natgillin/translations-raw huggingface dataset:
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Remicade i alle undergrupper af den pædiatriske population med reumatoid arthritis, juvenil idiopatisk arthritis, psoriasis arthritis, ankyloserende spondylitis, psoriasis og Crohns sygdom (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Remicade in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Sjælden: Toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, erythema multiforme, furunkulose, lineær IgA bulløs dermatose (LABD), akut generaliseret eksantematøs pustulose (AGEP), lichenoide reaktioner.
Rare: Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Kontroller at koncentratet er farveløst til lysegult og opaliserende.
Check that the solution is colourless to light yellow and opalescent.
Hvis disse lægemidler ikke virker godt nok, vil du få Remicade til behandling af din sygdom.
If these medicines do not work well enough, you will be given Remicade to treat your disease.
Remicade administreres intravenøst.
Remicade should be administered intravenously.
• Aktivt stof: infliximab.
• The active substance is infliximab.
For patienter, der fik kortikosteroider ved baseline, var andelen af patienter i remission, og som ikke fik kortikosteroider ved uge 54, 38,5 % (5/13) for 8-ugers vedligeholdelsesbehandlingsgruppen og 0 % (0/13) for 12-ugers vedligeholdelsesbehandlingsgruppen.
For patients receiving corticosteroids at baseline, the proportion of patients in remission and not receiving corticosteroids at week 54 was 38.5% (5/13) for the q8 week and 0% (0/13) for the q12 week maintenance treatment group.
Efter markedsføring er der rapporteret maligniteter, hvoraf nogle har været letale, hos børn, unge og unge voksne (op til 22 år), som er behandlet med TNF-blokkere inklusive Remicade (behandlingsstart før 18-års alderen).
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including Remicade in the post-marketing setting.
Nogle tilfælde har haft dødelig udgang.
Some cases have had fatal outcome.
Procent forsøgspersoner i klinisk respons og i vedvarende klinisk respons Klinisk respons i uge 8
Percentage of subjects in clinical response and in sustained clinical response Clinical response at week 8
• Øjenproblemer inklusive sløret eller nedsat syn, hævede øjne eller bygkorn
• Eye problems including blurred or reduced vision, puffy eyes or sties
En risiko for udvikling af maligniteter hos patienter behandlet med TNF-blokkere kan ikke udelukkes.
A risk for the development of malignancies in patients treated with TNF-blockers cannot be excluded.
• Væske rundt om lungerne (pleuraekssudat)
• Fluid around the lungs (pleural effusion)
• Forværring af en sygdom der hedder dermatomyositis (muskelsvaghed med hududslæt som følgetilstand)
• Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
I de kontrollerede dele af kliniske studier med TNF-blokerende midler er der set flere maligne tilfælde, inklusive lymfom, blandt patienter, som fik en TNF-blokker sammenlignet med patienter i kontrolgruppen.
In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients.
Blandt patienter i infliximab-gruppen 5 mg/kg, der krydsede over på grund af tab af fistula respons efter uge 22, responderede 57 % (12/21) på genbehandling med infliximab 10 mg/kg hver 8. uge.
Among patients in the infliximab 5 mg/kg group who crossed over because of loss of fistula response after week 22, 57% (12/21) responded to re-treatment with infliximab 10 mg/kg every 8 weeks.
Alle patienterne fik konstante methotrexat doser (median 15 mg/uge) i 6 måneder før inklusionen og skulle fortsætte med konstante doser under hele studiet.
All patients were on stable methotrexate doses (median 15 mg/wk) for 6 months prior to enrolment and were to remain on stable doses throughout the study.
I uge 4 opnåede endvidere 13/27 (48 %) af infliximab-behandlede patienter en klinisk remission (CDAI < 150) i forhold til 1/25 (4 %) af placebobehandlede patienter.
Also at week 4, 13/27 (48%) of infliximab-treated patients achieved a clinical remission (CDAI < 150) vs. 1/25 (4%) of placebo-treated patients.
