FrancophonIA/ELRC3.0 huggingface dataset:
English: This build-up can be seen using an imaging technique called single-photon-emission computed tomography (SPECT), which detects the radioactive iodine-123.
Croatian: To se nakupljanje može vidjeti uz pomoć kompjuterizirane tomografije emisije jednog fotona (SPECT), kojom se detektira radioaktivni jod-123.
English: In patients with Parkinson's disease and related diseases, and in patients with dementia with Lewy bodies, there is typically a loss of the dopamine-containing nerve cells in the striatum.
Croatian: U bolesnika s Parkinsonovom bolesti i srodnim bolestima, te u bolesnika s demencijom Lewyjevih tjelešaca, u striatumu obično dolazi do gubitka živčanih stanica koje sadrže dopamin.
English: This enables diseases related to Parkinson's disease to be distinguished from essential tremor, and for Lewy body dementia to be distinguished from Alzheimer's disease.
Croatian: Time se bolesti srodne Parkinsonovoj bolesti mogu razlikovati od esencijalnog tremora, a demencija Lewyjevih tjelešaca može se razlikovati od Alzheimerove bolesti.
English: It contains a substance called ioflupane, which is labelled with 123I (iodine-123), a radioactive form of iodine.
Croatian: Sadrži tvar ioflupan, označenu simbolom 123I (jod-123) za radioaktivni oblik joda.
English: Striascan is only handled and given by people who have experience in the safe handling of radioactive materials.
Croatian: Lijekom Striascan trebaju rukovati te ga trebaju davati samo osobe s iskustvom u sigurnom rukovanju radioaktivnim materijalima.
English: As for every medicine, the company provided studies on the quality of Striascan.
Croatian: Kao i za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće lijeka Striascan.
English: As for all medicines, data on the use of Striascan are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Striascan kontinuirano se prate.
English: Why is Striascan authorised in the EU?
Croatian: Zašto je lijek Striascan odobren u EU-u?
English: Therefore, the Agency's view was that, as for DaTSCAN, the benefit of Striascan outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka DaTSCAN, kao i od lijeka Striascan, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: Striascan (ioflupane (
Croatian: Striascan (ioflupan (123I))
English: How has Striascan been studied?
Croatian: Kako je Striascan ispitivan?
English: How is Striascan used?
Croatian: Kako se Striascan primjenjuje?
English: I) is distributed by the blood and builds up in the striatum, where it attaches to the structures that transport dopamine.
Croatian: Kad se injicira Striascan, ioflupan (123I) se distribuira krvotokom i nakuplja u striatumu, gdje se veže na strukture koje prenose dopamin.
English: Olmesartan 40
Croatian: Prilog I.
English: If necessary it may be given up to the age of 32 weeks.
Croatian: Ako je potrebno, može se dati do dobi od 32 tjedna.
English: They vary in that they may carry different antigens.
Croatian: One se razlikuju po tome što mogu nositi različite antigene.
English: It contains five live rotavirus strains, each carrying a different antigen (G1, G2, G3, G4 and P1[8]).
Croatian: Sadrži pet sojeva živog rotavirusa, od kojih svaki nosi različiti antigen (G1, G2, G3, G4 i P1[8]).
English: It is available as a solution in a single-dose tube.
Croatian: Dostupno je kao otopina u jednodoznoj tubi.
English: It must also not be used in babies whose immune system is weakened.
Croatian: Ne smije se također primjenjivati u djece s oslabljenim imunosnim sustavom.
English: The full EPAR for RotaTeq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za cjepivo RotaTeq nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: There are various types of rotaviruses that cause gastroenteritis.
Croatian: Postoje razne vrste rotavirusa koje uzrokuju gastroenteritis.
English: It is recommended that the last dose be given to the child by the age of 20 to 22 weeks.
Croatian: Preporučuje se da se posljednja doza dojenčetu daje u dobi od 20 do 22 tjedna.
English: An antigen is a specific structure that the body can recognise as ‘foreign' and against which the body can make an antibody, a special protein that can neutralise or destroy the antigen.
Croatian: Antigen je posebna tvar koju tijelo prepoznaje kao „strano tijelo”, a protiv koje može stvoriti antitijelo, tj. poseban protein koji može neutralizirati ili uništiti antigen.
English: The first dose should be given six weeks after birth at the earliest.
Croatian: Prvu je dozu potrebno dati najranije šest tjedana nakon rođenja.
