SINCALIDE injection, powder, lyophilized, for solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Kupi sada

Svojstava lijeka Svojstava lijeka (SPC)
19-06-2012

Aktivni sastojci:

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

Dostupno od:

AnazaoHealth Corporation

INN (International ime):

SINCALIDE

Sastav:

SINCALIDE 3 ug

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Sincalide may be used: 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; to stimulate pancreatic secretion (especially in conjunction with secretin) prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology;  to 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 Gallbladder stones (stimulation of gallbladder contraction in patients with small gallbladder stones may lead to the evacuation of the stones from the gallbladder resulting in their lodging in the cystic duct or in the common bile duct; however, this is unlikely with usual doses of Sincalide since complete contraction of the gallbladder is not induced.)

Status autorizacije:

unapproved drug other

Svojstava lijeka

                                SINCALIDE - SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ANAZAOHEALTH CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SINCALIDE
Dear Medical Professional,
Per your order, we have compounded Sincalide as a sterile lyophilized
powder, sealed under nitrogen.
The characteristics of this compounded preparation are as follows
DESCRIPTION
Upon reconstitution with 3 ml normal saline, the vial contains
1 mcg/ml Sincalide
5 mg Mannitol
Lyophilized product should be stored at room temperature. After
reconstitution with normal saline,
the vial can be stored in the refrigerator for use within 12 hours.
Normal dosing is 0.02 micrograms per kilogram patient weight. A 70 kg
patient would receive 1.4 mcg
or 1.4 ml
CLINICAL PHARMACOLOGY
Sincalide, a synthetically prepared C-terminal octapeptide of the
natural hormone cholecystokinin,
induces contraction of the gallbladder muscle, resulting in reduction
of gallbladder size and evacuation
of bile. Also, Sincalide, like cholecystokinin, stimulates secretion
of pancreatic enzymes;Sincalide
decreases intestinal transit time; delays gastric emptying; decreases
esophageal sphincter tone; inhibits
gastric secretions; and stimulates intestinal muscle. Maximum
contraction (40% reduction in size) of
gallbladder occurs 5 to 15 minutes after injection. Gallbladder
returns to basal size within 1 hour
INDICATIONS AND USAGE
Sincalide may be used: 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; to stimulate
pancreatic secretion (especially in
conjunction with secretin) prior to obtaining a duodenal aspirate for
analysis of enzyme activity,
composition, and cytology; to accelerate the transit of a barium meal
through the small bowel, thereby
decre
                                
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