natgillin/translations-raw huggingface dataset:
Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and
Ovaj lijek se ne smije primjenjivati u bolesnika s oštećenjem jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
Urinary tract infection1, 2
Infekcija mokraćnog sustava1, 2
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.
Srednji plazmatski AUC i Cmax u stanju dinamičke ravnoteže iznosili su 1870 nmol.h i 259 nmol/l uz empagliflozin 10 mg te 4740 nmol.h i 687 nmol/l uz empagliflozin 25 mg primijenjenim jedanput dnevno.
A greater proportion of patients treated with empagliflozin and with a baseline HbA1c ≥7.0% achieved a target HbA1c of <7% compared to placebo (Table 5).
Veći udio bolesnika liječenih empagliflozinom s početnom vrijednošću HbA1c ≥ 7,0 % postigao je ciljnu vrijednost < 7 % u usporedbi s placebom (tablica 5).
Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away.
Odmah prestanite uzimati ovaj lijek i odmah se obratite liječniku ili se javite u najbližu bolnicu.
2 Identified adverse reactions of empagliflozin monotherapy 3 Identified adverse reactions of metformin monotherapy 4 Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia)
4 Dugotrajno liječenje metforminom bilo je povezano sa smanjenom apsorpcijom vitamina B12 što vrlo rijetko može rezultirati klinički značajnom deficijencijom vitamina B12 (npr. megaloblastična anemija).
Iron oxide black (E172) Iron oxide red (E172)
talk željezov oksid, crni (E172) željezov oksid, crveni (E172) 6.2 Inkompatibilnosti
Table 3: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformina
Rezultati djelotvornosti u 104. tjednu u aktivno kontroliranom ispitivanju u kojem se uspoređivao empagliflozin naspram glimepirida kao dodatak metforminua
A total of 4704 patients with type 2 diabetes were treated in 7 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 1109 patients received empagliflozin 10 mg and 1863 received empagliflozin 25 mg as add-on to metformin therapy.
Ukupno je bilo liječeno 4 704 bolesnika s šećernom bolešću tipa 2 u 7 dvostruko slijepih, placebom ili aktivno kontroliranih kliničkih ispitivanja u minimalnom trajanju od 24 tjedna, od kojih je 1 109 bolesnika primalo empagliflozin 10 mg, a njih 1 863 empagliflozin 25 mg kao dodatak terapiji metforminom.
* p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
(engl. antihypertensive rescue) * p-vrijednost< 0,0001 za neinferiornost i p-vrijednost = 0,0153 za superiornost ** p-vrijednost < 0,0001
Due to the mechanism of action, decreased renal function will result in reduced efficacy of empagliflozin.
Zbog mehanizma djelovanja empagliflozina, smanjena funkcija bubrega rezultirat će smanjenjem njegove djelotvornosti.
Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
Table 5 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformina
Rezultati djelotvornosti u 18. i 78. tjednu u placebom kontroliranom ispitivanju empagliflozina kao dodatka bazalnom inzulinu s metforminoma
Table 2: Efficacy results of 24 week placebo-controlled studies Add-on to metformin therapya
Rezultati djelotvornosti 24-tjednih placebom kontroliranih ispitivanja Dodatak terapiji metforminoma
• difficulty breathing
• teški umor • otežano disanje
Liver function tests abnormalities3 Hepatitis3
Abnormalni nalazi pretrage jetrene funkcije3
Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently in metformin-treated patients who received empagliflozin 10 mg (4.0%) and empagliflozin 25 mg (3.9%) compared to placebo (1.3%), and were reported more frequently for empagliflozin compared to placebo in female patients.
Vaginalna monilijaza, vulvovaginitis, balanitis i druge genitalne infekcije Vaginalna monilijaza, vulvovaginitis, balanitis i druge genitalne infekcije češće su bile prijavljene u bolesnika liječenih metforminom koji su primali empagliflozin 10 mg (4,0 %) i empagliflozin 25 mg
No major metabolites of empagliflozin were detected in human plasma, as defined by at least 10% of total drug-related material, and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O-glucuronide).
ukupnog materijala povezanog s lijekom, a najzastupljeniji metaboliti bila su tri konjugata glukuronida (2-, 3-, i 6-O-glukuronid).
