qanastek/EMEA-V3 huggingface dataset:
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).
Jei NovoMix 30 vartojimas du kartus per dien nesuteikia pakankamos glikemijos kontrol s ir/ ar pasireiškia dienin s hipoglikemijos epizod, tuomet rytin doz gali b ti dalijama dvi lygias dalis, vartojant pusry i ir piet metu (trij dozi vartojimas).
The following titration guideline is recommended for dose adjustments:
Tolimesnis doz s koregavimas turi b ti atliekamas remiantis titravimo rekomendacijomis, esan iomis žemiau:
Pre-meal blood glucose level
Gliukoz s kiekis kraujyje prieš valg < 4, 4 mmol/ l < 80 mg/ dl
NovoMix 30 dose adjustment
NovoMix 30 doz s reguliavimas - 2V
+2U +4U +6U
+2V +4V +6V
The lowest of three previous days’ pre-meal levels should be used.
Turi b ti naudojamas žemiausias prieš tai buvusi trij dien gliukoz s kiekio kraujyje prieš valg parodymas.
The dose should not be increased if hypoglycaemia occurred within these days.
Doz s negalima didinti, jei per tas dienas pasireišk hipoglikemija.
Dose adjustments can be made once a week until target HbA1c is reached.
Doz s reguliavimai gali b ti atliekami kart per savait, kol yra pasiekimas HbA1c rodiklis.
Pre-meal blood glucose levels should be used to evaluate the adequacy of the preceding dose.
Turi b ti stebimas gliukoz s kiekis kraujyje prieš valg siekiant sitikinti prieš tai buvusios doz s atitikimu.
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.
NovoMix 30 kartu su pioglitazonu turi b ti skiriamas tik kliniškai vertinus sutrikusios skys i apykaitos nepageidaujam poveiki požymi ar simptom rizik pacientui.
The initiation of NovoMix 30 should be undertaken cautiously titrating to the lowest dose required to achieve glycaemic control (see section 4.4)
4. 4 skyri).
In patients with type 1 diabetes the individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day.
Pacientams, sergantiems 1 tipo cukriniu diabetu, individualus insulino poreikis paprastai yra tarp 0, 5 ir 1, 0 Vieneto/ kg/ per par.
NovoMix 30 may fully or partially meet this requirement.
NovoMix 30 pilnai ar iš dalies atitinka š reikalavim.
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.
Insulino paros poreikis gali padid ti pacientams, kuriems atsirado rezistentiškumas insulinui (pvz., d l nutukimo), ir sumaž ti pacientams, kuriems išlikusi endogeninio insulino gamyba.
When transferring a patient from biphasic human insulin to NovoMix 30, start with the same dose and regimen.
Pervedant pacientus nuo dvifazio žmogaus insulino prie NovoMix 30, gydym reikia prad ti nuo tos pa ios doz s ir režimo.
Then titrate according to individual needs (See titration guidelines in table above).
V liau koreguoti pagal individualius poreikius (žr. titravimo rekomendacijas lentel je aukš iau).
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.
NovoMix 30 gali b ti skiriamas senyviems pacientams; ta iau, n ra pakankamai patirties, kaip NovoMix 30 vartoti kartu su geriamaisiais vaistais nuo diabeto vyresniems nei 75 met amžiaus žmon ms.
• Hypersensitivity to the active substance or to any of the excipients • Hypoglycaemia.
• Padid j s jautrumas veikliajai arba bet kuriai pagalbinei medžiagai. • 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.
Nepakankam dozi vartojimas ar gydymo nutraukimas, ypa sergant nuo insulino priklausomu cukriniu diabetu, gali paskatinti hiperglikemijos ir diabetin s ketoacidoz s atsiradim; šios b kl s yra pavojingos gyvybei.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia (see section 4.8 and section 4.9).
4. 8 skyri ir 4. 9 skyri).
Compared with biphasic human insulin, NovoMix 30 may have a more pronounced glucose lowering effect up to 6 hours after injection.
Palyginti su dvifaziu žmogaus insulinu, NovoMix 30 gali tur ti stipresn cukraus kiek
This may have to be compensated for in the individual patient, through adjustment of insulin dose and/ or food intake.
Tai gali tekti kompensuoti, individualiai sureguliuojant insulino doz ir / ar mityb.
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.
Pacientams, kuri gliukoz s kiekis kraujyje yra gerai kontroliuojamas, pvz., taikant intensyvesn insulino terapij, gali pasikeisti sp jam j hipoglikemijos simptom pob dis, tod l juos reikia apie tai sp ti.
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.
Gliukoz s kiekio reguliavimas gali padidinti hipoglikemijos epizod rizika, tod l tai reikia atkreipti d mes nustatant dozes, kaip pažym ta 4. 2 skyriuje.
NovoMix 30 should be administered in immediate relation to a meal.
NovoMix 30 tur t b ti vartojamas, esant betarpiškam ryšiui su maistu.
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.
Tod l reik t prisiminti greit vaisto veikimo pradži pacientams, sergantiems gretutin mis ligomis ar vartojantiems kit medicinini preparat, kurie gali l tinti maisto rezorbcij.
Concomitant illness, especially infections, usually increases the patient’ s insulin requirements.
Gretutin s ligos, ypa infekcin s, paprastai padidina paciento insulino poreik.
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.
