FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients using CSII should be comprehensively instructed on the use of the pump system.
Danish: Patienter, der får CSII, skal være grundigt instruerede i brugen af pumpesystemet.
English: Insulin glulisine is produced by recombinant DNA technology in Escherichia coli.
Danish: Insulin glulisin fremstilles ved rekombinant DNA-teknologi i Escherichia coli.
English: It is therefore recommended that the diabetic patient constantly carries some sugar lumps, sweets, biscuits or sugary fruit juice.
Danish: Det anbefales derfor, at diabetikere altid har hugget sukker, slik, kiks eller sukkerholdig frugtjuice med sig.
English: Apidra is a clear insulin.
Danish: Apidra er en klar insulin.
English: Cases of diabetic ketoacidosis have been reported when Apidra has been given in continuous subcutaneous insulin infusion in pump systems.
Danish: Tilfælde af diabetisk ketoacidose er blevet rapporteret, når Apidra er blevet givet som kontinuerlig subkutan infusion i pumpesystemer.
English: This helps prevent contamination and/or infection, entry of air into the insulin reservoir and leakage of insulin.
Danish: Dette forhindrer kontaminering og/eller infektion, og at der kommer luftbobler i insulinbeholderen og lækage af insulin.
English: You may need to use Apidra with syringes or pens.
Danish: Det kan være, at du skal tage Apidra med sprøjte eller pen.
English: Medication errors have been reported in which other insulins, particularly long-acting insulins, have been accidentally administered instead of insulin glulisine.
Danish: Der er indrapporteret tilfælde af medicineringsfejl, hvor andre insuliner, særligt langtidsvirkende, utilsigtet er blevet administreret i stedet for insulin glulisin.
English: You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Danish: Du bør kende disse faktorer for at kunne handle korrekt ved ændringer i dit blodsukker og for at forhindre, at blodsukkeret bliver for højt eller for lavt.
English: When you use Apidra in the pump system, it is important that you always follow these specific instructions.
Danish: Når du bruger Apidra i et pumpesystem, er det vigtigt, at du altid følger de Apidra-specifikke instruktioner.
English: A number of substances affect glucose metabolism and may require dose adjustment of insulin glulisine and particularly close monitoring.
Danish: En række stoffer har indflydelse på glucosemetabolismen og kan nødvendiggøre dosisjustering af insulin glulisin og særlig omhyggelig monitorering.
English: GLULISINE - pre REGULAR - 30 min
Danish: GLULISINE - før REGULAR - 30 min
English: These conditions can happen when there are problems with the infusion pump or when the pump system is used incorrectly.
Danish: Disse tilstande kan opstå, hvis der er problemer med infusionspumpen eller hvis pumpesystemet bruges forkert.
English: The infusion set and reservoir used with Apidra must be changed at least every 48 hours using aseptic technique.
Danish: Det infusionsset og reservoir, der anvendes sammen med Apidra, skal skiftes mindst hver 48. time under anvendelse af aseptisk teknik.
English: The following related adverse reactions from clinical studies were listed below by system organ class and in order of decreasing incidence (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: Skema over bivirkninger Følgende relaterede bivirkninger, forekommet i kliniske studier, er nedenfor opstillet efter systemorganklasse og faldende hyppighed (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),
English: There are no specific data available concerning overdoses with insulin glulisine.
Danish: Der foreligger ikke specifikke data vedrørende overdosering af insulin glulisin.
English: The time to 10% of total INS exposure was reached earlier by approximately 5-6 min with insulin glulisine.
Danish: Den tid, det tog, til 10 % af total INS-påvirkning var nået, var ca. 5-6 minutter hurtigere med insulin glulisin.
English: In addition, you should have been provided with information about what to do if you become ill or if your blood sugar levels get too high or too low, or if the pump system fails.
Danish: Desuden skal du have fået at vide, hvad du skal gøre, hvis du bliver syg, får for højt eller for lavt blodsukker, eller hvis pumpesystemet svigter.
English: Patients must be educated to use proper injection techniques.
Danish: Patienterne skal oplæres i korrekt injektionsteknik.
