FrancophonIA/ELRC3.0 huggingface dataset:
English: For studies of dapagliflozin in monotherapy, 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 v monoterapiji, kot dodatek metforminu ali kot dodatek sitagliptinu (z ali brez metformina), je bila pogostost blagih hipoglikemij med terapevtskimi skupinami, vključno s placebom, do 102 tednov zdravljenja podobna (< 5 %).
English: Dapagliflozin acts independently of insulin secretion and insulin action.
Slovenian: Dapagliflozin deluje neodvisno od izločanja in delovanja insulina.
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 (časovni obdobji, ki ustrezata drugemu in tretjemu trimesečju nosečnosti glede na dozorevanje ledvic pri človeku) ter med obdobjem dojenja sta bili povezani z večjo pojavnostjo in/ali izrazitostjo razširitev ledvičnega meha in tubulov pri potomstvu.
English: • loss of too much fluid from your body (dehydration), seen uncommonly.
Slovenian: • čezmerna izguba tekočine iz vašega telesa (dehidracija), ki se lahko pojavi občasno.
English: Combinations not studied Dapagliflozin has not been studied in combination with glucagon-like peptide 1 (GLP-1) analogues.
Slovenian: Dapagliflozin ni bil raziskan v kombinaciji z analogi glukagonu podobnega peptida 1 (GLP-1glucagon-like peptide 1).
English: What Forxiga looks like and contents of the pack
Slovenian: Izgled zdravila Forxiga in vsebina pakiranja
English: Consequently, low-weight patients may have somewhat increased exposure and patients with high weight somewhat decreased exposure.
Slovenian: Zato je lahko izpostavljenost pri bolnikih z majhno telesno maso nekoliko večja in pri bolnikih z veliko telesno maso nekoliko manjša.
English: Dapagliflozin should not be used while breast-feeding.
Slovenian: Dapagliflozina se v obdobju dojenja ne sme uporabljati.
English: Dapagliflozin is not recommended for use in patients receiving loop diuretics (see section 4.5) or who are volume depleted, e.g. due to acute illness (such as gastrointestinal illness).
Slovenian: Uporaba dapagliflozina ni priporočljiva pri bolnikih, ki prejemajo diuretike zanke (glejte poglavje 4.5) ali imajo pomanjkanje volumna, npr. zaradi akutne bolezni (kot je bolezen prebavil).
English: The formation of dapagliflozin 3-O-glucuronide is mediated by UGT1A9, an enzyme present in the liver and kidney, and CYP-mediated metabolism was a minor clearance pathway in humans.
Slovenian: Nastajanje dapagliflozin-3-O-glukuronida poteka z encimom UGT1A9, ki je prisoten v jetrih in ledvicah; presnova s sistemom CYP je bila pri človeku manj pomembna pot očistka.
English: Moderate renal impairment (eGFR ≥ 30 to < 60 ml/min/1.73 m2) The efficacy of dapagliflozin was also assessed separately in a dedicated study of diabetic subjects with moderate renal impairment (252 subjects with mean eGFR 45 ml/min/1.73 m2).
Slovenian: Zmerna okvara ledvic (eGFR ≥ 30 do < 60 ml/min/1,73 m Učinkovitost dapagliflozina so ločeno ocenili tudi v namenski študiji sladkornih bolnikov z zmerno okvaro ledvic (252 preiskovancev s povprečnim eGFR 45 ml/min/1,73 m2).
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 pojavnost in izrazitost razširitve ledvičnega meha so opažali pri odraslem potomstvu obravnavanih samic-mater, vendar le pri največjem preskušanem odmerku (pri katerem je bila izpostavljenost mater dapagliflozinu 1.415-krat in mladičev 137-krat večja od izpostavljenosti človeka pri največjemu priporočenemu odmerku za človeka).
