FrancophonIA/ELRC3.0 huggingface dataset:
English: Metformin is a biguanide with anti-hyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Slovenian: Metformin je bigvanid z antihiperglikemičnimi učinki, ki znižuje bazalno in postprandialno glukozo v plazmi.
English: This medicinal product should not be used while breast-feeding.
Slovenian: Tega zdravila se med obdobjem dojenja ne sme uporabljati.
English: Xigduo should not be used to treat this condition.
Slovenian: Za zdravljenje te bolezni se zdravila Xigduo ne sme uporabljati.
English: In a separate study of pre- and postnatal development, maternal rats were dosed from gestation day 6 through postnatal day 21, and pups were indirectly exposed in utero and throughout lactation.
Slovenian: V ločeni študiji pre- in postnatalnega razvoja so podganjim samicam-materam dajali dapagliflozin od 6. dne gestacije do 21. postnatalnega dneva; mladiči so bili posredno izpostavljeni in utero in med obdobjem dojenja.
English: In type 1 diabetes mellitus studies, DKA was reported with common frequency.
Slovenian: V študijah pri sladkorni bolezni tipa 1 so pogosto poročali o DKA.
English: Adverse reactions related to increased creatinine were grouped (e.g. decreased renal creatinine clearance, renal impairment, increased blood creatinine and decreased glomerular filtration rate).
Slovenian: Neželene učinke, povezane z zvišanjem kreatinina, so združili v skupino (npr. zmanjšan ledvični očistek kreatinina, okvara ledvic, zvišan kreatinin v krvi in zmanjšana hitrost glomerularne filtracije).
English: • decreases in creatinine renal clearance (shown in tests) in the beginning of treatment
Slovenian: • zmanjšanje ledvičnega očistka kreatinina (to se pokaže v preiskavah) na začetku zdravljenja
English: • if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away.
Slovenian: • če se vam pojavi hitra izguba telesne mase, slabost ali bruhanje, bolečine v trebuhu, prekomerna žeja, hitro in globoko dihanje, zmedenost, neobičajna zaspanost ali utrujenost, sladek vonj izdihanega zraka, sladek ali kovinski okus v ustih ali spremenjen vonj urina ali znoja; če se pojavi kar koli od tega, se takoj posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
English: If you stop taking Xigduo
Slovenian: Če ste prenehali jemati zdravilo Xigduo
English: Renal function should be assessed:
Slovenian: Oceniti je treba delovanje ledvic:
English: If you need to have major surgery, you must stop taking Xigduo during and for some time after the procedure.
Slovenian: Če morate na večji kirurški poseg, morate v času posega in še nekaj časa po tem prenehati z jemanjem zdravila Xigduo.
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 60 film-coated tablets 60x1 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 56 filmsko obloženih tablet 60 filmsko obloženih tablet 60 x 1 filmsko obložena tableta
English: Gastrointestinal symptoms i,§
Slovenian: Bolezni prebavil gastrointestin alni simptomi i,§
English: No interaction studies have been performed for Xigduo.
Slovenian: Študij medsebojnega delovanja z zdravilom Xigduo niso izvedli.
English: Contact your doctor as soon as possible if you have any of the following side effects:
Slovenian: Čim prej se posvetujte z zdravnikom, če imate katerega od naslednjih neželenih učinkov:
English: • if you have uncontrolled diabetes, with, for example severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Slovenian: • če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
English: Metformin or metformin hydrochloride were part of the usual care in 69.4% and 64.0% of the patients for the dapagliflozin and placebo groups, respectively.
Slovenian: Metformin ali metforminijev klorid je bil del običajnega zdravljenja pri 69,4 % bolnikov v skupini z dapagliflozinom in pri 64,0 % bolnikov v skupini s placebom.
English: Your doctor will decide when you must stop and when to restart your treatment with Xigduo.
Slovenian: Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Xigduo prenehati in kdaj lahko nadaljujete.
English: Stop taking Xigduo and see a doctor straight away if you notice any of the following serious or potentially serious side effects:
Slovenian: Nehajte jemati zdravilo Xigduo in takoj obiščite zdravnika, če opazite katerega od naslednjih resnih ali potencialno resnih neželenih učinkov:
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Slovenian: Ker ne spodbuja izločanja insulina, ne povzroča hipoglikemije.
English: Xigduo should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Slovenian: Zdravilo Xigduo je treba uporabljati dvakrat na dan in s hrano, da bi zmanjšali z metforminom povezane neželene učinke na prebavilih.
