FrancophonIA/ELRC3.0 huggingface dataset:
English: These five processes take place in the analyser of a mass spectrometer, which consists of three separate sections: the source, flight tube, and collector.
Danish: Disse fem processer foregår i analysatoren i massespektrometret, som består af tre separationsdele: Kilde, analyserør og kollektor.
English: • 1 g citric acid dissolved in 200 ml water
Danish: • 1 g citronsyre opløst i 200 ml vand
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: If you cannot take either of these test meals, please tell your doctor, who will suggest an alternative.
Danish: Hvis De ikke kan indtage et af disse testmåltider, skal De informere lægen, som vil foreslå et alternativ.
English: This ensures the high accuracy of this system, as calculation of the isotopic content in carbon dioxide is done with respect to an independent standard.
Danish: Dette sikrer systemets nøjagtighed, idet beregning af isotopindholdet i kuldioxid udføres over for en uafhængig standard.
English: It is recommended to take notice of the product information of eradication therapy products for their use during pregnancy and lactation.
Danish: Det anbefales at rådføre sig med produktinformationen for eradikationspræparater for deres brug under graviditet og amning.
English: • This medicine has been prescribed for you only.
Danish: • Lægen har ordineret dette lægemiddel til Dem personligt.
English: The infrared radiation in the measuring chamber is weakened by the gas component to be measured.
Danish: Den infrarøde stråling i målekammeret svækkes af gaskomponenten, der skal måles.
English: • inflammation of the stomach lining caused by immune system
Danish: • betændelse i mavens slimhinde forårsaget af immunsystemet
English: Ask your doctor, if fasting is a problem, for example for diabetic patients.
Danish: Spørg lægen, hvis det er et problem at faste, f.eks. hvis De har sukkersyge (diabetes).
English: The accuracy of the test strongly depends on the quality of the breath analysis.
Danish: Nøjagtigheden af testen afhænger helt af kvaliteten af analysen af udåndingstesten.
English: This should be done in fasted condition and not before the following day.
Danish: Dette skal gøres fastende og ikke før den næste dag.
English: If the test needs to be carried out later in the day, only a light meal like tea and toast is recommended.
Danish: Hvis testen skal udføres senere på dagen, anbefales det, at De kun indtager et lettere måltid, f.eks. en kop te og et stykke ristet brød.
English: 13C/12C-ratio with respect to Pee Dee Beliminate (PDB)
Danish: 13C/12C-forholdet overfor PDB (Pee Dee Beliminate)
English: • the enzyme urease, which stimulate the reduction of urea Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: • enzymet urease, som stimulerer omdannelsen af urinstof Fortæl det altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: Further samples of your breath will then be taken 30 minutes later and the amount of carbon-13 in the samples measured as before.
Danish: Yderligere prøver af Deres udåndingsluft vil derefter blive taget 30 minutter senere, og mængden af kulstof 13 i prøverne vil blive målt som tidligere.
English: See “Special instructions for use”.
Danish: Se ”Brugervejledning”.
English: • if you have or suspect that you have a stomach infection or a certain inflammation of the stomach lining (atrophic gastritis).
Danish: • hvis De har eller har mistanke om, at De har en maveinfektion eller en særlig form for betændelse i mavesækkens slimhinde (atrofisk gastritis).
English: Medical or healthcare professionals can find detailed information on the analysis of breath samples and the testing specifications for laboratories, in section 6.6 of the Summary of Product Characteristics.
Danish: Læger og sundhedspersonale kan finde detaljerede oplysninger om analysering af udåndingsprøver og testspecifikationer for laboratorier i punkt 6.6 i produktresuméet.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Storing of operating parameters and of results under security access to avoid later manipulation
Danish: Opbevaring af måleparametre og af resultater under sikre forhold for at undgå efterfølgende manipulation.
English: 2H2N(13CO)NH2 + 2H2O Enzyme urease 4NH3 + 213CO2
Danish: 2H2N(13CO)NH2 + 2H2O enzymet urease 4NH3 + 213CO2
English: The test procedure takes approximately 40 minutes.
Danish: Testproceduren tager ca. 40 minutter.
English: A positive test alone does not constitute indication for eradication therapy.
Danish: Et positivt resultat alene er ikke tilstrækkelig indikation for behandling.
