SINCALIDE injection, powder, lyophilized, for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

SINCALIDE (UNII: M03GIQ7Z6P) (SINCALIDE - UNII:M03GIQ7Z6P)

Tilgængelig fra:

MAIA Pharmaceuticals, Inc.

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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].

Autorisation status:

New Drug Application

Produktets egenskaber

SINCALIDE - SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
MAIA PHARMACEUTICALS, INC.
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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