FrancophonIA/ELRC3.0 huggingface dataset:
English: Empagliflozin twice daily versus once daily as add on to metformin therapy The efficacy and safety of empagliflozin twice daily versus once daily (daily dose of 10 mg and 25 mg) as add-on therapy in patients with in sufficient glycemic control on metformin monotherapy was evaluated in a double blind placebo-controlled study of 16 weeks duration.
Slovenian: Učinkovitost in varnost empagliflozina dvakrat dnevno v primerjavi z empagliflozinom enkrat dnevno (dnevni odmerek 10 mg in 25 mg) kot dodatnim zdravljenjem k metforminu pri bolnikih z nezadostno urejeno glikemijo, ki prejemajo metformin v monoterapiji, so ocenili v dvojno slepi, s placebom nadzorovani študiji, ki je trajala 16 tednov.
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Up to 4 mg glimepiride Mean adjusted for baseline value Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure LOCF, values after antihypertensive rescue censored * p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
Slovenian: IZ) Niz celotne analize (FAS, full analysis set) z uporabo zadnjega opazovanja prenesenega naprej (LOCF, last observation carried forward) pred uporabo reševalnega zdravljenja za ureditev glikemije Do 4 mg glimepirida Povprečje, prilagojeno za izhodiščne vrednosti Statistična značilnost ni bila ocenjena zaradi zaporednega potrditvenega postopka testiranja LOCF, vrednosti po cenzuriranju antihipertenzivnega reševanja * vrednost p < 0,0001 za enakovrednost, in vrednost p = 0,0153 za superiornost ** vrednost p < 0,0001
English: Synjardy 12.5 mg/850 mg and Synjardy 12.5 mg/1,000 mg tablets also contain iron oxide black (E172) and iron oxide red (E172).
Slovenian: Zdravilo Synjardy 12,5 mg/850 mg in zdravilo Synjardy 12,5 mg/1000 mg tablete vsebujejo tudi črni (E172) in rdeči železov oksid (E172).
English: For the different doses of metformin, Synjardy is available in strengths of 5 mg empagliflozin plus 850 mg metformin hydrochloride, 5 mg empagliflozin plus 1,000 mg metformin hydrochloride, 12.5 mg empagliflozin plus 850 mg metformin hydrochloride, and 12.5 mg empagliflozin plus 1,000 mg metformin hydrochloride.
Slovenian: Zaradi potrebe po različnih odmerkih metformina je zdravilo Synjardy na voljo v jakostih 5 mg empagliflozina in 850 mg metforminijevega klorida, 5 mg empagliflozina in 1.000 mg metforminijevega klorida, 12,5 mg empagliflozina in 850 mg metforminijevega klorida ter 12,5 mg empagliflozina in 1.000 mg metforminijevega klorida.
English: Subgroup analysis for patients on additional background of metformin (PPS-Completers, LOCF) Mean adjusted for baseline value not evaluated for statistical significance as a part of the sequential confirmatory testing procedure Week 19-40: treat-to-target regimen for insulin dose adjustment to achieve pre-defined glucose target levels (pre-prandial <100 mg/dl (5.5 mmol/l), post-prandial <140 mg/dl (7.8 mmol/l) * p-value ≤0.0005 ** p-value <0.005
Slovenian: Statistična značilnost ni bila ocenjena zaradi zaporednega potrditvenega postopka testiranja 19.-40. teden: usmerjen (treat-to-target) režim prilagajanja odmerka insulina za doseganje vnaprej določenih ciljnih ravni glukoze (preprandialna < 100 mg/dl (5,5 mmol/l), postprandialna < 140 mg/dl (7,8 mmol/l) * vrednost p ≤ 0,0005 ** vrednost p < 0,005
English: At week 12, an adjusted mean (SE) improvement in HbA1c when compared to baseline of 0.11% (0.02) in the placebo group, 0.65% (0.02) and 0.71% (0.02) in the empagliflozin 10 and 25 mg groups was observed.
Slovenian: V 12. tednu so opazili prilagojeno povprečje (SE - standardna napaka) izboljšanja vrednosti HbA1c glede na izhodiščno vrednost 0,11 % (0,02) v skupini s placebom ter 0,65 % (0,02) ali 0,71 % (0,02) v skupinah z empagliflozinom 10 mg oziroma 25 mg.