English: INFAI GmbH An der Kohlenbahn 39 D-58135 Hagen Germany
Danish: INFAI GmbH An der Kohlenbahn 39 D-58135 Hagen Tyskland
English: It is recommended that you take the test in a resting position.
Danish: Det anbefales, at De tager testen i en hvileposition.
English: Component
Danish: Komponent
English: Pharmacotherapeutic group: Other diagnostic agents, ATC code: VO4CX
Danish: Farmakoterapeutisk klassifikation: andre diagnostika, ATC-kode: VO4CX.
English: For calibration and measurement necessary CO2-free air (zero-gas) will be produced via an integrated CO2-absorber in the analysator.
Danish: Til kalibrering og målinger produceres den nødvendige CO2-fri luft (nulgas) vha. en integreret CO2-absorber i analysatoren.
English: • 2 weeks after the last administration of a medicine to reduce release of stomach acid Both groups of medicines could influence the results of the Helicobacter Test INFAI.
Danish: • 2 uger efter sidste administration af et lægemiddel, der nedsætter dannelsen af mavesyre Disse 2 lægemiddelgrupper kan påvirke resultatet af Helicobacter Test INFAI.
English: Analysis of breath samples and testing specification for laboratories
Danish: Analyse af udåndingsprøver og testspecifikationer for laboratorier
English: The test procedure lasts approximately 40 minutes.
Danish: Gennemførelse af testen varer omkring 40 minutter.
English: The water content of the breath sample will be kept mostly constant through Nafion water trap.
Danish: Udåndingsprøvens vandindhold bevares stort set konstant gennem en Nafion-vandskiller.
English: Other urease producing bacteria were seldom found in the gastric flora.
Danish: Andre ureaseproducerende bakterier er sjældent fundet i ventrikelflora.
English: Differential diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, e.g. ulcer, autoimmune gastritis and malignancies.
Danish: Differential diagnose med brug af invasive endoskopiske metoder kan være indiceret for at undersøge eventuel tilstedeværelse af komplicerende tilstande som ulcus, autoimmun gastritis og maligne tilstande.
English: 13C-urea
Danish: 13C-urinstof
English: EXPIRY DATE BATCH NUMBER OTHER
Danish: UDLØBSDATO BATCHNUMMER ANDET
English: This medicinal product is for diagnostic use only.
Danish: Medicinsk produkt kun til diagnostisk brug.
English: Ionisation, beam formation and acceleration all occur in the source, magnetic deflection takes place in the flight tube and detection takes place in the collector.
Danish: Ionisering, dannelse af stråle og acceleration sker alle i kilden, magnetisk afbøjning sker i analyserøret og detektionen sker i kollektoren.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Date of test
Danish: Dato for test
English: The modulated infrared beams then enter the infrared detectors, which are double layer transmission detectors with a front, and a rear chamber each filled with one of the isotopicly pure gases (13CO2 or 12CO2, respectively) to be measured.
Danish: De modulerede infrarøde stråler trænger derefter ind i de infrarøde detektorer, der er tolags transmissionsdetektorer med et for- og bagkammer, der hver især er fyldt med en af de isotopisk rene gasser (henholdsvis 13CO2 eller 12CO2), der skal måles.
English: • Specifications for determining 13C/12C-ratios
Danish: • Specifikationer for bestemmelse af 13C/12C-forhold
English: If the test needs to be repeated, this should be done on the following day at the earliest.
Danish: Hvis det er nødvendigt at gentage testen, bør det tidligst ske dagen efter.
English: Endpoint adjustment of the detectors by means of calibration gases of precisely known concentration.
Danish: Slutpunktsjustering af detektorerne vha. kalibreringsgasser, hvis nøjagtige koncentration er kendt.
English: The test meal is not provided within the kit.
Danish: Testmåltidet følger ikke med i pakken.
English: All foods contain a substance called carbon-13 (13C).
Danish: Alle fødevarer indeholder stoffet kulstof 13 (13C).
English: • 2 weeks after the last administration of a medicine to reduce release of stomach acid
Danish: • 2 uger efter sidste administration af et lægemiddel, der nedsætter dannelsen af mavesyre
English: This enables measurement of the 13C/12C-ratio at any CO2 concentration above 1 %.
Danish: På den måde er det muligt at måle 13C/12C-forholdet i en vilkårlig CO2-koncentration over 1 %.
English: Water is removed from the sample by means of a Nafion water trap or the gas-chromatographic preparation system that separates the individual gases in a gas chromatographic column with Helium as eluent.
