FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (for pH adjustment) (see section 2 “Important information about some of the ingredients of LUSDUNA”), hydrochloric acid (for pH adjustment) and water for injections.
Danish: - Øvrige indholdsstoffer: Zinkchlorid, metacresol, glycerol, natriumhydroxid (til pH-justering) (se punkt 2 ”Vigtig information om nogen af de øvrige indholdsstoffer i Lusduna”), saltsyre (til pHjustering) og vand til injektionsvæsker.
English: Dial a 2-unit test dose Dial a test dose of two units by turning the dial until the black line points to “2”.
Danish: Vælg en testdosis på 2 enheder Vælg en testdosis på 2 enheder ved at dreje på dosisvælgeren, indtil den sorte markør står ud for tallet
English: How to handle Nexvue Nexvue is a pre-filled disposable pen containing insulin glargine.
Danish: Håndtering af Nexvue Nexvue er en fyldt engangspen med insulin glargin.
English: For information on how to care for your pen, see section “Caring for your pen”.
Danish: Se punktet ”Vedligeholdelse af pennen” for oplysninger om, hvordan du skal behandle din pen.
English: What should you do if you experience hypoglycaemia?
Danish: Hvad du skal gøre, hvis du får hypoglykæmi
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 faldet i fasteplasmaglucose fra baseline større i insulin glargin-gruppen end i NPH-gruppen.
English: Complaints of injection site reactions (injection site reaction, injection site pain) 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 (reaktioner på injektionsstedet og smerter på injektionsstedet) og hudreaktioner (udslæt og nældefeber) er rapporteret relativt oftere hos børn og unge under 18 år end hos voksne.
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 symptomer på lavt blodsukker i hjernen er: Hovedpine, udtalt sultfornemmelse, kvalme, opkastning, træthed, søvnighed, søvnforstyrrelser, rastløshed, aggressiv adfærd, koncentrationsbesvær, nedsat reaktionsevne, depression, forvirring (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: LUSDUNA is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above.
Danish: Lusduna anvendes til at behandle sukkersyge (diabetes mellitus) hos voksne, unge og børn fra 2 år og opefter.
English: For storage conditions after removing this medicinal product from the refrigerator, see section 6.3.
Danish: Opbevaringsforhold efter lægemidlet er taget ud af køleskabet, se pkt.
English: No significant difference was seen in the progression of diabetic retinopathy when insulin glargine was compared to NPH insulin.
Danish: Der blev ikke observeret signifikant forskel i progressionen af diabetisk retinopati ved sammenligning af insulin glargin og NPH-insulin.
English: • Skin and allergic reactions at the injection site These signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Danish: • Hudreaktioner og allergiske reaktioner ved injektionsstedet Symptomerne kan omfatte rødme, usædvanlig stærk smerte når der injiceres, kløe, udslæt, hævelse eller betændelse.
English: LUSDUNA is only suitable for subcutaneous injections via a disposable pen.
Danish: LUSDUNA er kun egnet til subkutan injektion ved hjælp af en engangspen.
English: See Step 9 for how to remove a needle.
Danish: Se hvordan, du fjerner nålen i trin 9.
English: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de
Danish: MSD SHARP & DOHME GMBH Tlf.: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de
English: Each pen contains 3 mL of solution for injection, equivalent to 300 units.
Danish: Hver pen indeholder 3 ml injektionsvæske, opløsning, svarende til 300 enheder.
English: LUSDUNA is only suitable for injection just under the skin.
Danish: Lusduna er kun egnet til indsprøjtning lige under huden.
English: If you dial the wrong dose, just dial backwards until the correct number lines up with the black line on the window.
Danish: Hvis du har valgt den forkerte dosis, skal du blot dreje tilbage, indtil det korrekte tal står ud for den sorte markør i dosisvinduet.
English: Pens in use must not be stored in the refrigerator.
Danish: Penne, der er taget i brug, må ikke opbevares i køleskabet.
English: Once you've opened and are using a pen:
Danish: Når pennen er anbrudt og er i brug:
English: If your pen is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up.
Danish: • Hvis pennen opbevares i køleskab, skal du tage den ud 1 til 2 timer, før du skal injicere, så den kan varme op. Kold insulin er mere smertefuld at injicere.
English: If you have any questions about this medicine or diabetes, please ask your doctor or nurse for assistance.
Danish: Hvis du har eventuelle spørgsmål vedrørende dette lægemiddel eller diabetes, så spørg din læge eller sygeplejerske.
