natgillin/translations-raw huggingface dataset:
2 not evaluated for statistical significance as a part of the sequential confirmatory testing procedure 3 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
3 19.-40. teden: usmerjen (treat-to-target) režim prilagajanja odmerka insulina za doseganje vnaprej določenih ciljnih ravni glukoze (preprandialna < 100 mg/dl (5,5 mmol/l), postprandialna < 140 mg/dl (7,8 mmol/l)
What you need to know before you take Synjardy
Kaj morate vedeti, preden boste vzeli zdravilo Synjardy Ne jemljite zdravila Synjardy:
• burning sensation when passing urine
• pekoč občutek pri uriniranju • moten urin
Overall hypoglycaemia
Skupna hipoglikemija
The active substances are empagliflozin and metformin.
Zdravilni učinkovini sta empagliflozin in metformin.
The overall frequency of urinary tract infection adverse events was higher in metformin-treated patients who received empagliflozin 10 mg (8.8%) compared to empagliflozin 25 mg (6.6%) or placebo (7.8%).
zdravljenih z metforminom, ki so prejemali empagliflozin 10 mg (8,8 %), višja kot pri bolnikih, ki so prejemali empagliflozin 25 mg (6,6 %) ali placebu (7,8 %).
Glimepirideb
Laktacidoza
Therefore, this medicinal product must be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further (see section 4.4).
Ponovno se ga sme uvesti šele po 48 urah in ponovni oceni delovanja ledvic, če se to ni dodatno poslabšalo (glejte poglavje 4.4).
Multiple-dose study: After repeated doses of 500 mg twice daily for 7 days in paediatric patients the peak plasma concentration (Cmax) and systemic exposure (AUC0-t) were approximately 33% and 40% lower, respectively, compared to diabetic adults who received repeated doses of 500 mg twice daily for 14 days.
Študija z večkratnimi odmerki: Po ponavljajočih odmerkih 500 mg, ki so jih dvakrat dnevno 7 dni prejemali pediatrični bolniki, sta bili pri njih največja koncentracija v plazmi (Cmax) za približno 33 %
Placebo empagliflozin
Empagliflozin Absorpcija
Add-on to metformin and a sulphonylurea therapya Placebo
Dodatno zdravljenje k metforminu s sulfonilsečninoa placebo empagliflozin
Treatment with iodinated contrast agent can reduce your kidney function and increase the risk of side effects due to the metformin component.
Izpostavljenost jodiranim kontrastnim sredstvom lahko poslabša delovanje ledvic in poveča tveganje neželenih učinkov zaradi metformina.
The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
enkratno dnevno uporabo empagliflozina so bile v stanju dinamičnega ravnovesja vrednosti v plazmi AUC 1.870 nmol.h in Cmax 259 nmol/l za empagliflozin 10 mg ter AUC 4.740 nmol.h in
Due to the metformin component, Synjardy may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly.
Zaradi metformina lahko zdravilo Synjardy zlasti pri osebah z okvarjenim delovanjem ledvic povzroči zelo redek in resen zaplet, imenovan laktacidoza.
An increased frequency was noted when empagliflozin given as add-on to metformin and a sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5% and placebo: 8.4%) or as add-on to metformin and insulin (empagliflozin 10 mg: 31.3%, empagliflozin 25 mg: 36.2% and placebo: 34.7%).
25 mg: 11,5 %, placebo: 8,4 %) ali kot dodatnega zdravljenja k metforminu in insulinu (empagliflozin 10 mg: 31,3 %, empagliflozin 25 mg: 36,2 % in placebo: 34,7 %).
Administration of iodinated contrast agent
Uporaba jodiranega kontrastnega sredstva
Empagliflozin does not inhibit human uptake transporters such as OAT3, OATP1B1, and OATP1B3 in vitro at clinically relevant plasma concentrations and, as such, drug-drug interactions with substrates of these uptake transporters are considered unlikely.
OATP1B3 v klinično pomembnih plazemskih koncentracijah, zato medsebojno delovanje zdravila s substrati teh privzemnih prenašalcev ni verjetno.
Major hypoglycaemia (hypoglycaemia requiring assistance) The frequency of patients with major hypoglycaemic events was low (<1%) and similar for empagliflozin and placebo as add-on to metformin.
Pogostnost bolnikov s hudimi hipoglikemičnimi dogodki je bila nizka (< 1 %) in podobna za empagliflozin in placebo kot dodatno zdravljenje k metforminu.
