FrancophonIA/ELRC3.0 huggingface dataset:
English: In approximately 93% of the patients, anti-insulin glargine antibodies showed cross-reactivity to human insulin.
Slovenian: Pri približno 93 % bolnikov so protitelesa proti insulinu glargin pokazala navzkrižno reaktivnost s humanim insulinom.
English: If necessary, you might need to test your blood sugar more often.
Slovenian: Če je treba, boste morda morali krvni sladkor meriti pogosteje.
English: • You have not injected your Suliqua or not injected enough.
Slovenian: • Niste si injicirali zdravila Suliqua ali si ga niste injicirali dovolj.
English: Suliqua should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila Suliqua se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
English: INFORMATION IN BRAILLE Suliqua 10 - 40
Slovenian: PODATKI V BRAILLOVI PISAVI Suliqua 10-40
English: • If the patient has been transferred from a different pre filled pen device, highlight the differences in design between the two devices (focus on colour differentiation, warning statements on carton/label and other safety design features such as tactile elements on the prefilled pen).
Slovenian: • Če je bolnik prešel z uporabe drugačnega napolnjenega injekcijskega peresnika, mu pojasnite razlike v zasnovi obeh pripomočkov (osredotočite se na razliko v barvi, opozorila na škatli/nalepki in druge varnostne lastnosti opreme, na primer na taktilne elemente na napolnjenem injekcijskem peresniku).
English: • Check your pen and the needle to make sure they are working properly
Slovenian: • da boste preverili peresnik in iglo in se prepričali, da delujeta pravilno,
English: If blood sugar remains very low for too long it may cause brain damage and may be life-threatening.
Slovenian: Če ostane krvni sladkor predolgo zelo nizek, to lahko povzroči okvaro možganov in je lahko smrtno nevarno.
English: These medicinal products should be taken in a standardised way in relation to lixisenatide.
Slovenian: Takšna zdravila mora jemati na standardiziran način glede na liksisenatid.
English: B. Push the needle into your skin as shown by your healthcare provider.
Slovenian: B. Zabodite iglo v kožo, kot vam je pokazal zdravnik.
English: Do not soak, wash or lubricate the pen.
Slovenian: Peresnika ne namakajte, ne umivajte in ne mažite.
English: • You are doing more exercise than usual or a different type of physical activity.
Slovenian: • Ste telesno bolj dejavni kot po navadi ali je telesna dejavnost drugačna kot po navadi.
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Slovenian: Bolnikom je treba svetovati, naj upoštevajo previdnostne ukrepe, da bi preprečili hipoglikemijo med vožnjo ali upravljanjem strojev.
English: *Not included in the pre-specified step-down testing procedure **2 hour PPG minus the pre-meal glucose value
Slovenian: *Ni vključeno v vnaprej opredeljeni postopek redukcijskega testiranja ("step-down") **Vrednost glukoze 2 uri po obroku minus vrednost glukoze pred obrokom
English: To avoid medication errors, the prescriber must make sure that the correct strength and number of dose steps is stated in the prescription (see section 4.4).
Slovenian: Za preprečevanje napak pri uporabi zdravila se mora predpisovalec prepričati, da sta na receptu navedena pravilna jakost in število odmernih korakov (glejte poglavje 4.4).
English: Therefore Suliqua should not be given in combination with a sulfonylurea.
Slovenian: Zato se zdravila Suliqua ne sme uporabljati v kombinaciji s sulfonilsečninami.
English: At screening 64.4% of patients were receiving insulin glargine as basal insulin and 95.0% received at least 1 concomitant OAD.
Slovenian: Ob presejanju je 64,4 % bolnikov kot bazalni insulin uporabljalo insulin glargin in 95,0 % bolnikov je sočasno prejemalo vsaj še 1 POAD.
English: The solution should be clear, colourless and water-like.
Slovenian: Raztopina mora biti bistra, brezbarvna in podobna vodi.
