FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Orencia have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Orencia.
English: In the first study, symptoms of the disease were reduced in 61% (70 out of 115) of the patients adding the recommended dose of Orencia to methotrexate for 6 months, compared with 35% (42 out of 119) of the patients adding placebo (a dummy treatment).
Danish: I det første studie blev symptomerne på sygdommen mindsket hos 61 % (70 ud af 115) af de patienter, der fik tilføjet den anbefalede dosis af Orencia til methotrexat i 6 måneder, sammenholdt med 35 % (42 ud af 119) af de patienter, der fik tilføjet placebo (ikke-aktivt stof).
English: Orencia was found effective in one main study involving 424 adult patients with psoriatic arthritis.
Danish: Orencia blev fundet effektivt til behandling af psoriasisartritis i et hovedstudie af 424 voksne patienter.
English: After being trained and with the agreement of their doctor, patients or carers may inject the medicine themselves.
Danish: Patienten selv eller en omsorgsperson kan injicere lægemidlet efter forudgående oplæring og efter aftale med lægen.
English: See also Serious allergic reaction above.
Danish: Se også Alvorlige allergiske reaktioner ovenfor.
English: Baseline values for these parameters were similar in the two groups.
Danish: Baseline-værdierne for disse parametre var ens i de to grupper.
English: The injection can be given at any time during the day, but at the same time each day.
Danish: Injektionen kan gives på et hvilket som helst tidspunkt af dagen, men på samme tid hver dag.
English: Intramuscular administration should also be avoided.
Danish: Intramuskulær administration bør også undgås.
English: 41% 32% Odds Ratio:
Danish: 41% 32% Oddsratio:
English: This is especially important if you take more than one type of insulin.
Danish: Dette er især vigtigt, hvis du tager mere end én type insulin.
English: Ask your doctor about this.
Danish: Spørg din læge om dette.
English: Select the dose you need.
Danish: Vælg den dosis du har brug for.
English: This medicinal product must not be mixed with other medicinal products.
Danish: Dette præparat må ikke blandes med andre lægemidler.
English: No change in dose (target)
Danish: Ingen ændring i dosis (mål)
English: If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Danish: Hvis en justering er nødvendig, kan det vise sig ved første dosis eller inden for de første uger eller måneder.
English: Difference:
Danish: Forskel:
English: Look through the insulin window.
Danish: Se igennem insulinvinduet.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Danish: Dette kan udgøre en risiko i situationer, hvor disse evner er af speciel vigtighed (f.eks. under bilkørsel og ved betjening af maskiner).
English: Levemir which has been frozen must not be used.
Danish: Levemir, som har været frosset, må ikke anvendes.
English: • If signs of allergy spread to other parts of your body.
Danish: • Hvis nogle af symptomerne på allergi spreder sig til andre dele af kroppen.
English: Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Frekvensenskategorierne er defineret i henhold til den følgende konvention: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: Treatment with Levemir can be considered during pregnancy, but any potential benefit must be weighed against a possibly increased risk of an adverse pregnancy outcome.
Danish: Behandling med Levemir kan overvejes under graviditet, men enhver potentiel fordel skal vejes op imod en mulig øget risiko for et ugunstigt udfald af graviditeten.
English: How often to inject
Danish: Hvor ofte du skal injicere
English: Your medicine might be harmful to their health.
Danish: Din medicin kan være sundhedsskadelig for dem.
English: ► If it has not been stored correctly or been frozen, see section 5, How to store Levemir.
Danish: ► Hvis det ikke har været opbevaret korrekt, eller har været frosset, se punkt 5, Opbevaring.
English: Discuss this with your doctor.
Danish: Diskutér dette med din læge.
English: It is therefore recommended that the diabetic patient always carries sugar-containing products.
Danish: Det anbefales derfor, at diabetespatienten altid bærer sukkerholdige produkter på sig.
English: Dose counter stopped: 52 units left
Danish: Dosis tæller stopper: 52 enheder tilbage
English: Animal studies do not indicate harmful effects with respect to fertility.
