FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Maviret, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Maviret glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: In a study in 47 children aged between 12 and 18 years with genotypes 1 to 4 and without cirrhosis, all patients tested negative for the virus after 12 weeks of treatment.
Slovenian: V študiji pri 47 otrocih, starih od 12 do 18 let, z genotipi od 1 do 4 in brez ciroze, je bil test za prisotnost virusa pri vseh bolnikih, ki so bili testirani po 12 tednih zdravljenja, negativen.
English: • atorvastatin, simvastatin (medicines for lowering cholesterol levels in the blood);
Slovenian: • atorvastatin, simvastatin (zdravili za zniževanje ravni holesterola v krvi);
English: • carbamazepine, phenobarbital, phenytoin, primidone (medicines for epilepsy);
Slovenian: • karbamazepin, fenobarbital, fenitoin, primidon (zdravila za zdravljenje epileptičnih napadov);
English: Maviret is an antiviral medicine used to treat adults and adolescents aged 12 years and older with chronic (long-term) hepatitis C, an infectious disease that affects the liver, which is caused by the hepatitis C virus.
Slovenian: Maviret je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih in mladostnikov, starejših od 12 let, s kroničnim (dolgotrajnim) hepatitisom C, tj. nalezljivo boleznijo, ki prizadene jetra in jo povzroča virus hepatitisa C.
English: Maviret must not be used in patients with severely reduced liver function.
Slovenian: Zdravila Maviret ne smejo uporabljati bolniki s hudo okvaro jeter.
English: By blocking these proteins, Maviret stops the hepatitis C virus from multiplying and infecting new cells.
Slovenian: Zdravilo Maviret z zaviranjem teh beljakovin prepreči virusu hepatitisa C, da bi se razmnoževal in okužil nove celice.
English: In 8 main studies involving over 2,300 adults with hepatitis C, 99% of non-cirrhotic patients with genotype 1, the most common genotype, tested negative for the virus after 8 weeks of Maviret treatment and 97% cirrhotic patients were negative after 12 weeks.
Slovenian: V osmih glavnih študijah, ki so vključevale več kot 2 300 odraslih bolnikov s hepatitisom C, je bil test za prisotnost virusa po osmih tednih zdravljenja z zdravilom Maviret negativen pri 99 % bolnikov brez ciroze in z genotipom 1, ki je najpogostejši genotip virusa hepatitisa C, in pri 97 % bolnikov s cirozo po 12 tednih zdravljenja.
English: This study is being carried out in light of data suggesting that patients treated with medicines belonging to the same class as Maviret and who have had liver cancer could be at risk of their cancer returning early.
Slovenian: Ta študija se izvaja na podlagi podatkov, ki kažejo, da pri bolnikih, zdravljenih z zdravili istega razreda, kot je zdravilo Maviret, in predhodno obolelih za rakom jeter, obstaja tveganje zgodnje ponovitve raka.
English: Maviret can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in the management of patients with hepatitis C virus infection.
Slovenian: Predpisovanje in izdaja zdravila Maviret je le na recept, zdravljenje pa mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem bolnikov, okuženih z virusom hepatitisa C.
English: With regard to its safety, Maviret's pattern of side effects raises no particular concern.
Slovenian: Vzorec neželenih učinkov zdravila Maviret ne vzbuja posebnih pomislekov glede varnosti.
English: There are 6 varieties (genotypes) of the hepatitis C virus and Maviret has been shown to be effective at clearing all genotypes from the blood.
Slovenian: Obstaja šest različic (genotipov) virusa hepatitisa C, zdravilo Maviret pa iz krvi dokazano učinkovito odstranjuje vse genotipe.
English: • ethinyl estradiol-containing products (such as contraceptive medicines);
Slovenian: • zdravila, ki vsebujejo etinilestradiol (kot so kontraceptivi);
English: The active substances in Maviret, glecaprevir and pibrentasvir, block two proteins essential for the hepatitis C virus to multiply.
Slovenian: Učinkovini v zdravilu Maviret, glekaprevir in pibrentasvir, zavirata dve beljakovini, ki ju virus hepatitisa C potrebuje za razmnoževanje.
English: For the full list of restrictions and side effects with Maviret, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov pri uporabi zdravila Maviret glejte navodilo za uporabo.
English: How does Maviret work?
