FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies conducted in mice treated with anti-IL-5 antibodies or genetically deficient in IL-5 or eosinophils have not shown impaired ability to clear parasitic infections.
Danish: Studier udført hos mus, der blev behandlet med anti-IL-5-antistoffer, eller som genetisk manglede IL-5 eller eosinofile celler, har ikke vist nedsat evne til at bekæmpe parasitinfektioner.
English: Investigation of a 40 mg subcutaneous dosing regimen administered every 4 weeks in children 6 to 11 years old over a 15-70 kg broad weight range by PK modelling and simulation predicts that the exposure of this dosing regimen would remain on average within 38% of adults at 100 mg.
Danish: Undersøgelse af et 40 mg subkutant doseringsregime givet hver 4. uge hos børn fra 6 til 11 år over et 15-70 kg bredt vægtinterval ved PK-modellering og -simulering forudser, at eksponeringen ved dette doseringsregime i gennemsnit vil forblive inden for 38 % af voksne ved 100 mg.
English: In 2 placebo-controlled studies the incidence of local injection site reactions with mepolizumab 100 mg subcutaneous and placebo was 8% and 3%, respectively.
Danish: I 2 placebokontrollerede studier var forekomsten af lokale reaktioner på administrationsstedet med mepolizumab 100 mg subkutant og placebo henholdsvis 8 % og 3 %.
English: Just prior to administration, remove 1 mL of reconstituted Nucala.
Danish: Umiddelbart før administration udtages 1 ml rekonstitueret Nucala.
English: In MEA115588 and in the double-blind placebo-controlled study 200862, there were 34 adolescents (12 to 17 years old).
Danish: MEA 115588-studiet og det dobbeltblindede, placebokontrollerede studie, 200862, inkluderede 34 unge (12 til 17 år).
English: The possible side effects of Nucala are unlikely to affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at bivirkningerne ved Nucala vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: White finger grip
Danish: Hvidt fingergreb
English: • Check the expiry date on the label of the syringe.
Danish: • Kontrollér udløbsdatoen på sprøjtens etiket.
English: Keep the skin pinched throughout your injection.
Danish: Hold huden klemt gennem din injektion.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Bortskaffelse Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: This study did not include a littering or functional offspring assessment.
Danish: I dette studie blev der ikke foretaget en vurdering af fødsler af kuld eller en funktionsundersøgelse af afkommet.
English: This could activate the pen too soon and may cause a needle injury.
Danish: Dette kan aktivere pennen for tidligt
English: • Place the pen straight onto your injection site with the yellow needle guard flat against the surface of your skin, as shown.
Danish: • Placér pennen lige på dit injektionssted med den gule kanylebeskyttelse fladt mod hudens overflade, som vist.
English: Based on population pharmacokinetic analyses, no dose adjustment is required in patients with creatinine clearance values between 50-80 mL/min.
Danish: På baggrund af farmakokinetiske populationsanalyser er det ikke nødvendigt at justere dosis hos patienter med kreatininclearance i intervallet 50-80 ml/min.
English: Before you use Nucala
Danish: Før du bruger Nucala
English: • Do not store it above 30°C.
Danish: • Må ikke opbevares ved temperaturer over 30 °C.
English: Instructions for reconstitution for each vial
Danish: Instruktion i rekonstitution for hvert hætteglas
English: Animal studies showed no adverse effects of anti-IL5 treatment on fertility (see section 5.3).
Danish: Dyrestudier viste ingen uønskede virkninger af anti-IL-5 på fertilitet (se pkt.
English: Asthma-related adverse symptoms or exacerbations may occur during treatment.
Danish: Der kan forekomme astmarelaterede symptomer eller eksacerbationer under behandlingen.
English: Do not warm the pen in a microwave, hot water, or direct sunlight.
Danish: Du må ikke opvarme pennen i mikrobølgeovn, varmt vand eller direkte sollys.
English: In clinical studies in subjects with severe refractory eosinophilic asthma, the most commonly reported adverse reactions during treatment were headache, injection site reactions and back pain.
