FrancophonIA/ELRC3.0 huggingface dataset:
English: When ertugliflozin is used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be required to reduce the risk of hypoglycaemia (see sections 4.4, 4.5, and 4.8).
Slovenian: Če se ertugliflozin uporablja v kombinaciji z insulinom ali insulinskim sekretagogom, bo morda potreben manjši odmerek insulina ali insulinskega sekretagoga, da bi se zmanjšalo tveganje za hipoglikemijo (glejte poglavja 4.4, 4.5 in 4.8).
English: Table 7: Results at Week-26 from a combination therapy study of ertugliflozin and sitagliptin*
Slovenian: Preglednica 7: Rezultati študije kombiniranega zdravljenja z ertugliflozinom in sitagliptinom po 26. tednih*
English: Least squares means adjusted for treatment, time, prior antihyperglycaemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status randomisation stratum (men, premenopausal women, women who are perimenopausal or < 3 years postmenopausal, women who are  3 years postmenopausal) and the interaction of time by treatment.
Slovenian: povprečja po metodi najmanjših kvadratov, prilagojena za zdravljenje, čas, predhodno antihiperglikemično zdravljenje (samostojno zdravljenje z metforminom ali metformin + še eno antihiperglikemično zdravilo), izhodiščno eGFR (kontinuirano), randomizacijski stratum glede na menopavzalno stanje (moški, ženske pred menopavzo, ženske v perimenopavzi ali < 3 leta po menopavzi, ženske, ki so  3 leta po menopavzi) in interakcijo med časom in zdravljenjem p  0,001 v primerjavi s placebom p < 0,001 v primerjavi s placebom (na podlagi primerjave prilagojenih razmerij obetov iz modela logistične regresije z uporabo metode večkratne imputacije za manjkajoče podatke)
English: In a 52-week, active-controlled study versus glimepiride, reductions from baseline in SBP were 2.2 mmHg and 3.8 mmHg for ertugliflozin 5 mg and 15 mg respectively, while subjects treated with glimepiride had an increase in SBP from baseline of 1.0 mmHg.
Slovenian: V 52-tedenski, s primerjalno učinkovino nadzorovani študiji, so bila v primerjavi z glimepiridom znižanja SBP od izhodišča za ertugliflozin 5 mg 2,2 mmHg, za ertugliflozin 15 mg pa 2, 8 mmHg, med tem ko je bilo pri osebah, ki so prejemale glimepirid, zvišanje SBP od izhodišča 1,0 mmHg.
English: The LS mean (95% CI) changes from baseline in HbA1c were -0.26 (-0.42, -0.11), -0.29 (-0.44, -0.14), and -0.41 (-0.56, -0.27) in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively.
Slovenian: Spremembe povprečja po metodi najmanjših kvadrantov (95 % IZ) od izhodišča so bile za HbA1c v skupinah bolnikov sledeče: skupina s placebom -0,26 (-0,42; -0,11), skupina z ertugliflozinom 5 mg0,29 ( 0,44; 0,14) in skupina z ertugliflozinom 15 mg 0,41 (0,56; 0,27).
English: How to store Steglatro 6.
Slovenian: Kako jemati zdravilo Steglatro 4.
English: Difference from placebo (LS mean
Slovenian: Razlika v primerjavi s placebom (povprečje LS
English: Assessment of renal function is recommended prior to initiation of Steglatro and periodically thereafter (see section 4.4).
Slovenian: Pred uvedbo zdravila Steglatro je priporočljivo oceniti delovanje ledvic in te kontrole pozneje redno ponavljati (glejte poglavje 4.4).
English: • The active substance is ertugliflozin.
Slovenian: • Učinkovina je ertugliflozin.
English: Ertugliflozin has also been studied in combination with current diabetes treatments, including insulin and a sulphonylurea, in patients with type 2 diabetes with moderate renal impairment.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 in zmerno okvaro ledvic so ertugliflozin preučevali tudi v kombinaciji z obstoječimi zdravili za zdravljenje sladkorne bolezni, vključno z insulinom in sulfonilsečnino.
