FrancophonIA/ELRC3.0 huggingface dataset:
English: Helicobacter Test INFAI will be affected by all treatments interfering with Helicobacter pylori status or urease activity.
Croatian: Na rezultate testa Helicobacter Test INFAI utjecat će svi lijekovi koji djeluju na Helicobacter pylori ili aktivnost ureaze.
English: There is insufficient data on the reliability of the Helicobacter Test INFAI for children of the age 3-11 for recommending its use in patients with removal of parts of the stomach.
Croatian: Nema dovoljno podataka o pouzdanosti Helicobacter Test INFAI za djecu u dobi od 3 do 11 godina da bi se mogla preporučiti njegova uporaba u bolesnika kojima su odstranjeni dijelovi želuca.
English: Essential items not supplied with Helicobacter Test INFAI for children of the age 3-11
Croatian: Važan sastavni dio koji se ne dobiva s Helicobacter Test INFAI za djecu u dobi od 3 do 11 godina
English: From there it is transported as bicarbonate into the lung and liberated as 13CO2 with the exhaled air.
Croatian: Odatle se prenosi kao bikarbonat u pluća i oslobađa kao
English: Please stick round barcode label
Croatian: Zalijepite naljepnicu s bar kodom oko spremnika
English: • Take the straw and the breath bag with the label
Croatian: • Iz kompleta za testiranje izvadite slamčicu i vrećicu za izdahnuti zrak s oznakom
English: Jar (10 ml volume, polystyrene with polyethylene snap cap)
Croatian: Posudica (volumena 10 ml, od polistirena s polietilenskim zatvaračem)
English: The method validated in the application is as follows:
Croatian: Slijedi opis validirane metode:
English: • Remove the stopper from the breath bag, unwrap the straw and place the straw into the breath bag.
Croatian: • Uklonite čep s vrećice za izdahnuti zrak, odmotajte slamčicu i umetnite je u vrećicu za izdahnuti zrak.
English: Helicobacter Test INFAI for children of the age 3-11 is a breath test for single administration.
Croatian: Helicobacter Test INFAI za djecu u dobi od 3 do 11 godina je izdisajni test za jednokratnu primjenu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON, PACK SIZE 50
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA, PAKIRANJE OD 50
English: Helicobacter Test INFAI 75 mg powder for oral solution
Croatian: Helicobacter Test INFAI 75 mg prašak za oralnu otopinu
English: • Now the patient breathes gently through the straw into the breath sample container.
Croatian: • Bolesnik polako izdiše kroz slamčicu u spremnik za uzorak izdahnutog zraka.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING INTERMEDIATE CARTON, PACK SIZE 50
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU UNUTARNJA KUTIJA, PAKIRANJE OD 50
English: The package must be sent to a qualified laboratory for analysis.
Croatian: Kutiju se mora poslati u ovlašteni laboratorij na analizu.
English: Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution
Croatian: Helicobacter Test INFAI za djecu u dobi od 3-11 godina, 45 mg praška za oralnu otopinu
English: Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 13C-urea
Croatian: Helicobacter Test INFAI za djecu u dobi od 3-11godina, 45 mg praška za oralnu otopinu 13C-urea
English: Helicobacter Test INFAI is a breath test for single administration.
Croatian: Helicobacter Test INFAI je izdisajni test za jednokratnu primjenu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS JAR LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA POSUDICI
English: 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.
Croatian: Helicobacter Test INFAI se može primjenjivati za in vivo dijagnosticiranje infekcije želuca i dvanaesnika Helicobacterom pylori u: - odraslih,
English: For children from the age of 3, Helicobacter Test INFAI for children aged 3 to 11 is available.
Croatian: Za djecu u dobi od treće godine dostupna je inačica Helicobacter Test INFAI za djecu od 3 do 11
English: 1 Jar (10 ml volume, polystyrene with polyethylene snap cap) containing 45 mg 13C-urea powder for oral solution
Croatian: Posudica (volumena 10 ml, od polistirena s polietilenskim zatvaračem) sadrži 45 mg 13C-uree u obliku praška za oralnu otopinu
English: Page of labels and sticker Barcode for data sheet for patient documentation Seal-Sticker
Croatian: Kartica s naljepnicama s bar kodovima i naljepnicom Bar kod za obrazac za podatke o bolesniku
English: Infrared spectroscopy (NDIR)
Croatian: Infracrvena spektroskopija (NDIR, engl. non-dispersive infrared spectrometry)
English: • The sample container should be held upright and the bar-code label marked “00-minute value” will be stuck round the sample container so that the lines of the bar code are horizontal.