English: The lixisenatide dose is increased or decreased along with insulin glargine dose and also depends on which pen is used.
Slovenian: Odmerek liksisenatida se povečuje ali zmanjšuje skupaj z odmerkom insulina glargin in je odvisen tudi od tega, kateri peresnik je uporabljen.
English: What Suliqua is and what it is used for
Slovenian: Kaj je zdravilo Suliqua in za kaj ga uporabljamo
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Common: may affect up to 1 in 10 people
Slovenian: Drugi neželeni učinki Zdravniku, farmacevtu ali medicinski sestri morate povedati, če opazite katerega od naslednjih neželenih učinkov: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
English: Patients adjusting the amount or timing of dosing should only do so under medical supervision with appropriate glucose monitoring (see section 4.4).
Slovenian: Bolniki, ki spremenijo odmerek ali čas uporabe, smejo to storiti le pod zdravniškim nadzorom in ob ustreznem nadzoru glukoze (glejte poglavje 4.4).
English: • You have recently changed from animal insulin to a manufactured insulin, like there is in
Slovenian: • če ste pred kratkim prešli z živalskega insulina na umetni insulin, kakršnega vsebuje zdravilo
English: Do not freeze or place next to the freezer compartment or a freezer pack.
Slovenian: Ne zamrzujte in ne shranjujte v bližini zmrzovalnega razdelka ali v bližini zmrzovalnih vložkov.
English: • If there are not enough dose steps left in your pen for your dose, the dose selector will stop at the number of dose steps left.
Slovenian: • Če v peresniku ni več dovolj odmernih korakov zdravila za vaš odmerek, se bo izbirnik odmerka ustavil na številu preostalih odmernih korakov.
English: Switch from GLP-1 receptor agonist has not been studied.
Slovenian: Prehod z agonista receptorjev GLP-1 ni raziskan.
English: • Monoamine oxidase inhibitors (MAOIs), for depression or Parkinson´s disease.
Slovenian: • Zaviralce monoaminooksidaze (zaviralce MAO), za depresijo ali Parkinsonovo bolezen.
English: • Always use needles that are compatible for use with Suliqua pen.
Slovenian: • Vedno uporabljajte igle, združljive s peresnikom Suliqua.
English: Drink or foods that contain artificial sweeteners (such as diet drinks) do not help treat low blood sugar.
Slovenian: Pijače ali živila, ki vsebujejo umetna sladila (na primer dietne pijače) ne pomagajo odpraviti nizkega krvnega sladkorja.
English: (-1.63 to -0.57)
Slovenian: (-1,63 do -0,57)
English: Please see the information regarding medicines that should not stay too long in your stomach in the section Other medicines and Suliqua.
Slovenian: Za informacije o zdravilih, ki ne smejo predolgo ostati v želodcu, glejte poglavje Druga zdravila in zdravilo Suliqua.
English: • Clozapine, olanzapine and phenothiazine derivatives, for mental health problems.
Slovenian: • Klozapin, olanzapin in derivate fenotiazina, za težave z duševnim zdravjem.
English: Metformin was a mandatory background therapy and 58% of patients received a second OAD at screening, being a sulfonylurea in 54% of patients.
Slovenian: Metformin je bil obvezno osnovno zdravljenje in 58 % je ob presejanju uporabljajo še en POAD, pri čemer je sulfonilsečnino uporabljalo 54 % bolnikov.
English: In each of the active-controlled trials, treatment with Suliqua produced clinically and statistically significant improvements in hemoglobin A1c (HbA1c).
Slovenian: V vsakem od preskušanj, kontroliranih z zdravilno učinkovino, je zdravljenje z zdravilom Suliqua klinično pomembno in statistično značilno izboljšalo hemoglobin A1c (HbA1c).
English: Your doctor may tell you to use Suliqua with other medicines for high blood sugar.
Slovenian: Zdravnik vam lahko naroči, da zdravilo Suliqua uporabljajte skupaj z drugimi zdravili proti visokemu krvnemu sladkorju.
