FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: HbA1c (%) Number of patients n = 65 n = 135
Croatian: HbA1c (%) Broj bolesnika n = 65 n = 135
English: Hepatitis very rare
Croatian: Hepatitis vrlo rijetko
English: Hospitalization for heart failure
Croatian: Hospitalizacija zbog zatajenja srca
English: * PY=patient years ** Test on non-inferiority to demonstrate that the upper bound of the 95% CI for the hazard ratio is less than 1.3
Croatian: * BG=bolesnik-godina ** Test na neinferiornost radi pokazivanja da je gornja granica za 95% CI za omjer hazarda manja od 1,3
English: The clinical trials before marketing authorization have been performed up to a BMI equal to 40 kg/m
Croatian: Provedena su klinička ispitivanja prije odobrenja za stavljanje lijeka u promet do BMI koji odgovara 40 kg/m
English: Therefore, it is considered unlikely that linagliptin affects reproduction at therapeutic exposures in humans.
Croatian: Stoga se ne smatra vjerojatnim da linagliptin utječe na reprodukciju pri terapijskim izloženostima u ljudi.
English: The mean age for study population was 64 years and included 2030 (34%) patients ≥ 70 years of age.
Croatian: Srednja dob za ispitivanu populaciju iznosila je 64 godine i uključivala je 2030 (34%) bolesnika u dobi od ≥ 70 godina.
English: The observed pharmacokinetic and pharmacodynamic responses were consistent with those found in adult subjects.
Croatian: Opaženi farmakokinetički i farmakodinamički odgovori bili su sukladni onima pronađenima u odraslih ispitanika.
English: Do not use this medicine if the package is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili su vidljivi znakovi otvaranja.
English: Further symptoms are reduced body temperature and heartbeat.
Croatian: Daljnji simptomi su snižena tjelesna temperatura i usporeni otkucaji srca.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Croatian: Bolesnike se mora informirati te im se češće pratiti glukoza u krvi, naročito na početku liječenja takvim lijekovima.
English: The absolute bioavailability of linagliptin is approximately 30%.
Croatian: Apsolutna bioraspoloživost linagliptina je oko 30%.
English: Older subjects (65 to 80 years, oldest patient was 78 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Croatian: Stariji ispitanici (65 do 80 godina, najstariji bolesnik imao je 78 godina) imali su usporedive koncentracije linagliptina u plazmi u usporedbi s mlađim osobama.
English: If a dose is missed, it should be taken as soon as the patient remembers.
Croatian: U slučaju propuštanja doze, potrebno ju je uzeti čim se bolesnik sjeti.
English: Your doctor will decide when you must stop and when to restart your treatment with Jentadueto.
Croatian: Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Jentadueto.
English: Incidence Rate per 1000 PY*
Croatian: Stopa incidencije na 1000 BG*
English: Other side effects of Jentadueto include:
Croatian: Druge nuspojave Jentadueta uključuju:
English: All patients should continue their diet with an adequate distribution of carbohydrate intake during the day.
Croatian: Svi bolesnici moraju nastaviti svoju dijetu s odgovarajućom raspodjelom unosa ugljikohidrata tijekom dana.
English: Incretins are secreted at a low basal level throughout the day and levels rise immediately after meal intake.
Croatian: Inkretini se izlučuju u niskoj bazalnoj razini tijekom dana, a vrijednosti se povisuju neposredno nakon unosa obroka.
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 Jentadueto 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 Jentadueto prije ili u vrijeme injekcije.
English: Metformin hydrochloride may act via 3 mechanisms:
Croatian: Metforminklorid može djelovati putem 3 mehanizma:
English: No clinically relevant effect of Cmax and Tmax changes is expected; therefore linagliptin may be administered with or without food.
Croatian: Ne očekuje se klinički značajan učinak promjena u Cmax i Tmax ; stoga se linagliptin može primjenjivati sa ili bez hrane.
English: Jentadueto should be taken twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Croatian: Jentadueto se uzima dvaput dnevno uz obroke kako bi se smanjile gastrointestinalne nuspojave povezane s metforminom.
