FrancophonIA/ELRC3.0 huggingface dataset:
English: • Explain what the patient should anticipate regarding dysglycemia and potential adverse reactions.
Slovenian: • Pojasnite, kaj naj bolnik pričakuje glede disglikemije in možnih neželenih učinkov.
English: Injecting cold medicine is more painful.
Slovenian: Injiciranje mrzlega zdravila bolj boli.
English: To prevent the possible transmission of disease, each pen must be used by one patient only.
Slovenian: Da bi preprečili možen prenos bolezni, mora vsak injekcijski peresnik uporabljati le en bolnik.
English: It is important to avoid dehydration by drinking plenty of fluids, especially during the first weeks of treatment with Suliqua.
Slovenian: Pomembno je, da preprečite dehidracijo tako, da veliko pijete, še zlasti v prvih tednih zdravljenja z zdravilom Suliqua.
English: • You have had diabetes for a long time.
Slovenian: • če imate sladkorno bolezen že dolgo časa,
English: The first warning signs of hypoglycaemia may change, be weaker or missing altogether if:
Slovenian: Prvi opozorilni znaki hipoglikemije se lahko spremenijo, postanejo šibkejši ali povsem izostanejo:
English: If you find it difficult to recognise your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Slovenian: Če težko prepoznate opozorilne znake hipoglikemije, se morate izogibati okoliščinam (npr. vožnji avta), v katerih bi zaradi hipoglikemije ogrožali sebe ali druge.
English: If no liquid appears:
Slovenian: Če se tekočina ne pojavi:
English: Turn your pen several times with your other hand to remove the needle.
Slovenian: Z drugo roko nekajkrat zasučite peresnik, da boste odstranili iglo.
English: • Danazol, for endometriosis.
Slovenian: • Danazol, za endometriozo.
English: The incidence of formation of antilixisenatide antibodies was approximately 43%.
Slovenian: Incidenca nastanka protiteles proti liksisenatidu je bila približno 43 %.
English: Then remove the needle from your skin.
Slovenian: Nato potegnite iglo iz kože.
English: • The time you eat meals and use your medicine.
Slovenian: • O času, ko uživate obroke in uporabljate zdravilo.
English: This means it is essentially ‘sodium-free'.
Slovenian: To pomeni, da je v bistvu "brez natrija".
English: • The possible effects of changing to different time zones.
Slovenian: • O možnih vplivih menjave časovnih pasov.
English: Empty pens must never be reused and must be properly discarded.
Slovenian: Praznih injekcijskih peresnikov se ne sme nikoli ponovno uporabiti in jih je treba pravilno zavreči.
English: The slowing effect of gastric emptying was maintained at the end of the study.
Slovenian: Upočasnitev praznjenja želodca je bila ob koncu študije ohranjena.
English: This may cause too low blood sugar which is sometimes followed by too high blood sugar.
Slovenian: To lahko povzroči prenizek krvni sladkor, ki mu včasih sledi previsok krvni sladkor.
English: If the pen is damaged, has not been stored correctly, if you are not sure that it is working properly or you notice that your blood sugar control is unexpectedly getting worse:
Slovenian: Če je peresnik poškodovan, če ni bil pravilno shranjen, če niste prepričani, da deluje pravilno, ali če opazite, da se vam urejenost krvnega sladkorja nepričakovano poslabša:
English: • You are doing less exercise than usual.
Slovenian: • Ste manj telesno dejavni kot po navadi.
English: The mean duration of diabetes was approximately 9 years.
Slovenian: Povprečno trajanje sladkorne bolezni je bilo približno 9 let.
English: • Your pen does not work properly.
Slovenian: • Vaš peresnik ne deluje pravilno.
English: These injections should be given even if it is not certain that you have hypoglycaemia.
Slovenian: Takšno injekcijo morate dobiti, tudi če ni gotovo, da imate hipoglikemijo.
English: If you see air bubbles • You may see air bubbles in the medicine.
Slovenian: Če opazite zračne mehurčke • V zdravilu lahko opazite zračne mehurčke.
English: Allergic reactions (urticaria) possibly related with Suliqua have been reported in 0.3% of patients.
Slovenian: O alergijskih reakcijah (urtikariji), ki bi lahko bila povezana z zdravilom Suliqua, so poročali pri 0,3 % bolnikov.
English: • You are recovering from an injury, operation or other stress.
Slovenian: • Okrevate po poškodbi, operaciji ali drugem stresu.
English: • Glucagon, for very low blood sugar.
Slovenian: • Glukagon, za zelo nizek krvni sladkor.
English: • You miss meals or delay them.
