natgillin/translations-raw huggingface dataset:
Mindst 2 uger før du begynder at få Soliris, vil din læge administrere en vaccine mod meningokokinfektion, hvis du ikke tidligere er vaccineret, eller hvis din vaccination er for gammel.
At least 2 weeks before you start treatment with Soliris, your doctor will administer a vaccine against meningococcal infection if it was not previously administered or if your vaccination is outdated.
• nældefeber, hudrødme, tør hud, røde eller lilla pletter under huden, øget svedtendens
• hives, redness of the skin, dry skin, red or purple spots under the skin, increased sweating
Ud af de 125 patienter, der indgik i ECU-MG-301, indgik 117 patienter efterfølgende i et langtidsforlængelsesstudie (studie ECU-MG-302), hvor alle fik Soliris.
Of the 125 patients enrolled in ECU-MG-301, 117 patients subsequently were enrolled in a long-term extension study (Study ECU-MG-302), in which all receive Soliris.
Anafylaktisk reaktion, overfølsomhed
Anaphylactic reaction, Hypersensitivity
Af de 195 patienter, der kom fra C04-001, C04-002 og andre indledende studier, indgik Solirisbehandlede PNH-patienter i et langvarigt forlængelsesstudie (E05-001).
From the 195 patients that originated in C04-001, C04-002 and other initial studies, Soliris-treated PNH patients were enrolled in a long term extension study (E05-001).
Den primære analyse af QMG var en Worst Rank ANCOVA med en gennemsnitlig rangering på 54,7 for Soliris og 70,7 for placebo, baseret på et studie med 125 patienter (p=0,0129).
The primary analysis of the QMG was a Worst-Rank ANCOVA with a mean rank of 54.7 for Soliris and 70.7 for placebo, based on 125 study patients (p=0.0129).
Din læge vil diskutere de mulige uønskede virkninger heraf med dig og forklare risiciene.
Your doctor will discuss the possible side effects with you and explain the risks.
Det skal du vide, før du begynder at bruge Soliris
What you need to know before you use Soliris
Almindelig (≥1/100 til <1/10)
(≥1/100 to <1/10)
• menstruationsforstyrrelser
• menstrual disorder
• pludselig og hurtig udvikling af ekstremt højt blodtryk, lavt blodtryk, hedeture, lidelser relateret til vener (blodårer)
• sudden and rapid development of extremely high blood pressure, low blood pressure, hot flush, vein disorder
Når behandlingen blev fortsat ud over 26 uger, opnåede og opretholdt yderligere seks patienter et fuldstændigt TMA-respons på grund af reduktion i serum-kreatinin.
When treatment was continued for more than 26 weeks, six additional patients achieved and maintained Complete TMA response due to a decrease in serum creatinine.
Antistoffer mod Soliris blev konstateret hos 2 % af PNH-patienterne ved en ELISA-analyse, hos 3 % af patienterne med aHUS og hos 2 % af patienterne med NMOSD ved en analyse med ECL-bridging format.
Antibodies to Soliris were detected in 2% of patients with PNH using an ELISA assay, 3% of patients with aHUS and 2% of patients with NMOSD using the ECL bridging format assay.
Læger skal diskutere fordele og risici ved Soliris-behandling med patienterne og give dem en patientinformationsbrochure og et patientsikkerhedskort (se beskrivelsen i indlægssedlen).
Physicians must discuss the benefits and risks of Soliris therapy with patients and provide them with a patient information brochure and a patient safety card (see Package Leaflet for a description).
Normalisering af trombocyttal TMA-hændelsesfri tilstand Fuldstændig TMA-respons eGFR-forbedring ≥ 15 ml/min/1,73m2
Platelet count normalization TMA event-free status Complete TMA response eGFR improvement ≥ 15 mL/min/1.73m2
Der er ikke udført specifikke studier vedrørende farmakokinetikken af Soliris hos særlige patientpopulationer identificeret ud fra køn, race, alder (geriatrisk) eller tilstedeværelse af nedsat nyreeller leverfunktion.
