E-Z-PAQUE

Posology E-Z-Paque is primarily intended for use in the upper gastro-intestinal tract. The administered dose of E-Z-Paque will depend on the patient in question and the section of the gastrointestinal tract to be viewed.

Adults:

Single contrast of the oesophagus, stomach and duodenum - give orally 175 to 300 mL of suspension at 100 % w/v. Small bowel - give orally 250 to 300 mL of suspension at 60 % w/v. The actual administered dose should be determined from experience, by the radiologist.

Children:

The dosage will be dependent on the size, age, health state and anatomic region to be imaged of the child. Individual requirements should be determined, from experience, by the radiologist.

Elderly:

There are no special dosage recommendations. The dosage should be determined, from experience, by the radiologist. 6.

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. Adverse events Clinical Trials Post-marketing Surveillance MedDRA System Organ Class Rare (≥1/10,000 to <1/1,000) 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 Abdominal pain Nausea; Vomiting 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:

Intestinal ischemia, Constipation and in severe cases gastrointestinal blockage; Gastrointestinal inflammation, ulceration or perforation; Abdominal discomfort abdominal distension; Diarrhoea; Colitis ulcerative may be aggravated; 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.

Barium impaction. 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. 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.

Paediatric patients The type of adverse reactions is similar in children and adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

uk/yellowcard

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.

Barium Sulphate should not be administered in its dry form. The powder must be reconstituted, and some of the commercially prepared suspensions require further dilution, prior to administration. 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.

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.

These responses are thought to be caused by the flavors and/or preservatives used in the product. Because of reported anaphylactoid reactions to latex, the use of non-latex gloves during the procedure should be considered. 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. Obstruction/Fluid Overload Barium Sulphate suspensions, after oral administration, have been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis.

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 intoxication. Constipation or Diarrhoea E-Z-Paque 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 administration of barium sulfate to prevent severe constipation and the risk of impaction.

Conversely, since E-Z-Paque contains sorbitol, administration may have a mild laxative effect. 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. Baroliths 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. 2 g of sorbitol per 100g powder • The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

• The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered […]

1 Gastrointestinal Disorders Patients with any of the following: - a known or suspected perforation t of the gastrointestinal tract - known or suspected tracheo-esophageal fistula (oral administration), - gastrointestinal haemorrhage - gastrointestinal ischemia - megacolon or toxic megacolon - necrotising entercolitis - severe ileus should not receive E-Z-Paque.

E-Z-Paque should not be used for infants with swallowing disorders. Surgical and Medical Procedures Barium sulfate should not be administered immediately after gastrointestinal surgery, including snare polypectomy or ‘hot’ colonic biopsy because of the potential for post- surgical or post-procedural leakage or the potential for gastrointestinal perforation.

In case the patient has to undergo gastrointestinal surgery immediately after barium sulfate administration, caution should be exercised. Injury, Poisoning and Procedural Complications Barium Sulphate products should not be used during and up to four weeks after radiotherapy to the rectum or prostate.

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