FrancophonIA/ELRC3.0 huggingface dataset:
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000) and not known: cannot be estimated from the available data).
Slovenian: Naslednji povezani neželeni učinki, ugotovljeni v kliničnih raziskavah, so navedeni spodaj po organskih sistemih in razvrščeni po padajoči pogostnosti zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000), ne znana pogostost (pogostosti ni mogoče oceniti na podlagi podatkov, ki so na voljo).
English: • This pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the pen.
Slovenian: • Ni priporočljivo, da bi slepe ali slabovidne osebe ta peresnik uporabljale brez pomoči nekoga, ki je usposobljen za njegovo uporabo.
English: • If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
Slovenian: • Če vam injekcijo daje kdo drug, ali če vi dajete injekcijo komu drugemu, je pri odstranjevanju in odlaganju igle potrebna posebna previdnost.
English: While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.
Slovenian: Dokler niste prepričani, da lahko prepoznate opozorilne simptome, se izogibajte okoliščinam (npr. vožnji avtomobila), v katerih bi zaradi hipoglikemije ogrozili sebe ali druge.
English: • you exercise or work too hard just before or after a meal;
Slovenian: • če ste telesno preveč dejavni ali preveč delate tik pred obrokom ali po njem,
English: • angiotensin II receptor blockers.
Slovenian: • blokatorje receptorjev angiotenzina II.
English: Severe cases of generalised allergy may be life-threatening.
Slovenian: Hudi primeri generalizirane alergije so lahko smrtno nevarni.
English: • rash over the whole body
Slovenian: • izpuščaj po vsem telesu
English: Subcutaneous and intravenous use
Slovenian: subkutana in intravenska uporaba
English: Severe symptoms are heavy breathing and a rapid pulse.
Slovenian: Huda simptoma sta težko dihanje in hitro bitje srca.
English: It works more quickly than normal human insulin because the insulin molecule has been changed slightly.
Slovenian: Deluje hitreje kakor običajni humani insulin, ker je molekula insulina v njem nekoliko spremenjena.
English: Three simple steps to avoid hypoglycaemia or hyperglycaemia are:
Slovenian: Trije preprosti koraki za preprečevanje hipoglikemije ali hiperglikemije so:
English: Wipe the top of the vial with an alcohol swab.
Slovenian: Vrh viale obrišite z alkoholnim lističem.
English: • using less insulin than your doctor tells you to;
Slovenian: • uporabili ste manj insulina, kot vam je predpisal zdravnik,
English: Store below 30°C and protect from direct heat and light.
Slovenian: Shranjujte pri temperaturi do 30°C in zaščiteno pred neposredno toploto ali svetlobo.
English: In some studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime hypoglycaemia.
Slovenian: V nekaterih študijah je bilo zmanjšanje števila nočnih hipoglikemij povezano z večjim številom dnevnih hipoglikemij.
English: • blood pressure dropping
Slovenian: • padec krvnega tlaka
English: After injection, the site of injection should not be massaged.
Slovenian: Po injiciranju se mesta injiciranja ne sme masirati.
English: Choose a site for injection.
Slovenian: Izberite mesto za injiciranje.
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 insulinih, npr. pri topnem ali izofanem insulinu.
English: This can be caused if:
Slovenian: To se lahko pojavi:
English: Patients with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.
Slovenian: Bolnicam s sladkorno boleznijo je treba svetovati, naj obvestijo svojega zdravnika, če zanosijo ali načrtujejo zanositev.
English: The typical activity profile following subcutaneous injection is illustrated below.
Slovenian: Značilni profil delovanja po subkutanem injiciranju je prikazan spodaj.
English: Illness
Slovenian: Bolezen
English: Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Slovenian: Čim prej obvestite svojega zdravnika, če se vam pojavijo znaki srčnega popuščanja, npr. nenavadno kratka sapa, hitro povečanje telesne teže ali lokalizirano otekanje (edem).
