FrancophonIA/ELRC3.0 huggingface dataset:
English: The target audience and the modalities for distribution all of these materials are to be agreed at Member State level.
Slovenian: Dogovori o ciljni skupini in načinih distribucije vseh teh gradiv bodo sklenjeni na ravni države članice.
English: Do not expose to excessive heat or direct sunlight.
Slovenian: Ne izpostavljajte čezmerni vročini ali neposredni sončni svetlobi.
English: This might just be for the first injection or it may be a gradual change over several weeks or months.
Slovenian: To lahko velja le za prvo injekcijo ali pa bo šlo za postopno spremembo skozi več tednov ali celo mesecev.
English: You may give an infection to them or get an infection from them.
Slovenian: S tem bi jim lahko prenesli okužbo ali pa bi dobili okužbo od njih.
English: Are you exercising more than usual?
Slovenian: − Ali ste telesno dejavnejši kot običajno?
English: The insulin should look evenly mixed.
Slovenian: Insulin mora biti videti enakomerno premešan.
English: • Always carry sugar with you.
Slovenian: • S seboj imejte vedno tudi nekaj sladkorja.
English: He will only do this under special circumstances such as surgery or if you are ill and your glucose levels are too high.
Slovenian: To bo naredil samo v posebnih okoliščinah, kot je operacijski poseg ali če ste bolni in so vaše ravni glukoze previsoke.
English: The symptoms are as follows:
Slovenian: Simptomi so naslednji:
English: (Needles are not included).
Slovenian: (Igle niso priložene.)
English: - Your Needle may be blocked.
Slovenian: - morda je vaša igla zamašena.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Viala Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: Therefore the amount of insulin needed may change.
Slovenian: Zato se količina potrebnega insulina lahko spremeni.
English: The patient communication should address the following key elements:
Slovenian: Informacije za bolnike morajo zajemati naslednje ključne elemente:
English: The first symptoms come on slowly over many hours or days.
Slovenian: Prvi simptomi se pojavijo postopoma v več urah ali celo dnevih.
English: The first symptoms of low blood sugar usually come on quickly and include the following: • tiredness
Slovenian: Prvi simptomi nizkega krvnega sladkorja se običajno pojavijo hitro in vključujejo naslednje:
English: This pen is designed to allow you to give more doses than other pens you may have used in the past.
Slovenian: Ta peresnik je zasnovan tako, da omogoča dajanje večjega števila odmerkov kot drugi peresniki, ki ste jih morda uporabljali v preteklosti.
English: The distance between each mark on the gauge is about 20 units.
Slovenian: Razdalja med dvema oznakama na merilu je približno 20 enot.
English: It is a changed form of human insulin and so is different from other human and animal insulins.
Slovenian: Gre za spremenjeno obliko humanega insulina, ki se razlikuje od drugih humanih in živalskih insulinov.
English: In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues.
Slovenian: Poleg tega ima insulin številne anabolične in antikatabolične učinke na različna tkiva.
English: Patients must be educated to use the proper injection techniques.
Slovenian: Bolnike je treba naučiti uporabe pravilnih metod injiciranja.
English: Even when you are not eating normally, you still need insulin.
Slovenian: Tudi če jeste manj kot običajno, še vedno potrebujete insulin.
English: See section 6.2.
Slovenian: Glejte poglavje 6.2.
English: Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
Slovenian: Odmerjanje bo morda treba prilagoditi tudi, če bolnik poveča telesno dejavnost ali spremeni običajni način prehrane.
English: If mixing insulins, refer to the instructions for mixing that follow in Section (ii) and 6.2.
Slovenian: Če insuline mešate, glejte navodila za mešanje, ki sledijo v poglavju (ii) in 6.2.
English: If not, repeat the above procedure until contents are mixed.
Slovenian: Če ni takega videza, ponavljajte zgoraj opisani postopek, dokler sestavine niso zmešane.
English: Severe symptoms are heavy breathing and a rapid pulse.
Slovenian: Hudi simptomi so težko dihanje in hitro bitje srca.
English: Warning signs are listed in section 4 of this leaflet.
Slovenian: Opozorilni znaki so našteti v poglavju 4 teh navodil.
English: Document Revision Date:
Slovenian: Datum revizije dokumenta:
English: Mixing is important to make sure you get the right dose.
Slovenian: Mešanje je pomembno za zagotovitev pravilnega odmerka.