English: You should know what they are so that you can take the right action if your blood sugar level changes and help stop it becoming too high or too low.
Slovenian: Te dejavnike morate poznati, da boste lahko pravilno ukrepali, če se vam koncentracija krvnega sladkorja spremeni, in da boste preprečili, da bi se vam preveč zvišal ali znižal.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: You should check your blood sugar level more often.
Slovenian: Krvni sladkor si morate kontrolirati pogosteje.
English: The patient should discard the needle after each injection.
Slovenian: Bolnik mora iglo po vsakem injiciranju zavreči.
English: If such medicinal products are to be administered with food, patients should be advised to, if possible, take them with a meal when lixisenatide is not administered.
Slovenian: Če mora takšna zdravila jemati s hrano, mu je treba svetovati, naj jih po možnosti vzame ob tistih obrokih, ob katerih ne uporabi liksisenatida.
English: • For any other basal insulin the same rule as for insulin glargine (100 units/ml) should be applied
Slovenian: • Za vse druge bazalne insuline je treba uporabiti enako pravilo kot za insulin glargin (100 enot/ml).
English: • Sympathomimetic medicines such as epinephrine (adrenaline), salbutamol and terbutaline, for asthma.
Slovenian: • Simpatikomimetična zdravila, na primer adrenalin, salbutamol in terbutalin, za astmo.
English: • Your low blood sugar is always around “normal” or your diabetes control has greatly improved recently.
Slovenian: • če imate krvni sladkor vedno blizu "normalnega" ali se vam je urejenost sladkorne bolezni v zadnjem času zelo izboljšala.
English: No interaction studies with Suliqua have been performed.
Slovenian: Študij medsebojnega delovanja z zdravilom Suliqua niso izvedli.
English: Reaching lower HbA1c levels and achieving greater HbA1c reduction did not increase rates of hypoglycaemia with combination treatment versus insulin glargine alone (see section 4.8).
Slovenian: Doseganje nižje ravni HbA1c in večjega znižanja HbA1c ni povečalo deleža hipoglikemij med kombiniranim zdravljenjem v primerjavi s samim insulinom glargin (glejte poglavje 4.8).
English: Prior to launch of Suliqua in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational materials for Suliqua, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravila Suliqua na trg v posamezni državi članici mora imetnik dovoljenja za promet z zdravilom (MAH) s pristojnim nacionalnim organom uskladiti vsebino in obliko izobraževalnih gradiv za zdravilo Suliqua, vključno s komunikacijskimi mediji, načinom distribucije in morebitnimi drugimi vidiki programa.
English: • if you are allergic to insulin glargine or lixisenatide or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na insulin glargin, liksisenatid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Suliqua in all subsets of the paediatric population for treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Suliqua za vse podskupine pediatrične populacije za zdravljenje sladkorne bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: - lixisenatide and/or insulin in combination with a sulfonylurea may result in an increased risk of hypoglycaemia.
Slovenian: - liksisenatid in/ali insulin lahko v kombinaciji s sulfonilsečnino povečata tveganje za hipoglikemijo.
English: Suliqua is used to treat adults with type 2 diabetes, to help control blood sugar levels when they are too high.
Slovenian: Zdravilo Suliqua se uporablja za zdravljenje odraslih s sladkorno boleznijo tipa 2, da pomaga obvladati koncentracijo krvnega sladkorja, kadar je previsoka.
English: • This will make sure you get your full dose.
Slovenian: • Tako boste zagotovili, da boste dobili celoten odmerek.
English: • Your pen contains a total of 300 dose steps.
Slovenian: • Peresnik vsebuje 300 odmernih korakov.
English: • Lithium salts, for mental health problems.
Slovenian: • Litijeve soli, za težave z duševnim zdravjem.
