natgillin/translations-raw huggingface dataset:
In type 2 diabetes (also known as non-insulin dependent diabetes), NovoMix can be given on its own or together with metformin.
Pri bolnikih s sladkorno boleznijo tipa 2 (sladkorno boleznijo, ki ni odvisna od insulina) se zdravilo NovoMix lahko daje samostojno ali v kombinaciji z metforminom.
NovoMix 30 can also be used with other antidiabetic medicines that can be taken by mouth in combination with insulin, but it should only be used with pioglitazone once the patient ’ s risk of fluid-related side effects has been evaluated.
Zdravilo NovoMix 30 se lahko uporablja tudi z drugimi antidiabetičnimi zdravili, ki se lahko jemljejo peroralno v kombinaciji z insulinom, medtem ko se v kombinaciji s pioglitazonom lahko uporablja šele po tem, ko se oceni bolnikovo tveganje za pojav neželenih učinkov, povezanih z zastajanjem tekočine.
NovoMix is a replacement insulin which is very similar to the insulin made by the pancreas.
Sladkorna bolezen je bolezen, pri kateri telo ne tvori dovolj insulina za ustrezno uravnavanje glukoze v krvi.
The active ingredient of NovoMix, insulin aspart, is produced by a method known as ‘ recombinant DNA technology’: it is made by a yeast that has received a gene (DNA), which makes it able to produce 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Zdravilo NovoMix je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged insulin aspart.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged slinavka.
Insulin aspart is very slightly different from human insulin, and the change means that it is absorbed faster by the body, and can therefore act faster than human insulin.
Insulin aspart se le malo razlikuje od humanega insulina, vendar pa mu ta razlika omogoča hitrejšo absorpcijo v telesu, zaradi česar lahko učinkuje hitreje kot humani insulin.
NovoMix contains insulin aspart in two forms: the soluble form, which acts quickly (within 10 minutes of injection) and the crystallised form, which is absorbed much more slowly during the day.
Zdravilo NovoMix vsebuje insulin aspart v dveh oblikah: v topni obliki, ki učinkuje hitro (v 10 minutah po injiciranju), ter v kristalizirani obliki, ki se absorbira počasneje v teku dneva.
This gives NovoMix a longer duration of action.
Posledično lahko zdravilo NovoMix učinkuje dalj časa.
The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Nadomestni insulin učinkuje na enak način kot naravno tvorjeni insulin in pomaga pri vstopanju glukoze iz krvi v celice.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Z uravnavanjem ravni glukoze v krvi se simptomi in zapleti, povezani s sladkorno boleznijo, zmanjšajo.
NovoMix 30 has been studied in patients with type 1 or type 2 diabetes (294 patients) where it was compared with human insulin over 12 weeks.
Zdravilo NovoMix 30 so preučevali pri bolnikih s sladkorno boleznijo tipa 1 ali tipa 2 (294 bolnikih), pri katerih so ga primerjali s humanim insulinom v obdobju 12 tednov.
NovoMix 50 and NovoMix 70 injected three times a day have been compared in 664 patients (with type 1 or type 2 diabetes) to human insulin 30 injected twice a day.
Zdravilo NovoMix 50 in NovoMix 70, injicirano trikrat dnevno, so pri 664 bolnikih (s sladkorno boleznijo tipa 1 ali tipa 2) primerjali s humanim insulinom 30, injiciranim dvakrat dnevno.
The effects of adding NovoMix 30 to other antidiabetic medicines taken by mouth (metformin, sulphonylureas and pioglitazone) have also been studied in four studies involving a total of 905 patients.
Učinke dodajanja zdravila NovoMix 30 k drugim antidiabetičnim zdravilom, ki se dajejo peroralno (metforminu, sulfonilsečnini in pioglitazonu), so preučevali v štirih študijah, v katerih je sodelovalo skupno 905 bolnikov.
In all studies, the main measure of effectiveness was the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, before and at the end of the study.
Glavno merilo učinkovitosti v vseh študijah je bila raven snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi nadzorovana, pred in ob koncu študije.
What benefit has NovoMix shown during the studies?
Kakšne koristi je zdravilo NovoMix izkazalo med raziskavami?
NovoMix 30 gave almost identical results to human insulin at the end of the study.
Rezultati za zdravilo NovoMix 30 so bili ob koncu študije skoraj identični tistim za humani insulin.
NovoMix 50 and NovoMix 70 gave better overall control of blood glucose than human insulin 30.
