ADMELOG Solution for injection Ref.[10741] Active ingredients: Insulin lispro

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

ADMELOG (insulin lispro injection) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin.

ADMELOG has the following primary structure:

ADMELOG is a sterile, aqueous, clear, and colorless solution. Each milliliter of ADMELOG contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg metacresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide.

Dosage Forms and Strengths

Insulin lispro injection 100 units per mL (U-100) is available as:

  • 10 mL multiple-dose vials
  • 3 mL multiple-dose vials
  • 3 mL single patient use SoloStar prefilled pens
How Supplied

ADMELOG: Insulin Lispro Injection 100 units per mL (U-100) is available as:

Dosage UnitPackage Size NDC #
10 mL multiple-dose vials Carton of 1 0024-5924-10
3 mL multiple-dose vials Carton of 1 0024-5926-05
3 mL single patient use SoloStar prefilled penCarton of 50024-5925-05

Each prefilled SoloStar pen is for use by a single patient. ADMELOG SoloStar pen must never be shared between patients, even if the needle is changed. Patients using ADMELOG vials must never share needles or syringes with another person.

The ADMELOG SoloStar prefilled pen dials in 1-unit increments.

sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY

Drugs

Drug Countries
ADMELOG Canada, United States, South Africa
 
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