FrancophonIA/ELRC3.0 huggingface dataset:
English: Intercurrent illness requires intensified metabolic monitoring.
Slovenian: V primeru sočasnih bolezni je potreben intenzivnejši presnovni nadzor.
English: The number in the dose window will return to “0” as you inject.
Slovenian: Ko boste injicirali, se bo številka v okencu odmerka vrnila na "0".
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Slovenian: Na drugo vrsto ali znamko insulina sme bolnik preiti le pod strogim zdravniškim nadzorstvom.
English: These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens.
Slovenian: Ti vložki se ne smejo uporabljati z drugimi injekcijskimi peresniki za ponovno uporabo, ker je natančnost odmerjanja dokazana samo za omenjene injekcijske peresnike.
English: Special populations Elderly population (≧65 years old) In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Slovenian: Starejša populacija (stari 65 let ali več) Pri starejših lahko progresivno slabšanje ledvične funkcije vodi v stalno upadanje potreb po insulinu.
English: The specific frequency cannot be estimated from available data (frequency not known).
Slovenian: Specifične pogostnosti ni mogoče oceniti iz razpoložljivih podatkov (neznana pogostnost).
English: Why does hypoglycaemia occur?
Slovenian: Zakaj se pojavi hipoglikemija?
English: Do not store above 25°C and protect from direct heat and light.
Slovenian: Shranjujte pri temperaturi do 25 °C in zaščitite pred neposredno toploto in svetlobo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 January 2007 Date of latest renewal: 17 January 2012
Slovenian: Datum prve odobritve: 17. januar 2007 Datum zadnjega podaljšanja: 17. januar 2012
English: Immediate type allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions);
Slovenian: Bolezni imunskega sistema šok takojšnje alergijske reakcije (hipotenzija, angionevrotični edem, bronhospazem, generalizirane kožne reakcije); protitelesa proti insulinu
English: Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.
Slovenian: Med prehodom in v prvih tednih po njem je potreben natančen nadzor presnove.
English: Carry some information with you to show you are diabetic.
Slovenian: Pri sebi imejte tudi nekaj, iz česar bo razvidno, da imate sladkorno bolezen.
English: Insulin - lowers blood glucose and promotes anabolic effects as well as decreasing catabolic effects,
Slovenian: Insulin - znižuje glukozo v krvi, spodbuja anabolne učinke in zmanjšuje katabolne učinke,
English: Your ability to concentrate or react may be reduced if: - you have hypoglycaemia (low blood sugar levels), - you have hyperglycaemia (high blood sugar levels), - you have problems with your sight.
Slovenian: Vaša sposobnost koncentracije ali reagiranja se vam lahko zmanjša, če: imate hipoglikemijo (nizko koncentracijo krvnega sladkorja), imate hiperglikemijo (visoko koncentracijo krvnega sladkorja), imate težave z vidom.
English: A. Remove the protective seal from a new needle.
Slovenian: A. Z nove igle odstranite zaščitno prelepko.
English: Prolonged or severe hypoglycaemic episodes may be life-threatening.
Slovenian: Dolgotrajne ali hude hipoglikemične epizode so lahko smrtno nevarne.
English: This helps prevent contamination, and potential needle blocks.
Slovenian: Tako boste pomagali preprečiti onesnaženje in zamašitev igle.
English: It must only be used in insulin pumps suitable for this insulin.
Slovenian: Uporabljati se sme samo z insulinskimi črpalkami, primernimi za ta insulin.
English: Select the dose
Slovenian: Izbira odmerka
English: MedDRA system organ classes
Slovenian: MedDRA organski sistemi
English: Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Slovenian: Nekatera zdravila povzročijo spremembe koncentracije krvnega sladkorja (znižanje, zvišanje ali oboje odvisno od okoliščin).
English: Your insulin dosage may need to be changed during pregnancy and after giving birth.
Slovenian: Med nosečnostjo in po porodu bo morda treba spremeniti odmerjanje insulina.
English: If you turn past your dose, you can turn back down.
Slovenian: Če zavrtite višje, kot je vaš odmerek, lahko izbirnik odmerka zavrtite nazaj.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Always remove the needle after each injection and store SoloStar without a needle attached.
Slovenian: Iglo po vsakem injiciranju odstranite in SoloStar shranite brez nameščene igle.