English: • sulpha antibiotics,
Slovenian: • sulfonamidne antibiotike,
English: A Choose a place to inject as shown in the picture
Slovenian: A Izberite mesto za injiciranje, kot prikazuje slika.
English: Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death.
Slovenian: Huda hipoglikemija lahko povzroči izgubo zavesti, v skrajnih primerih celo v smrt.
English: If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.
Slovenian: Če imate hipoglikemije pogosto, ali če jih težko prepoznate, se morate o tem posvetovati z zdravnikom.
English: Press the knob.
Slovenian: Pritisnite na gumb.
English: • Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Slovenian: • Upoštevajte priporočene varnostne ukrepe za odstranjevanje in odlaganje igel (obrnite se na zdravnika, farmacevta ali medicinsko sestro), da boste zmanjšali tveganje za naključno poškodbo z iglo in prenos nalezljivih bolezni.
English: Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
Slovenian: Slepim ali slabovidnim bolnikom je treba naročiti, naj vedno poskrbijo za pomoč druge osebe, ki dobro vidi in je usposobljena za uporabo pripomočka za insulin.
English: Systemic allergy
Slovenian: Sistemska alergija
English: • If you cannot select your full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete your dose.
Slovenian: • Če ne morete nastaviti celotnega predpisanega odmerka, uporabite nov peresnik ali injicirajte preostanek enot, nato pa za dokončanje odmerka uporabite nov peresnik.
English: For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Slovenian: Zdravljenje odraslih in otrok s sladkorno boleznijo, ki potrebujejo insulin za vzdrževanje normalne homeostaze glukoze.
English: Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do this.
Slovenian: Zavrzite ga ustrezno - farmacevt ali diabetološka medicinska sestra vam bosta povedala, kako to storiti.
English: Here are some reminders.
Slovenian: Tukaj je nekaj pomembnih opozoril.
English: • a puncture resistant container for used needles and pens (see Throwing your pen away).
Slovenian: • vsebnik za ostre odpadke za uporabljene igle in peresnike (glejte Kako zavreči peresnik).
English: You should only inject it into a muscle if your doctor has told you to.
Slovenian: V mišico ga smete injicirati le, če vam tako naroči zdravnik.
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, piskajoče dihanje, znižanje krvnega tlaka, hiter srčni utrip ali znojenje.
English: These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens (see section 4.2 and 6.6).
Slovenian: Teh vložkov se ne sme uporabljati z nobenim drugim injekcijskim peresnikom za večkratno uporabo, ker je točnost odmerjanja ugotovljena le z navedenimi peresniki (glejte poglavji 4.2 in 6.6).
English: This may damage your pen.
Slovenian: S tem namreč lahko poškodujete peresnik.
English: C Place your thumb on the injection button.
Slovenian: C Položite palec na gumb za injiciranje.
English: This is normal, they will not harm you.
Slovenian: To je normalno in neškodljivo.
English: - if you are allergic to insulin lispro or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na insulin lispro ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
Slovenian: • Če v peresniku ni več dovolj enot insulina za vaš odmerek, se bo izbirnik odmerka ustavil na številu enot, ki so preostale.
English: • You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.
Slovenian: • Zdravnika, farmacevta ali diabetološko medicinsko sestro obvestite tudi, če načrtujete potovanje v tujino.
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 isto mesto ni uporabljeno več kot približno enkrat na mesec.
English: Never share your pen - it is only for you.
Slovenian: Svojega peresnika nikdar ne uporabljajte skupaj s kom drugim - namenjen je le za vašo uporabo.
English: • steroids,
Slovenian: • steroide,
English: • Use a clean needle.
Slovenian: • Uporabite čisto iglo.
English: If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.
Slovenian: Če ste bolni, še posebej, če vam je slabo ali bruhate, se vam lahko potreba po insulinu spremeni.
