FrancophonIA/ELRC3.0 huggingface dataset:
English: Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Dutch: Afgaand op de populatiefarmacokinetische analyse had de body mass index (BMI) geen klinisch relevant effect op de farmacokinetiek van empagliflozine.
English: They have “S12” and the Boehringer Ingelheim logo on one side and “850” on the other.
Dutch: Op de ene kant staat 'S12' en het logo van Boehringer Ingelheim en op de andere kant ‘850'.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Dutch: Bij de mens heeft metformine gunstige effecten op het vetmetabolisme, onafhankelijk van de bloedglucoseverlagende werking.
English: Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Dutch: Baseline (gemiddelde) Verandering vanaf baseline Verschil met placebo (97,5%-BI)
English: What Synjardy is and what it is used for 2.
Dutch: Hoe ziet Synjardy eruit en hoeveel zit er in een verpakking?
English: - 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.
Dutch: • een zoete geur van uw adem, een zoete of metaalachtige smaak in uw mond of een andere geur van uw urine of zweet.
English: They have “S5” and the Boehringer Ingelheim logo on one side and “1000” on the other.
Dutch: Op de ene kant staat ‘S5' en het logo van Boehringer Ingelheim en op de andere kant ‘1000'.
English: • if you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6);
Dutch: • U bent allergisch voor een van de stoffen in dit geneesmiddel.
English: Patients randomized to the placebo group were receiving the placebo plus linagliptin 5 mg with background metformin Patients randomized to the empagliflozin 10 mg or 25 mg groups were receiving empagliflozin 10 mg or 25 mg and linagliptin 5 mg with background metformin * p-value <0.0001
Dutch: Patiënten die gerandomiseerd waren naar de empagliflozine 10 mg of 25 mg-groepen kregen empagliflozine 10 mg of 25 mg en linagliptine 5 mg toegevoegd aan metformine.
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Dutch: SBD (mmHg) Baseline (gemiddelde) Verandering vanaf baseline Verschil met placebo BI)
English: Your blood sugar levels may increase when you stop taking Synjardy.
Dutch: Wanneer u stopt met het innemen van Synjardy, kan uw bloedsuikergehalte stijgen.
English: Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.
Dutch: Dit kan leiden tot symptomen als trillen, zweten en verandering in het gezichtsvermogen, en het kan uw rijvaardigheid en het vermogen om machines te bedienen beïnvloeden.
English: Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');
Dutch: Uitdroging kan nierproblemen tot gevolg hebben, waardoor u risico loopt op lactaatacidose (zie ‘Wanneer moet u extra voorzichtig zijn met dit middel?
English: Comparison vs. met (95% CI)
Dutch: Hazardratio vs. placebo (95% BI) p-waarde
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.
Dutch: • OCT2-remmers (zoals cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib,
English: HbA1c (%) at week 78 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Dutch: HbA1c (%) in week 78 Baseline (gemiddelde) Verandering vanaf baseline Verschil met placebo (97,5%-BI)
English: HbA1c (%) at week 18 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Dutch: HbA1c (%) in week 18 Baseline (gemiddelde) Verandering vanaf baseline Verschil met placebo (97,5%-BI)
English: (40.1 events/1,000 patient-years), p=0.0034,
Dutch: (43,3 voorvallen/1000 patiëntjaren), p = 0,0023, en versus de gecombineerde sulfonylureumderivaat- en insulinemonotherapiegroepen (40,1 voorvallen/1000 patiëntjaren),
English: Synjardy 12.5 mg/850 mg film-coated tablets are pinkish white, oval, biconvex.
Dutch: Synjardy 12,5 mg/850 mg filmomhulde tabletten zijn rozewit, ovaal en bolrond.
English: Each Synjardy 5 mg/850 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Dutch: Elke Synjardy 5 mg/850 mg filmomhulde tablet (tablet) bevat 5 mg empagliflozine en 850 mg metforminehydrochloride.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/850 mg
Dutch: GEGEVENS DIE OP DE BUITENVERPAKKING MOETEN WORDEN VERMELD MULTIVERPAKKING - TUSSENVERPAKKING ZONDER BLUE BOX - 5 mg/850 mg
English: Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish purple, oval, biconvex.