English: Examples include: - you inject too much insulin, - you miss meals or delay them, - you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT
Slovenian: Primeri: - injicirate preveč insulina, - izpustite obroke ali jih imate prepozno, - ne jeste dovolj ali uživate hrano, ki vsebuje manj ogljikovih hidratov kot normalno (sladkor in sladkorju podobne snovi imenujemo ogljikovi hidrati; toda umetna sladila NISO ogljikovi
English: In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.
Slovenian: V takšnem primeru lahko injicirate insulin, ki je še v injekcijskem peresniku, in razliko do celotnega odmerka injicirate z novim SoloStarjem, ali pa uporabite nov SoloStar in z njim injicirate celotni odmerek.
English: Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and glucose and ketone bodies in urine.
Slovenian: Žeja, pogostejše siljenje na vodo, utrujenost, suha koža, pordelost obraza, izguba teka, nizek krvni tlak, hitro bitje srca ter glukoza in ketoni v urinu.
English: Immediately before withdrawal from the vial into the injection syringe, the insulin must be resuspended.
Slovenian: Tik pred izvlekom iz viale v injekcijsko brizgo je treba insulin ponovno suspendirati.
English: Instructions for Use.
Slovenian: Navodilo za uporabo
English: • ensuring that pen and needle work properly
Slovenian: • zagotovi, da injekcijski peresnik in igla delujeta pravilno,
English: If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Slovenian: Če niste prepričani, ali morda ne jemljete katerega od naštetih zdravil, vprašajte zdravnika ali farmacevta.
English: Mix the insulin well and check it before you insert it into the pen.
Slovenian: Insulin dobro premešajte in ga preverite, preden ga vstavite v injekcijski peresnik.
English: If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
Slovenian: Če imate težave z jetri ali ledvicami ali če ste starejši, se pogovorite z zdravnikom; morda boste potrebovali manjši odmerek.
English: The desired blood glucose levels, the insulin preparations to be used and the insulin dose regimen (doses and timings) must be determined individually and adjusted to suit the patient's diet, physical activity and life-style.
Slovenian: Želeno koncentracijo glukoze v krvi, ustrezni pripravek insulina in shemo njegovega odmerjanja (odmerke in čas uporabe) je treba določiti individualno in jih prilagoditi tako, da ustrezajo bolnikovi prehrani, telesni dejavnosti in življenjskemu slogu.
English: You should always consider the possibility of a technical problem if, in order to achieve the desired blood sugar levels, - you need additional insulin ("bolus doses") at larger doses or more often than usual, or - you need additional insulin ("bolus doses") at smaller doses or less often than usual.
Slovenian: Vedno morate pomisliti na možnost tehničnih težav, če za dosego želene koncentracije krvnega sladkorja - potrebujete večje dodatne ("bolusne") odmerke insulina ali jih potrebujete pogosteje kot ponavadi ali - potrebujete manjše dodatne ("bolusne") odmerke ali jih potrebujete redkeje kot ponavadi.
English: Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
Slovenian: Pozor: Umetna sladila in hrana z umetnimi sladili ( kot so dietne pijače) pri zdravljenju hipoglikemije ne pomagajo.
English: Read carefully the "SoloStar Instructions for Use" included in this package leaflet.
Slovenian: Natančno preberite "Navodila za ravnanje s SoloStarjem", ki jih vključuje to navodilo.
English: Do not shake the vial vigorously as this may cause frothing.
Slovenian: Viale ne stresajte močno, ker to lahko povzroči penjenje.
English: This leaflet was last revised in {date}
Slovenian: Navodilo je bilo nazadnje revidirano dne {datum} Drugi viri informacij
English: Your blood sugar levels may either rise or fall if you drink alcohol.
Slovenian: Krvni sladkor se vam lahko zviša ali zniža, če jemljete:
English: • SoloStar must never be used if it is damaged or if the patient is not sure if it is working properly.
Slovenian: SoloStarja ne sme uporabljati, če je poškodovan ali če ni prepričan, da deluje pravilno.
English: Improved metabolic control may result in increased insulin sensitivity, leading to a reduced insulin requirement.
Slovenian: Izboljšan nadzor presnove lahko zveča občutljivost za insulin in tako zmanjša potrebo po insulinu.
