FrancophonIA/ELRC3.0 huggingface dataset:
English: Insulin glulisine for intravenous use at a concentration of 1 Unit/ml is stable at room temperature for 48 hours.
Danish: Insulin glulisin til intravenøs anvendelse i en koncentration på 1 enhed/ml er stabil ved stuetemperatur i 48 timer.
English: If the patient is concerned that the SoloStar may be damaged, he must use a new one.
Danish: Hvis patienten er bekymret for, om SoloStar kan være beskadiget, skal patienten anvende en ny pen.
English: Apidra may be used for Continuous Subcutaneous Insulin Infusion (CSII) in pump systems suitable for insulin infusion with the appropriate catheters and reservoirs.
Danish: Apidra kan administreres som kontinuerlig subkutan insulin-infusion (CSII) i pumpesystemer beregnet til insulin-infusion med passende katetre og reservoirer.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting.
Danish: Farmakoterapeutisk klassifikation: Insuliner og analoger til injektion, hurtigtvirkende.
English: A phase I study carried out with insulin glulisine, lispro and regular human insulin in an obese population has demonstrated that insulin glulisine maintains its rapid-acting properties.
Danish: Et fase I studie udført med insulin glulisin, lispro og regular human insulin i en overvægtig population har påvist, at insulin glulisin bevarer dets hurtigtvirkende egenskaber.
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Danish: Når en patient skifter til en anden type insulin eller et nyt insulinpræparat, bør det ske under omhyggelig medicinsk supervision.
English: Talk with your doctor, pharmacist or nurse about proper injection technique before using SoloStar.
Danish: Tal med sundhedspersonalet om korrekt injektionsteknik før anvendelse af SoloStar.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter faldende alvorlighed.
English: There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Danish: Der er utilstrækkelig klinisk information vedrørende brug af Apidra til børn under 6 år.
English: Do not use this SoloStar if the insulin is cloudy, coloured or has particles.
Danish: Anvend ikke SoloStar, hvis insulinet er uklart, farvet eller indeholder partikler.
English: - If you are allergic to insulin glulisine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for insulin glulisin eller et af de øvrige indholdsstoffer i Apidra (angivet i punkt 6).
English: Apidra can be administered intravenously.
Danish: Apidra kan gives intravenøst.
English: Figure 2: Glucose infusion rates (GIR) after subcutaneous injection of 0.3 Units/kg of insulin glulisine (GLULISINE) or insulin lispro (LISPRO) or regular human insulin (REGULAR) in an obese population.
Danish: Figur 2: Glucoseinfusionshastigheder (GIR) efter subkutan injektion med 0,3 enheder/kg insulin glulisin (GLULISINE) eller insulin lispro (LISPRO) eller regular human insulin (REGULAR) hos en overvægtig population.
English: These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1).
Danish: Disse enheder gælder specielt for Apidra og er ikke det samme som IE eller enhederne, som angiver styrken på andre insulinanaloger (se pkt.
English: The instructions for using the insulin pen are provided with your insulin pen.
Danish: Instruktion i at anvende insulinpennen er vedlagt din insulinpen.
English: These could be symptoms of severe cases of generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
Danish: Dette kan være symptomer på generaliserede allergiske reaktioner over for insulin, herunder anafylaktiske reaktioner, som kan være livstruende.
English: The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
Danish: Fremstillerens instruktioner vedrørende anvendelse af pennen skal følges nøje for isætning af cylinderampul, påsætning af nål og administration af insulininjektionen.
English: Failure to follow Apidra specific instructions may lead to serious adverse events.
Danish: Hvis man undlader at følge de Apidra-specifikke instruktioner, kan det medføre alvorlige bivirkninger.
English: When insulin glulisine is injected subcutaneously, the glucose lowering activity will begin within 10-20 minutes.
Danish: Efter subkutan injektion med insulin glulisin begynder den glucosesænkende effekt inden for 10-20 minutter.
English: Apidra should be given by subcutaneous injection shortly (0-15 min) before or soon after meals or by continuous subcutaneous pump infusion.
Danish: Apidra bør gives som subkutan injektion kort tid (0-15 minutter) før eller lige efter måltider eller som kontinuerlig subkutan infusion via en pumpe.