The dosage should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability using the recommended daily dose of 10 mg or 25 mg of empagliflozin, while not exceeding maximum recommended daily dose of metformin.
Uporabljati je potrebno priporočeni dnevni odmerek empagliflozina po 10 mg ali 25 mg, ne da bi pri tem presegli največji priporočeni dnevni odmerek metformina.
Therefore, this medicinal product must be discontinued prior to, or at the time of the test and not be reinstituted until at least 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further (see section 4.5).
Ponovno se ga sme uvesti šele po 48 urah in ponovni oceni delovanja ledvic, če se to ni dodatno poslabšalo (glejte poglavje 4.5).
• iodinated contrast agents (medicines used during an X-ray, see section 2 ‘Warnings and precautions'.
• jodirana kontrastna sredstva (ki jih lahko prejmete pri rentgenskem slikanju, glejte poglavje 2
The most commonly reported adverse events in clinical trials were hypoglycaemia in combination with insulin and/or sulphonylurea, urinary tract infections,
Najpogostejši neželeni učinki, o katerih so poročali v kliničnih preskušanjih, so bili hipoglikemija (pri kombinaciji z insulinom in/ali sulfonilsečnino), okužba sečil, okužba spolovil in pogostejše uriniranje (glejte opis izbranih neželenih učinkov).
Table 3: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformina
Preglednica 3: Rezultati učinkovitosti v 104. tednu v z zdravilno učinkovino nadzorovani študiji, v kateri so empagliflozin primerjali z glimepiridom kot dodatnim zdravljenjem k metforminua empagliflozin 25 mg glimepiridb
Volume depletion1, 2
Žilne bolezni zmanjšanje volumna1, 2
At Week 52, treatment with empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared with placebo and a reduction in body weight.
HbA1c, varčevanje z insulinom v primerjavi s placebom in zmanjšanje telesne mase.
• redness of the skin (erythema) or an itchy rash (hives)
• pordelost kože (eritem) ali srbeč izpuščaj (koprivnica) Poročanje o neželenih učinkih
Add-on to pioglitazone + metformin therapyb Placebo
Dodatno zdravljenje k pioglitazonu z metforminomb placebo empagliflozin
Urinary tract infection1, 2
okužbe sečil1, 2
An interaction study with gemfibrozil, an in vitro inhibitor of OAT3 and OATP1B1/1B3 transporters, showed that empagliflozin Cmax increased by 15% and AUC increased by 59% following co-administration.
OATP1B1/1B3, je pokazala, da se je po sočasni uporabi Cmax empagliflozina povečal za 15 %, AUC pa za 59 %.
4 Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products 5 Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001
4 Povprečje, prilagojeno za vrednost sistoličnega krvnega tlaka ob izhodišču, vrednost HbA1c ob izhodišču, vrednost eGFR ob izhodišču, geografsko regijo in število antihipertenzivnih zdravil 5 Povprečje, prilagojeno za vrednost diastoličnega krvnega tlaka ob izhodišču, vrednost HbA1c ob izhodišču, vrednost eGFR ob izhodišču, geografsko regijo in število antihipertenzivnih zdravil
The onset of lactic acidosis can be subtle and the symptoms can be non-specific such as vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing.
Nastop laktacidoze je lahko skoraj nezaznaven z nespecifičnimi simptomi, kot so bruhanje, trebušne bolečine z mišičnimi krči, splošno slabo počutje z izrazito utrujenostjo in oteženo dihanje.
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).
12,5 mg/1000 mg tablete vsebujejo tudi črni (E172) in rdeči železov oksid (E172).
2 Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure 3 LOCF, values after antihypertensive rescue censored
1 Povprečje, prilagojeno za izhodiščne vrednosti 2 Statistična značilnost ni bila ocenjena zaradi zaporednega potrditvenega postopka testiranja
N HbA1c (%) at week 52b
Vrednost HbA1c (%) v 52. tednub
N HbA1c (%) at week 18a
N Vrednost HbA1c (%) v 18. tednua
Synjardy 12.5 mg/1,000 mg film-coated tablets
Synjardy 12,5 mg/1000 mg filmsko obložene tablete
** p-value <0.001
* vrednost p < 0,0001
Increased urination1, 2
Bolezni sečil pogostejše uriniranje1, 2
Following administration of a dose of 850 mg metformin hydrochloride, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 minute prolongation of the time to peak plasma concentration were observed.
