Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
urea (13C)
INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH
V04CX
13C-urea
Diagnostic agents
Breath Tests; Helicobacter Infections
Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in:adults;adolescents, who are likely to have peptic ulcer disease.Helicobacter Test INFAI for children aged three to 11 years may be used for in vivo diagnosis of gastrduodenal Helicobacter pylori infection:for the evaluation of the success of eradication treatment, or;when invasive tests cannot be performed, or;when there are discordant results arising from invasive tests.This medicinal product is for diagnostic use only.
Revision: 20
Authorised
1997-08-14
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON, PACK OF 1 JAR AND 50 JARS 1. NAME OF THE MEDICINAL PRODUCT Helicobacter Test INFAI 75 mg powder for oral solution 13 C-urea 2. STATEMENT OF ACTIVE SUBSTANCE(S) 1 jar containing 75 mg 13 C-urea. 3. LIST OF EXCIPIENTS None 4. PHARMACEUTICAL FORM AND CONTENTS Powder for oral solution 1 diagnostic test kit contains: 1 jar containing 75 mg 13 C-urea powder for oral solution 4 containers for breath samples 1 bendable straw Package leaflet Data sheet for patient documentation Page of labels and sticker 1 diagnostic test kit contains: 1 jar containing 75 mg 13 C-urea powder for oral solution 2 breath bags for breath samples 1 bendable straw Package leaflet Data sheet for patient documentation Bar code labels and sticker 1 diagnostic test kit contains: 50 jars containing 75 mg 13 C-urea powder for oral solution 100 breath bags for breath samples 50 bendable straws 50 Package leaflet 50 Data sheets for patient documentation 50 Barcode labels and sticker 5. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use 34 For Mass Spectrometry For Infrared Spectroscopy Please read enclosed instructions for 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. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP: {MM/YYYY} 9. SPECIAL STORAGE CONDITIONS Do not store above 25 C. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 35 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Marketing Authorisation Holder: INFAI GmbH Riehler Str. 36 D-50668 Köln Germany 12. MARKETING AUTHORISATION NUMBER(S) Marketing Authorisation Number: EU/1/97/045/001 EU/1/97/045/002 EU/1/97/045/004 13. BATCH NUMBER Batch: 14. GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE Helicobacter Test INFAI 75 mg 17. UNIQUE IDEN Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Helicobacter Test INFAI 75 mg powder for oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One jar contains 75 mg of 13 C-urea powder. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White, crystalline powder for oral solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Helicobacter Test INFAI may be used for _in vivo_ diagnosis of gastroduodenal _Helicobacter pylori_ infection in: - adults, - adolescents, who are likely to have peptic ulcer disease. This medicinal product is for diagnostic use only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should be administered by a healthcare professional and under appropriate medical supervision. Posology Helicobacter Test INFAI is a breath test for single administration. Patients from the age of 12 must take the contents of 1 jar with 75 mg. Method of administration For performance of the test, 200 ml 100 % orange juice or 1 g citric acid in 200 ml water for patients from the age of 12 and older (as a pre-administered test meal), as well as tap water (for dissolving the 13 C-urea powder) are necessary. The patient must have fasted for over 6 hours, preferably overnight. The test procedure takes approximately 40 minutes. In case it is necessary to repeat the test procedure, this should not be done until the following day. The suppression of _Helicobacter pylori_ might give false negative results. Therefore the test shall be used after at least four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents. Both might interfere with the _Helicobacter pylori_ status. This is especially important after Helicobacter eradication therapy. It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability of the outcome will become questionable. 3 4.3 CONTRAINDICATIONS The test must not be used in patients with documented or suspected gastric infection or Pročitajte cijeli dokument