Danish: Vand fjernes fra prøven ved en NAFION vandskiller eller i et gaskromatografisk system, som adskiller de enkelte gasser på en gaskromatografisk kolonne med Helium som eluent.
English: Do not store above 25 °C.
Danish: Må ikke opbevares over 25°C.
English: These samples will be analysed to measure the “normal” amount of carbon-13 content in the carbon dioxide in your breath.
Danish: Disse prøver analyseres for at måle den ”normale” mængde kulstof 13 i udåndingsluftens kuldioxid.
English: Any increase in 13CO2 will be measured by isotopic analysis.
Danish: En stigning i 13CO2 vil blive målt med isotopanalyse.
English: You should perform the test in the presence of your doctor or another qualified person.
Danish: Testen skal udføres i nærværelse af en læge eller en anden kvalificeret person.
English: To analyse the separated carbon dioxide sample gas its molecules must be ionised, formed into a beam, accelerated by an electric field, deflected in a magnetic field, and finally detected.
Danish: For at analysere den separerede kuldioxidprøve skal molekylerne ioniseres, formes i en stråle, accelereres i et elektrisk felt, afbøjes i et magnetfelt og til slut detekteres.
English: The results will be compared and a significant increase in the amount of carbon-13 in the second set of samples will suggest to your doctor that Helicobacter pylori is present.
Danish: Resultaterne sammenlignes, og en større stigning af mængden af kulstof 13 i nr. toprøverne vil give Deres læge et tegn på tilstedeværelse af Helicobacter pylori.
English: If the patient vomits during the test procedure, repetition of the test is necessary.
Danish: Ved opkastning under testproceduren er det nødvendigt at gentage testen.
English: You will then be asked to drink a solution of carbon-13-urea.
Danish: De bliver herefter bedt om at drikke en opløsning af kulstof 13-urinstof.
English: The automatic preparation system for isotope mass spectrometers which is dedicated for breath test analysis is based on a gas-chromatographic continuous flow separation technique.
Danish: Det automatiske system til isotop massespektrometre, som anvendes til analyse af udåndingstesten, er baseret på gaskromatografisk separationsteknik ved kontinuerligt fremløb.
English: Mass spectrometry (IRMS)
Danish: Massespektrometri (IRMS)
English: The actual amount of carbon-13 in the breath will depend on the kind of food that you have eaten.
Danish: Mængden af kulstof 13 i Deres udåndingsluft afhænger af, hvilke fødevarer De har indtaget.
English: A membrane capacitor connected with this chamber, which is exposed to a high resistance direct voltage, transforms these pressure fluctuations into an alternating voltage, which is a measure of the isotopic composition of breath carbon dioxide.
Danish: En membrankapacitor tilsluttet dette kammer, som udsættes for direkte højohmsspænding, transformerer disse trykfluktuationer til en vekselstrøm, der er et mål for den isotopiske sammensætning af udåndingsluftens kuldioxid.
English: This medicinal product should be administered by a healthcare professional and under appropriate medical supervision.
Danish: Dette lægemiddel bør administreres af sundhedspersoner og under supervision af en læge.
English: For verifying the specifications linearity, stability, and precision of measurement have to be tested.
Danish: Til verificering af specifikationerne skal linearitet, stabilitet og målepræcision afprøves.
English: It is recommended to perform the test with the patient being in a resting position.
Danish: Det anbefales at udføre testen med patienten i en afslappet stilling.
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ.
English: INFAI GmbH Gottfried-Hagen-Str. 60-62 D-51105 Köln Germany
Danish: INFAI GmbH Gottfried-Hagen-Str. 60-62 D-51105 Köln Tyskland
English: Do not store above 25°C.
Danish: Må ikke opbevares over 25°C
English: Powder for oral solution
Danish: pulver til oral opløsning
English: Analysis of breath samples and testing specification for laboratories for infrared analyzer or mass spectrometry (IRMS)
Danish: Analyse af udåndingsprøver og testspecifikationer for laboratorier for infrarød analyseapparat eller massespektrometri (IRMS)
English: It is not expected that the test procedure may be harmful during pregnancy or lactation.
Danish: Det forventes ikke, at testen har skadelige virkninger i forbindelse med graviditet og amning.
English: 3 % CO2 breath concentration
Danish: CO2-koncentration
English: It is important to follow the instructions for use exactly, otherwise the result may be questionable.
