natgillin/translations-raw huggingface dataset:
Hulio er i kombination med methotrexat er indiceret til:
Hulio in combination with methotrexate, is indicated for:
TNF-antagonister, såsom adalimumab, påvirker immunsystemet og brugen af dem kan påvirke kroppens forsvar mod infektion og cancer.
TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
Som en hjælp til at huske på, hvilken/hvilke dag/dage du skal injicere Hulio, kan det være en god ide at lave en note i en kalender eller en lommebog.
To help you remember which day(s) of the week Hulio should be injected, it may be helpful to make a note on a calendar or in a diary.
b 2-sidet P-værdi fra log rank test. c NE = ikke estimerbar.
b 2-sided P value from log rank test. c NE = not estimable.
Hulio er et biosimilært lægemiddel.
Hulio is a biosimilar medicinal product.
Hulio fås i pakninger med 1 eller 2 æsker.
Hulio is supplied as packs containing 1 or 2 boxes.
• Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager Hulio.
• If you are over 65 years you may be more susceptible to infections while taking Hulio.
Begrænset information i offentliggjort litteratur indikerer, at adalimumab udskilles i brystmælk i meget lave koncentrationer med en tilstedeværelse af adalimumab i human brystmælk i koncentrationer på 0,1% til 1% af det maternale serumniveau.
Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level.
Det første ”KLIK” betyder, at injektionen er begyndt.
This 1st “CLICK” signals the start of the injection.
Frafald, som skyldtes andet end behandlingssvigt, blev censureret på tidspunktet for frafald.
Drop outs due to reasons other than treatment failure were censored at the time of dropping out.
Omkring 40% af patienterne i UC-studie II havde tidligere haft mislykket anti-TNF-behandling med infliximab.
Approximately 40% of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Den tilsvarende andel af patienter uden radiografisk progression var henholdsvis 31,3%, 23,7% og 36,7%.
The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively.
- Hvis du har moderat eller alvorlig hjerteinsufficiens.
- If you have moderate or severe heart failure.
Bliv ved med at trykke pennen mod injektionsstedet, indtil en eller flere af følgende ting sker:
Continue holding the body of the pen down against the injection site until one, or all, of the following occur:
Behandling med Hulio kan medføre dannelse af autoimmune antistoffer.
Treatment with Hulio may result in the formation of autoimmune antibodies.
Ved at binde sig til TNFα reducerer Hulio den inflammatoriske proces i disse sygdomme.
By attaching to TNFα, Hulio decreases the process of inflammation in these diseases.
Trin 2 - Vask hænder Vask hænderne grundigt med vand og sæbe.
Step 2 - Wash hands Wash your hands with soap and water.
Patienter i adalimumab-behandling kan modtage samtidige vaccinationer, undtagen levende vacciner.
Patients on adalimumab may receive concurrent vaccinations, except for live vaccines.
Hulio er beregnet til behandling af følgende inflammatoriske sygdomme:
Hulio is intended for the treatment of the following inflammatory diseases:
• GENBRUG IKKE pennen.
• DO NOT re-use the pen.
Klinisk remission 12%
Clinical remission 12%
Hulio virker ved at reducere denne inflammation.
Hulio works by reducing this inflammation.
Forværring eller nye udbrud af psoriasis (herunder palmoplantar pustuløs psoriasis)1),
Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1),
Klinisk remission er Mayo-score < 2 uden subscore > 1;
Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Der findes detaljeret instruktion om injektion af Hulio i afsnit 7 ”Brugsvejledning”.
Detailed instructions on how to inject Hulio are provided in Section 7 - Instructions for use.
Patientvægt
Patient Weight
Blandt patienter med klinisk respons ved uge 4 havde 48% tidligere været eksponeret for anden TNF-antagonist.
Of those in clinical response at week 4, 48% had been previously exposed to other TNF-antagonists.
Kriterier for opblussen af sygdommen var defineret som en forværring på ≥ 30% i forhold til baseline af ≥ 3 ud af 6 pædiatrisk ACR-hovedkriterier, ≥ 2 aktive led og en forbedring på > 30% i ikke mere end 1 af de 6 kriterier.
Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30% in no more than 1 of the 6 criteria.
I et udviklingstoksicitetsstudie udført på aber, var der ingen tegn på maternel toksicitet, embryotoksicitet eller teratogenicitet.
