Bracco UK Limited

In section 1:

Polibar is replaced by Polibar 94 % w/w powder for rectal suspension.

In section 2:

For a full list of excipients, see section 6.1. is added.

In section 3:

Powder.

For preparation as a suspension following the addition of water as directed.

is replaced by

Powder for rectal suspension.

White powder.

In section 4.1:

‘Polibar’ is a diagnostic reagent for radiological examination of the gastro- intestinal tract.

is replaced by

This medicinal product is for diagnostic use only.

Polibar is a diagnostic reagent for radiological examination of the gastro-intestinal tract.

In section 4.2:

For rectal administration.

            Adults: As prescribed by the radiologist.

            Add water to the powder as directed and shake well until a uniform suspension is             obtained.

            Usual Dosage Range 150- 750 g barium sulphate in a suitable suspension.

            ‘Polibar’ is designed for use in the GI tract and can be suspended over density range of    20 - 115% w/v (20 - 60% w/w).

            Double contrast of the large bowel - Give 400- 700 ml of suspension using between

            60- 115%w/v.

            Single contrast of the large bowel - Give as required between 20- 40% w/v.

            Children: The dosage will be dependent on the size and age of the child. The dosage        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.

is replaced by

Polibar is for rectal (enema) administration.The powder must be reconstituted prior to administration (see section 6.6).

The administered dose of Polibar will depend on the patient in question and the section of the gastrointestinal tract to be viewed. 

Adults:  Usual Dosage Range 150- 750 g barium sulfate in a suitable suspension.

Double contrast of the large bowel - Give as required between 60 - 115 % w/v.

Single contrast of the large bowel - Give as required between 20 - 40 % 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.

In section 4.3:

‘Polibar’ should not be used in patients with real or suspected perforation of the gastro­-intestinal tract or in those other cases where the use of barium sulphate is contra-indicated.

is replaced by

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 of the lower gastro­intestinal tract

–          lower gastrointestinal haemorrhage

–          gastrointestinal ischemia

–          megacolon or toxic megacolon

–          necrotising entercolitis

–          colonic ileus

should not receive Polibar.

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 lower gastrointestinal tract.

In section 4.4:

The product should be used under medical supervision. As with any barium sulphate enema preparation, care should be taken when administering ‘Polibar’ to children, the elderly or the debilitated. It should be used cautiously in patients with pre-existing heart disease

is replaced by

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.

Known hypersensitivity or allergy to latex is a contraindication for the use of balloon retention enema tips containing latex.  The use of a retention cuff enema tip is not necessary or desirable in patients with normal sphincter tone.  The presence of adequate sphincter tone can be judged by preliminary rectal digital examination.

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 of the lower gastrointestinal tract, 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.

Care must be taken during insertion of the enema tip into the patient and when using a retention balloon, particularly in the newborn, the elderly and in patients with recto-sigmoidal strictures, inflammatory bowel disease, rectal neoplasm or radiation therapy.  Enema tip forceful, too deep insertion or balloon inflation may cause tearing or perforation of the rectum.

Insertion of an enema tip should be performed only after digital examination by qualified medical personnel.  When balloon retention tips are used, care should be taken to avoid over inflation of the balloon, since overfilling or asymmetrical filling may cause displacement of the tip.  Such a displacement can lead to rectal perforation or barium sulfate granulomas.

Inflation of the balloon should be done under fluoroscopic control by qualified medical personnel.  Do not unnecessarily move the enema tip once inserted.  A specially designed enema tip is required for a barium sulfate suspension examination of a colostomy patient.  Intubation of an enteroclysis catheter should be done by qualified medical personnel.

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.

It is suggested to not fill the entire colon when evaluating a child with Hirschsprung’s Disease; use only the amount of fluid necessary for the diagnosis.

Preparatory enemas in patients with Hirschsprung’s Disease should be avoided.

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, but 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.  It has been associated with inadvertent vaginal placement of the rectal catheter.  The diagnosis should be considered in any patient who collapses during or shortly after barium enema, 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.

This complication may be prevented by ensuring correct placement of the rectal catheter and by reducing the use of balloon catheters.

Misplacement of the rectal catheter in the vagina can lead to intravasation: correct rectal catheter placement should be confirmed prior to enema administration.

Constipation

Polibar 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.