English: Adverse reactions in placebo-controlled studiesa
Slovenian: Neželeni učinki v s placebom kontroliranih študijah a
English: The reductions in HbA1c observed at Week 24 were sustained in add-on combination studies (glimepiride and insulin) with 48-week data (glimepiride) and up to 104-week data (insulin).
Slovenian: Zmanjšanje HbA1c, ugotovljeno 24. teden, v študijah dodatka h kombiniranemu zdravljenju (z glimepiridom in insulinom), se je ohranilo do 48. tedna (glimepirid) in do 104. tedna (insulin).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Forxiga, and during treatment:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Forxiga in med zdravljenjem z njim se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), Forxiga was evaluated as add-on therapy to metformin compared with a sulphonylurea (glipizide) as add-on therapy to metformin in subjects with inadequate glycaemic control (HbA1c > 6.5% and ≤ 10%).
Slovenian: V 52-tedenski, z zdravilno učinkovino kontrolirani študiji neinferiornosti (z 52-tedenskim in 104tedenskim obdobjem podaljšanja), so zdravilo Forxiga ocenjevali kot dodatek k zdravljenju z metforminom v primerjavi s sulfonilsečnino (glipizid) kot dodatkom k zdravljenju z metforminom pri osebah z neustrezno urejenostjo glikemije (HbA1c > 6,5 % in ≤ 10 %).
English: approximately 15% of the dose was excreted as parent drug.
Slovenian: V blatu se je približno 15 % odmerka izločilo kot nespremenjenega.
English: If you forget to take Forxiga
Slovenian: Če ste pozabili vzeti zdravilo Forxiga
English: fPolyuria includes the preferred terms: pollakiuria, polyuria, urine output increased.
Slovenian: Poliurija vključuje prednostne izraze: polakisurija, poliurija, zmanjšano izločanje urina.
English: Additional developmental toxicity was limited to dose-related reductions in pup body weights, and observed only at doses ≥ 15 mg/kg/day (associated with pup exposures that are ≥ 29 times the human values at the maximum recommended human dose).
Slovenian: Dodatni toksični učinki na razvoj so bili omejeni na z odmerkom povezana zmanjšanja telesne mase mladičev, zabeležili pa so jih le pri odmerkih ≥ 15 mg/kg/dan (to je povezano z izpostavljenostjo mladičev, ki je ≥ 29-krat večja od izpostavljenosti človeka pri največjemu priporočenemu odmerku za človeka).
English: At Week 12 for both studies, dapagliflozin 10 mg plus usual antidiabetic treatment provided improvement in HbA1c and decreased the placebo-corrected systolic blood pressure on average by 3.1 and 4.3 mmHg, respectively.
Slovenian: Po 12 tednih je 10 mg dapagliflozina skupaj z običajnim antidiabetičnim zdravljenjem v obeh študijah prineslo izboljšanje HbA1c ter znižanje za placebo korigiranega sistoličnega krvnega tlaka za povprečno 3,1 oz. 4,3 mmHg.
English: The frequency of hypoglycaemia depended on the type of background therapy used in each study.
Slovenian: Pogostost pojavljanja hipoglikemij je bila odvisna od vrste osnovnega zdravljenja v posamezni študiji.
English: The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by UDP glucuronosyltransferase 1A9 (UGT1A9).
Slovenian: Farmakokinetična medsebojna delovanja Presnova dapagliflozina poteka predvsem z glukuronidno konjugacijo preko UDP-glukuronoziltransferaze 1A9 (UGT1A9).
English: Neither maternal nor developmental toxicities were observed in rabbits at any dose tested; the highest dose tested is associated with a systemic exposure multiple of approximately 1,191 times the maximum recommended human dose.
Slovenian: Pri kuncih niso pri nobenem od odmerkov ugotovili niti maternalne niti razvojne toksičnosti; največji preskušani odmerek je bil povezan s sistemsko izpostavljenostjo, ki je bila približno 1.191-krat tolikšna kot pri največjemu priporočenemu odmerku za človeka.
