natgillin/translations-raw huggingface dataset:
Immunsystemet Ikke almindelige - Nældefeber, udslæt
Immune system disorders Uncommon - Urticaria, rash, eruptions
Meget sjælden - Anafylaktiske reaktioner Symptomer på generel hypersensibilitet kan inkludere hududslæt, kløe, svedtendens, gastrointestinal ubehag, angioneurotisk ødem, åndedrætsbesvær, hjertebanken og blodtryksfald.
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.
Generel hypersensibilitet er potentielt livstruende.
Generalised hypersensitivity reactions are potentially life threatening.
5 Nervesystemet Sjælden - Perifer neuropati Hurtig forbedring af blodglucosekontrollen kan være forbundet med en tilstand som akut smertefuld neuropati, som sædvanligvis er reversibel.
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.
Øjne Ikke almindelig - Refraktionsanomalier Refraktionsanomalier kan forekomme ved initiering af insulinterapi.
Eye disorders Uncommon - Refraction disorder Refraction anomalies may occur upon initiation of insulin therapy.
Imidlertid kan en intensivering af insulinbehandlingen med en akut forbedring af blodglucosekontrollen være forbundet med en forværring af den diabetiske retinopati.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
Ikke almindelig - Lokal hypersensibilitet Lokal hypersensibile reaktioner (rødmen, hævelser og kløe på injektionsstedet) kan forekomme ved insulinbehandling.
Uncommon - Local hypersensitivity Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Disse reaktioner er sædvanligvis forbigående og vil normalt forsvinde ved fortsat behandling.
These reactions are usually transitory and normally they disappear during continued treatment.
Almene symptomer og reaktioner på administrationsstedet Ikke almindelig - Ødem Ødemer kan forekomme ved initiering af insulinbehandling.
General disorders and administration site conditions Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Disse symptomer er sædvanligvis af forbigående karakter.
These symptoms are usually of transitory nature.
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.
Det er ikke muligt at definere en specifik overdosering af insulin, men hypoglykæmi kan udvikles over sekventielle faser, hvis der indgives større doser end svarende til patientens behov:
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:
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.
Der skal også indgives glucose intravenøst, 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.
Når patienten igen er ved bevidsthed, anbefales orale kulhydrater for at forhindre recidiv.
Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Antidiabetica.
Drugs used in diabetes.
Insuliner og analoger til injektion, middelvirkende kombineret med hurtigtvirkende.
Insulins and analogues for injection, intermediate-acting combined with fast-acting.
NovoMix 30 er en bifasisk suspension af insulin aspart (human insulinanalog med hurtigt indsættende virkning) og protaminkrystalliseret insulin aspart (middelvirkende human insulinanalog).
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 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.
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.
Det har en hurtigt indsættende virkning, hvorfor det kan indgives tættere på et måltid (0- 10 minutter før eller efter måltidet) end opløseligt humant insulin.
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.
Den krystallinske fase (70%) består af protaminkrystalliseret insulin aspart, hvis aktivitetsprofil ligger tæt på humant NPH- insulins aktivitetsprofil (figur 1).
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).
Når NovoMix 30 injiceres subkutant, indtræder virkningen inden for 10- 20 minutter efter injektion.
When NovoMix 30 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Maksimal virkning opnås 1- 4 timer efter injektion.
The maximum effect is exerted between 1 and 4 hours after injection.
Den maksimale virkningsvarighed er 24 timer.
The duration of action is up to 24 hours.
Glukose - infusions hastighed
Glucose infusion rate
Aktivitetsprofil for NovoMix 30 (___) og bifasisk humant insulin 30 (---) hos raske personer.
Activity profile of NovoMix 30 (___) and biphasic human insulin 30 (---) in healthy subjects.
I et tre måneders forsøg med patienter med type 1 og type 2- diabetes har NovoMix 30 vist samme glykosyleret hæmoglobinkontrol som behandling med bifasisk humant insulin 30.
