FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 7 Primary and secondary clinical endpoints by treatment group in the SAVOR study*
Croatian: Tablica 7: Primarne i sekundarne kliničke mjere ishoda prema skupini bolesnika u ispitivanju SAVOR*
English: Immune system disorders Hypersensitivity reactions
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti
English: • Tablet core: povidone K30, magnesium stearate.
Croatian: • Jezgra tablete: povidon K30, magnezijev stearat
English: Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Croatian: Gastrointestinalni simptomi poput mučnine, povraćanja, proljeva, boli u abdomenu i gubitka teka najčešće se javljaju na početku liječenja i u većini se slučajeva sami povuku.
English: At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 μg/mL.
Croatian: Pri uobičajenim dozama i režimu doziranja metformina koncentracije u plazmi u stanju dinamičke ravnoteže postižu se za 24 do 48 sati i obično su niže od 1 µg/ml.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Komboglyze.
Croatian: Sljedeći podaci odražavaju farmakokinetička svojstva pojedinačnih djelatnih tvari u lijeku Komboglyze.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 μg/mL, even at maximum doses.
Croatian: U kontroliranim kliničkim ispitivanjima vršne razine metformina u plazmi (Cmax) nisu čak ni pri najvišim dozama prelazile prag od 4 µg/ml.
English: The primary safety (noninferiority) and efficacy (superiority) endpoint was a composite endpoint consisting of the time-to-first occurrence of any of the following major adverse CV events (MACE): CV death, nonfatal myocardial infarction, or nonfatal ischaemic stroke.
Croatian: Primarna mjera ishoda sigurnosti (neinferiornost) i djelotvornosti (superiornost) bila je kompozitna mjera ishoda koju je činilo vrijeme do prve pojave bilo kojeg od sljedećih velikih kardiovaskularnih štetnih događaja (engl. major adverse cardiac events, MACE): kardiovaskularna smrt, infarkta miokarda bez smrtnog ishoda ili ishemijski moždani udar bez smrtnog ishoda.
English: LRM = Longitudinal repeated measures (using values prior to rescue).
Croatian: LRM: analiza longitudinalnih podataka ponovljenih mjerenja (koristeći vrijednosti prije potrebe za hitnom terapijom hiperglikemije)
English: In particular, if you are following a diabetic weight control diet, keep on with this while you are taking this medicine.
Croatian: Posebice, ako ste na režimu prehrane za održavanje tjelesne težine namijenjenom oboljelima od šećerne bolesti, nastavite s time dok uzimate ovaj lijek.
English: Komboglyze should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Croatian: Komboglyze se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 niti za liječenje dijabetičke ketoacidoze.
English: As this medicinal product contains saxagliptin, it should not be used in patients who have had any serious hypersensitivity reaction to a dipeptidyl peptidase 4 (DPP4) inhibitor.
Croatian: Budući da ovaj lijek sadrži saksagliptin, ne smije se primjenjivati u bolesnika koji su prethodno imali ozbiljnu reakciju preosjetljivosti na neki od inhibitora dipeptidil peptidaze 4 (DPP4).
English: The use of Komboglyze or saxagliptin has not been studied in pregnant women.
Croatian: Primjena lijeka Komboglyze ili saksagliptina nije ispitivana u trudnica.
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels above 5 mmol/L, and an increased anion gap and lactate/pyruvate ratio.
Croatian: Dijagnostički laboratorijski nalazi su sniženi pH krvi (<7,35), povišene razine laktata u plazmi (>5 mmol/l) i povećan anionski procjep i omjer laktata/piruvata.
English: A small decrease in absolute lymphocyte count was observed.
Croatian: Opaženo je malo smanjenje apsolutnog broja limfocita.
English: As initial combination with metformin: gastritis (common), arthralgia
Croatian: U početnoj kombiniranoj terapiji s metforminom: gastritis (često), artralgija
English: The effect on offspring body weights were noted until postnatal day 92 and 120 in females and males, respectively.
Croatian: Učinak na tjelesnu težinu mladunaca zamijećen je u ženki do 92. dana, a u mužjaka do 120. dana postnatalno.
English: The pharmacokinetics of saxagliptin and its major metabolite were similar in healthy subjects and in patients with type 2 diabetes.
Croatian: Farmakokinetika saksagliptina i njegova glavnog metabolita bila je slična u zdravih ispitanika i bolesnika sa šećernom bolešću tipa 2.
English: Saxagliptin was not genotoxic in a conventional battery of genotoxicity studies in vitro and in vivo.
Croatian: Saksagliptin nije bio genotoksičan u konvencionalnom nizu ispitivanja genotoksičnosti in vitro i in vivo.