English: The contents of the tube of RotaTeq are given directly into the baby's mouth.
Croatian: Sadržaj tube RotaTeqa izravno se daje u usta dojenčeta.
English: RotaTeq should never be injected under any circumstances.
Croatian: RotaTeq se ni pod kojim okolnostima ne smije injicirati.
English: The European Commission granted a marketing authorisation valid throughout the European Union for RotaTeq on 27 June 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za cjepivo RotaTeq na snazi u Europskoj uniji od 27. lipnja 2006.
English: When a baby is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these antigens, which help prevent infections caused by rotaviruses that occur naturally and carry the same or very similar antigens.
Croatian: Nakon što se dojenče cijepi, imunosni sustav (sustav koji se bori protiv bolesti) proizvodi antitijela za borbu protiv tih antigena koja pomažu u sprečavanju infekcija uzrokovanih rotavirusima koji se prirodno pojavljuju i koji nose iste ili vrlo slične antigene.
English: The first dose is given when the baby is between 6 and 12 weeks of age.
Croatian: Prva se doza daje kada je dojenče u dobi od 6 do 12 tjedana.
English: RotaTeq can be given at the same time as other vaccinations (except the oral polio vaccine, when a two-week interval is needed between the two vaccines).
Croatian: RotaTeq se može primjenjivati u isto vrijeme kao i ostala cjepiva (osim oralnog cjepiva protiv poliomijelitisa kada je potreban dvotjedni interval između tih dvaju cjepiva).
English: RotaTeq can be given to premature babies, as long as the pregnancy lasted at least 25 weeks.
Croatian: RotaTeq se može primjenjivati u prijevremeno rođene dojenčadi ako je trudnoća trajala najmanje 25 tjedana.
English: RotaTeq contains viruses that carry the antigens for some of the most commonly occurring types of rotaviruses.
Croatian: RotaTeq sadrži viruse koji nose antigene za neke vrste rotavirusa koje se najčešće pojavljuju.
English: RotaTeq rotavirus vaccine, live
Croatian: RotaTeq cjepivo protiv rotavirusa, živo
English: This document is a summary of the European public assessment report (EPAR) for RotaTeq.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku RotaTeq.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for RotaTeq.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka RotaTeq.
English: Other information about RotaTeq:
Croatian: Ostale informacije o lijeku RotaTeq:
English: Overall, the studies of RotaTeq involved over 72,000 babies, including about 2,000 premature babies.
Croatian: Ispitivanja lijeka RotaTeq provedena su na ukupno više od 72 000 dojenčadi, uključujući oko 2 000 prijevremeno rođene djece.
English: What measures are being taken to ensure the safe and effective use of RotaTeq?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka RotaTeq?
English: For more information about treatment with RotaTeq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji cjepivom RotaTeq pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: RotaTeq is used in babies from 6 to 32 weeks of age to protect against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Croatian: RotaTeq se primjenjuje u dojenčadi u dobi od 6 do 32 tjedna radi sprečavanja gastroenteritisa (proljeva i povraćanja) izazvanog infekcijom rotavirusom.
English: About half of the babies received RotaTeq, and the others received placebo (a dummy vaccine).
Croatian: Otprilike polovica dojenčadi primila je RotaTeq, a ostala dojenčad placebo (lažno cjepivo).
English: The main measure of effectiveness, which was studied in 6,000 babies, was the number of babies who developed rotavirus gastroenteritis during the following rotavirus season (the time of the year when rotaviruses are known to circulate and cause infection, generally during the cooler months in winter to early spring).
Croatian: Glavno mjerilo djelotvornosti, promatrano u ispitivanjima na 6 000 dojenčadi, bio je broj dojenčadi u koje se razvio gastroenteritis uzrokovan rotavirusom tijekom naredne sezone rotavirusa (u doba godine kada je poznato da rotavirusi kruže i uzrokuju infekciju, a to je obično u doba hladnijih mjeseci zime do ranog proljeća).
English: The number of cases of rotavirus gastroenteritis due to viruses with the same antigens as in the vaccine decreased following vaccination with RotaTeq.
Croatian: Broj slučajeva gastroenteritisa uzrokovanog rotavirusom zbog virusa s istim antigenima kao i u cjepivu smanjio se nakon cijepljenja lijekom RotaTeq.