Zdravili NovoMix 50 in NovoMix 70 sta, splošno gledano, bolje uravnavali raven glukoze v krvi kot humani insulin 30.
Adding NovoMix 30 to other antidiabetic medicines resulted in better control of blood glucose than the other medicines taken alone.
Dodajanje zdravila NovoMix 30 k drugim antidiabetičnim zdravilom je privedlo do boljšega uravnavanja ravni glukoze v krvi kot v primeru uporabe teh drugih zdravil samostojno.
As with other insulins, NovoMix may cause hypoglycaemia (low blood glucose).
Zdravilo NovoMix lahko tako kot drugi insulini povzroči hipoglikemijo (nizko raven glukoze v krvi).
For the full list of all side effects reported with NovoMix, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila NovoMix, glejte Navodilo za uporabo.
NovoMix should not be used in people who may be hypersensitive (allergic) to insulin aspart or to any of the other ingredients, or in patients with hypoglycaemia.
Zdravila NovoMix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) insulin aspart ali katerokoli drugo sestavino zdravila, ali bolniki s hipoglikemijo.
NovoMix doses might also need to be adjusted when given with a number of other medicines which can have an effect on blood glucose.
Odmerke zdravila NovoMix bo morda treba prilagoditi, če se zdravilo daje skupaj z različnimi drugimi zdravili, ki lahko vplivajo na raven glukoze v krvi.
For the full list, see the Package Leaflet.
Za celoten seznam glejte Navodilo za uporabo.
The Committee for Medicinal products for Human Use (CHMP) decided that NovoMix’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila NovoMix pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
The Committee recommended that NovoMix be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo NovoMix odobri dovoljenje za promet z zdravilom.
The European Commission granted a marketing authorisation valid throughout the European Union for NovoMix to Novo Nordisk A/ S on 1 August 2000.
Evropska komisija je dovoljenje za promet z zdravilom NovoMix, veljavno po vsej Evropski uniji, odobrila družbi Novo Nordisk A/ S dne 1. avgusta 2000.
The marketing authorisation was renewed on 1 August 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano 1. avgusta 2005.
The full EPAR for NovoMix can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo NovoMix je na voljo tukaj.
100 U/ ml
100 e. / ml
cartridge (glass)
injekcijski vložek (steklo)
cartridge (glass) in pre- filled pen
injekcijski vložek (steklo) v napolnjenem injekcijskem peresniku
EU/ 1/ 00/ 142/ 021
1/ 2 EU/ 1/ 00/ 142/ 021
NovoMix 30 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 30 Penfill 100 e. / ml suspenzija za injiciranje v injekcijskem vložku
Soluble insulin aspart*/ protamine-crystallised insulin aspart*……... 100 U/ ml in the ratio of 30/ 70
Topni insulin aspart * / s protaminom kristalizirani insulin aspart * ……... 100 e. / ml v razmerju 30/ 70
* produced by recombinant DNA technology in Saccharomyces cerevisiae.
* pridobljen s tehnologijo rekombinantne DNA iz Saccharomyces cerevisiae.
One unit of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free anhydrous insulin aspart.
Ena enota insulina aspart ustreza 6 nmol, 0, 035 mg brezvodnega insulina aspart brez soli.
NovoMix 30 is a white suspension.
Zdravilo NovoMix 30 je bela suspenzija.
When necessary, NovoMix 30 can be given soon after a meal.
Zdravilo NovoMix 30 za ne delovati hitreje kot dvofazni humani insulin in ga je treba praviloma dati tik pred obrokom. e je potrebno, je mogo e zdravilo NovoMix 30 dati kmalu po obroku.
If convenient, the gluteal or deltoid region may be used.
Zdravilo NovoMix 30 se aplicira subkutano v stegno ali trebušno steno. e je prikladno, je mogo e uporabiti glutealni ali deltoidni predel.
Injection sites should be rotated within the same region.
Mesta injiciranj je treba znotraj anatomskega predela krožno menjati.
As with all insulins the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Tako kot pri vseh insulinih je trajanje delovanja spremenljivo, odvisno od odmerka, mesta injiciranja, krvnega pretoka, temperature in stopnje telesne dejavnosti.
The influence of different injection sites on the absorption of NovoMix 30 has not been investigated.
Vpliv razli nih mest injiciranj na absorpcijo zdravila NovoMix 30 ni raziskan.
NovoMix 30 should never be administered intravenously.
Zdravila NovoMix 30 se nikdar ne sme aplicirati intravensko.
