FrancophonIA/ELRC3.0 huggingface dataset:
English: Spectrila is effective at reducing blood asparagine that the cancer cells need to survive.
Croatian: Lijek Spectrila učinkovit je u smanjenju asparagina u krvi koji je stanicama raka potreban za preživljavanje.
English: As for its risks, the side effects of Spectrila are similar to those of other asparaginase medicines and are addressed in the medicine's risk minimisation plan.
Croatian: U pogledu rizika, nuspojave lijeka Spectrila slične su onima koje se javljaju kod drugih lijekova koji sadrže asparaginazu i o njima se govori u planu za smanjivanje rizika od lijeka.
English: How does Spectrila work?
Croatian: Kako djeluje Spectrila?
English: For more information about treatment with Spectrila, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Spectrila pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The cancer cells need this amino acid to grow and
Croatian: Za razvoj stanica raka potrebno je da ta aminokiselina raste te da se
English: The active substance in Spectrila, asparaginase, is an enzyme that works by breaking up and reducing the blood levels of the amino acid asparagine.
Croatian: Djelatna tvar u lijeku Spectrila, asparaginaza, enzim je koji djeluje razbijanjem i smanjenjem razine aminokiseline asparagin u krvi.
English: It must also not be used in patients who have ever had pancreatitis, or severe bleeding or blood clots following asparaginase treatment.
Croatian: Ne smije se primjenjivati niti u bolesnika koji su prije imali pankreatitis ili kod kojih je zabilježeno krvarenje ili zgrušavanje krvi težeg stupnja nakon liječenja asparaginazom.
English: Spectrila can only be obtained with a prescription and is available in a vial as a powder to be made into a solution for infusion.
Croatian: Lijek Spectrila izdaje se samo na liječnički recept i dostupan je u bočici u obliku praška za pripremu otopine za infuziju.
English: How is Spectrila used?
Croatian: Kako se Spectrila koristi?
English: The most serious side effects with Spectrila include severe allergic reactions, blood clots, pancreatitis (inflammation of the pancreas), and liver problems.
Croatian: Najozbiljnije nuspojave zabilježene pri primjeni lijeka Spectrila uključuju teške alergijske reakcije, stvaranje krvnih ugrušaka, pankreatitis (upalu gušterače) i probleme s jetrom.
English: For practical information about using Spectrila, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Spectrila pročitajte u uputi o lijeku ili se obratite svom liječniku ili ljekarniku.
English: Spectrila must not be used in patients who are allergic to any asparaginase preparation and those who have pancreatitis (inflammation of the pancreas), severe liver disease or blood clotting problems.
Croatian: Lijek Spectrila ne smije se primjenjivati u bolesnika koji su alergični na pripravke koji sadrže asparaginazu te u bolesnika koji imaju pankreatitis (upalu gušterače), teže bolesti jetre ili probleme sa zgrušavanjem krvi.
English: What benefits of Spectrila have been shown in studies?
Croatian: Koje su koristi lijeka Spectrila utvrđene u ispitivanjima?
English: Spectrila is used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts, in combination with other cancer medicines.
Croatian: Spectrila je lijek za liječenje akutne limfoblastične leukemije (ALL), raka bijelih krvnih stanica koje se nazivaju limfoblasti.
English: Only healthcare professionals experienced in cancer treatments should prescribe and give Spectrila.
Croatian: Lijek Spectrila trebaju propisivati i primjenjivati samo zdravstveni djelatnici s iskustvom u liječenju raka.
English: For the full list of side effects reported with Spectrila, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Spectrila potražite u uputi o lijeku.
English: Strength Pharmaceutical Form Route of administration Packaging
Croatian: Farmaceutski oblik
English: EU Numbers
Croatian: Veličina
English: Package size
Croatian: Unutarnje pakovanje
English: Elderly (≥ 65 years)
Croatian: Starije osobe (≥65 godina)
English: However, this has not been established in the target population.
Croatian: Ovo, međutim, nije ustanovljeno u ciljnoj populaciji.
English: - if you drink alcohol excessively (whether every day or only from time to time).
