FrancophonIA/ELRC3.0 huggingface dataset:
English: The potential for harm to a human fetus is unknown.
Danish: Potentialet for skadelige virkninger hos menneskefostre kendes ikke.
English: MEA112997+MEA115588 <150 cells/µL
Danish: MEA 112997+MEA115588 <150 celler/ µl n
English: Neutralising antibodies were detected in one adult subject.
Danish: Der blev målt neutraliserende antistoffer hos én voksen person.
English: The pre-filled pen or pre-filled syringe must be administered within 8 hours once the pack is opened.
Danish: Den fyldte pen eller fyldte sprøjte skal administreres inden for 8 timer efter åbning af pakningen.
English: In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: In the population pharmacokinetic analysis estimated mepolizumab systemic clearance was 3.1 mL/day/kg.
Danish: I den farmakokinetiske populationsanalyse var den estimerede systemiske clearance af mepolizumab 3,1 ml/dag/kg.
English: Nucala contains sodium
Danish: Nucala indeholder natrium
English: For self-administration the recommended injection sites are the abdomen or thigh.
Danish: Ved selvadministration er de anbefalede injektionssteder abdomen eller låret.
English: No additional adverse reactions were identified.
Danish: Der blev ikke identificeret nogen yderligere bivirkninger.
English: Do not use the pen if the yellow needle guard doesn't slide up as described.
Danish: Du må ikke bruge pennen, hvis den gule kanylebeskyttelse ikke glider op som beskrevet.
English: • Check the expiry date on the label of the pen.
Danish: • Kontrollér udløbsdatoen på pennens etiket.
English: There are no data regarding the excretion of mepolizumab in human milk.
Danish: Der er ingen data vedrørende udskillelse af mepolizumab i human mælk.
English: • Do not shake the pen.
Danish: • Du må ikke ryste pennen.
English: Do not lift the pen until you are sure you have completed your injection.
Danish: Du må ikke løfte pennen, før du er sikker på, at du har fuldført injektionen.
English: • Discarded if not used within 8 hours of reconstitution
Danish: • kasseres, hvis den ikke bruges inden for 8 timer efter rekonstitution.
English: Nucala should not be used to treat acute asthma exacerbations.
Danish: Nucala bør ikke anvendes til behandling af akutte astma-eksacerbationer.
English: However, mepolizumab was excreted into the milk of cynomolgous monkeys at concentrations of less than 0.5% of those detected in plasma.
Danish: Mepolizumab blev dog udskilt i mælken hos cynomolgusaber i koncentrationer, der var lavere end 0,5 % af de koncentrationer, der blev målt i plasma.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeated dose toxicity studies in monkeys.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi eller fra toksicitetsstudier med gentagne doser hos aber.
English: • Clean your injection site by wiping the skin with an alcohol wipe and allowing the skin to air dry.
Danish: • Rengør dit injektionssted ved at rense din hud med en alkoholserviet og lade huden lufttørre.
English: • fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)
Danish: • besvimelse, svimmelhed, omtågethed (på grund af fald i blodtrykket)
English: Do not touch the plunger at this stage, as you can accidentally push liquid out and will not receive your full dose.
Danish: Du må ikke røre stemplet på dette tidspunkt, da du ved et uheld kan skubbe væske ud og ikke modtage din fulde dosis.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Mepolizumab, the active substance in Nucala, blocks a protein called interleukin-5.
Danish: Mepolizumab, det aktive stof i Nucala, blokerer et protein, der kaldes interleukin-5.
English: Following a single subcutaneous administration in the abdomen, thigh or arm of healthy subjects, mepolizumab absolute bioavailability was 64%, 71% and 75%, respectively.
Danish: Efter en enkelt subkutan administration i abdomen, låret eller armen hos raske personer var den absolutte biotilgængelighed af mepolizumab henholdsvis 64 %, 71 % og 75 %.
English: If appropriate, they will then provide training to show you or your caregiver the correct way to use Nucala.
Danish: Hvis det er hensigtsmæssigt, vil de give dig eller din plejeperson træning i den korrekte måde at bruge Nucala på.
English: Following administration of a single 100 mg subcutaneous dose in healthy subjects, mepolizumab systemic exposure was comparable between formulations.
Danish: Efter administration af en enkelt 100 mg subkutan dosis hos raske forsøgspersoner var den systemiske eksponering for mepolizumab sammenlignelig mellem formuleringer.
