FrancophonIA/ELRC3.0 huggingface dataset:
English: The suggested pathophysiologic mechanism includes immune-complex formation and deposition due to development of antibodies against omalizumab.
Danish: Den foreslåede patofysiologiske mekanisme omfatter immunkompleksdannelse og -aflejring på grund af udvikling af antistoffer mod omalizumab.
English: This depends on your body weight and the results of a blood test carried out before the start of the treatment to measure the amount of IgE in your blood.
Danish: Dette afhænger af din kropsvægt og resultatet af en blodprøve, der tages før behandlingens start for at måle mængden af IgE i dit blod.
English: DO NOT USE if the product has expired.
Danish: BRUG IKKE injektionssprøjten, hvis produktet er udløbet.
English: In all five studies a significantly greater proportion of Xolair treated patients were judged to have achieved either a marked improvement or complete control of their asthma compared to placebo patients.
Danish: I alle fem studier var bedømmelsen, at en betydelig større andel af Xolair-behandlede patienter havde opnået enten en markant forbedring i eller fuldstændig kontrol af deres astma sammenlignet med placebo-patienter.
English: The serum concentration required to attain a 50% drop in platelets from baseline in adult cynomolgus monkeys was roughly 4- to 20-fold higher than anticipated maximum clinical serum concentrations.
Danish: Serumkoncentrationen, der var nødvendig for at opnå et fald på 50 % i trombocytter fra baseline hos voksne cynomolgusaber, var cirka 4- til 20gange højere end forventede maksimale kliniske serumkoncentrationer.
English: This is especially important if you are taking: - medicines to treat an infection caused by a parasite, as Xolair may reduce the effect of your medicines, - inhaled corticosteroids and other medicines for allergic asthma.
Danish: Dette er især vigtigt, hvis du tager: - medicin til behandling af en infektion forårsaget af en parasit, da Xolair kan nedsætte effekten af din behandling, - inhaleret kortikosteroid og anden medicin mod allergisk astma.
English: The primary endpoint was the change from baseline to week 12 in weekly itch severity score.
Danish: Det primære endepunkt var ændring fra baseline til uge 12 i ugentlig score for sværhedsgrad af kløe.
English: Table 5 Adverse reactions from the pooled CSU safety database (day 1 to week 24) at 300 mg omalizumab
Danish: Tabel 5 Bivirkninger fra poolet CSU-bivirkningsdatabase (dag 1 til uge 24) ved 300 mg omalizumab
English: The adverse reactions presented are divided into two groups: those identified in the 12-week and the 24-week treatment periods.
Danish: Bivirkningerne er delt i to grupper: dem, der er set i 12-ugers henholdsvis i 24-ugers behandlingsperioderne.
English: Doubling of body weight approximately doubled apparent clearance.
Danish: En fordobling af legemsvægt medførte cirka en fordobling af en tilsyneladende clearance.
English: • The syringe cannot be re-used.
Danish: • Injektionssprøjten må ikke genbruges.
English: If the wings are touched, the syringe guard may be activated too early.
Danish: Rører du ved dem, kan de måske blive aktiveret for tidligt.
English: Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body.
Danish: Xolair virker ved at blokere et stof, som kaldes immunglobulin E (IgE), som kroppen producerer.
English: Table 4 lists the adverse reactions recorded in clinical studies in the total safety population treated with Xolair by MedDRA system organ class and frequency.
Danish: Tabel 4 lister de bivirkninger, der er rapporteret i kliniske studier hos den totale sikkerhedspopulation, der er behandlet med Xolair, efter MedDRA systemorganklasse og hyppighed.
English: From a microbiological point of view, the medicinal product should be used immediately after reconstitution (see section 6.3).
Danish: Fra et mikrobiologisk synspunkt bør lægemidlet anvendes straks efter rekonstitution (se pkt.
English: Serum sickness, may include fever and lymphadenopathy
Danish: Serumsyge, som kan inkludere feber og lymfadenopati
English: You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
Danish: Du kan også bruge den nederste del af maven, men ikke området 5 cm omkring navlen.
English: Formal carcinogenicity studies have not been conducted with omalizumab.
Danish: Der er ikke udført formelle karcinogenicitetsstudier med omalizumab.
English: In addition more patients had clinically meaningful responses in the total IgE ≥76 IU/ml population across the Xolair severe asthma programme.
Danish: Derudover havde flere patienter klinisk betydningsfulde responser i den totale IgE ≥76 IE/ml population på tværs af programmet med Xolair for svær astma.
