FrancophonIA/ELRC3.0 huggingface dataset:
English: It is advisable to inject immediately after mixing.
Slovenian: Mešanico je priporočljivo injicirati takoj po mešanju.
English: Please note: The needles shown are for illustrative purposes only.
Slovenian: Prosimo upoštevajte: Prikazane igle imajo samo ponazorilen namen.
English: You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Slovenian: Poznati jih morate, da se boste lahko pravilno odzvali na spremembe v koncentraciji krvnega sladkorja in preprečili, da bi se preveč zvečala ali zmanjšala.
English: If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Slovenian: Če se pojavijo normalne ali znižane vrednosti glikiranega hemoglobina, je treba pomisliti na možnost ponavljajočih se, neugotovljenih (zlasti nočnih) hipoglikemij.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Slovenian: To je lahko nevarno v okoliščinah, v katerih sta ti zmožnosti posebno pomembni (npr. pri vožnji avta ali upravljanju s stroji).
English: Secondary dose adjustment
Slovenian: Sekundarna prilagoditev odmerka
English: After inserting a new cartridge:
Slovenian: Po vstavitvi novega vložka:
English: If you are not able to use SoloStar or follow all the instructions completely on your own, you must use SoloStar only if you have help from a person who is able to follow the instructions completely.
Slovenian: Če Solostarja ne morete uporabljati ali vseh teh navodil ne morete popolnoma upoštevati vi sami, uporabite SoloStar le v primeru, da vam lahko pomaga oseba, ki lahko popolnoma upošteva ta navodila.
English: It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Slovenian: Nujno je, da bolnice z obstoječim ali gestacijskim diabetesom vso nosečnost vzdržujejo dobro presnovno urejenost.
English: Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.
Slovenian: Raziskave farmakodinamičnih učinkov po subkutani uporabi pri kuncih in psih so pokazale pričakovane hipoglikemične reakcije.
English: For insulin human, no clinical data on exposed pregnancies from controlled clinical studies are available.
Slovenian: Za humani insulin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu v kontroliranih kliničnih študijah.
English: Perform a safety test
Slovenian: Opravite varnostni preizkus
English: In clinical studies and during marketed use, the frequency varies with patient population and dose regimens.
Slovenian: V kliničnih študijah in med marketinško uporabo se je pogostnost razlikovala glede na populacijo bolnikov in sheme odmerjanja.
English: If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Slovenian: Če se ne morete povsem zanesti na prepoznavanje svojih opozorilnih simptomov, se izogibajte okoliščinam (na primer vožnji avtomobila), v katerih bi zaradi hipoglikemije ogrožali sebe ali druge.
English: Changing the injection site with each injection may help to prevent such skin changes.
Slovenian: Menjavanje mesta injiciranja pri vsaki injekciji pomaga preprečiti takšne kožne spremembe.
English: Frequency of these reactions cannot be estimated from available data.
Slovenian: Pogostnosti teh reakcij ni mogoče oceniti iz razpoložljivih podatkov.
English: In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
Slovenian: Pri zdravih osebah je razpolovni čas insulina v serumu približno 4 do 6 minut.
English: This is facilitated by the special equipment available for the insulin pumps (e.g. catheters, cannulas).
Slovenian: To olajšuje posebna oprema, ki je na voljo za insulinske črpalke (npr. katetri, kanile).
English: Your doctor will show you in which area of the skin you should inject your insulin.
Slovenian: Zdravnik vam bo pokazal, v kateri predel kože morate injicirati insulin.
English: Intravenous insulin therapy must generally take place in an intensive care unit or under comparable monitoring and treatment conditions (see "Daily doses and timing of administration").
Slovenian: Intravensko zdravljenje z insulinom mora praviloma potekati v enoti za intenzivno nego oz. v primerljivih pogojih za nadzor in zdravljenje (glejte "Dnevni odmerki in čas uporabe").
English: For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Slovenian: Za dodatne informacije glede neželenih učinkov nizkega krvnega sladkorja ali visokega krvnega sladkorja glejte okvir na koncu tega navodila za uporabo.