English: cVulvovaginitis, 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 vključujejo, npr. vnaprej definirane prednostne izraze: vulvovaginalna glivična okužba, vaginalna okužba, balanitis, glivična okužba spolovil, vulvovaginalna kandidoza, vulvovaginitis, balanitis kandida, genitalna kandidoza, okužba spolovil, okužba spolovil pri moškem, okužba spolnega uda, vulvitis, bakterijski vaginitis, absces vulve.
English: • decrease in kidney function
Slovenian: • zmanjšano delovanje ledvic
English: Dapagliflozin improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion.
Slovenian: Dapagliflozin izboljša koncentracijo glukoze v plazmi na tešče in po obroku, tako da zmanjša ledvično reabsorpcijo glukoze in tako povzroči njeno izločanje z urinom.
English: If you stop taking Forxiga
Slovenian: Če ste prenehali jemati zdravilo Forxiga
English: Increased creatinine
Slovenian: Zvišan kreatinin
English: Improvement in homeostasis model assessment for beta cell function (HOMA beta-cell) has been observed in clinical studies with Forxiga.
Slovenian: V kliničnih študijah zdravila Forxiga so ugotovili izboljšanje homeostatske modelne ocene delovanja celic beta (HOMA celic beta).
English: These differences were not considered to be clinically meaningful.
Slovenian: Vendar se te razlike ne smatrajo kot klinično pomembne.
English: Do not use Forxiga if you are breast-feeding.
Slovenian: Ne uporabljajte zdravila Forxiga, če dojite.
English: This may be another medicine taken by mouth and/or insulin given by injection.
Slovenian: To so lahko zdravila, ki jih zaužijete, ali insulin, ki se daje z injekcijo.
English: Minor episodes of hypoglycaemia were reported in 12.8% of subjects who received dapagliflozin 10 mg plus metformin and a sulphonylurea and in 3.7% of subjects who received placebo plus metformin and a sulphonylurea.
Slovenian: Blage hipoglikemije so zabeležili pri 12,8 % bolnikov, ki so prejemali 10 mg dapagliflozina ter metformin in sulfonilsečnino, in pri 3,7 % bolnikov, ki so prejemali placebo ter metformin in sulfonilsečnino.
English: Your doctor may ask you to stop taking Forxiga until you recover to prevent dehydration.
Slovenian: Zdravnik vam bo morda svetoval, da za preprečitev dehidracije prenehate z jemanjem zdravila Forxiga vse dokler si ne opomorete.
English: SE-151 85 Södertälje Sweden
Slovenian: AstraZeneca AB SE-151 85 Södertälje Švedska
English: At 52, 104 and 208 weeks, a significantly lower proportion of subjects in the group treated with dapagliflozin (3.5%, 4.3% and 5.0%, respectively) experienced at least one event of hypoglycaemia compared to the group treated with glipizide (40.8%, 47.0% and 50.0%, respectively).
Slovenian: 52., 104. in 208. teden je imel vsaj eno hipoglikemijo značilno manjši delež oseb, ki so prejemale dapagliflozin (3,5 %, 4,3 % in 5,0 %) v primerjavi s skupino, zdravljeno z glipizidom (40,8 %, 47,0 % in 50,0 %).
English: These are signs of a severe infection of the urinary tract: - fever and/or chills - burning sensation when passing water (urinating) - pain in your back or side.
Slovenian: Znaki hude okužbe sečil so: - zvišana telesna temperatura ali mrzlica ali oboje - pekoč občutek pri odvajanju vode (uriniranju) - stranska bolečina ali bolečina v hrbtu.
English: Combination therapies with sulphonylurea and add-on insulin had higher rates of hypoglycaemia (see Hypoglycaemia below).
Slovenian: Pri kombiniranih zdravljenjih s sulfonilsečnino in dodatkom insulina je bila stopnja hipoglikemije večja (glejte Hipoglikemija spodaj).
