FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are not sure what the side effects below are, ask your doctor to explain them to you.
Danish: Hvis du ikke helt forstår, hvad nedenstående bivirkninger er, kan du bede lægen forklare dem.
English: The steady state is achieved by 4 weeks using the PNH adult dosing regimen.
Danish: Steady state opnås efter 4 uger med dosisregimet for PNH hos voksne.
English: The clearance and half-life of eculizumab were also evaluated during plasma exchange interventions.
Danish: Eculizumabs clearance og halveringstid blev også evalueret ved plasmaudskiftnings-interventioner.
English: Human antibodies undergo endocytotic digestion in the cells of the reticuloendothelial system.
Danish: Humane antistoffer undergår endocytotisk nedbrydning i cellerne i det retikuloendotelielle system.
English: Therefore, an individual risk benefit analysis is recommended before starting and during treatment with eculizumab in pregnant women.
Danish: Derfor anbefales en individuel benefit/risk-analyse før og under behandlingen med eculizumab hos gravide kvinder.
English: Paediatric patients in PNH and aHUS:
Danish: Pædiatriske patienter med PNH og aHUS:
English: • All patients must be monitored for signs of meningococcal infection.
Danish: • alle patienter skal monitoreres for tegn på meningokokinfektion.
English: Plasma exchange resulted in an approximately 50% decline in eculizumab concentrations following a 1 hour intervention and the elimination half-life of eculizumab was reduced to 1.3 hours.
Danish: Plasmaudskiftning resulterede i et fald på ca. 50 % i eculizumabkoncentrationen efter en intervention på 1 time, og eliminationshalveringstiden af eculizumab blev reduceret til 1,3 timer.
English: Malignant melanoma, Myelodysplastic syndrome
Danish: Malignt melanom, myelodysplastisk syndrom
English: Eculizumab contains only naturally occurring amino acids and has no known active metabolites.
Danish: Eculizumab indeholder kun naturligt forekommende aminosyrer og har ingen kendte aktive metabolitter.
English: Physicians should advise patients about gonorrhoea prevention.
Danish: Lægerne bør rådgive patienterne om, hvordan gonorré undgås.
English: Patients may have increased susceptibility to infections, especially with Neisseria and encapsulated bacteria.
Danish: Patienterne kan have øget følsomhed for infektioner, især med Neisseria og indkapslede bakterier.
English: It is recommended that the beginning of your treatments, called the initial phase, will extend over 4 weeks, followed by a maintenance phase.
Danish: Det anbefales, at din behandling indledes med en startfase på 4 uger, efterfulgt af en vedligeholdelsesfase.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Indenfor hver frekvensgruppe præsenteres bivirkninger ordnet efter faldende alvorlighed.
English: All patients included in the trial were refractory gMG patients and met the following predefined criteria:
Danish: Alle patienter, der blev inkluderet i studiet, var patienter med refraktær gMG, som opfyldte de følgende prædefinerede kriterier:
English: However, due to the limitations of the available data, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eculizumab and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition.
Danish: På grund af begrænsningerne i de tilgængelige data skal de udviklings- og sundhedsmæssige fordele ved amningen dog afvejes i forhold til moderens kliniske behov for eculizumab og mulige bivirkninger for det ammede barn fra eculizumab eller fra moderens underliggende tilstand.
English: In SHEPHERD study, 96 of the 97 enrolled patients completed the study (one patient died following a thrombotic event).
Danish: I SHEPHERD-studiet fuldførte 96 af de 97 patienter, der indgik i studiet (én patient døde efter en trombotisk hændelse).
English: • yellowing of the skin and/or eyes (jaundice)
Danish: • gulfarvning af huden og/eller øjnene (gulsot)
English: Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes.
Danish: Eculizumab bevarer de tidlige komponenter af komplementaktiveringen, der er essentiel for opsonisering af mikroorganismer og elimination af immunkomplekser.
English: Soliris vials in the original package may be removed from refrigerated storage for only one single period of up to 3 days.
Danish: Hætteglassene med Soliris i den originale emballage må kun opbevares uden for køleskabet i en enkelt periode på op til 3 dage.
English: The bulk drug substance manufacturing process also includes specific viral inactivation and removal steps.
Danish: Fremstillingsprocessen for lægemiddelstoffet omfatter desuden specifikke trin til inaktivering og fjernelse af virus.
