natgillin/translations-raw huggingface dataset:
Eosinofile celler kan være involveret i det immunologiske respons på nogle infektioner med indvoldsorme. 
Eosinophils may be involved in the immunological response to some helminth infections.
CINQAERO nedsætter hyppigheden af pludselig opblussen af astma, hjælper dig til nemmere at trække vejret og nedsætter dine astmasymptomer. 
CINQAERO reduces how often you have flare-ups of your asthma, helps you breathe better and decreases your asthma symptoms.
Data indikerede ikke forskel i reslizumabs sikkerhedsprofil hos pædiatriske patienter sammenlignet med profilen hos voksne patienter. 
The data did not indicate a difference in the safety profile of reslizumab in paediatric patients compared with that in adult patients.
Reslizumabs reduktion af eosinofiltallet i blodet hos anti-reslizumab-antistof-positive patienter var ikke forskelligt fra patienter, der var anti-reslizumab-antistof-negative. 
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.
Kan indeholde proteinholdige partikler. 
Proteinaceous particles might be present.
CINQAERO indeholder natrium 
CINQAERO contains sodium
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. 
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.
Tabel 3 viser demografiske karakteristika og baseline-karakteristika for studie I, II og III. 
Table 3 presents the demographics and baseline characteristics of Studies I, II and III.
Koncentratet kan indeholde proteinholdige partikler, der fremstår som gennemsigtige til hvide amorfe partikler, hvor nogle kan se fibrøse ud. 
Proteinaceous particles may be present in the concentrate that appear as translucent to white, amorphous particles, some of which may look fibrous.
Tabel 1: Hætteglas-baseret doseringsskema* for patienter med en legemsvægt fra 35 kg til 199 kg 
Table 1: Vial-based dosing scheme* for patients with body weight between 35 kg and 199 kg Body weight (kg)
Hvis patienten bliver inficeret under behandling med reslizumab og ikke responderer på behandlingen mod ormeinfektionen, bør det overvejes at afbryde behandlingen midlertidigt. 
If patients become infected whilst receiving treatment with reslizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
De tilgængelige farmakodynamiske/toksikologiske data fra dyrestudier viser, at reslizumab udskilles i mælk. 
Available pharmacodynamic/toxicological data in animals have shown excretion of reslizumab in milk.
Reslizumab er et humaniseret monoklonalt antistof (IgG4, κ) mod humant interleukin-5 (IL-5). 
Reslizumab is a humanised monoclonal antibody (IgG4, κ) against the human interleukin-5 (IL-5).
Reslizumab total dosis (mg) 
Reslizumab total dose (mg)
Hvis du holder op med at få CINQAERO 
If you stop using CINQAERO
Den maksimale dosis er 3 mg pr. kg legemsvægt. 
The maximum dose is 3 mg per kg of body weight.
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. 
Do not use this medicine after the expiry date which is stated on the outer carton and label after EXP.
- hvis du er allergisk over for reslizumab eller et af de øvrige indholdsstoffer i CINQAERO (angivet i punkt 6). 
- if you are allergic to reslizumab or any of the other ingredients of this medicine (listed in section 6).
Det forventes ikke, at leverfunktionen har nogen direkte indvirkning på reslizumabs farmakokinetik, da antistoffer primært udskilles via katabolisme. 
No direct effect of hepatic function on the pharmacokinetics of reslizumab is expected because antibodies are principally cleared by catabolism.
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. 
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).
Hos mennesker kan der overføres antistoffer til det nyfødte barn via mælken i de første par dage efter fødslen. 
In humans, during the first few days after birth antibodies may be transferred to the newborns through milk.
CINQAERO blokerer aktiviteten af interleukin-5 og nedsætter antallet af eosinofile celler i blodet og lungerne. 
CINQAERO blocks interleukin-5 activity and reduces the number of eosinophils in your blood and lungs.
GINA trin 5-patienter fik derudover i tillæg vedligeholdelsesbehandling med OCS. 
GINA step 5 patients received in addition, as an add-on, maintenance OCS.
Reslizumabkoncentrationen i serum falder generelt fra den maksimale koncentration på en bifasisk måde. 
Serum reslizumab concentrations generally decline from peak in a biphasic manner.
Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) • Muskelsmerter (myalgi). 
Uncommon (may affect up to 1 in 100 people) • Muscle pain (myalgia).