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%).
Povećana učestalost je zabilježena kada je empagliflozin primjenjivan kao dodatak metforminu i sulfonilureji (empagliflozin 10 mg: 16,1 %, empagliflozin 25 mg: 11,5 %, placebo: 8,4 %) ili kao dodatak metforminu ili inzulinu (empagliflozin 10 mg: 31,3 %, empagliflozin 25 mg: 36,2 %, placebo 34,7 %).
However, only hypochloremia was considered adverse at exposures of approximately 9- and 3-times the clinical AUC exposure of the maximum recommended dose of empagliflozin and metformin, respectively.
Međutim, samo se hipokloremija smatrala štetnom pri izloženosti od približno 9 i 3 puta većoj od kliničke AUC
If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma.
Ako se to dogodi Vama, potrebno Vam je hitno bolničko liječenje, jer laktacidoza može dovesti do kome.
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%).
Infekcije mokraćnog sustava Sveukupna učestalost infekcija mokraćnog sustava prijavljenih kao štetni događaji bila je veća u bolesnika liječenih metforminom koji su primali empagliflozin od 10 mg (8,8 %) u usporedbi s bolesnicima koji su primali empagliflozin 25 mg (6,6 %) ili placebo (7,8 %).
* p-value <0.0001 ** p-value ≤0.025
* p-vrijednost < 0,0001 ** p-vrijednost ≤ 0,025
Administration of empagliflozin 25 mg resulted in a higher proportion of patients achieving HbA1c goal of less than 7% and fewer patients needing glycaemic rescue compared to empagliflozin 10 mg and placebo.
Primjena empagliflozina 25 mg rezultirala je većim udjelom bolesnika koji su postigli ciljne vrijednosti HbA1c niže od 7 % i manjim brojem bolesnika koji su trebali dodatno liječenje u cilju postizanja zadovoljavajuće glikemije (engl. glycaemic rescue) u usporedbi s primjenom empagliflozina 10 mg i placeba.
Add-on to metformin and a sulphonylurea therapya Placebo
Dodatak terapiji metforminom i sulfonilurejoma Placebo
Metformin is excreted by the kidney.
Metformin se izlučuje putem bubrega.
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.
Nakon primjene doze od 850 mg metforminklorida uočena je 40 % niža vršna koncentracija u plazmi, 25 %-tno smanjenje vrijednosti
Table 4: Efficacy results at 18 and 52 weeks in a placebo-controlled study of empagliflozin as add-on to multiple daily doses of insulin with concomitant metformin therapy
Rezultati djelotvornosti u 18. i 52. tjednu u placebom kontroliranom ispitivanju empagliflozina kao dodatka višekratnim dnevnim dozama inzulina uz istodobnu terapiju metforminom.
Treatment with iodinated contrast agent can reduce your kidney function and increase the risk of side effects due to the metformin component.
Uzimanje jodiranog kontrastnog sredstva može smanjiti Vašu funkciju bubrega i povećati rizik od nuspojava zbogmetformina.
In subjects with mild, moderate, and severe hepatic impairment according to the Child-Pugh classification, AUC of empagliflozin increased approximately by 23%, 47%, and 75% and Cmax by approximately 4%, 23%, and 48%, respectively, compared to subjects with normal hepatic function.
empagliflozina se povećao za približno 23 %, 47 % odnosno 75 %, a Cmax za približno 4 %, 23 % odnosno 48 % u usporedbi s ispitanicima s normalnom funkcijom jetre.
Treatment with empagliflozin in combination with metformin with or without other antidiabetic medicinal products (pioglitazone, sulfonylurea, DPP-4 inhibitors, and insulin) led to clinically relevant improvements in HbA1c, fasting plasma glucose (FPG), body weight, systolic and diastolic blood pressure.
sulfonilureje, inhibitora enzima DPP-4 i inzulina) dovelo je do klinički značajnih poboljšanja vrijednosti HbA1c, glukoze u plazmi natašte (engl. fasting plasma glucose, FPG), tjelesne težine, te sistoličkog i dijastoličkog krvnog tlaka.
