FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are unable to read or follow all of the instructions on your own, ask for help from someone trained to use this pen.
Danish: Hvis du ikke selv er i stand til at følge alle instruktionerne fuldstændig, så brug kun Semglee, hvis du har hjælp fra en person, som er blevet trænet i at bruge pennen.
English: Semglee is not the insulin of choice for the treatment of diabetic ketoacidosis.
Danish: Semglee er ikke det insulinpræparat, man først skal vælge til behandling af diabetisk ketoacidose.
English: Put your used needle in a sharps disposal container right away after use.
Danish: Kassér den brugte nål i en kanyleboks straks efter brug.
English: Semglee with alcohol
Danish: Brug af Semglee sammen med alkohol
English: Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH.
Danish: Insulin glargin er en human insulin-analog, der er udviklet til at have lille opløselighed ved neutral pH.
English: D - Hold the purple injection button down for 10 seconds after the dose window shows “0” to make sure all of the insulin is injected.
Danish: D - Hold den lilla injektionsknap inde i 10 sekunder, efter vinduet har vist “0”, for at være sikker på, at hele din dosis er udløst.
English: • Inject the amount left in your pen and use a new pen to give the rest of your dose, or
Danish: • Injicere resten af enhederne og så bruge en ny pen til resten af din dosis,
English: A - Take the outer needle cap that you had saved in step 2D, hold it at the widest part and carefully cover the needle without touching it.
Danish: A - Tag den ydre nålehætte, som du gemte i trin 2D og hold den som vist på billedet, mens du forsigtigt sætter den på nålen uden at røre nålen.
English: You may give other people a serious infection, or get a serious infection from them.
Danish: Du kan give andre en alvorlig infektion, eller andre kan give dig en alvorlig infektion.
English: It may take several twists to release the needle.
Danish: Det er muligt, at du skal dreje flere gange for at få nålen af.
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: HbA1c ændringer fra baseline var ens mellem behandlingsgrupperne; dog var blodsukkerværdierne målt over natten signifikant højere i insulin glargin/ lispro-gruppen end i NPH/regulær-gruppen med en gennemsnitlig nadir på 5,4 mM versus 4,1 mM.
English: Multipack: 10 (2 packs of 5) pens of 3 ml.
Danish: Multipakning: 10 (2 pakninger af 5) penne á 3 ml
English: Do not inject with the needle at an angle.
Danish: Du må ikke trykke nålen ind i en skæv vinkel.
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 5 års open-label 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 Early Treatment Diabetic Retinopathy Study (ETDRS) standarden, blev undersøgt ved hjælp af fundus-fotografering.
English: Do not use it after this time period.
Danish: Brug ikke pennen efter denne periode.
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og etiketten efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Common reported side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer)
English: The following graph shows the results from a study in patients: Activity profile in patients with type 1 diabetes
Danish: Det følgende diagram viser resultater fra et studie på patienter:
English: • Always carry an extra insulin pre-filled pen injector as recommended by your healthcare provider in case your pen gets lost or damaged.
Danish: • Du skal altid have en ekstra fyldt injektionspen på dig som anvist af lægen eller sundhedspersonalet, hvis din pen bliver væk eller går i stykker.
English: The white dose knob will turn and you will hear “clicks” as you press down.
Danish: Den hvide doseringsvælger drejer, og du kan høre, at den siger “klik”, når du trykker på injektionsknappen.
English: Semglee is a long-acting insulin.
Danish: Semglee er et langtidsvirkende insulin.
English: Empty pens must not be re-filled and must be properly discarded.
Danish: Tomme penne må ikke fyldes igen og skal kasseres på passende vis.
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 hyperglycemia.
Danish: Det er meget vigtigt at opretholde en god metabolisk kontrol under graviditeten hos patienter med forudeksisterende eller gestationel diabetes for at forebygge skadelige følgevirkninger i forbindelse med hyperglykæmi.