English: Glucose Infusion Rate (mg/min)
Slovenian: Hitrost infuzije glukoze (mg/min)
English: Speak to your doctor if this applies to you.
Slovenian: Posvetujte se z zdravnikom, če to velja za vas.
English: Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death.
Slovenian: Huda hipoglikemija lahko vodi v izgubo zavesti, v skrajnih primerih pa celo v smrt.
English: General information about the safe and effective use of your pen
Slovenian: Splošne informacije o varni in učinkoviti uporabi vašega peresnika
English: But your doctor will have told you exactly how much to use, when to use it, and how often.
Slovenian: Zdravnik vam bo povedal, natančno koliko zdravila potrebujete, kdaj ga uporabite in kako pogosto.
English: Frequent monitoring of the blood glucose levels is required.
Slovenian: Potrebno je pogosto spremljanje ravni glukoze v krvi.
English: Ask your doctor to tell you about glucagon.
Slovenian: Zdravnika prosite, naj vam pove kaj več o glukagonu.
English: • The amount of insulin you need may also change if you drink alcohol.
Slovenian: • Količina potrebnega insulina se lahko spremeni tudi, če pijete alkoholne pijače.
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano {MM/YYYY}.
English: Speak to your doctor if you need to inject your insulin by another method.
Slovenian: Pogovorite se s svojim zdravnikom, če si morate insulin injicirati na drug način.
English: It is recommended that the system is primed before starting the infusion to the patient.
Slovenian: Priporočeno je, da se sistem pred začetkom infundiranja bolniku pripravi.
English: • cold sweat.
Slovenian: • hladen znoj.
English: 2 units.
Slovenian: 20 enot.
English: • Always use a new Needle for each injection to help prevent infections and blocked Needles.
Slovenian: • Vedno uporabite novo iglo za vsako injiciranje, da boste pomagali preprečiti okužbe in zamašenost igle.
English: In one clinical study there was a small (0.38 mmol/l) increase in blood glucose levels at night (3a.m.
Slovenian: V eni klinični študiji je bil majhen (0.38 mmol/l) porast ravni glukoze merjene ponoči (3:00 zjutraj).
English: In some studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime hypoglycaemia.
Slovenian: V nekaterih študijah je bilo znižanje števila nočnih hipoglikemij povezano s povišanjem števila dnevnih hipoglikemij.
English: • eating a lot more than your diet allows; or
Slovenian: •pojedli ste veliko več, kot predpisuje vaša dieta; ali
English: • You will set the dose to 1 or 2 units.
Slovenian: • Odmerek boste nastavili na 1 ali 2 enoti.
English: This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Slovenian: To je še posebno pomembno pri tistih, ki se manj ali sploh ne zavedajo opozorilnih znakov hipoglikemije ali imajo pogoste hipoglikemije.
English: Subcutaneous and intravenous use
Slovenian: Za subkutano in intravensko uporabo
English: ATC Code: A10A D04.
Slovenian: Oznaka ATC: A10A D04.
English: Do not put it near heat or in the sun.
Slovenian: Ne puščajte ga v bližini virov toplote ali na soncu.
English: It will not affect your dose.
Slovenian: Ta kapljica ne bo vplivala na vaš odmerek.
English: You should contact your doctor about the advisability of driving if you have:
Slovenian: Z zdravnikom se morate pogovoriti, ali je za vas sploh priporočljivo, da vozite motorno vozilo, če imate:
English: • Your healthcare professional will tell you how many units to give as your dose and how to inject your prescribed dose of insulin.
Slovenian: • Zdravnik vam bo povedal, koliko enot zdravila potrebujete za svoj odmerek in kako si injicirate svoj predpisani odmerek insulina.
English: Haemoglobin A1c -Reduction
Slovenian: Hemoglobin A1c - zmanjšanje1
English: Clinical trials have been performed in children (61 patients aged 2 to 11) and children and adolescents (481 patients aged 9 to 19 years), comparing insulin lispro to human soluble insulin.
Slovenian: Klinična preskušanja so izvajali pri otrocih (61 bolnikov, starih od 2 do 11 let) ter pri otrocih in mladostnikih (481 bolnikov, starih od 9 do 19 let) in primerjali insulin lispro s topnim humanim insulinom.
English: • You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.
Slovenian: • Svojega zdravnika, farmacevta ali medicinsko sestro v diabetološki ambulanti obvestite tudi, če načrtujete potovanje v tujino.
English: • Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept in the refrigerator.
