natgillin/translations-raw huggingface dataset:
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. 
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
Your blood sugar levels may increase when you stop taking Synjardy. 
Če boste zdravilo Synjardy prenehali jemati, se bodo ravni krvnega sladkorja morda povišale.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/850 mg 
PODATKI NA ZUNANJI OVOJNINI SKUPNO PAKIRANJE - VMESNA OVOJNINA BREZ MODREGA OKENCA - 5 mg/850 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION Synjardy 5 mg/850 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Synjardy 5 mg/850 mg filmsko obložene tablete Ena tableta vsebuje 5 mg empagliflozina in 850 mg metforminijevega klorida.
Adults with normal renal function (GFR ≥90 ml/min) The recommended dose is one tablet twice daily. 
Odrasli z normalnim delovanjem ledvic (GFR ≥ 90 ml/min) Priporočeni odmerek je ena tableta dvakrat na dan. Odmerek je treba prilagoditi vsakemu bolniku na podlagi obstoječega režima zdravljenja, učinkovitosti in prenašanja.
The intensity of urinary tract infections (i.e. mild/moderate/severe) was similar to placebo. 
Okužbe sečil so bile po jakosti (blaga, zmerna, huda) podobne kot pri bolnikih, zdravljenih s placebom.
No major metabolites of empagliflozin were detected in human plasma, as defined by at least 10% of total drug-related material, and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O-glucuronide). 
Prevladujoči presnovki so bili trije konjugati glukuronida (2-, 3- in 6-O-glukuronid).
When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma. 
Razpolovni čas izločanja se tako podaljša, kar povzroči povečanje koncentracije metformina v plazmi.
Table 8: Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformin Placebo 
Preglednica 8: Rezultati učinkovitosti v 18. in 78. tednu v s placebom nadzorovani študiji empagliflozina kot dodatnega zdravljenja k bazalnemu insulinu z metforminom placebo empagliflozin 10 mg empagliflozin 25 mg
Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration. 
• zaviralci OCT2 (npr. cimetidin, dolutegravir, ranolazin, trimetoprim, vandetanib, izavukonazol)
As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance. 
Ta rezultat ima majhen klinični pomen, saj se odmerki titrirajo individualno na podlagi urejenosti glikemije.
Taste disturbance 
Jetrna okvara
Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish purple, oval, biconvex. 
Synjardy 12,5 mg/1000 mg filmsko obložene tablete so temno rjavkasto vijoličaste, ovalne, bikonveksne tablete.
Serum lipids increased 
Preiskave zvišana raven lipidov v serumu
Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (95% CI) 
Telesna masa (kg) Izhodišče (povprečja) Sprememba od izhodišča Razlika glede na placebo (95 % IZ)
A greater proportion of patients with a baseline HbA1c ≥7.0% and treated with empagliflozin plus linagliptin achieved a target HbA1c of <7% compared to linagliptin 5 mg. Clinically meaningful reductions in HbA1c were maintained for 52 weeks. 
V primerjavi z linagliptinom 5 mg je večji delež bolnikov, zdravljenih z empagliflozinom z linagliptinom in z izhodiščno vrednostjo HbA1c ≥ 7,0 %, dosegel ciljno vrednost HbA1c < 7 %.
Yellowish white, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm). 
Rumenkasto bela, ovalna, bikonveksna filmsko obložena tableta z oznako “S5” in logotipom podjetja Boehringer Ingelheim na eni strani ter oznako “850” na drugi strani (dolžina tablete: 19,2 mm, širina tablete: 9,4 mm).
Brownish yellow, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm). 
Rjavkasto rumena, ovalna, bikonveksna filmsko obložena tableta z oznako “S5” in logotipom podjetja Boehringer Ingelheim na eni strani ter oznako “1000” na drugi strani (dolžina tablete: 21,1 mm, širina tablete: 9,7 mm).