Danish: I kliniske studier med personer med svær refraktær eosinofil astma var de hyppigst rapporterede bivirkninger under behandlingen hovedpine, reaktioner på injektionsstedet og rygsmerter.
English: Thirty-seven adolescents (aged 12-17) were enrolled in four placebo-controlled studies (25 mepolizumab treated intravenously or subcutaneously) of 24 to 52 weeks duration.
Danish: Syvogtredive unge (12-17 år) var indskrevet i fire placebokontrollerede studier (hvor 25 fik mepolizumab intravenøst eller subkutant) af 24 til 52 ugers varighed.
English: Common Rare
Danish: Almindelig Sjælden
English: Additional maintenance treatments included long-acting beta2 -adrenergic agonists (LABA), leukotriene modifiers, long-acting muscarinic antagonists (LAMA), theophylline, and oral corticosteroids (OCS).
Danish: Yderligere vedligeholdelsesbehandling inkluderede langtidsvirkende beta2-agonister (LABA), leukotrien-antagonister, langtidsvirkende antikolinergika (LAMA), theofyllin og orale kortikosteroider (OCS).
English: ≥500 cells/µL
Danish: ≥500 celler/ µl n
English: Nucala contains the active substance mepolizumab, a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body.
Danish: Nucala indeholder det aktive stof mepolizumab, som er et monoklonalt antistof, en slags protein designet til at genkende en bestemt substans i kroppen.
English: Patients were required to have a history of two or more severe asthma exacerbations requiring oral or systemic corticosteroid treatment in the past 12 months and reduced lung function at baseline (pre-bronchodilator FEV1<80% in adults and <90% in adolescents).
Danish: Patienterne skulle have haft to eller flere svære astma-eksacerbationer, der krævede oral eller systemisk behandling med kortikosteroider, i de forudgående 12 måneder samt nedsat lungefunktion ved baseline (præ-bronkodilatator FEV1 < 80 % hos voksne og < 90 % hos unge).
English: However, in the population pharmacokinetic analysis, there were no indications of an effect of age on the pharmacokinetics of mepolizumab over the age range of 12 to 82 years.
Danish: I den farmakokinetiske populationsanalyse var der dog ingen tegn på, at alder har indflydelse på farmakokinetikken af mepolizumab i aldersintervallet 12 til 82 år.
English: Oral corticosteroid reduction study MEA115575 (SIRIUS)
Danish: Oral kortikosteroid-reduktion studie MEA 115575- (SIRIUS)
English: You may need to pull the needle cap quite firmly to remove it.
Danish: Det kan være nødvendigt at trække ret fast for at fjerne kanylehætten.
English: • injection-site reaction (pain, redness, swelling, itching, and burning sensation of the skin near where the injection was given)
Danish: • reaktioner på injektionsstedet (smerter, rødme, hævelse, kløe, brændende fornemmelse i huden i området, hvor injektionen blev givet)
English: The reduction rate with mepolizumab was greater in patients with higher blood eosinophil counts.
Danish: Reduktionsraten med mepolizumab var større hos patienter med højere eosinofiltal i blodet.
English: Anti-mepolizumab antibodies did not discernibly impact the pharmacokinetics and pharmacodynamics of mepolizumab in the majority of patients and there was no evidence of a correlation between antibody titres and change in blood eosinophil level.
Danish: Hos størstedelen af patienterne påvirkede antimepolizumab-antistoffer ikke mærkbart farmakokinetikken og farmakodynamikken af mepolizumab, og der var ingen tegn på en korrelation mellem antistoftitre og ændring i niveauet af eosinofile celler i blodet.
English: Just prior to administration, remove 0.4mL of reconstituted Nucala.
Danish: Umiddelbart før administration udtages 0,4 ml rekonstitueret Nucala.
English: Some people get asthma-related side effects, or their asthma may become worse, during treatment with Nucala.
Danish: Nogle personer får astmarelaterede bivirkninger eller deres astma bliver værre under behandlingen med Nucala.