English: Primary endpoint Frequency of clinically significant exacerbations
Danish: Primært endepunkt Hyppighed af klinisk signifikante eksacerbationer
English: • To start your injection, push the pen down all the way and keep it held down against your skin.
Danish: • For at starte din injektion skal du trykke pennen helt ned og holde den nede mod din hud.
English: If you may have had a similar reaction to any injection or medicine:
Danish: Hvis du nogensinde har haft en lignende reaktion på en injektion eller et lægemiddel:
English: Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT United Kingdom
Danish: Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT Storbritannien
English: The pack should be discarded if not administered within 8 hours.
Danish: Pakningen skal kassérs, hvis den ikke administreres inden for 8 timer.
English: These may affect up to 1 in 1,000 people: • Severe allergic reactions (anaphylaxis)
Danish: Kan forekommer hos op til 1 ud af 1.000 personer: • alvorlige allergiske reaktioner (anafylaksi).
English: There are limited pharmacokinetic data available in elderly patients (≥65 years old) across all clinical studies (N=90).
Danish: Der er begrænsede farmakokinetiske data tilgængelige fra ældre patienter (≥ 65 år) på tværs af de kliniske studier (N = 90).
English: 2nd “Click”
Danish: Andet “klik”
English: • Do not worry if you see a drop of liquid at the end of the needle.
Danish: • Vær ikke bekymret, hvis du ser en dråbe væske ved kanylens spids.
English: Seek medical attention immediately if you think you (or your child) may be having a reaction.
Danish: Søg straks lægehjælp, hvis du tror, at du (eller dit barn) har en allergisk reaktion.
English: Table 2 provides the results of the primary and secondary endpoints for patients treated with subcutaneous mepolizumab or placebo.
Danish: Tabel 2 viser resultaterne for de primære og sekundære endepunkter for patienter, der fik subkutant mepolizumab eller placebo.
English: Check the expiry date
Danish: Kontrollér udløbsdatoen
English: Do not use Nucala after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke Nucala efter den udløbsdato, der står på etiketten og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Inject 6.
Danish: Injicér 6.
English: If you think you have injected too much Nucala, contact your doctor for advice.
Danish: Hvis du tror, at du har injiceret for meget Nucala, skal du kontakte din læge.
English: Local injection site reactions Pyrexia
Danish: Lokale reaktioner på injektionsstedet Pyreksi
English: The primary endpoint was the frequency of clinically significant exacerbations of asthma and the reductions for both mepolizumab treatment arms compared to placebo were statistically significant (p<0.001).
Danish: Det primære endepunkt var nedsat hyppighed af klinisk signifikante astmaeksacerbationer, og reduktionerne i begge behandlingsarme med mepolizumab var statistisk signifikante sammenlignet med placebo (p < 0,001).
English: By blocking the action of this protein, it limits the production of more eosinophils from the bone marrow and lowers the number of eosinophils in the bloodstream and the lungs.
Danish: Ved at blokere for aktiviteten af dette protein begrænser Nucala dannelsen af flere eosinofile celler fra knoglemarven og nedsætter antallet af eosinofile celler i blodbanen og lungerne.
English: There is no specific treatment for an overdose with mepolizumab.
Danish: Der findes ingen specifik behandling af overdosering med mepolizumab.
English: Do not inject within 5 cm of your navel (belly button).
Danish: Du må ikke injicere inden for 5 cm af navlen.
English: Do not touch your injection site again until you have finished your injection.
Danish: Du må ikke røre dit injektionssted igen, før du er færdig med din injektion.
English: Data in cynomolgus monkeys demonstrate that mepolizumab crossed the placenta.
Danish: Data fra cynomolgusaber viste, at mepolizumab passer placenta.
English: The solution for injection can be stored between 2°C to 30°C for no more than 8 hours.
Danish: Injektionsvæsken kan opbevares ved 2 °C til 30 °C i maksimalt 8 timer.
English: The reconstituted solution, if not used immediately must be:
Danish: Hvis den rekonstituerede injektionsvæske ikke bruges med det samme, skal den:
English: Nucala is for subcutaneous injection only and should be administered by a healthcare professional.
Danish: Nucala er kun til subkutan injektion og skal administreres af sundhedspersonale.
English: The pre-filled pen should be used only once and then discarded.
