natgillin/translations-raw huggingface dataset:
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.
U slučaju predoziranja, razumno je primijeniti uobičajene suportivne mjere, npr. uklanjanje neapsorbiranog lijeka iz gastrointestinalnog trakta, uz kliničko praćenje te primjenu kliničkih mjera prema potrebi.
Oral 2 year carcinogenicity studies in rats and mice revealed no evidence of carcinogenicity in rats or male mice.
2-godišnja ispitivanja kancerogenosti oralne doze na štakorima i miševima nisu otkrila dokaze kancerogenosti u štakora ili mužjaka miševa.
Oral anti-diabetics are used to treat high blood sugar levels.
Oralni antidijabetici se primjenjuju u liječenju visoke razine šećera u krvi.
If you stop taking Trajenta
Ako prestanete uzimati Trajentu
At more than 100 times human exposure, irritation of the stomach was the major finding in these monkeys.
Pri izloženosti većoj od 100 puta od one kod ljudi, glavni nalaz bila je nadraženost želuca kod ovih majmuna.
There was a further follow up 40 week treatment period during which dose adjustments in antidiabetes background therapies were allowed.
Uslijedilo je daljnje 40-tjedno liječenje s praćenjem, tijekom kojeg je bilo dozvoljeno prilagođavanje doze osnovnih terapija antidijabeticima.
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.
C] linagliptina kod zdravih osoba, oko 85% primijenjene radioaktivnosti bilo je eliminirano putem fecesa (80%) ili urina (5%) unutar 4 dana od doziranja.
Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH05
Farmakoterapijska skupina: Lijekovi koji se primjenjuju u dijabetesu, inhibitori dipeptidil peptidaze 4 (DPP-4), ATK oznaka: A10BH05
• Common: level of lipase in the blood increased.
• Često: povišena razina enzima lipaze u krvi.
During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were generally well tolerated.
Tijekom kontroliranih kliničkih ispitivanja na zdravim osobama, jednostruke doze do 600 mg linagliptina (što odgovara 120 puta višim dozama od preporučenih) bile su općenito dobro podnošene.
Linagliptin once daily produced clinically significant improvements in glycaemic control, with no clinically relevant change in body weight.
Linagliptin jedanput dnevno doveo je do klinički značajnih poboljšanja kontrole glikemije, bez klinički relevantne promjene tjelesne težine.
Thus, full efficacy of linagliptin in combination with strong P-gp inducers might not be achieved, particularly if these are administered long-term.
Stoga se ne mora nužno postići potpuna djelotvornost linagliptina u kombinaciji sa snažnim P-gp induktorima, osobito pri njihovoj dugotrajnoj primjeni.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOG II. A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (PERFORATED)
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI (PERFORIRANI)
The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
It is not known if Trajenta passes into human breast milk.
Nije poznato prelazi li Trajenta u majčino mlijeko.
The European Medicines Agency has deferred the obligation to submit the results of studies with linagliptin in one or more subsets of the paediatric population in Type 2 diabetes (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja linagliptina u jednoj ili više podskupina pedijatrijske populacije s dijabetesom tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Viša početna vrijednost HbA1c bila je povezana s većim smanjenjem u HbA1c.
When linagliptin is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly.
Kada se linagliptin dodaje uz metformin, doza metformina se mora održavati, a linagliptin primjenjivati istodobno.
Some symptoms need immediate medical attention You should stop taking Trajenta and see your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or confusion (hypoglycaemia).
Potrebno je prekinuti uzimanje Trajente i odmah se javiti liječniku ako imate sljedeće simptome niske razine šećera u krvi: drhtanje, znojenje, tjeskoba, zamagljen vid, trnci usana, bljedilo, promjena raspoloženja ili smetenost (hipoglikemija).
A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Trajenta therapy.
Vaš liječnik mora odlučiti treba li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja Trajentom.
In addition the pharmacokinetic characteristics of linagliptin were found to be similar in dedicated phase I studies in Japanese, Chinese and Caucasian healthy volunteers.
Nadalje, pronađena je sličnost farmakokinetičkih svojstava linagliptina u ciljanim ispitivanjima faze I na japanskim, kineskim i bjelačkim zdravim dobrovoljcima.
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „EXP“.
Do not use Trajenta if the package is damaged or shows signs of tampering.
Ovaj lijek se ne smije upotrijebiti ako primjetite da je pakiranje oštećeno ili su vidljivi znakovi otvaranja.
