FrancophonIA/ELRC3.0 huggingface dataset:
English: This effect on HbA1c was sustained in long term studies for up to 76 weeks.
Slovenian: Ta učinek na HbA1c se je v dolgoročnih študijah ohranil do 76 tednov.
English: It should be clear and colourless and with no particles.
Slovenian: Biti mora bistra in brezbarvna, brez delcev.
English: No treatment-related effect was demonstrated.
Slovenian: Z zdravljenjem povezanega učinka niso dokazali.
English: The percentage of patients who were antibody positive was similar at the end of the entire 76-week treatment period.
Slovenian: Odstotek bolnikov s pozitivnimi protitelesi je bil podoben tudi ob koncu celotnega 76-tedenskega obdobja zdravljenja.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred začetkom jemanja uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Do not use Lyxumia - if you are allergic to lixisenatide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Lyxumia - če ste alergični na liksisenatid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: If this happens do not drive or use any tools or machines.
Slovenian: Če se vam to zgodi, ne vozite in ne uporabljajte orodij oziroma ne uporabljajte strojev.
English: HR [95% CI]
Slovenian: ROg [95% IZ]
English: Overall, 37% of the patients were ≥75 years old (N=131) and 31% had moderate renal impairment (N=107).
Slovenian: V celoti je bilo 37 % bolnikov starih ≥ 75 let (N = 131) in 31 % je imelo zmerno okvaro ledvic (N = 107).
English: This could possibly pass on infection.
Slovenian: Tako se namreč lahko prenese kakšna okužba.
English: Similar HbA1c decreases were observed regardless of which meal was the main meal (breakfast, lunch or dinner).
Slovenian: Podobno znižanje HbA1c so opažali ne glede na to, kateri obrok (zajtrk, kosilo ali večerja) je bil glavni dnevni obrok.
English: Lixisenatide has no or negligible influence on the ability to drive or use machines.
Slovenian: Liksisenatid nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Section 3 - DAILY USE OF PEN Only follow this section when the activation window is white.
Slovenian: 3. poglavje - VSAKODNEVNA UPORABA PERESNIKA Postopke v tem poglavju opravite le, če je aktivacijsko okence belo.
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, če menite, da bi lahko bili noseči, ali če načrtujete zanositev, se posvetujte s svojim zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
English: Populations not studied Lixisenatide has not been studied in combination with dipeptidyl peptidase 4 (DPP-4) inhibitors.
Slovenian: Neraziskane populacije Liksenatid ni raziskan v kombinaciji z zaviralci dipeptidil-peptidaze 4 (DPP-4).
English: It is not known if Lyxumia may harm your unborn child.
Slovenian: Ni znano, ali lahko zdravilo Lyxumia škoduje vašemu nerojenemu otroku.
English: Repeat Section 3 for your daily injections until your pen is empty.
Slovenian: Ponavljajte 3. poglavje za vsakodnevno injiciranje zdravila, dokler peresnik ni prazen.
English: The needle may be blocked or not properly screwed on.
Slovenian: Morda je igla zamašena ali ni pravilno privita.
English: They were mostly mild and transient and occurred during the first 3 weeks after starting treatment.
Slovenian: Neželena učinka sta bila večinoma blaga in prehodna ter sta se pojavila v prvih 3 tednih po začetku zdravljenja.
English: • Beta cell function
Slovenian: • Delovanje celic beta
English: Figure 1: Forest plot: analyses of each individual cardiovascular event -- ITT population
Slovenian: Slika 1: Drevesni diagram (forest plot): analize vsakega posameznega srčno-žilnega dogodka -populacija ZNZ
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
Slovenian: • hudo in nenehno bolečino v trebuhu, ki se lahko širi v hrbet, pa tudi siljenje na bruhanje in bruhanje, ker so to lahko znaki vnetja trebušne slinavke (pankreatitisa).
English: If no liquid comes out see the “Questions and answers” section.
Slovenian: Če ne priteče nič tekočine, glejte poglavje "Vprašanja in odgovori".
English: Other important information about using the pre-filled pens There is more information on how to use the pens in the “Instructions for Use”.
Slovenian: Druge pomembne informacije o uporabi napolnjenih injekcijskih peresnikov Več informacij o uporabi peresnika boste našli v "Navodilih za uporabo".
English: Check the number of doses in the pen.
Slovenian: Preverite število odmerkov v peresniku.
English: Body weight reduction was sustained in long term studies up to 76 weeks.
Slovenian: Znižanje telesne mase se je v dolgoročnih študijah ohranilo do 76 tednov.
