FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Segluromet may be restarted when the ketone values are normal and the patient's condition has stabilised.
Slovenian: Zdravljenje z zdravilom Segluromet je mogoče znova uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g., every 3-6 months.
Slovenian: Pri bolnikih s povečanim tveganjem za dodatno napredovanje okvare ledvic in pri starejših je treba delovanje ledvic oceniti pogosteje, na primer vsake 3 do 6 mesecev.
English: If you forget a dose, take it as soon as you remember.
Slovenian: Če pozabite vzeti odmerek, ga vzemite, takoj ko se spomnite.
English: Patients and/or care-givers should be informed of the risk of lactic acidosis.
Slovenian: Bolnike in/ali negovalce je treba opozoriti na tveganje za laktacidozo.
English: Patients should not take two doses of Segluromet at the same time.
Slovenian: Bolnik ne sme vzeti dveh odmerkov zdravila Segluromet istočasno.
English: Alternative methods should be used to monitor glycaemic control.
Slovenian: Za spremljanje urejenosti glikemije je treba uporabiti alternativne metode.
English: The effects on kidney and bone did not fully reverse after the 1-month recovery period.
Slovenian: Vplivi na ledvice in kosti po 1-mesečnem obdobju okrevanja niso povsem izginili.
English: • if you have recently had a heart attack or have severe circulatory problems, such as ‘shock' or breathing difficulties.
Slovenian: • če ste nedavno imeli srčni infarkt ali imate hude težave s krvnim obtokom, kot so "šok" ali težave pri dihanju.
English: • The dose of Segluromet that you take will depend on your condition and the amount of ertugliflozin and metformin needed to control your blood sugar.
Slovenian: • Odmerek zdravila Segluromet, ki ga boste jemali, bo odvisen od vašega stanja in količine ertugliflozina in metformina, potrebne za uravnavanje vašega krvnega sladkorja.
English: p< 0.001 compared to glimepiride.
Slovenian: p < 0,001 v primerjavi z glimepiridom
English: • The recommended dose of Segluromet is one tablet twice a day.
Slovenian: • Priporočeni odmerek zdravila Segluromet je ena tableta dvakrat na dan.
English: • if you are allergic to ertugliflozin or metformin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na ertugliflozin ali metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • increased levels of “ketone bodies” in your urine or blood
Slovenian: • zvišana raven "ketonskih teles" v urinu ali krvi,
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavni del multi pakiranja, ločena prodaja ni možna.
English: • decreased vitamin B12 levels.
Slovenian: • znižanje ravni vitamina B12.
English: Non-inferiority is declared when the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.
Slovenian: Neinferiornost je potrjena, če je zgornja meja dvostranskega 95-odstotnega intervala zaupanja (IZ) za povprečno razliko manj kot 0,3 %.
English: • change in taste
Slovenian: • sprememba okusa,
English: Hispanic or Latino patients comprised 15.6% to 34.5% of the population.
Slovenian: Latinoameričani so predstavljali od 15,6 % do 34,5 % populacije.
English: Renal clearance is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination.
Slovenian: Ledvični očistek je približno 3,5-krat večji od očistka kreatinina, kar kaže, da je tubularna sekrecija glavna pot izločanja metformina.
English: If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
Slovenian: Če ste noseči, se z zdravnikom posvetujte o tem, kako najbolje uravnavati krvni sladkor med nosečnostjo.
English: In this population, the incidence of severe hypoglycaemia was 0.4% in each group.
Slovenian: V tej populaciji je bila pojavnost hude hipoglikemije v vseh skupinah 0,4 %.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: , Vitamin B12 deficiency
Slovenian: , pomanjkanje vitamina B12
English: Not recommended.
Slovenian: Ni priporočljiv.
English: These data reflect exposure of 1,029 patients to ertugliflozin with a mean exposure duration of approximately 25 weeks.
Slovenian: Ti podatki odražajo izpostavljenost 1.029 bolnikov ertugliflozinu s povprečnim trajanjem izpostavljenosti približno 25 tednov.
English: This can lead to serious medical problems, like heart disease, kidney disease, blindness and poor circulation.
Slovenian: To lahko povzroči resne zdravstvene težave, kot so bolezen srca, bolezen ledvic, slepota in slab pretok krvi.
