FrancophonIA/ELRC3.0 huggingface dataset:
English: Xolair has not been studied in patients with hyperimmunoglobulin E syndrome or allergic bronchopulmonary aspergillosis or for the prevention of anaphylactic reactions, including those provoked by food allergy, atopic dermatitis, or allergic rhinitis.
Danish: Xolair er ikke blevet undersøgt hos patienter med hyperimmunglobulin E-syndrom eller allergisk bronkopulmonær aspergillose eller til forebyggelsen af anafylaktiske reaktioner, herunder reaktioner fremkaldt ved fødevareallergi, atopisk dermatitis eller allergisk rhinitis.
English: The LS mean was estimated using an ANCOVA model.
Danish: LS-gennemsnittet blev estimeret ud fra en ANCOVAmodel.
English: The efficacy and safety of Xolair were demonstrated in two randomised, placebo-controlled phase III studies (study 1 and 2) in patients with CSU who remained symptomatic despite H1 antihistamine therapy at the approved dose.
Danish: Xolairs effekt og sikkerhed blev demonstreret i to randomiserede, placebo-kontrollerede fase IIIstudier (studie 1 og 2) hos patienter med CSU, som forblev symptomatiske på trods af H1antihistaminbehandling med godkendt dosis.
English: P-value vs. placebo *Modified intent-to-treat (mITT) population: included all patients who were randomised and received at least one dose of study medication.
Danish: *Modificeret intent-to-treat (mITT) population: inkluderede alle patienter, der blev randomiseret og behandlet mindst en gang med studiemedicin.
English: If a dose of Xolair is missed Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Danish: Hvis du har glemt at få en dosis af Xolair Kontakt din læge eller hospitalet så hurtigt som muligt for at få en ny tid.
English: In rare cases, patients on therapy with anti-asthma medicinal products, including omalizumab, may present or develop systemic eosinophilia and vasculitis.
Danish: Patienter, der er i behandling med lægemidler mod astma, inklusive omalizumab, kan i sjældne tilfælde udvise eller udvikle systemisk eosinofili eller vaskulitis.
English: There is limited experience with self-administration of Xolair powder and solvent for solution for injection.
Danish: Der er begrænset erfaring med selvadministration af Xolair pulver og solvens til injektionsvæske, opløsning.
English: If clinically needed, the use of Xolair may be considered during pregnancy.
Danish: Hvis klinisk indiceret, kan det overvejes at anvende Xolair under graviditet.
English: Table 2 ADMINISTRATION EVERY 4 WEEKS.
Danish: Tabel 2 ADMINISTRATION HVER 4.
English: In reproduction studies in cynomolgus monkeys, subcutaneous doses up to 75 mg/kg per week (at least 8 times the highest recommended clinical dose in mg/kg over a 4-week period) did not elicit maternal toxicity, embryotoxicity or teratogenicity when administered throughout organogenesis and did not elicit adverse effects on foetal or neonatal growth when administered throughout late gestation, delivery and nursing.
Danish: I reproduktionsstudier hos cynomolgusaber udløste subkutane doser på op til 75 mg/kg per uge (mindst 8 gange den højst anbefalede kliniske dosis i mg/kg over en 4-ugers periode) ikke maternal toksicitet, embryotoksicitet eller teratogenicitet, når de blev administreret under organogenese, og de udløste ikke bivirkninger på føtal eller neonatal vækst, når de blev administreret under den sidste del af svangerskabsperioden, fødslen og amning.
English: Syncope, paraesthesia, somnolence, dizziness
Danish: Synkope, paræstesi, døsighed, svimmelhed
English: Push the needle all the way in to ensure that the medicine can be fully administered.
Danish: Skub kanylen hele vejen ind for at sikre dig, at alt lægemidlet kan sprøjtes ind.
English: Clinical studies in CSU included some patients aged 12 to 17 years taking Xolair in conjunction with antihistamines (anti-H1, anti-H2) and LTRAs.
Danish: Kliniske studier med CSU inkluderede patienter i alderen 12 til 17 år, som fik Xolair sammen med antihistaminer (anti-H1, anti-H2) og LTRA'er.