• Tegn på et problem i nervesystemet (inklusive øjenproblemer) såsom tegn på slagtilfælde (pludselig følelsesløshed eller svaghed i ansigt, arme eller ben, særligt i den ene side af kroppen; pludselig forvirring, besvær med at tale eller forstå; besvær med at se med det ene eller begge øjne, gangbesvær, svimmelhed, tab af balance- eller koordinationsevne eller svær hovedpine), krampeanfald, prikken/følelsesløshed et sted i kroppen, eller svaghed i arme eller ben, ændringer i synet såsom dobbeltsyn eller andre øjenproblemer.
• Signs of a nervous system problem (including eye problems) such as signs of a stroke (sudden numbness or weakness of your face, arm or leg, especially on one side of your body; sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble walking, dizziness, loss of balance or coordination or a severe headache), fits, tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight such as double vision or other eye problems.
Procent forsøgspersoner i klinisk remission og vedvarende remission Klinisk remission i uge 8
Percentage of subjects in clinical remission and sustained remission Clinical remission at week 8
Crohns sygdom (6 til 17 år)
Crohn's disease (6 to 17 years)
Sjælden: Agranulocytose (inklusive hos spædbørn, der har været eksponeret for infliximab i uterus), trombotisk trombocytopenisk purpura, pancytopeni, hæmolytisk anæmi, idiopatisk trombocytopenisk purpura.
Rare: Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura.
I et 6-måneders flerdosis toxicitetsstudie hos mus, ved brug af det samme analoge antistof mod muse TNF, sås krystalaflejringer på linsekapslerne hos nogle af de behandlede hanmus.
In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNF, crystalline deposits were observed on the lens capsule of some of the treated male mice.
Ingen tidsafhængig farmakokinetik sås.
No time-dependency of the Pharmacokinetics was observed.
Der udvikledes infliximab-antistoffer hos 38 % af patienterne, som fik 3 mg/kg sammenlignet med 12 % af patienterne, som fik 6 mg/kg.
Antibodies to infliximab developed in 38% of patients receiving 3 mg/kg compared with 12% of patients receiving 6 mg/kg.
Alle patienter skal informeres om at søge læge, hvis sygdomstegn/symptomer, der tyder på tuberkulose (fx vedvarende hoste, skranten/vægttab, let feber), forekommer under eller efter Remicadebehandling.
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after Remicade treatment.
Den samlede forekomst af infektioner i C0168T72 var 13/22 (59 %) i 8-ugers vedligeholdelsesbehandlingsgruppen og 14/23 (60,9 %) i 12-ugers vedligeholdelsesbehandlingsgruppen.
The overall incidence of infections in C0168T72 was 13/22 (59%) in the every 8 week maintenance treatment group and 14/23 (60.9%) in the every 12 week maintenance treatment group.
Sjældne: Meningitis, opportunistiske infektioner (såsom invasive svampeinfektioner [pneumocystose, histoplasmose, aspergillose, kokcidioidomykose, kryptokokkose, blastomykose], bakterielle infektioner [atypiske mykobakterier, listeria, salmonella] og virale infektioner [cytomegalovirus]), parasitære infektioner, reaktivering af hepatitis B.
Rare: Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Sjælden: Transvers myelitis, demyeliniseringsforstyrrelser i centralnervesystemet (dissemineret sklerose-lignende sygdom og optisk neuritis), perifere demyeliniseringsforstyrrelser (såsom Guillain-Barré syndrom, kronisk inflammatorisk demyeliniserende polyneuropati og multifokal motorisk neuropati).
Rare: Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy).
I dette studie fik 66 % af patienterne (686 ud af 1.040) mindst én kort infusion på 90 minutter eller mindre.
In this trial, sixty six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less.
Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas 100 mg
Powder for concentrate for solution for infusion 1 vial 100 mg
Beregn dosis og det nødvendige antal Remicade-hætteglas.
Calculate the dose and the number of Remicade vials needed.