English: It is important to avoid dehydration by drinking plenty of fluids, especially when starting treatment with Lyxumia
Slovenian: Pomembno je preprečiti dehidracijo (izsušitev) s pitjem veliko tekočine, zlasti na začetku zdravljenja z zdravilom Lyxumia.
English: The pictures below show how the activation window on the injection button of your pen changes after activation.
Slovenian: Spodnji sliki kažeta, kako se aktivacijsko okence na gumbu za injiciranje po aktivaciji spremeni.
English: • Before injecting a dose - before injecting you must first remove excess liquid from your new pen.
Slovenian: • Pred injiciranjem odmerka - pred injiciranjem morate iz novega peresnika najprej odstraniti odvečno tekočino.
English: Lixisenatide should not be used for treatment of diabetic ketoacidosis.
Slovenian: Liksisenatid se ne sme uporabljati za zdravljenje diabetične ketoacidoze.
English: The pen is activated and ready for injections.
Slovenian: Peresnik je aktiviran in pripravljen za injiciranje.
English: Point the needle into a suitable container (like a paper cup or tissue) to capture the liquid so that it can be thrown away.
Slovenian: Usmerite iglo v primeren vsebnik (npr. papirnat kozarec ali papirnat robček), da boste tekočino prestregli in jo boste lahko zavrgli.
English: Throw away a pen 14 days after activation.
Slovenian: Peresnik zavrzite 14 dni po aktivaciji.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP
English: Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain.
Slovenian: Bolnike je treba seznaniti z značilnimi simptomi akutnega pankreatitisa: trdovratnimi, hudimi bolečinami v trebuhu.
English: Your doctor will tell you what to do if you get a low blood sugar.
Slovenian: Zdravnik vam bo povedal, kaj morate storiti, če se vam pojavi nizek sladkor v krvi (hipa).
English: Do not try to repair the pen.
Slovenian: Peresnika ne poskušajte popraviti.
English: There is no need to measure each dose.
Slovenian: Posameznega odmerka vam ni treba meriti.
English: - you suffer from heart problems which can cause shortness of breath or ankle swelling, since there is limited experience in this population.
Slovenian: - če imate težave s srcem, ki lahko povzročajo kratko sapo in otekanje gležnjev, saj obstaja le malo izkušenj v tej populaciji.
English: The patient should be instructed to discard the needle after each use in accordance with local requirements and to store the pen without the needle attached.
Slovenian: Bolniku je treba naročiti, da mora iglo po vsaki uporabi zavreči v skladu z lokalnimi zahtevami in peresnik shraniti brez nameščene igle.
English: (-2.257 to -1.062)
Slovenian: (-2,257 do -1,062)
English: The majority of injection site reactions were mild, regardless of antibody status.
Slovenian: Večina reakcij na mestu injiciranja je bila blagih, ne glede na izvid protiteles.
English: • Only use needles that are compatible for use with Lyxumia pen (see “Instructions for Use”).
Slovenian: • Uporabljajte le igle, ki so združljive z injekcijskim peresnikom Lyxumia (glejte "Navodila za uporabo").
English: Frequency of occurrence
Slovenian: Pogostnost pojavljanja
English: Most of these reported allergic reactions were mild in severity.
Slovenian: Večina opisanih alergijskih reakcij je bila blagih.
English: In case of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms and the lixisenatide dose should be reduced to the prescribed dose.
Slovenian: V primeru prevelikega odmerjanja je treba uvesti ustrezno podporno zdravljenje, na podlagi bolnikovih znakov in simptomov, odmerek liksisenatida pa je treba zmanjšati na predpisani odmerek.
English: (-0.170 to 0.064)
Slovenian: (-0,170 do 0,064)
English: Keep away from the freezer compartment.
Slovenian: Shranjujte proč od zamrzovalnega razdelka hladilnika.
English: If you have any questions about Lyxumia or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number in the Lyxumia “Package leaflet: Information for the user” (provided separately in the box).
Slovenian: Če imate kakšna vprašanja o zdravilu Lyxumia ali o sladkorni bolezni, vprašajte svojega zdravnika, farmacevta ali medicinsko sestro, ali pokličite lokalno številko družbe sanofi-aventis, ki jo najdete v "Navodilu za uporabo" zdravila Lyxumia (to navodilo je posebej priloženo v škatli).
English: Pull the injection button out firmly until it stops.
Slovenian: Gumb za injiciranje odločno izvlecite, dokler se ne ustavi.
English: In both species, there was a slight maternal toxicity consisting of low food consumption and reduced body weight.
Slovenian: Pri obeh živalskih vrstah so bili prisotni rahli maternalni toksični učinki, ki so obsegali majhno uživanje hrane in zmanjšanje telesne mase.