Slovenian: Kako zdravilo Maviret deluje?
English: How is Maviret used?
Slovenian: Kako se zdravilo Maviret uporablja?
English: The company that markets Maviret will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Maviret.
Slovenian: Družba, ki trži zdravilo Maviret, bo za oceno tveganja ponovitve raka jeter po zdravljenju z neposredno delujočimi protivirusnimi zdravili, kot je Maviret, izvedla študijo pri bolnikih, ki so preboleli raka jeter.
English: Maviret contains the active substances glecaprevir and pibrentasvir.
Slovenian: Zdravilo Maviret vsebuje učinkovini glekaprevir in pibrentasvir.
English: The fact that Maviret can be given without ribavirin and without dose adjustments in patients with severe kidney problems is a further advantage in comparison with similar medicines.
Slovenian: V primerjavi s podobnimi zdravili je njegova dodatna prednost za bolnike s hudo okvaro ledvic ta, da ga je mogoče dajati brez ribavirina in da odmerkov ni treba prilagajati.
English: A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275)………………………………...15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)........................15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)…………………………………………………………….….15 micrograms HA**
Slovenian: A/Michigan/45/2015, NYMC X-275, ki je podoben sevu A/Michigan/45/2015 (H1N1)pdm09) ...................... 15 mikrogramov HA** A/Hong Kong/4801/2014, NYMC X-263B, ki je podoben sevu A/Hong Kong/4801/2014 (H3N2) .................. 15 mikrogramov HA** B/Brisbane/60/2008, divji tip, ki je podoben sevu B/Brisbane/60/2008 ................................................... 15 mikrogramov HA**
English: Influenza virus (inactivated, split) of the following strains*:
Slovenian: --1 Virusi influence (inaktivirani, razcepljeni) naslednjih sevov*:
English: Per 0.1 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin
Slovenian: na 0,1 ml odmerka razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat ** hemaglutinin
English: MA (EU) number (Invented) name Strength Pharmaceutical
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
English: Especially tell your doctor:
Slovenian: Še zlasti obvestite svojega zdravnika:
English: - a change in your mood or feeling confused.
Slovenian: - sprememba razpoloženja ali občutek zmedenosti.
English: These are the signs of low blood sugar:
Slovenian: Znaki nizkega krvnega sladkorja so:
English: Talk to your doctor about the best way to control your blood sugar while you are pregnant.
Slovenian: Posvetujte se s svojim zdravnikom o tem, kako najbolje obvladati krvni sladkor med nosečnostjo.
English: Contact your doctor as soon as possible if you have any of the following side effects: Very common (may affect more than 1 in 10 people)
Slovenian: Čim prej se posvetujte s svojim zdravnikom, če imate katerega od naslednjih neželenih učinkov: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov):
English: Fifty-one percent (51 %) of the subjects were men, 84 % were White, 9 % were Asian, 3 % were Black and 4 % were of other racial groups.
Slovenian: Enainpetdeset odstotkov (51 %) preiskovancev je bilo moških, 84 % belcev, 9 % Azijcev, 3 % črncev in 4 % drugih rasnih skupin.
English: Dapagliflozin is approximately 91 % protein bound.
Slovenian: Dapagliflozin je približno v 91 % vezan na beljakovine.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Eighty percent (80 %) of the subjects had a body mass index (BMI)  27.
Slovenian: Osemdeset odstotkov (80 %) preiskovancev je imelo indeks telesne mase (ITM)  27.
English: Although uncommon, if you see blood in your urine, tell your doctor immediately.
Slovenian: Običajno se kri v urinu ne pojavi, a če jo opazite, takoj obvestite svojega zdravnika.
English: Film-coated tablet (tablet).
Slovenian: filmsko obložena tableta (tableta).
English: - shaking, sweating, feeling very anxious, fast heart beat
Slovenian: - tresenje, znojenje, občutek hude tesnobe, hitro utripanje srca
English: - feeling hungry, headache, change in vision
Slovenian: - lakota, glavobol, spremembe vida
English: • if you are 75 years old or older, you should not start taking Edistride.
Slovenian: • če ste stari 75 let ali več, ne smete začeti z jemanjem zdravila Edistride.
English: Do not stop taking Edistride without talking to your doctor first.
Slovenian: Ne prenehajte z jemanjem zdravila Edistride, ne da bi se prej posvetovali s svojim zdravnikom.