English: Included Studies: Asthma (C07-002), aHUS(C08-002, C08-003, C10-003, C10-004), Dermatomyositis (C99-006), gMG (C08-001, ECU-MG-301, ECU-MG-302 data cut as of 31Dec2017), Neuromyelitis Optica Spectrum Disorder (ECU-NMO-301), IMG (C99-004, E99-004), PNH (C02-001, C04-001, C04-002, C06-002, C07-001, E02-001, E05001, E07-001, M07-005, X03-001, X03-001A), Psoriasis (C99-007), RA (C01-004, C97-001, C99-001, E01-004, E99-001), STEC-HUS (C11-001), SLE (C97-002).
Danish: Inkluderede studier: Astma (C07-002), aHUS (C08-002, C08-003, C10-003, C10-004), dermatomyositis (C99006), gMG (C08-001, ECU-MG-301, ECU-MG-302 dataafskæring den 31. dec 2017), neuromyelitis optica spektrumsygdom (ECU-NMO-301), IMG (C99-004, E99-004), PNH (C02-001, C04-001, C04-002, C06-002, C07-001, E02-001, E05-001, E07-001, M07-005, X03-001, X03-001A), psoriasis (C99-007), RA (C01-004, C97-001, C99-001, E01-004, E99-001), STEC-HUS (C11-001), SLE (C97-002).
English: However, renal function was not changed due to prior irreversible kidney damage (Table 16).
Danish: På grund af forudgående irreversible nyreskader ændredes nyrefunktionen dog ikke (tabel 16).
English: • Enrolment in the PNH and aHUS registries.
Danish: • indskrivning i PNH og aHUS registrene.
English: Patients must receive vaccination according to current national vaccination guidelines for vaccination use.
Danish: Patienten skal vaccineres i henhold til den gældende nationale vaccinationsvejledning.
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA25
Danish: Farmakoterapeutisk klassifikation: Selektive immunsuppressive midler, ATC-kode: L04AA25
English: Positive ADA samples were low titer and transient.
Danish: Positive ADA-prøver havde lavt titer, som var forbigående.
English: Complete TMA response was maintained by all responders.
Danish: Komplet TMA-respons blev opretholdt hos alle responderende patienter.
English: The healthcare professionals should be advised to look for risk factors and signs and symptoms of Aspergillus infection.
Danish: Sundhedspersonalet bør rådes til at være på udkig efter risikofaktorer og tegn og symptomer på Aspergillus-infektion.
English: DATE OF REVISION OF THE TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN Dato:
English: Maintenance Phase
Danish: Vedligeholdelsesfase
English: Discontinuation of treatment should only be considered if medically justified.
Danish: Det bør kun overvejes at afbryde behandlingen, hvis det er medicinsk indiceret.
English: • There is an important risk of Aspergillus infection in patients treated with eculizumab.
Danish: • der er en vigtig risiko for Aspergillus-infektion hos patienter i behandling med eculizumab.
English: • Maintenance Phase:
Danish: • Vedligeholdelsesfase:
English: Clear, colorless, pH 7.0 solution.
Danish: Klar, farveløs opløsning med pH 7,0.
English: There is no evidence to suggest that any special precautions are needed when older people are treated - although experience with Soliris in this patient population is still limited.
Danish: Intet tyder på, at særlige sikkerhedsregler skulle være nødvendige ved behandling af ældre, men erfaringerne med Soliris til denne patientpopulation er stadig begrænsede.
English: Other cases of Neisseria species have been reported including sepsis with Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp unspecified.
Danish: Andre tilfælde af Neisseria-arter er blevet indberettet, herunder sepsis med Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp ikke specificeret.
English: If you are at risk of gonorrhoea, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis du har risiko for gonorré, skal du spørge lægen eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: 1 Based on the Kaplan-Meier product limit method.
Danish: 1 Baseret på Kaplan-Meier-estimatormetoden.
English: Responses were similar across all ages from 5 months to 17 years of age.
Danish: Sammenlignelige responser blev observeret i alle aldersgrupper fra 5 måneder til 17 år.
English: Major baseline characteristics were balanced (see Table 2).
Danish: De vigtigste baseline-karakteristika blev afbalanceret (se tabel 2).
English: Based on the potential inhibitory effect of eculizumab on complement-dependent cytotoxicity of rituximab, eculizumab may reduce the expected pharmacodynamic effects of rituximab.
Danish: Baseret på den mulige hæmmende virkning af eculizumab på den komplementafhængige cytotoksicitet af rituximab, kan eculizuab reducere de forventede farmakodyaniske virkninger af rituximab.
