natgillin/translations-raw huggingface dataset:
Der skal også indgives glucose intravenøst,
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
14 hvis patienten ikke reagerer på glucagon inden for 10- 15 minutter.
Glucose must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
NovoMix 50 er en bifasisk suspension af insulin aspart (human insulinanalog med hurtigt indsættende virkning) og protaminkrystalliseret insulin aspart (middelvirkende human insulinanalog).
NovoMix 50 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
Insulins blodglucosenedsættende virkning indtræder, når molekylerne faciliterer optagelsen af glucose ved at binde sig til insulinreceptorer i muskel - og fedtceller og samtidig hæmmer leverens glucoseudskillelse.
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.
Den krystallinske fase (50%) består af protaminkrystalliseret insulin aspart, hvis aktivitetsprofil ligger tæt på humant NPH- insulins aktivitetsprofil.
The crystalline phase (50%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Når NovoMix 50 injiceres subkutant, indtræder virkningen inden for 10- 20 minutter efter injektion.
When NovoMix 50 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Den maksimale virkningsvarighed er op til 14 timer til 24 timer (figur 1).
The duration of action is up to 14 hours to 24 hours (Figure 1).
Glukoseinfusions hastighed
Glucose Infusion Rate
Timer NovoMix 50
Hours NovoMix 50
Aktivitetsprofil for NovoMix 50 hos raske personer.
Activity Profile for NovoMix 50 in Healthy Caucasian Subjects.
Insulin aspart er ækvipotent med humaninsulin på molekulært niveau.
Insulin aspart is equipotent to human insulin on a molar basis.
15 5. 2 Farmakokinetiske egenskaber
15 5.2 Pharmacokinetic properties
I insulin aspart nedsætter udskiftning af aminosyren prolin med aspartinsyre på position B28 tendensen til at danne hexamerer i den opløselige fraktion af NovoMix 50 sammenlignet med opløseligt humant insulin.
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 50, as compared with soluble human insulin.
De resterende 50% er i krystallinsk form som protaminkrystalliseret insulin aspart, der har en forlænget absorptionsprofil, som ligner humant NPH- insulins.
The remaining 50% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Hos frivillige raske personer blev gennemsnitlig maksimal serumkoncentration på 445 ± 135 pmol/ l opnået ca.
In healthy volunteers a mean maximum serum concentration of 445 ± 135 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
95 minutter efter injektion.
In type 2 patients with diabetes, the maximum concentration was reached about 95 minutes after dosing.
De farmakokinetiske egenskaber for NovoMix 50 er ikke blevet undersøgt hos ældre, børn eller patienter med nedsat nyre - eller leverfunktion.
The pharmacokinetics of NovoMix 50 has not been investigated in elderly, children or patients with impaired renal or liver function.
16 NovoMix 50 Penfill cylinderampuller, som er taget i brug eller som medbringes i reserve: kan opbevares ved omgivelsestemperatur (under 30°C) i op til 4 uger, men derefter skal al tiloversbleven insulin smides ud.
16 NovoMix 50 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.
Efter, at NovoMix 50 Penfill er taget ud af køleskabet, bør NovoMix 50 Penfill opnå stuetemperatur inden insulinet opblandes som beskrevet første gang.
After removing NovoMix 50 Penfill from the refrigerator it is recommended to allow NovoMix 50 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
Cylinderampul (type 1 glas) som er lukket med latexfri (brombutyl) gummistempel i den ene ende og med latexfri (brombutyl/ polyisoprene) gummilukning i den anden.
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.
Pakninger med 1, 5 eller 10 cylinderampuller.
Cartons of 1, 5 or 10 cartridges.
NovoMix 50 Penfill må kun anvendes af én person.
NovoMix 50 Penfill is for use by one person only.
NovoMix 70 Penfill 100 E/ ml, injektionsvæske, suspension i en cylinderampul.
NovoMix 70 Penfill 100 U/ ml, suspension for injection in a cartridge.
Opløseligt insulin aspart * / protaminkrystalliseret insulin aspart * ……... 100 E/ ml i forholdet 70/ 30
Soluble insulin aspart*/ protamine-crystallised insulin aspart*…… ..100 U/ ml in the ratio of 70/ 30
NovoMix 70 er en hvid suspension
NovoMix 70 is a white suspension.
NovoMix 70 kan gives umiddelbart før et måltid på grund af den hurtige indsættende virkning og tidlige effekt kulmination af insulin aspart.
