FrancophonIA/ELRC3.0 huggingface dataset:
English: ► Always make sure that you have resuspended the insulin prior to each injection.
Danish: ► Kontrollér altid, at du har opblandet insulinet inden hver injektion.
English: If the moving procedure alone is not enough to give a uniformly white, cloudy and aqueous liquid, repeat the rolling and moving procedures (see B and C) until the liquid does appear uniformly white, cloudy and aqueous.
Danish: Hvis vendeproceduren alene ikke er tilstrækkelig til at give en ensartet, hvid, uklar og vandig væske, gentag da rulle- og vendeprocedurerne (se B og C), indtil væsken fremstår ensartet hvid, uklar og vandig.
English: ► Always use a new needle for each injection to prevent contamination.
Danish: ► Brug altid en ny nål til hver injektion for at undgå urenheder.
English: 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.
Danish: 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.
English: The advisability of driving or operating a machine should be considered in these circumstances.
Danish: I disse tilfælde bør det nøje vurderes, om motorkørsel eller betjening af maskiner kan tilrådes.
English: This could be the result of an insulin leakage.
Danish: Dette kan være forårsaget af en insulinlækage.
English: ► If after resuspension, clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge.
Danish: ► Hvis væsken efter opblanding indeholder klumper, eller hvis der sidder hvide partikler fast på cylinderampullens bund eller sider.
English: NovoMix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.
Danish: NovoMix 30 er indiceret til behandling af diabetes mellitus hos voksne, unge og børn i alderen 10 år og derover.
English: This may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Danish: Dette kan føre til upræcis dosering, hvilket kan føre til for højt eller for lavt blodsukkerniveau.
English: During use or when carried as a spare: Store below 30°C.
Danish: Under brug eller hvis medbragt som reserve: Opbevares ved temperaturer under 30°C.
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen, sygeplejersken eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Injektionsvæske, suspension
English: OTHER SPECIAL WARNINGS, IF NECESSARY Resuspend according to instructions Only use resuspension if uniformly white, cloudy and aqueous For use by one person only
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Opblandes i henhold til vejledningen Brug kun opblanding der er ensartet hvid, uklar og vandig Kun til anvendelse af én person
English: NovoMix 50 may be used in combination with metformin.
Danish: NovoMix 50 kan anvendes i kombination med metformin.
English: METHOD OF ADMINISTRATION Resuspend according to instructions FlexPen
Danish: ANVENDELSESMÅDE Opblandes i henhold til vejledningen FlexPen
English: J Turn the dose selector to select the number of units you need to inject.
Danish: J Indstil dosisvælgeren til det antal enheder du skal injicere.
English: Changing the site with each injection reduces the risk of developing such skin changes.
Danish: Hvis man injicerer et nyt sted hver gang, nedsættes risikoen for at udvikle sådanne ændringer i huden.
English: If you stop taking your insulin
Danish: Hvis du holder op med at tage dit insulin
English: • Glucocorticoids (such as ‘cortisone' used to treat inflammation)
Danish: • Glukokortikoider (såsom ‘cortison' til behandling af inflammation/betændelsestilstande)
English: In elderly patients (≥65 years old) and in patients with hepatic or renal impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.
Danish: Hos ældre patienter (≥65 år) og hos patienter med nedsat lever- eller nyrefunktion, skal glucosemonitoreringen intensiveres og insulin aspart doseringen justeres på individuel basis.
English: Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur.
Danish: Symptomer på allergi: Lokale allergiske reaktioner (smerte, rødme, udslæt, betændelse, blå mærker, hævelse og kløe) på injektionsstedet kan forekomme.
English: NovoMix 70 may fully or partially meet this requirement.
Danish: NovoMix 70 kan helt eller delvist imødekomme dette behov.
English: leakage of insulin, blocked needles and inaccurate dosing.
Danish: insulinlækage, tilstoppede nåle og upræcis dosering.
English: There is limited clinical experience with NovoMix 30 in children aged 6-9 years (see section 5.1).
Danish: Der er begrænsede kliniske data med NovoMix 30 hos børn fra 6-9 år (se pkt.