Danish: Det er vigtigt at følge instruktionerne for udførelse af testen omhyggeligt, ellers er resultatet af testen usikker.
English: The patient must have fasted for over 6 hours, preferably overnight.
Danish: Patienten skal være fastende i mindst 6 timer, helst natten over.
English: A semi-automatic sample inlet system injects the measuring gas in definite amounts into the zero gas circulating in the gas circuit of the infrared spectrometer.
Danish: Et halvautomatisk prøveindføringssystem injicerer målegassen i definitive mængder i den nulgas, der cirkulerer i det infrarøde spektrometers gaskredsløb.
English: and stated as an absolute difference (Δδ-value) between the 00-minute- and the 30-minute-values.
Danish: (IRMS) og angives som den absolutte difference (Δδ-værdi) mellem 00-værdien og 30-minutværdien.
English: Ammonia which is produced as described above by the bacterial hydrolysis is included into the metabolism as NH4+.
Danish: Ammoniak, dannet ved bakteriel hydrolyse, som tidligere beskrevet, metaboliseres i form af NH4+.
English: It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability of the outcome will become questionable.
Danish: Det er vigtigt at følge brugsanvisningen, beskrevet i afsnit 6.6, omhyggeligt, ellers er resultatet af testen usikkert.
English: Then the patient must drink the recommended test meal (100 ml 100 % orange juice).
Danish: Derefter skal patienten drikke det anbefalede testmåltid (100 ml 100 % appelsinjuice).
English: The second breath sample container is only required for mass spectrometry.
Danish: Den anden testbeholder til udånding er kun nødvendig til massespektrometri.
English: In case it is necessary to repeat the test procedure, this should not be done until the following day.
Danish: Hvis det er nødvendigt at gentage testen, kan det ikke gøres før næste dag.
English: Passing the column the separated gas species of breath are detected by an ionisation detector.
Danish: De separerede gasser fra udåndingsluften detekteres af en ioniseringsdetektor.
English: ≤ 0.3 ‰ at 10 consecutive pulses
Danish: ≤ 0,3 ‰ for 10 på hinanden følgende pulser
English: Zero point adjustment of the detectors by means of the zero gas generated in the spectrometer.
Danish: Nulpunktsjustering af detektorerne vha. nulgas genereret i spektrometeret.
English: You have already been determined as being infected with Helicobacter pylori and have been taking medication aimed to clear up the infection.
Danish: Det er tidligere blevet konstateret, at De har en infektion med Helicobacter pylori, og De har taget medicin for at bekæmpe infektionen.
English: This test solution must now be drunk immediately by the patient, and the time of application must be noted.
Danish: Patienten drikker testopløsningen med det samme, og tidspunktet noteres.
English: To analyse the carbon dioxide in breath a broad band infrared radiation bunch emitted by an infrared radiation source is alternately sent through the measuring chamber and a reference chamber by means of a beam chopper.
Danish: For at analysere kuldioxiden i udåndingsluften udsendes infrarøde bredbåndsstråler fra en infrarød strålingskilde skiftevis gennem målekammeret og et referencekammer vha. en stråle-chopper.
English: From there it is transported as bicarbonate into the lung and liberated as 13CO2 with the exhaled air.
Danish: Den transporteres som bikarbonat med blodet til lungerne og frigøres i form af 13CO2 med udåndingsluften.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: • 200 ml 100 % orange juice or
Danish: • 200 ml 100 % appelsinjuice eller
English: The following is a suitable test meal:
Danish: Følgende er et egnet testmåltid:
English: The package must be sent to a qualified laboratory for analysis.
Danish: Pakningen skal sendes til et kvalificeret laboratorium til analysering.
English: Therefore, the rate-limiting step in the whole process is the cleavage of 13C-urea by Helicobacter's urease.
Danish: Det hastighedsbestemmende trin i hele processen er derfor spaltningen af 13C-urinstof med Helicobacters urease.
English: It is recommended to measure as soon as possible after the breath collection, in any case not later than 4 weeks.
Danish: Det anbefales, at målingen foretages så hurtigt som muligt og aldrig senere end fire uger efter prøvetagningen.
English: It has to be ensured that the analysis is carried out by a qualified laboratory.
Danish: Det skal sikres, at analyserne udføres af godkendte laboratorier.