English: • if you are taking medicines which increase urine production (diuretics).
Slovenian: • če jemljete zdravila, ki povečajo nastajanje urina (diuretike).
English: In case of swallowing difficulties, the tablet could be broken or crushed as it is an immediate-release dosage form.
Slovenian: V primeru težav pri požiranju se tableto lahko prelomi ali zdrobi, saj gre za farmacevtsko obliko s takojšnjim sproščanjem.
English: Since human kidney maturation occurs in utero and during the first 2 years of life when exposure from breast-feeding may occur, a risk to newborns/infants cannot be excluded.
Slovenian: Ker pri človeku dozorevanje ledvic poteka in utero ter v prvih 2 letih življenja, ko lahko pride do izpostavljenosti zaradi dojenja, tveganja za novorojence/otroke ne moremo izključiti.
English: As precautionary measures, consideration should be given to carefully monitoring patients with a higher risk for amputation events and counselling patients about the importance of routine preventative foot care and maintaining adequate hydration.
Slovenian: V okviru previdnostnih ukrepov je treba razmisliti o skrbnem spremljanju bolnikov z višjim tveganjem za amputacije ter o svetovanju bolnikom glede pomembnosti redne preventivne oskrbe stopal in vzdrževanja ustrezne hidracije.
English: If no adequate strength of Segluromet is available, individual monocomponents should be used instead of the fixed-dose combination.
Slovenian: Če ni na voljo ustrezne jakosti zdravila Segluromet, je treba namesto fiksne kombinacije uporabiti posamezne monokomponente.
English: (For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5 and 5.1.)
Slovenian: (Za rezultate študij glede kombiniranega zdravljenja in učinkov na urejenost glikemije glejte poglavja 4.4, 4.5 in 5.1.)
English: • Metformin belongs to a group of medicines called biguanides.
Slovenian: • Metformin spada v skupino zdravil, imenovanih bigvanidi.
English: Do not stop taking this medicine without talking to your doctor.
Slovenian: Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Segluromet in all subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Segluromet za vse podskupine pediatrične populacije za zdravljenje sladkorne bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Type 2 diabetes is a condition in which your body does not make enough insulin or the insulin that your body produces does not work as well as it should.
Slovenian: Sladkorna bolezen tipa 2 je bolezensko stanje, pri katerem v telesu ne nastaja dovolj insulina ali pa insulin, ki v telesu nastane, ne deluje tako dobro, kot bi moral.
English: • unusual sleepiness or tiredness
Slovenian: • neobičajna zaspanost ali utrujenost,
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Segluromet.
Slovenian: Morda boste potrebovali pogostejše meritve glukoze v krvi in preiskave delovanja ledvic, ali pa vam bo zdravnik moral prilagoditi odmerek zdravila Segluromet.
English: This finding was attributed to carbohydrate malabsorption leading to altered calcium homeostasis and was not considered relevant to human risk.
Slovenian: Ta izsledek so pripisali malabsorpciji ogljikovih hidratov, ki je spremenila homeostazo kalcija, in ni veljal za pomembnega, kar zadeva tveganje za človeka.
English: 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).
Slovenian: Dolgotrajno zdravljenje z metforminom je bilo povezano z zmanjšanjem absorpcije vitamina B12, kar lahko zelo redko povzroči klinično pomembno pomanjkanje vitamina B12 (npr. megaloblastno anemijo).
English: • changes in urination, including urgent need to urinate more often, in larger amounts, or at night
Slovenian: • spremembe uriniranja, vključno z nujno potrebo po pogostejšem uriniranju, večjo količino urina ali uriniranjem ponoči,
English: • feeling dizzy, light-headed, or weak, especially when you stand up
Slovenian: • občutek omotičnosti, vrtoglavice ali šibkosti, zlasti ob vstajanju,
English: Patients with moderate renal impairment at baseline had larger mean changes that did not return to baseline at Week 26; these changes reversed after treatment discontinuation.
Slovenian: Bolniki z zmerno okvaro ledvic v izhodišču so imeli večje povprečne spremembe, ki se po 26 tednih niso vrnile na izhodišče; te spremembe so izginile po prenehanju zdravljenja.
