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Glaritus

Glaritus Description

insulin glargine

Manufacturer:

Ambica

Distributor:

Zuellig

Marketer:

Multicare
Full Prescribing Info
Description
Each pen delivery device contains one 3 mL cartridge of Insulin Glargine. Each mL of cartridge contains: Insulin Glargine (rDNA) 100 IU, m-Cresol USP 0.27% w/v, Water for Injection q.s.
Insulin Glargine (GLARITUS) is a sterile solution of insulin glargine for subcutaneous use. Insulin glargine is a recombinant human insulin analog 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 (GLARITUS) 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. Insulin Glargine (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 C267H404N72O78S6 and a molecular weight of 6063.
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