English: In insulin glulisine the replacement of the human insulin amino acid asparagine in position B3 by lysine and the lysine in position B29 by glutamic acid favours more rapid absorption.
Danish: I insulin glulisin faciliterer udskiftningen af den humane insulinaminosyre asparagin i position B3 med lysin og af lysin i position B29 med glutaminsyre en hurtigere absorption.
English: Problems with the insulin pen?
Danish: Har du problemer med insulinpennen?
English: • SoloStar must never be used if it is damaged or if the patient is not sure if it is working properly.
Danish: • SoloStar må aldrig anvendes, hvis den er beskadiget, eller hvis patienten ikke er sikker på, om den virker korrekt.
English: • Skin changes at the injection site (lipodystrophy) If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
Danish: • Hudforandringer på injektionsstedet (lipodystrofi) Hvis du for ofte injicerer din insulin på samme sted på huden, kan fedtvævet under huden på dette sted enten svinde ind eller blive tykkere.
English: Pump or infusion set problems or using the pump incorrectly can result in you not getting enough insulin.
Danish: Problemer med pumpe- eller infusionssæt eller forkert brug af pumpen, kan resultere i, at du ikke får nok insulin.
English: The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables.
Danish: Absorptionshastigheden, og dermed indtræden og varighed af virkningen, kan variere afhængigt af injektionsstedet, fysisk aktivitet og andre variable.
English: A. Check that the dose window shows “0” following the safety test.
Danish: A. Kontroller at doseringsdisplayet viser ”0” efter sikkerhedstesten.
English: Do not inject insulin.
Danish: Injicer ikke insulin.
English: Protective seal
Danish: Beskyttelsessegl
English: Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse.
Danish: Brug altid en ny pen, hvis du bemærker, at dit blodsukker uventet forværres.
English: Most of the cases were related to handling errors or pump system failure.
Danish: De fleste tilfælde var relateret til håndteringsfejl eller pumpesvigt.
English: • If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
Danish: • Hvis en anden person injicerer dig, eller hvis du giver injektion til en anden person, skal der tages særlige forholdsregler af denne person, når nålen fjernes og bortskaffes.
English: What to do if the pump system fails or when the pump is used incorrectly
Danish: Hvad skal du gøre, hvis pumpesystemet svigter eller hvis pumpen bruges forkert?
English: After dilution for intravenous use, the solution should be inspected visually for particulate matter prior to administration.
Danish: Efter fortynding til intravenøs anvendelse bør opløsningen inspiceres visuelt for partikler før administration.
English: These instructions may differ from the instructions that come with your insulin infusion pump.
Danish: Disse instruksioner kan afvige fra de instruktioner, der følger med din insulin-infusionspumpe.
English: Instruction for intravenous administration
Danish: Instruktion til intravenøs administration.
English: Apidra with alcohol
Danish: Brug af Apidra sammen med alkohol
English: Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Danish: Pioglitazon bør seponeres, hvis der sker en forværring af symptomer fra hjertet.
English: The absolute bioavailability (70%) of insulin glulisine was similar between injection sites and of low intra-subject variability (11% CV).
Danish: Den absolutte biotilgængelighed (70 %) for insulin glulisin var ækvipotent for injektionsstederne, og der var en lav intra-patient variabilitet (11% CV).
English: In the per-protocol population there was a significantly larger observed reduction in GHb in the pre-meal glulisine group compared with the regular insulin group.
Danish: I per-protokolpopulationen sås en signifikant større reduktion i GHb i gruppen med præprandial insulin glulisin end i gruppen med regular insulin.
English: If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked.
Danish: Hvis det er nødvendigt kan en hyppigere kontrol af dit blodsukker hjælpe dig med at erkende milde tilfælde af hypoglykæmi, som ellers ville blive overset.
English: The pen should be used as recommended in the information provided by the device manufacturer.
Danish: Pennen bør anvendes som anbefalet i informationen fra fremstilleren af pennen.
English: Before using Apidra in the pump system you should have been given detailed instructions on how to use the pump system.