English: Nucala should be prescribed by physicians experienced in the diagnosis and treatment of severe refractory eosinophilic asthma.
Danish: Nucala skal ordineres af læger med erfaring i diagnosticering og behandling af svær refraktær eosinofil astma.
English: MEA115575 evaluated the effect of mepolizumab 100 mg administered subcutaneously on reducing the requirement for maintenance oral corticosteroids (OCS) while maintaining asthma control in subjects with severe refractory eosinophilic asthma.
Danish: MEA115575 vurderede effekten af mepolizumab 100 mg subkutant til at reducere behovet for orale kortikosteroider (OCS) som vedligeholdelsesbehandling under samtidig astmakontrol hos personer med svær refraktær eosinofil astma.
English: Following subcutaneous administration to healthy subjects or patients with asthma, mepolizumab was absorbed slowly with a median time to reach maximum plasma concentration (Tmax) ranging from 4 to 8 days.
Danish: Efter subkutan administration til raske personer eller patienter med astma blev mepolizumab absorberet langsomt med en mediantid til maksimal plasmakoncentration (Tmax) på 4-8 dage.
English: Worsening asthma
Danish: Forværring af astma
English: • Look in the inspection window to check that the liquid is clear (free from cloudiness or particles)
Danish: • Kig i inspektionsvinduet for at kontrollere, at væsken er klar (fri for sløring eller partikler) og farveløs til lysegul til lysebrun.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded in the patient file.
Danish: For at forbedre sporbarheden af biologiske lægemidler bør navnet og batchnummeret for det administrerede produkt registreres tydeligt i patientjournalen.
English: Mepolizumab 100 mg (subcutaneous) N= 194
Danish: Mepolizumab 100 mg (subkutant) N = 194
English: Ask your doctor or pharmacist for advice if necessary.
Danish: Spørg lægen eller apotekspersonalet, hvis nødvendigt.
English: Check the security seals are not broken.
Danish: Kontrollér, at sikkerhedsforseglingen ikke er brudt.
English: • Do not share your Nucala pre-filled syringe with another person.
Danish: • Du må ikke dele din Nucala fyldte sprøjte med en anden person.
English: In patients with asthma the absolute bioavailability of mepolizumab administered subcutaneously in the arm ranged from 74-80%.
Danish: Hos patienter med astma lå den absolutte biotilgængelighed af mepolizumab, administreret subkutant i armen, fra 74 til 80 %.
English: Instructions for administration of 40 mg dose 1.
Danish: Instruktion i administration af 40 mg dosis 1.
English: Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 10 seconds with circular motion at 15-second intervals until the powder is dissolved.
Danish: Roter forsigtigt hætteglasset i 10 sekunder med en cirkulær bevægelse hvert 15. sekund, indtil pulveret er opløst.
English: No impairment of fertility was observed in a fertility and general reproduction toxicity study in mice performed with an analogous antibody that inhibits IL-5 in mice.
Danish: Der blev ikke set nogen påvirkning af fertiliteten hos mus i et studie af fertilitet og generel reproduktionstoksicitet, som blev udført med et analogt antistof, der hæmmer IL-5 hos mus.
English: Start your injection
Danish: Start din injektion
English: Do not inject if the solution looks cloudy or discoloured, or has particles.
Danish: Du må ikke injicere, hvis opløsningen ser uklar eller misfarvet ud, eller indeholder partikler.
English: Following subcutaneous dosing in patients with asthma, mepolizumab exhibited approximately doseproportional pharmacokinetics over a dose range of 12.5 mg to 250 mg.
Danish: Efter subkutan dosering hos patienter med astma udviste mepolizumab en omtrentlig dosisproportional farmakokinetik over et dosisinterval på 12,5 mg til 250 mg.
English: The table below presents the adverse reactions from the two placebo-controlled studies in patients receiving mepolizumab 100 mg subcutaneously (n=263).
