FrancophonIA/ELRC3.0 huggingface dataset:
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: Lantus must not be mixed with any other insulin or diluted.
Danish: Lantus må ikke blandes med andre insuliner eller fortyndes.
English: Very rare reported side-effects (may affect up to 1 in 10,000 people) In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
Danish: Meget sjældne bivirkninger (forekommer hos færre end 1 ud af 10.000 patienter) I meget sjældne tilfælde kan forekomme dysgeusia (smagsforstyrrelser) og myalgia (muskelsmerter).
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 Lantus 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 daglig til et regime med Lantus en gang daglig, reducere deres dosis med cirka 20 %.
English: Although Lantus contains the same active substance as Toujeo (insulin glargine 300 units/ml), these medicines are not interchangeable.
Danish: Selvom Lantus indeholder det samme aktive stof som Toujeo (insulin glargin 300 enheder/ml), kan man ikke umiddelbart skifte mellem de to præparater.
English: Before injection remove any air bubbles (see instructions for using the pen).
Danish: Før injektion skal eventuelle luftbobler fjernes (se brugsanvisningen for pennen).
English: A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.
Danish: A. Sæt det ydre nålehylster tilbage på nålen og brug det til at tage nålen af pennen.
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: 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 ændring i linsens turgiditet og refraktionsindex.
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
Danish: Beta-blokkere, clonidin, lithiumsalte og alkohol kan enten øge eller hæmme insulins blodsukkersænkende effekt.
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 alvorlige hypoglykæmiske anfald forårsage forbigående synstab.
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 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: Use this medicine exactly as your doctor has told you.
Danish: Brug dette lægemiddel nøjagtigt efter lægens anvisning.
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: Lantus can be used in adolescents and children aged 2 years and above.
Danish: Lantus kan anvendes til unge og børn fra 2 år og opefter.
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: 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, hvis f.eks. patientens vægt eller livsstil ændres, ændring af tidspunkt for insulindosis, eller hvis andre omstændigheder gør, at følsomheden for hypo- eller hyperglykæmi øges (se pkt.
English: B. Take off the outer needle cap and keep it to remove the used needle after injection.
Danish: Tag det ydre nålehylster af og behold det til at fjerne den brugte nål efter injektionen.
English: B. Take off the pen cap.
Danish: B. Tag penhætten af.
English: Look at the cartridge before you use the pen.
Danish: Se på cylinderampullen, før du anvender pennen.
English: C. Deliver the dose by pressing the injection button in all the way.
Danish: C. C. Udløs dosis ved at trykke dosisknappen helt i bund.
English: B. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
Danish: B. B. Hold nålen vandret på linie med pennen når du sætter nålen på (skru eller tryk nålen på afhængig af nåletypen).
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: Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Danish: Faktorer, der øger risikoen for hypoglykæmi, kræver nøje kontrol og dosisjustering kan blive nødvendig.
English: Pack sizes of 1, 2, 5 and 10 vials of 5 ml or 1 vial of 10 ml.
Danish: Pakninger med 1, 2, 5 og 10 hætteglas af 5 ml eller 1 hætteglas af 10 ml.
English: Hydrochloric acid (for pH adjustment) Polysorbate 20
Danish: Saltsyre (til pH-justering) Polysorbat 20
English: Keep the pen protected from light.
Danish: Opbevar pennen beskyttet mod lys.
English: There is no experience with the use of Lantus in children below the age of 2 years.
Danish: Der er ingen erfaring med anvendelse af Lantus til børn under 2 år.
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 kliniske farmakologiforsøg har intravenøst insulin glargin og humant insulin vist sig at være equipotente, når disse blev givet i samme doser.
English: 10 ml vial 3 years.
Danish: 10 ml hætteglas 3 år.
English: When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Lantus, 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 Lantus kan det blive nødvendigt at ændre dosis af basalinsulin 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: 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 light sodavand) ikke kan anvendes til behandling af hypoglykæmi.
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-armen og et gennemsnitligt vægttab på 0,8 kg i standardbehandlings-armen.
English: Handling of the SoloStar pre-filled pen
Danish: Anvendelse af SoloStar fyldt pen
English: Only use needles that are compatible for use with SoloStar.
Danish: Anvend kun nåle som er kompatible til anvendelse med SoloStar.
English: 5 ml vial, cartridge, SoloStar pre-filled pen Zinc chloride
Danish: 5 ml hætteglas, cylinderampul, SoloStar fyldt pen Zinkchlorid
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 patienter per 100 patientår) var 1,05 i insulin glarginarmen og 0,30 i standardbehandlings-armen, og forekomsten af bekræftet ikke-alvorlig hypoglykæmi var 7,71 for insulin glargin og 2,44 for standardbehandling.
English: Talk to your doctor, pharmacist or nurse before using Lantus.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Lantus.
English: Take off the inner needle cap and discard it.
Danish: Tag det indre nålehylster af og kasser det.
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 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: In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Danish: Hos patienter med svært nedsat leverfunktion kan insulinbehovet mindskes på grund af nedsat evne til glukoneogenese og nedsat insulinmetabolisme.
English: If you stop using Lantus
Danish: Hvis du holder op med at tage Lantus
English: If you forget to use Lantus
Danish: Hvis du har glemt at tage Lantus
English: Lantus is a long-acting insulin.
Danish: Lantus er et langtidsvirkende insulin.
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: 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 blodsukker reduktionen fra basisline større i insulin glargin-gruppen end i NPH gruppen.
English: Lantus is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above.
Danish: Lantus anvendes til behandling af sukkersyge (diabetes mellitus) hos voksne, unge og børn fra 2 år og opefter.
English: SoloStar is a pre-filled pen for the injection of insulin.
Danish: SoloStar er en fyldt pen til injektion af insulin.