Danish: Før du bruger Apidra i et pumpesystem, skal du have fået detaljerede instruktioner om, hvordan du bruger pumpesystemet.
English: Your doctor will show you in which area of the skin you should inject Apidra.
Danish: Din læge vil vise dig, i hvilke hudområder du skal injicere Apidra.
English: It has a dark blue injection button with a raised ring on the top.
Danish: Den har en mørkeblå dosisknap med en ophøjet ring.
English: • Never use SoloStar if it is damaged or if you are not sure that it is working properly.
Danish: • Anvend aldrig SoloStart, hvis den er beskadiget eller hvis du er usikker på, om den virker korrekt.
English: Insulin glulisine was rapidly absorbed in both age groups, with similar Tmax and Cmax as in adults (see section 4.2).
Danish: Insulin glulisin blev absorberet hurtigt i begge aldersgrupper med samme Tmax og Cmax som hos voksne (se pkt.
English: Since Apidra is a solution, it does not require resuspension before use.
Danish: Da Apidra er en opløsning, er resuspension ikke nødvendig før brug.
English: Intravenous bolus administration of insulin glulisine resulted in a higher systemic exposure when compared to subcutaneous injection, with a Cmax approximately 40-fold higher.
Danish: Intravenøs bolus-administration med insulin glulisin resulterede i en højere systemisk indvirkning sammenlignet med subkutan injektion med en Cmax ca. 40 gange højere.
English: • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
Danish: • Hvis nålen ikke holdes lige, mens du påsætter den, kan gummistemplet blive ødelagt og give lækage eller brække nålen.
English: Changes in strength, brand (manufacturer), type (regular, neutral protamine Hagedorn [NPH], lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Danish: Ændringer i styrke, præparat (fremstiller), type (regular, Neutral Protamin Hagedorn (NPH), lente, langtidsvirkende, etc.), oprindelse (animalsk, human, human insulinanalog) og/eller fremstillingsmetode kan medføre, at der er behov for dosisjustering.
English: Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur.
Danish: Kontrollér blodsukkeret, og undersøg urinen for ketonstoffer, så snart du får nogen af disse symptomer.
English: If a dose greater than 80 units is required, it should be given as two or more injections.
Danish: Hvis der kræves en dosis på mere end 80 enheder, skal dosis gives som to eller flere injektioner.
English: If you are concerned that your SoloStar may be damaged, use a new one.
Danish: Hvis De er bekymret for om SoloStar kan være ødelagt, så brug en ny.
English: Mixing with insulins
Danish: Blanding med insuliner
English: Figure 1C
Danish: Figur 1C
English: The patient should avoid situations where SoloStar may be damaged.
Danish: Patienten bør undgå situationer, hvor SoloStar kan blive beskadiget.
English: Insulins lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
Danish: Insulin sænker blodglucoseniveauet ved at stimulere den perifere glucoseoptagelse, især i skeletmuskulatur og fedt, og ved at hæmme leverens glucoseproduktion.
English: The pharmacokinetic and pharmacodynamic properties of insulin glulisine were investigated in children (7-11 years) and adolescents (12-16 years) with type 1 diabetes mellitus.
Danish: Insulin glulisins farmakokinetiske og farmakodynamiske egenskaber blev undersøgt hos børn (7-11 år) og unge (12-16 år) med type 1 diabetes mellitus.
English: Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
Danish: Der kan forekomme hypoglykæmi som følge af overdreven stor insulinaktivitet i forhold til fødeindtagelse og energiforbrug.
English: You must check that your insulin pen is working properly before you inject the first dose.
Danish: Kontroller, at insulinpennen fungerer korrekt, før den første injektion foretages.
English: The advisability of driving should be considered in these circumstances.
Danish: I sådanne tilfælde bør det overvejes, om bilkørsel er tilrådelig.
English: Apidra is injected under the skin (subcutaneously).
Danish: Apidra injiceres under huden (subkutant).
English: Deterioration of renal function may lead to a decrease in insulin requirements.
Danish: Forværring af nyrefunktionen kan dog medføre et nedsat insulinbehov.
