meet a patient’s basal insulin needs. BEFORE YOU USE GLARITUS _WHEN YOU MUST NOT USE IT _ Inform your doctor if you have any problem listed below, as the doctor will decide whether you should be started on Glaritus • If you have diabetic ketoacidosis_ _ • In patients with renal impairment, insulin requirements may be diminished_ _ • In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. _ _ _ _ _ _ _ _ _ _ _ _ _BEFORE YOU START TO USE IT _ Insulin glargine must not be used in patients hypersensitive to insulin glargine or any of its excipients. _ TAKING OTHER MEDICINES _ A number of substances affect glucose metabolism and may require insulin dose adjustment. Substances that may enhance the blood glucose lowering effect Lugege kogu dokumenti
II/XXXX FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY INSULIN GLARGINE INJECTION 3 ML CARTRIDGE / 100 IU/ML SOLUTION FOR INJECTION / SUBCUTANEOUS Composition Each mL contains: Insulin Glargine Ph. Eur. …..100 IU m-Cresol Ph. Eur.…..0.27% w/v as preservative Water for injection Ph. Eur. ….q.s. Excipients: Zinc (as Zinc Chloride) 30 μg, Glycerol (85%) 20 mg, Hydrochloric Acid q. s. to pH, Sodium Hydroxide q. s. to pH Pharmacotherapeutic group: Anti-diabetic agent (Long acting human insulin analogue) ATC (Anatomical Therapeutic Chemical) Classification Code: A10AE04 Description ® GLARITUS (insulin glargine injection) is a sterile clear and colourless solution of insulin glargine for subcutaneous use. Insulin glargine is a recombinant human insulin analogue that is a long-acting, parenteral blood-glucose-lowering agent. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows once daily dosing as ® basal insulin. GLARITUS is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, insulin glargine is 21A-Gly-30Ba-L-Arg-3030b-L-Arg-human insulin and has the empirical formula C267 H404 N72 O78 S6 and a molecular weight is 6063. Insulin glargine has the following structural formula: CLINICAL PHARMACOLOGY Mechanism of Action The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogues lower blood g Lugege kogu dokumenti