The rapid onset of action and early peak of activity of insulin aspart allows NovoMix 70 to be given immediately before a meal.
Hvis det er nødvendigt, kan NovoMix 70 gives lige efter starten af et måltid.
When necessary, NovoMix 70 can be given soon after start of a meal.
Doseringen af NovoMix 70 er individuel og fastsættes baseret på lægens anvisning i overensstemmelse med patientens behov.
Dosage of NovoMix 70 is individual and determined on the basis of the physician’ s advice in accordance with the patient’ s needs.
Den individuelle insulin dosering er sædvanligvis mellem 0, 5 og 1, 0 enheder/ kg/ dag, og dette kan dækkes helt eller delvis med NovoMix 70.
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 70.
Hos patienter med type 2- diabetes kan NovoMix 70 gives som monoterapi eller i kombination med metformin, når blodglucosen er utilstrækkeligt kontrolleret med metformin alene.
In patients with type 2 diabetes, NovoMix 70 can be given in monotherapy or in combination with metformin, when the blood glucose is inadequately controlled with metformin alone.
Skift til NovoMix 70 fra andre insulintyper kan muligvis medføre justering af dosis og doserings tidspunkt.
Transfer to NovoMix 70 from other insulin preparations may require adjustment of dose and timing of administration.
19 Som ved alle insulintyper, bør glucosemonitoreringen intensiveres og doseringen justeres på individuel basis hos ældre patienter og patienter med lever - eller nyrelidelser.
18 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.
Der er ingen klinisk erfaring med NovoMix 70 hos børn og unge under 18 år.
No studies have been performed with NovoMix 70 in children and adolescents under the age of 18 years.
NovoMix 70 indgives subkutant i låret eller i abdominalvæggen.
NovoMix 70 is administered subcutaneously by injection in the thigh or in the abdominal wall.
NovoMix 70 må aldrig indgives intravenøst.
NovoMix 70 should never be administered intravenously.
NovoMix 70 bør indgives i umiddelbar forbindelse med et måltid.
NovoMix 70 should be administered in immediate relation to a meal.
Patienter, der skifter til NovoMix 70, skal muligvis have ændret dosis i forhold til dosis af de sædvanlige insulintyper.
Patients taking NovoMix 70 may need a change in dosage from that used with their usual insulin.
NovoMix 70 indeholder metacresol, som kan give allergiske reaktioner.
19 NovoMix 70 contains metacresol, which may cause allergic reactions.
20 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Der er ingen restriktioner på behandling med NovoMix 70 under amning.
There are no restrictions on treatment with NovoMix 70 during lactation.
Det kan dog være nødvendigt at justere dosis af NovoMix 70.
However, the NovoMix 70 dosage may need to be adjusted.
Der kan derfor ikke angives en specifik frekvens.
20 regimens therefore no specific frequency can be presented.
21 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.
22 hvis patienten ikke reagerer på glucagon inden for 10- 15 minutter.
Glucose must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
NovoMix 70 er en bifasisk suspension af insulin aspart (human insulinanalog med hurtigt indsættende virkning) og protaminkrystalliseret insulin aspart (middelvirkende human insulinanalog).
NovoMix 70 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
Den krystallinske fase (30%) består af protaminkrystalliseret insulin aspart, hvis aktivitetsprofil ligger tæt på humant NPH- insulins aktivitetsprofil.
The crystalline phase (30%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Når NovoMix 70 injiceres subkutant, indtræder virkningen inden for 10- 20 minutter efter injektion.
When NovoMix 70 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Timer NovoMix 70
Hours NovoMix 70
Aktivitetsprofil for NovoMix 70 hos raske personer.
Activity Profile for NovoMix 70 in Healthy Caucasian Subjects.
23 5. 2 Farmakokinetiske egenskaber
22 5.2 Pharmacokinetic properties
I insulin aspart nedsætter udskiftning af aminosyren prolin med aspartinsyre på position B28 tendensen til at danne hexamerer i den opløselige fraktion af NovoMix 70 sammenlignet med opløseligt humant insulin.
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 70, as compared with soluble human insulin.
De resterende 30% er i krystallinsk form som protaminkrystalliseret insulin aspart, der har en forlænget absorptionsprofil, som ligner humant NPH- insulins.
The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Hos frivillige raske personer blev gennemsnitlig maksimal serumkoncentration på 645 ± 185 pmol/ l opnået ca.
In healthy volunteers a mean maximum serum concentration of 645 ± 185 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
Hos type 2 diabetikere blev maksimal koncentration opnået ca.