Croatian: - ako pijete velike količine alkohola (bilo svaki dan ili samo s vremena na vrijeme).
English: Medical attention may be necessary.
Croatian: Možda će biti potrebna medicinska pomoć.
English: Not to be sold separately.
Croatian: Ne prodaje se zasebno.
English: What Zomarist is and what it is used for
Croatian: Što je Zomarist i za što se koristi
English: The amount of Zomarist that people have to take varies depending on their condition.
Croatian: Količina Zomariste koju ljudi moraju uzimati ovisi o njihovu stanju.
English: Do not take a double dose (two tablets at once) to make up for a forgotten tablet.
Croatian: Nemojte uzeti dvostruku dozu (dvije tablete odjednom) kako biste nadoknadili zaboravljenu tabletu.
English: Combinations not recommended
Croatian: Kombinacije koje se ne preporučuju
English: An updated RMP shall be submitted every three years.
Croatian: Ažurirani RMP treba se dostaviti svake tri godine.
English: Your doctor will discuss with you the potential risk of taking Zomarist during pregnancy.
Croatian: Vaš liječnik će s Vama razgovarati o mogućim rizicima uzimanja Zomarist tijekom trudnoće.
English: Assessment of each individual MACE component showed no increased risk (similar M-H RR).
Croatian: Ocjena svake pojedinačne MACE komponente pokazala je da nema povećanog rizika (sličan M-H RR).
English: The mean volume of distribution (Vd) ranged between 63-276 litres.
Croatian: Srednji volumen raspodjele (Vd) je između 63-276 litara.
English: These were consistently located on the extremities (hands, feet, ears and tail).
Croatian: Bile su dosljedno smještene na ekstremitetima (šake, stopala, uši i rep).
English: If you take more Zomarist than you should
Croatian: Ako uzmete više Zomariste nego što ste trebali
English: The expiry date refers to the last day of that month.
Croatian: „EXP“.Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: - if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body).
Croatian: - ako imate tešku infekciju ili ste ozbiljno dehidrirali (izgubili ste mnogo tekućine iz Vašeg tijela).
English: The clinical relevance of this decrease is unknown.
Croatian: Nije poznat klinički značaj ovog smanjenja.
English: No metabolites have been identified in humans.
Croatian: Nisu pronađeni metaboliti u ljudi.
English: Cardiovascular risk
Croatian: Kardiovaskularni rizik
English: Continue to take this medicine as long as your doctor prescribes it so that it can continue to control your blood sugar.
Croatian: Nastavite uzimati ovaj lijek dok god Vam ga liječnik propisuje tako da može nastaviti kontrolirati Vaš šećer u krvi.
English: When and how to take Zomarist - Swallow the tablets whole with a glass of water, - Take one tablet in the morning and the other in the evening with or just after food.
Croatian: Kada i kako uzimati Zomarist - Tablete progutajte cijele sa čašom vode, - Uzmite jednu tabletu ujutro i drugu navečer s obrokom ili odmah nakon obroka.
English: No new toxicities associated with the combination were identified.
Croatian: Nisu utvrđene nove toksičnosti povezane s kombinacijom.
English: Zomarist is not a substitute for insulin.
Croatian: Zomarist nije zamjena za inzulin.
English: If you have previously taken vildagliptin but had to stop taking it because of liver disease, you should not take this medicine.
Croatian: Ako ste prethodno uzimali vildagliptin, ali ste ga morali prestati uzimati zbog jetrene bolesti, ne smijete uzimati ovaj lijek.
English: Zomarist should not be used during pregnancy.
Croatian: Zomarist se ne smije primjenjivati tijekom trudnoće.
English: Plasma protein binding is negligible.
Croatian: Vezanje na proteine plazme je zanemarivo.
English: Do not stop taking Zomarist unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Zomarist ako Vam to nije rekao Vaš liječnik.
English: PA/Alu/PVC/Alu 2 years PCTFE/PVC/Alu 18 months
Croatian: PA/Al/PVC/Al 2 godine PCTFE/PVC/Al 18 mjeseci
English: A slow increase in the dose may also improve gastrointestinal tolerability.
