Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
SINCALIDE (UNII: M03GIQ7Z6P) (SINCALIDE - UNII:M03GIQ7Z6P)
MAIA Pharmaceuticals, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
Sincalide for Injection is indicated in adults to: - stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. Sincalide for Injection is contraindicated in patients with: - a history of a hypersensitivity reaction to sulfites or sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see Warnings and Precautions (5.1), Adverse Reactions (6)]. - intestinal obstruction. Risk Summary Based on limited human data and mechanism of action, Sincalide for Inj
Sincalide for Injection is supplied as 5 mcg of sincalide as a lyophilized white to off-white cake or powder for reconstitution in a single-dose vial; in packages of 10 vials (NDC 70511-131-05). Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
New Drug Application
SINCALIDE - SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION MAIA PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SINCALIDE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SINCALIDE FOR INJECTION SINCALIDE FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1976 RECENT MAJOR CHANGES Contraindications (4) 10/2023 Warnings and Precautions, Anaphylaxis, Anaphylactic Shock and other Serious Hypersensitvity Reactions (5.1) 10/2023 INDICATIONS AND USAGE Sincalide for Injection is a cholecystokinin (CCK) analog indicated in adults to: • stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals. (1) • stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology. (1) • accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. (1) (1) DOSAGE AND ADMINISTRATION Recommended Adult Dosage and Administration by Indication: To Stimulate Contraction of the Gallbladder (2) 0.02 mcg/kg as a single dose over 30 to 60 seconds via intravenous injection. If satisfactory contraction does not occur in 15 minutes, administer a dose of 0.04 mcg/kg over 30 to 60 seconds. (2.1) _Alternatively consider an intravenous infusion to reduce gastrointestinal adverse reactions:_ 0.12 mcg/kg diluted in 100 mL of 0.9% Sodium Chloride Injection USP and infused over 50 minutes at a rate of 2 mL per minute. (2.1, 2.2, 5.3) To Stimulate Pancreatic Secretion in Combination with Secretin (2) 30 minutes after initiation of secretin for injection, administer 0.02 mcg/kg diluted in 30 mL of 0.9% Sodium Chloride Injection USP and inf Lees het volledige document