English: This leaflet was last revised in.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: Magyarország MSD Pharma Hungary Kft. Tel.: +36 1 888 5300 hungary_msd@merck.com
Danish: Magyarország MSD Pharma Hungary Kft. Tlf.: +36 1 888 5300 hungary_msd@merck.com
English: The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if - you are elderly, if you have had diabetes for a long time or if 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 have recently changed from an animal insulin to a human insulin such as LUSDUNA, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Danish: De første symptomer på, at der er ved at opstå hypoglykæmi (”advarselssymptomer”), kan ændre sig, svækkes eller kan helt mangle, hvis: - du er ældre, hvis du har haft diabetes i lang tid, eller hvis du lider af en bestemt form for sygdom i nervesystemet (diabetisk autonom neuropati), - du for nylig har haft hypoglykæmi (f.eks. dagen før), eller hvis tilstanden udvikles langsomt, - du har et næsten normalt eller i det mindste betydeligt forbedret blodsukker, - du for nylig har skiftet fra animalsk insulin til human insulin såsom Lusduna, - du tager eller har taget visse andre lægemidler (se punkt 2, "Brug af anden medicin sammen
English: In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
Danish: I euglykæmiske clamp-studier med raske forsøgspersoner og type 1-diabetikere var tidspunktet for virkningens indtræden af subkutant insulin glargin langsommere end ved humant NPH-insulin, virkningsprofilen var jævn og uden koncentrationstoppe, og virkningens varighed var forlænget.
English: Switch from twice daily NPH insulin to LUSDUNA
Danish: Skift fra NPH-insulin to gange dagligt til LUSDUNA
English: Tel: +43 (0) 1 26 044 msd-medizin@merck.com
Danish: Tlf.: +43 (0) 1 26 044 msd-medizin@merck.com
English: Tel: + 385 1 6611 333 croatia_info@merck.com
Danish: Tlf.: + 385 1 6611 333 croatia_info@merck.com
English: 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 LUSDUNA should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment.
Danish: For at mindske risikoen for natlig hypoglykæmi og hypoglykæmi tidligt om morgenen skal patienter, der skiftes fra basalinsulin 2 gange dagligt som NPH-insulin til LUSDUNA 1 gang dagligt, nedsætte den daglige dosis af basalinsulin med 20-30% i de første behandlingsuger.
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 (0,971,44)].
English: If you stop using LUSDUNA
Danish: Hvis du holder op med at tage Lusduna
English: Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta).
Danish: Spis herefter madvarer med langsomt optagelige kulhydrater (f.eks. brød eller pasta).
English: In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults.
Danish: Anvendelse til børn og unge Generelt svarer bivirkningerne set hos børn og unge under 18 år til bivirkningerne set hos voksne.
English: General disorders and administration site conditions Injection site reactions include redness, pain, itching, hives, swelling, or inflammation.
Danish: Almene symptomer og reaktioner på administrationsstedet Reaktioner på injektionsstedet omfatter rødme, smerter, kløe, udslæt, hævelse eller inflammation.
English: A safety test must be performed before each injection.
Danish: Udfør en sikkerhedstest inden hver injektion.
English: Tel: +420 233 010 111 dpoc_czechslovak@merck.com
Danish: Tlf.: +420 233 010 111 dpoc_czechslovak@merck.com
English: Inner needle cap must be removed before injecting the dose.
Danish: Den indre nålehætte skal fjernes inden injektion af dosis.
English: What should you do if you experience hyperglycaemia?
Danish: Hvad du skal gøre, hvis du får hyperglykæmi
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 sympatolytiske lægemidler som f.eks. betablokkere, clonidin, guanethidin og reserpin kan symptomerne på adrenerg modregulation ligeledes være reduceret eller helt mangle.
English: LUSDUNA should be administered once daily at any time but at the same time each day.
Danish: Det kan gives på et hvilket som helst tidspunkt af dagen, men på samme tid hver dag.
English: - determine how much LUSDUNA per day you will need and at what time, - tell you when to check your blood sugar level, and whether you need to carry out urine tests, - tell you when you may need to inject a higher or lower dose of LUSDUNA.
Danish: - afgøre, hvor meget Lusduna du skal have pr. dag og på hvilket tidspunkt af dagen, - fortælle dig, hvornår du skal kontrollere dit blodsukker, og om det er nødvendigt at udføre
English: - change in the injection area, - improved insulin sensitivity (e.g., by removal of stress factors), - unaccustomed, increased or prolonged physical activity, - intercurrent illness (e.g. vomiting, diarrhoea), - inadequate food intake, - missed meals, - alcohol consumption, - certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or
Danish: - skift til andet injektionsfelt, - forbedret insulinfølsomhed (f.eks. pga. fjernelse af stressfaktorer), - uvant, øget eller længerevarende fysisk aktivitet, - anden samtidig sygdom (f.eks. opkastning, diarré), - utilstrækkelig fødeindtagelse, - oversprungne måltider, - alkoholindtagelse, - visse ukompenserede endokrine lidelser (f.eks. hypotyroidisme, hypofyseforlaps- eller
English: When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Danish: Ved intravenøs administration var eliminationshalveringstiden for insulin glargin og human insulin sammenlignelig.
