E-Z-CAT

Israel - English - Ministry of Health

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Active ingredient:
BARIUM SULFATE
Available from:
PROMEDICO LTD
ATC code:
V08BA
Pharmaceutical form:
SUSPENSION
Composition:
BARIUM SULFATE 4.9224 %W/V
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
E-Z-EM INC., USA
Therapeutic group:
BARIUM SULFATE CONTAINING X-RAY CONTRAST MEDIA
Therapeutic indications:
For use in x-ray departments.Opacification of the gastro intestinal tract prior to computerized axial tomography.
Authorization number:
124 99 30407 00
Authorization date:
2012-02-28

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

31-08-2016

PATIENT PACKAGE INSERT ACCORDING TO THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986

This medicine can be sold with a physician’s prescription only

E-Z-CAT

Oral suspension

Each 100 ml of preparation contain 4.9 g Barium sulfate

Excipients and allergens in the preparation: See section

6 in the leaflet – “Additional information”.

Read this entire leaflet carefully before you start using

the preparation. This leaflet contains concise information

about the preparation. If you have any further questions,

refer to the physician or pharmacist.

This preparation has been prescribed for you. Do not pass

it on to others. It may harm them, even if you think that their

medical condition is similar to yours.

1. What is the preparation intended for?

E-Z-CAT is a contrast agent given to a patient for the purpose

of a CT examination of the gastrointestinal tract, in order to

increase the quality of the stimulation.

This preparation is used for diagnostic purposes only.

The active ingredient, barium sulfate, is not absorbed and is

not metabolized by the body and is eliminated unchanged

from the body.

Therapeutic group: This preparation belongs to a group of

preparations used as opaque to x-rays contrasting agents.

2. Before using the preparation:

Do not use the preparation if

You are hypersensitive to barium sulfate or to any of

the additional ingredients this preparation contains )see

section 6 in the leaflet – “Additional information”)

suffer

from

following

gastrointestinal

disorders:

Fistula, perforation or obstruction in any part of the

gastrointestinal tract

Gastrointestinal hemorrhage

Insufficient blood flow (ischemia) in the gastrointestinal

tract

Enlarged colon )megacolon or toxic megacolon(

Necrotizing enterocolitis )NEC(

Severe constipation

severe impaired gastric emptying

You suffer from injuries or chemical burns of the gastrointestinal

tract

Immediately before or immediately after gastrointestinal

surgery or any surgical procedure in the gastrointestinal

tract.

During and up to 4 weeks after radiotherapy to the rectum

or prostate

In infants with swallowing difficulties

Special warnings regarding the use of this preparation

Inform the physician before taking the preparation if:

You are pregnant.

You are allergic to any medicine or food

You have had previous reactions to barium sulfate

preparations or other contrast agents used in x-ray

procedures

You are taking, or if you have recently taken, other

medicines, including non-prescription medicines

and food supplements

You have or there is a family history of allergy

You suffer from gastrointestinal diseases or

disturbances

You suffer from amebiasis )amebic dysentery(

You suffer from a medical condition called Hirchsprung’s

disease

You suffer or have suffered in the past from aspirations

(inhalation of food or liquids to the lungs)

You experience swallowing difficulties

You have suffered in the past from a stroke

You suffer from impaired renal function

You suffer from constipation

You suffer from dehydration

You suffer from a heart disease

Take the preparation under the supervision of a physician.

Diagnostic procedures which involve contrast agents

should be carried out under the direction of personnel

with the required knowledge and training.

Other possible complications

You may be asked to rest lying down under supervision

after the examination, if you are feeling weakness, pallor,

sense of ringing in the ears (tinnitus), increased sweating

and slow heart rate.

Preparation for gastrointestinal examinations often

requires a liquid diet and laxatives and can result in water

loss. Drink immediately after the examination.

Tell the physician or pharmacist if you are taking or

have recently taken any other medicines, including non-

prescription drugs and food supplements.

You should consider not taking other medicines in close

proximity to taking this preparation, since the presence of

barium sulfate in the gastrointestinal tract may alter the

absorption of other medicines taken concomitantly.

Pregnancy and breastfeeding

If you are pregnant, consult a physician before using this

preparation. The preparation may be used during pregnancy

however, since x-ray can harm the fetus in the womb,

procedures that include x-ray during pregnancy will only be

conducted if the physician determines that it is essential for

your welfare.

The preparation may be used while breastfeeding.

Driving and use of machinery

This preparation may cause dizziness. If you feel dizzy, do

not drive and do not operate dangerous machinery until the

dizziness passes.

Important information about some of the ingredients of

the medicine

Do not use the preparation if you are sensitive to

fructose. Consult a physician before you administer the

preparation to infants and children due to the possibility

of sensitivity to fructose.

Report to the physician if you are on a low sodium

or potassium diet or if you suffer from impaired renal

function.

The preparation contains methyl parahydroxybenzoate,

which may cause allergic reactions, sometimes after

time.

The preparation contains sorbitol which is a substance

with a laxative effect.

If you have been told by a physician that you have an

intolerance to certain sugars, contact the physician

before using this preparation.

3. How to use the preparation?

Take the preparation under the supervision of a physician.

Always use according to the physician’s instructions. Check

with the physician if you are not sure.

Dosage

administration

will

determined

physician only.

Do not exceed the recommended dose.

E-Z-CAT

intended

dilution

prior

use.

measuring mean intended for measuring the correct amount

of preparation. If not attached to the package, consult the

pharmacist.

Shake

well

before

after

dilution.

Take

E-Z-CAT

immediately after dilution and do not store it.

You may be given a laxative prior to using this preparation if

you suffer from dehydration, have a tendency for constipation

or are elderly.