English: Following coadministration of dapagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes) a 22% decrease in dapagliflozin systemic exposure (AUC) was observed, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Slovenian: Po sočasnem dajanju dapagliflozina in rifampicina (induktorja različnih aktivnih prenašalcev in encimov za presnovo zdravil), so zabeležili 22 % zmanjšanje sistemske izpostavljenosti (AUC) dapagliflozinu, vendar brez klinično pomembnega vpliva na 24-urno izločanje glukoze z urinom.
English: Very common (may affect more than 1 in 10 people)
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov):
English: It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.
Slovenian: Pomembno je, da še naprej upoštevate navodila glede diete in telesne dejavnosti, ki ste jih dobili od zdravnika, farmacevta ali medicinske sestre.
English: Manufacturer AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
Slovenian: Izdelovalec AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Nemčija
English: If renal function falls below CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2, dapagliflozin treatment should be discontinued.
Slovenian: Če se delovanje ledvic poslabša, tako da je CrCl < 60 ml/min ali eGFR < 60 ml/min/1,73 m2, je treba zdravljenje z dapagliflozinom prekiniti.
English: As an add-on therapy to metformin in an active-controlled non-inferiority study, dapagliflozin resulted in a statistically significant body weight reduction compared with glipizide of -4.65 kg at 52 weeks (p < 0.0001, Table 3) that was sustained at 104 and 208 weeks (-5.06 kg and -4.38 kg, respectively).
Slovenian: Dapagliflozin je kot dodatek zdravljenju z metforminom v z zdravilno učinkovino kontrolirani študiji neinferiornosti, v primerjavi z glipizidom, statistično značilno znižal telesno maso za -4,65 kg po 52 tednih (p < 0,0001, preglednica 3); znižanje se je 104. in 208. teden ohranilo (-5,06 kg po 104 in -4,38 kg po 208 tednih).
English: In subjects with mild or moderate hepatic impairment (Child-Pugh classes A and B), mean Cmax and AUC of dapagliflozin were up to 12% and 36% higher, respectively, compared to healthy matched control subjects.
Slovenian: Pri osebah z blago ali zmerno okvaro jeter (razreda A in B po Child-Pughu) sta bila povprečna Cmax in AUC dapagliflozina večja do 12 % oziroma do 36 % v primerjavi z usklajenimi zdravimi primerjalnimi osebami.
English: In interaction studies conducted in healthy subjects, using mainly a single-dose design, dapagliflozin did not alter the pharmacokinetics of metformin, pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (a P-gp substrate) or warfarin (S-warfarin, a CYP2C9 substrate), or the anticoagulatory effects of warfarin as measured by INR.
Slovenian: V študijah medsebojnega delovanja pri zdravih preiskovancih, ki so bile v glavnem izvedene po raziskovalnem načrtu z uporabo enkratnega odmerka, dapagliflozin ni spremenil farmakokinetike metformina, pioglitazona, sitagliptina, glimepirida, hidroklorotiazida, bumetanida, valsartana, digoksina (ki je substrat P-gp ) ali varfarina (S-varfarina, ki je substrat CYP2C9 ); prav tako ni spremenil antikoagulantnih učinkov varfarina, merjenih z INR.
English: In a juvenile toxicity study, when dapagliflozin was dosed directly to young rats from postnatal day 21 until postnatal day 90, renal pelvic and tubular dilatations were reported at all dose levels; pup exposures at the lowest dose tested were ≥ 15 times the maximum recommended human dose.
Slovenian: V študiji toksičnosti pri mladičih so po neposredni uporabi dapagliflozina pri mladih podganah od 21. do 90. postnatalnega dneva pri vseh ravneh odmerkov ugotovili razširitve ledvičnega meha in tubulov; izpostavljenost mladičev pri najmanjšem preskušanem odmerku je bila ≥ 15-krat tolikšna kot je največji priporočeni odmerek za človeka.
