natgillin/translations-raw huggingface dataset:
In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal. 
V randomizirani, kontrolirani klinični študiji so pediatrične bolnike (stare od 6 do 15 let) s sladkorno boleznijo tipa 1 (n = 349) 28 tednov zdravili z bazalno-bolusno insulinsko shemo, v kateri so pred vsakim obrokom prejeli običajni humani insulin.
Glycohaemoglobin and glucose variabilities were comparable in both treatment groups. 
Glikirani hemoglobin in variabilnost glukoze sta bila med terapevtskima skupinama primerljiva.
If it does not work with a new needle, you will need to speak to your doctor or nurse. 
Če ne deluje niti z novo iglo, se boste morali posvetovati z zdravnikom ali medicinsko sestro.
Effects of insulin glargine (once daily) on diabetic retinopathy were evaluated in an open-label 5 year NPH-controlled study (NPH given bid) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography. 
Učinke insulina glargin (enkrat na dan) na diabetično retinopatijo so ocenili v odprti 5-letni z insulinom NPH nadzorovani študiji (insulin NPH apliciran dvakrat na dan) pri 1.024 bolnikih s sladkorno boleznijo tipa 2, v kateri so napredovanje retinopatije za 3 stopnje ali več po lestvici ETDRS (Early Treatment Diabetic Retinopathy Study) raziskali s slikanjem očesnega ozadja.
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia. 
V takšnih okoliščinah se huda hipoglikemija (in možna izguba zavesti) lahko pojavi, še preden se bolnik hipoglikemije sploh zave.
In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see section 5.1). 
V redkih primerih je zaradi prisotnosti takšnih protiteles proti insulinu treba prilagoditi odmerek insulina, da bi odpravili nagnjenost k hiper- ali hipoglikemiji (glejte poglavje 5.1).
• If you use more than one type of medicine, make sure you have the right medicine before 
• Če uporabljate več kot eno vrsto zdravil, se pred injiciranjem vedno prepričajte, da imate pravo
No new safety signals were seen during this extended treatment with insulin glargine. 
Med tem podaljšanjem zdravljenja z insulinom glargin niso opazili nobenih novih varnostnih signalov.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery. 
Morda bo potrebno dolgotrajnejše uživanje ogljikovih hidratov in opazovanje, saj se lahko hipoglikemija po navideznem kliničnem izboljšanju ponovi.
The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicentre, randomised, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12 % of participants) or type 2 diabetes mellitus treated with ≤ 1 antidiabetic oral agent (88 % of participants). 
Študija ORIGIN (Outcome Reduction with Initial Glargine INtervention) je bila multicentrična, randomizirana študija s faktorskim načrtom 2 x 2, v katero je bilo vključenih 12.537 preskušancev z velikim srčno-žilnim (CV) tveganjem, z nenormalno vrednostjo glukoze na tešče (IFG) ali okvarjeno toleranco za glukozo (IGT) (12 % preskušancev) ali s sladkorno boleznijo tipa 2, zdravljenih z ≤ 1 peroralnim antidiabetičnim zdravilom (88 % preskušancev).
Change the injection site with each injection to help prevent these skin changes. 
Mesto injiciranja zamenjajte pri vsakem injiciranju, da boste pomagali preprečiti takšne kožne spremembe.
If not, get a new pen. 
Če ni, vzemite nov injekcijski peresnik.
Each pen contains 3 mL of solution for injection, equivalent to 300 units. 
En injekcijski peresnik vsebuje 3 ml raztopine za injiciranje, kar ustreza 300 enotam.
Combination of LUSDUNA with pioglitazone 
Kombinacija zdravila LUSDUNA in pioglitazona
You should change injection site with each injection following the advice of your doctor. 
Mesto injiciranja morate ob vsakem injiciranju menjati, kot vam je naročil zdravnik.
LUSDUNA is a biosimilar medicinal product. 
Zdravilo LUSDUNA je podobno biološko zdravilo.
This pen works with most kinds and sizes of pen needles such as those manufactured by Becton, Dickinson & Company and Ypsomed. 