English: The impact of haemodialysis on dapagliflozin exposure is not known.
Slovenian: Vpliv hemodialize na izpostavljenost dapagliflozinu ni znan.
English: Temporary interruption of treatment with this medicinal product is recommended for patients who develop volume depletion until the depletion is corrected (see section 4.8).
Slovenian: Če se pri bolniku pojavi pomanjkanje volumna, je zdravljenje s tem zdravilom priporočljivo začasno prekiniti, dokler pomanjkanje ni odpravljeno (glejte poglavje 4.8).
English: The mean steady-state volume of distribution of dapagliflozin was 118 liters.
Slovenian: Povprečni volumen porazdelitve dapagliflozina v stanju dinamičnega ravnovesja je 118 litrov.
English: 60x1 film-coated tablets in perforated unit dose blisters.
Slovenian: 60 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek.
English: Metformin is excreted by the kidney, and moderate to severe renal insufficiency increases the risk of lactic acidosis (see section 4.4).
Slovenian: Metformin se izloča preko ledvic in zmerna do huda ledvična insuficienca poveča tveganje za laktacidozo (glejte poglavje 4.4).
English: Polyuria includes the preferred terms: pollakiuria, polyuria, urine output increased.
Slovenian: Poliurija vključuje prednostne izraze: polakisurija, poliurija, zmanjšano izločanje urina.
English: Vulvovaginitis, balanitis and related genital infections
Slovenian: Infekcijske in parazitske bolezni vulvovaginitis, balanitis in sorodne okužbe spolovil
English: • The other ingredients are: tablet core: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate (type A).
Slovenian: • Druge sestavine zdravila so: jedro tablete: hidroksipropilceluloza (E463), mikrokristalna celuloza (E460(i)), magnezijev stearat (E470b), natrijev karboksimetilškrob (vrsta A).
English: Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (associated maternal and pup dapagliflozin exposures were 1,415 times and 137 times, respectively, the human values at the maximum recommended human dose).
Slovenian: Večjo incidenco in izrazitost razširitve ledvičnega meha so opažali pri odraslem potomstvu obravnavanih samic-mater, vendar le pri največjem testiranem odmerku (pri katerem je bila izpostavljenost mater dapagliflozinu 1.415-krat in mladičev 137-krat večja od izpostavljenosti človeka pri največjem priporočenem odmerku za človeka).
English: The amount of glucose removed by the kidney through this mechanism is dependent upon the blood glucose concentration and GFR.
Slovenian: Količina glukoze, ki se tako odstrani skozi ledvice, je odvisna od koncentracije glukoze v krvi in od hitrosti glomerularne filtracije (GFR).
English: This medicine has no or negligible influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: They have “5/850” on one side and “1067” on the other side.
Slovenian: Na eni strani imajo vtisnjeno oznako "5/850" in na drugi strani "1067".
English: Adjusted least squares means (LS Means) and treatment group difference(s) in the change from baseline values at Week 28 are modelled using a mixed model with repeated measures (MMRM) including treatment, region, baseline HbA1c stratum (< 9.0% or ≥ 9.0%), week, and treatment by week interaction as fixed factors, and baseline value as a covariate.
Slovenian: Prilagojena povprečja po metodi najmanjših kvadratov (povprečja po LS - least squares) in razlika/razlike sprememb vrednosti od izhodišča po 28. tednih med zdravljenimi skupinami so modelirali z uporabo mešanega modela s ponavljajočimi se meritvami (MMRM - mixed model with repeated measures), v katerem so bili zdravljenje, regija, izhodiščni stratum HbA1c (< 9,0 % ali ≥ 9,0 %), teden in zdravljenje glede na teden vključeni kot fiksni dejavniki in izhodiščna vrednost kot sospremenljivka.
English: For studies of dapagliflozin as add-on to metformin or as add-on to sitagliptin (with or without metformin), the frequency of minor episodes of hypoglycaemia was similar (< 5%) between treatment groups, including placebo up to 102 weeks of treatment.
Slovenian: V študijah dapagliflozina kot dodatka metforminu ali kot dodatka sitagliptinu (z metforminom ali brez njega) je bila pogostnost blagih hipoglikemij med terapevtskimi skupinami podobna (< 5 %), vključno s placebom do 102 tedna zdravljenja.
English: If you take more Xigduo tablets than you should, you may experience lactic acidosis.
Slovenian: Če ste vzeli večji odmerek zdravila Xigduo, kot bi smeli Če ste vzeli več tablet zdravila Xigduo, kot bi smeli, se vam lahko pojavi laktacidoza.