English: Nevertheless, the use of Xolair solution for injection in pre-filled syringe in latex-sensitive individuals has not been studied and thus there is a potential risk for hypersensitivity reactions which cannot be completely ruled out.
Danish: Anvendelse af Xolair injektionsvæske, opløsning i fyldt injektionssprøjte, er imidlertid ikke blevet undersøgt hos personer med overfølsomhed over for latex, og derfor kan en potentiel risiko for overfølsomhedsreaktioner ikke helt udelukkes.
English: There is no pharmacological reason to expect that commonly prescribed medicinal products used in the treatment of asthma or CSU will interact with omalizumab.
Danish: Der er ingen farmakologisk grund til at forvente, at hyppigt ordinerede lægemidler anvendt i behandlingen af astma eller CSU vil interagere med omalizumab.
English: The omalizumab group showed greater decreases in beta-agonist rescue medication use than the placebo group at the end of the 52-week treatment period, although the difference between treatment groups was not statistically significant.
Danish: Ved slutningen af de 52 ugers behandlingsperiode viste omalizumab-gruppen et større fald i brugen af beta-agonist anfaldsmedicin end placebogruppen, selvom forskellen mellem behandlingsgrupperne ikke var statistisk signifikant.
English: Xolair is not meant to prevent or treat other allergy-type conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungus-related lung disease), food allergy, eczema or hay fever because Xolair has not been studied in these conditions.
Danish: Xolair er ikke beregnet til at forebygge eller behandle andre typer af allergiske tilstande, såsom pludselige allergiske reaktioner, hyperimmunoglobulin E-syndrom (en arvelig immunlidelse), aspergillose (svamperelateret infektion i lungerne), fødevareallergi, eksem eller høfeber, fordi Xolair ikke er blevet testet på disse tilstande.
English: You may cover the injection site with a small adhesive bandage, if needed.
Danish: Hvis det er nødvendigt, kan du dække indsprøjtningsstedet med et lille stykke plaster.
English: In clinical studies in CSU, Xolair was used in conjunction with antihistamines (anti-H1, anti-H2) and leukotriene receptor antagonists (LTRAs).
Danish: I kliniske studier med CSU-patienter blev Xolair brugt sammen med antihistaminer (anti-H1, anti-H2) og leukotrienreceptor-antagonister (LTRA'er).
English: IgE plays a key role in causing allergic asthma or CSU.
Danish: IgE spiller en vigtig rolle i fremkaldelse af allergisk astma og CSU.
English: Description of selected adverse reactions pertinent to allergic asthma and CSU indications
Danish: Beskrivelse af udvalgte bivirkninger for indikationerne allergisk astma og CSU
English: Adults and adolescents (12 years of age and older)
Danish: Voksne og unge (12 år og derover)
English: Antibodies to omalizumab have been detected in a low number of patients in clinical trials (see section 4.8).
Danish: Antistoffer mod omalizumab er blevet påvist hos få patienter i kliniske studier (se pkt.
English: *Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
Danish: *Omalizumab er et humaniseret monoklonalt antistof, som er fremstillet ved rekombinant dnateknologi i en pattedyrscellelinje fra kinesiske hamstres æggeestokke (CHO).
English: - Systemic lupus erythematosus (SLE).
Danish: - Systemisk lupus erythematosus (SLE).
English: If you are breast-feeding or plan to breast-feed, ask your doctor for advice before using this medicine.
Danish: Hvis du ammer eller planlægger at amme, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: In studies 3, 4 and 5 patients treated with Xolair had respective reductions in asthma exacerbation rates of 37.5% (p = 0.027), 40.3% (p<0.001) and 57.6% (p<0.001) compared to placebo.
Danish: I studie 3, 4 og 5 havde patienter behandlet med Xolair en reduktion i hyppigheden af astmaeksacerbationer på henholdvis 37,5 % (p=0,027), 40,3 % (p<0,001) og 57,6 % (p<0,001) sammenlignet med placebo.