Pervedant pacientus nuo vieno insulino tipo prie kito, ankstyvieji sp jamieji hipoglikemijos požymiai gali pakisti ar b ti mažiau išreikšti, nei vartojant ankstesnio insulino.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
Kei iant vieno tipo ar r šies insulin kitu, pacient turi atidžiai priži r ti gydytojas.
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.
Pakeitus insulino stiprum, prekin ženkl (gamintoj), tip, r š (gyvulinis, žmogaus, žmogaus insulino analogas) ir / ar gamybos b d (rekombinantin s DNR ar gyvulin s kilm s insulinas), gali tekti keisti insulino doz.
Patients taking NovoMix 30 may need a change in dosage from that used with their usual insulin.
Pacientams, vartojantiems NovoMix 30, gali reik ti pakeisti doz, prie kurios jie buvo prat vartodami prast insulin preparat.
If dosage adjustment is needed, it may be done with the first dose or during the first few weeks or months.
Jei reikia sureguliuoti doz, tai gali b ti atlikta skiriant pirm j doz, ar per pirmas kelet savai i ar m nesi.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
Doz s sureguliavimas gali b ti b tinas, jei pacientas padidina fizin aktyvum ar pakei ia prast diet.
Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
Pratimai, atliekami iš karto po valgio, gali padidinti hipoglikemijos rizik.
Insulin suspensions are not to be used in insulin infusion pumps.
Insulino suspensijos negalima vartoti insulino infuzij pompose.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Injekcijos viet reikia nuolat keisti nustatytame plote, kad išvengti ar sušvelninti šias reakcijas.
On rare occasions, injection site reactions may require discontinuation of NovoMix 30.
Retais atvejais reikia nutraukti NovoMix 30 vartojim, kad išnykt injekcijos vietos reakcijos.
Combination of NovoMix 30 with pioglitazone:
NovoMix 30 vartojimas kartu su pioglitazonu:
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.
Vartojant pioglitazon kartu su insulinu pasteb ta širdies nepakankamumo atvej, ypa pacientams, kuriems yra padid jusi rizika susirgti širdies nepakankamumu.
Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when NovoMix 30 is used in combination with pioglitazone.
NovoMix 30 vartojant kartu su pioglitazonu, reikia steb ti ar pacientams neatsiranda širdies nepakankamumo požymi bei simptom, ar nedid ja svoris ir edema.
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.
Dvigubos terapijos pasekoje, kuomet pacientai gydomi pioglitazonu ir insulinu, padid ja jautrumas insulinui, ir padid ja nuo doz s priklausomos hipoglikemijos rizika.
4.5 Interaction with other medicinal products and other forms of interaction
Tuomet, gali reik ti mažinti insulino doz.
A number of medicinal products are known to interact with the glucose metabolism.
4. 5 S veika su kitais vaistiniais preparatais ir kitokia s veika
The following substances may reduce the patient’ s insulin requirements:
Žinoma, kad nemažai vaist s veikauja su gliukoz s metabolizmu.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics and danazol.
Šios medžiagos gali sumažinti insulino poreik: geriamieji priešdiabetiniai vaistai, oktreotidas, monoaminoksidaz s inhibitoriai (MAOI), neselektyv s beta - adrenoblokatoriai, angiotenzin konvertuojan i ferment (AKF) inhibitoriai, salicilatai, alkoholis, anaboliniai steroidai ir sulfonamidai.
Alcohol may intensify and prolong the glucose lowering effect of insulin.
Šios medžiagos gali padidinti insulino poreik: geriamieji kontraceptikai, tiazidai, gliukokortikoidai, skydliauk s hormonai, simpatomimetikai ir
4 4.6 Pregnancy and lactation
4 danazolis.
There is limited clinical experience with NovoMix 30 in pregnancy.
Turima ribota klinikin patirtis, vartojant NovoMix 30 n štumo metu.
Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity.
Gyv n reprodukcijos tyrimai, susij su embriotoksiškumu ir teratogeniškumu, neparod joki skirtum tarp insulino asparto ir žmogaus insulino.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Paprastai, rekomenduojama intensyvi n š i j, sergan i diabetu, gydymo kontrol n štumo ir n štumo planavimo metu.
Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters.
Insulino poreikis paprastai sumaž ja pirm j n štumo trimestr ir v liau padid ja antr j ir tre i j trimestr.
After delivery, insulin requirements return rapidly to pre-pregnancy levels.
Po gimdymo, insulino poreikis paprastai gr žta prieš tai buvus lyg.
There are no restrictions on treatment with NovoMix 30 during lactation.
Žindymo metu n ra joki apribojim gydyti NovoMix 30.
Insulin treatment of the breast-feeding mother presents no risk to the baby.
Kr timi maitinan i motin gydymas insulinu nekelia jokios rizikos vaikui.
However, the NovoMix 30 dosage may need to be adjusted.
Ta iau NovoMix 30 doz gali reik ti koreguoti.
No studies on the effects on the ability to drive and use machines have been performed.
Poveikis geb jimui vairuoti ir valdyti mechanizmus netirtas.
Patients should be advised to take precautions in order to avoid hypoglycaemia whilst driving.
Pacientui reik t patarti imtis atsargumo priemoni, siekiant išvengti hipoglikemijos vairuojant.
Adverse drug reactions observed in patients using NovoMix products are mainly dose-dependent and due to the pharmacologic effect of insulin.
Nepageidaujamos reakcijos vaist pacientams, vartojantiems NovoMix preparatus, daugiausiai yra priklausomos nuo doz s ir farmakologinio insulino poveikio.
