POLIBAR Powder for rectal suspension (2016)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Bracco UK Limited |
|---|---|
| Διεύθυνση | Bracco House, Mercury Park, Wycombe Lane, Wooburn Green, High Wycombe, Bucks, HP10 0HH |
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Περιεχόμενα
Name of the medicinal product
Polibar 94% w/w powder for rectal suspension.
Qualitative and quantitative composition
<u>Active Constituent:</u> Barium sulfate 94.015% w/w. For a full list of excipients, see section 6.1.
Pharmaceutical form
Powder for rectal suspension. White powder.
Therapeutic indications
This medicinal product is for diagnostic use only. Polibar is a diagnostic reagent for radiological examination of the gastro-intestinal tract. Polibar is indicated in adults and children.
Posology and method of administration
Posology Polibar is for rectal (enema) administration. 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 ...
Contraindications
Immune System Disorders Hypersensitivity to barium sulfate or to any of the excipients listed in section 6.1. Gastrointestinal Disorders Patients with any of the following: a known or suspected perforation ...
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 ...
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 sulfate formulations ...
Fertility, pregnancy and lactation
Pregnancy 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. ...
Effects on ability to drive and use machines
Polibar has negligible influence on the ability to drive and use machines.
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 ...
Overdose
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. ...
Pharmacodynamic properties
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. ...
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.
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included elsewhere in the SPC.
List of excipients
Gum ghatti Sorbitol (E420) Sodium citrate (E331) Sodium carrageenan (E407) Simeticone Polyoxyethylene glyceryl mono-oleate Citric acid anhydrous (E330)
Incompatibilities
Not applicable.
Shelf life
Three years. This pack is for single-use only. Polibar should be administered immediately following reconstitution and must not be stored.
Special precautions for storage
Store below 25°C. Store in the original package. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Unit dose prefilled enema bag composed of polyvinylchloride containing 397 g, 567 g or 680 g of product. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
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. Attach clamp to tubing and close. Study the appropriate ...
Marketing authorization holder
Bracco Imaging spa, Via Egidio Folli 50, 20134, Milano, Italy
Marketing authorization number(s)
PL 12032/0021
Date of first authorization / renewal of the authorization
7th May 1993 / 15th January 2004
Date of revision of the text
26/09/2016
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