Po dajanju odmerka metforminijevega klorida 850 mg so izmerili za 40 % manjšo največjo koncentracijo v plazmi, za
Nervous system disorders
Bolezni živčevja motnje okušanja3
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).
V predhodno specificirani analizi bolnikov z izhodiščno vrednostjo HbA1c ≥ 9,0 % je zdravljenje z empagliflozinom 10 mg ali 25 mg kot dodatno zdravljenje k metforminu povzročilo statistično pomembno zmanjšanje vrednosti HbA1c v 24. tednu (prilagojena povprečna sprememba od izhodišča: -1,49 % za empagliflozin 25 mg, -1,40 % za empagliflozin 10 mg in -0,44 % za placebo).
Difference from glimepiride1 (97.5% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy b Up to 4 mg glimepiride
IZ) a Niz celotne analize (FAS, full analysis set) z uporabo zadnjega opazovanja prenesenega naprej (LOCF, last observation carried forward) pred uporabo reševalnega zdravljenja za ureditev glikemije b Do 4 mg glimepirida
Your kidneys will be tested by a blood test before you start taking and while you are taking this medicine.
Pred začetkom jemanja ali med jemanjem tega zdravila boste morali opraviti krvne preiskave za preverjanje delovanja ledvic.
** p-value <0.005
* vrednost p ≤ 0,0005
Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Bolniki (%) z izhodiščno vrednostjo HbA1c ≥ 7 %, ki so dosegli vrednost HbA1c N
2 Mean adjusted for baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products 3 LOCF, values after taking antidiabetic rescue therapy or changing antihypertensive rescue therapy censored
1 LOCF, vrednosti po cenzuriranju uporabe antidiabetičnega reševalnega zdravljenja 2 Povprečje, prilagojeno za vrednost HbA1c ob izhodišču, vrednost eGFR ob izhodišču, geografsko regijo in število antihipertenzivnih zdravil
HbA1c of <7% compared to linagliptin 5 mg. Clinically meaningful reductions in HbA1c were maintained for 52 weeks.
Klinično pomembna znižanja vrednosti HbA1c so se ohranila 52 tednov.
(95% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy bSubgroup analysis for patients on additional background of metformin (FAS, LOCF) 1 Mean adjusted for baseline value
Sprememba od izhodišča1 Razlika glede na placebo1 (95-odstotni IZ) a Niz celotne analize (FAS, full analysis set) z uporabo zadnjega opazovanja prenesenega naprej (LOCF, last observation carried forward) pred uporabo reševalnega zdravljenja za ureditev glikemije b Analiza pri podskupinah bolnikov ob prisotnosti metformina (FAS, LOCF)
Change from baseline1
Sprememba od izhodišča5
Table 5 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformina
Preglednica 5: Rezultati učinkovitosti v 18. in 78. tednu v s placebom nadzorovani študiji empagliflozina kot dodatnega zdravljenja k bazalnemu insulinu z metforminoma placebo empagliflozin 10 mg empagliflozin 25 mg
Other side effects while taking Synjardy: Very common
Drugi neželeni učinki, ki se lahko pojavijo med jemanjem zdravila Synjardy:
Your blood sugar levels may increase when you stop taking Synjardy.
Synjardy prenehali jemati, se bodo ravni krvnega sladkorja morda povišale.
HbA1c <7% with baseline HbA1c ≥7% at week 52b, 2
Bolniki (%) z izhodiščno vrednostjo HbA1c ≥ 7 %, ki so dosegli vrednost HbA1c < 7 % v 52. tednub, 2
Similar results were obtained when Synjardy (empagliflozin/metformin) combination tablets were administered with high-fat and high calorie meal.
(empagliflozin/metmorfin) sočasno z obrokom z visoko vsebnostjo maščob in kalorij.
Effects of other medicinal products on empagliflozin In vitro data suggest that the primary route of metabolism of empagliflozin in humans is glucuronidation by uridine 5'-diphosphoglucuronosyltransferases UGT1A3, UGT1A8, UGT1A9, and UGT2B7.
