FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy measure for both Studies I and II was the frequency of asthma exacerbations for each patient during the 52-week treatment period.
Danish: Det primære virkningsmål for både studie I og II var hyppigheden af astmaeksacerbationer for hver patient i løbet af behandlingsperioden på 52 uger.
English: Your doctor or nurse will watch you closely during and after your infusion for signs of an allergic reaction.
Danish: Lægen eller sundhedspersonerne vil observere dig nøje under og efter infusionen for tegn på en allergisk reaktion.
English: It is unlikely that CINQAERO will affect your ability to drive and use machines.
Danish: Det er ikke sandsynligt, at CINQAERO vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: No formal clinical drug interaction studies have been performed with reslizumab.
Danish: Der er ikke udført formelle kliniske lægemiddelinteraktionsstudier med reslizumab.
English: If the solution for infusion has been stored in a refrigerator, allow it to reach room temperature (15 °C-25 °C).
Danish: Hvis infusionsvæsken er blevet opbevaret i køleskab, skal den have tid til at opnå stuetemperatur (15 °C-25 °C).
English: Serious allergic reactions have occurred in patients receiving this medicine (see section “4.
Danish: Alvorlige allergiske reaktioner er opstået hos patienter, der har fået dette lægemiddel (se punkt 4 ”Bivirkninger”).
English: The recommended dose is achieved using the vial-based dosing scheme in Table 1 below.
Danish: Den anbefalede dosis opnås med det hætteglas-baserede doseringsskema, der er vist i tabel 1 nedenfor.
English: Improvements were observed as early as 4 weeks following the first dose of reslizumab (AQLQ at 16 weeks) and sustained through week 52.
Danish: Forbedringer blev observeret så tidligt som 4 uger efter den første dosis reslizumab (AQLQ ved uge 16) og blev opretholdt til og med uge 52.
English: The volume (in mL) required from the vial(s) should be calculated as follows: 0.3 x patient body weight (in kg).
Danish: Det nødvendige volumen (i ml) fra hætteglasset/hætteglassene skal beregnes på følgende måde: 0,3 x patientens legemsvægt (i kg).
English: Afterwards, CINQAERO could be used during breast-feeding if appropriate.
Danish: Derefter kan CINQAERO anvendes under amning, hvis det er relevant.
English: Improvements were noted in FEV1 at 4 weeks following the first dose of reslizumab.
Danish: Der blev bemærket forbedringer i FEV1 4 uger efter den første dosis reslizumab.
English: Posology CINQAERO is given as intravenous infusion once every four weeks.
Danish: Dosering CINQAERO gives som en intravenøs infusion én gang hver 4. uge.
English: Reslizumab has a volume of distribution of approximately 5 L, suggesting minimal distribution to the extravascular tissues.
Danish: Reslizumab har et fordelingsvolumen på ca. 5 l, hvilket tyder på minimal fordeling til de ekstravaskulære væv.
English: Data by study Study I
Danish: Data pr. studie Studie I
English: These reactions were observed during or within 20 minutes after completion of the reslizumab infusion and were reported as early as the second dose of reslizumab.
Danish: Disse reaktioner blev observeret under eller inden for 20 minutter efter infusion af reslizumab og blev rapporteret så tidligt som under den anden dosis af reslizumab.
English: Integrated Studies I and II
Danish: Integrerede studier I og II
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 infektioner med indvoldsorme.
English: CINQAERO reduces how often you have flare-ups of your asthma, helps you breathe better and decreases your asthma symptoms.
Danish: CINQAERO nedsætter hyppigheden af pludselig opblussen af astma, hjælper dig til nemmere at trække vejret og nedsætter dine astmasymptomer.
English: The data did not indicate a difference in the safety profile of reslizumab in paediatric patients compared with that in adult patients.
Danish: Data indikerede ikke forskel i reslizumabs sikkerhedsprofil hos pædiatriske patienter sammenlignet med profilen hos voksne patienter.
English: The reduction in blood eosinophil counts by reslizumab in anti-reslizumab antibody-positive patients was not different from patients who were anti-reslizumab antibody-negative.
Danish: Reslizumabs reduktion af eosinofiltallet i blodet hos anti-reslizumab-antistof-positive patienter var ikke forskelligt fra patienter, der var anti-reslizumab-antistof-negative.
English: Proteinaceous particles might be present.
Danish: Kan indeholde proteinholdige partikler.
English: CINQAERO contains sodium
Danish: CINQAERO indeholder natrium
English: CINQAERO is a medicine containing the active substance reslizumab, a monoclonal antibody, a type of protein that recognises and binds to a specific target substance in the body.