English: This helps make sure you get your full dose of insulin.
Danish: Herved sikres det, at du får den fulde insulindosis.
English: Date out of the refrigerator: Write-in space for placing date the pen was out of refrigerator.
Danish: Dato for udtagning fra køleskab: Felt til angivelse af dato for pennens udtagning fra køleskab
English: If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Danish: Tal med din læge, hvis du ammer, da det kan være nødvendigt at justere din insulindosis og kost.
English: 5 pre-filled pens of 3 mL.
Danish: 5 fyldte penne a 3 ml.
English: Multipack: 10 (2 packs of 5) pre-filled pens of 3 mL.
Danish: Multipakning: 10 (2 pakninger a 5) fyldte penne a 3 ml.
English: Excipients: zinc chloride, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.
Danish: Hjælpestoffer: zinkchlorid, metacresol, glycerol, saltsyre og natriumhydroxid (til pH-justering), vand til injektionsvæsker.
English: Children There is no experience with the use of LUSDUNA in children below the age of 2 years.
Danish: Børn Der er ingen erfaring med anvendelse af Lusduna til børn under 2 år.
English: In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
Danish: I et klinisk studie var symptomerne på hypoglykæmi eller modreguleret hormonrespons sammenlignelige efter administration af intravenøs insulin glargin og humant insulin til både raske forsøgspersoner og type 1-diabetikere.
English: If you forget to use LUSDUNA - If you have missed a dose of LUSDUNA or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia).
Danish: Hvis du har glemt at tage Lusduna - Hvis du har sprunget en dosis Lusduna over, eller hvis du ikke har injiceret nok insulin, kan blodsukkeret blive for højt (hyperglykæmi).
English: Each mL contains 100 units (3.64 mg) insulin glargine.
Danish: Hver ml indeholder 100 enheder (3,64 mg) insulin glargin.
English: Keep the pen straight, not at an angle or sideways.
Danish: Den må ikke indføres i en vinkel eller fra siden.
English: Safety and efficacy of insulin glargine have not been established in children below the age of 2 years.
Danish: Insulin glargins sikkerhed og virkning hos børn under 2 år er ikke klarlagt.
English: Safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older.
Danish: Insulin glargins sikkerhed og virkning hos unge og børn i alderen 2 år og derover er klarlagt.
English: Hypoglycaemia is also more likely to occur if - you have just begun insulin treatment or changed to another insulin preparation (when changing from your previous basal insulin to LUSDUNA, hypoglycaemia, if it occurs, may be more likely to occur in the morning than at night), - your blood sugar levels are almost normal or are unstable, - you change the area of skin where you inject insulin (for example from the thigh to the upper arm), - you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
Danish: Der er endvidere større risiko for udvikling af hypoglykæmi, hvis: - du netop har påbegyndt insulinbehandling eller har skiftet til et andet insulinpræparat, (hvis du skifter fra dit tidligere basalinsulin til Lusduna, vil hypoglykæmi, hvis det opstår, hyppigere opstå om morgenen end om natten), - dit blodsukker er næsten normalt eller ustabilt, - du skifter injektionssted fra et hudområde til et andet (f.eks. fra låret til overarmen), - du lider af en alvorlig nyre- eller leversygdom eller af anden sygdom som f.eks. hypotyroidisme
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver gruppe af bivirkninger med samme hyppighed er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Make sure the pens are away from the freezer compartment or a freezer pack.
Danish: Sørg for, at pennene ikke er i direkte berøring med frostboks eller fryseelementer.
English: Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com
Danish: Merck Sharp & Dohme Cyprus Limited Tlf.: 8007 4433 (+356 99917558) malta_info@merck.com
English: There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of insulin glargine.
Danish: Der er ikke set klinisk relevante forskelle i serum-insulin eller glucoseniveau efter administration af insulin glargin i abdomen, overarmen eller låret.
English: However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Danish: Intensivering af insulinbehandlingen med pludselig forbedring af den glykæmiske kontrol kan midlertidigt forværre en diabetisk retinopati.
English: Tel: +386 1 5204 201 msd.slovenia@merck.com
Danish: Tlf.: +386 1 5204 201 msd.slovenia@merck.com
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com
Danish: Slovenská republika Merck Sharp & Dohme, s. r. o. Tlf.: +421 2 58282010 dpoc_czechslovak@merck.com
English: If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see section “Hyperglycaemia and Hypoglycaemia” at the end of this leaflet).
