FrancophonIA/ELRC3.0 huggingface dataset:
English: As a consequence, these components induce immunity against equine influenza virus (H3N8).
Croatian: Posljedica toga je da te komponente induciraju aktivni imunitet na virus influence konja (H3N8).
English: Onset of immunity: 14 days after primary vaccination course.
Croatian: Početak imuniteta: 14 dana nakon prvog cijepljenja.
English: • In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Croatian: • U izuzetnim okolnostima može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući simptomatski tretman.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Croatian: 13. RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA“ I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous Water for injections
Croatian: Dinatrij hidrogen ortofosfat Monokalij fosfat anhidrid Voda za injekcije
English: Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.
Croatian: Aktivna imunizacija konja starih 4 mjeseca ili starijih protiv influence konja za smanjenje kliničkih znakova i izlučenja virusa nakon infekcije, kao i protiv tetanusa u svrhu sprječavanja smrtnosti.
English: • Do not use after the expiry date stated on the label.
Croatian: • Ne koristiti poslije isteka roka valjanosti naznačenog na etiketi.
English: The periodic safety update report (PSUR) cycle would be re-started for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
Croatian: Ciklus periodičkog izvješća o neškodljivosti (PSUR) predavat će se ponovo u formi izvješća svakih 6 mjeseci (pokrivajući sva odobrena pakovanja proizvoda) slijedeće dvije godine, nakon toga slijede godišnja izvješća tijekom dvije slijedeće godine te potom u intervalima od tri godine.
English: * vCP content checked by global FAID50 (fluorescent assay infectious dose 50 %) and qPCR ratio between vCP.
Croatian: * vCP sadržaj provjeren globalnim FAID50 (fluorescentna analiza infektivne doze 50 %) uz qPCR odnos za vCP.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove (http://www.ema.europa.eu).
English: • 5 months after primary vaccination course with ProteqFlu-Te.
Croatian: • 5 mjeseci nakon prvog cijepljenja s ProteqFlu-Te.
English: For the administration of the vaccine, use sterile and antiseptic-free and/or disinfectant-free material.
Croatian: Za davanje cjepiva koristite sterilne materijale bez antiseptičkog i/ili dezinfekcijskog sredstva.
English: • Keep out of the sight and reach of children.
Croatian: • Čuvati izvan pogleda i dosega djece.
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Croatian: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCUSKA
English: EXP Use immediately after opening.
Croatian: EXP Primijeniti odmah nakon otvaranja.
English: Following the administration of overdoses of vaccine, no side-effects other than those described under section 4.6 have been observed.
Croatian: Nakon predoziranja cjepivom, nisu primijećene nikakve nuspojave osim onih opisanih u odjeljku 4.6.
English: Butyl elastomer closure and aluminium cap.
Croatian: Zatvarač od butil elastomera i aluminijski poklopac.
English: Do not mix with any other veterinary medicinal product.
Croatian: Ne miješati ni s jednim drugim veterinarsko medicinskim proizvodom.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Croatian: RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA“
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
English: Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
Croatian: Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux69007 Lyon, FRANCUSKA
English: No interaction has been observed when the vaccine was administered simultaneously, but at a separate site, with MERIAL's inactivated vaccine against rabies.
Croatian: Nisu primijećene interakcije kada se cjepivo daje istovremeno, ali na drugom mjestu, s inaktiviranim cjepivom protiv bjesnoće tvrtke MERIAL.
English: Only healthy animals should be vaccinated.
Croatian: Cijepiti se smiju samo zdrave životinje.
English: Box of 10 vials of 1 dose.
Croatian: Kutija s 10 bočica s jednom dozom.
English: Intramuscular use (preferably in the neck region).
Croatian: Intramuskularna primjena (najbolje u području vrata).
English: • In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
Croatian: • U izuzetnim okolnostima, može se uočiti apatija i smanjeni tek, dan nakon cijepljenja.
English: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Čuvati i prevoziti rashlađeno (2 °C-8 °C).