Synjardy 5 mg/850 mg film-coated tablets Synjardy 5 mg/1,000 mg film-coated tablets Synjardy 12.5 mg/850 mg film-coated tablets Synjardy 12.5 mg/1,000 mg film-coated tablets Empagliflozin/metformin hydrochloride 
Synjardy 5 mg/850 mg filmsko obložene tablete Synjardy 5 mg/1000 mg filmsko obložene tablete Synjardy 12,5 mg/850 mg filmsko obložene tablete Synjardy 12,5 mg/1000 mg filmsko obložene tablete empagliflozin/metforminijev klorid
Synjardy 5 mg/850 mg film-coated tablets EU/1/15/1003/001 
Synjardy 5 mg/850 mg filmsko obložene tablete EU/1/15/1003/001
HbA1c (%) at week 18 Baseline (mean) Change from baseline Difference from placebo (97.5% CI) 
Vrednost HbA1c (%) v 18. tednu Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (97,5-odstotni IZ)
SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (95% CI) 
Vrednost SBP (mmHg) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (95-odstotni IZ)
• Diabetic pre-coma. 
• Diabetična predkoma.
Each Synjardy 5 mg/850 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 850 mg metformin hydrochloride. 
Ena filmsko obložena tableta Synjardy 5 mg/850 mg (tableta) vsebuje 5 mg empagliflozina in 850 mg metforminijevega klorida.
Synjardy 12.5 mg/1,000 mg film-coated tablets EU/1/15/1003/028 
Synjardy 12,5 mg/1000 mg filmsko obložene tablete EU/1/15/1003/028
Do not drive or use any tools or machines if you feel dizzy while taking Synjardy. 
Če ste med jemanjem zdravila Synjardy omotični, ne vozite in ne upravljajte z orodji ali stroji.
Synjardy 5 mg/1,000 mg film-coated tablets EU/1/15/1003/010 
Synjardy 5 mg/1000 mg filmsko obložene tablete EU/1/15/1003/010
Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7% at week 52 
Bolniki (%) z izhodiščno vrednostjo HbA1c ≥ 7 %, ki so dosegli vrednost HbA1c < 7 % v 52. tednu b, 2
Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (97.5% CI) 
Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (97,5-odstotni IZ)
Synjardy 5 mg/850 mg film-coated tablets Synjardy 5 mg/1,000 mg film-coated tablets Synjardy 12.5 mg/850 mg film-coated tablets Synjardy 12.5 mg/1,000 mg film-coated tablets 
Synjardy 5 mg/850 mg filmsko obložene tablete Synjardy 5 mg/1000 mg filmsko obložene tablete Synjardy 12,5 mg/850 mg filmsko obložene tablete Synjardy 12,5 mg/1000 mg filmsko obložene tablete
• vomiting 
• bruhanje,
Synjardy 12.5 mg/850 mg film-coated tablets EU/1/15/1003/019 
Synjardy 12,5 mg/850 mg filmsko obložene tablete EU/1/15/1003/019
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/850 mg 
ZUNANJA NALEPKA NA SKUPNEM PAKIRANJU - VKLJUČNO Z MODRIM OKENCEM - 12,5 mg/850 mg
Synjardy 5 mg/1,000 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride. 
Synjardy 5 mg/1000 mg filmsko obložene tablete Ena tableta vsebuje 5 mg empagliflozina in 1.000 mg metforminijevega klorida.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/1,000 mg 
ZUNANJA NALEPKA NA SKUPNEM PAKIRANJU - VKLJUČNO Z MODRIM OKENCEM - 5 mg/1.000 mg
• a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), 
• pomembno zmanjšanje absolutnega tveganja za kateri koli s sladkorno boleznijo povezan zaplet v skupini z metforminom (29,8 dogodka/1.000 bolnikov-let), v primerjavi s samo dieto (43,3 dogodka/1.000 bolnikov-let), p = 0,0023, in v primerjavi z obema skupinama s sulfonilsečnino ali insulinom v monoterapiji (40,1 dogodka/1.000 bolnikov-let), p = 0,0034;
Synjardy 12.5 mg/850 mg film-coated tablets and Synjardy 12.5 mg/1,000 mg film-coated tablets Tablet core 
Synjardy 12,5 mg/850 mg filmsko obložene tablete in Synjardy 12,5 mg/1000 mg filmsko obložene tablete
Major hypoglycaemic events occurred in 0.5%, 0% and 0.5% of patients treated with empagliflozin 10 mg, empagliflozin 25 mg and placebo when added on to metformin and insulin, respectively. 
Pri 0,5 % bolnikov, ki so kot dodatek k metforminu in insulinu prejemali empagliflozin 10 mg, 0 % bolnikov, ki so prejemali empagliflozin 25 mg, in 0,5 % bolnikov, ki so prejemali placebo, so se pojavili hudi hipoglikemični dogodki.
Synjardy 12.5 mg/850 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride. 