English: The breath from the bags will be introduced into the NDIR spectrometer using a variable gas pump.
Danish: Udåndingsluften fra poserne introduceres til NDIR-spektrometrien vha. en variabel gaspumpe.
English: Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minutevalue exceeds 4.0 ‰.
Danish: Infektion med Helicobacter pylori foreligger, hvis forskellen i 13C/12C-forholdet mellem nulværdien og 30-minut-værdien overstiger 4,0 ‰.
English: The method validated in the application is as follows:
Danish: Den validerede metode er som beskrevet nedenfor:
English: Special instructions for use (for mass spectrometry)
Danish: Særlige instruktioner vedrørende anvendelsen (til massespektrometri)
English: To determine the 13C/12C-ratio of carbon dioxide in breath by mass spectrometric analysis the carbon dioxide must be separated from the breath and introduced into the mass spectrometer.
Danish: For at bestemme 13C/12C-forholdet i udåndingsluftens kuldioxid ved massespektrometrisk analyse skal kuldioxid separeres fra udåndingsluften og indføres i massespektrometret.
English: • Fill the 13C-urea jar to the brim with water for a second and third time and add these contents to the drinking glass (total volume of tap water should be approximately 30 ml).
Danish: • Fyld beholderen med 13C-urinstof med vand til kanten for anden og tredje gang, hæld indholdet herfra over i drikkeglasset (den totale mængde postevand bør være ca. 30 ml).
English: The fraction of carbon dioxide gas, identified by its characteristic retention time, is introduced into mass spectrometer.
Danish: Gasfraktionen med kuldioxid, som er identificeret med den karakteristiske fraktionstid, føres ind i massespektrometret.
English: For infrared spectroscopy, only one breath bag is required.
Danish: Til infrarød spektroskopi er kun en udåndingspose nødvendig.
English: • There are no other ingredients.
Danish: • Øvrige indholdsstoffer: ingen
English: Before the breath test is performed a liquid test meal is taken to delay the stomach from emptying.
Danish: Inden udåndingstesten udføres, skal De indtage et flydende testmåltid for at forsinke mavens tømning.
English: In the absence of bacterial urease, the whole amount of the administered urea after absorption from the gastrointestinal tract will be metabolised like the endogenous urea.
Danish: I fravær af bakteriel urease metaboliseres hele den indtagne mængde urinstof efter absorption fra mave-tarmkanalen på samme måde som det endogene urinstof.
English: • All mass spectrometers for breath analysis must comply with the following specifications: Linearity:
Danish: • Alle massespektrometre til analyse af udåndingstesten skal overholde følgende specifikationer: Linearitet:
English: The suppression of Helicobacter pylori might give false negative results.
Danish: Hvis Helicobacter pylori udsættes for væksthæmning, kan man få falske negative resultater.
English: Your doctor has recommended that you have a Helicobacter Test INFAI for one of the following reasons:
Danish: Deres læge anbefaler, at De bliver testet med Helicobacter Test INFAI af en af følgende årsager:
English: The following are suitable test meals:
Danish: Følgende er egnede testmåltider:
English: In the presence of bacterial urease the ratio of the 13C/12C-carbon isotopes is significantly changed.
Danish: I nærværelse af det bakterielle enzym urease ændres kulstofisotopforholdet 13C/12C signifikant.
English: In individual cases of A-gastritis (atrophic gastritis) the breath test may have false positive results; other tests may be required to confirm the Helicobacter pylori status.
Danish: I enkelte tilfælde af A-gastritis (atrofisk gastritis) kan udåndingstesten give falske, positive resultater; det kan være nødvendigt at lave andre undersøgelser for at bekræfte tilstedeværelse af Helicobacter pylori.
English: This is particularly after a therapy to remove Helicobacter pylori.
Danish: Dette gælder især efter en behandling, som fjerner Helicobacter pylori.
English: The test is to be performed after instruction by a healthcare professional and under appropriate medical supervision.
Danish: Testen skal udføres efter sundhedspersonalets anvisning og under passende overvågning af en læge.
English: White, crystalline powder for oral solution.
Danish: Hvidt, krystallinsk pulver til oral opløsning.
English: • 100 ml 100 % orange juice
Danish: • 100 ml 100 % appelsinjuice eller
English: All breath bags should be placed back into the original packaging.
Danish: Alle beholdere med udåndingsprøver skal sættes tilbage i den oprindelig pakning.