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov):
English: Furthermore, two 12week, placebo-controlled studies were conducted in patients with inadequately controlled type 2 diabetes and hypertension.
Slovenian: Poleg tega sta bili pri bolnikih z neustrezno urejeno sladkorno boleznijo tipa 2 in hipertenzijo opravljeni dve 12-tedenski, s placebom kontrolirani študiji.
English: How to take Forxiga
Slovenian: Kako jemati zdravilo Forxiga
English: Forxiga has not been studied in severe renal impairment (CrCl < 30 ml/min or eGFR < 30 ml/min/1.73 m2) or end-stage renal disease (ESRD).
Slovenian: Zdravilo Forxiga ni bilo raziskano pri hudi okvari ledvic (CrCl < 30 ml/min ali eGFR < 30 ml/min/1,73 m2) ali pri končni odpovedi ledvic (ESRD - end-stage renal disease).
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excluding insulins, ATC code: A10BX09
Slovenian: Drugi peroralni antidiabetiki brez insulina, oznaka ATC: A10BX09
English: Vulvovaginitis, balanitis and related genital infections Vulvovaginitis, balanitis and related genital infections were reported in 5.5% and 0.6% of subjects who received dapagliflozin 10 mg and placebo, respectively.
Slovenian: Vulvovaginitis, balanitis in sorodne okužbe spolovil O vulvovaginitisu, balanitisu in sorodnih okužbah spolovil so poročali pri 5,5 % oseb, ki so prejemale 10 mg dapagliflozina, in 0,6 % oseb, ki so prejemale placebo.
English: When dapagliflozin is used in combination with insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).
Slovenian: Kadar se dapagliflozin uporablja v kombinaciji z insulinom ali z zdravili, ki spodbujajo izločanje insulina, kot so sulfonilsečnine, je za zmanjšanje tveganja za pojav hipoglikemije treba razmisliti o manjšem odmerku insulina oziroma zdravila, ki spodbuja izločanje insulina (glejte poglavji 4.5 in 4.8).
English: In subjects ≥ 65 years of age, adverse reactions related to renal impairment or failure were reported in 7.7% of subjects treated with dapagliflozin and 3.8% of subjects treated with placebo (see section 4.4).
Slovenian: Pri osebah, starih ≥ 65 let, so o neželenih učinkih povezanih z okvaro ledvic ali odpovedjo, poročali pri 7,7 % oseb, ki so prejemale dapagliflozin in 3,8 % oseb, ki so prejemale placebo (glejte poglavje 4.4).
English: Dapagliflozin exposure was found to decrease with increased weight.
Slovenian: Izpostavljenost dapagliflozinu se s povečevanjem telesne mase zmanjšuje.
English: bColumns 1 and 2, HbA1c analyzed using LOCF (see footnote d); Columns 3 and 4, HbA1c analyzed using LRM (see footnote e) cLeast squares mean adjusted for baseline value dLOCF: Last observation (prior to rescue for rescued subjects) carried forward LRM: Longitudinal repeated measures analysis *p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product(s)
Slovenian: Stolpca 1 in 2, HbA1c analiziran po metodi LOCF (glejte opombo d), stolpca 3 in 4, HbA1c analiziran z metodo LRM (glejte opombo e) Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost LOCF: Prenos zadnjega opažanja (pred rešilnim zdravljenjem za preiskovance s takšnim zdravljenjem) [Last observation carried forward] eLRM: longitudinalna analiza s ponovljenimi meritvami Vrednost p < 0,0001 v primerjavi s kombinacijo placebo + peroralni antidiabetik/antidiabetiki
English: In patients where DKA is suspected or diagnosed, treatment with dapagliflozin should be discontinued immediately.
Slovenian: V primeru suma na DKA ali potrjene DKA je treba zdravljenje z dapagliflozinom takoj prekiniti.
English: Yellow, biconvex, 0.7 cm diameter round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side.
