VOLUMEN- barium sulfate suspension

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

E-Z-EM Canada Inc

INN (الاسم الدولي):

BARIUM SULFATE

تركيب:

BARIUM SULFATE 1 mg in 1 mL

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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.

ملخص المنتج:

VoLumen® is supplied in the following quantity: 450 mL bottles, Cat. No. 9450, NDC 32909-945-03 Rx Only (USA) SHAKE WELL PRIOR TO USE Patent Pending Manufactured by E-Z-EM Canada Inc. for E-Z-EM, Inc. a subsidiary of Bracco Diagnostics Inc. Monroe Township, NJ 08831 Tel: [phone] 544-4624 rev. 05/14 TX1272-3  ©2006 E-Z-EM, Inc.

الوضع إذن:

unapproved drug other

خصائص المنتج

VOLUMEN- 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 32909-945-03
VOLUMEN
BARIUM SULFATE SUSPENSION
(0.1% W/V, 0.1% W/W)
DESCRIPTION
VoLumen 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 and should
remain available for at leas