FrancophonIA/ELRC3.0 huggingface dataset:
English: At the last on-treatment visit, there was a mean increase in body weight from baseline of 1.4 kg in the insulin glargine group and a mean decrease of 0.8 kg in the standard care group.
Danish: Ved det sidste besøg i behandlingsperioden var der en gennemsnitlig stigning i vægt fra baseline på 1,4 kg i insulin glargin-gruppen og et gennemsnitligt fald på 0,8 kg i standardbehandlingsgruppen.
English: Lilly France S.A.S., rue du Colonel Lilly, F-67640 Fegersheim, France.
Danish: Lilly France S.A.S., rue du Colonel Lilly, F-67640 Fegersheim, Frankrig.
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: Glycohaemoglobin and glucose variabilities were comparable in both treatment groups.
Danish: Variabiliteten for glykohæmoglobin og glucose var sammenlignelige i de 2 behandlingsgrupper.
English: Insulin glargine was administered once daily at bedtime and NPH human insulin was administered once or twice daily.
Danish: Insulin glargin blev givet en gang dagligt ved sengetid og NPH human insulin blev givet en eller 2 gange dagligt.
English: Participants were randomised (1:1) to receive insulin glargine (n=6,264), titrated to reach FPG ≤95 mg/dL (5.3 mM), or standard care (n=6,273).
Danish: Deltagerne blev randomiseret (1:1) til behandling med insulin glargin (n = 6.264) titreret til at opnå FPG ≤95 mg/dl (5,3 mM), eller standardbehandling (n = 6.273).
English: Dose Knob with green ring
Danish: Doseringsknap med grøn ring
English: Complaints of injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.
Danish: Klager over reaktioner på injektionsstedet (smerter på injektionsstedet og reaktioner på injektionsstedet) og hudreaktioner (udslæt og nældefeber) er rapporteret relativt oftere hos børn og unge på 18 år eller yngre end hos voksne patienter.
English: • If you cannot remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off.
Danish: • Hvis du ikke kan fjerne penhætten, vrid da forsigtigt hætten frem og tilbage, og træk den derefter lige af.
English: - The pen dials 1 unit at a time.
Danish: - Pennen indstilles med 1 enhed ad gangen.
English: Insulin glargine is metabolised into 2 active metabolites M1 and M2 (see section 5.2).
Danish: Insulin glargin metaboliseres til to aktive metabolitter M1 og M2 (se pkt.
English: KwikPen Parts
Danish: KwikPennens dele
English: The cartridges should only be used in conjunction with a Lilly reusable insulin pen and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.
Danish: Cylinderampullerne må kun anvendes sammen med en Lilly flergangspen og ikke med andre flergangspenne, da dosisnøjagtighed ikke er vist med andre penne.
English: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Danish: En udtalt ændring i den glykæmiske kontrol kan føre til midlertidige synsforstyrrelser, der skyldes forbigående ændringer i linsens turgiditet og refraktionsindex.
English: In vitro studies indicate that the affinity of insulin glargine and its metabolites M1 and M2 for the human insulin receptor is similar to the one of human insulin.
Danish: In vitro studier indikerer, at affiniteten af insulin glargin og dets metabolitter M1 og M2 til den humane insulinreceptor ligner human insulins affinitet.
English: The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a half maximal occupation of the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by the IGF-1 receptor.
Danish: Den totale terapeutiske insulinkoncentration (insulin glargin og dets metabolitter) hos type 1diabetespatienter var betydeligt lavere, end hvad der ville kræves for halv maksimal mætning af IGF1-receptoren og den efterfølgende aktivering af den mitogen-proliferative mekanisme.
English: ABASAGLAR can be used in adolescents and children aged 2 years and above.
Danish: ABASAGLAR kan anvendes til unge og børn på 2 år og derover.
English: • Push the capped needle straight onto the pen and twist the needle on until it is tight.
Danish: • Sæt nålen med den ydre nålehætte lige på pennen, og drej nålen, indtil den sidder fast.
English: Prolonged or severe hypoglycaemic episodes may be life-threatening.
Danish: Lange og alvorlige hypoglykæmiske episoder kan være livstruende.
English: In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see section 5.1).
Danish: I sjældne tilfælde kræver forekomsten af sådanne insulinantistoffer justering af insulindosis for at korrigere for tendensen til hypereller hypoglykæmi (se pkt.
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 kontakte din læge og få råd om bilkørsel hvis: - du har hyppige tilfælde af hypoglykæmi, - de første advarselssymptomer som kan advare dig om hypoglykæmi er nedsatte eller helt mangler.
English: Hypoglycaemia (very common), in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement (see section 4.4).