English: Manufacturer for the batch release: MERIAL
Croatian: Nositelj odobrenja za proizvodnju za puštanje proizvodne serije: MERIAL
English: Tetanus component: MERIAL Toulouse 4, chemin du Calquet 31057 Toulouse Cedex FRANCE
Croatian: 4, chemin du Calquet 31057 Toulouse Cedex FRANCUSKA
English: Use immediately after opening.
Croatian: Primijeniti odmah nakon otvaranja.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samo-injiciranja, odmah potražite pomoć liječnika i pokažite mu uputu o VMP
English: Type I glass vial.
Croatian: Staklena bočica tip I.
English: The vaccine stimulates active immunity against equine influenza and tetanus.
Croatian: Cjepivo potiče aktivni imunitet na influencu konja i tetanus.
English: • Use immediately after opening.
Croatian: • Primijeniti odmah nakon otvaranja.
English: Veterinary medicinal product subject to prescription.
Croatian: Veterinarsko-medicinski proizvod izdaje se na recept.
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu-Te can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
Croatian: U slučaju povećanog rizika ili nedostatnog uzimanja kolostruma, može se dati dodatna injekcija ProteqFlu-Te u dobi od 4 mjeseca nakon čega slijedi program potpunog cijepljenja (prvo cijepljenje u dobi od 5-6 mjeseci i ponovno cijepljenje 4-6 tjedana kasnije).
English: • Pain, local hyperthermia and muscle stiffness can occur in rare cases.
Croatian: • U rijetkim se slučajevima mogu javiti bol i lokalna hipertermija te ukočenost mišića.
English: Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Croatian: Nositelj odobrenja za stavljanje u promet: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: To be supplied only on veterinary prescription.
Croatian: -Izdaje se samo na veterinarski recept.
English: In rare occasions, swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks,
Croatian: U rijetkim slučajevima otok može imati promjer do 15-20 cm u trajanju od 2-3 tjedna kada može biti potrebno simptomatsko liječenje.
English: • A slight increase in temperature (max. 1.5 °C) may occur for 1 day, exceptionally 2 days.
Croatian: • Može se javiti malo povišenje tjelesne temperature (najviše 1,5°C) tijekom jednog do najviše dva dana nakon cijepljenja.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: DRUGI UVJETI ILI ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET
English: The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 if the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno,
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL's inactivated vaccine against rabies.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti primijenjeno istog dana, ali na drugom mjestu i ne pomiješano s inaktiviranim cjepivom protiv bjesnoće tvrtke MERIAL. 4.9 Količine koje se primjenjuju i način primjene
English: • A transient swelling which usually regresses within 4 days may appear at the injection site.
Croatian: • Na mjestu injiciranja može se pojaviti prolazni otok koji se obično tijekom 4 dana smanjuje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer package for 10 doses: 10 vials of 1 dose
Croatian: Vanjsko pakovanje za 10 doza: 10 bočica s 1 dozom
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo često (više od 1od 10 životinja pokazuje nuspojavu(e) nakon jednokratne primjene) - često (više od 1, ali manje od 10 životinja od 100 životinja) - manje često (više od 1, ali manje od 10 životinja od 1000 životinja)
English: • In very rare occasions, abscessation may be observed.
Croatian: • Vrlo rijetko mogu se zamijetiti apscesi.
English: Duration of immunity induced by the vaccination scheme: - 5 months after the primary vaccination course; - after the primary vaccination course and the booster injection 5 months later: 1 year with regard to equine influenza and 2 years with regard to tetanus.
Croatian: Shema trajanja imuniteta induciranog cijepljenjem: - 5 dana nakon prvog cijepljenja; - nakon prvog cijepljenja i poticajne doze 5 mjeseci kasnije: 1 godinu na influencu konja i
English: - Revaccination:
Croatian: - Docjepljivanje:
English: Shake the vaccine gently before use.
Croatian: Prije primjene cjepivo dobro protresite.
English: Following the administration of overdoses of vaccine, no side-effects other than those described under “Adverse reactions” have been observed.