As for other insulin products, hypoglycaemia, in general is the most frequently occurring undesirable effect.
Kaip ir vartojant kitus insulino preparatus, hipoglikemija yra dažniausiai pasireiškiantis nepageidaujamas poveikis.
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.
Taip gali atsitikti, jei insulino doz yra per didel, lyginant su insulino poreikiu ir tod l b tina atkreipti tai d mes, nustatant insulino dozes, kaip pažym ta 4. 2 skyriuje.
In clinical trials and during marketed use the frequency varies with patient population and dose regimens therefore no specific frequency can be presented.
Klinikini tyrim metu ir pateikus vaist rink, hipoglikemijos dažnis kinta priklausomai nuo sergan i j skai iaus tarp gyventoj ir dozavimo, tod l negalima nurodyti jokio specifinio dažnio.
During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
Klinikini tyrim metu nustatyta, kad hipoglikemijos dažnis, gydant pacient insulinu aspartu ar žmogaus insulinu, yra panašus.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
Klinikini tyrim metu nustatytas nepageidaujam reakcij dažnis, susij s su insulino asparto vartojimu, pateikiamas žemiau.
Uncommon (> 1/ 1,000 ,< 1/100) and rare (> 1/10 ,000, < 1/1,000).
Dažnis apib dinamas: nedažni (> 1/ 1000, < 1/ 100) ir reti (> 1/ 10000, < 1/ 1000).
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.
Pavieniai, spontaniniai atvejai pateikiami kaip labai reti ir apib dinami kaip (< 1/ 10000), skaitant ir pavienius pranešimus,.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Kiekvienoje dažnio grup je nepageidaujamas poveikis pateikiamas maž jan ia sunkumo tvarka.
Immune system disorders Uncommon - Urticaria, rash, eruptions
Imunin s sistemos sutrikimai Nedažni - Dilg lin, išb rimas, erupcija.
Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure.
5 Generalizuoti padid jusio jautrumo simptomai apima bendr odos išb rim, niež jim, prakaitavim, virškinamojo trakto sutrikim, angioneurozin edem, sunkum kv puoti, širdies plakim ir kraujo spaudimo maž jim.
Generalised hypersensitivity reactions are potentially life threatening.
Generalizuotos padid jusio jautrumo reakcijos yra pavojingos gyvybei.
5 Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
Greitas gliukoz s kiekio kraujyje pagerinimas gali b ti susij s su tam tikra b kle, vadinama mia skausminga neuropatija, kuri paprastai yra gr žtama.
Eye disorders Uncommon - Refraction disorder Refraction anomalies may occur upon initiation of insulin therapy.
Refrakcijos sutrikim gali atsirasti gydymo insulinu pradžioje.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
Ta iau insulino terapijos sustiprinimas, siekiant staigaus glikemijos kontrol s pagerinimo, gali b ti susij s su diabetin s retinopatijos blog jimu.
Uncommon - Local hypersensitivity Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Vietin s padid jusio jautrumo reakcijos (paraudimas, patinimas ir niež jimas injekcijos vietoje) gali pasireikšti gydymo insulinu metu.
These reactions are usually transitory and normally they disappear during continued treatment.
Šios reakcijos yra praeinan ios savaime ir paprastai išnyksta t siant gydym.
General disorders and administration site conditions Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Edema gali atsirasti gydymo insulinu pradžioje.
Oedema and weight increase may occur when NovoMix 30 is used in combination with OADs.
NovoMix 30 vartojant kartu su geriamaisiais vaistais nuo diabeto, gali atsirasti edema ir padid ti svoris.
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’ s requirement are administered:
Nenustatyta joki specifini insulino perdozavimo simptom, ta iau gali b ti šios hipoglikemijos stadijos, jei vartojamos didesn s, nei reikalinga pacientui, doz s:
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
• Silpni hipoglikemijos epizodai gali b ti gydomi skiriant geriamosios gliukoz s ar cukraus produkt.
It is therefore recommended that the diabetic patient always carry sugar-containing products • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
Tod l rekomenduojama, kad cukriniu diabetu sergantys pacientai visada nešiot si cukraus turin i produkt. • Stipr s hipoglikemijos epizodai, kai pacientas netenka s mon s, gali b ti gydomi gliukagono (0, 5 - 1 mg) injekcija raumenis ar pood, kuri sušvirkšti gali tai daryti mokantis asmuo, arba gliukoze, kurios ven turi sušvirkšti gydytojas.
Glucose must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Taip pat ven gliukoz s turi b ti švirkš iama tada, kai gliukagonas per 10 - 15 minu i nepadeda.
Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Pacientui atgavus s mon, rekomenduojama duoti geriam j angliavandeni, siekiant išvengti priepuolio pasikartojimo.
Drugs used in diabetes.
Farmakoterapin grup: vaistai, vartojami cukrinio diabeto gydymui.
Insulins and analogues for injection, intermediate-acting combined with fast-acting.
Injekciniai insulinai ir analogai, vidutinio veikimo, kombinuoti su greito veikimo.
A10AD05.
ATC kodas - A10AD05.
NovoMix 30 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
6 NovoMix 30 yra dvifaz insulino asparto (greitai veikian io žmogaus insulino analogo) ir insulino asparto kristalizuoto protamino (vidutinio veikimo žmogaus insulino analogo) suspensija.