Študije in vitro so pokazale, da je glavna presnovna pot empagliflozina pri človeku glukuronidacija z uridin 5‘-difosfo-glukuronoziltransferazami UGT2B7,
Interaction studies conducted in healthy volunteers suggest that the pharmacokinetics of empagliflozin were not influenced by co-dministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
glimepirida, pioglitazona, sitagliptina, linagliptina, varfarina, verapamila, ramiprila, simvastatina, torasemida in hidroklorotiazida ni vplivala na farmakokinetiko empagliflozina.
Insulin dose (IU/day)
Odmerek bazalnega insulina (i.e./dan) v 78. tednu
• loss of appetite
• izguba teka Pogosti
Empagliflozin 25 mg
povezani z odmerkom 25 mg.
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Synjardy ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
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).
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).
* p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
Statistična značilnost ni bila ocenjena zaradi zaporednega potrditvenega postopka testiranja 3 LOCF, vrednosti po cenzuriranju antihipertenzivnega reševanja * vrednost p < 0,0001 za enakovrednost, in vrednost p = 0,0153 za superiornost ** vrednost p < 0,0001
• changes the way things taste
• spremembe v okušanju
This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.
metformin znižuje ravni skupnega holesterola, LDL holesterola in ravni trigliceridov.
(97.5% CI) a Subgroup analysis for patients on additional background of metformin (FAS, LOCF) b Subgroup analysis for patients on additional background of metformin (PPS-Completers, LOCF) 1 Mean adjusted for baseline value
Razlika glede na placebo1 (97,5-odstotni IZ) a Analiza pri podskupinah bolnikov ob dodatni prisotnosti metformina (FAS, LOCF)
• 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), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034,
(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;
Major hypoglycaemic events occurred in 0.5%, 0% and 0.5% of patients treated with empagliflozin 10 mg, empagliflozin 25 mg and placebo when added on to metformin and insulin, respectively.
Pri 0,5 % bolnikov, ki so kot dodatek k metforminu in insulinu prejemali empagliflozin 10 mg, 0 % bolnikov, ki so prejemali empagliflozin
Empagliflozin twice daily versus once daily as add on to metformin therapy The efficacy and safety of empagliflozin twice daily versus once daily (daily dose of 10 mg and 25 mg) as add-on therapy in patients with in sufficient glycemic control on metformin monotherapy was evaluated in a double blind placebo-controlled study of 16 weeks duration.
(dnevni odmerek 10 mg in 25 mg) kot dodatnim zdravljenjem k metforminu pri bolnikih z nezadostno urejeno glikemijo, ki prejemajo metformin v monoterapiji, so ocenili v dvojno slepi, s placebom nadzorovani študiji, ki je trajala 16 tednov.
No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea.
Pri kombinaciji z metforminom in sulfonilsečnino se pri nobenem od bolnikov ni pojavil hud hipoglikemični dogodek.
Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post marketing in patients treated with SGLT2 inhibitors, including empagliflozin.
V kliničnih preskušanjih in v obdobju trženja so pri bolnikih, ki so bili zdravljeni z zaviralci SGLT2,
The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) in metformin-treated patients who received empagliflozin was low: 0.6% for empagliflozin 10 mg, 0.3% for empagliflozin 25 mg and 0.1% for placebo.
hipovolemija, ortostatska hipotenzija in sinkopa) je bila pri bolnikih, zdravljenih z metforminom, ki so prejemali empagliflozin nizka: 0,6 % za empagliflozin 10 mg, 0,3 % za empagliflozin 25 mg in 0,1 %
• itching
(NSAID).
• excessive hunger, headache
• bruhanje, trebušne bolečine • mišični krči
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.
V predhodno specificirani analizi zbranih podatkov iz 4 s placebom nadzorovanih študij je zdravljenje z empagliflozinom (68 % vseh bolnikov je ob tem prejemalo metformin) v 24. tednu povzročilo znižanje sistoličnega krvnega tlaka (empagliflozin 10 mg: -3,9 mmHg; empagliflozin
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Ena tableta vsebuje 12,5 mg empagliflozina in 850 mg metforminijevega klorida.
Therefore, serum creatinine levels should be determined before initiating treatment and regularly thereafter:
Ker se metformin izloča skozi ledvice, je treba pred začetkom zdravljenja in redno med zdravljenjem meriti raven kreatinina v serumu: • vsaj enkrat letno pri bolnikih z normalnim delovanjem ledvic,
A greater proportion of patients with a baseline HbA1c ≥7.0% and treated with empagliflozin plus linagliptin achieved a target
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 %.