English: The body weight reduction is independent from the occurrence of nausea and vomiting.
Slovenian: Znižanje telesne mase je neodvisno od pojava navzee in bruhanja.
English: The antibody status (positive or negative) is not predictive of the reduction of HbA1c for an individual patient.
Slovenian: Izvid protiteles (pozitiven ali negativen) pri posameznem bolniku nima napovedne vrednosti glede znižanja HbA1c.
English: There was no cross-reactivity versus either native glucagon or endogenous GLP-1.
Slovenian: Navzkrižne reaktivnosti ni bilo ne proti naravnemu glukagonu ne proti endogenemu GLP-1.
English: You must dispose of the needle after each use, in an appropriate sharp's container, following local recommendations.
Slovenian: Iglo morate po vsaki uporabi zavreči; zavrzite jo v ustrezen vsebnik za ostre odpadke upoštevaje lokalna priporočila.
English: The use of Lyxumia does not require specific blood glucose monitoring.
Slovenian: Uporaba zdravila Lyxumia ne zahteva posebnega spremljanja ravni glukoze v krvi.
English: This effect on post-prandial glucose was confirmed in a 4-week study versus liraglutide 1.8 mg once a day in combination with metformin.
Slovenian: Ta učinek na postprandialno glukozo so potrdili v 4-tedenski primerjalni študiji z 1,8 mg liraglutida enkrat na dan v kombinaciji z metforminom.
English: There is no experience with Lyxumia in children and adolescents less than 18 years and therefore, the use of Lyxumia is not recommended in this age group.
Slovenian: Izkušenj z zdravilom Lyxumia pri otrocih in mladostnikih, mlajših od 18 let, ni, zato zdravila Lyxumia v tej starostni skupini ni priporočljivo uporabljati.
English: Keep it straight as you screw it on.
Slovenian: Ko jo privijate, jo držite naravnost.
English: Before first use Store in a refrigerator.
Slovenian: Pred prvo uporabo Shranjujte v hladilniku.
English: In in vitro studies, lixisenatide did not affect the activity of cytochrome P450 isozymes or human transporters tested.
Slovenian: V študijah in vitro liksisenatid ni vplival na aktivnost izoencimov citokroma P450 ali testiranih človeških prenašalcev.
English: Each dose contains 540 micrograms of metacresol.
Slovenian: En odmerek vsebuje 540 mikrogramov metakrezola.
English: An attached needle might lead to contamination and possible intake of air which might impact the dose accuracy.
Slovenian: Če igla ostane nameščena, lahko pride do onesnaženja in do vstopanja zraka, ki lahko vpliva na točnost odmerka.
English: C-cell hyperplasia and adenoma were seen at all doses in rats and a no observed adverse effect level (NOAEL) could be not defined.
Slovenian: Hiperplazijo celic C in adenome so pri podganah opažali pri vseh odmerkih: ravni brez opaženega neželenega učinka (NOAEL - no observed adverse effect level) ni bilo mogoče opredeliti.
English: Clinical studies with Lyxumia indicate improved beta-cell function as measured by the homeostasis model assessment for beta-cell function (HOMA-β).
Slovenian: Klinične študije z zdravilom Lyxumia kažejo izboljšanje delovanja celic beta, merjeno z oceno delovanja celic beta na podlagi modela homeostaze (HOMA-ß).
English: EXP Discard pen 14 days after first use
Slovenian: EXP Peresnik zavrzite 14 dni po prvi uporabi
English: • Always check the label to ensure you have the correct Lyxumia pen.
Slovenian: • Vedno preverite nalepko in se tako prepričajte, da imate pravi peresnik Lyxumia.
English: (0.095 to 0.328)
Slovenian: (0,095 do 0,328)
English: A total of 350 patients were randomized (randomization ratio
Slovenian: Skupaj je bilo randomiziranih 350 bolnikov (randomizacijsko razmerje 1:1).
English: No dose adjustment is required based on age.
Slovenian: Starejši Odmerka ni treba prilagoditi glede na starost.
English: The level of HbA1c reduction was comparable between groups (table 5).
Slovenian: Znižanje HbA1c je bilo med skupinami podobno (preglednica 5).
English: - you have type 1 diabetes or diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin) since this medicine will not be right for you
Slovenian: - če imate sladkorno bolezen tipa 1 ali "diabetično ketoacidozo" (zaplet sladkorne bolezni, ki se pojavi, če telo ne more razgrajevati glukoze, ker nima dovolj insulina), ker to zdravilo ne bo primerno za vas.
English: • Only inject one dose per day.