English: +6 units
Danish: +6 enheder
English: NovoMix 30 can be used in adolescents and children aged 10 years and above when premixed insulin is preferred.
Danish: NovoMix 30 kan anvendes til unge og børn på 10 år og derover, når blandingsinsulin foretrækkes.
English: NovoMix 70 is indicated for treatment of diabetes mellitus in adults.
Danish: NovoMix 70 er indiceret til behandling af diabetes mellitus hos voksne.
English: 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.
Danish: 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.
English: Only use resuspension if uniformly white, cloudy and aqueous For use by one person only
Danish: Brug kun opblanding der er ensartet hvid, uklar og vandig Kun til anvendelse af én person
English: NovoMix 30 may fully or partially meet this requirement.
Danish: NovoMix 30 kan helt eller delvist imødekomme dette behov.
English: In type 2 patients with diabetes, the maximum concentration was reached about 75 minutes after dosing.
Danish: Hos type 2-diabetikere blev maksimal koncentration opnået ca. 75 minutter efter injektion.
English: Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints.
Danish: Hævede led: Når du påbegynder insulinbehandling, kan væskeophobning forårsage hævelse af ankler eller led.
English: +4 units
Danish: +4 enheder
English: NovoMix 50 is indicated for treatment of diabetes mellitus in adults.
Danish: NovoMix 50 er indiceret til behandling af diabetes mellitus hos voksne.
English: 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.
Danish: 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.
English: • Monoamine oxidase inhibitors (MAOI) (used to treat depression)
Danish: • Monoaminoxidase-hæmmere (MAO-hæmmere) (til behandling af depression)
English: They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentrating, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Danish: De kan omfatte koldsved, kold bleg hud, træthed, nervøsitet eller rysten, ængstelse, usædvanlig træthed eller svaghed, forvirring, koncentrationsbesvær, døsighed, overdreven sult, synsforstyrrelser, hovedpine, kvalme og palpitationer.
English: Each pre-filled pen contains 300 units of insulin aspart in 3 ml suspension for injection.
Danish: Hver fyldt pen indeholder 300 enheder insulin aspart i 3 ml injektionsvæske, suspension.
English: Figure 1: Activity Profile for NovoMix 70 in Healthy Caucasian Subjects.
Danish: Figur 1: Aktivitetsprofil for NovoMix 70 hos raske personer.
English: In patients with type 2 diabetes, NovoMix 70 can be given as monotherapy or in combination with metformin when the blood glucose is inadequately controlled with metformin alone.
Danish: 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.
English: In elderly patients, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.
Danish: Hos ældre patienter skal monitorering af glucose intensiveres og dosis af insulin aspart justeres individuelt.
English: NovoMix 50 may fully or partially meet this requirement.
Danish: NovoMix 50 kan helt eller delvist imødekomme dette behov.
English: In type 2 patients with diabetes, the maximum concentration was reached about 95 minutes after dosing.
Danish: Hos type 2-diabetikere blev maksimal koncentration opnået ca. 95 minutter efter injektion.
English: Each cartridge contains 300 units of insulin aspart in 3 ml suspension for injection.
Danish: Hver cylinderampul indeholder 300 enheder insulin aspart i 3 ml injektionsvæske, suspension.
English: K Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
Danish: K Injicér dosis ved at trykke på trykknappen indtil der står 0 ud for markøren.
English: During clinical trials, the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
Danish: I 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.
English: 4.2, the mean reduction in HbA1c was 2.8% with NovoMix 30 (mean at baseline = 9.7%).
Danish: Efter 28 ugers behandling, hvor man fulgte de retningslinier for dosering, der er angivet i afsnit 4.2, var der et gennemsnitligt fald i HbA1c på 2,8 % med NovoMix 30 (gennemsnit ved baseline = 9,7 %).
English: ► If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
Danish: ► Hvis cylinderampullen eller insulindispenseringssystemet indeholdende cylinderampullen tabes, beskadiges eller knuses.
English: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in the paediatric population do not indicate any differences to the broader experience in the general population.
