natgillin/translations-raw huggingface dataset:
• It is best to take your tablet with a meal. 
• Najboljše je, da tableto vzamete s hrano.
* See Section 4.4. 
*Glejte poglavje 4.4.
Your body can also make too much sugar. 
V telesu lahko preveč sladkorja tudi nastaja.
Your doctor will tell you how to treat low blood sugar and what to do if you have any of the symptoms or signs below. 
Zdravnik vam bo povedal, kako zdraviti nizek krvni sladkor in kaj morate narediti, če se pojavi kateri od spodaj naštetih simptomov ali znakov.
Subgroup analysis 
Analiza podskupine
No potential acute symptoms and signs of overdose were identified. 
Možnih akutnih simptomov in znakov prevelikega odmerjanja niso ugotovili.
If any of the above apply to you (or you are not sure), tell your doctor. 
Če kaj od navedenega velja za vas (ali če niste prepričani), povejte zdravniku.
This may cause anaemia (low levels of red blood cells). 
To lahko povzroči anemijo (nizko število rdečih krvnih celic).
Serious diabetic ketoacidosis occurred rarely. 
Resna diabetična ketoacidoza se je pojavila redko.
• Your doctor will prescribe the right dose for you. 
• Zdravnik vam bo predpisal odmerek, ki je za vas primeren.
This leaflet was last revised in {MM/YYYY} 
Navodilo je bilo nazadnje revidirano dne {MM. LLLL}
However, if it is nearly time for your next dose, skip the missed dose and go back to your regular schedule. 
Če pa je že skoraj čas za naslednji odmerek, preskočite izpuščeni odmerek in nadaljujte jemanje po svojem običajnem urniku.
Effects of age, body weight, gender and race 
Vpliv starosti, telesne mase, spola in rase
This causes blood sugar to be removed in your urine. 
To povzroči izločanje krvnega sladkorja v urinu.
See subsections below for additional information. 
Za dodatne informacije glejte podpoglavja spodaj.
As an underlying mechanism has not been established, risk factors, apart from general risk factors, for amputation are unknown. 
Ker osnovni mehanizem ni bil ugotovljen, dejavniki tveganja za amputacije, z izjemo splošnih dejavnikov tveganja, niso znani.
• if you have a severe infection or are dehydrated. 
• če imate hudo okužbo ali ste dehidrirani.
General introduction 
Splošni uvod
Treatment with Segluromet may be restarted when the ketone values are normal and the patient's condition has stabilised. 
Zdravljenje z zdravilom Segluromet je mogoče znova uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
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. 
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.
If you forget a dose, take it as soon as you remember. 
Če pozabite vzeti odmerek, ga vzemite, takoj ko se spomnite.
Patients and/or care-givers should be informed of the risk of lactic acidosis. 
Bolnike in/ali negovalce je treba opozoriti na tveganje za laktacidozo.
Patients should not take two doses of Segluromet at the same time. 
Bolnik ne sme vzeti dveh odmerkov zdravila Segluromet istočasno.
Alternative methods should be used to monitor glycaemic control. 
Za spremljanje urejenosti glikemije je treba uporabiti alternativne metode.
The effects on kidney and bone did not fully reverse after the 1-month recovery period. 
Vplivi na ledvice in kosti po 1-mesečnem obdobju okrevanja niso povsem izginili.
• if you have recently had a heart attack or have severe circulatory problems, such as ‘shock' or breathing difficulties. 
• če ste nedavno imeli srčni infarkt ali imate hude težave s krvnim obtokom, kot so "šok" ali težave pri dihanju.
• 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. 
• Odmerek zdravila Segluromet, ki ga boste jemali, bo odvisen od vašega stanja in količine ertugliflozina in metformina, potrebne za uravnavanje vašega krvnega sladkorja.
p< 0.001 compared to glimepiride. 
p < 0,001 v primerjavi z glimepiridom
• The recommended dose of Segluromet is one tablet twice a day. 
• Priporočeni odmerek zdravila Segluromet je ena tableta dvakrat na dan.
• if you are allergic to ertugliflozin or metformin or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na ertugliflozin ali metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• increased levels of “ketone bodies” in your urine or blood 
• zvišana raven "ketonskih teles" v urinu ali krvi,
Component of a multipack, can't be sold separately. 
Sestavni del multi pakiranja, ločena prodaja ni možna.
• decreased vitamin B12 levels. 
• znižanje ravni vitamina B12.
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%. 