English: It is not known if dapagliflozin passes into human breast milk.
Slovenian: Ni znano, ali se dapaglifozin izloča v materino mleko.
English: The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by UDP-glucuronosyltransferase 1A9 (UGT1A9).
Slovenian: Farmakokinetično medsebojno delovanje Presnova dapagliflozina poteka predvsem z glukuronidno konjugacijo, ki poteka z UDP-glukuronoziltransferazo 1A9 (UGT1A9).
English: Vulvovaginitis, balanitis and related genital infections includes, e.g. the predefined preferred terms: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess.
Slovenian: Vulvovaginitis, balanitis in sorodne okužbe spolovil vključuje npr. definirane prednostne izraze: vulvovaginalna glivična okužba, okužba nožnice, balanitis, glivična okužba spolovil, vulvovaginalna kandidoza, vulvovaginitis, balanitis candida, genitalna kandidoza, okužba spolovil, okužba spolovil pri moškem, okužba spolnega uda, vulvitis, bakterijski vaginitis, absces vulve.
English: BLISTERS (PERFORATED)
Slovenian: PRETISNI OMOTI (PERFORIRANI)
English: - hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis); - diabetic pre-coma; - severe renal failure (GFR < 30 mL/min) (see sections 4.2, 4.4 and 5.2); - acute conditions with the potential to alter renal function such as: - dehydration, - severe infection, - shock; - acute or chronic disease which may cause tissue hypoxia such as: - cardiac or respiratory failure, - recent myocardial infarction, - shock; - hepatic impairment (see sections 4.2, 4.4 and 5.2); - acute alcohol intoxication, alcoholism (see section 4.5).
Slovenian: - preobčutljivostjo na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, - vse vrste akutne metabolne acidoze (kot sta laktacidoza, diabetična ketoacidoza), - diabetično predkomo, - hudo okvaro ledvic (GFR < 30 ml/min) (glejte poglavja 4.2, 4.4 in 5.2), - akutnimi motnjami, ki lahko spremenijo delovanje ledvic, kot so npr.: - dehidracija, - huda okužba, - šok, - akutnimi ali kroničnimi boleznimi, ki lahko povzročijo hipoksijo tkiv, kot so npr.: - srčno popuščanje ali respiratorna insuficienca, - nedaven miokardni infarkt, - šok, - okvaro jeter (glejte poglavja 4.2, 4.4 in 5.2), - akutno intoksikacijo z alkoholom, alkoholizmom (glejte poglavje 4.5).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in nursing offspring (see section 5.3).
Slovenian: Farmakodinamični in toksikološki podatki za živali, ki so na voljo, kažejo izločanje dapagliflozina oz. njegovih presnovkov v mleko ter farmakološke učinke pri dojenih mladičih (glejte poglavje 5.3).
English: • increases in creatinine (shown in laboratory blood tests) in the beginning of treatment
Slovenian: • zvišanje kreatinina (to se pokaže v laboratorijskih preiskavah) na začetku zdravljenja
English: Xigduo combines two anti-hyperglycaemic medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: dapagliflozin, a SGLT2 inhibitor, and metformin hydrochloride, a member of the biguanide class.
Slovenian: Zdravilo Xigduo je kombinacija dveh antihiperglikemičnih učinkovin z različnima in komplementarnima mehanizmoma delovanja, ki izboljšata urejenost glikemije pri bolnikih s sladkorno boleznijo tipa 2: dapagliflozina, zaviralca SGLT2, in metforminijevega klorida, ki spada v skupino bigvanidov.
English: In the dapagliflozin cardiovascular outcomes study, including elderly patients and patients with renal impairment (eGFR less than 60 mL/min/1.73 m2), eGFR decreased over time in both treatment groups.
Slovenian: V študiji srčno-žilnih izidov z dapagliflozinom, ki je zajela starejše bolnike in bolnike z okvaro ledvic (eGFR manj kot 60 ml/min/1,73 m2), se je eGFR sčasoma zmanjšal v obeh terapevtskih skupinah.
English: Lower limb amputations
Slovenian: Amputacije na spodnjih okončinah
English: In clinical studies where once daily doses of up to 100 mg (10 times the maximum recommended human dose) were administered for 2 weeks in healthy subjects and type 2 diabetes subjects, the incidence of hypoglycaemia was slightly higher than placebo and was not dose-related.