Croatian: • Spremnik za uzorak treba držati u uspravnom položaju i na spremnik za uzorak nalijepiti naljepnicu s bar kodom označenu s „00-minutna vrijednost“ tako da linije bar koda budu vodoravne.
English: The sample tubes have to be sent in the original packaging, for analysis, to a qualified laboratory.
Croatian: Epruvete s uzorcima treba poslati na analizu u ovlašteni laboratorij u originalnom pakiranju.
English: Helicobacter Test INFAI for children of the age 3-11 is influenced by medicines influencing
Croatian: Na Helicobacter Test INFAI za djecu u dobi od 3 do 11 godina utječu svi lijekovi koji djeluju na
English: The test meal is not provided within the kit.
Croatian: Ni epruvete niti vrećice za izdahnuti zrak nisu uključene u pakiranje.
English: 1 diagnostic test kit contains:
Croatian: 1 dijagnostički komplet sadrži:
English: Now 200 ml of 100 % orange juice or 1 g citric acid in 200 ml water must be drunk by the patient without delay.
Croatian: Odmah, bez odgađanja bolesnik mora popiti 200 ml 100%-tnog soka od naranče ili 1 g citratne kiseline u 200 ml vode.
English: Jar (10 ml volume, polystyrene with polyethylene snap cap) containing 75 mg 13C-urea powder for oral solution
Croatian: Posudica (volumena 10 ml, od polistirena s polietilenskim zatvaračem) sadrži 75 mg 13C-uree u obliku praška za oralnu otopinu
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Sample loop:
Croatian: Volumen uzorka:
English: • Now the patient breathes gently through the straw into the sample tube until the inside of the sample tube steams up.
Croatian: • Bolesnik treba lagano izdisati kroz slamčicu sve dok se unutrašnjost epruvete za uzimanje uzoraka ne zamagli.
English: Sampling time: 00-minute-value
Croatian: „Vrijeme uzorkovanja: 00 minutna vrijednost“.
English: Data sheet for patient documentation Bar code labels and sticker
Croatian: Obrazac za podatke o bolesniku Naljepnice s bar kodovima i naljepnicu
English: (If the sample tube remains open for more than 30 seconds, the test result might be falsified.)
Croatian: (Ako je epruveta za uzimanje uzoraka otvorena dulje od 30 sekundi, rezultati testa mogu biti lažni.)
English: (If the breath bag remains open for more than 30 seconds, the test result might be falsified.)
Croatian: (Ako je vrećica za izdahnuti zrak otvorena dulje od 30 sekundi, rezultati testa mogu biti lažni.)
English: Precision of measurement: ≤ 0.5 ‰ for 13C at natural abundance using a 100 ml breath bag with
Croatian: ≤ 0,5‰ za 13C u prirodnoj zastupljenosti uz korištenje vrećice za izdahnuti zrak od 100 ml s koncentracijom 3% CO2 u izdahnutom zraku.
English: • Now the patient breathes gently through the straw into the breath bag.
Croatian: • Bolesnik treba lagano izdisati kroz slamčicu u vrećicu za izdahnuti zrak.
English: 50 jars containing 75 mg 13C-urea powder for oral solution
Croatian: 50 posudica koje sadrže 75 mg praška 13C-uree za oralnu otopinu
English: Now the second breath sample container (labelled “sampling time: 00-minute-value”) has to be filled up with breath in the same way as described above.
Croatian: Zatim se izdahnutim zrakom mora napuniti i drugi spremnik za uzorak (također označen naljepnicom „Vrijeme uzorkovanja: 00-minutna vrijednost“) na isti način kao i prvi.
English: 6 Page of barcode labels and sticker
Croatian: 6 Kartica s naljepnicama s bar kodovima i naljepnica
English: Each patient should be documented according to the provided data sheet.
