natgillin/translations-raw huggingface dataset:
NovoMix gives umiddelbart før et måltid, men kan om nødvendigt gives efter måltidet.
NovoMix is given immediately before a meal, but may be given after a meal if necessary.
Den sædvanlige dosis er er mellem 0, 5 og 1, 0 E pr. kg legemsvægt dagligt.
The usual dose is between 0.5 and 1.0 U per kilogram body weight per day.
Ved type 2- sukkersyge (der også kaldes ikke- insulinafhængig sukkersyge) kan NovoMix gives alene eller sammen med metformin.
In type 2 diabetes (also known as non-insulin dependent diabetes), NovoMix can be given on its own or together with metformin.
Det bør dog ikke anvendes i kombination med pioglitazon uden forudgående vurdering af risikoen for bivirkninger vedrørende væskebalancen.
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.
Sukkersyge er en sygdom, hvor kroppen ikke producerer tilstrækkeligt med insulin til at regulere blodsukkeret.
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose.
NovoMix er et erstatningsinsulin, der stærkt ligner det insulin, der produceres af bugspytkirtlen.
NovoMix is a replacement insulin which is very similar to the insulin made by the pancreas.
Det aktive stof i NovoMix, insulin aspart, fremstilles ved "rekombinant DNA - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
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.
(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 teknologi ":
(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.
Insulin aspart er kun ganske lidt forskelligt fra humant insulin.
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.
NovoMix indeholder to forskellige former for insulin aspart: den opløselige form, der virker hurtigt (i løbet af 10 minutter efter indsprøjtningen), og den krystallinske form, der optages meget langsommere dagen igennem.
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.
Derfor holder virkningen af NovoMix sig længere.
This gives NovoMix a longer duration of action.
Gennem reguleringen af blodsukkeret mindskes symptomerne og komplikationerne ved sukkersygen.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Hvordan blev NovoMix undersøgt?
How has NovoMix been studied?
Det blev her sammenlignet med humant insulin i 12 uger.
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.
Det blev sammenlignet med humant insulin 30, givet som to indsprøjtninger dagligt.
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.
Virkningen af at tilføje NovoMix 30 til anden sukkersygemedicin, der tages gennem munden (metformin, sulfonylurinstoffer og pioglitazon) blev desuden undersøgt i fire undersøgelser med i alt 905 patienter.
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.
Dette blev anvendt til at vise, hvor godt blodsukkeret var reguleret ved undersøgelsens start og ved dens slutning.
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.
Hvilken fordel viser undersøgelserne, der er ved NovoMix?
What benefit has NovoMix shown during the studies?
Ved undersøgelsens slutning gav NovoMix 30 næsten samme resultater som humant insulin.
NovoMix 30 gave almost identical results to human insulin at the end of the study.
NovoMix 50 og NovoMix 70 var alt i alt bedre til at regulere blodsukkeret end humant insulin 30.
NovoMix 50 and NovoMix 70 gave better overall control of blood glucose than human insulin 30.
NovoMix 30 som tillægsbehandling til andre sukkersygemidler gav bedre blodsukkerregulering end de andre sukkersygemidler alene.
Adding NovoMix 30 to other antidiabetic medicines resulted in better control of blood glucose than the other medicines taken alone.
Som andre insuliner kan NovoMix medføre for lavt blodsukker.
As with other insulins, NovoMix may cause hypoglycaemia (low blood glucose).
Den fuldstændige liste over de indberettede bivirkninger for NovoMix fremgår af indlægssedlen.
For the full list of all side effects reported with NovoMix, see the Package Leaflet.
NovoMix bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for insulin aspart eller andre af indholdsstofferne, eller hos patienter med for lavt blodsukker.
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.
Det kan desuden være nødvendigt at justere dosis af NovoMix, når det gives sammen med en række andre lægemidler, der kan påvirke blodsukkeret.
NovoMix doses might also need to be adjusted when given with a number of other medicines which can have an effect on blood glucose.
En fuldstændig fortegnelse står i indlægssedlen.
For the full list, see the Package Leaflet.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved NovoMix til behandling af sukkersyge opvejer risiciene.
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.
Udvalget anbefalede udstedelse af markedsføringstilladelse for NovoMix.
The Committee recommended that NovoMix be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for NovoMix til Novo Nordisk A/ S den 1. august 2000.
The European Commission granted a marketing authorisation valid throughout the European Union for NovoMix to Novo Nordisk A/ S on 1 August 2000.
Denne tilladelse blev fornyet den 1. august 2005.
The marketing authorisation was renewed on 1 August 2005.