Dedicated studies have not been conducted to evaluate the pharmacokinetics of Soliris in special patient populations identified by gender, race, age (geriatric), or the presence of renal or hepatic impairment.
Patienterne i de 2 prospektive studier blev behandlet med Soliris i 26 uger, og de fleste patienter fortsatte derefter i et langvarigt, ikkeblindet forlængelsesstudie.
Patients in both prospective studies were treated with Soliris for 26 weeks and most patients enrolled into a long-term, open-label extension study.
Tidligere aplastisk anæmi eller myelodysplastisk syndrom (%) Samtidig behandling med antikoagulantia (%) Samtidig behandling med steroider/immunosuppressiva (%) Behandling afbrudt
Gender - Female (%) History of Aplastic Anaemia or MDS (%) Concomitant Anticoagulants (%) Concomitant Steroids/Immunosuppressant Treatments (%)
Hos patienter med aHUS i behandling med Soliris blev der detekteret antistoffer mod Soliris hos 3/100 (3 %) i en analyse med ECL-bridging format.
In patients with aHUS treated with Soliris, antibodies to Soliris were detected in 3/100 (3%) by the ECL bridging format assay.
Ændring med Soliris i forhold til placebo - LSgennemsnitlig forskel (95 % CI)
Soliris change relative to placebo - LS Mean Difference (95%
Børn og unge Patienter under 18 år skal være vaccineret imod Haemophilus influenzae og pneumokokinfektioner.
Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections
Efter 6 måneder havde Soliris-behandlede patienter uden RBCtransfusion i anamnesen signifikant (p < 0,001) reducerede LDH-niveauer (median-LDH på 305 E/l; tabel 4).
At 6 months, patients treated with Soliris with no history of RBC transfusion had significantly (p<0.001) reduced LDH levels (median LDH of 305 U/L; Table 4).
Der er ikke iagttaget sammenhæng mellem antistofdannelse og klinisk respons eller bivirkninger.
There has been no observed correlation of antibody development to clinical response or adverse events.
Patienter under 18 år skal være vaccineret mod Haemophilus influenzae og pneumokokinfektioner og skal nøje overholde de nationale vaccinationsanbefalinger for de respektive aldersgrupper.
Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections, and strictly need to adhere to the national vaccination recommendations for each age group.
• risikoen for reaktioner som følge af infusion, inklusive anafylaktisk shock, og rådgivning omkring post-infusion monitorering.
• The risk of infusion reactions including anaphylaxis and advice on post-infusion monitoring.
Komplet TMA-respons blev defineret som hæmatologisk normalisering og ≥ 25 % reduktion i serum-kreatinin i ≥ 2 på hinanden følgende målinger og opretholdt i ≥ 4 uger.
Complete TMA response was defined as haematologic normalization and a ≥25% reduction in serum creatinine sustained in ≥ 2 consecutive measurements for ≥ 4 weeks.
a Absces omfatter den følgende gruppe af foretrukne betegnelser: Absces lemmer, kolonabsces, nyreabsces, subkutan absces, tandabsces, hepatosplenisk absces, perirektal absces, rektal absces.
Abscess includes the following group of PTs: Abscess limb, Colonic abscess, Renal abscess, Subcutaneous abscess, Tooth abscess, Hepatosplenic abscess, Perirectal abscess, Rectal abscess.
Hver uge i de første 4 uger vil lægen give dig en intravenøs infusion af fortyndet Soliris.
Every week for the first four weeks, your doctor will administer an intravenous infusion of diluted
Studie ECU-MG-301 (REGAIN) var et 26-ugers, dobbeltblindet, randomiseret, placebokontrolleret, fase 3-multicenterstudie af Soliris hos patienter, hvor tidligere behandlinger havde svigtet, og som fortsat var symptomatiske.
Study ECU-MG-301 (REGAIN) was a 26-week double-blind, randomized, placebo-controlled, multicenter Phase 3 study of Soliris in patients who had failed previous therapies and remain symptomatic.
(i) lav EDSS ved randomisering (<=2,0), (ii) høj EDSS (>=2,5 til <=7) og behandlingsnaive ved randomisering, (iii) høj EDSS (>=2,5 til <=7) og fortsættelse med samme IST(er) siden det sidste recidiv ved randomisering, (iv) høj EDSS (>=2,5 til <=7) og ændringer i IST(er) siden sidste recidiv ved randomisering.