English: In the study of ertugliflozin added-on to metformin in patients with baseline HbA1c from 7.0-10.5%, the placebo-corrected reductions in HbA1c for the subgroup of patients in the study with baseline HbA1c ≥ 9% were 1.31% and 1.43% with ertugliflozin 5 and 15 mg, respectively.
Slovenian: V študiji ertugliflozina kot dodatka k metforminu pri bolnikih z izhodiščnim HbA1c od 7,0 do 10,5 % je bilo za placebo korigirano znižanje HbA1c v podskupini bolnikov z izhodiščnim HbA1c ≥ 9 % s 5 mg ertugliflozina 1,31 % in s 15 mg ertugliflozina 1,43 %.
English: o Film coating: hypromellose 2910/6 (E464), lactose monohydrate (see section 2), macrogol 3350 (E1521), triacetin (E1518), titanium dioxide (E171), iron oxide red (E172).
Slovenian: • Druge sestavine zdravila so: o Jedro tablete: mikrokristalna celuloza (E460), laktoza monohidrat (glejte poglavje 2), natrijev karboksimetilškrob (tip A), magnezijev stearat (E470b) o Filmska obloga: hipromeloza 2910/6 (E464), laktoza monohidrat (glejte poglavje 2), makrogol 3350 (E1521), triacetin (E1518), titanov dioksid (E171), rdeči železov oksid (E172)
English: Steglatro 5 mg Steglatro 15 mg Glimepiride
Slovenian: Steglatro 5 mg Steglatro 15 mg glimepirid
English: In females, discontinuation due to genital mycotic infections occurred in 0.6% and 0% of patients treated with ertugliflozin and placebo, respectively (see section 4.4).
Slovenian: Delež prenehanja uporabe zdravila zaradi glivičnih okužb spolovil je bil pri ženskah, ki so prejemale ertugliflozin, 0,6 %, in pri ženskah, ki so prejemale placebo, 0 % (glejte poglavje 4.4).
English: Initiation of this medicinal product is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2 or CrCl less than 60 ml/min (see section 4.4).
Slovenian: Uvedba tega zdravila ni priporočljiva pri bolnikih, ki imajo ocenjeno hitrost glomerulne filtracije (eGFR - estimated glomerular filtration rate) manj kot 60 ml/min/1,73 m ali kreatininski očistek
English: The proportion of subjects having any occurrence of BUN values ≥ 50% increase and value >ULN was numerically higher in the ertugliflozin 5 mg group and higher in the 15 mg group (7.9% and 9.8%, respectively) relative to the placebo group
Slovenian: Delež oseb, pri katerih so se vrednosti dušika sečnine v krvi (BUN - blood urea nitrogen) kadar koli zvišale za ≥ 50 % in bile > ZMN, je bil številčno večji v skupini, ki je prejemala 5 mg oz. 15 mg ertugliflozina (7,9 % oz. 9,8 %) glede na skupino, ki je prejemala placebo (5,1 %).
English: These patients, who were not receiving any background anti-hyperglycaemic treatment, were randomised to ertugliflozin 5 mg or ertugliflozin 15 mg in combination with sitagliptin (100 mg) or to placebo once daily (see Table 7).
Slovenian: Te bolnike, ki niso prejemali nobenega osnovnega antihiperglikemičnega zdravljenja, so randomizirali tako, da so prejemali ertugliflozin 5 mg ali ertugliflozin 15 mg v kombinaciji s sitagliptinom (100 mg) ali placebo enkrat na dan (glejte preglednico 7).
English: These patients, who were receiving metformin monotherapy (≥ 1,500 mg/day), were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or glimepiride administered once daily in addition to continuation of background metformin therapy.
Slovenian: Bolnike, ki so prejemali samostojno zdravljenje z metforminom (≥ 1.500 mg/dan), so randomizirali tako, da so prejemali ertugliflozin 5 mg, ertugliflozin15 mg ali glimepirid enkrat na dan kot dodatek k osnovnemu zdravljenju z metforminom.