3 ml
3.0 ml
NovoMix 30 FlexPen
NovoMix 30 Flexpen
Fyldt pen
cartridge (glass) in pre- filled pen
Cylinderampul (glas))
cartridge (glass)
NovoMix 30 Penfill 100 E/ ml, injektionsvæske, suspension i en cylinderampul.
NovoMix 30 Penfill 100 U/ ml, suspension for injection in a cartridge.
Opløseligt insulin aspart * / protaminkrystalliseret insulin aspart * ……... 100 E/ ml i forholdet 30/ 70
Soluble insulin aspart*/ protamine-crystallised insulin aspart*……... 100 U/ ml in the ratio of 30/ 70
* fremstillet ved rekombinant DNA- teknologi i Saccharomyces cerevisiae.
* produced by recombinant DNA technology in Saccharomyces cerevisiae.
1 enhed insulin aspart svarer til 6 nmol, 0, 035 mg saltfrit insulin aspart anhydrat.
One unit of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free anhydrous insulin aspart.
NovoMix 30 er en hvid suspension.
NovoMix 30 is a white suspension.
Virkningen af NovoMix 30 indsætter hurtigere end for bifasisk humant insulin, og NovoMix 30 bør generelt indgives umiddelbart før et måltid.
NovoMix 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal.
NovoMix 30 kan om nødvendigt indgives umiddelbart efter et måltid.
When necessary, NovoMix 30 can be given soon after a meal.
NovoMix 30 indgives subkutant i låret eller abdominalvæggen.
NovoMix 30 is administered subcutaneously in the thigh or in the abdominal wall.
Injektionen kan dog også gives i gluteal - eller deltoidregionen.
If convenient, the gluteal or deltoid region may be used.
Injektionsstederne bør roteres inden for samme område.
Injection sites should be rotated within the same region.
Som for alle insulintyper varierer virkningsvarigheden alt efter dosis, injektionssted, blodgennemstrømning, temperatur og fysisk aktivitetsniveau.
As with all insulins the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
NovoMix 30 må aldrig indgives intravenøst.
NovoMix 30 should never be administered intravenously.
Nedsat nyre - eller leverfunktion kan reducere patientens insulinbehov.
Renal or hepatic impairment may reduce the patient’ s insulin requirements.
NovoMix kan anvendes til børn og unge på 10 år og derover, når blandingsinsulin foretrækkes.
NovoMix 30 can be used in children and adolescents aged 10 years and above when premixed insulin is preferred.
Der eksisterer begrænsede kliniske data hos børn fra 6- 9 år (se sektion 5. 1).
For children 6-9 years limited clinical data exists (see section 5.1).
Der har ikke været udført nogen studier med børn under 6 år.
No studies have been performed in children under the age of 6 years.
Anbefalet dosis:
Dose recommendation:
Dosering af NovoMix 30 er individuel og fastsættes efter patientens behov.
Dosage of NovoMix 30 is individual and determined in accordance with the needs of the patient.
Hos patienter med type 2- diabetes kan NovoMix 30 gives som monoterapi eller i kombination med orale antidiabetica, som er godkendt til kombination med insulin, når blodglucosekontrollen er utilstrækkelig med disse orale antidiabetica alene.
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.
Den anbefalede startdosering af NovoMix 30 er 6 E ved morgenmaden og 6 E ved aftensmaden til patienter med type 2- diabetes.
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).
NovoMix 30 kan også
When using
I forbindelse med anvendelse af NovoMix 30 en gang daglig anbefales det generelt at dele doseringen til to gange dagligt, når man når op på 30 enheder, ved at dele dosis op i lige morgen - og aftendoser.
2 NovoMix 30 once daily, it is generally recommended to move to twice-daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses.
Hvis to daglige doser med NovoMix 30 resulterer i tilbagevendende hypoglykæmiske episoder i dagtimerne, kan morgendosis deles op i to lige morgen - og frokostdoser (tre doser dagligt).
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).
Følgende retningslinier for titrering anbefales til dosisjustering.
The following titration guideline is recommended for dose adjustments:
Glucoseniveau før
Pre-meal blood glucose level
4. 4 mmol/ l
< 4.4 mmol/ l
< 80 mg/ dl
< 80 mg/ dL
- 2E
-2U
4. 4 – 6. 1 mmol/ l
4.4 – 6.1 mmol/ l
80 – 110 mg/ dl
80 – 110 mg/ dL
6. 2 – 7. 8 mmol/ l 7. 9 – 10 mmol/ l > 10 mmol/ l
6.2 – 7.8 mmol/ l 7.9 – 10 mmol/ l > 10 mmol/ l
111 – 140 mg/ dl 141 – 180 mg/ dl > 180 mg/ dl
111 – 140 mg/ dL 141 – 180 mg/ dL > 180 mg/ dL
+2E +4E +6E
+2U +4U +6U
Det laveste niveau fra tre foregående dages niveauer før måltider skal anvendes.