Danish: CINQAERO er et lægemiddel, der indeholder det aktive stof reslizumab, et monoklonalt antistof (en type protein), der genkender og binder til et specifikt stof i kroppen.
English: Table 3 presents the demographics and baseline characteristics of Studies I, II and III.
Danish: Tabel 3 viser demografiske karakteristika og baseline-karakteristika for studie I, II og III.
English: Proteinaceous particles may be present in the concentrate that appear as translucent to white, amorphous particles, some of which may look fibrous.
Danish: Koncentratet kan indeholde proteinholdige partikler, der fremstår som gennemsigtige til hvide amorfe partikler, hvor nogle kan se fibrøse ud.
English: Table 1: Vial-based dosing scheme* for patients with body weight between 35 kg and 199 kg Body weight (kg)
Danish: Tabel 1: Hætteglas-baseret doseringsskema* for patienter med en legemsvægt fra 35 kg til 199 kg
English: If patients become infected whilst receiving treatment with reslizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Danish: Hvis patienten bliver inficeret under behandling med reslizumab og ikke responderer på behandlingen mod ormeinfektionen, bør det overvejes at afbryde behandlingen midlertidigt.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of reslizumab in milk.
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyrestudier viser, at reslizumab udskilles i mælk.
English: Reslizumab is a humanised monoclonal antibody (IgG4, κ) against the human interleukin-5 (IL-5).
Danish: Reslizumab er et humaniseret monoklonalt antistof (IgG4, κ) mod humant interleukin-5 (IL-5).
English: Reslizumab total dose (mg)
Danish: Reslizumab total dosis (mg)
English: If you stop using CINQAERO
Danish: Hvis du holder op med at få CINQAERO
English: The maximum dose is 3 mg per kg of body weight.
Danish: Den maksimale dosis er 3 mg pr. kg legemsvægt.
English: Do not use this medicine after the expiry date which is stated on the outer carton and label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre æske og på etiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: - if you are allergic to reslizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for reslizumab eller et af de øvrige indholdsstoffer i CINQAERO (angivet i punkt 6).
English: No direct effect of hepatic function on the pharmacokinetics of reslizumab is expected because antibodies are principally cleared by catabolism.
Danish: Det forventes ikke, at leverfunktionen har nogen direkte indvirkning på reslizumabs farmakokinetik, da antistoffer primært udskilles via katabolisme.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with CINQAERO in one or more subsets of the paediatric population in asthma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med CINQAERO i en eller flere undergrupper af den pædiatriske population med astma (se pkt.
English: In humans, during the first few days after birth antibodies may be transferred to the newborns through milk.
Danish: Hos mennesker kan der overføres antistoffer til det nyfødte barn via mælken i de første par dage efter fødslen.
English: CINQAERO blocks interleukin-5 activity and reduces the number of eosinophils in your blood and lungs.
Danish: CINQAERO blokerer aktiviteten af interleukin-5 og nedsætter antallet af eosinofile celler i blodet og lungerne.
English: GINA step 5 patients received in addition, as an add-on, maintenance OCS.
Danish: GINA trin 5-patienter fik derudover i tillæg vedligeholdelsesbehandling med OCS.
English: Serum reslizumab concentrations generally decline from peak in a biphasic manner.
Danish: Reslizumabkoncentrationen i serum falder generelt fra den maksimale koncentration på en bifasisk måde.
English: Uncommon (may affect up to 1 in 100 people) • Muscle pain (myalgia).
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) • Muskelsmerter (myalgi).
English: CINQAERO must not be administered as a bolus injection or as undiluted concentrate.
Danish: CINQAERO må ikke administreres som bolusinjektion eller som ufortyndet koncentrat.
English: Package leaflet: Information for the patient CINQAERO 10 mg/mL concentrate for solution for infusion reslizumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten CINQAERO 10 mg/ml koncentrat til infusionsvæske, opløsning reslizumab Dette lægemiddel er underlagt supplerende overvågning.
English: Due to an overlap in signs and symptoms, it was not possible to distinguish between an anaphylactic reaction, another hypersensitivity reaction and an infusion-related reaction in all cases (see section 4.4).
Danish: Da symptomerne overlapper, var det ikke muligt at skelne mellem en anafylaktisk reaktion, en anden overfølsomhedsreaktion og en infusionsrelateret reaktion i alle tilfælde (se pkt.
English: Patients between 35 kg and 199 kg
Danish: Patienter fra 35 kg til 199 kg
English: No treatment effect on asthma exacerbations was observed for this age group (asthma exacerbation rate ratio [reslizumab/placebo] of 2.09).