English: No specific adverse reactions have emerged from these clinical studies.
Danish: Der fremkom ingen specielle bivirkninger i forbindelse med disse kliniske studier.
English: No effects on the breastfed newborn / infant are anticipated as limited data available suggest that eculizumab is not excreted in human breast milk.
Danish: Der forventes ingen påvirkning af ammede nyfødte/spædbørn, da tilgængelige begrænsede data tyder på, at eculizumab ikke udskilles i human brystmælk.
English: • The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature.
Danish: • Den fortyndede opløsning må ikke opvarmes i mikroovn eller anden varmekilde end den forekommende rumtemperatur.
English: Infections Before starting Soliris, inform your doctor if you have any infections.
Danish: Infektioner Inden du starter med at få Soliris, skal du fortælle det til lægen, hvis du har en infektion
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Single use Type I glass vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Engangshætteglas, glas type I
English: No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of eculizumab.
Danish: Der er ikke udført dyreforsøg til vurdering af eculizumabs genotoksiske potentiale og karcinogenicitet.
English: The most common reason for change in immunosuppressant therapy was improvement in MG symptoms while on eculizumab treatment.
Danish: Den mest almindelige årsag til at ændre behandling med immunsuppressive midler var forbedring af MG-symptomer, mens de var i behandling med eculizumab.
English: The tissue cross-reactivity of eculizumab was evaluated by assessing binding to a panel of 38 human tissues.
Danish: Krydsreaktiviteten af eculizumab over for andre væv blev vurderet ved bestemmelse af bindingen til et panel på 38 humane væv.
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”Anv.
English: FACIT-Fatigue score at last available assessment (median)
Danish: FACIT-træthedsscore ved sidste tilgængelige vurdering (median)
English: Available data suggest that clinical response is usually achieved by 12 weeks of Soliris treatment.
Danish: Tilgængelige data tyder på, at der normalt opnås et klinisk respons efter 12 ugers behandling med Soliris.
English: The median patient age was 35 (range: 18 to 80 years).
Danish: Den mediane patientalder var 35 (interval: 18 til 80 år).
English: Vaccination may not be sufficient to prevent meningococcal infection.
Danish: Vaccination beskytter ikke nødvendigvis tilstrækkeligt til at forhindre meningokokinfektion.
English: Dermatitis, Skin depigmentation
Danish: Dermatitis, depigmentering af huden
English: Soliris contains sodium
Danish: Soliris indeholder natrium
English: Please speak to your doctor before stopping Soliris.
Danish: Tal med din læge, før du holder op med at bruge Soliris.
English: If you suspect that you have been accidentally administered a higher dose of Soliris than prescribed, please contact your doctor for advice.
Danish: Hvis du har mistanke om, at du ved en fejl har fået en større dosis Soliris end den ordinerede, skal du spørge din læge til råds.
English: Because of the study sample size and duration, the effects of Soliris on thrombotic events could not be determined.
Danish: På grund af studiets stikprøvestørrelse og varighed kunne virkningerne af Soliris på trombotiske hændelser ikke bestemmes.
English: Soliris should only be administered via intravenous infusion as described below.
Danish: Soliris bør kun indgives ved intravenøs infusion som beskrevet nedenfor.
English: Patients should be informed of these signs and symptoms and steps taken to seek medical care immediately.
Danish: Patienterne bør informeres om sådanne tegn og symptomer og om, at de straks skal søge lægehjælp.
English: ADRs identified in postmarketing reports
Danish: cBivirkninger, der er identificeret i indberetninger efter markedsføringen
English: Additional endpoints included TMA intervention rate, haematologic normalization, complete TMA response, changes in LDH, renal function and quality of life.
Danish: Yderligere endepunkter omfattede forekomst af TMA-intervention, hæmatologisk normalisering, komplet TMA-respons, ændringer i LDH, nyrefunktion og livskvalitet.
English: There were fewer thrombotic events with Soliris treatment than during the same period of time prior to treatment.
Danish: Der var færre trombotiske hændelser ved behandling med Soliris end i det tilsvarende tidsrum inden behandlingen.
English: Concomitant medications included anti-thrombotic agents in 63% of the patients and systemic corticosteroids in 40% of the patients.
Danish: Anden samtidig medicin var trombocytfunktionshæmmende midler hos 63 % af patienterne og systemiske kortikosteroider hos 40 % af patienterne.
