FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Patienter med markant forbedret blodglucosekontrol, opnået f.eks. ved intensiv insulinbehandling, kan opleve en ændring af de normale advarselssymptomer på hypoglykæmi og bør advares herom.
English: ► If you are allergic to insulin aspart or any of the other ingredients in this medicine (see section
Danish: ► Hvis du er allergisk over for insulin aspart eller et af de øvrige indholdsstoffer i denne medicin
English: Serum insulin levels returned to baseline 15-18 hours after a subcutaneous dose.
Danish: Tilbagevenden til udgangsniveau for seruminsulin sås 15-18 timer efter subkutan injektion.
English: Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Danish: Dosisjustering kan blive nødvendig, hvis patienterne udøver øget fysisk aktivitet, ændrer deres kostvaner eller i forbindelse med samtidig sygdom.
English: If you forget to take your insulin, your blood sugar may get too high (hyperglycaemia).
Danish: Hvis du glemmer at tage dit insulin, kan dit blodsukker blive for højt (hyperglykæmi).
English: • Roll the cartridge between your palms 10 times - it is important that the cartridge is kept horizontal (level with the ground) (see picture A).
Danish: • Rul cylinderampullen mellem hænderne 10 gange - det er vigtigt, at cylinderampullen holdes horisontalt (vandret) (se figur A).
English: Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
Danish: Undersøgelser viser også, at insulin asparts dissociation af bindingen til insulinreceptoren er den samme som for humant insulin.
English: • Danazol (medicine acting on ovulation).
Danish: • Danazol (lægemiddel der virker på ægløsning).
English: ► Always carry a spare Penfill cartridge in case the one in use is lost or damaged.
Danish: ► Medbring altid en ekstra Penfill cylinderampul i tilfælde af, at den, der er i brug, mistes eller ødelægges.
English: 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 patients aged 10 to 18 years.
Danish: En 16-uger klinisk undersøgelse, som sammenlignede postprandiel glykæmisk kontrol af måltidsrelateret NovoMix 30 med måltidsrelateret humant insulin/bifasisk humant insulin 30 og NPH ved sengetid, blev udført med 167 patienter i alderen fra 10 til 18 år.
English: In clinical trials, the frequency of hypoglycaemia varied with patient population, dose regimens and level of glycaemic control.
Danish: I kliniske forsøg varierede frekvensen af hypoglykæmi afhængigt af patientgruppe, dosisregime og niveau af glykæmisk kontrol.
English: When using 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.
Danish: I forbindelse med anvendelse af NovoMix 30 en gang dagligt anbefales det generelt at dele doseringen til to gange dagligt, når man når op på 30 enheder, ved at dele dosis op i lige morgenog aftendoser.
English: Before travelling between different time zones, the patient should seek the doctor's advice since this may mean that the patient has to take the insulin and meals at different times.
Danish: Patienterne skal informeres om at rådføre sig med deres læge før rejse mellem forskellige tidszoner, da dette kan medføre, at patienten skal tage insulin og måltider på andre tidspunkter.
English: -2 units
Danish: -2 enheder
English: 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.
Danish: 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.
English: What to do if you experience high blood sugar: ► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
Danish: Hvad du bør gøre, hvis du føler, at du får højt blodsukker: ► Hvis du oplever nogle af ovennævnte symptomer: Mål dit blodsukkerniveau, om muligt kontrollér din urin for ketonstoffer og søg straks lægehjælp.
English: ► If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor.
Danish: ► Hvis du får så lavt blodsukker, at du bliver bevidstløs, hvis du har haft behov for en glukagoninjektion, eller hvis du har haft gentagne tilfælde af lavt blodsukker, skal du tale med din læge.
English: Figure 1: Activity profile of NovoMix 30 (___) and biphasic human insulin 30 (---) in healthy subjects.
Danish: Figur 1: Aktivitetsprofil for NovoMix 30 (___) og bifasisk humant insulin 30 (---) hos raske personer.
English: In a smaller (54 patients) 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 were significantly lower with NovoMix 30 compared to biphasic human insulin 30.
Danish: I en mindre (54 patienter) og yngre (i alderen fra 6-12 år) befolkningsgruppe, som blev behandlet i et dobbeltblindet overkrydsningsstudie (12 uger med hver behandling), var antallet af hypoglykæmiske tilfælde og den postprandielle glucoseforhøjelse signifikant lavere med NovoMix 30 sammenlignet med bifasisk humant insulin 30.
