VANILLA SILQ HD- barium sulfate for suspension powder, for suspension

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

اشتر الآن

تأكيد الحساب خصائص المنتج (SPC)
11-01-2021

العنصر النشط:

BARIUM SULFATE (UNII: 25BB7EKE2E) (BARIUM SULFATE - UNII:25BB7EKE2E)

متاح من:

Genus Medical Technologies, LLC

INN (الاسم الدولي):

BARIUM SULFATE

تركيب:

BARIUM SULFATE 98 g in 100 g

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 anastomos

الوضع إذن:

unapproved drug other

خصائص المنتج

                                VANILLA SILQ HD- BARIUM SULFATE FOR SUSPENSION POWDER, FOR 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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VANILLA SILQ HD
DESCRIPTION
VANILLA SILQ HD™ is a barium sulfate for suspension 98% w/w for oral
and rectal administration.
Each 100 g contains 98 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
simethicone, sorbitol, saccharin sodium, natural and artificial
vanilla flavor, emulsifiers, and thickening
agents.
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.
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
bo
                                
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