FrancophonIA/ELRC3.0 huggingface dataset:
English: The rate of asthma exacerbations requiring treatment with bursts of systemic corticosteroids was the primary endpoint.
Danish: Hyppigheden af astmaeksacerbationer, der krævede behandling med systemiske kortikosteroider, var det primære endepunkt.
English: However, caution may be warranted in patients at high risk of helminth infection, in particular when travelling to areas where helminthic infections are endemic.
Danish: Forsigtighed kan imidlertid være berettiget hos patienter med høj risiko for helminth-infektion, specielt i forbindelse med rejser til områder, hvor helminthiske infektioner er endemiske.
English: All studies had a 16-week treatment-free follow-up period.
Danish: Alle studier havde en 16-ugers behandlingsfri opfølgningsperiode.
English: For the safety and health of you and others, needles and used syringes must never be re-used.
Danish: Af hensyn til din egen og andres sikkerhed må kanyler og brugte sprøjter aldrig genbruges.
English: From a microbiological point of view, the medicinal product should be used immediately after reconstitution.
Danish: Fra et mikrobiologisk synspunkt bør lægemidlet anvendes straks efter rekonstitution.
English: The time that the syringe is kept at room temperature (25°C) before use must not exceed 4 hours.
Danish: Tiden, hvor injektionssprøjten opbevares ved stuetemperatur (25°C) før brug, må ikke overskride 4 timer.
English: Physician's overall assessment was performed in five of the above studies as a broad measure of asthma control performed by the treating physician.
Danish: Lægens overordnet evaluering blev udført i fem af ovenstående studier som en bred måling af astmakontrol udført af den behandlende læge.
English: You will need the injections either every two weeks, or every four weeks.
Danish: Du vil få brug for indsprøjtningerne enten hver anden uge eller hver fjerde uge.
English: None of these changes were associated with bleeding episodes or a decrease in haemoglobin.
Danish: Ingen af disse ændringer blev forbundet med blødningsepisoder eller et fald i hæmoglobin.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX05
Danish: Farmakoterapeutisk klassifikation: Lægemidler til obstruktive luftvejssygdomme, andre systemiske lægemidler til obstruktive luftvejssygdomme, ATC-kode: R03DX05
English: Injecting Xolair - You and your doctor will decide if you should inject Xolair yourself.
Danish: Indsprøjtning af Xolair - Du og din læge bør i fællesskab beslutte, om du selv skal indsprøjte Xolair eller ej.
English: In vitro, omalizumab forms complexes of limited size with IgE.
Danish: In vitro danner omalizumab komplekser af begrænset størrelse med IgE.
English: There are no human fertility data for omalizumab.
Danish: Der foreligger ingen humane fertilitetsdata for omalizumab.
English: Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment.
Danish: Total-IgE-niveauer er forhøjede under behandling og forbliver forhøjede i op til ét år efter behandlingsophør.
English: The first 3 doses are always given by or under the supervision of a healthcare professional (see section 2).
Danish: 3 doser gives altid af eller under opsyn af en sundhedsperson (se punkt 2).
English: Because the solution is slightly viscous, it may take 5-10 seconds to administer the solution by subcutaneous injection.
Danish: Da opløsningen er lettere viskøs, kan det tage 5-10 sekunder at administrere opløsningen ved subkutan injektion.
English: Therefore Xolair should not be used to treat such symptoms.
Danish: Derfor må Xolair ikke bruges til at behandle sådanne symptomer.
English: Look out for signs of allergic reactions and other serious side effects Xolair can potentially cause serious side effects.
Danish: Vær opmærksom på tegn på allergiske reaktioner og andre alvorlige bivirkninger Xolair kan muligvis medføre alvorlige bivirkninger.
English: Seek medical attention immediately if you notice any signs of the following side effects: Rare (may affect up to 1 in 1,000 people) - Severe allergic reactions (including anaphylaxis).
Danish: Kontakt straks lægen, hvis du bemærker tegn på nogen af følgende bivirkninger: Sjældne (kan forekomme hos op til 1 ud af 1.000 patienter) - Alvorlige allergiske reaktioner (inklusive anafylaksi).
English: Precipitating complexes and complexes larger than one million Daltons in molecular weight are not observed in vitro or in vivo.
Danish: Præcipiterende komplekser og komplekser med en molekylevægt på over én million dalton er ikke observeret in vitro eller in vivo.
English: Discontinuation of omalizumab should be considered in all severe cases with the above mentioned immune system disorders.
Danish: Ophør med omalizumab skal overvejes i alle alvorlige tilfælde med ovenstående lidelser i immunsystemet.