English: Read carefully the instructions for use included in this package leaflet.
Danish: Læs omhyggeligt Brugervejledningen, som er i denne indlægsseddel.
English: Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Frekvensenskategorierne er defineret i henhold til den følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til ≤1/100), sjælden (≥1/10.000 til ≤1/1.000), meget sjælden (≤1/10.000), ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: 3 ml suspension in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).
Danish: 3 ml suspension i cylinderampul (type 1 glas) med et stempel (brombutyl) og en gummiprop (brombutyl/polyisopren).
English: Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity.
Danish: Reproduktionsstudier hos dyr har ikke vist forskelle mellem insulin aspart og humant insulin med hensyn til embryotoxicitet eller teratogenicitet.
English: Insulin administration may cause insulin antibodies to form.
Danish: Administration af insulin kan forårsage dannelse af insulin-antistoffer.
English: Read the following instructions carefully before using your FlexPen.
Danish: Læs denne brugervejledning omhyggeligt, inden du tager FlexPen i brug.
English: In patients with type 1 diabetes, the individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day.
Danish: Hos patienter med type 1-diabetes ligger det individuelle insulinbehov normalt mellem 0,5 og 1,0 enheder/kg/dag.
English: Insulin aspart is equipotent to human insulin on a molar basis.
Danish: Insulin aspart er ækvipotent med humant insulin på molær basis.
English: Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Danish: Når patienten igen er ved bevidsthed, anbefales orale kulhydrater for at forhindre recidiv.
English: 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).
Danish: 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).
English: • NovoMix 30 can be used in adolescents and children aged 10 years and above.
Danish: • NovoMix 30 kan anvendes til unge og børn, der er fyldt 10 år og derover.
English: Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with NovoMix 30.
Danish: Endelig var HbA1c signifikant lavere i den gruppe, som blev behandlet med bifasisk humant insulin 30 sammenlignet med NovoMix 30.
English: If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level.
Danish: Hvis ikke du følger denne vejledning omhyggeligt, kan du risikere at få for lidt eller for meget insulin, hvilket kan føre til for højt eller for lavt blodsukkerniveau.
English: The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Danish: Den blodglucosenedsættende virkning af insulin aspart skyldes den faciliterede optagelse af glucose efter insulin er bundet til insulinreceptorer i muskel- og fedtceller, og den samtidige hæmning af leverens glucoseudskillelse.
English: Administration with an insulin delivery system
Danish: Administration via et insulindispenseringssystem
English: The time to maximum concentration is, on average, half of that for biphasic human insulin 30.
Danish: Maksimal koncentration opnås gennemsnitligt på halvdelen af tiden for bifasisk humant insulin 30.
English: Adverse reactions observed in patients using NovoMix are mainly due to the pharmacological effect of insulin aspart.
Danish: Hos patienter, som bruger NovoMix, er de observerede bivirkninger fortrinsvis forårsaget af insulin asparts farmakologiske effekt.
English: The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life-threatening.
Danish: Generelle overfølsomhedsreaktioner (inklusive generelt hududslæt, kløe, svedtendens, gastrointestinalt ubehag, angioneurotisk ødem, åndedrætsbesvær, palpitationer og blodtryksfald) er forekommet meget sjældent, men kan være potentielt livstruende.
English: In treatment of type 2 diabetes mellitus, NovoMix 30 may be used in combination with tablets for diabetes and/or with injectable antidiabetic products.
Danish: Ved behandling af type 2-diabetes mellitus kan NovoMix 30 anvendes i kombination med tabletter mod diabetes og/eller med injicérbare præparater mod diabetes.
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between NovoMix and other insulin products.
Danish: Patienten skal instrueres i altid at kontrollere etiketten på insulinet før hver injektion for at undgå utilsigtet forveksling mellem NovoMix og andre insulinpræparater.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Danmark
English: Limited clinical data exists for children aged 6-9 years.
Danish: Der er begrænset klinisk data for børn i alderen 6-9 år.
English: Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding fertility.
Danish: Reproduktionsstudier hos dyr har ikke vist forskelle mellem insulin aspart og humant insulin med hensyn til fertilitet.
English: In insulin aspart, substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with soluble human insulin.
Danish: I insulin aspart nedsætter udskiftning af aminosyren prolin med aspartinsyre på position B28 tendensen til at danne hexamerer som set med opløseligt humant insulin.
English: This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.