The lowest of three previous days’ pre-meal levels should be used.
Kombinationen af NovoMix 30 med pioglitazon bør kun overvejes på baggrund af en klinisk vurdering af patientens risici for at udvikle tegn eller symptomer på væskerelaterede bivirkninger.
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.
Initiering af NovoMix 30 bør foretages ved omhyggelig titrering til den lavest nødvendige dosis for at opretholde glykæmisk kontrol (se pkt 4. 4).
The initiation of NovoMix 30 should be undertaken cautiously titrating to the lowest dose required to achieve glycaemic control (see section 4.4)
Hos patienter med type 1- diabetes ligger det individuelle insulinbehov normalt mellem 0, 5 og 1, 0 enheder/ kg/ dag.
In patients with type 1 diabetes the individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day.
Det daglige insulinbehov kan være højere hos patienter med insulinresistens (f. eks. forårsaget af fedme) og lavere hos patienter med residual endogen insulinproduktion.
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.
Derefter titreres i forhold til den enkeltes behov (se titreringsvejledningen i tabellen oven over).
Then titrate according to individual needs (See titration guidelines in table above).
NovoMix 30 kan ordineres til ældre patienter: dog er der begrænset erfaring med brug af NovoMix 30 i kombination med orale antidiabetica til patienter ældre end 75 år.
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.
• Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne • Hypoglykæmi.
• Hypersensitivity to the active substance or to any of the excipients • Hypoglycaemia.
For lav dosering eller ophør af behandlingen kan, specielt ved insulinafhængig diabetes, føre til hyperglykæmi og diabetisk ketoacidose, tilstande som er potentielle livstruende.
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.
4. 8 og pkt.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia (see section 4.8 and section 4.9).
NovoMix 30 kan have mere udtalt glucose nedsættende effekt end bifasisk humant insulin indtil 6 timer efter injektion.
Compared with biphasic human insulin, NovoMix 30 may have a more pronounced glucose lowering effect up to 6 hours after injection.
Det kan være nødvendigt at kompensere for dette hos hver enkelt patient ved justering af insulindosis og/ eller fødeindtagelse.
This may have to be compensated for in the individual patient, through adjustment of insulin dose and/ or food intake.
Patienter med markant forbedret blodglucosekontrol, opnået f. eks. ved intensiv insulinbehandling, kan opleve ændring af de normale advarselssymptomer på hypoglykæmi og bør advares herom.
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.
4. 2.
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.
NovoMix 30 bør indgives i umiddelbar forbindelse med et måltid.
NovoMix 30 should be administered in immediate relation to a meal.
Den hurtigt indtrædende virkning skal derfor tages i betragtning hos patienter med anden samtidig sygdom eller som er i anden medicinsk behandling, hvor der kan forventes forsinket absorption af levnedsmidler.
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.
Anden samtidig sygdom, især infektioner, øger normalt patientens insulinbehov.
Concomitant illness, especially infections, usually increases the patient’ s insulin requirements.
Skift til anden type insulin, kan betyde, at de tidlige advarselssymptomer på hypoglykæmi kan ændres eller blive mindre udtalte end dem, der oplevedes med tidligere insulin.
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.
Patientens skift til en ny insulintype eller - mærke bør foregå under streng medicinsk kontrol.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
Ændringer i styrke, mærke (fabrikant), type, oprindelse (animalsk eller human, human insulinanalog) og/ eller fremstillingsmetode (rekombinant DNA i forhold til insulin af animalsk oprindelse) kan kræve ændring af dosis.
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.
Patienter, der skifter til NovoMix 30, skal muligvis have ændret dosis i forhold til dosis af de sædvanlige insulintyper.
Patients taking NovoMix 30 may need a change in dosage from that used with their usual insulin.
Hvis der er behov for justering, kan det gøres med den første dosis eller i løbet af de første få uger eller måneder.
If dosage adjustment is needed, it may be done with the first dose or during the first few weeks or months.
Justering af dosis kan også være nødvendig, hvis patienten øger sin fysiske aktivitet eller kost.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
Insulinsuspensioner må ikke anvendes i insulinpumper.
Insulin suspensions are not to be used in insulin infusion pumps.