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.
En metaanalyse der inkluderede ni studier viste, at fasteblodsukkeret hos patienter med type 1 - og type 2- diabetes var højere hos patienter behandlet med NovoMix 30 end hos patienter behandlet med bifasisk humant insulin 30.
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.
341 patienter med type 2- diabetes blev i et randomiseret studie behandlet med enten NovoMix 30 alene eller i kombination med metformin, eller med metformin sammen med sulfonylurea.
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.
57% af patienterne i dette studie havde en HbA1c- baseline over 9%; disse patienter havde, efter behandling med NovoMix 30 kombineret med metformin, en HbA1c, som var betydelig lavere end de patienter, som var blevet behandlet med metformin og sulfonylurea.
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.
I et studie blev patienter med type 2- diabetes, der var utilstrækkeligt kontrolleret med oral hypoglykæmisk stof alene, randomiseret til behandling med NovoMix 30 to gange daglig (117 patienter) eller insulin glargin en gang daglig (116 patienter).
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).
Efter 28 ugers behandling, hvor man fulgte de retningslinier for dosering, der er angivet i afsnit 4. 2, var der et gennemsnitlige fald i HbA1c på 2, 8% med NovoMix 30 (gennemsnit ved baseline = 9, 7%).
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 mmol/ l (fra 14, 0 mmol/ l ved baseline til 7, 1 mmol/ l).
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).
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.
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.
Risikoen for generelle hypoglykæmiske episoder i dagtimerne var øget hos patienter behandlet med NovoMix 30.
The risk of overall daytime hypoglycaemic episodes was increased in patients treated with NovoMix 30
En 16- uger klinisk undersøgelse, som sammenlignede postprandiel glykæmisk kontrol af måltidsrelateret NovoMix 30 med måltidsrelateret humaninsulin / bifasisk humaninsulin 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.
Gennemsnittet af HbA1c forblev ens med baseline under undersøgelsen i begge behandlingsgrupper, og der var ingen forskel i hypoglykæmi forekomsten med NovoMix 30 eller bifasisk humaninsulin 30.
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.
I en mindre (54 personer) og yngre (i alderen fra 6- 12 år) befolkningsgruppe, som blev behandlet i et dobbeltblindet overkrydsningsstudie (12 uger med hver behandling), var antallet af hypoglykæmi tilfælde og den postprandielle glucoseforhøjelse signifikant lavere med NovoMix 30 sammenlignet med bifasisk humant 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.
Endelig var HbA1c signifikant lavere i den gruppe, som blev behandlet med bifasisk humant insulin 30 sammenligned med NovoMix 30.
Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with NovoMix 30.
I insulin aspart nedsætter udskiftning af aminosyren prolin med aspartinsyre på position B28 tendensen til at danne hexamerer i den opløselige fraktion af NovoMix 30 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 30, as compared with soluble human insulin.
De resterende 70% er i krystallinsk form som protaminkrystalliseret insulin aspart, der har en forlænget absorptionsprofil, som ligner humant NPH- insulins.
The remaining 70% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Den maksimale seruminsulinkoncentration er gennemsnitligt 50% højere med NovoMix 30 end med bifasisk humant insulin 30.
The maximum serum insulin concentration is, on average, 50% higher with NovoMix 30 than with biphasic human insulin 30.
60 minutter efter subkutan injektion af 0, 20 E/ kg legemsvægt.
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.
8- 9 timer.
The mean half life (t½) of NovoMix 30, reflecting the absorption rate of the protamine bound fraction, was about 8-9 hours.
Tilbagevenden til seruminsulinudgangsniveau sås 15- 18 timer efter subkutan injektion.
Serum insulin levels returned to baseline 15-18 hours after a subcutaneous dose.
95 minutter efter injektion, og der blev målt koncentrationer godt over nul i ikke mindre end 14 timer efter injektion.
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.
Farmakokinetikken af NovoMix30 har ikke været undersøgt hos børn og unge.