English: During the 52-week double-blind treatment period (including the 24-week fixed-dose steroid phase and the 28-week steroid adjustment phase) the difference in rates between treatment groups represented a 50% (rate ratio 0.504, p<0.001) relative decrease in exacerbations for omalizumab patients.
Danish: Under den 52 ugers dobbeltblindede behandlingsperiode (inklusive de 24 ugers fast dosis steroidfase og 28 ugers steroidtilpasningsfase) viste forskellen i hyppigheder mellem behandlingsgrupper et 50 % (forhold 0,504, p<0,001) relativt fald i eksacerbationer for patienter behandlet med omalizumab.
English: Solvent ampoule: Clear, colourless type I glass ampoule containing 2 ml water for injections.
Danish: Solvens ampul: Klar, farveløs type I-glasampul indeholdende 2 ml vand til injektionsvæsker.
English: The population pharmacokinetics of omalizumab were analysed to evaluate the effects of demographic characteristics.
Danish: Populationsfarmakokinetiske data for omalizumab blev analyseret for at evaluere effekten af demografiske karakteristika.
English: Dose determination after treatment interruptions lasting less than one year should be based on serum IgE levels obtained at the initial dose determination.
Danish: Dosisfastsættelse efter behandlingsafbrydelse på mindre end ét år bør baseres på de serum-IgEniveauer, der blev målt ved fastsættelse af initialdosis.
English: During clinical trials in adult and adolescent patients 12 years of age and older, the most commonly reported adverse reactions were headaches and injection site reactions, including injection site pain, swelling, erythema and pruritus.
Danish: I kliniske afprøvninger med voksne og unge på 12 år og derover var de hyppigst indberettede bivirkninger hovedpine og reaktioner i forbindelse med injektionsstedet, herunder smerte på injektionsstedet, hævelse, erytem og pruritus.
English: Photosensitivity, urticaria, rash, pruritus
Danish: Lysfølsomhed, urticaria, udslæt, pruritus
English: The strata were baseline weekly itch severity score (<13 vs. ≥13) and baseline weight (<80 kg vs. ≥80 kg).
Danish: Strataen var ugentlig score for sværhedsgrad af kløe (<13 versus ≥13) ved baseline og vægt (<80 kg mod ≥80 kg) ved baseline.
English: Statistically significant results were further observed in the responder rates for UAS7≤6 (at week 12) which were higher for the 300 mg treatment groups, ranging from 52-66% (p<0.0001) compared to 11-19% for the placebo groups, and complete response (UAS7=0) was achieved by 34-44% (p<0.0001) of patients treated with 300 mg compared to 5-9% of patients in the placebo groups.
Danish: Statistisk signifikante resultater blev yderligere observeret i responsraten for UAS7≤6 (ved uge 12), som var højere for 300 mg-behandlingsgruppen, varierende fra 52-66 % (p<0,0001) sammenlignet med 11-19 % for placebogruppen, og komplet respons (UAS7=0) blev opnået af 34-44 % (p<0,0001) af patienterne behandlet med 300 mg sammenlignet med 5-9 % af patienterne i placebogruppen.
English: Table 6 Results of study 1
Danish: Tabel 6 Resultater af studie 1
English: Solvent for Xolair Water for injections
Danish: Solvens for Xolair vand til injektionsvæsker
English: In clinical studies, serum free IgE levels were reduced in a dose-dependent manner within one hour following the first dose and maintained between doses.
Danish: I kliniske studier blev niveauerne af frit IgE i serum reduceret alt efter dosis inden for én time efter den første dosis og opretholdt mellem doser.
English: Based on population pharmacokinetics, distribution of omalizumab was similar in patients with allergic asthma and patients with CSU.
Danish: Baseret på farmakokinetiske populationsanalyser var fordelingen af omalizumab sammenlignelig hos patienter med allergisk astma og patienter med CSU.
English: Omalizumab binds to IgE and prevents binding of IgE to FcRI (high-affinity IgE receptor), thereby reducing the amount of free IgE that is available to trigger the allergic cascade.
