FrancophonIA/ELRC3.0 huggingface dataset:
English: The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicentre, randomised, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12 % of participants) or type 2 diabetes mellitus treated with ≤ 1 antidiabetic oral agent (88 % of participants).
Danish: ORIGIN-studiet (Outcome Reduction with Initial Glargine INtervention) var et randomiseret multicenterstudie med et 2x2 faktorielt design omfattende 12.537 patienter med høj kardiovaskulær (CV) risiko og enten forhøjet fasteblodsukker (IFG) eller nedsat glucosetolerance (IGT) (12 % af deltagerne) eller type 2-diabetes mellitus behandlet med ≤ 1 oralt antidiabetikum (88% af deltagerne).
English: Merck Sharp & Dohme BV Tel: 0800 9999000
Danish: Merck Sharp & Dohme BV Tlf.: 0800 9999000
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 personer)
English: OUTER CARTON (with blue box) multipack - 10 (2 x 5)
Danish: YDRE KARTON (med blå boks) del af en multipakning - 10 (2 x 5)
English: These units are exclusive to insulin glargine 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 udelukkende for insulin glargin og er ikke det samme som IE eller de enheder, der bruges til at angive styrken på andre insulinanaloger (se pkt.
English: In the following situations, the management of your diabetes may require a lot of care (for example, adjustment to insulin dose, blood and urine tests): - If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
Danish: I følgende situationer kan kontrollen af din diabetes kræve ekstra opmærksomhed (for eksempel tilpasning af insulindosis, blod- og urinprøver): - Hvis du bliver syg eller kommer alvorligt til skade, kan dit blodsukkerniveau blive for højt
English: PLEASE READ THESE INSTRUCTIONS BEFORE USE.
Danish: LÆS DENNE BRUGSANVISNING INDEN BRUG.
English: In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.
Danish: Insulinbehandlingen kan i sjældne tilfælde også føre til forbigående væskeophobning i kroppen med hævede lægge og ankler.
English: Before you inject, make sure that the dose window is facing you.
Danish: Inden injektionen skal du sikre, at dosisvinduet vender ind mod dig.
English: Important information about some of the ingredients of LUSDUNA This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Danish: Vigtige oplysninger om visse af indholdsstofferne i Lusduna Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige ”natriumfrit”.
English: PEN LABEL -NEXVUE
Danish: PENETIKET - NEXVUE
English: Look at the cartridge before you use the pen.
Danish: Se på cylinderampullen, inden du bruger pennen.
English: Effects of insulin glargine (once daily) on diabetic retinopathy were evaluated in an open-label 5 year NPH-controlled study (NPH given bid) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography.
Danish: Effekten af insulin glargin (en gang dagligt) på diabetisk retinopati blev undersøgt i et åbent, 5-årigt NPH-kontrolleret studie (NPH givet 2 gange dagligt) med 1.024 patienter med type 2-diabetes, i hvilket progression af retinopati med 3 eller flere trin på ETDRS-skalaen (Early Treatment Diabetic Retinopathy Study), blev undersøgt ved hjælp af fundus-fotografering.
English: LUSDUNA is injected under the skin.
Danish: Lusduna injiceres under huden.
English: Press the injection button all the way in while pointing the needle up into the air.
Danish: Tryk dosisknappen helt i bund, mens nålen peger op i luften.
English: Clinical study safety data are not available for children under 2 years.
Danish: Der er ingen tilgængelige sikkerhedsdata fra kliniske studier med børn under 2 år.
English: In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal.
Danish: I et randomiseret kontrolleret klinisk studie blev pædiatriske patienter (i alderen 6-15 år) med type 1diabetes (n=349) behandlet i 28 uger med et regime med basal-bolusinsulin, hvor hurtigtvirkende human insulin blev anvendt før hvert måltid.
English: After subcutaneous injection in diabetic patients, insulin glargine is rapidly metabolised at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Danish: Efter subkutan injektion af insulin glargin til diabetespatienter bliver insulin glargin hurtigt metaboliseret ved carboxylenden af beta-kæden under dannelse af to aktive metabolitter M1 (21AGly-insulin) og M2 (21A-Gly-des-30B-Thr-insulin).
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, som igangsættes af IGF-1-receptoren.
English: Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Danish: Faktorer, der øger risikoen for hypoglykæmi, kræver ekstra nøje overvågning, og dosisjustering kan blive nødvendig.
English: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Danish: Milde tilfælde af hypoglykæmi kan sædvanligvis behandles ved oral indtagelse af kulhydrater.