English: Other medicines and Suliqua
Slovenian: Druga zdravila in zdravilo Suliqua
English: • you have a severe stomach or gut problem such as a disease of the muscles of the stomach called “gastroparesis” which results in delayed stomach emptying.
Slovenian: • če imate hude težave z želodcem ali črevesjem, npr. bolezen želodčnih mišic, imenovano "gastropareza", ki upočasni praznjenje želodca.
English: * Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of ≤3.9 mmol/L.
Slovenian: * Dokumentirana simptomatska hipoglikemija je bila pojav značilnih simptomov hipoglikemije, ki jih je spremljala izmerjena koncentracija glukoze v plazmi ≤ 3,9 mmol/l.
English: • you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to use glucose because there is not enough insulin) since this medicine will not be right for you.
Slovenian: • če imate diabetično ketoacidozo (to je zaplet sladkorne bolezni, ki se pojavi, če telo ne more uporabljati glukoze, ker ni dovolj insulina), kajti v takšnem primeru to zdravilo ni primerno za vas.
English: The cartridge should be inspected before use.
Slovenian: Vložek je treba pred uporabo pregledati.
English: In embryo-foetal development studies, malformations, growth retardation, ossification retardation and skeletal effects were observed in rats at all doses (5-fold exposure ratio compared to human exposure) and in rabbits at high doses (32-fold exposure ratio compared to human exposure) of lixisenatide.
Slovenian: V študijah embrio-fetalnega razvoja so malformacije, upočasnitev rasti, zapoznelo osifikacijo in skeletne učinke pri podganah opažali ob vseh odmerkih (5-kratno razmerje izpostavljenosti v primerjavi z izpostavljenostjo pri človeku) ter pri kuncih ob velikih odmerkih (32-kratno razmerje izpostavljenosti v primerjavi z izpostavljenostjo pri človeku) liksisenatida.
English: • For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.
Slovenian: • Za informacije o zdravljenju hiperglikemije glejte okvir na koncu tega navodila.
English: The safety and effectiveness of Suliqua on glycaemic control were evaluated in two randomised clinical studies in patients with type 2 diabetes mellitus:
Slovenian: Varnost in učinkovitost zdravila Suliqua za urejanje glikemije so ocenili v dveh randomiziranih kliničnih študijah pri bolnikih s sladkorno boleznijo tipa 2:
English: [12.2 to 24.0]
Slovenian: [12,2 do 24,0]
English: To avoid mistakes, always check the medicine pack and label on the pen before each injection to make sure you have the correct pen, especially if you inject more than one medicine.
Slovenian: Da boste preprečili napake, vedno pred vsakim injiciranjem preverite pakiranje zdravila in nalepko na peresniku ter se tako prepričajte, da imate pravi peresnik, še zlasti če si injicirate več kot eno zdravilo.
English: • Ensure that your patients and their caretakers are adequately informed on how to use insulin glargine/lixisenatide.
Slovenian: • Poskrbite, da bodo bolniki in njihovi negovalci ustrezno seznanjeni s tem, kako uporabljati insulin glargin/liksisenatid.
English: • Always check the label of the pen before use to make sure you have the correct pen.
Slovenian: • Pred uporabo vedno preverite nalepko peresnika, da se prepričate da imate ustrezen peresnik.
English: In a 28-day placebo-controlled study in patients with type 2 diabetes 5 to 20 mcg lixisenatide resulted in a statistically significant decreases in postprandial blood glucose after breakfast, lunch and dinner.
Slovenian: V 28-dnevni s placebom kontrolirani študiji pri bolnikih s sladkorno boleznijo tipa 2 je liksisenatid v odmerku od 5 do 20 mcg statistično značilno znižal postprandialno glukozo v krvi po zajtrku, kosilu in večerji.
English: In 2-year subcutaneous carcinogenicity studies, non-lethal C-cell thyroid tumors were seen in rats and mice and are considered to be caused by a non-genotoxic GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive.