In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Hulio.
Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Hulio.
På grund af sin TNF-hæmmende virkning kan adalimumab administreret under graviditet påvirke de normale immunresponser hos nyfødte.
Due to its inhibition of TNF, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Adalimumabs lange halveringstid bør tages med i overvejelserne, når der planlægges kirurgisk indgreb.
The long half-life of adalimumab should be taken into consideration if a surgical procedure is planned.
Nogle tilfælde havde letalt udfald.
Some cases have had a fatal outcome.
b Patienter, som opfyldte protokol-specifikke kriterier for tab af respons eller ingen forbedring, udgik af studierne og blev talt som non-respondere.
b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders.
Hulio bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
Hulio should be used with caution in patients with mild heart failure (NYHA class I/II).
Hvis der stadig er luftbobler i væsken, kan du gentage processen op til 3 gange.
If you see air bubbles in the solution again, you may repeat this step up to 3 times.
Bivirkninger kan forekomme op til mindst 4 måneder efter den sidste Hulio-injektion.
Side effects may occur up to 4 months or more after the last Hulio injection.
Samtidige faste doser af aminosalicylater, kortikosteroider, og/eller immunmodulerende midler var tilladt, og 80% af patienterne fortsatte med at få mindst et af disse lægemidler.
Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
Fase
phase
Adalimumab er et rekombinant humant monoklonalt antistof fremstillet i ovarieceller fra kinesiske hamstere.
Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Delvis opblussen af sygdomd a Assessment of Spondyloarthritis International Society bBaseline er defineret som åben periode baseline, når patienterne har aktiv sygdom.
Partial Flared a Assessment of SpondyloArthritis international Society b Baseline is defined as open label baseline when patients have active disease.
Ud af 250 patienter, som afsluttede det åbne forlængelsesstudie, blev forbedring af fysisk funktion opretholdt gennem 10 års behandling.
Among the 250 subjects who completed the open-label extension study, improvements in physical function were maintained through 10 years of treatment.
Klinisk remission (defineret som Mayo-score < 2 med ingen subscore > 1) blev vurderet ved uge 8.
Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 8.
Serumniveauer af matrixmetalloproteinaser (MMP-1 og MMP-3), som forårsager vævsomdannelse, der er ansvarlig for brusknedbrydning, var også nedsatte efter adalimumab-administration.
Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after adalimumab administration.
Nogle af disse patienter blev også behandlet med azathioprin eller mercaptopurin.
Some of those patients were also treated with the medicines azathioprine or mercaptopurine.
• multipel sklerose;
• multiple sclerosis;
Du og din læge bør være særligt opmærksomme på tegn på infektion mens du er i behandling med Hulio.
You and your doctor should pay special attention to signs of infection while you are being treated with Hulio.
• INJICER IKKE gennem tøjet.
• DO NOT inject through clothes.
• Der var ifølge et graviditetsstudie ikke højere risiko for misdannelser, når moderen havde fået Hulio under graviditeten, ved sammenligning med mødre med samme sygdom, som ikke havde fået Hulio.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received Hulio during pregnancy compared with mothers with the same disease who did not receive Hulio.
Resultater af effekt Dobbeltblindet uge 32 Adalimumab /MTX (N = 38)
Efficacy Outcomes Double Blind 32 weeks Adalimumab /MTX (N = 38)
Uge 26 Klinisk remission Klinisk respons Uge 52 Klinisk remission Klinisk respons * p-værdi for sammenligning af standard-dosis versus lav-dosis.
Week 26 Clinical remission Clinical response Week 52 Clinical remission Clinical response * p value for Standard Dose versus Low Dose comparison.
Ud af disse var 109 patienter (63,7%) i remission efter 10 år.
Among those, 109 subjects (63.7%) were reported to be in remission at 10 years.
Dit barns læge, sygeplejerske eller andet sundhedspersonale vil instruere dig i, hvordan du skal forberede og give injektionen til dit barn.
Your child's doctor, nurse or other healthcare professional will show you how to prepare the injection and give it to your child.
I CD-studie III oplevede 58% (499/854) af patienterne klinisk respons ved uge 4 og blev vurderet i den primære analyse.
In CD Study III, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Hulio Sæt de vedlagte mærkater ind i din kalender som en påmindelse om tidspunktet for næste dosis.
Hulio Mark your calendar with the stickers provided to remind you of the date for your next dose.