Renal or hepatic impairment may reduce the patient’ s insulin requirements.
Okvara ledvic ali jeter lahko bolnikovo potrebo po insulinu zmanjša.
NovoMix 30 can be used in children and adolescents aged 10 years and above when premixed insulin is preferred.
NovoMix 30 je mogo e uporabiti pri otrocih in mladostnikih od 10. leta starosti naprej, kadar ima v terapiji prednost uporaba mešanega insulina.
For children 6-9 years limited clinical data exists (see section 5.1).
Pri otrocih od 6. do 9. leta starosti je klini nih podatkov malo (glejte poglavje 5. 1).
No studies have been performed in children under the age of 6 years.
Pri otrocih do 6. leta starosti študije niso bile izvedene.
Dose recommendation:
Priporo ila za odmerjanje:
Dosage of NovoMix 30 is individual and determined in accordance with the needs of the patient.
Odmerjanje zdravila NovoMix 30 je individualno in ga je treba dolo iti v skladu z bolnikovimi potrebami.
In patients with type 2 diabetes, NovoMix 30 can be given in monotherapy or in combination with oral antidiabetic drugs for which the combination with insulin is approved, when the blood glucose is inadequately controlled with those oral antidiabetic drugs alone.
Pri bolnikih z diabetesom tipa 2 je mogo e zdravilo NovoMix 30 uporabljati v monoterapiji ali v kombinaciji s peroralnimi antidiabetiki, za katere je odobrena kombinacija z insulinom, e glukoza v
For patients with type 2 diabetes, the recommended starting dose of NovoMix 30 is 6 U at breakfast and 6 U at dinner (evening meal).
Za bolnike z diabetesom tipa 2 je priporo eni za etni odmerek zdravila NovoMix 30 6 e. pri zajtrku in 6 e. pri ve erji (ve ernem obroku).
If twice daily dosing with NovoMix 30 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses (thrice daily dosing).
Zdravilo NovoMix 30 je mogo e uvesti tudi enkrat na dan z 12 e. pri ve erji (ve ernem obroku). e uporabljate zdravilo NovoMix 30 enkrat na dan, je praviloma priporo ljivo preiti na uporabo dvakrat na dan, ko odmerek doseže 30 enot; odmerek v tem primeru razdelite na enako velik jutranji in ve erni odmerek. e odmerjanje zdravila NovoMix 30 dvakrat na dan povzro a hipoglikemije ez dan, lahko jutranji odmerek razdelite na jutranji odmerek in odmerek pri kosilu (odmerjanje trikrat na dan).
The following titration guideline is recommended for dose adjustments:
Za prilagajanje odmerka so priporo ene naslednje smernice:
-2U
- 2 e.
+2U +4U +6U
+ 2 e. + 4 e. + 6 e.
The lowest of three previous days’ pre-meal levels should be used.
Za ocenjevanje je treba uporabiti najnižjo koncentracijo pred obrokom v zadnjih treh dneh.
The dose should not be increased if hypoglycaemia occurred within these days.
Odmerka ne smete pove ati, e se je v teh dneh pojavila hipoglikemija.
Dose adjustments can be made once a week until target HbA1c is reached.
Odmerek je mogo e prilagajati enkrat na teden, dokler ni dosežen ciljni HbA1c.
The combination of NovoMix 30 with pioglitazone should only be considered following clinical evaluation of the patient’ s risk of developing signs or symptoms of fluid-related adverse events.
Uporabo kombinacije zdravila NovoMix 30 in pioglitazona pretehtajte šele po klini ni oceni bolnikove ogroženosti za pojav znakov ali simptomov s teko ino povezanih neželenih u inkov.
The initiation of NovoMix 30 should be undertaken cautiously titrating to the lowest dose required to achieve glycaemic control (see section 4.4)
Zdravilo NovoMix 30 morate uvesti previdno in ga titrirati do najmanjšega odmerka, ki je potreben, da dosežete urejenost glikemije (glejte poglavje 4. 4).
In patients with type 1 diabetes the individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day.
Pri bolnikih z diabetesom tipa 1 je individualna potreba po insulinu ponavadi med 0, 5 in 1, 0 enot/ kg/ dan.
The daily insulin requirement may be higher in patients with insulin resistance (e. g. due to obesity), and lower in patients with residual endogenous insulin production.
Dnevne potrebe po insulinu so lahko ve je pri bolnikih z odpornostjo proti insulinu (npr. zaradi debelosti) in manjše pri bolnikih z rezidualnim endogenim nastajanjem insulina.