English: Results of 24-week (LOCF
Slovenian: Rezultati 24-tedenskih (LOCF
English: • Do not use this medicine after the expiry date, which is stated on the blister or carton after ‘EXP'.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu ali škatli poleg oznake "EXP".
English: After administration of a 50 mg [
Slovenian: Po dajanju 50-mg odmerka [
English: • if you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking Edistride.
Slovenian: • če jemljete drugo zdravilo za zdravljenje sladkorne bolezni, ki vsebuje "pioglitazon", ne smete začeti z jemanjem zdravila Edistride.
English: C]-dapagliflozin dose, 96 % was recovered, 75 % in urine and 21 % in feces.
Slovenian: C]-dapagliflozina se ga je 96 % izločilo, in sicer 75 % v urinu in 21 % v blatu.
English: Edistride has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Edistride nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Patients with baseline HbA1c ≥ 9 %
Slovenian: Bolniki z izhodiščno vrednostjo HbA1c ≥ 9 %
English: Fifty-two percent (52 %) had mild renal impairment and 11 % had moderate renal impairment.
Slovenian: Dvainpetdeset odstotkov (52 %) preiskovancev je imelo blago, 11 % pa zmerno okvaro ledvic.
English: Edistride should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila Edistride se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
English: • Edistride is used if your diabetes cannot be controlled with other medicines for diabetes, diet and exercise.
Slovenian: • Zdravilo Edistride se uporablja, če vaše sladkorne bolezni ni mogoče urediti z drugimi zdravili proti sladkorni bolezni, z dieto in s telesno dejavnostjo.
English: Final analysis of these studies, after unblinding, will provide further information on the benefit/risk of SGLT2 inhibitors particularly of the risk of lower limb amputations.
Slovenian: Končna analiza teh študij bo po razkritju zagotovila več informacij o razmerju med tveganji in koristmi zaviralcev SGLT2, zlasti o tveganju za amputacije spodnjih okončin.
English: Edistride is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (aged 18 years and older).
Slovenian: Zdravilo Edistride se uporablja za zdravljenje sladkorne bolezni, ki jo imenujemo "sladkorna bolezen tipa 2" pri odraslih bolnikih (starih 18 let in več).
English: Possible signs of losing too much fluid from your body are listed at the top of section 4 ‘Possible side effects'.
Slovenian: Možni znaki čezmernega izgubljanja tekočine iz telesa so našteti na začetku poglavja 4, 'Možni neželeni učinki'.
English: Cardiovascular death, MI and stroke were observed with a hazard ratio of 0.77 (95 % CI: 0.54, 1.10).
Slovenian: Kardiovaskularna smrt, MI in možganska kap so bile opažene z vrednostjo razmerja ogroženosti 0,77 (95 % IZ: 0,54, 1,10).
English: Gender The mean dapagliflozin AUCss in females was estimated to be about 22 % higher than in males.
Slovenian: Spol Ocenjeno je, da je povprečna AUCss dapagliflozina pri ženskah približno 22 % večja kot pri moških.
English: In rats, dapagliflozin was neither embryolethal nor teratogenic at exposures up to 1,441 times the maximum recommended human dose.
Slovenian: Pri podganah ni bil dapagliflozin ne embrioletalen ne teratogen pri izpostavljenostih, ki so bile do 1441-krat tolikšne kot pri največjemu priporočenemu odmerku za človeka.
English: The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78 %.
Slovenian: Absolutna peroralna biološka uporabnost dapagliflozina po dajanju odmerka 10 mg je 78 %.
English: Edistride is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
Slovenian: Zdravilo Edistride je indicirano pri odraslih, starih 18 let in več, s sladkorno boleznijo tipa 2 za izboljšanje urejenosti glikemije kot:
English: Other medicines and Edistride
Slovenian: Druga zdravila in zdravilo Edistride
English: More information is given below in Other medicines and Edistride.
Slovenian: Več informacij je na voljo v nadaljevanju v "Druga zdravila in zdravilo Edistride".
English: In the clinical program, 34.4 % of subjects had a history of cardiovascular disease (excluding hypertension) at baseline and 67.9 % had hypertension.