English: GENERATION was a 52-week glycaemic control study in 720 elderly patients, the mean age was 72.6 years; 433 subjects (60.1%) were < 75 years of age, and 287 subjects (39.9%) were ≥ 75 years of age.
Croatian: GENERATION je bilo 52-tjedno ispitivanje kontrole glikemije provedeno u 720 starijih bolesnika, čija je srednja dob iznosila 72,6 godina; 433 ispitanika (60,1%) bila su u dobi od < 75 godina, a njih 287 (39,9%) u dobi od ≥ 75 godina.
English: If you stop taking Komboglyze
Croatian: Ako prestanete uzimati Komboglyze
English: In the SAVOR study subgroups over 65 and over 75 years of age, efficacy and safety were consistent with the overall study population.
Croatian: U ispitivanju SAVOR su djelotvornost i sigurnost u podskupinama bolesnika starijih od 65 godina i starijih od 75 godina bile u sukladu s onima zabilježenima u cjelokupnoj ispitivanoj populaciji.
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Croatian: Ne stimulira izlučivanje inzulina te stoga ne izaziva hipoglikemiju.
English: If you have these symptoms, stop taking this medicine and call your doctor or nurse right away.
Croatian: Ako imate ove simptome, prestanite uzimati ovaj lijek i odmah se javite svom liječniku ili medicinskoj sestri.
English: Arthralgia has also been reported during postmarketing surveillance (see section 4.4).
Croatian: Artralgija je također prijavljena i tijekom praćenja nakon stavljanja lijeka u promet (vidjeti dio 4.4).
English: Adverse reactions of hypoglycaemia were based on all reports of hypoglycaemia; a concurrent glucose measurement was not required.
Croatian: Nuspojave hipoglikemije temelje se na svim prijavljenim slučajevima hipoglikemije; nije bilo potrebno istodobno mjerenje glukoze.
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Croatian: Ispitivanje provedeno u sedam zdravih dobrovoljaca pokazalo je da cimetidin u dozi od 400 mg dvaput na dan povećava sistemsku izloženost metforminu (AUC) za 50%, a Cmax za 81%.
English: When driving or using machines, it should be taken into account that dizziness has been reported in studies with saxagliptin.
Croatian: Kod upravljanja vozilom ili rada na strojevima treba uzeti u obzir da je u ispitivanjima saksagliptina prijavljena omaglica.
English: Some patients have had a small reduction in the number of one type of white blood cells (lymphocytes) shown in a blood test when saxagliptin was used alone or in combination.
Croatian: U nekih je bolesnika nastupilo blago smanjenje broja jedne vrste bijelih krvnih stanica (limfocita), što se vidjelo u krvnoj slici kada je saksagliptin bio korišten sam ili u kombinaciji.
English: Lactic acidosis is a medical emergency and must be treated in hospital.
Croatian: Laktacidoza je hitno medicinsko stanje koje mora biti liječeno u bolnici.
English: As metformin and saxagliptin are excreted by the kidney, this medicinal product should be used with caution in the elderly.
Croatian: Budući da se metformin i saksagliptin izlučuju putem bubrega, ovaj lijek se mora primjenjivati uz oprez u starijih bolesnika.
English: The in vitro protein binding of saxagliptin and its major metabolite in human serum is negligible.
Croatian: In vitro vezanje saksagliptina i njegovog glavnog metabolita za proteine u ljudskom serumu je zanemarivo.
English: The mean metformin dose was approximately 1900 mg in each treatment group.
Croatian: Prosječna doza metformina u svakoj je terapijskoj skupini iznosila približno 1900 mg.
English: In the SAVOR trial a small increase in the rate for hospitalisation for heart failure was observed in the saxagliptin treated patients compared to placebo, although a causal relationship has not been established (see section 5.1).
Croatian: U ispitvanju SAVOR, opaženo je malo povećanje stope hospitalizacije zbog zatajenja srca u skupini bolesnika liječenih saksagliptinom u usporedbi s placebom, iako nije ustanovljena uzročna povezanost (vidjeti dio 5.1).
English: Do not use this medicine if the package is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako je pakiranje oštećeno ili se vidi da je otvarano.
English: What Komboglyze contains
Croatian: Što Komboglyze sadrži
English: Overall population (n=300)
Croatian: Ukupna populacija (n=300) 24 tjedna
English: Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis in muscle; - by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation; - by delaying intestinal glucose absorption.
