FrancophonIA/ELRC3.0 huggingface dataset:
English: When using other medicines, ask your doctor if your treatment needs to be adjusted.
Slovenian: V primeru uporabe drugih zdravil se z zdravnikom posvetujte, ali je treba vaše zdravljenje prilagoditi.
English: Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Slovenian: Glukozo je treba dati intravensko v primeru, da se bolnik v 10 do 15 minutah ne odzove na glukagon.
English: • when to check your blood sugar level and if you need a higher or lower dose.
Slovenian: • kdaj morate preveriti koncentracijo krvnega sladkorja in ali potrebujete višji ali nižji odmerek.
English: How to inject
Slovenian: Kako injicirati
English: • you have had too low blood sugar a few times recently.
Slovenian: • ste imeli pred kratkim večkrat prenizek krvni sladkor.
English: You should therefore monitor your blood sugar level more often than usual.
Slovenian: Koncentracijo krvnega sladkorja morate torej kontrolirati bolj pogosto kot običajno.
English: This medicinal product is for use by one person only.
Slovenian: To zdravilo je namenjeno uporabi ene same osebe.
English: Do not inject it into a vein or muscle.
Slovenian: Nikoli ga ne injicirajte v veno ali mišico.
English: • you suddenly feel unwell with sweating
Slovenian: • nenadno slabo počutje in znojenje,
English: This medicinal product can be used in adolescents and children from the age of 1 year (see section 5.1).
Slovenian: To zdravilo se lahko uporablja pri mladostnikih in otrocih, starejših od 1 leta (glejte poglavje 5.1).
English: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Denmark
Slovenian: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Danska
English: • Get medical help straight away.
Slovenian: • Nemudoma poiščite zdravniško pomoč.
English: • Leave the needle under the skin for at least 6 seconds to make sure you get your full dose.
Slovenian: • Pustite iglo pod kožo vsaj 6 sekund, da zagotovite injiciranje celotnega odmerka.
English: After first opening: Do not refrigerate.
Slovenian: Po prvem odprtju: ne shranjujte v hladilniku.
English: • Please also read the manual that comes with your insulin delivery system.
Slovenian: • Preberite tudi priročnik, ki ste ga dobili s sistemom za dajanje insulina.
English: IDeg 0.6 units/kg
Slovenian: IDeg 0,6 enot/kg
English: • if you are allergic to insulin degludec or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na insulin degludek ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Insulin requirements usually decrease in the first trimester and increase subsequently during the second and third trimesters.
Slovenian: Potreba po insulinu se v prvem trimesečju ponavadi zmanjša, potem pa se v drugem in tretjem trimesečju zveča.
English: This causes swelling around your ankles and other joints.
Slovenian: To povzroči otekline okrog gležnjev in drugih sklepov.
English: 6 How much insulin is left?
Slovenian: 6 Koliko je preostalega insulina?
English: OTHER Novo Nordisk A/S
Slovenian: Novo Nordisk A/S
English: Never use a bent or damaged needle.
Slovenian: Nikoli ne uporabljajte zvite ali poškodovane igle.
English: Avoiding too low blood sugar (hypoglycaemia) is particularly important for the health of your baby.
Slovenian: Preprečevanje prenizkega krvnega sladkorja (hipoglikemije) je še posebej pomembno za zdravje vašega otroka.
English: • If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.
Slovenian: • Če želite spremeniti svojo običajno prehrano, se najprej posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, kajti sprememba prehrane lahko spremeni vaše potrebe po insulinu.
English: A specific overdose for insulin cannot be defined.
Slovenian: Specifičnega prevelikega odmerjanja insulina ni mogoče opredeliti.
English: Avoidance of medication errors
Slovenian: Preprečevanje napak pri zdravljenju
English: EXP After first opening: Use within 8 weeks
Slovenian: EXP Po prvem odprtju: porabite v 8 tednih.
English: Use in elderly (≥65 years old)
Slovenian: Uporaba pri starejših (≥ 65 let)
English: After first opening: Use within 8 weeks
Slovenian: Po prvem odprtju: porabite v 8 tednih.
English: *Produced in Saccharomyces cerevisiae by recombinant DNA technology.
Slovenian: *Pridobljen iz Saccharomyces cerevisiae s tehnologijo rekombinantne DNA.
English: The half-life of Tresiba is approximately 25 hours independent of dose.
Slovenian: Razpolovni čas zdravila Tresiba je približno 25 ur, neodvisno od odmerka.
English: Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Slovenian: Skupine 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
English: If not treated, this could lead to diabetic coma and eventually death.