Danish: Den fyldte pen må kun anvendes én gang og derefter kasseres.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen
English: Abrupt discontinuation of corticosteroids after initiation of Nucala therapy is not recommended.
Danish: Pludselig seponering af kortikosteroider efter indledning af behandling med Nucala anbefales ikke.
English: After removal, do not put the needle cap back onto the pen, as it may accidentally start the injection.
Danish: Efter fjernelse må du ikke sætte kanylehætten tilbage på pennen, da det ved et uheld kan starte injektionen.
English: The most common manifestations reported with these events included pain, erythema, swelling, itching, and burning sensation.
Danish: De hyppigste symptomer, der blev rapporteret i forbindelse med disse reaktioner, omfattede smerte, erytem, hævelse, kløe og en brændende fornemmelse.
English: • urinary tract infection (blood in urine, painful and frequent urination, fever, pain in lower back)
Danish: • urinvejsinfektion (blod i urinen, smertefuld og hyppig vandladning, feber, lændesmerter)
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX09.
Danish: Farmakoterapeutisk klassifikation: Midler mod obstruktiv lungesygdom, andre systemiske midler mod obstruktiv lungesygdom, ATC-kode: R03DX09.
English: This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, i.e., it is essentially “sodiumfree”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. 100 mg dosis, dvs. det er i det væsentlige natriumfrit.
English: The powder should be reconstituted prior to administration and the reconstituted solution should be used immediately.
Danish: Pulveret skal rekonstitueres før administration og den rekonstituerede injektionsvæske skal anvendes med det samme.
English: Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Danish: Patienten skal informeres om at søge lægehjælp, hvis deres astma ikke kommer under kontrol, eller hvis den forværres efter indledning af behandlingen.
English: If a dose of Nucala 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 Nucala Kontakt lægen eller hospitalet så hurtigt som muligt for at lave en ny aftale.
English: Reconstitute the contents of the vial with 1.2 mL of sterile water for injections preferably using a 2
Danish: Rekonstituér indholdet af hætteglasset med 1,2 ml sterilt vand til injektionsvæsker og brug helst en
English: The relevance of these findings for humans is unknown.
Danish: Den kliniske relevans for mennesker af disse fund kendes ikke.
English: Table 1: Frequency of clinically significant exacerbations at week 52 in the intent to treat population
Danish: Tabel 1: Hyppighed af klinisk signifikante eksacerbationer ved uge 52 i intent to treat (ITT) populationen
English: If you already have a parasitic infection; it should be treated before you start treatment with Nucala.
Danish: Hvis du allerede har en parasitinfektion, skal den behandles, før du starter behandling med Nucala.
English: In a combined analysis of these studies, a 40% reduction in clinically significant exacerbations was observed in adolescents following mepolizumab treatment compared to placebo (rate ratio 0.60; 95% CI: 0.17, 2.10).
Danish: I en kombineret analyse af disse studier blev der observeret en reduktion på 40 % af klinisk signifikante eksacerbationer hos unge efter behandling med mepolizumab sammenlignet med placebo (rate ratio 0,60, 95 % konfidensinterval: 0,17; 2,10).
English: As mepolizumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted.
Danish: Da mepolizumab er et monoklonalt antistof, er der ikke udført genotoksicitets- og karcinogenicitetsstudier.
English: Secondary endpoints Frequency of exacerbations requiring hospitalisations/emergency room visits
Danish: Sekundære endepunkter Hyppighed af eksacerbationer, der kræver hospitalsindlæggelser/skadestuebesøg
English: Patients continued to receive their existing asthma medicine during the study with the exception of their OCS dose which was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained.
Danish: Patienterne fortsatte med deres nuværende astmamedicin under studiet med undtagelse af OCS-dosis, der blev reduceret hver 4. uge i fasen med reduktion af OCS (uge 4-20), så længe astmaen forblev under kontrol.
English: It is not known whether the ingredients of Nucala can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i Nucala går over i mælken hos mennesker.
English: There are limited pharmacokinetic data available in the paediatric population (59 subjects with eosinophilic esophagitis, 55 subjects with severe refractory eosinophilic asthma).
Danish: Der er begrænsede farmakokinetiske data tilgængelige for den pædiatriske population (59 personer med eosinofil øsofagitis, 55 personer med svær refraktær eosinofil astma).
English: • Make sure the plunger is pushed all the way down, until the stopper reaches the bottom of the syringe and all of the solution is injected.