S tem injekcijskim peresnikom je mogo e uporabiti ve ino vrst in velikosti igel za injekcijske peresnike, kot so na primer igle, ki jih izdelujeta Becton, Dickinson & Company ter Ypsomed.
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness. 
Primeri simptomov, ki nakazujejo nizko koncentracijo sladkorja v možganih, so: glavobol, huda lakota, siljenje na bruhanje, bruhanje, utrujenost, zaspanost, motnje spanja, nemir, napadalno vedenje, motena koncentracija, slabše reakcije, depresija, zmedenost, motnje govora (včasih popolna izguba govora), motnje vida, tresenje, paraliza, mravljinčenje (parestezija), odrevenelost in mravljinčenje v predelu ust, omotica, izguba nadzora nad seboj, nezmožnost poskrbeti zase, krči, izguba zavesti.
Participants were randomized (1:1) to receive insulin glargine (n=6,264), titrated to reach FPG ≤ 95 mg/dL (5.3 mM), or standard care (n=6,273). 
Preskušance so v razmerju 1:1 randomizirali na prejemanje insulina glargin (n = 6.264), titriranega tako, da je bila dosežena glukoza v plazmi na tešče ≤ 95 mg/dl (5.3 mM), ali na standardno zdravljenje (n = 6.273).
Complaints of injection site reactions (injection site reaction, injection site pain) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults. 
O težavah na mestu injiciranja (reakcija na mestu injiciranja, bolečina na mestu injiciranja) in kožnih reakcijah (izpuščaj, koprivnica) so relativno pogosteje poročali pri otrocih in mladostnikih, starih 18 let ali manj, kot pri odraslih.
• Carry some information with you to show you are diabetic. 
• Pri sebi imejte tudi nekaj, iz česar bo razvidno, da imate sladkorno bolezen.
Cartridge (type I colourless glass) with a plunger (bromobutyl rubber) and aluminium combi-seal fitted with a bi-layered bromobutyl rubber and polyisoprene rubber flat disc containing 3 mL of solution. 
Vložek (brezbarvno steklo tipa 1) z batom iz brombutilne gume in aluminijasto kombinirano zaporko, opremljeno z dvoplastno bromobutilno gumo in ploščatim diskom iz poliizoprenske gume, ki vsebuje 3 ml raztopine.
More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. 
Hujše primere s komo, krči ali nevrološko prizadetostjo se lahko zdravi z glukagonom intramuskularno ali subkutano oziroma s koncentrirano glukozo intravensko.
The prolonged duration of action of insulin glargine is dependent on its injection into subcutaneous tissue. 
Podaljšano trajanje delovanja insulina glargin je pogojeno z injiciranjem v podkožno tkivo.
Caring for your pen New pens you haven't used before: 
Ravnanje z injekcijskim peresnikom Novi injekcijski peresniki, ki jih še niste uporabili:
LUSDUNA must not be mixed with any other insulin or diluted. 
Zdravila LUSDUNA se ne sme mešati z nobenim drugim insulinom in se ga ne sme redčiti.
Follow the advice of your healthcare provider. 
Upoštevajte zdravnikov nasvet.
The pharmacokinetic and pharmacodynamic findings indicate that the effect of the subcutaneous injection with insulin glargine is principally based on exposure to M1. Insulin glargine and the metabolite M2 were not detectable in the vast majority of subjects and, when they were detectable their concentration was independent of the administered dose of insulin glargine. 
Farmakokinetični in farmakodinamični izsledki kažejo, da učinek subkutano injiciranega insulina glargin temelji predvsem na izpostavljenosti presnovku M1. Insulin glargin in presnovek M2 pri veliki večini preiskovancev nista bila zaznavna; če sta bila zaznavna, pa njuna koncentracija ni bila odvisna od uporabljenega odmerka insulina glargin.
When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with LUSDUNA, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products). 
Pri prehodu s srednjedolgo- ali dolgodelujočega insulina na zdravljenje z zdravilom LUSDUNA bosta morda potrebni sprememba odmerka bazalnega insulina in prilagoditev sočasnega antidiabetičnega zdravljenja (odmerek in čas uporabe dodatnih običajnih insulinov ali hitrodelujočih insulinskih analogov oz. odmerek peroralnih antidiabetičnih zdravil).