English: Physician's overall assessment % responders* p-value**
Danish: Lægens overordnet vurdering % respondenter* p-værdi**
English: Patients with CSU
Danish: Patienter med CSU
English: A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) based on pregnancy registry and post-marketing spontaneous reports, indicates no malformative or foeto/neonatal toxicity.
Danish: En moderat mængde data for gravide kvinder (300-1.000 graviditetsudfald), baseret på et graviditetsregister og spontane rapporter efter markedsføring, tyder ikke på misdannelser eller føtal/neonatal toksicitet.
English: The appropriate dose and frequency of Xolair is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg).
Danish: Den relevante dosis og hyppighed af Xolair fastsættes ved hjælp af baseline-IgE (IE/ml), der måles, før behandlingen påbegyndes, og legemsvægt (kg).
English: Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions listed first.
Danish: Inden for hver systemorganklasse er bivirkningerne opstillet efter hyppighed med de hyppigste anført først.
English: Characteristics in patient populations
Danish: Karakteristika hos patientpopulationer
English: • Do not use this medicine if either the seal on the outer box or the seal of the plastic tray is broken, as it may not be safe for you to use.
Danish: • Du må ikke bruge lægemidlet, hvis enten forseglingen på yderpakningen eller forseglingen på plastbakken er brudt, da det så måske ikke er sikkert for dig at bruge.
English: Oral corticosteroid, theophylline and leukotrienemodifier maintenance therapies were allowed (22%, 27%, and 35% of patients, respectively).
Danish: Vedligeholdelsesbehandling med orale kortikosteroider, theophylliner og leukotriene modifikatorer var tilladte (henholdsvis 22 %, 27 %, og 35 % patienter).
English: However, no apparent toxicity, such as immune complex-mediated disease or complement-dependent cytotoxicity, was seen.
Danish: Der blev imidlertid ikke observeret nogen oplagt toksicitet, så som immunkompleks-medieret sygdom eller komplement-afhængig cytotoksicitet.
English: Overall, 733 patients were treated with omalizumab for up to 12 weeks and 490 patients for up to 24 weeks.
Danish: Overordnet blev 733 patienter behandlet med omalizumab i op til 12 uger og 490 patienter i op til 24 uger.
English: • Do not inject into areas where the skin is tender, bruised, red, or hard.
Danish: • Brug ikke områder, hvor huden er øm, har blå mærker, er rød eller hård.
English: The course, severity, and response to treatment of infections were unaltered (see section 4.4).
Danish: Forløbet af, sværhedsgraden af og responset på behandling af infektioner var uændret (se pkt.
English: Immunoglobulins G (IgGs) are present in human milk and therefore it is expected that omalizumab will be present in human milk.
Danish: Immunoglobulin G (IgG) findes i human modermælk, og derfor forventes det også, at omalizumab vil være til stede i human modermælk.
English: Omalizumab studies 1 and 3 Pooled
Danish: Omalizumab-studie 1 og 3 Poolet
English: Prescribers are advised to periodically reassess the need for continued therapy.
Danish: Den ordinerende læge rådes til regelmæssigt at revurdere, om der fortsat er behov for behandling.
English: In all these cases, return the entire pack to the pharmacy.
Danish: I alle disse tilfælde skal hele pakningen afleveres på apoteket.
English: • The needle cap of the syringe may contain dry rubber (latex), which should not be handled by anyone who is sensitive to this substance.
Danish: • Sprøjtens kanylehætte kan indeholde tørt gummi (latex), der ikke må håndteres af personer, der er overfølsomme for dette stof.
English: Single intravenous doses up to 4,000 mg have been administered to patients without evidence of dose-limiting toxicities.
Danish: Enkelte intravenøse doser på op til 4.000 mg er blevet administreret til patienter uden tegn på dosisbegrænsende toksiciteter.
English: Anaphylactic reactions were rare in clinical trials.
Danish: Anafylaktiske reaktioner var sjældne i kliniske afprøvninger.
English: The shelf life includes potential temperature excursions.
Danish: Opbevaringstiden inkluderer mulige temperaturudsving.
English: Note: It is possible to rotate the inner part of the syringe assembly so that the label can be read in the viewing window.
Danish: Bemærk: Det er muligt at dreje den indre del af sprøjten, så etiketten kan læses i vinduet.
English: Liver elimination of IgG includes degradation in the reticuloendothelial system and endothelial cells.
Danish: Leverens elimination af IgG inkluderer degradering i det reticuloendotheliale system og endotelcellerne.
English: 1 vial and 1 ampoule.
Danish: 1 hætteglas og 1 ampul.