Synjardy 12,5 mg/850 mg filmsko obložene tablete Ena tableta vsebuje 12,5 mg empagliflozina in 850 mg metforminijevega klorida.
Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis. 
Na podlagi populacijske farmakokinetične analize spol ni imel klinično pomembnega učinka na farmakokinetiko empagliflozina.
Identified adverse reactions of empagliflozin monotherapy Identified adverse reactions of metformin monotherapy 
Neželeni učinki, o katerih so poročali pri metforminu v monoterapiji.
Dark brownish purple, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm). 
Synjardy 12,5 mg/1000 mg filmsko obložene tablete Temno rjavkasto vijoličasta, ovalna, bikonveksna filmsko obložena tableta z oznako “S12” in logotipom podjetja Boehringer Ingelheim na eni strani ter oznako “1000” na drugi strani (dolžina tablete: 21,1 mm, širina tablete: 9,7 mm).
Each Synjardy 12.5 mg/850 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride. 
Ena filmsko obložena tableta Synjardy 12,5 mg/850 mg (tableta) vsebuje 12,5 mg empagliflozina in 850 mg metforminijevega klorida.
Each Synjardy 12.5 mg/1,000 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride. 
Ena filmsko obložena tableta Synjardy 12,5 mg/1000 mg (tableta) vsebuje 12,5 mg empagliflozina in 1.000 mg metforminijevega klorida.
Each Synjardy 5 mg/1,000 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride. 
Ena filmsko obložena tableta Synjardy 5 mg/1000 mg (tableta) vsebuje 5 mg empagliflozina in 1.000 mg metforminijevega klorida.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/1,000 mg 
ZUNANJA NALEPKA NA SKUPNEM PAKIRANJU - VKLJUČNO Z MODRIM OKENCEM - 12,5 mg/1.000 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/850 mg 
ZUNANJA NALEPKA NA SKUPNEM PAKIRANJU - VKLJUČNO Z MODRIM OKENCEM - 5 mg/850 mg
Synjardy 12.5 mg/1,000 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride. 
Synjardy 12,5 mg/1000 mg filmsko obložene tablete Ena tableta vsebuje 12,5 mg empagliflozina in 1.000 mg metforminijevega klorida.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 12,5 mg empagliflozina in 850 mg metforminijevega klorida.
No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea and as add-on to linagliptin and metformin. 
Pri kombinaciji z metforminom in sulfonilsečnino in kot dodatno zdravljenje z linagliptinom in metforminom se pri nobenem od bolnikov ni pojavil hud hipoglikemični dogodek.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 12,5 mg empagliflozina in 1.000 mg metforminijevega klorida.
NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg tablets empagliflozin/metformin HCL 
IME ZDRAVILA Synjardy 12,5 mg/850 mg tablete empagliflozin/metforminijev klorid
Angioedema 
Nevropatija
HbA1c (%) Baseline (mean) Change from baseline Difference from placebo (97.5% CI) 
Vrednost HbA1c (%) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (97,5-odstotni IZ)
NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg tablets empagliflozin/metformin HCL 
IME ZDRAVILA Synjardy 12,5 mg/1000 mg tablete empagliflozin/metforminijev klorid
NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg tablets empagliflozin/metformin HCL 
IME ZDRAVILA Synjardy 5 mg/1000 mg tablete empagliflozin/metforminijev klorid
Basal insulin dose (IU/day) at week 78 
Vrednost HbA1c (%) v 78. tednu
NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg tablets empagliflozin/metformin HCL 
IME ZDRAVILA Synjardy 5 mg/850 mg tablete empagliflozin/metforminijev klorid
Pinkish white, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm). 