After the examination you may be asked to drink, a laxative

will be given to you or you will be connected to a fluid infusion.

The package is for single use only.

Overdose:

If you have taken an overdose or if a child has

accidentally swallowed the preparation, proceed

immediately to a physician or a hospital emergency room

and bring the package of the preparation with you.

On rare occasions following repeated administration,

severe stomach cramps, nausea, vomiting, diarrhea

or constipation may occur. These symptoms pass and

are not considered serious. Refer to a physician if they

appear.

Do not take medicines in the dark! Check the label and the

dose each time you take a preparation. Wear glasses if you

need them.

If you have any further questions regarding the use of this

preparation, consult a physician or pharmacist.

4. Side effects

Like any preparation, the use of E-Z-CAT may cause side

effects in some users. Do not be alarmed while reading the

list of side effects. You may not suffer from any of them.

Seek immediate medical assistance if you feel one of the

following side effects:

Swelling of the throat or face

Breathing difficulties, wheezing or shortness of breath

Feel you are about to faint or lose consciousness

These side effects are signs of a severe and occasionally life

threatening allergic reaction

Side effects may occur during or after the treatment with

barium sulfate.

Most common side effects:

Skin and subcutaneous disorders together with immune

system disorders caused by an allergic reaction to the

preparation, such as tingling skin rash (urticaria), skin

redness or inflammation (erythema) and rash.

Gastrointestinal disorders, such as diarrhea, nausea,

abdominal pain and swelling and constipation.

Additional side effects, which appeared very rarely (less

than one user out of 10,000) and their accurate frequency

is unknown:

Infections and infestations: Appendicitis, presence of

bacteria in blood, other infections including intestine or

liver abscess, peritoneal infection and pneumonia

Blood and the lymph system disorders: Enlargement of

lymph nodes

Immune system disorders: Allergic reactions manifested

by symptoms which include skin and subcutaneous

reactions such as tingling skin rash (urticaria), itching,

rash, skin redness or inflammation (erythema) and

facial swelling. Respiratory symptoms which may

be related to allergy include shortness of breath,

pharyngeal edema and throat tightness. Anaphylactic

reaction or shock

Metabolism and nutrition disorders: Rare cases of

hyperglycemia in diabetic patients have been reported

Psychiatric disorders: Agitation, confusion, nervousness

)reported during the administration of barium sulfate(

Nervous system disorders: Loss or consciousness,

fainting, vasovagal syncope, dizziness, burning

sensation, headache, speech impairment, hypotonia

Eye disorders, including eye swelling, usually

associated with allergic reactions

Constant noise in ear )tinnitus(

Cardiac disorders: Slowing of heart rate (bradycardia),

cyanosis, faster than normal heart rate (tachycardia)

Vascular disorders: Hypotension, pallor, vasodilation

Respiratory, thoracic and mediastinal disorders:

Bronchospasm, breathing difficulties, laryngeal

edema, pharyngeal edema and pain, throat irritation or

tightness, cough. When administered orally, aspiration,

pneumonia aspiration

Gastrointestinal disorders: Constipation, gastrointestinal

blockage, ulcer, gastrointestinal perforation or inflammation,

abdominal discomfort, abdominal pain and bloating,

diarrhea, worsening of ulcerative colitis, nausea, vomiting

and retching, flatulence, swollen tongue

Skin and subcutaneous disorders: Usually associated

with

allergic

reactions

include

skin

redness

inflammation, excessive scarring, excessive sweating,

facial swelling, itch, rash, tingling skin rash (urticaria), pallor,

skin turning blue due to impaired blood flow

Renal and urinary disorders: Pain when urinating

Discomfort, pain, swelling, weakness, pyrexia, face

edema

Abnormal ECG

Injury and poisoning: Barium sulfate invasion to blood

due to bowel inflammation (diverticulitis)

Rarer side effects resulting from complications during the

procedure, medical condition and allergy can even be fatal.

If a side effect appears, if any of the side effects worsens

or when you suffer from a side effect not mentioned in this

leaflet, consult the physician.

5. How to store the preparation?

Avoid poisoning! This preparation, and any other

medicine, must be stored in a closed place out of the

reach of children and/or infants, to avoid poisoning. Do

not induce vomiting unless explicitly instructed to do so by

the physician.

Do not use after the expiry date stated on the package

)exp. date(. The expiry date refers to the last day of that

month.

Storage conditions: Do not freeze or store at a

temperature higher than 30

Excess preparation should be disposed of in accordance

with local requirements.

6. Additional information

In addition to the active ingredient, the preparation also

contains:

Sorbitol solution 70%, Pectin, Xanthan gum, Simeticone

30% emulsion, Potassium Sorbate, Saccharin sodium,

Methyl parahydroxybenzoate, Anhydrous citric acid,

Sodium citrate dihydrate, Polyoxyethylene glyceryl mono-

oleate, Artificial orange flavor, Sodium carrageenan,

Purified Water

What does the preparation look like and what does

the package contain?

E-Z-CAT is supplied in 225 ml bottles.

This is a white, viscous suspension.

Registration holder and address: Promedico Ltd., 6

Hashiloach st., P.O. box 3340 Petah Tikva 49170

Fax number: 03-9373774

e-mail address: drugsafety@neopharmgroup.com

Manufacturer’s name and address: E-Z-EM Inc.,

Quebec, Canada

The format of this leaflet was determined by the

Ministry of Health and its content was checked and

approved in August 2014

Drug registration number at the national medicines

registry of the Ministry of Health: 124 99 30407 00

E-Z-CAT

PIL PB1214-03

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

E-Z-CAT 4.9 % w/v oral suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Constituent:

Barium sulfate 4.9 % w/v (4.6 % w/w)

For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Oral suspension.