English: 150 mg b c c c c a
Danish: 150 mg b c c c
English: Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability.
Danish: Immunoglobulin G-proteiner, der gives oralt, gennemgår intestinal proteolyse og har lav biotilgængelighed.
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design.
Danish: Det kan have indflydelse på fortolkningen af data, at studiet har metodologiske begrænsninger, herunder ringe populationsstørrelse og et ikke-randomiseret studiedesign.
English: - if you have had a previous severe allergic reaction (anaphylaxis) for example resulting from a medicine, an insect bite or food.
Danish: - hvis du tidligere har haft en alvorlig allergisk reaktion (anafylaksi), som for eksempel blev udløst af en medicinsk behandling, et insektbid eller mad.
English: If patients do not respond to recommended anti-helminth treatment, discontinuation of Xolair should be considered.
Danish: Hvis patienter ikke responderer på anbefalet antihelminth-behandling, bør seponering af Xolair overvejes.
English: There was no indication that the safety of Xolair was altered with these other commonly used anti-asthma medicinal products.
Danish: Der var ikke noget, der tydede på, at sikkerheden af Xolair blev ændret af disse andre hyppigt anvendte lægemidler mod astma.
English: Children (6 to 11 years of age) are not expected to self-administer Xolair.
Danish: Børn (6 til 11 år) forventes ikke at skulle indsprøjte Xolair selv.
English: In a multivariate analysis controlling for available baseline cardiovascular risk factors, the hazard ratio was 1.32 (95% confidence interval 0.91-1.91).
Danish: I en multivariat analyse, der kontrollerede tilgængelige baseline kardiovaskulære risikofaktorer, var hazard ratio 1,32 (95 % konfidensinterval 0,91-1,91).
English: Powder: white to off-white lyophilisate Solvent: clear and colourless solution
Danish: Pulver: hvidt til råhvidt lyofilisat Solvens: klar og farveløs opløsning
English: Of those, 412 patients were treated for up to 12 weeks and 333 patients were treated for up to 24 weeks at the 300 mg dose.
Danish: Af disse blev 412 behandlet i op til 12 uger og 333 i op til 24 uger med 300 mg dosen.
English: Seek medical help immediately if you notice any signs indicating a possible serious side effect.
Danish: Kontakt en læge hurtigst muligt, hvis du bemærker tegn, der tyder på en mulig alvorlig bivirkning.
English: Number of injections
Danish: Antal injektioner
English: Administration of Xolair manufactured as a lyophilised or liquid formulation resulted in similar serum concentration-time profiles of omalizumab.
Danish: Administration af Xolair fremstillet som en lyofiliseret eller som en flydende formulering resulterede i sammenlignelige serumkoncentration/tid-profiler for omalizumab.
English: Your doctor will work out how much Xolair your child needs and how often it needs to be given.
Danish: Din læge vil beregne, hvor meget Xolair dit barn har behov for, og hvor ofte det skal gives.
English: The EXPECT study, with 154 infants who had been exposed to Xolair during pregnancy and through breast-feeding did not indicate adverse effects on the breast-fed infant.
Danish: EXPECT-studiet, der inkluderede 154 spædbørn, som havde været eksponeret for Xolair under graviditeten samt gennem amning, indikerede ikke bivirkninger hos det ammede spædbarn.
English: Elderly (65 years of age and older)
Danish: Ældre (65 år eller derover)
English: Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
Danish: Udskift 18-gauge kanylen med en 25-gauge kanyle til subkutan injektion.
English: Xolair must not be administered by the intravenous or intramuscular route.
Danish: Xolair må ikke administreres intravenøst eller intramuskulært.
English: Serum sickness and serum sickness-like reactions, which are delayed allergic type III reactions, have been seen in patients treated with humanised monoclonal antibodies including omalizumab.
Danish: Serumsyge og serumsyge-lignende reaktioner, som er forskinkede type III allergiske reaktioner, er set hos patienter behandlet med humaniserede monoklonale antistoffer, inklusive omalizumab.
English: No relevant data was obtained in clinical studies in CSU that would require a modification of the sections below.
Danish: Der blev ikke opnået data i kliniske studier med CSU, hvor det vil være relevant at ændre i nedenstående afsnit.
English: The safety of omalizumab has been studied in the cynomolgus monkey, since omalizumab binds to cynomolgus and human IgE with similar affinity.
Danish: Sikkerheden af omalizumab er blevet undersøgt i cynomolgusaber, idet omalizumab bindes til cynomolgus og humant IgE med omtrent den samme affinitet.