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.
Ispitivanja interakcija provedenih u zdravih dobrovoljaca sugeriraju da istodobna primjena s metforminom, glimepiridom, pioglitazonom, sitagliptinom, linagliptinom, varfarinom, verapamilom, ramiprilom, simvastatinom, torasemidom i hidroklortiazidom nije utjecala na farmakokinetiku empagliflozina.
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).
Sveukupna učestalost infekcija mokraćnog sustava prijavljenih kao štetni događaj bila je veće u bolesnika koji su liječeni empagliflozinom 10 mg uz osnovnu terapiju metforminom u usporedbi s bolesnicima koji su primali placebo ili liječeni empagliflozinom 25 mg uz osnovnu terapiju metforminom (vidjeti dio 4.8).
Empagliflozin 24 months data, as add-on to metformin in comparison to glimepiride In a study comparing the efficacy and safety of empagliflozin 25 mg versus glimepiride (up to 4 mg per day) in patients with inadequate glycaemic control on metformin alone, treatment with empagliflozin daily resulted in superior reduction in HbA1c (Table 3), and a clinically meaningful reduction in FPG, compared to glimepiride.
U ispitivanju u kojem su uspoređivane djelotvornost i sigurnost empagliflozina 25 mg naspram glimepirida (do 4 mg na dan) u bolesnika s nezadovoljavajućom regulacijom glikemije na monoterapiji metforminom, svakodnevno liječenje empagliflozinom rezultiralo je superiornim sniženjem vrijednosti HbA1c (Tablica 3) te klinički značajnim sniženjem vrijednosti FPG u usporedbi s glimepiridom.
HbA1c <7% with baseline HbA1c ≥7% at week 52b, 2
HbA1c ≥ 7 % u 52. tjednub, 2
Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Bolesnici (%) s postignutim HbA1c < 7 %
• muscular cramps
• grčevi u mišićima
For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products including insulin In patients not adequately controlled on metformin alone or in combination with other glucose-lowering medicinal products, including insulin, the recommended starting dose of Synjardy should provide empagliflozin 5 mg twice daily (10 mg daily dose) and the dose of metformin similar to the dose already being taken.
U bolesnika u kojih nije postignuta zadovoljavajuća regulacija uz metformin kao monoterapiju ili u kombinaciji s drugim lijekovima za snižavanje glukoze u krvi, uključujući inzulin, preporučena početna doza lijeka Synjardy mora osigurati 5 mg empagliflozina dvaput dnevno (dnevna doza 10 mg)
• feeling sick (nausea), vomiting
Vrlo često • mučnina, povraćanje
This medicinal product must not be used in patients with moderate or severe renal impairment (creatinine clearance <60 ml/min) (see sections 4.3 and 4.4).
Lijek se ne smije primjenjivati u bolesnika s umjerenim ili teškim oštećenjem bubrega (klirens kreatinina < 60 ml/min.)
• if you need to have an injection of contrast agent that contains iodine, for example before an X-ray or scan.
Vaš liječnik može zatražiti prekid primjene lijeka Synjardy sve dok se ne oporavite; • ako trebate primiti injekciju kontrastnog sredstva koje sadrži jod, na primjer prije rendgenskog snimanja ili skeniranja.
The efficacy and safety of empagliflozin as add on to basal insulin with concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 78 weeks duration.
Djelotvornost i sigurnost empagliflozina kao dodatka bazalnom inzulinu s istodobnom terapijom metforminom ocjenjivane su u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od
N HbA1c (%) at week 18a
N HbA1c (%) u 18. tjednu
Completers using last observation carried forward (LOCF) prior to glycaemic rescue therapy 1 mean adjusted for baseline value
last observation carried forward, LOCF) prije primjene pomoćne terapije za postizanje zadovoljavajuće glikemije (engl. glycaemic rescue)
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. tjedan režima liječenja usmjerenog ka cilju (engl. treat-to-target) za prilagođavanje doze inzulina kako bi se postigle prethodno definirane ciljne razine glukoze u krvi ( < 100 mg/dl (5,5 mmol/l) preprandijalno, < 140 mg/dl (7,8 mmol/l) postprandijalno) ** p-vrijednost ≤ 0,0005 ** p-vrijednost < 0,005
* p-value <0.0001 ** p-value <0.01
* p-vrijednost < 0,0001 ** p-vrijednost < 0,001
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.
