FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Synjardy 5 mg/850 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Synjardy 5 mg/850 mg filmsko obložene tablete Ena tableta vsebuje 5 mg empagliflozina in 850 mg metforminijevega klorida.
English: Adults with normal renal function (GFR ≥90 ml/min) The recommended dose is one tablet twice daily.
Slovenian: 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.
English: The intensity of urinary tract infections (i.e. mild/moderate/severe) was similar to placebo.
Slovenian: Okužbe sečil so bile po jakosti (blaga, zmerna, huda) podobne kot pri bolnikih, zdravljenih s placebom.
English: 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).
Slovenian: Prevladujoči presnovki so bili trije konjugati glukuronida (2-, 3- in 6-O-glukuronid).
English: 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.
Slovenian: Razpolovni čas izločanja se tako podaljša, kar povzroči povečanje koncentracije metformina v plazmi.
English: 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
Slovenian: 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
English: 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.
Slovenian: • zaviralci OCT2 (npr. cimetidin, dolutegravir, ranolazin, trimetoprim, vandetanib, izavukonazol)
English: As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance.
Slovenian: Ta rezultat ima majhen klinični pomen, saj se odmerki titrirajo individualno na podlagi urejenosti glikemije.
English: Taste disturbance
Slovenian: Jetrna okvara
English: Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish purple, oval, biconvex.
Slovenian: Synjardy 12,5 mg/1000 mg filmsko obložene tablete so temno rjavkasto vijoličaste, ovalne, bikonveksne tablete.
English: Serum lipids increased
Slovenian: Preiskave zvišana raven lipidov v serumu
English: Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Slovenian: Telesna masa (kg) Izhodišče (povprečja) Sprememba od izhodišča Razlika glede na placebo (95 % IZ)
English: 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.
Slovenian: 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 %.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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
Slovenian: 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
English: Synjardy 5 mg/850 mg film-coated tablets EU/1/15/1003/001
Slovenian: Synjardy 5 mg/850 mg filmsko obložene tablete EU/1/15/1003/001
English: HbA1c (%) at week 18 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Slovenian: Vrednost HbA1c (%) v 18. tednu Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (97,5-odstotni IZ)
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Slovenian: Vrednost SBP (mmHg) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (95-odstotni IZ)
English: • Diabetic pre-coma.
Slovenian: • Diabetična predkoma.
English: Each Synjardy 5 mg/850 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovenian: Ena filmsko obložena tableta Synjardy 5 mg/850 mg (tableta) vsebuje 5 mg empagliflozina in 850 mg metforminijevega klorida.
English: Synjardy 12.5 mg/1,000 mg film-coated tablets EU/1/15/1003/028
Slovenian: Synjardy 12,5 mg/1000 mg filmsko obložene tablete EU/1/15/1003/028
English: Do not drive or use any tools or machines if you feel dizzy while taking Synjardy.
Slovenian: Če ste med jemanjem zdravila Synjardy omotični, ne vozite in ne upravljajte z orodji ali stroji.
English: Synjardy 5 mg/1,000 mg film-coated tablets EU/1/15/1003/010
Slovenian: Synjardy 5 mg/1000 mg filmsko obložene tablete EU/1/15/1003/010
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7% at week 52
Slovenian: Bolniki (%) z izhodiščno vrednostjo HbA1c ≥ 7 %, ki so dosegli vrednost HbA1c < 7 % v 52. tednu b, 2
English: Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Slovenian: Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (97,5-odstotni IZ)
English: 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
Slovenian: 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
English: • vomiting
Slovenian: • bruhanje,
English: Synjardy 12.5 mg/850 mg film-coated tablets EU/1/15/1003/019
Slovenian: Synjardy 12,5 mg/850 mg filmsko obložene tablete EU/1/15/1003/019
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/850 mg
Slovenian: ZUNANJA NALEPKA NA SKUPNEM PAKIRANJU - VKLJUČNO Z MODRIM OKENCEM - 12,5 mg/850 mg
English: Synjardy 5 mg/1,000 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovenian: Synjardy 5 mg/1000 mg filmsko obložene tablete Ena tableta vsebuje 5 mg empagliflozina in 1.000 mg metforminijevega klorida.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/1,000 mg
Slovenian: ZUNANJA NALEPKA NA SKUPNEM PAKIRANJU - VKLJUČNO Z MODRIM OKENCEM - 5 mg/1.000 mg
English: • 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),
Slovenian: • 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;
English: Synjardy 12.5 mg/850 mg film-coated tablets and Synjardy 12.5 mg/1,000 mg film-coated tablets Tablet core
Slovenian: Synjardy 12,5 mg/850 mg filmsko obložene tablete in Synjardy 12,5 mg/1000 mg filmsko obložene tablete
English: 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.
