natgillin/translations-raw huggingface dataset:
I de puljede placebo-kontrollerede, dobbeltblinde studier af 18 til 24 ugers varighed var den overordnede frekvens af urinvejsinfektioner højere hos patienter, der fik empagliflozin 10 mg plus metformin, sammenlignet med patienter, der fik placebo plus metformin eller empagliflozin 25 mg plus metformin (se pkt.
In the pooled placebo-controlled double-blind trials of 18 to 24 weeks duration, the overall frequency of urinary tract infection reported as adverse event was higher in patients treated with empagliflozin 10 mg on a background of metformin compared to patients treated with placebo or empagliflozin 25 mg on a background of metformin (see section 4.8).
Synjardy 5 mg/850 mg filmovertrukne tabletter
Synjardy 5 mg/850 mg film-coated tablets
Analyserne er udført på fuldstændigt analysedatasæt (FAS) ved brug af observerede tilfælde (OC) Administreret i to lige doser dagligt ved samtidig administration af metformin Administreret i to lige doser dagligt * p ≤ 0,0062 for HbA1c
Met = metformin; empa = empagliflozin mean adjusted for baseline value Analyses were performed on the full analysis set (FAS) using an observed cases (OC) approach Given in two equally divided doses per day when given together with metformin Given in two equally divided doses per day *p≤0.0062 for HbA1c
Nedsat leverfunktion Dette lægemiddel må ikke bruges til patienter med nedsat leverfunktion (se pkt.
Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and
Patienterne skal rådes til at tage forholdsregler for at undgå hypoglykæmi, når de fører motorkøretøj og betjener maskiner.
Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Synjardy is used in combination with a sulphonylurea and/or insulin.
Hos patienter med type 2-diabetes forbedrer empagliflozin den glykæmiske kontrol ved at nedsætte reabsorptionen af glucose i nyrerne.
Empagliflozin improves glycaemic control in patients with type 2 diabetes by reducing renal glucose reabsorption.
Dehydrering kan medføre nyreproblemer, hvorved du risikerer at få laktatacidose (se 'Advarsler og forsigtighedsregler')
Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');
Patienter (%) der opnåede HbA1c < 7 % efter et baseline-HbA1c ≥ 7 % i uge 52
Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7% at week 52
I en præspecificeret analyse af patienter med baseline-HbA1c ≥ 9 % medførte behandling med empagliflozin 10 mg eller 25 mg som supplement til metformin statistisk signifikante fald i HbA1c i uge 24 (korrigeret gennemsnitlig ændring i forhold til baseline på -1,49 % for empagliflozin 25 mg, -1,40 % for empagliflozin 10 mg og -0,44 % for placebo).
In a pre-specified analysis of subjects with baseline HbA1c ≥9.0%, treatment with empagliflozin 10 mg or 25 mg as add-on to metformin resulted in statistically significant reductions in HbA1c at Week 24 (adjusted mean change from baseline of -1.49% for empagliflozin 25 mg, -1.40% for empagliflozin 10 mg, and -0.44% for placebo).
Lægen fortæller dig, hvilken styrke af Synjardy du skal tage.
Your doctor will adjust your dose as necessary and tell you exactly which strength of the medicine to take.
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.
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.
SBP (mmHg) Baseline (middelværdi) Ændring fra baseline Forskel til glimepirid
SBP (mmHg) Baseline (mean) Change from baseline Difference from glimepiride
Alvorlige infektioner kan medføre nyreproblemer, hvorved du risikerer at få laktatacidose (se 'Advarsler og forsigtighedsregler')
Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');
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.
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.
• Et signifikant fald i den absolutte risiko for enhver diabetesrelateret komplikation i metformingruppen (29,8 tilfælde/1.000 patientår) i forhold til diæt alene
• 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),
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.
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.
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
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%).
INFORMATION I BRAILLESKRIFT Synjardy 5 mg/850 mg
INFORMATION IN BRAILLE Synjardy 5 mg/850 mg
INFORMATION I BRAILLESKRIFT Synjardy 12,5 mg/850 mg
INFORMATION IN BRAILLE Synjardy 12.5 mg/850 mg
Heraf fik 8.199 patienter empagliflozin som supplement til metformin enten alene eller som supplement til sulfonylurinstof, pioglitazon eller insulin.
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.
Kontrol af nyrefunktionen er nødvendig for at forhindre metformin-associeret laktatacidose (se pkt.
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).
Du kan få lavt blodsukker, hvis du tager Synjardy sammen med andre lægemidler, der sænker blodsukkeret, f.eks. et sulfonylurinstof eller insulin.
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.
