FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive
English: This packaging should be sealed with the remaining sticker.
Croatian: Kutiju treba zapečatiti preostalom priloženom naljepnicom.
English: The infrared radiation in the measuring chamber is weakened by the gas component to be measured.
Croatian: Infracrveno zračenje u komori za mjerenje oslabljeno je plinskom komponentom koja se mjeri.
English: • tumours
Croatian: • tumora.
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.
Croatian: Zdravstveni djelatnici mogu pronaći detaljne informacije o analizi uzoraka izdahnutog zraka i specifikacijama testiranja za laboratorije u dijelu 6.6 Sažetka opisa svojstava lijeka.
English: Ammonia which is produced as described above by the bacterial hydrolysis is included into the metabolism as NH4+.
Croatian: Amonijak nastao bakterijskom hidrolizom, kao što je prethodno opisano, uključuje se u metabolizam kao NH4+.
English: For verifying the specifications linearity, stability, and precision of measurement have to be tested.
Croatian: Za potvrdu specifikacija potrebno je testirati linearnost, stabilnost i preciznost mjerenja.
English: ≤ 0.3 ‰ at 10 consecutive pulses
Croatian: ≤ 0,3 ‰ na 10 uzastopnih pulseva
English: 3 % CO2 breath concentration
Croatian: 7% u koncentraciji CO2.
English: 4.7 Effects on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada ssa strojevima
English: It is important to follow the instructions for use exactly, otherwise the result may be questionable.
Croatian: Važno je strogo se pridržavati uputa o upotrebi jer u suprotnom rezultat testa može biti upitan.
English: Analysis of breath samples and testing specification for laboratories
Croatian: Analiza uzoraka izdahnutog zraka i specifikacije testa za laboratorije
English: No concerns in relation to the clinical use of the product.
Croatian: Nema značaja u odnosu na kliničku primjenu lijeka.
English: • 100 ml 100 % orange juice
Croatian: • 100 ml 100%-tnog soka od naranče
English: Other urease producing bacteria were seldom found in the gastric flora.
Croatian: Ostale bakterije koje izlučuju ureazu rijetko su prisutne u želučanoj flori.
English: • if you have or suspect that you have a stomach infection or a certain inflammation of the stomach lining (atrophic gastritis).
Croatian: • ako imate ili se sumnja da imate infekciju želuca ili određenu upalu želučane sluznice
English: Before the breath test is performed a liquid test meal is taken to delay the stomach from emptying.
Croatian: Prije provedbe izdisajnog testa uzima se tekući obrok koji odgađa pražnjenje želuca.
English: INFORMATION IN BRAILLE
Croatian: PODACI NA BRAILLEOVOM PISMU
English: Multiple replicate analyses: Minimum of 3 replicate analyses of the same sample during operation
Croatian: Višestruko ponavljanje analize: najmanje 3 ponovljene analize istog uzorka tijekom postupka.
English: If the patient vomits during the test procedure, necessitating the repetition of the test, this should be done in fasted condition and not before the following day (see section 4.2).
Croatian: Ako bolesnik povraća tijekom postupka, testiranje je potrebno ponoviti, no to treba napraviti natašte i najranije sljedećeg dana (vidjeti dio 4.2).
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji.
English: Please read enclosed instructions for use.
Croatian: Molimo pročitajte priložene upute za uporabu.
English: If you cannot take this test meal, please tell your doctor, who will suggest an alternative.
Croatian: Ako ne možete uzeti ovaj obrok prije testa, molimo da to kažete liječniku, koji će predložiti zamjenu.
English: Mass spectrometry (IRMS)
Croatian: Masena spektrometrija (IRMS)
English: For mass spectrometric analysis, please use sample tubes for collection the breath samples; for infrared spectroscopy, use breath bags.
Croatian: Za analizu masenom spektrometrijom, molimo da koristite epruvete za uzimanje uzorka izdahnutog zraka; za infracrvenu spektroskopiju, koristite vrećice za izdahnuti zrak.
English: The specification of breath analysis parameters like linearity, stability (reference gas precision), and precision of measurement are fundamental for the accuracy of the system.
Croatian: Specifikacija parametara analize izdahnutog zraka kao što su linearnost, stabilnost (preciznost referentnog plina) i preciznost mjerenja od osnovne su važnosti za točnost sustava.