English: In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar.
Slovenian: Na splošno morate za preprečitev hipoglikemije uživati več hrane in nadzirati krvni sladkor.
English: This ensures that the full dose of insulin has been injected.
Slovenian: To zagotovi, da je bil injiciran celoten odmerek insulina.
English: Check your blood sugar frequently.
Slovenian: Pogosto si merite krvni sladkor.
English: If a dose greater than 80 units is required, it should be given as two or more injections.
Slovenian: Če je potrebni odmerek večji od 80 enot, ga je treba dati z dvema ali več injiciranji.
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), not known (cannot be estimated from the available data).
Slovenian: Naslednji neželeni učinki iz kliničnih raziskav, povezani z uporabo zdravila, so našteti spodaj po organskih sistemih in upadajoči pogostnosti: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti iz razpoložljivih podatkov).
English: In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
Slovenian: V številnih primerih je indicirano testiranje ketonov v urinu in odmerek insulina je pogosto treba prilagoditi.
English: If you do not follow these instructions completely, you may get too much or too little insulin, which may affect your blood glucose.
Slovenian: Če ne sledite tem navodilom v celoti, si lahko injicirate premalo ali preveč insulina, kar lahko vpliva na vaš krvni sladkor.
English: SoloStar has to be protected from dust and dirt.
Slovenian: SoloStar mora zaščititi pred prahom in umazanijo.
English: Your doctor will tell you if you have to mix insulin human preparations.
Slovenian: Zdravnik vam bo povedal, ali morate mešati pripravke s humanim insulinom.
English: The acute toxicity was studied following subcutaneous administration in rats.
Slovenian: Akutno toksičnost so proučili po subkutani uporabi pri podganah.
English: If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked.
Slovenian: Če je potrebno, lahko pogostejše merjenje krvnega sladkorja pomaga odkriti blage hipoglikemije, ki bi sicer ostale prezrte.
English: It is longer in patients with severe renal insufficiency.
Slovenian: Pri bolnikih s hudo ledvično insuficienco je daljši.
English: Insulin does cross the placental barrier, although not in clinically significant amount.
Slovenian: Insulin prestopa placentno pregrad, vendar ne v klinično pomembni količini.
English: This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
Slovenian: To je posebno pomembno pri bolnikih z zmanjšanim ali odsotnim zaznavanjem opozorilnih znakov hipoglikemije in pri tistih, ki imajo pogoste hipoglikemije.
English: Select a dose of 2 units.
Slovenian: Nastavi naj odmerek 2 enoti.
English: Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Slovenian: V prvem trimesečju se lahko potreba po insulinu zmanjša, v drugem in tretjem trimesečju pa se praviloma zveča.
English: A limited amount of data on pregnant women (less than 300 pregnancy outcomes reported) exposed to marketed insulin human indicates no safety issues in use of insulin human in pregnancy.
Slovenian: Maloštevilni podatki o nosečnicah (manj kot 300 opisanih izidov nosečnosti), izpostavljenih humanemu insulinu, ki je na trgu, ne kažejo varnostnih težav glede uporabe humanega insulina med nosečnostjo.
English: In the treatment of severe hyperglycaemia or ketoacidosis in particular, insulin administration is part of a complex therapeutic regimen which includes measures to protect patients from possible severe complications of a relatively rapid lowering of blood glucose.
Slovenian: Zlasti med zdravljenjem hude hiperglikemije ali ketoacidoze je uporaba insulina del kompleksne terapevtske sheme, ki obsega tudi ukrepe za zavarovanje bolnika pred možnimi hudimi zapleti razmeroma hitrega znižanja glukoze v krvi.
English: If you are allergic to insulin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na insulin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Consequently, about 40% to 60% of the daily dose is administered at a basal rate, and the rest is given as bolus injections before meals.
Slovenian: Zato se od 40 do 60 % dnevnega odmerka aplicira v bazalni infuziji, preostanek pa v bolusnih injekcijah pred obroki.
English: Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia).