Slovenian: V 2-letnih študijah kancerogenosti med subkutano uporabo so pri podganah in miših ugotovili neusodne ščitnične tumorje celic C; za te tumorje velja, da nastanejo zaradi negenotoksičnega mehanizma preko receptorjev GLP-1, za katerega so glodalci posebej občutljivi.
English: Your concentration may be affected.
Slovenian: Prizadeta je lahko vaša zbranost.
English: Change the injection site with each injection to help prevent these changes.
Slovenian: Mesto injiciranja zamenjajte pri vsakem injiciranju, da boste preprečili takšne spremembe.
English: The starting dose of Suliqua isbased on previous anti-diabetic treatment, and in order not to exceed the recommended lixisenatide starting dose of 10 mcg:
Slovenian: Začetni odmerek zdravila Suliqua temelji na predhodnem antidiabetičnem zdravljenju; da ne bi prekoračili priporočenega začetnega odmerka 10 mcg liksisenatida, je treba upoštevati naslednje:
English: Your doctor may tell you to use a different dose of Suliqua compared to your previous insulin dose.
Slovenian: Zdravnik vam lahko naroči, da uporabljajte drugačen odmerek zdravila Suliqua, kot je bil odmerek prejšnjega insulina.
English: • Only use your pen for up to 28 days after its first use.
Slovenian: • Peresnik uporabljajte največ 28 dni po prvi uporabi.
English: Examples include:
Slovenian: Med možnimi vzroki so:
English: However, the patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Slovenian: Vendar pa se bolnikova zmožnost zbranosti in reagiranja lahko poslabša zaradi hipoglikemije ali hiperglikemije, pa tudi npr. zaradi okvare vida.
English: • Change the place within the area you inject each day.
Slovenian: • Vsak dan zamenjajte mesto na predelu, kamor injicirate zdravilo.
English: • Only use needles that are compatible with Suliqua pen (see “Instructions for Use”).
Slovenian: • Uporabljajte le igle, ki so združljive s peresnikom Suliqua (glejte "Navodila za uporabo").
English: Following a standardised labelled test meal, in the study referred to above, it was confirmed that lixisenatide slows gastric emptying, thereby reducing the rate of postprandial glucose absorption.
Slovenian: Po standardiziranem označenem testnem obroku so v zgoraj omenjeni študiji potrdili, da liksisenatid upočasni praznjenje želodca in tako zmanjša hitrost absorpcije glukoze po obroku.
English: Excipient(s) with known effects: Each ml contains 2.7 milligrams of metacresol.
Slovenian: Pomožne snovi z znanim učinkom: En ml vsebuje 2,7 miligrama metakrezola.
English: • Do not press at an angle.
Slovenian: • Ne pritiskajte pod kotom.
English: • You are taking or have taken certain other medicines (see section 2, "Other medicines and
Slovenian: • Jemljete ali ste jemali določena druga zdravila (glejte poglavje 2, "Druga zdravila in zdravilo
English: The incidence of the primary endpoint was similar in the lixisenatide (13.4%) and placebo (13.2%) groups: the hazard ratio (HR) for lixisenatide versus placebo was 1.017, with an associated 2-sided 95% confidence interval (CI) of 0.886 to 1.168.
Slovenian: Incidenca primarnega opazovanega dogodka je bila v skupini z liksisenatidom (13,4 %) in skupini s placebom (13,2 %) podobna: razmerje ogroženosti (ROg) za liksisenatid v primerjavi s placebom je bilo 1,017 in 2-stranski 95 % interval zaupanja (IZ) za to vrednost je bil od 0,886 do 1,168.
English: After holding and slowly counting to 10, release the injection button.
Slovenian: Potem, ko ste gumb držali in počasi prešteli do 10, gumb za injiciranje spustite.
English: (-2.79 to -1.96)
Slovenian: (-2,79 do -1,96)
English: In 2-year subcutaneous carcinogenicity study in mice, 3 cases of adenocarcinoma in the endometrium were seen in the mid dose group with a statistically significant increase, corresponding to an exposure ratio of 97-fold.
