Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
urea (13C)
Torbet Laboratories Ireland Limited
V04CX
13C-urea
Diagnostic agents
Breath Tests; Helicobacter Infections
This medicinal product is for diagnostic use only.For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.
Revision: 12
Authorised
1998-05-07
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON/CARDBOARD BOX 1. NAME OF THE MEDICINAL PRODUCT Pylobactell, 100 mg, soluble tablet 13 C-urea 2. STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains: 100 mg 13 C-urea 3. LIST OF EXCIPIENTS Povidone (E1201), Microcrystalline Cellulose (E460i), Colloidal Anhydrous Silica, Sodium Benzoate (E211). 4. PHARMACEUTICAL FORM AND CONTENTS The kit contains: A sachet containing one Pylobactell 100 mg soluble tablet. Six glass tubes, with caps and bar code labels. 30 ml mixing and administration glass vial with cap. Two straws. Package Leaflet. Analysis Request Form. Security Label and three additional bar code labels. 5. METHOD AND ROUTE(S) OF ADMINISTRATION _ _ Diagnostic test kit FOR ORAL ADMINISTRATION Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 8. EXPIRY DATE _ _ EXP: {MM/YYYY} 9. SPECIAL STORAGE CONDITIONS _ _ 13 Do not store above 25 C 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Richen Europe S.R.L VIA San Cristoforo 78-20090 Trezzano Sul Naviglio (Ml) Italy 12. MARKETING AUTHORISATION NUMBER(S) EU/1/98/064/001 13. BATCH NUMBER _ _ BN 14. GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 16. INFORMATION IN BRAILLE Pylobactell 17. UNIQUE IDENTIFIER – 2D BARCODE_ _ Not applicable 18. UNIQUE IDENTIFIER - HUMAN READABLE DATA_ _ Not applicable 14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET LABEL 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pylobactell, 100 mg, soluble tablet 13 C-urea Oral 2. METHOD OF ADMINISTRATION To be dissolved in water and taken orally. Read the package leaflet before use. 3. EXPIRY DATE _ _ EXP {MM/YYYY} 4. BATCH NUMBER _ _ Batch 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT One tablet 6. OTHER Richen Europe S.R.L VIA San Cristoforo 78-20090 Trezzano Sul Naviglio (Ml) Italy EU/1/98/064/001 15 ADDITIONAL KI Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pylobactell, 100 mg, Soluble Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Quantity per tablet 13 C-urea 100 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soluble tablet A white, biconvex tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. For _in vivo_ diagnosis of gastroduodenal _Helicobacter_ _pylori_ infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Pylobactell is not recommended for use in children below the age of 18 years due to insufficient data on efficacy. The Pylobactell tablet is for oral administration. _Adults_ : The tablet is to be dissolved in water and taken 10 minutes after the start of the breath test procedure. The patient should fast for at least 4 hours before the test so that the test is taken on an empty stomach. If the patient has eaten a heavy meal then it will be necessary to fast for six hours prior to the test. It is important to follow the instructions for use described in Section 6.6 adequately, otherwise the validity of the test result will be questionable. 4.3 CONTRAINDICATIONS The test must not be used in patients with documented or suspected gastric infection that might interfere with the urea breath test. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE A positive urea breath test alone does not clinically confirm that eradication therapy is indicated. Alternative diagnosis with invasive endoscopic methods might be indicated in 3 order to examine the presence of any other complicating conditions, eg. gastric ulcer, autoimmune gastritis and malignancies. In individual cases of atrophic gastritis, the breath test result may have a false positive outcome and other tests may be required to confirm the presence of _H.pylori_ . If a repeat test is required, it should not be carried out until the following day Les hele dokumentet