English: Iron oxide black (E172) Iron oxide red (E172)
Slovenian: Filmska obloga hipromeloza makrogol 400 titanov dioksid (E171) smukec črni železov oksid (E172) rdeči železov oksid (E172)
English: INFORMATION IN BRAILLE Synjardy 5 mg/850 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Synjardy 5 mg/850 mg
English: The efficacy and safety of empagliflozin as add on to basal insulin with concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 78 weeks duration.
Slovenian: Empagliflozin kot dodatno zdravljenje k bazalnemu insulinu Učinkovitost in varnost empagliflozina kot dodatnega zdravljenja k bazalnemu insulinu s sočasnim metforminom so ocenili v dvojno slepem, s placebom nadzorovanem 78-tedenskem preskušanju.
English: Multipack comprising 2 packs, each containing 90 x 1 film-coated tablets.
Slovenian: Skupno pakiranje vključuje 2 enoti, od katerih vsaka vsebuje 90 x 1 filmsko obloženo tableto.
English: In a pre-specified pooled analysis of 4 placebo controlled studies, treatment with empagliflozin (68% of all patients were on metformin background) resulted in body weight reduction compared to placebo at week 24 (-2.04 kg for empagliflozin 10 mg, -2.26 kg for empagliflozin 25 mg and -0.24 kg for placebo) that was maintained up to week 52 (-1.96 kg for empagliflozin 10 mg, -2.25 kg for empagliflozin 25 mg and -0.16 kg for placebo).
Slovenian: V predhodno specificirani analizi zbranih podatkov 4 s placebom nadzorovanih študij je zdravljenje z empagliflozinom (68 % vseh bolnikov je ob tem prejemalo metformin) v primerjavi s placebom v 24. tednu povzročilo zmanjšanje telesne mase (-2,04 kg za empagliflozin 10 mg, -2,26 kg za empagliflozin 25 mg in -0,24 kg za placebo), ki se je ohranilo do 52. tedna (-1,96 kg za empagliflozin 10 mg in -2,25 kg za empagliflozin 25 mg in -0,16 kg za placebo).
English: Empagliflozin and linagliptin as add-on therapy to metformin In a double-blind trial in patients with inadequate glycemic control, 24-weeks treatment with both doses of empagliflozin plus linagliptin as add-on to metformin therapy provided statistically significant (p<0.0001) reductions in HbA1c (change from baseline of -1.08% for empagliflozin 10 mg plus linagliptin 5 mg, -1.19% for empagliflozin 25 mg plus linagliptin 5 mg, -0.70% for linagliptin 5 mg).
Slovenian: Empagliflozin in linagliptin kot dodatno zdravljenje k metforminu V dvojno slepem preskušanju pri bolnikih z neustrezno urejeno glikemijo so v 24-tedenskem zdravljenju z obema odmerkoma empagliflozina skupaj z linagliptinom kot dodatnim zdravljenjem k metforminu odkrili statistično značilno (p < 0,0001) zmanjšanje vrednosti HbA1c (sprememba glede na izhodiščno vrednost -1,08 % za empagliflozin 10 mg in linagliptin 5 mg, -1,19 % za empagliflozin 25 mg in linagliptin 5 mg ter -0,70 % za linagliptin 5 mg).
English: Multipack comprising 2 packs, each containing 100 x 1 film-coated tablets.
Slovenian: Skupno pakiranje vključuje 2 enoti, od katerih vsaka vsebuje 100 x 1 filmsko obloženo tableto.
English: What Synjardy contains
Slovenian: Kaj vsebuje zdravilo Synjardy
English: 1 (97.5% CI) Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7% Body Weight (kg) Baseline (mean) Change from baseline Difference from glimepiride
Slovenian: IZ) Bolniki (%) z izhodiščno vrednostjo HbA1c ≥ 7 %, ki so dosegli vrednost HbA1c < 7 % Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na glimepirid 1 (97,5-odstotni
English: An increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing long-term clinical studies with another SGLT2 inhibitor.