Dutch: Synjardy 12,5 mg/1000 mg filmomhulde tabletten zijn donkerbruinpaars, ovaal en bolrond.
English: Synjardy 5 mg/1,000 mg film-coated tablets are brownish yellow, oval, biconvex.
Dutch: Synjardy 5 mg/1000 mg filmomhulde tabletten zijn bruingeel, ovaal en bolrond.
English: Synjardy 5 mg/850 mg film-coated tablets EU/1/15/1003/001
Dutch: Synjardy 5 mg/850 mg filmomhulde tabletten EU/1/15/1003/001
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/850 mg
Dutch: GEGEVENS DIE OP DE BUITENVERPAKKING MOETEN WORDEN VERMELD MULTIVERPAKKING - TUSSENVERPAKKING ZONDER BLUE BOX - 12,5 mg/850 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/850 mg
Dutch: GEGEVENS DIE OP DE BUITENVERPAKKING MOETEN WORDEN VERMELD ETIKET BUITENWIKKEL OM MULTIVERPAKKINGEN - INCLUSIEF DE BLUE BOX5 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.
Dutch: Synjardy 5 mg/1000 mg filmomhulde tabletten Elke tablet bevat 5 mg empagliflozine en 1000 mg metforminehydrochloride.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/850 mg
Dutch: GEGEVENS DIE OP DE BUITENVERPAKKING MOETEN WORDEN VERMELD ETIKET BUITENWIKKEL OM MULTIVERPAKKINGEN - INCLUSIEF DE BLUE BOX12,5 mg/850 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Dutch: GEHALTE AAN WERKZAME STOF(FEN) Elke tablet bevat 12,5 mg empagliflozine en 850 mg metforminehydrochloride.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Dutch: GEHALTE AAN WERKZAME STOF(FEN) Elke tablet bevat 5 mg empagliflozine en 850 mg metforminehydrochloride.
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).
Dutch: Geelwitte, ovale, biconvexe filmomhulde tabletten met de inscriptie 'S5' en het logo van Boehringer Ingelheim aan de ene kant en '850' aan de andere kant (tabletlengte: 19,2 mm, tabletbreedte: 9,4 mm).
English: Synjardy 12.5 mg/850 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Dutch: Synjardy 12,5 mg/850 mg filmomhulde tabletten Elke tablet bevat 12,5 mg empagliflozine en 850 mg metforminehydrochloride.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Dutch: GEHALTE AAN WERKZAME STOF(FEN) Elke tablet bevat 5 mg empagliflozine en 1000 mg metforminehydrochloride.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Dutch: GEHALTE AAN WERKZAME STOF(FEN) Elke tablet bevat 12,5 mg empagliflozine en 1000 mg metforminehydrochloride.
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
Dutch: Synjardy 5 mg/850 mg filmomhulde tabletten Synjardy 5 mg/1000 mg filmomhulde tabletten Synjardy 12,5 mg/850 mg filmomhulde tabletten Synjardy 12,5 mg/1000 mg filmomhulde tabletten empagliflozine/metforminehydrochloride
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).
Dutch: Rozewitte, ovale, biconvexe filmomhulde tabletten met de inscriptie 'S12' en het logo van Boehringer Ingelheim aan de ene kant en '850' aan de andere kant (tabletlengte: 19,2 mm, tabletbreedte: 9,4 mm).