Slovenian: V kliničnih študijah, v katerih so zdravim osebam in bolnikom s sladkorno boleznijo tipa 2 dva tedna dajali odmerke do 100 mg enkrat na dan (to je 10-kratni največji priporočeni odmerek za človeka), je bila incidenca hipoglikemij rahlo večja kot s placebom in ni bila povezana z odmerkom.
English: In a cardiovascular outcomes study (DECLARE), dapagliflozin as adjunct to standard care therapy reduced cardiovascular and renal events in patients with type 2 diabetes.
Slovenian: V študiji srčno-žilnih izidov (DECLARE) je dapagliflozin kot dodatek standardnemu zdravljenju pri bolnikih s sladkorno boleznijo tipa 2 zmanjšal srčno-žilne in ledvične dogodke.
English: Xigduo 5 mg/1,000 mg film-coated tablets EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tablets EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tablets EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablets EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablets EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tablet (unit dose) EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
Slovenian: Xigduo 5 mg/1000 mg filmsko obložene tablete EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tablet EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tablet EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablet EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablet EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tableta (enkratni odmerek) EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablet (skupno pakiranje)
English: Cardiac failure There is no experience in clinical studies with dapagliflozin in NYHA class IV.
Slovenian: Srčno popuščanje Izkušenj iz kliničnih študij dapagliflozina v razredu IV po NYHA ni.
English: Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see sections 4.3 and 4.4).
Slovenian: Za preprečitev laktacidoze, povezane z metforminom, je treba kontrolirati delovanje ledvic, še zlasti pri starejših bolnikih (glejte poglavje 4.3 in 4.4).
English: In the dapagliflozin cardiovascular outcomes study, no increased risk of major hypoglycaemia was observed with dapagliflozin therapy compared with placebo.
Slovenian: V študiji srčno-žilnih izidov z dapagliflozinom med uporabo dapagliflozina niso opazili večjega tveganja za hude hipoglikemije v primerjavi s placebom.
English: The steady-state inhibition of renal glucose reabsorption and the amount of urinary glucose excretion over a 24-hour period was the same for both dosing regimens.
Slovenian: V stanju dinamičnega ravnovesja sta bila zavrtje ledvične reabsorpcije glukoze in količina z urinom izločene glukoze v 24-urnem obdobju enaka z obema odmernima shemama.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Slovenian: Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Multipack containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.
Slovenian: Skupno pakiranje, ki vsebuje 196 (2 pakiranji po 98) filmsko obloženih tablet v neperforiranih pretisnih omotih.
English: (95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline
Slovenian: (95 % IZ) Preiskovanci (%), ki so dosegli: HbA1c < 7 % Korigirano za izhodišče
English: In the dapagliflozin cardiovascular outcomes study, the numbers of patients with events suggestive of volume depletion were balanced between treatment groups: 213 (2.5%) and 207 (2.4%) in the dapagliflozin and placebo groups, respectively.
Slovenian: V študiji srčno-žilnih izidov z dapagliflozinom je bilo število bolnikov z dogodki, ki so nakazovali pomanjkanje volumna, med terapevtskima skupinama uravnoteženo: 213 (2,5 %) v skupini z dapagliflozinom in 207 (2,4 %) v skupini s placebom.
English: Mean eGFR was 85.2 mL/min/1.73 m 7.4% of patients had eGFR < 60 mL/min/1.73 m2, and 30.3% of patients had micro- or macroalbuminuria (urine albumin to creatinine ratio [UACR] ≥ 30 to ≤ 300 mg/g or > 300 mg/g, respectively).
Slovenian: Povprečna eGFR je bila 85,2 ml/min/1,73 m2, 7,4 % bolnikov je imelo eGFR < 60 ml/min/1,73 m2 in 30,3 % bolnikov je imelo mikro- ali makroalbuminurijo (razmerje med albuminom in kreatininom v urinu [UACR] ≥ 30 do ≤ 300 mg/g [mikro-] oz. > 300 mg/g [makro-]).
English: Glipizide + metformin
Slovenian: Glipizid + metformin
English: • changes in the amount of cholesterol or fats in your blood (shown in tests)
Slovenian: • spremenjena količina holesterola ali maščob v krvi (to pokažejo laboratorijske preiskave)
English: Remember to take these other medicine(s) as your doctor has told you.
Slovenian: Pri jemanju tega drugega zdravila (zdravil) upoštevajte zdravnikova navodila.
English: Direct administration of dapagliflozin to weanling juvenile rats and indirect exposure during late pregnancy (time periods corresponding to the second and third trimesters of pregnancy with respect to human renal maturation) and lactation are each associated with increased incidence and/or severity of renal pelvic and tubular dilatations in progeny.
