Source: FDA, National Drug Code (US) Revision Year: 2018
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 |
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For injection: 5 mcg of sincalide as a lyophilized white powder for reconstitution in a single-dose vial. |
| How Supplied |
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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 |
| Drug | Countries | |
|---|---|---|
| KINEVAC | Canada, United States |
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