English: How to take Steglatro
Slovenian: Kako jemati zdravilo Steglatro
English: How Steglatro works
Slovenian: Kako deluje zdravilo Steglatro
English: Hypoglycaemia
Slovenian: Hipovolemija
English: Table 3: Results at Week 26 from a placebo-controlled study for Steglatro used in combination with metformin*
Slovenian: Preglednica 3: Rezultati s placebom nadzorovane študije zdravila Steglatro v kombinaciji z metforminom po 26 tednih*
English: A total of 461 patients with type 2 diabetes inadequately controlled on diet and exercise participated in a randomised, double-blind, multi-centre, 26-week, placebo-controlled study to evaluate the efficacy and safety of ertugliflozin monotherapy.
Slovenian: Skupno 461 bolnikov s sladkorno boleznijo tipa 2, neustrezno urejenih z dieto in telesno aktivnostjo, je sodelovalo v randomizirani, dvojno slepi, multicentrični 26-tedenski s placebom nadzorovani študiji za oceno učinkovitosti in varnosti samostojnega zdravljenja z ertugliflozinom.
English: In the monotherapy study, ertugliflozin 5 and 15 mg resulted in statistically significant placebocorrected reductions in 2-hour PPG of 3.83 and 3.74 mmol/l.
Slovenian: V študiji samostojnega zdravljenja je ertugliflozin statistično značilno znižal za placebo korigirano koncentracijo glukoze 2 uri po obroku, in sicer odmerek 5 mg za 3,83 mmol/l in odmerek 15 mg za 3,74 mmol/l.
English: Table 2: Results at Week 26 from a placebo-controlled monotherapy study of Steglatro*
Slovenian: Preglednica 2: Rezultati s placebom nadzorovane študije samostojnega zdravljenja z zdravilom Steglatro po 26 tednih*
English: Pink, 6.4 x 6.6 mm, triangular-shaped, film-coated tablets debossed with “701” on one side and plain on the other side.
Slovenian: velikosti 6,4 x 6,6 mm, z oznako "701" na eni strani in brez oznake na drugi strani.
English: These patients, who were not receiving any background antihyperglycaemic treatment, were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily (see Table 2).
Slovenian: Te bolnike, ki niso prejemali nobenega osnovnega antihiperglikemičnega zdravljenja, so randomizirali tako, da so prejemali ertugliflozin 5 mg, ertugliflozin 15 mg ali placebo enkrat na dan (glejte preglednico 2).
English: In males, discontinuations due to genital mycotic infections occurred in 0.2% and 0% of patients treated with ertugliflozin and placebo, respectively.
Slovenian: Delež prenehanj uporabe zdravila zaradi glivičnih okužb spolovil je bil pri moških, ki so prejemali ertugliflozin, 0,2 %, in pri moških, ki so prejemali placebo, 0 %.
English: Red, 9.0 x 9.4 mm, triangular-shaped, film-coated tablets debossed with “702” on one side and plain on the other side.
Slovenian: velikosti 9,0 x 9,4 mm, z oznako "702" na eni strani in brez oznake na drugi strani.
English: Combination therapy of ertugliflozin and sitagliptin A total of 291 patients with type 2 diabetes inadequately controlled on diet and exercise participated in a randomised, double-blind, multi-centre, placebo-controlled 26-week study to evaluate the efficacy and safety of ertugliflozin in combination with sitagliptin.
Slovenian: Kombinirano zdravljenje z ertugliflozinom in sitagliptinom Skupno 291 bolnikov s sladkorno boleznijo tipa 2, neustrezno urejenih z dieto in telesno aktivnostjo, je sodelovalo v randomizirani, dvojno slepi, multicentrični, 26-tedenski, s placebom nadzorovani študiji za oceno učinkovitosti in varnosti ertugliflozina v kombinaciji s sitagliptinom.
English: Temporary interruption of treatment with ertugliflozin should be considered until the fluid loss is corrected.
Slovenian: Dokler izguba tekočine ni odpravljena, pride v poštev začasna prekinitev zdravljenja z ertugliflozinom.
English: • have kidney problems.
Slovenian: • če imate težave z ledvicami.
English: Steglatro should not be initiated in patients with an eGFR below 60 ml/min/1.73 m 2 or CrCl below 60 ml/min.