White, milky, viscous suspension.

4

CLINICAL PARTICULARS

4. 1

Therapeutic indications

For use in X-ray departments. Opacification of the gastro-intestinal tract prior to

computerized axial tomography

4. 2 Posology and method of administration

E-Z-CAT is for oral administration.

The suspension is diluted with water to obtain a desired concentration.

Recommended dilutions are shown in section 6.6.

Adults and the Elderly: 350 - 450 mL of diluted suspension 30 minutes

prior to the scan and the same volume 5 minutes prior to the scan, or, as directed

by the physician.

Children: The dosage will be dependent on the size, age, health state and

anatomical region to be imaged of the child. Individual requirements

should be determined, from experience, by the radiologist.

4.3

Contraindications

Immune System Disorders

Hypersensitivity to barium sulfate or to any of the excipients.

Gastrointestinal Disorders

Patients with any of the following:

a known or suspected fistula, perforation or obstruction in any part of

the gastrointestinal tract

gastrointestinal haemorrhage

gastrointestinal ischemia

megacolon or toxic megacolon

necrotising entercolitis

severe constipation

severe impaired gastric emptying

should not receive E-Z-CAT.

E-Z-CAT should not be used for infants with swallowing disorders.

Surgical and Medical Procedures

Barium sulfate should not be administered immediately before or immediately

after gastrointestinal surgery, including snare polypectomy or ‘hot’ colonic

biopsy. If post procedural leakage is expected the product must not be used.

Do not use during and up to four weeks after radiotherapy to the rectum or

prostate.

Injury, Poisoning and Procedural Complications

Do not use if there are new injuries or chemical burns of the gastrointestinal

tract.

4.4

Special warnings and precautions for use

The product should be administered under the supervision of a physician.

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.

Hypersensitivity

A history of bronchial asthma, atopy, as evidenced by hay fever and eczema,

a family history of allergy, or a previous reaction to a contrast agent warrant

special attention.

As stated in section 4.8, 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. Anaphylactic and

allergic reactions have been reported during double contrast examinations in

which glucagon has been used. Rapid recognition, assessment, and

diagnosis are crucial to the effective implementation of treatment. Imaging

facilities should be staffed with well-trained personnel for the diagnosis and

treatment of hypersensitivity reactions.

Barium sulfate preparations used as radiopaque media contain a number of

additives to provide diagnostic properties and patient palatability. Allergic

responses following the use of barium sulfate suspensions have been

reported. Skin irritation, redness, inflammation and hives have been reported

for infants and small children following spillage of barium sulfate suspension

on their skin.

Perforation

In patients with a serious stenosis at any level of the gastro-intestinal tract,

especially if it is distal to the stomach, and in the presence of conditions and

ailments that increase the risk of perforation such as known gastrointestinal

fistulae and carcinomas, inflammatory intestinal disease, diverticulitis and

diverticulosis and amoebiasis, careful consideration of the risks and benefits

of the administration of a barium sulfate suspension is required.

Aspiration

For patients who are prone to aspiration (the newborn, elderly and stroke

patients), it is recommended that the procedure starts with a small ingested

volume.

Vomiting following oral administration of barium sulfate may lead to aspiration

pneumonitis. Oral administration of barium sulfate suspension by an infant

sucking a bottle and administration of large quantities by catheter are reported

to be likely to result in aspiration into the tracheobronchial tree.

Cardiopulmonary arrest leading to fatality has been reported in infants

following aspiration. Aspiration of smaller amounts may cause respiratory tract

inflammation and pneumonia.

Ingestion of barium is not recommended in patients with a history of food

aspiration. If barium procedures are required in these patients or in patients in

whom integrity of the swallowing mechanism, may be compromised, proceed

with caution. If this product is aspirated into the larynx, further administration

should be immediately discontinued.

Fluid Overload

Barium sulfate suspensions have been reported to cause fluid overload due to

water absorption.

Children and patients with impaired renal function are the most susceptible to

water intoxification, as are children with Hirschsprung’s Disease.

Intravasation

Barium sulfate may also intravasate into the venous drainage of the large

bowel and enter the circulation as a "barium embolus". This complication

occurs rarely during a barium enema and is exceedingly uncommon in oral

administration. It can lead to potentially fatal complications, including

systemic and pulmonary embolism, disseminated intravascular coagulation,

septicaemia and prolonged severe hypotension. It is more likely to occur in

elderly patients, due to thinning of the rectal wall and vaginal thinning with

age, and in those with colorectal disease, when intraluminal pressure

overcomes the resistance of the colonic wall affected by colitis, diverticulitis or

intestinal obstruction. The diagnosis should be considered in any patient who

collapses during or shortly after a barium procedure, and in those who

become suddenly unwell in the hours following the procedure. The diagnosis

can be confirmed by simple plain radiography; CT scanning may also be

useful to detect dissemination of barium sulfate.

Constipation or Diarrhoea

E-Z-CAT should be used with care if the patient is dehydrated, suffers from

any condition or is on any other treatment that can cause constipation, or if

the patient has history of constipation. In this situation a mild bulk laxative

should be administered following completion of the X-ray examination.

Increased intake of liquids is recommended after oral or rectal administration

of barium sulfate to prevent severe constipation and the risk of impaction.

Conversely, since E-Z-CAT contains sorbitol, administration may have a mild

laxative effect. The calorific value of sorbitol is 2.6 kcal/g.

Other Possible Complications

Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis

and bradycardia following the administration of any diagnostic agent. Such

reactions are usually unpredictable and are best treated by having the patient

lie flat for an additional 10 - 30 minutes under observation.