English: It is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your healthcare professional.
Slovenian: Pomembno je, da si redno pregledujete stopala in upoštevate vse druge nasvete zdravstvenega osebja glede oskrbe stopal in ustrezne hidracije.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake "EXP".
English: Patients [N (%)] with HbA1c < 7% 66 (26.4)
Slovenian: Bolniki [n (%)] s HbA1c < 7 % 66 (26,4)
English: • if you have severely reduced kidney function or need dialysis.
Slovenian: • če imate zelo zmanjšano delovanje ledvic ali potrebujete dializo.
English: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: If needed, dose adjustment of metformin may be considered as OCT inhibitors/inducers may alter the efficacy of metformin.
Slovenian: Po potrebi lahko pride v poštev prilagoditev odmerka metformina, saj lahko zaviralci/induktorji OCT spremenijo učinkovitost metformina.
English: Try to take it at the same time each day; this will help you remember to take it.
Slovenian: • Vzemite eno tableto dvakrat na dan. Tableto poskusite vzeti vsak dan ob istem času; to vam bo pomagalo, da je ne boste pozabili vzeti.
English: The safety and efficacy of Segluromet in children under 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Segluromet pri otrocih, mlajših od 18 let, nista bili dokazani.
English: You should notify your doctor immediately if you notice any wounds or discolouration, or if you experience any tenderness or pain in your feet.
Slovenian: Nemudoma obvestite zdravnika, če opazite kakršne koli rane ali obarvanje, oziroma če občutite občutljivost ali bolečino v stopalih.
English: • if you are taking other medicines that lower the sugar in your blood, such as insulin or medicines that increase insulin release from the pancreas.
Slovenian: • če jemljete druga zdravila, ki znižujejo sladkor v krvi, kot so insulin ali zdravila, ki povečajo sproščanje insulina iz trebušne slinavke.
English: Your doctor may decide to temporarily or permanently stop your treatment with Segluromet.
Slovenian: Zdravnik bo morda odločil, da z zdravljenjem z zdravilom Segluromet začasno ali trajno prenehate.
English: It is not known if Segluromet can harm your unborn baby.
Slovenian: Ni znano, ali lahko zdravilo Segluromet škoduje nerojenemu otroku.
English: The effect of Segluromet on fertility in humans has not been studied.
Slovenian: Vpliva zdravila Segluromet na plodnost pri ljudeh niso preučevali.
English: A limited amount of data suggests the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Slovenian: Maloštevilni podatki nakazujejo, da uporaba metformina pri nosečnicah ni povezana z večjim tveganjem za prirojene malformacije.
English: There is limited experience with Segluromet in patients ≥ 75 years of age.
Slovenian: Izkušenj z uporabo zdravila Segluromet pri bolnikih ≥ 75 let je malo.
English: During treatment with Segluromet, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Slovenian: Med zdravljenjem z zdravilom Segluromet bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
English: Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours.
Slovenian: Po peroralni uporabi se približno 90 % absorbiranega zdravila izloči skozi ledvice v prvih 24 urah, s plazemskim eliminacijskim razpolovnim časom približno 6,2 ure.
English: It is not known if Segluromet passes into breast milk.
Slovenian: Ni znano, ali zdravilo Segluromet prehaja v materino mleko.
English: Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycaemic agents.
Slovenian: Farmakološki mehanizmi njegovega delovanja se razlikujejo od drugih razredov peroralnih antihiperglikemičnih zdravil.
English: See “Description of selected adverse reactions” for frequencies and see section 4.4.
Slovenian: Glejte "Opis izbranih neželenih učinkov" za pogostnosti ter poglavje 4.4.
English: Low blood sugar (hypoglycaemia; common)
Slovenian: Nizek krvni sladkor (hipoglikemija; pogosta)
English: Some studies indicate that taking ertugliflozin may have contributed to an increase in cases of lower limb amputation (mainly of the toe).
Slovenian: Nekatere študije nakazujejo, da je jemanje ertugliflozina morda prispevalo k povečanju števila primerov amputacij na spodnjih okončinah (predvsem prstov).
English: , Haemoglobin increased ß,1
Slovenian: , zvišanje hemoglobina ß,1
English: • if you are taking certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Slovenian: • če jemljete določena zdravila za zdravljenje visokega krvnega tlaka (zaviralci ACE in antagonisti receptorjev angiotenzina II).