Croatian: Metformin može djelovati putem tri mehanizma: - smanjujući proizvodnju glukoze u jetri time što inhibira glukoneogenezu i glikogenolizu u mišićima; - umjereno povećavajući osjetljivost na inzulin, čime se poboljšava unos i iskorištavanje glukoze u perifernim tkivima; - usporavajući apsorpciju glukoze u crijevima.
English: Studies in animals have shown reproductive toxicity at high doses of saxagliptin alone or in combination with metformin (see section 5.3).
Croatian: Istraživanja na životinjama pokazala su reproduktivnu toksičnost kod primjene visokih doza saksagliptina samog, ili u kombinaciji s metforminom (vidjeti dio 5.3).
English: Monitoring of renal function is necessary to prevent metformin-associated lactic acidosis, particularly in the elderly (see sections 4.3, 4.4 and 5.2).
Croatian: Potrebno je kontrolirati bubrežnu funkciju radi sprječavanja laktacidoze povezane s metforminom, pogotovo u starijih osoba (vidjeti dijelove 4.3, 4.4 i 5.2).
English: Saxagliptin also resulted in a significantly lower proportion of patients with hypoglycaemia, 3% (19 events in 13 subjects) vs. 36.3% (750 events in 156 patients) for glipizide.
Croatian: Primjena saksagliptina rezultirala je i značajno manjim udjelom bolesnika s hipoglikemijom, 3% (19 slučajeva u 13 bolesnika) u odnosu na glipizid, 36,3% (750 slučajeva u 156 bolesnika).
English: Komboglyze may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Croatian: Komboglyze može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza, osobito ako Vam bubrezi ne rade ispravno.
English: p-value < 0.001 for noninferiority (based on HR < 1.3) compared to placebo.
Croatian: ‡ p-vrijednost <0,001 za neinferiornost (na temelju HR <1,3) u usporedbi s placebom.
English: The red blood cells most likely represent a secondary compartment of distribution.
Croatian: Eritrociti su vrlo vjerojatno sekundarni odjeljak raspodjele.
English: • infection of the structures that carry urine (urinary tract infection)
Croatian: • infekcija struktura kojima se izlučuje mokraća (infekcija mokraćnih putova)
English: The effect of saxagliptin on fertility in humans has not been studied.
Croatian: Nisu ispitivani učinci saksagliptina na plodnost ljudi.
English: Effects on fertility were observed in male and female rats at high doses producing overt signs of toxicity.
Croatian: Opaženi su učinci na plodnost mužjaka i ženki štakora pri visokim dozama koje su proizvele vidljive znakove toksičnosti.
English: In patients with type 2 diabetes, administration of saxagliptin led to inhibition of DPP4 enzyme activity for a 24-hour period.
Croatian: U bolesnika sa šećernom bolešću tipa 2 primjena saksagliptina izazvala je inhibiciju djelovanja enzima DPP-4 tijekom razdoblja od 24 sata.
English: For metformin, studies in animals have not shown reproductive toxicity (see section 5.3).
Croatian: Što se tiče metformina, u istraživanjima na životinjama nije zabilježena reproduktivna toksičnost (vidjeti dio 5.3).
English: Saxagliptin has been shown to be well-tolerated with no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose).
Croatian: Pokazalo se da je saksagliptin dobro podnošljiv lijek te da nema klinički značajnog učinka na QTc interval ni na frekvenciju srca pri oralnim dozama do 400 mg na dan tijekom 2 tjedna (što je 80 puta više od preporučene doze).
English: Komboglyze is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Croatian: Komboglyze je indiciran u odraslih sa šećernom bolesti tipa 2 kao dodatak dijeti i tjelovježbi za poboljšanje kontrole glikemije:
English: Glucocorticoids (given by systemic and local routes), beta-2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Croatian: Glukokortikoidi (primjenjeni sistemski i lokalno), beta-2 agonisti i diuretici sami po sebi djeluju hiperglikemijski.
English: Talk to your doctor or pharmacist before taking Komboglyze If you have type1diabetes (your body does not produce any insulin).
Croatian: Obratite sesvomliječnikuili ljekarnikuprije uzimanja lijeka Komboglyze ako imate šećernu bolesti tipa 1 (tijelo uopće ne proizvodi inzulin).
English: If a patient presents with severe joint pain, continuation of drug therapy should be individually assessed.
Croatian: Ako u bolesnika dođe do jakih bolova u zglobovima, potrebno je procijeniti nastavak liječenja za pojedinog bolesnika.
English: The effects of smoking, diet, herbal products, and alcohol use on the pharmacokinetics of saxagliptin have not been specifically studied.
