FrancophonIA/ELRC3.0 huggingface dataset:
English: These reactions are usually of a transitory nature.
Slovenian: Te reakcije so ponavadi prehodne narave.
English: Careful monitoring is recommended.
Slovenian: Priporočljivo je natančno spremljanje.
English: ATC code: A10AD05.
Slovenian: Oznaka ATC: A10AD05.
English: They must not give you any food or drink because you may choke.
Slovenian: Ne smejo vam dajati hrane ali pijače, ker se lahko zadušite.
English: Elderly (≥65 years old)
Slovenian: Starejši bolniki (≥ 65 let)
English: Dose adjustments can be made once a week until target HbA1c is reached.
Slovenian: Odmerek je mogoče prilagajati enkrat na teden, dokler ni dosežen ciljni HbA1c.
English: Normally, this soon disappears.
Slovenian: Običajno to kmalu mine.
English: Date of last renewal: 2 July 2010
Slovenian: Datum zadnjega podaljšanja: 2. julij 2010
English: If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Slovenian: Če je potrebna prilagoditev odmerka, jo je mogoče narediti pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
English: You should always measure your blood sugar regularly.
Slovenian: Redno si morate meriti krvni sladkor.
English: Intramuscular administration should be avoided.
Slovenian: Intramuskularnemu apliciranju se je treba izogibati.
English: This makes it easier to resuspend.
Slovenian: To vam bo olajšalo resuspendiranje.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Zaradi odsotnosti študij kompatibilnosti zdravila ne smete mešati z drugimi zdravili.
English: Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done.
Slovenian: Ne prenehajte uporabljati vašega insulina, ne da bi se pogovorili z zdravnikom, ki vam bo povedal, kaj je potrebno storiti.
English: If convenient, the gluteal or deltoid region may be used.
Slovenian: Če je prikladno, je mogoče uporabiti tudi glutealni ali deltoidni predel.
English: The dose should not be increased if hypoglycaemia occurred within these days.
Slovenian: Odmerka ne smete povečati, če se je v teh dneh pojavila hipoglikemija.
English: The duration of action is up to 24 hours (Figure 1).
Slovenian: Trajanje delovanja je do 24 ur (slika 1).
English: The duration of action is 14 to 24 hours (Figure 1).
Slovenian: Trajanje delovanja je 14 do 24 ur (slika 1).
English: Hours
Slovenian: Ure
English: • Whenever the risk management system is modified, especially as the results of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: ► You can select doses from 1 to 60 units in increments of 1 unit.
Slovenian: ► Izberete lahko odmerke od 1 do 60 enot v koraku po 1 enoto.
English: ► If you are ill, carry on taking your insulin and consult your doctor.
Slovenian: ► če ste bolni; insulin uporabljajte še naprej in se posvetujte s svojim zdravnikom,
English: The maximum effect is exerted between 1 and 4 hours after injection.
Slovenian: Največji učinek doseže od 1 do 4 ure po injekciji.
English: After delivery, insulin requirements return rapidly to pre-pregnancy levels.
Slovenian: Po porodu se potreba po insulinu hitro vrne na raven pred nosečnostjo.
English: The following titration guideline is recommended for dose adjustments:
Slovenian: Za prilagajanje odmerka so priporočene naslednje smernice:
English: Never inject your insulin directly into a vein (intravenously) or muscle (intramuscularly).
Slovenian: Insulina si nikoli ne injicirajte neposredno v veno (intravensko) ali mišico (intramuskularno).
English: After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.2, 4.8 and
Slovenian: Po ureditvi bolnikove glukoze v krvi je treba razmisliti o prilagoditvi odmerka (glejte poglavja 4.2, 4.8
English: Do not soak, wash or lubricate it as it may damage the pen.
Slovenian: Ne namakajte, ne umivajte in ne mažite ga, ker ga s tem lahko poškodujete.
English: Warning signs of high blood sugar:
Slovenian: Opozorilni znaki zvišanega krvnega sladkorja
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 August 2000
Slovenian: Datum prve odobritve: 1. avgust 2000
English: This has a rapid onset of action, thus allowing it to be given closer to a meal (within zero to 10 minutes of the meal) when compared to soluble human insulin.