English: In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g. remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute clinical measures if required.
Croatian: U slučaju predoziranja, razumno je primijeniti uobičajene potporne mjere, npr. uklanjanje neapsorbiranog lijeka iz gastrointestinalnog trakta, uz kliničko praćenje, te uspostaviti kliničke mjere prema potrebi.
English: In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.
Croatian: U slučaju sumnje na simptome, bolesnik treba prestati uzimati metformin i odmah potražiti pomoć liječnika.
English: Plasma protein binding is negligible.
Croatian: Vezanje na proteine plazme je neznatno.
English: Keep taking Jentadueto until your doctor tells you to stop.
Croatian: Nastavite uzimati Jentadueto sve dok Vam liječnik ne odredi drugačije.
English: Ketoacidosis is a condition in which substances called ‘ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma.
Croatian: Ketoacidoza je stanje u kojem se tvari koje se nazivaju „ketonska tijela“ nakupljaju u krvi i mogu dovesti do dijabetičke predkome.
English: Because glibenclamide is primarily metabolised by CYP2C9, these data also support the conclusion that linagliptin is not a CYP2C9 inhibitor.
Croatian: S obzirom da se glibenklamid prvenstveno metabolizira putem CYP2C9, ovi podaci također idu u prilog zaključku da linagliptin nije inhibitor CYP2C9.
English: (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Croatian: (za dostupne podatke o različitim kombinacijama vidjeti dijelove 4.4, 4.5 i 5.1).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Jentadueto therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je donijeti odluku treba li prekinuti dojenje ili prekinuti primjenu Jentadueta, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Croatian: Liječnik Vam može propisati lijek za liječenje alergijske reakcije i drugi lijek za dijabetes.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Croatian: Nakon oralne doze, neapsorbirana frakcija nađena u fecesu iznosila je 20-30%.
English: If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid.
Croatian: Ako primijetite mjehuriće na koži, to može biti znak stanja pod imenom bulozni pemfigoid.
English: If you are overweight, continue your energy-restricted diet as instructed.
Croatian: Ako imate prekomjernu težinu, nastavite svoju dijetu s ograničenim energetskim unosom prema uputama.
English: Glimepiride (1-4mg)
Croatian: Glimepirid (1 - 4 mg)
English: Metformin must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Croatian: Primjena metformina mora se prekinuti u vrijeme kirurškog zahvata pod općom, spinalnom ili epiduralnom anestezijom.
English: In addition, linagliptin is not expected to be eliminated to a therapeutically significant degree by hemodialysis or peritoneal dialysis.
Croatian: Nadalje, ne očekuje se eliminacija linagliptina u terapijski značajnom stupnju putem hemodijalize ili peritonealne dijalize.
English: If any of the above apply to you, talk to your doctor for further instructions.
Croatian: Ako se nešto od navedenog odnosi na Vas, obratite se liječniku za daljnje upute.
English: With metformin there was no change in AUC, however mean peak serum concentration of metformin was decreased by 18% when administered with food.
Croatian: S metforminom nije bilo promjene u AUC, međutim srednja vršna koncentracija metformina u serumu smanjila se za 18% kada se uzimao s hranom.
English: • Severe renal failure (GFR <30 ml/min).
Croatian: • Teško zatajenje bubrega (GFR < 30 ml/min).
English: Both treatments were added to standard of care targeting regional standards for HbA1c and CV risk factors.
Croatian: Obje terapije bile su dodane standardnom liječenju usmjerenom na postizanje lokalno važećih standarda za HbA1c i kardiovaskularne faktore rizika.
English: If no adequate strength of Jentadueto is available, individual monocomponents should be used instead of the fixed dose combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Jentadueto, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
English: • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
Croatian: • Bilo koja vrsta akutne metaboličke acidoze (kao što je laktacidoza, dijabetička ketoacidoza).
English: A limited amount of data suggests that the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Croatian: Ograničeni podaci u trudnica ukazuju da upotreba metformina u trudnica nije povezana s povećanim rizikom od kongenitalnih malformacija.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 July 2012
Croatian: Datum prvog odobrenja: 20. srpnja 2012.