Croatian: Nisu posebno ispitivani učinci pušenja, prehrane, biljnih preparata i alkohola na farmakokinetiku saksagliptina.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with a NSAID.
Croatian: Poseban oprez nužan je u situacijama u kojima bi bubrežna funkcija mogla biti oslabljena, primjerice kada se uvodi liječenje antihipertenzivima ili diureticima, odnosno započinje s primjenom NSAIL-a.
English: Side effects seen when taking saxagliptin alone: Common
Croatian: Nuspojave zabilježene pri uzimanju samo saksagliptina: Česte
English: No dose adjustment is recommended for patients with mild renal impairment (GFR 60-89 mL/min).
Croatian: Ne preporučuje se prilagođavati dozu u bolesnika s blagim oštećenjem funkcije bubrega (GFR 60-89 ml/min).
English: Placebo-corrected mean change in HbA1c (%) (95% CI)
Croatian: Placebo-korigirana srednja promjena vrijednosti HbA1c (%) (95% CI)
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Croatian: Bubrežni klirens metformina veći je od 400 ml/min, što upućuje na to da se metformin eliminira glomerularnom filtracijom i tubularnom sekrecijom.
English: Pharmacotherapeutic group: Drugs used in diabetes, Combinations of oral blood glucose lowering drugs, ATC code: A10BD10.
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje dijabetesa, Kombinacije oralnih antidijabetika, ATK oznaka: A10BD10.
English: You should call your doctor if you experience the following side effect: • severe joint pain.
Croatian: Morate obavijestiti svog liječnika ako osjetite sljedeću nuspojavu: • jaka bol u zglobovima
English: p-value = 0.99 for superiority (based on HR < 1.0) compared to placebo.
Croatian: § p- vrijednost = 0,99 za superiornost (na temelju HR <1,0) u usporedbi s placebom.
English: If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Croatian: Ako je potrebno, dozu antidijabetika treba prilagoditi tijekom i po završetku liječenja drugim lijekovima.
English: Do not take this medicine if you are pregnant or might become pregnant.
Croatian: Nemojte uzimati ovaj lijek ako ste trudni ili biste mogli zatrudnjeti jer ovaj lijek može utjecati na dijete.
English: During postmarketing experience, including spontaneous reports and clinical trials, the following adverse reactions have been reported with the use of saxagliptin: serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, and angioedema.
Croatian: Nakon stavljanja lijeka u promet, uključujući spontane prijave i klinička ispitivanja, prijavljene su sljedeće nuspojave kod primjene saksagliptina: ozbiljne reakcije preosjetljivosti, uključujući anafilaktičku reakciju, anafilaktički šok i angioedem.
English: saxagliptin, part of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin, part of a class of medicines called biguanides.
Croatian: saksagliptin, tvar iz skupine lijekova koji se nazivaju inhibitorima DPP-4 (inhibitorima dipeptidil peptidaze 4) i metformin, tvar iz skupine lijekova koji se nazivaju bigvanidi.
English: Decrease in body weight in the treatment groups given saxagliptin in combination with metformin was similar to that in the groups given metformin alone.
Croatian: Smanjenje tjelesne težine u terapijskim skupinama koje su primale saksagliptin u kombinaciji s metforminom bilo je podjednako onome u skupinama koje su primale samo metformin.
English: The decreases in lymphocyte count were not associated with clinically relevant adverse reactions.
Croatian: Smanjenja broja limfocita nisu bila povezana s klinički značajnim nuspojavama.
English: Skin and subcutaneous tissue disorders Urticaria, erythema, pruritus
Croatian: Poremećaji kože i potkožnog tkiva urtikarija, eritem, pruritus vrlo rijetko
English: AEs, considered by the investigator to be at least possibly drug-related and reported in at least two more patients treated with saxagliptin 5 mg compared to control, are described below by treatment regimen.
Croatian: Nuspojave za koje je ispitivač smatrao da su barem moguće povezane s primjenom lijeka i koje su prijavljene u najmanje dva bolesnika više liječena saksagliptinom u dozi od 5 mg u usporedbi s kontrolnom skupinom, opisane su u nastavku prema režimu liječenja.
English: If a serious hypersensitivity reaction to saxagliptin is suspected, discontinue this medicinal product, assess for other potential causes for the event, and institute alternative treatment for diabetes (see sections 4.3 and 4.8).
Croatian: Posumnja li se na ozbiljnu reakciju preosjetljivosti na saksagliptin, treba obustaviti primjenu ovog lijeka, ispitati druge moguće uzroke nuspojave te uvesti zamjensko liječenje za šećernu bolest (vidjeti dijelove 4.3 i 4.8).