Danish: Nedenstående tabel viser bivirkningerne fra de to placebokontrollerede studier hos patienter, der fik mepolizumab 100 mg subkutant (n = 263).
English: Eosinophils may be involved in the immunological response to some helminth infections.
Danish: Eosinofile celler kan være involveret i det immunologiske respons på nogle ormeinfektioner.
English: Dispose 9.
Danish: Bortskaf 9.
English: The primary endpoint was the percent reduction in daily OCS dose (weeks 20-24), whilst maintaining asthma control by defined dose reduction categories (see Table 4).
Danish: Det primære endepunkt var reduktion i procent i den daglige OCS-dosis (uge 20-24) i henhold til definerede dosisreduktionskategorier (se tabel 4) samtidig med, at astmaen forblev under kontrol.
English: Make sure you have within reach:
Danish: Sørg for at du har følgende inden for rækkevidde:
English: Intravenous and subcutaneous administration to monkeys was associated with reductions in peripheral and lung eosinophil counts, with no toxicological findings.
Danish: Intravenøs og subkutan administration til aber var forbundet med reduktion i eosinofiltallene perifert og i lungerne uden toksikologiske fund.
English: Do not warm the syringe in a microwave, hot water, or direct sunlight.
Danish: Du må ikke opvarme sprøjten i mikrobølgeovn, varmt vand eller direkte sollys.
English: Contents of the pack and other information What Nucala contains
Danish: Pakningsstørrelser og yderligere oplysninger Nucala indeholder:
English: • Remove the needle cap from the syringe by firmly pulling it straight off, extending your hand away from the needle end (as shown).
Danish: • Fjern kanylehætten fra sprøjten ved at trække den fast og lige af, idet du strækker din hånd væk fra kanylespidsen (som vist).
English: This medicine is not intended for use in children below 6 years of age.
Danish: Denne medicin er ikke beregnet til børn under 6 år.
English: Since mepolizumab is degraded by widely distributed proteolytic enzymes, not restricted to hepatic tissue, changes in hepatic function are unlikely to have any effect on the elimination of mepolizumab.
Danish: Da mepolizumab nedbrydes af proteolytiske enzymer, som findes vidt udbredt i kroppen og ikke kun i levervæv, er det ikke sandsynligt, at ændringer i leverfunktionen har nogen effekt på eliminationen af mepolizumab.
English: Tell your doctor or nurse if your asthma remains uncontrolled, or gets worse, after you start Nucala treatment.
Danish: Fortæl lægen eller sundhedspersonalet, hvis din astma ikke kommer under kontrol, eller hvis den bliver værre, efter at du er startet behandlingen med Nucala.
English: Instructions for administration of 100 mg dose 1.
Danish: Instruktion i administration af 100 mg dosis 1.
English: Following a single intravenous administration to patients with asthma, the mean systemic clearance (CL) ranged from 1.9 to 3.3 mL/day/kg, with a mean terminal half-life of approximately 20 days.
Danish: Efter en enkelt intravenøs injektion til patienter med astma lå den gennemsnitlige systemiske clearance (CL) i intervallet 1,9-3,3 ml/dag/kg med en gennemsnitlig terminal halveringstid (t½) på ca. 20 dage.
English: Mepolizumab is a humanised monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Danish: Mepolizumab er et humaniseret monoklonalt antistof produceret i ovarieceller fra kinesisk hamster ved rekombinant DNA-teknologi.
English: Complete your injection
Danish: Fuldfør din injektion
English: Table 3: Combined analysis of the rate of clinically significant exacerbations by baseline blood eosinophil count in patients with severe refractory eosinophilic asthma
Danish: Tabel 3: Kombineret analyse af hyppigheden af klinisk signifikante af eksacerbationer i forhold til baseline eosinofiltal i blodet hos patienter med svær refraktær eosinofil astma.
English: Each vial of Nucala should be used for a single patient, and any remainder of the vial should be discarded.
Danish: Hvert hætteglas af Nucala må kun anvendes til én enkelt patient, hvorefter hætteglasset skal kasseres.