English: In the following situations, the management of your diabetes may require extra care: - If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
Danish: I følgende situationer kan kontrol af din diabetes kræve ekstra opmærksomhed: - Hvis du bliver syg eller kommer alvorligt til skade, kan dit blodsukkerniveau blive for højt
English: Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening.
Danish: Svære tilfælde af generaliseret allergi, herunder en anafylaktisk reaktion, kan være livstruende.
English: Always use a new vial if you notice that your blood sugar control is unexpectedly getting worse.
Danish: Brug altid et nyt hætteglas, hvis du opdager, at din blodsukkerkontrol uventet forværres.
English: The patient should always follow the Apidra specific instructions and always have access to alternative insulin delivery system in case of pump system failure.
Danish: Patienten skal altid følge de Apidra-specifikke instruktioner og altid have adgang til et alternativt insulin-device i tilfælde af pumpesvigt.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere oplysninger om Apidra findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
Danish: Pentamidin kan medføre hypoglykæmi, der til tider kan efterfølges af hyperglykæmi.
English: Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Danish: Der kan forekomme lipodystrofi på injektionsstedet som følge af manglende skift af injektionssted inden for det enkelte område.
English: Changing the injection site with each injection may help to prevent such skin changes.
Danish: Hvis du skifter injektionssted fra gang til gang, kan du muligvis forebygge disse forandringer i huden.
English: • Metabolism and nutrition disorders
Danish: • Metabolisme og ernæring
English: • Special caution must be taken to avoid accidental needle injury and transmission of infection.
Danish: • Der skal udvises særlig forsigtighed for at undgå skader ved et uheld med nålen og overførsel af infektioner.
English: Pharmacokinetic profiles in healthy volunteers and diabetes patients (type 1 or 2) demonstrated that absorption of insulin glulisine was about twice as fast with a peak concentration approximately twice as high as compared to regular human insulin.
Danish: Farmakokinetiske profiler for raske frivillige forsøgspersoner og patienter med diabetes (type 1 eller 2) viste, at absorptionen af insulin glulisin var ca. dobbelt så hurtig med en peak koncentration, der var ca. dobbelt så høj, sammenlignet med regular human insulin.
English: After removing the pen cap, the appearance of insulin should also be checked: the insulin solution must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
Danish: Efter fjernelse af penhætten skal insulinets udseende også kontrolleres: insulinopløsningen skal være klar, farveløs, uden synlige faste partikler og skal have en vandlignende konsistens.
English: For more information on signs and symptoms of hyperglycaemia refer to the box at the end of this leaflet.
Danish: For mere information om tegn og symptomer på hyperglykæmi henvises til den indrammede tekst sidst i denne indlægsseddel.
English: Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Danish: Mavesmerter, hurtig og dyb vejrtrækning, søvnighed og eventuelt besvimelse kan være tegn på en alvorlig syreophobning i blodet (ketoacidose), som er en følge af mangel på insulin.
English: The outside of the SoloStar can be cleaned by wiping it with a damp cloth.
Danish: Ydersiden af SoloStar pennen kan rengøres ved at tøre den af med en fugtig klud.
English: The distribution and elimination of insulin glulisine and regular human insulin after intravenous administration is similar with volumes of distribution of 13 l and 22 l and half-lives of 13 and 18 minutes, respectively.
Danish: Efter intravenøs administration er fordeling og elimination for insulin glulisin og regular human insulin ens, med fordelingsvolumina på henholdsvis 13 l og 22 l og halveringstider på henholdsvis 13 og 18 minutter.
English: Your ability to concentrate or react may be reduced if: - you have hypoglycaemia (low blood sugar levels), - you have hyperglycaemia (high blood sugar levels).
Danish: Din koncentrations- og reaktionsevne kan være nedsat, hvis du: - har hypoglykæmi (for lavt blodsukker), - har hyperglykæmi (for højt blodsukker).
English: Treatment of adults, adolescents and children 6 years or older, with diabetes mellitus, where treatment with insulin is required.
Danish: Til behandling af voksne, unge og børn fra 6 år med insulinkrævende diabetes mellitus.
English: When mixed with NPH human insulin, Apidra should be drawn into the syringe first.
Danish: Ved blanding med NPH human insulin skal Apidra trækkes op i sprøjten først.
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering activity of insulin.