6 The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
Gliukoz s kiek kraujyje mažinantis insulino poveikis pasireiškia tod l, kad insulinas, prisijungdamas prie receptori raumenyse ir riebal l stel se, gerina gliukoz s suvartojim ir tuo pa iu metu slopina gliukoz s išsiskyrim iš kepen.
NovoMix 30 is a biphasic insulin, which contains 30% soluble insulin aspart.
NovoMix 30 yra dvifazis insulinas, kuriame yra 30% tirpaus insulino asparto.
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.
Palyginus su tirpiu žmogaus insulinu, NovoMix 30 poveikis pasireiškia grei iau, tod l gali b ti skiriamas valgant (iki 10 minu i prieš valg arba nuo valgymo pradžios).
The crystalline phase (70%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin (Figure 1).
Kristalin faz (70%) sudaro insulino asparto kristalizuotas protaminas, kurio veikimo pob dis panašus žmogaus NPH insulino (1 pav.).
When NovoMix 30 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Kai NovoMix 30 švirkš iama po oda, jis pradeda veikti per 10 - 20 min. po injekcijos.
The maximum effect is exerted between 1 and 4 hours after injection.
Veikimo trukm - iki 24 val.
Hours
Valandos
Figure 1:
1 pav.
Activity profile of NovoMix 30 (___) and biphasic human insulin 30 (---) in healthy subjects.
NovoMix 30 (___) ir dvifazio žmogaus insulino 30 (- - -) veikimo pob dis po švirkštimo sveikiems asmenims.
In a 3 month trial in patients with type 1 and type 2 diabetes NovoMix 30 showed equal control of glycosylated haemoglobin compared to treatment with biphasic human insulin 30.
3 m n. trukm s tyrim metu, tiriant pacientus, sergan ius 1 ir 2 tipo cukriniu diabetu, NovoMix 30 glikolizuoto hemoglobino kiek kontroliavo taip pat, kaip ir dvifazis žmogaus insulinas 30.
Insulin aspart is equipotent to human insulin on a molar basis.
Insulinas aspartas pagal moliariškum yra ekvipotencinis žmogaus insulinui.
Compared to biphasic human insulin 30, administration of NovoMix 30 before breakfast and dinner resulted in lower postprandial blood glucose after both meals (breakfast and dinner).
Palyginus su dvifaziu žmogaus insulinu 30, NovoMix 30 vartojimas prieš pusry ius ir vakarien sumažina postprandin glikemij po abiej valgym (pusry i ir vakarien s).
A meta-analysis including nine trials in patients with type 1 and type 2 diabetes showed that fasting blood glucose was higher in patients treated with NovoMix 30, than in patients treated with biphasic human insulin 30.
Devyni tyrim, atlikt su 1 ir 2 tipo diabetu sergan iais pacientais, duomen analiz parod, kad nevalgius cukraus kiekis kraujyje buvo didesnis pacientams, gydytiems NovoMix 30 nei pacientams, vartojusiems dvifaz žmogaus insulin 30.
In one study, 341 patients with type 2 diabetes were randomised to treatment with NovoMix 30 either alone or in combination with metformin, or to metformin together with sulfonylurea.
Viename tyrime 341 pacientas, sergantis 2 tipo cukriniu diabetu, buvo atsitiktinai gydomi arba tik NovoMix 30, arba skiriant j kartu su metforminu, arba skiriant metformin kartu su sulfonilšlapalu.
The primary efficacy variable - HbA1c after 16 weeks of treatment - did not differ between patients with NovoMix 30 combined with metformin and patients with metformin plus sulfonylurea.
Pirminis efektyvumas - HbA1c po 16 gydymo savai i - nesiskyr pacientams, gydytiems NovoMix 30 ir metforminu, bei pacientams, kuriems buvo skiriama metformino ir sulfonilšlapalo.
In this trial 57% of the patients had baseline HbA1c above 9%; in these patients treatment with NovoMix 30 in combination with metformin resulted in significantly lower HbA1c than metformin in combination with sulfonylurea.
Šiame tyrime 57% pacient bazinis HbA1c buvo virš 9%; šiems pacientams gydymas, skiriant NovoMix 30 kartu su metforminu, žymiai sumažino HbA1c, nei skiriant metformin kartu su sulfonilšlapalu.
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).
Po 28 savai i gydymo
After 28 weeks treatment following the dosing guideline outlined in section 4.2, the mean reduction in HbA1c was 2.8% with NovoMix 30 (mean at baseline = 9.7%).
7 remiantis dozavimo rekomendacijomis (pažym tomis 4. 2 dalyje), vidutinis HbA1c sumaž jimas vartojant NovoMix 30 buvo 2, 8% (vidutiniškai nuo bazinio =9, 7%).
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).
Vartojant NovoMix 30, 66% ir 42% pacient pasiek HbA1c lyg žemiau 7% ir 6, 5% ir FPG vidurkis buvo sumažintas apie 7 mmol/ l (nuo 14, 0 mmol/ l iki bazinio 7, 1 mmol/ l).
7 In patients with type 2 diabetes a meta-analysis showed a reduced risk of overall nocturnal hypoglycaemic episodes and major hypoglycaemia with NovoMix 30 compared to biphasic human insulin 30.
Pacientams, sergantiems 2 tipo diabetu ir vartojusiems NovoMix 30, tyrim duomenys rodo sumaž jusi naktini ir sunki hipoglikemij rizik, lyginant su dvifaziu žmogaus insulinu 30.