Som ved anden insulinbehandling kan der opstå reaktioner på injektionsstedet i form af smerte, kløe, udslæt, hævelse og inflammation.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Kombinationsbehandling med NovoMix 30 og pioglitazone:
Combination of NovoMix 30 with pioglitazone:
Der har været indrapporteret tilfælde af hjerteinsufficiens fra markedet, når pioglitazone har været brugt i kombination med insulin, særligt hvis det har været brugt til patienter med risikofaktorer for udvikling af hjerteinsufficiens.
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.
Patienter bør observeres for tegn og symptomer på hjerteinsufficiens, vægtforøgelse og ødemer, når NovoMix 30 gives i kombination med pioglitazone.
Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when NovoMix 30 is used in combination with pioglitazone.
Som en konsekvens af øget insulinfølsomhed kan patienter, der modtager pioglitazone i kombination med insulin, have risiko for at få dosisrelateret hypoglykæmi, og en reduktion i dosis kan være nødvendig.
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.
Følgende stoffer kan nedsætte patientens insulinbehov:
The following substances may reduce the patient’ s insulin requirements:
Orale antidiabetica (OAD), octreotid, monoaminooxidasehæmmere (MAO- hæmmere), non- selektive betablokkere, ACE- hæmmere, salicylater, alkohol, anaboliske steroider og sulfonamider.
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.
Følgende stoffer kan øge patientens insulinbehov:
The following substances may increase the patient’ s insulin requirements:
Orale kontraceptiva, thiazider, glukokortikoider, thyreoideahormoner, sympatomimetika og danazol.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics and danazol.
Betablokkere kan skjule symptomerne på hypoglykæmi.
Beta-blocking agents may mask the symptoms of hypoglycaemia.
Alkohol kan forstærke og forlænge den glucosesænkende effekt af insulin.
Alcohol may intensify and prolong the glucose lowering effect of insulin.
Generelt anbefales intensiv blodglucosekontrol og overvågning af gravide kvinder med diabetes under hele graviditeten og hvis graviditet påtænkes.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Der er ingen restriktioner på behandling med NovoMix 30 under amning.
There are no restrictions on treatment with NovoMix 30 during lactation.
Insulinbehandling af moderen udgør ingen risiko for det ammede barn.
Insulin treatment of the breast-feeding mother presents no risk to the baby.
Det kan dog være nødvendigt at justere dosis af NovoMix 30.
However, the NovoMix 30 dosage may need to be adjusted.
Dette kan udgøre en risiko i situationer, hvor disse evner er af særlig betydning (f. eks. under bilkørsel eller ved maskinbetjening).
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Patienter bør rådes til at tage forholdsregler for at undgå hypoglykæmi, når de fører motorkøretøj.
Patients should be advised to take precautions in order to avoid hypoglycaemia whilst driving.
Hos patienter, som bruger NovoMix produkter er de observerede bivirkninger fortrinsvis dosisrelaterede og forårsaget af insulins farmakologiske effekt.
Adverse drug reactions observed in patients using NovoMix products are mainly dose-dependent and due to the pharmacologic effect of insulin.
Som for andre insulinprodukter er hypoglykæmi generelt den oftest forekommende bivirkning.
As for other insulin products, hypoglycaemia, in general is the most frequently occurring undesirable effect.
Den kan forekomme, når insulindosis er for høj i forhold til insulinbehovet og derfor er særlig opmærksomhed påkrævet i løbet af intensivering af dosis som angivet i pkt.
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.
Alvorlig hypoglykæmi kan føre til bevidstløshed og/ eller kramper og kan resultere i midlertidig eller permanent hjerneskade eller død.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Der kan derfor ikke angives en specifik frekvens.
In clinical trials and during marketed use the frequency varies with patient population and dose regimens therefore no specific frequency can be presented.
I de kliniske forsøg var der ingen forskel på den samlede hyppighed af hypoglykæmi hos patienter, som blev behandlet med insulin aspart sammenlignet med patienter, som blev behandlet med humant insulin.
During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
Frekvensen af bivirkninger fra de kliniske forsøg, som efter en overordnet vurdering kan betragtes at være relateret til insulin aspart, er angivet nedenfor.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
Frekvenserne er defineret således:
The frequencies are defined as:
Ikke almindelig (> 1/ 1. 000, < 1/ 100) og sjælden (> 1/ 10. 000, < 1/ 1. 000).
Uncommon (> 1/ 1,000 ,< 1/100) and rare (> 1/10 ,000, < 1/1,000).
Meget sjælden (< 1/ 10. 000), herunder enkeltstående indberetninger.
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.