English: Check the cartridge to make sure the insulin is clear, colourless and free of particles.
Danish: Kontroller cylinderampullen for at sikre, at insulinet er klart, farveløst og uden synlige partikler.
English: The pen in use or carried as a spare must not be stored in the refrigerator.
Danish: Den anbrudte pen eller pennen, der medtages som reserve, må ikke opbevares i køleskab.
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER
English: With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary.
Danish: Ved forbedret metabolisk kontrol, og deraf følgende øget insulinfølsomhed, kan yderligere dosisjustering blive nødvendig.
English: It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemia.
Danish: Det er meget vigtigt at opretholde en god metabolisk kontrol under graviditeten hos patienter med allerede eksisterende diabetes eller svangerskabsdiabetes for at forebygge skadelige følgevirkninger i forbindelse med hyperglykæmi.
English: Throw away the needle safely, as instructed by your doctor, pharmacist or nurse.
Danish: Kasser nålen på sikker vis i henhold til lægens, apotekspersonalets eller sundhedspersonalets anvisninger.
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 vægtstigning fra baseline på 1,4 kg i insulin glargin-gruppen og et gennemsnitligt vægttab på 0,8 kg i standardbehandlingsgruppen.
English: A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin (each treatment administered for 16 weeks in random order) in 26 adolescent type 1 diabetic patients aged 12 to 18 years was also performed.
Danish: Der blev også udført et overkrydsningsstudie, der sammenlignede insulin glargin plus lispro insulin med NPH plus hurtigtvirkende human insulin (hver behandling blev administreret i 16 uger i tilfældig rækkefølge) hos 26 unge patienter med type 1-diabetes i alderen 12-18 år.
English: Insulin receptor binding: 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: Insulinreceptorbinding: In vitro-studier indikerer, at affiniteten af insulin glargin og dets metabolitter M1 og M2 til den humane insulinreceptor ligner human insulins affinitet.
English: Do not use LUSDUNA - If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in
Danish: Tag ikke Lusduna - hvis du er allergisk over for insulin glargin eller et af de øvrige indholdsstoffer i Lusduna
English: Choose your injection site
Danish: Vælg injektionssted
English: To reduce the risk of hypoglycaemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/mL to a once daily regimen with LUSDUNA should reduce their dose by approximately 20%.
Danish: For at reducere risikoen for hypoglykæmi skal patienter, som skifter deres basalinsulinregime fra et insulinregime med insulin glargin 300 enheder/ml en gang dagligt til et regime med LUSDUNA en gang dagligt, reducere deres dosis med cirka 20%.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone (oral anti-diabetic medicine used to treat type 2 diabetes mellitus) and insulin experienced the development of heart failure.
Danish: Nogle patienter med årelang type 2-diabetes mellitus og hjertesygdom eller tidligere slagtilfælde, der var i behandling med pioglitazon (diabetesmedicin, der tages gennem munden, til behandling af type 2-diabetes mellitus) og insulin, udviklede hjertesvigt.
English: The pen cap must be put back on the pen after each injection in order to protect from light.
Danish: Penhætten skal sættes tilbage på pennen efter hver injektion for at beskytte den mod lys.
English: Participants were randomized (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: Patienterne blev randomiseret i forholdet 1:1 til at få insulin glargin titreret til at nå FPG ≤ 95 mg/dl (5,3 mM) (n=6.264), eller standardbehandling (n=6.273).
English: If it does not work with a new needle, you will need to speak to your doctor or nurse.
Danish: Hvis det ikke virker med en ny nål, skal du tale med lægen eller sygeplejersken.
English: There was less severe hypoglycaemia in the insulin glargine group as well.
Danish: Forekomsten af alvorlig hypoglykæmi var også lavere i insulin glargin-gruppen.
English: Discard pen 28 days after removal from refrigerator.
Danish: Kasser pennen 28 dage efter udtagning fra køleskabet.
English: Simply re-cap the pen, and store it without the needle for your next injection.
Danish: Sæt penhætten tilbage på pennen og gem den uden nålen på indtil næste injektion.
English: Switch from insulin glargine 300 units/mL to LUSDUNA
Danish: Skift fra insulin glargin 300 enheder/ml til LUSDUNA
English: If administration by syringe is necessary, another insulin glargine product available in a vial should be used.
Danish: Hvis det er nødvendigt at anvende en sprøjte til administrationen, bør et hætteglas med et andet tilgængeligt insulin glarginprodukt anvendes.
