FrancophonIA/ELRC3.0 huggingface dataset:
English: Three studies were carried out in Asia and Latin America involving over 35,000 children aged 2 to 16 years.
Croatian: U Aziji i Latinskoj Americi provedena su tri ispitivanja kojima je bilo obuhvaćeno 35 000 djece u dobi od 2 do 16 godina.
English: Additional studies showed that the vaccine is also effective in people aged 16 to 45 years.
Croatian: Dodatna ispitivanja pokazala su da je cjepivo učinkovito i u osoba u dobi od 16 do 45 godina.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend the body against a disease.
Croatian: Cjepiva djeluju „učeći” imunosni sustav (prirodnu obranu tijela) kako tijelo obraniti od bolesti.
English: Cases of dengue disease were recorded for one year after the last injection.
Croatian: Slučajevi denge bilježeni su godinu dana nakon zadnje injekcije.
English: The risk of severe disease is higher in people who have been infected a second time.
Croatian: Rizik od teškog oblika bolesti veći je u osoba koje su se zarazile drugi put.
English: The injection is given under the skin, preferably in the upper arm.
Croatian: Injekcija se daje pod kožu, po mogućnosti u nadlakticu.
English: The vaccine is given as 3 doses, 6 months apart.
Croatian: Cjepivo se daje u tri doze, s razmacima od 6 mjeseci.
English: There are several varieties (called serotypes) of dengue virus and Dengvaxia protects against serotypes 1, 2, 3 and 4.
Croatian: Postoji nekoliko sorti (serotipova) virusa denge, a Dengvaxia štiti od serotipova 1, 2, 3 i 4.
English: In the future, when the person comes into contact with dengue virus, these antibodies together with other components of the immune system will be able to kill the virus and help protect against the disease.
Croatian: U budućnosti, kada osoba dođe u kontakt s virusom denge, ta će protutijela zajedno s drugim dijelovima imunosnog sustava moći uništiti virus i pomoći pri zaštiti od bolesti.
English: Dengvaxia contains weakened viruses that do not cause disease.
Croatian: Dengvaxia sadržava oslabljene viruse koji ne izazivaju bolest.
English: Allergic reactions, which may be severe, are a very rare side effect of Dengvaxia.
Croatian: Alergijske reakcije, koje mogu biti ozbiljne, vrlo su rijetka nuspojava cjepiva Dengvaxia.
English: However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage.
Croatian: Međutim, u malog broja bolesnika razvije se težak oblik bolesti praćen krvarenjem i oštećenjem organa koji mogu biti smrtonosni.
English: What measures are being taken to ensure the safe and effective use of Dengvaxia?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Dengvaxia?
English: The most common side effects with Dengvaxia (which may affect more than 1 in 10 people) are headache, injection site pain, malaise (feeling unwell), muscle pain, weakness and fever.
Croatian: Najčešće su nuspojave cjepiva Dengvaxia (koje se mogu javiti u više od 1 na 10 osoba) glavobolja, bol na mjestu injekcije, malaksalost (opće loše osjećanje), bol u mišićima, slabost i vrućica.
English: There is no other vaccine for dengue disease and neither is there a specific treatment.
Croatian: Protiv denge ne postoji drugo cjepivo ni posebno liječenje.
English: Children were given either 3 injections of Dengvaxia or 3 injections of placebo (a dummy vaccine) with 6 months between each injection.
Croatian: Djeca su primila 3 injekcije cjepiva Dengvaxia ili 3 injekcije placeba (prividno cjepivo) s razmakom od 6 mjeseci između svake injekcije.
English: Dengvaxia's side effects are usually mild or moderate and do not last longer than three days.
Croatian: Nuspojave cjepiva Dengvaxia obično su blage ili umjerene i ne traju dulje od tri dana.
English: Dengvaxia must not be given to people with weakened immune systems, including people whose immune system has been weakened by HIV infection or medicines such as cancer medicines or high doses of corticosteroids.
Croatian: Dengvaxia se ne smije davati osobama s oslabljenim imunosnim sustavom, uključujući one čiji je imunosni sustav oslabljen infekcijom virusom HIV-a ili lijekovima kao što su citostatici ili visokim dozama kortikosteroida.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dengvaxia have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene cjepiva Dengvaxia nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: Other information about Dengvaxia
Croatian: Ostale informacije o lijeku Dengvaxia
English: Side effects reported with Dengvaxia are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za cjepivo Dengvaxia pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Dengvaxia must also not be given to women who are pregnant or breastfeeding.