Slovenian: Takoj po porodu se potreba po insulinu hitro zmanjša (zato se zveča nevarnost hipoglikemije).
English: To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
Slovenian: Da preberete odmerek pravilno, držite injekcijski peresnik vodoravno z iglo na levi strani in izbirnikom odmerka na desni, kot je prikazano na spodnji ilustraciji.
English: Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
Slovenian: Resna hipoglikemija lahko povzroči srčno kap ali poškodbe možganov in lahko ogroža življenje.
English: In case of hypoglycaemia, the insulin pump should temporarily be turned off, at least until the patient has recovered complete consciousness.
Slovenian: V primeru hipoglikemije je treba insulinsko črpalko začasno izključiti, vsaj dokler ni bolnik znova povsem pri zavesti.
English: The insulin cartridge of the pump must be sterile and must be used once only.
Slovenian: Insulinski vložek črpalke mora biti sterilen in se ga sme uporabiti samo enkrat.
English: Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
Slovenian: Stalna krožna menjava mest injiciranja na posameznem injekcijskem predelu pomaga zmanjšati ali preprečiti te reakcije.
English: • Never use SoloStar if it is damaged or if you are not sure that it is working properly.
Slovenian: • Ne uporabljajte SoloStarja, če je poškodovan ali če niste prepričani, da deluje pravilno.
English: HYPERGLYCAEMIA AND HYPOGLYCAEMIA Always carry some sugar (at least 20 grams) with you.
Slovenian: HIPERGLIKEMIJA IN HIPOGLIKEMIJA Vedno imejte pri sebi nekaj sladkorja (vsaj 20 gramov).
English: Daily doses and timing of administration
Slovenian: Dnevni odmerki in čas uporabe
English: Prior to each injection, a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
Slovenian: Pred vsakim injiciranjem mora opraviti varnostni preizkus, s katerim se prepriča, da injekcijski peresnik in igla pravilno delujeta, in odstrani zračne mehurčke.
English: - In your brain
Slovenian: - V vaših možganih
English: Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Slovenian: Uporabo pioglitazona je potrebno nemudoma ukiniti v primeru pojava poslabšanja srčnih simptomov.
English: Caution should be exercised when prescribing to pregnant women.
Slovenian: Pri predpisovanju zdravila nosečnicam je potrebna previdnost.
English: If you need a dose greater than 80 units, you should give it as two or more injections.
Slovenian: Če potrebujete odmerek, večji od 80 enot, ga morate dati z dvema ali več injiciranji.
English: Situations in which you must not start or continue to use insulin pumps are described in the operating manuals for these pumps.
Slovenian: Okoliščine, v katerih insulinske črpalke ne smete vključiti ali je še naprej uporabljati, so opisane v navodilih za uporabo teh črpalk.
English: In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered.
Slovenian: Pri bolnikih, ki zaradi insulinskih protiteles potrebujejo velike odmerke insulina, je treba razmisliti o prehodu pod zdravniškim nadzorom v bolnišnici ali podobnem okolju.
English: Insulin that you inject in such a site may not work very well.
Slovenian: Lahko se zgodi, da insulin, injiciran na tako spremenjeno mesto, ne bo deloval dobro.
English: If your blood sugar level falls too much you may become unconscious.
Slovenian: Če vam koncentracija krvnega sladkorja preveč pade, lahko izgubite zavest.
English: If two different insulins have to be drawn into one single injection syringe, it is recommended that the shorter-acting insulin be drawn first to prevent contamination of the vial by the longer-acting preparation.
Slovenian: Če je treba v eno samo injekcijsko brizgo potegniti dva različna insulina, je priporočljivo najprej izvleči krajše delujoči insulin, da bi preprečili onesnaženje viale z dlje delujočim pripravkom.
English: Injection needles are not included in the pack.
Slovenian: Injekcijske igle niso priložene v pakiranju.
English: However, it must be noted that the pharmacokinetics of insulin do not reflect its metabolic action.
Slovenian: Treba pa je opozoriti, da farmakokinetika insulina ne odseva njegovega presnovnega delovanja.