Slovenian: Če ga ne zdravite, lahko povzroči diabetično komo in navsezadnje smrt.
English: Listed below are the most common medicines which may affect your insulin treatment.
Slovenian: Spodaj so našteta najpogostejša zdravila, ki lahko vplivajo na vaše zdravljenje z insulinom.
English: This medicinal product has no or negligible influence on the ability to drive and use machines.
Slovenian: To zdravilo nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Antibody development was sparse and had no clinical impact.
Slovenian: Razvoj protiteles je bil redek in ni imel kliničnega pomena.
English: The ratio between AUCGIR,0-12h,SS and AUCGIR,τ,SS was 0.5.
Slovenian: Razmerje med AUCGIR,0-12h,SS in AUCGIR,τ,SS je bilo 0,5.
English: CV: within-patient coefficient of variation in %
Slovenian: CV: intraindividualni koeficient spremenljivosti v %
English: After first opening or if carried as a spare
Slovenian: Po odprtju ali ko ga imate pri sebi kot rezervo
English: Nocturnal
Slovenian: Nočne
English: Detailed instructions for use are provided on the other side of this leaflet.
Slovenian: Podrobna navodila najdete na drugi strani tega navodila za uporabo.
English: If necessary, clean it with mild detergent on a moistened cloth.
Slovenian: Če je potrebno, ga očistite s krpo, navlaženo z blagim detergentom.
English: • Always keep your pen and needles out of sight and reach of others, especially children.
Slovenian: • Injekcijski peresnik in igle vedno hranite zunaj pogleda in dosega drugih, zlasti otrok.
English: In rats, insulin degludec was secreted in milk; the concentration in milk was lower than in plasma.
Slovenian: Pri podganah se je insulin degludek izločal v mleko; koncentracija v mleku je bila nižja kot v plazmi.
English: Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.5, 4.8 and 4.9).
Slovenian: Hipoglikemija se lahko pojavi, če je odmerek insulina prevelik glede na potrebo po insulinu (glejte poglavja 4.5, 4.8 in 4.9).
English: In both treatment arms, children aged 6-11 years had a numerically higher rate of confirmed hypoglycaemia than in the other age groups.
Slovenian: V obeh skupinah zdravljenja so pri otrocih, starih 6 - 11 let, poročali o številčno večjem deležu potrjene hipoglikemije kot v drugih starostnih skupinah.
English: Dose counter stopped: 52 units left
Slovenian: števec odmerka se je ustavil: ostalo je še 52 enot primer
English: Patients in the Tresiba arm included 43 children aged 1-5 years, 70 children aged 6-11 years and 61 adolescents aged 12-17 years.
Slovenian: V skupino, ki je prejemala zdravilo Tresiba, je bilo vključenih 43 otrok, starih 1 - 5 let, 70 otrok, starih 6 - 11 let, in 61 mladostnikov, starih 12 - 17 let.
English: • you experience difficulty in breathing
Slovenian: • težko dihanje,
English: • If you are given glucagon, you will need sugar or a sugary snack as soon as you come round.
Slovenian: • Če dobite injekcijo glukagona, boste potrebovali sladkor ali sladek prigrizek, takoj ko se zaveste.
English: Paediatric population The European Medicines Agency has waived the obligation to submit the results of trials with Tresiba in:
Slovenian: Pediatrična populacija Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov preskušanj z zdravilom
English: Tresiba helps your body reduce your blood sugar level.
Slovenian: Zdravilo Tresiba pomaga telesu zniževati količino krvnega sladkorja.
English: The recommended daily starting dose is 10 units followed by individual dosage adjustments.
Slovenian: Priporočeni začetni dnevni odmerek je 10 enot, čemur sledi prilagoditev odmerjanja posamezniku.
English: This should be kept in mind if treatment with the combination of pioglitazone and Tresiba is considered.
Slovenian: To je treba upoštevati pri načrtovanju zdravljenja s kombinacijo pioglitazona in zdravila Tresiba.
English: Tresiba is to be dosed in accordance with the individual patient's needs.
Slovenian: Zdravilo Tresiba je treba odmerjati glede na potrebe posameznega bolnika.
English: • anabolic steroids, such as testosterone
Slovenian: • anabolne steroide (na primer testosteron),
English: This medicinal product must not be administered intramuscularly as it may change the absorption.
Slovenian: Tega zdravila se ne sme aplicirati intramuskularno, ker lahko povzroči spremembo v absorpciji.
English: This helps you to ensure that you get your full insulin dose.
Slovenian: Tako zagotovite, da dobite celoten odmerek insulina.