English: Clinical efficacy and safety in allergic asthma
Danish: Klinisk virkning og sikkerhed ved allergisk astma
English: After repeated dosing once every 4 weeks, pre-dose serum free IgE levels remained stable between 12 and 24 weeks of treatment.
Danish: Efter gentagen dosering en gang hver 4. uge forblev præ-dosis frit IgE-niveau i serum stabilt mellem 12 og 24 ugers behandling.
English: The physician was able to take into account PEF (peak expiratory flow), day and night time symptoms, rescue medication use, spirometry and exacerbations.
Danish: Lægen var i stand til at tage højde for PEF (peak expiratory flow), dag- og natsymptomer, anvendelse af behovsmedicin, spirometri og eksacerbationer.
English: The definition of the composite endpoint ATE included stroke, transient ischaemic attack, myocardial infarction, unstable angina, and cardiovascular death (including death from unknown cause).
Danish: Definitionen af det sammensatte endepunkt ATE inkluderede apopleksi, transitorisk iskæmisk attak, myokardieinfarkt, ustabil angina og kardiovaskulær død (herunder dødsfald fra ukendt årsag).
English: Study 2 assessed the efficacy and safety of Xolair in a population of 312 severe allergic asthmatics which matched the population in study 1.
Danish: Studie 2 vurderede effekten og sikkerheden af Xolair i en population med 312 svære allergiske astmatikere, som tilsvarede populationen i studie 1.
English: Children 6 to <12 years of age
Danish: Børn 6 til <12 år
English: Xolair has no or negligible influence on the ability to drive and use machines.
Danish: Xolair påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: - Low blood platelet count with symptoms such as bleeding or bruising more easily than normal.
Danish: - Lavt antal blodplader i blodet med symptomer, hvor du lettere får sår eller blå mærker end normalt.
English: In addition, a population pharmacokinetic analysis showed no relevant effect of H2 antihistamines and LTRAs on omalizumab pharmacokinetics (see section 5.2).
Danish: Derudover viste farmakokinetiske populationsanalyser ingen relevant effekt af H2-antihistaminer og LTRA'er på omalizumab farmakokinetik (se pkt.
English: • Never leave the syringe where others might tamper with it.
Danish: • Lad aldrig injektionssprøjten ligge tilgængelig, så andre kan komme til at pille ved den.
English: No effects on the breast-fed newborns/infants are anticipated.
Danish: Der forventes ingen påvirkning af nyfødte/spædbørn, der ammes.
English: • Do not remove the needle cap until just before you give the injection.
Danish: • Kanylehætten må ikke fjernes, før lige inden du giver indsprøjtningen.
English: Keeping the vial in an upright position, vigorously swirl it (do not shake) for approximately 1 minute to evenly wet the powder.
Danish: Bevar hætteglasset i lodret position, rotér glasset kraftigt (ryst det ikke) i cirka 1 minut, så pulveret fugtes jævnt.
English: Medicinal product or vaccine interaction studies have not been performed with Xolair.
Danish: Der er ikke blevet udført lægemiddelprodukt- eller vaccineinteraktionsstudier med Xolair.
English: In clinical studies in CSU patients, maximum suppression of free IgE was observed 3 days after the first subcutaneous dose.
Danish: I kliniske studier med CSU-patienter blev maksimal suppression af frit IgE set 3 dage efter første subkutane dosis.
English: Omalizumab has been associated with age-dependent decreases in blood platelets in non-human primates, with a greater relative sensitivity in juvenile animals (see section 5.3).
Danish: Omalizumab er blevet forbundet med aldersafhængige fald i blodplader hos ikke-menneskelige primater med en større relativ følsomhed herfor i unge dyr (se pkt.
English: Subcutaneous Xolair or placebo were administered as add-on therapy to >1,000 micrograms beclomethasone dipropionate (or equivalent) plus a long-acting beta2-agonist.
Danish: Subkutant Xolair eller placebo blev administreret som tillægsterapi til >1.000 mikrogram beclomethasondipropionat (eller tilsvarende) plus en langtidsvirkende beta2-agonist.
English: Therefore treatment with this formulation is intended to be administered by a healthcare provider only.
Danish: Derfor er behandling med denne lægemiddelform kun beregnet til administration af sundhedspersonale.
English: IgE plays a key role in causing allergic asthma.
Danish: IgE spiller en vigtig rolle i fremkaldelse af allergisk astma.
English: Allergic asthma
Danish: Allergisk astma
English: Therefore medicinal products for the treatment of anaphylactic reactions should always be available for immediate use following administration of Xolair.
