FrancophonIA/ELRC3.0 huggingface dataset:
English: Lantus is injected under the skin.
Danish: Lantus injiceres under huden.
English: To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
Danish: For at sikre, at du aflæser dosis korrekt skal du holde pennen vandret med nålen til venstre og dosisskalaen til højre, som vist på illustrationen nedenfor.
English: These units are exclusive to Lantus 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 Lantus og er ikke det samme som IE eller enhederne, som angiver styrken på andre insulin analoger (se pkt.
English: Mean dose of insulin glargine by study end was 0.42 U/kg.
Danish: Gennemsnitsdosis af insulin glargin ved studiets afslutning var 0,42 E/kg.
English: There is no experience in children under 2 years.
Danish: Der er ingen erfaring med børn under 2 år.
English: Due to more sustained basal insulin supply with Lantus, less nocturnal but more early morning hypoglycaemia can be expected.
Danish: På grund af et mere vedvarende tilskud af basalinsulin ved Lantus kan der forventes færre natlige men flere tidlig morgen hypoglykæmier.
English: Insulin glargine did not alter the relative risk for CV disease and CV mortality when compared to standard of care.
Danish: Insulin glargin ændrede ikke den relative risiko for CV-sygdom og CV-mortalitet sammenlignet med standardbehandling.
English: *determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values)
Danish: * den mængde glucose, der er infunderet for at holde en konstant plasmaglucosekoncentration (gennemsnitsværdi per time).
English: Before travelling consult your doctor.
Danish: Før du skal ud at rejse, bør du tale med din læge.
English: Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
Danish: Diabetes mellitus er en sygdom, som skyldes, at kroppen ikke danner tilstrækkeligt insulin til at holde blodsukkeret under kontrol.
English: D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.
Danish: D. Bank på insulinbeholderen, således at eventuelle luftbobler stiger op mod nålen.
English: See the reverse (insulin) side of this leaflet for instructions on how to store SoloStar.
Danish: Læs den modsatte (insulin) side af denne indlægsseddel vedrørende hvordan SoloStar opbevares.
English: Tell a doctor straight away if you notice signs of severe allergic reactions.
Danish: Du skal straks kontakte lægen, hvis du får symptomer på alvorlige allergiske reaktioner.
English: You may have to perform the safety test several times before insulin is seen.
Danish: Det er muligt at sikkerhedstesten skal gentages flere gange før der ses insulin på spidsen.
English: In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products.
Danish: Til patienter med type 2-diabetes mellitus kan Lantus også indgives sammen med oralt aktive antidiabetika.
English: This can spread around the injection site.
Danish: Disse kan brede sig til området omkring injektionsstedet.
English: If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Danish: Hvis du ikke er i stand til at synke, eller hvis du er bevidstløs, skal du have en injektion med sukker (glucose) eller glucagon (et lægemiddel, der øger blodsukkeret).
English: You must check that your insulin pen is working properly before you inject the first dose.
Danish: Kontrollér at din insulinpen fungerer rigtigt, før den første injektion foretages.
English: Do not shake or mix it before use.
Danish: Skal ikke rystes eller blandes før anvendelse.
English: It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Danish: Det anbefales, at blodsukkeret kontrolleres umiddelbart efter indtagelsen af sukker for at se, om du virkelig havde hypoglykæmi.
English: Do not dilute it. Mixing or diluting may change the action of Lantus.
Danish: Blanding eller fortynding kan ændre virkningen af Lantus.
English: Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis.
Danish: Lantus er ikke det insulinpræparat, man først skal vælge til behandling af diabetisk ketoacidose.
English: Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.
Danish: Din læge vil muligvis give dig besked på at tage det sammen med et hurtigtvirkende insulin eller med tabletter mod højt blodsukker.