English: Use immediately after reconstitution (may be stored at 2°C - 8°C for up to 8 hours or at 25°C for 2 hours).
Danish: Anvendes umiddelbart efter rekonstitution (kan opbevares ved 2 °C - 8 °C i op til 8 timer eller ved 25 °C i 2 timer).
English: Clearance of omalizumab involves IgG clearance processes as well as clearance via specific binding and complex formation with its target ligand, IgE.
Danish: Clearance af omalizumab omfatter IgG-clearanceprocesser samt clearance via specifik binding og kompleksdannelse med dens målligand, IgE.
English: IgE may be involved in the immunological response to some helminth infections.
Danish: IgE kan muligvis være involveret i det immunologiske respons på visse helminth-infektioner.
English: Immune system disorders For further information, see section 4.4.
Danish: Immunsystemet For yderligere information se pkt.
English: Based on these measurements, 75 to 600 mg of Xolair in 1 to 4 injections may be needed for each administration.
Danish: På basis af disse målinger kan 75 til 600 mg Xolair fordelt på 1 til 4 injektioner være nødvendig ved hver administration.
English: Caution should be exercised when administering Xolair in these patient populations.
Danish: Forsigtighed skal udvises ved administration af Xolair til disse patientpopulationer.
English: Common * Despite not showing a 2% difference to placebo, injection site reactions were included as all cases were assessed causally related to study treatment.
Danish: * På trods af at der ikke blev vist en 2 % forskel fra placebo, blev reaktioner på injektionsstedet inkluderet, da alle tilfælde blev vurderet at have kausal sammenhæng med studie-behandlingen.
English: SEE TABLE 2
Danish: SE TABEL 2
English: Patients or caregivers should be instructed to inject the full amount of Xolair according to the instructions provided in the package leaflet.
Danish: Patienter eller omsorgspersoner skal instrueres i at injicere den fulde mængde Xolair ifølge anvisningen i indlægssedlen.
English: Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dose table should not be given Xolair.
Danish: Patienter, hvis baseline-IgE-niveauer eller legemsvægt i kilogram er uden for grænserne i dosistabellen, bør ikke indgives Xolair.
English: Very common (may affect more than 1 in 10 people) - fever (in children)
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) - feber (hos børn)
English: The onset has typically been 1-5 days after administration of the first or subsequent injections, also after long duration of treatment.
Danish: Frembruddet er typisk optrådt 1-5 dage efter første eller efterfølgende injektioner, og er også optrådt efter lang tids behandling.
English: • Do not open the sealed outer box until you are ready to use this medicine.
Danish: • Du må ikke åbne den forseglede yderpakning, før du er klar til at bruge lægemidlet.
English: If you stop treatment with Xolair
Danish: Hvis du stopper behandling med Xolair
English: The clinical relevance of anti-Xolair antibodies is not well understood.
Danish: Den kliniske relevans af anti-Xolair-antistoffer er man ikke helt klar over.
English: The results were similar in study 3.
Danish: Studie 3 viste tilsvarende resultater.
English: The adverse reactions are listed by MedDRA system organ class.
Danish: Bivirkningerne er listet efter MedDRA-systemorganklasse.
English: If a caregiver is giving the injection, the outer upper arms may also be used.
Danish: Hvis det er en omsorgsperson, der giver indsprøjtningen, kan det udvendige af overarmen også bruges.
English: Limited data are available on the use of Xolair in combination with specific immunotherapy (hypo-sensitisation therapy).
Danish: Der er begrænsede data tilgængelige om anvendelsen af Xolair i kombination med specifik immunterapi (hyposensibiliseringsterapi).
English: DO NOT USE if the syringe is broken or if the liquid looks distinctly cloudy or distinctly brown, or contains particles.
Danish: BRUG IKKE sprøjten, hvis den er beskadiget eller hvis væsken er tydeligt uklar eller tydeligt brun eller indeholder partikler.
English: At 16 weeks after commencing Xolair therapy patients should be assessed by their physician for treatment effectiveness before further injections are administered.
Danish: 16 uger efter påbegyndelse af Xolair-terapi bør patienterne vurderes af deres læge for behandlingsvirkning, før yderligere injektioner administreres.
English: However, if you are being treated for CSU, your doctor may stop Xolair treatment from time to time so that your symptoms can be assessed.
Danish: Hvis du er i behandling for CSU, kan din læge imidlertid stoppe behandlingen en gang imellem for at vurdere dine symptomer.
English: INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Danish: OPLYSNINGER TIL SUNDHEDSPERSONALET
English: Furthermore, no genotoxic effects were observed in a separate non-clinical genotoxicity study.