Croatian: Nakon predoziranja cjepivom, nisu primijećene nikakve nuspojave osim onih opisanih u odjeljku
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNIH TVARI I PROIZVOĐAČ ODGOVORANZA
English: • Store and transport refrigerated (2 °C - 8 °C).
Croatian: • Čuvati i prevoziti rashlađeno (2 °C-8 °C) Čuvati od zamrzavanja.
English: ProteqFlu-Te suspension for injection for horses
Croatian: ProteqFlu-Te Suspenzija za injekcije za konje
English: ProteqFlu-Te Suspension for injection for horses
Croatian: ProteqFlu-Te suspenzija za injekcije za konje
English: ** antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to Ph. Eur.
Croatian: ** titar antitoksičnih protutijela induciran nakon ponovljenog cijepljenja u serumu zamorčića rema
English: The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively.
Croatian: Sojevi cjepiva vCP2242 i vCP3011 su rekombinanti virusa boginja kanarinca koji iz sojeva virusa influence konja A/ eq/Ohio/03 (američki soj, Florida podlinija „clade 1“) i A/ eq/Richmond/1/07 (američki soj, Florida podlinija „clade 2“) izražavaju gen hemaglutinin HA.
English: • Followed by: o against tetanus: injection of 1 dose at an interval of maximum 2 years with ProteqFlu-Te.
Croatian: • Nakon toga: o antitetanus: injekcija 1 doze ProteqFlu-Te u razmaku od najviše 2 godine. o protiv influence konja: injekcija 1 doze ProteqFlu ili ProteqFlu-Te svake godine,
English: that may require symptomatic treatment.
Croatian: U izuzetnim okolnostima može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući simptomatski tretman.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Croatian: 14. RIJEČI „ČUVATI IZVAN POGLEDA
English: Influenza A/eq/Ohio/03 [H3N8] (vCP2242) ............................................................. ≥ 5.3 log10 FAID50 Influenza A/eq/Richmond/1/07 [H3N8] (vCP3011) .................................................. ≥ 5.3 log10 FAID50 Clostridium tetani toxoid ............................................................................................................. ≥ 30 IU
Croatian: Virus influence konja A/ aq/Ohio/03 [H3N8] rekombiniran s virusom boginja kanarinca (vCP2242) ................................................................................... ≥ 5,3 log10 FAID50* Virus influence konja A/eq/Richmond/1/07 [H3N8] rekombiniran s virusom boginja kanarinca (vCP3011) ..................................................................... ≥ 5,3 log10 FAID50* Clostridium tetani toksoid ....................................................................................................... ≥ 30 -IU**
English: Influenza component: MERIAL
Croatian: Komponenta influence:
English: Influenza A/eq/Ohio/03 [H3N8] recombinant Canarypox virus (vCP2242) ........... ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant Canarypox virus (vCP3011) ≥ 5.3 log10 FAID50* Clostridium tetani toxoid ......................................................................................................... ≥ 30 IU**
Croatian: Virus influence konja A/eq/Ohio/03 [H3N8] rekombiniran s virusom boginja kanarinca (vCP2242) ................................................................................... ≥ 5,3 log10 FAID50* Virus influence konja A/ eq/Richmond/1/07 [H3N8] rekombiniran s virusom boginja kanarinca(vCP3011) ...................................................................... ≥ 5,3 log10 FAID50* Clostridium tetani toksoid ........................................................................................................ ≥ 30 IU**
English: o against equine influenza: injection of 1 dose every year, alternatively with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum 2 years for the tetanus component.
Croatian: • Nakon toga: o antitetanus: jedna doza cjepiva ProteqFlu-Te u razmaku od najviše 2 godine. o protiv influence konja: jedna doza cjepiva ProteqFlu ili ProteqFlu-Te svake godine,
English: ≥ 5.3 log10 FAID50* Clostridium tetani toxoid ......................................................................................................... ≥ 30 IU** * vCP content checked by global FAID50 (fluorescent assay infectious dose 50 %) and qPCR ratio between vCP.
