FrancophonIA/ELRC3.0 huggingface dataset:
English: As the maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use), the MAHs should provide a detailed plan including precise short timelines on the adaptation of the lower pack size (25g) and the withdrawal of the 35g and 50g pack sizes, in all EU member states where they are currently authorised.
Croatian: Maksimalno trajanje kure liječenja s lijekovima koji sadrže 0,01% w/w estradiola za topikalnu primjenu ograničeno je na 4 tjedna (bez ponovljene primjene), nositelji odobrenja trebaju dostaviti detaljan plan koji uključuje precizne kratke vremenske skale vezane uz adaptaciju pakiranja manje jačine (25g) kako bi se dodao aplikator u pakiranje i povlačenje pakiranja od 35g i 50g u svim državama članicama EU-a u kojima su isti trenutno odobreni.
English: 250 mg Capsule, hard
Croatian: 250 mg Kapsula, tvrda Primjena kroz usta
English: Oral use blister (PVC/alu)
Croatian: Blister (PVC/aluminij) 100 kapsula
English: • about what you can do to prevent dehydration
Croatian: ● vezano uz to što možete poduzeti radi sprječavanja dehidracije
English: • Swallow the tablet whole with at least a half glass of water.
Croatian: Progutajte tabletu cijelu s najmanje pola čaše vode.
English: • if you have a severe infection
Croatian: ● ako imate tešku infekciju
English: • if you drink alcohol to excess (either every day or from time to time)
Croatian: ● ako prekomjerno pijete alkohol (bilo svaki dan ili povremeno)
English: • If you forget to take a dose, take it as soon as you remember.
Croatian: Ako ste zaboravili uzeti dozu, uzmite ju čim se sjetite.
English: • Do not take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: • medicines that contain alcohol.
Croatian: ● lijekove koji sadrže alkohol.
English: UGT2B4*2/*2 carriers.
Croatian: UGT2B4*2/*2 nositelja.
English: • if you have type 1 diabetes (your body does not produce any insulin).
Croatian: ● ako imate šećernu bolest tipa 1 (Vaše tijelo uopće ne stvara inzulin).
English: • if you have or have recently had heart failure.
Croatian: ● ako imate ili ste nedavno imali zatajenje srca.
English: You may need to stop taking Vokanamet for a couple of days before and after the operation.
Croatian: Možda ćete morati prestati uzimati Vokanamet nekoliko dana prije i nakon operativnog zahvata.
English: If you take more Vokanamet than you should If you take more of this medicine than you should, talk to a doctor straight away.
Croatian: Ako uzmete više lijeka Vokanamet nego što je potrebno Ako uzmete više ovog lijeka nego što je potrebno, odmah se obratite liječniku.
English: This happens more often in people with kidney problems.
Croatian: Ovo se češće događa u ljudi koji imaju bubrežne probleme.
English: • It is best to take your tablet with a meal.
Croatian: Najbolje je tabletu uzeti uz obrok.
English: • common: a metallic taste (taste disturbance)
Croatian: ● često: metalni okus (poremećaj okusa)
English: Possible signs of losing too much fluid from your body are listed under “Dehydration” in section 4.
Croatian: Mogući znakovi prevelikog gubitka tjelesne tekućine navedene su u odjeljku “Dehidracija” u dijelu 4.
English: • The dose of Vokanamet is one tablet twice a day.
Croatian: Početna doza lijeka Vokanamet je jedna tableta dva puta na dan.
English: • severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing).
Croatian: ● teška alergijska reakcija (može uključivati oticanje lica, usnica, usta, jezika ili grla što može dovesti do otežanog disanja ili gutanja).
English: ● at least two to four times a year in patients with eGFR (creatinine clearance) at the lower limit of normal and in elderly patients.
Croatian: ● najmanje dva do četiri puta godišnje u bolesnika s eGFR (klirens kreatinina) na donjim granicama normale i u starijih bolesnika.