Croatian: Podatke o svakom bolesniku treba upisati u priloženi obrazac za podatke o bolesniku.
English: Labelled sample glass- or plastic containers for sampling, storing and transporting the breath samples for analysis: Sampling time: 00-minute-value Sampling time: 30-minute-value 3 Bendable straw for collection of the breath samples into the corresponding sample containers 4 Data sheet for patient documentation 5 Package leaflet 6 Page of barcode labels and sticker
Croatian: Označeni stakleni ili plastični spremnici za uzorkovanje, pohranu i prijenos uzoraka izdahnutog zraka za analizu: Vrijeme uzorkovanja: 00-minutna vrijednost Vrijeme uzorkovanja: 30-minutna vrijednost
English: • By continuously breathing the patient must pull out the straw and immediately close the sample tube with its stopper.
Croatian: • Stalnim izdisanjem bolesnik treba izvlačiti slamčicu i odmah zatvoriti epruvetu za uzimanje uzoraka čepom.
English: • Remove the stopper from one of the sample tubes, unwrap the straw and place the straw into the container.
Croatian: • Uklonite čep s jedne od epruveta za uzimanje uzoraka, odmotajte slamčicu i umetnite je u epruvetu.
English: • The patient must continue to breathe through the straw while removing it from the breath bag, and then immediately seal the breath bag with its stopper.
Croatian: • Bolesnik mora nastaviti puhati kroz slamčicu dok je izvlači iz vrećice za izdahnuti zrak te odmah zatvoriti vrećicu za izdahnuti njenim čepom.
English: Now 100 ml of 100 % orange juice must be drunk by the patient without delay.
Croatian: Odmah, bez odgađanja bolesnik mora popiti 100 ml 100%-tnog soka od naranče.
English: Jar contains 45 mg 13C-urea
Croatian: Posudica sadrži 45 mg 13C-uree
English: Ask your doctor, if fasting is a problem, for example for diabetic patients.
Croatian: Ako je gladovanje problem, kao npr. u bolesnika sa šećernom bolešću, obratite se liječniku.
English: How to take Helicobacter Test INFAI
Croatian: Kako primijeniti Helicobacter test INFAI
English: Oral use Please read the package leaflet before use.
Croatian: Prije uporabe pročitajte Uputu o lijeku.
English: C-urea powder for oral solution 100 breath bags for breath samples 50 bendable straws
Croatian: 100 vrećica za uzorke izdahnutog zraka 50 savitljivih slamčica
English: 94.05 %-99.72 %], and a specificity range from 96.7 % to 100 % [95 %-CI: 94.17 %-103.63 %].
Croatian: 94,05% 94,05 % - 99,72 %] i specifičnost u rasponu od 96,7 % do 100 %.
English: • By continuously breathing the patient must pull out the straw and immediately close the breath bag with its stopper.
Croatian: • Stalnim izdisanjem bolesnik treba izvlačiti slamčicu i odmah zatvoriti vrećicu za izdahunuti zrak čepom.
English: (If the breath sample container remains open for more than 30 seconds, the test result might be falsified.)
Croatian: (Ako je spremnik za uzorak izdahnutog zraka otvoren dulje od 30 sekundi, rezultati testa mogu biti lažni.)
English: The breath bags have to be sent in the original packaging, for analysis, to a qualified laboratory.
Croatian: Vrećice s uzorcima izdahnutog zraka treba poslati na analizu u ovlašteni laboratorij u originalnom pakiranju.
English: • Remove the stopper from one of the breath sample containers (tube or breath bag),
Croatian: • Uklonite čep s jednog od spremnika za uzorak izdahnutog zraka (epruvete ili vrećice za izdahnuti zrak), odmotajte slamčicu i umetnite je u spremnik.
English: If the breath bag remains open for more than 30 seconds, the result could be inaccurate.
Croatian: Ako je vrećica za izdahnuti zrak otvorena dulje od 30 sekundi, rezultat testa može biti netočan.
English: • The jar labelled “13C-urea powder” is removed from the pack, opened, and filled up to about three quarters with tap water.
Croatian: • Iz pakiranja izvaditi posudicu s naljepnicom „13C-urea prašak“, otvoriti je i napuniti običnom vodom do tri četvrtine zapremine.