Danish: Omalizumab bindes til IgE og forhindrer binding af IgE til FcRI (høj-affinitets-IgE-receptor), hvorved mængden af frit IgE, som kan udløse den allergiske kaskade, reduceres.
English: Patients with IgE lower than 76 IU/ml were less likely to experience benefit (see section 5.1).
Danish: Det var mindre sandsynligt, at patienter med IgE under 76 IE/ml ville opleve en fordel (se pkt.
English: These analyses suggest that no dose adjustments are necessary in patients with CSU for age (12-75 years), race/ethnicity, gender, body weight, body mass index, baseline IgE, anti-FcRI autoantibodies or concomitant use of H2 antihistamines or LTRAs.
Danish: Disse analyser tyder på, at det ikke er nødvendigt at justere dosis på grund af alder (12-75 år), race/etnisk oprindelse, køn eller body mass index, baseline-IgE, anti-FcRI-autoantistoffer eller ved samtidig brug af H2antihistaminer eller LTRA'er hos patienter med CSU.
English: Store in the refrigerator between 2°C and 8°C.
Danish: Opbevares i køleskab ved mellem 2 °C og 8 °C.
English: Do not rub the injection site.
Danish: • Ryst ikke injektionssprøjten.
English: Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma.
Danish: Behandlingen med Xolair bør indledes af læger med erfaring i diagnosen og behandlingen af svær vedvarende astma.
English: Available data in non-human primates have shown excretion of omalizumab into milk (see section 5.3).
Danish: De tilgængelige data fra non-humane primater viser, at omalizumab udskilles i mælk (se pkt.
English: Remove the plastic tray from the box, peel back the paper cover.
Danish: Tag plastikbakken ud af pakningen og træk papirforseglingen af.
English: Symptoms suggestive of serum sickness include arthritis/arthralgias, rash (urticaria or other forms), fever and lymphadenopathy.
Danish: Symptomer, som tyder på serumsyge, inkluderer arthritis/artralgi, udslæt (urtikarielt eller andre typer), feber og lymfadenopati.
English: • Store this medicine sealed in its outer box to protect it from light.
Danish: • Opbevar lægemidlet forseglet i yderpakningen for at beskytte den mod lys.
English: Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
Danish: Pres langsomt stemplet helt i bund, så stempelhovedet når helt ind mellem aktiveringsklipsene.
English: Following a single subcutaneous dose in adult and adolescent patients with asthma or CSU, omalizumab was absorbed slowly, reaching peak serum concentrations after an average of 6-8 days.
Danish: Efter en enkelt subkutan dosis hos voksne og unge patienter med astma eller CSU blev omalizumab absorberet langsomt, idet peakkoncentrationer af serum blev opnået efter gennemsnitligt 6-8 dage.
English: Clinical efficacy and safety in chronic spontaneous urticaria (CSU)
Danish: Klinisk virkning og sikkerhed ved kronisk spontan urticaria (CSU)
English: Patients with no known history of anaphylaxis may self-inject Xolair or be injected by a caregiver from the 4th dose onwards if a physician determines that this is appropriate (see section 4.4).
Danish: Patienter, som ikke har anafylaksi i anamnesen, kan selv injicere Xolair eller få injektionen af en omsorgsperson fra 4. dosis og herefter, hvis lægen vurderer det relevant (se pkt.
English: Table 5 Results of study 1
Danish: Tabel 5 Resultater af studie 1
English: Adults and adolescents ≥12 years of age
Danish: Voksne og unge 12 år
English: The liquid should be clear to slightly cloudy.
Danish: Væsken skal være klar til let uigennemsigtig.
English: Omalizumab binds to IgE and prevents binding of IgE to FcRI (high-affinity IgE receptor) on basophils and mast cells, thereby reducing the amount of free IgE that is available to trigger the allergic cascade.
Danish: Omalizumab bindes til IgE og forhindrer binding af IgE til FcRI (høj-affinitets-IgE-receptor) på basofile celler og mastceller, hvorved mængden af frit IgE, som kan udløse den allergiske kaskade, reduceres.