English: Time since injection (hours) Treatment
Slovenian: Čas od injiciranja insulina (v urah) Zdravljenje
English: If no drop appears, repeat steps 2A to 2C up to 6 times.
Slovenian: Če se kapljica ne pojavi, ponovite korake od 2A do 2C, vendar ne več kot 6 krat.
English: The MAH shall agree on the final text of the Direct Healthcare Professional Communication letter and the content of the patient brochure together with a communication plan, with the National Competent Authority in each Member State prior to distribution of the educational pack in the Member State.
Slovenian: Imetnik dovoljenja za promet bo končno besedilo neposrednega pisma zdravstvenim delavcem, vsebino brošure za bolnike in načrt komuniciranja pred distribucijo izobraževalnega gradiva v državi članici uskladil v dogovoru s pristojnim nacionalnim organom v vsaki državi članici.
English: Elderly (≥65 years old)
Slovenian: Starejši (≥ 65 let)
English: The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of >99% in human plasma.
Slovenian: Porazdelitev Afiniteta insulina degludek za serumski albumin ustreza > 99 % vezavi na plazemske beljakovine v človeški plazmi.
English: It is not known if Tresiba affects the baby in pregnancy or during breast-feeding.
Slovenian: Ni znano, ali zdravilo Tresiba vpliva na otroka med nosečnostjo ali dojenjem.
English: Transferring a patient to another type, brand or manufacturer of insulin must be done under medical supervision and may result in the need for a change in dosage.
Slovenian: Prehod bolnika na drugo vrsto, znamko ali izdelovalca insulina mora potekati pod zdravniškim nadzorom in ima lahko za posledico spremembo odmerka.
English: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or other products containing sugar.
Slovenian: • Blage epizode hipoglikemije je mogoče zdraviti z zaužitjem glukoze ali drugih izdelkov, ki vsebujejo sladkor.
English: Detailed information on this medicinal product is available on the web site of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: It must not be refilled.
Slovenian: Ne sme se ga znova polniti.
English: • Use Tresiba once each day, preferably at the same time every day.
Slovenian: • Zdravilo Tresiba uporabljajte enkrat na dan, po možnosti vsak dan ob istem času.
English: This can only be given by someone who knows how to use it.
Slovenian: Injicira vam ga lahko samo oseba, ki ga zna ustrezno uporabljati.
English: 4 Inject your dose
Slovenian: 4 Injicirajte odmerek
English: MI: Myocardial infarction.
Slovenian: MI: Miokardni infarkt.
English: Tell them what could happen if your blood sugar gets too low, including the risk of passing out.
Slovenian: Povejte jim, kaj se lahko zgodi v primeru prenizkega krvnega sladkorja, vključno s tveganjem, da se onesvestite.
English: During a period of 24 hours with once-daily treatment, the exposure of insulin degludec was evenly distributed between the first and second 12 hours.
Slovenian: V prvih 24 urah zdravljenja enkrat na dan je bila izpostavljenost insulinu degludek enakomerno porazdeljena med prvimi in drugimi 12 urami.
English: Tresiba can be used in elderly.
Slovenian: Zdravilo Tresiba se lahko uporablja pri starejših.
English: 6 The ratio is for Tresiba Flex/Tresiba.
Slovenian: 6 To je razmerje med Tresiba Flex/Tresiba.
English: The 0 must line up with the dose pointer.
Slovenian: Število 0 mora biti poravnano s kazalnikom odmerka.
English: No safety issues were identified with Tresiba with respect to adverse events and standard safety parameters.
Slovenian: Pri uporabi zdravila Tresiba niso ugotovili težav z varnostjo v smislu neželenih učinkov in običajnih parametrov varnosti.
English: • Neonates and infants from birth to less than 12 months of age with type 1 diabetes mellitus and children from birth to less than 10 years of age with type 2 diabetes mellitus on the grounds that the disease or condition for which the specific medicinal product is intended does not occur in the specified paediatric subset (see section 4.2 for information on paediatric use).
Slovenian: • novorojenčke in dojenčke, od rojstva do manj kot 12 mesecev starosti, s sladkorno boleznijo tipa 1 ter za otroke, od rojstva do manj kot 10. leta starosti, s sladkorno boleznijo tipa 2 z utemeljitvijo, da se bolezen ali stanje, za katero je namenjeno to zdravilo, v tej podskupini pediatričnih bolnikov ne pojavlja (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2);
English: Careful control of your diabetes is needed in pregnancy.
Slovenian: Med nosečnostjo je potreben skrben nadzor vaše sladkorne bolezni.