Stratified analyses are based on four randomization strata: (i) low EDSS at randomization (<=2.0), (ii) high EDSS (>=2.5 to <=7) and treatment naive at randomization, (iii) high EDSS (>=2.5 to <=7) and continuing on the same IST(s) since last relapse at randomization, (iv) high EDSS (>=2.5 to <=7) and changes in IST(s) since last relapse at randomization.
Supplerende dosis anbefales, når Soliris administreres til aHUS-patienter, der får plasmainfusion eller plasmaudskiftning (se pkt.
Supplemental dosing is recommended when Soliris is administered to aHUS patients receiving plasma infusion or exchange (see section 4.2).
Vacciner mod serogruppe A, C, Y, W 135 og B (hvis tilgængelig) anbefales til forebyggelse af de normalt patogene meningokok-serogrupper.
Vaccines against serogroups A, C, Y, W 135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups.
PNH-registret (M07-001) blev anvendt til at evaluere virkningen af Soliris hos PNH-patienter uden RBC-transfusion i anamnesen.
The PNH registry (M07-001) was used to evaluate the efficacy of Soliris in PNH patients with no history of RBC transfusion.
Soliris blev administreret som intravenøs infusion over 35 minutter.
Soliris was administered as an intravenous infusion over 35 minutes.
• forhøjet niveau af leverenzymer, nedsat antal røde blodlegemer, nedsat indhold af det protein i de røde blodlegemer, der transporterer ilt
• increase of liver enzymes, decrease of the proportion of blood volume that is occupied by red blood cells, decrease in the protein in red blood cells that carries oxygen
30 ml koncentrat i et hætteglas (glas type I) med prop af butylgummi (silikoneret), forsegling (aluminium) og afrivningskapsel (polypropylen).
30 ml of concentrate in a vial (Type I glass) with a stopper (butyl, siliconised), and a seal (aluminium) with flip-off cap (polypropylene).
En reduktion i intravaskulær hæmolyse, målt ved serum-LDH, vedvarede i hele behandlingsperioden og førte til øget undgåelse af transfusion, mindsket behov for erytrocyttransfusion og mindsket træthed.
A reduction in intravascular haemolysis as measured by serum LDH levels was sustained for the treatment period and resulted in increased transfusion avoidance, a reduced need for RBC transfusion and less fatigue.
PNH-patienter i behandling med Soliris bør tilsvarende monitoreres for intravaskulær hæmolyse ved måling af LDH-værdien, og kan have behov for dosisjustering inden for det anbefalede 14±2-dages doseringsskema i vedligeholdelsesfasen (op til hver 12. dag).
PNH patients receiving Soliris therapy should be similarly monitored for intravascular haemolysis by measuring LDH levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days).
I et placebokontrolleret studie af refraktær gMG viste ingen (0/62) af patienterne behandlet med Soliris et antilægemiddel-antistofrespons i løbet af de 26 uger med aktiv behandling.
In a refractory gMG placebo controlled study, none (0/62) of the Soliris treated patients showed antidrug antibody response during the 26 week active treatment.
Studiet C08-003A/B var et prospektivt, kontrolleret, ikke-blindet studie, hvori der deltog patienter med længerevarende aHUS uden synlige tegn på kliniske manifestationer af trombotisk mikroangiopati, som var i kronisk PE/PI-behandling (≥ 1 PE/PI-behandling hver 2. uge og ikke over 3 PE/PI-behandlinger/uge i mindst 8 uger før den første dosis).
Study C08-003A/B was a prospective, controlled, open-label study which accrued patients with longer term aHUS without apparent evidence of clinical thrombotic microangiopathy manifestations and receiving chronic PE/PI (≥1 PE/PI treatment every two weeks and no more than 3 PE/PI treatments/week for at least 8 weeks before the first dose).