Neinferiornost je potrjena, če je zgornja meja dvostranskega 95-odstotnega intervala zaupanja (IZ) za povprečno razliko manj kot 0,3 %.
• change in taste 
• sprememba okusa,
Hispanic or Latino patients comprised 15.6% to 34.5% of the population. 
Latinoameričani so predstavljali od 15,6 % do 34,5 % populacije.
Renal clearance is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination. 
Ledvični očistek je približno 3,5-krat večji od očistka kreatinina, kar kaže, da je tubularna sekrecija glavna pot izločanja metformina.
If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant. 
Če ste noseči, se z zdravnikom posvetujte o tem, kako najbolje uravnavati krvni sladkor med nosečnostjo.
In this population, the incidence of severe hypoglycaemia was 0.4% in each group. 
V tej populaciji je bila pojavnost hude hipoglikemije v vseh skupinah 0,4 %.
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. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
, Vitamin B12 deficiency 
, pomanjkanje vitamina B12
Not recommended. 
Ni priporočljiv.
These data reflect exposure of 1,029 patients to ertugliflozin with a mean exposure duration of approximately 25 weeks. 
Ti podatki odražajo izpostavljenost 1.029 bolnikov ertugliflozinu s povprečnim trajanjem izpostavljenosti približno 25 tednov.
This can lead to serious medical problems, like heart disease, kidney disease, blindness and poor circulation. 
To lahko povzroči resne zdravstvene težave, kot so bolezen srca, bolezen ledvic, slepota in slab pretok krvi.
• if you are taking medicines which increase urine production (diuretics). 
• če jemljete zdravila, ki povečajo nastajanje urina (diuretike).
In case of swallowing difficulties, the tablet could be broken or crushed as it is an immediate-release dosage form. 
V primeru težav pri požiranju se tableto lahko prelomi ali zdrobi, saj gre za farmacevtsko obliko s takojšnjim sproščanjem.
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. 
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.
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. 
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.
If no adequate strength of Segluromet is available, individual monocomponents should be used instead of the fixed-dose combination. 
Če ni na voljo ustrezne jakosti zdravila Segluromet, je treba namesto fiksne kombinacije uporabiti posamezne monokomponente.
(For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5 and 5.1.) 
(Za rezultate študij glede kombiniranega zdravljenja in učinkov na urejenost glikemije glejte poglavja 4.4, 4.5 in 5.1.)
• Metformin belongs to a group of medicines called biguanides. 
• Metformin spada v skupino zdravil, imenovanih bigvanidi.
Do not stop taking this medicine without talking to your doctor. 
Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom.
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). 
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).
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. 
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.
• unusual sleepiness or tiredness 
• neobičajna zaspanost ali utrujenost,
You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Segluromet. 
Morda boste potrebovali pogostejše meritve glukoze v krvi in preiskave delovanja ledvic, ali pa vam bo zdravnik moral prilagoditi odmerek zdravila Segluromet.
This finding was attributed to carbohydrate malabsorption leading to altered calcium homeostasis and was not considered relevant to human risk. 
Ta izsledek so pripisali malabsorpciji ogljikovih hidratov, ki je spremenila homeostazo kalcija, in ni veljal za pomembnega, kar zadeva tveganje za človeka.
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). 
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).
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night 
• spremembe uriniranja, vključno z nujno potrebo po pogostejšem uriniranju, večjo količino urina ali uriniranjem ponoči,
• feeling dizzy, light-headed, or weak, especially when you stand up 
• občutek omotičnosti, vrtoglavice ali šibkosti, zlasti ob vstajanju,
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. 
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.
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. 
Pomembno je, da si redno pregledujete stopala in upoštevate vse druge nasvete zdravstvenega osebja glede oskrbe stopal in ustrezne hidracije.
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake "EXP".
Patients [N (%)] with HbA1c < 7% 66 (26.4) 
Bolniki [n (%)] s HbA1c < 7 % 66 (26,4)
• if you have severely reduced kidney function or need dialysis. 
• če imate zelo zmanjšano delovanje ledvic ali potrebujete dializo.
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). 
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).
If needed, dose adjustment of metformin may be considered as OCT inhibitors/inducers may alter the efficacy of metformin. 
Po potrebi lahko pride v poštev prilagoditev odmerka metformina, saj lahko zaviralci/induktorji OCT spremenijo učinkovitost metformina.
Try to take it at the same time each day; this will help you remember to take it. 