English: The effect on HbA1c observed at Week 24 was sustained at Week 52.
Croatian: Učinak na HbA1c zapažen u 24. tjednu održan je i u 52. tjednu.
English: A total of 22% of the administered radioactivity was recovered in faeces representing the fraction of the saxagliptin dose excreted in bile and/or unabsorbed medicinal product from the gastrointestinal tract.
Croatian: Ukupno je 22% primijenjene radioaktivnosti ustanovljeno u fecesu, što predstavlja dio doze saksagliptina koji se izlučuje u žuči i/ili neapsorbirani lijek iz gastrointestinalnog trakta.
English: In addition, saxagliptin did not meaningfully alter the pharmacokinetics of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, the active components of a combined oral contraceptive (ethinyl estradiol and norgestimate), diltiazem or ketoconazole.
Croatian: Nadalje, saksagliptin nije značajno promijenio farmakokinetiku metformina, glibenklamida, pioglitazona, digoksina, simvastatina, djelatnih sastavnica kombiniranog oralnog kontraceptiva (etinilestradiola i norgestimata), diltiazema ni ketokonazola.
English: The average renal clearance of saxagliptin (230 mL/min) was greater than the average estimated glomerular filtration rate (120 mL/min), suggesting some active renal excretion.
Croatian: Prosječan bubrežni klirens saksagliptina (~230 ml/min) bio je veći nego prosječna procijenjena brzina glomerularne filtracije (~120 ml/min), što upućuje na aktivno izlučivanje putem bubrega u određenoj mjeri.
English: No carcinogenic potential was observed in two-year carcinogenicity assays with mice and rats.
Croatian: U dvogodišnjim ispitivanjima kancerogenosti na miševima i štakorima nije opažen kancerogeni potencijal.
English: The Cmax and AUC of saxagliptin and its major metabolite increased proportionally to the saxagliptin dose.
Croatian: Cmax i AUC saksagliptina i njegova glavnog metabolita povećavali su se proporcionalno dozi saksagliptina.
English: This medicine can be used alone or together with other antidiabetic medicines, including insulin.
Croatian: Ovaj lijek se može uzimati sam ili s drugim lijekom za liječenje šećerne bolesti uključujući inzulin.
English: Clinically relevant factors predictive of increased relative risk with saxagliptin treatment could not be definitively identified.
Croatian: Nisu se mogli definitivno odrediti klinički značajni faktori prediktivni za povećan relativan rizik uz liječenje saksagliptinom.
English: The study population included those ≥ 65 years (n=8561) and ≥ 75 years (n=2330), with normal or mild renal impairment (n=13916) as well as moderate (n=2240) or severe (n=336) renal impairment.
Croatian: Ispitivana populacija uključivala je osobe u dobi od ≥ 65 godina (n=8561) i ≥ 75 godina (n=2330) s normalnom ili blago oštećenom bubrežnom funkcijom (n=13 916), kao i one s umjereno (n=2240) ili teško (n=336) oštećenom bubrežnom funkcijom.
English: The increased risk of overall and major hypoglycaemia was primarily observed in subjects with A1C < 7% at baseline.
Croatian: Povećan rizik od ukupne i teške hipoglikemije prvenstveno je primijećen u ispitanika koji su na početku ispitivanja imali A1C od < 7%.
English: Frequency categories are based on information available from metformin Summary of Product Characteristics available in the European Union.
Croatian: Kategorije učestalosti temelje se na dostupnim podacima iz Sažetka opisa svojstava lijeka za metformin dostupnog u Europskoj uniji.
English: In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with saxagliptin.
Croatian: U randomiziranim, kontroliranim, dvostruko slijepim kliničkim ispitivanjima (uključujući iskustvo tijekom razvoja lijeka i nakon njegova stavljanja u promet) saksagliptinom je liječeno više od 17 000 bolesnika sa šećernom bolešću tipa 2.
English: However, among surviving mothers with evaluable litters, maternal toxicity was limited to marginal reductions in body weight over the course of gestation days 21 to 29; and associated developmental toxicity in these litters was limited to foetal body weight decrements of 7%, and a low incidence of delayed ossification of the foetal hyoid.
Croatian: Ipak, među ženkama koje su preživjele i okotile potomke koji su se mogli ispitati, toksičnost za majku bila je ograničena na marginalno smanjenje tjelesne težine tijekom razdoblja od 21. do 29. dana gestacije, a s tim povezana razvojna toksičnost u potomaka bila je ograničena na smanjenje tjelesne težine fetusa za 7% te nisku incidenciju odgođenog okoštavanja hioidne kosti fetusa.