DESCRIPTION
READI-CAT® 2 is a barium sulfate suspension 2.1% w/v, 2.0% w/w for oral
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 BaSO4. 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 orange flavor, natural and artificial
vanilla flavor, potassium sorbate, purified water, saccharin sodium,
simethicone emulsion, sodium benzoate, sorbitol solution and xanthan
gum.
BANANA SMOOTHIE READI-CAT® 2 is a barium sulfate suspension 2.1% w/v,
2.0% w/w for oral 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 BaSO4. 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
Artificial vanilla flavor, benzoic acid, citric acid, natural banana
flavor (with other natural flavors), potassium sorbate, purified water,
saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate,
sorbitol solution and xanthan gum.
CREAMY VANILLA SMOOTHIE READI-CAT® 2 is a barium sulfate suspension 2.1% w/v, 2.0% w/w for oral
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 BaSO4. 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
Artificial vanilla flavor, benzoic acid, citric acid, potassium
sorbate, purified water, saccharin sodium, simethicone emulsion, sodium
benzoate, sodium citrate, sorbitol solution and xanthan gum.
BERRY SMOOTHIE READI-CAT® 2 is a barium sulfate suspension 2.1% w/v,
2.0% w/w for oral 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 BaSO4. 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
Benzoic acid, citric acid, natural and artificial blueberry flavor,
potassium sorbate, purified water, saccharin sodium, simethicone emulsion,
sodium benzoate, sodium citrate, sorbitol solution and xanthan gum.
MOCHACCINO SMOOTHIE READI-CAT® 2 is a barium sulfate suspension 2.1% w/v,
2.0% w/w for oral 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 BaSO4. 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
Benzoic acid, citric acid, natural and artificial bavarian chocolate
flavor, natural and artificial coffee cappuccino flavor, potassium
sorbate, purified water, saccharin sodium, simethicone emulsion, sodium
benzoate, sodium citrate, sorbitol solution and xanthan gum.
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 gastric or intestinal 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 least 30 to 60 minutes following administration,
since delayed reactions can occur.
PRECAUTIONS
General
Diagnostic procedures which involve the use of
radiopaque contrast agents should be carried out under the direction
of personnel with the requisite training and with a thorough knowledge
of the particular procedure to be performed. A history of bronchial
asthma, atopy, as evidenced by hay fever and eczema, or a previous
reaction to a contrast agent, warrant special attention. Caution should
be exercised with the use of radiopaque media in severely debilitated
patients and in those with marked hypertension or advanced cardiac
disease. Ingestion of barium is not recommended in patients with a
history of food aspiration. If barium studies are required in these
patients or in patients in whom integrity of the swallowing mechanism
is unknown, proceed with caution. If barium is aspirated into the
larynx, further administration should be immediately discontinued.
After any barium study of the GI tract, it is important to rehydrate
the patient as quickly as possible to prevent impaction of the barium.
To prevent barium impaction in the colon, the use of mild laxatives
such as milk of magnesia or lactulose following completion of the
examination may also be required. These mild laxatives are recommended
on a routine basis and in patients with a history of constipation
unless clinically contraindicated.
Information
for Patients
Before using
this product patients should be instructed to tell the physician ordering
the procedure and the imaging technologist:
- if they are pregnant.
- if they are allergic to any foods or medication, or if they
have had any prior reactions to barium sulfate products or other x-ray
contrast agents.
- if they are currently taking any medications, have any serious
medical condition for which they are being treated or followed, or
had any recent surgery.
- seek immediate medical attention if they experience an allergic
reaction after using this product.
Drug Interactions
The presence of barium sulfate formulations in
the GI tract may alter the absorption of therapeutic agents taken
concomitantly. In order to minimize any potential change in absorption,
the separate administration of barium sulfate from that of other agents
should be considered.
Usage
in Pregnancy
Radiation is known to cause harm
to the unborn fetus exposed in utero. Therefore,
radiographic procedures should only be used when, in the judgement
of the physician, its use is deemed essential to the welfare of the
pregnant patient.
Nursing
Mothers
Barium sulfate products
may be used during lactation.
ADVERSE
REACTIONS
Adverse reactions,
such as nausea, vomiting, diarrhea and abdominal cramping, accompanying
the use of barium sulfate formulations are infrequent and usually
mild. Severe reactions (approximately 1 in 1,000,000) and fatalities
(approximately 1 in 10,000,000) have occurred. Procedural complications
are rare, but may include aspiration pneumonitis, barium impaction,
granuloma formation, intravasation, embolization and peritonitis following
intestinal perforation, vasovagal and syncopal episodes, and fatalities.