English: Xolair does not treat acute asthma symptoms, such as a sudden asthma attack.
Danish: Xolair kan ikke bruges til behandling af akutte astmasymptomer, såsom et pludseligt astmaanfald.
English: CARTON FOR UNIT PACK
Danish: KARTON TIL ENKELTPAKNING
English: Omalizumab is excreted in breast milk in cynomolgus monkeys.
Danish: Omalizumb udskilles i brystmælk hos cynomolgusaber.
English: Chronic spontaneous urticaria (CSU) You will need two 150 mg injections at a time every four weeks.
Danish: Kronisk spontan nældefeber Du vil få brug for to 150 mg injektioner på en gang hver fjerde uge.
English: Viewing window Label & expiry date
Danish: Beskyttelsesnet for nålen Vindue, etiket og udløbsdato
English: The removable needle cap of this pre-filled syringe contains a derivative of natural rubber latex.
Danish: Den aftagelige nålehætte på den fyldte injektionssprøjte indeholder et derivat af naturgummilatex.
English: Following a single subcutaneous dose in adult and adolescent patients with asthma, omalizumab was absorbed slowly, reaching peak serum concentrations after an average of 7-8 days.
Danish: Efter en enkelt subkutan dosis hos voksne og unge patienter med astma blev omalizumab absorberet langsomt, idet peakkoncentrationer af serum blev opnået efter gennemsnitligt 7-8 dage.
English: Disposal instructions
Danish: Anvisninger til bortskaffelse
English: Its colour may vary from colourless to pale brownish-yellow.
Danish: Farven kan variere fra farveløs til lys brunliggul.
English: • Cotton ball or gauze.
Danish: • Vatkugle eller gaze.
English: Based on an estimated exposure of 566,923 patient treatment years, this results in a reporting rate of approximately
Danish: Dette resulterer i en indberetningsfrekvens på 0,20%, baseret på en estimeret eksponering af 566.923 patient-årsbehandling.
English: Table 5 includes results in the study 1 population.
Danish: Tabel 5 omfatter resultaterne fra studie 1 populationen.
English: In the specific subgroup of patients on high dose inhaled corticosteroids, the omalizumab group had a statistically significantly lower rate of clinically significant asthma exacerbations than the placebo group.
Danish: I den specifikke undergruppe af patienter på høj dosis af inhalationskortikosteroid havde gruppen, som fik omalizumab, en statistisk signifikant lavere hyppighed af klinisk signifikante astmaeksacerbationer end placebogruppen.
English: Expel air, large bubbles, and any excess solution in order to obtain the required 1.2 ml dose.
Danish: Pres luft, store bobler og eventuel overskydende opløsning ud for at opnå den ønskede 1,2 mldosis.
English: Churg-Strauss syndrome and hypereosinophilic syndrome Patients with severe asthma may rarely present systemic hypereosinophilic syndrome or allergic eosinophilic granulomatous vasculitis (Churg-Strauss syndrome), both of which are usually treated with systemic corticosteroids.
Danish: Churg-Strauss syndrom og hypereosinofilt syndrom Patienter med svær astma kan i sjældne tilfælde få systemisk hypereosinofilt syndrom eller allergisk eosinofil granulomatøs vaskulitis (Churg-Strauss syndrom).
English: Xolair contains the active substance omalizumab.
Danish: Xolair indeholder det aktive stof omalizumab.
English: While no particular dose adjustment is recommended for these patients, Xolair should be administered with caution (see section 4.4).
Danish: Der er ingen særlige anbefalinger vedrørende dosisjustering til disse patienter, men der skal udvises forsigtighed, når Xolair indgives (se pkt.
English: Allergic bronchospasm, coughing
Danish: Allergisk bronkospasme, hoste
English: Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma or chronic spontaneous urticaria.
Danish: Behandlingen med Xolair bør indledes af læger med erfaring i diagnosen og behandlingen af svær vedvarende astma og kronisk spontan urticaria.
English: L-histidine hydrochloride monohydrate Polysorbate 20
Danish: L-histidinhydrochloridmonohydrat Polysorbat 20
English: Xolair is not recommended for children under 6 years of age.