Then titrate according to individual needs (See titration guidelines in table above).
Potem odmerek prilagodite potrebam posameznega bolnika (glejte smernice za prilagajanje v zgornji preglednici).
NovoMix 30 can be used in elderly patients; however there is limited experience with the use of NovoMix 30 in combination with OADs in patients older than 75 years.
Zdravilo NovoMix 30 lahko uporabite pri starejših bolnikih, vendar so pri bolnikih, starejših od 75 let, izkušnje z njegovo uporabo v kombinaciji s peroralnimi antidiabetiki omejene.
• Hypersensitivity to the active substance or to any of the excipients • Hypoglycaemia.
• Preob utljivost za zdravilno u inkovino ali katero koli pomožno snov. • Hipoglikemija.
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin- dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Neustrezno odmerjanje ali prekinitev zdravljenja, posebno pri diabetesu, odvisnem od insulina, lahko vodi v hiperglikemijo in diabeti no ketoacidozo; stanji, ki sta lahko smrtni.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia (see section 4.8 and section 4.9).
Izpustitev obroka ali nena rtovana, naporna telesna dejavnost lahko povzro ita hipoglikemijo (glejte poglavji 4. 8 in 4. 9).
Compared with biphasic human insulin, NovoMix 30 may have a more pronounced glucose lowering effect up to 6 hours after injection.
V primerjavi z dvofaznim humanim insulinom lahko zdravilo NovoMix 30 mo neje znižuje glukozo do 6 ur po injiciranju.
This may have to be compensated for in the individual patient, through adjustment of insulin dose and/ or food intake.
Pri posameznih bolnikih je morda to treba kompenzirati s prilagoditvijo odmerka insulina in/ ali uživanjem hrane.
Patients, whose blood glucose control is greatly improved, e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
3 Bolnikom, ki se jim uravnanost glukoze v krvi zelo izboljša, npr. z intenziviranim insulinskim zdravljenjem, se obi ajni opozorilni simptomi hipoglikemije lahko spremenijo in jih je s to možnostjo treba seznaniti.
3 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.
Strožja urejenost koncentracije glukoze lahko pove a možnost hipoglikemije, zato je med pove evanjem odmerka potrebna posebna previdnost, kot je opisano v poglavju 4. 2.
NovoMix 30 should be administered in immediate relation to a meal.
Zdravilo NovoMix 30 je treba aplicirati neposredno ob obroku.
The rapid onset of action should therefore be considered in patients with concomitant diseases or treatment with other medicinal products where a delayed absorption of food might be expected.
Hiter za etek delovanja je treba upoštevati pri bolnikih, pri katerih je mogo e zaradi spremljajo ih bolezni ali zdravljenja z drugimi zdravili pri akovati upo asnjeno absorpcijo hrane.
Concomitant illness, especially infections, usually increases the patient’ s insulin requirements.
Spremljajo e bolezni, posebno okužbe, ponavadi zve ajo bolnikovo potrebo po insulinu.
When patients are transferred between different types of insulin products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Ob prehodu med razli nimi vrstami insulinov se lahko zgodnji opozorilni simptomi hipoglikemije spremenijo ali postanejo manj izraziti, kot so bili pri insulinu, ki ga je bolnik uporabljal prej.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
Prehod bolnika na novo vrsto ali znamko insulina mora potekati pod strogim zdravniškim nadzorom.
Changes in strength, brand (manufacturer), type, origin (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.
Zaradi sprememb v jakosti, znamki (izdelovalec), tipu, izvoru (živalski, humani, analog humanega insulina) in/ ali na inu izdelave insulina (tehnologija rekombinantne DNA v primerjavi z insulini živalskega izvora), bo morda treba spremeniti tudi odmerjanje insulina.
If dosage adjustment is needed, it may be done with the first dose or during the first few weeks or months.
Bolniki, ki uporabljajo zdravilo NovoMix 30, utegnejo potrebovati spremembo odmerjanja v primerjavi s svojimi obi ajnimi insulini. e je potrebna prilagoditev odmerka, jo je mogo e narediti pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
Prilagoditev odmerka je tudi lahko potrebna, e bolnik pove a telesno aktivnost ali spremeni obi ajno prehrano.
Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
Telesna aktivnost takoj po obroku lahko pove a tveganje za hipoglikemijo.
Insulin suspensions are not to be used in insulin infusion pumps.