The pharmacokinetics of NovoMix 30 has not been investigated in children or adolescents.
De farmakokinetiske - og farmakodynamiske egenskaber af opløselig insulin aspart har dog været undersøgt hos børn (6- 12 år) og unge (13- 17 år) med type 1- diabetes.
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.
De farmakokinetiske egenskaber for NovoMix 30 er ikke blevet undersøgt hos ældre, børn eller patienter med nedsat nyre - eller leverfunktion.
The pharmacokinetics of NovoMix 30 has not been investigated in elderly, or patients with impaired renal or liver function.
De prækliniske data med insulin aspart viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og reproduktionstoksicitet.
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.
I in vitro- undersøgelser af bl. a. binding til insulin - og IGF- 1- receptorsteder samt virkning på cellevækst opførte insulin aspart sig meget lig humant insulin.
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.
Glycerol Phenol Metacresol Zinkchlorid Natriumchlorid Dinatriumphosphatdihydrat Protaminsulfat Natriumhydroxid (til pH- justering) Saltsyre (til pH- justering) Vand til injektionsvæsker
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
4 uger (ikke over 30°C).
The in-use shelf life is 4 weeks (not above 30°C).
Opbevares i køleskab (2°C - 8°C), ikke for tæt på fryseelementerne.
Store in a refrigerator (2°C – 8°C) away from the freezing compartment.
NovoMix 30 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 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.
Må ikke opbevares over 30˚C.
Do not store above 30°C.
Efter, at NovoMix 30 Penfill er taget ud af køleskabet, bør NovoMix 30 Penfill opnå stuetemperatur inden insulinet opblandes som beskrevet første gang.
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.
Cylinderampul (type 1 glas) som er lukket med latexfri (brombutyl) gummistempel i den ene ende og med latexfri (brombutyl/ polyisopren) 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.
Hver cylinderampul indeholder 3 ml suspension.
Each cartridge contains 3 ml suspension.
Pakninger med 5 eller 10 cylinderampuller.
Cartons of 5 or 10 cartridges.
Cylinderampullerne er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer (til flergangsbrug) og NovoFine nåle.
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
Instruktionerne som er vedlagt cylinderampullerne og insulindispenseringssystemet skal følges.
Detailed instruction accompanying the cartridge and delivery system must be followed.
NovoMix 30 Penfill må kun anvendes af én person.
NovoMix 30 Penfill is for use by one person only.
9 Det er vigtigt at understrege over for patienten, at NovoMix 30 suspensionen skal opblandes umiddelbart før brug.
9 The necessity of resuspending the NovoMix 30 suspension immediately before use is to be stressed to the patient.
Den opblandede væske skal være ensartet hvid og uklar.
The resuspended liquid must appear uniformly white and cloudy.
Dato for seneste fornyelse af tilladelse:
1 August 2000 Date of last renewal:
NovoMix 50 Penfill 100 E/ ml, injektionsvæske, suspension i en cylinderampul.
NovoMix 50 Penfill 100 U/ ml, suspension for injection in a cartridge.
Opløseligt insulin aspart * / protaminkrystalliseret insulin aspart * ……... 100 E/ ml i forholdet 50/ 50
Soluble insulin aspart*/ protamine-crystallised insulin aspart*…… ..100 U/ ml in the ratio of 50/ 50
NovoMix 50 er en hvid suspension
NovoMix 50 is a white suspension.
NovoMix 50 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 50 to be given immediately before a meal.
Hvis det er nødvendigt, kan NovoMix 50 gives lige efter starten af et måltid.
When necessary, NovoMix 50 can be given soon after start of a meal.
Doseringen af NovoMix 50 er individuel og fastsættes baseret på lægens anvisning i overensstemmelse med patientens behov.
Dosage of NovoMix 50 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 50.
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.