English: Among the almost 6,000 babies in whom the main measure of effectiveness was studied, 82 of the babies vaccinated with RotaTeq developed rotavirus gastroenteritis (one with severe gastroenteritis) compared with 315 of the babies who received placebo (51 severe cases).
Croatian: Među gotovo 6 000 dojenčadi u koje je ispitivano glavno mjerilo djelotvornosti, u njih 82 cijepljenih cjepivom RotaTeq razvio se gastroenteritis uzrokovan rotavirusom (pri čemu je u jednog dojenčeta došlo do pojave teškog gastroenteritisa) u usporedbi s 315 dojenčadi koja je primila placebo (51 teži slučaj).
English: RotaTeq is given according to official recommendations.
Croatian: RotaTeq se primjenjuje sukladno službenim preporukama.
English: RotaTeq is given as three doses, with at least four weeks between each dose.
Croatian: RotaTeq se primjenjuje u tri doze s razmakom od najmanje četiri tjedna.
English: The most common side effects with RotaTeq (seen in more than 1 patient in 10) are pyrexia (fever), diarrhoea and vomiting.
Croatian: Najčešće nuspojave cjepiva RotaTeq (zabilježene u više od 1 na 10 bolesnika) su pireksija (vrućica), proljev i povraćanje.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for RotaTeq, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za RotaTeq nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The CHMP decided that RotaTeq's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od cjepiva RotaTeq nadmašuju s njim povezane rizike te je za njega preporučio izdavanje odobrenja za stavljanje u promet.
English: A risk management plan has been developed to ensure that RotaTeq is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena cjepiva RotaTeq.
English: RotaTeq must not be given to babies who have had intussusception in the past or who have problems with their bowel that could put them at risk of intussusception.
Croatian: RotaTeq se također ne smije primjenjivati u djece koja su imala intususcepciju u prošlosti ili koja imaju problema s crijevima zbog kojih mogu biti podložna riziku od intususcepcije.
English: RotaTeq must not be used in babies who are hypersensitive (allergic) to the active substance or any of the other ingredients, or who showed signs of allergy after receiving a dose of RotaTeq or another vaccine against rotavirus in the past.
Croatian: RotaTeq se ne smije primjenjivati u djece koja su preosjetljiva (alergična) na djelatnu tvar ili bilo koji drugi sastojak cjepiva ili u djece koja su pokazala znakove alergije nakon primanja doze cjepiva RotaTeq ili nekog drugog cjepiva protiv rotavirusa u prošlosti.
English: Very rarely (seen in less than 1 patient in 10,000), a serious condition called intussusception (in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage) has been reported after the use of rotavirus vaccines.
Croatian: Vrlo rijetko (kod manje od 1 na 10 000 bolesnika) uočena je pojava teškog stanja koje se naziva intususcepcija (kada se jedan dio crijeva uvuče unutar drugog dijela što dovodi do začepljenja crijeva) nakon primjene cjepiva protiv rotavirusa.
English: What is the risk associated with RotaTeq?
Croatian: Koji su rizici povezani s lijekom RotaTeq?
English: Why has RotaTeq been approved?
Croatian: Zašto je RotaTeq odobren?
English: What is RotaTeq?
Croatian: Što je RotaTeq?
English: RotaTeq is a vaccine that is taken by mouth.
Croatian: RotaTeq je cjepivo koje se primjenjuje oralno.
English: The study also showed that there were fewer hospital admissions or visits to emergency clinics for rotavirus gastroenteritis in babies vaccinated with RotaTeq.
Croatian: Ispitivanje je također pokazalo da je u dojenčadi cijepljene cjepivom RotaTeq zabilježen manji broj prijema u bolnicu ili posjeta ustanovama za hitnu medicinsku pomoć zbog gastroenteritisa uzrokovanog rotavirusom.
English: What is RotaTeq used for?
Croatian: Za što se RotaTeq koristi?
English: What benefit has RotaTeq shown during the studies?
Croatian: Koje su koristi lijeka RotaTeq utvrđene u ispitivanjima?
English: For the full list of all side effects reported with RotaTeq, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni cjepiva RotaTeq potražite u uputi o lijeku.
English: How does RotaTeq work?
Croatian: Kako djeluje RotaTeq?
English: How is RotaTeq used?
Croatian: Kako se RotaTeq koristi?
English: How has RotaTeq been studied?
Croatian: Kako je RotaTeq ispitivan?
English: Vaccination with RotaTeq should be postponed in babies who have a sudden high fever, diarrhoea or vomiting.