Slovenian: 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.
English: Synjardy 12.5 mg/850 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovenian: Synjardy 12,5 mg/850 mg filmsko obložene tablete Ena tableta vsebuje 12,5 mg empagliflozina in 850 mg metforminijevega klorida.
English: Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Slovenian: Na podlagi populacijske farmakokinetične analize spol ni imel klinično pomembnega učinka na farmakokinetiko empagliflozina.
English: Identified adverse reactions of empagliflozin monotherapy Identified adverse reactions of metformin monotherapy
Slovenian: Neželeni učinki, o katerih so poročali pri metforminu v monoterapiji.
English: 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).
Slovenian: 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).
English: Each Synjardy 12.5 mg/850 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovenian: Ena filmsko obložena tableta Synjardy 12,5 mg/850 mg (tableta) vsebuje 12,5 mg empagliflozina in 850 mg metforminijevega klorida.
English: Each Synjardy 12.5 mg/1,000 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovenian: Ena filmsko obložena tableta Synjardy 12,5 mg/1000 mg (tableta) vsebuje 12,5 mg empagliflozina in 1.000 mg metforminijevega klorida.
English: Each Synjardy 5 mg/1,000 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovenian: Ena filmsko obložena tableta Synjardy 5 mg/1000 mg (tableta) vsebuje 5 mg empagliflozina in 1.000 mg metforminijevega klorida.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/1,000 mg
Slovenian: ZUNANJA NALEPKA NA SKUPNEM PAKIRANJU - VKLJUČNO Z MODRIM OKENCEM - 12,5 mg/1.000 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/850 mg
Slovenian: ZUNANJA NALEPKA NA SKUPNEM PAKIRANJU - VKLJUČNO Z MODRIM OKENCEM - 5 mg/850 mg
English: Synjardy 12.5 mg/1,000 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovenian: Synjardy 12,5 mg/1000 mg filmsko obložene tablete Ena tableta vsebuje 12,5 mg empagliflozina in 1.000 mg metforminijevega klorida.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 12,5 mg empagliflozina in 850 mg metforminijevega klorida.
English: No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea and as add-on to linagliptin and metformin.
Slovenian: Pri kombinaciji z metforminom in sulfonilsečnino in kot dodatno zdravljenje z linagliptinom in metforminom se pri nobenem od bolnikov ni pojavil hud hipoglikemični dogodek.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 12,5 mg empagliflozina in 1.000 mg metforminijevega klorida.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg tablets empagliflozin/metformin HCL
Slovenian: IME ZDRAVILA Synjardy 12,5 mg/850 mg tablete empagliflozin/metforminijev klorid
English: Angioedema
Slovenian: Nevropatija
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Slovenian: Vrednost HbA1c (%) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (97,5-odstotni IZ)
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg tablets empagliflozin/metformin HCL
Slovenian: IME ZDRAVILA Synjardy 12,5 mg/1000 mg tablete empagliflozin/metforminijev klorid
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg tablets empagliflozin/metformin HCL
Slovenian: IME ZDRAVILA Synjardy 5 mg/1000 mg tablete empagliflozin/metforminijev klorid
English: Basal insulin dose (IU/day) at week 78
Slovenian: Vrednost HbA1c (%) v 78. tednu
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg tablets empagliflozin/metformin HCL
Slovenian: IME ZDRAVILA Synjardy 5 mg/850 mg tablete empagliflozin/metforminijev klorid
English: 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).