Hos patienter med allerede eksisterende eller nyligt opståede demyeliniseringssygdomme skal vurdering af forventet gavn og risiko ved anti-TNF-behandlingen overvejes omhyggeligt før initiering af behandling med Remicade.
In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of Remicade therapy.
I uge 24 krydsede placebogruppen over til infliximab induktionsbehandling (5 mg/kg) efterfulgt af infliximab vedligeholdelsesbehandling (5 mg/kg).
At week 24, the placebo group crossed over to infliximab induction therapy (5 mg/kg) followed by infliximab maintenance therapy (5 mg/kg).
Læs indlægssedlen for Remicade grundigt, inden du begynder at tage medicinen.
Please read the Remicade ‘Package Leaflet' carefully before you start using this medicine.
Samlet oplevede en højere andel af de patienter, som fik infliximabmonoterapi, en infusionsrelateret reaktion sammenlignet med patienter, som fik infliximab samtidig med immunmodulatorer.
Overall, a higher proportion of patients receiving infliximab monotherapy experienced an infusion-related reaction compared to patients receiving infliximab with concomitant immunomodulators.
Antallet af patienter i hver undergruppe er for lille til at drage definitive konklusioner om alderens indflydelse på bivirkninger, men der var en større andel af patienter med alvorlige bivirkninger og patienter, som stoppede behandlingen på grund af bivirkninger, i den yngre aldergruppe end i den ældre aldersgruppe.
While the numbers of patients in each subgroup are too small to make any definitive conclusions about the effect of age on safety events, there were higher proportions of patients with serious adverse events and discontinuation due to adverse events in the younger age group than in the older age group.
I SPIRIT var andelen af patienter, der opnåede PASI 75 i uge 10 71,7 % i 3 mg/kg infliximabgruppen, 87,9 % i 5 mg/kg infliximab-gruppen og 5,9 % i placebogruppen (p < 0,001).
In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p < 0.001).
En risiko for udvikling af hepatosplenisk T-celle-lymfom hos patienter, der bliver behandlet med Remicade, kan ikke udelukkes (se pkt.
A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Remicade cannot be excluded (see section 4.8).
• Opbevares i køleskab (2 °C - 8 °C)
• Store in a refrigerator (2 °C - 8 °C).
Hvis du har fået Remicade, mens du var gravid, skal du fortælle dit barns læge og andet sundhedspersonale, der tager sig af dit barn, at du har fået Remicade, før barnet bliver vaccineret.
If you were using Remicade during pregnancy, tell your baby's doctor and other healthcare professionals caring for your baby about your Remicade use before the baby receives any vaccines.
Begrænset erfaring ved gentagelse af induktionsbehandling ved genbehandling efter opblussen af sygdom tyder på en højere hyppighed af infusionsreaktioner, inklusive alvorlige reaktioner, sammenlignet med 8-uges vedligeholdelsesbehandling (se pkt.
Limited experience from re-treatment following disease flare by a re-induction regimen suggests a higher incidence of infusion reactions, including serious ones, when compared to 8-weekly maintenance treatment (see section 4.8).
• Reaktioner på injektionsstedet såsom smerte, hævelse, rødme eller kløe
• Reactions at the injection site such as pain, swelling, redness or itching
Reumatoid arthritis Crohns sygdom Crohns sygdom (børn)
Rheumatoid arthritis Crohn's disease Paediatric Crohn's disease
Hvis du er i tvivl, så tal med din læge, før du får Remicade.
If you are not sure, talk to your doctor before you are given Remicade.
≥ 90 % forbedring
≥ 90% improvement
En risiko for udvikling af maligniteter hos børn og unge i behandling med TNFblokkere kan ikke udelukkes.
A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Der blev rapporteret infektioner oftere hos personer som fik infusioner hver 8. uge i forhold til hver 12. uge (hhv. 73,6 % og 38,0 %), mens der blev rapporteret alvorlige infektioner hos 3 personer i 8 ugers gruppen og 4 personer i 12 ugers vedligeholdelsesbehandlingsgruppen.
Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6% and 38.0%, respectively), while serious infections were reported for 3 subjects in the q8 week and 4 subjects in the q12 week maintenance treatment group.
I kliniske studier af reumatoid arthritis var hyppigheden af alvorlige infektioner højere hos infliximabplus methotrexatbehandlede patienter på 65 år og derover (11,3 %) sammenlignet med patienter under
In rheumatoid arthritis clinical studies, the incidence of serious infections was greater in infliximab plus methotrexate-treated patients 65 years and older (11.3%) than in those under 65 years of age
Lungesygdom eller højt tobaksforbrug
Lung disease or heavy smoking
Der var 53 patienter, som fortsatte på 5 mg/kg hver 6. uge.
There were 53 subjects who continued on 5 mg/kg every 6 weeks.
Opmærksomheden henledes på risikoen for falsk negative resultater af tuberkulin testen, især hos patienter, der er alvorligt syge eller immunsupprimerede.
It is recommended that the conduct of these tests should be recorded in the patient's reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
I uge 54 var tallene 55,8 % (29/52) og 23,5 % (12/51) for henholdsvis 8-ugers gruppen og 12-ugers gruppen (p < 0,001).
At week 54, the figures were 55.8% (29/52) and 23.5% (12/51) in the q8 weeks and q12 weeks maintenance groups, respectively (p < 0.001).
Undersøg Remicade visuelt for partikler eller misfarvning før indgivelsen.
Visually inspect Remicade for particulate matter or discolouration prior to administration.
Almindelig: Hypotension, hypertension, ekkymose, hedeture, Flushing.
Common: Hypotension, hypertension, ecchymosis, hot flush, flushing.
• Fortæl din læge, hvis du har en infektion, også selvom det er en meget let infektion.
• Tell your doctor if you have an infection even if it is a very minor one
Induktionsbehandling af fistulerende, aktiv Crohns sygdom Effekten blev også vurderet i et randomiseret, dobbeltblind, placebokontrolleret studie hos 94 patienter med fistulerende Crohns sygdom, som havde fistler af mindst 3 måneders varighed.
Induction treatment in fistulising active Crohn's disease The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulae that were of at least 3 months' duration.
• Debuterende eller forværring af eksisterende hjertesvigt, langsom hjertefrekvens (puls)
• New or worsening heart failure, slow heart rate
Effekt og sikkerhed blev vurderet i to dobbeltblinde, placebokontrollerede multicenterstudier hos patienter med aktiv psoriasis arthritis.
Efficacy and safety were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
Nogle af disse infektioner har været letale; de opportunistiske infektioner, der oftest er set med en mortalitetsrate > 5 %, indbefatter pneumocystose, candidiasis, listeriose og aspergillose (se pkt.
Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of > 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis (see section 4.4).
• Følelsesløshed eller en prikkende fornemmelse.
• Feeling numb or having a tingling feeling.
• Behandling med TNF-blokkere, såsom Remicade, kan medføre, at hepatitis B igen bliver aktiv hos patienter, som bærer denne virus.
• Treatment with TNF blockers such as Remicade may result in reactivation of hepatitis B
Klinisk remission i uge 30
Clinical remission at week 30
• Ansamling af blod uden for blodkarrene (hæmatom) eller blå mærker
• Collection of blood outside the blood vessels (haematoma) or bruising
I det andet kliniske studie (IMPACT 2) blev effekt og sikkerhed af infliximab undersøgt hos 200 patienter med aktiv psoriasis arthritis (≥ 5 hævede led og ≥ 5 ømme led).
In the second clinical study (IMPACT 2), efficacy and safety of infliximab were studied in 200 patients with active psoriatic arthritis (≥ 5 swollen joints and ≥ 5 tender joints).
I begge studier var samtidig brug af konstante doser af folinsyre, orale kortikosteroider (≤ 10 mg/dag) og/eller nonsteroide anti-inflammatoriske stoffer (NSAIDs) tilladt.
In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/day) and/or non-steroidal antiinflammatory drugs (NSAIDs) was permitted.