English: In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Danish: I tilfælde af utilstrækkelig glucosekontrol eller ved tendens til udvikling af hyper- eller hypoglykæmi skal det vurderes, hvorvidt patienten har overholdt den ordinerede behandlingsforskrift, injektionssteder og korrekt injektionsteknik og alle øvrige relevante faktorer, inden en dosisjustering overvejes.
English: Lantus with alcohol
Danish: Brug af Lantus sammen med alkohol
English: -In your body
Danish: - I kroppen
English: A. Remove the protective seal from a new needle.
Danish: A. Fjern folieforseglingen fra en ny nål.
English: The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
Danish: Fremstillerens instruktioner for anvendelse af pennen skal følges nøje for isætning af cylinderampul, påsætning af nål og administration af insulin-injektionen.
English: If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink (lipoatrophy, may affect up to 1 in 100 people) or thicken (lipohypertrophy).
Danish: Hvis du for ofte injicerer dit insulin på samme sted på huden kan fedtvævet under huden på dette sted svinde ind (lipoatrofi, forekommer hos mellem 1 og 100 patienter) eller blive tykkere (lipohypertrofi).
English: Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
Danish: Insulin og dets analoger sænker blodglucoseniveauet ved at stimulere den perifere glucoseoptagelse, især fra skeletmuskulatur og fedt, og ved at hæmme leverens glucoseproduktionen.
English: Sanofi S.p.A., Via Valcanello, 4 03012 Anagni (FR), Italy.
Danish: Sanofi S.p.A., Via Valcanello, 4 03012 Anagni (FR), Italien.
English: The first co-primary efficacy outcome was the time to the first occurrence of CV death, nonfatal myocardial infarction (MI), or nonfatal stroke, and the second co-primary efficacy outcome was the time to the first occurrence of any of the first co-primary events, or revascularisation procedure (coronary, carotid, or peripheral), or hospitalisation for heart failure.
Danish: Det første sammensatte primære effektmål var tiden til første forekomst af CV-død, ikke-letalt myokardieinfarkt (MI) eller ikke-letal apopleksi, og det andet sammensatte primære effektmål var tiden til første forekomst af enhver af de første primære hændelser, revaskulariseringsprocedure (koronar, karotid eller perifer) eller indlæggelse for hjertesvigt.
English: The pen plunger moves with each dose.
Danish: Penstemplet vil bevæge sig med hver dosis.
English: Correspondingly, the incidences of nocturnal hypoglycaemia were 32% in the insulin glargine / lispro group versus 52% in the NPH / regular group.
Danish: Modsat var incidensen af natlige hypoglykæmier 32% i insulin glargin/lispro gruppen versus 52% i NPH/regular gruppen.
English: • If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
Danish: • Hvis din injektion gives af en anden person, eller du giver injektionen til en anden person skal der udvises speciel forsigtighed når nålen fjernes og kasseres.
English: In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high.
Danish: I hver enkelt situation kan det blive nødvendigt at justere din insulindosis for at undgå for lavt eller for højt blodsukker.
English: INSTRUCTION FOR USE
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per dosis, dvs. det er i det væsentlige ”natriumfrit”.
English: Talk with your doctor, pharmacist or nurse about proper injection technique before using SoloStar.
Danish: Tal med dit sundhedspersonale om korrekt injektionsteknik, før anvendelse af SoloStar.
English: What should you do if you experience hypoglycaemia?
Danish: Hvad skal du gøre, hvis du får hypoglykæmi?
English: Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Danish: Følg anbefalede retningslinjer for fjernelse og kassering af nåle (kontakt dit sundhedspersonale) for at reducere risikoen for skader med nålen ved uheld og overførsel af infektionssygdomme.
English: SoloStar has to be used as recommended in these instructions for use (see section 6.6).
Danish: SoloStar skal anvendes som anbefalet i denne brugsanvisning (se pkt.
English: IGF-1 receptor binding: The affinity of insulin glargine for the human IGF-1 receptor is approximately 5 to 8-fold greater than that of human insulin (but approximately 70 to 80-fold lower than the one of IGF-1), whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human insulin.