Slovenian: 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).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 5 mg empagliflozina in 1.000 mg metforminijevega klorida.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/1,000 mg
Slovenian: SKUPNO PAKIRANJE - VMESNA OVOJNINA BREZ MODREGA OKENCA12,5 mg/1.000 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 5 mg empagliflozina in 850 mg metforminijevega klorida.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (perforated)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Urticaria
Slovenian: Diuretiki
English: Placebo empagliflozin
Slovenian: Učinki drugih zdravil na empagliflozin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/850 mg
Slovenian: SKUPNO PAKIRANJE - VMESNA OVOJNINA BREZ MODREGA OKENCA12,5 mg/850 mg
English: 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
Slovenian: 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
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets.
Slovenian: Skupno pakiranje vključuje 2 enoti, od katerih vsaka vsebuje 60 x 1 filmsko obloženo tableto.
English: Copovidone (K-value nominally 28)
Slovenian: Jedro tablete koruzni škrob kopovidon (nazivna K-vrednost 28) koloidni brezvodni silicijev dioksid magnezijev stearat
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/1,000 mg
Slovenian: SKUPNO PAKIRANJE - VMESNA OVOJNINA BREZ MODREGA OKENCA5 mg/1.000 mg
English: Gastrointestinal symptoms
Slovenian: Bolezni prebavil prebavni simptomi
English: 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
Slovenian: 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
English: 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
Slovenian: 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
English: HbA1c (%) at week 78 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Slovenian: Odmerek bazalnega insulina (i.e./dan) v 78. tednu Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (97,5-odstotni IZ)
English: 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
Slovenian: 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
English: Treatment with empagliflozin provided reductions in seated SBP and DBP.
Slovenian: Zdravljenje z empagliflozinom je povzročilo zmanjšanje sistoličnega in diastoličnega krvnega tlaka, merjenega sede.
English: Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Slovenian: Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo (97,5-odstotni IZ)
English: 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
Slovenian: 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
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Slovenian: Synjardy 5 mg/850 mg filmsko obložene tablete empagliflozin/metforminijev klorid
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Slovenian: Synjardy 12,5 mg/850 mg filmsko obložene tablete empagliflozin/metforminijev klorid
English: Nephropathy
Slovenian: Laktacidoza
English: 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
Slovenian: 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
English: 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
Slovenian: 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
English: 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
Slovenian: 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
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Slovenian: Synjardy 12,5 mg/1000 mg filmsko obložene tablete empagliflozin/metforminijev klorid
English: Eli Lilly Italia S.p.A. Tel: +39 055 42571
Slovenian: Tel: +39 055 42571
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Slovenian: Synjardy 5 mg/1000 mg filmsko obložene tablete empagliflozin/metforminijev klorid
English: Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Slovenian: Na podlagi populacijske farmakokinetične analize starost ni imela klinično pomembnega učinka na farmakokinetiko empagliflozina.
English: Erythema
Slovenian: IZ)
English: The difference in frequency was less pronounced in male patients.
Slovenian: O teh okužbah so pri ženskah pogosteje poročali pri empagliflozinu kot pri placebu, medtem ko je bila pri moških razlika v pogostnosti manj izrazita.
English: Maximum daily dose is 2000 mg.
Slovenian: 45 do 59 Največji dnevni odmerek je 2.000 mg.
English: Empagliflozin as add-on to multiple daily insulin
Slovenian: Empagliflozin dvakrat dnevno v primerjavi z empagliflozinom enkrat dnevno kot dodatnim zdravljenjem k metforminu
English: What Synjardy looks like and contents of the pack Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex.
Slovenian: Synjardy 5 mg/850 mg filmsko obložene tablete so rumenkasto bele, ovalne, bikonveksne tablete.
English: 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
Slovenian: 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
English: 90 (3 x 30) tablets (multipack)
Slovenian: 90 (3 x 30) filmsko obloženih tablet
English: Annex A
Slovenian: HDPE plastenka
English: Pack size
Slovenian: (alu/alu) pretisni omot
English: The application was withdrawn in the Netherlands and United Kingdom.
Slovenian: Vloga je bila umaknjena na Nizozemskem in v Združenem kraljestvu.
English: 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.
Slovenian: Referenčna država članica je bila Finska, zadevne države članice pa so bile Avstrija, Belgija, Danska, Nemčija, Italija, Luksemburg, Nizozemska, Portugalska, Švedska in Združeno kraljestvo.
English: 21 February 2006 EMEA/CHMP/373061/2005
Slovenian: EMEA/CHMP/373061/2005