Danish: Baseret på erfaringer post-marketing samt kliniske forsøg, indikerer bivirkningernes frekvens, type og alvor observeret i den pædiatriske population ikke, at der er forskelle i forhold til den bredere erfaring hos den generelle patientgruppe.
English: In patients with type 2 diabetes, NovoMix 50 can be given as monotherapy or in combination with metformin when the blood glucose is inadequately controlled with metformin alone.
Danish: 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.
English: • Repeat the rolling and moving procedures (see pictures A and B) until the liquid appears uniformly white, cloudy and aqueous.
Danish: • Gentag rulle- og vendeprocedurerne (se billederne A og B), indtil al væsken fremstår ensartet hvid, uklar og vandig.
English: This makes sure that the insulin flows.
Danish: Dette sikrer gennemløb af insulinet.
English: LIST OF EXCIPIENTS glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid/sodium hydroxide for pH adjustment and water for injections
Danish: LISTE OVER HJÆLPESTOFFER glycerol, phenol, metacresol, zinkchlorid, dinatriumphosphatdihydrat, natriumchlorid, protaminsulfat, saltsyre/natriumhydroxid til pH justering og vand til injektionsvæsker
English: +2 units
Danish: +2 enheder
English: Making the injection Insert the needle into your skin.
Danish: Injektion af insulin Stik nålen ind under huden.
English: NovoMix 30 is used to reduce the high blood sugar level in adults, adolescents and children aged 10 years and above with diabetes mellitus (diabetes).
Danish: NovoMix 30 anvendes til at reducere det høje blodsukkerniveau hos voksne, unge og børn, der er fyldt 10 år og derover med sukkersyge (diabetes mellitus).
English: Figure 1: Activity Profile for NovoMix 50 in Healthy Caucasian Subjects.
Danish: Figur 1: Aktivitetsprofil for NovoMix 50 hos raske personer.
English: Pull off the inner needle cap and dispose of it.
Danish: Fjern den indre nålehætte og kassér den.
English: Transfer to NovoMix 70 from other insulin preparations may require adjustment of dose and timing of administration.
Danish: Skift til NovoMix 70 fra andre insulinpræparater kan muligvis medføre justering af dosis og doseringstidspunkt.
English: It may affect less than 1 in 10,000 people.
Danish: Det forekommer hos færre end 1 ud af 10.000 behandlede.
English: It may affect more than 1 in 10 people.
Danish: Det forekommer hos mere end 1 ud af 10 behandlede.
English: • The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide and water for injections.
Danish: • Øvrige indholdsstoffer: Glycerol, phenol, metacresol, zinkchlorid, dinatriumphosphatdihydrat, natriumchlorid, protaminsulfat, saltsyre, natriumhydroxid og vand til injektionsvæsker.
English: For patients with type 2 diabetes, the recommended starting dose of NovoMix 30 is 6 units at breakfast and 6 units at dinner (evening meal).
Danish: Den anbefalede startdosering af NovoMix 30 er 6 enheder ved morgenmaden og 6 enheder ved aftensmaden til patienter med type 2-diabetes.
English: The safety and efficacy of NovoMix 50 in children below 18 years of age have not been established.
Danish: Sikkerheden og virkningen af NovoMix 50 hos børn under 18 år er ikke påvist.
English: The safety and efficacy of NovoMix 70 in children below 18 years of age have not been established.
Danish: Sikkerheden og virkningen af NovoMix 70 hos børn under 18 år er ikke påvist.
English: Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Danish: Symptomer på lavt blodsukker: Koldsved, kold bleg hud, hovedpine, hurtig hjerterytme (puls), kvalme, usædvanlig stor sultfornemmelse, midlertidige synsforstyrrelser, døsighed, unormal træthed og svaghed, nervøsitet eller rysten, indre uro, forvirring og koncentrationsbesvær.
English: b) List of other side effects
Danish: Oversigt over andre bivirkninger
English: Compared with biphasic human insulin, NovoMix 30 may have a more pronounced glucose lowering effect up to 6 hours after injection.
Danish: NovoMix 30 kan have mere udtalt glucosenedsættende effekt end bifasisk humant insulin indtil 6 timer efter injektion.