Slovenian: • Neuporabljene peresnike lahko uporabite do roka uporabnosti, ki je natisnjen na oznaki, če je bil peresnik shranjen v hladilniku.
English: Storing your Pen Unused Pens
Slovenian: Shranjevanje vašega peresnika Neuporabljeni peresniki
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavnih delov večjega pakiranja ni mogoče prodajati posamično.
English: • When prescribing, to ensure that the correct strength is mentioned on the prescription
Slovenian: • Ob predpisovanju je treba zagotoviti, da je na receptu navedena pravilna jakost.
English: Are you pregnant or thinking about becoming pregnant, or are you breast-feeding?
Slovenian: Ali ste noseči, načrtujete nosečnost oz. ali dojite?
English: If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink.
Slovenian: Če vam krvni sladkor upade (blaga hipoglikemija), pojejte nekaj tablet glukoze, malo sladkorja ali popijte sladkano pijačo.
English: Alcohol and some medicines can affect your blood sugar levels (see section 2).
Slovenian: Na raven sladkorja v vaši krvi lahko vplivajo alkohol in nekatera zdravila (glejte poglavje 2).
English: Do you have trouble with your kidneys or liver?
Slovenian: − Imate težave z ledvicami ali jetri?
English: Before use 3 years.
Slovenian: Pred prvo uporabo 3 leta.
English: This condition usually resolves in a few days to a few weeks.
Slovenian: Takšno stanje običajno mine v nekaj dneh do nekaj tednih.
English: Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin.
Slovenian: Sistemska alergijska reakcija Sistemska alergijska reakcija, ki je redka, a potencialno nevarnejša, je generalizirana alergija na insulin.
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Slovenian: Bolnikom je treba svetovati, naj upoštevajo varnostne ukrepe za preprečevanje hipoglikemije med vožnjo.
English: • Always carry something to show you are diabetic.
Slovenian: • Vedno nosite s seboj nekaj, kar bo pokazalo, da ste sladkorni bolnik.
English: Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Slovenian: Morda bosta potrebna vzdrževan vnos ogljikovih hidratov in opazovanje, ker se lahko hipoglikemija po navideznem kliničnem okrevanju ponovno pojavi.
English: Cartridges contain a small glass bead to assist mixing.
Slovenian: Vložki vsebujejo majhno stekleno kroglico, ki je v pomoč pri mešanju.
English: Now inject air into the Liprolog vial in the same manner, but do not withdraw the needle.
Slovenian: Zdaj injicirajte zrak v vialo zdravila Liprolog na enak način, vendar ne izvlecite igle.
English: The patient should discard the needle after every injection.
Slovenian: Bolnik mora po vsakem injiciranju zavreči iglo.
English: The reduction of HbA1c would also be expected with other insulin products e.g. soluble or isophane insulins.
Slovenian: Znižanje HbA1c bi pričakovali tudi pri drugih pripravkih insulina, npr. pri topnem ali izofan insulinu.
English: and how often.
Slovenian: kdaj ga uporabite in kako pogosto.
English: Patients with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.
Slovenian: Bolnicam z diabetesom je treba svetovati, naj obvestijo svojega zdravnika, če zanosijo ali načrtujejo zanositev.
English: The dosage should be determined by the physician, according to the requirement of the patient.
Slovenian: Odmerjanje naj določi zdravnik glede na potrebe bolnika.
English: - If you still do not think you received the full amount you dialled for your injection, do not start over or repeat that injection.
Slovenian: - Če še vedno menite, da niste prejeli celotnega odmerka, ki ste ga odmerili, ne začenjajte znova in ne ponavljajte te injekcije.
English: Push the Dose Knob in until it stops, and “0” is seen in the Dose Window.
Slovenian: Gumb za odmerjanje pritiskajte navznoter, dokler se ne zaustavi in v okencu za odmerjanje ne zagledate številke »0«.
English: The half units (0.5 units) are shown as lines between the numbers.
Slovenian: Polovične enote (0,5 enote) so prikazane kot črtice med številkami.
English: The Dose Indicator should line up with your dose.
Slovenian: Kazalnik odmerkov se mora poravnati z vašim odmerkom.
English: • The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
Slovenian: • Navodila za ravnanje z iglami niso namenjena temu, da bi nadomestila lokalne smernice, smernice zdravstvenih delavcev ali ustanov.
English: Insulin lispro is made in the laboratory by a ‘recombinant DNA technology' process.
Slovenian: Insulin lispro izdelajo v laboratoriju z uporabo postopka ‘tehnologije rekombinantne DNA'.