Danish: IGF-1-receptorbinding: affiniteten af insulin glargin til den humane IGF-1-receptor er omkring 5-8 gange højere end human insulins affinitet (men omkring 70-80 gange lavere end affiniteten af IGF-1), hvorimod M1 og M2 bindes til IGF-1-receptoren med en lidt lavere affinitet end human insulin.
English: -In your brain
Danish: - I hjernen
English: Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin).
Danish: Behandling med insulin kan føre til, at kroppen danner antistoffer mod insulin (stoffer, der reagerer mod insulin).
English: If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Danish: Hvis du er usikker på, om du tager et af disse lægemidler, bør du spørge din læge eller apotekspersonalet.
English: A. Check the label on your SoloStar to make sure you have the correct insulin.
Danish: A. Etiketten på pennen skal tjekkes for at sikre at den indeholder den korrekte insulin.
English: The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.
Danish: Stemplet vil nå enden af ampullen, når alle 300 enheder er brugt.
English: Do not soak, wash or lubricate the pen as this may damage it.
Danish: Pennen må aldrig skylles, vaskes eller smøres, da dette kan ødelægge den.
English: After subcutaneous injection of Lantus in diabetic patients, insulin glargine is rapidly metabolized 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 Lantus til diabetespatienter bliver insulin glargin hurtigt metaboliseret ved carboxylenden af beta-kæden under dannelse af to aktive metabolitter M1 (21A-Gly-insulin) og M2 (21A-Gly-des-30B-Thr-insulin).
English: • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
Danish: • Hvis nålen ikke holdes lige mens du påsætter den, kan gummistemplet blive ødelagt og give lækage eller nålen kan blive ødelagt.
English: Lantus should not be administered intravenously.
Danish: Lantus må ikke gives intravenøst.
English: - If you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for insulin glargin eller et af de øvrige indholdsstoffer i Lantus (angivet i punkt 6).
English: There were no differences between insulin glargine and standard care for the two co-primary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Danish: Der var ingen forskel mellem insulin glargin og standardbehandling for de to sammensatte primære effektmål, for enkeltkomponenterne af disse effektmål, for mortalitet af alle årsager eller for det sammensatte mikrovaskulære effektmål.
English: The instructions for using the insulin pen are provided with your insulin pen.
Danish: Instruktionen for anvendelse af insulinpennen ligger sammen med din insulinpen.
English: Very common Common Uncommon Rare
Danish: Almindelig Ikke almindelig
English: D-65926 Frankfurt / Main Germany
Danish: D-65926 Frankfurt / Main Tyskland
English: During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.
Danish: I de første uger bør reduktionen i det mindste til dels kompenseres med en øget dosis insulin til måltiderne.
English: It is recommended that the date of the first use be noted on the label.
Danish: Det anbefales, at datoen for første optrækning noteres på hætteglassets etiket.
English: Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio-oedema, bronchospasm, hypotension and shock, and may be life-threatening.
Danish: Sådanne reaktioner over for insulin (herunder insulin glargin) eller øvrige indholdsstoffer kan f.eks. ledsages af generaliserede hudreaktioner, angioødem, bronkospasmer, hypotension og shock, og de kan være livstruende.
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 fra 6 -15 år) med type I- diabetes (n=349) behandlet i 28 uger med et basal bolus insulin regime, hvor regular human insulin blev anvendt før hvert måltid.
English: Do not use this SoloStar if the insulin is cloudy, coloured or has particles.
Danish: Anvend ikke SoloStar hvis insulinet er uklart, farvet eller indeholder partikler.
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 besvimelse kan være tegn på den alvorlige tilstand, ketoacidose (syreophobning i blodet), som er en følge af mangel på insulin.
English: Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Lantus.
Danish: Patienter, som på grund af antistoffer mod humant insulin får høje insulindoser, kan få et bedre insulinrespons med Lantus.
English: Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will: - determine how much Lantus 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 Lantus.