Slovenian: Neposredna uporaba dapagliflozina pri nedavno odstavljenih podganjih mladičih in posredna izpostavljenost med pozno brejostjo (časovno obdobje, ki ustreza drugemu in tretjemu trimesečju nosečnosti glede na dozorevanje ledvic pri človeku) ter med obdobjem dojenja sta bili povezani z večjo incidenco in/ali izrazitostjo razširitev ledvičnega meha in tubulov pri potomstvu.
English: Xigduo 5 mg/850 mg film-coated tablets EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tablets EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tablets EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tablets EU/1/13/900/004 Xigduo 5 mg/850 mg 60 tablets EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tablet (unit dose) EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tablets (multipack)
Slovenian: Xigduo 5 mg/850 mg filmsko obložene tablete EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tablet EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tablet EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tablet EU/1/13/900/004 Xigduo 5 mg/850 mg 60 tablet EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tableta (enkratni odmerek) EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tablet (skupno pakiranje)
English: Treatment with dapagliflozin 10 mg as an add-on to sitagliptin plus metformin resulted in reductions in 2-hour post-prandial glucose at 24 weeks that were maintained up to Week 48.
Slovenian: Zdravljenje z 10 mg dapagliflozina kot dodatkom kombinaciji sitagliptina in metformina je po 24 tednih znižalo postprandialno glukozo 2 uri po obroku; to znižanje se je ohranilo do 48. tedna.
English: Xigduo is used for a type of diabetes called “type 2 diabetes” in adult patients (aged 18 years and older) and usually occurs when you are older.
Slovenian: Zdravilo Xigduo se uporablja za zdravljenje sladkorne bolezni, ki jo imenujemo "sladkorna bolezen tipa 2", pri odraslih bolnikih (starih 18 let in več).
English: Metformin is excreted in human milk in small amounts.
Slovenian: Metformin se v majhni količini izloča v materino mleko.
English: Geometric mean steady-state dapagliflozin Cmax and AUCτ values following once daily 10 mg doses of dapagliflozin were 158 ng/mL and 628 ng h/mL, respectively.
Slovenian: Geometrična sredina Cmax in AUCτ dapagliflozina v stanju dinamičnega ravnovesja po odmerkih 10 mg enkrat na dan sta bili 158 ng/ml in 628 ng h/ml.
English: In the dapagliflozin cardiovascular outcomes study (see section 5.1), 8,574 patients received dapagliflozin 10 mg and 8,569 received placebo for a median exposure time of 48 months.
Slovenian: V študiji srčno-žilnih izidov z dapagliflozinom (glejte poglavje 5.1) je 8.574 bolnikov prejemalo 10 mg dapagliflozina in 8.569 placebo; mediani čas izpostavljenosti je bil 48 tednov.
English: Treatment with dapagliflozin 10 mg in combination with metformin (up to 2,000 mg per day) provided significant improvements in HbA1c compared to the individual components (Table 7), and led to greater reductions in FPG (compared to the individual components) and body weight (compared to metformin).
Slovenian: Zdravljenje z 10 mg dapagliflozina v kombinaciji z metforminom (do 2000 mg na dan) je doseglo značilno izboljšanje HbA1c v primerjavi z vsako posamezno od obeh učinkovin (preglednica 7) in je povzročilo večje znižanje glukoze v plazmi na tešče (v primerjavi s posameznima učinkovinama) in večje zmanjšanje telesne mase (v primerjavi z metforminom).
English: If this happens you must stop taking Xigduo and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Slovenian: V tem primeru morate prenehati jemati zdravilo Xigduo in se takoj obrniti na zdravnika ali najbližjo bolnišnico, saj lahko laktacidoza vodi v komo.
English: Dapagliflozin 5 mg twice daily provided statistically significant reductions in HbA1c at 16 weeks compared with subjects receiving placebo (p < 0.0001; Table 4).
Slovenian: Dapagliflozin v odmerku 5 mg dvakrat na dan je po 16 tednih statistično značilno znižal HbA1c v primerjavi s prejemniki placeba (p < 0,0001, preglednica 4).
English: Dapagliflozin 10 mg demonstrated superiority versus placebo in preventing the composite of hospitalisation for heart failure or cardiovascular death (Figure 1).
Slovenian: Dapagliflozin v odmerku 10 mg je bil v primerjavi s placebom superioren, kar zadeva preprečitev sestavljenega dogodka sprejema v bolnišnico zaradi srčnega popuščanja ali srčno-žilne smrti (slika 1).