EKG changes have been reported following or during barium enema procedures.
It is of the utmost importance to be completely prepared to treat
any such occurrence.
ALLERGIC
REACTIONS
Due to the increased
likelihood of allergic reactions in atopic patients, it is important
that a complete history of known and suspected allergies as well as
allergiclike symptoms, e.g., rhinitis, bronchial asthma, eczema and
urticaria, must be obtained prior to any medical procedure utilizing
these products. A mild allergic reaction would most likely include
generalized pruritus, erythema or urticaria (approximately 1 in 250,000).
Such reactions will generally respond to an antihistamine such as
50 mg of diphenhydramine or its equivalent. In the rarer, more serious
reactions (approximately 1 in 1,000,000) laryngeal edema, bronchospasm
or hypotension could develop. Severe reactions which may require emergency
measures are often characterized by peripheral vasodilation, hypotension,
reflex tachycardia, dyspnea, agitation, confusion and cyanosis, progressing
to unconsciousness. Treatment should be initiated immediately with
0.3 to 0.5 cc of 1:1000 epinephrine subcutaneously. If bronchospasm
predominates, 0.25 to 0.50 grams of intravenous aminophylline should
be given slowly. Appropriate vasopressors might be required. Adrenocorticosteroids,
even if given intravenously, exert no significant effect on the acute
allergic reactions for a few hours. The administration of these agents
should not be regarded as emergency measures for the treatment of
allergic reactions.
Apprehensive
patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia
following the administration of any diagnostic agent. Such reactions
are usually non-allergic in nature and are best treated by having
the patient lie flat for an additional 10 to 30 minutes under observation.
OVERDOSAGE
On rare occasions following repeated administration,
severe stomach cramps, nausea, vomiting, diarrhea or constipation
may occur. These indicated responses can be present in both fluoroscopic
and CT procedures. These are transitory in nature and are not considered
serious. Symptoms may be treated according to currently accepted standards
of medical care.
DOSAGE
AND ADMINISTRATION
The volume
and concentration of the CT barium sulfate suspension to be administered
will depend on the degree and extent of contrast required in the area(s)
under examination and on the equipment and technique employed.
Suggested 30 Minute Barium Administration
Protocol for Abdomen Studies:
Administer 300 mL
CT barium suspension 30 minutes before scan and 150 mL immediately
prior to scan; or use as directed by physician.
Suggested 90 Minute Barium Administration Protocol
for Abdomen/Pelvis Studies: Administer 450 mL CT barium suspension
90 minutes before scan, another 300 mL 30 minutes before scan, and
finally 150 mL immediately prior to scan; or use as directed by physician.
Other dosing regimens may be followed as applicable.
STORAGE
USP Controlled Room Temperature, 20 to 25°C (68
to 77°F). Protect from freezing.
HOW SUPPLIED
READI-CAT® 2 is supplied in the following quantities:
450 mL bottles,
Cat. No. 723, NDC 32909-723-01.
BANANA SMOOTHIE READI-CAT® 2 is supplied in the following quantities:
450 mL bottles,
Cat. No. 7450, NDC 32909-725-03.
CREAMY VANILLA SMOOTHIE READI-CAT® 2 is supplied in the following quantities:
450
mL bottles, Cat. No. 7550, NDC 32909-755-03.
BERRY SMOOTHIE READI-CAT® 2 is supplied in the following quantities:
450
mL bottles, Cat. No. 7150, NDC 32909-715-03.
MOCHACCINO SMOOTHIE READI-CAT® 2 is supplied in the following quantities:
450
mL bottles, Cat. No. 450307, NDC 32909-775-03.
SHAKE WELL
PRIOR TO USE
Manufactured by E-Z-EM Canada Inc.
for
E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc.
Monroe
Township, NJ 08831
Tel. 1-516-333-8230 1-800 544-4624
rev. 11/13 TX1665-1
Readi–Cat® 2 Barium Sulfate Suspension
CAT. NO. 723
NDC: 32909–723–01
Readi–Cat® 2 Barium Sulfate Suspension
CAT. NO. 7150
NDC: 32909–715–03
Readi–Cat® 2 Barium Sulfate Suspension
CAT.
NO. 7450
NDC: 32909–725–03
Readi–Cat® 2 Barium Sulfate Suspension
CAT.
NO. 7550
NDC: 32909–755–03
Readi–Cat® 2 Barium Sulfate Suspension
CAT NO. 450307
NDC: 32909–775–03