Slovenian: • Izpustili ste obroke ali ste jih imeli prepozno.
English: Follow closely your doctor's instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique.
Slovenian: Natančno upoštevajte zdravnikova navodila glede odmerka, nadzora (testiranje krvi in urina), prehrane in telesne dejavnosti (fizično delo in telovadba) ter postopka injiciranja.
English: If you do not follow all of these instructions, you may get too much or too little medicine.
Slovenian: Če ne upoštevate teh navodil, lahko dobite preveč ali premalo zdravila.
English: • Check your blood sugar and then inject your next dose at the usual time.
Slovenian: • Izmerite krvni sladkor in si nato injicirajte naslednji odmerek ob običajnem času.
English: • Any other medicine to treat diabetes.
Slovenian: • Katero koli drugo zdravilo za zdravljenje sladkorne bolezni.
English: It can even hide or stop the first signs that your blood sugar is too low.
Slovenian: Lahko celo prikrijejo ali preprečijo prve znake prenizkega krvnega sladkorja.
English: Take about 15 to 20 grams sugar straight away - such as glucose, sugar cubes or a sugary drink.
Slovenian: Takoj zaužijte od 15 do 20 gramov sladkorja - na primer glukozo, kocke sladkorja ali kakšno sladko pijačo.
English: D. Keep the injection button held in and when you see "0" in the dose window, slowly count to 10.
Slovenian: D. Držite gumb za injiciranje pritisnjen noter; ko v okencu odmerka zagledate "0", počasi preštejte do 10.
English: • The Pharmacist should clarify with the prescriber any incomplete prescription.
Slovenian: • Farmacevt mora z zdravnikom, ki je predpisal zdravilo, razjasniti vsak morebiten nepopoln recept.
English: • When to check your blood sugar level and if you need to carry out urine tests.
Slovenian: • Kdaj si morate meriti krvni sladkor in ali morate opravljati teste urina.
English: • Never use your pen if it is damaged or if you are not sure that it is working properly.
Slovenian: • Peresnika ne uporabite, če je poškodovan ali če niste prepričani, da deluje pravilno.
English: Use only in this pen.
Slovenian: Uporabljajte samo s tem peresnikom.
English: Before you use insulin glargine/lixisenatide, be clear on how many dose steps you require.
Slovenian: Preden uporabite insulin glargin/liksisenatid, si morate biti povsem na jasnem, koliko odmernih korakov potrebujete.
English: Industriepark Hochst 65926 Frankfurt am Main GERMANY
Slovenian: Industriepark Hochst 65926 Frankfurt am Main Nemčija
English: Packs of 3, 5 and 10 pre-filled pens.
Slovenian: Pakiranja s 3, 5 in 10 napolnjenimi injekcijskimi peresniki.
English: The Healthcare Professional Guide shall contain the following key messages:
Slovenian: Vodnik za zdravstvene delavce bo vseboval naslednja ključna sporočila:
English: Dispose of the needle safely after each use.
Slovenian: Iglo po vsaki uporabi varno zavrzite.
English: • Your blood sugar levels are almost normal or are unstable.
Slovenian: • če imate koncentracijo krvnega sladkorja skoraj normalno ali ni stabilna.
English: The time course of action of insulins, including Suliqua, may vary between individuals and within the same individual.
Slovenian: Časovni potek delovanja insulinov, vključno z zdravilom Suliqua, se lahko razlikuje od človeka do človeka in tudi pri eni in isti osebi.
English: You will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Slovenian: Potrebovali boste injekcijo glukoze ali glukagona (zdravila, ki zviša krvni sladkor).
English: Patients should be instructed to always use a new needle.
Slovenian: Bolniku je potrebno naročiti, da mora vedno uporabiti novo iglo.
English: • You have a certain type of nerve damage (called “diabetic autonomic neuropathy”).
Slovenian: • če imate določeno vrsto okvare živcev (imenovano "diabetična avtonomna nevropatija"),
English: • You have just started Suliqua treatment- if low blood sugar occurs, it may be more likely to happen in the morning.
Slovenian: • če ste pravkar začeli zdravljenje z zdravilom Suliqua - če se pojavi nizek krvni sladkor, je bolj verjetno, da se to zgodi zjutraj.
English: How to read the dose window
Slovenian: Kako odčitati okence odmerka
English: This can spread around the injection site.
Slovenian: To se lahko razširi na okolico mesta injiciranja.
English: Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed.
Slovenian: Potrebne so lahko prilagoditve odmerka zdravila, razporeda obrokov ali telesne dejavnosti.