English: If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or call sanofi-aventis number on the front of this leaflet.
Slovenian: Če imate vprašanja o peresniku ali o sladkorni bolezni, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, ali pokličite številko družbe sanofi-aventis, ki je napisana na sprednji strani tega navodila.
English: • Make sure you have the correct insulin.
Slovenian: • Preverite, da imate pravi insulin.
English: If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema.
Slovenian: Če je uporabljena ta kombinacija, je treba bolnike spremljati glede znakov in simptomov srčnega popuščanja, povečevanja telesne mase in edemov.
English: The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.
Slovenian: Zaradi časovne razlike med državami boste morda morali na potovanjih jesti obroke in si injicirati insulin ob drugem času kot doma.
English: • “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),
Slovenian: • “stimulatorje receptorjev beta2” (na primer ritodrin, salbutamol ali terbutalin),
English: • some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and
Slovenian: • nekatere zaviralce angiotenzinske konvertaze (ACE) (na primer kaptopril, enalapril) ali
English: Use a new pen.
Slovenian: Uporabite nov peresnik.
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc.), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage.
Slovenian: V primeru spremembe jakosti, blagovne znamke (izdelovalca), tipa (navadni, NPH, lente itn.), vrste (živalski, humani, analog humanega insulina) in/ali načina izdelave (z rekombinantno DNA ali z insulinom živalskega izvora) je lahko potrebna sprememba odmerjanja insulina.
English: • If you still find it hard to press in, get a new pen.
Slovenian: • Če gumb še vedno težko pritisnete noter, vzemite nov peresnik.
English: If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top.
Slovenian: Če so prisotni mehurčki, držite injekcijsko brizgo navpično navzgor in trkajte po njej, dokler mehurčki ne splavajo na vrh.
English: The number of units are displayed in the dose window, always check this before your injection.
Slovenian: Število enot je prikazano v odmernem okencu; pred injiciranjem morate to število vedno preveriti.
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: It should be clear and colourless.
Slovenian: Biti mora bistra in brezbarvna.
English: This condition usually resolves in a few days to a few weeks.
Slovenian: Takšno stanje po navadi mine v nekaj dneh do nekaj tednih.
English: If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once.
Slovenian: Če se vam stanje poslabša in postane dihanje plitvo in koža bleda, nemudoma pokličite zdravnika.
English: Mixing of the insulins ahead of time or just before the injection should be on advice of the physician.
Slovenian: Mešanje insulinov vnaprej ali tik pred injiciranjem je treba opraviti po zdravnikovem navodilu.
English: For both, the needed dose is dialled in units.
Slovenian: Pri obeh se potrebni odmerek nastavi v enotah.
English: If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink.
Slovenian: Če imate nizek krvni sladkor (blago hipoglikemijo), zaužijte nekaj tablet glukoze, nekaj sladkorja ali popijte sladko pijačo.
English: Protect your pen from dust and dirt
Slovenian: Zaščitite peresnik pred prahom in umazanijo.
English: • no appetite
Slovenian: • pomanjkanje apetita
English: B Push the needle into your skin as shown by your doctor, pharmacist or nurse.
Slovenian: B Zabodite iglo v kožo, kot vam je pokazal zdravnik, farmacevt ali medicinska sestra.
English: • If no insulin comes out after the third time, the needle may be blocked.
Slovenian: • Če tudi tretjič ne priteče nič insulina, je igla morda zamašena.
English: The symptoms include the following:
Slovenian: Med simptomi so:
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/new-born.
Slovenian: Podatki o velikem številu izpostavljenih nosečnosti ne kažejo neželenih učinkov insulina lispro na nosečnost ali zdravje ploda ali novorojenčka.
English: If using a new vial, flip off the plastic protective cap, but do not remove the stopper.
Slovenian: Če uporabljate novo vialo, snemite plastični zaščitni pokrovček, ne odstranite pa zamaška.