Slovenian: V dolgoročnih kliničnih študijah z drugim zaviralcem SGLT2, ki še potekajo, so opazili povečano število primerov amputacij na spodnjih okončinah (predvsem prstov na nogah).
English: Co-administration of multiple doses of empagliflozin and metformin does not meaningfully alter the pharmacokinetics of either empagliflozin or metformin in healthy subjects.
Slovenian: Večkratno sočasno dajanje empagliflozina in metformina pri zdravih preizkušancih ni pomembno spremenilo njune farmakokinetike.
English: In a pre-specified analysis of subjects with baseline HbA1c ≥9.0%, treatment with empagliflozin 10 mg or 25 mg as add-on to metformin resulted in statistically significant reductions in HbA1c at Week 24 (adjusted mean change from baseline of -1.49% for empagliflozin 25 mg, -1.40% for empagliflozin 10 mg, and -0.44% for placebo).
Slovenian: V predhodno specificirani analizi bolnikov z izhodiščno vrednostjo HbA1c ≥ 9,0 % je zdravljenje z empagliflozinom 10 mg ali 25 mg kot dodatno zdravljenje k metforminu povzročilo statistično pomembno zmanjšanje vrednosti HbA1c v 24. tednu (prilagojena povprečna sprememba od izhodišča: -1,49 % za empagliflozin 25 mg, -1,40 % za empagliflozin 10 mg in -0,44 % za placebo).
English: Component of a multipack, cannot be sold separately.
Slovenian: Ni za posamično prodajo.
English: Empagliflozin twice daily dose regimens on a background of metformin led to comparable reductions in HbA1c versus once daily dose regimens with a treatment difference in HbA1c reductions from baseline to week 16 of -0.02% (95% CI -0.16, 0.13) for empagliflozin 5 mg twice daily versus 10 mg once daily, and -0.11% (95% CI -0.26, 0.03) for empagliflozin 12.5 mg twice daily versus 25 mg once daily.
Slovenian: Pri režimu odmerjanja z empagliflozinom dvakrat dnevno ob prisotnosti metformina je bilo v primerjavi z režimom odmerjanja enkrat dnevno opaženo primerljivo zmanjšanje vrednosti HbA1c, pri čemer so bile razlike v zmanjšanju vrednosti HbA1c pri obeh oblikah zdravljenja od izhodišča do 16. tedna -0,02 % (95-odstotni IZ; -0,16, 0,13) za empagliflozin 5 mg dvakrat dnevno v primerjavi z empagliflozinom 10 mg enkrat dnevno ter -0,11 % (95-odstotni IZ; -0,26, 0,03) za empagliflozin 12,5 mg dvakrat dnevno v primerjavi z empagliflozinom 25 mg enkrat dnevno.
English: • loss of appetite
Slovenian: • izguba teka.
English: Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');
Slovenian: Dehidracija lahko privede do težav z ledvicami, kar lahko predstavlja tveganje za nastanek laktacidoze (glejte 'Opozorila in previdnostni ukrepi');
English: Low blood sugar (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) If you take Synjardy with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is increased.
Slovenian: Če jemljete zdravilo Synjardy skupaj s še enim zdravilom, ki lahko zniža krvni sladkor, kot je sulfonilsečnina ali insulin, je vaše tveganje za nizek krvni sladkor večje.
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%
Slovenian: Bolniki (%), ki so dosegli vrednost HbA1c < 7 % z izhodiščno vrednostjo HbA1c ≥ 7 %
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia) 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.
Slovenian: Dolgotrajno zdravljenje z metforminom so povezali z zmanjšano absorpcijo vitamina B12, kar lahko zelo redko pripelje do klinično pomembnega pomanjkanja tega vitamina (npr. megaloblastne anemije).
English: Synjardy 5 mg/850 mg and Synjardy 5 mg/1,000 mg tablets also contain iron oxide yellow (E172).
Slovenian: Zdravilo Synjardy 5 mg/850 mg in zdravilo Synjardy 5 mg/1000 mg tablete vsebujejo tudi rumeni železov oksid (E172).
English: All treatments with empagliflozin resulted in significant reductions in HbA1c from baseline (total mean 7.8%) after 16 weeks of treatment compared with placebo.
