VANILLA SILQ- barium sulfate suspension

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)

Disponible des:

Genus Medical Technologies, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

INDICATIONS AND USAGE: For use as a contrast agent in radiographic studies. CONTRAINDICATIONS: This product should not be used in patients with known or suspected gastric or intestinal perforation, or hypersensitivity to barium sulfate or any component of this barium sulfate formulation; in patients with known or suspected obstruction of the colon; suspected tracheoesophageal fistula; obstructing lesions of the small intestine; pyloric stenosis; inflammation or neoplastic lesions of the rectum; or in patients who have had a recent rectal biopsy. Barium sulfate suspensions should not be used for infants with swallowing disorders or for newborns with complete duodenal or jejunal obstruction or when distal small bowel or colon obstruction is suspected. Barium sulfate suspension is not recommended for very small preterm infants and young babies requiring small volumes of contrast media or for infants and young children when there is a possibility of leakage from the gastrointestinal tract, such as nectrotizing

Estat d'Autorització:

unapproved drug other

Fitxa tècnica

VANILLA SILQ- BARIUM SULFATE SUSPENSION
GENUS MEDICAL TECHNOLOGIES, LLC
_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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DESCRIPTION: SILQ™ is a barium sulfate suspension 2.1% w/v, 2.0% w/w
for oral and rectal
administration. Each 100 mL contains 2.1 g barium sulfate. Barium
sulfate, due to its high molecular
density is opaque to x-rays and therefore, acts as a positive contrast
agent for radiographic studies. The
active ingredient is barium sulfate and its structural formula is BaSO
. Barium sulfate occurs as a fine,
white, odorless, tasteless, bulky powder which is free from
grittiness. Its aqueous suspensions are
neutral to litmus. It is practically insoluble in water solutions of
acids and alkalies, and organic solvents.
INACTIVE INGREDIENTS: citric acid, natural and artificial flavors,
benzoic acid, suspending agent,
potassium sorbate, purified water, sodium saccharin, sodium citrate,
simethicone, sodium benzoate,
sorbitol
CLINICAL PHARMACOLOGY: Barium sulfate, due to its high molecular
density is opaque to x-
rays and, therefore, acts as a positive contrast agent for
radiographic studies. Barium sulfate is
biologically inert and, therefore, is not absorbed or metabolized by
the body, and is eliminated from the
GI tract unchanged. Excretion rate is a function of gastrointestinal
transit time.
INDICATIONS AND USAGE: For use as a contrast agent in radiographic
studies.
CONTRAINDICATIONS: This product should not be used in patients with
known or suspected
gastric or intestinal perforation, or hypersensitivity to barium
sulfate or any component of this barium
sulfate formulation; in patients with known or suspected obstruction
of the colon; suspected
tracheoesophageal fistula; obstructing lesions of the small intestine;
pyloric stenosis; inflammation or
neoplastic lesions of the rectum; or in patients who have had a recent
rectal biopsy.
Barium sulfate suspensions