The risk of overall daytime hypoglycaemic episodes was increased in patients treated with NovoMix 30
Ta iau bendra dienini hipoglikemij rizika padid jo pacientams, gydytiems NovoMix 30.
A 16-week clinical trial comparing postprandial glycaemic control of meal- related NovoMix 30 with meal-related human insulin/ biphasic human insulin 30 and bedtime NPH insulin was performed in 167 subjects aged 10 to 18 years.
Tyrimas atliktas 167- iems 10- 18 met amžiaus asmenims.
Mean HbA1c remained similar to baseline throughout the trial in both treatment groups, and there was no difference in hypoglycaemia rate with NovoMix 30 or biphasic human insulin 30.
Vidutinis glikuotas hemoglobinas liko toks pat, kaip ir pradžioje, viso tyrimo metu abiejose grup se, hipoglikemij dažnis buvo vienodas naudojant NovoMix 30 ar dvifaz žmogaus insulin 30.
In a smaller (54 subjects) and younger (age range 6 to 12 years) population, treated in a double-blind, cross-over trial (12 weeks on each treatment) the rate of hypoglycaemic episodes and the postprandial glucose increase was significantly lower with NovoMix 30 compared to biphasic human insulin 30.
Mažesn je (54 asmenys) grup je ir jaunesni asmen populiacijoje (6- 12 met amžiaus), dvigubai aklas ir kryžminis tyrimas (12 savai i trukm s gydymas su kiekvienu medikamentu) parod, kad hipoglikemijos epizod dažnumas ir postprandin s glikemijos padid jimas buvo žymiai mažesni vartojant NovoMix 30 nei dvifaz žmogaus insulin 30.
Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with NovoMix 30.
Galutinis HbA1C buvo žymiai mažesnis gydant dvifaziu žmogaus insulinu 30 nei NovoMix 30,
In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers in the soluble fraction of NovoMix 30, as compared with soluble human insulin.
Palyginus su tirpiu žmogaus insulinu, pakei iant insuline asparte amino r gšt prolin asparto r gštimi B28 pad tyje, sumaž ja polinkis sudaryti heksamerus tirpioje NovoMix 30 frakcijoje.
The insulin aspart in the soluble phase of NovoMix 30 comprises 30% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
Insulinas aspartas tirpioje NovoMix 30 faz je sudaro 30% viso insulino: tai iš poodinio sluoksnio rezorbuojama daug grei iau nei tirpaus insulino dalis iš dvifazio žmogaus insulino.
The remaining 70% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Likusieji 70% yra kristal formos kaip kristalizuotas insulino asparto protaminas; jo rezorbcija ilga, panaši žmogaus NPH insulino.
The maximum serum insulin concentration is, on average, 50% higher with NovoMix 30 than with biphasic human insulin 30.
Vidutiniškai maksimali insulino koncentracija serume yra 50% didesn vartojant NovoMix 30 nei dvifazio žmogaus insulino 30.
The time to maximum concentration is, on average, half of that for biphasic human insulin 30.
Laikas iki maksimalios koncentracijos susidarymo vidutiniškai yra pus dvifazio žmogaus insulino 30 laiko.
In healthy volunteers a mean maximum serum concentration of 140 ± 32 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.20 U/ kg body weight.
Sveikiems savanoriams vidutin maksimali serumo koncentracija 140 ± 32 pmol/ l susidar pra jus 60 min. po poodin s 0, 20 V/ kg k no svorio doz s.
The mean half life (t½) of NovoMix 30, reflecting the absorption rate of the protamine bound fraction, was about 8-9 hours.
Vidutinis NovoMix 30 pusin s eliminacijos laikas (t½), atspindintis su protaminu susijungusios frakcijos rezorbcij, buvo apie 8 - 9 val.
Serum insulin levels returned to baseline 15-18 hours after a subcutaneous dose.
Insulino kiekis serume toks, kaip buvo pradžioje tapo pra jus 15 - 18 val. po poodin s doz s.
In type 2 diabetic patients, the maximum concentration was reached about 95 minutes after dosing, and concentrations well above zero for not less than 14 hours post-dosing were measured.
2 tipo cukriniu diabetu sergantiems pacientams maksimali koncentracija susidar po 95 min. sušvirkštus doz, o koncentracija, gerokai didesn už nulin, susidar pra jus ne mažiau kaip 14 val. po doz s sušvirkštimo.
The pharmacokinetics of NovoMix 30 has not been investigated in children or adolescents.
NovoMix 30 farmakokinetika nebuvo tirta vaisto vartojant vaikams ir paaugliams.
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.
Ta iau, farmakokinetin s ir farmakodinamin s tirpaus insulino asparto savyb s buvo tirtos, vaisto vartojant vaikams (6 – 12 met) bei paaugliams (13 – 17 met), sergantiems 1 tipo diabetu.
Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults.
Insulinas aspartas buvo greitai rezorbuojamas abiejose amžiaus grup se, esant panašiam tmax kaip ir suaugusiesiems.
However, Cmax differed between the age groups, stressing the importance of the individual titration of insulin aspart.
Ta iau Cmax skyr si tarp amžiaus grupi, tai pabr žia individualaus insulino asparto titravimo svarb.
The pharmacokinetics of NovoMix 30 has not been investigated in elderly, or patients with impaired renal or liver function.
NovoMix 30 farmakokinetika nebuvo tirta vyresnio amžiaus pacientams, ar pacientams, kuri inkst ar kepen funkcija buvo pažeista.