English: LUSDUNA must not be mixed with any other insulin or diluted.
Danish: LUSDUNA må ikke blandes med andre insuliner eller fortyndes.
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, kan opstå, hvis insulindosis er for høj i forhold til insulinbehovet (se pkt.
English: • Always perform the safety test before each injection.
Danish: • Udfør altid sikkerhedstesten før hver injektion.
English: If you haven't been trained before, ask your doctor or nurse to show you how to use your pen.
Danish: Hvis du ikke er blevet undervist i brug af pennen før, skal du bede lægen eller sygeplejersken om at vise dig, hvordan
English: Tap the pen Hold the pen upright and tap the cartridge gently to allow any air bubbles to rise to the top.
Danish: Hold pennen lodret og bank let på cylinderampullen, så eventuelle luftbobler kan komme op til toppen.
English: The rates of severe hypoglycaemia (affected participants per 100 participant years of exposure) were 1.05 for insulin glargine and 0.30 for standard care group and the rates of confirmed non-severe hypoglycaemia were 7.71 for insulin glargine and 2.44 for standard care group.
Danish: Forekomsten af alvorlig hypoglykæmi (antal berørte patienter pr. 100 patientår) var 1,05 i insulin glargin-gruppen og 0,30 i standardbehandlingsgruppen, og forekomsten af bekræftet ikkealvorlig hypoglykæmi var 7,71 for insulin glargin-gruppen og 2,44 for standardbehandlingsgruppen.
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 hypo- or hyperglycaemia (see section 4.4).
Danish: Dosisjustering kan også blive nødvendig ved f.eks. ændring i patientens vægt eller livsstil, ændring af tidspunkt for insulindosis, eller hvis andre omstændigheder gør, at følsomheden for hypo- eller hyperglykæmi øges (se pkt.
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 to gange dagligt.
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 proliferativ retinopati (en øjensygdom, der kan ses i forbindelse med diabetes), kan svære hypoglykæmiske anfald forårsage forbigående synstab.
English: • Carry some information with you to show you are diabetic.
Danish: • Du skal altid have et kort eller lignende på dig, hvoraf det fremgår, at du er diabetiker.
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
Danish: Betablokkere, clonidin, lithiumsalte og alkohol kan enten øge eller hæmme insulins blodsukkersænkende effekt.
English: • LUSDUNA contains a medicine called insulin glargine.
Danish: • Lusduna indeholder et lægemiddel kaldet insulin glargin.
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 blodglucosekontrol tilrådes hos patienter, hvor hypoglykæmi kan være af særlig klinisk betydning, f.eks. hos patienter med væsentlige stenoser i koronararterierne eller i hjernens forsyningskar (risiko for kardielle eller cerebrale hypoglykæmikomplikationer) og også hos patienter med proliferativ retinopati, især hvis denne ikke er behandlet med fotokoagulation (risiko for forbigående amaurose efter hypoglykæmi).
English: The use of LUSDUNA may be considered during pregnancy, if clinically needed.
Danish: Anvendelsen af LUSDUNA til gravide kan overvejes, hvis der er et behandlingsbehov.
English: If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Danish: Hvis du er i tvivl om, hvorvidt du tager et af disse lægemidler, skal du spørge din læge eller apotekspersonalet.
English: The pen won't let you dial past the number of insulin units left in the pen.
Danish: Du kan ikke dreje dosisvælgeren forbi det antal enheder af insulin, som er tilbage i pennen.
English: Do not shake or mix it before use.
Danish: Nexvue må ikke rystes eller blandes før brug.
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 insulinanaloger, som f.eks. insulin glargin, kan variere betydeligt fra person til person og hos personen selv.
English: Talk to your doctor, pharmacist or nurse before using LUSDUNA.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Lusduna.
English: Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with LUSDUNA.
Danish: Patienter, som på grund af antistoffer mod humant insulin får høje insulindoser, kan få et bedre insulinrespons med LUSDUNA.
English: Switch from other insulins to LUSDUNA
Danish: Skift fra andre insuliner til LUSDUNA
English: Deliver the dose by pressing the injection button until you see 0 and a green stripe appears in the window.
Danish: Tryk for at injicere Injicer dosis ved at trykke på dosisknappen, indtil du kan se et 0 og en grøn stribe i dosisvinduet.
English: In clinical pharmacology studies, intravenous insulin glargine and human insulin have been shown to be equipotent when given at the same doses.