English: In controlled clinical trials, Cmax did not exceed 5 μg/mL, even at maximum doses.
Croatian: U kontroliranim kliničkim ispitivanjima, Cmax nisu prešle 5 μg/mL, čak i pri maksimalnim dozama.
English: • kidney failure (mainly as a consequence of loss of too much fluid from your body).
Croatian: ● zatajenje bubrega (većinom kao posljedica prevelikog gubitka tekućine iz Vašeg tijela).
English: • Try to take it at the same times each day.
Croatian: Nastojte tablete uzeti svaki dan u isto vrijeme.
English: • if you are on medicines to lower your blood pressure (anti-hypertensives) or have ever had low blood pressure (hypotension).
Croatian: ● ako uzimate lijekove za snižavanje krvnog tlaka (antihipertenzivni lijekovi) ili ste ikada imali nizak krvni tlak (hipotenziju).
English: * Related to volume depletion; see section 4.4.
Croatian: * Povezano s deplecijom volumena; vidjeti dio 4.4.
English: CrCl < 60 mL/min), (see sections 4.2 and 4.4);
Croatian: CrCl < 60 mL/min), (vidjeti dijelove 4.2 i 4.4);
English: • if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row
Croatian: ● ako ste izgubili puno vode iz tijela (dehidracija), npr. radi dugotrajnog ili teškog proljeva ili ako ste povraćali uzastopno nekoliko puta
English: • digoxin or digitoxin (medicines used for certain heart problems).
Croatian: ● digoksin ili digitoksin (lijekovi koji se uzimaju za određene probleme sa srcem).
English: You will need to stop taking Vokanamet before, or at the time of the X-ray and for 2 or more days after.
Croatian: Morati ćete prestati uzimati Vokanamet prije ili za vrijeme rendgenskog snimanja, te 2 ili više dana nakon toga.
English: Before taking Vokanamet again, your kidney function should be tested.
Croatian: Prije nego što ponovno uzmete Vokanamet, mora Vam se provjeriti funkcija bubrega.
English: • If your doctor has prescribed this medicine along with any medicine for lowering cholesterol such as cholestyramine you should take this medicine at least 1 hour before or 4 hours to
Croatian: ● Ako Vam je liječnik propisao ovaj lijek zajedno s bilo kojim od lijekova za snižavanje kolesterola, poput kolestiramina, ovaj lijek morate uzeti najmanje 1 sat prije ili 4 sata do 6 sati nakon lijeka za snižavanje kolesterola.
English: This is more likely if you are already fasting, have malnutrition, or liver problems.
Croatian: Ovo će se vjerojatnije dogoditi ako već gladujete, ako ste pothranjeni ili imate probleme s jetrom.
English: In both cases, treatment with Vokanamet may be restarted once the patient's condition has stabilised.
Croatian: U oba slučaja, liječenje kanagliflozinom može se ponovno započeti nakon što se bolesnikovo stanje stabiliziralo.
English: • too much lactic acid in your blood (lactic acidosis).
Croatian: ● previše mliječne kiseline u krvi (laktacidoza).
English: • The strength of Vokanamet that you will take varies depending on your condition and the amount of canagliflozin and metformin needed to control your blood sugar.
Croatian: Jačina lijeka Vokanamet koju uzimate varira ovisno o Vašem stanju i količini kanagliflozina i metformina, potrebnoj za kontrolu šećera u Vašoj krvi.
English: Your kidneys will be tested by a blood test before you start taking and while you are taking this medicine.
Croatian: Funkcija Vaših bubrega će se provjeravati krvnim pretragama prije početka uzimanja i dok uzimate ovaj lijek.
English: Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation.
Croatian: Laktacidoza je rijetka, ali ozbiljna (visok mortalitet u slučaju izostanka hitnog liječenja) metabolička komplikacija koja se može javiti uslijed nakupljanja metformina.