Danish: Dyrestudier indikerer ikke skadelige virkninger hvad angår fertilitet.
English: EXP During use: Use within 6 weeks
Danish: EXP Under brug: Bruges inden 6 uger
English: However, this does not appear to have any impact on glycaemic control.
Danish: Dette synes dog ikke at have nogen indvirkning på glykæmisk kontrol.
English: The terminal half-life is between 5 and 7 hours depending on the dose.
Danish: Den endelige halveringstid er 5-7 timer, afhængigt af dosis.
English: *Self-Monitored Plasma Glucose
Danish: *Selvmonitoreret plasmaglucose
English: These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.
Danish: Sådanne reaktioner kan blive mere alvorlige, eller måske ændre optagelsen af dit insulin, hvis du injicerer på et sådant sted.
English: Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Danish: Glucose skal gives intravenøst, hvis patienten ikke responderer på glukagon inden for 10 til 15 minutter.
English: The overall percentage of treated patients expected to experience adverse reactions is estimated to be 12%.
Danish: Den samlede procentdel af behandlede patienter, der forventes at opleve en bivirkning, er estimeret til 12%.
English: If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Danish: Hvis du er blind eller har nedsat syn, og ikke kan aflæse dosistælleren på pennen, må du ikke bruge denne pen uden hjælp.
English: You must never inject Levemir directly into a vein (intravenously) or muscle (intramuscularly).
Danish: Du må aldrig injicere Levemir direkte ind i en vene (intravenøst) eller muskel (intramuskulært).
English: This should be kept in mind if treatment with the combination of pioglitazone and Levemir is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Levemir overvejes.
English: Levemir must not be administered intravenously, as it may result in severe hypoglycaemia.
Danish: Levemir må ikke administreres intravenøst, da det kan resultere i alvorlig hypoglykæmi.
English: If you need more insulin than the units left in your pen, you can split your dose between two pens.
Danish: Hvis du skal bruge mere insulin end det antal enheder, der er tilbage i din pen, kan du opdele dosis mellem to penne.
English: Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester.
Danish: Insulinbehovet falder normalt i første trimester og stiger siden i løbet af andet og tredje trimester.
English: ► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: ► Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: During use: Use within 6 weeks
Danish: Under brug: Bruges inden 6 uger
English: Addition of Levemir provided a further reduction of HbA1c from 7.6% to 7.1% after 52 weeks.
Danish: Tillæg af Levemir gav en yderligere reduktion i HbA1c fra 7,6% til 7,1% efter 52 uger.
English: Levemir can be used in elderly patients.
Danish: Levemir kan anvendes til ældre patienter.
English: Do not use Levemir
Danish: Brug ikke Levemir
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Severe low blood sugar can lead to unconsciousness.
Danish: Alvorligt lavt blodsukker kan medføre bevidstløshed.
English: Levemir is for subcutaneous administration only.
Danish: Levemir er kun til subkutan administration.
English: Store below 30°C Do not freeze
Danish: Opbevares under 30 °C Må ikke fryses
English: Careful monitoring is recommended in these patients.
Danish: Det anbefales at overvåge disse patienter nøje.
English: Your dose may have to be adjusted by your doctor if:
Danish: Det kan være nødvendigt, at lægen ændrer din dosis hvis:
English: The dose of Levemir should be titrated based on the individual patient's needs.
Danish: Dosis af Levemir skal titreres baseret på den enkelte patients behov.
English: *Insulin detemir is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Danish: *Insulin detemir er fremstillet i Saccharomyces cerevisiae ved rekombinant DNA-teknologi.
English: • Drink alcohol (see section 2 Drinking alcohol and taking Levemir).
Danish: • Drikker alkohol (se Brug af Levemir sammen med alkohol under punkt 2).
English: B. Check that the insulin in your pen is clear and colourless.
Danish: B. Kontrollér, at insulinet i pennen er klart og farveløst.
English: Most of the injection site reactions are minor and of a transitory nature, i.e. they normally disappear during continued treatment in a few days to a few weeks.