Danish: • Sørg for, at stemplet trykkes helt ned, indtil proppen når bunden af sprøjten, og hele opløsningen er injiceret.
English: Reduction in the daily OCS dose to 0 mg/d
Danish: Reduktion i daglig OCS-dosis til 0 mg/dag
English: The trade name (Nucala) and batch number of the administered product should be clearly recorded in the patient file.
Danish: Handelsnavnet (Nucala) og batchnummeret for det administrerede produkt skal registreres tydeligt i patientjournalen.
English: This condition is called eosinophilic asthma - the type of asthma Nucala can treat.
Danish: Denne tilstand kaldes eosinofil astma, og det er den type astma, som Nucala kan behandle.
English: Patients were administered mepolizumab or placebo treatment once every 4 weeks over the treatment period.
Danish: Patienterne fik mepolizumab eller placebo én gang hver 4. uge i behandlingsperioden.
English: • You can inject Nucala into your thighs or abdomen.
Danish: • Du kan injicere Nucala i dine lår eller maven.
English: Table 2: Results of primary and secondary endpoints at week 32 in the intent to treat population (MEA115588)
Danish: Tabel 2: Resultater for primære og sekundære endepunkter ved uge 32 i intent to treat (ITT) populationen (MEA115588)
English: A caregiver can also inject Nucala into the upper arm.
Danish: En plejeperson kan også injicere Nucala i overarmen.
English: Nucala has no or negligible influence on the ability to drive and use machines.
Danish: Nucala påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Medicines of this type (monoclonal antibodies) can cause severe allergic reactions when injected into the body (see section 4, ‘Possible side effects').
Danish: Allergiske reaktioner og reaktioner på injektionsstedet Lægemidler af denne type (monoklonale antistoffer) kan forårsage alvorlige allergiske reaktioner, når de injiceres i kroppen (se punkt 4 'Bivirkninger').
English: A decision must be made whether to discontinue breast-feeding or to discontinue Nucala therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Nucala seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Hold the pen in place to complete your injection
Danish: Hold pennen på plads for at fuldføre injektionen
English: Lyophilised white powder.
Danish: Frysetørret, hvidt pulver.
English: • Hold the pen with its inspection window facing towards you, so you can see it, and with the yellow needle guard facing down.
Danish: • Hold pennen med inspektionsvinduet vendt mod dig, så du kan se det, og med den gule kanylebeskyttelse vendt nedad.
English: No decrease in OCS/lack of asthma control/ withdrawal from treatment Odds ratio (95% CI) p-value
Danish: Ingen reduktion i OCS/ manglende astmakontrol/ seponering af behandling Odds ratio (95 % konfidensinterval) p-værdi
English: • Do not remove the needle cap until just before your injection.
Danish: • Du må ikke fjerne kanylehætten før lige inden din injektion.
English: These medicines (especially ones called corticosteriods) must be stopped gradually, under the direct supervision of your doctor and dependant on your response to Nucala.
Danish: Disse lægemidler (især dem, der kaldes kortikosteroider) skal nedtrappes gradvist under direkte overvågning af lægen og afhængigt af, hvordan Nucala virker på dig.
English: Mepolizumab is a humanised monoclonal antibody (IgG1, kappa), which targets human interleukin-5 (IL-5) with high affinity and specificity.
Danish: Mepolizumab er et humaniseret monoklonalt antistof (IgG1, kappa), der retter sig mod humant interleukin-5 (IL-5) med høj affinitet og specificitet.
English: Increased levels of pro-inflammatory cytokines (e.g. IL-6), via interaction with their cognate receptors on hepatocytes, have been shown to suppress the formation of CYP450 enzymes and drug transporters, however, elevation of systemic pro-inflammatory markers in severe refractory eosinophilic asthma is minimal and there is no evidence of IL-5 receptor alpha expression on hepatocytes.
Danish: Forhøjede niveauer af pro-inflammatoriske cytokiner (f.eks. IL-6), via interaktion med deres beslægtede hepatocytreceptorer, er vist at undertrykke dannelsen af CYP-enzymer og lægemiddeltransportører, dog er stigningen i systemiske pro-inflammatoriske markører ved svær refraktær eosinofil astma minimal, og der er ingen tegn på IL-5-alfa-receptor-ekspression af hepatocytter.