Croatian: U djece kod koje dođe do iznenadne vrućice, proljeva ili povraćanja cijepljenje cjepivom RotaTeq treba odgoditi.
English: Death from any cause
Croatian: Smrt zbog bilo kojeg uzroka
English: Urticaria a,
Croatian: urtikarija a,
English: Steglujan should be taken orally once daily in the morning, with or without food.
Croatian: Steglujan treba uzimati peroralno jedanput na dan, ujutro, s hranom ili bez nje.
English: Talk with your doctor about the best way to feed your baby if you take Steglujan.
Croatian: Razgovarajte sa svojim liječnikom o najboljem načinu hranjenja svog djeteta dok uzimate Steglujan.
English: Hispanic or Latino patients comprised 15.6% to 36.1% of the population.
Croatian: Bolesnici hispanoameričkog ili latinoameričkog podrijetla činili su 15,6% do 36,1% populacije.
English: It also lowers the amount of sugar made by your body.
Croatian: Također smanjuje količinu šećera koja se proizvodi u tijelu.
English: Ask about ways to prevent dehydration.
Croatian: Pitajte liječnika kako možete spriječiti dehidraciju
English: • if you are taking digoxin (a medicine used to treat irregular heart beat and other heart problems).
Croatian: • ako uzimate digoksin (lijek koji se koristi za liječenje nepravilnog srčanog ritma i drugih problema sa srcem).
English: Your doctor may decide to temporarily or permanently stop your treatment with Steglujan.
Croatian: Vaš će liječnik možda odlučiti privremeno ili trajno prekinuti liječenje lijekom Steglujan.
English: When this happens, sugar (glucose) builds up in the blood.
Croatian: Kad se to dogodi šećer (glukoza) se nakuplja u krvi.
English: • Swallow the tablet; if you have difficulties with swallowing the tablet can be broken or crushed.
Croatian: • Progutajte tabletu; ako imate poteškoća s gutanjem, tabletu možete prelomiti ili zdrobiti.
English: • kidney problems (sometimes requiring dialysis)
Croatian: • problemi s bubrezima (ponekad zahtijevaju dijalizu)
English: Onset of these reactions occurred within the first 3 months after initiation of treatment, with some reports occurring after the first dose.
Croatian: Ove su reakcije nastupile unutar prva 3 mjeseca nakon početka liječenja, a u nekim slučajevima prijavljene su nakon prve doze.
English: (For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5, and 5.1)
Croatian: (Za rezultate ispitivanja koji se odnose na kombinacije i učinke na regulaciju glikemije vidjeti dijelove 4.4, 4.5 i 5.1).
English: There is no experience with doses above 800 mg in clinical studies.
Croatian: Nema iskustava s dozama višima od 800 mg u kliničkim ispitivanjima.
English: • Sitagliptin helps to increase the levels of insulin produced after a meal.
Croatian: • Sitagliptin pomaže povisiti razine inzulina koji se proizvodi nakon obroka.
English: • low blood sugar
Croatian: • niska razina šećera u krvi
English: Hospitalisation for unstable angina
Croatian: Hospitalizacija zbog nestabilne angine
English: Sitagliptin was not carcinogenic in mice.
Croatian: Sitagliptin nije bio kancerogen u miševa.
English: The effects on kidney and bone did not fully reverse after the 1 month recovery period.
Croatian: Učinci na bubrege i kosti nisu se u potpunosti povukli nakon 1-mjesečnog razdoblja oporavka.
English: Table 5: Rates of composite cardiovascular outcomes and key secondary outcomes
Croatian: Tablica 5: Stope objedinjenih kardiovaskularnih ishoda i ključnih sekundarnih ishoda
English: Patients should not take two doses of Steglujan on the same day.
Croatian: Bolesnici ne smiju uzeti dvije doze lijeka Steglujan u istom danu.
English: You should not take this medicine during pregnancy.
Croatian: Nemojte uzimati ovaj lijek tijekom trudnoće.
English: Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Croatian: Budući da su sigurnosne granice visoke (19 puta više od razine bez učinka), ove se neoplastične promjene ne smatraju značajnima za situaciju u ljudi.
English: Dehydration (losing too much water from your body; common, may affect up to 1 in 10 people) Symptoms of dehydration include:
Croatian: Dehidracija (prekomjeran gubitak tekućine iz tijela; često, može se javiti u do 1 na 10 osoba) Simptomi dehidracije uključuju:
English: Because of the high safety margins, these findings do not suggest a relevant risk for human reproduction.