English: After first use: use within 28 days First use on: / / /
Slovenian: Po prvi uporabi: porabite v 28 dneh Datum odprtja: / / /
English: • Somatropin, a growth hormone.
Slovenian: • Somatropin, rastni hormon.
English: • If you do not follow all of these instructions, you may get too much or too little of Suliqua.
Slovenian: • Če ne upoštevate vseh teh navodil, lahko dobite preveč ali premalo zdravila Suliqua.
English: Test your blood glucose levels after 10-15 minutes after taking sugar.
Slovenian: Koncentracijo glukoze v krvi si izmerite 10 do 15 minut po zaužitju sladkorja.
English: • Isoniazid, for tuberculosis.
Slovenian: • Izoniazid, za tuberkulozo.
English: C. Place your thumb on the injection button.
Slovenian: C. Položite palec na gumb za injiciranje.
English: • If no medicine comes out after the third time, the needle may be blocked.
Slovenian: • Če tudi tretjič ne priteče nič zdravila, je igla morda zamašena.
English: • You do not eat enough, or eat food containing less carbohydrates than normal - artificial sweeteners are not carbohydrates.
Slovenian: • Ne jeste dovolj ali uživate hrano, ki vsebuje manj ogljikovih hidratov kot po navadi - umetna sladila niso ogljikovi hidrati.
English: 2 hour PPG (mmol/L)**
Slovenian: PPG - 2 uri (mmol/l)**
English: Lixisenatide has a low level (55%) of binding to human proteins.
Slovenian: Liksisenatid se malo (55 %) veže na človeške beljakovine.
English: The information given below is based on studies with the monocomponents.
Slovenian: Informacije, navedene spodaj, temeljijo na študijah vsake posamezne od obeh učinkovin.
English: If blood glucose levels are still too low (<4 mmol/L) or hypoglycaemia comes back take another 15 to 20 gram of sugar.
Slovenian: Če je koncentracija glukoze v krvi še vedno nizka (< 4 mmol/l) ali se hipoglikemija znova pojavi, zaužijte dodatnih 15 do 20 gramov sladkorja.
English: • Sulfonamide antibiotics, to treat infections.
Slovenian: • Sulfonamidne antibiotike, za zdravljenje okužb.
English: Use in elderly patients (65 years and older) If you are 65 years or older, talk to your doctor as you may need a lower dose.
Slovenian: Uporaba pri starejših bolnikih (starih 65 let ali več) Če ste stari 65 let ali več, se posvetujte z zdravnikom, ker boste morda potrebovali manjši odmerek.
English: Other important information about using the pre-filled pens
Slovenian: Druge pomembne informacije o uporabi napolnjenih injekcijskih peresnikov
English: • Always follow the “Instructions for use” that come with this package leaflet.
Slovenian: • Vedno upoštevajte "Navodila za uporabo", ki so priložena temu navodilu.
English: This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
Slovenian: To je posebej pomembno pri bolnikih z zmanjšanim ali odsotnim zaznavanjem opozorilnih simptomov hipoglikemije in pri tistih, ki imajo pogoste hipoglikemije.
English: • Suliqua is injected under the skin (subcutaneous use or “SC”).
Slovenian: • Zdravilo Suliqua je treba injicirati pod kožo (subkutana uporaba ali "s.c.").
English: • Do not use two injections per day
Slovenian: • Ne uporabite dveh injekcij na dan.
English: Tell your relatives, friends and close colleagues to get medical help straight away if you are not able to swallow or if you pass out (become unconscious).
Slovenian: Sorodnikom, prijateljem in bližnjim sodelavcem povejte, naj takoj poskrbijo za zdravniško pomoč, če ne morete požirati ali se onesvestite (izgubite zavest).
English: The therapeutic experience of Suliqua in patients ≥75 years of age is limited.
Slovenian: Terapevtskih izkušenj z zdravilom Suliqua pri bolnikih, starih ≥ 75 let, je malo.
English: Keep the needle straight and screw it onto the pen until fixed.
Slovenian: Iglo držite naravnost in jo privijte na peresnik, dokler ni do konca pritrjena.
English: If you have any questions about Suliqua, the pen or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number given at the end of the Package Leaflet (see other side).
Slovenian: Če imate vprašanja o zdravilu Suliqua, o peresniku ali o sladkorni bolezni, se lahko obrnete na zdravnika, farmacevta ali medicinsko sestro, ali pokličete lokalno številko družbe sanofi-aventis, ki je navedena na koncu tega navodila (glejte drugo stran).