Croatian: Blago povećavanje doze može također poboljšati gastrointestinalnu podnošljivost.
English: - Do not use Zomarist if you are pregnant or breast-feeding (see also “Do not take Zomarist”).
Croatian: - Nemojte uzimati Zomarist ako ste trudni ili dojite (također pogledajte „Nemojte uzimati Zomarist“).
English: What Zomarist is and what it is used for What you need to know before you take Zomarist How to take Zomarist
Croatian: Što je Zomarist i za što se koristi Što morate znati prije nego počnete uzimati Zomarist Kako uzimati Zomarist
English: You are also advised to pay particular attention to new onset of blisters or ulcers while taking Zomarist.
Croatian: Također Vam se savjetuje da posvetite posebnu pozornost novoj pojavi mjehurića ili čireva dok uzimate Zomarist.
English: They were reversible despite continued treatment and were not associated with histopathological abnormalities.
Croatian: Oni su bili reverzibilni unatoč nastavljenom liječenju te nisu bili povezani s histopatološkim abnormalnostima.
English: Do not take Zomarist - if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Zomarist - ako ste alergični na vildagliptin, metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: To prevent them, it is recommended that metformin be taken in 2 daily doses during or after meals.
Croatian: Kako bi se spriječili, preporučuje se primjena metformina u 2 dnevne doze tijekom ili nakon obroka.
English: Infections and infestations Very rare
Croatian: Infekcije i infestacije Vrlo rijetko
English: Food slightly delays the time to peak plasma concentration to 2.5 hours, but does not alter the overall exposure (AUC).
Croatian: Hrana neznatno odgađa vrijeme do postizanja vršne koncentracije u plazmi na 2,5 sata, ali ne mijenja ukupnu izloženost (AUC).
English: Date of first authorisation: 01 December 2008 Date of latest renewal: 31 July 2013
Croatian: Datum posljednje obnove odobrenja: 31. srpnja 2013.
English: Your doctor may prescribe this medicine alone or with certain other medicines that lower the level of sugar in your blood.
Croatian: Liječnik Vam može propisati ovaj lijek sam ili zajedno s određenim drugim lijekovima koji snižavaju razinu šećera u krvi.
English: - Do not store above 30C.
Croatian: - Ne čuvati na temperaturi iznad 30C.
English: Should these occur, you should promptly consult your doctor.
Croatian: Ako se oni pojave, trebate se odmah obratiti liječniku.
English: Your doctor will decide when you must stop and when to restart your treatment with Zomarist.
Croatian: Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Zomarist.
English: If you have any questions about how long to take this medicine, talk to your doctor.
Croatian: Ako imate pitanja o tome koliko dugo uzimati lijek, obratite se svom liječniku.
English: During treatment with Zomarist, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or have worsening renal function.
Croatian: Tijekom liječenja lijekom Zomarist, liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
English: However, the magnitude of change is not clinically significant, so that vildagliptin can be given with or without food.
Croatian: Međutim, stupanj promjene nije klinički značajan pa se vildagliptin može primjenjivati s hranom ili bez nje.
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 da se pridržavate preporuka za njegu kože i stopala koje Vam je dao liječnik ili medicinska sestra.
English: Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should.
Croatian: Šećerna bolest tipa 2 razvija se ako tijelo ne stvara dovoljno inzulina ili ako inzulin što ga stvara tijelo ne radi onako kako bi trebao.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera koristi/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimalizacije rizika).
English: Combination with ACE inhibitors
Croatian: Kombinacija s ACE inhibitorima
English: However, vildagliptin cannot be removed by haemodialysis, although the major hydrolysis metabolite (LAY 151) can.
Croatian: Međutim, vildagliptin se ne može ukloniti hemodijalizom premda se njegov glavni metabolit hidrolize (LAY 151) može.
English: Since this product has been marketed, the following side effects have also been reported:
Croatian: Nakon što je lijek stavljen u promet, prijavljene su i sljedeće nuspojave:
English: Both active substances, vildagliptin and metformin, help to control the level of sugar in the blood.