Učestalost bolesnika s događajima teške hipoglikemije bila je niska (< 1 %) i slična uz empagliflozin i placeb kao dodatkom metforminu.
Inhibition of OATP1B1/1B3 transporters by co-administration with rifampicin resulted in a 75% increase in Cmax and a 35% increase in AUC of empagliflozin.
Inhibicija prijenosnika OATP1B1/1B3 putem istodobne primjene s rifampicinom rezultirala je 75 %
• a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017,
metformin 7,5 događaja/1000 bolesnik-godina, samo režim prehrane 12,7 događaja/1000 bolesnik-godina, p= 0,017.
Hypoglycaemia The frequency of hypoglycaemia depended on the background therapy in the respective studies.
Učestalost hipoglikemije ovisila je o osnovnom liječenju u odgovarajućim ispitivanjima.
N HbA1c (%) at week 52b
HbA1c (%) u 52. tjednub
2 Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure 3 LOCF, values after antihypertensive rescue censored
1 Srednja vrijednost prilagođena za početnu vrijednost 2 Statistička značajnost nije ocjenjivana zbog provođenja naknadnog testa kao potvrde 3 LOCF, cenzurirane vrijednosti nakon dodavanja terapije za postizanje zadovoljavajućeg krvnog tlaka
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.
(šećera u krvi) putem mokraće tako što apsorbira glukozu u krvotok dok se krv filtrira u bubrezima.
It is important to stay on the diet and exercise program recommended by your doctor while taking Synjardy.
Važno je, tijekom uzimanja lijeka Synjardy, pridržavati se režima prehrane i provoditi tjelovježbu prema preporuci
ketoacidosisa, b Lactic acidosis3
Dijabetička ketoacidoza a, b
As expected, empagliflozin 5 mg administered twice daily compared with 10 mg empagliflozin once daily resulted in lower Cmax and higher trough plasma empagliflozin concentrations (Cmin).
Kao što se pretpostavljalo, empagliflozin 5 mg primijenjen dvaput dnevno u usporedbi s empagliflozinom 10 mg primijenjenim jedanput dnevno rezultirao je nižim vrijednostima
• feeling or being very sick
• mučnina ili jako povraćanje
Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Ispitivanja interakcija provedena na zdravim dobrovoljcima sugeriraju da empagliflozin nije imao klinički značajan učinak na farmakokinetiku metformina, glimepirida, pioglitazona, sitagliptina,
(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
Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5 % CI) a Analiza podskupine u bolesnika na dodatnoj osnovnoj terapiji metforminom (FAS, LOCF) b Analiza podskupine u bolesnika na dodatnoj osnovnoj terapiji metforminom (bolesnici koji su završili ispitivanje po protokolu, LOCF)
Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio.
Dijagnostički laboratorijski nalazi su snižena pH vrijednost u krvi, razina laktata u plazmi iznad
• reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis,
Metformin može djelovati putem triju mehanizama: • smanjenjem proizvodnje glukoze u jetri inhibicijom glukoneogeneze i glikogenolize,
Lactic acidosis.
Laktacidoza.
The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps, digestive disorders as abdominal pain and severe asthenia.
Rizik od laktacidoze mora se uzeti u obzir kod nespecifičnih znakova poput grčeva u mišićima,
As expected from the mechanism of action, increased urination (as assessed by PT search including pollakiuria, polyuria, nocturia) was observed at higher frequencies in metformin-treated patients who received empagliflozin 10 mg (3.0%) and empagliflozin 25 mg (2.9%) compared to placebo (1.4%) as add-on to metformin therapy.
(pretragom preporučenih izraza uključujući polakizuriju, poliuriju i nokturiju) u bolesnika liječenih metforminom koji su primali empagliflozin 10 mg (3,0 %) i empagliflozin 25 mg (2,9 %) u usporedbi s placebom (1,4 %) kao dodatkom terapiji metforminom.