English: Severe TMA complications occurred in patients regardless of whether they had an identified genetic mutation, high risk polymorphism or auto-antibody.
Danish: Svære komplikationer som følge af TMA indtrådte hos patienterne uafhængigt af, om de havde en identificeret genmutation, højrisiko-polymorfisme eller autoantistof.
English: Data on a limited number of pregnancies exposed to eculizumab (less than 300 pregnancy outcomes) indicate there is no increased risk of foetal malformation or foetal-neonatal toxicity.
Danish: Data fra et begrænset antal graviditeter eksponeret for eculizumab (mindre end 300 gravide forsøgspersoner) indikerer, at der ikke er nogen øget risiko for føtale misdannelser eller føtal-neonatal toksicitet.
English: METHOD OF ADMINISTRATION To be diluted before use.
Danish: ADMINISTRATIONSMETODE Skal fortyndes inden anvendelse.
English: All Patients (N = 22)
Danish: Alle patienter (N = 22)
English: In normal kidneys, antibodies are not excreted and are excluded from filtration by their size.
Danish: Antistoffer udskilles ikke i normale nyrer, da de er udelukket fra filtrering på grund af deres størrelse.
English: Patients receiving anticoagulants and systemic corticosteroids at baseline continued these medications.
Danish: Patienter, der ved baseline fik antikoagulantia og systemiske kortikosteroider, fortsatte med denne medicin.
English: Drug distribution will only be possible after written confirmation that the patient received or will receive meningococcal vaccination and/or antibiotic prophylaxis.
Danish: Udlevering af lægemidlet kun vil være mulig efter skriftlig bekræftelse af, at patienten har fået eller vil få en meningokok-vaccination og/eller profylaktisk antibiotisk behandling
English: Refractory gMG
Danish: Refraktær gMG
English: Supplemental Soliris Dose With Each PE/PI Intervention
Danish: Supplerende Soliris-dosis ved hver enkelt PE/PIintervention
English: Additional serious medical complications occurred in these patients including severe worsening of kidney function, disease-related hospitalization and progression to end stage renal disease requiring dialysis.
Danish: Der opstod yderligere alvorlige medicinske komplikationer hos disse patienter, herunder svær forværring af nyrefunktionen, sygdomsrelateret hospitalsindlæggelse og progression til dialysekrævende nyresygdom i slutstadiet.
English: All Patients (N = 22) At 26-weeks
Danish: Alle patienter (N = 22) Efter 26 uger
English: No IST usage at baseline n (%)
Danish: Intet IST-forbrug ved baseline n (%)
English: Efficacy Endpoints: Total score change from baseline at Week 26
Danish: Effektendepunkter: Ændring i total score fra baseline ved uge 26
English: Figure 2: Kaplan-Meier Survival Estimates for Time to First Adjudicated On-Trial Relapse - Full Analysis Set
Danish: Figur 2: Kaplan-Meier overlevelsesestimater for tid til første adjudikerede recidiv i løbet af studiet - fuldstændigt analysesæt
English: Your doctor's instructions should be carefully observed.
Danish: Følg nøje lægens anvisninger.
English: Soliris is specifically indicated for patients who remain symptomatic despite treatment with other existing MG therapies.
Danish: Soliris er specifikt indiceret til patienter, der stadig har symptomer trods behandling med andre tilgængelige behandlinger mod MG.
English: Animal reproduction studies have not been conducted with eculizumab due to lack of pharmacologic activity in non-human species.
Danish: Der er ikke udført reproduktionsstudier hos dyr med eculizumab på grund af den manglende farmakologiske aktivitet hos andre arter end mennesker.
English: The use of adequate contraception to prevent pregnancy and for at least 5 months after the last dose of treatment with eculizumab should be considered for women of childbearing potential.
Danish: Anvendelse af tilstrækkelig kontraception til at forhindre graviditet og i mindst 5 måneder efter den sidste dosis af behandlingen med eculizumab bør overvejes for kvinder i den fertile alder.
English: Due to its mechanism of action, the use of Soliris increases the patient's susceptibility to meningococcal infection (Neisseria meningitidis).
Danish: Som følge af sin virkningsmekanisme øger Soliris patientens følsomhed for infektion med meningokokker (Neisseria meningitidis).
English: If you use this medicine to treat PNH
Danish: Hvis du bruger dette lægemiddel til behandling af PNH Til voksne:
English: Patients should be instructed that if they develop fever, headache accompanied with fever and/or stiff neck or sensitivity to light, they should immediately seek medical care as these signs may be indicative of meningococcal infection.