Slovenian: Rumene, bikonveksne, okrogle, filmsko obložene tablete s premerom 0,7 cm in z vtisnjeno oznako "5" na eni strani ter "1427" na drugi strani.
English: Across all studies, major events of hypoglycaemia were uncommon and comparable between the groups treated with dapagliflozin or placebo.
Slovenian: V vseh študijah je bilo hudih hipoglikemij malo, njihova pogostost pa je bila med skupinami, zdravljenimi z dapagliflozinom oziroma s placebom, primerljiva.
English: Urine glucose Because of how Forxiga works, your urine will test positive for sugar while you are on this medicine.
Slovenian: Zaradi načina delovanja zdravila Forxiga, bo med zdravljenjem s tem zdravilom vaš urin pozitiven v preiskavah za prisotnost sladkorja.
English: Treatment with dapagliflozin 10 mg as a monotherapy or as an add-on to either metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant reductions in fasting plasma glucose (-1.90 to -1.20 mmol/l [-34.2 to -21.7 mg/dl]) compared to placebo (-0.33 to 0.21 mmol/l [-6.0 to 3.8 mg/dl]).
Slovenian: Zdravljenje z 10 mg dapagliflozina v monoterapiji ali kot dodatkom bodisi k metforminu, glimepiridu, metforminu in sulfonilsečnini, sitagliptinu (z ali brez metformina) ali insulinu, je statistično značilno zmanjšalo glukozo v plazmi na tešče (-1,90 do -1,20 mmol/l [-34,2 do -21,7 mg/dl]) v primerjavi s placebom (-0,33 do 0,21 mmol/l [-6,0 do 3,8 mg/dl]).
English: Urinary volume increases in subjects with type 2 diabetes mellitus treated with dapagliflozin 10 mg were sustained at 12 weeks and amounted to approximately 375 ml/day.
Slovenian: Pri osebah s sladkorno boleznijo tipa 2 se je med zdravljenjem z 10 mg dapagliflozina ohranila večja količina urina 12 tednov in je znašala približno 375 ml/dan.
English: Following coadministration of dapagliflozin with mefenamic acid (an inhibitor of UGT1A9), a 55% increase in dapagliflozin systemic exposure was seen, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Slovenian: Po sočasnem dajanju dapagliflozina in mefenaminske kisline (zaviralca UGT1A9), so zabeležili 55 % povečanje sistemske izpostavljenosti dapagliflozinu, vendar brez klinično pomembnega učinka na 24-urno izločanje glukoze z urinom.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and fertility.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na plodnost ne kažejo posebnega tveganja za človeka.
English: Primary episodes occurred at a rate of 1.62% per patient-year in subjects treated with dapagliflozin and 2.06% in comparator-treatment subjects, per patient-year.
Slovenian: Delež primarnega dogodka je bil pri osebah, ki so prejemale dapagliflozin 1,62 % na bolnikleto in pri osebah, ki so prejemale primerjalno zdravilo 2,06 % na bolnik-leto.
English: Forxiga is not recommended for use in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.4, 4.8, 5.1 and 5.2).
Slovenian: Zdravila Forxiga ni priporočljivo uporabljati pri bolnikih z zmerno do hudo okvaro ledvic (bolnikih s kreatininskim očistkom [CrCl] < 60 ml/min ali z ocenjeno hitrostjo glomerulne filtracije [eGFR] < 60 ml/min/1,73 m2, glejte poglavja 4.4, 4.8, 5.1 in 5.2).
English: The mean steady-state volume of distribution of dapagliflozin was 118 l.
Slovenian: Povprečni volumen porazdelitve dapagliflozina v stanju dinamičnega ravnovesja je 118 l.
English: Difference from glipizide + metforminc
Slovenian: Razlika glede na glipizid + metformin c
English: The following adverse reactions have been identified in the placebo-controlled clinical trials.
Slovenian: V s placebom kontroliranih kliničnih preskušanjih so ugotovili naslednje neželene učinke.