English: Steady state will occur after 2-3 days of dose administration.
Slovenian: Stanje dinamičnega ravnovesja bo doseženo po 2-3 dneh uporabe zdravila.
English: If you select a wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
Slovenian: Če izberete napačen odmerek, lahko z vrtenjem izbirnika naprej ali nazaj izberete pravilen odmerek.
English: SS: Steady State
Slovenian: SS: stanje dinamičnega ravnovesja
English: Glucose Infusion Rate (mg/(kg*min))
Slovenian: Hitrost infuzije glukoze (mg/(kg*min))
English: It is therefore recommended that the patient always carries glucose-containing products.
Slovenian: Zato je priporočljivo, da bolniki s sladkorno boleznijo vedno nosijo pri sebi živila, ki vsebujejo sladkor.
English: This medicinal product must not be used in insulin infusion pumps.
Slovenian: Tega zdravila se ne sme uporabljati v infuzijskih črpalkah za insulin.
English: If you keep injecting in the same place, these reactions can become more severe and affect the amount of medicine your body gets.
Slovenian: Če zdravilo nenehno injicirate na isto mesto, lahko te reakcije postanejo hujše in vplivajo na količino zdravila, ki jo telo dobi.
English: • Severe hypoglycaemic episodes, where the patient is not able to treat himself, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
Slovenian: • Hude epizode hipoglikemije, kjer si bolnik sam ne more pomagati, je mogoče zdraviti z glukagonom (0,5 do 1 mg), ki ga intramuskularno ali subkutano aplicira ustrezno poučena oseba, ali z glukozo, ki jo intravensko aplicira zdravstveni delavec.
English: If you try to put it back on, you may accidentally stick yourself with the needle.
Slovenian: Če ga poskušate znova namestiti na iglo, se lahko po nesreči zbodete.
English: In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Slovenian: Na splošno sta pri ženskah s sladkorno boleznijo med celotno nosečnostjo in pred nameravano nosečnostjo priporočljiva intenzivnejša kontrola koncentracije glukoze v krvi in spremljanje nosečnice.
English: Solution for injection (FlexTouch)
Slovenian: raztopina za injiciranje (FlexTouch)
English: Insulin degludec binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.
Slovenian: Insulin degludek se specifično veže na človeški receptor za insulin in ima enake farmakološke učinke kot humani insulin.
English: There is no difference in the pharmacokinetics of insulin degludec between elderly and younger adult patients, between races or between healthy subjects and patients with renal or hepatic impairment.
Slovenian: Farmakokinetika insulina degludek se ne razlikuje med starejšimi in mlajšimi odraslimi bolniki, med rasami ter med zdravimi osebami in bolniki z okvaro ledvic ali jeter.
English: If blood appears at the injection site, press lightly with a cotton swab.
Slovenian: Če se na mestu injiciranja pojavi kri, na mesto rahlo pritisnite z bombažno blazinico.
English: This is usually only short-lasting.
Slovenian: Običajno to kmalu mine.
English: To avoid dosing errors and potential overdose, patients and healthcare professionals should never use a syringe to draw the medicinal product from the cartridge in the pre-filled pen.
Slovenian: Da bi se izognili napakam pri odmerjanju in morebitnemu prevelikemu odmerjanju, zdravstveni delavci in bolniki nikoli ne smejo uporabiti injekcijske brizge, da bi z njo izvlekli zdravilo iz vložka napolnjenega injekcijskega peresnika.
English: • Test your blood sugar level.
Slovenian: • Izmerite si krvni sladkor.
English: What Tresiba is and what it is used for What you need to know before you use Tresiba How to use Tresiba
Slovenian: Kaj je zdravilo Tresiba in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Tresiba Kako uporabljati zdravilo Tresiba
English: What Tresiba is and what it is used for
Slovenian: Kaj je zdravilo Tresiba in za kaj ga uporabljamo
English: Tresiba has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see section 5.2).
Slovenian: Otroci in mladostniki do 18. leta starosti so zdravilo Tresiba dobivali za preučitev farmakokinetičnih lastnosti (glejte poglavje 5.2).
English: If you discover that you missed your previous dose when it is time to take your next regular scheduled dose, do not inject a double dose, but resume your once-daily dosing schedule.
Slovenian: Če ste pozabili uporabiti odmerek in to ugotovite, ko je že čas, da uporabite naslednji redni odmerek, si ne injicirajte dvojnega odmerka, ampak le nadaljujte z uporabo običajnega odmerka enkrat na dan.