English: • rifampicin (an antibiotic used to treat tuberculosis)
Croatian: ● rifampicin (antibiotik koji se uzima za liječenje tuberkuloze)
English: Physicians should alert the patients on the risk and on the symptoms of lactic acidosis.
Croatian: Liječnici moraju bolesnike upozoriti na rizike i simptome laktacidoze.
English: Moderate increases (generally < 400 mL to 500 mL) in daily urine volume were seen that attenuated over several days of dosing.
Croatian: Uočeno je da su umjerena povišenja (uglavnom < 400 mL do 500 mL) u dnevnom volumenu mokraće smanjena kroz nekoliko dana doziranja.
English: • blood tests may show increases in your blood phosphate level
Croatian: ● krvne pretrage mogu pokazati povišenje razine fosfata u Vašoj krvi
English: • Your doctor will prescribe the strength that is right for you.
Croatian: ● Liječnik će propisati odgovarajuću jačinu lijeka primjerenog Vama.
English: ● at least annually in patients with normal renal function
Croatian: ● najmanje jedanput godišnje u bolesnika s normalnom funkcijom bubrega
English: If a dose is missed, it should be taken as soon as the patient remembers unless it is nearly time for the next dose in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time.
Croatian: U slučaju propuštanja doze, bolesnik ju treba uzeti čim primijeti da je propuštena, osim ako je blizu vrijeme za uzimanje slijedeće doze, tada bolesnik mora preskočiti propuštenu dozu i uzeti lijek kada je vrijeme za slijedeću redovnu dozu.
English: • an operation under general, spinal, or peridural anaesthetic.
Croatian: ● operativnom zahvatu pod općim, spinalnim ili periduralnim anestetikom.
English: Frequency categories are defined according to the following convention: 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: manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • iodinated contrast agents (medicines used during an X-ray).
Croatian: ● jodna kontrastna sredstva (lijekovi koji se koriste tijekom rendgenskog snimanja).
English: As Vokanamet contains metformin, therapy must be discontinued 48 hours before elective surgery with general, spinal, or peridural anaesthesia.
Croatian: Budući da Vokanamet sadrži metformin, liječenje se mora prekinuti 48 sati prije elektivnog operativnog zahvata pod općom, spinalnom ili periduralnom anestezijom.
English: ** See section 4.4.
Croatian: Vidjeti dio 4.4.
English: • blood tests may show changes related to kidney function (increased creatinine or urea) or increased potassium
Croatian: ● krvne pretrage mogu pokazati promjene povezane s bubrežnom funkcijom (povišen kreatinin ili urea) ili povišen kalij
English: If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient should be hospitalised immediately (see section 4.9).
Croatian: U slučaju sumnje na metaboličku acidozu, liječenje lijekom mora se prekinuti, te se bolesnik mora odmah hospitalizirati (vidjeti dio 4.9).
English: • blood tests may show changes in blood fat (cholesterol) levels and increases in the amount of red blood cells in your blood (haematocrit).
Croatian: ● krvne pretrage mogu pokazati promjene u razini masnoća u krvi (kolesterol) i povišenje količine crvenih krvnih stanica u krvi (hematokrit).
English: Single dose study: After single doses of metformin hydrochloride 500 mg, paediatric patients have shown a similar pharmacokinetic profile to that observed in healthy adults.
Croatian: Ispitivanje jedne doze: Nakon jedne doze metforminklorida od 500 mg, pedijatrijski bolesnici pokazali su sličan farmakokinetički profil, u odnosu na onaj koji je uočen u zdravih odraslih osoba.
English: • At the request of the European Medicines Agency;
Croatian: Nadalje, nadopunjeni RMP treba dostaviti: ● Na zahtjev Europske agencije za lijekove;
English: These are two medicines that work together in different ways to lower blood glucose (sugar) levels in adults with type 2 diabetes.
