NEULUMEX- barium sulfate suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

E-Z-EM Canada Inc

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

For use in Computed Tomography to opacify the GI tract. This product should not be used in patients with known or suspected gastrointestinal perforation or hypersensitivity to barium sulfate or any component of this barium sulfate formulation.

Περίληψη προϊόντος:

NeuLumEX is supplied in the following quantity: 450 mL bottles, NDC 32909-927-03 Rx Only SHAKE WELL PRIOR TO USE Manufactured by E-Z-EM Canada Inc for Bracco Diagnostics Inc. Monroe Township, NJ 08831 Tel: [phone] rev. 02/20 CL110501

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

NEULUMEX- BARIUM SULFATE SUSPENSION
E-Z-EM CANADA INC
_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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NDC 32909-927-03
NEULUMEX™
BARIUM SULFATE SUSPENSION
(0.1% W/V)
DESCRIPTION:
NeuLumEX is a barium sulfate suspension 0.1% w/v, 0.1% w/w for oral
administration.
Each 100 mL contains 0.1 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 gum, benzoic acid, sodium citrate,
natural and artificial
blueberry flavor, potassium sorbate, purified water, saccharin sodium,
simethicone
emulsion, sodium benzoate, and 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.
INDICATIONS AND USAGE:
For use in Computed Tomography to opacify the GI tract.
CONTRAINDICATIONS:
This product should not be used in patients with known or suspected
gastrointestinal
perforation or hypersensitivity to barium sulfate or any component of
this barium sulfate
formulation.
WARNINGS:
Rarely, severe allergic reactions of an anaphylactoid nature, have
been reported
following administration of barium sulfate contrast agents.
Appropriately trained
personnel and facilities should be available for emergency treatment
of severe reactions
4
and should remain available for at