Danish: Der blev ikke observeret nogen virkning af behandlingen for denne aldersgruppe (forhold mellem antal astmaeksacerbationer [reslizumab/placebo] på 2,09).
English: Experience in paediatric patients is limited (see section 5.1).
Danish: Erfaringen hos pædiatriske patienter er begrænset (se pkt.
English: These adverse reactions were observed during or within 20 minutes after completion of the infusion.
Danish: Disse bivirkninger blev observeret under infusionen eller inden for 20 minutter efter afsluttet infusion.
English: No apparent deviation from dose-proportional reslizumab pharmacokinetics was noted over the dose range of 0.3 mg/kg to 3.0 mg/kg.
Danish: Der blev ikke bemærket nogen tydelig afvigelse fra dosisproportional reslizumabfarmakokinetik over dosisintervallet fra 0,3 mg/kg til 3,0 mg/kg.
English: The recommended dose is 3 mg/kg body weight.
Danish: Den anbefalede dosis er 3 mg/kg legemsvægt.
English: In both studies, an asthma exacerbation was defined as a worsening of asthma that required the following medical intervention: 1) use of systemic corticosteroids or an increase in the use of ICS treatment for 3 or more days, and/or 2) asthma-related emergency treatment including at least one of the following: an unscheduled visit to their healthcare professional for nebuliser treatment or other urgent treatment to prevent worsening of asthma symptoms; a visit to the emergency room for asthma-related treatment; or asthma-related hospitalisation.
Danish: I begge studier blev en astmaeksacerbation defineret som en forværring af astma, der krævede følgende medicinsk intervention: 1) anvendelse af systemisk kortikosteroid eller en øget anvendelse af ICS i 3 eller flere dage, og/eller 2) astmarelateret akutbehandling, herunder mindst ét af følgende: et ikke planlagt besøg hos læge eller sundhedsperson for behandling med nebulisator eller anden akutbehandling for at hindre forværring af astmasymptomer; besøg på skadestue for astmarelateret behandling eller astmarelateret indlæggelse.
English: It must not be administered by the subcutaneous, oral or intramuscular route.
Danish: Det må ikke administreres subkutant, oralt eller intramuskulært.
English: CINQAERO is used together with other medicines to treat asthma (inhaled corticosteroids plus other asthma medicines).
Danish: CINQAERO anvendes sammen med andre lægemidler til at behandle astma (inhalerede kortikosteroider plus andre astmalægemidler).
English: Anaphylactic reaction (see section 4.4) occurred in less than 1% of patients.
Danish: 4.4) opstod hos under 1 % af patienterne.
English: Eosinophilic asthma is a type of asthma where patients have too many eosinophils in the blood or lungs.
Danish: Eosinofil astma er en type astma, hvor patienterne har for mange eosinofile celler i blodet eller lungerne.
English: CI = Confidence interval
Danish: b CI = Konfidensinterval
English: Reslizumab binds specifically to IL-5 and interferes with IL-5 binding to its cell-surface receptor.
Danish: Reslizumab binder specifikt til IL-5 og interfererer med IL-5-bindingen til dennes receptor på celleoverfladen.
English: Table 3: Demographics and baseline characteristics of asthma studies I - III Demographic or baseline characteristic
Danish: Tabel 3: Demografiske karakteristika og baseline-karakteristika for astmastudie I-III Demografiske eller baseline karakteristika
English: Eosinophils began to return towards baseline in those reslizumab patients completing a 90-day follow-up assessment (394 µL-1, n=36).
Danish: Eosinofile celler begyndte at vende tilbage til baseline-niveau hos de reslizumabpatienter, der gennemførte en 90-dages opfølgende vurdering (0,394 x 109/l, n = 36).
English: In Studies I and II only, patients were required to have at least one asthma exacerbation requiring systemic corticosteroid use in the year prior to study entry.
Danish: Kun i studie I og II var det et krav, at patienterne havde haft mindst en astmaeksacerbation, hvor systemisk kortikosteroid var nødvendig i året før studieinklusion.
English: Systemic exposure to reslizumab appears to be unaffected by anti-reslizumab antibodies.
Danish: Den systemiske eksponering for reslizumab forekommer at være upåvirket af anti-reslizumab-antistoffer.
English: Interleukin-5 is a protein your body makes that plays a key role in inflammation in asthma by activating eosinophils.
Danish: Interleukin-5 er et protein, der dannes i kroppen, og det spiller en vigtig rolle ved inflammation i forbindelse med astma, da det aktiverer de eosinofile celler.
English: CINQAERO has no or negligible influence on the ability to drive and use machines.