Croatian: ≥ 5,3 log10 FAID50* Clostridium tetani toksoid ............................................................................................................ ≥ 30 IU
English: PACKAGE LEAFLET FOR: ProteqFlu-Te suspension for injection for horses
Croatian: UPUTA O VMP ProteqFlu-Te suspenzija za injekcije za konje
English: Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ............ ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) .
Croatian: Influenza A/eq/Ohio/03 [H3N8] (vCP2242) ............................................................ ≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] (vCP3011) .................................................
English: Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule: - primary vaccination course with ProteqFlu-Te: first injection from 5-6 months of age, second injection 4-6 weeks later.
Croatian: - Prvo cijepljenje s ProteqFlu-Te: prva injekcija u dobi 5-6 mjeseci, druga injekcija 4-6 tjedana kasnije.
English: Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course with ProteqFlu-Te: first injection from 5-6 months of age, second injection 4-6 weeks later.
Croatian: Primijenite jednu dozu (1 ml), intramuskularnom injekcijom, najbolje u području vrata, prema slijedećem rasporedu:
English: Elderly (≥ 65 years)
Croatian: Starije osobe (≥ 65 godina)
English: It can also help prevent heart disease.
Croatian: Također može pomoći u sprječavanju srčane bolesti.
English: • Take your tablet twice daily, once in the morning (breakfast) and once in the evening (dinner).
Croatian: • Uzmite tabletu dvaput na dan, jedanput ujutro (uz doručak) i jedanput navečer (uz večeru).
English: • changes in taste
Croatian: • promjene u okusu
English: Take the medicine pack with you.
Croatian: Uzmite pakiranje lijeka sa sobom.
English: Do not take a double dose of this medicine to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu ovog lijeka kako biste nadoknadili zaboravljenu dozu.
English: If you miss a dose, take it as soon as you remember.
Croatian: Ako ste propustili dozu, uzmite ju čim se sjetite.
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Croatian: Uzimanje alkohola i lijekova koji sadrže alkohol mora se izbjegavati.
English: The safety and efficacy of Xigduo in children and adolescents aged 0 to < 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Xigduo u djece i adolescenata u dobi od 0 do < 18 godina nisu još ustanovljene.
English: This medicine is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Croatian: Primjena ovog lijeka ne preporučuje se u djece i adolescenata mlađih od 18 godina jer u tih bolesnika lijek nije ispitan.
English: Your doctor may ask you to stop taking this medicine.
Croatian: Liječnik može zatražiti da prestanete uzimati ovaj lijek.
English: • if you have ever had a diabetic coma.
Croatian: • ako ste ikada bili u dijabetičkoj komi
English: Your doctor will tell you exactly which strength of this medicine to take.
Croatian: Liječnik će Vam reći točno koju jačinu ovog lijeka morate uzeti.
English: This leads to a high level of sugar (glucose) in your blood.
Croatian: To dovodi do visoke razine šećera (glukoze) u Vašoj krvi.
English: Similar reductions were observed at up to 104 weeks.
Croatian: Slična smanjenja primijećena su do 104. tjedna.
English: p-values are two-sided.
Croatian: P-vrijednosti su dvostrane.
English: Time to first event was analysed in a Cox proportional hazards model.
Croatian: Vrijeme do prvog događaja analiziralo se uporabom Coxova modela proporcionalnih hazarda.
English: Other side effects include: Very common
Croatian: Ostale nuspojave uključuju: Vrlo česte
English: PVC/PCTFE/Alu blister.
Croatian: PVC/PCTFE/Al blister.
English: • if you drink large amounts of alcohol, either every day or only from time to time (please see section “Xigduo with alcohol”).
Croatian: • ako pijete velike količine alkohola (bilo svakodnevno ili samo povremeno) (molimo pogledajte dio „Xigduo s alkoholom“).
English: CI=confidence interval.
Croatian: CI = interval pouzdanosti.
English: • if you have a severe infection.