Danish: Derfor bør lægemidler til behandling af anafylaktiske reaktioner altid være tilgængelige for omgående anvendelse efter administration af Xolair.
English: After the medicine has been injected, the syringe guard will be activated to cover the needle.
Danish: Når lægemidlet er indsprøjtet, aktiveres beskyttelsesnettet, så kanylen dækkes.
English: In addition, acute haemorrhage and inflammation were observed at injection sites in cynomolgus monkeys.
Danish: Derudover blev akut blødning og inflammation observeret ved injektionsstedet hos cynomolgusaber.
English: The syringe should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room temperature.
Danish: Sprøjten skal tages ud af køleskabet 20 minutter før injektion, så den opnår stuetemperatur.
English: Xolair is used for the treatment of: - allergic asthma - chronic spontaneous urticaria (CSU)
Danish: Xolair anvendes til behandling af: - allergisk astma - kronisk spontan nældefeber (urticaria) (CSU)
English: - Do not use any pack that is damaged or shows signs of tampering.
Danish: - Brug ikke pakningen, hvis den er beskadiget eller viser tegn på at have været åbnet.
English: Infections and infestations Sinusitis
Danish: Infektioner og parasitære sygdomme Sinusitis
English: Treatment with Xolair in this open label study led to a 61% reduction in clinically significant asthma exacerbation rate compared to current asthma therapy alone.
Danish: Behandling med Xolair i dette ublindede studie medførte en reduktion på 61 % i hyppigheden for klinisk signifikant astmaeksacerbation sammenlignet med gængs astmaterapi alene.
English: Prescribing physicians should ensure that adult and adolescent patients with IgE below 76 IU/ml and children (6 to < 12 years of age) with IgE below 200 IU/ml have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy.
Danish: De ordinerende læger bør sikre, at voksne og unge patienter med IgE under 76 IE/ml og børn (6 til <12 år) med IgE under 200 IE/ml har en utvetydig in vitro-reaktivitet (RAST) for et helårsallergen, før behandlingen startes.
English: Allergic granulomatous vasculitis (i.e. Churg-Strauss syndrome)
Danish: Allergisk granulomatøs vaskulitis (dvs. Churg-Strauss-syndrom)
English: Use 1.4 ml and discard the rest.
Danish: Brug 1,4 ml og kassér resten af indholdet.
English: After discontinuation of Xolair, free IgE levels increased towards pre-treatment levels over a 16-week treatment-free follow-up period.
Danish: Efter seponering af Xolair steg frit IgE-niveau mod niveauet før behandling over en 16-ugers behandlingsfri opfølgningsperiode.
English: Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site.
Danish: Hold stemplet presset helt i bund, mens du forsigtigt løfter kanylen lige ud fra indsprøjtningsstedet.
English: In a clinical trial where Xolair was co-administered with immunotherapy, the safety and efficacy of Xolair in combination with specific immunotherapy were found to be no different to that of Xolair alone.
Danish: I et klinisk studie, hvor Xolair blev administreret samtidig med immunterapi, blev der ikke fundet nogen forskel i Xolairs sikkerhed og virkning i kombination med specifik immunterapi.
English: If your doctor decides that you or a caregiver may be able to give your injections of Xolair at home, you need to be trained by your doctor, nurse or pharmacist before you inject yourself or others.
Danish: Hvis din læge beslutter, at du eller en omsorgsperson kan give dig injektionen hjemme, er det vigtigt, at du eller omsorgspersonen er blevet undervist i at indsprøjte af lægen, sygeplejersken eller apotekspersonalet.
English: Not known (frequency cannot be estimated from the available data) - Churg-Strauss syndrome or hypereosinophilic syndrome.
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data) - Churg-Strauss syndrom eller hypereosinofilt syndrom.
English: The pharmacokinetics of omalizumab are linear at doses greater than 0.5 mg/kg.
Danish: Omalizumabs farmakokinetik er lineær ved doser på over 0,5 mg/kg.
English: The majority of anaphylactic reactions occurred within the first 3 doses of Xolair.
Danish: Størstedelen af anafylaktiske reaktioner opstod inden for de første 3 doser af Xolair.
English: Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE).
Danish: Omalizumab er en rekombinant dna-afledt humaniseret monoklonalt antistof, som selektivt bindes til humant immunglobulin E (IgE).
English: Multipack comprising 10 packs
Danish: Multipakning bestående af 10 pakninger
English: Holding the syringe horizontally, look into the viewing window to check the expiry date printed on the label.