English: Contents of the pack and other information What Tresiba contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Tresiba
English: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Slovenian: Intenziviranje insulinskega zdravljenja s hitrim izboljšanjem urejenosti glikemije lahko spremlja prehodno poslabšanje diabetične retinopatije, medtem ko dolgoročno izboljšana urejenost glikemije zmanjša tveganje za napredovanje diabetične retinopatije.
English: Results from subgroup analyses (e.g. sex, diabetes duration, CV risk group and previous insulin regimen) was aligned with the primary analysis.
Slovenian: Rezultati analiz podskupin (npr. spol, trajanje sladkorne bolezni, skupina s tveganjem za pojav srčnožilnih dogodkov in predhodni režim insulina) so bili skladni s primarno analizo.
English: The most frequently reported adverse reaction during treatment is hypoglycaemia (see section ‘Description of selected adverse reactions' below).
Slovenian: Najpogosteje opisani neželeni učinek med zdravljenjem je hipoglikemija (glejte poglavje »Opis izbranih neželenih učinkov« v nadaljevanju).
English: One (1) unit of insulin degludec corresponds to 1 international unit of human insulin, 1 unit of insulin glargine (100 units/mL), or 1 unit of insulin detemir.
Slovenian: Ena (1) enota insulina degludek ustreza 1 mednarodni enoti humanega insulina, 1 enoti insulina glargin (100 enot/ml) ali 1 enoti insulina detemir.
English: Some medicines affect your blood sugar level, this may mean your insulin dose has to be changed.
Slovenian: Nekatera zdravila vplivajo na koncentracijo krvnega sladkorja, kar pomeni, da bo morda potrebna sprememba vašega odmerka insulina.
English: Tell everyone you spend time with that you have diabetes.
Slovenian: Vsem, s katerimi živite oz. se družite, povejte, da imate sladkorno bolezen.
English: • Insert the needle into your skin as your doctor or nurse has shown you.
Slovenian: • Zabodite iglo v kožo, kot sta vam pokazala vaš zdravnik ali medicinska sestra.
English: Tresiba can be used in elderly, but if you are elderly, you may need to check your blood sugar level more often.
Slovenian: Zdravilo Tresiba se lahko uporablja pri starejših, a si morate krvni sladkor kontrolirati pogosteje.
English: A small air bubble may remain at the needle tip, but it will not be injected.
Slovenian: Na vrhu igle ostane majhen zračni mehurček, a ne bo injiciran.
English: Estimated risk ratio (Insulin degludec/Insulin glargine)
Slovenian: Ocenjeno razmerje tveganj (insulin degludek/insulin glargin)
English: It is unknown whether insulin degludec is excreted in human milk.
Slovenian: Ni znano, ali se insulin degludek izloča v materino mleko.
English: There is no clinically relevant difference in the pharmacodynamics of this medicinal product between elderly and younger adult patients.
Slovenian: V farmakodinamiki tega zdravila ni klinično pomembne razlike med starejšimi in mlajšimi odraslimi bolniki.
English: With insulin preparations, allergic reactions may occur.
Slovenian: Insulinska zdravila lahko povzročijo alergijske reakcije.
English: • sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline, for asthma
Slovenian: • simpatikomimetike (na primer epinefrin (adrenalin), salbutamol ali terbutalin; uporabljajo se za zdravljenje astme),
English: After subcutaneous injection, soluble and stable multi-hexamers are formed creating a depot of insulin in the subcutaneous tissue.
Slovenian: Po subkutanem injiciranju nastanejo topni in stabilni multiheksameri, ki ustvarijo depo insulina v podkožnem tkivu.
English: Patients must be advised to take precautions to avoid hypoglycaemia while driving.
Slovenian: Bolnikom je treba svetovati, naj upoštevajo ustrezne previdnostne ukrepe, da bi se izognili hipoglikemiji med upravljanjem vozila.
English: • thiazides, for high blood pressure or if your body keeps too much water (water retention).
Slovenian: • tiazide (uporabljajo se za zdravljenje visokega krvnega tlaka ali prekomernega zadrževanja tekočin v telesu (zadrževanje vode)).
English: If no drop appears, you will not inject any insulin, even though the dose counter may move.
Slovenian: Če se kapljica ne pojavi, ne boste injicirali insulina, tudi če se števec odmerka premakne.
English: • if the cartridge or the delivery system you are using is damaged.
Slovenian: • če je injekcijski vložek ali sistem za dajanje insulina, ki ga uporabljate, poškodovan.
English: If the needle is blocked, you will not inject any insulin.
Slovenian: Če je igla zamašena, si ne boste injicirali insulina.