Danish: I klinisk farmakologiske studier har intravenøst insulin glargin og humant insulin vist sig at være ækvipotente, når de blev givet i samme doser.
English: Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise hypoglycaemia.
Danish: Betablokkere og andre sympatolytiske lægemidler (som f.eks. clonidin, guanethidin og reserpin) kan endvidere svække eller helt undertrykke de første advarselssymptomer, der hjælper dig med at opdage lavt blodsukker.
English: After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of micro-precipitates 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 injektionsvæske, 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: Injection sites must be rotated within a given injection area from one injection to the next to prevent injection site reactions (see section 4.8).
Danish: Injektionsstedet inden for det enkelte injektionsfelt skal skiftes fra injektion til injektion for at undgå reaktion på injektionsstedet (se pkt.
English: If your blood sugar level falls too low, you may become unconscious.
Danish: Hvis dit blodsukker bliver for lavt, kan du miste bevidstheden.
English: No metabolic effects of ingested insulin glargine on the breastfed newborn/infant are anticipated since insulin glargine as a peptide is digested into amino acids in the human gastrointestinal tract.
Danish: Der forventes ingen metabolisk effekt af insulin glargin indtaget af det ammede nyfødte barn/spædbarn, da insulin glargin, som et peptid, fordøjes som aminosyrer i den humane mave-tarm-kanal.
English: Tel: +39 06 361911 medicalinformation.it@merck.com
Danish: Tlf.: +39 06 361911 medicalinformation.it@merck.com
English: Your blood sugar level may either rise or fall if you take: - beta-blockers (used to treat high blood pressure), - clonidine (used to treat high blood pressure), - lithium salts (used to treat psychiatric disorders).
Danish: Blodsukkeret kan enten stige eller falde, hvis du tager: - betablokkere (anvendes til behandling af forhøjet blodtryk), - clonidin (anvendes til behandling af forhøjet blodtryk), - lithiumsalte (anvendes til behandling af psykiske sygdomme).
English: Glycohaemoglobin and glucose variabilities were comparable in both treatment groups.
Danish: Variabiliteten for glycocyleret hæmoglobin og glucose var sammenlignelige i de 2 behandlingsgrupper.
English: LUSDUNA is a long-acting insulin.
Danish: Lusduna er et langtidsvirkende insulin.
English: The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (≤ 18 years of age) than in adults.
Danish: Bivirkningsrapporter modtaget efter post marketing-evaluering viser relativt flere reaktioner på injektionsstedet (smerte på injektionsstedet, reaktioner på injektionsstedet) og hudreaktioner (udslæt, urticaria) hos børn og unge (≤ 18 år) end hos voksne.
English: Double-check your dose!
Danish: Kontroller din dosis en ekstra gang!
English: Read carefully the "Nexvue Instructions for Use" included in this pack.
Danish: Læs omhyggeligt ”Brugsanvisning til Nexvue”, som er vedlagt denne pakning.
English: When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with LUSDUNA, 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 fast-acting insulin analogues or the dose of oral antidiabetic medicinal products).
Danish: Ved skift fra behandling med middellangt virkende eller langtidsvirkende insulin til behandling med LUSDUNA kan det blive nødvendigt at ændre dosis af basalinsulin og justere anden samtidig antidiabetisk behandling (dosis og tidspunkt for anden regular insulin eller hurtigtvirkende insulinanaloger eller dosis af orale antidiabetika).
English: Also, be sure to remove the needle before disposing of the pen.
Danish: Fjern også nålen, inden pennen kasseres.
English: Open the needle Remove the seal from the needle.
Danish: Åbn nålen Fjern forseglingen fra nålen.
English: Store pens in the box in the refrigerator (2°C- 8°C).
Danish: • Opbevar pennene i pakningen i køleskabet (2 °C-8 °C).
English: Similar effects on glycohaemoglobin and the incidence of symptomatic hypoglycaemia were observed in both treatment groups, however fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group.
Danish: Der blev observeret ens effekt på glycohæmoglobin og incidensen af symptomatisk hypoglykæmi i begge behandlingsgrupper, men fasteplasmaglucose faldt mere fra baseline i insulin glargin-gruppen end i NPH-gruppen.
English: Driving and using machines 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: Before first use, the pen must be stored at room temperature for 1 to 2 hours to allow it to warm up.
Danish: Inden første brug skal pennen opbevares ved stuetemperatur i 1-2 timer for at lade den varme op. Undersøg cylinderampullen før brug.