Danish: De fleste reaktioner overfor insulin på injektionsstedet er mindre og er for det meste forbigående, dvs. de forsvinder normalt ved fortsat behandling i løbet af få dage eller uger.
English: Change in body weight after insulin treatment Study duration Levemir once daily
Danish: Ændring i kropsvægt efter insulinbehandling Studievarighed Levemir én gang dagligt
English: Listed below are the most common medicines which may affect your insulin treatment.
Danish: Nedenstående liste omfatter de mest almindelige lægemidler, som kan påvirke din insulinbehandling.
English: There are limited data in patients with severe hypoalbuminaemia.
Danish: Der er begrænsede data om patienter med svær hypoalbuminæmi.
English: From clinical investigations, it is known that major hypoglycaemia, defined as requirement for third party intervention, occurs in approximately 6% of the patients treated with Levemir.
Danish: Kliniske undersøgelser viser, at svær hypoglykæmi, defineret som behov for hjælp fra tredje part, optræder hos ca. 6% af de patienter, der behandles med Levemir.
English: Antibody development has been observed with the use of Levemir.
Danish: Udvikling af antistoffer er blevet observeret ved brug af Levemir.
English: Before travelling between different time zones, the patient should seek the doctor's advice since this may mean that the patient has to take the insulin and meals at different times.
Danish: Før rejse mellem forskellige tidszoner skal patienten rådføre sig med sin læge, da dette kan medføre, at patienten skal tage sin insulin og mad på andre tidspunkter.
English: ► If you have very low albumin you need to carefully monitor your blood sugar level.
Danish: ► Hvis du har meget lavt albumin-niveau, skal du holde nøje kontrol med dit blodsukkerniveau.
English: • Forget to take your insulin or stop taking insulin.
Danish: • Glemmer at tage insulin eller stopper med at tage insulin.
English: Overall number of major hypoglycaemia episodes during pregnancy (per patient year)
Danish: Totalt antal alvorlige hypoglykæmiske episoder under graviditet (per patientår)
English: Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.
Danish: Få hjælp af en person med godt syn, som er blevet instrueret i at bruge den fyldte FlexTouch pen.
English: Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar.
Danish: Sukkersyge er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at kunne kontrollere blodsukkerniveauet.
English: The number of live born children of women becoming pregnant after randomisation were 50 (83%) for Levemir and 55 (89%) for NPH.
Danish: Antallet af levendefødte børn af kvinder, der blev gravide efter randomisering, var 50 (83%) for Levemir og 55 (89%) for NPH.
English: Rate Ratio:
Danish: Hyppighedsratio:
English: Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.
Danish: Nøje kontrol med din diabetes, særligt forebyggelse af hypoglykæmi (lavt blodsukker), er vigtig for dit barns helbred.
English: Results indicate that antibody development had no negative effect on glycaemic control and Levemir dose.
Danish: Resultaterne indikerer, at antistofudvikling ikke havde nogen negativ effekt på glykæmisk kontrol og dosis af Levemir.
English: The trial including children above 2 years was extended for an additional 12 months (total of 24 months treatment data) to assess antibody formation after long-term treatment with Levemir.
Danish: Det kliniske studie, der inkluderede børn i alderen over 2 år, blev forlænget i yderligere 12 måneder (i alt 24 måneders behandlingsdata) for at vurdere antistofdannelse efter langvarig behandling med Levemir.
English: K. Remove the needle from the skin.
Danish: K. Fjern nålen fra huden.
English: Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy.
Danish: Injektionsstederne skal altid roteres inden for samme område for at nedsætte risikoen for lipodystrofi.
English: Injecting your dose Make sure that you receive your full dose by using the right injection technique.
Danish: Injektion af din dosis Vær sikker på, at du får hele din dosis ved at anvende den korrekte injektionsteknik.
English: If your blood sugar is low or high, it might affect your concentration and ability to react and therefore also your ability to drive a car or operate a machine. Bear in mind that you could endanger yourself or others.