Croatian: Dengvaxia se ne smije davati ni ženama koje su trudne ili doje.
English: Dengvaxia can only be obtained with a prescription and should be used according to official recommendations.
Croatian: Dengvaxia se izdaje samo na liječnički recept te se treba primjenjivati u skladu sa službenim preporukama.
English: However, among children aged between 9 and 16 years who had not had previous dengue infection, the risk of severe dengue disease if they later became infected with the virus was higher in people vaccinated compared with those given placebo (estimated at 2 additional cases per 1000 people vaccinated over 5 years).
Croatian: Međutim, među djecom u dobi između 9 i 16 godina koja prethodno nisu bila zaražena virusom denge, rizik od razvoja teškog oblika bolesti u slučaju kasnije zaraze virusom bio je viši u cijepljenih osoba nego u onih koje su primile placebo (procijenjen na 2 dodatna slučaja u 1 000 cijepljenih osoba tijekom razdoblja od 5 godina).
English: What is Dengvaxia and what is it used for?
Croatian: Što je Dengvaxia i za što se primjenjuje?
English: The company that markets Dengvaxia will provide educational material for healthcare professionals with information on the use of Dengvaxia including the need to test for previous dengue infection and how to detect early dengue disease.
Croatian: Tvrtka koja stavlja na tržište cjepivo Dengvaxia osigurat će materijal za obuku zdravstvenih radnika koji sadržava informacije o primjeni cjepiva Dengvaxia, uključujući i potrebu testiranja na prethodnu zarazu dengom te načine ranog otkrivanja bolesti.
English: As for all medicines, data on the use of Dengvaxia are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni cjepiva Dengvaxia kontinuirano se prate.
English: Overall, among children aged between 9 and 16 years and who had previous dengue infection, there were around 79% fewer cases of dengue disease in children vaccinated with 3 doses of Dengvaxia compared with placebo.
Croatian: Ukupno gledajući, među djecom u dobi od 9 do 16 godina koja su prethodno bila zaražena dengom bilo je oko 79 % manje slučajeva bolesti u djece koja su primila tri doze cjepiva Dengvaxia nego u djece koja su primila placebo.
English: However, people who have not had dengue infection in the past may have a higher risk of severe dengue disease if they become infected with the virus after vaccination with Dengvaxia.
Croatian: Međutim, osobe koje u prošlosti nisu bile zaražene virusom denge mogu biti izložene većem riziku od teškog oblika bolesti ako se zaraze virusom nakon što su primile cjepivo Dengvaxia.
English: For more information about using Dengvaxia, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni cjepiva Dengvaxia pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Therefore, the vaccine should only be given to people who have had a previous dengue infection, as confirmed by laboratory testing.
Croatian: Stoga se cjepivo smije davati samo osobama koje su prethodno bile zaražene virusom denge, što je potvrđeno laboratorijskim testom.
English: An overview of Dengvaxia and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Dengvaxia i zašto je odobren u EU-u
English: The European Medicines Agency therefore decided that Dengvaxia's benefits are greater than its risks and it can be authorised for use in the EU in areas where dengue disease is endemic.
Croatian: Europska agencija za lijekove zaključila je da koristi od cjepiva Dengvaxia nadmašuju s njim povezane rizike te da cjepivo može biti odobreno za primjenu u Europskoj uniji u endemskim područjima.
English: What are the risks associated with Dengvaxia?
Croatian: Koji su rizici povezani s lijekom Dengvaxia?
English: Dengvaxia is effective at reducing the number of cases of dengue disease in people aged between 9 and 45 years who have had the infection in the past.
Croatian: Cjepivo Dengvaxia učinkovito smanjuje broj oboljenja od denge u osoba u dobi od 9 do 45 godina koje su u prošlosti već bile zaražene.
English: Why is Dengvaxia authorised in the EU?
Croatian: Zašto je lijek Dengvaxia odobren u EU-u?
English: Available data are not sufficient to confirm how well the vaccine works in individuals previously infected by dengue virus and younger than 9 years.
Croatian: Raspoloživi podatci nisu dostatni za potvrdu djelotvornosti cjepiva u pojedinaca mlađih od 9 godina koji su prethodno bili zaraženi virusom denge.