As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables. 
Kot pri vseh insulinih, lahko telesna aktivnost in druge spremenljivke vplivajo na časovni potek delovanja insulina glargin.
This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). 
Če ste prenehali uporabljati zdravilo LUSDUNA To lahko povzroči hudo hiperglikemijo (zelo visok krvni sladkor) in ketoacidozo (kopičenje kisline v krvi, ker telo namesto sladkorja razgrajuje maščobe).
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. 
Primarno delovanje insulina, vključno z insulinom glargin, je uravnavanje presnove glukoze.
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. 
Zdravljenje sladkorne bolezni pri odraslih, mladostnikih in otrocih, starih 2 leti ali več.
Be careful you do not dirty the needle. 
Pazite, da igle ne onesnažite.
Once you've opened and are using a pen: 
Ko injekcijski peresnik odprete in ga uporabljate:
Only use needles that are compatible for use with your pen (see section “Parts of your pen” below). 
Uporabljajte le igle, ki so združljive z vašim injekcijskim peresnikom (glejte poglavje "Deli injekcijskega peresnika" spodaj).
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. 
Pri uporabi pioglitazona v kombinaciji z insulinom so poročali o primerih srčnega popuščanja, zlasti pri bolnikih z dejavniki tveganja za srčno popuščanje.
Clean the cartridge head with an alcohol swab. 
Očistite glavo vložka z alkoholnim zložencem.
With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. 
Z boljšo urejenostjo metabolne presnove in posledično večjo občutljivostjo za insulin bo morda potrebna nadaljnja prilagoditev odmerka.
The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a half maximal occupation of the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by the IGF-1 receptor. 
Skupna terapevtska koncentracija insulina (insulina glargin in njegovih presnovkov), ugotovljena pri bolnikih s sladkorno boleznijo tipa 1, je bila bistveno manjša od koncentracije, ki bi bila potrebna za polovično največjo zasedenost receptorjev za IGF-1 in posledično aktivacijo mitogeno-proliferacijske poti, ki jo sproža receptor za IGF-1.
The pen in use or carried as a spare must not be stored in the refrigerator. 
Injekcijskega peresnika, ki je v uporabi ali ga nosite s seboj za rezervo, ne smete shranjevati v hladilniku.
Keep the needle straight so you do not damage the pen or needle. 
Iglo držite naravnost, da ne boste poškodovali injekcijskega peresnika ali igle.
LUSDUNA should not be administered intravenously. 
Zdravila LUSDUNA se ne sme uporabljati intravensko.
Medication errors have been reported in which other insulins, particularly short-acting insulins, have been accidentally administered instead of insulin glargine. 
Poročali so o napakah pri uporabi zdravila, pri katerih so bili namesto insulina glargin pomotoma aplicirani drugi insulini, zlasti kratkodelujoči.
In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high. 
V vsakem primeru bo morda potrebna prilagoditev odmerka insulina, da bi preprečili previsoko ali prenizko koncentracijo krvnega sladkorja.
The pen contains a total of 300 units. 
Injekcijski peresnik vsebuje skupaj 300 enot.
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise hypoglycaemia. 
Antagonisti adrenergičnih receptorjev beta lahko, tako kot druga simpatikolitična zdravila (na primer klonidin, gvanetidin in reserpin), oslabijo ali povsem preprečijo prve opozorilne simptome za prepoznavanje hipoglikemije.
How to handle Nexvue Nexvue is a pre-filled disposable pen containing insulin glargine. 
Ravnanje s peresnikom Nexvue Nexvue je napolnjen injekcijski peresnik, ki vsebuje insulin glargin.
• Always perform the safety test before each injection. 
• Pred vsakim injiciranjem vedno opravite varnostni preizkus.
Safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older. 
Varnost in učinkovitost insulina glargin sta bili dokazani pri mladostnikih in otrocih, starih 2 leti ali več.