Other Possible Complications

Care must be taken during an enema procedure as vasovagal reactions, syncopal episodes, cardiac dysrhythmia and other cardiovascular side effects can occur during barium enemas.

All plastic/rubber accessories are disposable, single-use devices that must not be reused or left in the body cavity for an extended period of time.

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.  In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema.  Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.

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.

Children, Elderly and Debilitated Patients

As with any barium sulfate preparation, care should be taken when administering Polibar to children, the elderly or the debilitated.  It should be used cautiously in patients with pre-existing heart disease.  As bacteraemia may occur during a barium enema, IV antibiotic cover is recommended for patients with prosthetic heart valves.

In section 4.5:

None known

is replaced by

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 sulfate formulations in the gastrointestinal tract may alter the absorption of therapeutic agents taken concomitantly.  In order to minimise any potential change in absorption, the separate administration of barium sulfate from that of other medicines 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.

In section 4.6:

Whilst this product is not contra-indicated in pregnancy, it should be noted that radiographic procedures may be harmful to the foetus

is replaced by

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.

In section 4.7:

Not applicable is replaced by Polibar has negligible influence on the ability to drive and use machines.

In section 4.8:

During or following any barium procedure, complications can occur. These may include constipation; barium impaction; intestinal perforation which may be followed by peritonitis and granuloma; intravasation and embolization. ECG changes have been shown to occur following or during barium enemas. Bacteraemia may occur during a barium enema, and IV antibiotic cover is recommended for patients with prosthetic heart            valves. Extremely rarely allergic reactions can occur. A barium enema with fill bowel        

preparation may exacerbate ulcerative colitis.

is replaced by

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.

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.

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.

In section 4.9:

Not applicable - the active constituent of Polibar, Barium Sulphate, is non toxic

is replaced by

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.

In section 5.1:

Barium Sulphate, the active constituent of ‘Polibar’ is inert and has no pharmacodynamic properties.

is replaced by

Pharmacotherapeutic group:  X-ray contrast media, barium sulfate with suspending agents, ATC code: V08BA01

The active constituent of Polibar, barium sulfate, is inert and has no pharmacodynamic properties.  It serves only as a radiopaque substance to opacify the gastro-intestinal track during X-ray examinations.

In section 5.2:

Barium sulphate is not absorbed or metabolised and hence does not produce any systemic effects. It is passed from the body unchanged.

is replaced by

Under physiological conditions, barium sulfate passes through the 
gastrointestinal tract in an unchanged form and is absorbed only in 
small, pharmacologically insignificant amounts.

In section 6.1:

Sorbitol BP, Simethicone USP, Polyoxyethylene Glyceryl Mono-oleate, Gum Ghatti US FCC*, Sodium Carrageenan, Sodium Citrate Ph.Eur.

·         US FCC United States Food Chemical Codex

is replaced by

Gum ghatti

Sorbitol (E420)

Sodium citrate (E331)

Sodium carrageenan (E407)

Simeticone

Polyoxyethylene glyceryl mono-oleate.

In section 6.2:

None known is replaced by not applicable.

In section 6.3 (6.3.1, 6.3.2, 6.3.3):

6.3.1.   Shelf-life as packaged for sale

                        ‘Polibar’ has a shelf life of three years from the date of manufacture.

                        6.3.2. Shelf-life after reconstitution according to directions

                        ‘Polibar’ should be used immediately following reconstitution as                                         directed.

                        6.3.3.   Shelf-life after first opening the container

                        Not applicable. ‘Polibar’ is presented in a unit dose which allows for                                   preparation for each patient as required. It is recommended that the                               reconstituted product is not stored.

is replaced by

6.3       Shelf life

Three years.

This pack is for single-use only.  Polibar should be administered immediately following reconstitution and must not be stored.

In section 6.4:

Store below 25°C in a dry place.

is replaced by

Store below 25 °C.  Store in the original package.

In section 6.5:

Not all pack sizes may be marketed is added.

In section 6.6:

Adults:  Polibar should be suspended over the density range of 20 - 115 % w/v (20 - 60 % w/w).

Reconstitution information for use of Polibar is provided below.

Water to be added (mL)

397 g enema bag

567 g enema bag

680 g enema bag

Any unused, opened product or waste material should be disposed of in accordance with local requirements, is added.

In section 10:

May 2009 is replaced by November 2009.