Croatian: Ta dva lijeka, na različite načine, zajednički djeluju na snižavanje glukoze (šećera) u krvi u odraslih s dijabetesom tipa
English: • cimetidine (medicine used to treat stomach problems)
Croatian: ● cimetidin (lijek za liječenje problema sa želucem)
English: • cholestyramine (medicine used to reduce cholesterol levels in the blood).
Croatian: ● kolestiramin (lijek koji se uzima za snižavanje razine kolesterola u krvi).
English: • an X-ray where you will be injected with a dye.
Croatian: ● rendgensko snimanje, pri čemu će Vam se primijeniti kontrast putem injekcije.
English: • if you have a diabetic pre-coma
Croatian: ● ako ste u dijabetičkoj predkomi
English: • if you are allergic to canagliflozin, metformin or any of the other ingredients of this medicine
Croatian: ● ako ste alergični na kanagliflozin, metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: This can be followed by acidotic dyspnea, abdominal pain, hypothermia and coma.
Croatian: Nakon toga mogu uslijediti acidozna dispneja, bol u abdomenu, hipotermija i koma.
English: • if you have kidney or liver problems
Croatian: ● ako imate problema s bubrezima ili jetrom
English: At the recommended metformin doses and dosing schedules, steady-state plasma concentrations are reached within 24-48 hours and are generally less than 1 μg/mL.
Croatian: Pri preporučenim dozama metformina i rasporedu doziranja, koncentracije u stanju dinamičke ravnoteže dostižu se unutar 24-48 sati te su općenito niže od 1 μg/mL.
English: See section “Operations and X-rays”.
Croatian: “Operativni zahvati i rendgensko snimanje”.
English: Lactic acidosis (very rare, may affect up to 1 in 10,000 people)
Croatian: Laktacidoza (vrlo rijetko, može se javiti u do 1 na 10 000 osoba)
English: • loss of too much fluid from your body (dehydration).
Croatian: ● gubitak prevelike količine tjelesne tekućine (dehidracija).
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin hydrochloride is eliminated by glomerular filtration and tubular secretion.
Croatian: Bubrežni klirens metformina je > 400 mL/min i ukazuje na to da se metforminklorid eliminira glomerularnom filtracijom i tubularnom sekrecijom.
English: • if you have ever had serious heart disease or if you have had a stroke
Croatian: ● ako ste ikada imali ozbiljnu bolest srca ili ako ste ikada imali moždani udar
English: • dabigatran (blood thinner medicine that lowers the risk of blood clot formation)
Croatian: ● dabigatran (lijek za razrjeđivanje krvi koji smanjuje rizik za formiranje krvnog ugruška)
English: Blood creatinine increased**, k, Blood urea increased**, l, Blood potassium increased**, m, Blood phosphate increasedn
Croatian: Povišen kreatinin u krvi**, k, povišena urea u krvi**, l, povišen kalij u krvi**, m, povišeni fosfati u krvi n
English: Johnson & Johnson România SRL Str. Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5
Croatian: Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5
English: • changes in urination (including urinating more frequently or in larger amounts, urgent need to urinate, need to urinate at night)
Croatian: ● promjene vezane uz mokrenje (uključujući češće mokrenje, veću količinu mokraće, osjećaj potrebe za žurnim mokrenjem, potreba mokrenja noću) ● zatvor
English: The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic impairment, and any conditions associated with hypoxia.
Croatian: Incidencija laktacidoze može se i mora smanjiti, procjenjujući i druge povezane faktore rizika, kao što su slabo kontroliran dijabetes, ketoza, produljeno gladovanje, prekomjeran unos alkohola, oštećenje jetrene funkcije i bilo koje stanje povezano s hipoksijom.
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established.
Croatian: Liječenje se može ponovno započeti, ne ranije od 48 sati nakon operativnog zahvata ili nastavka peroralne prehrane i isključivo uz uspostavljenu normalnu funkciju bubrega.