English: • 2 weeks after the last administration of a medicine to reduce release of stomach acid
Croatian: • najmanje 2 tjedna nakon zadnje doze lijeka za smanjenje lučenja želučane kiseline.
English: Gottfried-Hagen-Str. 60-62 D-51105 Köln
Croatian: 60-62 D-51105 Köln
English: In the presence of bacterial urease the ratio of the 13C/12C-carbon isotopes is significantly changed.
Croatian: U prisutnosti bakterijske ureaze omjer izotopa 13C/12C znatno je izmijenjen.
English: • Infrared spectrometers for breath analysis must comply with the following specifications:
Croatian: • Infracrveni spektrometri za izdisajni test moraju odgovarati sljedećim specifikacijama:
English: The second breath sample container is only required for mass spectrometry.
Croatian: Drugi spremnik za uzorak izdahnutog zraka potreban je samo za masenu spektrometriju.
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.
Croatian: U nedostatku bakterijske ureaze cjelokupna količina primijenjene uree nakon apsorpcije iz gastrointestinalnog trakta metabolizirat će se isto kao i endogena urea.
English: Date of birth Barcode
Croatian: Datum rođenja
English: Then the patient must drink the recommended test meal (100 ml 100 % orange juice).
Croatian: Nakon toga bolesnik treba popiti preporučeni obrok (100 ml 100%-tnog soka od naranče).
English: ≤ 0.2 ‰ on 10 consecutive pulses
Croatian: ≤ 0,2 ‰ na 10 uzastopnih pulseva
English: This should be done in fasted condition and not before the following day.
Croatian: To se može učiniti samo natašte i tek idući dan.
English: • 200 ml 100 % orange juice or
Croatian: • 200 ml 100%-tnog soka od naranče ili
English: The principal tests to verify the specifications are linearity, stability (reference gas precision), and precision of measurement.
Croatian: Glavni testovi za potvrdu specifikacija su linearnost, stabilnost (preciznost referentnog plina) i preciznost mjerenja.
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.
Croatian: Modulirane infracrvene zrake zatim ulaze u infracrvene detektore.To su dvoslojni detektori prijenosa s prednjom ili stražnjom komorom od kojih je svaka napunjena jednim izotopno čistim plinom koji će se mjeriti (13CO2 odnosno 12CO2 ).
English: Helicobacter pylori infection is present if the difference in
Croatian: Infekcija bakterijom Helicobacter pylori je prisutna, ako je razlika omjera
English: The test must not be used in patients with documented or suspected gastric infection or atrophic gastritis, which might interfere with the urea breath test (see section 4.2).
Croatian: Test se ne smije koristiti u bolesnika s dokazanom ili suspektnom želučanom infekcijom ili atrofičnim gastritisom jer ova stanja mogu utjecati na urea izdisajni test (vidjeti dio 4.2).
English: These samples will be analysed to measure the “normal” amount of carbon-13 content in the carbon dioxide in your breath.
Croatian: U tim će se uzorcima izmjeriti koliki je „normalan“ sadržaj ugljika-13 u ugljičnom dioksidu iz izdahnutog zraka.
English: The test is to be performed after instruction by a healthcare professional and under appropriate medical supervision.
Croatian: Ovaj test se primjenjuje prema uputama zdravstvenog djelatnika i pod odgovarajućim liječničkim nadzorom.
English: Analysis of breath samples and testing specification for laboratories for infrared analyzer or mass spectrometry (IRMS)
Croatian: Analiza uzoraka izdahnutog zraka i specifikacije testa za laboratorije za infracrveni analizator ili masenu spektrometriju (IRMS)
English: The water content of the breath sample will be kept mostly constant through Nafion water trap.
Croatian: Konstantan sadržaj vode u uzorku izdahnutog zraka održava se pomoću Nafion hvatača vode.
English: MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BREATH SAMPLE CONTAINERS: GLASS OR PLASTIC
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI UNUTARNJE PAKIRANJE SPREMNICI ZA UZORKE IZDAHNUTOG ZRAKA: STAKLENI ILI PLASTIČNI
English: Your doctor has recommended that you have a Helicobacter Test INFAI for one of the following reasons:
Croatian: Vaš liječnik je preporučio da obavite Helicobacter test INFAI zbog jednog od sljedećih razloga:
English: The test begins with the collection of samples for determining the baseline values:
Croatian: Testiranje započinje prikupljanjem uzoraka za određivanje početnih vrijednosti:
English: • the enzyme urease, which stimulate the reduction of urea
Croatian: • enzim ureazu, koji potiče razgradnju uree.