The results of bioequivalence studies in healthy subjects demonstrated that Synjardy (empagliflozin/metformin hydrochloride) 5 mg/850 mg, 5 mg/1,000 mg, 12.5 mg/850 mg, and 12.5 mg/1,000 mg combination tablets are bioequivalent to co-administration of corresponding doses of empagliflozin and metformin as individual tablets.
Rezultati bioekvivalenčnih študij pri zdravih prostovoljcih so pokazali, da so kombinirane tablete zdravila Synjardy (empagliflozin/metforminijev klorid) 5 mg/850 mg, 5 mg/1.000 mg,
* p-value <0.0001 ** p-value ≤0.025
** vrednost p ≤ 0,025
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Ena tableta vsebuje 5 mg empagliflozina in 850 mg metforminijevega klorida.
• in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin (see sections 4.5 and 5.1 for available data on different combinations)
18 let in več, za izboljšanje urejenosti glikemije kot dopolnilo k dieti in telesni aktivnosti: • pri bolnikih z nezadostno urejeno boleznijo pri jemanju največjega odmerka metformina, ki ga še prenašajo, v monoterapiji; • pri bolnikih z nezadostno urejeno boleznijo pri jemanju metformina v kombinaciji z drugimi zdravili, ki nižajo raven glukoze, vključno z insulinom (glejte poglavji 4.5 in 5.1 za podatke o različnih kombinacijah);
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Ena tableta vsebuje 12,5 mg empagliflozina in 1.000 mg metforminijevega klorida.
Patients with baseline HbA1c ≥9% In a pre-specified analysis of subjects with baseline HbA1c ≥9.0%, treatment with empagliflozin
Bolniki z izhodiščno vrednostjo HbA1c ≥ 9 %
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Ena tableta vsebuje 5 mg empagliflozina in 1.000 mg metforminijevega klorida.
Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish purple, oval, biconvex.
Synjardy 12,5 mg/1000 mg filmsko obložene tablete so temno rjavkasto vijoličaste, ovalne,
Treatment with empagliflozin as add-on to metformin or metformin plus sulfonylurea resulted in clinically meaningful improvement of 2-hour post-prandial glucose (meal tolerance test) at 24 weeks (add-on to metformin, placebo: +5.9 mg/dl, empagliflozin 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg/dl; add-on to metformin plus sulphonylurea, placebo: -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl).
24. tednu (dodatno zdravljenje k metforminu, placebo +5,9 mg/dl, empagliflozin 10 mg: -46,0 mg/dl,
In male rats, treatment-related benign vascular proliferative lesions (haemangiomas) of the mesenteric lymph node were observed at the highest dose, but not at 300 mg/kg/day, which corresponds to approximately 26-times the maximal clinical exposure to empagliflozin.
Pri podganjih samcih so pri najvišjih odmerkih, ne pa tudi pri 300 mg/kg/dan, kar ustreza približno 26-kratni največji klinični izpostavljenosti empagliflozinu,
At exposures sufficiently in excess of exposure in humans after therapeutic doses, empagliflozin had no adverse effects on fertility or early embryonic development.
empagliflozin ni imel neželenih učinkov na sposobnost razmnoževanja ali zgodnji razvoj zarodka.
Vascular disorders
Po peroralnem zaužitju raztopine
Baseline (mean) Change from baseline1
Izhodišče (povprečje) Sprememba od izhodišča1
QUALITATIVE AND QUANTITATIVE COMPOSITION Synjardy 5 mg/850 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Synjardy 5 mg/850 mg filmsko obložene tablete Ena tableta vsebuje 5 mg empagliflozina in 850 mg metforminijevega klorida.
• severe tiredness
• srbečica
PHARMACEUTICAL FORM AND CONTENTS 60 x 1 film-coated tablets.
60 x 1 filmsko obložena tableta.
SBP (mmHg)2, 3
Razlika glede na placebo1 (97,5-odstotni IZ) N Vrednost SBP (mmHg)2, 3
Symptoms of lactic acidosis are non-specific such as feeling or being very sick, vomiting, stomach ache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing.
trebušne bolečine z mišičnimi krči, splošno slabo počutje z izrazito utrujenostjo in oteženo dihanje.
24 hour SBP at week 123
24-urni diastolični krvni tlak v 12. tednu3 Izhodišče (povprečje)