Danish: CINQAERO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Gently invert the bag to mix the solution.
Danish: Vend forsigtigt posen på hovedet for at blande opløsningen.
English: You will be given CINQAERO by a doctor or nurse as an infusion (drip) into a vein.
Danish: En læge eller sygeplejerske vil give dig CINQAERO som en infusion (drop) i en vene.
English: CINQAERO is compatible with polyvinylchloride (PVC) or polyolefin (PO) infusion bags.
Danish: CINQAERO er kompatibelt med infusionsposer af polyvinylchlorid (PVC) eller polyolefin (PO).
English: FEV1 (mL) Mean diff (95% CIb) (p-value)
Danish: FEV1 (ml) Gennemsnitli g forskel (95 % CIb) (p-værdi)
English: Decreases in blood eosinophils were related to reslizumab levels.
Danish: Reduktionen af eosinofile celler i blodet var relateret til reslizumabniveauet.
English: Reslizumab binds human IL-5 with picomolar affinity blocking its biological function; consequently survival and activity of eosinophils are reduced.
Danish: Reslizumab binder til humant IL-5 med pikomolær affinitet og blokerer dennes biologiske funktion, hvorfor overlevelsen og aktiviteten af eosinofile celler reduceres.
English: Pre-bronchodilator FEV1a, mean % predicted
Danish: FEV1a før bronkodilatator, gennemsnit % af forventet
English: Patients with pre-existing helminth infections should be treated before starting reslizumab therapy.
Danish: Patienter med ormeinfektioner skal behandles, før de påbegynder behandlingen med reslizumab.
English: In common with other monoclonal antibodies, reslizumab is believed to be degraded by enzymatic proteolysis into small peptides and amino acids.
Danish: Som for andre monoklonale antistoffer antages det, at reslizumab nedbrydes til små peptider og aminosyrer ved enzymatisk proteolyse.
English: (p<0.0001) a The values represent the treatment difference between placebo and reslizumab 3 mg/kg based on adjusted means over the specified time period for each treatment group, except for the change to week 16 for AQLQ, which was the first timepoint where AQLQ was assessed.
Danish: a Værdierne repræsenterer behandlingsforskellen mellem placebo og reslizumab 3 mg/kg baseret på justerede gennemsnit over den specificerede tidsperiode for hver behandlingsgruppe undtagen for ændringen til uge 16 for AQLQ, som var det første tidspunkt, hvor AQLQ blev vurderet.
English: Manifestations included skin or mucosal involvement, dyspnoea, wheezing, gastrointestinal symptoms and chills.
Danish: Manifestationerne omfattede involvering af hud og mukosa, dyspnø, hvæsende vejrtrækning, gastrointestinale symptomer samt kulderystelser.
English: Study III
Danish: Studie III
English: Table 5: Treatment difference in mean change from baseline for selected secondary efficacy variables - Integrated data (Studies I and II) for the overall population and subgroup GINA 4 and 5
Danish: Tabel 5: Behandlingsforskel i gennemsnitlig ændring fra baseline for udvalgte sekundære virkningsmål - integrerede data (studie I og II) for den samlede population og for undergruppe GINA 4 og 5
English: Tell your doctor or nurse straight away if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).
Danish: Du skal straks fortælle det til lægen eller sygeplejersken, hvis du får nogen som helst symptomer på en allergisk reaktion (f.eks. kløe, vejrtrækningsbesvær, hvæsende vejrtrækning, feber, kulderystelser, svimmelhed, hovedpine, kvalme, opkastning, mavegener, hududslæt, rødme eller hævelse).
English: The effect of reslizumab 3 mg/kg administered once every 4 weeks on secondary endpoints, including FEV1, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ) and Asthma Symptom Utility Index (ASUI), further supports the efficacy of reslizumab 3 mg/kg compared to placebo.
Danish: Virkningen af reslizumab 3 mg/kg administreret én gang hver 4. uge på de sekundære endepunkter, herunder FEV1, score i spørgeskema vedrørende livskvalitet ved astma (Asthma Quality of Life Questionnaire (AQLQ)) og astmakontrol (Asthma Control Questionnaire (ACQ)) samt astmasymptomer (Asthma Symptom Utility Index (ASUI)) støtter yderligere virkningen af reslizumab
English: Studies I and II were 52-week, randomised, placebo-controlled studies in patients who had at least one asthma exacerbation requiring systemic corticosteroid use over the past twelve months.
Danish: Studie I og II var 52-ugers randomiserede, placebokontrollerede studier hos patienter, som havde haft mindst en astmaeksacerbation, der krævede systemisk kortikosteroid, inden for de seneste 12 måneder.