Danish: Dette vil sikre korrekt injektion og nedsætte risikoen for, at der kommer blod op i nålen eller op i insulinreservoiret.
English: Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose.
Danish: Samtidige sygdomme i nyrer, lever eller påvirkning af binyrer, hypofyse eller thyreoidea kan nødvendiggøre ændringer i insulindosis.
English: METHOD OF ADMINISTRATION Resuspend according to instructions Penfill
Danish: ANVENDELSESMÅDE Opblandes i henhold til vejledningen Penfill
English: Consult your doctor: ► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
Danish: Kontakt lægen: ► Hvis du har problemer med nyrer eller lever, eller med binyrer, hypofyse eller skjoldbruskkirtel.
English: Uncommon - Urticaria, rash, eruptions Very rare - Anaphylactic reactions*
Danish: Ikke almindelige - Nældefeber, udslæt, eruptioner Meget sjælden - Anafylaktiske reaktioner*
English: 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.
Danish: 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.
English: What to do if you experience low blood sugar: ► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice).
Danish: Hvad du skal gøre, hvis du føler, at du får lavt blodsukker: ► Hvis du føler, at du får lavt blodsukker, spis glukosetabletter eller et sukkerholdigt produkt (slik, kiks, frugtjuice).
English: Insulin antibodies
Danish: Insulin-antistoffer
English: The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
Danish: De bedste steder til injektion er: Maveskindet, ballen, foran på låret eller overarmen.
English: This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Danish: Dette nedsætter risikoen for urenheder, infektion, insulinlækage, tilstoppede nåle og upræcis dosering.
English: When patients are transferred between different types of insulin medicinal products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Danish: 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.
English: Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Danish: Nogle lægemidler påvirker dit blodsukkerniveau, og det kan betyde, at din insulindosis skal ændres.
English: Do not use this medicine after the expiry date, which is stated on the FlexPen label and carton after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på etiketten og pakningen med FlexPen.
English: 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.
Danish: Hos type 2-diabetikere blev maksimal koncentration opnået ca. 95 minutter efter injektion, og der blev målt koncentrationer godt over nul i ikke mindre end 14 timer efter injektion.
English: Then move the pen up and down 10 times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other.
Danish: Derefter vendes pennen, som vist, op og ned mellem de to positioner mindst 10 gange, så glaskuglen bevæger sig fra den ene til den anden ende i cylinderampullen.
English: The maximum serum insulin concentration is, on average, 50% higher with NovoMix 30 than with biphasic human insulin 30.
Danish: Den maksimale seruminsulinkoncentration er gennemsnitligt 50 % højere med NovoMix 30 end med bifasisk humant insulin 30.
English: Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.
Danish: Diabetisk retinopati (en øjensygdom med relation til sukkersyge, som kan medføre tab af synet): Hvis du har diabetisk retinopati, kan den blive værre, hvis dit blodsukkerniveau forbedres meget hurtigt.
English: L ► Keep the push-button fully depressed and let the needle remain under the skin for at least
Danish: L ► Hold trykknappen helt i bund og lad nålen forblive under huden i mindst 6 sekunder.
English: Low blood sugar may occur if you:
Danish: Lavt blodsukker kan opstå, hvis du:
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMAs) hjemmeside http://www.ema.europa.eu
English: If you take the wrong type of insulin, your blood sugar level may get too high or too low.
Danish: Hvis du tager en forkert type insulin, kan dit blodsukkerniveau blive for højt eller for lavt.
English: • There is limited experience with NovoMix 30 in children aged 6-9 years.
Danish: • Der er begrænset erfaring med NovoMix 30 hos børn i alderen 6 til 9 år.
English: In patients with type 2 diabetes, NovoMix 30 can be given as monotherapy.
Danish: Hos patienter med type 2-diabetes kan NovoMix 30 gives som monoterapi.
English: The individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day.
Danish: Den individuelle insulindosering er sædvanligvis mellem 0,5 og 1,0 enheder/kg/dag.
English: This will make sure you get the full dose.
Danish: Dette sikrer injektion af hele dosis.
English: 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.
Danish: Der var ingen forskel på den primære effektivitetsvariabel - HbA1c efter 16 ugers behandling - hos patienter der var behandlet med NovoMix 30 kombineret med metformin og patienter behandlet med metformin og sulfonylurea.
English: When NovoMix 30 is used in combination with tablets for diabetes and/or with injectable antidiabetic products your dose may have to be adjusted by your doctor.