English: Learn to inject:
Slovenian: Naučite se injiciranja:
English: What other people should do if you have hypoglycaemia
Slovenian: Kaj morajo storiti drugi, če imate hipoglikemijo
English: When the signs of hypoglycaemia may be less clear:
Slovenian: Kdaj so lahko znaki hipoglikemije manj jasni:
English: Warfarin or other anticoagulants
Slovenian: Varfarin in drugi antikoagulanti
English: Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain.
Slovenian: Bolnike je treba seznaniti z značilnim simptomom akutnega pankreatitisa: trdovratnimi, hudimi bolečinami v trebuhu.
English: • Fluoxetine, for depression.
Slovenian: • Fluoksetin, za depresijo.
English: Tell your doctor if you are taking warfarin or other anticoagulants (medicines used to prevent clotting of the blood) as you might need to have more frequent blood tests (called ‘International Normalised Ratio' or INR test) to check your blood clotting.
Slovenian: Zdravniku morate povedati, če jemljete varfarin ali kakšne druge antikoagulante (zdravila, ki se uporabljajo za preprečevanje strjevanja krvi), ker boste morda potrebovali pogostejše testiranje krvi (imenovano "internacionalno normalizirano razmerje" ali INR) za preverjanje strjevanja krvi.
English: Cardiovascular outcome studies
Slovenian: Študije srčno-žilnih izidov
English: When needed, Suliqua can be injected before the next meal.
Slovenian: Če je treba, lahko zdravilo Suliqua injicirate pred naslednjim obrokom.
English: • How to arrange the supply of your medicine, needles and other items.
Slovenian: • Kako poskrbeti za oskrbo z zdravilom, iglami in drugo opremo.
English: ** Severe symptomatic hypoglycaemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Slovenian: ** Huda simptomatska hipoglikemija je bila dogodek, ki je zahteval pomoč druge osebe za aktivno uporabo ogljikovih hidratov, glukagona ali drugih rešilnih ukrepov.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, insulini in analogi za injiciranje, z dolgotrajnim delovanjem.
English: Important information about some of the ingredients of Suliqua This medicine contains less than 1 mmol (23 mg) sodium per dose.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Suliqua To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek.
English: Suliqua can be used in elderly patients.
Slovenian: Zdravilo Suliqua se lahko uporablja pri starejših bolnikih.
English: This could be a sign of of inflamed pancreas (acute pancreatitis).
Slovenian: To je lahko znak vnetja trebušne slinavke (akutnega pankreatitisa).
English: In the presence of anti-lixisenatide antibodies, lixisenatide exposure and variability in exposure are markedly increased regardless of the dose level.
Slovenian: Če so prisotna protitelesa proti liksisenatidu, se izpostavljenost liksisenatidu in variabilnost izpostavljenosti izrazito povečata, ne glede na raven odmerka.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: sanofi-aventis groupe
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom: sanofi-aventis groupe
English: This helps stop blocked needles, contamination, and infection.
Slovenian: To pomaga preprečiti zamašitev, onesnaženje ali okužbo igle.
English: In both studies the dose was titrated once weekly, based on fasting self-measured plasma glucose values.
Slovenian: V obeh študijah so odmerek prilagajali enkrat na teden na podlagi samoizmerjene vrednosti glukoze v plazmi na tešče.
English: • To prevent infection being passed from one person to another, pens should never be used for more than one person, even when the needle is changed
Slovenian: • Za preprečevanje prenosa okužbe z ene osebe na drugo peresnikov nikdar ne sme uporabljati več kot ena oseba; to velja tudi, če je igla zamenjana.
English: The mean diabetes duration was approximately 12 years and the mean duration of previous basal insulin treatment was approximately 3 years.
Slovenian: Povprečno trajanje sladkorne bolezni je bilo približno 12 let in povprečno trajanje predhodnega zdravljenja z bazalnim insulinom je bilo približno 3 leta.
English: [-2.246 to -1.682]
Slovenian: [-2,246 do -1,682]
English: A. Make sure a needle is attached and the dose is set to ‘0'.
Slovenian: A. Preverite, da je igla nameščena in da je odmerek nastavljen na "0".
English: This may damage it.
Slovenian: S tem ga lahko pokvarite.
English: During this run-in phase metformin treatment was optimised and any other OADs were discontinued.
Slovenian: Med tem obdobjem uvajanja so zdravljenje z metforminom optimizirali, morebitne druge POAD pa so ukinili.
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Slovenian: Razmisliti je treba, ali je priporočljivo, da bolnik v takšnih okoliščinah vozi ali upravlja s stroji.
English: • If you cannot select your full prescribed dose, use a new pen or inject the remaining dose steps and use a new pen to complete your dose.