English: A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter.
Croatian: GFR treba procijeniti prije početka liječenja lijekovima koji sadrže metformin te najmanje jedanput godišnje nakon toga.
English: Elderly Caution should be exercised when treating patients 80 years and older (see section 4.2).
Croatian: Nužan je oprez u liječenju bolesnika u dobi od 80 i više godina (vidjeti dio 4.2).
English: • Hepatic impairment, acute alcohol intoxication, alcoholism (see section 4.5).
Croatian: • Oštećenje jetre, akutna alkoholna intoksikacija, alkoholizam (vidjeti dio 4.5).
English: In humans, independently of its action on glycaemia, metformin hydrochloride has favourable effects on lipid metabolism.
Croatian: U ljudi, neovisno o njegovom djelovanju na glikemiju, metforminklorid ima povoljne učinke na metabolizam lipida.
English: Adverse reactions previously reported with one of the individual active substances may be potential adverse reactions with Jentadueto, even if not observed in clinical trials with this medicinal product.
Croatian: Nuspojave koje su prethodno bile prijavljene uz primjenu pojedinačnih djelatnih tvari mogu biti potencijalne nuspojave lijeka Jentadueto, čak i ako nisu bile opažene u kliničkim ispitivanjima s ovim lijekom.
English: The amount of Jentadueto that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of linagliptin and metformin.
Croatian: Količina Jentadueta koju ćete uzeti varira ovisno o Vašem stanju i dozama metformina i/ili pojedinačnih tableta linagliptina i metformina, koje trenutno uzimate.
English: Combination requiring precautions for use
Croatian: Kombinacija čija primjena zahtijeva mjere opreza
English: As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance.
Croatian: S obzirom da se doza individualno titrira na temelju kontrole glikemije, ovo ima ograničen klinički značaj.
English: If needed, dose adjustment of metformin may be considered as OCT inhibitors/inducers may alter the efficacy of metformin.
Croatian: Ako je potrebno, može se razmotriti i prilagodba doze metformina jer inhibitori/induktori OCT-a mogu promijeniti djelotvornost metformina.
English: The incidence of hypoglycaemia in the linagliptin group (7.5%) was significantly lower than that in the glimepiride group (36.1%).
Croatian: Incidencija hipoglikemije u skupini na linagliptinu (7,5%) bila je značajno niža nego u skupini na glimepiridu (36,1%).
English: Talk to your doctor if you want to breast-feed while taking this medicine.
Croatian: Obratite se svom liječniku ako želite dojiti tijekom primjene ovog lijeka.
English: The only observed interaction between linagliptin and metformin was a reduction of body weight gain.
Croatian: Jedina opažena interakcija između linagliptina i metformina bila je smanjenje porasta tjelesne težine.
English: If acidosis of either form occurs, Jentadueto must be stopped immediately and other appropriate corrective measures initiated.
Croatian: Ako nastupi acidoza bilo kojeg oblika, liječenje Jentaduetom mora se smjesta prekinuti, te započeti druge odgovarajuće korektivne mjere.
English: Overweight patients should continue their energy-restricted diet.
Croatian: Bolesnici s prekomjernom tjelesnom težinom moraju nastaviti režim prehrane s ograničenim energetskim unosom.
English: If pancreatitis is suspected, Jentadueto should be discontinued; if acute pancreatitis is confirmed, Jentadueto should not be restarted.
Croatian: Ako se sumnja na pankreatitis, potrebno je prekinuti primjenu Jentadueta; a ukoliko se akutni pankreatitis potvrdi, Jentadueto se ne smije ponovo primijeniti.
English: In controlled clinical trials, maximum metformin hydrochloride plasma levels (Cmax) did not exceed 5 microgram/ml, even at maximum doses.
Croatian: U kontroliranim kliničkim ispitivanjima, maksimalne vrijednosti metforminklorida u plazmi (Cmax) nisu prelazile 5 mikrograma/ml, čak niti pri maksimalnim dozama.
English: Patients and/or care-givers should be informed of the risk of lactic acidosis.