Patient preparation for diagnostic gastrointestinal examinations frequently

requires cathartics and a liquid diet. The various preparations can result in

water loss for the patient. Patients should be rehydrated quickly following a

barium sulfate suspension examination of the gastrointestinal tract. Saline

cathartics are recommended on a routine basis in patients with a history of

constipation unless clinically contraindicated.

Baroliths consist of inspissated barium associated with faeces. They are often

asymptomatic, but may be associated with abdominal pain, appendicitis,

bowel obstruction, or perforation. Patients who are elderly, with impaired

gastrointestinal motility, colon obstruction, electrolyte imbalance, dehydration

or on a low residue diet may be at risk of developing baroliths. To reduce this

risk, adequate hydration should be maintained during and in the days

following barium sulfate procedure. The use of laxatives (especially in case of

constipation) should be considered.

Hereditary Fructose Intolerance

E-Z-CAT contains sorbitol. Patients with rare hereditary problems of fructose

intolerance should not use this medicine. Therefore, it should only be used in

babies and small children after consultation with the doctor, due to the

possibility of unknown hereditary fructose intolerance.

Patients on a Controlled Sodium or Potassium diet

E-Z-CAT contains sodium among the excipients. Care should be taken in

patients on a controlled sodium diet, especially in the cases of repeated

administration.

It also contains potassium. Care should be taken with patients who have

reduced kidney function or those on a controlled potassium diet.

Other Excipients

E-Z-CAT contains methyl parahydroxybenzoate, which may cause allergic

reactions, sometimes delayed.

Children, Elderly and Debilitated Patients

As with any barium sulfate preparation, care should be taken when

administering E-Z-CAT to children, the elderly or the debilitated.

It should be

used cautiously in patients with pre-existing heart disease.

4.5 Interaction with other medicinal products and other forms of

interaction

No interaction studies have been performed.

Barium sulfate is biologically inert and there are no known interactions with other

medicinal products. However, The presence of barium sulphate formulation in

tract

alter

absorption

therapeutic

agents

taken

concomitantly. In order to minimize any potential change in absorption, the

separate administration of barium sulphate from that of other agents should

be considered.

Other examinations of the same area of the gastrointestinal tract with another

contrast agent may be complicated by the presence of barium sulfate

(residue) in the gastrointestinal tract up to several days following the

examination with barium contrast media.

4.5

Pregnancy and lactation

Following oral or rectal administration, barium sulfate is absorbed systemically

in negligible amounts. Though barium sulfate is pharmacologically inert, no

studies of its mutagenic or teratogenic potential are available.

.

Although this product is not contraindicated in pregnancy, we would like to

point out that radiographic procedures may damage the foetus, particularly

during the first trimester of pregnancy. Any examination should only be

carried out after careful consideration of the benefit/risk of the procedure.

Since the absorption of barium sulfate is negligible, its use is not

contraindicated during breastfeeding.

4.7 Effects on ability to drive and use machines

E-Z-CAT has negligible influence on the ability to drive and use machines.

4.8

Undesirable effects

Undesirable effects may occur during or after a procedure with barium sulfate.

Skin and subcutaneous disorders together with immune system disorders,

reflecting allergic reactions either to barium sulfate or the product excipients,

are among the most commonly reported effects; for example urticaria,

erythema and rash.

Gastrointestinal disorders are also one of the most frequently reported class

of undesirable effects; for example diarrhoea, nausea, abdominal

pain/distention, constipation.

Within the table below, clinically significant adverse reactions are listed if they

have been reported during post approval use of all barium sulfate

formulations. Their frequency is not known, therefore relative reporting rate

(for example, less commonly) compared to overall reporting for barium sulfate

is used.

MedDRA System Organ

Class

MedDRA Preferred Term

Infections and infestations

Appendicitis, Bacteraemia. Less commonly

other infections have been reported including

rare cases of Abscess intestinal, Liver abscess,

Peritoneal infection and Pneumonia

Blood and the lymphatic

system disorders

Lymphadenopathy

Immune system disorders

Hypersensitivity presenting with a wide range of

signs and symptoms including skin and

subcutaneous reactions such as urticaria,

pruritus, rash, erythema and facial swelling.

Potential hypersensitivity associated respiratory

signs and symptoms including dyspnoea,

pharyngeal oedema and throat tightness have

been reported.

Anaphylactic reaction and anaphylactic shock

have been reported less commonly.

Metabolism and nutrition

disorders

Infrequent cases of Hyperglycaemia have been

reported in diabetic patients

Psychiatric disorders

Agitation, Confusional state, Nervousness and

related symptoms have been reported during

the administration of barium sulfate

Nervous system disorders

Loss of consciousness, Syncope, Syncope

vasovagal, Dizziness, Burning sensation,

Headache, Dysarthria, Hypotonia

Eye disorders

Eye disorders, including Eye swelling, usually

associated with allergic reactions have been

reported

Ear and labyrinth disorders

Tinnitus

Cardiac disorders

Bradycardia, Cyanosis, Tachycardia

Vascular disorders

Hypotension, Pallor, Vasodilatation

Respiratory, thoracic and

mediastinal disorders

Bronchospasm, Dyspnoea, Laryngeal oedema,

Pharyngeal oedema and pain, Throat irritation

or tightness, Cough.

When administered orally, Aspiration,

Pneumonia aspiration.

Gastrointestinal disorders

Gastrointestinal signs and symptoms are widely

reported, it is not always possible to

differentiate between pre-existing medical

conditions and procedural complications.