English: The patient data should be documented using the provided data sheet.
Croatian: Podatke o bolesniku treba upisati u priloženi obrazac za podatke o bolesniku.
English: Your doctor wants to confirm whether you are suffering from Helicobacter pylori infection to help diagnose your condition.
Croatian: U sklopu dijagnostičke obrade Vaših tegoba liječnik želi potvrditi imate li infekciju bakterijom Helicobacter pylori.
English: Patient ID
Croatian: KLINIČKI PODACI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON, PACK OF 1 JAR AND 50 JARS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA, PAKIRANJE S 1 POSUDICOM
English: The portion of 13CO2 in the breath samples is determined by isotope-ratio-mass-spectrometry (IRMS)
Croatian: Udio 13CO2 u uzorcima izdahnutog zraka određuje se spektrometrijskom metodom mjerenja udjela mase izotopa (IRMS, engl. isotope-ratio-mass-spectrometry) i prikazuje se kao apsolutna razlika (vrijednost Δδ) između vrijednosti od 00 minuta do 30 minuta.
English: How to take Helicobacter Test INFAI for children of the age 3-11
Croatian: Kako primijeniti Helicobacter test INFAI za djecu u dobi od 3 do 11 godina
English: If the sample tube remains open for more than 30 seconds, the result could be inaccurate.
Croatian: Ako je epruveta za uzimanje uzoraka otvorena dulje od 30 sekundi, rezultat testa može biti netočan.
English: For the amount of 75 mg 13C-urea, which is administered per unit in the course of the breath test, no pharmacodynamic activity is described.
Croatian: Nije opisana farmakodinamička aktivnost za količinu od 75 mg 13C-uree koja se primjenjuje u jednom izdisajnom testu.
English: • The stopper is removed from one of the sample containers and place the unwrapped straw into the container.
Croatian: • Ukloniti gumeni čep s jednog od spremnika za uzorak, izvaditi slamčicu iz njenog omotača i umetnuti u spremnik.
English: 4 Page of barcode labels and sticker
Croatian: 4 Kartice s naljepnicama s bar kodovima i naljepnicom
English: How to store Helicobacter Test INFAI for children of the age 3-11
Croatian: Kako čuvati Helicobacter Test INFAI za djecu u dobi od 3 do 11 godina
English: • Specifications for determining
Croatian: • Unos uzoraka
English: If the breath sample container remains open for more than 30 seconds, the result could be inaccurate.
Croatian: Ako je spremnik s uzorkom izdahnutog zraka otvoren dulje od 30 sekundi, rezultat testa može biti netočan.
English: Component
Croatian: OBLIK
English: Jar contains 75 mg 13C-urea
Croatian: Posudica sadrži 75 mg 13C-uree
English: • The jar labelled “13C-urea powder” is taken from the test set, opened, and filled up to three quarters of its volume with tap water.
Croatian: • Iz seta za testiranje izvadite posudicu označenu s „prašak 13C-urea“, otvorite je i napunite običnom vodom do tri četvrtine volumena.
English: • The patient must continue to breathe through the straw while removing it from the breath sample container, and then immediately seal the breath sample container with its stopper.
Croatian: • Bolesnik mora nastaviti puhati kroz slamčicu dok je izvlači iz spremnika za uzorak izdahnutog zraka te ga odmah zatvoriti njegovim čepom.
English: C-urea powder for oral solution Labelled sample glass- or plastic- containers for sampling, storing and transporting the breath samples for analysis: Sampling time: 00-minute-value Sampling time: 30-minute-value 3 Bendable straw for collection of the breath samples into the corresponding sample containers 4 Data sheet for patient documentation 5 Package leaflet 6 Page of barcode labels and sticker
Croatian: 2 Označeni stakleni ili plastični spremnici za uzorkovanje, pohranu i prijenos uzoraka izdahnutog zraka za analizu: Vrijeme uzorkovanja: 00-minutna vrijednost Vrijeme uzorkovanja: 30-minutna vrijednost
English: One jar contains 45 mg 13C-urea.
Croatian: 1 posudica sadrži 45 mg 13C-uree.