English: • Do not touch the injection button yet
Slovenian: • Ne dotikajte se še gumba za injiciranje.
English: Learn to inject
Slovenian: Naučite se injicirati
English: Insulin requirements usually fall during the first trimester and increase during the second and third trimesters.
Slovenian: Potreba po insulinu se po navadi zmanjša v prvem trimesečju nosečnosti in se poveča v drugem in tretjem trimesečju.
English: The symptoms are as follows:
Slovenian: Simptomi so:
English: It is not for use in 1.5 ml pens.
Slovenian: Ni namenjen uporabi v 1,5-ml injekcijskih peresnikih.
English: Use the correct reservoir and catheter for the pump.
Slovenian: Uporabite ustrezen rezervoar in kateter za črpalko.
English: Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Slovenian: Nekorigirane hipoglikemije ali hiperglikemije lahko povzročijo izgubo zavesti, komo ali smrt.
English: Transferring a patient to another type or brand of insulin Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Slovenian: Prehod bolnika na drugo vrsto ali blagovno znamko insulina Prehod bolnika na drugo vrsto ali blagovno znamko insulina mora potekati pod strogim zdravniškim nadzorom.
English: After injecting
Slovenian: Po injiciranju
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 dražečimi snovmi v sredstvih za čiščenje kože ali s slabo tehniko injiciranja.
English: Acute, one month and twelve month toxicology studies produced no significant toxicity findings.
Slovenian: Študije akutne toksičnosti, toksičnosti po enem mesecu uporabe in toksičnosti po dvanajstih mesecih uporabe niso pokazale pomembne toksičnosti.
English: Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
Slovenian: Hipoglikemija se lahko pojavi zaradi prekomernega delovanja insulina glede na vnos hrane in porabo energije.
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 regular insulin (30 to 45 minutes before).
Slovenian: Insulin lispro začne delovati hitro (po približno 15 minutah), zato ga je mogoče injicirati bliže obroku (0 do 15 minut pred obrokom) kot navadni insulin (od 30 do 45 minut pred obrokom).
English: Local allergy is common (may affect up to 1 in 10 people).
Slovenian: Lokalna alergija je pogosta (pojavi se lahko pri do 1 od 10 oseb).
English: A Check the name and expiration date on the label of your pen.
Slovenian: A Preverite ime in datum izteka uporabnosti na nalepki peresnika.
English: • Ask for help if you have problems handling the pen, for example if you have problems with your sight.
Slovenian: • Če imate pri ravnanju s peresnikom težave (na primer če imate težave z vidom), prosite za pomoč.
English: Special populations Renal impairment
Slovenian: Posebne populacije bolnikov Okvara ledvic
English: Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people).
Slovenian: Lipodistrofija (zadebelitev ali vdolbina v koži) je občasen neželen učinek (pojavi se lahko pri do 1 od 100 oseb).
English: It is recommended that the system is primed before starting the infusion to the patient.
Slovenian: Sistem je pred začetkom infundiranja bolniku priporočljivo pripraviti za uporabo.
English: • the contraceptive pill,
Slovenian: • kontracepcijske tablete,
English: Systemic allergy is rare (may affect up to 1 in 1,000 people).
Slovenian: Sistemska alergija je redka (pojavi se lahko pri do 1 od 1.000 oseb).
English: • difficulty in breathing
Slovenian: • težko dihanje
English: • nervousness or shakiness
Slovenian: • živčnost ali tresavica
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek; to pomeni, da je praktično "brez natrija".
English: Patients must visually verify the dialled units on the dose counter of the pen.
Slovenian: Bolniki morajo s pregledom preveriti nastavljeno število enot na števcu odmerkov peresnika.
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 insuline ni specifične opredelitve prevelikega odmerjanja, ker je koncentracija glukoze v serumu posledica zapletenih medsebojnih delovanj med ravnjo insulina, razpoložljivostjo glukoze in drugimi presnovnimi procesi.