Tabel 3: Resultater vedrørende virkning i C04-001 og C04-002 C04-001
Table 3: Efficacy Outcomes in C04-001 and C04-002 C04-001
Den farmakodynamiske aktivitet, målt ved frie C5-koncentrationer på < 0,5 µg/ml, korrelerer med en stort set fuldstændig blokering af den terminale komplementaktivitet hos patienter med PNH, aHUS, refraktær gMG og NMOSD.
Pharmacodynamic activity measured by free C5 concentrations of <0.5 ug/mL, is correlated with essentially complete blockade of terminal complement activity in PNH, aHUS, refractory gMG and NMOSD patients.
Hos patienter med NMOSD fører ukontrolleret terminal komplementaktivering forårsaget af autoantistoffer mod AQP4 til dannelsen af MAC- og C5a-afhængig inflammation, hvilket fører til astrocytnekrose og øget permeabilitet af blod-hjerne-barrieren samt død af omgivende oligodendrocytter og neuroner.
In patients with NMOSD, uncontrolled terminal complement activation caused by autoantibodies against AQP4 leads to the formation of the MAC and C5a-dependent inflammation which results in astrocyte necrosis and increased permeability of the blood brain barrier, as well as death of the surrounding oligodendrocytes and neurons.
b Meningokokinfektion omfatter den følgende gruppe af foretrukne betegnelser: Meningokok-infektion, meningokok-sepsis, meningokok-meningitis, Neisseria-infektion.
Meningococcal infection includes the following group of PTs: Meningococcal infection, Meningococcal sepsis, Meningitis meningococcal, Neisseria infection.
Eculizumabs farmakokinetik blev evalueret i studie M07-005 hos pædiatriske PNH-patienter (i alderen fra 11 år til under 18 år) og i studie C08-002, C08-003, C09-001r og C10-003 hos pædiatriske patienter med aHUS (i alderen fra 2 måneder til under 18 år) med et kropsvægtbaseret dosisregime.
The pharmacokinetics of eculizumab was evaluated in Study M07-005 in PNH paediatric patients (aged from 11 to less than 18 years) and in Studies C08-002, C08-003, C09-001r and C10-003 in aHUS pediatric patients (aged 2 months to less than 18 years) with body-weight based dose regimen.
I alt 35 patienter fik PE/PI før eculizumab.
A total of 35 patients received PE/PI prior to eculizumab.
Den anbefalede dosis overføres til en infusionspose.
Transfer the recommended dose to an infusion bag.
På grund af virkningsmekanismen bør forsigtighed udvises ved anvendelse af Soliris til patienter med aktive systemiske infektioner.
Due to its mechanism of action, Soliris therapy should be administered with caution to patients with active systemic infections.
Mediantiden fra aHUS-diagnose til første Soliris-dosis var 14 måneder (interval <1 til 110 måneder).
The median time from aHUS diagnosis to first dose of Soliris was 14 months (range <1, 110 months).
• behovet for at patienter vaccineres mod Neisseria meningitidis-infektion to uger før de modtager eculizumab og/eller at de modtager profylaktisk antibiotisk behandling.
• The need for patients to be vaccinated against Neisseria meningitidis two weeks prior to receiving eculizumab and/or to receive antibiotic prophylaxis.
2 Årvågenhed over for meningokokinfektion og andre Neisseria-infektioner), skal du straks informere lægen.
If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal and other Neisseria infections alert), you should immediately inform your doctor.
Ændring fra baseline efter 12 uger i LDHværdi (E/l)
Change from baseline at 12 weeks of LDH Value (U/L)
Ved maternel eksponering for antistoffet under organogenesen blev der iagttaget to tilfælde af retinal dysplasi og ét tilfælde af umbilikalhernie blandt 230 unger af hunner, der blev eksponeret for den høje antistofdosis (ca. 4 gange den anbefalede maksimale humane Soliris-dosis, baseret på kropsvægt).
When maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose (approximately 4 times the maximum recommended human Soliris dose, based on a body weight comparison); however, the exposure did not increase foetal loss or neonatal death.