English: In patients with renal or hepatic impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.
Danish: Hos patienter med nedsat nyre- eller leverfunktion skal monitorering af glucose intensiveres og dosis af insulin aspart justeres individuelt.
English: Continuous rotation of the injection site within the particular area reduces the risk of developing these reactions.
Danish: Kontinuerligt skift af injektionssted inden for det enkelte injektionsområde kan reducere risikoen for udvikling af disse reaktioner.
English: The influence of different injection sites on the absorption of NovoMix 70 has not been investigated.
Danish: Forskellige injektionssteders indflydelse på absorptionen af NovoMix 70 er ikke undersøgt.
English: These usually disappear after a few weeks of taking your insulin.
Danish: Disse forsvinder normalt inden for få uger ved fortsat behandling.
English: NovoMix 70 dosing is individual and determined in accordance with the needs of the patient.
Danish: Doseringen af NovoMix 70 er individuel og fastsættes efter patientens behov.
English: The insulin will work more quickly if you inject around the waist.
Danish: Du vil få en hurtigere virkning, hvis insulinet injiceres i maveskindet.
English: NovoMix 30 dosing is individual and determined in accordance with the needs of the patient.
Danish: Doseringen af NovoMix 30 er individuel og fastsættes efter patientens behov.
English: NovoMix 70 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 70 is essentially ‘sodium-free'.
Danish: NovoMix 70 indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. NovoMix 70 er stort set natriumfrit.
English: However, the NovoMix 30 dose may need to be adjusted.
Danish: Det kan dog være nødvendigt at justere dosis af NovoMix 30.
English: No clinical studies with NovoMix 70 have been carried out in children and adolescents under the age of 18 years.
Danish: Der har ikke været udført kliniske studier med NovoMix 70 hos børn og unge under 18 år.
English: NovoMix 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 30 is essentially ‘sodium-free'.
Danish: NovoMix 30 indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. NovoMix 30 er stort set natriumfrit.
English: The influence of different injection sites on the absorption of NovoMix 30 has not been investigated.
Danish: Forskellige injektionssteders indflydelse på absorptionen af NovoMix 30 er ikke undersøgt.
English: NovoMix 50 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 50 is essentially ‘sodium-free'.
Danish: NovoMix 50 indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. NovoMix 50 er stort set natriumfrit.
English: The influence of different injection sites on the absorption of NovoMix 50 has not been investigated.
Danish: Forskellige injektionssteders indflydelse på absorptionen af NovoMix 50 er ikke undersøgt.
English: NovoMix 70 which has been frozen must not be used.
Danish: NovoMix 70 må ikke anvendes, hvis det har været frosset.
English: As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, inflammation, bruising, swelling and itching.
Danish: Som ved enhver anden insulinbehandling kan der opstå reaktioner på injektionsstedet i form af smerte, rødme, udslæt, inflammation, blå mærker, hævelse og kløe.
English: • Drink alcohol (see Drinking alcohol and taking NovoMix 50 in section 2).
Danish: • Drikker alkohol (se Brug af NovoMix 50 sammen med alkohol, under punkt 2).
English: After removing NovoMix 50 Penfill or NovoMix 50 FlexPen from the refrigerator, it is recommended to allow NovoMix 50 Penfill or NovoMix 50 FlexPen to reach room temperature before resuspending the insulin as instructed for first time use.
Danish: Efter at NovoMix 50 Penfill eller NovoMix 50 FlexPen er taget ud af køleskabet, bør NovoMix 50 Penfill eller NovoMix 50 FlexPen opnå stuetemperatur inden insulinet opblandes som beskrevet ved brug første gang.
English: Always keep the cartridge in the outer carton when you are not using it, in order to protect it from light.
Danish: Opbevar altid cylinderampullen i den ydre karton, når den ikke er i brug, for at beskytte den mod lys.
English: At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur.
Danish: Initialt under insulinbehandlingen kan der forekomme refraktionsanomalier, ødemer og reaktioner på injektionsstedet (smerte, rødmen, udslæt, inflammation, blå mærker, hævelser og kløe på injektionsstedet).