Danish: Patienter skal informeres om, at hvis de får feber, hovedpine ledsaget af feber og/eller stivhed i nakken eller oplever lysfølsomhed, skal de straks søge lægehjælp, da disse symptomer kan være tegn på meningokokinfektion.
English: Subjects who undergo plasma exchange may receive additional doses of Soliris.
Danish: Personer, som får plasmaudskiftning, vil eventuelt få supplerende doser af Soliris.
English: 1) Failed treatment for at least one year with 2 or more immunosuppressant therapies (either in combination or as monotherapy), ie, patients continued to have impairment in activities of daily living despite immunosuppressant therapies
Danish: 1) Svigtet behandling i mindst et år med 2 eller flere immunsuppressive behandlinger (enten i kombination eller som monoterapi), dvs. patienterne fortsatte med at have nedsat funktionsevne i deres dagligdags aktiviteter trods immunsuppressive behandlinger
English: Older people There are no special precautions needed for the treatment of patients aged from 65 years and over.
Danish: Ældre personer Særlige forholdsregler er ikke nødvendigt ved behandling af ældre (65 år og derover).
English: • The patient safety card and the need to carry it on their person and tell any treating healthcare professional that they are being treated with eculizumab.
Danish: • patientsikkerhedskortet og behovet for at patienterne bærer dette på sig, og informerer eventuelt behandlende sundhedspersonale, om at de er i behandling med eculizumab.
English: • The need to explain to and ensure understanding of by patients/carers: o the risks of treatment with eculizumab o the signs and symptoms of sepsis/severe infection and what action to take o the patient's/carer's guides and their contents o the need to carry the patient safety card and to tell any healthcare practitioner that he/she is receiving treatment with eculizumab o the requirement for vaccinations/antibiotic prophylaxis o the enrolment in the registries
Danish: • behovet for at forklare, og sikre at patienter/plejere har forstået: o risikoen ved behandling med eculizumab o tegn og symptomer på sepsis/svær infektion og hvilken handling de skal foretage o patientens/plejerens vejledninger og disses indhold o behovet om at bære patientsikkerhedskortet og fortælle eventuelt sundhedspersonale at han/hun modtager behandling med eculizumab o kravet om vaccinationer/profylaktisk antibiotisk behandling o indskrivning i registrene
English: The median duration of Soliris therapy was 16 weeks (range 4 to 70 weeks) for children < 2 years of age (n=5) and 31 weeks (range 19 to 63 weeks) for children 2 to <12 years of age (n=10).
Danish: Den mediane varighed af Soliris-behandling var 16 uger (fra 4 til 70 uger) for børn <2 år (n=5) og 31 uger (fra 19 til 63 uger) for børn på 2 år til <12 år (n=10).
English: Abnormal dreams, Sleep disorder
Danish: Unormale drømme, søvnforstyrrelser
English: Patients should be monitored for one hour following infusion.
Danish: Patienterne bør monitoreres i en time efter infusionen.
English: The median patient age was 6.5 years (range: 5 months to 17 years).
Danish: Den mediane patientalder var 6,5 år (interval: 5 måneder til 17 år).
English: Periodic Safety Update Reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: • pain in thejoints (arms and legs)
Danish: • smerter i led (arme og ben)
English: p-value a Based on a Poisson regression adjusted for randomization strata and historical ARR in 24 months prior to Screening.
Danish: 95 % CI p-værdi a Baseret på en Poisson-regression justeret for randomiseringsstrata og historisk ARR i de 24 måneder før screeningen.
English: 1- How is Soliris supplied?
Danish: 1- Hvordan leveres Soliris?
English: The most common adverse reaction reported in paediatric patients was headache.
Danish: Den hyppigst rapporterede bivirkning hos pædiatriske patienter var hovedpine.
English: SEM= Standard Error of the Mean CI= Confidence Interval, MGC= Myasthenia Gravis Composite, MG-QoL15= Myasthenia Gravis Qualtiy of Life 15
Danish: SEM = standardfejl af gennemsnit (Standard Error of the Mean) CI = konfidensinterval, MGC= Myasthenia Gravis Composite, MG-QoL15= Myasthenia Gravis livskvalitet (Quality of Life) 15
English: Date of latest renewal : 18 June 2012
Danish: Dato for første markedsføringstilladelse: 20 juni 2007 Dato for seneste fornyelse: 18 juni 2012