Danish: Desuden blev der ikke observeret genotoksiske virkninger i et separat præklinisk genotoksicitetsstudie.
English: Idiopathic thrombocytopenia, including severe cases
Danish: Idiopatisk trombocytopeni, inklusive alvorlige tilfælde
English: Anaphylactic reaction, other serious allergic conditions, antiomalizumab antibody development
Danish: Anafylaktisk reaktion, andre alvorlige allergiske tilstande, udvikling af anti-omalizumab-antistof
English: Xolair is indicated in adults, adolescents and children (6 to <12 years of age).
Danish: Xolair er indiceret til voksne, unge og børn (6 til <12 år).
English: Omalizumab is a man-made protein that is similar to natural proteins produced by the body.
Danish: Omalizumab er et syntetisk protein, der ligner de naturlige proteiner, der produceres i kroppen.
English: In addition, covariate effects were evaluated by analysing the relationship between omalizumab concentrations and clinical responses.
Danish: Derudover blev kovariate effekter vurderet ved at analysere sammenhængen mellem omalizumab-koncentration og klinisk respons.
English: If you have forgotten to give yourself a dose of Xolair, inject the dose as soon as you remember.
Danish: Hvis du har glemt at indsprøjte en dosis af Xolair, skal du indsprøjte den, så snart du husker det.
English: In addition, doubling of body weight approximately doubled apparent clearance.
Danish: Derudover medførte en fordobling af legemsvægt cirka en fordobling af en tilsyneladende clearance.
English: Total serum IgE levels may be re-tested for dose determination if treatment with Xolair has been interrupted for one year or more.
Danish: Måling af total-serum-IgE-niveauer kan gentages med henblik på fastsættelse af dosis, hvis behandling med Xolair har været seponeret i ét år eller længere.
English: Influenza-like illness, swelling arms, weight increase, fatigue *: Very common in children 6 to <12 years of age **: In children 6 to <12 years of age
Danish: Influenzalignende sygdom, hævede arme, vægtstigning, træthed *: Meget almindelig hos børn 6 til <12 år **: Set hos børn 6 til <12 år
English: Xolair is not indicated for the treatment of these conditions.
Danish: Xolair er ikke indiceret til behandling af disse tilstande.
English: Medical treatment should be sought and instituted appropriately.
Danish: Hensigtsmæssig behandling bør iværksættes.
English: The responder rates were: 33% at week 12 and 67% at week 24 for UAS7=0, and 56% at week 12 and 67% at week 24 for UAS7≤6.
Danish: Responsraten var 33 % ved uge 12 og 67 % ved uge 24 for UAS7=0, og 56 % ved uge 12 og 67 % ved uge 24 for UAS7≤6.
English: The antibody is an IgG1 kappa that contains human framework regions with the complementary-determining regions of a murine parent antibody that binds to IgE.
Danish: Antistoffet er en IgG1, kappa, som indeholder humane strukturelle regioner med komplementær-bestemmende regioner af et murint moderantistof, som bindes til IgE.
English: You will be given 1 to 4 injections at a time, either every two weeks, or every four weeks.
Danish: Du vil få 1-4 injektioner på en gang, enten hver anden uge eller hver fjerde uge.
English: Intact IgG is also excreted in bile.
Danish: Intakt IgG udskilles også i galde.
English: This will depend on your child's weight and the results of a blood test carried out before the start of the treatment to measure the amount of IgE in his/her blood.
Danish: Dette vil afhænge af dit barns vægt og resultatet af en blodprøve, der tages inden behandlingen startes, for at måle mængden af IgE i hans/hendes blod.
English: The patient or the caregiver must have been trained in the correct injection technique and the recognition of the early signs and symptoms of serious allergic reactions.
Danish: Patienten eller omsorgspersonen skal være oplært i den korrekte injektionsteknik samt kunne genkende tidlige tegn og symptomer på alvorlige allergiske reaktioner.
English: The maximum recommended dose is 600 mg omalizumab every two weeks.
Danish: Den højeste anbefalede dosis er 600 mg omalizumab hver anden uge.
English: Mean values at the end of the follow-up period were similar to the placebo group, but lower than respective mean baseline values.
Danish: Gennemsnitsværdierne ved slutningen af opfølgningsperioden svarede til placebogruppen, men var lavere end de respektive gennemsnitværdier ved baseline.
English: Abrupt discontinuation of systemic or inhaled corticosteroids after initiation of Xolair therapy is not recommended.
Danish: Pludseligt ophør af systemisk eller inhaleret kortikosteroid efter start af Xolair-behandling kan ikke anbefales.