CINQAERO må ikke administreres som bolusinjektion eller som ufortyndet koncentrat. 
CINQAERO must not be administered as a bolus injection or as undiluted concentrate.
Indlægsseddel: Information til patienten CINQAERO 10 mg/ml koncentrat til infusionsvæske, opløsning reslizumab Dette lægemiddel er underlagt supplerende overvågning. 
Package leaflet: Information for the patient CINQAERO 10 mg/mL concentrate for solution for infusion reslizumab This medicine is subject to additional monitoring.
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. 
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).
Patienter fra 35 kg til 199 kg 
Patients between 35 kg and 199 kg
Der blev ikke observeret nogen virkning af behandlingen for denne aldersgruppe (forhold mellem antal astmaeksacerbationer [reslizumab/placebo] på 2,09). 
No treatment effect on asthma exacerbations was observed for this age group (asthma exacerbation rate ratio [reslizumab/placebo] of 2.09).
Erfaringen hos pædiatriske patienter er begrænset (se pkt. 
Experience in paediatric patients is limited (see section 5.1).
Disse bivirkninger blev observeret under infusionen eller inden for 20 minutter efter afsluttet infusion. 
These adverse reactions were observed during or within 20 minutes after completion of the infusion.
Der blev ikke bemærket nogen tydelig afvigelse fra dosisproportional reslizumabfarmakokinetik over dosisintervallet fra 0,3 mg/kg til 3,0 mg/kg. 
No apparent deviation from dose-proportional reslizumab pharmacokinetics was noted over the dose range of 0.3 mg/kg to 3.0 mg/kg.
Den anbefalede dosis er 3 mg/kg legemsvægt. 
The recommended dose is 3 mg/kg body weight.
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. 
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.
Det må ikke administreres subkutant, oralt eller intramuskulært. 
It must not be administered by the subcutaneous, oral or intramuscular route.
CINQAERO anvendes sammen med andre lægemidler til at behandle astma (inhalerede kortikosteroider plus andre astmalægemidler). 
CINQAERO is used together with other medicines to treat asthma (inhaled corticosteroids plus other asthma medicines).
4.4) opstod hos under 1 % af patienterne. 
Anaphylactic reaction (see section 4.4) occurred in less than 1% of patients.
Eosinofil astma er en type astma, hvor patienterne har for mange eosinofile celler i blodet eller lungerne. 
Eosinophilic asthma is a type of asthma where patients have too many eosinophils in the blood or lungs.
b CI = Konfidensinterval 
CI = Confidence interval
Reslizumab binder specifikt til IL-5 og interfererer med IL-5-bindingen til dennes receptor på celleoverfladen. 
Reslizumab binds specifically to IL-5 and interferes with IL-5 binding to its cell-surface receptor.
Tabel 3: Demografiske karakteristika og baseline-karakteristika for astmastudie I-III Demografiske eller baseline karakteristika 
Table 3: Demographics and baseline characteristics of asthma studies I - III Demographic or baseline characteristic
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). 
Eosinophils began to return towards baseline in those reslizumab patients completing a 90-day follow-up assessment (394 µL-1, n=36).
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. 
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.
Den systemiske eksponering for reslizumab forekommer at være upåvirket af anti-reslizumab-antistoffer. 
Systemic exposure to reslizumab appears to be unaffected by anti-reslizumab antibodies.
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. 
Interleukin-5 is a protein your body makes that plays a key role in inflammation in asthma by activating eosinophils.
CINQAERO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
CINQAERO has no or negligible influence on the ability to drive and use machines.
Vend forsigtigt posen på hovedet for at blande opløsningen. 
Gently invert the bag to mix the solution.
En læge eller sygeplejerske vil give dig CINQAERO som en infusion (drop) i en vene. 
You will be given CINQAERO by a doctor or nurse as an infusion (drip) into a vein.
CINQAERO er kompatibelt med infusionsposer af polyvinylchlorid (PVC) eller polyolefin (PO). 
CINQAERO is compatible with polyvinylchloride (PVC) or polyolefin (PO) infusion bags.
FEV1 (ml) Gennemsnitli g forskel (95 % CIb) (p-værdi) 
FEV1 (mL) Mean diff (95% CIb) (p-value)
Reduktionen af eosinofile celler i blodet var relateret til reslizumabniveauet. 
Decreases in blood eosinophils were related to reslizumab levels.