Slovenian: Zdravila Steglatro se ne sme uvesti pri bolnikih z eGFR pod 60 ml/min/1,73 m ali CrCl pod
English: Ertugliflozin 15 mg + Sitagliptin
Slovenian: ertugliflozin 5 mg + sitagliptin ertugliflozin 15 mg + sitagliptin placebo
English: Patients should be alerted to the risk of hypoglycaemia when Steglatro is used in combination with insulin or an insulin secretagogue and to the elevated risk of adverse reactions related to volume depletion, such as postural dizziness (see sections 4.2, 4.4, and 4.8).
Slovenian: Če se zdravilo Steglatro uporablja v kombinaciji z insulinom ali insulinskim sekretagogom, je treba bolnike opozoriti na tveganje za hipoglikemijo in na povečano tveganje za neželene učinke, povezane s hipovolemijo, kot je posturalna omotica (glejte poglavja 4.2, 4.4 in 4.8).
English: No dose adjustment of ertugliflozin is necessary in patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter prilagoditev odmerka ertugliflozina ni potrebna.
English: Patients were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily in addition to continuation of background metformin and sitagliptin therapy (see Table 6).
Slovenian: Bolnike so randomizirali tako, da so prejemali ertugliflozin 5 mg, ertugliflozin 15 mg ali placebo enkrat na dan kot dodatek k osnovnemu zdravljenju z metforminom in sitagliptinom (glejte preglednico 6).
English: • If you get any side effects, talk to your doctor, or pharmacist or nurse.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Table 6: Results at Week 26 from an add-on study of Steglatro in combination with metformin and sitagliptin*
Slovenian: Preglednica 6: Rezultati študije dodatka zdravila Steglatro v kombinaciji z metforminom in sitagliptinom po 26 tednih*
English: Consideration may also be given to stopping treatment with ertugliflozin in patients who develop events which may precede amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Slovenian: Pri bolnikih, pri katerih se pojavijo dogodki, ki lahko vodijo do amputacije, kot so kožne razjede na spodnjih okončinah, okužba, osteomielitis ali gangrena, je treba razmisliti o prekinitvi zdravljenja z ertugliflozinom.
English: CrCl is persistently below 45 ml/min due to a reduction of efficacy.
Slovenian: Če je eGFR neprestano manjša od 45 ml/min/1,73 m ali CrCl neprestano manj kot 45 ml/min, je treba zdravilo Steglatro ukiniti zaradi zmanjšane učinkovitosti.
English: Patients were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily in addition to continuation of background metformin therapy (see Table 3).
Slovenian: Bolnike so randomizirali tako, da so prejemali ertugliflozin 5 mg, ertugliflozin 15 mg ali placebo enkrat na dan kot dodatek k osnovnemu zdravljenju z metforminom (glejte preglednico 3).
English: In the monotherapy study conducted on a background of diet and exercise in patients with baseline HbA1c from 7-10.5%, the subgroup of patients in the study with a baseline HbA1c ≥ 8% had placebo-corrected reductions in HbA1c of 1.11% and 1.52% with ertugliflozin 5 or 15 mg, respectively.
Slovenian: Učinkovitost pri bolnikih z izhodiščnim HbA1c ≥ 8 % V študiji samostojnega zdravljenja ob osnovni shemi diete in telesne aktivnosti pri bolnikih z izhodiščnim HbA1c od 7,0 do 10,5 % sta bili za placebo korigirani znižanji HbA1c v podskupini bolnikov z izhodiščnim HbA1c ≥ 8 % s 5 mg ertugliflozina 1,11 % in s 15 mg ertugliflozina 1,52 %.
English: If you get any side effects, talk to your doctor or, pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Do not use Steglatro if you are breast-feeding.
Slovenian: Če dojite, ne uporabljajte zdravila Steglatro.
English: Vulvovaginal mycotic infection and other female genital mycotic infections*
Slovenian: Infekcijske in parazitske bolezni zelo pogosti pogosti neznana pogostnost vulvovaginalne glivične okužbe in druge glivične okužbe ženskih spolovil*
English: Do not drive or use any tools or machines if you feel dizzy while taking Steglatro.
Slovenian: Če se med jemanjem zdravila Steglatro počutite omotični, ne upravljajte vozil in ne uporabljajte nobenega orodja ali strojev.