Forholdet mellem den adjudikerede annualiserede recidivrate (ARR) i løbet af studiet (ARR) (95 % CI) for eculizumab sammenlignet med placebo var 0,045 (0,013; 0,151), hvilket udgør en 95,5 % relativ reduktion i adjudikeret ARR i løbet af studiet for patienter i behandling med eculizumab sammenlignet med placebo (p<0,0001) (tabel 13).
The adjudicated on-trial annualized relapse rate (ARR) ratio (95% CI) for eculizumab compared with placebo was 0.045 (0.013, 0.151), representing a 95.5% relative reduction in adjudicated On-trial ARR for patients treated with eculizumab compared with placebo (p<0.0001) (Table 13).
Når behandlinger med immunsuppressive midler og anticholinesterase reduceres eller seponeres, skal patienterne overvåges nøje for tegn på sygdomsforværring.
When immunosuppressant and anticholinesterase therapies are decreased or discontinued, patients should be monitored closely for signs of disease exacerbation.
Tabel 9: Patientdemografi og karakteristika i studie ECU-MG-301
Table 9: Patient Demographic and Characteristics in Study ECU-MG-301
• risikoen for reaktioner som følge af infusion, inklusive anafylaktisk shock, og behovet for klinisk post-infusion monitorering.
• The risk of infusion reactions with eculizumab, including anaphylaxis, and the need for clinical monitoring post-infusion.
Tidligere ventilatorstøtte siden diagnose, n
Any prior ventilator support since diagnosis,
• Den anbefalede dosis overføres til en infusionspose.
• Transfer the recommended dose to an infusion bag.
Der er ikke udført dyrereproduktionsstudier med eculizumab (se pkt.
Animal reproduction studies have not been conducted with eculizumab (see section 5.3).
• alvorlig allergisk reaktion, der forårsager vejrtrækningsbesvær eller svimmelhed (anafylaktisk reaktion), overfølsomhed
• serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction),
Seponering af behandlinger med immunsuppressive midler og anticholinesterase under behandling med Soliris for refraktær gMG blev ikke vurderet i de placebokontrollerede studier.
Withdrawal of immunosuppressant and anticholinesterase therapies during Soliris treatment for refractory gMG was not assessed in the placebocontrolled studies.
Hos patienter med NMOSD angribes og beskadiges øjennerverne og rygmarven af kroppens eget immunsystem, hvilket kan føre til blindhed i det ene eller i begge øjne, svaghed eller lammelse i arme og ben, smertefulde spasmer, følelsesløshed og markant hæmning af dagligdags aktiviteter.
In patients with NMOSD, their eye nerve and spinal cord are attacked and damaged by the immune system which can lead to blindness in one or both eyes, weakness or paralysis in the legs or arms, painful spasms, loss of sensation, and markedly impaired activities of daily living.
Kontakt lægen, hvis du får nogen af disse symptomer.
If you have any of these symptoms, contact your doctor.
I alle kliniske studier var den alvorligste bivirkning meningokoksepsis, som er et almindeligt symptom på meningokokinfektioner hos patienter behandlet med Soliris (se pkt.
In all clinical studies, the most serious adverse reaction was meningococcal sepsis which is a common presentation of meningococcal infections in patients treated with Soliris (see section 4.4).
Når behandlingen blev fortsat ud over 26 uger, opnåede og opretholdt yderligere to patienter et fuldstændigt TMA-respons på grund af normalisering af LDH (1 patient) og reduktion i serum-kreatinin (2 patienter).
When treatment was continued for more than 26 weeks, two additional patients achieved and maintained Complete TMA response due to normalization of LDH (1 patient) and a decrease in serum creatinine (2 patients).
Studie ECU-NMO-301 var et dobbeltblindet, randomiseret, placebokontrolleret fase 3 multicenterstudie af Soliris hos patienter med NMOSD.
Study ECU-NMO-301 was a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study of Soliris in patients with NMOSD.
Soliris (eculizumab) er ikke blevet undersøgt til behandling af akutte recidiver hos NMOSD-patienter.
Soliris (eculizumab) has not been studied for the treatment of acute relapses in NMOSD patients.
Proteiner kan hos nogle fremkalde allergiske reaktioner.
Allergic reactions Soliris contains a protein and proteins can cause allergic reactions in some people.