Danish: Beta-blokkere, clonidin, lithiumsalte eller alkohol kan enten øge eller nedsætte insulins blodglucosesænkende effekt.
English: • General disorders and administration site conditions Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnoea, allergic dermatitis and pruritus.
Danish: • Almene symptomer og reaktioner på administrationsstedet Systemiske overfølsomhedsreaktioner kan omfatte urticaria, trykken for brystet, dyspnø, allergisk dermatitis og kløe.
English: GLULISINE LISPRO REGULAR
Danish: GLULISINE REGULAR
English: Insulin glulisine
Danish: insulin glulisin
English: While holding the pen with the needle pointing upwards, the insulin reservoir should be tapped gently with the finger so that any air bubbles rise up towards the needle.
Danish: Mens pennen holdes med nålen opad, bankes forsigtigt med en finger på insulinbeholderen, så eventuelle luftbobler stiger op mod nålen.
English: You should always have an alternative insulin delivery system available for injection under the skin in case the pump system fails.
Danish: Du skal altid have et alternativt insulinsystem i reserve, så du kan sprøjte insulin ind under huden i tilfælde af, at pumpesystemet svigter.
English: Type 1 diabetes mellitus-Paediatric
Danish: Type 1 diabetes mellitus-pædiatrisk
English: If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates.
Danish: Hvis du har insulinkrævende diabetes mellitus (type 1-diabetes), må du ikke afbryde insulinbehandlingen, og du skal sørge for fortsat at få tilstrækkelig med kulhydrater.
English: Insulin glulisine was shown to be comparable to regular human insulin with regard to glycated haemoglobin (expressed as HbA1c equivalent) changes from baseline to the 6-month endpoint (-0.46% for insulin glulisine and -0.30% for regular human insulin, p=0.0029) and from baseline to the 12-month endpoint (-0.23% for insulin glulisine and -0.13% for regular human insulin, difference not significant).
Danish: Det blev påvist, at insulin glulisin var sammenlignelig med regular human insulin med hensyn til ændringer i glykosyleret hæmoglobin (udtrykt som HbA1c ækvivalent) fra baseline til 6 måneders endepunktet (-0,46 % for insulin glulisin og -0,30 % for regular human insulin p=0,0029) og fra baseline til 12 måneders endepunktet (-0,23 % for insulin glulisin og - 0,13 % for regular human insulin, forskel ikke signifikant).
English: Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Danish: Ukorrigerede hypoglykæmiske eller hyperglykæmiske reaktioner kan medføre bevidstløshed, koma eller død.
English: After injection, the site of injection should not be massaged.
Danish: Injektionsstedet må ikke masseres efter injektionen.
English: The primary activity of insulins and insulin analogues, including insulin glulisine, is regulation of glucose metabolism.
Danish: Den primære effekt af insuliner og insulinanaloger, herunder insulin glulisin, er regulering af glucosemetabolismen.
English: No increase in the basal insulin dose was needed with insulin glulisine, in contrast to insulin lispro.
Danish: Med insulin glulisin var der ikke behov for at øge dosis af basal insulin, i modsætning til hvad der var tilfældet med insulin lispro.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM FOIL USED FOR SEALING TRANSPARENT PLASTIC TRAY CONTAINING THE CARTRIDGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ALUMINIUMSFOLIE, DER FORSEGLER DEN GENNEMSIGTIGE PLASTIKBEHOLDER MED CYLINDERAMPULLEN
English: The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if: - you are elderly, - you have had diabetes for a long time, - you suffer from a certain type of nervous disease (diabetic autonomic neuropathy), - you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly, - you have almost normal or, at least, greatly improved blood sugar levels, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Danish: De første symptomer, der advarer dig om hypoglykæmi (”advarselssymptomer”), kan ændre sig, være svækket eller kan helt mangle, hvis: - du tilhører den ældre aldersgruppe, - du har haft diabetes i lang tid, - du lider af en bestemt form for nervesygdom (diabetisk autonom neuropati), - du for nylig har haft for lavt blodsukker (hypoglykæmi), f.eks. dagen før, eller hvis tilstanden udvikles langsomt, - du har et næsten normalt eller i det mindste betydeligt forbedret blodsukker, - du tager eller har taget visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med
English: Figure 3: Pharmacokinetic profile of insulin glulisine and regular human insulin in type 1 diabetes mellitus patients after a dose of 0.15 Units/kg.