English: Dengvaxia is a vaccine used to help protect against dengue disease.
Croatian: Dengvaxia je cjepivo koje se primjenjuje kao pomoć u zaštiti od denge.
English: Dengvaxia is only for use in people from 9 to 45 years of age who have been infected with dengue virus before and who live in areas where this infection is endemic.
Croatian: Dengvaxia se primjenjuje samo u osoba u dobi od 9 do 45 godina koje su prethodno bile zaražene virusom denge i koje žive u endemskim područjima.
English: Dengvaxia must only be given to people who have had a positive test result showing a previous infection with dengue virus.
Croatian: Dengvaxia se smije davati samo osobama koje su imale pozitivne rezultate testa, što upućuje na prethodnu infekciju virusom denge.
English: Dengvaxia contains attenuated (weakened) yellow fever viruses that have been manipulated so that they contain proteins from dengue virus.
Croatian: Dengvaxia sadržava atenuirane (oslabljene) viruse žute groznice koji su obrađeni na način da sadržavaju bjelančevine virusa denge.
English: How does Dengvaxia work?
Croatian: Kako djeluje Dengvaxia?
English: What benefits of Dengvaxia have been shown in studies?
Croatian: Koje su koristi od lijeka Dengvaxia utvrđene u ispitivanjima?
English: The studies included both children who had and had not been infected with dengue virus in the past.
Croatian: Ispitivanjima su bila obuhvaćena i djeca koja su prethodno bila zaražena virusom denge i ona koja nisu bila.
English: When a person is given the vaccine, the immune system recognises the dengue proteins in the weakened viruses as
Croatian: Kad osoba primi cjepivo, imunosni sustav prepoznaje bjelančevine denge u oslabljenim virusima kao „strana tijela” i proizvodi protutijela za njih.
English: For the full list of side effects and restrictions with Dengvaxia, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja prilikom primjene cjepiva Dengvaxia potražite u uputi o lijeku.
English: Dengue disease is a mosquito-borne tropical disease caused by the dengue virus leading to mild, flulike symptoms in most people.
Croatian: Denga je bolest tropskog područja koju uzrokuje virus denge, a prenose je komarci.
English: Content (concentration)
Croatian: Sastav (koncentracija)
English: MA (EU) number (Invented) name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik
English: Pack size
Croatian: 1 bočica
English: Route of Administration
Croatian: Put primjene Unutarnje pakovanje
English: Your body can also make too much sugar.
Croatian: Tijelo također može proizvesti previše šećera.
English: Never take two doses at the same time (morning or evening).
Croatian: Nikad nemojte uzeti dvije doze istovremeno (ujutro ili navečer).
English: However, a double dose should not be taken at the same time.
Croatian: Međutim, ne smije se istovremeno uzeti dvostruka doza.
English: It is unknown if this medicine is harmful to the unborn child.
Croatian: Nije poznato je li ovaj lijek štetan za nerođeno dijete.
English: Take the medicine pack with you.
Croatian: Uzmite sa sobom pakiranje lijeka.
English: How to take this medicine - one tablet twice daily by mouth in the dose prescribed by your doctor.
Croatian: Kako uzimati ovaj lijek - jedna tableta dvaput dnevno kroz usta u dozi koju je propisao Vaš liječnik.
English: The red blood cells most likely represent a secondary compartment of distribution.
Croatian: Crvene krvne stanice najvjerojatnije predstavljaju sekundarni odjeljak distribucije.
English: This leaflet was last revised in {MM/YYYY}
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: Body weight did not differ significantly between the groups.
Croatian: Tjelesna težina nije se značajno razlikovala između skupina.
English: Due to the limited nature of the data set the results should be interpreted cautiously.
Croatian: Zbog ograničenih podataka, rezultate je potrebno tumačiti s oprezom.
English: - if you have or have had a disease of the pancreas.
Croatian: - ako imate ili ste imali bolest gušterače.
English: CV death
Croatian: KV smrt
English: This is to help keep your blood sugar under control.
Croatian: Time pomažete da se Vaš šećer u krvi drži pod kontrolom.
English: Number of Subjects (%)
Croatian: Broj ispitanika (%)
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Date of latest renewal: 22 March 2017
Croatian: Datum posljednje obnove odobrenja: 22. ožujka 2017.