English: Any unused concentrate or solution remaining after 8 hours must be discarded.
Danish: Eventuelt ubrugt koncentrat eller injektionsvæske, der er tilovers efter 8 timer, skal kasseres.
English: After use, the automatic needle guard is activated and pulls up (retracts) the needle.
Danish: Efter brug aktiveres den automatiske kanylebeskyttelse og trækker kanylen op.
English: • Remove the tray from the carton.
Danish: • Fjern bakken fra kartonen.
English: For examples of the associated manifestations reported and a description of the time to onset, see section 4.4.
Danish: Eksempler på rapporterede symptomer i forbindelse med disse samt en beskrivelse af tiden til indtræden findes i pkt.
English: • Do not use the pen if it appears damaged.
Danish: • Du må ikke bruge pennen, hvis den ser ud til at være beskadiget.
English: Lower respiratory tract infection Urinary tract infection Pharyngitis
Danish: Infektion i nedre luftveje Urinvejsinfektion Faryngitis
English: 1 pre-filled pen.
Danish: 1 fyldt pen.
English: Paediatric pharmacokinetics was largely predictable from adults, after taking into account bodyweight.
Danish: Farmakokinetikken hos pædiatriske personer kunne i stor udstrækning forudsiges ud fra farmakokinetikken hos voksne efter at have taget højde for kropsvægt.
English: Make sure the security seals are not broken
Danish: Kontrollér, at sikkerhedsforseglingen ikke er brudt
English: • upper abdominal pain (stomach pain or discomfort in the upper area of the stomach)
Danish: • smerter eller ubehag i den øvre del af maven
English: Patients received mepolizumab 100 mg administered subcutaneously, mepolizumab 75 mg administered intravenously or placebo treatment once every 4 weeks over 32 weeks.
Danish: Patienterne fik mepolizumab 100 mg subkutant, mepolizumab 75 mg intravenøst eller placebo én gang hver 4. uge over 32 uger.
English: Following subcutaneous administration of mepolizumab the mean terminal half-life (t1/2) ranged from 16 to 22 days.
Danish: Efter subkutan administration af mepolizumab lå den gennemsnitlige terminale halveringstid i intervallet 16-22 dage.
English: The posology of Nucala in children and adolescents aged between 6 to 17 years old with severe refractory eosinophilic asthma has been determined by limited efficacy, pharmacokinetic and pharmacodynamic studies and supported by modelling and simulation data (see sections 5.1 and 5.2).
Danish: Doseringen af Nucala til børn og unge fra 6 til 17 år med svær refraktær eosinofil astma er blevet bestemt ved begrænsede virknings, farmakokinetiske og farmakodynamiske studier og er understøttet af modellerings- og simuleringsdata (se pkt.
English: Failure to follow these instructions may affect proper function of the pre-filled syringe.
Danish: Hvis disse instruktioner ikke følges, kan den fyldte sprøjtes korrekte funktion påvirkes.
English: mg (for a weight < 40kg) or 100 mg (for a weight ≥ 40 kg) was 1.32 and 1.97 times of that observed in adults at 100 mg.
Danish: Eksponering efter subkutan dosering af enten 40 mg (for en kropsvægt < 40 kg) eller 100 mg (for en kropsvægt ≥ 40 kg) var henholdsvis 1,32 og 1,97 gange større end det observerede hos voksne ved 100 mg.
English: Tell your doctor before you are given Nucala.
Danish: Fortæl det til lægen, før du får Nucala.
English: • Stored below 30°C, not frozen
Danish: • opbevares ved temperaturer under 30 °C og over frysepunktet
English: Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of mepolizumab.
Danish: CYP-enzymer, efflukspumper og proteinbindende mekanismer er ikke involveret i clearence af mepolizumab.
English: Exacerbation rate/year Percent reduction
Danish: Eksacerbationsrate/år Reduktion udtrykt i procent
English: Paediatric pharmacokinetics were broadly consistent with adults and adolescents after accounting for bodyweight and bioavailability.