English: If using a new vial, flip off the plastic protective cap, but do not remove the stopper.
Slovenian: Če uporabite novo vialo, snemite plastični zaščitni pokrovček, ne odstranite pa zamaška.
English: The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months.
Slovenian: Količina insulina, ki ga potrebujete običajno v prvih treh mesecih nosečnosti upade, v naslednjih šestih mesecih pa se poveča.
English: Immune system disorders Local allergy
Slovenian: Bolezni imunskega sistema Lokalna alergijska reakcija
English: Use of the injection sites should be rotated so that the same is not used more than approximately once a month.
Slovenian: Mesta injiciranja je treba menjati, tako da istega ne uporabite več kot približno enkrat na mesec.
English: The needed dose is dialled in units.
Slovenian: Potrebni odmerek se nastavi v enotah.
English: • Check the Pen to make sure you are taking the right type of insulin.
Slovenian: • Preverite injekcijski peresnik, da se boste prepričali, da jemljete pravo vrsto insulina.
English: If there is not enough for your dose, change the cartridge.
Slovenian: Če to ne zadostuje za vaš odmerek, zamenjajte vložek.
English: - LIPROLOG suspensions - cloudy insulins - should look white after mixing.
Slovenian: - Suspenzije LIPROLOG - motni insulini - morajo biti po mešanju bele barve.
English: Liprolog Basal has an activity profile that is very similar to that of a basal insulin (NPH) over a period of approximately 15 hours.
Slovenian: Liprolog Basal ima profil delovanja zelo podoben bazalnemu insulinu (NPH) v obdobju približno 15 ur.
English: • danazol (medicine acting on ovulation),
Slovenian: • danazol (zdravilo, ki vpliva na ovulacijo),
English: Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to soluble insulin (30 to 45 minutes before).
Slovenian: Insulin lispro začne delovati hitro (po približno 15 minutah), zato si ga je mogoče dati časovno bliže obroku (0 do 15 minut pred obrokom) v primerjavi s topnim insulinom (30 do 45 minut pred obrokom).
English: In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
Slovenian: V nekaterih primerih je to stanje lahko povezano z drugimi dejavniki in ne z insulinom samim, na primer z dražili v sredstvih za čiščenje kože ali nepravilno tehniko injiciranja.
English: It is not for use in 1.5 ml pens.
Slovenian: Ni namenjen uporabi v 1,5 ml injekcijskih peresnikih.
English: When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as discussed in 5.1).
Slovenian: Za oceno kliničnega pomena te kinetike je bolj primerno upoštevati krivulji utilizacije glukoze (glejte poglavje 5.1).
English: The vial is to be used in conjunction with an appropriate syringe (100 unit markings).
Slovenian: Vialo je treba uporabiti z ustrezno injekcijsko brizgo (oznake 100 enot).
English: Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/newborn.
Slovenian: Podatki zbrani na velikem številu nosečnic ne kažejo na možnost škodljivih vplivov insulina lispro na nosečnost ali zdravje ploda/novorojenca.
English: The number of units are displayed in the dose window, always check this before your injection.
Slovenian: Število enot je prikazano v okencu odmerkov, to morate vedno preveriti, preden si daste injekcijo.
English: • there is a change in your need for insulin; or
Slovenian: •se pri vas spremenijo potrebe po insulinu; ali
English: If you do not respond to glucagon, you will have to go to hospital.
Slovenian: Če vam injiciranje glukagona ni pomagalo, boste morali v bolnišnico.
English: If necessary, Liprolog may also be administered intravenously, for example: for the control of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.
Slovenian: Po potrebi se zdravilo Liprolog lahko injicira tudi intravensko, na primer za nadzor ravni glukoze v krvi med ketoacidozo, med akutno boleznijo ali med operacijami in po njih.
English: Insulins have no specific overdose definitions because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes.
Slovenian: Za insulinske pripravke nimamo specifične opredelitve prevelikega odmerjanja, ker so serumske koncentracije glukoze rezultat kompleksnih medsebojnih vplivov med ravnmi insulina, razpoložljivostjo glukoze in drugimi presnovnimi procesi.
English: Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more rapid and of a shorter duration.
Slovenian: Za insulin lispro je bilo dokazano, da je na molarni osnovi enako močan kot humani insulin, a je njegov učinek hitrejši in bolj kratkotrajen.