Danish: Hvis dit blodsukker er lavt eller højt, kan det påvirke din koncentrations- og reaktionsevne, og dermed også din evne til at køre bil eller arbejde med maskiner.
English: Change in body weight from baseline (kg)
Danish: Ændring i kropsvægt fra baseline (kg)
English: It is unknown whether insulin detemir is excreted in human milk.
Danish: Det er ukendt, om insulin detemir udskilles i human mælk.
English: Serious allergic reaction to Levemir or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening.
Danish: Alvorlige allergiske reaktioner over for Levemir eller et af de øvrige indholdsstoffer (kaldet systemisk allergisk reaktion) er en meget sjælden bivirkning, som eventuelt kan være livstruende.
English: Maternal glycaemic control Levemir NPH Difference/ Odds Ratio/ Rate Ratio 95% CI
Danish: Maternel glykæmisk kontrol Levemir NPH Forskel/Oddsratio/ Hyppighedsratio 95% CI
English: Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose.
Danish: Ændringer i styrke, mærke (fremstiller), type, oprindelse (animalsk insulin, humant insulin eller insulinanalog) og/eller fremstillingsmetode (rekombinant DNA i modsætning til insulin af animalsk oprindelse) kan medføre et behov for ændring af dosis.
English: You may recover more quickly from unconsciousness with an injection of the hormone glucagon given by someone who knows how to use it.
Danish: Du kan genvinde bevidstheden hurtigere, hvis du får en injektion af hormonet glucagon af en person, der er instrueret i, hvordan det anvendes.
English: This is part of a multipack of 10 pens and not for sale as individual pens
Danish: Dette er en del af en multipakning med 10 penne og sælges ikke som individuelle penne
English: This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Det er især vigtigt for personer, som har nedsatte eller manglende advarselssymptomer på hypoglykæmi eller hyppige episoder med hypoglykæmi.
English: Start by checking your pen to make sure that it contains Levemir 100 units/ml, then look at the illustrations to the right to get to know the different parts of your pen and needle.
Danish: Kontrollér først pennen for at sikre dig, at den indeholder Levemir 100 enheder/ml, og se derefter på nedenstående illustrationer, så du kan blive fortrolig med de forskellige dele af din pen og nål.
English: Primary objective of this study was to assess the effect of Levemir on blood glucose regulation in pregnant women with diabetes (see section 5.1).
Danish: Det primære mål med studiet var at vurdere effekten af Levemir på reguleringen af blodglucose hos gravide kvinder med diabetes (se pkt.
English: It can also be used in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists.
Danish: Det kan også bruges i kombination med orale antidiabetika og/eller GLP-1-receptor-agonister.
English: • The active substance is insulin detemir.
Danish: • Aktivt stof: Insulin detemir.
English: GIRmax** *Area under the curve ** Glucose Infusion Rate p-value <0.001 for all comparisons with Levemir
Danish: GIRmax** *Område under kurven **Glucoseinfusionshastighed p-værdi < 0,001 for alle sammenligninger med Levemir
English: The duration of action is up to 24 hours depending on dose providing an opportunity for once or twice daily administration.
Danish: Virkningen varer i op til 24 timer afhængig af dosis, hvilket giver mulighed for at dosere én eller to gange dagligt.
English: A major hypoglycaemic episode is defined as an episode where the subject was not able to treat him/herself and if glucagon or i.v.
Danish: En alvorlig episode med hypoglykæmi er defineret som en episode, hvor patienten ikke er i stand til at behandle sig selv, og hvis der var behov for glucagon eller i.v.
English: The pharmacokinetic properties of Levemir were investigated in young children (1-5 years), children (6-12 years) and adolescents (13-17 years) and compared to adults with type 1 diabetes.
Danish: De farmakokinetiske egenskaber af Levemir er undersøgt hos små børn (1-5 år), børn (6-12 år) og unge (13-17 år) og sammenlignet med voksne med type 1-diabetes.
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Levemir and other insulin products.
Danish: Patienten skal informeres om altid at kontrollere etiketten på insulinet før hver injektion, for at undgå utilsigtet forveksling mellem Levemir og andre insulinpræparater.