English: Synjardy 5 mg/1,000 mg film-coated tablets EU/1/15/1003/010
Dutch: Synjardy 5 mg/1000 mg filmomhulde tabletten EU/1/15/1003/010
English: Synjardy 12.5 mg/1,000 mg film-coated tablets EU/1/15/1003/028
Dutch: Synjardy 12,5 mg/1000 mg filmomhulde tabletten EU/1/15/1003/028
English: Synjardy 12.5 mg/850 mg film-coated tablets EU/1/15/1003/019
Dutch: Synjardy 12,5 mg/850 mg filmomhulde tabletten EU/1/15/1003/019
English: Synjardy 5 mg/850 mg film-coated tablets and Synjardy 5 mg/1,000 mg film-coated tablets Tablet core
Dutch: Synjardy 5 mg/850 mg filmomhulde tabletten en Synjardy 5 mg/1000 mg filmomhulde tabletten Tabletkern
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/1,000 mg
Dutch: GEGEVENS DIE OP DE BUITENVERPAKKING MOETEN WORDEN VERMELD MULTIVERPAKKING - TUSSENVERPAKKING ZONDER BLUE BOX - 12,5 mg/1000 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/1,000 mg
Dutch: GEGEVENS DIE OP DE BUITENVERPAKKING MOETEN WORDEN VERMELD ETIKET BUITENWIKKEL OM MULTIVERPAKKINGEN - INCLUSIEF DE BLUE BOX12,5 mg/1000 mg
English: Each Synjardy 5 mg/1,000 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Dutch: Elke Synjardy 5 mg/1000 mg filmomhulde tablet (tablet) bevat 5 mg empagliflozine en 1000 mg metforminehydrochloride.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/1,000 mg
Dutch: GEGEVENS DIE OP DE BUITENVERPAKKING MOETEN WORDEN VERMELD MULTIVERPAKKING - TUSSENVERPAKKING ZONDER BLUE BOX - 5 mg/1000 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/1,000 mg
Dutch: GEGEVENS DIE OP DE BUITENVERPAKKING MOETEN WORDEN VERMELD ETIKET BUITENWIKKEL OM MULTIVERPAKKINGEN - INCLUSIEF DE BLUE BOX5 mg/1000 mg
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
Dutch: Synjardy 5 mg/850 mg filmomhulde tabletten Synjardy 5 mg/1000 mg filmomhulde tabletten Synjardy 12,5 mg/850 mg filmomhulde tabletten Synjardy 12,5 mg/1000 mg filmomhulde tabletten
English: Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Dutch: Afgaand op de populatiefarmacokinetische analyse had leeftijd geen klinisch betekenisvol effect op de farmacokinetiek van empagliflozine.
English: Each Synjardy 12.5 mg/850 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Dutch: Elke Synjardy 12,5 mg/850 mg filmomhulde tablet (tablet) bevat 12,5 mg empagliflozine en 850 mg metforminehydrochloride.
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).
Dutch: Bruingele, ovale, biconvexe filmomhulde tabletten met de inscriptie 'S5' en het logo van Boehringer Ingelheim aan de ene kant en '1000' aan de andere kant (tabletlengte: 21,1 mm, tabletbreedte: 9,7 mm).
English: Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Dutch: Afgaand op de populatiefarmacokinetische analyse had geslacht geen klinisch relevant effect op de farmacokinetiek van empagliflozine.
English: Synjardy 12.5 mg/1,000 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Dutch: Synjardy 12,5 mg/1000 mg filmomhulde tabletten Elke tablet bevat 12,5 mg empagliflozine en 1000 mg metforminehydrochloride.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg tablets empagliflozin/metformin HCL
Dutch: NAAM VAN HET GENEESMIDDEL Synjardy 5 mg/1000 mg tabletten empagliflozine/metformine HCl
English: Each Synjardy 12.5 mg/1,000 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Dutch: Elke Synjardy 12,5 mg/1000 mg filmomhulde tablet (tablet) bevat 12,5 mg empagliflozine en 1000 mg metforminehydrochloride.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg tablets empagliflozin/metformin HCL
Dutch: NAAM VAN HET GENEESMIDDEL Synjardy 5 mg/850 mg tabletten empagliflozine/metformine HCl
English: Synjardy 12.5 mg/850 mg film-coated tablets and Synjardy 12.5 mg/1,000 mg film-coated tablets Tablet core
Dutch: Synjardy 12,5 mg/850 mg filmomhulde tabletten en Synjardy 12,5 mg/1000 mg filmomhulde tabletten Tabletkern
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg tablets empagliflozin/metformin HCL
Dutch: NAAM VAN HET GENEESMIDDEL Synjardy 12,5 mg/1000 mg tabletten empagliflozine/metformine HCl
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg tablets empagliflozin/metformin HCL
Dutch: NAAM VAN HET GENEESMIDDEL Synjardy 12,5 mg/850 mg tabletten empagliflozine/metformine HCl
English: Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people) Synjardy may cause a very rare but very serious side effect called lactic acidosis (see section ‘Warnings and precautions').