English: ● Hypersensitivity to the active substances or any of the excipients (see section 6.1);
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari (vidjeti dio 6.1);
English: See section “Look out for side effects” and section 4.
Croatian: “Obratite pažnju na nuspojave” i dio 4.
English: Vokanamet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Croatian: Vokanamet je indiciran u odraslih u dobi od 18 godina i starijih sa šećernom bolešću tipa 2, kao dopuna uz dijetu i tjelovježbu, za poboljšanje regulacije glikemije:
English: In patients where DKA is suspected or diagnosed, treatment with Vokanamet should be discontinued immediately.
Croatian: U bolesnika u kojih se sumnja na DKA ili je ista dijagnosticirana, liječenje kanagliflozinom treba odmah prekinuti.
English: This may induce metformin accumulation which may increase the risk for lactic acidosis.
Croatian: To može dovesti do nakupljanja metformina i može povećati rizik za laktacidozu.
English: The mean steady-state volume of distribution (Vd) of canagliflozin following a single intravenous infusion in healthy subjects was 119 litres, suggesting extensive tissue distribution.
Croatian: Srednja vrijednost volumena distribucije (Vd) kanagliflozina u stanju dinamičke ravnoteže nakon jedne intravenske infuzije u zdravih ispitanika bila je 119 litara, što ukazuje na opsežnu distribuciju u tkiva.
English: • medicines used to lower your blood pressure (anti-hypertensives), including diuretics (medicines used to remove levels of excess water in the body, also known as water tablets) since this medicine can also lower your blood pressure by removing levels of excess water in the body.
Croatian: (lijekove koji se uzimaju za uklanjanje prekomjerne vode iz tijela, također poznate kao tablete za izlučivanje vode) budući da ovaj lijek također može smanjiti krvni tlak na način da uklanjaju prekomjernu vodu iz tijela.
English: Lactic acidosis may also be caused by excessive alcohol intake or prolonged fasting.
Croatian: Laktacidozu također može izazvati prekomjeran unos alkohola ili produljeno gladovanje.
English: • low blood sugar levels (hypoglycaemia) - when taking this medicine with insulin or a sulphonylurea (such as glimepiride or glipizide).
Croatian: ● niske razine šećera u krvi (hipoglikemija) - kad se ovaj lijek uzima s inzulinom ili sulfonilurejom (poput glimepirida ili glipizida).
English: Adverse reactions in table 1 are based on the pooled analysis of the four 26-week placebo-controlled studies (n=2,313) described above.
Croatian: Tablični prikaz nuspojava Nuspojave u tablici 1 temelje se na analizi udruženih podataka iz četiri 26-tjedna placebom kontrolirana ispitivanja (n=2313) opisana iznad.
English: Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Croatian: Prijavljeni slučajevi laktacidoze u bolesnika na metforminu prvenstveno su se pojavili u bolesnika s dijabetesom i značajnim zatajenjem bubrežne funkcije.
English: A subset of patients (N=208) from the active-controlled dual therapy study with metformin who underwent dual energy X-ray densitometry (DXA) and abdominal computed tomography (CT) scans for evaluation of body composition demonstrated that approximately two-thirds of the weight loss with canagliflozin was due to loss of fat mass with similar amounts of visceral and abdominal subcutaneous fat being lost.
Croatian: Podskupina bolesnika (N=208) iz dvojne terapije ispitivanja s aktivnim usporednim lijekom s metforminom u kojem su bili podvrgnuti denzitometriji X-zrakama dualne energije (DXA) i kompjuteriziranoj tomografiji (CT) abdomena za procjenu sastava tijela, pokazao je da se oko dvije trećine gubitka težine s kanagliflozinom dogodio zbog gubitka mase masnoće uz sličan gubitak visceralne i abdominalne supkutane masnoće.