Omhyggelig kontrol af volumenstatus (f.eks. objektiv undersøgelse, blodtryksmålinger, laboratorieundersøgelser inkl.
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.
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.
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).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 120 (2 pakker af 60 x 1) filmovertrukne tabletter.
PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets.
Tag ikke Synjardy, hvis du ammer.
Do not take Synjardy if you are breast-feeding.
INFORMATION I BRAILLESKRIFT Synjardy 12,5 mg/1000 mg
INFORMATION IN BRAILLE Synjardy 12.5 mg/1,000 mg
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.
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.
INFORMATION I BRAILLESKRIFT Synjardy 5 mg/1000 mg
INFORMATION IN BRAILLE Synjardy 5 mg/1,000 mg
Patienter (%), der opnår HbA1c < 7 %, med baselineHbA1c ≥ 7 %
Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%
I uge 18 var der et statistisk signifikant fald i HbA1c med empagliflozin.
At week 18, empagliflozin provided statistically significant improvement in HbA1c.
• Rødme af huden
• redness of the skin (erythema)
Perforerede enkeltdosisblistere af PVC/PVDC/aluminium.
PVC/PVDC/aluminium perforated unit dose blisters.
Synjardy kan også bruges sammen med andre lægemidler mod diabetes - både lægemidler, der tages gennem munden, og lægemidler, der gives som indsprøjtning, herunder insulin.
These may be medicines taken by mouth or given by injection such as insulin.
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.
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.
Faldet i HbA1c og den insulinbesparende virkning af empagliflozin var vedvarende, da der var gået 78 uger.
At 78 weeks, the decrease in HbA1c and insulin sparing effect of empagliflozin was maintained.
Multipakning: 200 (2 pakker af 100 x 1) filmovertrukne tabletter.
Multipack comprising 2 packs, each containing 100 x 1 film-coated tablets.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Synjardy 5 mg/850 mg filmovertrukne tabletter Hver tablet indeholder 5 mg empagliflozin og 850 mg metforminhydrochlorid.
QUALITATIVE AND QUANTITATIVE COMPOSITION Synjardy 5 mg/850 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
(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.
(40.1 events/1,000 patient-years), p=0.0034,
4.3 og 4.4).
See section 4.4
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.
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.
SBP (mmHg) Baseline (middelværdi) Ændring fra baseline Forskel til placebo (95 % CI)
SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Proteinet SGLT2 binder glukose og forhindrer dermed glukose i at blive filtreret i nyrerne og dermed udskilt i urinen.
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.
Det kan betyde, at du ikke får nok ilt ud i vævene, hvorved du risikerer at få laktatacidose (se 'Advarsler og forsigtighedsregler')
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');
Multipakning: 180 (2 pakker af 90 x 1) filmovertrukne tabletter.
Multipack comprising 2 packs, each containing 90 x 1 film-coated tablets.
Derfor skal dosis af insulin eller beta-cellestimulerende midler måske sættes ned ved samtidig brug af metformin (se pkt.
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).
• lægemidler der udvider luftvejene i lungerne, og som bruges til behandling af astma
• bronchodilators (beta-2 agonists) which are used to treat asthma.
Derfor skal dosis af insulin eller beta-cellestimulerende midler måske sættes ned ved samtidig brug af empagliflozin (se pkt.
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).
Middelværdi korrigeret for baselineværdi.
For weight, baseline weight was included.
Baseline (middelværdi) Ændring fra baseline Forskel til placebo (97,5 % CI)
Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Synjardy er kontraindiceret hos patienter med akut og ustabil hjerteinsufficiens (se pkt.
For patients with acute and unstable heart failure, Synjardy is contraindicated due to the metformin component (see section 4.3).
Hvis du har taget for meget Synjardy
If you take more Synjardy than you should
Middelværdi korrigeret for baseline-SBP, baseline-HbA1c, baseline-eGFR, geografisk område og antal antihypertensiva.
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.
I kombination med metformin og et sulfonylurinstof og som supplement til linagliptin og metformin sås ingen tilfælde af svær hypoglykæmi.
No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea and as add-on to linagliptin and metformin.
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
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
Risikoen for hypoglykæmi kan øges ved brug af insulin og beta-cellestimulerende midler, som f.eks. sulfonylurinstoffer.
Insulin and insulin secretagogues, such as sulphonylureas, may increase the risk of hypoglycaemia.
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).
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
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
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
Hver Synjardy 5 mg/850 mg filmovertrukket tablet (tablet) indeholder 5 mg empagliflozin og 850 mg metforminhydrochlorid.