Slovenian: V 16 tednih so vse oblike zdravljenja z empagliflozinom povzročile statistično značilno zmanjšanje vrednosti HbA1c od izhodišča (skupno povprečje 7,8 %) v primerjavi s placebom.
English: In a pre-specified pooled analysis of 4 placebo-controlled studies, treatment with empagliflozin (68% of all patients were on metformin background) resulted in a reduction in systolic blood pressure (empagliflozin 10 mg: -3.9 mmHg, empagliflozin 25 mg: -4.3 mmHg) compared with placebo (-0.5 mmHg), and in diastolic blood pressure (empagliflozin 10 mg: -1.8 mmHg, empagliflozin 25 mg: -2.0 mmHg) compared with placebo (-0.5 mmHg), at week 24, that were maintained up to week 52.
Slovenian: V predhodno specificirani analizi zbranih podatkov iz 4 s placebom nadzorovanih študij je zdravljenje z empagliflozinom (68 % vseh bolnikov je ob tem prejemalo metformin) v 24. tednu povzročilo znižanje sistoličnega krvnega tlaka (empagliflozin 10 mg: -3,9 mmHg; empagliflozin 25 mg: -4,3 mmHg) v primerjavi s placebom (-0,5 mmHg) in diastoličnega krvnega tlaka (empagliflozin 10 mg: -1,8 mmHg; empagliflozin 25 mg: -2,0 mmHg) v primerjavi s placebom (-0,5 mmHg), ki se je ohranilo do 52. tedna.
English: INFORMATION IN BRAILLE Synjardy 5 mg/1,000 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Synjardy 5 mg/1000 mg
English: • diarrhoea or stomach ache
Slovenian: • driska ali trebušne bolečine,
English: INFORMATION IN BRAILLE Synjardy 12.5 mg/850 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Synjardy 12,5 mg/850 mg
English: Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');
Slovenian: Hude okužbe lahko privedejo do težav z ledvicami, kar lahko predstavlja tveganje za nastanek laktacidoze (glejte 'Opozorila in previdnostni ukrepi');
English: INFORMATION IN BRAILLE Synjardy 12.5 mg/1,000 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Synjardy 12,5 mg/1000 mg
English: Interaction studies suggest that the pharmacokinetics of empagliflozin were not influenced by co-administration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Slovenian: Študije medsebojnega delovanja kažejo, da sočasna uporaba metformina, glimepirida, pioglitazona, sitagliptina, linagliptina, varfarina, verapamila, ramiprila, simvastatina, torasemida in hidroklorotiazida ni vplivala na farmakokinetiko empagliflozina.
English: As expected from the mechanism of action, increased urination (as assessed by PT search including pollakiuria, polyuria, nocturia) was observed at higher frequencies in metformin-treated patients who received empagliflozin 10 mg (3.0%) and empagliflozin 25 mg (2.9%) compared to placebo (1.4%) as add-on to metformin therapy.
Slovenian: Kot je mogoče pričakovati na podlagi mehanizma delovanja, so v primerjavi s placebom (1,4 %) kot dodatnim zdravljenjem k metforminu opazili večjo pogostnost pogostejšega uriniranja (vključno s predhodno opredeljenimi pojmi polakiurija, poliurija, nokturija) pri bolnikih, zdravljenih z metforminom, ki so prejemali empagliflozin 10 mg (3,0 %) in empagliflozin 25 mg (2,9 %).
English: General toxicity studies in rats of up to 13 weeks were performed with the combination of empagliflozin and metformin and did not reveal any additional target organs when compared to empagliflozin or metformin alone.
Slovenian: Študije splošne toksičnosti pri podganah, ki so trajale do 13 tednov, so vključevale zdravljenje s kombinacijo empagliflozina in metformina.
English: The dosage should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability using the recommended daily dose of 10 mg or 25 mg of empagliflozin, while not exceeding the maximum recommended daily dose of metformin.
Slovenian: Uporabljati je potrebno priporočeni dnevni odmerek empagliflozina po 10 mg ali 25 mg, ne da bi pri tem presegli največji priporočeni dnevni odmerek metformina.