English: One jar contains 75 mg 13C-urea.
Croatian: 1 posudica sadrži 75 mg 13C-uree.
English: • The breath bag should be held upright and the bar-code label marked “00-minute-value”
Croatian: • Vrećicu za izdahnuti zrak treba držati u uspravnom položaju i na vrećicu za izdahnuti zrak nalijepiti naljepnicu s bar kodom označenu s „00-minutna vrijednost“
English: 30 minutes after the test solution has been taken (point 5), the “30-minute-value” sample is collected in the breath bag, which remains in the pack (labelled “sampling time: 30-minutevalue”) as described under point 2.
Croatian: 30 minuta nakon uzimanja otopine za testiranje (točka 5) treba prikupiti uzorke u vrećicu za izdahnuti zrak koja je preostala u kutiji (označena naljepnicom: „Vrijeme uzorkovanja: 30minutna vrijednost”), kako je opisano pod korakom 2.
English: Helicobacter Test INFAI is influenced by medicines influencing
Croatian: Na Helicobacter Test INFAI utječu svi lijekovi koji djeluju na
English: All breath bags should be placed back into the original packaging.
Croatian: Sve vrećice s uzorcima izdahnutog zraka je potrebno vratiti u kutiju.
English: Breath bags: Sampling time: 00-minute-value Sampling time: 30-minute-value 3 Bendable straw for collection of the breath samples into the corresponding breath bags 4 Data sheet for patient documentation 5 Package leaflet 6 Page of barcode labels and sticker
Croatian: Posudica (volumena 10 ml, od polistirena sa s polietilenskim zatvaračem ) sadrži 75 mg 13C-uree u obliku praška za oralnu otopinu 2 Obrazac za podatke o bolesniku 3 Uputa o lijeku 4 Kartica s naljepnicama s bar kodovima i naljepnicom
English: The bar-code label marked “30-minute-value” must be used for this sample.
Croatian: Za ovaj uzorak mora se upotrijebiti naljepnica s bar kodom označena s “30-minutna vrijednost”.
English: Thirty minutes after administration of the test solution (point 7), collect the 30-minute-value samples in the two containers which are left in the test package (Label “Sampling time: 30-minute-value”), as described under steps 3 to 4.
Croatian: Trideset minuta nakon primjene otopine za testiranje (točka 7), valja prikupiti uzorke s 30minutnom vrijednošću u dva spremnika preostala u pakiranju testa (oznaka: „Vrijeme uzorkovanja: 30-minutna vrijednost”), kako je to opisano pod koracima 3 do 4.
English: 30 minutes after the test solution has been taken (point 6), the “30-minute-value” samples are collected in both containers, which remain in the pack (labelled “sampling time: 30-minutevalue”) as described under points 2 and 3.
Croatian: 30 minuta nakon uzimanja otopine za testiranje (točka 6) treba prikupiti uzorke u oba spremnika koji su preostali u kutiji (označeni naljepnicom: „Vrijeme uzorkovanja: 30-minutna vrijednost”), kako je opisano pod koracima 2 i 3.
English: 30 minutes after the test solution has been taken (point 7), the “30-minute-value” samples are collected in the breath sample containers labelled “sampling time: 30-minute-value” as described under point 3 and 4.
Croatian: 30 minuta nakon uzimanja otopine za testiranje (točka 7) treba prikupiti uzorke u spremnike za uzorak izdahnutog zraka označene naljepnicom: „Vrijeme uzorkovanja: 30-minutna vrijednost”, kako je opisano pod koracima 3 i 4.
English: Thirty minutes after administration of the test solution (point 7), collect the 30-minute-value samples in the breath sample container (tube or breath bags) (Label “Sampling time: 30-minutevalue”), as described under steps 3 to 4.
Croatian: Trideset minuta nakon primjene otopine za testiranje (točka 7), valja prikupiti uzorke s 30minutnom vrijednosti u spremnik za uzorak izdahnutog zraka (epruvetu ili vrećicu za izdahnuti zrak) (oznaka: „Vrijeme uzorkovanja: 30-minutna vrijednost”), kako je to opisano pod koracima 3 do 4.
English: Both might interfere with the Helicobacter pylori status.