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 krydsover-studie, der sammenlignede insulin glargin plus lispro insulin med NPH plus regulær humant insulin (hver behandling blev administreret i 16 uger i tilfældig rækkefølge) på 26 unge type1-diabetespatienter i alderen 12-18 år.
English: Semglee must not be mixed with any other insulin or diluted.
Danish: Semglee må ikke blandes med andre insuliner eller fortyndes.
English: To reduce the risk of hypoglycemia, 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 Semglee should reduce their dose by approximately 20%.
Danish: For at reducere risikoen for hypoglykæmi bør patienter, som skifter deres basalinsulinregime fra et insulinregime med insulin glargin 300 enheder/ml en gang dagligt til et regime med Semglee en gang dagligt, reducere deres dosis med cirka 20%.
English: If you do not keep the injection button pressed down for 10 seconds after “0” is displayed you may get the wrong dose of medicine.
Danish: Hvis du ikke holder injektionsknappen inde i 10 sekunder, efter du kan se “0” i vinduet, kan du risikere, at du ikke får den rigtige dosis.
English: Semglee is available in pack sizes of 1, 3, 5, 10 pens and in a multipack compromising of 2 cartons, each containing 5 pens.
Danish: Semglee fås i pakninger med 1, 3, 5, 10 penne og i en multipakning bestående af 2 kartoner, der hver indeholde 5 penne.
English: Switch from insulin glargine 300 units/ml to Semglee Semglee and insulin glargine 300 units/ml are not bioequivalent and are not directly interchangeable.
Danish: Skift fra insulin glargin 300 enheder/ml til Semglee Semglee og insulin glargin 300 enheder/ml er ikke bioækvivalente og er ikke direkte udskiftelige.
English: The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, 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 (Outcome Reduction with Initial Glargine INtervention)-studiet var et multicenter, randomiseret, 2x2 faktorielt design studie omfattende 12.537 patienter med høj kardiovaskulær (CV) risiko og enten forhøjet fasteblodsukker (IFG) eller nedsat glucosetolerance (IGT) (12% af patienterne) eller type 2-diabetes mellitus behandlet med ≤ 1 oralt antidiabetikum (88% af patienterne).
English: Rare reported side effect (may affect up to 1 in 1,000 people)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer)
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 Semglee 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,
Danish: Der er endvidere større risiko for at få hypoglykæmi, hvis: - du netop har påbegyndt insulinbehandling eller har skiftet til et andet insulinpræparat (hvis du skifter fra dit tidligere basalinsulin til Semglee, vil hypoglykæmi, hvis den opstår, hyppigere opstå om morgenen end om natten), - dit blodsukker er næsten normalt eller ustabilt,
English: Do not leave the needle attached to the pen during storage or reuse needles.
Danish: Du må ikke lade nålen side på under opbevaringen eller genbruge nålen.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Ikke relevant
English: A - Take a new sterile disposable needle and peel off the protective seal.
Danish: A - Tag en ny steril nål til engangsbrug og fjern beskyttelsesfolien.
English: Severe allergic reactions (rare, may affect up to 1 in 1,000 people) - the signs may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Danish: Alvorlige allergiske reaktioner (sjælden, kan forekomme hos op til 1 ud af 1.000 personer) - kan give følgende symptomer såsom omfattende hudreaktioner (udslæt og kløe overalt på kroppen), alvorlig hævelse af hud eller slimhinder (angioødem), åndenød, blodtryksfald med hurtig hjerterytme og svedudbrud.
English: This information does not take the place of talking to your doctor, nurse, or pharmacist about your medical condition or your treatment.
Danish: Denne indlægsseddel kan ikke træde i stedet for samtaler om din tilstand eller behandling med din læge, sundhedspersonalet eller apotekspersonalet.
English: C - Turn the outer needle cap in a clockwise (right) direction until it feels tightly fixed on the pen.
Danish: C - Skru den ydre nålehætte på med uret (mod højre), indtil den sidder fast på pennen.
