FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: I en præspecificeret samlet analyse af 4 placebokontrollerede studier medførte behandling med empagliflozin (68 % af alle patienter fik også metformin) et fald i systolisk blodtryk (empagliflozin 10 mg: -3,9 mmHg, empagliflozin 25 mg: -4,3 mmHg) sammenlignet med placebo (-0,5 mmHg) og i diastolisk blodtryk (empagliflozin 10 mg: -1,8 mmHg, empagliflozin 25 mg: -2,0 mmHg) sammenlignet med placebo (-0,5 mmHg) i uge 24, som varede ved til uge 52.
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from glimepiride
Danish: SBP (mmHg) Baseline (middelværdi) Ændring fra baseline Forskel til glimepirid
English: Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');
Danish: Alvorlige infektioner kan medføre nyreproblemer, hvorved du risikerer at få laktatacidose (se 'Advarsler og forsigtighedsregler')
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.
Danish: Forskellen mellem behandlingerne med hensyn til faldet i HbA1c fra baseline til uge 16 var -0,02 % (95 % CI -0,16; 0,13) for empagliflozin 5 mg to gange daglig sammenlignet med 10 mg én gang daglig, og -0,11 % (95 % CI -0,26; 0,03) for empagliflozin 12,5 mg to gange daglig sammenlignet med 25 mg én gang daglig.
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),
Danish: • Et signifikant fald i den absolutte risiko for enhver diabetesrelateret komplikation i metformingruppen (29,8 tilfælde/1.000 patientår) i forhold til diæt alene
English: In patients tolerating a total daily dose of empagliflozin 10 mg and who need tighter glycaemic control, the dose can be increased to a total daily dose of empagliflozin 25 mg.
Danish: Dosis kan øges til en daglig dosis på 25 mg empagliflozin hos patienter, der tåler en daglig dosis på 10 mg empagliflozin og har behov for en bedre glykæmisk kontrol.
English: Blood creatinine increased/Glomerular filtration rate decreased The overall frequency of patients with increased blood creatinine and decreased glomerular filtration rate were similar between empagliflozin and placebo as add-on to metformin (blood creatinine increased: empagliflozin 10 mg 0.5%, empagliflozin 25 mg 0.1%, placebo 0.4%; glomerular filtration rate decreased: empagliflozin 10 mg 0.1%, empagliflozin 25 mg 0%, placebo 0.2%).
Danish: Øget serumkreatinin/nedsat glomerulær filtrationshastighed Den generelle frekvens af patienter med øget serumkreatinin og nedsat glomerulær filtrationshastighed var næsten den samme i empagliflozin-gruppen og placebogruppen som supplement til metformin (øget serumkreatinin: empagliflozin 10 mg 0,5 %, empagliflozin 25 mg 0,1 %, placebo 0,4 %; nedsat glomerulær filtrationshastighed: empagliflozin 10 mg 0,1 %, empagliflozin 25 mg 0 %, placebo
English: INFORMATION IN BRAILLE Synjardy 5 mg/850 mg
Danish: INFORMATION I BRAILLESKRIFT Synjardy 5 mg/850 mg
English: INFORMATION IN BRAILLE Synjardy 12.5 mg/850 mg
Danish: INFORMATION I BRAILLESKRIFT Synjardy 12,5 mg/850 mg
English: A total of 12245 patients with type 2 diabetes were treated in clinical studies to evaluate the safety of empagliflozin as add-on to metformin, of which 8199 patients were treated with empagliflozin as add-on to metformin either alone or in addition to a sulfonylurea, pioglitazone, or insulin.
Danish: Heraf fik 8.199 patienter empagliflozin som supplement til metformin enten alene eller som supplement til sulfonylurinstof, pioglitazon eller insulin.
English: Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see sections 4.3 and 4.4).
Danish: Kontrol af nyrefunktionen er nødvendig for at forhindre metformin-associeret laktatacidose (se pkt.
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.
Danish: Du kan få lavt blodsukker, hvis du tager Synjardy sammen med andre lægemidler, der sænker blodsukkeret, f.eks. et sulfonylurinstof eller insulin.
English: In case of conditions that may lead to fluid loss (e.g. gastrointestinal illness), careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving Synjardy.
Danish: Omhyggelig kontrol af volumenstatus (f.eks. objektiv undersøgelse, blodtryksmålinger, laboratorieundersøgelser inkl.
English: Empagliflozin as add-on to metformin, sulphonylurea, pioglitazone Empagliflozin as add-on to metformin, metformin and a sulphonylurea, or pioglitazone and metformin resulted in statistically significant (p<0.0001) reductions in HbA1c and body weight compared to placebo (Table 3).