Administration af Hulio bør ophøre, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling iværksættes, indtil infektionen er under kontrol.
Administration of Hulio should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter enkeltdoser og gentagne doser og genotoksicitet.
Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
• milde allergiske reaktioner (herunder sæsonbestemt allergi);
• mild allergic reactions (including seasonal allergy);
Tryk langsomt stemplet helt ned, indtil al medicinen er injiceret og sprøjten er tom.
Slowly push the plunger completely down until all the medicine is injected and the syringe is empty.
• Den orange indikator bevæger sig ikke mere og fylder hele vinduet.
• Orange Indicator has stopped and completely blocked the Viewing Window.
Behandling med Hulio bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Hulio er indiceret til.
Hulio treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Hulio is indicated.
Bærere af HBV, som kræver behandling med Hulio, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
Carriers of HBV who require treatment with Hulio should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Udførlig instruktion vedrørende brug findes i indlægssedlen.
Full instructions for use are provided in the package leaflet.
≥30% reduktion af hudsmerterb
≥30% Reduction in Skin Painb
Bliv ved med at holde pennen nede når du hører det første ”KLIK”.
Continue holding down after hearing the 1st
Behandling med Hulio bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
Treatment with Hulio should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Adalimumab kan passere placenta og findes i serum hos spædbørn, der er født af kvinder, som blev behandlet med adalimumab under graviditeten.
Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy.
Hvis der er en anden Hulio-pakning tilbage i æsken, skal den lægges tilbage i køleskabet med det samme.
If there is a second box in the Hulio pack for a future injection, place it back in the refrigerator immediately.
Hepatitis, reaktivering af hepatitis B1), autoimmun hepatitis1)
Hepatitis, reactivation of hepatitis B1), autoimmune hepatitis1)
Der har imidlertid også været post-marketing rapporter om leversvigt samt mindre alvorlige leverlidelser, som kan optræde forud for leversvigt, såsom hepatitis, inklusive autoimmun hepatitis hos patienter, som får adalimumab.
However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
[Tekst på bakke i æske:] Hulio
[Text displayed on the tray inside the box:] Hulio
Det samlede respons var generelt bedre, og færre patienter udviklede antistoffer, når de blev behandlet med kombinationen adalimumab og MTX sammenlignet med adalimumab alene.
Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of adalimumab and MTX compared to adalimumab alone.
Administration af levende vacciner (f.eks. BCG vaccine) til spædbørn, som har været eksponeret for adalimumab in utero, anbefales ikke i 5 måneder efter moderens sidste adalimumab-injektion under graviditeten.
Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Et hundrede patienter (n=100) fra det pædiatriske Crohn-studie fortsatte i langtidsbehandling i et åbent forlængelsesstudie.
One hundred patients (n=100) from the Paediatric CD Study continued in an open-label long-term extension study.
Aftør huden på det valgte injektionssted med en ny alkoholserviet.
Wipe the skin at the chosen injection site with a new alcohol swab.
I betragtning af disse resultater anbefales adalimumab til anvendelse i kombination med MTX og til anvendelse som monoterapi til patienter, som ikke egner sig til behandling med MTX (se pkt.
Taking these results into consideration, adalimumab is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Den korrigerede OR (som tager højde for baseline forskelle) var 1,10 (95% CI 0,45-2,73) for RA og CD kombineret.
The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD combined.
Målet for adalimumab er et protein kaldet tumornekrosefaktor (TNFα) som er til stede i øgede mængder i de inflammatoriske sygdomme nævnt ovenfor.
The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
• smerter i knogler og muskler.
• pain in bone and muscles.
Eksisterende data tyder ikke på, at adalimumab forværrer eller forårsager forsnævringer.
Available data suggest that adalimumab does not worsen or cause strictures.
Behandling med Hulio kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
Treatment with Hulio can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Før behandling med Hulio påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
Before initiation of therapy with Hulio, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
• Der er set meget sjældne tilfælde af visse kræfttyper hos børn og voksne patienter, som tager adalimumab eller andre TNFα-hæmmere.
• There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
Der er ved post-marketing erfaring fra januar 2003 til december 2010, hovedsageligt hos patienter med reumatoid artrit rapporteret en hyppighed af maligniteter på cirka 2,7 pr. 1.000 patientbehandlingsår.