Croatian: Obje djelatne tvari, vildagliptin i metformin, pomažu u kontroliranju razine šećera u krvi.
English: Do not store above 30C.
Croatian: Ne čuvati na temperaturi iznad 30C.
English: What you need to know before you take Zomarist
Croatian: Što morate znati prije nego počnete uzimati Zomarist
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); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost se definira 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), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Although skin lesions were not observed at an increased incidence in clinical trials, there was limited experience in patients with diabetic skin complications.
Croatian: Iako u kliničkim ispitivanjima nije uočena povećana incidencija kožnih lezija, postojalo je ograničeno iskustvo u bolesnika s dijabetičkim komplikacijama na koži.
English: GFR should be assessed before treatment initiation and regularly thereafter (see section 4.2).
Croatian: GFR je potrebno procijeniti prije početka liječenja i redovito nakon toga, (vidjeti dio 4.2).
English: This is so that signs of increased liver enzymes can be detected as early as possible.
Croatian: Razlog tome je nastojanje da se znakovi povišenih vrijednosti jetrenih enzima uoče što je moguće ranije.
English: If you have to go to a doctor or hospital, take the pack and this leaflet with you.
Croatian: Ako trebate otići liječniku ili u bolnicu, pakiranje i ovu uputu o lijeku ponesite sa sobom.
English: Other medicines and Zomarist
Croatian: Drugi lijekovi i Zomarist
English: If you take too many Zomarist tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Croatian: Ako uzmete previše tableta Zomariste, ili ako je netko drugi uzeo Vaše tablete, odmah se obratite liječniku ili ljekarniku.
English: Your doctor will test your blood and urine for sugar regularly.
Croatian: Vaš će liječnik redovito provjeravati razinu šećera u krvi i urinu.
English: Ethnic group: Limited data suggest that race does not have any major influence on vildagliptin pharmacokinetics.
Croatian: Etnička skupina: ograničeni podaci navode na zaključak da rasa nema nikakav značajniji utjecaj na farmakokinetiku vildagliptina.
English: - if you have severely reduced kidney function.
Croatian: - ako imate jako smanjenu funkciju bubrega.
English: This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes.
Croatian: Ovaj lijek dokazano snižava razinu šećera u krvi, što može pomoći spriječiti komplikacije povezane s Vašom šećernom bolešću.
English: No association was found between adverse reactions and age, ethnicity, duration of exposure or daily dose.
Croatian: Nije utvrđena povezanost između nuspojava i dobi, etničke pripadnosti, trajanja izloženosti ili dnevne doze.
English: Embryofoetal toxicity was evaluated in rats and rabbits.
Croatian: Embriofetalna toksičnost je ispitivana u štakora i kunića.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Zomarist before or at the time of the injection.
Croatian: Ako trebate dobiti injekciju kontrastnog sredstva koje sadrži jod u krvnu žilu, na primjer, u sklopu rendgenskog snimanja ili skeniranja, morate prestati uzimati lijek Zomarist prije ili u vrijeme injekcije.
English: Insulin helps to lower the level of sugar in the blood, especially after meals.
Croatian: Inzulin je tvar koja pomaže u snižavanju razine šećera u krvi, osobito poslije obroka.
English: Non-clinical data on metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Croatian: Neklinički podaci o metforminu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala i reproduktivne toksičnosti.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja o učincima na sposobnost upravljanja vozilima i rada sa strojevima.
English: The substance metformin works by helping the body to make better use of insulin.
Croatian: Djelatna tvar metformin djeluje pomažući tijelu da bolje iskoristi inzulin.
English: It can also develop if the body produces too much glucagon.
Croatian: Bolest se također može razviti ako tijelo stvara previše glukagona.
English: If you think you may be allergic to any of these, talk to your doctor before taking Zomarist.
Croatian: Ako mislite da biste mogli biti alergični na bilo što od navedenog, razgovarajte sa svojim liječnikom prije uzimanja Zomariste.
English: It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Croatian: Pretpostavlja se da farmakokinetika apsorpcije metformina nije linearna.
English: Your doctor will tell you exactly the dose of Zomarist to take.