Slovenian: Ta začne delovati hitro in tako omogoča uporabo bližje obroku (od nič do 10 minut od obroka) kot topni humani insulin.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Frequency categories are defined according to the following convention: 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: Skupine pogostnosti so opredeljene po naslednjem dogovoru: 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar.
Slovenian: V 10 minutah po injiciranju pojejte obrok ali prigrizek, da se izognete nizkemu krvnemu sladkorju.
English: If you take more insulin than you should
Slovenian: Če ste uporabili več insulina, kot bi smeli
English: You must use the pen as described in the Instructions for use.
Slovenian: Injekcijski peresnik morate uporabljati, kot je opisano v navodilih za uporabo.
English: This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects).
Slovenian: Tako lahko zmanjšate tveganje za nastanek zatrdlin in ugreznjenosti kože (glejte poglavje 4, Možni neželeni učinki).
English: ► Withdraw the needle from the skin, then release the pressure on the push-button.
Slovenian: ► Izvlecite iglo iz kože in nato spustite potisni gumb.
English: You may recover more quickly from unconsciousness with an injection of the hormone glucagon given by someone who knows how to use it.
Slovenian: Iz nezavesti se boste zbudili prej, če dobite injekcijo hormona glukagona od osebe, ki ga zna uporabljati.
English: Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Slovenian: Prilagoditev odmerka je lahko potrebna tudi v primeru večje telesne aktivnosti bolnika, spremenjene običajne prehrane ali med sočasnimi boleznimi.
English: Anaphylactic reactions:
Slovenian: Anafilaktične reakcije:
English: This should be kept in mind if treatment with the combination of pioglitazone and NovoMix is considered.
Slovenian: To je treba upoštevati pri načrtovanju zdravljenja s kombinacijo pioglitazona in zdravila NovoMix.
English: EXP During use: Use within 4 weeks
Slovenian: Uporabno do: Med uporabo: porabite v 4 tednih.
English: Rare - Peripheral neuropathy (painful neuropathy)
Slovenian: Redko - periferna nevropatija (boleča nevropatija)
English: For patients with an HbA1c higher than 8% a dose reduction should be considered.
Slovenian: Pri bolnikih z vrednostjo HbA1c višjo od 8 % je treba presoditi o zmanjšanju odmerka.
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
Slovenian: • Hude hipoglikemije, ko je bolnik nezavesten, je mogoče zdraviti z glukagonom (0,5 do 1 mg), ki ga intramuskularno ali subkutano aplicira ustrezno podučena oseba, ali z glukozo, ki jo intravensko aplicira zdravstveni delavec.
English: Adverse reactions observed in patients using NovoMix are mainly due to the pharmacological effect of insulin aspart.
Slovenian: Neželeni učinki, opaženi pri bolnikih, ki uporabljajo zdravilo NovoMix, so v glavnem posledica farmakološkega učinka insulina aspart.
English: • Complete the other stages of injection without delay.
Slovenian: • Brez odlašanja opravite vse ostale korake za injiciranje.
English: Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis.
Slovenian: Neustrezno odmerjanje ali prekinitev zdravljenja, posebno pri sladkorni bolezni tipa 1, lahko vodi v hiperglikemijo in diabetično ketoacidozo.
English: The adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class.
Slovenian: Neželeni učinki, navedeni spodaj, temeljijo na podatkih iz kliničnih preskušanj in so razvrščeni po MedDRA pogostnosti in organskih sistemih.
English: Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar.
Slovenian: Sladkorna bolezen je bolezen, pri kateri vaše telo ne tvori dovolj insulina, da bi uravnalo koncentracijo sladkorja v krvi.
English: The insulin will work more quickly if you inject around the waist.
Slovenian: Insulin bo deloval hitreje, če ga injicirate v predelu trebuha.
English: During use or when carried as a spare: The product can be stored for a maximum of 4 weeks.
Slovenian: Med uporabo in ko se zdravilo uporablja kot rezerva: zdravilo je lahko shranjeno največ 4 tedne.