Croatian: Mogu biti potrebne dodatne pretrage da bi se potvrdila prisutnost bakterije Helicobacter pylori.
English: • Hold the breath bag upright and stick the bar-code label marked “00-minute-value” on the breath bag.
Croatian: • Vrećicu za izdahnuti zrak treba držati u uspravnom položaju i na vrećicu za izdahnuti zrak nalijepiti naljepnicu s bar kodom označenu s „00-minutna vrijednost“.
English: • The stopper is removed from the breath bag and place the unwrapped straw into the breath bag.
Croatian: • Ukloniti gumeni čep s vrećice za izdahnuti zrak, izvaditi slamčicu iz njenog omotača i umetnuti u vrećicu za izdahnuti zrak.
English: • Hold the sample tube upright and stick the bar-code label marked “00-minute-value”
Croatian: • Spremnik s uzorkom izdahnutog zraka treba držati u uspravnom položaju i na spremnik za uzorak nalijepiti naljepnicu s bar kodom označenu s „00-minutna vrijednost“.
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.
Croatian: Da bi se analizirao odvojeni uzorak plina ugljikovog dioksida njegove molekule se moraju ionizirati,
English: 1 jar containing 45 mg 13C-urea powder for oral solution
Croatian: koja sadrži 45 mg 13C-uree u obliku praška za oralnu otopinu
English: • The straw and the breath bag labelled “sampling time: 00-minute-value” are taken from the test set.
Croatian: • Iz kutije treba izvaditi slamčicu i epruvete za uzimanje uzoraka označene naljepnicom na kojoj piše: „Vrijeme uzorkovanja: 00-minutna vrijednost“.
English: Use the bar-code label marked “30-minute-value” for this sample.
Croatian: Za ove uzorke upotrijebite naljepnicu s bar kodom i oznakom “30-minutna vrijednost”.
English: Use the bar-code labels marked “30-minute-value” for these samples.
Croatian: Za ove uzorke upotrijebite naljepnice s bar kodovima i oznakom“ 30-minutna vrijednost”.
English: One jar contains 75 mg of 13C-urea powder.
Croatian: Jedna posudica sadrži 75 mg praška 13C-uree.
English: Urease is produced in the stomach only by Helicobacter pylori.
Croatian: Samo Helicobacter pylori u želucu izlučuje ureazu.
English: This inflammation of the stomach lining may cause incorrect positive results of your breath test. Further investigations may be required to confirm the presence of Helicobacter pylori.
Croatian: Ta upala želučane sluznice može biti uzrok netočno pozitivnih rezultata Vašeg izdisajnog testa.
English: Marketing Authorisation Number: EU/1/97/045/001
Croatian: Broj odobrenja za stavljanje lijeka u promet: EU/1/97/045/001
English: Marketing Authorisation Number: EU/1/97/045/004
Croatian: Broj odobrenja za stavljanje lijeka u promet: EU/1/97/045/004
English: Use the bar-code labels marked “30-minutevalue” for these samples.
Croatian: Za ove uzorke upotrijebite naljepnice s bar kodovima i oznakom “30-minutna vrijednost”.
English: One jar contains 45 mg of 13C-urea powder.
Croatian: Jedna posudica sadrži 45 mg praška 13C-uree.
English: Marketing Authorisation Number: EU/1/97/045/005
Croatian: Broj odobrenja za stavljanje lijeka u promet: EU/1/97/045/005
English: Marketing Authorisation Number: EU/1/97/045/003
Croatian: Broj odobrenja za stavljanje lijeka u promet: EU/1/97/045/003
English: • The mass spectrometer must be capable of:
Croatian: • Maseni spektrometar mora odgovarati specifikacijama u nastavku:
English: and place the unwrapped straw into the breath sample container.
Croatian: 2, izvadite slamčicu iz njenog omotača i umetnite je u spremnik za uzorak izdahnutog zraka.
English: Endemic areas are areas where the disease occurs regularly throughout the year.
Croatian: Endemska područja su ona u kojima se bolest redovito pojavljuje tijekom cijele godine.
English: Further information on Dengvaxia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Dengvaxia.
Croatian: Više informacija o cjepivu Dengvaxia nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Dengvaxia.