Danish: Hypoglykæmi (meget almindelig), der normalt er den hyppigste bivirkning ved insulinbehandling, opstår, hvis insulindosis er for høj i forhold til insulinbehovet (se pkt.
English: A new needle must be attached before each use.
Danish: Før hver anvendelse skal der påsættes en ny nål.
English: There were no differences between insulin glargine and standard care for the two coprimary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Danish: Der var ikke forskel på insulin glargin og standardbehandlingen med hensyn til de to primære endepunkter, delendepunkter som inkluderede disse hændelser, dødelighed uanset årsag og det sammensatte mikrovaskulære endepunkt.
English: Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Danish: Særlig forsigtighed bør udvises og intensiveret blodglukosekontrol tilrådes til patienter, hvor hypoglykæmi kan være af særlig klinisk betydning, f.eks. hos patienter med betydende stenoser i koronararterierne eller i hjernens forsyningskar (risiko for kardiale eller cerebrale hypoglykæmikomplikationer) og også til patienter med proliferativ retinopati, især hvis denne ikke er laserbehandlet (risiko for forbigående amaurose efter hypoglykæmi).
English: Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide, water for injections
Danish: Hjælpestoffer: Zinkoxid, metacresol, glycerol, saltsyre og natriumhydroxid, vand til injektionsvæsker
English: If you forget to use ABASAGLAR
Danish: Hvis du har glemt at tage ABASAGLAR
English: Do not use if it is cloudy, coloured, or has particles or clumps in it.
Danish: Brug det ikke, hvis væsken er uklar, farvet eller indeholder partikler eller klumper.
English: What should you do if you experience hypoglycaemia?
Danish: Hvad skal du gøre hvis du får hypoglykæmi?
English: The medicinal product may be stored for a maximum of 28 days up to 30°C and away from direct heat or direct light.
Danish: Lægemidlet kan opbevares i maksimalt 28 dage ved temperaturer, der ikke overstiger 30°C og væk fra direkte varme eller direkte lys.
English: * Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Danish: *Insulin glargin er fremstillet ved rekombinant DNA-teknologi i Escherichia coli Alle hjælpestoffer er anført under pkt.
English: For more information, see the box at the end of this leaflet.
Danish: For mere information se den indrammede del sidst i denne indlægsseddel.
English: Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Danish: Insulinoverdosering kan medføre svær og til tider langvarig og livstruende hypoglykæmi.
English: PLEASE READ THESE INSTRUCTIONS BEFORE USE
Danish: LÆS DENNE VEJLEDNING INDEN BRUG
English: Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypoglycaemia or hyperglycaemia (see section 4.4).
Danish: Dosisjustering kan også blive nødvendig, hvis f.eks. patientens vægt eller livsstil ændres, ændring af tidspunkt for insulindosis, eller hvis andre omstændigheder gør, at følsomheden for hypoglykæmi eller hyperglykæmi øges (se pkt.
English: Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
Danish: Pentamidin kan føre til hypoglykæmi, som til tider efterfølges af hyperglykæmi.
English: The instructions for using the insulin pen are provided with your insulin pen.
Danish: Informationen for at anvende insulinpennen er vedlagt din insulinpen.
English: Light grey with green ring on the end
Danish: • Doseringsknappen: Lysegrå med en grøn ring for enden
English: As in the paediatric study described above, fasting plasma glucose reduction from baseline was greater in the insulin glargine group than in the NPH group.
Danish: Som i det pædiatriske studie beskrevet ovenfor, var blodsukkerreduktionen fra baseline større i insulin glargin gruppen end i NPH gruppen.
English: Figure 1 above shows the activity profiles over time of insulin glargine and NPH insulin.
Danish: Figur 1 ovenfor viser virkningsprofilen over tid for insulin glargin og NPH-insulin.
English: EXP Discard pen 28 days after first use.
Danish: EXP Pennen skal bortskaffes 28 dage efter første anvendelse.
English: The time course of action of insulin and insulin analogues such as insulin glargine may vary considerably in different individuals or within the same individual
Danish: Virkningsvarigheden af insulin og insulin-analoger, som f.eks. insulin glargin, kan variere betydeligt fra person til person og selv hos samme person.
English: Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
Danish: OBS: Husk, at kunstige sødemidler og madvarer indeholdende kunstige sødemidler (såsom f.eks. light sodavand) ikke kan anvendes til behandling af hypoglykæmi.
English: Talk to your doctor, pharmacist or nurse before using ABASAGLAR.
Danish: Kontakt lægen eller apotekspersonalet eller sundhedspersonalet, før du tager ABASAGLAR.
English: Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Danish: Vedvarende indtagelse af kulhydrater og overvågning kan være nødvendig, fordi hypoglykæmien selv efter indledende klinisk bedring, kan opstå igen.