• Vzemite eno tableto dvakrat na dan. Tableto poskusite vzeti vsak dan ob istem času; to vam bo pomagalo, da je ne boste pozabili vzeti.
The safety and efficacy of Segluromet in children under 18 years of age have not been established. 
Varnost in učinkovitost zdravila Segluromet pri otrocih, mlajših od 18 let, nista bili dokazani.
You should notify your doctor immediately if you notice any wounds or discolouration, or if you experience any tenderness or pain in your feet. 
Nemudoma obvestite zdravnika, če opazite kakršne koli rane ali obarvanje, oziroma če občutite občutljivost ali bolečino v stopalih.
• 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. 
• če jemljete druga zdravila, ki znižujejo sladkor v krvi, kot so insulin ali zdravila, ki povečajo sproščanje insulina iz trebušne slinavke.
Your doctor may decide to temporarily or permanently stop your treatment with Segluromet. 
Zdravnik bo morda odločil, da z zdravljenjem z zdravilom Segluromet začasno ali trajno prenehate.
It is not known if Segluromet can harm your unborn baby. 
Ni znano, ali lahko zdravilo Segluromet škoduje nerojenemu otroku.
The effect of Segluromet on fertility in humans has not been studied. 
Vpliva zdravila Segluromet na plodnost pri ljudeh niso preučevali.
A limited amount of data suggests the use of metformin in pregnant women is not associated with an increased risk of congenital malformations. 
Maloštevilni podatki nakazujejo, da uporaba metformina pri nosečnicah ni povezana z večjim tveganjem za prirojene malformacije.
There is limited experience with Segluromet in patients ≥ 75 years of age. 
Izkušenj z uporabo zdravila Segluromet pri bolnikih ≥ 75 let je malo.
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. 
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.
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. 
Po peroralni uporabi se približno 90 % absorbiranega zdravila izloči skozi ledvice v prvih 24 urah, s plazemskim eliminacijskim razpolovnim časom približno 6,2 ure.
It is not known if Segluromet passes into breast milk. 
Ni znano, ali zdravilo Segluromet prehaja v materino mleko.
Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycaemic agents. 
Farmakološki mehanizmi njegovega delovanja se razlikujejo od drugih razredov peroralnih antihiperglikemičnih zdravil.
See “Description of selected adverse reactions” for frequencies and see section 4.4. 
Glejte "Opis izbranih neželenih učinkov" za pogostnosti ter poglavje 4.4.
Low blood sugar (hypoglycaemia; common) 
Nizek krvni sladkor (hipoglikemija; pogosta)
Some studies indicate that taking ertugliflozin may have contributed to an increase in cases of lower limb amputation (mainly of the toe). 
Nekatere študije nakazujejo, da je jemanje ertugliflozina morda prispevalo k povečanju števila primerov amputacij na spodnjih okončinah (predvsem prstov).
, Haemoglobin increased ß,1 
, zvišanje hemoglobina ß,1
• if you are taking certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists). 
• če jemljete določena zdravila za zdravljenje visokega krvnega tlaka (zaviralci ACE in antagonisti receptorjev angiotenzina II).
This decrease in exposure is not considered clinically relevant and therefore, no dose adjustment is recommended. 
To zmanjšanje izpostavljenosti ne velja za klinično pomembno, zato se prilagoditev odmerka ne priporoča.
When this happens, sugar (glucose) builds up in the blood. 
V tem primeru se sladkor (glukoza) kopiči v krvi.
• Segluromet can be used alone or with some other medicines that lower blood sugar. 
• Zdravilo Segluromet se lahko uporablja samostojno ali skupaj s kakšnimi drugimi zdravili za zniževanje krvnega sladkorja.
Caution is therefore advised, especially in patients with renal impairment, when these drugs are coadministered with metformin, as metformin plasma concentration may increase. 
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.
Results in the in vivo mouse micronucleus test were also negative. 
Rezultati mikrojedrnega testa in vivo pri miših so bili prav tako negativni.
Organic cation transporters (OCT) Metformin is a substrate of both transporters OCT1 and OCT2. 
Organski kationski prenašalci (OCT) Metformin je substrat obeh prenašalcev, OCT1 in OCT2.
If you are not sure, talk to your doctor before taking Segluromet. 
Če ste negotovi, se posvetujte z zdravnikom, preden začnete jemati zdravilo Segluromet.
Ertugliflozin and metformin are present in the milk of lactating rats. 
Ertugliflozin in metformin sta prisotna v mleku doječih podgan.