The dose of linagliptin is 5 mg once daily.
Doza linagliptina je 5 mg jedanput dnevno.
After a median follow up of 6.25 years, linagliptin did not increase the risk of major adverse cardiovascular events (see table 3) as compared to glimepiride.
Nakon medijana praćenja od 6,25 godina, linagliptin nije povećao rizik od velikih štetnih kardiovaskularnih događaja (vidjeti tablicu 3) u usporedbi s glimepiridom.
The unbound concentrations, which are usually less than 1% at the therapeutic dose of linagliptin, were increased 4-5-fold after coadministration with ritonavir.
Nevezane koncentracije, koje su obično niže od 1% pri terapijskoj dozi linagliptina, povećale su se 4-5 puta nakon istodobne primjene s ritonavirom.
Your doctor may prescribe Trajenta together with another oral anti-diabetic medicine.
Liječnik Vam može propisati Trajentu u kombinaciji s drugim oralnim antidijabetikom.
If you forget to take Trajenta
Ako ste zaboravili uzeti Trajentu
8 phase III randomised controlled trials involving 5,239 patients with type 2 diabetes, of which 3,319 were treated with linagliptin were conducted to evaluate efficacy and safety.
8 randomiziranih kontroliranih ispitivanja faze 3, koja su uključivala 5 239 bolesnika s dijabetesom tipa 2, od kojih je 3 319 liječeno linagliptinom, provedeno je kako bi se ocijenila djelotvornost i sigurnost.
After a median follow up of 2.2 years, linagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or renal outcome events.
Nakon medijana praćenja od 2,2 godine, linagliptin, kada je bio dodan uobičajenom liječenju, nije povećao rizik od velikih štetnih kardiovaskularnih događaja ili događaja bubrežnog ishoda.
• Rare: blistering of skin (bullous pemphigoid).
• Rijetko: stvaranje mjehura na koži (bulozni pemfigoid).
If you experience any of the signs of illness mentioned above, stop taking Trajenta and call your doctor right away.
Ako imate neki od prethodno spomenutih znakova bolesti, prekinite s primjenom Trajente te se odmah obratite liječniku.
Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is an identified side effect when Trajenta is taken together with metformin and a sulphonylurea.
Hipoglikemija (učestalost; vrlo često, može se javiti kod više od 1 na 10 osoba) je prepoznata kao nuspojava kada se Trajenta uzima uz metformin i uz sulfonilureju.
Diabetic skin lesions are a common complication of diabetes.
Dijabetička oštećenja kože su česta komplikacija u dijabetesu.
The most frequently reported adverse reaction was “hypoglycaemia” observed under the triple combination, linagliptin plus metformin plus sulphonylurea 14.8% versus 7.6% in placebo.
Najčešće prijavljena nuspojava bila je „hipoglikemija”, primijećena u trojnoj kombinaciji, linagliptin plus metformin plus sulfonilureja, 14,8% u odnosu na 7,6% uz placebo.
Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase 4, EC 3.4.14.5) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide1, glucose-dependent insulinotropic polypeptide).
Linagliptin je inhibitor enzima DPP-4 (dipeptidil peptidaza 4, EC 3.4.14.5), enzima koji je uključen u inaktivaciju inkretinskih hormona GLP-1 i GIP (peptid-1 sličan glukagonu, inzulinotropični polipeptid koji je ovisan o glukozi).
Trajenta is used for ‘type 2 diabetes' in adults, if the disease cannot be adequately controlled with one oral anti-diabetic medicine (metformin or sulphonylureas) or diet and exercise alone.
Trajenta se primjenjuje za liječenje dijabetesa tipa 2 kod odraslih osoba, ako se bolest ne može odgovarajuće kontrolirati jednim oralnim antidijabetikom (metformin ili sulfonilureja), ili samo prehranom i fizičkom aktivnošću.
At high concentrations, where DPP-4 is fully saturated, 70-80% of linagliptin was bound to other plasma proteins than DPP-4, hence 30-20% were unbound in plasma.
Pri visokim koncentracijama, gdje je DPP-4 potpuno zasićen, 70-80% linagliptina se veže na druge proteine plazme osim DPP-4, stoga je 30-20% ostalo nevezano u plazmi.
• are taking an anti-diabetic medicine known as a ‘sulphonylurea'(e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with Trajenta in order to avoid your blood sugar going too low.