Danish: Alt efter din levevis og resultatet af dine blodsukkermålinger (glucosemålinger) og din tidligere anvendelse af insulin vil din læge: - afgøre hvor meget Lantus du skal have per dag og på hvilket tidspunkt af dagen, - fortælle dig, hvornår du skal kontrollere dit blodsukker, og om det er nødvendigt at udføre urinprøver, - fortælle dig, hvornår du eventuelt skal have en større eller mindre dosis Lantus.
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 basisline var ens mellem behandlingsgrupperne; dog var blodsukker værdierne 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: 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 1024 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: Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.
Danish: Hyppig måling af blodsukker er nødvendig ved præparatskift og i de første uger herefter.
English: Switch from insulin glargine 300 units/ml to Lantus Lantus and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable.
Danish: Skift fra insulin glargin 300 enheder/ml til Lantus Lantus og Toujeo (insulin glargin 300 enheder/ml) er ikke bioækvivalente og er ikke direkte udskiftelige.
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 insulin-dosis, blod- og urinprøver): - Hvis du bliver syg eller kommer alvorligt til skade, kan dit blodsukkerniveau blive for højt
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst Brüningstraße 50
Danish: Sanofi-Aventis Deutschland GmbH Industriepark Höchst Brüningstrasse 50
English: Method of administration Lantus is administered subcutaneously.
Danish: Administration Lantus indgives subkutant.
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 neutralt pH.
English: SANOFI BULGARIA EOOD Тел.
Danish: SANOFI BULGARIA EOOD
English: The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring.
Danish: Skift fra den ene insulinbehandling til den anden kræver recept, kontrol hos din læge og regelmæssige blodsukkermålinger.
English: You should contact your doctor for advice on driving if: - you have frequent episodes of hypoglycaemia, - the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.
Danish: Du skal kontakte din læge og få råd om bilkørsel hvis: - du har hyppige tilfælde af hypoglykæmi, - de første advarselssymptomer, som kan advare dig om hypoglykæmi, er svage eller helt mangler.
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 (oral antidiabetika, der anvendes til behandling af type 2-diabetes mellitus) og insulin, udviklede hjertesvigt.
English: Read all of this leaflet carefully including the Instructions for Use of Lantus SoloStar, pre-filled pen, before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel og brugsanvisningen for Lantus SoloStar fyldt pen grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Danish: Hvis insulinpennen er beskadiget eller ikke virker ordentligt (pga. mekaniske fejl) skal den kasseres, og en ny insulinpen tages i brug.
English: However, only very rarely, this will require a change to your insulin dose.
Danish: Kun i sjældne tilfælde vil det betyde, at din insulindosis skal ændres.
English: Lantus is a clear insulin.
Danish: Lantus er en klar insulin.
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 gestational diabetes for at forebygge skadelige følgevirkninger i forbindelse med hyperglykæmi.
English: Participants were randomised (1:1) to receive insulin glargine (n=6264), titrated to reach FPG ≤95 mg/dl (5.3 mM), or standard care (n=6273).
Danish: Patienterne blev randomiseret (1:1) til at få insulin glargin, titreret til at opnå FPG ≤ 5,3 mM (95 mg/dl) (n=6.264), eller standardbehandling (n=6.273).
English: Switch from twice daily NPH insulin to Lantus
Danish: Skift fra NPH-insulin to gange daglig til Lantus
English: To reduce the risk of accidental needle injury, never replace the inner needle cap.
Danish: For reducere risikoen for uheld med nålen må de indre nålehylster aldrig sættes på igen.
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 regular human insulin (hver behandling blev administreret i 16 uger i tilfældig rækkefølge) på 26 unge type1 diabetes patienter i alderen 12-18 år.
English: In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see section 5.1).
Danish: I sjældne tilfælde kræver forekomsten af sådanne insulinantistoffer justering af insulindosis for at korrigere for tendensen til hyper- eller hypoglykæmi (se pkt.
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.