Insulinskih suspenzij se ne sme uporabljati v infuzijskih rpalkah za insulin.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Kot pri vsakem zdravljenju z insulinom se lahko pojavijo reakcije na mestu injiciranja, vklju no z bole inami, srbenjem, koprivnico, oteklino in vnetjem.
Combination of NovoMix 30 with pioglitazone:
Kombinacija zdravila NovoMix 30 s pioglitazonom:
Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when NovoMix 30 is used in combination with pioglitazone.
Med pomarketinškim obdobjem so bili opisani primeri sr nega popuš anja med uporabo pioglitazona v kombinaciji z insulinom, zlasti pri bolnikih z dejavniki tveganja za sr no popuš anje. e zdravilo NovoMix 30 uporabite v kombinaciji s pioglitazonom, morate bolnike nadzirati glede znakov in simptomov sr nega popuš anja, pove evanja telesne mase in edemov.
As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of insulin may be necessary.
Morda bo potrebno zmanjšanje odmerka insulina.
Oral antidiabetic drugs (OAD), octreotide, monoamine oxidase inhibitors (MAOIs), non-selective beta-adrenergic blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Bolnikovo potrebo po insulinu lahko zmanjšajo naslednje snovi: peroralni antidiabetiki, oktreotid, zaviralci monoaminoksidaze (MAOI), neselektivni zaviralci adrenergi nih receptorjev beta, zaviralci encima angiotenzinske konvertaze (ACE), salicilati, alkohol, anabolni steroidi in sulfonamidi.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics and danazol.
Bolnikovo potrebo po insulinu lahko zve ajo naslednje snovi: peroralni kontraceptivi, tiazidi, glukokortikoidi, š itni ni hormoni, simpatikomimetiki in danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia.
4 Zaviralci beta lahko prikrijejo simptome hipoglikemije.
Alcohol may intensify and prolong the glucose lowering effect of insulin.
Alkohol lahko stopnjuje in podaljša u inek insulina na znižanje glukoze.
4 4.6 Pregnancy and lactation
4. 6 Nose nost in dojenje
There is limited clinical experience with NovoMix 30 in pregnancy.
Klini ne izkušnje z zdravilom NovoMix 30 med nose nostjo so omejene.
Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity.
Reprodukcijske študije na živalih niso odkrile razlik v embriotoksi nosti ali teratogenosti med insulinom aspart in humanim insulinom.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
V splošnem sta pri ženskah z diabetesom med celotno nose nostjo in pred na rtovano nose nostjo priporo ljiva intenzivnejša kontrola glukoze v krvi in spremljanje nose nice.
Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters.
Potreba po insulinu se v prvem trimese ju ponavadi zmanjša, potem pa se v drugem in tretjem trimese ju zve a.
After delivery, insulin requirements return rapidly to pre-pregnancy levels.
Po porodu se potreba po insulinu hitro vrne na raven pred nose nostjo.
There are no restrictions on treatment with NovoMix 30 during lactation.
Omejitev za zdravljenje z zdravilom NovoMix 30 med nose nostjo ni.
Insulin treatment of the breast-feeding mother presents no risk to the baby.
Zdravljenje doje e matere z insulinom ne pomeni nobene nevarnosti za dojen ka.
However, the NovoMix 30 dosage may need to be adjusted.
Lahko pa je potrebna prilagoditev odmerka zdravila NovoMix 30.
Patients should be advised to take precautions in order to avoid hypoglycaemia whilst driving.
Bolnikom je treba svetovati, naj upoštevajo ustrezne previdnostne ukrepe, da bi se izognili hipoglikemiji med upravljanjem vozila.
Adverse drug reactions observed in patients using NovoMix products are mainly dose-dependent and due to the pharmacologic effect of insulin.
Neželene reakcije, opažene pri bolnikih, ki uporabljajo zdravilo NovoMix, so v glavnem odvisne od odmerka in so posledica farmakološkega u inka insulina.
As for other insulin products, hypoglycaemia, in general is the most frequently occurring undesirable effect.
Tako kot pri drugih insulinih je praviloma najpogostejši neželeni u inek hipoglikemija.
It may occur if the insulin dose is too high in relation to the insulin requirement and therefore require special attention during dose intensification as outlined in section 4.2.
Pojavi se lahko, e je odmerek insulina prevelik glede na potrebo po insulinu, zato je med pove evanjem odmerka potrebna posebna previdnost, kot je opisano v poglavju 4. 2.