English: Now the preparation of the test solution follows.
Croatian: Potom slijedi pripremanje otopine za testiranje.
English: It is recommended that you take the test in a resting position.
Croatian: Preporučuje se testiranje u opuštenom položaju.
English: Pharmacotherapeutic group: Other diagnostic agents, ATC code: VO4CX
Croatian: Farmakoterapijska skupina: Druga dijagnostička sredstva, ATK oznaka: V04CX
English: The accuracy of the test strongly depends on the quality of the breath analysis.
Croatian: Točnost testa jako ovisi o kvaliteti analize izdahnutog zraka.
English: For calibration and measurement necessary CO2-free air (zero-gas) will be produced via an integrated CO2-absorber in the analysator.
Croatian: Zrak bez CO2 (kontrolni plin) koji je potreban za baždarenje i mjerenje, proizvodi se pomoću integriranog apsorbera CO2 u analizatoru.
English: • Close the jar and shake it carefully until all the powder is dissolved.
Croatian: • Pažljivo zatvorite posudicu i tresite je pažljivo dok se sav prašak ne otopi.
English: It is recommended to perform the test with the patient being in a resting position.
Croatian: Preporučuje se da bolesnik pri testiranju bude u opuštenom položaju.
English: You have already been determined as being infected with Helicobacter pylori and have been taking medication aimed to clear up the infection.
Croatian: Već Vam je potvrđena infekcija bakterijom Helicobacter pylori i uzimali ste lijekove za suzbijanje infekcije.
English: If you take more Helicobacter Test INFAI than you should
Croatian: Ako primijenite više Helicobacter Test INFAI nego što ste trebali
English: • Sample preparation for Infrared Spectroscopy (NDIR)
Croatian: • Priprema uzoraka za infracrvenu spektroskopiju (NDIR)
English: After oral ingestion the labelled urea reaches the gastric mucosa.
Croatian: Nakon peroralne ingestije obilježena urea dolazi do želučane sluznice.
English: • The active substance is 13C-urea.
Croatian: • Djelatna tvar je 13C-urea.
English: Zero point adjustment of the detectors by means of the zero gas generated in the spectrometer.
Croatian: Prilagodba nulte točke detektora putem kontrolnog plina koji se proizvodi u spektrometru.
English: Talk to your doctor or pharmacist before taking Helicobacter Test INFAI if you have any condition that can affect or be affected by the test.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Helicobacter test INFAI ako imate neko zdravstveno stanje koje može utjecati na test ili na koje test može utjecati.
English: Therefore, the rate-limiting step in the whole process is the cleavage of 13C-urea by Helicobacter's urease.
Croatian: Stoga je ograničavajući korak s obzirom na brzinu u cijelom procesu cijepanje 13C-uree ureazom iz Helicobacter pylori.
English: For Mass Spectrometry
Croatian: Za masenu spektrometriju
English: The patient must have fasted for over 6 hours, preferably overnight.
Croatian: Bolesnik mora biti natašte najmanje 6 sati, po mogućnosti preko noći.
English: ≤ 0.5 ‰ for breath samples varying between 1 % and 7 % CO2-concentration
Croatian: ≤ 0,5 ‰ za uzorke izdahnutog zraka koji variraju između 1% i 7% u koncentraciji CO2.
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.
Croatian: Automatski sustav pripreme uzoraka u spektrometrima koji analiziraju masu izotopa koji je namijenjen za analizu izdahnutog zraka temelji se na tehnici odvajanja plinskom kromatografijom neprekinutog protoka.
English: The test starts with the collection of samples for the determination of baseline-value (00-minutevalue):
Croatian: Testiranje počinje prikupljanjem uzoraka za određivanje osnovne vrijednosti (00-minutna vrijednost):
English: • If you have any further questions, ask your doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
English: This medicinal product should be administered by a healthcare professional and under appropriate medical supervision.
Croatian: Ovaj lijek mora primjenjivati zdravstveni djelatnik pod odgovarajućim liječničkim nadzorom.
English: What you need to know before you take Helicobacter Test INFAI Do not take Helicobacter Test INFAI
Croatian: Što morate znati prije nego primijenite Helicobacter Test INFAI Nemojte uzimati Helicobacter Test INFAI
English: This test solution must now be drunk immediately by the patient, and the time of application must be noted.