Danish: Figur 3: Farmakokinetisk profil for insulin glulisin og regular human insulin hos patienter med type 1 diabetes mellitus efter en dosis på 0,15 enheder/kg.
English: Type 2 diabetes mellitus-Adults
Danish: Type 2 diabetes mellitus-voksne
English: INFORMATION IN BRAILLE Apidra
Danish: INFORMATION I BRAILLESKRIFT
English: If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Danish: Hvis du ammer, skal du tale med din læge, da det kan være nødvendigt at justere din insulindosis og din kost.
English: • Skin and allergic reactions at the injection site Reactions at the injection site may occur (such as reddening, unusually intense pain on injection, itching, hives, swelling or inflammation).
Danish: • Hud- og allergiske reaktioner på injektionsstedet Der kan opstå reaktioner på injektionsstedet (som f.eks. rødme, usædvanlig stærk smerte under injektion, kløe, udslæt, hævelse eller betændelse).
English: Recommended safety measures for removal and disposal of needles must be followed (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Danish: De anbefalede retningslinier for fjernelse og bortskaffelse af nåle skal følges (f.eks enkelthåndsteknikken ved påsætning af nålekapslen) for at reducere risikoen for utilsigtede skader med nålen og overførsel af infektionssygdomme.
English: The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.
Danish: Stemplet vil nå bunden af ampullen, når alle 300 enheder er brugt.
English: • The patient must always have a spare SoloStar available in case the SoloStar is lost or damaged.
Danish: • Patienten skal altid have en ekstra SoloStar i tilfælde af, at SoloStar-pennen bliver væk eller bliver beskadiget.
English: Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Danish: Når patienten har genvundet bevidstheden, anbefales det at give orale kulhydrater for at forhindre recidiv.
English: Malfunction of the insulin pump or infusion set or handling errors can rapidly lead to hyperglycaemia, ketosis and diabetic ketoacidosis.
Danish: Funktionsfejl i insulinpumpen eller infusionssættet eller håndteringsfejl kan hurtigt medføre hyperglykæmi, ketose eller diabetisk ketoacidose.
English: • Skin and subcutaneous tissue disorders
Danish: • Hud og subkutane væv
English: If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Danish: Hvis insulinpennen er beskadiget eller ikke fungerer korrekt (pga. mekaniske fejl) skal den kasseres, og en ny insulinpen tages i brug.
English: You must use the pen as described in these Instructions for use.
Danish: Du skal anvende pennen som beskrevet i brugsanvisningen.
English: Do not use the vial after this time period.
Danish: Anvend ikke hætteglasset efter denne periode.
English: The patient should be informed on the injection technique by his health care professional.
Danish: Sundhedspersonalet bør informere patienten om injektionsteknik.
English: If insulin has been expelled through the needle tip, then the pen and the needle are working properly.
Danish: Hvis der kommer insulin frem ved nålespidsen, virker pennen og nålen korrekt.
English: The glucose excursion (AUC 0-6h) was 641 mg.h.dl-1 for insulin glulisine and 801 mg.h.dl-1 for regular human insulin.
Danish: Glucoseudsvingene (AUC0-6 timer) var 641 mg.time.dl-1 for insulin glulisin og 801 mg.time.dl-1 for regular human insulin.
English: The average total GIR AUC between 0-1 hour was 102 ± 75 mg/kg and 158 ± 100 mg/kg with 0.2 and 0.4 Units/kg insulin glulisine, respectively, and was 83.1 ± 72.8 mg/kg and 112.3 ± 70.8 mg/kg with 0.2 and 0.4 Units/kg insulin lispro, respectively.
Danish: Den gennemsnitlige totale GIR AUC ved 0-1 time var henholdsvis 102 ± 75 mg/kg og 158 ± 100 mg/kg med 0,2 og 0,4 enheder/kg insulin glulisin og henholdsvis 83,1 ± 72,8 mg/kg og 112,3 ± 70,8 mg/kg med 0,2 og 0,4 enheder/kg insulin lispro.
English: HYPERGLYCAEMIA AND HYPOGLYCAEMIA Always carry some sugar (at least 20 grams) with you.
Danish: HYPERGLYKÆMI OG HYPOGLYKÆMI Du bør altid have mindst 20 gram sukker på dig.