In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
• Hvis stemplet ikke trykkes helt ned, vil kanylehuset ikke blive aktiveret bagefter og dække kanylen.
• If the plunger is not pressed all the way the safety feature will not activate afterwards to cover the needle.
• kræft i lymfesystemet (lymfom);
• cancer of the lymph system (lymphoma);
Raterne for klinisk remission forblev forholdsvis konstante uanset tidligere TNFantagonisteksposition.
Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
JSNd score a methotrexat b 95% Konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab.
JSNd score a methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
Selvom det ikke var statistisk signifikant, viste størstedelen af patienterne klinisk bedring i sekundære endepunkter, såsom antallet af steder med entesopatirelateret artrit, antallet af ømme led (TJC), antallet af hævede led (SJC), pædiatrisk ACR50-respons og pædiatrisk ACR 70-respons.
Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Injektionssprøjten eller pen skal beskyttes mod lys og kasseres, hvis den ikke anvendes inden for 14-dages perioden.
The pre-filled syringe or pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Der er en øget baggrundsrisiko for lymfomer og leukæmi hos reumatoid artrit patienter med længerevarende, højaktiv, inflammatorisk sygdom, hvilket komplicerer risikoestimeringen.
There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing highly active, inflammatory disease, which complicates the risk estimation.
Af de forsøgspersoner, som blev behandlet med adalimumab uden at vise progression radiografisk fra baseline til uge 48 (n=102), viste 84% fortsat ingen progression radiografisk i løbet af de 144 ugers behandling.
In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
I studie UC-II resulterede behandling med adalimumab i forbedringer i score i det tarmsygdomsspecifikke-spørgeskema (IBDQ).
In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
Hos patienter, der udvikler reaktivering af HBV, bør Hulio seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres.
In patients who develop HBV reactivation, Hulio should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
• BRUG IKKE pennen, hvis den er blevet tabt på et hårdt underlag.
• DO NOT use the pen if it has been dropped onto a hard surface.
Trin 7 Injicér Hulio
Step 7 - Inject Hulio
Læs indlægssedlen for at få yderligere information.
See the package leaflet for further information.
Patienter, der udvikler en ny infektion under behandling med Hulio, bør monitoreres nøje og gennemgå en fuldstændig diagnostisk evaluering.
Patients who develop a new infection while undergoing treatment with Hulio, should be monitored closely and undergo a complete diagnostic evaluation.
Du må ikke blande Hulio opløsningen med anden medicin.
Do not mix the Hulio solution with any other medicine.
• Yderligere risikominimeringsforanstaltninger Før Hulio markedsføres i hvert medlemsland skal indehaveren af markedsføringstilladelsen nå til enighed med den nationale kompetente myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, udleveringskanaler samt alle andre aspekter af programmet.
Prior to launch of Hulio in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Patienter med klinisk respons (nedgang i CDAI ≥ 70) ved uge 4 blev stratificeret og analyseret adskilt fra dem, som ikke havde klinisk respons ved uge 4.
Patients in clinical response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Dato for første markedsføringstilladelse: 17 september 2018
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2018
SPARCC MRI rygsøjlend,j a Assessment of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d gennemsnitlig ændring fra baseline e n=91 placebo og n=87 adalimumab f høj følsomhed C-reaktivt protein (mg/l) g n=73 placebo og n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo og adalimumab j n=82 placebo og n=85 adalimumab
SPARCC MRI Spined,j a Assessment of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
I vinduet kan du kan se den orange indikator, der viser hvor langt injektionen er nået.
In the Viewing Window, the Orange Indicator will advance to show the progress of the injection.
CD-studie I: Infliximab-naive patienter
CD Study I: Infliximab Naive Patients
Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (kræft som påvirker lymfesystemet) og leukæmi (kræft som påvirker blodceller og knoglemarv).
People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow).
Patienter bør testes for HBV-infektion inden behandling med Hulio.
Patients should be tested for HBV infection before initiating treatment with Hulio.
Tuberkulose kan udvikles under behandlingen, også selvom dit barn har fået forebyggende behandling mod tuberkulose.
Tuberculosis can develop during therapy even if your child have had preventative treatment for tuberculosis.
Normalt gives Hulio sammen med methotrexat.
Usually, Hulio is used with methotrexate.
For information vedrørende opbevaring, se indlægssedlen.
For storage information, see the package leaflet.