Croatian: Ovu otopinu za testiranje bolesnik mora odmah popiti te zabilježiti vrijeme uzimanja otopine.
English: It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability of the outcome will become questionable.
Croatian: Važno je pravilno se pridržavati uputa za uporabu (vidjeti dio 6.6), u slučaju nepridržavanja uputa pouzdanost rezultata može biti upitna.
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.
Croatian: Poluautomatski sustav za unošenje uzoraka injektira mjereni plin u određenim količinama u početni plin koji cirkulira u infracrvenom spektrometru.
English: Alternatively, any other suitable-validated method may be used, carried out by any objectively qualified laboratory.
Croatian: Može se koristiti i bilo koja druga prikladna, validirana metoda, ako se izvodi u ovlaštenom laboratoriju.
English: This is especially important after Helicobacter eradication therapy.
Croatian: To je posebice važno nakon provođenja eradikacijske terapije Helicobactera.
English: Passing the column the separated gas species of breath are detected by an ionisation detector.
Croatian: Odvojene vrste plinova iz izdahnutog zraka pri prolasku kroz kolonu detektiraju se ionizacijskim detektorom.
English: MINIMUM PARTICULARS TO APPEAR ON DATA SHEET FOR PATIENT DOCUMENTATION
Croatian: MINIMALNI PODACI KOJI SE MORAJU NALAZITI NA OBRASCU ZA PODATKE BOLESNIKA
English: Patients from the age of 12 must take the contents of 1 jar with 75 mg.
Croatian: Bolesnici od 12 godina moraju uzeti sadržaj jedne posudice sa 75 mg.
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.
Croatian: Usporedit će se dobivene vrijednosti i bude li u uzorcima uzetima nakon 30 minuta količina ugljika-13 značajno veća, to će Vašem liječniku biti znak da je prisutna bakterija Helicobacter pylori.
English: For infrared spectroscopy, only one breath bag is required.
Croatian: Za infracrvenu spektroskopiju potrebna je samo jedna vrećica za izdahnuti zrak.
English: No side effects are known.
Croatian: Nema poznatih nuspojava.
English: Talk to your doctor or pharmacist before taking Helicobacter Test INFAI for children of the age 3-11 if you have any condition that can affect or be affected by the test.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Helicobacter test INFAI za djecu u dobi od 3 do 11 godina ako imate neko zdravstveno stanje koje može utjecati na test ili na koje test može utjecati.
English: Finally seal the package with the sticker.
Croatian: Na kraju zapečatite paket naljepnicom.
English: All breath sample containers and the patient documentation must be sent to a qualified laboratory for analysis.
Croatian: Sve spremnike s uzorcima izdahnutog zraka i dokumentaciju bolesnika mora se poslati u ovlašteni laboratorij na analizu.
English: If the test needs to be repeated, this should be done on the following day at the earliest.
Croatian: Ako test treba ponoviti, to se najranije smije učiniti idući dan.
English: • stomach ulcer
Croatian: • vrijeda želuca
English: What Helicobacter Test INFAI is and what it is used for
Croatian: Što je Helicobacter Test INFAI i za što se koristi
English: White, crystalline powder for oral solution.
Croatian: Bijeli, kristalični prašak za oralnu otopinu.
English: A test set contains 50 jars with the additional components:
Croatian: Komplet za test sadrži 50 spremnika s dodatnim komponentama:
English: Quantity
Croatian: Količina
English: The orally applied
Croatian: Peroralno primijenjena
English: A test set contains the following parts:
Croatian: Komplet za testiranje sastoji se od sljedećih dijelova:
English: It is a breath test for adolescents from the age of 12 and adults to determine the presence of bacterium Helicobacter pylori in the stomach.
Croatian: To je izdisajni test koji se koristi u adolescenata starijih od 12 godina i odraslih osoba kako bi se utvrdila prisutnost bakterije Helicobacter pylori u želucu.
English: Your doctor has recommended that you have a Helicobacter Test INFAI for children of the age 3-11 for one of the following reasons:
Croatian: Vaš liječnik je preporučio da obavite Helicobacter test INFAI za djecu u dobi od 3 do 11 godina zbog jednog od sljedećih razloga:
English: In the presence of Helicobacter pylori the 13C-urea is metabolised by the enzyme urease of Helicobacter pylori.
Croatian: Helicobacter pylori 13C-urea se metabolizira enzimom ureazom bakterije Helicobacter pylori.
