BASAGLAR 100IU PFS 5X3ML
Details
Details
**REFRIGERATED PRODUCT**
BASAGLAR 100IU PFS 5X3ML
RX - PHARMACEUTICAL
DESCRIPTION
Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) 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-30B-a-L-Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6.063 kDa. Insulin glargine has the following structural formula:
BASAGLAR (insulin glargine) injection is a sterile clear and colorless aqueous solution for subcutaneous use. Each mL contains 100 units of insulin glargine (3.6378 mg).
The 3 mL BASAGLAR prefilled pen presentations contain the following inactive ingredients per mL: glycerin (17 mg), metacresol (2.7 mg), zinc oxide (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP.
The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%. BASAGLAR has a pH of approximately
INDICATION AND USAGE
BASAGLAR® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Limitations of Use
BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.
Storage and Handling
Dispense in the original sealed carton with the enclosed Instructions for Use.
Protect BASAGLAR from heat and light. Do not freeze BASAGLAR.
In-use BASAGLAR prefilled pens must be used within 28 days or be discarded, even if they still contain BASAGLAR.