English: The graph above shows the activity profiles over time of insulin glargine and NPH insulin.
Danish: Diagrammet ovenfor viser virkningsprofilen over tid for insulin glargin og NPH-insulin.
English: Empty pre-filled pens must never be reused and must be properly discarded.
Danish: Tomme penne må aldrig genbruges og skal bortskaffes på betryggende måde.
English: You can clean the outside of your SoloStar by wiping it with a damp cloth.
Danish: Ydersiden af SoloStar kan rengøres ved at tørre den af med en fugtig klud.
English: Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Danish: Luftbobler bør fjernes fra cylinderampullen før injektionen (se brugsanvisningen for pennen).
English: Clear colourless solution.
Danish: Klar farveløs opløsning.
English: Unopened vials, unopened cartridges, not in-use SoloStar pens Store in a refrigerator (2°C-8°C).
Danish: Uanbrudte hætteglas, uanbrudte cylinderampuller, SoloStar penne, som ikke er i brug: Opbevares i køleskab (2°C - 8°C).
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, bevidstløshed.
English: There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Lantus.
Danish: Der er ikke set klinisk relevante forskelle i serum-insulin og glucoseniveau efter indgift af Lantus på abdomen, lår eller overarm.
English: Not all of these pens may be marketed in your country (see section 4.2 and 6.6)
Danish: Ikke alle disse penne er nødvendigvis markedsført i dit land (see pkt.
English: If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Danish: HYPERGLYKÆMI (for højt blodsukker) Hvis dit blodsukker er for højt (hyperglykæmi), har du måske ikke injiceret nok insulin.
English: Hold the pen as shown in this leaflet.
Danish: Hold pennen som vist her i brugsanvisningen.
English: • If no insulin comes out after changing the needle, your SoloStar may be damaged.
Danish: • Hvis der ikke kommer insulin ud efter erstatning af nålen kan SoloStar være ødelagt.
English: Other medicines and Lantus
Danish: Brug af anden medicin sammen med Lantus
English: This is a modified insulin, very similar to human insulin.
Danish: Dette er et modificeret insulin, der ligner det insulin, der dannes i kroppen.
English: Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.
Danish: Overhold nøje anvisningerne vedrørende dosering, kontrollerne (blod- og urinprøver), kostplan, den fysiske aktivitet (fysisk arbejde og motion) og injektionsteknik, som er aftalt med lægen.
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 Lantus, - 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 er skiftet fra animalsk insulin til human insulin såsom Lantus, - du tager eller har taget visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med
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 hypoglycemic 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: 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 ingivelsesstedet (smerte på injektionsstedet, reaktioner på injektionsstedet) og hudreaktioner (udslæt, urtikaria) hos børn og unge (≤ 18 år) end hos voksne.
English: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.
Danish: Kombinationbehandling med Lantus og pioglitazon Der er indrapporteret tilfælde af hjertesvigt ved anvendelse af pioglitazon i kombination med insulin, særligt hos patienter med risikofaktorer for udvikling af hjertesvigt.
English: 1 ml contains 100 units (3.64 mg) insulin glargine.
Danish: 1 ml indeholder 100 enheder (3,64 mg) insulin glargin.
English: Do not freeze or place next to the freezer compartment or a freezer pack.
Danish: Må ikke nedfryses eller placeres op ad køleskabets køleelementer eller oven på fryseelementer.
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 Lantus 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 omstilles fra basalinsulin givet 2 gange daglig som NPH-insulin til Lantus givet 1 gang daglig, nedsætte den daglige dosis af basalinsulin med 20-30% i de første behandlingsuger.
English: Consult your insulin pen instruction booklet for further details.
Danish: Se insulinpennens brugsanvisning for yderligere oplysninger.
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, forekommer hos mellem 1 og 1.000 patienter) - 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: 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: Do not use SoloStar if you notice particles in it. Only use SoloStar if the solution is clear, colourless and waterlike.
Danish: Anvend ikke SoloStar, hvis du bemærker partikler i den. Anvend kun SoloStar, hvis opløsningen er klar, farveløs og ligner vand.
English: SPECIAL STORAGE CONDITIONS
Danish: Opbevaringsbetingelser
English: You must always check the insulin label before each injection to avoid mix-ups between Lantus and other insulins.
Danish: Du skal altid kontrollere etiketten før hver injektion for at undgå forveksling mellem Lantus og andre insuliner.
English: If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).
Danish: Hvis dit blodsukker er for lavt (hypoglykæmi), skal du følge vejledningen vedrørende hypoglykæmi (se det indrammede afsnit sidst i denne indlægsseddel).
English: Important information for use of SoloStar:
Danish: Skematisk diagram af pennen Vigtig information vedrørende anvendelse af SoloStar:
English: Do not mix Lantus with any other insulins or medicines.
Danish: Lantus må ikke blandes med andre insuliner eller lægemidler.
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-forsøg på raske forsøgspersoner og type 1-diabetikere var tidspunktet for virkningens indtræden af subkutant insulin glargin langsommere end ved humant NPH-insulin, og virkningsprofilen var jævn og uden koncentrationstoppe, og virkningens varighed var forlænget.
English: If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Danish: Kontakt din læge, hvis du ammer, da det kan være nødvendigt at justere din insulindosis og diæt.
English: Lantus 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: You may need to talk about - the availability of your insulin in the country you are visiting,
Danish: Du kan måske have behov for at tale om: - det er muligt at købe dit insulin i det land, som du skal besøge, - forsyninger af insulin, sprøjter etc.,
English: If administration by syringe is necessary, a vial should be used.
Danish: Hvis det er nødvendigt at anvende en sprøjte til administrationen, bør et hætteglas anvendes.
English: Zinc chloride
Danish: Zinkchlorid