English: Proliferative retinopathy; Diabetic retinopathy;
Slovenian: Očesne bolezni proliferativna retinopatija; diabetična retinopatija; okvara vida
English: For further details on handling, see section 6.6.
Slovenian: Za podrobnosti o ravnanju z zdravilom glejte poglavje 6.6.
English: Pack of 5 cartridges of 3.15 ml is available.
Slovenian: Na voljo je pakiranje s 5 vložki po 3,15 ml.
English: • Injection site urticaria (itchy rash)
Slovenian: • Urtikarija na mestu injiciranja (srbeči izpuščaj)
English: A safety test must be performed before each injection.
Slovenian: Pred vsakim injiciranjem opravite varnostni preizkus.
English: 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.
Slovenian: Primeri simptomov, ki nakazujejo nizek krvni sladkor v možganih so:glavobol, huda lakota, slabost, bruhanje, utrujenost, zaspanost, motnje spanja, nemir, agresivno vedenje, motena koncentracija, poslabšane reakcije, depresija, zmedenost, motnje govora (včasih popolna izguba govora), motnje vida, tresenje, paraliza, mravljinčenje (parestezije), omrtvelost in mravljinčenje v predelu ust, omotica, izguba nadzora nad seboj, nezmožnost poskrbeti zase, krči, izguba zavesti.
English: Other side effects include (frequency cannot be estimated from the available data)
Slovenian: Drugi neželeni učinki vključujejo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Slovenian: Vendar se lahko z intenziviranjem insulinskega zdravljenja in nenadnim izboljšanjem glikemične urejenosti diabetična retinopatija prehodno poslabša.
English: Combination of Insulin Human Winthrop with pioglitazone 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.
Slovenian: Kombinacija zdravila Insulin Human Winthrop s pioglitazonom Ob uporabi pioglitazona v kombinaciji z insulinom so poročali o primerih srčnega popuščanja, predvsem pri bolnikih z dejavniki tveganja za razvoj srčnega popuščanja.
English: Before the first withdrawal of insulin you must remove the safety tear-off cap on the vial.
Slovenian: Pred prvim izvlekom insulina morate z viale odstraniti varnostni pokrovček.
English: Immediate type allergic reactions to insulin or to the excipients may be life-threatening.
Slovenian: Takojšnje alergijske reakcije na insulin ali pomožne snovi so lahko smrtno nevarne.
English: You can set doses from 1 to 80 units in steps of 1 unit.
Slovenian: Nastavite lahko odmerke od 1 do 80 enot v korakih po 1 enoto.
English: Before withdrawing insulin from the vial for the first time, remove the plastic protective cap.
Slovenian: Pred prvim izvlekom insulina iz viale odstranite plastično zaščitno zaporko.
English: The dose can be set in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units.
Slovenian: Odmerek je mogoče nastaviti v korakih po 1 enoto, od najmanj 1 enote do največ 80 enot.
English: Before taking a medicine ask your doctor if it can affect your blood sugar level, and what action, if any, you need to take.
Slovenian: Preden uporabite zdravilo, zdravnika vprašajte, ali lahko vpliva na krvni sladkor, ali je v zvezi s tem potrebno kakšno posebno ravnanje in če, kakšno.
English: Insulin Human Winthrop Infusat must only be used in insulin pumps suitable for this insulin.
Slovenian: Insulin Human Winthrop Infusat morate uporabljati samo v insulinskih črpalkah, primernih za ta insulin.
English: • Injection site reactions
Slovenian: • Reakcije na mestu injiciranja
English: It must be remembered that - insulin protamine crystals dissolve in an acid pH range, - the soluble insulin part precipitates out at a pH of approximately 4.5 to 6.5.
Slovenian: Zavedati se je treba, da: - se kristali insulin protamina raztapljajo v kislem pH območju, - topni del insulina precipitira v območju pH približno od 4,5 do 6,5.
English: Empty cartridges must not be refilled.
Slovenian: Praznih vložkov se ne sme ponovno polniti.
English: Recommended safety measures for removal and disposal of needles must be followed (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Slovenian: Upošteva naj priporočene varnostne ukrepe, ko igle odstranjuje in zavrže (npr. tehniko pokrivanja z eno roko), da bo zmanjšal tveganje za naključno poškodbo z iglo in prenos nalezljivih bolezni.
English: The used SoloStar must be discarded as required by your local authorities.