Croatian: Liječnik će Vam reći točno koliko tableta Zomariste trebate uzimati.
English: C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose was recovered in the faeces.
Croatian: C] vildagliptina oko 85% doze se izlučuje u mokraću, a 15% doze pronađeno je u stolici.
English: Continue to follow any advice about diet that your doctor has given you.
Croatian: Nastavite slijediti svaki savjet o prehrani koji ste dobili od svog liječnika.
English: Supportive management is recommended.
Croatian: Preporučuje se suportivno liječenje.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment.
Croatian: Bolesnike se mora informirati i češće im kontrolirati glukozu u krvi, posebno na početku liječenja.
English: Rare cases of hepatic dysfunction (including hepatitis) have been reported with vildagliptin.
Croatian: Rijetko su bili prijavljeni slučajevi poremećaja jetrene funkcije (uključujući hepatitis) s vildagliptinom.
English: Taking the tablet just after food will lower the risk of an upset stomach.
Croatian: Uzimanje tablete odmah nakon obroka smanjuje rizik od želučanih tegoba.
English: These elevations in transaminases were generally asymptomatic, non-progressive in nature and not associated with cholestasis or jaundice.
Croatian: Ova povišenja transaminaza su općenito bila asimptomatska, neprogresivna i nisu bila povezana s kolestazom ili žuticom.
English: In patients at 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: - if you are breast-feeding (see also “Pregnancy and breast-feeding”).
Croatian: - ako dojite (pogledajte također dio „Trudnoća i dojenje”).
English: Zomarist with alcohol
Croatian: Zomarist s alkoholom
English: Biotransformation Metformin is excreted unchanged in the urine.
Croatian: Biotransformacija Metformin se izlučuje nepromijenjen u mokraći.
English: Additional information on the individual active substances of the fixed combination
Croatian: Dodatne informacije za pojedine djelatne tvari fiksne kombinacije
English: If you need to have major surgery you must stop taking Zomarist during and for some time after the procedure.
Croatian: Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Zomarist tijekom i još neko vrijeme nakon zahvata.
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
Croatian: VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: Avoid excessive alcohol intake while taking Zomarist since this may increase the risk of lactic acidosis (please see section “Warnings and precautions”).
Croatian: Izbjegavajte prekomjerni unos alkohola dok uzimate Zomarist jer to može povećati rizik od laktacidoze (vidjeti dio „Upozorenja i mjere opreza”).
English: If you stop taking Zomarist
Croatian: Ako prestanete uzimati Zomarist
English: If no adequate strength of Zomarist is available, individual monocomponents should be used instead of the fixed dose combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Zomarist, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
English: Acute or chronic disease which may cause tissue hypoxia, such as: cardiac or respiratory failure, recent myocardial infarction, shock.
Croatian: Akutna ili kronična bolest koja može uzrokovati hipoksiju tkiva, kao što je: zatajivanje srca ili disanja, nedavni infarkt miokarda, šok.
English: - if you are going to have a contrast x-ray (a specific type of x-ray involving an injectable dye).
Croatian: - ako trebate napraviti kontrastno rendgensko snimanje (poseban rendgenski pregled koji uključuje injekciju kontrastnog sredstva).
English: Metformin must be discontinuedat the time of surgery under general, spinal or epidural anaesthesia.
Croatian: Primjena metformina mora se prekinuti u vrijeme kirurškog zahvata pod općom, spinalnom ili epiduralnom anestezijom.
English: Patients should be informed of the characteristic symptom of acute pancreatitis.
Croatian: Bolesnike treba obavijestiti o karakterističnom simptomu akutnog pankreatitisa.
English: The most effective method of removing metformin is haemodialysis.
Croatian: Najdjelotvornija metoda uklanjanjanja metformina je hemodijaliza.
English: Three other subjects experienced oedema of the feet, with paraesthesia in two cases.
Croatian: U druga je tri ispitanika došlo do edema stopala, s parestezijom u dva slučaja.
English: Metformin is contraindicated.
Croatian: Metformin je kontraindiciran.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetkoj stranici Europske agencije za lijekove: http://www.ema.europa.eu