Croatian: • ako imate tešku infekciju
English: Talk to your doctor, pharmacist or nurse before taking Xigduo, and during treatment:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Xigduo, i tijekom liječenja:
English: What Xigduo is and what it is used for
Croatian: Što je Xigduo i za što se koristi
English: P-values are all adjusted p-values for multiplicity.
Croatian: P-vrijednosti su sve p-vrijednosti prilagođene za multiplicitet.
English: • decreased vitamin B12 levels in the blood
Croatian: • smanjene razine vitamina B12 u krvi
English: It is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
Croatian: Važno je redovito provjeravati svoja stopala i pridržavati se svih drugih savjeta o njezi stopala koje vam daje Vaš zdravstveni radnik.
English: Your blood sugar may increase without this medicine.
Croatian: Razina Vašeg šećera u krvi može porasti ako ne uzimate ovaj lijek.
English: Frequency is based on annual rate.
Croatian: Učestalost se temelji na godišnjoj stopi.
English: Date of first authorisation: 16 January 2014 Date of latest renewal: 28 September 2018
Croatian: Datum posljednje obnove odobrenja: 28. rujna 2018.
English: The most frequently reported adverse reactions across the clinical studies were genital infections.
Croatian: Najčešće prijavljene nuspojave u svim kliničkim ispitivanjima bile su genitalne infekcije.
English: Loc. Fontana del Ceraso Anagni, 03012
Croatian: Fontana del Ceraso Anagni, 03012
English: Bristol Myers Squibb S.r.l.
Croatian: Bristol Myers Squibb S.r.l. Loc.
English: • Before initiation of treatment and regularly thereafter (see sections 4.2, 4.8, 5.1 and 5.2).
Croatian: • prije početka liječenja i redovito nakon toga (vidjeti dijelove 4.2, 4.8, 5.1 i 5.2)
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Croatian: Nakon peroralne doze prividno terminalno poluvrijeme eliminacije iznosi približno 6,5 sati.
English: These effects were sustained in longer-term trials.
Croatian: Ti su se učinci održali u dugoročnim ispitivanjima.
English: Body weight reductions were sustained in long-term extensions up to 208 weeks.
Croatian: Smanjenje tjelesne težine u dugoročnim se nastavcima ispitivanjima održalo do 208 tjedana.
English: Your doctor will check your kidney function.
Croatian: Liječnik će Vam provjeriti rad bubrega.
English: No metabolites have been identified in humans.
Croatian: U ljudi nisu pronađeni njegovi metaboliti.
English: Both belong to a group of medicines called oral anti-diabetics.
Croatian: Obje pripadaju skupini lijekova koji se nazivaju oralnim antidijabeticima.
English: There have been no therapeutic clinical trials conducted with Xigduo tablets.
Croatian: Nisu provedena terapijska klinička ispitivanja sa Xigduo tabletama.
English: Results on primary and secondary endpoints are displayed in Figure 2.
Croatian: Rezultati za primarne i sekundarne mjere ishoda prikazani su na Slici 2.
English: There are insufficient data to draw conclusions regarding exposure in patients > 70 years old.
Croatian: Nema dovoljno podataka da bi se donijeli zaključci o izloženosti u bolesnika starijih od 70 godina.
English: The events occurred evenly distributed over the study period.
Croatian: Ti su događaji bili ravnomjerno raspoređeni tijekom cijelog razdoblja ispitivanja.
English: Patients at risk is the number of patients at risk at the beginning of the period.
Croatian: Bolesnici pod rizikom odnose se na broj bolesnika kod kojih je postojao rizik na početku razdoblja.
English: During treatment with Xigduo, your doctor will check your kidney function at least once every year or more frequently if you are elderly and/or if you have worsening kidney function.
Croatian: Tijekom liječenja lijekom Xigduo, liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
English: Do not drive or use any tools or machines, if you start to feel these symptoms.
Croatian: Nemojte upravljati vozilima ni rukovati alatima ili strojevima ako počnete osjećati ove simptome.