Страна: Філіппіни
мова: англійська
Джерело: FDA (Food And Drug Administration)
Basagine
N/A; Importer: Getz Pharma Phils., Inc.; Distributor: N/A
Basagine
100 Units/mL
Solution For Injection (SC)
1-PVC Tray containing 3 mL Solution in 5 mL USP Type I Clear Glass Vial with Cream Color Rubber Stopper and Aluminum Seal with Purple Color Flip-off Cap (Box of 1's), 1-PVC Tray containing 3 mL Solution in 5 mL USP Type I Clear Glass Vial with Cream Color Rubber Stopper and Aluminum Seal with P
Getz Pharma Pvt. Ltd., Pakistan
Anti-Diabetic
To improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
2021-04-27
DESCRIPTION: Insulin Glargine (Basagine ) is a solution for injection used as antidiabetic agent. Insulin Glargine (Basagine ) is a biosynthetic long-acting, human insulin analogue administered subcutaneously to lower the excess blood- glucose-level. It is synthesized by using recombinant DNA technology and a special laboratory strain of non-pathogenic _Escherichia coli_. 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, it is 21 A -Gly-30 B a-L-Arg-30 B b- L-Arg-human insulin and has the molecular formula C 267 H 404 N 72 O 78 S 6 . FORMULATION: Insulin Glargine (Basagine ) is available as solution for injection for subcutaneous administration as: Insulin Glargine (Basagine ) 100Units/ mL: Each mL contains: Insulin Glargine (r-DNA origin) ... 100 Units (3.64mg) Preservative: Metacresol... 0.27% w/v CLINICAL PHARMACOLOGY MECHANISM OF ACTIOn The primary activity of insulin glargine is the regulation of glucose metabolism. It inhibits hepatic glucose production and lowers blood glucose level by enhancing peripheral glucose uptake especially by skeletal muscle and fat. It also inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis. Insulin Glargine is a human insulin analogue designed to have a low solubility at neutral pH. It is completely soluble at the acidic pH of the injection solution (pH 4). After injection into the subcutaneous tissue, the acidic solution is neutralized 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. PHARMACOKINETICS _Absorption and Bioavailability_ Following subcutaneous injection, absorption of insulin glargine is slower and more prolonged compared with that of isophane (NPH) human insulin; the serum concentration-time profile for insulin glargine Прочитайте повний документ