English: The study included 8 subjects with normal renal function (CrCl ≥ 80 mL/min), 8 subjects with mild renal impairment (CrCl 50 mL/min to < 80 mL/min), 8 subjects with moderate renal impairment (CrCl 30 mL/min to < 50 mL/min), and 8 subjects with severe renal impairment (CrCl < 30 mL/min) as well as 8 subjects with end-stage renal disease (ESRD) on haemodialysis.
Croatian: Ispitivanje je uključilo 8 ispitanika s normalnom funkcijom bubrega (CrCl ≥ 80 mL/min), 8 ispitanika s blagim oštećenjem bubrega (CrCl 50 mL/min do < 80 mL/min), 8 ispitanika s umjerenim oštećenjem bubrega (CrCl 30 mL/min do < 50 mL/min),
English: ● Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock (see section 4.4);
Croatian: Akutna stanja s potencijalom promjene bubrežne funkcije kao što su: dehidracija, teška infekcija, šok (vijdeti dio 4.4);
English: Avoid consumption of large amounts of alcohol, or medicines containing alcohol, when taking this medicine.
Croatian: Dok uzimate ovaj lijek izbjegavajte uzimanje velike količine alkohola ili lijekova koji sadrže alkohol.
English: The primary assessment of safety and tolerability was conducted in a pooled analysis (N = 2,313) of four 26-week placebo-controlled clinical studies (monotherapy and add-on therapy with metformin, metformin and a sulphonylurea, and metformin and pioglitazone).
Croatian: Primarna procjena sigurnosti i podnošljivosti provedena analizom udruženih podataka (n=2313) iz četiri 26-tjedna placebom kontrolirana klinička ispitivanja (monoterapija i dodatna terapija s metforminom, metforminom i sulfonilurejom, i metforminom i pioglitazonom).
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Croatian: Kombinacije koje zahtijevaju mjere opreza pri uporabi Glukokortikoidi (primijenjeni sistemski ili lokalno), beta-2-agonisti i diuretici imaju intrinzičnu hiperglikemijsku aktivnost.
English: • rash or red skin - this may be itchy and include raised bumps, oozing fluid or blisters.
Croatian: ● osip ili crvena koža - koji može svrbiti i biti izbočen, uz curenje tekućine ili mjehuriće.
English: Therefore, Vokanamet must be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.4).
Croatian: Stoga se uzimanje lijeka Vokanamet mora prekinuti prije ili za vrijeme ispitivanja, i ne smije se ponovno uvoditi dok ne prođe 48 sati, te dok se ponovnom procijenjenom funkcije bubrega ne ustanovi da je normalna (vidjeti dio 4.4).
English: If you experience some of the signs of lactic acidosis which include feeling sick (nausea) or being sick (vomiting), stomach ache, severe weakness, muscle cramps, unexplained weight loss, rapid breathing, or feeling cold or uncomfortable, stop taking Vokanamet immediately and contact a doctor or go to the nearest hospital straight away.
Croatian: Ako doživite neki od znakova i simptoma laktacidoze koji uključuju mučninu ili povraćanje, bol u trbuhu, tešku slabost, grčeve u mišićima, neobjašnjen gubitak težine, ubrzano disanje, osjećaj hladnoće ili nelagode, odmah prestanite uzimati Vokanamet i obratite se liječniku ili se odmah uputite u najbližu bolnicu Pogledajte dio 4.
English: In a study comparing canagliflozin 300 mg once daily to sitagliptin 100 mg in triple therapy with metformin and a sulphonylurea, canagliflozin demonstrated non-inferior (p < 0.05) and superior (p < 0.05) reduction in HbA1c relative to sitagliptin.
Croatian: U ispitivanju u kojem je kanagliflozin od 300 mg jedanput na dan uspoređen sa sitagliptinom od 100 mg u trojnoj terapiji s metforminom i sulfonilurejom, kanagliflozin je pokazao neinferiorno (p<0,05) i superiorno (p<0,05) smanjenje HbA1c u odnosu na sitagliptin.