English: 50 Data sheets for patient documentation 50 Barcode labels and sticker
Croatian: 50 obrazaca za podatke o bolesniku 50 naljepnica s bar kodovima i naljepnicom
English: The patient should drink this test solution immediately.
Croatian: Otopinu za testiranje bolesnik treba odmah popiti.
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.
Croatian: Nakon 30 minuta ponovno će se uzeti uzorci izdahnutog zraka u kojima će se izmjeriti količina ugljika-13 kao i ranije.
English: If you cannot take either of these test meals, please tell your doctor, who will suggest an alternative.
Croatian: Ako ne možete uzeti jedan ili drugi navedeni tekući obrok prije testa, molimo da to kažete liječniku, koji će predložiti zamjenu.
English: Contents of the pack and other information What Helicobacter Test INFAI contains
Croatian: Sadržaj pakiranja i druge informacije Što Helicobacter Test INFAI sadrži
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.
Croatian: koji je izložen direktnom naponu visokog otpora, pretvara ove fluktuacije tlaka u izmjenični napon,
English: Then the patient must drink the recommended test meal (200 ml 100 % orange juice or 1 g citric acid in 200 ml water).
Croatian: Nakon toga bolesnik treba popiti preporučeni obrok (200 ml 100%-tnog soka od naranče ili 1 g limunske kiseline u 200 ml vode).
English: Security access:
Croatian: Zaštitićeni pristup:
English: Special instructions for use (for infrared spectroscopy)
Croatian: Posebne upute za uporabu (za infracrvenu spektroskopiju)
English: For Infrared Spectroscopy
Croatian: Za infracrvenu spektroskopiju
English: • The stopper is removed from one of the breath sample containers described under point 2
Croatian: • Uklonite gumeni čep s jednog od spremnika za uzorak izdahnutog zraka opisanog u točki
English: Special instructions for use (for mass spectrometry)
Croatian: Posebne upute za uporabu (za masenu spektrometriju)
English: Powder for oral solution
Croatian: Prašak za oralnu otopinu
English: Content of the test kit:
Croatian: Sadržaj kompleta za testiranje:
English: C-urea is metabolised to carbon dioxide and ammonia or is integrated into the body's own urea cycle.
Croatian: C-urea metabolizira se do ugljičnog dioksida i amonijaka, ili se uključi u metabolizam endogene uree organizma.
English: What Helicobacter Test INFAI is and what it is used for What you need to know before you take Helicobacter Test INFAI How to take Helicobacter Test INFAI Possible side effects
Croatian: Što je Helicobacter Test INFAI i za što se koristi Što morate znati prije nego primijenite Helicobacter Test INFAI Kako primijeniti Helicobacter Test INFAI
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.
Croatian: Diferencijalno dijagnostički može biti indicirana invazivna endoskopska metoda kako bi se ispitala prisutnost neke od komplikacija, primjerice, ulkus, autoimuni gastritis ili zloćudne bolesti.
English: 2 breath bags for breath samples 1 bendable straw
Croatian: 2 vrećice za uzorke izdahnutog zraka 1 savitljivu slamčicu
English: A drinking vessel and tap water is required to dissolve the 13C-urea powder.
Croatian: Potrebni su i čaša i obična voda za otapanje 13C-uree u obliku praška.
English: • All mass spectrometers for breath analysis must comply with the following specifications: Linearity:
Croatian: • Svi maseni spektrometri za izdisajni test moraju odgovarati sljedećim specifikacijama:
English: Helicobacter Test INFAI is a white, crystalline powder for oral solution.
Croatian: Helicobacter Test INFAI je bijeli, kristalični prašak za oralnu otopinu.
English: Special instructions for use (for infrared spectroscopy or mass spectrometry)
Croatian: Posebne upute za uporabu (za infracrvenu spektroskopiju ili masenu spektrometriju)
English: Even if the result of Helicobacter Test INFAI is positive, further tests might be necessary before a treatment of a Helicobacter pylori infection may be started.
Croatian: Čak i ako su rezultati Helicobacter Test INFAI pozitivni, mogu biti potrebni daljnji testovi prije početka liječenja infekcije Helicobacterom pylori.
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.
Croatian: Da bi se analizirao ugljikov dioksid u uzorku izdahnutog zraka iz izvora infracrvenog zračenja naizmjenično se šalje široki snop zraka kroz komoru za mjerenje i referentnu komoru cijepanjem zraka zračenja.