English: Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose.
Slovenian: Spremembe v jakosti, znamki (izdelovalec), vrsti, izvoru (živalski insulin, humani insulin ali analog humanega insulina) in/ali načinu izdelave (rekombinantna DNA ali živalski vir insulina) imajo lahko za posledico spremembo odmerka.
English: Always check if there is enough insulin left (at least 12 units) in the cartridge to allow even resuspension.
Slovenian: Vedno preverite, če je v vložku dovolj insulina (vsaj 12 enot), da bi zagotovili enakomerno resuspendiranje.
English: D Take a new needle and tear off the paper tab.
Slovenian: D Vzemite novo iglo in z nje odstranite papirno nalepko.
English: NovoMix 30 can also be initiated once daily with 12 units at dinner (evening meal).
Slovenian: Zdravilo NovoMix 30 je mogoče uvesti tudi enkrat na dan z 12 enotami pri večerji (večernem obroku).
English: • Repeatedly take less insulin than you need.
Slovenian: • si večkrat zapored injicirate manj insulina, kot ga potrebujete,
English: ► When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.
Slovenian: ► Ko simptomi nizkega krvnega sladkorja izginejo ali se koncentracija sladkorja v krvi stabilizira, nadaljujte zdravljenje z insulinom kot ponavadi.
English: Serum insulin levels returned to baseline 15-18 hours after a subcutaneous dose.
Slovenian: Koncentracija insulina v serumu se je vrnila na izhodiščno od 15 do 18 ur po subkutanem odmerku.
English: However, Cmax differed between the age groups, stressing the importance of the individual titration of insulin aspart.
Slovenian: Cmax pa se je med starostnima skupinama razlikovala, kar kaže, da je individualno titriranje insulina aspart pomembno.
English: Needles are not included
Slovenian: Igle niso priložene.
English: Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain.
Slovenian: Boleča nevropatija (bolečina zaradi okvare živca): če se vam koncentracija krvnega sladkorja izboljša zelo hitro, lahko doživite z živci povezane bolečine.
English: However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been investigated in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes.
Slovenian: Vendar so farmakokinetične in farmakodinamične lastnosti topnega insulina aspart raziskali pri otrocih (od 6. do 12. leta) in mladostnikih (od 13. do 17. leta) s sladkorno boleznijo tipa 1.
English: Caregivers must be very careful when handling used needles to reduce the risk of needle sticks and cross-infection.
Slovenian: Osebe, ki skrbijo za bolnika, morajo biti pri ravnanju z uporabljenimi iglami nadvse pazljive, da zmanjšajo tveganje za vbode z iglami in prenos okužb.
English: For every following injection
Slovenian: Za vsako naslednje injiciranje
English: It is therefore recommended that the diabetic patient always carries sugar-containing products.
Slovenian: Zato naj ima sladkorni bolnik vedno pri sebi nekaj živil, ki vsebujejo sladkor.
English: Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention during dose intensification as outlined in section 4.2.
Slovenian: Strožja urejenost koncentracije glukoze lahko poveča možnost hipoglikemije, zato je med povečevanjem odmerka potrebna posebna previdnost, kot je opisano v poglavju 4.2.
English: This may have to be compensated for in the individual patient through adjustment of insulin dose and/or food intake.
Slovenian: Pri posameznih bolnikih je morda to treba kompenzirati s prilagoditvijo odmerka insulina in/ali uživanjem hrane.
English: If no drop appears you will not inject any insulin, even though the dose selector may move.
Slovenian: Če se kapljica ne pojavi, ne boste injicirali insulina, tudi če se izbirnik odmerka premakne.
English: 1 ml contains 100 units of insulin aspart.
Slovenian: 1 ml vsebuje 100 enot insulina aspart.
English: In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Slovenian: Na splošno sta pri ženskah s sladkorno boleznijo med celotno nosečnostjo in pred načrtovano nosečnostjo priporočljiva intenzivnejši nadzor glukoze v krvi in spremljanje nosečnice.
English: Then titrate according to individual needs (see the titration guideline in the table above).