Det daglige insulinbehov kan være højere hos patienter med insulinresistens (f. eks. på grund af overvægt) og lavere hos patienter med resterende endogen insulinsekretion.
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.
Hos patienter med type 2- diabetes kan NovoMix 50 gives som monoterapi eller i kombination med metformin, når blodglucosen er utilstrækkeligt kontrolleret med metformin alene.
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.
Skift til NovoMix 50 fra andre insulintyper kan muligvis medføre justering af dosis og doserings tidspunkt.
Transfer to NovoMix 50 from other insulin preparations may require adjustment of dose and timing of administration.
4. 4)
As with all insulins, close glucose monitoring is recommended during transition and the initial weeks thereafter (see section 4.4).
Justering af dosis kan også blive nødvendig, hvis patienten ændrer sin kost.
Adjustment of dosage may also be necessary if patients change their diet.
Fysisk aktivitet kan reducere patientens insulin behov.
Physical activity may reduce the patients’ insulin requirements.
Hos patienter med diabetes mellitus vil en optimeret metabolisk kontrol effektivt forsinke opståen og udvikling af diabetiske senkomplikationer.
In patients with diabetes mellitus optimised metabolic control effectively delays the onset and slows the progression of diabetic late complications.
Optimeret diabetisk kontrol med blodglucose monitorering er derfor anbefalet.
Optimised metabolic control, including glucose monitoring, is therefore recommended.
11 Som ved alle insulintyper, bør glucosemonitoreringen intensiveres og doseringen justeres på individuel basis hos ældre patienter og patienter med lever - eller nyrelidelser.
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.
Lever - eller nyrelidelser kan reducere patientens insulinbehov.
Renal or hepatic impairment may reduce the patient’ s insulin requirements.
Der er ingen klinisk erfaring med NovoMix 50 hos børn og unge under 18 år.
No studies have been performed with NovoMix 50 in children and adolescents under the age of 18 years.
Administration:
Administration:
NovoMix 50 indgives subkutant i låret eller i abdominalvæggen.
NovoMix 50 is administered subcutaneously by injection in the thigh or in the abdominal wall.
Injektionen kan dog også gives i glutereal - eller deltoidregionen.
If convenient, the gluteal or deltoid region may be used.
Injektionsstederne bør roteres inden for samme område.
Injection sites should be alternated within the same region.
Som for alle insulintyper varierer virkningsvarigheden alt efter dosis, injektionssted, blodgennemstrømning, temperatur og fysisk aktivitetsniveau.
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.
NovoMix 50 må aldrig indgives intravenøst.
NovoMix 50 should never be administered intravenously.
4. 8 og 4. 9).
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia (see section 4.8 and section 4.9).
NovoMix 50 bør indgives i umiddelbar forbindelse med et måltid.
NovoMix 50 should be administered in immediate relation to a meal.
Patienter, der skifter til NovoMix 50, skal muligvis have ændret dosis i forhold til dosis af de sædvanlige insulintyper.
Patients taking NovoMix 50 may need a change in dosage from that used with their usual insulin.
NovoMix 50 indeholder metacresol, som kan give allergiske reaktioner.
12 NovoMix 50 contains metacresol, which may cause allergic reactions.
Der er ingen restriktioner på behandling med NovoMix 50 under amning.
There are no restrictions on treatment with NovoMix 50 during lactation.
Det kan dog være nødvendigt at justere dosis af NovoMix 50.
However, the NovoMix 50 dosage may need to be adjusted.
I kliniske forsøg og efter markedsføringen varierer frekvensen i forhold til patientpopulation og dosisregime.
In clinical trials and during marketed use the frequency varies with patient population and dose
Der kan derfor ikke angives en specifik frekvens.
13 regimens therefore no specific frequency can be presented.
13 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.
Nervesystemet Sjælden - Perifer neuropati Hurtig forbedring af blodglucosekontrollen kan være forbundet med en tilstand som akut smertefuld neuropati, som sædvanligvis er reversibel.
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.