English: Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
Slovenian: Mesta injiciranja je treba menjati, tako da istega mesta ne uporabimo večkrat kot približno enkrat mesečno.
English: • Additional risk minimisation measures (Liprolog 200 units/ml)
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj (Liprolog 200 enot/ml)
English: • somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too much growth hormone),
Slovenian: • analoge somatostatina (npr. oktreotid, ki se uporablja za zdravljenje redke bolezni, pri kateri proizvajate preveč rastnega hormona),
English: Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
Slovenian: Hipoglikemija lahko nastopi kot posledica čezmernega delovanja insulina glede na vnos hrane in porabo energije.
English: Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose.
Slovenian: Ne stresajte močno, ker lahko to povzroči penjenje, ki lahko ovira pravilno odmerjanje odmerka.
English: • It is normal to see a small amount of insulin left in the Pen that you can not inject.
Slovenian: • Povsem normalno je, da v peresniku vidite majhno količino preostalega insulina, ki ga ni mogoče vbrizgati.
English: Your insulin needs may change if you are taking
Slovenian: Vaše potrebe po insulinu se lahko spremenijo, če jemljete
English: • you have an infection or illness (especially diarrhoea or vomiting);
Slovenian: •imate okužbo ali zbolite (še posebej driska ali bruhanje);
English: • you have trouble with your kidneys or liver which gets worse.
Slovenian: •imate težave z ledvicami ali jetri in se stanje poslabša.
English: • Do not use your Pen past the expiration date printed on the Label or for more than 28 days after you first start using the Pen.
Slovenian: • Ne uporabljajte svojega peresnika po preteku roka uporabnosti, ki je natisnjen na oznaki, ali več kot 28 dni po prvi uporabi.
English: • Throw away the Pen you are using after 28 days, even if it still has insulin left in it.
Slovenian: • Peresnik, ki ga uporabljate, zavrzite po 28 dneh, tudi če je v njem še insulin.
English: You should never mix Liprolog with insulins produced by other manufacturers or animal insulins.
Slovenian: Nikoli pa ne smete mešati zdravila Liprolog z insulini drugih izdelovalcev ali z živalskimi insulini.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJE
English: • you exercise or work too hard just before or after a meal;
Slovenian: •ste telesno preveč dejavni ali preveč delate tik pred obrokom ali po njem;
English: • Do not use your Pen if any part looks broken or damaged.
Slovenian: • Ne uporabljajte peresnika, če je kateri koli njegov del videti zlomljen ali okvarjen.
English: The Junior KwikPen is blue.
Slovenian: Peresnik Junior KwikPen je modre barve.
English: Step 2: (For LIPROLOG suspensions cloudy insulins only)
Slovenian: Korak 2: (samo za motne insuline v suspenziji LIPROLOG)
English: How to recognize your KwikPen:
Slovenian: Kako prepoznati svoj peresnik KwikPen:
English: 0.63 units/kg
Slovenian: 0,63 enote/kg
English: • Check the appearance of the insulin.
Slovenian: • Preverite videz insulina.
English: • If you need to inject more than the number of units left in the Pen, you may either:
Slovenian: • Če si morate injicirati večje število enot, kot vam jih je še ostalo v peresniku, lahko bodisi:
English: Patients using vials must never share needles or syringes.
Slovenian: Bolniki, ki uporabljajo viale, si ne smejo deliti igel ali brizg med seboj.
English: The MAH shall ensure that healthcare professionals are informed that all patients who have been prescribed Liprolog should be trained on the correct use of the pre-filled pen before prescribing or dispensing Liprolog.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo zdravstveni delavci obveščeni, da morajo biti vsi bolniki, ki jim je bilo predpisano zdravilo Liprolog, usposobljeni za pravilno uporabo napolnjenega peresnika, preden jim bo zdravilo Liprolog predpisano ali izdano.
English: It may cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating.
Slovenian: Povzroči lahko izpuščaj po vsem telesu, težko dihanje, piskanje v pljučih, padec krvnega tlaka, tahikardijo ali znojenje.
English: • Key features of the design of the package and pre-filled pen device
Slovenian: • Ključne lastnosti zasnove pakiranja in napolnjenega peresnika.
English: • KwikPen containing your insulin
Slovenian: • peresnik KwikPen, ki vsebuje vašo vrsto insulina
English: • Your doctor will tell you if you have to mix Liprolog with one of the human insulins.
Slovenian: • Zdravnik vam bo povedal, ali morate zdravilo Liprolog mešati s katerim od humanih insulinov.