Slovenian: Porabljeni SoloStar mora zavreči v skladu z lokalnimi predpisi.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja lipodistrofija
English: • Always have a spare SoloStar in case your SoloStar is lost or damaged.
Slovenian: • Vedno imejte na zalogi rezervni SoloStar, če injekcijski peresnik izgubite ali se poškoduje.
English: After filling the cartridge of the pump keep it at room temperature for 1 to 2 hours before using it, so that you can see and remove any air bubbles which form during warming-up.
Slovenian: Ko ste vložek črpalke napolnili, ga pred uporabo od 1 do 2 uri pustite na sobni temperaturi, da boste opazili in odstranili morebitne mehurčke, ki nastanejo med segrevanjem.
English: HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Slovenian: HIPERGLIKEMIJA IN HIPOGLIKEMIJA
English: Warning symptoms of hyperglycaemia
Slovenian: Opozorilni znaki hiperglikemije
English: Do not mix insulin with any other medicines.
Slovenian: Insulina ne mešajte z nobenimi drugimi zdravili.
English: For use in an infusion pump, Insulin Human Winthrop Infusat is filled into the sterile cartridge of the pump.
Slovenian: Za uporabo v infuzijski črpalki se Insulin Human Winthrop Infusat napolni v sterilni vložek črpalke.
English: - Do not mix insulin with any other medicines.
Slovenian: - Insulina ne mešajte z nobenimi drugimi zdravili.
English: If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Slovenian: Če je insulinski injekcijski peresnik poškodovan ali ne deluje pravilno (zaradi mehanskih poškodb), ga zavrzite in uporabite novega.
English: The patient should be advised to read the instructions for use included in the package leaflet carefully before using SoloStar.
Slovenian: Bolniku naj se svetuje, da si pred uporabo natančno prebere navodila za ravnanje s SoloStarjem v navodilu za uporabo.
English: SoloStar delivers insulin in doses from 1 to 80 units in steps of 1 unit.
Slovenian: Z injekcijskim peresnikom SoloStar je mogoče nastaviti odmerke od 1 do 80 enot v korakih po 1 enoto.
English: Injection sites within an injection area must be rotated from one injection to the next.
Slovenian: Mesto injiciranja na posameznem predelu je treba od injekcije do injekcije krožno menjavati.
English: Insulin Human Winthrop SoloStar is white with a colour on the injection button.
Slovenian: Insulin Human Winthrop SoloStar je bele barve z obarvanim gumbom za injiciranje.
English: Care must be taken to ensure that no alcohol or other disinfectants enter the insulin suspension.
Slovenian: Paziti je treba, da v suspenzijo insulina ne pridejo alkohol ali drugi dezinficiensi.
English: It must be remembered that insulin protamine crystals dissolve in an acid pH range.
Slovenian: Zavedati se je treba, da se kristali insulin protamina raztapljajo v kislem pH območju.
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
Slovenian: Zaviralci adrenergičnih receptorjev beta, klonidin, litijeve soli in alkohol lahko hipoglikemično delovanje insulina bodisi stopnjujejo ali oslabijo.
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Slovenian: Pri starejših lahko progresivno slabšanje ledvične funkcije vodi v stalno upadanje potreb po insulinu.
English: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Slovenian: Blage hipoglikemije je ponavadi mogoče obvladati z uživanjem ogljikovih hidratov.
English: The label on the pen should be checked to make sure it contains the correct insulin.
Slovenian: Preveriti mora napis na injekcijskem peresniku, da se prepriča, če vsebuje pravi insulin.
English: Do not force the dosage selector to turn.
Slovenian: Izbirnika odmerka ne vrtite na silo.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom.
English: Hold the pen as shown in this leaflet.
Slovenian: Injekcijski peresnik držite tako kot je prikazano v tem navodilu.
English: Also, it must NOT be mixed with animal source insulins or insulin analogues.
Slovenian: Prav tako se ga NE sme mešati z insulini živalskega izvora ali analogi insulina.
English: Needles mut not be re-used.
Slovenian: Igel ne sme ponovno uporabiti.
English: The operating manual provided with the pump will tell you how to use it.
Slovenian: V navodilu za uporabo, priloženem črpalki, lahko preberete, kako jo uporabljati.
English: The needle should always be removed after each injection and discarded.