Slovenian: • Injicirajte le en odmerek na dan.
English: Step 5 The pen is now activated.
Slovenian: 5. korak Peresnik je zdaj aktiviran.
English: In case of hypoglycaemia, the rescue mechanism of glucagon secretion is preserved.
Slovenian: V primeru hipoglikemije je rešilni mehanizem izločanja glukagona ohranjen.
English: Within each system organ class, adverse reactions are presented in order of decreasing frequency.
Slovenian: Pri vsakem organskem sistemu so neželeni učinki navedeni po padajoči pogostnosti.
English: Frail patients, including patients at risk for malnutrition, patients with recent cardiovascular events and patients with moderate to severe cognitive impairment were excluded.
Slovenian: Študija ni zajela krhkih bolnikov, vključno z bolniki s tveganjem za podhranjenost, bolniki z nedavnimi srčno-žilnimi dogodki in bolniki z zmerno do hudo kognitivno okvaro.
English: Keep the outer needle cap - you will need it to remove the needle later.
Slovenian: Shranite zunanji pokrovček igle - pozneje ga boste potrebovali za odstranitev igle.
English: Check the label on your pen to make sure you have the correct medicine.
Slovenian: Preverite nalepko na peresniku in se prepričajte, da imate pravo zdravilo.
English: In mice, these effects occurred at exposure ratio above 9.3-fold when compared to human exposure at the therapeutic dose.
Slovenian: Pri miših so se ti učinki pojavili pri več kot 9,3-kratnem razmerju izpostavljenosti v primerjavi s terapevtskim odmerkom pri človeku.
English: • You must activate your Lyxumia pen before you use it for the first time.
Slovenian: • Peresnik Lyxumia morate aktivirati, preden ga prvič uporabite.
English: Other side effects include
Slovenian: Ostali neželeni učinki vključujejo:
English: Once you have thrown away the green pen continue to Section 4 to begin using the purple pen.
Slovenian: Ko ste zavrgli zeleni peresnik, nadaljujte s 4. poglavjem, da boste začeli uporabljati škrlatni peresnik.
English: • If another person is giving the injection, they should take care not to injure anyone accidentally with the needle.
Slovenian: • Če vam injekcijo daje nekdo drug, mora paziti, da z iglo po nesreči koga ne poškoduje.
English: What if it is hard to press the injection button all the way in?
Slovenian: Kaj, če je injekcijski gumb težko pritisniti do konca noter?
English: Caution should be exercised in patients with a history of pancreatitis.
Slovenian: Previdnost je potrebna pri bolnikih z anamnezo pankreatitisa.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Lyxumia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Lyxumia za eno ali več skupin pediatrične populacije pri sladkorni bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Lixisenatide is a selective GLP-1 receptor agonist.
Slovenian: Liksisenatid je selektiven agonist receptorjev GLP-1.
English: • Do not repeat the activation process or you will not obtain 14 doses from your Lyxumia pen.
Slovenian: • Ne ponavljajte postopka aktivacije, ker sicer iz peresnika Lyxumia ne boste dobili 14 odmerkov.
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 mišic želodca, imenovano gastroparezo, ki upočasni praznenje želodca.
English: Turn over
Slovenian: Obrnite
English: Paracetamol was used as a model medicinal product to evaluate the effect of lixisenatide on gastric emptying.
Slovenian: Paracetamol so uporabili kot modelno zdravilo za oceno vpliva liksisenatida na praznjenje želodca.
English: • Only use needles that are approved for use with Lyxumia.
Slovenian: • Uporabljajte le igle, odobrene za uporabo s peresnikom Lyxumia.
English: The change in HbA1c from baseline was similar regardless of the antibody status (positive or negative).
Slovenian: Sprememba HbA1c od izhodišča je bila podobna, ne glede na izvid protiteles (pozitiven ali negativen).
English: Do not activate this pen again.
Slovenian: Tega peresnika ne aktivirajte več.
English: What if I forget to activate the Lyxumia pen or inject myself before activation?
Slovenian: Kaj, če pozabim aktivirati peresnik Lyxumia, ali če si zdravilo injiciram pred aktivacijo?
English: The most frequently reported adverse reactions during clinical studies were nausea, vomiting and diarrhoea.
Slovenian: Najpogosteje zabeleženi neželeni učinki v kliničnih študijah so bili navzea, bruhanje in driska.
English: During the 12-week run-in period, addition and titration of insulin glargine resulted approximately in an HbA1c decrease of 1%.
Slovenian: Med 12-tedenskim obdobjem uvajanja sta dodatek in titriranje insulina glargina povzročila znižanje HbA1c za približno 1 %.