Dutch: Lactaatacidose, komt zeer zelden voor (kan zich voordoen bij maximaal 1 op de 10.000 personen)
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Dutch: NAAM VAN HET GENEESMIDDEL Synjardy 5 mg/1000 mg filmomhulde tabletten empagliflozine/metforminehydrochloride
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Dutch: NAAM VAN HET GENEESMIDDEL Synjardy 5 mg/850 mg filmomhulde tabletten empagliflozine/metforminehydrochloride
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Dutch: NAAM VAN HET GENEESMIDDEL Synjardy 12,5 mg/1000 mg filmomhulde tabletten empagliflozine/metforminehydrochloride
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).
Dutch: Synjardy 12,5 mg/850 mg en Synjardy 12,5 mg/1000 mg tabletten bevatten ook zwart ijzeroxide
English: See section 4.
Dutch: Tabel 7:
English: Hepatic impairment
Dutch: Bloedvataandoeni ngen
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Dutch: NAAM VAN HET GENEESMIDDEL Synjardy 12,5 mg/850 mg filmomhulde tabletten empagliflozine/metforminehydrochloride
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
Dutch: EU/1/15/1003/001 10 filmomhulde tabletten EU/1/15/1003/002 14 filmomhulde tabletten EU/1/15/1003/003 30 filmomhulde tabletten EU/1/15/1003/004 56 filmomhulde tabletten EU/1/15/1003/005 60 filmomhulde tabletten EU/1/15/1003/037 90 filmomhulde tabletten EU/1/15/1003/006 100 filmomhulde tabletten
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).
Dutch: Synjardy 12,5 mg/1000 mg filmomhulde tabletten Donkerbruinpaarse, ovale, biconvexe filmomhulde tabletten met de inscriptie 'S12' en het logo van Boehringer Ingelheim aan de ene kant en '1000' aan de andere kant (tabletlengte: 21,1 mm, tabletbreedte: 9,7 mm).
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (95% CI) Mean adjusted for baseline value Not evaluated for statistical significance; not part of sequential testing procedure for the secondary endpoints MMRM model on FAS (OC) included baseline HbA1c, baseline eGFR (MDRD), geographical region, visit, treatment, and treatment by visit interaction.
Dutch: MMRM model voor FAS (OC) omvatte baseline HbA1c, baseline eGFR (MDRD), geografische regio, bezoek, behandeling en behandeling per bezoek interactie.
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
Dutch: EU/1/15/1003/019 10 filmomhulde tabletten EU/1/15/1003/020 14 filmomhulde tabletten EU/1/15/1003/021 30 filmomhulde tabletten EU/1/15/1003/022 56 filmomhulde tabletten EU/1/15/1003/023 60 filmomhulde tabletten EU/1/15/1003/039 90 filmomhulde tabletten EU/1/15/1003/024 100 filmomhulde tabletten
English: Identified adverse reactions of empagliflozin monotherapy Identified adverse reactions of metformin monotherapy
Dutch: Empagliflozine bij patiënten die onvoldoende adequaat reageren op metformine en linagliptine
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
Dutch: EU/1/15/1003/028 10 filmomhulde tabletten EU/1/15/1003/029 14 filmomhulde tabletten EU/1/15/1003/030 30 filmomhulde tabletten EU/1/15/1003/031 56 filmomhulde tabletten EU/1/15/1003/032 60 filmomhulde tabletten EU/1/15/1003/040 90 filmomhulde tabletten EU/1/15/1003/033 100 filmomhulde tabletten
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
Dutch: EU/1/15/1003/010 10 filmomhulde tabletten EU/1/15/1003/011 14 filmomhulde tabletten EU/1/15/1003/012 30 filmomhulde tabletten EU/1/15/1003/013 56 filmomhulde tabletten EU/1/15/1003/014 60 filmomhulde tabletten EU/1/15/1003/038 90 filmomhulde tabletten EU/1/15/1003/015 100 filmomhulde tabletten
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