Danish: Farmakokinetikken hos pædiatriske patienter var stort set i overensstemmelse med den hos voksne og unge efter at have taget hensyn til kropsvægt og biotilgængelighed.
English: If you (or your child) may have had a similar reaction to any injection or medicine: Tell your doctor before you are given Nucala.
Danish: Hvis du (eller dit barn) nogensinde har haft en lignende reaktion på en injektion eller et lægemiddel: Fortæl det til lægen, før du får Nucala.
English: Note: The reconstituted solution must not be shaken during the procedure as this may lead to product foaming or precipitation.
Danish: Bemærk: Den rekonstituerede injektionsvæske må ikke omrystes under proceduren, da dette kan medføre skumdannelse eller give bundfald.
English: Patients had a blood eosinophil count of ≥150/µL at baseline or a blood eosinophil count of ≥300/µL in the 12 months prior to screening.
Danish: Patienterne havde et eosinofiltal i blodet på ≥ 150/µl ved baseline eller et eosinofiltal i blodet på ≥ 300 celler/μl i de forudgående 12 måneder før screeningen.
English: Do not touch the needle.
Danish: Du må ikke røre kanylen.
English: In the placebo-controlled trials, 15/260 (6%) of adults and adolescents treated with 100 mg dose subcutaneously had detectable anti-mepolizumab antibodies after having received at least one dose of mepolizumab.
Danish: I de placebokontrollerede studier havde 15/260 (6 %) af de voksne og unge, der fik 100 mg subkutant, målbare anti-mepolizumabantistoffer efter at have fået mindst én dosis mepolizumab.
English: Median % reduction in daily OCS dose from baseline (95% CI) Median difference (95% CI) p-value
Danish: Median reduktion i procent i daglig OCS-dosis i forhold til baseline (95 % konfidensinterval) Median forskel (95 % konfidensinterval) p-værdi
English: Failure to follow these instructions may affect proper function of the pre-filled pen.
Danish: Hvis disse instruktioner ikke følges, kan den fyldte pens korrekte funktion påvirkes.
English: Do not use the syringe if the security seal on the carton is broken.
Danish: Du må ikke bruge sprøjten, hvis sikkerhedsforseglingen på kartonen er brudt.
English: Each vial contains 100 mg mepolizumab (100 mg/ml after reconstitution)
Danish: Hvert hætteglas indeholder 100 mg mepolizumab (100 mg/ml efter rekonstitution)
English: Do not use the pen if the security seal on the carton is broken.
Danish: Du må ikke bruge pennen, hvis sikkerhedsforseglingen på kartonen er brudt.
English: Do not use the pen if left out of the carton for more than 8 hours.
Danish: Du må ikke bruge pennen, hvis den har været uden for kartonen i mere end 8 timer.
English: For subcutaneous administration, a 1 mL polypropylene syringe fitted with a disposable needle 21 gauge to 27 gauge x 0.5 inch (13 mm) should preferably be used.
Danish: Til subkutan administration skal der helst bruges en 1 ml polypropylen-sprøjte med en engangsnål i dimensionerne 21 gauge til 27 gauge x 13 mm (0,5 tommer).
English: The stream of sterile water should be directed vertically, onto the centre of the lyophilised cake.
Danish: Strålen af det sterile vand skal rettes lodret ned mod midten af det frysetørrede pulver.
English: Choose your injection site
Danish: Vælg dit injektionssted
English: • Remove the clear needle cap from the pen by firmly pulling it straight off.
Danish: • Fjern den klare kanylehætte fra pennen ved at trække den fast og lige af.
English: EDTA disodium dihydrate Water for injections
Danish: EDTA-dinatriumdihydrat Vand til injektionsvæsker
English: Do not use the syringe if left out of the carton for more than 8 hours.
Danish: Du må ikke bruge sprøjten, hvis den har været uden for kartonen i mere end 8 timer.
English: The pre-filled pen is not intended for use in children below 12 years of age.
Danish: Den fyldte pen er ikke beregnet til børn under 12 år.