Danish: Empagliflozin som supplement til metformin, sulfonylurinstof, pioglitazon Der blev set statistisk signifikante (p< 0,0001) fald i HbA1c og legemsvægt sammenlignet med placebo (Tabel 3), når empagliflozin blev givet som supplement til metformin, metformin plus et sulfonylurinstof, eller pioglitazon plus metformin.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 120 (2 pakker af 60 x 1) filmovertrukne tabletter.
English: Do not take Synjardy if you are breast-feeding.
Danish: Tag ikke Synjardy, hvis du ammer.
English: INFORMATION IN BRAILLE Synjardy 12.5 mg/1,000 mg
Danish: INFORMATION I BRAILLESKRIFT Synjardy 12,5 mg/1000 mg
English: Placebo controlled double-blinded trials of 18 to 24 weeks of exposure included 3456 patients, of which 1271 were treated with empagliflozin 10 mg as add-on to metformin and 1259 with empagliflozin 25 mg as add-on to metformin.
Danish: Der har deltaget 3.456 patienter i placebokontrollerede, dobbeltblindede studier med 18 til 24 ugers eksponering, hvor 1.271 fik 10 mg empagliflozin plus metformin og 1.259 fik 25 mg empagliflozin plus metformin.
English: INFORMATION IN BRAILLE Synjardy 5 mg/1,000 mg
Danish: INFORMATION I BRAILLESKRIFT Synjardy 5 mg/1000 mg
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%
Danish: Patienter (%), der opnår HbA1c < 7 %, med baselineHbA1c ≥ 7 %
English: At week 18, empagliflozin provided statistically significant improvement in HbA1c.
Danish: I uge 18 var der et statistisk signifikant fald i HbA1c med empagliflozin.
English: • redness of the skin (erythema)
Danish: • Rødme af huden
English: PVC/PVDC/aluminium perforated unit dose blisters.
Danish: Perforerede enkeltdosisblistere af PVC/PVDC/aluminium.
English: These may be medicines taken by mouth or given by injection such as insulin.
Danish: Synjardy kan også bruges sammen med andre lægemidler mod diabetes - både lægemidler, der tages gennem munden, og lægemidler, der gives som indsprøjtning, herunder insulin.
English: The efficacy and safety of empagliflozin was evaluated in a double-blind, placebo controlled study of 12 weeks duration in patients with type 2 diabetes and high blood pressure on different antidiabetic and up to 2 antihypertensive therapies.
Danish: Virkning og sikkerhed af empagliflozin hos patienter med type 2-diabetes og højt blodtryk og i behandling med forskellige antidiabetika og op til to antihypertensive behandlinger blev undersøgt i et 12 uger varende dobbeltblindet placebokontrolleret studie.
English: At 78 weeks, the decrease in HbA1c and insulin sparing effect of empagliflozin was maintained.
Danish: Faldet i HbA1c og den insulinbesparende virkning af empagliflozin var vedvarende, da der var gået 78 uger.
English: Multipack comprising 2 packs, each containing 100 x 1 film-coated tablets.
Danish: Multipakning: 200 (2 pakker af 100 x 1) filmovertrukne tabletter.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Synjardy 5 mg/850 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Synjardy 5 mg/850 mg filmovertrukne tabletter Hver tablet indeholder 5 mg empagliflozin og 850 mg metforminhydrochlorid.
English: (40.1 events/1,000 patient-years), p=0.0034,
Danish: (43,3 tilfælde/1.000 patientår), p= 0,0023, og i forhold til de kombinerede grupper med sulfonylurinstof alene og insulin alene (40,1 tilfælde/1.000 patientår), p= 0,0034.
English: See section 4.4
Danish: 4.3 og 4.4).
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.
Danish: Empagliflozin som supplement til flere daglige doser insulin Virkning og sikkerhed af empagliflozin som supplement til flere daglige doser insulin med samtidig metforminbehandling blev undersøgt i et 52 uger varende, dobbeltblindet placebokontrolleret studie.
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Danish: SBP (mmHg) Baseline (middelværdi) Ændring fra baseline Forskel til placebo (95 % CI)
English: SGLT2 prevents glucose (blood sugar) from being lost in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys.
Danish: Proteinet SGLT2 binder glukose og forhindrer dermed glukose i at blive filtreret i nyrerne og dermed udskilt i urinen.
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');
Danish: Det kan betyde, at du ikke får nok ilt ud i vævene, hvorved du risikerer at få laktatacidose (se 'Advarsler og forsigtighedsregler')
English: Multipack comprising 2 packs, each containing 90 x 1 film-coated tablets.
Danish: Multipakning: 180 (2 pakker af 90 x 1) filmovertrukne tabletter.
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with metformin (see sections 4.2 and 4.8).
Danish: Derfor skal dosis af insulin eller beta-cellestimulerende midler måske sættes ned ved samtidig brug af metformin (se pkt.