Safety and efficacy of insulin glargine have not been established in children below the age of 2 years. 
Varnost in učinkovitost insulina glargin pri otrocih, mlajših od 2 let, nista bili dokazani.
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes. 
V klinični študiji so bili simptomi hipoglikemije in protiregulacijski hormonski odzivi po intravenski uporabi insulina glargin in človeškega insulina pri zdravih prostovoljcih in bolnikih s sladkorno boleznijo tipa 1 podobni.
Insert the needle Simply insert the needle fully into the skin. 
Iglo enostavno do konca zabodite v kožo.
To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with LUSDUNA should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment. 
Da bi zmanjšali tveganje za nočne in zgodnje jutranje hipoglikemije, je treba pri bolnikih, ki spreminjajo shemo zdravljenja z bazalnim insulinom tako, da z insulina NPH dvakrat na dan preidejo na zdravilo LUSDUNA enkrat na dan, v prvih tednih zdravljenja zmanjšati dnevni odmerek bazalnega insulina za 20 do 30 %.
To reduce the risk of hypoglycaemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/mL to a once daily regimen with LUSDUNA should reduce their dose by approximately 20%. 
Da bi zmanjšali tveganje za hipoglikemijo, je treba bolnikom, ki spreminjajo shemo zdravljenja z bazalnim insulinom tako, da z insulina glargin 300 enot/ml enkrat na dan preidejo na zdravilo LUSDUNA enkrat na dan, zmanjšati odmerek za približno 20 %.
The use of LUSDUNA may be considered during pregnancy, if clinically needed. 
Če je klinično potrebno, se lahko razmisli o uporabi zdravila LUSDUNA med nosečnostjo.
• Skin and allergic reactions at the injection site These signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. 
• Kožne in alergijske reakcije na mestu injiciranja Znaki lahko vključujejo pordelost, nenavadno močno bolečino pri injiciranju, srbenje, koprivnico, oteklino ali vnetje.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone (oral anti-diabetic medicine used to treat type 2 diabetes mellitus) and insulin experienced the development of heart failure. 
Pri nekaterih bolnikih z dolgotrajno sladkorno boleznijo tipa 2 in boleznijo srca ali predhodno možgansko kapjo, ki so se zdravili s pioglitazonom (peroralno zdravilo za zdravljenje sladkorne bolezni tipa 2) in insulinom, se je pojavilo srčno popuščanje.
Also, be sure to remove the needle before disposing of the pen. 
Prav tako pazite, da boste iglo odstranili, preden injekcijski peresnik zavržete.
Place a new sterile needle, two alcohol swabs and a pen on a clean, dry surface. 
Na čisto, suho površino položite novo sterilno iglo, dva alkoholna zloženca in injekcijski peresnik.
Double-check your dose! 
Ponovno preverite odmerek!
Before you inject, make sure that the dose window is facing you. 
Pred injiciranjem poskrbite, da bo okence odmerka obrnjeno proti vam.
- in whom glycaemic control is markedly improved, - who have experienced recurrent and/or recent events of hypoglycaemia, - in whom hypoglycaemia develops gradually, - who are elderly, - after transfer from animal insulin to human insulin, - in whom an autonomic neuropathy is present, - with a long history of diabetes, - suffering from a psychiatric illness, - receiving concurrent treatment with certain other medicinal products (see section 4.5). 
- pri katerih je urejenost glikemije občutno izboljšana, - ki so imeli ponavljajoče se in/ali nedavne hipoglikemije, - pri katerih se hipoglikemija razvije postopoma, - ki so starejši, - ki preidejo z živalskega na humani insulin, - ki imajo avtonomno nevropatijo, - ki imajo dolgo anamnezo sladkorne bolezni, - ki imajo kakšno psihiatrično bolezen, - ki sočasno prejemajo določena druga zdravila (glejte poglavje 4.5).
Insulin receptor binding: In vitro studies indicate that the affinity of insulin glargine and its metabolites M1 and M2 for the human insulin receptor is similar to the one of human insulin. 