Croatian: Bolesnici i/ili njegovatelji moraju biti informirani o riziku od laktacidoze.
English: GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels.
Croatian: GLP-1 i GIP povećavaju biosintezu inzulina i sekreciju iz pankreatičnih beta-stanica u prisustvu normalnih i povišenih razina glukoze u krvi.
English: A slow increase in dose of metformin hydrochloride may also improve gastrointestinal tolerability.
Croatian: Postupno povišenje doze metforminklorida također može poboljšati gastrointestinalnu podnošljivost.
English: At more than 100 times human exposure, irritation of the stomach was the major finding in these monkeys.
Croatian: Pri izloženosti većoj od 100 puta od one kod ljudi glavni nalaz bila je nadraženost želuca kod ovih majmuna.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Croatian: Vršna razina u krvi niža je od vršne razine u plazmi te se javlja približno u isto vrijeme.
English: These changes in linagliptin pharmacokinetics were not considered to be clinically relevant.
Croatian: Ove promjene u farmakokinetici linagliptina ne smatraju se klinički značajnima.
English: If you need to have major surgery you must stop taking Jentadueto during and for some time after the procedure.
Croatian: Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Jentadueto tijekom i još neko vrijeme nakon zahvata.
English: It is not an inducer of CYP isozymes.
Croatian: Nije induktor CYP izoenzima.
English: Number of patients n = 61 n = 134
Croatian: Broj bolesnika n = 61 n = 134
English: Due to the metformin component, Jentadueto may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly.
Croatian: Zbog sadržanog metformina, Jentadueto može uzrokovati vrlo rijetku, ali vrlo ozbiljnu komplikaciju koja se naziva laktacidoza, osobito ako Vam bubrezi ne rade ispravno.
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Jentadueto.
Croatian: Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Jentadueto.
English: C] linagliptin dose to healthy subjects, approximately 85% of the administered radioactivity was eliminated in faeces (80%) or urine (5%) within 4 days of dosing.
Croatian: C] linagliptina kod zdravih osoba oko 85% primijenjene radioaktivnosti bilo je eliminirano putem fecesa (80%) ili urina (5%) unutar 4 dana od doziranja.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku su dostupne na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: This medicine alone is unlikely to cause abnormally low blood sugar (hypoglycaemia).
Croatian: Ne smatra se da ovaj lijek sam uzrokuje neuobičajeno nizak šećer u krvi (hipoglikemija).
English: If the patient plans to become pregnant, or if pregnancy occurs, treatment with Jentadueto should be discontinued and switched to insulin treatment as soon as possible in order to lower the risk of foetal malformations associated with abnormal blood glucose levels.
Croatian: Ako bolesnica namjerava zatrudnjeti, ili ako dođe do trudnoće, liječenje Jentaduetom se mora prekinuti te se prebaciti na liječenje inzulinom čim je prije moguće u cilju smanjenja rizika od fetalnih malformacija povezanih s abnormalnim vrijednostima glukoze u krvi.
English: Diabetic skin problems are a common complication of diabetes.
Croatian: Problemi s kožom su česta komplikacija u dijabetesu.
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Croatian: Glukokortikoidi (primijenjeni sistemskim i lokalnim putevima), beta-2 agonisti i diuretici imaju intrinzičnu hiperglikemijsku aktivnost.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Croatian: Dugotrajno liječenje metforminom je povezano sa smanjenjem apsorpcije vitamina B12 koja vrlo rijetko može rezultirati klinički značajnim manjkom vitamina B12 (npr. megaloblastična anemija).
English: A significantly higher incidence of malignant lymphomas only in female mice at the highest dose (> 200 times human exposure) is not considered relevant for humans (explanation: nontreatment related but due to highly variable background incidence).
Croatian: Značajno veća incidencija malignih limfoma samo u ženki miševa, pri najvišim dozama (> 200 puta više od izloženosti kod ljudi), se ne smatra značajnom za ljude (objašnjenje: nije povezano s liječenjem već s visokovarijabilnom pozadinskom incidencijom).