English: Repeat rolling and moving the pen until the liquid does appear uniformly white, cloudy and aqueous.
Danish: Gentag rulle- og vendeproceduren, indtil al væsken er ensartet hvid, uklar og vandig.
English: NovoMix 50 which has been frozen must not be used.
Danish: NovoMix 50 må ikke anvendes, hvis det har været frosset.
English: ► If the resuspended insulin does not appear uniformly white, cloudy and aqueous.
Danish: ► Hvis det opblandede insulin ikke fremstår ensartet hvidt, uklart og vandigt.
English: • Drink alcohol (see Drinking alcohol and taking NovoMix 70 in section 2).
Danish: • Drikker alkohol (se Brug af NovoMix 70 sammen med alkohol, under punkt 2).
English: They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
Danish: Symptomerne inkluderer tørst, hyppig vandladning, kvalme, opkastning, døsighed, rødme og tør hud, mundtørhed, appetitløshed og acetoneånde.
English: After resuspension, the liquid should appear uniformly white, cloudy and aqueous.
Danish: Efter opblanding skal væsken være ensartet hvid, uklar og vandig.
English: Always carry glucose tablets or high sugar snacks with you, just in case.
Danish: Medbring for en sikkerheds skyld altid glukosetabletter, slik, kiks eller frugtjuice.
English: NovoMix 30 is presented as a suspension for injection.
Danish: NovoMix 30 leveres som en suspension til injektion.
English: What NovoMix 30 contains
Danish: NovoMix 30 indeholder
English: See Resuspension of NovoMix 50 in section 3.
Danish: Se Opblanding af NovoMix 50, under punkt 3.
English: No clinical studies with NovoMix 50 have been carried out in children and adolescents under the age of 18 years.
Danish: Der har ikke været udført kliniske studier med NovoMix 50 hos børn og unge under 18 år.
English: See Instructions for use.
Danish: Se Brugervejledningen.
English: EU/1/00/142/023 1 pen of 3 ml EU/1/00/142/009 5 pens of 3 ml EU/1/00/142/010 10 pens of 3 ml EU/1/00/142/024 1 pen of 3 ml and 7 NovoFine needles EU/1/00/142/025 1 pen of 3 ml and 7 NovoTwist needles
Danish: EU/1/00/142/023 1 pen med 3 ml EU/1/00/142/009 5 penne med 3 ml EU/1/00/142/010 10 penne med 3 ml EU/1/00/142/024 1 pen med 3 ml og 7 NovoFine nåle EU/1/00/142/025 1 pen med 3 ml og 7 NovoTwist nåle
English: Do not use NovoMix 70
Danish: Brug ikke NovoMix 70
English: See Resuspension of NovoMix 70 in section 3.
Danish: Se Opblanding af NovoMix 70, under punkt 3.
English: • Move the delivery system with the cartridge inside up and down between a and b (see picture B) at least 10 times until the liquid appears uniformly white, cloudy and aqueous.
Danish: • Vend dispenseringssystemet, med cylinderampullen indeni, op og ned fra position a til b (se figur B) mindst 10 gange, indtil al væsken er ensartet hvid, uklar og vandig.
English: NovoMix 50 must not be administered intravenously, as it may result in severe hypoglycaemia.
Danish: NovoMix 50 må ikke administreres intravenøst, da dette kan medføre alvorlig hypoglykæmi.
English: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Danish: Baseret på erfaringer post-marketing samt kliniske forsøg indikerer bivirkningernes frekvens, type og alvor observeret hos ældre patienter, samt hos ældre patienter med nedsat nyre- eller leverfunktion ikke, at der er forskelle i forhold til den bredere erfaring hos den generelle patientgruppe.
English: No data are available for NovoMix 30 in children below 6 years of age.
Danish: Der foreligger ingen data for NovoMix 30 hos børn under 6 år.
English: NovoMix 70 must not be administered intravenously, as it may result in severe hypoglycaemia.
Danish: NovoMix 70 må ikke administreres intravenøst, da dette kan medføre alvorlig hypoglykæmi.