English: C - Check the insulin through the cartridge holder to make sure:
Danish: C - Kig på insulinet i cylinderampullen for at sikre at:
English: If you forget to use Semglee
Danish: Hvis du har glemt at bruge Semglee
English: Packs of 1, 3, 5, 10 and multipack containing 10 (2 packs of 5) pens.
Danish: Pakninger med 1, 3, 5, 10 og en multipakning med 10 (2 pakninger af 5) penne.
English: Read these Instructions for Use as well as the package leaflet carefully before using Semglee pre-filled pen and each time you get another pen.
Danish: Læs denne brugsanvisning og indlægssedlen omhyggeligt, før du anvender Semglee, og hver gang du tager en ny pen i brug.
English: At baseline, participants had a median HbA1c value of 6.4% and median on-treatment HbA1c values ranged from 5.9 to 6.4% in the insulin glargine group, and 6.2% to 6.6% in the standard care group throughout the duration of follow-up.
Danish: Ved baseline havde patienterne en gennemsnitlig HbA1c på 6,4%, og i hele opfølgningsperioden var den gennemsnitlige HbA1c i insulin glargin-armen mellem 5,9 og 6,4%, og i standardbehandlings-armen mellem 6,2% og 6,6%.
English: Instead, regular insulin administered intravenously is recommended in such cases.
Danish: I sådanne tilfælde anbefales det i stedet for at indgive regulær insulin intravenøst.
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 halfmaximal 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 1-diabetespatienter var betydeligt lavere, end hvad der ville kræves for halv maksimal mætning af IGF-1-receptoren og den efterfølgende aktivering af den mitogen-proliferative mekanisme.
English: Do not share your Semglee pre-filled pen with other people, even if the needle has been changed.
Danish: Du må ikke dele din Semglee pen med andre, heller ikke selv om nålen udskiftes.
English: Needles must not be re-used.
Danish: Kanylen må ikke genbruges.
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 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: Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Semglee.
Danish: Patienter, som på grund af antistoffer mod humant insulin får høje insulindoser, kan få et bedre insulinrespons med Semglee.
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: - beta-blokkere (anvendes til behandling af højt blodtryk), - clonidin (anvendes til behandling af højt blodtryk), - lithiumsalte (anvendes til behandling af psykiske sygdomme).
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-humant insulin blev givet en eller 2 gange dagligt.
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: ↑ Afslutning af observationsperioden insulin og insulin-analoger, som f.eks. insulin glargin, kan variere betydeligt fra person til person og selv hos samme person.
English: B - Turn the white dose knob until the yellow dose pointer lines up with your required dose.
Danish: B - Drej den hvide dosisvælger, indtil den gule dosismarkør peger på din dosis.
English: Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, 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: There is no experience with the use of Semglee in children below the age of 2 years.
Danish: Der er ingen erfaring med anvendelse af Semglee til børn under 2 år.
English: • Skin and allergic reactions at the injection site The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Danish: • Hud og allergiske reaktioner ved injektionsstedet Symptomerne kan omfatte rødme, usædvanligt stærke smerter når der injiceres, kløe, udslæt, hævelse eller betændelse.
English: Do not freeze the pen.
Danish: Pennen må ikke nedfryses.
English: Type I colourless glass cartridge with a plunger (bromobutyl rubber), sealed using lined seals (laminate of polyisoprene and bromobutyl rubber).
Danish: Type 1 farveløs cylinderampul af glas med et stempel (bromobutylgummi) lukket med en forseglet prop (laminat af polyisopren og bromobutylgummi).
English: E - With the pen upright, press the injection button in until it stops moving and the dose window shows
Danish: E - Hold pennen lodret og tryk på injektionsknappen, indtil den stopper med at bevæge sig og dosisvinduet viser “0”.
English: When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Semglee, 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 eller langtidsvirkende insulin til behandling med Semglee kan det blive nødvendigt at ændre dosis af basalinsulin og at justere anden samtidig antidiabetisk behandling (dosis og tidspunkt for anden regulær insulin eller insulin-analoger med hurtigt indsættende virkning eller dosis af orale antidiabetika).