English: The European Medicines Agency has waived the obligation to submit the results of the studies with Jentadueto in all subsets of the paediatric population in type 2 diabetes (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Jentadueto u svim podskupinama pedijatrijske populacije s dijabetesom tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Oral 2 year carcinogenicity studies in rats and mice revealed no evidence of carcinogenicity in rats or male mice.
Croatian: 2-godišnja ispitivanja kancerogenosti oralne doze u štakora i miševa nisu otkrila dokaze kancerogenosti u štakora i mužjaka miševa.
English: - Common (may affect up to 1 in 10 people): a metallic taste (taste disturbance).
Croatian: - Često (mogu se javiti u do 1 na 10 osoba): metalni okus (poremećaj okusa).
English: In patients with stable chronic heart failure, Jentadueto may be used with a regular monitoring of cardiac and renal function.
Croatian: U bolesnika sa stabilnim kroničnim zatajenjem srca, Jentadueto se može primjenjivati uz redoviti nadzor funkcije srca i bubrega.
English: Linagliptin binds selectively to DPP-4 and exhibits a > 10,000 fold selectivity versus DPP-8 or DPP-9 activity in vitro.
Croatian: Linagliptin se selektivno veže na DPP-4 i pokazuje > 10 000 puta veću selektivnost u odnosu na aktivnost DPP-8 ili DPP-9 in vitro.
English: For patients with acute and unstable heart failure, Jentadueto is contraindicated (see section 4.3).
Croatian: Za bolesnike s akutnim i nestabilnim zatajenjem srca, Jentadueto je kontraindiciran (vidjeti dio 4.3).
English: Immune system disorders Hypersensitivity (e.g. bronchial hyperreactivity)
Croatian: Poremećaji imunološkog sustava Preosjetljivost (npr. hiperreaktivnost bronha)
English: This medicine can be used alone or with certain other medicines for diabetes like sulphonylureas, empagliflozin, or insulin.
Croatian: Ovaj lijek se može primjenjivati sam ili s nekim drugim lijekovima za dijabetes poput sulfonilureje, empagliflozina ili inzulina.
English: Metabolism plays a subordinate role in the elimination of linagliptin.
Croatian: Metabolizam ima sporednu ulogu u eliminaciji linagliptina.
English: D-55216 Ingelheim am Rhein, Germany.
Croatian: D-55216 Ingelheim am Rhein, Njemačka.
English: Jentadueto has no or negligible influence on the ability to drive and use machines.
Croatian: Jentadueto ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku su dostupne na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), metformin should be temporarily discontinued and contact with a health care professional is recommended.
Croatian: U slučaju dehidracije (teški proljev ili povraćanje, vrućica ili smanjen unos tekućine), potrebno je privremeno prekinuti primjenu metformina i preporučuje se obratiti se zdravstvenom radniku.
English: Factors that may increase the risk of lactic acidosis (see 4.4) should be reviewed before considering initiation of metformin in patients with GFR<60 ml/min.
Croatian: Čimbenike koji mogu povećati rizik od laktacidoze (vidjeti dio 4.4) potrebno je provjeriti prije nego što se počne razmatrati uvođenje metformina u bolesnika s GFR<60 ml/min.
English: When starting or using such products in combination with metformin, close monitoring of renal function is necessary.
Croatian: Kad se takvi lijekovi uvode ili primjenjuju u kombinaciji s metforminom, potrebno je pažljivo praćenje funkcije bubrega.
English: The study was designed to demonstrate non-inferiority for the primary cardiovascular endpoint which was a composite of the first occurrence of cardiovascular death or a non-fatal myocardial infarction (MI) or a non-fatal stroke (3P-MACE).
Croatian: Ispitivanje je bilo ustrojeno tako da dokaže neinferiornost za primarnu kardiovaskularnu mjeru ishoda, koja je bila kompozitna mjera sastavljena od prve pojave kardiovaskularne smrti ili infarkta miokarda (MI) bez smrtnog ishoda ili moždanog udara bez smrtnog ishoda (3P-MACE).
English: • Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib,
Croatian: • inhibitorima OCT2 (kao što su cimetidin, dolutegravir, ranolazin, trimetoprim, vandetanib,