Croatian: Budući da je granica sigurnosti visoka, ovi nalazi ne upućuju na značajan rizik za reprodukciju u ljudi.
English: Exfoliative skin conditions including Stevens-Johnson syndrome a,
Croatian: eksfolijativna stanja kože uključujući Stevens-Johnsonov sindrom a,
English: In case of swallowing difficulties, the tablet could be broken or crushed as it is an immediate-release dosage form.
Croatian: U slučaju poteškoća s gutanjem, tablete se mogu prelomiti ili zdrobiti jer radi se o formulaciji s trenutnim oslobađanjem.
English: For composite endpoints, the p-values correspond to a test of non-inferiority seeking to show that the hazard ratio is less than 1.3.
Croatian: Za objedinjene mjere ishoda, p-vrijednosti odgovaraju ispitivanju neinferiornosti kojim se želi dokazati da je omjer hazarda manji od 1,3.
English: The level of digoxin in your blood may need to be checked if you are taking it with Steglujan.
Croatian: Možda će biti potrebno provjeravati razinu digoksina u krvi ako ga uzimate s lijekom Steglujan.
English: There is no information regarding the presence of Steglujan or its individual components in human milk, the effects on the breast-fed infant, or the effects on milk production.
Croatian: Nema informacija o prisutnosti lijeka Steglujan ili njegovih pojedinačnih sastavnica u majčinom mlijeku, učincima na dojenče ni učincima na proizvodnju mlijeka.
English: • have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Croatian: • ako imate ili ste imali žučne kamence, ovisnost o alkoholu ili vrlo visoke razine triglicerida (vrsta masnoća) u krvi.
English: Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported.
Croatian: Prijavljene su ozbiljne nuspojave, uključujući pankreatitis i reakcije preosjetljivosti.
English: Warnings and precautions Talk to your doctor, pharmacist, or nurse before and while taking Steglujan if you:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije ili tijekom liječenja lijekom Steglujan:
English: Rare • reduced number of platelets
Croatian: Rijetko • smanjen broj krvnih pločica
English: • The dose of Steglujan that you take will depend on your condition and the amount of ertugliflozin and sitagliptin needed to control your blood sugar.
Croatian: • Doza lijeka Steglujan koju ćete uzimati ovisit će o Vašem stanju te količini ertugliflozina i sitagliptina koja je potrebna za regulaciju šećera u krvi.
English: For all other endpoints, the p-values correspond to a test of differences in hazard rates.
Croatian: Za sve ostale mjere ishoda p-vrijednosti odgovaraju ispitivanju razlika u omjerima hazarda.
English: *Incidence rate per 100 patient-years is calculated as 100 × (total number of patients with ≥ 1 event during eligible exposure period per total patient-years of follow-up).
Croatian: * Stopa incidencije na 100 bolesnik-godina izračunava se kao 100 × (ukupan broj bolesnika s ≥ 1 događajem tijekom primjenjivog razdoblja izloženosti po ukupnom broju bolesnik-godina praćenja).
English: What you need to know before you take Steglujan
Croatian: Što morate znati prije nego počnete uzimati Steglujan
English: However, patients at risk of digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly.
Croatian: Međutim, bolesnike s rizikom od toksičnosti digoksina treba pratiti kada se sitagliptin i digoksin primjenjuju istodobno.
English: • Steglujan can be used alone or with some other medicines that lower blood sugar.
Croatian: • Steglujan se može uzimati samostalno ili u kombinaciji s nekim drugim lijekovima koji snizuju razinu šećera u krvi.
English: If you stop taking Steglujan
Croatian: Ako prestanete uzimati Steglujan
English: • have or have had a disease of the pancreas (such as pancreatitis).
Croatian: • ako imate ili ste imali bolest gušterače (kao što je pankreatitis),
English: Sitagliptin is secreted in considerable amounts into the milk of lactating rats (milk/plasma ratio: 4:1).
Croatian: Sitagliptin se u znatnim količinama izlučuje u mlijeko ženki štakora u laktaciji (omjer mlijeko/plazma: 4:1).
English: The safety and efficacy of Steglujan in children under 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Steglujan u djece mlađe od 18 godina nisu ustanovljene.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Steglujan in all subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Steglujan u svim podskupinama pedijatrijske populacije u liječenju dijabetesa tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).