Država: Izrael
Jezik: angleščina
Source: Ministry of Health
BARIUM SULFATE
PROMEDICO LTD
V08BA
SUSPENSION
BARIUM SULFATE 4.9224 %W/V
PER OS
Required
E-Z-EM INC., USA
BARIUM SULFATE CONTAINING X-RAY CONTRAST MEDIA
For use in x-ray departments.Opacification of the gastro intestinal tract prior to computerized axial tomography.
2012-02-28
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”) • You suffer from any of the 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 gastrointest Preberite celoten dokument
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 Preberite celoten dokument