English: The insulin requirement is often increased.
Slovenian: Potreba po insulinu se pogosto zveča.
English: In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter-regulation.
Slovenian: Pri mnogih bolnikih se pred znaki in simptomi nevroglikopenije pojavijo znaki adrenergične protiregulacije.
English: If you are concerned that your SoloStar may be damaged, use a new one.
Slovenian: Če vas skrbi, da je vaš SoloStar poškodovan, uporabite novega.
English: B. Select your required dose (in the example below, the selected dose is 30 units).
Slovenian: B. Nastavite potrebni odmerek (v spodnjem primeru je nastavljen odmerek 30 enot).
English: You must use the pen as described in these Instructions for Use.
Slovenian: Injekcijski peresnik morate uporabljati, kot je opisano v teh navodilih za ravnanje.
English: Avoid situations where SoloStar might be damaged.
Slovenian: Izogiba naj se okoliščinam, v katerih se SoloStar lahko poškoduje.
English: Do not inject insulin.
Slovenian: Ne injicirajte si insulina.
English: Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Slovenian: Nemudoma zaužijte približno 10 do 20 gramov sladkorja, v obliki glukoze, kock sladkorja ali s sladkorjem sladkane pijače.
English: Your doctor will show you how and in which area of the skin you should infuse your insulin and how often you must change the puncture site within the particular area of skin where you are infusing the insulin.
Slovenian: Zdravnik vam bo pokazal, kako in v kateri predel kože morate infundirati insulin ter kako pogosto morate menjavati punkcijsko mesto na predelu kože, kamor insulin infundirate.
English: Subcutaneous use.
Slovenian: Za subkutano uporabo.
English: You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Slovenian: Običajno lahko zaznate, če vam krvni sladkor pade preveč, tako da lahko pravilno ukrepate.
English: Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Slovenian: Dolgoročno izboljšanje glikemične urejenosti zmanjša nevarnost za napredovanje diabetične retinopatije.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
English: Many factors may influence your blood sugar level.
Slovenian: Na koncentracijo krvnega sladkorja lahko vplivajo številni dejavniki.
English: • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
Slovenian: • vstopanje zraka v rezervoar z insulinom in iztekanje insulina, ki lahko povzročita netočno
English: If the patient is concerned that the SoloStar may be damaged, he must use a new one.
Slovenian: Če bolnika skrbi, da je njegov SoloStar poškodovan, naj uporabi novega.
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Slovenian: V takšnih okoliščinah je treba razmisliti, ali je priporočljivo, da bolnik vozi ali upravlja s stroji.
English: It may also be used in other insulin pumps for which it has been shown that they are suitable for this insulin (see pump manual).
Slovenian: Uporablja se lahko tudi v drugih insulinskih črpalkah, za katere je dokazano, da so primerne za ta insulin (glejte priročnik črpalke).
English: A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
Slovenian: Izrazita sprememba (izboljšanje ali poslabšanje) urejenosti krvnega sladkorja lahko prehodno vpliva na vaš vid.
English: Stop your insulin infusion (if necessary, by withdrawing the needle) at least until you feel that you are fully alert again.
Slovenian: Prekinite infundiranje insulina (če je treba, izvlecite iglo) vsaj za čas, dokler se ne počutite spet povsem pri sebi.
English: Cold insulin is more painful to inject.
Slovenian: Injiciranje mrzlega insulina je bolj boleče.
English: Insulin administration into a vein for example to treat severe hyperglycaemia and ketoacidosis, requires experience and special safety precautions.
Slovenian: Dajanje insulina v veno, na primer za zdravljenje hude hiperglikemije in ketoacidoze, zahteva izkušnje in posebne varnostne ukrepe.
English: Each cartridge contains 3 balls (stainless steel).
Slovenian: V vsakem vložku so 3 kroglice (iz nerjavnega jekla).
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 da druga oseba ali če vi dajete injekcijo drugi osebi, morate posebej paziti, ko iglo odstranjujete in zavržete.
English: Diabetes mellitus where treatment with insulin is required.