Co-administration of empagliflozin with probenecid, an inhibitor of UGT enzymes and OAT3, resulted in a 26% increase in peak empagliflozin plasma concentrations (Cmax) and a 53% increase in area under the concentration-time curve (AUC).
rezultirala je 26 %-tnim povećanjem vršne koncentracije empagliflozina u plazmi (Cmax) i 53 %-tnim povećanjem površine ispod krivulje koncentracija-vrijeme (AUC).
An embryofetal development study in pregnant rats did not indicate a teratogenic effect attributed to the co-administration of empagliflozin and metformin at exposures of approximately 14-times the clinical AUC exposure of empagliflozin associated with the highest dose, and 4-times the clinical AUC exposure of metformin associated with the 2000 mg dose.
Ispitivanje embrio-fetalnog razvoja u skotnih štakora nije ukazalo na teratogene učinke pripisane istodobnoj primjeni empagliflozina i metformina pri izloženosti približno 14 puta većoj od kliničke
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
3 LOCF, cenzurirane vrijednosti nakon uzimanja pomoćne antidijabetičke terapije (engl. antidiabetic rescue therapy) ili promjene pomoćne antihipertenzivne terapije (engl. antihypertensive rescue therapy)
Uncommon • straining or pain when emptying the bladder
• naprezanje ili bol kod pražnjenja mjehura Vrlo rijetko
During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels <100 mg/dl [5.5 mmol/l], and post-prandial glucose levels <140 mg/dl [7.8 mmol/l] between Weeks 19 and 40.
Tijekom početnih 18 tjedana i posljednjih 12 tjedana doza inzulina je bila stalna, ali se između 19. i 40. tjedna prilagođavala u cilju postizanja razine glukoze < 100 mg/dl
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).
U prethodno specificiranoj analizi ispitanika s početnom vrijednošću HbA1c ≥ 9,0 % liječenje empagliflozinom 10 mg ili 25 mg kao dodatkom metforminu rezultiralo je statistički značajnim sniženjima vrijednosti HbA1c u 24. tjednu (prilagođena srednja promjena u odnosu na početnu vrijednost u iznosu od -1,49 % za empagliflozin od 25 mg, -1,40 % za empagliflozin od 10 mg te -0,44 % za placebo).
• diarrhoea or stomach ache
• proljev ili bol u trbuhu • gubitak teka
• a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021),
20,6 događaja/1000 bolesnik-godina (p= 0,011) te naspram skupina liječenih kombinacijom sa sulfonilurejom i inzulinom u monoterapiji 18,9 događaja/1000 bolesnik-godina (p= 0,021),
(97.5% CI) N Basal insulin dose (IU/day) at week 78 Baseline (mean) Change from baseline1 Difference from placebo1
Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5 % CI) N Doza bazalnog inzulina (IU/dan) u 78. tjednu
Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1
Početna vrijednost (prosječna) Promjena od početne vrijednosti4 Razlika od placeba4
Hepatic injury
Hepatitis3
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
• Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Dijabetička ketoacidoza, dijabetička pretkoma.
N HbA1c (%) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2 N Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N SBP (mmHg)2 Baseline (mean) Change from baseline1 Difference from placebo1 (95% CI)
Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5 % CI) N Bolesnici (%) s postignutim HbA1c < 7 %
How to store Synjardy 6.
Moguće nuspojave 5. Kako čuvati Synjardy
• a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
11 događaja/1000 bolesnik-godina, samo režim prehrane 18 događaja/1000 bolesnik-godina (p= 0,01).
• vomiting, stomach ache
• povraćanje, bol u trbuhu
• redness of the skin (erythema) or an itchy rash (hives)
• crvenilo kože (eritem) ili osip koji svrbi (koprivnjača) Prijavljivanje nuspojava
HbA1c of <7% compared to linagliptin 5 mg. Clinically meaningful reductions in HbA1c were maintained for 52 weeks.
Klinički značajna smanjenja vrijednosti HbA1c održana su tijekom 52 tjedna.