English: In the EMPA-REG Outcome study, haematocrit values returned towards baseline values after a follow-up period of 30 days after treatment stop.
Slovenian: Po 30-dnevnem obdobju spremljanja po prenehanju zdravljenja so se v študiji EMPA-REG Outcome vrednosti hematokrita približale izhodiščnim.
English: Synjardy 5 mg/850 mg film-coated tablets
Slovenian: Synjardy 5 mg/850 mg filmsko obložene tablete
English: MMRM model included baseline SBP and baseline HbA1c as linear covariate(s), and baseline eGFR, geographical region, treatment, visit, and visit by treatment interaction as fixed effects.
Slovenian: Mešani model ponovljene meritve (MMRM), izveden na nizu celotne analize (FAS-full analysis set) s pristopom opazovanih primerov (OC-observed cases), je vključeval izhodiščni SBP (sistolični krvni tlak) in izhodiščno vrednost HbA1c kot linearni spremenljivki in izhodiščno vrednost eGFR, geografsko območje, zdravljenje, obisk zdravnika ter obisk zdravnika glede na vrsto zdravljenja kot fiksne učinke.
English: This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see section ‘Warnings and precautions');
Slovenian: To lahko privede do zmanjšane oskrbe tkiv s kisikom, kar lahko predstavlja tveganje za nastanek laktacidoze (glejte poglavje 'Opozorila in previdnostni ukrepi');
English: Table 3: Efficacy results of 24 week placebo-controlled studies Add-on to metformin therapy
Slovenian: Preglednica 3: Rezultati učinkovitosti 24-tedenskih s placebom nadzorovanih študij Dodatno zdravljenje k metforminu placebo empagliflozin
English: No dose adjustment is recommended for patients with mild renal impairment.
Slovenian: Pri bolnikih z blago ledvično okvaro ni potrebno prilagajati odmerka.
English: • genital yeast infection (thrush)
Slovenian: • glivična okužba spolovil (vaginalna kandidoza),
English: Add-on to pioglitazone + metformin therapy Placebo
Slovenian: Dodatno zdravljenje k pioglitazonu z metforminom placebo empagliflozin
English: Urinary tract infection events were reported more frequently for empagliflozin 10 mg compared with placebo in female patients, but not for empagliflozin 25 mg.
Slovenian: O okužbah sečil so pri ženskah poročali pogosteje pri empagliflozinu 10 mg kot pri placebu, vendar to ne velja za empagliflozin 25 mg. Pogostnost okužb sečil je bila pri moških majhna in enakomerno razporejena v vseh zdravljenih skupinah.
English: The other ingredient(s) are: - Tablet core: maize starch, copovidone, colloidal anhydrous silica, magnesium stearate.
Slovenian: Druge sestavine zdravila so: - Jedro tablete: koruzni škrob, kopovidon, koloidni brezvodni silicijev dioksid, magnezijev stearat; - Filmska obloga: hipromeloza, makrogol 400, titanov dioksid (E171), smukec.
English: Synjardy 5 mg/1,000 mg film-coated tablets
Slovenian: Synjardy 5 mg/1000 mg filmsko obložene tablete
English: Table 6: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformin
Slovenian: Preglednica 6: Rezultati učinkovitosti v 104. tednu v z zdravilno učinkovino nadzorovani študiji, v kateri so empagliflozin primerjali z glimepiridom kot dodatnim zdravljenjem k metforminu empagliflozin 25 mg glimepirid
English: The efficacy and safety of empagliflozin as add-on to multiple daily insulin with concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 52 weeks duration.
Slovenian: Empagliflozin kot dodatno zdravljenje k večkratnim dnevnim odmerkom insulina Učinkovitost in varnost empagliflozina kot dodatnega zdravljenja k večkratnim dnevnim odmerkom insulina s sočasnim zdravljenjem z metforminom so ocenili v dvojno slepem, s placebom nadzorovanem 52-tedenskem preskušanju.