Danish: Når NovoMix 30 anvendes i kombination med tabletter mod diabetes og/eller med injicérbare præparater mod diabetes, er det muligt, at dosis skal justeres af din læge.
English: Always check if there is enough insulin left (at least 12 units) in the cartridge to allow even resuspension.
Danish: Kontrollér altid, om der er nok insulin tilbage (mindst 12 enheder) i cylinderampullen, for at sikre en ensartet opblanding.
English: Manufacturer
Danish: Fremstillere
English: Move the pen up and down between the two positions at least 10 times until the liquid does appear uniformly white, cloudy and aqueous.
Danish: Vend pennen op og ned mellem de to positioner mindst 10 gange, indtil al væsken er ensartet hvid, uklar og vandig.
English: ► If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.
Danish: ► Hvis du har planer om at rejse til udlandet, da tidsforskellen mellem landene kan påvirke dit insulinbehov og tidspunkt.
English: The pharmacokinetics of NovoMix 30 have not been investigated in children or adolescents.
Danish: Farmakokinetikken af NovoMix 30 har ikke været undersøgt hos børn eller unge.
English: 3 ml suspension in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Danish: 3 ml suspension i cylinderampul (type 1 glas) med et stempel (brombutyl) og en gummiprop (brombutyl/polyisopren) i en fyldt engangspen til flergangsbrug fremstillet af polypropylen.
English: After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.2, 4.8 and
Danish: Når patientens blodglucose er stabiliseret, skal dosisjustering overvejes (se pkt.
English: Combination of NovoMix with pioglitazone
Danish: Kombinationsbehandling med NovoMix og pioglitazon
English: 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.
Danish: Gennemsnittet af HbA1c forblev ens med baseline under undersøgelsen i begge behandlingsgrupper, og der var ingen forskel i forekomsten af hypoglykæmi med NovoMix 30 eller bifasisk humant insulin 30.
English: The cartridge contains a glass ball to facilitate resuspension.
Danish: Cylinderampullen indeholder en glaskugle for at lette opblandingen.
English: • Move the cartridge up and down between positions a and b (see picture B) 10 times so that the glass ball moves from one end of the cartridge to the other.
Danish: • Vend cylinderampullen op og ned fra position a til b (se figur B) 10 gange, så glaskuglen bevæger sig fra den ene ende af cylinderampullen til den anden.
English: NovoMix 70 may be used in combination with metformin.
Danish: NovoMix 70 kan anvendes i kombination med metformin.
English: Needles, cartridges and pre-filled pens must not be shared.
Danish: Nåle, cylinderampuller og fyldte penne må ikke deles.
English: Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens of 3 ml.
Danish: Pakningsstørrelser med 1 (med eller uden nåle), 5 (uden nåle) eller 10 (uden nåle) fyldte penne med 3 ml.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 August 2000
Danish: Dato for første tilladelse: 1. august 2000.
English: 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.
Danish: 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.
English: If you take too much insulin, your blood sugar gets too low (hypoglycaemia).
Danish: Hvis du har taget for meget insulin, bliver dit blodsukker for lavt (hypoglykæmi).
English: Talk to your doctor, nurse or pharmacist for advice.
Danish: Tal med din læge, sygeplejerske eller spørg apotekspersonalet for at få rådgivning.
English: Resuspending your insulin
Danish: Opblanding af dit insulin
English: The suspension is cloudy, white and aqueous.
Danish: Suspensionen er uklar, hvid og vandig
English: For every following injection
Danish: Før hver efterfølgende injektion
English: Always keep the pen cap on your FlexPen when you are not using it, in order to protect it from light.
Danish: Opbevar altid penhætten på din Flexpen, når den ikke er i brug, for at beskytte den mod lys.
English: Continuous rotation of the injection site within a given area reduces the risk of developing these reactions.
Danish: Kontinuerligt skift af injektionssted inden for et givet område reducerer risikoen for at udvikle disse reaktioner.
English: • If the moving procedure alone is not enough to give a uniformly white, cloudy and aqueous liquid, repeat the rolling and moving procedures described above until the liquid appears uniformly white, cloudy and aqueous.
Danish: • Hvis vendeproceduren alene ikke er tilstrækkelig til at give en ensartet, hvid, uklar og vandig væske, skal rulle- og vendeprocedurerne gentages, indtil væsken fremstår ensartet hvid, uklar og vandig.