• uzimate antidijabetik poznat kao ‘sulfonilureja' (npr. glimepirid, glipizid), liječnik će Vam možda sniziti dozu sulfonilureje, ako ju uzimate u kombinaciji s Trajentom kako bi se izbjeglo da se Vaša razina šećera u krvi previše snizi;
The placebo-controlled studies included studies where linagliptin was given as
Placebom kontrolirana ispitivanja uključivala su ispitivanja u kojima je linagliptin primjenjivan u obliku
Taking Trajenta in combination with medicines called sulphonylureas and/or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines or work without safe foothold.
Uzimanje Trajente u kombinaciji s lijekovima koji se nazivaju sulfonilureje i/ili inzulina može dovesti do pretjerano niskih vrijednosti šećera u krvi (hipoglikemija), što može utjecati na sposobnost upravljanja vozilima i rada sa strojevima bez čvrstog uporišta.
• Uncommon: inflamed nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), level of amylase in the blood increased.
• Manje često: upala nosa ili grla (nazofaringitis), kašalj, zatvor (u kombinaciji s primjenom inzulina), povišena razina enzima amilaze u krvi.
Do not stop taking Trajenta without first consulting your doctor.
Trajente bez prethodne konzultacije s liječnikom.
Linagliptin has no or negligible influence on the ability to drive and use machines.
Linagliptin ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
No studies on the effect on human fertility have been conducted for linagliptin.
Nisu provedena ispitivanja učinka linagliptina na ljudsku plodnost.
Simulations of steady-state plasma concentrations of linagliptin with and without ritonavir indicated that the increase in exposure will be not associated with an increased accumulation.
Simulacije koncentracija linagliptina u plazmi u stanju dinamičke ravnoteže, sa ili bez ritonavira, ukazale su da povećanje u izloženosti nije povezano s povećanom akumulacijom.
One main metabolite with a relative exposure of 13.3% of linagliptin at steady-state was detected which was found to be pharmacologically inactive and thus does not contribute to the plasma DPP-4 inhibitory activity of linagliptin.
Pronađen je jedan glavni metabolit s relativnom izloženosti od 13,3% linagliptina u stanju dinamičke ravnoteže, za koji je otkriveno da je farmakološki neaktivan te stoga ne pridonosi DPP-4-inhibicijskoj aktivnosti linagliptina u plazmi.
C] linagliptin oral 10 mg dose, approximately 5% of the radioactivity was excreted in urine.
C] linagliptina od 10 mg, oko 5% radioaktivnosti izlučuje se putem urina.
A paediatric Phase 2 study examined the pharmacokinetics and pharmacodynamics of 1 mg and 5 mg linagliptin in children and adolescents ≥10 to <18 years of age with type 2 diabetes mellitus.
U pedijatrijskom ispitivanju faze 2 istražila se farmakokinetika i farmakodinamika 1 mg i 5 mg linagliptina u djece i adolescenata u dobi od ≥10 do <18 godina sa šećernom bolešću tipa
It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.
Važno je slijediti preporuke o prehrani i fizičkoj aktivnosti koje Vam je dao liječnik ili medicinska sestra.
Most patients (80.5%) received insulin as background therapy, alone or in combination with other oral anti-diabetics such as sulphonylurea, glinide and pioglitazone.
Većina bolesnika (80,5%) primala je inzulin kao osnovnu terapiju, u obliku monoterapije ili u kombinaciji s oralnim antidijabeticima, kao što su sulfonilureja, glinid i pioglitazon.
Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Linagliptin se ne smije primjenjivati kod bolesnika s dijabetesom tipa 1 ili u liječenju dijabetičke ketoacidoze.
Film coating: Hypromellose, titanium dioxide (E171), talc, macrogol (6000), iron oxide red (E172)
Ovojnica tablete: hipromeloza, titanijev dioksid (E171), talk, makrogol (6000), crveni željezov oksid (E172)
In moderate renal impairment, a moderate increase in exposure of about 1.7 fold was observed compared with control.
U umjerenom oštećenju bubrega, primijećeno je umjereno povećanje u izloženosti od oko 1,7 puta u usporedbi s kontrolnom skupinom.
Plasma concentrations of linagliptin decline in a triphasic manner with a long terminal half-life (terminal half-life for linagliptin more than 100 hours), that is mostly related to the saturable, tight binding of linagliptin to DPP-4 and does not contribute to the accumulation of the medicinal product.