Reslizumab binder til humant IL-5 med pikomolær affinitet og blokerer dennes biologiske funktion, hvorfor overlevelsen og aktiviteten af eosinofile celler reduceres. 
Reslizumab binds human IL-5 with picomolar affinity blocking its biological function; consequently survival and activity of eosinophils are reduced.
FEV1a før bronkodilatator, gennemsnit % af forventet 
Pre-bronchodilator FEV1a, mean % predicted
Patienter med ormeinfektioner skal behandles, før de påbegynder behandlingen med reslizumab. 
Patients with pre-existing helminth infections should be treated before starting reslizumab therapy.
Som for andre monoklonale antistoffer antages det, at reslizumab nedbrydes til små peptider og aminosyrer ved enzymatisk proteolyse. 
In common with other monoclonal antibodies, reslizumab is believed to be degraded by enzymatic proteolysis into small peptides and amino acids.
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. 
(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.
Manifestationerne omfattede involvering af hud og mukosa, dyspnø, hvæsende vejrtrækning, gastrointestinale symptomer samt kulderystelser. 
Manifestations included skin or mucosal involvement, dyspnoea, wheezing, gastrointestinal symptoms and chills.
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 
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
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). 
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).
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 
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.
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. 
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.
GINA trin 4-patienter fik medium- til højdosis-ICS plus et andet forebyggende middel. 
GINA step 4 patients received medium- to high-dose ICS plus another controller.
Reslizumab er et humaniseret monoklonalt antistof, som fremstilles i myelomceller (NS0) fra musved rekombinant dna-teknologi. 
Reslizumab is a humanised monoclonal antibody produced in mouse myeloma cells (NS0) by recombinant DNA technology.
Det fortyndede lægemiddel skal administreres som en 20-50 minutters intravenøs infusion gennem et sterilt, ikke-pyrogent engangsinfusionsfilter med lav proteinbinding (0,2 µm). 
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).
Resultater fra farmakokinetiske populationsanalyser bekræfter, at samtidig anvendelse af enten leukotrienantagonister eller systemiske kortikosteroider ikke påvirker farmakokinetikken af reslizumab (se pkt. 
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).
De observerede maligniteter hos patienter behandlet med reslizumab var forskelligartede og kan ikke henføres til særlige væv. 
The malignancies observed in reslizumab-treated patients were diverse in nature and without clustering of any particular tissue type.
Gennemsnitl ig forskel (95 % CI) (p-værdi) AQLQ Gennemsnitl ig forskel (95 % CI) (p-værdi) 
ACQ Mean diff (95% CI) (p-value) AQLQ Mean diff (95% CI) (p-value)
Efter flere doser akkumuleres reslizumab til serumkoncentrationer, der er ca. 1,5 til 1,9 gange højere. 
Following multiple doses, serum concentrations of reslizumab accumulate approximately 1.5- to 1.9-fold.
Forhøjet kreatinkinase i blodet Forhøjelser af kreatinkinase i blodet var forbigående og asymptomatiske og medførte ikke seponering. 
Blood creatine phosphokinase elevations were transient and asymptomatic, and did not lead to treatment discontinuation.
Studie I og II 
Studies I and II
Hvis der opstår en anafylaktisk reaktion, skal infusionen stoppes straks og passende behandling gives, og reslizumab skal seponeres permanent (se pkt. 
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).
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). 
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).
CINQAERO skal ordineres af læger med erfaring i diagnosticering og behandling af ovenstående indikation (se pkt. 
CINQAERO should be prescribed by physicians experienced in the diagnosis and treatment of the above-mentioned indication (see section 4.1).
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). 
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).
Farmakokinetikken for reslizumab var sammenlignelig hos voksne (18-65 år, n = 759) og ældre patienter (over 65 år, n = 30). 
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).
Infusionsvæsken må ikke gives samtidigt med andre lægemidler i den samme intravenøse slange. 
The solution for infusion should not be infused concomitantly in the same intravenous line with other medicinal products.
I studie III havde patienterne, der fik reslizumab 3 mg/kg, signifikant større stigninger i FEV1 fra baseline sammenlignet med placebogruppen (behandlingsforskel 160 ml, p = 0,0018). 
In Study III, patients receiving reslizumab 3 mg/kg had significantly larger increases in FEV1 from baseline compared to placebo (treatment difference: 160 mL, p=0.0018).
