Vanilla SilQ MD

Name: Vanilla SilQ MD

Vanilla SilQ MD Description

Vanilla SilQ MD™ is a barium sulfate for suspension 96% w/w for oral and rectal administration. Each 100 g contains 96 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 4. 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.

Contraindications

This product should not be used in patients with known or suspected gastric or intestinal perforation, patients with conditions that may increase the risk of perforation; hypersensitivity to barium sulfate products; 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 enterocolitis, unexplained pneumoperitoneum, gasless abdomen, other bowel perforation, esophageal perforation or post operative anastomosis.

Warnings

Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and / or patient hypersensitivities.

Overdosage

On rare occasions following repeated administrations, stomach cramps, nausea, vomiting, diarrhea or constipation may occur. Symptoms may be treated according to currently accepted standards of medical care.

Storage

Store product to protect from excessive heat (above 40 degrees centigrade)

Vanilla SilQ MD 
barium sulfate for suspension powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69307-4096
Route of Administration RECTAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Barium Sulfate (Barium Sulfate) Barium Sulfate 96 g  in 100 g
Packaging
# Item Code Package Description
1 NDC:69307-4096-2 176 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2015
Labeler - Genus Medical Technologies, LLC (079478547)
Revised: 07/2017   Genus Medical Technologies, LLC
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