Slovenian: Po vsakem injiciranju mora iglo vedno odstraniti in zavreči.
English: Inject the dose
Slovenian: Injiciranje odmerka
English: Empty pens must not be re-filled and must be properly discarded.
Slovenian: Praznih injekcijskih peresnikov se ne sme ponovno polniti in jih je treba pravilno zavreči.
English: Check if insulin comes out of the needle tip.
Slovenian: Preverite, ali se na konici igle pokaže insulin.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, Before taking a medicine ask your doctor if it can affect your blood sugar level, and what action, if any, you need to take.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.Preden uporabite zdravilo, zdravnika vprašajte, ali lahko vpliva na krvni sladkor, ali je v zvezi s tem potrebno kakšno posebno ravnanje in če, kakšno.
English: SoloStar is a pre-filled disposable pen containing human insulin.
Slovenian: SoloStar je napolnjen injekcijski peresnik, ki vsebuje humani insulin.
English: Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat.
Slovenian: Primeri simptomov, ki vam povedo, da se je krvni sladkor znižal preveč ali prehitro, so na primer: znojenje, vlažna in lepljiva koža, tesnoba, hiter srčni utrip, visok krvni tlak, palpitacije in nereden srčni utrip.
English: These include: - change in the injection area, - improved insulin sensitivity (e.g. by removal of stress factors), - unaccustomed, increased or prolonged physical activity, - intercurrent illness (e.g. vomiting, diarrhoea), - inadequate food intake, - missed meals, - alcohol consumption, - certain uncompensated endocrine disorders (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency), - concomitant treatment with certain other medicinal products.
Slovenian: Med takšne spadajo: - sprememba predela injiciranja, - boljša občutljivost za insulin (npr. zaradi odprave dejavnikov stresa), - nevajena, večja ali dolgotrajnejša telesna dejavnost, - sočasna bolezen (npr. bruhanje, driska), - nezadostno uživanje hrane, - izpuščeni obroki, - pitje alkohola, - določene nekompenzirane endokrine motnje (npr. hipotiroidizem, insuficienca sprednjega režnja hipofize ali insuficienca nadledvične skorje), - sočasno zdravljenje z določenimi drugimi zdravili.
English: Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Slovenian: Hude hipoglikemije lahko povzročijo nevrološke okvare, zlasti če se ponavljajo.
English: These changes sometimes give the cartridge a frosted appearance.
Slovenian: Te spremembe včasih dajo videz, kot bi bila vložek zamrznjen.
English: Before use, the filled cartridge must be kept at room temperature for 1 to 2 hours.
Slovenian: Pred uporabo je treba napolnjeni vložek hraniti na sobni temperaturi od 1 do 2 uri.
English: Warning symptoms of hypoglycaemia
Slovenian: Opozorilni znaki hipoglikemije
English: Each pen contains multiple doses.
Slovenian: Vsak injekcijski peresnik je večodmerni.
English: The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.
Slovenian: Dosledno upoštevajte izdelovalčeva navodila za uporabo injekcijskega peresnika glede nameščanja vložka in injekcijske igle ter injiciranja insulina.
English: Opened vials
Slovenian: Odprte viale
English: Keep this leaflet for future reference.
Slovenian: Shranite to navodilo, da ga boste lahko v prihodnje spet pogledali.
English: Inspect the cartridge before use.
Slovenian: Vložek pred uporabo preglejte.
English: Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines).
Slovenian: Ne pozabite na to v okoliščinah, v katerih bi lahko ogrozili sebe in druge (kot je vožnja avta ali upravljanje strojev).
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: Later, you must mix the insulin well again immediately before each injection.
Slovenian: Pozneje morate insulin znova dobro premešati tik pred vsakim injiciranjem.
English: Insulin Human Winthrop Infusat has been specially designed for use in external portable insulin pumps.
Slovenian: Insulin Human Winthrop Infusat je posebej pripravljen za uporabo v zunanjih prenosnih insulinskih črpalkah.
English: Refer to the manufacturer's instructions for using the pen.
Slovenian: Glejte še izdelovalčeva navodila za uporabo injekcijskega peresnika.
English: - If you are not eating enough, your blood sugar level may become too low (hypoglycaemia).
Slovenian: - Če ne jeste dovolj, se lahko koncentracija krvnega sladkorja preveč zniža (hipoglikemija).