Synjardy 12,5 mg/850 mg filmsko obložene tablete Rožnato bela, ovalna, bikonveksna filmsko obložena tableta z oznako “S12” in logotipom podjetja Boehringer Ingelheim na eni strani ter oznako “850” na drugi strani (dolžina tablete: 19,2 mm, širina tablete: 9,4 mm).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 5 mg empagliflozina in 1.000 mg metforminijevega klorida.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/1,000 mg 
SKUPNO PAKIRANJE - VMESNA OVOJNINA BREZ MODREGA OKENCA12,5 mg/1.000 mg
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 5 mg empagliflozina in 850 mg metforminijevega klorida.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (perforated) 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Urticaria 
Diuretiki
Placebo empagliflozin 
Učinki drugih zdravil na empagliflozin
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/850 mg 
SKUPNO PAKIRANJE - VMESNA OVOJNINA BREZ MODREGA OKENCA12,5 mg/850 mg
EU/1/15/1003/001 10 film-coated tablets EU/1/15/1003/002 14 film-coated tablets EU/1/15/1003/003 30 film-coated tablets EU/1/15/1003/004 56 film-coated tablets EU/1/15/1003/005 60 film-coated tablets EU/1/15/1003/037 90 film-coated tablets EU/1/15/1003/006 100 film-coated tablets 
EU/1/15/1003/001 10 filmsko obloženih tablet EU/1/15/1003/002 14 filmsko obloženih tablet EU/1/15/1003/003 30 filmsko obloženih tablet EU/1/15/1003/004 56 filmsko obloženih tablet EU/1/15/1003/005 60 filmsko obloženih tablet EU/1/15/1003/037 90 filmsko obloženih tablet EU/1/15/1003/006 100 filmsko obloženih tablet
PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets. 
Skupno pakiranje vključuje 2 enoti, od katerih vsaka vsebuje 60 x 1 filmsko obloženo tableto.
Copovidone (K-value nominally 28) 
Jedro tablete koruzni škrob kopovidon (nazivna K-vrednost 28) koloidni brezvodni silicijev dioksid magnezijev stearat
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/1,000 mg 
SKUPNO PAKIRANJE - VMESNA OVOJNINA BREZ MODREGA OKENCA5 mg/1.000 mg
Gastrointestinal symptoms 
Bolezni prebavil prebavni simptomi
EU/1/15/1003/019 10 film-coated tablets EU/1/15/1003/020 14 film-coated tablets EU/1/15/1003/021 30 film-coated tablets EU/1/15/1003/022 56 film-coated tablets EU/1/15/1003/023 60 film-coated tablets EU/1/15/1003/039 90 film-coated tablets EU/1/15/1003/024 100 film-coated tablets 
EU/1/15/1003/019 10 filmsko obloženih tablet EU/1/15/1003/020 14 filmsko obloženih tablet EU/1/15/1003/021 30 filmsko obloženih tablet EU/1/15/1003/022 56 filmsko obloženih tablet EU/1/15/1003/023 60 filmsko obloženih tablet EU/1/15/1003/039 90 filmsko obloženih tablet EU/1/15/1003/024 100 filmsko obloženih tablet
EU/1/15/1003/028 10 film-coated tablets EU/1/15/1003/029 14 film-coated tablets EU/1/15/1003/030 30 film-coated tablets EU/1/15/1003/031 56 film-coated tablets EU/1/15/1003/032 60 film-coated tablets EU/1/15/1003/040 90 film-coated tablets EU/1/15/1003/033 100 film-coated tablets 
EU/1/15/1003/028 10 filmsko obloženih tablet EU/1/15/1003/029 14 filmsko obloženih tablet EU/1/15/1003/030 30 filmsko obloženih tablet EU/1/15/1003/031 56 filmsko obloženih tablet EU/1/15/1003/032 60 filmsko obloženih tablet EU/1/15/1003/040 90 filmsko obloženih tablet EU/1/15/1003/033 100 filmsko obloženih tablet
HbA1c (%) at week 78 Baseline (mean) Change from baseline Difference from placebo (97.5% CI) 
Odmerek bazalnega insulina (i.e./dan) v 78. tednu Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (97,5-odstotni IZ)
EU/1/15/1003/010 10 film-coated tablets EU/1/15/1003/011 14 film-coated tablets EU/1/15/1003/012 30 film-coated tablets EU/1/15/1003/013 56 film-coated tablets EU/1/15/1003/014 60 film-coated tablets EU/1/15/1003/038 90 film-coated tablets EU/1/15/1003/015 100 film-coated tablets 
EU/1/15/1003/010 10 filmsko obloženih tablet EU/1/15/1003/011 14 filmsko obloženih tablet EU/1/15/1003/012 30 filmsko obloženih tablet EU/1/15/1003/013 56 filmsko obloženih tablet EU/1/15/1003/014 60 filmsko obloženih tablet EU/1/15/1003/038 90 filmsko obloženih tablet EU/1/15/1003/015 100 filmsko obloženih tablet
Treatment with empagliflozin provided reductions in seated SBP and DBP. 