English: However, animal studies do not indicate either direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier indikerer dog hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
English: For all six studies there was a statistically significant improvement from baseline in quality of life scores for Xolair patients versus the placebo or control group.
Danish: I alle seks studier var der en statistisk signifikant forbedring fra baseline i scoren for livskvalitet for Xolair-patienter versus placebo- eller kontrolgruppen.
English: • Be careful not to touch the syringe guard wings before use.
Danish: • Vær omhyggelig med ikke at røre ved aktiveringsklipsene før brug.
English: The general pharmacokinetic characteristics of omalizumab are similar in these populations.
Danish: Omalizumabs generelle farmakokinetiske karakteristika er sammenlignelige i disse populationer.
English: 12-Week
Danish: 12-uger
English: No studies have been performed in children under 12 years.
Danish: Der er ikke udført studier med børn under 12 år.
English: For a 75 mg dose, draw up 0.6 ml into the syringe and discard the remaining solution.
Danish: For en 75 mg dosis, træk 0,6 ml op i sprøjten, og kassér den resterende opløsning.
English: Antibodies to omalizumab were detected in some monkeys following repeated subcutaneous or intravenous administration.
Danish: Antistoffer til omalizumab blev påvist i nogle aber efter gentagen subkutan eller intravenøs administration.
English: Clinical trials have demonstrated that it takes at least 12-16 weeks for Xolair treatment to show effectiveness.
Danish: Kliniske studier har vist, at det tager mindst 12-16 uger, før Xolairs virkning kan ses.
English: The majority of severe allergic reactions occur within the first 3 doses of Xolair.
Danish: Størstedelen af alvorlige allergiske reaktioner opstår inden for de første 3 doser af Xolair.
English: If an anaphylactic or other serious allergic reaction occurs, administration of Xolair must be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår anafylaktiske eller andre alvorlige allergiske reaktioner, skal administration af Xolair afbrydes omgående og relevant behandling skal iværksættes.
English: The three studies enrolled 975 patients aged between 12 and 75 years (mean age 42.3 years; 39 patients 12-17 years, 54 patients ≥65 years; 259 males and 716 females).
Danish: De tre studier inkluderede 975 patienter i alderen 12 til 75 år (gennemsnitsalder 42,3 år; 39 patienter i alderen 12-17 år; 54 patienter ≥65 år; 259 mænd og 716 kvinder).
English: Most of the reactions were mild or moderate in severity.
Danish: De fleste reaktioner var lette til moderate i sværhedsgrad.
English: In clinical trials few patients had platelet counts below the lower limit of the normal laboratory range.
Danish: I kliniske afprøvninger havde få patienter blodpladetællinger under den normale laboratorieværdis nedre grænse.
English: Across all three studies, patients reported receiving on average 4 to 6 medications (including H1 antihistamines) for CSU symptoms prior to study enrollment.
Danish: På tværs af alle tre studier rapporterede patienterne, at de blev behandlet med gennemsnitligt 4 til 6 lægemidler (inklusive H1-antihistaminer) for CSU-symptomer inden inklusion i studiet.
English: Mean change from baseline in weekly itch severity score showed a reduction of 8.25 at week 12 and of 8.95 at week 24.
Danish: Den gennemsnitlige ændring fra baseline i ugentlig score for sværhedsgrad af kløe viste en reduktion på 8,25 ved uge 12 og på 8,95 ved uge 24.
English: Rare (may affect up to 1 in 1,000 people) - parasitic infection
Danish: Sjældne (kan forekomme hos op til 1 ud af 1.000 patienter) - infektion med parasitter
English: The primary support for safety and efficacy of Xolair in the group aged 6 to <12 years comes from one randomised, double-blind, placebo-controlled, multi-centre trial (study 7).
Danish: Det primære belæg for Xolairs sikkerhed og virkning i aldersgruppen 6 til <12 år stammer fra ét randomiseret, dobbeltblindet, placebokontrolleret, multicenter-studie (studie 7).
English: • Remember to take the syringe out of the refrigerator and allow it to reach room temperature (25°C) before preparing it for injection (it will take about 20 minutes).
Danish: • Husk at tage injektionssprøjten ud af køleskabet, og lad den opnå stuetemperatur (25°C), før den klargøres til indsprøjtning (det vil tage ca. 20 minutter).
English: Discontinuation of Xolair treatment generally results in a return to elevated free IgE levels and associated symptoms.
Danish: Afbrydelse af Xolair-behandling medfører sædvanligvis en tilbagevenden til forhøjede frie IgEniveauer og dermed forbundne symptomer.
English: Do not use if solid particles are present.
Danish: Det må ikke anvendes, hvis der forekommer faste partikler.