Slovenian: • Če ne morete nastaviti celotnega predpisanega odmerka, uporabite nov peresnik ali injicirajte preostanek odmernih korakov, nato pa za dokončanje odmerka uporabite nov peresnik.
English: Avoidance of medication errors
Slovenian: Preprečevanje napak pri uporabi zdravila
English: The Patient Guide shall contain the following key messages:
Slovenian: Vodnik za bolnike bo obsegal naslednja ključna sporočila:
English: Studies with lixisenatide in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije liksisenatida na živalih so pokazale reproduktivne toksične učinke (glejte poglavje 5.3).
English: Pharmacists should also check that patients have been trained on how to use the pen.
Slovenian: Preverijo naj tudi, ali so bolniki opravili usposabljanje za uporabo peresnika.
English: Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
Slovenian: Huda hipoglikemija lahko povzroči srčni infarkt ali možgansko kap in je lahko smrtno nevarna.
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 in ravni brez opaženega neželenega učinka (NOAEL - no observed adverse effect level) ni bilo mogoče opredeliti.
English: • Do not touch the injection button yet.
Slovenian: • Ne dotikajte se še gumba za injiciranje.
English: The educational materials are aimed at increasing awareness about the two available strengths of the product and at minimising the risk of medication errors including mix-ups between the different strengths of the product.
Slovenian: Izobraževalno gradivo je namenjeno večji ozaveščenosti o dveh jakostih zdravila, ki sta na voljo, in zmanjšanju tveganja za napake pri uporabi zdravila, vključno z nenamerno zamenjavo različnih jakosti zdravila.
English: You should learn to recognise the signs when your blood sugar is falling - so you can take action to stop it getting worse.
Slovenian: Naučiti se morate prepoznati znake zniževanja krvnega sladkorja - tako boste lahko ukrepali in preprečili, da bi se stanje poslabšalo.
English: In case of gastrointestinal adverse reactions, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Slovenian: V primeru neželenih učinkov na prebavilih je treba uvesti ustrezno podporno zdravljenje glede na bolnikove klinične znake in simptome.
English: Hypoglycaemia can be very serious and is very common with medicines containing insulin (may affect more than 1 in 10 people).
Slovenian: Hipoglikemija je lahko zelo resna in je pri zdravljenju z zdravili, ki vsebujejo insulin, zelo pogosta (pojavi se lahko pri več kot 1 od 10 oseb).
English: *You will not see the plunger until you have injected a few doses
Slovenian: *Bata ne boste videli, dokler ne injicirate nekaj odmerkov.
English: • Do not take two injections per day
Slovenian: • Ne dajte si dveh injekcij na dan.
English: • Never share your pen - it is only for you
Slovenian: • Peresnika nikdar ne souporabljajte s kom drugim - namenjen je samo vam.
English: Stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Slovenian: Bolečine v trebuhu, hitro in globoko dihanje, zaspanost ali izguba zavesti pa so lahko znaki resnega stanja (ketoacidoze), ki se pojavi zaradi pomanjkanja insulina.
English: Press the injection button all the way in.
Slovenian: Pritisnite gumb za injiciranje do konca noter.
English: After 30 weeks of treatment with Suliqua in two phase 3 trials, the incidence of formation of antiinsulin glargine antibodies was 21.0% and 26.2%.
Slovenian: Po 30 tednih zdravljenja z zdravilom Suliqua v dveh preskušanjih 3. faze je bila incidenca nastanka protiteles proti insulinu glargin 21,0 % in 26,2 %.
English: (-3.89 to -2.77)
Slovenian: (-3,89 do -2,77)
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek; kar v bistvu pomeni "brez natrija".
English: • You find it hard to recognise when your blood sugar is too low.
Slovenian: • Če težko prepoznate, kdaj imate prenizek krvni sladkor.
English: • Always carry a spare pen and spare needles in case they get lost or stop working.
Slovenian: • Vedno imejte pri sebi rezervni peresnik in rezervne igle za primer, da peresnik izgubite ali da neha delovati.
English: So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, you need to take.
Slovenian: Zato pred uporabo vsakega zdravila zdravnika vprašajte, ali bo vplivalo na krvni sladkor, ali je v zvezi s tem potrebno kakšno posebno ravnanje in če, kakšno.
English: • You have an injury, infection or fever or have had an operation.
Slovenian: • Imate kakšno poškodbo, okužbo, zvišano telesno temperaturo, ali ste imeli operacijo.
English: Suliqua has no or negligible influence on the ability to drive or use machines.
Slovenian: Zdravilo Suliqua nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Tell your doctor, pharmacist or nurse if you are using have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.