Patienten skal observeres under hele infusionen og i en passende periode derefter. 
The patient has to be observed over the duration of the infusion and for an appropriate period afterwards.
Populationsfarmakokinetiske analyser indikerede, at reslizumabs farmakokinetik ikke er signifikant forskellig mellem etniske grupper (hvide, sorte og asiater). 
Population pharmacokinetic analyses indicated that the pharmacokinetics of reslizumab is not significantly different between ethnic groups (white, black and Asian).
Lungefunktionsprøver 
Pulmonary function tests
En kohorte på 763 patienter i studie I og II opfyldte dette kriterium. 
cohort of 763 patients within Studies I and II met this criterion; the primary efficacy outcome is presented in Table 4.
De fleste patienter havde normale leverfunktionsprøver (n = 766, ca. 95 %) eller let forhøjede leverfunktionsprøver (enten, i det første tilfælde, total-bilirubin > øvre normalgrænse [ULN], men ≤ 1,5 gange ULN, eller i det andet tilfælde, aspartat-aminotransferase > ULN, og total-bilirubin ≤ ULN; n = 35, ca. 4 %). 
Most patients had normal liver function tests (n=766, approximately 95%) or mildly increased liver function tests (either, in the first case, total bilirubin above the upper limit of normal [ULN] but less than or equal to 1.5 times the ULN or, in the second case, aspartate aminotransferase greater than the ULN and total bilirubin less than or equal to the ULN; n=35, approximately 4%).
Da der er observeret sammenlignelige eksponeringer for reslizumab hos patienter over 65 år og patienter mellem 18 og <65 år, anbefales dosisjustering ikke (se pkt. 
Based on the similar reslizumab exposure observed in patients older than 65 years of age as compared to patients 18 to <65 years of age, no dose adjustment is recommended (see section 5.2).
Der kan være partikler i koncentratet. 
Particles might be present.
Den alvorlige bivirkning anafylaktisk reaktion, blev rapporteret og anset for at være relateret til reslizumab hos 3 patienter (0,19 %) i placebokontrollerede og open-label astmastudier. 
The serious adverse reaction of anaphylactic reaction was reported and considered related to reslizumab in 3 patients (0.19%) during placebo-controlled and open-label asthma studies.
I undergruppen med patienter, der havde behov for behandling med OCS for astmaeksacerbationer, blev det vist, at reslizumab nedsatte hyppigheden af astmaeksacerbationer med hhv. 56 % (p < 0,0001) og 60 % (p < 0,0001) i studie I og studie II. 
In the subset of patients requiring courses of OCS treatment for management of their asthma exacerbation, reslizumab was shown to reduce the frequency of asthma exacerbations by 56% (p<0.0001) and 60% (p<0.0001) in Study I and Study II, respectively.
For doseringsanvisninger, se punkt 4.2 i Produktresuméet. 
For dosing instructions see section 4.2 of Summary of Product Characteristics.
Der skal anvendes et infusionssæt med et in-line sterilt, ikke-pyrogent filter med lav proteinbinding (porestørrelse på 0,2 µm) til infusionen. 
An infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 µm) should be used for infusion.
Samlet population 
Overall population
Reslizumab har en halveringstid på ca. 24 dage. 
Reslizumab has a half-life of about 24 days.
Hvis du har glemt at få en planlagt dosis CINQAERO 
If you miss your scheduled dose of CINQAERO
Patienter med refraktær astmad 
Patients with refractory asthmad
De fleste patienter i den populationsfarmakokinetiske analyse havde normal nyrefunktion (estimeret glomerulær filtrationshastighed [eGFR]) ≥ 90 ml/min/1,73 m2; n = 294, ca. 37 %), let nedsat nyrefunktion (eGFR 60-89 ml/min/1,73 m2; n = 446, ca. 56 %) eller moderat nedsat nyrefunktion (eGFR 30-59 ml/min/1,73 m2; n = 63, ca. 8 %). 
Most patients in the population pharmacokinetic analysis had normal renal function (estimated glomerular filtration rate [eGFR]) greater than or equal to 90 mL/min/1.73 m2; n=294, approximately 37%), mild renal impairment (eGFR 60-89 mL/min/1.73 m2; n=446, approximately 56%), or moderate renal impairment (eGFR 30-59 mL/min/1.73 m2; n=63, approximately 8%).