Vezava na insulinske receptorje: Študije in vitro kažejo, da je afiniteta insulina glargin in njegovih presnovkov M1 in M2 za človeške insulinske receptorje podobna afiniteti humanega insulina.
If you need help deciding how to divide your dose, ask your doctor or nurse. 
Če potrebujete pomoč pri tem, kako razdeliti odmerek, se posvetujte z zdravnikom ali medicinsko sestro.
Press the injection button all the way in while pointing the needle up into the air. 
Pritisnite gumb za injiciranje povsem do konca, medtem ko je igla obrnjena navzgor.
If you dial the wrong dose, just dial backwards until the correct number lines up with the black line on the window. 
Če nastavite napačen odmerek, preprosto zavrtite gumb za nastavitev nazaj, dokler se pravo število odmerka ne poravna s črno črto na okencu.
If you use more LUSDUNA than you should - If you have injected too much LUSDUNA, your blood sugar level may become too low (hypoglycaemia). 
Če ste uporabili večji odmerek zdravila LUSDUNA, kot bi smeli - Če ste si injicirali preveč zdravila LUSDUNA, se vam koncentracija krvnega sladkorja lahko preveč zniža (hipoglikemija).
What LUSDUNA looks like and contents of the pack LUSDUNA 100 units/mL solution for injection in a pre-filled pen is a clear and colourless solution. 
Izgled zdravila LUSDUNA in vsebina pakiranja Zdravilo LUSDUNA 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku je bistra in brezbarvna raztopina.
An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
- The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (for pH adjustment) (see section 2 “Important information about some of the ingredients of LUSDUNA”), hydrochloric acid (for pH adjustment) and water for injections. 
- Druge sestavine so: cinkov klorid, metakrezol, glicerol, natrijev hidroksid (za uravnavanje pH) (glejte poglavje 2, "Pomembne informacije o nekaterih sestavinah zdravila LUSDUNA"), klorovodikova kislina (za uravnavanje pH) in voda za injekcije.
Instead, regular insulin administered intravenously is recommended in such cases. 
V takšnih primerih je priporočena intravenska uporaba običajnega insulina.
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet. 
Če dojite, se posvetujte z zdravnikom, saj bo morda potrebna prilagoditev odmerkov insulina in prehrane.
A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens. 
Izrazita sprememba glikemične urejenosti lahko prehodno okvari vid zaradi prehodno spremenjenega turgorja in lomnega količnika leče.
Simply re-cap the pen, and store it without the needle for your next injection. 
Preprosto pokrijte injekcijski peresnik z njegovim pokrovčkom in ga brez igle shranite za naslednje injiciranje.
LUSDUNA contains insulin glargine, an insulin analogue, and has a prolonged duration of action. 
Zdravilo LUSDUNA vsebuje insulin glargin, insulinski analog, in ima podaljšan čas delovanja.
Shelf-life after removing the pen from the refrigerator 
Rok uporabnosti po odstranitvi peresnika iz hladilnika
If you forget to use LUSDUNA - If you have missed a dose of LUSDUNA or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). 
Če ste pozabili uporabiti zdravilo LUSDUNA: - Če ste izpustili odmerek zdravila LUSDUNA ali če si niste injicirali dovolj insulina, se vam koncentracija krvnega sladkorja lahko preveč zviša (hiperglikemija).
In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. 
Pri bolnikih z okvaro jeter se potreba po insulinu lahko zmanjša zaradi zmanjšane zmožnosti za glukoneogenezo in zmanjšane presnove insulina.
Figure 1 above shows the activity profiles over time of insulin glargine and NPH insulin. 
Slika 1 prikazuje časovni potek delovanja insulina glargin in insulina NPH.
Don't use your pen after the expiration date. 
Injekcijskega peresnika ne uporabljajte po izteku datuma roka uporabnosti.
Switch from insulin glargine 300 units/mL to LUSDUNA 
Prehod z insulina glargin 300 enot/ml na zdravilo LUSDUNA
Multipack: 10 (2 packs of 5) pre-filled pens of 3 mL. 
Multi pakiranje: 10 (2 pakiranji po 5) napolnjenih injekcijskih peresnikov s 3 ml.