English: In this study, the majority of patients (79%) mixed their short acting insulin with NPH insulin immediately prior to injection and 58% of subjects used oral hypoglycaemic agents at randomization and were instructed to continue to use them at the same dose.
Danish: I dette studie blandede størstedelen af patienterne (79 %) deres kortvarigt virkende insulin med NPH insulin lige før injektionen, og 58 % af patienterne brugte orale antidiabetika ved randomiseringen og fik besked på fortsat at bruge disse i uændret dosis.
English: If you think you may have a problem with SoloStar, please consult your Health Care Professional.
Danish: Hvis du mener, du har et problem med SoloStar så kontakt sundhedspersonalet.
English: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Danish: Patientens koncentrations- og reaktionsevne kan være nedsat som følge af hypoglykæmi eller hyperglykæmi eller f.eks. på grund af nedsat syn.
English: • Before each use, a new needle must always be carefully attached and a safety test must be performed.
Danish: • Før hver anvendelse skal en ny nål påsættes og en sikkerhedstest udføres.
English: SoloStar has to be used as recommended in these Instructions for use (see section 6.6).
Danish: SoloStar skal anvendes som anbefalet i denne brugsanvisning (se pkt.
English: Hydrochloric acid, concentrated Sodium hydroxide Water for injections
Danish: Saltsyre, koncentreret Natriumhydroxid Vand til injektionsvæsker
English: Prompt identification and correction of the cause of hyperglycaemia or ketosis or diabetic ketoacidosis is necessary.
Danish: Øjeblikkelig identifikation og korrektion af årsagen til hyperglykæmi, ketose eller diabetisk ketoacidose er nødvendig.
English: This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Dette er af særlig betydning for patienter med nedsat eller manglende evne til at mærke advarselssymptomer på hypoglykæmi eller hos patienter, som har hyppige tilfælde af hypoglykæmi.
English: The mean residence time of insulin glulisine was shorter (98 min) than for regular human insulin (161 min) (see figure 3).
Danish: Dengennemsnitlige residenstid for insulin glulisin var kortere (98 minutter) end for regular human insulin (161 minutter) (se figur 3).
English: If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Danish: Hvis du ikke er i stand til at synke, eller hvis du er bevidstløs, skal du have en injektion med glucose eller med glucagon (lægemiddel, der forhøjer blodsukkeret).
English: Uncommon Rare
Danish: Almindelig Ikke almindelig Sjælden Ukendt
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Danish: Nogle patienter med årelang type 2-diabetes mellitus og hjertesygdom eller tidligere slagtilfælde, som var i behandling med pioglitazon og insulin, udviklede hjertesvigt.
English: Always have available an alternative insulin delivery system for injection under the skin (see section 3 under “How to handle an infusion pump system” and “What to do if the pump system fails or when the pump is used incorrectly”).
Danish: Du skal altid have et alternativt insulin-system i reserve, så du kan sprøjte insulin ind under huden (se punkt 3 ”Håndtering af insulinpumpesystem” og ”Hvad skal du gøre, hvis pumpesystemet svigter, eller hvis pumpen bruges forkert?”).
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Danish: Kontakt din læge hurtigst muligt, hvis du oplever tegn på hjertesvigt såsom unormal åndenød, hurtig vægtstigning eller ophobning af væske (ødemer).
English: The pen plunger moves with each dose.
Danish: Pennens stempel vil bevæge sig med hver dosis.
English: Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Danish: Lokale overfølsomhedsreaktioner (rødme, hævelse og kløe på injektionsstedet) kan forekomme under insulinbehandling.
English: You should contact your doctor for advice on driving if: - you have frequent episodes of hypoglycaemia, - the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.
Danish: Du bør tale med din læge, om bilkørsel er tilrådelig, hvis: - du har hyppige tilfælde af hypoglykæmi, - de første advarselssymptomer, som kan advare dig om hypoglykæmi, er nedsatte eller helt mangler.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Apidra contains metacresol, which may cause allergic reactions.
Danish: Apidra indeholder metacresol, som kan forårsage allergiske reaktioner.