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. 
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.
• Swallow the tablet; if you have difficulties in swallowing the tablet can be broken or crushed. 
Jemanje tega zdravila • Tableto pogoltnite; če imate težave s požiranjem, lahko tableto prelomite ali zdrobite.
• 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). 
• 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).
Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 ml/min) 
Odrasli z normalnim delovanjem ledvic (hitrost glomerulne filtracije [GFR] ≥ 90 ml/min)
The mean daily dose of glimepiride was 3.0 mg (see Table 5). 
Povprečni dnevni odmerek glimepirida je bil 3,0 mg (glejte preglednico 5).
Contact your doctor as soon as possible if you notice the following side effects: 
Čim prej se posvetujte z zdravnikom, če opazite katerega od naslednjih neželenih učinkov:
The primary assessment of safety was conducted in a pool of three 26-week, placebo-controlled trials. 
Prvotno oceno varnosti so izvedli v treh združenih 26-tedenskih, s placebom nadzorovanih preskušanjih.
What you need to know before you take Segluromet 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Segluromet 3.
Based on a population pharmacokinetic analysis, age, body weight, gender, and race do not have a clinically meaningful effect on the pharmacokinetics of ertugliflozin. 
Na podlagi populacijske farmakokinetične analize starost, telesna masa, spol in rasa nimajo klinično pomembnega vpliva na farmakokinetiko ertugliflozina.
The blood-to-plasma concentration ratio of ertugliflozin is 0.66. 
Razmerje koncentracij ertugliflozina med krvjo in plazmo je 0,66.
If you take more Segluromet than you should If you take too much Segluromet, talk to a doctor or pharmacist straight away. 
Če ste vzeli večji odmerek zdravila Segluromet, kot bi smeli Če vzamete preveč zdravila Segluromet, se takoj posvetujte z zdravnikom ali farmacevtom.
Contact a doctor or the nearest hospital straight away if you have any of the following serious side effects: 
Takoj se posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico, če imate katerega od naslednjih resnih neželenih učinkov:
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. 
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.
Multipack: 196 (4 packs of 49) film-coated tablets 
Multi pakiranje: 196 (4 pakiranja po 49) filmsko obloženih tablet
• painful urination 
• boleče uriniranje.
What Segluromet is and what it is used for 2. 
Kaj je zdravilo Segluromet in za kaj ga uporabljamo 2.
Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see section 4.4). 
O laktacidozi so poročali v približno 32 % primerov prevelikega odmerjanja metformina (glejte poglavje 4.4).
Segluromet must be discontinued at the time of surgery under general, spinal, or epidural anaesthesia. 
Uporabo zdravila Segluromet je treba v času kirurškega posega pod splošno, spinalno ali epiduralno anestezijo prekiniti.
This medicine has no or negligible influence on the ability to drive and use machines. 
To zdravilo nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
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. 
Gastrointestinalni simptomi, kot so navzea, bruhanje, diareja, abdominalna bolečina in izguba apetita, nastopijo najpogosteje med uvedbo zdravljenja in v večini primerov spontano izzvenijo.
Initial increases in mean creatinine and decreases in mean eGFR in patients treated with ertugliflozin were generally transient during continuous treatment. 
Uvodno zvišanje povprečnega kreatinina in zmanjšanje povprečne eGFR pri bolnikih, zdravljenih z ertugliflozinom, je bilo med neprekinjenim zdravljenjem na splošno prehodno.
Similarly, there was no tumorigenic potential observed with metformin in male rats. 
Podobno niso opazili tumorogenega potenciala metformina pri podganjih samcih.
The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products. 
Bolnika je treba s tem seznaniti in pogosteje opravljati teste za določanje koncentracije glukoze v krvi, zlasti na začetku zdravljenja s takimi zdravili.
Discontinue when GFR is persistently less than 45 ml/min. 
Ukiniti, če je GFR trajno manj kot 45 ml/min.
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. 
Povečanje števila primerov amputacij na spodnjih okončinah (predvsem prstov) so opazili tudi v dolgotrajnih kliničnih študijah z drugim zaviralcem SGLT2.
Ertugliflozin is a potent, selective, and reversible inhibitor of SGLT2. 
Ertugliflozin je močan selektiven in reverzibilen zaviralec SGLT2.
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. 
Glede prisotnosti ertugliflozina v materinem mleku, njegovih učinkih na dojenega otroka ali njegovih učinkih na nastajanje mleka ni podatkov.