In type 2 patients with diabetes, the maximum concentration was reached about 75 minutes after dosing.
60 minutter efter injektion efter subkutan injektion af 0, 30 E/ kg legemsvægt.
In type 1 patients with diabetes a mean maximum serum concentration of 721 ± 184 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
De farmakokinetiske egenskaber for NovoMix 70 er ikke blevet undersøgt hos ældre, børn eller patienter med nedsat nyre - eller leverfunktion.
The pharmacokinetics of NovoMix 70 has not been investigated in elderly, children or patients with impaired renal or liver function.
24 6. 4 Særlige opbevaringsforhold
23 6.4 Special precautions for storage
NovoMix 70 Penfill cylinderampuller, som er taget i brug eller som medbringes i reserve: kan opbevares ved omgivelsestemperatur (under 30°C) i op til 4 uger, men derefter skal al tiloversbleven insulin smides ud.
NovoMix 70 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.
Efter, at NovoMix 70 Penfill er taget ud af køleskabet, bør NovoMix 70 Penfill opnå stuetemperatur inden insulinet opblandes som beskrevet første gang.
After removing NovoMix 70 Penfill from the refrigerator it is recommended to allow NovoMix 70 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
NovoMix 70 Penfill må kun anvendes af én person.
NovoMix 70 Penfill is for use by one person only.
NovoMix 30 FlexPen 100 E/ ml, injektionsvæske, suspension i en fyldt pen.
NovoMix 30 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
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.
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.
26 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.
Følgende retningslinier for titrering anbefales til dosisjustering
The following titration guideline is recommended for dose adjustments:
4. 2.
27 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.
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.
29 4. 6 Graviditet og amning
28 4.6 Pregnancy and lactation
Den kliniske erfaring med NovMix 30 under graviditet er begrænset.
There is limited clinical experience with NovoMix 30 in pregnancy.
30 Nervesystemet Sjælden - Perifer neuropati Hurtig forbedring af blodglucosekontrollen kan være forbundet med en tilstand som akut smertefuld neuropati, som sædvanligvis er reversibel.
29 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.
Ødemer og vægtforøgelse kan opstå når NovoMix 30 bruges i kombination med orale antidiabetica.
Oedema and weight increase may occur when NovoMix 30 is used in combination with OADs.
Diabetespatienter anbefales derfor altid at være i besiddelse af nogle sukkerholdige fødevarer. • Svære hypoglykæmiske episoder, hvor patienten bliver bevidstløs, kan behandles med glucagon (0, 5- 1 mg) indgivet intramuskulært eller subkutant af en instrueret person, eller intravenøs glucose indgivet af en medicinsk uddannet person.
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.
31 Insulins blodglucosenedsættende virkning indtræder, når molekylerne faciliterer optagelsen af glucose ved at binde sig til insulinreceptorer i muskel - og fedtceller og samtidig hæmmer leverens glucoseudskillelse.
30 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.
32 Hos patienter med type 2- diabetes viste en metaanalyse, at der er en reduceret risiko for generelle natlige hypoglykæmiske episoder og alvorlige hypoglykæmi med NovoMix 30 sammenlignet med bifasisk humant insulin 30.
31 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.
En 16- uger klinisk undersøgelse, som sammenlignede postprandiel glykæmisk kontrol af måltidsrelateret NovoMix 30 med måltidsrelateret humaninsulin / bifasisk humant insulin 30 og NPH ved sengetid, blev udført med 167 personer i alderen fra 10 til 18 år.
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.
Endelig var HbA1c signifikant lavere i den gruppe, som blev - behandlet med bifasisk humant insulin 30 sammenlignet med NovoMix 30.
Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with NovoMix 30.
NovoMix 30 FlexPen, som er taget i brug, eller som medbringes i reserve: kan opbevares ved omgivelsestemperatur (under 30°C) i op til 4 uger, men derefter skal al tiloversbleven insulin smides ud.
NovoMix 30 FlexPen 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.
Må ikke opbevares i køleskab Må ikke opbevares over 30°C.
Do not store above 30°C.
Opbevar NovoMix 30 FlexPen med penhætten på for at beskytte mod lys, når den ikke er i brug.
Keep the cap on the pen when NovoMix 30 FlexPen is not in use in order to protect from light.
Efter, at NovoMix 30 FlexPen er taget ud af køleskabet, bør NovoMix 30 FlexPen opnå stuetemperatur inden insulinet opblandes som beskrevet første gang.