Slovenian: Diabetes mellitus, kadar je potrebno zdravljenje z insulinom.
English: It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Slovenian: Nemudoma po zaužitju glukoze je priporočljivo izmeriti krvni sladkor, da preverite, ali gre res za hipoglikemijo.
English: Frequency of administration
Slovenian: Pogostnost uporabe
English: Also do not use it in peristaltic pumps with silicone tubing.
Slovenian: Prav tako ga ne uporabljajte v peristaltičnih črpalkah s silikonskimi cevkami.
English: Whenever the patient notices a rapid increase in blood glucose which does not respond to a bolus dose, a check must be made for possible catheter obstruction.
Slovenian: Bolnik mora vedno, kadar opazi hitro zvišanje glukoze v krvi, ki se ne odzove na bolusni odmerek, preveriti, ali je kateter morda zamašen.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use only clear and colourless solutions.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Uporabite le bistre in brezbarvne raztopine.
English: Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin).
Slovenian: Zdravljenje z insulinom lahko povzroči, da začne telo tvoriti protitelesa proti insulinu (snovi, ki delujejo proti insulinu).
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dosage.
Slovenian: Spremembe jakosti, zaščitne znamke (izdelovalec), tipa (običajni humani insulin, NPH, lente, dolgo delujoči), izvora (živalski, humani, analog humanega insulina) in/ali načina izdelave, lahko posledično vplivajo na spremembo odmerjanja.
English: Symptoms Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Slovenian: Preveliko odmerjanje insulina lahko povzroči hudo ter včasih dolgotrajno in smrtno nevarno hipoglikemijo.
English: After resuspension, milky-white suspension.
Slovenian: Po ponovnem suspendiranju je suspenzija mlečno bela.
English: Adjustments in dose regimen of the medicinal product, meal patterns, or physical activity may be needed.
Slovenian: Potrebne utegnejo biti prilagoditve sheme odmerjanja zdravila, razporeda obrokov ali telesne dejavnosti.
English: Insulin that has been filled into the pump reservoir may be used for two weeks thereafter.
Slovenian: Insulin, napolnjen v rezervoar črpalke, je mogoče uporabljati dva tedna po napolnitvi.
English: • If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
Slovenian: • Če se insulin ne pokaže, poglejte, ali so v vložku zračni mehurčki, in varnostni test še dvakrat
English: The cartridge must only be used once.
Slovenian: Vložek se sme uporabiti le enkrat.
English: Special populations Elderly population (≧65 years old)
Slovenian: Posebne populacije Starejša populacija (stari 65 let ali več)
English: Special caution must be taken when removing and disposing of the needle.
Slovenian: Posebna previdnost je potrebna, ko iglo odstranjuje in zavrže.
English: If you have any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number on the front of this leaflet.
Slovenian: Če imate kakšna vprašanja o SoloStarju ali o sladkorni bolezni, vprašajte svojega zdravnika, farmacevta ali medicinsko sestro ali pokličite na lokalno telefonsko številko družbe sanofi-aventis, ki jo najdete na sprednji strani tega navodila.
English: Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Slovenian: Potrebno utegne biti dolgotrajnejše uživanje ogljikovih hidratov in opazovanje, kajti hipoglikemija se lahko po navideznem kliničnem izboljšanju ponovi.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2°C - 8°C).
English: Fertility No clinical or animal data with insulin human on male or female fertility are available.
Slovenian: Kliničnih podatkov ali podatkov iz študij na živalih o vplivu humanega insulina na moško ali žensko plodnost ni na voljo.
English: General disorders and administration site conditions Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks.
Slovenian: Splošne težave in spremembe na mestu aplikacije Večina manjših reakcij na insuline na mestu injiciranja ponavadi mine v nekaj dneh do nekaj tednih.
English: Travel
Slovenian: Potovanje
English: How to handle SoloStar
Slovenian: Ravnanje s SoloStarjem
English: They can also spread around the injection site.
Slovenian: Razširijo se lahko tudi na okolico mesta injiciranja.