Each Synjardy 5 mg/850 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Derved forlænges eliminationshalveringstiden, hvilket medfører øgede koncentrationer af metformin i plasma.
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.
Legemsvægt (kg) Baseline (middel) Ændring fra baseline Forskel fra placebo (95 % CI)
Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Synjardy 5 mg/850 mg filmovertrukne tabletter EU/1/15/1003/001
Synjardy 5 mg/850 mg film-coated tablets EU/1/15/1003/001
Synjardy 5 mg/1000 mg filmovertrukne tabletter Hver tablet indeholder 5 mg empagliflozin og 1000 mg metforminhydrochlorid.
Synjardy 5 mg/1,000 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
• hæmmere af OCT2 (f.eks. cimetidin, dolutegravir, ranolazin, trimethoprim, vandetanib,
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.
Den populationsfarmakokinetiske analyse viste, at køn ikke havde nogen klinisk betydende virkning på empagliflozins farmakokinetik.
Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Legemsvægt (kg) Baseline (middelværdi) Ændring fra baseline Forskel til placebo (97,5 % CI)
Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGEETIKET PÅ MULTIPAKNING - INDEHOLDER BLUE BOX5 mg/850 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/850 mg
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg empagliflozin og 850 mg metforminhydrochlorid.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Legemsvægt (kg) Baseline (middelværdi) Ændring fra baseline Forskel til glimepirid
Baseline (mean) Change from baseline Difference from glimepiride
Synjardy 12,5 mg/850 mg filmovertrukne tabletter Hver tablet indeholder 12,5 mg empagliflozin og 850 mg metforminhydrochlorid.
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 filmovertrukne tabletter EU/1/15/1003/019
Synjardy 12.5 mg/850 mg film-coated tablets EU/1/15/1003/019
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg empagliflozin og 1000 mg metforminhydrochlorid.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 12,5 mg empagliflozin og 850 mg metforminhydrochlorid.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Synjardy 12,5 mg/1000 mg filmovertrukne tabletter EU/1/15/1003/028
Synjardy 12.5 mg/1,000 mg film-coated tablets EU/1/15/1003/028
Almindelige:
Common
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 12,5 mg empagliflozin og 1000 mg metforminhydrochlorid.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
HbA1c (%) Baseline (middel) Ændring fra baseline Forskel fra placebo (95 % CI)
HbA1c (%) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Synjardy 5 mg/850 mg filmovertrukne tabletter og Synjardy 5 mg/1.000 mg filmovertrukne tabletter Tabletkerne:
Synjardy 5 mg/850 mg film-coated tablets and Synjardy 5 mg/1,000 mg film-coated tablets Tablet core
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGEETIKET PÅ MULTIPAKNING - INDEHOLDER BLUE BOX12,5 mg/850 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/850 mg
Synjardy 5 mg/1000 mg filmovertrukne tabletter EU/1/15/1003/010
Synjardy 5 mg/1,000 mg film-coated tablets EU/1/15/1003/010
Synjardy 12,5 mg/850 mg filmovertrukne tabletter og Synjardy 12,5 mg/1.000 mg filmovertrukne tabletter
Synjardy 12.5 mg/850 mg film-coated tablets and Synjardy 12.5 mg/1,000 mg film-coated tablets Tablet core
Hver Synjardy 5 mg/1.000 mg filmovertrukket tablet (tablet) indeholder 5 mg empagliflozin og 1.000 mg metforminhydrochlorid.
Each Synjardy 5 mg/1,000 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Den populationsfarmakokinetiske analyse viste, at BMI ikke havde nogen klinisk betydende virkning på empagliflozins farmakokinetik.
Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGEETIKET PÅ MULTIPAKNING - INDEHOLDER BLUE BOX5 mg/1000 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/1,000 mg
Administration af empagliflozin 25 mg efter indtagelse af et fedt- og kalorierigt måltid medførte en lidt lavere eksponering.
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.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGEETIKET PÅ MULTIPAKNINGER - INDEHOLDER BLUE BOX12,5 mg/1000 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/1,000 mg
Hver Synjardy 12,5 mg/850 mg filmovertrukket tablet (tablet) indeholder 12,5 mg empagliflozin og 850 mg metforminhydrochlorid.
Each Synjardy 12.5 mg/850 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Hver Synjardy 12,5 mg/1.000 mg filmovertrukket tablet (tablet) indeholder 12,5 mg empagliflozin og 1.000 mg metforminhydrochlorid.
Each Synjardy 12.5 mg/1,000 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
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.
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).
LÆGEMIDLETS NAVN Synjardy 5 mg/850 mg tabletter empagliflozin/metformin HCl
NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg tablets empagliflozin/metformin HCL