Danish: Hvis dit blodsukker er for lavt (hypoglykæmi), så følg vejledningen vedrørende hypoglykæmi (se punktet ”Hyperglykæmi og hypoglykæmi” sidst i denne indlægsseddel).
English: You must always check the insulin label before each injection to avoid mix-ups between LUSDUNA and other insulins.
Danish: Du skal altid kontrollere etiketten før hver injektion for at undgå forveksling mellem Lusduna og andre insuliner.
English: Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
Danish: Tlf.: +353 (0)1 2998700 medinfo_ireland@merck.com
English: LUSDUNA 100 units/mL injection Nexvue
Danish: LUSDUNA 100 enheder/ml injektion Nexvue insulin glargin
English: Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates, somatostatin analogues and sulphonamide antibiotics.
Danish: Stoffer, som kan forstærke den blodsukkersænkende effekt, og som kan øge risikoen for hypoglykæmi, omfatter orale antidiabetika, ACE (angiotensinkonverterende enzym)-hæmmere, disopyramid, fibrater, fluoxetin, monoaminoxydase (MAO)-hæmmere, pentoxifyllin, propoxyphen, salicylater, somatostatinanaloger og sulfonamidantibiotika.
English: Instead, regular insulin administered intravenously is recommended in such cases.
Danish: I sådanne tilfælde anbefales det i stedet for at indgive hurtigtvirkende insulin intravenøst.
English: Cartridge (type I colourless glass) with a plunger (bromobutyl rubber) and aluminium combi-seal fitted with a bi-layered bromobutyl rubber and polyisoprene rubber flat disc containing 3 mL of solution.
Danish: 3 ml opløsning i en cylinderampul (type I farveløst glas) med et stempel (brombutylgummi) og en kombiprop af aluminium og hætte (laminat af brombutylgummi og polyisoprengummi).
English: Clean the area with an alcohol swab.
Danish: Rengør injektionsstedet Rengør området med en spritserviet.
English: HbA1c changes from baseline were similar between treatment groups; however blood glucose values recorded overnight were significantly higher in the insulin glargine/ lispro group than the NPH/regular group, with a mean nadir of 5.4 mM versus 4.1 mM.
Danish: Dog var blodsukkerværdierne målt over natten signifikant højere i insulin glargin/lispro-gruppen end i NPH/regular-gruppen med en gennemsnitlig nadir på 5,4 mM versus 4,1 mM.
English: If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straight away (see section “Hyperglycaemia and Hypoglycaemia” at the end of this leaflet).
Danish: Hvis du får symptomer på for lavt blodsukker (hypoglykæmi), skal du straks gøre noget for at øge dit blodsukker (se punktet ”Hyperglykæmi og hypoglykæmi” sidst i denne indlægsseddel.
English: Packs of 1, 5 and a multipack with 10 (2 x 5) pre-filled pens are available.
Danish: Der findes pakninger med 1 og 5 penne og en multipakning med 10 (2 x 5) fyldte penne.
English: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tél/Tel: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com
Danish: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tlf.: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com
English: What LUSDUNA contains - The active substance is insulin glargine.
Danish: Lusduna indeholder: - Aktivt stof: Insulin glargin.
English: Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com
Danish: Merck Sharp & Dohme (Sweden) AB Tlf.: +46 77 5700488 medicinskinfo@merck.com
English: A new needle must be attached before each use.
Danish: Påsæt altid en ny nål før hver anvendelse.
English: Adherence of the patient to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Danish: For at mindske risikoen for hypoglykæmi er det vigtigt, at patienten overholder dosering og diæt, administrerer insulinen korrekt og er opmærksom på symptomer på hypoglykæmi.
English: Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
Danish: Merck Sharp & Dohme Limited Tlf.: +44 (0) 1992 467272 medicalinformationuk@merck.com
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Danish: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tlf.: +32(0)27766211 dpoc_belux@merck.com
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 bevidsthedstab kan være tegn på den alvorlige tilstand ketoacidose (syreforgiftning - ophobning af syre i blodet, da kroppen nedbryder fedt i stedet for sukker), som er en følge af mangel på insulin.
English: EU/1/16/1162/002
Danish: EU/1/16/1162/001 EU/1/16/1162/002 EU/1/16/1162/003
English: UAB Merck Sharp & Dohme Tel. + 370 5 278 02 47 msd_lietuva@merck.com
Danish: UAB Merck Sharp & Dohme Tlf. + 370 5 278 02 47 msd_lietuva@merck.com
English: LUSDUNA can be used in adolescents and children aged 2 years and above.
Danish: Lusduna kan anvendes til unge og børn fra 2 år og opefter.
English: Name and address of the manufacturer(s) responsible for batch release N.V. Organon
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Shelf-life after removing the pen from the refrigerator
Danish: Opbevaringstid efter pennen er taget ud af køleskabet