English: This decrease in exposure is not considered clinically relevant and therefore, no dose adjustment is recommended.
Slovenian: To zmanjšanje izpostavljenosti ne velja za klinično pomembno, zato se prilagoditev odmerka ne priporoča.
English: When this happens, sugar (glucose) builds up in the blood.
Slovenian: V tem primeru se sladkor (glukoza) kopiči v krvi.
English: • Segluromet can be used alone or with some other medicines that lower blood sugar.
Slovenian: • Zdravilo Segluromet se lahko uporablja samostojno ali skupaj s kakšnimi drugimi zdravili za zniževanje krvnega sladkorja.
English: Caution is therefore advised, especially in patients with renal impairment, when these drugs are coadministered with metformin, as metformin plasma concentration may increase.
Slovenian: Previdnost se torej priporoča predvsem pri bolnikih z okvaro ledvic, pri katerih se ta zdravila uporabljajo sočasno z metforminom, saj se koncentracija metformina v plazmi lahko poveča.
English: Results in the in vivo mouse micronucleus test were also negative.
Slovenian: Rezultati mikrojedrnega testa in vivo pri miših so bili prav tako negativni.
English: Organic cation transporters (OCT) Metformin is a substrate of both transporters OCT1 and OCT2.
Slovenian: Organski kationski prenašalci (OCT) Metformin je substrat obeh prenašalcev, OCT1 in OCT2.
English: If you are not sure, talk to your doctor before taking Segluromet.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, preden začnete jemati zdravilo Segluromet.
English: Ertugliflozin and metformin are present in the milk of lactating rats.
Slovenian: Ertugliflozin in metformin sta prisotna v mleku doječih podgan.
English: Glimepiride was initiated at 1 mg/day and titrated up to a maximum dose of 6 or 8 mg/day (depending on maximum approved dose in each country) or a maximum tolerated dose or down-titrated to avoid or manage hypoglycaemia.
Slovenian: Glimepirid so uvedli v odmerku 1 mg/dan in so ga povečevali do največjega odmerka 6 ali 8 mg/dan (odvisno od največjega odobrenega odmerka v posamezni državi) ali do največjega toleriranega odmerka, ali pa so ga zmanjševali za preprečitev ali obvladanje hipoglikemije.
English: • Swallow the tablet; if you have difficulties in swallowing the tablet can be broken or crushed.
Slovenian: Jemanje tega zdravila • Tableto pogoltnite; če imate težave s požiranjem, lahko tableto prelomite ali zdrobite.
English: • might be at risk of dehydration (for example, if you are taking medicines that increase urine production [diuretics] lower blood pressure or if you are over 65 years old).
Slovenian: • če obstaja tveganje za dehidracijo (če na primer jemljete tablete, ki povečajo nastajanje urina [diuretike] ali znižajo krvni tlak, ali če ste stari več kot 65 let).
English: Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 ml/min)
Slovenian: Odrasli z normalnim delovanjem ledvic (hitrost glomerulne filtracije [GFR] ≥ 90 ml/min)
English: The mean daily dose of glimepiride was 3.0 mg (see Table 5).
Slovenian: Povprečni dnevni odmerek glimepirida je bil 3,0 mg (glejte preglednico 5).
English: Contact your doctor as soon as possible if you notice the following side effects:
Slovenian: Čim prej se posvetujte z zdravnikom, če opazite katerega od naslednjih neželenih učinkov:
English: The primary assessment of safety was conducted in a pool of three 26-week, placebo-controlled trials.
Slovenian: Prvotno oceno varnosti so izvedli v treh združenih 26-tedenskih, s placebom nadzorovanih preskušanjih.
English: What you need to know before you take Segluromet 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Segluromet 3.
English: Based on a population pharmacokinetic analysis, age, body weight, gender, and race do not have a clinically meaningful effect on the pharmacokinetics of ertugliflozin.
Slovenian: Na podlagi populacijske farmakokinetične analize starost, telesna masa, spol in rasa nimajo klinično pomembnega vpliva na farmakokinetiko ertugliflozina.