Events reported include:

Constipation and in severe cases

gastrointestinal blockage; Gastrointestinal

inflammation, ulceration or perforation;

Abdominal discomfort, Abdominal pain and

distension; Diarrhoea; Colitis ulcerative may be

aggravated; Nausea; Vomiting and Retching;

Flatulence; Swollen tongue

Skin and subcutaneous

tissue disorders

Skin reactions are varied and most likely to be

associated with allergic reactions.

Reports include: Erythema, Dermatitis Contact,

Excessive granulation tissue, Hyperhidrosis,

Periorbital oedema, Pruritus, Rash, Swelling

face, Urticaria

Renal and urinary disorders

Dysuria

General disorders and

administration site conditions

Malaise, Pain, Swelling, Asthenia, Pyrexia,

Face oedema

Investigations

Electrocardiogram abnormal

Injury and poisoning

Intravasation by barium sulfate, associated with

pre-existing bowel disease or diverticulitis, has

been reported rarely

More rarely and depending on the route of administration, i.e. oral or rectal,

the following procedural complications have been reported:

Infections (e.g. peritonitis) subsequent to existing or new gastrointestinal

perforation. Complications include adhesions and granuloma.

Subsequent to existing or procedural gastrointestinal trauma, intravasation of

barium sulfate with rare subsequent venous emboli formation, including the

hepatic portal vein, vena cava and pulmonary embolism that may be fatal in

approx 50% of cases.

Following oral administration, aspiration, with pulmonary complications, may

occur and may be fatal in rare cases.

Please see section 4.4 for measures to be taken to avoid these adverse

reactions, and actions to take if such adverse reactions occur.

Very rare cases of death associated with barium sulfate administration have

been reported in the literature. The majority of the deaths relate to procedural

complications usually caused by failure to follow generally accepted

radiological practice. Some cases had a history indicating that barium sulfate

administration was highly unlikely to be a primary or even secondary

causative factor in patient fatality.

4.9

Overdose

Barium

sulfate

non-toxic

absorbed

systemically

negligible

amounts.

Repeated use within a very short period of time has led to abdominal cramps,

nausea, vomiting, diarrhoea, and constipation. These symptoms are transitory

in nature and may be allowed to resolve without medical intervention or may

be treated according to currently accepted standards of care.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: X-ray contrast media, barium sulfate with

suspending agents, ATC code: V08BA01

active

constituent

E-Z-CAT,

barium

sulfate,

inert

pharmacological action. It serves only as a radiopaque substance to opacify the

gastro-intestinal tract during computed axial tomography.

5.2 Pharmacokinetic properties

Under physiological conditions, barium sulfate passes through the

gastrointestinal tract in an unchanged form and is absorbed only in

small, pharmacologically insignificant amounts.

5.3

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are

additional to that already included elsewhere in the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sorbitol solution 70%

Pectin

Xanthan gum

Simeticone 30% emulsion

Potassium Sorbate

Saccharin sodium

Methyl parahydroxybenzoate

Citric acid anhydrous

Sodium citrate dihydrate

Polyoxyethylene glyceryl mono-oleate

Artificial orange flavour

Sodium carrageenan

Purified water

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

24 month.

This pack is for single-dose use only. E-Z-CAT should be administered

immediately following reconstitution with water and must not be stored.

6.4

Special precautions for storage

Store product to protect from freezing and heat

Store below 30

6.5

Nature and contents of container

High density polyethylene bottle with polypropylene screw-on cap with

aluminium tamper-evident seal containing 225 mL.

6.6

Special precautions for disposal and other handling

The volume and concentration of E-Z-CAT to be administered will depend on

the degree and extent of contrast required in the area(s) under examination

and the equipment and technique employed.

Shake well before use. E-Z-CAT is intended for dilution prior to

administration.

Mixing Instructions: Pour contents into supplied mixing container. Add water

to slightly below top of the container. Close the lid and shake the container

well. Yield: 900 mL of 1.2% w/w barium sulphate suspension.

Alternately, E-Z-Cat barium sulphate suspension may be mixed to yield a

different density. Some suggestions are as follows:

Add E-Z-Cat contents into the mixing Container and add water to the 700 mL

level.

Yield: 700mL of a 1.5% w/w suspension.

Add water to the 600mL level.

Yield: 600 mL of a 1.7 w/w suspension.

Add water to the 500 mL level.

Yield: 500 mL of a 2.1% w/w suspension.

Suggested 30 minutes barium administration protocol for Abdomen Studies:

Administer

E-Z-Cat.

minutes

before

scan

immediately prior to scan; or use as directed by physician.

Suggested 30 Minute Barium Administration Protocol for Abdomen/Pelvis

Studies: Administer 300 mL E-Z-Cat, 30 minutes before scan and 150 mL

immediately prior scan.

Then administer a barium enema using E-Z-EM's 400 mL CAT-PAK

enema system (Cat. No. P410); or use by physician.

Suggested 90 Minute Barium Administration Protocol for Abdomen/Pelvis

Studies: Administer 450 mL E-Z-Cat, 90 minutes before scan, another 300 mL

30 minutes before scan, and 150 mL immediately prior scan; or use as

directed by physician.

Other dosing regimen may be followed as applicable.

Any unused, opened product or waste material should be disposed of in

accordance with local requirements.

Manufacturer : E-Z-EM Canada Inc., Canada

Registration Holder: Promedico Ltd., P.O. Box 3340 Petach-Tikva.

The format of this leaflet has been defined by the MOH and its content has been

checked and approved -February 2012.