English: Minor hypoglycaemic episodes (per patient year)
Danish: Minor hypoglykæmiske episoder (per patientår)
English: For doses in the interval of 0.2-0.4 units/kg (U/kg), Levemir exerts more than 50% of its maximum effect from 3-4 hours and up to approximately 14 hours after dose administration.
Danish: Ved injektion af doser mellem 0,2-0,4 enheder/kg (E/kg) opnås mere end 50% af den maksimale virkning med Levemir efter 3-4 timer og op til ca. 14 timer efter dosering.
English: Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Danish: Nogle lægemidler påvirker dit blodsukkerniveau og det kan betyde, at din insulindosis skal ændres.
English: The most frequently reported adverse reaction during treatment is hypoglycaemia, please see section 4.8, Description of selected adverse reactions.
Danish: Den hyppigst rapporterede bivirkning under behandling er hypoglykæmi, se afsnit 4.8, Beskrivelse af udvalgte bivirkninger.
English: • Have not injected enough insulin.
Danish: • Ikke har injiceret tilstrækkeligt insulin.
English: The trial started with a 12-week run-in period with liraglutide+metformin, where 61% reached an HbA1c <7%.
Danish: Studiet blev initieret med en 12 ugers opstartsperiode med liraglutid+metformin, hvoraf 61% nåede et HbA1c <7%.
English: Receptor affinity data and in vitro mitogenicity tests revealed no evidence of an increased mitogenic potential compared to human insulin.
Danish: Data for receptoraffinitet og in vitro-mitogenicitetsundersøgelser afslørerede ikke tegn på øget mitogenisk potentiale i forhold til humaninsulin.
English: The 39% of patients not achieving target were randomised to have Levemir once-daily added or continue on liraglutide+metformin for 52 weeks.
Danish: De 39% af patienterne der ikke nåede målet, blev randomiseret til at få Levemir én gang dagligt som tillæg hertil eller til at fortsætte med liraglutid+metformin i 52 uger.
English: Stop when the right number of units lines up with the dose pointer.
Danish: Stop når det korrekte antal enheder står ud for dosismarkøren.
English: 6.6 Special precautions for disposal and other handling Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Dette lægemiddel må ikke anvendes, hvis du bemærker at opløsningen ikke er klar, farveløs og vandig.
English: The results of the in vitro and in vivo protein binding studies suggest that there is no clinically relevant interaction between insulin detemir and fatty acids or other protein bound medicinal products.
Danish: Resultater af in vitro og in vivo proteinbindingsstudier tyder på, at der ikke er klinisk relevante interaktioner mellem insulin detemir og fedtsyrer eller andre proteinbundne lægemidler.
English: ► If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common side effects in section 4.
Danish: ► Hvis du har mistanke om begyndende hypoglykæmi (for lavt blodsukker), se a) Oversigt over alvorlige og meget almindelige bivirkninger under punkt 4.
English: • Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
Danish: • Sympatomimetika (såsom epinephrin [adrenalin] eller salbutamol og terbutalin til behandling af astma)
English: You must use the pen as described in the Instructions for use.
Danish: Du skal bruge pennen som beskrevet i Brugervejledningen.
English: The terminal half-life after subcutaneous administration is determined by the rate of absorption from the subcutaneous tissue.
Danish: Den endelige halveringstid efter subkutan administration bestemmes af absorptionshastigheden fra det subkutane væv.
English: Levemir should not be added to infusion fluids.
Danish: Levemir skal ikke tilsættes til infusionsvæsker.
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving.
Danish: Patienter skal informeres om at tage forholdsregler for at undgå hypoglykæmi, når de kører bil.
English: There were no major hypoglycaemic episodes.
Danish: Der var ingen alvorlige episoder med hypoglykæmi.
English: Make sure you can see the dose counter.
Danish: Kontrollér at du kan se dosistælleren.
English: Randomised liraglutide + metformin n=149
Danish: Randomiseret liraglutid + metformin n = 149