English: Foot care
Slovenian: Nega stopal
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Subgroup analysis for patients on additional background of metformin (FAS, LOCF) Mean adjusted for baseline value Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure LOCF, values after antihypertensive rescue censored * p-value <0.0001 ** p-value <0.01
Slovenian: Vrednost SBP (mmHg) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (95-odstotni IZ) Niz celotne analize (FAS, full analysis set) z uporabo zadnjega opazovanja prenesenega naprej (LOCF, last observation carried forward) pred uporabo reševalnega zdravljenja za ureditev glikemije Analiza pri podskupinah bolnikov ob prisotnosti metformina (FAS, LOCF) Povprečje, prilagojeno za izhodiščne vrednosti Statistična značilnost ni bila ocenjena zaradi zaporednega potrditvenega postopka testiranja LOCF, vrednosti po cenzuriranju antihipertenzivnega reševanja * vrednost p < 0,0001 ** vrednost p < 0,01
English: Co-administration of metformin with Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin.
Slovenian: • zaviralci OCT1 (npr. verapamil) lahko zmanjša učinkovitost metformina.
English: They have “S12” and the Boehringer Ingelheim logo on one side and “1000” on the other.
Slovenian: Na eni strani imajo oznako “S12”, in logotip podjetja Boehringer Ingelheim, na drugi strani pa oznako “1000”.
English: Post marketing cases of complicated urinary tract infections including pyelonephritis and urosepsis have been reported in patients treated with empagliflozin.
Slovenian: V obdobju trženja so pri bolnikih, zdravljenih z empagliflozinom, poročali o primerih zapletenih okužb sečil, vključno s pielonefritisom in urosepso.Vendar pa je treba pri bolnikih z zapleteno okužbo sečil razmisliti o začasni prekinitvi zdravljenja.
English: They have “S5” and the Boehringer Ingelheim logo on one side and “850” on the other.
Slovenian: Na eni strani imajo oznako “S5” in logotip podjetja Boehringer Ingelheim, na drugi strani pa oznako “850”.
English: How to store Synjardy
Slovenian: Shranjevanje zdravila Synjardy
English: They have “S12” and the Boehringer Ingelheim logo on one side and “850” on the other.
Slovenian: Na eni strani imajo oznako “S12” in logotip podjetja Boehringer Ingelheim, na drugi strani pa oznako “850”.
English: Synjardy 12.5 mg/850 mg film-coated tablets are pinkish white, oval, biconvex.
Slovenian: Synjardy 12,5 mg/850 mg filmsko obložene tablete so rožnato bele, ovalne, bikonveksne tablete.
English: - Film coating: hypromellose, macrogol 400, titanium dioxide (E171), talc.
Slovenian: Filmska obloga hipromeloza makrogol 400 titanov dioksid (E171) smukec rumeni železov oksid (E172)
English: • changes to the way things taste
Slovenian: • spremembe v okušanju,
English: They have “S5” and the Boehringer Ingelheim logo on one side and “1000” on the other.
Slovenian: Na eni strani imajo oznako “S5” in logotip podjetja Boehringer Ingelheim, na drugi strani pa ozanko “1000”.
English: Synjardy 5 mg/1,000 mg film-coated tablets are brownish yellow, oval, biconvex.
Slovenian: Synjardy 5 mg/1000 mg filmsko obložene tablete so rjavkasto rumene, ovalne, bikonveksne tablete.
English: Time to first event of CV death, non-fatal MI, or non-fatal stroke N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority CV Death N (%) Hazard ratio vs. placebo (95% CI) p-value Non-fatal MI N (%) Hazard ratio vs. placebo (95% CI) p−value Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI) CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Slovenian: Čas do prve srčno-žilne smrti, miokardnega infarkta brez smrtnega izida ali kapi brez smrtnega izida) N (%) razmerje tveganja v primerjavi s placebom (95,02 % IZ) vrednost p za superiornost srčno-žilna smrt N (%) razmerje tveganja v primerjavi s placebom (95 % IZ) vrednost p miokardni infarkt brez smrtnega izida N
English: Your blood sugar levels may increase when you stop taking Synjardy.
Slovenian: Če boste zdravilo Synjardy prenehali jemati, se bodo ravni krvnega sladkorja morda povišale.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/850 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI SKUPNO PAKIRANJE - VMESNA OVOJNINA BREZ MODREGA OKENCA - 5 mg/850 mg