Koncentracije linagliptina u plazmi padaju na trifazičan način, s dugačkim terminalnim poluživotom (terminalni poluživot linagliptina više od 100 sati), što je uglavnom povezano sa saturabilnim, čvrstim vezanjem linagliptina na DPP-4 te ne pridonosi akumulaciji lijeka.
The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo (22.2% linagliptin; 21.2% placebo).
Primijećena incidencija hipoglikemije kod bolesnika liječenih linagliptinom bila je slična placebu (22,2% linagliptin; 21,2% placebo).
Due to the concentration dependent binding of linagliptin to DPP-4, the pharmacokinetics of linagliptin based on total exposure is not linear; indeed total plasma AUC of linagliptin increased in a less than dose-proportional manner while unbound AUC increases in a roughly dose-proportional manner.
Zbog vezanja linagliptina na DPP-4 ovisno o koncentraciji, farmakokinetika linagliptina koja se bazira na ukupnoj izloženosti nije linearna; uistinu, ukupni AUC linagliptina u plazmi se povećao na način manje nego proporcionalno s dozom, dok se nevezani AUC ugrubo povećao proporcionalno s dozom.
In clinical studies, as described below, linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives providing in vivo evidence of a low propensity for causing medicinal product interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-glycoprotein, and organic cationic transporter (OCT).
U kliničkim ispitivanjima, kako je opisano u nastavku, linagliptin nije imao klinički značajan učinak na farmakokinetiku metformina, gliburida, simvastatina, varfarina, digoksina, ili oralnih kontraceptiva, pružajući in vivo dokaz niskog potencijala za izazivanje interakcija među lijekovima sa supstratima CYP3A4, CYP2C9, CYP2C8, P-glikoproteina i organskih kationskih prijenosnika (OCT).
Following administration of a supratherapeutic dose of 10 mg linagliptin concomitantly with 40 mg of simvastatin daily for 6 days, the plasma AUC of simvastatin was increased by 34%, and the plasma Cmax by 10%.
Nakon primjene supraterapijske doze 10 mg linagliptina istodobno s 40 mg simvastatina dnevno u trajanju od 6 dana, AUC simvastatina u plazmi povećan je za 34%, a Cmax u plazmi za 10%.
Warfarin: multiple daily doses of 5 mg linagliptin did not alter the pharmacokinetics of S(-) or R(+) warfarin, a CYP2C9 substrate, administered in a single dose.
Varfarin: Višekratne dnevne doze 5 mg linagliptina nisu promijenile farmakokinetiku S(-) ili R(+) varfarina, supstrata CYP2C9, primjenjivanog u jednokratnoj dozi.
Some patients have had the following side effects while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes:
Neki bolesnici su tijekom uzimanja lijeka Trajenta, samog ili u kombinaciji s drugim lijekovima za liječenje dijabetesa, imali sljedeće nuspojave:
Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.
Farmakokinetička ispitivanja ne ukazuju na potrebu prilagođavanja doze za bolesnike s oštećenjem jetre, ali niti nema kliničkog iskustva za te bolesnike.
There was no increased risk in hospitalization for heart failure which was an additional adjudicated endpoint observed compared to usual care without linagliptin in patients with type 2 diabetes (see table 2).
Nije bilo povećanog rizika od hospitalizacije zbog zatajenja srca, što je bila dodatno procijenjena mjera ishoda promatrana u odnosu na uobičajeno liječenje bez linagliptina u bolesnika s dijabetesom tipa 2 (vidjeti tablicu 2).
The intra-subject and inter-subject coefficients of variation for linagliptin AUC were small (12.6% and 28.5%, respectively).
Koeficijenti varijacije kod istog ispitanika i između ispitanika za AUC linagliptina bili su niski (12,6%, odnosno 28,5%).
Therefore, clinically relevant interactions would not be expected with other Pglycoprotein/CYP3A4 inhibitors.
Stoga se ne očekuju klinički značajne interakcije s drugim inhibitorima P-glikoproteina/CYP3A4.
Tablet core: Mannitol, pregelatinised starch (maize), maize starch, copovidone, magnesium stearate
Jezgra tablete: manitol, prethodno gelirani škrob (kukuruzni), kukuruzni škrob, kopovidon, magnezijev stearat
Patients received metformin and/or sulphonylurea and/or insulin as background therapy.
Bolesnici su primali metformin, i/ili sulfonilureju, i/ili inzulin kao osnovnu terapiju.
In addition patients with T2DM and severe renal impairment (<30 ml/min) were compared to T2DM patients with normal renal function.