Slovenian: Potem odmerek prilagodite potrebam posameznega bolnika (glejte smernice za prilagajanje v zgornji preglednici).
English: Never try to put the inner needle cap back on the needle.
Slovenian: Nikoli ga ne poskušajte znova namestiti na iglo.
English: If they do not disappear, see your doctor.
Slovenian: Če ne minejo, pojdite k zdravniku.
English: ► If you are allergic to insulin aspart or any of the other ingredients in this medicine (see section
Slovenian: ► če ste alergični na insulin aspart ali katero koli sestavino tega zdravila (glejte poglavje 6,
English: ► If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.
Slovenian: ► če potujete v tujino; potovanje med različnimi časovnimi pasovi lahko vpliva na potrebe po insulinu in časovni razpored injekcij.
English: The individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day.
Slovenian: Individualna potreba po insulinu je ponavadi od 0,5 do 1,0 enote/kg/dan.
English: The patient should be advised to discard the needle after each injection.
Slovenian: Bolniku je treba naročiti, naj iglo po vsakem injiciranju zavrže.
English: What to do if you experience high blood sugar: ► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
Slovenian: Kaj narediti, če se vam pojavi visok krvni sladkor ► Če se vam pojavi kateri od zgoraj omenjenih znakov, si izmerite sladkor v krvi, določite ketone v urinu, če imate to možnost, potem pa takoj poiščite zdravniški nasvet.
English: ► For every following injection
Slovenian: ► Za vsako naslednjo injekcijo
English: Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible.
Slovenian: Hitro izboljšanje urejenosti glukoze v krvi lahko spremlja akutna boleča nevropatija, ki je ponavadi reverzibilna.
English: If it is dropped, damaged or crushed, there is a risk of insulin leakage.
Slovenian: Če vam pade, se okvari ali poškoduje, obstaja nevarnost puščanja insulina.
English: Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirements.
Slovenian: Sočasne bolezni, posebno okužbe in stanja z zvišano telesno temperaturo, ponavadi zvečajo bolnikovo potrebo po insulinu.
English: Check that the dose selector is set at 0.
Slovenian: Preverite, da je izbirnik odmerka nastavljen na 0.
English: NovoMix 30 can also be given in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists.
Slovenian: Zdravilo NovoMix 30 se lahko uporablja tudi v kombinaciji s peroralnimi antidiabetiki in/ali agonisti receptorjev GLP-1.
English: -2 units
Slovenian: - 2 enoti
English: • Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)
Slovenian: • simpatikomimetike (na primer adrenalin, salbutamol ali terbutalin, uporabljajo se za zdravljenje astme),
English: Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.
Slovenian: Diabetična retinopatija (očesna bolezen, povezana s sladkorno boleznijo, ki lahko povzroči izgubo vida): če imate diabetično retinopatijo in se vam koncentracija krvnega sladkorja zelo hitro izboljša, se lahko retinopatija poslabša.
English: For patients with type 2 diabetes, the recommended starting dose of NovoMix 30 is 6 units at breakfast and 6 units at dinner (evening meal).
Slovenian: Za bolnike s sladkorno boleznijo tipa 2 je priporočeni začetni odmerek zdravila NovoMix 30 6 enot pri zajtrku in 6 enot pri večerji (večernem obroku).
English: Lead the needle into the big outer needle cap without touching it.
Slovenian: Iglo vstavite v veliki zunanji pokrovček igle, ne da bi se ga dotaknili.
English: In one study, patients with type 2 diabetes, insufficiently controlled on oral hypoglycaemic agents alone, were randomised to treatment with twice daily NovoMix 30 (117 patients) or once daily insulin glargine (116 patients).
Slovenian: V eni študiji so bolnike s sladkorno boleznijo tipa 2, ki samo s peroralnimi antidiabetiki niso bili zadostno urejeni, randomizirali na zdravljenje z zdravilom NovoMix 30 dvakrat na dan (117 bolnikov) ali insulinom glarginom enkrat na dan (116 bolnikov).
English: The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control, please see Description of selected adverse reactions below.