English: • bronchodilators (beta-2 agonists) which are used to treat asthma.
Danish: • lægemidler der udvider luftvejene i lungerne, og som bruges til behandling af astma
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with empagliflozin (see sections 4.2 and 4.8).
Danish: Derfor skal dosis af insulin eller beta-cellestimulerende midler måske sættes ned ved samtidig brug af empagliflozin (se pkt.
English: For weight, baseline weight was included.
Danish: Middelværdi korrigeret for baselineværdi.
English: Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Danish: Baseline (middelværdi) Ændring fra baseline Forskel til placebo (97,5 % CI)
English: For patients with acute and unstable heart failure, Synjardy is contraindicated due to the metformin component (see section 4.3).
Danish: Synjardy er kontraindiceret hos patienter med akut og ustabil hjerteinsufficiens (se pkt.
English: If you take more Synjardy than you should
Danish: Hvis du har taget for meget Synjardy
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.
Danish: Middelværdi korrigeret for baseline-SBP, baseline-HbA1c, baseline-eGFR, geografisk område og antal antihypertensiva.
English: No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea and as add-on to linagliptin and metformin.
Danish: I kombination med metformin og et sulfonylurinstof og som supplement til linagliptin og metformin sås ingen tilfælde af svær hypoglykæmi.
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
Danish: Synjardy 5 mg/850 mg filmovertrukne tabletter Synjardy 5 mg/1000 mg filmovertrukne tabletter Synjardy 12,5 mg/850 mg filmovertrukne tabletter Synjardy 12,5 mg/1000 mg filmovertrukne tabletter empagliflozin/metforminhydrochlorid
English: Insulin and insulin secretagogues, such as sulphonylureas, may increase the risk of hypoglycaemia.
Danish: Risikoen for hypoglykæmi kan øges ved brug af insulin og beta-cellestimulerende midler, som f.eks. sulfonylurinstoffer.
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
Danish: Uge 19-40: treat-to-target regime til justering af insulindosis for at opnå foruddefinerede målværdier for glucose (præprandial < 100 mg/dl (5,5 mmol/l), postprandial < 140 mg/dl (7,8 mmol/l).
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
Danish: Synjardy 5 mg/850 mg filmovertrukne tabletter Synjardy 5 mg/1000 mg filmovertrukne tabletter Synjardy 12,5 mg/850 mg filmovertrukne tabletter Synjardy 12,5 mg/1000 mg filmovertrukne tabletter
English: Each Synjardy 5 mg/850 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Danish: Hver Synjardy 5 mg/850 mg filmovertrukket tablet (tablet) indeholder 5 mg empagliflozin og 850 mg metforminhydrochlorid.
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.
Danish: Derved forlænges eliminationshalveringstiden, hvilket medfører øgede koncentrationer af metformin i plasma.
English: Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Danish: Legemsvægt (kg) Baseline (middel) Ændring fra baseline Forskel fra placebo (95 % CI)
English: Synjardy 5 mg/850 mg film-coated tablets EU/1/15/1003/001
Danish: Synjardy 5 mg/850 mg filmovertrukne tabletter EU/1/15/1003/001
English: Synjardy 5 mg/1,000 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Danish: Synjardy 5 mg/1000 mg filmovertrukne tabletter Hver tablet indeholder 5 mg empagliflozin og 1000 mg metforminhydrochlorid.
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.
Danish: • hæmmere af OCT2 (f.eks. cimetidin, dolutegravir, ranolazin, trimethoprim, vandetanib,
English: Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Danish: Den populationsfarmakokinetiske analyse viste, at køn ikke havde nogen klinisk betydende virkning på empagliflozins farmakokinetik.
English: Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Danish: Legemsvægt (kg) Baseline (middelværdi) Ændring fra baseline Forskel til placebo (97,5 % CI)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/850 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGEETIKET PÅ MULTIPAKNING - INDEHOLDER BLUE BOX5 mg/850 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg empagliflozin og 850 mg metforminhydrochlorid.
English: Baseline (mean) Change from baseline Difference from glimepiride
Danish: Legemsvægt (kg) Baseline (middelværdi) Ændring fra baseline Forskel til glimepirid
English: Synjardy 12.5 mg/850 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Danish: Synjardy 12,5 mg/850 mg filmovertrukne tabletter Hver tablet indeholder 12,5 mg empagliflozin og 850 mg metforminhydrochlorid.
English: Synjardy 12.5 mg/850 mg film-coated tablets EU/1/15/1003/019
Danish: Synjardy 12,5 mg/850 mg filmovertrukne tabletter EU/1/15/1003/019
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg empagliflozin og 1000 mg metforminhydrochlorid.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 12,5 mg empagliflozin og 850 mg metforminhydrochlorid.