Slovenian: V 2-letni študiji kancerogenosti med subkutano uporabo pri miših so v skupini s srednjo ravnjo odmerka ugotovili 3 primere adenokarcinoma v endometriju s statistično značilnim povečanjem ob 97-kratnem razmerju izpostavljenosti.
English: • Skin and allergic reactions at the injection site: The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Slovenian: • Kožne in alergijske reakcije na mestu injiciranja: Med znaki so lahko pordelost, nenavadno močna bolečina pri injiciranju, srbenje, koprivnica, oteklost ali vnetje.
English: • Lixisenatide: a “GLP-1 analogue” that helps the body produce its own additional insulin in response to increases in blood sugar, and slows the absorption of sugar from foods.
Slovenian: • liksisenatid: "analog GLP-1", ki telesu pomaga izdelovati lasten dodatni insulin v odziv na zvišanje krvnega sladkorja in upočasni absorpcijo sladkorja iz hrane.
English: This may mean your Suliqua dose has to change.
Slovenian: To lahko pomeni, da je treba odmerek zdravila Suliqua spremeniti.
English: In a pre-specified analysis of this primary endpoint, the differences observed were consistent with regard to baseline HbA1c (<8% or ≥8%) or baseline OAD use (metformin alone or metformin plus second OAD).
Slovenian: V vnaprej opredeljeni analizi tega primarnega opazovanega dogodka so bile opažene razlike dosledne glede na izhodiščni HbA1c (< 8 % ali ≥ 8 %) ali izhodiščno uporabo POAD (samo metformin ali metformin skupaj s še enim POAD).
English: • Foods containing sugar, such as dextrose tablets or a sugary drink (at least 20 grams).
Slovenian: • Hrano, ki vsebuje sladkor, na primer tablete glukoze ali sladko pijačo (vsaj 20 gramov sladkorja).
English: The ELIXA study was a randomised, double-blind, placebo-controlled, multinational study that evaluated cardiovascular (CV) outcomes during treatment with lixisenatide in patients (n=6068) with type 2 diabetes mellitus after a recent Acute Coronary Syndrome.
Slovenian: Študije ELIXA je bila randomizirana, dvojno slepa, s placebom kontrolirana multinacionalna študija, ki je ocenjevala srčno-žilne (SŽ) izide med zdravljenjem z liksisenatidom pri bolnikih (n = 6068) s sladkorno boleznijo tipa 2 po nedavnem akutnem koronarnem sindromu.
English: You might then need to eat something (such as bread or pasta) that will raise your blood sugar over a longer time, especially if your next meal is not due.
Slovenian: Potem boste morda morali zaužiti kaj, kar krvni sladkor zviša za dalj časa (na primer kruh ali testenine), zlasti če še ni čas za vaš naslednji obrok.
English: You can select your dose in steps of 1 dose step.
Slovenian: Odmerek lahko nastavite v korakih po 1 odmerni korak.
English: More severe episodes of hypoglycaemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
Slovenian: Hujše primere hipoglikemij s komo, konvulzijami ali nevrološko prizadetostjo je mogoče zdraviti z glukagonom intramuskularno ali subkutano ali s koncentrirano glukozo intravensko.
English: Shelf-life after first use of the pen: 28 days
Slovenian: Rok uporabnosti po prvi uporabi injekcijskega peresnika: 28 dni
English: Hypoglycaemia is also more likely to happen if:
Slovenian: Prav tako je hipoglikemija bolj verjetna:
English: The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from beta cells and suppresses glucagon from alpha cells in the pancreas.
Slovenian: Receptor GLP-1 je cilj naravnega GLP-1; to je endogeni inkretinski hormon, ki poveča od glukoze odvisno izločanje insulina iz pankreatičnih celic beta in zavre izločanje glukagona iz pankreatičnih celic alfa.