Slovenian: Pogostnost hipoglikemij se razlikuje med populacijami bolnikov, odmernimi shemami in ravnjo urejenosti glikemije; glejte podpoglavje Opis izbranih neželenih učinkov, spodaj.
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
Slovenian: Če imate zmanjšano funkcijo ledvic ali jeter, ali če ste starejši od 65 let, si morate krvni sladkor meriti bolj redno, o spremembah odmerka insulina pa se morate posvetovati z zdravnikom.
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving or operating a machine.
Slovenian: Bolnikom je treba naročiti, naj upoštevajo ustrezne previdnostne ukrepe, da bi se izognili hipoglikemiji med vožnjo ali upravljanjem s stroji.
English: • Thiazides (used to treat high blood pressure or excessive fluid retention)
Slovenian: • tiazide (uporabljajo se za zdravljenje visokega krvnega tlaka ali za prekomerno zadrževanje tekočin),
English: In case of hypoglycaemia or if hypoglycaemia is suspected, NovoMix must not be injected.
Slovenian: V primeru pojava hipoglikemije ali suma na pojav hipoglikemije se zdravila NovoMix ne sme injicirati.
English: If not, contact your doctor.
Slovenian: Če ne mine, se pogovorite s svojim zdravnikom.
English: Then move the pen up and down 10 times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other.
Slovenian: Potem injekcijski peresnik 10-krat obrnite gor in dol med obema položajema, kot je prikazano, tako da se steklena kroglica premika z enega konca vložka na drugega.
English: Use the injection technique advised by your doctor or nurse and as described in your pen manual.
Slovenian: Za injiciranje uporabite postopek, ki vam ga je svetoval zdravnik ali medicinska sestra in je opisan v priročniku vašega injekcijskega peresnika.
English: Resuspend according to instructions
Slovenian: Resuspendirajte po navodilih!
English: The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life-threatening.
Slovenian: Pojav generaliziranih preobčutljivostnih reakcij (med drugim generalizirani izpuščaj na koži, srbenje, znojenje, prebavne motnje, angionevrotični edem, težave pri dihanju, palpitacije in znižanje krvnega tlaka) je zelo redek, vendar je lahko smrtno nevaren.
English: With NovoMix 30, 66% and 42% of the patients reached HbA1c levels below 7% and 6.5%, respectively, and mean FPG was reduced by about 7 mmol/l (from 14.0 mmol/l at baseline to 7.1 mmol/l).
Slovenian: Z zdravilom NovoMix 30 je vrednosti HbA1c pod 7 % doseglo 66 % bolnikov, vrednosti pod 6,5 % pa 42 % bolnikov; povprečna koncentracija glukoze v plazmi na tešče se je znižala za približno 7 mmol/l (s 14,0 mmol/l izhodiščno na 7,1 mmol/l).
English: Insulin aspart is equipotent to human insulin on a molar basis.
Slovenian: Insulin aspart je na molarni osnovi ekvipotenten humanemu insulinu.
English: There is limited clinical experience with insulin aspart in pregnancy.
Slovenian: Kliničnih izkušenj z insulinom aspart v nosečnosti je malo.
English: ► Always use a new needle for each injection to prevent contamination.
Slovenian: ► Za vsako injiciranje uporabite novo iglo, da preprečite kontaminacijo.
English: If your blood sugar is low or high, it might affect your concentration and ability to react and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others.
Slovenian: Če imate visok ali nizek krvni sladkor, se vam zbranost in sposobnost reagiranja lahko spremenita, s tem pa tudi vaša sposobnost za upravljanje vozil in strojev.
English: Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens.
Slovenian: Pakiranja z 1 (z iglami ali brez), 5 (brez igel) in 10 (brez igel) napolnjenimi injekcijskimi peresniki.
English: In patients with type 1 diabetes, the individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 1 je individualna potreba po insulinu ponavadi med 0,5 in 1,0 enote/kg/dan.
English: Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Slovenian: Nekatera zdravila vplivajo na koncentracijo krvnega sladkorja in lahko tako vplivajo na vaš odmerek insulina.