English: Steglatro 15 mg tablets ertugliflozin
Slovenian: Steglatro 15 mg tablete ertugliflozin
English: Ertugliflozin as add-on combination therapy with metformin A total of 621 patients with type 2 diabetes inadequately controlled on metformin monotherapy (≥ 1,500 mg/day) participated in a randomised, double-blind, multi-centre, 26-week, placebocontrolled study to evaluate the efficacy and safety of ertugliflozin in combination with metformin.
Slovenian: Ertugliflozin kot dodatek h kombiniranemu zdravljenju z metforminom Skupno 621 bolnikov s sladkorno boleznijo tipa 2, neustrezno urejenih s samostojnim zdravljenjem z metforminom (≥ 1.500 mg/dan), je sodelovalo v randomizirani, dvojno slepi, multicentrični, 26-tedenski s placebom nadzorovani študiji za oceno učinkovitosti in varnosti ertugliflozina v kombinaciji z metforminom.
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 ertugliflozin (see sections 4.2, 4.4, and 4.8).
Slovenian: Za zmanjšanje tveganja za hipoglikemijo bo zato v kombinaciji z ertugliflozinom morda potreben manjši odmerek insulina ali insulinskega sekretagoga (glejte poglavja 4.2, 4.4 in 4.8).
English: Steglatro 5 mg tablets ertugliflozin
Slovenian: Steglatro 5 mg tablete ertugliflozin
English: What Steglatro contains
Slovenian: Kaj vsebuje zdravilo Steglatro
English: What Steglatro is used for
Slovenian: Za kaj uporabljamo zdravilo Steglatro
English: Least squares means adjusted for treatment, time, prior antihyperglycaemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.
Slovenian: (samostojno zdravljenje ali dvotirno zdravljenje), izhodiščno eGFR (kontinuirano) in interakcijo med časom in zdravljenjem.
English: • Steglatro 5 mg film-coated tablets (tablets) are pink, 6.4 x 6.6 mm, triangular-shaped, with
Slovenian: • Zdravilo Steglatro 5 mg filmsko obložene tablete (tablete) so rožnate barve, trikotne oblike,
English: Therefore, a lower dose of insulin or insulin secretagogue may be required to minimise the risk of hypoglycaemia when used in combination with ertugliflozin (see sections 4.2 and 4.5).
Slovenian: Da bi zmanjšali tveganje za hipoglikemijo, bo pri uporabi v kombinaciji z ertugliflozinom morda potreben manjši odmerek insulina ali insulinskega sekretagoga (glejte poglavji 4.2 in 4.5).
English: Each film-coated tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline).
English: Each film-coated tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Slovenian: Ena filmsko obložena tableta vsebuje 15 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline).
English: Steglatro 5 mg film-coated tablets Steglatro 15 mg film-coated tablets ertugliflozin
Slovenian: Steglatro 5 mg filmsko obložene tablete Steglatro 15 mg filmsko obložene tablete ertugliflozin
English: p< 0.001 compared to placebo (based on adjusted odds ratio comparisons from a logistic regression model using multiple imputation for missing data values).
Slovenian: † povprečja po metodi najmanjših kvadratov so prilagojena na podlagi longitudinalnega modela z vključenimi členi za zdravljenje, čas in interakcijo med časom in zdravljenjem ‡ p < 0,001 v primerjavi s placebom § p < 0,001 v primerjavi s placebom (na podlagi primerjave prilagojenih razmerij obetov iz modela logistične regresije z uporabo metode večkratne imputacije za manjkajoče podatke)
English: Steglatro 15 mg film-coated tablets ertugliflozin
Slovenian: Steglatro 15 mg filmsko obložene tablete ertugliflozin
English: Steglatro 5 mg film-coated tablets Each tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Slovenian: Steglatro 5 mg filmsko obložene tablete Ena tableta vsebuje 5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline).
English: Steglatro 5 mg film-coated tablets ertugliflozin
Slovenian: Steglatro 5 mg filmsko obložene tablete ertugliflozin
English: Effects on bone (shorter femur length, increased trabecular bone in the femur) as well as effects of delayed puberty were observed at an exposure 817 times the MRHD of 15 mg/day based on AUC.