English: The clinical relevance of these decreases is unknown.
Croatian: Klinički značaj ovih smanjenja nije poznat.
English: The mean volume of distribution (Vd) ranged between 63-276 l.
Croatian: Prosječni volumen distribucije (Vd) varirao je između 63-276 l.
English: However, if it is nearly time for the next dose, skip the missed dose.
Croatian: Međutim, ako je uskoro vrijeme za sljedeću dozu, preskočite propuštenu dozu.
English: Effects on plasma lipids were generally neutral.
Croatian: Učinci na lipide u plazmi bili su općenito neutralni.
English: Do not take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu.
English: Organic cation transporters (OCT)
Croatian: Transporteri organskih kationa (OCT)
English: Your doctor will tell you exactly the dose of this medicine to take.
Croatian: Liječnik će Vam reći točnu dozu ovog lijeka koju ćete uzimati.
English: Oral contraceptives:
Croatian: Oralni kontraceptivi:
English: There is no experience with doses above 600 mg in humans.
Croatian: Nema iskustva s dozama iznad 600 mg u ljudi.
English: Continue to take Jentadueto as long as your doctor prescribes it so you can continue to help control your blood sugar.
Croatian: Nastavite uzimati Jentadueto sve dok to Vaš liječnik propisuje kako biste mogli i dalje pomoći kontroli svog šećera u krvi.
English: Lipase increased*
Croatian: Povišena lipaza*
English: For prevention, it is recommended that Jentadueto be taken during or after meals.
Croatian: Za prevenciju se preporučuje uzimanje Jentadueta tijekom ili nakon obroka.
English: Doses of background anti-diabetic therapy were kept stable during the first 12 weeks, after which adjustments were permitted.
Croatian: Doze osnovne antidijabetičke terapije bile su stabilne tijekom prvih 12 tjedana, nakon čega su bile dozvoljene prilagodbe.
English: What is type 2 diabetes?
Croatian: Što je dijabetes tipa 2?
English: If you forget to take a dose, take it as soon as you remember it.
Croatian: Ako zaboravite uzeti dozu, uzmite ju čim se sjetite.
English: Remember to take all medicines as directed by your doctor to achieve the best results for your health.
Croatian: Upamtite da se svi lijekovi uzimaju prema uputama liječnika kako bi se postigao maksimalan rezultat za Vaše zdravlje.
English: Based on these studies there is no concern for carcinogenicity in humans.
Croatian: Na temelju ovih ispitivanja nema razloga za zabrinutost zbog kancerogenosti u ljudi.
English: Talk to your doctor for further instruction.
Croatian: Obratite se liječniku za daljnje upute.
English: Alcohol
Croatian: Alkohol
English: What Jentadueto is and what it is used for What you need to know before you take Jentadueto How to take Jentadueto
Croatian: Što je Jentadueto i za što se koristi Što morate znati prije nego počnete uzimati Jentadueto Kako uzimati Jentadueto
English: The safety and efficacy of Jentadueto in children and adolescents aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost Jentadueta u djece i adolescenata, u dobi od 0 do 18 godina nisu ustanovljene.
English: These changes are not likely to be clinically meaningful.
Croatian: Nije vjerojatno da su ove promjene klinički značajne.
English: Multiple-dose study: data are restricted to one study.
Croatian: Ispitivanja višekratnih doza: podaci su ograničeni na jedno ispitivanje.
English: What Jentadueto is and what it is used for
Croatian: Što je Jentadueto i za što se koristi
English: If you take more Jentadueto than you should
Croatian: Ako uzmete više Jentadueta nego što ste trebali
English: Children and adolescents This medicine is not recommended for use in children and adolescents under 18 years.
Croatian: Ovaj lijek se ne preporučuje djeci i adolescentima ispod 18 godina.
English: Patients (%) receiving rescue treatment
Croatian: Bolesnici (%) koji su primili simptomatsko liječenje („rescue treatment“ )
English: Linagliptin and its main metabolite did not show a genotoxic potential.
Croatian: Linagliptin i njegov glavni metabolit nisu pokazali genotoksični potencijal.
English: No metabolites have been identified in humans.
Croatian: Nisu prepoznati metaboliti u ljudi.
English: You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Croatian: Savjetuje Vam se slijediti preporuke za njegu kože i stopala koje su Vam dali liječnik ili medicinska sestra.