Dutch: NUMMER(S) VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN EU/1/15/1003/034 120 (2 x 60 x 1) filmomhulde tabletten EU/1/15/1003/035 180 (2 x 90 x 1) filmomhulde tabletten EU/1/15/1003/036 200 (2 x 100 x 1) filmomhulde tabletten
English: Hepatic injury
Dutch: Hepatitis
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
Dutch: NUMMER(S) VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN EU/1/15/1003/025 120 (2 x 60 x 1) filmomhulde tabletten EU/1/15/1003/026 180 (2 x 90 x 1) filmomhulde tabletten EU/1/15/1003/027 200 (2 x 100 x 1) filmomhulde tabletten
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
Dutch: NUMMER(S) VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN EU/1/15/1003/016 120 (2 x 60 x 1) filmomhulde tabletten EU/1/15/1003/017 180 (2 x 90 x 1) filmomhulde tabletten EU/1/15/1003/018 200 (2 x 100 x 1) filmomhulde tabletten
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
Dutch: NUMMER(S) VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN EU/1/15/1003/007 120 (2 x 60 x 1) filmomhulde tabletten EU/1/15/1003/008 180 (2 x 90 x 1) filmomhulde tabletten EU/1/15/1003/009 200 (2 x 100 x 1) filmomhulde tabletten
English: Eli Lilly Italia S.p.A. Tel: +39 055 42571
Dutch: Tel: +39 055 42571
English: Angioedema
Dutch: Urineglucose
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
Dutch: Basale insulinedosis (IE/dag) in week 78 Baseline (gemiddelde) Verandering vanaf baseline Verschil met placebo (97,5%-BI) Subgroepanalyse van volledige analyseset (full analysis set, FAS) voor patiënten met additionele achtergrond van metformine - Voltooiers met gebruikmaking van last observation carried forward (LOCF) voorafgaand aan glykemische noodmedicatie gemiddelde gecorrigeerd voor baselinewaarde * p-waarde < 0,0001 ** p-waarde ≤ 0,025
English: Renal impairment
Dutch: Zenuwstelselaand oeningen
English: Metabolism and nutrition disorders
Dutch: Voedings- en stofwisselingsstoo rnissen
English: • feeling sick (nausea), vomiting
Dutch: • misselijkheid, overgeven
English: Marketing Authorisation Holder
Dutch: Houder van de vergunning voor het in de handel brengen.
English: What Synjardy looks like and contents of the pack Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex.
Dutch: Synjardy 5 mg/850 mg filmomhulde tabletten zijn geelwit, ovaal en bolrond.
English: 90 (3 x 30) tablets (multipack)
Dutch: 90 (3 x 30) tabletten (multiverpakking)
English: Pack size
Dutch: EMA-nummer
English: 1 Article 29(2) of Directive 2001/83/EC, as amended.
Dutch: 1 Artikel 29, lid 2, Richtlijn 2001/83/EG, als gewijzigd.
English: The application was withdrawn in the Netherlands and United Kingdom.
Dutch: In Nederland en het Verenigd Koninkrijk werd de aanvraag ingetrokken.
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.
Dutch: De rapporterende lidstaat was Finland en de betrokken lidstaten waren Oostenrijk, België, Denemarken, Duitsland, Italië, Luxemburg, Nederland, Portugal, Zweden en het Verenigd Koninkrijk.
English: 21 February 2006 EMEA/CHMP/373061/2005
Dutch: 21 februari 2006 EMEA/CHMP/373061/2005
English: The final opinion was converted into a Decision by the European Commission on 21 February 2006.
Dutch: Het definitieve advies werd op 21 februari 2006 omgezet in een Besluit van de Europese Commissie.
English: Portugal and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Dutch: Op 15 december 2004 hebben Portugal en Duitsland de redenen voor het gebrek aan overeenstemming bij het EMEA ingediend.
English: 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.
Dutch: De betrokken lidstaten hebben niet tot overeenstemming kunnen komen inzake de wederzijdse erkenning van de door de rapporterende lidstaat verleende vergunning voor het in de handel brengen.