Slovenian: Pri izpostavljenosti, ki je bila na podlagi AUC 817-kratnik tiste ob MRHD 15 mg/dan, so opažali vplive na kosti (krajša dolžina stegnenice, povečana trabekularna kost stegnenice) in zapoznelo puberteto.
English: Steglatro 5 mg film-coated tablets Steglatro 15 mg film-coated tablets
Slovenian: Steglatro 5 mg filmsko obložene tablete Steglatro 15 mg filmsko obložene tablete
English: Change from baseline (LS mean Difference from placebo (LS mean
Slovenian: Izhodišče (povprečje) Sprememba od izhodišča (povprečje LS Razlika v primerjavi s placebom (povprečje LS
English: Steglatro 15 mg film-coated tablets Each tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Slovenian: Steglatro 15 mg filmsko obložene tablete Ena tableta vsebuje 15 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline).
English: Least squares means adjusted for treatment, time, prior antihyperglycaemic medication, baseline eGFR and the interaction of time by treatment.
Slovenian: povprečja po metodi najmanjših kvadratov, prilagojena za zdravljenje, čas in predhodno antihiperglikemično zdravljenje p < 0,001 v primerjavi s placebom
English: • Steglatro 15 mg film-coated tablets (tablets) are red, 9.0 x 9.4 mm, triangular-shaped, with
Slovenian: • Zdravilo Steglatro 15 mg filmsko obložene tablete (tablete) so rdeče barve, trikotne oblike,
English: A total of 1,326 patients with type 2 diabetes inadequately controlled on metformin monotherapy participated in a randomised, double-blind, multi-centre, 52-week, active comparator-controlled study to evaluate the efficacy and safety of ertugliflozin in combination with metformin.
Slovenian: S primerjalno učinkovino nadzorovana študija ertugliflozina v primerjavi z glimepiridom kot dodatkom kombiniranemu zdravljenju z metforminom Skupno 1.326 bolnikov s sladkorno boleznijo tipa 2, neustrezno urejenih s samostojnim zdravljenjem z metforminom, je sodelovalo v randomizirani, dvojno slepi, multicentrični 52-tedenski, s primerjalno učinkovino nadzorovani študiji za oceno učinkovitosti in varnosti ertugliflozina v kombinaciji z metforminom.
English: Baseline (mean)
Slovenian: "kreatininu"),
English: o Each Steglatro 5 mg film-coated tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Slovenian: o Ena tableta Steglatro 5 mg filmsko obložena tableta vsebuje 5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline).
English: o Each Steglatro 15 mg film-coated tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Slovenian: o Ena tableta Steglatro 15 mg filmsko obložena tableta vsebuje 15 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline).
English: Your bladder will need some time to adapt.
Slovenian: Vaš sečni mehur bo potreboval nekaj časa, da se bo prilagodil.
English: Incontinence episodes per week
Slovenian: število inkontinenčnih epizod na teden
English: It has been shown that taking all doses at the appropriate times can greatly increase the effectiveness of your medicine.
Slovenian: Izkazalo se je, da lahko jemanje vseh odmerkov ob ustreznem času močno zveča učinkovitost vašega zdravila.
English: A risk to the nursing child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ni mogoče izključiti.
English: The tablet may be taken with or without food.
Slovenian: Tablete lahko vzamete s hrano ali brez nje.
English: Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events cannot be estimated from the available data.
Slovenian: Ker gre za spontano sporočene dogodke na podlagi postmarketiških izkušenj širom sveta, iz razpoložljivih podatkov ni mogoče oceniti pogostnosti dogodkov.
English: Take Emselex tablets once a day with water, at about the same time each day.
Slovenian: Tablete Emselex vzemite enkrat na dan z vodo, in sicer vsak dan približno ob istem času.
English: (median)
Slovenian: (mediana)
English: Week 12 (median)
Slovenian: 12. teden (mediana)
English: If you forget to take Emselex at the usual time, take it as soon as you remember, unless it is the time for your next dose.
Slovenian: Če ste pozabili vzeti Emselex ob običajnem času, ga vzemite, takoj ko se spomnite, razen če je že čas za naslednji odmerek.