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SINCALIDE FOR is a brand name for Sincalide, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SINCALIDE FOR INJECTION (sincalide) is indicated for: • Inducing contraction of the gallbladder during cholecystography. In many instances, the cystic and common bile ducts can also be visualized, especially if viewed 1 to 3 minutes after injection of sincalide. Contraction of the gallbladder provides bile that may be…
Verbatim from this product's HC label. Tap a section to expand.
0 mcg for a 50 kg patient) may be administered. Radiographs are usually taken at 5 minute intervals after the injection. For visualization of the cystic duct, it may be necessary to take radiographs at 1 minute intervals during the first 5 minutes after the injection.
25 units of secretin/kg infused intravenously over a 60 minute period. 02 mcg/kg is administered over a 30 minute interval. 4 mL of reconstituted SINCALIDE FOR INJECTION solution to 30 mL with Sodium Chloride Injection USP and administer at a rate of 1 mL/minute.
8 mcg/70 kg) is injected intravenously over a 30 to 60 second interval. 08 mcg/kg given at 4 hour intervals up to a maximum of 5 doses of sincalide. The initial dose may be repeated once in patients undergoing radiologic study of the small bowel.
0 mcg/mL After reconstitution, the solution may be stored at room temperature for up to 8 hours or under refrigeration for up to 24 hours after which time any unused portion should be discarded. This reconstituted solution is used for contraction of the gallbladder during cholecystography but must be further diluted for the Secretin-sincalide test.
2 Recommended Dose and Dosage Adjustment. SINCALIDE FOR INJECTION (sincalide) Page 6 of 16
1 Adverse Reaction Overview Adverse effects are often seen with sincalide; but they are limited mainly to mild and transitory gastrointestinal phenomena, usually consisting of abdominal discomfort, cramps and nausea. Dizziness, flushing, vomiting, sweating and an urge to defecate have occurred occasionally.
Diarrhea, headache, bitter taste, shortness of breath, pain at the injection site, extremity tremor and sneezing have occurred rarely. These phenomena may be manifestations of sincalide's physiological action, which include delayed gastric emptying and an increase in gastrointestinal motility.
04/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................
4 4 DOSAGE AND ADMINISTRATION................................................................................ 2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution ........................................................................................................
5 5 OVERDOSAGE............................................................................................................ 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 6 7 WARNINGS AND PRECAUTIONS .................................................................................
1 Special Populations ................................................................................................ 1 Pregnant Women ............................................................................................... 2 Breast-feeding ....................................................................................................
• SINCALIDE FOR INJECTION is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 7 WARNINGS AND PRECAUTIONS).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • SINCALIDE FOR INJECTION should not be used in cases where a fatty meal would be contraindicated such as: acute pancreatitis, acute cholecystitis, cystic duct obstruction, obstruction of the common bile duct, infection or empyema of the gallbladder, in patients with small gallbladder stones, appendicitis, hollow viscous perforation, peritonitis, penetrating, perforating or bleeding peptic ulcer, pyloric stenosis, mechanical obstruction of the gastrointestinal tract and generally, acute abdomen.
SINCALIDE FOR INJECTION (sincalide) Page 5 of 16
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 Pediatrics............................................................................................................ 4 Geriatrics ............................................................................................................
7 8 ADVERSE REACTIONS................................................................................................. 1 Adverse Reaction Overview ................................................................................... 8 9 DRUG INTERACTIONS ................................................................................................
2 Drug Interactions Overview ................................................................................... 8 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action .............................................................................................
2 Pharmacodynamics ................................................................................................ 8 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 9 SINCALIDE FOR INJECTION (sincalide) Page 3 of 16 12 SPECIAL HANDLING INSTRUCTIONS............................................................................
9 PART II: SCIENTIFIC INFORMATION ..................................................................................... 10 13 PHARMACEUTICAL INFORMATION .......................................................................... 10 14 CLINICAL TRIALS ......................................................................................................
10 15 MICROBIOLOGY ...................................................................................................... 10 16 NON-CLINICAL TOXICOLOGY ....................................................................................
11 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................... 12 PATIENT MEDICATION INFORMATION ................................................................................ 13 SINCALIDE FOR INJECTION (sincalide) Page 4 of 16 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS SINCALIDE FOR INJECTION (sincalide) is indicated for: • Inducing contraction of the gallbladder during cholecystography.
In many instances, the cystic and common bile ducts can also be visualized, especially if viewed 1 to 3 minutes after injection of sincalide. , to determine the degree of cholesterol saturation. , in suspected cancer of the pancreas.
• The relief of postoperative ileus uncomplicated by inflammatory processes such as pancreatitis and peritonitis or by the presence of tumors or other obstructions in the lower digestive tract. • Decreasing the small bowel transit time of contrast media.
1 Pediatrics Pediatrics (<18 years): The safety and efficacy of sincalide in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (>65 years of age): Clinical studies of sincalide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
2 CONTRAINDICATIONS • SINCALIDE FOR INJECTION is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 7 WARNINGS AND PRECAUTIONS).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • SINCALIDE FOR INJECTION should not be used in cases where a fatty meal would be […]