KINEVAC Powder for solution for injection Ref.[10405] Active ingredients: Sincalide

Source: FDA, National Drug Code (US)  Revision Year: 2018 

Product description

Kinevac (sincalide for injection) is a cholecystopancreatic-gastrointestinal hormone for parenteral administration. The agent is a synthetically-prepared C-terminal octapeptide of cholecystokinin.

Each single-dose vial of sincalide provides a sterile nonpyrogenic lyophilized white powder consisting of 5 mcg sincalide with 30 mg arginine hydrochloride, 15 mg lysine hydrochloride, 170 mg mannitol, 4 mg methionine, 2 mg pentetic acid, 0.005 mcg polysorbate 20, 9 mg potassium phosphate dibasic, and 0.04 mg sodium metabisulfite.

The pH is adjusted to 6.0 to 8.0 with hydrochloric acid and/or sodium hydroxide prior to lyophilization. Sincalide is designated chemically as L-α-aspartyl-O-sulfo-L-tyrosyl-L-methionylglycyl-L-tryptophyl-L-methionyl- L-α-aspartyl-L-phenylalaninamide. Graphic formula:

Dosage Forms and Strengths

For injection: 5 mcg of sincalide as a lyophilized white powder for reconstitution in a single-dose vial.

How Supplied

Kinevac (sincalide for injection) is supplied as 5 mcg of sincalide as a lyophilized white powder for reconstitution in a single-dose vial; in packages of 10 vials (NDC 0270-0556-15).

Manufactured for: Bracco Diagnostics Inc., Monroe Township, NJ 08831

By Jubilant HollisterStier LLC, Spokane, WA 99207

Drugs

Drug Countries
KINEVAC Canada, United States

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