English: There are no or limited data on the use of Apidra in pregnant women.
Danish: Der er ingen eller utilstrækkelige data vedrørende anvendelse af Apidra til gravide kvinder.
English: Figure 1B
Danish: Figur 1B
English: Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 mg to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a healthcare professional.
Danish: Svære tilfælde af hypoglykæmi, hvor patienten er bevidstløs, kan behandles med glucagon (0,5-1 mg) givet intramuskulært eller subkutant af en person, der har fået passende instruktion, eller med glucose givet intravenøst af en sundhedsperson.
English: Before first use, the pen must be stored at room temperature for 1 to 2 hours.
Danish: Før første anvendelse skal pennen opbevares ved stuetemperatur i 1 til 2 timer.
English: • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
Danish: • at der kommer luft i insulinbeholderen og lækage af insulin, som kan medføre forkert dosering
English: Fertility Animal reproduction studies with insulin glulisine have not revealed any adverse effects on fertility.
Danish: Fertilitet Reproduktionsstudier med insulin glulisin i dyr har ikke afdækket nogen skadelig effekt på fertilitet.
English: Hold the pen as shown in this leaflet.
Danish: Hold pennen som vist i denne instruktion.
English: Always remove the needle after each injection and store SoloStar without a needle attached.
Danish: Tag altid nålen af efter hver injektion og opbevar SoloSatr uden nål påsat.
English: Hypoglycaemia can become severe and may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
Danish: Hypoglykæmi kan blive svær og kan medføre bevidstløshed og/eller kramper og kan resultere i forbigående eller permanent nedsat cerebral funktion eller sågar død.
English: You can set doses from 1 to 80 units in steps of 1 unit.
Danish: Du kan indstille dosis fra 1 til 80 enheder i trin på 1 enhed.
English: It is recommended that the date of the first use be noted on the label.
Danish: Det anbefales, at datoen for første anvendelse noteres på hætteglassets etiket.
English: To reduce the risk of accidental needle injury, never replace the inner needle cap.
Danish: For at reducere risikoen for uheld med nålen, må den indre nålekapsel aldrig sættes på igen.
English: If no insulin appears at the needle tip, step 3 should be repeated until insulin appears at the needle tip.
Danish: Hvis der ikke kommer insulin frem ved nålespidsen, skal trin 3 gentages, indtil der kommer insulin frem ved nålespidsen.
English: Change the infusion set and reservoir at least every 48 hours using aseptic technique.
Danish: Skift infusionssæt og reservoir mindst hver 48. time under aseptiske betingelser.
English: After subcutaneous administration, insulin glulisine is eliminated more rapidly than regular human insulin with an apparent half-life of 42 minutes compared to 86 minutes.
Danish: Efter subkutan administration elimineres insulin glulisin hurtigere end regular human insulin, med en tilsyneladende halveringstid på henholdsvis 42 minutter og 86 minutter.
English: The use of inadequate doses or discontinuation of treatment, especially in insulin-dependent diabetic, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Danish: Brug af utilstrækkelige doser eller ophør af behandlingen, især hos insulin-afhængige diabetikere, kan medføre hyperglykæmi og diabetisk ketoacidose - tilstande der er potentielt dødelige.
English: If you stop using Apidra
Danish: Hvis du holder op med at tage Apidra
English: Figure 1A
Danish: Figur 1 A
English: If the hypoglycaemia comes back again take another 10 to 20 g sugar.
Danish: Hvis du igen får et for lavt blodsukker (hypoglykæmi), skal du igen indtage 10-20 g sukker.
English: Talk to your doctor, pharmacist or nurse before using Apidra.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Apidra.
English: In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Danish: Hos patienter med nedsat leverfunktion kan insulinbehovet være nedsat på grund af nedsat gluconeogenese og nedsat insulinmetabolisme.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Danish: Hvis du lider af en øjensygdom, der er relateret til diabetes (proliferativ retinopati), kan alvorlige anfald af for lavt blodsukker (hypoglykæmi) forårsage forbigående synstab.