Tabel 5: Patientdemografi og karakteristika i C08-002A/B og C08-003A/B Parameter
Table 5: Patient Demographics and Characteristics in C08-002A/B and C08-003A/B
Et hundrede og atten (118) af de 125 (94 %) patienter gennemførte den 26ugers behandlingsperiode, og 117 (94 %) patienter indgik efterfølgende i studie ECU-MG-302, et åbent multicenter-forlængelsesstudie til vurdering af langtidssikkerhed og -virkning, hvor alle patienterne fik behandling med Soliris.
One hundred and eighteen (118) of the 125 (94%) patients completed the 26-week treatment period and 117 (94%) patients subsequently enrolled in Study ECU-MG-302, an open-label, multi-center long-term safety and efficacy extension study in which all patients received Soliris treatment.
I alt (N = 143)
(N = 143)
Hæmolyse*, abnorm koagulationsfaktor, agglutination af røde blodlegemer, koagulopati
Haemolysis*, Abnormal clotting factor, Red blood cell agglutination, Coagulopathy
Wilcoxon Signed Rank
P - Value Mean (SD) Wilcoxon Signed Rank
Årvågenhed over for meningokok- og andre Neisseria-infektioner Soliris kan svække din naturlige modstandskraft over for infektioner, især med visse organismer, der er årsag til meningokokinfektion (svær hjernehindebetændelse og blodforgiftning) og andre Neisseriainfektioner, herunder dissemineret gonorré.
Meningococcal and other Neisseria infections alert Soliris treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningococcal infection (severe infection of the linings of the brain and sepsis) and other Neisseria infections including disseminated gonorrhea.
Baseline-karakteristika er vist i tabel 2.
Baseline characteristics are shown in Table 2.
Tabel 4: Effektresultater (LDH-niveau og FACIT-træthedsscore) hos PNH-patienter uden transfusion i anamnesen i PNH-register M07-001
Table 4: Efficacy Outcomes (LDH level and FACIT-Fatigue) in Patients with PNH with No History of Transfusion in M07-001
2 til <12 år (n=10)
2 to <12 years (n=10)
I det ikke-kontrollerede studie C04-002 (SHEPHERD) blev PNH-patienter, der havde fået mindst én transfusion de foregående 24 måneder og havde et trombocyttal på mindst 30 000/μl, behandlet med Soliris i en periode på 52 uger.
In the non-controlled study C04-002 (SHEPHERD), PNH patients with at least one transfusion in the prior 24 months and at least 30,000 platelets/microliter received Soliris over a 52-week period.
Hvis du kommer ud for nogen af nedenstående symptomer, skal du straks henvende dig til lægen: hovedpine med kvalme eller opkastning hovedpine med nakke- eller rygstivhed feber udslæt omtågethed stærk muskelømhed samtidig med influenzalignende symptomer lysfølsomhed.
If you experience any of the following symptoms, you should immediately inform your doctor: - headache with nausea or vomiting - headache with a stiff neck or back - fever - rash - confusion - severe muscle aches combined with flu-like symptoms
Det primære endepunkt for studie ECU-MG-301 var ændringen fra baseline i MG-Activities of Daily Living-profilen (MG-ADL - en patientrapporteret udfaldsmåling valideret i gMG) total score ved uge 26.
The primary endpoint for Study ECU-MG-301 was the change from baseline in the MG Activities of Daily Living Profile (MG-ADL - a patient reported outcome measure validated in gMG) total score at Week 26.
Soliris produceres i et ekspressionssystem for murint myelom (NS0 cellelinje) og renses ved affinitetsog ionbytningskromatografi.
Soliris is produced in a murine myeloma (NS0 cell line) expression system and purified by affinity and ion exchange chromatography.
Før iværksættelse af Soliris-behandling anbefales det, at PNH-, aHUS-, refraktær gMG- og NMOSDpatienter påbegynder vaccination i henhold til de gældende retningslinjer.
Prior to initiating Soliris therapy, it is recommended that PNH, aHUS, refractory gMG and NMOSD patients initiate immunizations according to current immunization guidelines.