English: Switch from twice daily NPH insulin to Semglee
Danish: Skift fra NPH-insulin to gange dagligt til Semglee
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: Prepare your pen
Danish: Klargøring af din pen
English: Select your dose
Danish: Indstilling af din dosis
English: Semglee pen has to be used as recommended in these instructions for use (see section 6.6).
Danish: Semglee skal anvendes som anbefalet i denne brugsanvisning (se pkt.
English: • 2 alcohol wipes
Danish: • 2 afspritningsservietter
English: Semglee can be used in adolescents and children aged 2 years and above.
Danish: Semglee kan anvendes til unge og børn fra 2 år og opefter.
English: • leak-resistant, and
Danish: • holder tæt og
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 relativ flere reaktioner på indgivelsesstedet (smerte på injektionsstedet, reaktioner på injektionsstedet) og hudreaktioner (udslæt, urtikaria) hos børn og unge (≤ 18 år) end hos voksne.
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 (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: Before first using the pen, store the cartons containing the pen in the refrigerator (2°C to 8°C).
Danish: Indtil den første pen tages i brug, skal æsken opbevares i køleskab (2°C-8°C).
English: • There are no cracks, breaks or leaks around the cartridge holder
Danish: • der ikke er sprækker, brud eller utætheder i cylinderampulholderen.
English: If you do not see any insulin at the needle tip after 4 priming attempts the needle may be clogged.
Danish: Hvis der efter 4 forsøg ikke kommer insulin ud af nålespidsen, kan nålen være tilstoppet.
English: Do not use the needle if the protective seal is damaged or missing as the needle may not be sterile.
Danish: Anvend ikke nålen, hvis beskyttelsesfolien er beskadiget eller mangler.
English: D - Tap the cartridge gently with your finger to help any large air bubbles to move to the top of the cartridge.
Danish: D - Bank let på cylinderampullen med fingeren for at samle eventuelle luftbobler i toppen.
English: • Avoid dropping your pen as this can cause the cartridge to break, or can damage the pen.
Danish: • Du må ikke tabe pennen, da cylinderampullen kan gå i stykker, eller pennen kan beskadiges.
English: How to handle Semglee pen
Danish: Håndtering af Semglee pennen
English: Although Semglee contains the same active substance as insulin glargine 300 units/ml, these medicines are not interchangeable.
Danish: Selvom Semglee indeholder det samme aktive stof som insulin glargin 300 enheder/ml, kan man ikke umiddelbart skifte mellem de to præparater.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml indeholder 100 enheder insulin glargin* (svarende til 3,64 mg).
English: The pen in use must not be stored in a refrigerator.
Danish: Penne i brug må ikke opbevares i køleskab.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 100 units (3.64 mg) insulin glargine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml indeholder 100 enheder (3,64 mg) insulin glargin
English: - 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: - du skifter injektionssted fra et hudområde på kroppen til et andet (f.eks. fra låret til overarmen), - du lider af en alvorlig nyre- eller leversygdom eller af en anden sygdom som f.eks. nedsat stofskifte (hypothyroidisme).
English: No.1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC, 79200 Iskandar Puteri, Johor,
Danish: 79200 Iskandar Puteri,
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, forvirring, 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, bevidstløshed.
English: Other medicines and Semglee
Danish: Brug af anden medicin sammen med Semglee
English: - The active substance is insulin glargine.
Danish: - Aktivt stof: insulin glargin.
English: • Always use a new sterile disposable needle for each injection.
Danish: • Anvend altid en ny steril nål til hver injektion.
English: Also, be sure to remove the needle before disposing of the pen.
Danish: Du skal også sikre dig, at du har fjernet kanylen før du kasserer pennen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY}
Danish: Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ}
English: • Wash your hands with soap and water before using your pen.
Danish: Det skal du gøre, hver gang du skal bruge pennen • Vask hænderne med vand og sæbe, før du bruger pennen.
English: McDermott Laboratories t/a Mylan Dublin Biologics Newenham Court
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse McDermott Laboratories t/a Mylan Dublin Biologics Newenham Court