Zdravljenje z empagliflozinom je povzročilo zmanjšanje sistoličnega in diastoličnega krvnega tlaka, merjenega sede.
Baseline (mean) Change from baseline Difference from placebo (97.5% CI) 
Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (97,5-odstotni IZ)
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/034 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/035 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/036 200 (2 x 100 x 1) film-coated tablets 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1003/034 120 (2 x 60 x 1) filmsko obloženih tablet EU/1/15/1003/035 180 (2 x 90 x 1) filmsko obloženih tablet EU/1/15/1003/036 200 (2 x 100 x 1) filmsko obloženih tablet
NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride 
Synjardy 5 mg/850 mg filmsko obložene tablete empagliflozin/metforminijev klorid
NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride 
Synjardy 12,5 mg/850 mg filmsko obložene tablete empagliflozin/metforminijev klorid
Nephropathy 
Laktacidoza
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/025 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/026 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/027 200 (2 x 100 x 1) film-coated tablets 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1003/025 120 (2 x 60 x 1) filmsko obloženih tablet EU/1/15/1003/026 180 (2 x 90 x 1) filmsko obloženih tablet EU/1/15/1003/027 200 (2 x 100 x 1) filmsko obloženih tablet
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/016 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/017 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/018 200 (2 x 100 x 1) film-coated tablets 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1003/016 120 (2 x 60 x 1) filmsko obloženih tablet EU/1/15/1003/017 180 (2 x 90 x 1) filmsko obloženih tablet EU/1/15/1003/018 200 (2 x 100 x 1) filmsko obloženih tablet
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/007 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/008180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/009 200 (2 x 100 x 1) film-coated tablets 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1003/007 120 (2 x 60 x 1) filmsko obloženih tablet EU/1/15/1003/008 180 (2 x 90 x 1) filmsko obloženih tablet EU/1/15/1003/009 200 (2 x 100 x 1) filmsko obloženih tablet
NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride 
Synjardy 12,5 mg/1000 mg filmsko obložene tablete empagliflozin/metforminijev klorid
NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride 
Synjardy 5 mg/1000 mg filmsko obložene tablete empagliflozin/metforminijev klorid
Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis. 
Na podlagi populacijske farmakokinetične analize starost ni imela klinično pomembnega učinka na farmakokinetiko empagliflozina.
Erythema 
IZ)
The difference in frequency was less pronounced in male patients. 
O teh okužbah so pri ženskah pogosteje poročali pri empagliflozinu kot pri placebu, medtem ko je bila pri moških razlika v pogostnosti manj izrazita.
Maximum daily dose is 2000 mg. 
45 do 59 Največji dnevni odmerek je 2.000 mg.
Empagliflozin as add-on to multiple daily insulin 
Empagliflozin dvakrat dnevno v primerjavi z empagliflozinom enkrat dnevno kot dodatnim zdravljenjem k metforminu
What Synjardy looks like and contents of the pack Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex. 
Synjardy 5 mg/850 mg filmsko obložene tablete so rumenkasto bele, ovalne, bikonveksne tablete.
Subgroup analysis of full analysis set (FAS) for patients on additional background of metforminCompleters using last observation carried forward (LOCF) prior to glycaemic rescue therapy mean adjusted for baseline value * p-value <0.0001 ** p-value ≤0.025 
Niz celotne analize (FAS, full analysis set) podskupine bolnikov ob prisotnosti metformina, ki so študijo končali, z uporabo zadnjega opazovanja prenesenega naprej (LOCF) pred uporabo reševalnega zdravljenja za ureditev glikemije
90 (3 x 30) tablets (multipack) 
90 (3 x 30) filmsko obloženih tablet
Annex A 
HDPE plastenka
Pack size 
(alu/alu) pretisni omot
The application was withdrawn in the Netherlands and United Kingdom. 
Vloga je bila umaknjena na Nizozemskem in v Združenem kraljestvu.
The Reference Member State was Finland and the Concerned Member States were Austria, Belgium, Denmark, Germany, Italy, Luxembourg, the Netherlands, Portugal, Sweden and United Kingdom. 
Referenčna država članica je bila Finska, zadevne države članice pa so bile Avstrija, Belgija, Danska, Nemčija, Italija, Luksemburg, Nizozemska, Portugalska, Švedska in Združeno kraljestvo.
The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. 
Zadevne države članice niso mogle doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.