Slovenian: V kliničnem programu je imelo izhodiščno anamnezo kardiovaskularne bolezni (izključujoč hipertenzijo) 34,4 % preiskovancev in 67,9 % jih je imelo hipertenzijo.
English: Dapagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is > 1,400 times more selective for SGLT2 versus SGLT1, the major transporter in the gut responsible for glucose absorption.
Slovenian: Dapagliflozin ne zavira drugih prenašalcev glukoze, pomembnih za prenos glukoze v periferna tkiva, in je > 1400-krat bolj selektiven za SGLT2 kot za SGLT1, tj. glavnega prenašalca, odgovornega za absorpcijo glukoze v črevesu.
English: Administration with a high-fat meal decreased dapagliflozin Cmax by up to 50 % and prolonged Tmax by approximately 1 hour, but did not alter AUC as compared with the fasted state.
Slovenian: Dajanje zelo mastnega obroka je zmanjšala Cmax dapagliflozina za do 50 % in podaljšala tmax za približno 1 uro, ni pa spremenila AUC v primerjavi s stanjem na tešče.
English: Your doctor may want to lower the dose of these other medicines, to prevent you from getting low blood sugar levels (hypo-glycaemia).
Slovenian: Zdravnik vam bo morda zmanjšal odmerek teh drugih zdravil, da bi preprečil prekomerno zmanjšanje količine sladkorja v vaši krvi (hipoglikemijo).
English: Diabetic Ketoacidosis
Slovenian: Diabetična ketoacidoza
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95 % Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis Edistride is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Slovenian: Razmerje ogroženosti z dapagliflozinom v primerjavi s primerjalnim zdravilom je bilo 0,79 (95 % interval zaupanja [IZ]: 0,58; 1,07), kar nakazuje, da v tej analizi zdravilo Edistride ni bilo povezano s povečanjem kardiovaskularnega tveganja pri bolnikih s sladkorno boleznijo tipa 2.
English: glimepiride 4 mg/day; Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrolment.
Slovenian: Metformin (oblike s takojšnjim ali podaljšanim sproščanjem) ≥ 1500 mg/dan ter največji tolerirani odmerek (ki mora biti vsaj polovičen maksimalni odmerek) sulfonilsečnine vsaj 8 tednov pred zajetjem v študijo.
English: These infections were more frequent in females (8.4 % and 1.2 % for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection.
Slovenian: O teh okužbah so pogosteje poročali pri ženskah (8,4 % za dapagliflozin in 1,2 % za placebo) ter pri preiskovancih s predhodno anamnezo in torej večjo verjetnostjo za pojav ponovne okužbe.
English: What Edistride looks like and contents of the pack
Slovenian: Izgled zdravila Edistride in vsebina pakiranja
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Edistride, and during treatment:
Slovenian: Opozorila in previdnostni ukrepi Posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro pred jemanjem zdravila Edistride:
English: For patients receiving dapagliflozin, in case of intercurrent conditions that may lead to volume depletion, careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended.
Slovenian: Pri bolnikih, ki prejemajo dapagliflozin, v primeru sočasno prisotnih stanj, ki lahko povzročijo pomanjkanje volumna, je priporočljivo skrbno spremljanje statusa volumna (npr. fizični pregled, meritve srčnega tlaka, laboratorijske preiskave, vključno s hematokritom) in elektrolitov.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Slovenian: • če jemljete druga zdravila, ki zmanjšujejo količino sladkorja v vaši krvi, npr. insulin ali kakšno
English: At 24 weeks, reductions in serum uric acid concentrations ranged from -48.3 to -18.3 micromoles/l (-0.87 to -0.33 mg/dl).
Slovenian: Po 24 tednih je zmanjšanje koncentracije sečne kisline v serumu segalo od -48,3 do -18,3 do mikromolov/l (-0,87 do -0,33 mg/dl).
English: Further evaluation of patients who had renal-related adverse events showed that most had serum creatinine changes of ≤ 0.5 mg/dl from baseline.
Slovenian: Dodatne ocene bolnikov, ki so imeli z ledvicami povezane neželene učinke, so pokazale, da se je večini kreatinin v serumu spremenil za ≤ 0,5 mg/dl v primerjavi z izhodiščem.
English: During clinical trials, the overall proportion of subjects with malignant or unspecified tumours was similar between those treated with dapagliflozin (1.50 %) and placebo/comparator (1.50 %), and there was no carcinogenicity or mutagenicity signal in animal data (see section 5.3).