English: • Periodic safety update reports
Slovenian: • Redna posodobljena poročila o varnosti zdravila (PSURs)
English: If a patient wishes to become pregnant, or pregnancy occurs, treatment with Lyxumia should be discontinued.
Slovenian: Če bolnica želi zanositi ali če zanosi, je treba zdravljenje z zdravilom Lyxumia prekiniti.
English: Learning how to use the pre-filled pens Before you use the pen for the first time, your doctor or nurse will show how to inject Lyxumia.
Slovenian: Naučite se uporabljati napolnjene injekcijske peresnike Preden boste prvič uporabili injekcijski peresnik, vam bosta zdravnik ali medicinska sestra pokazala, kako injicirati zdravilo Lyxumia.
English: • Once your Lyxumia pen is activated it can be used for up to 14 days.
Slovenian: • Ko je peresnik Lyxumia aktiviran, ga lahko uporabljate do 14 dni.
English: This helps prevent contamination and potential needle blockage.
Slovenian: To pomaga preprečiti kontaminacijo in morebitno zamašitev igle.
English: Table of activation and disposal In the table, write the date when you activated your pen and the date to throw it away 14 days later.
Slovenian: Preglednica datumov aktivacije in datumov, ko je peresnik treba zavreči Sem vpišite datum, ko ste peresnik aktivirali, in datum, ko ga morate 14 dni pozneje zavreči.
English: • Allow your pen to warm at room temperature before using.
Slovenian: • Pred uporabo pustite, da se peresnik ogreje na sobno temperaturo.
English: What Lyxumia is and what it is used for 2.
Slovenian: Kaj je zdravilo Lyxumia in za kaj ga uporabljamo 2.
English: • Do not activate the purple 20 microgram Lyxumia pen until you have finished the green pen.
Slovenian: • Ne aktivirajte škrlatnega peresnika Lyxumia 20 mikrogramov, dokler ne dokončate zelenega peresnika.
English: - you have or have had inflammation of the pancreas (pancreatitis)
Slovenian: - če imate ali ste imeli vnetje trebušne slinavke (pankreatitis).
English: This is to make sure that it is working correctly and that the dose for your first injection is correct.
Slovenian: Tako boste preverili njegovo pravilno delovanje in boste zagotovili, da je odmerek za vaše prvo injiciranje pravilen.
English: • Do not use Lyxumia after the expiry date which is stated on the label and on the carton.
Slovenian: • Zdravila Lyxumia ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
English: Pen ready for injections (white window)
Slovenian: Peresnik, pripravljen za injiciranje (belo okence)
English: • Throw away your Lyxumia pen, ask your pharmacist how to throw away medicines you no longer use.
Slovenian: • Peresnik Lyxumia zavrzite, s farmacevtom se posvetujte o načinu odstranjevanja zdravil, ki jih ne potrebujete več.
English: Pharmacotherapeutic group: Drugs used in Diabetes, Glucagon-like peptide-1 (GLP-1) analogues, ATC code: A10BJ03
Slovenian: Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, analogi glukagonu podobnega peptida-1 (GLP-1), oznaka ATC: A10BJ03
English: The tmax of ramipril and ramiprilat were delayed by approximately 2.5 hours.
Slovenian: tmax ramiprila in ramiprilata sta se podaljšala za približno 2,5 ure.
English: • The starting dose is 10 micrograms once a day for the first 14 days - injected using the green pen.
Slovenian: • Začetni odmerek je 10 mikrogramov enkrat na dan prvih 14 dni - injiciran z zelenim peresnikom).
English: - you are taking other medicines, as there are other medicines such as antibiotics or stomach resistant tablets or capsules that should not stay too long in your stomach (see section Other medicines and Lyxumia)
Slovenian: - če jemljete druga zdravila, npr. antibiotike ali gastrorezistentne tablete ali kapsule, ki v želodcu ne smejo ostati predolgo (glejte poglavje Druga zdravila in zdravilo Lyxumia).
English: • Drowsiness (somnolence)
Slovenian: • zaspanost (somnolenca)
English: • Always use the pen as described in the “Instructions for Use”.
Slovenian: • Peresnik vedno uporabljajte tako, kot je opisano v Navodilih za uporabo.
English: • Viral infection
Slovenian: • virusne okužbe
English: Other medicines and Lyxumia
Slovenian: Druga zdravila in zdravilo Lyxumia
English: • Activation is done to make sure that the pen is working correctly and that the dose for your first injection is correct.
Slovenian: • Aktivacija je potrebna, da preverite pravilno delovanje peresnika in zagotovite, da je odmerek za vaše prvo injiciranje pravilen.