English: The starting dose is at most half of the maximum dose.
Croatian: Početna doza iznosi najviše polovicu maksimalne doze.
English: Do not take Jentadueto if any of the above applies to you.
Croatian: Ne uzimajte Jentadueto ako se nešto od prethodno navedenog odnosi na Vas.
English: Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Croatian: Dijabetes tipa 2 je stanje u kojem Vaše tijelo ne stvara dovoljno inzulina, a inzulin kojeg je Vaše tijelo proizvelo ne djeluje onako dobro kako bi trebao.
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2).
Croatian: Odmah prestanite uzimati ovaj lijek i odmah se obratite liječniku ili najbližoj bolnici (vidjeti dio 2).
English: No dose adjustment
Croatian: Nema prilagođavanja doze
English: Safety data from this study was in line with previous known safety profile of linagliptin.
Croatian: Podaci o sigurnosti primjene iz ovog ispitivanja bili su u skladu s otprije poznatim sigurnosnim profilom linagliptina.
English: Body Mass Index (BMI)
Croatian: Indeks tjelesne mase (BMI)
English: Concomitant use not recommended
Croatian: Istodobna primjena koja se ne preporučuje
English: During treatment with Jentadueto, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Croatian: Tijekom liječenja lijekom Jentadueto, liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), or very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), ili vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Jentadueto.
Croatian: Sljedeće izjave odražavaju farmakokinetička svojstva pojedinačnih djelatnih tvari Jentadueta.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Croatian: Nakon oralne doze vidljivi terminalni poluvijek eliminacije iznosi približno 6,5 sati.
English: Your doctor may ask you to stop Jentadueto.
Croatian: Vaš liječnik može zatražiti da prestanete uzimati Jentadueto.
English: What Jentadueto looks like and contents of the pack
Croatian: Kako Jentadueto izgleda i sadržaj pakiranja
English: After an oral dose of metformin, Tmax is reached in 2.5 hours.
Croatian: Nakon oralne doze metformina, Tmax se postiže u roku 2,5 sata.
English: - with meals to lower your chance of an upset stomach.
Croatian: - uz obroke radi smanjenja mogućnosti tegoba sa želucem.
English: Both incretin hormones are involved in the physiological regulation of glucose homeostasis.
Croatian: Oba inkretinska hormona uključena su u fiziološku regulaciju homeostaze glukoze.
English: Talk to your doctor, pharmacist or nurse before taking Jentadueto - if you have type 1 diabetes (your body does not produce any insulin).
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Jentadueto ako: - imate dijabetes tipa 1 (kada Vaše tijelo ne proizvodi inzulin).
English: In that case, the missed dose should be skipped.
Croatian: U tom je slučaju propuštenu dozu potrebno preskočiti.
English: In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Croatian: U bolesnika s povećanim rizikom od daljnje progresije oštećenja funkcije bubrega i u starijih osoba, funkciju bubrega treba procjenjivati češće, npr. svakih 3-6 mjeseci.
English: These hormones are rapidly degraded by the enzyme DPP-4.
Croatian: Ovi hormoni se vrlo brzo razgrađuju putem enzima DPP-4.
English: If you take more Jentadueto tablets than you should have, you may experience lactic acidosis.
Croatian: Ako uzmete više Jentadueto tableta nego što ste trebali, možete doživjeti laktacidozu.
English: The name of your tablet is Jentadueto.
Croatian: Naziv ovog lijeka je Jentadueto.
English: Jentadueto with alcohol
Croatian: Jentadueto s alkoholom
English: Patients should be informed of the characteristic symptoms of acute pancreatitis.
Croatian: Bolesnike je potrebno informirati o karakterističnim simptomima akutnog pankreatitisa.
English: Strong pseudo-allergic reactions were observed in dogs at medium doses, secondarily causing cardiovascular changes, which were considered dog-specific.
Croatian: Primijećene su snažne pseudoalergijske reakcije u pasa pri srednjim dozama, sa sekundarnim učinkom izazivanja kardiovaskularnih promjena koje su se smatrale specifičnima za pse.
English: - Metformin belongs to a class of medicines called biguanides.
Croatian: - metformin pripada skupini lijekova koji se nazivaju bigvanidi.
English: Other medicines and Jentadueto
Croatian: Drugi lijekovi i Jentadueto
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1.