העדוה

לע

הרמחה

עדימ (

)תוחיטב :ךיראת

07/02/2012

םש

רישכת

:תילגנאב

E-Z-CAT

רפסמ

:םושיר

124-99-30407-00

םש

לעב

:םושירה

Promedico LTD

םייונישה

ןולעב

םינמוסמ

לע

עקר

בוהצ ןולעב

אפורל םי/שקובמה םי/יונישה לע םיטרפ ןולעב קרפ יחכונ טסקט שדח טסקט

4.3

Contraindications

Contra-indications

‘E-Z-Cat’ is a diagnostic agent for

professional use. Barium Sulfate

products for radiography procedures

should not be used in patients with

known gastric or intestinal perforation

or hypersensitivity to barium sulfate

and other ingredients of the product

Immune System Disorders

Hypersensitivity to barium sulfate or to any of

the excipients.

Gastrointestinal Disorders

Patients with any of the following:

a known or suspected fistula,

perforation or obstruction in any part of the

gastrointestinal tract

gastrointestinal haemorrhage

gastrointestinal ischemia

megacolon or toxic megacolon

necrotising entercolitis

severe constipation

severe impaired gastric emptying

should not receive E-Z-CAT.

E-Z-CAT should not be used for infants with

swallowing disorders.

Surgical and Medical Procedures

Barium sulfate should not be administered

immediately before or immediately after

gastrointestinal surgery, including snare

polypectomy or ‘hot’ colonic biopsy. If post

procedural leakage is expected the product

must not be used.

Do not use during and up to four weeks after

radiotherapy to the rectum or prostate.

Injury, Poisoning and Procedural

Complications

Do not use if there are new injuries or

chemical burns of the gastrointestinal tract.

4.4

Special warnings

and precautions for

use

Warnings

Rarely, severe allergic reactions of an

anaphilactoid nature, have been

reported following administration of

barium sulfate contrast agents.

Appropriately trained personal and

The product should be administered under the

supervision of a physician.

Diagnostic procedures which involve the use

of radiopaque contrast agents should be

carried out under the direction of personnel

facilities and trained personnel 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 preformed

A history of bronchial asthma, atopy,

as evidenced by hay fever and eczema,

or a previous reation to a contrast

agent, warrant special attention.

Caution should be excercised with the

use of radiopaque media in severely

debilitated patients and in those with

marked hypertension or advanced

cardiac disease

Ingestion of this product 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 this product 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 bowel by barium

sulfate.To prevent barium sulfate

impaction in the bowel, 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

contraindicated

Use with caution in patients with

complete or nearly complete

obstruction of the GI tract

Information for Patients: before

administration of this product patients

should be instructed to

Inform their

physician if they are

pregnant

Inform their

physician if they are

allergic to any drugs

or food, or if they

have had any prior

reactions to barium

sulphate products or

other contrast agents

used in x-ray

with the requisite training and with a thorough

knowledge of the particular procedure to be

performed.

Hypersensitivity

A history of bronchial asthma, atopy, as

evidenced by hay fever and eczema, a family

history of allergy, or a previous reaction to a

contrast agent warrant special attention.

As stated in section 4.8, 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. Anaphylactic and allergic

reactions have been reported during double

contrast examinations in which glucagon has

been used. Rapid recognition, assessment, and

diagnosis are crucial to the effective

implementation of treatment. Imaging

facilities should be staffed with well-trained

personnel for the diagnosis and treatment of

hypersensitivity reactions.

Barium sulfate preparations used as

radiopaque media contain a number of

additives to provide diagnostic properties and

patient palatability. Allergic responses

following the use of barium sulfate

suspensions have been reported. Skin

irritation, redness, inflammation and hives

have been reported for infants and small

children following spillage of barium sulfate

suspension on their skin.

Perforation

In patients with a serious stenosis at any level

of the gastro-intestinal tract, especially if it is

distal to the stomach, and in the presence of

conditions and ailments that increase the risk

of perforation such as known gastrointestinal

fistulae and carcinomas, inflammatory

intestinal disease, diverticulitis and

diverticulosis and amoebiasis, careful

consideration of the risks and benefits of the

administration of a barium sulfate suspension

is required.

Aspiration

For patients who are prone to aspiration (the

newborn, elderly and stroke patients), it is

recommended that the procedure starts with a

small ingested volume.

Vomiting following oral administration of

barium sulfate may lead to aspiration

pneumonitis. Oral administration of barium

sulfate suspension by an infant sucking a

bottle and administration of large quantities by

catheter are reported to be likely to result in

aspiration into the tracheobronchial tree.

Cardiopulmonary arrest leading to fatality has

been reported in infants following aspiration.

Aspiration of smaller amounts may cause

procedures (see

Precautions-

General)

Inform their

physician about any

other medications

they are currently

taking

respiratory tract inflammation and pneumonia.

Ingestion of barium is not recommended in

patients with a history of food aspiration. If

barium procedures are required in these

patients or in patients in whom integrity of the

swallowing mechanism ,may be compromised,

proceed with caution. If this product is

aspirated into the larynx, further

administration should be immediately

discontinued.

Fluid Overload

Barium sulfate suspensions have been reported

to cause fluid overload due to water

absorption.

Children and patients with impaired renal

function are the most susceptible to water

intoxification, as are children with

Hirschsprung’s Disease.

Intravasation

Barium sulfate may also intravasate into the

venous drainage of the large bowel and enter

the circulation as a "barium embolus". This

complication occurs rarely during a barium

enema and is exceedingly uncommon in oral

administration. It can lead to potentially fatal

complications, including systemic and

pulmonary embolism, disseminated

intravascular coagulation, septicaemia and

prolonged severe hypotension. It is more

likely to occur in elderly patients, due to

thinning of the rectal wall and vaginal thinning

with age, and in those with colorectal disease,

when intraluminal pressure overcomes the

resistance of the colonic wall affected by

colitis, diverticulitis or intestinal obstruction.