English: Rare side effects (may affect up to 1 in 1,000 people)
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter)
English: Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR.
Danish: Patienter, der får høje insulindoser på grund af antistoffer mod human insulin, kan få et bedre insulinrespons med ABASAGLAR.
English: - If you normally need to give 2 injections for your full dose, be sure to give your second injection.
Danish: - Husk at tage din anden indsprøjtning, hvis du normalt har brug for 2 indsprøjtninger for at få din fulde dosis.
English: Injection sites must be rotated within a given injection area from one injection to the next.
Danish: Injektionsstedet skal skiftes inden for det enkelte injektionsfelt fra injektion til injektion.
English: The instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
Danish: Instruktioner for anvendelse af pennen skal følges nøje for isætning af cylinderampul, påsætning af nål og administration af insulininjektionen.
English: Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and glucose and ketone bodies in urine.
Danish: Tørst, øget vandladning, træthed, tør hud, ansigtsrødme, nedsat appetit, lavt blodtryk, hjertebanken og sukker og ketonstoffer i urinen.
English: • Ask your healthcare professional about options to dispose of the pens and sharps container properly.
Danish: • Spørg sundhedspersonalet til råds om, hvordan du bortskaffer penne og den fyldte beholder.
English: If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section
Danish: - hvis du er allergisk over for insulin glargin eller et af de øvrige indholdsstoffer i ABASAGLAR (angivet i punkt 6).
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), - you have problems with your sight.
Danish: Din koncentrations- og reaktionsevne kan være nedsat, hvis du: - har hypoglykæmi (for lavt blodsukker) - har hyperglykæmi (for højt blodsukker) - har problemer med synet.
English: The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Danish: Symptomerne kan inkludere rødme, usædvanlig stærk smerte ved indsprøjtning, kløe, udslæt, hævelse eller betændelse.
English: • Insert the needle into your skin.
Danish: • Før nålen ind i huden.
English: With each injection, change the puncture site within the particular area of skin that you are using.
Danish: Ved hver indsprøjtning skal du skifte til et nyt indsprøjtningssted inden for det bestemte hudområde, som du bruger.
English: • Unscrew the capped needle and dispose of it as directed by your healthcare professional.
Danish: • Skru nålen med nålehætten af, og bortskaf den som anvist af sundhedspersonalet.
English: When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with ABASAGLAR, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fastacting insulin analogues or the dose of oral antidiabetic medicinal products).
Danish: Ved omstilling fra behandling med middellangt eller langtidsvirkende insulin til behandling med ABASAGLAR kan det blive nødvendigt at ændre dosis af basal insulin og at justere anden samtidig antidiabetisk behandling (dosis og tidspunkt for anden regular insulin eller insulin-analoger med hurtigt indsættende virkning eller dosis af orale antidiabetika).
English: Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
Danish: Medicin der kan få dit blodsukker til at stige (hyperglykæmi) omfatter:
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 mindskes på grund af nedsat evne til glukoneogenese og nedsat insulinmetabolisme.
English: • Priming your pen means removing the air from the needle and cartridge that may collect during normal use and ensures that the pen is working correctly.
Danish: • Kontrollen af insulinflowet sikrer, at den luft, som kan have samlet sig i cylinderampullen under normalt brug, bliver fjernet, og at pennen fungerer korrekt.
English: Switch from twice daily NPH insulin to ABASAGLAR To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with ABASAGLAR should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment.
Danish: Omstilling fra NPH-insulin to gange dagligt til ABASAGLAR For at mindske risikoen for natlig hypoglykæmi og hypoglykæmi, der opstår tidligt om morgenen, skal patienter, der omstilles fra basal insulin givet 2 gange daglig som NPH-insulin til ABASAGLAR givet 1 gang daglig, nedsætte den daglige dosis af basal insulin med 20-30 % under de første behandlingsuger.
English: Clear, colourless solution.
Danish: Klar farveløs opløsning.
English: If you think you may have a problem with ABASAGLAR KwikPen, consult your doctor, pharmacist or nurse.
Danish: Hvis du tror, du kan have et problem med ABASAGLAR KwikPen, spørg din læge, sygeplejerske eller apotekspersonalet.
English: Children below 2 years of age The safety and efficacy of insulin glargine have not been established.
Danish: Børn under 2 år Sikkerheden og effekten af insulin glargin er ikke klarlagt.
English: The use of ABASAGLAR may be considered during pregnancy, if clinically needed.
Danish: Ved klinisk behov kan anvendelse af ABASAGLAR til gravide overvejes.