Slovenian: Med kliničnimi preskušanji je bil celotni delež oseb z malignimi ali nespecificiranimi tumorji med tistimi, ki so prejemali dapagliflozin (1,50 %) in tistimi, ki so prejemali placebo/primerjalno zdravilo (1,50 %) podoben in podatki na živalih niso pokazali signalov kancerogenosti ali mutagenosti (glejte poglavje 5.3).
English: In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking Edistride.
Slovenian: Še zlasti, če se držite diabetične diete za obvladovanje telesne mase, nadaljujte z dieto tudi med jemanjem zdravila Edistride.
English: • low blood sugar levels (hypo-glycaemia) - when taking this medicine with a sulphonylurea or insulin
Slovenian: • nizek krvni sladkor (hipoglikemija) - če jemljete to zdravilo skupaj s kakšnim sulfonilsečninskim zdravilom ali insulinom.
English: In a pre-specified pooled analysis of 13 placebo-controlled studies, 2,360 subjects were treated with dapagliflozin 10 mg and 2,295 were treated with placebo.
Slovenian: V vnaprej specificirani kumulativni analizi 13, s placebom kontroliranih študij, je 2360 preiskovancev bilo zdravljenih z 10 mg dapagliflozina in 2295 je prejemalo placebo.
English: If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Edistride.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro, preden vzamete zdravilo Edistride.
English: Adverse reactions in placebo-controlled studies System organ class
Slovenian: Neželeni učinki v s placebom kontroliranih študijah Organski sistem Zelo pogosti
English: Thirteen double-blind, randomised, controlled clinical trials were conducted with 6,362 subjects with type 2 diabetes to evaluate the efficacy and safety of Edistride; 4,273 subjects in these studies were treated with dapagliflozin.
Slovenian: Za oceno učinkovitosti in varnosti zdravila Edistride so izvedli trinajst dvojno slepih, randomiziranih, kontroliranih kliničnih preskušanj, ki so zajela 6362 oseb s sladkorno boleznijo tipa 2; 4273 oseb je v teh študijah prejemalo dapagliflozin.
English: In feces, approximately 15 % of the dose was excreted as parent drug.
Slovenian: V blatu se je približno 15 % odmerka izločilo kot nespremenjenega.
English: • diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): - increased levels of “ketone bodies” in your urine or blood - 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.
Slovenian: • diabetično ketoacidozo, ki je redka (lahko se pojavi pri največ 1 od 1.000 bolnikov) Znaki diabetične ketoacidoze (glejte tudi 2. poglavje, Opozorila in previdnostni ukrepi) so: - zvišana raven "ketonskih teles" v urinu ali krvi - hitra izguba telesne mase - slabost ali bruhanje - bolečine v trebuhu - prekomerna žeja - hitro in globoko dihanje - zmedenost
English: • Your doctor may ask you to take Edistride on its own if you are intolerant to metformin or together with other medicines to treat diabetes.
Slovenian: • Zdravnik vam lahko predpiše samo zdravilo Edistride, če ne prenašate metformina, ali pa skupaj s kakšnim drugim zdravilom za zdravljenje sladkorne bolezni.
English: Urinary tract infections were more frequently reported for dapagliflozin 10 mg compared to placebo (4.7 % versus 3.5 %, respectively; see section 4.4).
Slovenian: O okužbah sečil so pogosteje poročali v povezavi z 10 mg dapagliflozina v primerjavi s placebom (4,7 % v primerjavi s 3,5 %; glejte poglavje 4.4).
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov):
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: Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5 % versus 0.0 %; HDL cholesterol 6.0 % versus 2.7 %; LDL cholesterol 2.9 % versus -1.0 %; triglycerides -2.7 % versus -0.7 %.
Slovenian: Povprečni odstotek spremembe od izhodišča za 10 mg dapagliflozina v primerjavi s placebom, je bil za: celokupni holesterol 2,5 % v primerjavi z 0,0 %; holesterol HDL 6,0 % v primerjavi z 2,7 %; holesterol LDL 2,9 % v primerjavi z -1,0 %; trigliceridi -2,7 % v primerjavi z -0,7 %.
English: Moderate renal impairment (eGFR ≥ 30 to < 60 ml/min/1.73 m 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).