English: Reduction in the daily OCS dose to ≤5mg/day
Danish: Reduktion i daglig OCS-dosis til ≤ 5 mg/dag
English: Dispose of the used pen
Danish: Bortskaf den brugte pen
English: These may affect more than 1 in 10 people: • headache
Danish: Kan forekomme hos flere end 1 ud af 10 personer: • hovedpine.
English: The active substance is mepolizumab.
Danish: Aktivt stof: mepolizumab.
English: Of these 34 subjects: 12 received placebo, 9 received mepolizumab 75 mg intravenously, and 13 received 100 mg subcutaneously.
Danish: Af disse 34 personer fik 12 personer placebo, 9 personer fik mepolizumab 75 mg intravenøst og 13 personer 100 mg subkutant.
English: Mepolizumab inhibits the bioactivity of IL-5 with nanomolar potency by blocking the binding of IL-5 to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface, thereby inhibiting IL-5 signalling and reducing the production and survival of eosinophils.
Danish: Mepolizumab hæmmer bioaktiviteten af IL-5 med nanomolær styrke ved at blokere bindingen af IL-5 til alfa-kæden i IL-5receptorkomplekset, der er udtrykt på overfladen af eosinofile celler, hvorved den IL-5-inducerede signalering hæmmes, og produktionen og overlevelsen af de eosinofile celler nedsættes.
English: Single doses of up to 1,500 mg were administered intravenously in a clinical trial to patients with eosinophilic disease without evidence of dose-related toxicities.
Danish: I et klinisk studie blev enkeltdoser på op til 1.500 mg administreret intravenøst til patienter med eosinofil sygdom uden tegn på dosisrelateret toksicitet.
English: Don't suddenly stop taking your preventer medicines for your asthma once you have started Nucala.
Danish: Stop ikke pludseligt med at tage dine lægemidler til at forebygge din astma, efter du er startet med Nucala.
English: Parasitic infections
Danish: Parasitinfektioner
English: The baseline mean prednisone equivalent dose was approximately 13 mg per day.
Danish: Den gennemsnitlige prednison-ækvivalente dosis var ca. 13 mg pr. dag ved baseline.
English: Seek medical attention immediately if you think you or your child may be having a reaction.
Danish: Søg straks lægehjælp, hvis du tror, at du eller dit barn har en allergisk reaktion.
English: Exacerbation reduction MEA115588 (MENSA) study
Danish: Eksacerbation-reduktion studie MEA115588 (MENSA)
English: • Do not share your Nucala pre-filled pen with another person.
Danish: • Du må ikke dele din Nucala fyldte pen med en anden person.
English: If patients become infected whilst receiving treatment with Nucala and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Danish: Hvis patienten bliver inficeret under behandling med Nucala og ikke responderer på en ormekur, bør det overvejes at afbryde behandlingen midlertidigt.
English: If the solution is cloudy, discoloured or contains particles, the solution should not be used.
Danish: Hvis opløsningen er uklar, misfarvet eller indeholder partikler, bør opløsningen ikke anvendes.
English: The two exacerbations studies MEA112997 and MEA115588 enrolled a total of 1192 patients, 60% females, with a mean age of 49 years (range 12- 82).
Danish: De to eksacerbationsstudier, MEA112997 og MEA115588, inkluderede i alt 1.192 patienter, hvoraf 60 % var kvinder og gennemsnitsalderen 49 år (interval 12-82).
English: Intravenous Mepolizumab
Danish: Intravenøs mepolizumab
English: Table 3 shows the results of a combined analysis of the two exacerbation studies (MEA112997 and MEA115588) by baseline blood eosinophil count.
Danish: Tabel 3 viser resultaterne af en kombineret analyse af to eksacerbationsstudier (MEA112997 og MEA115588) i forhold til baseline eosinofiltal i blodet.
English: Eosinophils are thought to be associated with immune system responses to some parasitic infections.
Danish: Eosinofile celler menes at være forbundet med immunsystemresponser på nogle parasitinfektioner.
English: GlaxoSmithKline LLC 893 River Road Conshohocken, PA 19428
Danish: GlaxoSmithKline LLC 893 River Road Conshohocen, PA19428
English: Open-label extension studies in severe refractory eosinophilic asthma MEA115666 (COLUMBA), MEA115661 (COSMOS) and 201312 (COSMEX)
Danish: Åbne forlængelsesstudier med svær refraktær eosinofil astma MEA115666 (COLOMBA), MEA115661 (COSMOS) og 201312 (COSMEX)