English: Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:
Danish: Medicin, der kan få dit blodsukker til at falde (hypoglykæmi) omfatter:
English: In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Danish: Under behandling med sympatikolytiske lægemidler som f.eks. beta-blokkere, clonidin, guanethidin og reserpin kan symptomerne på adrenerg modregulation ligeledes være reduceret eller helt mangle.
English: If you notice signs of your blood sugar being too low (hypoglycaemia), take the action to increase your blood sugar levels inmediately.
Danish: Hvis du får symptomer på for lavt blodsukker (hypoglykæmi), skal du straks gøre noget for at øge dit blodsukkerniveau.
English: Tap the cartridge holder gently to collect air bubbles at the top.
Danish: Bank let med en finger på holderen til cylinderampullen for at samle luftbobler i toppen.
English: Before injection remove any air bubbles (see instructions for using the pen).
Danish: Før injektion skal eventuelle luftbobler fjernes (se brugermanualen for pennen).
English: Name and address of the manufacturers of the biological active substance
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer)
English: • Pull off the inner needle shield and throw it away.
Danish: • Træk den indre nålehætte af, og smid den ud.
English: How to handle ABASAGLAR KwikPen
Danish: Håndtering af ABASAGLAR KwikPen
English: Selecting your dose
Danish: Indstil din dosis
English: Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Danish: Eksempler på symptomerne på lavt blodsukker i hjernen er: Hovedpine, udtalt sultfornemmelse, kvalme, opkastning, træthed, søvnighed, søvnforstyrrelser, rastløshed, aggressiv adfærd, koncentrationsbesvær, nedsat reaktionsevne, depression, konfusion, taleforstyrrelser (til tider fuldstændig tab af talens brug), synsforstyrrelser, rysten, lammelser, prikkende og stikkende fornemmelse (paræstesi), følelsesløshed og prikken og stikken omkring munden, svimmelhed, manglende selvbeherskelse, hjælpeløshed, kramper, bevidsthedstab.
English: After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of microprecipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/time profile with a prolonged duration of action.
Danish: Efter injektion i subkutant væv neutraliseres den sure opløsning, og der dannes mikropræcipitater, hvorfra små mængder insulin glargin til stadighed frigives således, at der opnås en jævn forudsigelig koncentrations-/tidsprofil med lang virkningsvarighed uden koncentrationstoppe.
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Danish: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland
English: Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
Danish: Insulin hæmmer lipolysen i fedtcellerne, hæmmer proteolysen og øger proteinsyntesen.
English: • Pull off the paper tab from the outer needle shield.
Danish: • Træk papirfligen af den ydre nålehætte.
English: Before use:
Danish: Før anbrud:
English: Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat.
Danish: Eksempler på symptomer på at dit blodsukker falder for meget eller for hurtigt: Svedtendens, klam hud, ængstelse, hurtig puls, højt blodtryk, hjertebanken og uregelmæssig puls.
English: • Prepare your skin as recommended by your healthcare professional.
Danish: • Klargør huden som vist af sundhedspersonalet.
English: Read all of this leaflet carefully including the Instructions for Use of the ABASAGLAR KwikPen pre-filled pen, before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel, herunder brugermanualen for ABASAGLAR KwikPen, grundigt inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: What should you do if you experience hyperglycaemia?
Danish: Hvad skal du gøre hvis du får hyperglykæmi?
English: Insulin glargine did not alter the relative risk for CV disease and CV mortality when compared to standard of care.
Danish: Sammenlignet med standardbehandlingen ændrede insulin glargin ikke på den relative risiko for CVsygdom og CV-dødelighed.
English: Instead, regular insulin administered intravenously is recommended in such cases.
Danish: I sådanne tilfælde anbefales det i stedet for at indgive regular insulin intravenøst.
English: If your blood sugar level falls too low, you may pass out (become unconscious).
Danish: Hvis dit blodsukkerniveau falder for meget, kan du besvime (blive bevidstløs).
English: Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
Danish: Svær hypoglykæmi kan medføre hjerteanfald eller hjerneskade og kan være livstruende.
English: Pen Needle Parts (Needles Not Included)
Danish: Nål-dele (Nåle medfølger ikke)
English: The primary aim of demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there was a trend to an increase of hypoglycaemic events with insulin glargine [insulin glargine: NPH rate ratio (95% CI) = 1.18 (0.97-1.44)].
Danish: Dette mål blev ikke nået, og der var en tendens til stigning i hypoglykæmiske episoder med insulin glargin [insulin glargin:NPH rate ratio (95% CI) = 1,18 (0,97-1,44)].
English: Insulin receptor binding
Danish: Insulinreceptorbinding
English: • Inject your insulin as your healthcare professional has shown you.
Danish: • Indsprøjt insulinen som anvist af sundhedspersonalet.