After removing NovoMix 30 FlexPen from the refrigerator it is recommended to allow NovoMix 30 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
Cylinderampullen er monteret i en engangspen (plastik) til multidosering.
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 in a multidose disposable pre-filled pen with a pen injector (plastic).
Hver fyldt pen indeholder 3 ml suspension.
Each pre-filled pen contains 3 ml suspension.
Pakninger med 5 eller 10 fyldte penne.
Cartons of 5 or 10 pre-filled pens.
NovoFine S nåle er beregnet til anvendelse sammen med den fyldte pen.
NovoFine S needles are designed to be used with the pre-filled pen.
Instruktionerne som er vedlagt NovoMix 30 FlexPen skal følges.
Detailed instruction accompanying NovoMix 30 FlexPen must be followed.
NovoMix 30 FlexPen må kun anvendes af én person.
NovoMix 30 FlexPen is for use by one person only.
NovoMix 30 FlexPen må ikke genopfyldes.
NovoMix 30 FlexPen must not be refilled.
34 Det er vigtigt at understrege over for patienten, at NovoMix 30 suspensionen skal opblandes umiddelbart før brug.
33 The necessity of resuspending the NovoMix 30 suspension immediately before use is to be stressed to the patient.
NovoMix 50 FlexPen 100 E/ ml, injektionsvæske, suspension i en fyldt pen.
NovoMix 50 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 50 er en hvid suspension.
NovoMix 50 is a white suspension.
36 Som ved alle insulintyper, bør glucosemonitoreringen intensiveres og doseringen justeres på individuel basis hos ældre patienter og patienter med lever - eller nyrelidelser.
35 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.
NovoMix 50 indeholder metacresol, som kan give allergiske reaktioner.
36 NovoMix 50 contains metacresol, which may cause allergic reactions.
37 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Der kan derfor ikke angives en specifik frekvens.
37 regimens therefore no specific frequency can be presented.
38 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.
39 hvis patienten ikke reagerer på glucagon inden for 10- 15 minutter.
Glucose must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
40 5. 2 Farmakokinetiske egenskaber
39 5.2 Pharmacokinetic properties
41 NovoMix 50 FlexPen, som er taget i brug, eller som medbringes i reserve: kan opbevares ved omgivelsestemperatur (under 30°C) i op til 4 uger, men derefter skal al tiloversbleven insulin smides ud.
40 NovoMix 50 FlexPen 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.
Opbevar NovoMix 50 FlexPen med penhætten på, for at beskytte mod lys, når den ikke er i brug.
Keep the cap on the pen when NovoMix 50 FlexPen is not in use in order to protect from light.
Efter, at NovoMix 50 FlexPen er taget ud af køleskabet, bør NovoMix 50 FlexPen opnå stuetemperatur inden insulinet opblandes som beskrevet første gang.
After removing NovoMix 50 FlexPen from the refrigerator it is recommended to allow NovoMix 50 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
Cylinderampul (type 1 glas) som er lukket med latexfri (brombutyl) gummistempel i den ene ende og med latexfri (brombutyl/ polyisoprene) gummilukning i den anden.
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 in a multidose disposable pre-filled pen with a pen injector (plastic).
Pakninger med 1, 5 eller 10 fyldte penne.
Cartons of 1, 5 or 10 pre-filled pens.
Instruktionerne som er vedlagt NovoMix 50 FlexPen skal følges.
Detailed instruction accompanying NovoMix 50 FlexPen must be followed.
NovoMix 50 FlexPen må kun anvendes af én person.
NovoMix 50 FlexPen is for use by one person only.
NovoMix 50 FlexPen må ikke genopfyldes.
NovoMix 50 FlexPen must not be refilled.
NovoMix 70 FlexPen 100 E/ ml, injektionsvæske, suspension i en fyldt pen.
NovoMix 70 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 70 er en hvid suspension.
NovoMix 70 is a white suspension.
43 Som ved alle insulintyper, bør glucosemonitoreringen intensiveres og doseringen justeres på individuel basis hos ældre patienter og patienter med lever - eller nyrelidelser.
42 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.
NovoMix 70 indeholder metacresol, som kan give allergiske reaktioner.
43 NovoMix 70 contains metacresol, which may cause allergic reactions.
44 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Der kan derfor ikke angives en specifik frekvens.
44 regimens therefore no specific frequency can be presented.
Frekvenserne er defineret således:
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.