English: Hyperglycaemia (high blood sugar) means that there is too much sugar in the blood.
Danish: Hyperglykæmi (højt blodsukker) betyder, at der er for meget sukker i blodet.
English: Also contains: metacresol, sodium chloride, trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections (see leaflet for further information).
Danish: Indeholder også: metacresol, natriumchlorid, trometamol, polysorbat 20, saltsyre, koncentreret, natriumhydroxid, vand til injektionsvæsker (se indlægssedlen for yderligere information).
English: Instructions for proper use
Danish: Instruktioner for sikker anvendelse
English: Apidra must never be mixed with diluents or any other insulin when used in a pump.
Danish: Apidra må aldrig fortyndes, og det må ikke blandes med andre insuliner, når det anvendes i en pumpe.
English: In controlled clinical studies in adults, insulin glulisine did not show differences in safety and efficacy in subgroup analyses based on race and gender.
Danish: I kontrollerede kliniske studier med voksne påviste analyser af undergrupper efter race og køn ikke forskelle med hensyn til sikkerhed og effekt af insulin glulisin.
English: Elderly Very limited pharmacokinetic data are available for elderly patients with diabetes mellitus.
Danish: Der foreligger meget begrænsede farmakokinetiske data vedrørende ældre patienter med diabetes mellitus
English: In this study, the time to 20% of total AUC and the AUC (0-2h) representing the early glucose lowering activity were respectively of 114 minutes and 427 mg/kg for insulin glulisine, 121 minutes and 354 mg/kg for lispro, 150 minutes and 197 mg/kg for regular human insulin (see figure 2).
Danish: I dette studie var tiden til 20 % af total AUC og AUC (0-2 timer), som udtryk for den tidlige blodglucosesænkende effekt, henholdsvis 114 minutter og 427 mg/kg for insulin glulisin, 121 minutter og 354 mg/kg for lispro, 150 minutter og 197 mg/kg for regular human insulin (se figur 2).
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per dosis, dvs. det er stort set natriumfri.
English: Care should be taken to ensure that a blood vessel has not been entered.
Danish: Man bør omhyggeligt sikre sig, at injektionen ikke gives i et blodkar.
English: Apidra must not be mixed with glucose or Ringer's solution or with any other insulin.
Danish: Apidra må ikke blandes med glucose, Ringers opløsning eller andre insuliner.
English: Read carefully the "SoloStar Instructions for use" included in this package leaflet.
Danish: Læs omhyggeligt “SoloStar Brugsanvisning”, der er vedlagt denne indlægsseddel.
English: Apidra was found to be incompatible with Glucose 5% solution and Ringer's solution and, therefore, must not be used with these solution fluids.
Danish: Apidra har vist sig at være uforligeligt med glucose 5 %-opløsning og Ringers opløsning og må derfor ikke anvendes sammen med disse opløsninger.
English: Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease, medicinal products such as beta blockers or after transfer from animal-source insulin to human insulin.
Danish: Tilstande, der kan ændre de tidlige advarselssymptomer på hypoglykæmi eller gøre dem mindre udtalte, omfatter diabetes gennem lang tid, intensiveret insulinbehandling, diabetisk nervesygdom, lægemidler som f.eks. beta-blokkere eller skift fra animalsk insulin til human insulin.
English: Systemic allergic reactions are side effects reported uncommonly (may affect up to 1 in 100 people).
Danish: Systemisk allergiske reaktioner er ikke almindelige bivirkninger (forekommer hos 1 ud af 100 patienter).
English: To ensure you get the accurate dose, the Apidra cartridges are to be used only with the following pens: - JuniorSTAR which delivers doses in steps of 0.5 units - ClikSTAR, Tactipen, Autopen 24, AllStar or AllStar PRO which deliver doses in steps of 1 unit.
Danish: For at sikre at du får den nøjagtige dosis, må Apidra cylinderampullerne kun anvendes med følgende penne: - JuniorSTAR som giver doser i trin af 0,5 enheder - ClikSTAR, Tactipen, Autopen 24, AllStar eller AllStar PRO som giver doser i trin af 1 enhed.
English: B. Take off the pen cap. C. Check the appearance of your insulin.
Danish: C. Kontroller udseendet af din insulin.