Nadalje, bolesnici s T2DM-om i teškim oštećenjem bubrega (< 30 ml/min) uspoređivani su s T2DM-bolesnicima s normalnom bubrežnom funkcijom.
Based on these results and in vivo interaction studies, linagliptin is considered unlikely to cause interactions with other P-gp substrates.
Na osnovi ovih rezultata kao i in vivo ispitivanja interakcija, ne smatra se da linagliptin izaziva interakcije s drugim
Pancreatitis was reported more often in patients randomized to linagliptin (7 events in 6,580 patients receiving linagliptin versus 2 events in 4,383 patients receiving placebo).
Pankreatitis je prijavljen češće u bolesnika randomiziranih za linagliptin (7 slučajeva na 6580 bolesnika na linagliptinu u odnosu na 2 slučaja na 4383 bolesnika na placebu).
Plasma protein binding of linagliptin is concentration-dependent, decreasing from about 99% at 1 nmol/l to 75-89% at ≥30 nmol/l, reflecting saturation of binding to DPP-4 with increasing concentration of linagliptin.
Vezanje linagliptina na proteine plazme ovisi o koncentraciji, smanjujući se za oko 99% pri 1 nmol/l na 75-89% pri ≥ 30 nmol/l, što odražava saturaciju vezanja na DPP-4, s porastom koncentracije linagliptina.
Table 2 Cardiovascular and renal outcomes by treatment group in the CARMELINA study
Tablica 2 Kardiovaskularni i bubrežni ishodi prema terapijskim skupinama u ispitivanju CARMELINA
Plasma AUC of linagliptin increased approximately 33% following 5 mg doses at steady-state compared to the first dose.
AUC linagliptina u plazmi se povećava oko 33% nakon doza od 5 mg u stanju dinamičke ravnoteže, u usporedbi s prvom dozom.
Co-administration of a high-fat meal with linagliptin prolonged the time to reach Cmax by 2 hours and lowered Cmax by 15% but no influence on AUC 0-72h was observed.
Istovremena primjena visokomasnog obroka s linagliptinom je produljila vrijeme do postizanja Cmax za 2 sata i smanjila Cmax za 15%, ali nije primijećen učinak na AUC0-72h.
There were also 1,238 patients with mild renal impairment, and 143 patients with moderate renal impairment on linagliptin.
Također je na linagliptinu bilo 1 238 bolesnika s blagim oštećenjem bubrega i 143 bolesnika s umjerenim oštećenjem bubrega.
When linagliptin was added to a sulphonylurea (on a background of metformin), the incidence of hypoglycaemia was increased over that of placebo (see section 4.8).
Kada je linagliptin dodavan uz sulfonilureju (na osnovno liječenje metforminom), incidencija hipoglikemije povećala se iznad incidencije uz placebo (vidjeti dio 4.8).
How to take Trajenta
Kako uzimati Trajentu
Co-administration with other potent inducers of P-glycoprotein and CYP3A4, such as carbamazepine, phenobarbital and phenytoin has not been studied.
Istodobna primjena s drugim snažnim induktorima P-glikoproteina i CYP3A4, kao što su karbamazepin, fenobarbital i fenitoin, nije ispitivana.
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to <80 ml/min), moderate (30 to <50 ml/min), and severe (<30 ml/min), as well as patients with ESRD on hemodialysis.
Ispitivanje je uključivalo bolesnike s insuficijencijom bubrega, klasificiranom na osnovi klirensa kreatinina kao: blaga (50 do < 80 ml/min), umjerena (30 do < 50 ml/min) i teška (< 30 ml/min), kao i bolesnika s bolešću bubrega u završnoj fazi na hemodijalizi.
Due to the impact of the background therapy on adverse reactions (e.g. on hypoglycaemias), adverse reactions were analysed based on the respective treatment regimens (monotherapy, add-on to metformin, add-on to meformin plus sulphonylurea, and add-on to insulin).
Zbog utjecaja osnovne terapije na nuspojave (npr. na hipoglikemije), nuspojave su analizirane na osnovi relevantnih režima liječenja (monoterapija, dodatak uz metformin, dodatak uz metformin plus sulfonilureja i dodatak uz inzulin).
Table 3 Major adverse cardiovascular events (MACE) and mortality by treatment group in the
Tablica 3 Veliki štetni kardiovaskularni događaji (engl. major adverse cardiovascular events, MACE) i mortalitet po liječenoj skupini u ispitivanju CAROLINA