Non-clinical data with insulin aspart reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
prast farmakologinio saugumo, kartotini dozi toksiškumo, genotoksiškumo ir toksinio poveikio reprodukcijai ikiklinikini tyrim su insulinu aspartu duomenys specifinio pavojaus žmogui nerodo.
In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin.
Tyrimai taip pat parod,
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
8 kad insulino asparto prisijungimo prie insulino receptori disociacija atitinka žmogaus insulino.
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Glicerolis Fenolis Metakrezolis Cinkas (chlorido pavidalu) Natrio chloridas Dinatrio fosfato dihidratas Protamino sulfatas Natrio hidroksidas (pH sureguliavimui) Vandenilio chlorido r gštis (pH sureguliavimui) Injekcinis vanduo
In absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Suderinamumo tyrim neatlikta, tod l šio vaistinio preparato maišyti su kitais negalima.
The in-use shelf life is 4 weeks (not above 30°C).
Prad jus vartoti, tinkamumo laikas yra 4 savait s (ne aukštesn je kaip 30 °C temperat roje).
Store in a refrigerator (2°C – 8°C) away from the freezing compartment.
Laikyti šaldytuve (2 °C – 8 °C temperat roje), toliau nuo šaldymo kameros.
NovoMix 30 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 30 Penfill užtaisai, kurie vartojami ar nešiojami kaip atsarga: gali b ti laikomi kambario temperat roje (ne aukštesn je kaip 30 ºC) iki 4 savai i, ta iau bet koks likutis po to turi b ti išmetamas.
Keep the cartridges in the outer carton in order to protect from light.
Užtaisus laikyti išorin je d žut je, kad preparatas b t apsaugotas nuo šviesos.
After removing NovoMix 30 Penfill from the refrigerator it is recommended to allow NovoMix 30 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
Iš mus NovoMix 30 Penfill iš šaldytuvo, prieš suplakant insulin pagal instrukcijas, kaip nurodoma naudojantis pirm kart, rekomenduojama palaikyti NovoMix 30 Penfill kambario temperat roje, kad sušilt.
A glass (Type 1) cartridge which is closed with a latex-free (bromobutyl) rubber piston at one end and a latex-free (bromobutyl/ polyisoprene) rubber closure at the other.
1 tipo stiklinis užtaisas yra su latekso neturin iu (bromobutilo) guminiu st mokliu ir yra uždarytas latekso neturin iu (bromobutilo / poliizopreno) guminiu kamš iu.
The cartridge contains a glass ball to facilitate resuspension.
Kad lengviau b t sumaišyti, užtaise yra stiklinis rutuliukas.
Each cartridge contains 3 ml suspension.
Viename užtaise yra 3 ml suspensijos.
Cartons of 5 or 10 cartridges.
D žut je gali b ti 5 ar 10 užtais.
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
Užtaisas yra skirtas naudoti su Novo Nordisk švirkštimo sistemomis (ilgalaikio daugkartinio naudojimo priemon mis) ir NovoFine adatomis.
Detailed instruction accompanying the cartridge and delivery system must be followed.
Kartu su užtaisu ir švirkštimo sistemomis turi b ti pateikiama detali naudojimo instrukcija.
NovoMix 30 Penfill is for use by one person only.
9 NovoMix 30 Penfill skirtas vartoti tik vienam asmeniui.
The cartridge must not be refilled.
Užtaiso negalima pildyti pakartotinai.
9 The necessity of resuspending the NovoMix 30 suspension immediately before use is to be stressed to the patient.
Pacientui turi b ti nurodyta, kad prieš pat naudojant NovoMix 30 suspensij b tina suplakti.
The resuspended liquid must appear uniformly white and cloudy.
Suplaktas skystis turi atrodyti tolygiai baltas ir drumstas.
NovoMix 30 which has been frozen must not be used.
Jei NovoMix 30 buvo užšaldytas, jo vartoti negalima.
The patient should be advised to discard the needle after each injection.
Pacientui tur t b ti patariama po kiekvienos injekcijos pakeisti adat.
MARKETING AUTHORISATION NUMBERS
RINKODAROS PAŽYM JIMO NUMERIAI
1 August 2000 Date of last renewal:
1 d.
1 August 2005
2005 m. rugpj io m n.
NovoMix 50 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 50 Penfill 100 V/ ml, injekcin suspensija užtaise.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*…… ..100 U/ ml in the ratio of 50/ 50
Tirpus insulinas aspartas / kristalizuotas insulino asparto protaminas * … 100 V/ ml, santykis 50/ 50.
1 cartridge contains 3 ml equivalent to 300 U.
1 užtaise yra 3 ml, atitinkantys 300 V.
NovoMix 50 is a white suspension.
NovoMix 50 yra balta suspensija.
The rapid onset of action and early peak of activity of insulin aspart allows NovoMix 50 to be given immediately before a meal.
Kadangi insulinas aspartas pradeda greitai veikti ir anksti pasiekia aktyvumo pik, NovoMix 50 galima skirti prieš pat valg.
When necessary, NovoMix 50 can be given soon after start of a meal.
Kai reikalinga, NovoMix 50 gali b ti vartojamas tuoj pat po valgio.
Dosage of NovoMix 50 is individual and determined on the basis of the physician’ s advice in accordance with the patient’ s needs.
NovoMix 50 doz individuali, j nustato gydytojas, atsižvelgdamas paciento poreikius.
The individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day in adult patients and this may be fully or partially supplied with NovoMix 50.
Individualus insulino poreikis suaugusiems pacientams paprastai yra tarp 0, 5 ir 1, 0 Vieneto/ kg/ per par, ir tai gali b ti visiškai arba iš dalies patenkinama su NovoMix 50.
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.
Insulino paros poreikis gali b ti didesnis pacientams, kurie yra rezistentiški insulinui (pvz., d l nutukimo), ir mažesnis pacientams, kuriems išlikusi endogeninio insulino gamyba.
In patients with type 2 diabetes, NovoMix 50 can be given in monotherapy or in combination with metformin, when the blood glucose is inadequately controlled with metformin alone.
Pacientams, sergantiems 2 tipo diabetu, NovoMix 50 gali b ti naudojamas vienas arba kartu su metforminu, kai gliukoz s kiekis kraujyje yra nepakankamai kontroliuojamas, vartojant vien tik metformin.
Transfer to NovoMix 50 from other insulin preparations may require adjustment of dose and timing of administration.
Gydym kitais insulin preparatais kei iant NovoMix 50, gali reik ti koreguoti doz ir skyrimo laik.
As with all insulins, close glucose monitoring is recommended during transition and the initial weeks thereafter (see section 4.4).
4. 4 skyri).
Adjustment of dosage may also be necessary if patients change their diet.
Jei pacientai kei ia diet, taip pat gali b ti reikalinga koreguoti dozavim.
Physical activity may reduce the patients’ insulin requirements.
Insulino poreikis gali sumaž ti d l paciento fizinio aktyvumo.
In patients with diabetes mellitus optimised metabolic control effectively delays the onset and slows the progression of diabetic late complications.
Cukriniu diabetu sergantiems pacientams taikoma optimali medžiag apykaitos kontrol efektyviai atitolina v lyv j diabeto komplikacij pradži ir sul tina j progresavim.
Optimised metabolic control, including glucose monitoring, is therefore recommended.
Tod l rekomenduojama optimaliai kontroliuoti medžiag apykait, taip pat ir tikrinti gliukoz s kiek kraujyje.
11 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
11 Kaip ir skiriant visus insulinus, vyresniems pacientams arba pacientams, kuriems yra kepen arba inkst funkcijos nepakankamumas, reik t atidžiau tikrinti gliukoz s kiek ir individualiai parinkti doz.
Renal or hepatic impairment may reduce the patient’ s insulin requirements.
Jei yra inkst arba kepen nepakankamumas, insulino poreikis gali b ti mažesnis.
No studies have been performed with NovoMix 50 in children and adolescents under the age of 18 years.
N ra atlikta NovoMix 50 tyrim, skiriant jo vaikams ir paaugliams iki 18 met.
Administration:
Vartojimo metodas:
NovoMix 50 is administered subcutaneously by injection in the thigh or in the abdominal wall.
NovoMix 50 švirkš iamas po oda šlaun ar pilvo sien.
If convenient, the gluteal or deltoid region may be used.
Jei patogu, galima švirkšti s dmen ar deltinio raumens paviršiaus srit.
Injection sites should be alternated within the same region.
Injekcijos vietos turi b ti kei iamos tos pa ios srities ribose.
As with all types of insulin, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Kaip ir vartojant vis tip insulinus, veikimo trukm gali kisti, ji priklauso nuo doz s, injekcijos vietos, kraujotakos, temperat ros ir fizinio aktyvumo.
The influence of different injection sites on the absorption of NovoMix 50 has not been investigated.
Skirting injekcijos viet taka NovoMix 50 rezorbcijai n ra tirta.
NovoMix 50 should never be administered intravenously.
NovoMix 50 negalima švirkšti ven.
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.
Nepakankam dozi vartojimas ar gydymo nutraukimas, ypa sergant nuo insulino priklausomu cukriniu diabetu, gali paskatinti hiperglikemijos ir diabetin s ketoacidoz s atsiradim; šios b kl s gali b ti pavojingos gyvybei.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia (see section 4.8 and section 4.9).
4. 8 ir 4. 9 skyrius).
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.
Pacientams, kuri gliukoz s kiekio kraujyje kontrol žymiai pager ja, pvz., taikant intensyvesn insulino terapij, gali pasikeisti sp jam j hipoglikemijos simptom pob dis, tod l juos reikia apie tai sp ti.
NovoMix 50 should be administered in immediate relation to a meal.
NovoMix 50 tur t b ti vartojamas, esant betarpiškam ryšiui su maistu.
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.
Pacientams, sergantiems gretutin mis ligomis ar gydomiems kitais vaistais, kurie gali l tinti maisto rezorbcij, reik t priminti apie šio vaisto greit veikimo pradži.
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.
Pakeitus vieno tipo insulin kitu, ankstyvieji sp jamieji hipoglikemijos požymiai gali pakisti ar pasireikšti silpniau, nei vartojant ankstesnio insulino.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
Kei iant vieno tipo ar r šies insulin kitu, pacient turi atidžiai steb ti gydytojas.
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.
Pakeitus insulino stiprum, prekin ženkl (gamintoj), tip, r š (gyvulinis, žmogaus, žmogaus insulino analogas) ir/ arba gamybos b d (rekombinantin s DNR technologijos / gyvulin s kilm s insulinas), gali tekti keisti insulino doz.
Patients taking NovoMix 50 may need a change in dosage from that used with their usual insulin.