The diagnosis should be considered in any

patient who collapses during or shortly after a

barium procedure, and in those who become

suddenly unwell in the hours following the

procedure. The diagnosis can be confirmed by

simple plain radiography; CT scanning may

also be useful to detect dissemination of

barium sulfate.

Constipation or Diarrhoea

E-Z-CAT should be used with care if the

patient is dehydrated, suffers from any

condition or is on any other treatment that can

cause constipation, or if the patient has history

of constipation. In this situation a mild bulk

laxative should be administered following

completion of the X-ray examination.

Increased intake of liquids is recommended

after oral or rectal administration of barium

sulfate to prevent severe constipation and the

risk of impaction.

Conversely, since E-Z-CAT contains sorbitol,

administration may have a mild laxative

effect. The calorific value of sorbitol is 2.6

kcal/g.

Other Possible Complications

Apprehensive patients may develop weakness,

pallor, tinnitus, diaphoresis and bradycardia

following the administration of any diagnostic

agent. Such reactions are usually unpredictable

and are best treated by having the patient lie

flat for an additional 10 - 30 minutes under

observation.

Patient preparation for diagnostic

gastrointestinal examinations frequently

requires cathartics and a liquid diet. The

various preparations can result in water loss

for the patient. Patients should be rehydrated

quickly following a barium sulfate suspension

examination of the gastrointestinal tract.

Saline cathartics are recommended on a

routine basis in patients with a history of

constipation unless clinically contraindicated.

Baroliths consist of inspissated barium

associated with faeces. They are often

asymptomatic, but may be associated with

abdominal pain, appendicitis, bowel

obstruction, or perforation. Patients who are

elderly, with impaired gastrointestinal

motility, colon obstruction, electrolyte

imbalance, dehydration or on a low residue

diet may be at risk of developing baroliths. To

reduce this risk, adequate hydration should be

maintained during and in the days following

barium sulfate procedure. The use of laxatives

(especially in case of constipation) should be

considered.

Hereditary Fructose Intolerance

E-Z-CAT contains sorbitol. Patients with rare

hereditary problems of fructose intolerance

should not use this medicine. Therefore, it

should only be used in babies and small

children after consultation with the doctor, due

to the possibility of unknown hereditary

fructose intolerance.

Patients on a Controlled Sodium or Potassium

diet

E-Z-CAT contains sodium among the

excipients. Care should be taken in patients on

a controlled sodium diet, especially in the

cases of repeated administration.

It also contains potassium. Care should be

taken with patients who have reduced kidney

function or those on a controlled potassium

diet.

Other Excipients

E-Z-CAT contains methyl

parahydroxybenzoate, which may cause

allergic reactions, sometimes delayed.

Children, Elderly and Debilitated Patients

As with any barium sulfate preparation, care

should be taken when administering E-Z-CAT

to children, the elderly or the debilitated.

should be used cautiously in patients with pre-

existing heart disease.

4.5.

Interaction with

other medicinal products

and other forms of

interaction

Drug Interactions

:

The presence of barium sulphate

formulation 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 sulphate from that of other

agents should be considered

No interaction studies have been performed.

Barium sulfate is biologically inert and there are no

known interactions with other medicinal products.

However, The presence of barium sulphate formulation

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 sulphate from that of other

agents should be considered

Other examinations of the same area of the

gastrointestinal tract with another contrast

agent may be complicated by the presence of

barium sulfate (residue) in the gastrointestinal

tract up to several days following the

examination with barium contrast media.

4.6.

Pregnancy and

lactation

Use in Pregnancy

Radiation is known to cause harm to

unborn

fetus

exposed

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 sulphate products may be used

during lactation

Following oral or rectal administration, barium

sulfate is absorbed systemically in negligible

amounts. Though barium sulfate is

pharmacologically inert, no studies of its

mutagenic or teratogenic potential are

available.

Although this product is not contraindicated in

pregnancy, we would like to point out that

radiographic procedures may damage the

foetus, particularly during the first trimester of

pregnancy. Any examination should only be

carried out after careful consideration of the

benefit/risk of the procedure.

Since the absorption of barium sulfate is

negligible, its use is not contraindicated during

breastfeeding.

4.7.

Effects on ability to

drive and use

machines

-

4.7 Effects on ability to drive and use machines

E-Z-CAT has negligible influence on the

ability to drive and use machines.

4.8.

Undesirable effects

Reactions

:

Adverse reactions, such as nausea,

vomiting,

diarrhea

abdominal

cramping accompanying the use of

barium

sulfate

formulations

infrequent and usually mild

Sever reactions (approximately 1 in

1,000,000)

fatalities

(approximately 1 in 10,000,000) have

occurred. Procedural complications are

rare,

include

aspiration

pneumonitis, barium sulfate impaction,

granuloma, formation, intravasation,

embolization

peritonotos

4.8

Undesirable effects

Undesirable effects may occur during or after

a procedure with barium sulfate.

Skin and subcutaneous disorders together with

immune system disorders, reflecting allergic

reactions either to barium sulfate or the

product excipients, are among the most

commonly reported effects; for example

urticaria, erythema and rash.

Gastrointestinal disorders are also one of the

following

intestinal

perforation,

vasovagal and syncopal episodes, and

fatalities. 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

allergic-like

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

urticaria

(approximately 1 in 250,000). Such

reactions will generally respond to an

antihistamine

such

50mg

diphenhydramine or its equivalent. In

rarer

more

serious

reactions

(approximately

1,000,000)

laryngeal edema, bronchonspasm or

hypotension could develop. Severe

reactions

which

require

emergency

measures

often

characterized

peripheral

vasodilation,

hypotension,

reflex

tachycardia,dyspnea,

agitation,

confusion and cyanosis progressing to

unconsciousness. Treatment should be

initiated immediately with 0,3 to 0,5

1:1000

epinephrine

subcuteneously.

bronchospasm

predominates,

0,25

intravenous aminophylline should be

given

slowly.