Danish: Hold sprøjten vandret og kig ind i vinduet for at tjekke udløbsdatoen, der er printet på etiketten.
English: Children (6 to <12 years of age)
Danish: Børn (6 til <12 år)
English: Because omalizumab clearance at clinical doses is dominated by the reticular endothelial system (RES) it is unlikely to be altered by renal or hepatic impairment.
Danish: Da omalizumab-clearance ved kliniske doser domineres af det retikuloendoteliale system (RES), er det usandsynligt, at clearance ændres af nedsat nyre- eller leverfunktion.
English: The pathogenesis of SLE is not well understood.
Danish: Patogenesen for SLE kendes ikke i detaljer.
English: The safety and tolerability of omalizumab were investigated with doses of 75 mg, 150 mg and 300 mg every four weeks in 975 CSU patients, 242 of whom received placebo.
Danish: Omalizumabs sikkerhedsprofil og tolerabilitet blev undersøgt med doserne 75 mg, 150 mg og 300 mg hver fjerde uge hos 975 CSU-patienter, hvoraf 242 fik placebo.
English: Description of selected adverse reactions pertinent to allergic asthma and CSU indications No relevant data was obtained in clinical studies in CSU that would require a modification of the sections below.
Danish: Beskrivelse af udvalgte bivirkninger for indikationerne allergisk astma og CSU Der blev ikke opnået data i kliniske studier med CSU, hvor det vil være relevant at ændre i nedenstående afsnit.
English: A prospective pregnancy registry study (EXPECT) in 250 pregnant women with asthma exposed to Xolair showed the prevalence of major congenital anomalies was similar (8.1% vs. 8.9%) between EXPECT and disease-matched (moderate and severe asthma) patients.
Danish: Et prospektivt graviditetsregisterstudie (EXPECT) hos 250 gravide kvinder med astma, som blev eksponeret for Xolair, viste, at prævalensen af større medfødte anomalier var sammenlignelige (8,1 % vs. 8,9 %) mellem patienter i EXPECT og patienter med tilsvarende sygdom (moderat og svær astma).
English: Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.
Danish: Xolair er indiceret som tillægsterapi til behandling af kronisk spontan urticaria hos voksne og unge (12 år og derover) med utilstrækkeligt respons på H1-antihistaminbehandling.
English: Follow carefully all instructions given by your doctor or nurse.
Danish: Du skal nøje følge lægens eller sygeplejerskens vejledning.
English: The injections are administered subcutaneously in the deltoid region of the arm, the lower abdomen (but not the area 5 centimetres around the navel) or the thigh.
Danish: Injektionerne administreres subkutant i deltoideusmusklen, den nederste del af maven (men ikke området 5 cm omkring navlen) eller i låret.
English: A clinically significant exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose for at least 3 days and/or treatment with rescue systemic (oral or intravenous) corticosteroids for at least 3 days.
Danish: En klinisk signifikant eksacerbation blev defineret som en forværring af astmasymptomer, som blev klinisk bedømt af investigatoren, med behov for fordobling af baseline-inhalationskortikosteroiddosen i mindst 3 dage og/eller behandling med rescue-systemisk (oral eller intravenøst) kortikosteroid i mindst 3 dage.
English: c or use 0.6 ml from a 150 mg vial.
Danish: c eller anvend 0,6 ml fra et 150 mg-hætteglas.
English: The corresponding frequency category for each adverse reaction is based on 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 <1/1000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Den tilhørende hyppighed for hver bivirkning er baseret på følgende definition: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Omalizumab reduced the rate of asthma exacerbations by 19% (p = 0.153).
Danish: Omalizumab reducerede hyppigheden af astmaeksacerbationer med 19 % (p = 0,153).
English: Driving and using machines It is unlikely that Xolair will affect your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Det er ikke sandsynligt, at Xolair påvirker din evne til at føre motorkøretøj og betjene maskiner.
English: In these patients in study 1 Xolair reduced the rate of asthma exacerbations by 40% (p = 0.002).
Danish: Hos disse patienter i studie 1 reducerede Xolair hyppigheden af astmaeksacerbationer med 40 % (p=0,002).
English: In all three studies the mean weekly itch severity score increased gradually during the 16-week treatment-free follow-up period, consistent with symptom re-occurrence.
Danish: I alle tre studier steg den gennemsnitlige ugentlige score for sværhedsgrad af kløe gradvist i løbet af den 16-ugers behandlingsfri opfølgningsperiode, svarende til at symptomer vendte tilbage.