Danish: Xolair anbefales ikke til børn under 6 år.
English: Talk to your doctor before using Xolair: - if you have kidney or liver problems.
Danish: Kontakt lægen, før du bruger Xolair: - hvis du har nyre- eller leverproblemer.
English: Analyses of these limited data suggest that no dose adjustments are necessary for age (6-76 years), race/ethnicity, gender or Body Mass Index (see section 4.2).
Danish: Analyser af disse begrænsede data tyder på, at det ikke er nødvendigt at justere dosis på grund af alder (6-76 år), race/etnisk oprindelse, køn eller body mass index (se pkt.
English: Table 6 includes results in the study 1 population.
Danish: Tabel 6 omfatter resultaterne fra studie 1 populationen.
English: Expel air, large bubbles, and any excess solution in order to obtain the required 0.6 ml dose.
Danish: Pres luft, store bobler og eventuel overskydende opløsning ud for at opnå den ønskede 0,6 mldosis.
English: Figure 1 Mean weekly itch severity score over time, study 1 (mITT population)
Danish: Figur 1 Gennemsnitlig ugentlig score for sværhedsgrad af kløe over tid, studie 1 (mITT population)
English: Table 4 Adverse reactions in allergic asthma
Danish: Tabel 4 Bivirkninger, allergisk astma
English: Omalizumab at 300 mg reduced the weekly itch severity score by 8.55 to 9.77 (p <0.0001) compared to a reduction of 3.63 to 5.14 for placebo (see Table 7).
Danish: Ved 300 mg reducerede omalizumab den ugentlige score for sværhedsgrad af kløe med 8,55 til 9,77 (p<0,0001) sammenlignet med en reduktion på 3,63 til 5,14 for placebo (se Tabel 7).
English: The efficacy and safety of Xolair were demonstrated in a 28-week double-blind placebo-controlled study (study 1) involving 419 severe allergic asthmatics, ages 12-79 years, who had reduced lung function (FEV1 40-80% predicted) and poor asthma symptom control despite receiving high dose inhaled corticosteroids and a long-acting beta2-agonist.
Danish: Effekt og sikkerhed af Xolair blev påvist i et 28-uges, dobbeltblindet, placebo-kontrolleret studie (studie 1), som omfattede 419 svært allergiske astmatikere i alderen 12-79 år, som havde nedsat lungefunktion (FEV1 40-80 % forudsagt) og dårlig astmasymptonkontrol på trods af behandlingen med højdosis-inhalationskortikosteroider og en langtidsvirkende beta2-agonist.
English: Xolair doses (milligrams per dose) administered by subcutaneous injection every 2 weeks
Danish: Xolair-doser (milligram per dosis) administreret ved subkutan injektion hver 2. uge
English: It is also important that you do not inject Xolair yourself until you have been trained by your doctor or nurse on: - how to recognise the early signs and symptoms of serious allergic reactions.
Danish: Undervisning i at genkende alvorlige allergiske reaktioner Det er også vigtigt, at du ikke indsprøjter selv, før du er blevet undervist af din læge eller sygeplejerske i: - hvordan du genkender tidlige tegn og symptomer på alvorlige allergiske reaktioner.
English: Other medicines and Xolair
Danish: Brug af anden medicin sammen med Xolair
English: Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
Danish: Før kanylen fjernes fra hætteglasset, træk stemplet hele vejen tilbage mod toppen på sprøjtecylinderen for at fjerne hele opløsningen fra det vendte hætteglas.
English: For more information about the early signs and symptoms of serious allergic reactions, see section 4.
Danish: Se punkt 4 for mere information om de tidlige tegn og symptomer på alvorlige allergiske reaktioner.
English: In clinical studies in allergic asthma patients, serum free IgE levels were reduced in a dose-dependent manner within one hour following the first dose and maintained between doses.
Danish: I kliniske studier med patienter med allergisk astma blev niveauerne af frit IgE i serum reduceret alt efter dosis inden for én time efter den første dosis og opretholdt mellem doser.