English: The blood-to-plasma concentration ratio of ertugliflozin is 0.66.
Slovenian: Razmerje koncentracij ertugliflozina med krvjo in plazmo je 0,66.
English: If you take more Segluromet than you should If you take too much Segluromet, talk to a doctor or pharmacist straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Segluromet, kot bi smeli Če vzamete preveč zdravila Segluromet, se takoj posvetujte z zdravnikom ali farmacevtom.
English: Contact a doctor or the nearest hospital straight away if you have any of the following serious side effects:
Slovenian: Takoj se posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico, če imate katerega od naslednjih resnih neželenih učinkov:
English: The safety and efficacy of Segluromet in patients with type 1 diabetes have not been established and Segluromet should not be used for treatment of patients with type 1 diabetes.
Slovenian: Varnost in učinkovitost zdravila Segluromet pri bolnikih s sladkorno boleznijo tipa 1 nista bili dokazani in se ga ne sme uporabljati za zdravljenje bolnikov s sladkorno boleznijo tipa 1.
English: Multipack: 196 (4 packs of 49) film-coated tablets
Slovenian: Multi pakiranje: 196 (4 pakiranja po 49) filmsko obloženih tablet
English: • painful urination
Slovenian: • boleče uriniranje.
English: What Segluromet is and what it is used for 2.
Slovenian: Kaj je zdravilo Segluromet in za kaj ga uporabljamo 2.
English: Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see section 4.4).
Slovenian: O laktacidozi so poročali v približno 32 % primerov prevelikega odmerjanja metformina (glejte poglavje 4.4).
English: Segluromet must be discontinued at the time of surgery under general, spinal, or epidural anaesthesia.
Slovenian: Uporabo zdravila Segluromet je treba v času kirurškega posega pod splošno, spinalno ali epiduralno anestezijo prekiniti.
English: This medicine has no or negligible influence on the ability to drive and use machines.
Slovenian: To zdravilo nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Slovenian: Gastrointestinalni simptomi, kot so navzea, bruhanje, diareja, abdominalna bolečina in izguba apetita, nastopijo najpogosteje med uvedbo zdravljenja in v večini primerov spontano izzvenijo.
English: Initial increases in mean creatinine and decreases in mean eGFR in patients treated with ertugliflozin were generally transient during continuous treatment.
Slovenian: Uvodno zvišanje povprečnega kreatinina in zmanjšanje povprečne eGFR pri bolnikih, zdravljenih z ertugliflozinom, je bilo med neprekinjenim zdravljenjem na splošno prehodno.
English: Similarly, there was no tumorigenic potential observed with metformin in male rats.
Slovenian: Podobno niso opazili tumorogenega potenciala metformina pri podganjih samcih.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Slovenian: Bolnika je treba s tem seznaniti in pogosteje opravljati teste za določanje koncentracije glukoze v krvi, zlasti na začetku zdravljenja s takimi zdravili.
English: Discontinue when GFR is persistently less than 45 ml/min.
Slovenian: Ukiniti, če je GFR trajno manj kot 45 ml/min.
English: An increase in cases of lower limb amputation (primarily of the toe) has also been observed in long-term clinical studies with another SGLT2 inhibitor.
Slovenian: Povečanje števila primerov amputacij na spodnjih okončinah (predvsem prstov) so opazili tudi v dolgotrajnih kliničnih študijah z drugim zaviralcem SGLT2.
English: Ertugliflozin is a potent, selective, and reversible inhibitor of SGLT2.
Slovenian: Ertugliflozin je močan selektiven in reverzibilen zaviralec SGLT2.
English: There is no information regarding the presence of ertugliflozin in human milk, the effects on the breast-fed infant, or the effects on milk production.
Slovenian: Glede prisotnosti ertugliflozina v materinem mleku, njegovih učinkih na dojenega otroka ali njegovih učinkih na nastajanje mleka ni podatkov.
English: If necessary, the dose of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Slovenian: Po potrebi je treba odmerek antidiabetika prilagoditi med zdravljenjem z drugim zdravilom in ob ukinitvi drugega zdravila.
English: Necrotising fasciitis of the perineum (Fournier's gangrene)*
Slovenian: nekrotizirajoči fasciitis presredka (Fournierjeva gangrena)*