SINCALIDE injection, powder, lyophilized, for solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

FOSUN PHARMA USA INC

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 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

Produkto santrauka:

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 5 vials (NDC 72266-248-05). 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].

Autorizacija statusas:

New Drug Application

Prekės savybės

SINCALIDE- SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
FOSUN PHARMA USA 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
INDICATIONS AND USAGE
Sincalide for Injection is a cholecystokinin (CCK) analog indicated in
adults to: (1)
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)
DOSAGE AND ADMINISTRATION
Recommended Adult Dosage and Administration by Indication: (2)
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 infused over 30 minutes at a rate of
1 mL per minute. (2.1, 2.2)
To Accelerate Transit of a Barium Meal Through the Small Intestine_:_
(2)
After the barium meal is beyond the proximal j