English: Synjardy 12.5 mg/1,000 mg film-coated tablets EU/1/15/1003/028
Danish: Synjardy 12,5 mg/1000 mg filmovertrukne tabletter EU/1/15/1003/028
English: Common
Danish: Almindelige:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 12,5 mg empagliflozin og 1000 mg metforminhydrochlorid.
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Danish: HbA1c (%) Baseline (middel) Ændring fra baseline Forskel fra placebo (95 % CI)
English: Synjardy 5 mg/850 mg film-coated tablets and Synjardy 5 mg/1,000 mg film-coated tablets Tablet core
Danish: Synjardy 5 mg/850 mg filmovertrukne tabletter og Synjardy 5 mg/1.000 mg filmovertrukne tabletter Tabletkerne:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/850 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGEETIKET PÅ MULTIPAKNING - INDEHOLDER BLUE BOX12,5 mg/850 mg
English: Synjardy 5 mg/1,000 mg film-coated tablets EU/1/15/1003/010
Danish: Synjardy 5 mg/1000 mg filmovertrukne tabletter EU/1/15/1003/010
English: Synjardy 12.5 mg/850 mg film-coated tablets and Synjardy 12.5 mg/1,000 mg film-coated tablets Tablet core
Danish: Synjardy 12,5 mg/850 mg filmovertrukne tabletter og Synjardy 12,5 mg/1.000 mg filmovertrukne tabletter
English: Each Synjardy 5 mg/1,000 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Danish: Hver Synjardy 5 mg/1.000 mg filmovertrukket tablet (tablet) indeholder 5 mg empagliflozin og 1.000 mg metforminhydrochlorid.
English: Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Danish: Den populationsfarmakokinetiske analyse viste, at BMI ikke havde nogen klinisk betydende virkning på empagliflozins farmakokinetik.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/1,000 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGEETIKET PÅ MULTIPAKNING - INDEHOLDER BLUE BOX5 mg/1000 mg
English: Administration of empagliflozin 25 mg after intake of a high-fat and high calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16% and Cmax by approximately 37% compared to fasted condition.
Danish: Administration af empagliflozin 25 mg efter indtagelse af et fedt- og kalorierigt måltid medførte en lidt lavere eksponering.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/1,000 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGEETIKET PÅ MULTIPAKNINGER - INDEHOLDER BLUE BOX12,5 mg/1000 mg
English: Each Synjardy 12.5 mg/850 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Danish: Hver Synjardy 12,5 mg/850 mg filmovertrukket tablet (tablet) indeholder 12,5 mg empagliflozin og 850 mg metforminhydrochlorid.
English: Each Synjardy 12.5 mg/1,000 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Danish: Hver Synjardy 12,5 mg/1.000 mg filmovertrukket tablet (tablet) indeholder 12,5 mg empagliflozin og 1.000 mg metforminhydrochlorid.
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).
Danish: Synjardy 5 mg/1000 mg filmovertrukne tabletter Brunlig gul, oval, bikonveks filmovertrukket tablet på 21,1 mm x 9,7 mm, præget med “S5” og Boehringer Ingelheim logo på den ene side og “1000” på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg tablets empagliflozin/metformin HCL
Danish: LÆGEMIDLETS NAVN Synjardy 5 mg/850 mg tabletter empagliflozin/metformin HCl
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
Danish: For så vidt angår vægt, blev baseline-vægten inkluderet MMRM-modellen omfattede baseline-SBP og baseline-HbA1c som lineære co-variater og interaktion mellem baseline-eGFR, geografisk område, behandling, besøg og behandling ved besøg som faste effekter De patienter, der blev randomiseret til placebogruppen, fik placebo + linagliptin 5 mg med metformin som baggrundsbehandling De patienter, der blev randomiseret til empagliflozin 10 mg- eller 25 mg-grupperne, fik empagliflozin 10 mg eller 25 mg samt linagliptin 5 mg med metformin som baggrundsbehandling * p-værdi < 0,0001
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/850 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING - KARTON SOM DEL AF MULTIPAKNING UDEN BLUE BOX12,5 mg/850 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/850 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNINGER - KARTON SOM DEL AF MULTIPAKNING UDEN BLUE BOX5 mg/850 mg
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg tablets empagliflozin/metformin HCL
Danish: LÆGEMIDLETS NAVN Synjardy 5 mg/1000 mg tabletter empagliflozin/metformin HCl
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg tablets empagliflozin/metformin HCL
Danish: LÆGEMIDLETS NAVN Synjardy 12,5 mg/850 mg tabletter empagliflozin/metformin HCl
English: Renal impairment
Danish: Empagliflozin frarådes
English: Synjardy 12.5 mg/1,000 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Danish: Synjardy 12,5 mg/1000 mg filmovertrukne tabletter Hver tablet indeholder 12,5 mg empagliflozin og 1000 mg metforminhydrochlorid.