English: • Never use your pen after the expiration date.
Slovenian: • Peresnika nikoli ne uporabljajte po datumu izteka roka uporabnosti.
English: If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
Slovenian: Če je bolnik komatozen, je treba glukagon dati intramuskularno ali subkutano.
English: Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Slovenian: Potrebno je lahko dolgotrajnejše uživanje ogljikovih hidratov in opazovanje, kajti hipoglikemija se lahko po navideznem kliničnem izboljšanju ponovi.
English: B Turn the dose selector until the dose pointer lines up with your dose.
Slovenian: B Zavrtite izbirnik odmerka, dokler kazalnik odmerka ni nastavljen na vaš odmerek.
English: If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids (dehydration), unconsciousness, coma or even death (see Hypoglycaemia and Hyperglycaemia and diabetic ketoacidosis in section 4 “Possible Side Effects”).
Slovenian: Nezdravljena hipoglikemija (nizek krvni sladkor) ali hiperglikemija (visok krvni sladkor) je lahko zelo resna: povzroči lahko glavobol, slabost (siljenje na bruhanje), izgubo tekočine (dehidracijo), nezavest, komo ali celo smrt (glejte Hipoglikemija ter Hiperglikemija in diabetična ketoacidoza v poglavju 4, "Možni neželeni učinki").
English: Your doctor or clinic will tell you how to do this.
Slovenian: Zdravnik ali osebje v diabetološki ambulanti vam bodo povedali, kako to narediti.
English: In a double-blind, crossover study, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentage points with insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004).
Slovenian: V dvojno slepi navzkrižni študiji se je po 12 tednih uporabe glikirani hemoglobin znižal za 0,37 odstotne točke z insulinom lispro in za 0,03 odstotne točke z navadnim insulinom (p =
English: Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood.
Slovenian: Hipoglikemija (nizek krvni sladkor) pomeni, da v krvi ni dovolj sladkorja.
English: Intravenous injection of insulin lispro should be carried out following normal clinical practice for intravenous injections, for example by an intravenous bolus or by an infusion system.
Slovenian: Intravensko injiciranje insulina lispro je treba izvajati v skladu z običajno klinično prakso za intravensko injiciranje, na primer z intravenskim bolusom ali z infuzijskim sistemom.
English: STEP 4: Select the dose
Slovenian: KORAK: Izberite odmerek
English: STEP 1: Check your pen
Slovenian: KORAK: Preverite vaš peresnik
English: • octreotide,
Slovenian: • oktreotid,
English: Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines).
Slovenian: To možno težavo morate imeti v mislih v vseh okoliščinah, v katerih bi lahko ogrozili svojo varnost ali varnost drugih (npr. pri vožnji avtomobila ali uporabi strojev).
English: • some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
Slovenian: • nekatere antidepresive (zaviralce monoaminooksidaze ali selektivne zaviralce prevzema serotonina),
English: Preparing a dose
Slovenian: Priprava odmerka
English: Units of insulin in your pen
Slovenian: Enote insulina v vašem peresniku
English: C Check that the insulin is clear.
Slovenian: C Preverite, da je insulin bister.
English: How to read the dose window Even numbers are shown in line with the dose pointer:
Slovenian: Kako odčitati okence odmerka Soda števila so prikazana uravnana s kazalnikom odmerka:
English: A Select 2 units by turning the dose selector until the dose pointer is at the 2 mark.
Slovenian: A Izberite 2 enoti tako, da zavrtite izbirnik odmerka, dokler kazalnik odmerka ne kaže oznake
English: Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.
Slovenian: Potrebe po insulinu so lahko manjše tudi pri bolnikih z okvaro jeter, ker sta zmogljivost za glukoneogenezo in razgradnjo insulina zmanjšani, a pri bolnikih s kronično okvaro jeter lahko povečanje odpornosti proti insulinu poveča potrebo po insulinu.