Appropriate

vasopressors

might

required.

Adrenocorticosteroids, even if given

intravenously,

exert

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

bradycardia

following

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

most frequently reported class of undesirable

effects; for example diarrhoea, nausea,

abdominal pain/distention, constipation.

Within the table below, clinically significant

adverse reactions are listed if they have been

reported during post approval use of all

barium sulfate formulations. Their frequency

is not known, therefore relative reporting rate

(for example, less commonly) compared to

overall reporting for barium sulfate is used.

More rarely and depending on the route of

administration, i.e. oral or rectal, the following

procedural complications have been reported:

Infections (e.g. peritonitis) subsequent to

existing or new gastrointestinal perforation.

Complications include adhesions and

granuloma.

Subsequent to existing or procedural

gastrointestinal trauma, intravasation of

barium sulfate with rare subsequent venous

emboli formation, including the hepatic portal

vein, vena cava and pulmonary embolism that

may be fatal in approx 50% of cases.

Following oral administration, aspiration, with

pulmonary complications, may occur and may

be fatal in rare cases.

Please see section 4.4 for measures to be taken

to avoid these adverse reactions, and actions to

take if such adverse reactions occur.

Very rare cases of death associated with

barium sulfate administration have been

reported in the literature. The majority of the

deaths relate to procedural complications

usually caused by failure to follow generally

accepted radiological practice. Some cases

had a history indicating that barium sulfate

administration was highly unlikely to be a

primary or even secondary causative factor in

patient fatality

4.9.

Overdose

Overdosage

:

On rare occasions following repeated

administration,

severe

stomach

cramps, nausea, vomiting, diarrhea or

constipation may occur. These are

transitory

nature

considered serious. Symptoms may be

treated according to currently accepted

standards of medical care

Barium sulfate is non-toxic and absorbed systemically in

negligible amounts

Repeated use within a very short period of time has led

to abdominal cramps, nausea, vomiting, diarrhoea, and

constipation. These symptoms are transitory in nature

and may be allowed to resolve without medical

intervention or may be treated according to currently

accepted standards of care.

6.6

Special

precautions for

disposal and

other handling

Dosage and administration

:

The volume and concentration of E-Z-

CAT to be administered will depend

on the degree and extent of contrast

required

area(s)

under

examination and the equipment and

technique employed

Mixing Instructions: Pour contents into

supplied mixing container. Add water

to slightly below top of the container.

Close the lid and shake the container

well. Yield: 900 mL of 1.2% w/w

barium sulphate suspension

Alternately, E-Z-Cat barium sulphate

suspension may be mixed to yield a

different density. Some suggestions are

as follows

Add E-Z-Cat contents into the mixing

Container and add water to the 700 mL

level

Yield:

700mL

1.5%

suspension

Add water to the 600mL level

Yield:

suspension

Add water to the 500 mL level

Yield: 500 mL of a 2.1% w/w

suspension

Suggested

minutes

barium

administration protocol

for Abdomen Studies

Administer 300 mL of E-Z-Cat. 30

minutes before scan and 150 mL

immediately prior to scan; or use as

directed by physician

Suggested

Minute

Barium

Administration Protocol for Abdomen/

Pelvis Studies: Administer 300 mL E-

Z-Cat, 30 minutes before scan and 150

mL immediately prior scan

Then administer a barium enema using

E-Z-EM's 400 mL CAT-PAK

enema system (Cat. No. P410); or use

by physician

Suggested

Minute

Barium

Administration Protocol for Abdomen/

Pelvis Studies: Administer 450 mL E-

Z-Cat, 90 minutes before scan, another

The volume and concentration of E-Z-CAT to be

administered will depend on the degree and extent of

contrast required in the area(s) under examination and

the equipment and technique employed

Shake well before use. E-Z-CAT is intended

for dilution prior to administration.

Mixing Instructions: Pour contents into supplied

mixing container. Add water to slightly below top of

the container. Close the lid and shake the container

well. Yield: 900 mL of 1.2% w/w barium sulphate

suspension

Alternately, E-Z-Cat barium sulphate suspension may

be mixed to yield a different density. Some suggestions

are as follows

Add E-Z-Cat contents into the mixing Container and

add water to the 700 mL level

Yield: 700mL of a 1.5% w/w suspension

Add water to the 600mL level

Yield: 600 mL of a 1.7 w/w suspension

Add water to the 500 mL level

Yield: 500 mL of a 2.1% w/w suspension

Suggested 30 minutes barium administration protocol

for Abdomen Studies

Administer 300 mL of E-Z-Cat. 30 minutes before scan

and 150 mL immediately prior to scan; or use as

directed by physician

Suggested 30 Minute Barium Administration Protocol

for Abdomen/Pelvis Studies: Administer 300 mL E-Z-

Cat, 30 minutes before scan and 150 mL immediately

prior scan

Then administer a barium enema using E-Z-EM's 400

mL CAT-PAK

CT enema system (Cat. No. P410); or

use by physician

Suggested 90 Minute Barium Administration Protocol

for Abdomen/Pelvis Studies: Administer 450 mL E-Z-

Cat, 90 minutes before scan, another 300 mL 30

minutes before scan, and 150 mL immediately prior

scan; or use as directed by physician

Other dosing regimen may be followed as applicable

Any unused, opened product or waste material

should be disposed of in accordance with

local requirements.

300 mL 30 minutes before scan, and

150 mL immediately prior scan; or use

as directed by physician

Other dosing regimen may be followed

as applicable

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