Pacientams, vartojantiems NovoMix 50, gali reik ti pakeisti doz, kuri buvo skiriama vartojant jiems prast insulin preparat.
If dosage adjustment is needed, it may be done with the first dose or during the first few weeks or months.
Jei reikia sureguliuoti doz, tai gali b ti atlikta skiriant pirm j doz ar per pirm sias kelet savai i ar m nesi.
On rare occasions, injection site reactions may require discontinuation of NovoMix 50.
Retais atvejais reikia nutraukti NovoMix 50 vartojim, kad išnykt injekcijos vietos reakcijos.
12 NovoMix 50 contains metacresol, which may cause allergic reactions.
NovoMix 50 sud tyje yra metakrezolio, kuris gali sukelti alergines reakcijas.
A number of medicinal products are known to interact with the glucose metabolism.
12 Žinoma, kad nemažai vaist veikia gliukoz s metabolizm.
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.
Šios medžiagos gali sumažinti paciento insulino poreik: geriamieji priešdiabetiniai vaistai, oktreotidas, monoaminoksidaz s inhibitoriai (MAOI), neselektyv s beta - adrenoblokatoriai, angiotenzin konvertuojan i ferment (AKF) inhibitoriai, salicilatai, alkoholis, anaboliniai steroidai ir sulfonamidai.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics and danazol.
Šios medžiagos gali padidinti paciento insulino poreik: geriamieji kontraceptikai, tiazidai, gliukokortikoidai, skydliauk s hormonai, simpatomimetikai ir danazolis.
Beta-blocking agents may mask the symptoms of hypoglycaemia.
Beta - blokatoriai gali maskuoti hipoglikemijos simptomus.
Alcohol may intensify and prolong the glucose lowering effect of insulin.
Alkoholis gali sustiprinti ir prailginti gliukoz s kiek kraujyje mažinant insulino poveik.
There is limited clinical experience with NovoMix 50 in pregnancy.
Turima ribota klinikin patirtis, vartojant NovoMix 50 n štumo metu.
Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity.
Atlikus gyv n reprodukcijos tyrimus, susijusius su embriotoksiškumu ir teratogeniškumu, nenustatyta joki skirtum tarp insulino asparto ir žmogaus insulino.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Paprastai, rekomenduojama intensyvi n š i j, sergan i diabetu, gliukoz s kiekio kraujyje kontrol ir steb jimas n štumo ir n štumo planavimo metu.
After delivery, insulin requirements return rapidly to pre-pregnancy levels.
Po gimdymo insulino poreikis paprastai gr žta prieš tai buvus.
There are no restrictions on treatment with NovoMix 50 during lactation.
Žindymo metu n ra joki apribojim gydyti NovoMix 50.
Insulin treatment of the breast-feeding mother presents no risk to the baby.
Kr timi maitinan i motin gydymas insulinu nekelia jokios rizikos k dikiui.
However, the NovoMix 50 dosage may need to be adjusted.
Ta iau NovoMix 50 doz gali reik ti koreguoti.
No studies on the effects on the ability to drive and use machines have been performed.
Neatlikta vaisto poveikio geb jimui vairuoti ir valdyti mechanizmus tyrim.
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Pacient sugeb jimas susikoncentruoti ir reaguoti d l hipoglikemijos gali sumaž ti.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Tai gali b ti rizikinga situacijose, kai šie sugeb jimai ypa svarb s (pvz., vairuojant automobil ar valdant mechanin rang).
Patients should be advised to take precautions in order to avoid hypoglycaemia whilst driving.
Pacientams reik t patarti imtis atsargumo priemoni, siekiant išvengti hipoglikemijos vairuojant.
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Tai ypa svarbu tiems, kuriems persp jamieji hipoglikemijos simptomai susilpn j, j visai n ra arba hipoglikemija pasireiškia dažnai.
The advisability of driving should be considered in these circumstances.
Šiomis aplinkyb mis reik t apsvarstyti galimyb vairuoti.
Adverse drug reactions observed in patients using NovoMix products are mainly dose-dependent and due to the pharmacologic effect of insulin.
Nepageidaujamos reakcijos vaist pacientams, vartojantiems NovoMix preparatus, daugiausia priklauso nuo doz s ir farmakologinio insulino efekto.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Ji gali pasireikšti, jei insulino doz yra per didel, lyginant su insulino poreikiu.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Sunki hipoglikemija gali sukelti s mon s praradim ir / ar traukulius ir nulemti laikin ar nuolatin smegen funkcijos pažeidim ar net mirt.
In clinical trials and during marketed use the frequency varies with patient population and dose
Klinikini tyrim metu ir pateikus vaist rink hipoglikemijos dažnis kinta priklausomai nuo sergan i j skai iaus tarp gyventoj ir dozavimo, tod l negalima nurodyti jokio specifinio dažnio.
During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
Klinikini tyrim metu bendras hipoglikemijos dažnis, gydant pacientus insulinu aspartu ir žmogaus insulinu, buvo panaš s.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
Klinikiniais tyrimais nustatytas nepageidaujam reakcij dažnis, susij s su insulino asparto vartojimu, pateikiamas žemiau.
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.
13 Pavieniai spontaniniai atvejai pateikiami kaip labai reti ir apib dinami kaip (< 10000), skaitant ir pavienius pranešimus.
Immune system disorders Uncommon - Urticaria, rash, eruptions
Imunin s sistemos sutrikimai Nedažni - Dilg lin, b rimas, erupcija.