English: GINA step 4 patients received medium- to high-dose ICS plus another controller.
Danish: GINA trin 4-patienter fik medium- til højdosis-ICS plus et andet forebyggende middel.
English: Reslizumab is a humanised monoclonal antibody produced in mouse myeloma cells (NS0) by recombinant DNA technology.
Danish: Reslizumab er et humaniseret monoklonalt antistof, som fremstilles i myelomceller (NS0) fra musved rekombinant dna-teknologi.
English: The diluted medicinal product should then be administered as a 20 - 50-minute intravenous infusion through a sterile, non-pyrogenic infusion, single-use, low protein binding filter (0.2 µm).
Danish: Det fortyndede lægemiddel skal administreres som en 20-50 minutters intravenøs infusion gennem et sterilt, ikke-pyrogent engangsinfusionsfilter med lav proteinbinding (0,2 µm).
English: Results of population pharmacokinetic analysis confirm that concomitant use of either leukotriene antagonists or systemic corticosteroids does not affect the pharmacokinetics of reslizumab (see section 5.2).
Danish: Resultater fra farmakokinetiske populationsanalyser bekræfter, at samtidig anvendelse af enten leukotrienantagonister eller systemiske kortikosteroider ikke påvirker farmakokinetikken af reslizumab (se pkt.
English: The malignancies observed in reslizumab-treated patients were diverse in nature and without clustering of any particular tissue type.
Danish: De observerede maligniteter hos patienter behandlet med reslizumab var forskelligartede og kan ikke henføres til særlige væv.
English: ACQ Mean diff (95% CI) (p-value) AQLQ Mean diff (95% CI) (p-value)
Danish: Gennemsnitl ig forskel (95 % CI) (p-værdi) AQLQ Gennemsnitl ig forskel (95 % CI) (p-værdi)
English: Following multiple doses, serum concentrations of reslizumab accumulate approximately 1.5- to 1.9-fold.
Danish: Efter flere doser akkumuleres reslizumab til serumkoncentrationer, der er ca. 1,5 til 1,9 gange højere.
English: Blood creatine phosphokinase elevations were transient and asymptomatic, and did not lead to treatment discontinuation.
Danish: Forhøjet kreatinkinase i blodet Forhøjelser af kreatinkinase i blodet var forbigående og asymptomatiske og medførte ikke seponering.
English: Studies I and II
Danish: Studie I og II
English: If an anaphylactic reaction occurs, administration of reslizumab should be stopped immediately and appropriate medical treatment should be provided; reslizumab must be discontinued permanently (see section 4.3).
Danish: Hvis der opstår en anafylaktisk reaktion, skal infusionen stoppes straks og passende behandling gives, og reslizumab skal seponeres permanent (se pkt.
English: The range of systemic exposures in patients from 12 to less than 18 years of age (n=15) overlapped that in the other groups although the median value was slightly lower than in adult patients (18-65 years of age; n=759) and elderly patients (greater than 65 years of age; n=30).
Danish: Intervallet for den systemiske eksponering hos patienter fra 12 til under 18 år (n = 15) overlappede eksponeringen hos de andre grupper, selvom medianværdien var lidt lavere end hos voksne (18-65 år, n = 759) og ældre patienter (over 65 år, n = 30).
English: CINQAERO should be prescribed by physicians experienced in the diagnosis and treatment of the above-mentioned indication (see section 4.1).
Danish: CINQAERO skal ordineres af læger med erfaring i diagnosticering og behandling af ovenstående indikation (se pkt.
English: Also, talk to your doctor or nurse when you are given CINQAERO: - if your asthma remains uncontrolled or worsens during treatment with this medicine; - if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).
Danish: Kontakt også lægen eller sygeplejersken, når du får CINQAERO: hvis din astma ikke kommer under kontrol eller bliver værre under behandlingen med dette lægemiddel, hvis du får symptomer på en allergisk reaktion (f.eks. kløe, vejrtrækningsbesvær, hvæsende vejrtrækning, feber, kulderystelser, svimmelhed, hovedpine, kvalme, opkastning, mavebesvær, hududslæt, rødme eller hævelse).
English: The pharmacokinetics of reslizumab was similar in adults (18-65 years of age; n=759) and elderly patients (greater than 65 years of age; n=30).
Danish: Farmakokinetikken for reslizumab var sammenlignelig hos voksne (18-65 år, n = 759) og ældre patienter (over 65 år, n = 30).
English: The solution for infusion should not be infused concomitantly in the same intravenous line with other medicinal products.
Danish: Infusionsvæsken må ikke gives samtidigt med andre lægemidler i den samme intravenøse slange.