Sjælden: Cyanose, perikardieeffusion.
Rare: Cyanosis, pericardial effusion.
• Væske omkring hjertet (perikardial effusion)
• Fluid in the lining of the heart (pericardial effusion)
Dato for start af Remicade-behandling:
Date of Remicade therapy initiation:
Infliximabs effekt og sikkerhed blev undersøgt i to multicenter, dobbelblind, placebokontrollerede studier hos patienter med aktiv ankyloserende spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [ BASDAI] score≥ 4 og spinalsmerte ≥ 4 på en skala på 1-10).
Efficacy and safety of infliximab were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
Efter markedsføring er der set tilfælde af leukæmi hos patienter, der er behandlet med en TNF-antagonist.
In the post-marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Rekonstituer under aseptiske forhold hvert Remicade-hætteglas med 10 ml vand til injektionvæsker ved hjælp af en sprøjte med en gauge 21 (0,8 mm) kanyle eller en mindre kanyle.
Under aseptic conditions, reconstitute each Remicade vial with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Ikke almindelig: Kramper, neuropati.
Uncommon: Seizure, neuropathy.
I et populationsbaseret, retrospektivt kohortestudie med data fra nationale svenske sundhedsregistre sås en øget incidens af livmoderhalskræft hos kvinder med reumatoid artrit, som var blevet behandlet med infliximab, sammenlignet med patienter, der var naive i forhold til biologiske lægemidler, eller befolkningen generelt, inklusive kvinder over 60 år.
A population-based retrospective cohort study using data from Swedish national health registries found an increased incidence of cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, including those over 60 years of age.
• Betændelse i hjernehinderne (meningitis)
• Inflammation of the lining of the brain (meningitis)
I begge studier var patienterne randomiseret til at få enten placebo, 5 mg/kg Remicade eller 10 mg/kg Remicade i uge 0, 2, 6, 14 og 22, og i ACT 1 i uge 30, 38 og 46.
In both studies, patients were randomised to receive either placebo, 5 mg/kg Remicade, or 10 mg/kg Remicade at weeks 0, 2, 6, 14 and 22, and in ACT 1 at weeks 30, 38 and 46.
Remicade er indiceret til behandling af moderat til svær plaque psoriasis hos voksne patienter, som ikke responderede på, eller som har en kontraindikation for eller som ikke tåler anden systemisk behandling inklusive ciclosporin, methotrexat eller PUVA (se pkt.
Remicade is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or PUVA (see section 5.1).
Tegn inkluderer åndenød eller hævede fødder.
Signs include shortness of breath or swelling of your feet.
I uge 12 var antallet af BASDAI 50 responders 3/35 (9 %) i placebogruppen og 20/35 (57 %) i 5 mg/kg gruppen (p < 0,01).
At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p < 0.01).
Ikke almindelig: Amnesi, uro, forvirring, søvnighed, nervøsitet.
Uncommon: Amnesia, agitation, confusion, somnolence, nervousness.
Tegn omfatter ledsmerter eller udslæt på kinder eller arme, som er følsomme over for solen.
Signs include joint pain or a rash on cheeks or arms that is sensitive to the sun.
Ved aktiv tuberkulose, må Remicadebehandling ikke påbegyndes (se pkt.
If active tuberculosis is diagnosed, Remicade therapy must not be initiated (see section 4.3).
Induktionsbehandling af moderat til svært aktiv Crohns sygdom Effekten af en éndosis behandling med infliximab blev vurderet hos 108 patienter med aktiv Crohns sygdom (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) i et randomiseret, dobbeltblind, placebokontrolleret, dosis-virknings studie.
Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double-blinded, placebo-controlled, dose-response study.
De bivirkninger, som børn i behandling med Remicade mod Crohns sygdom fik, var forskellige fra de bivirkninger, som voksne i behandling med Remicade mod Crohns sygdom fik.
Additional side effects in children and adolescents Children who took Remicade for Crohn's disease showed some differences in side effects compared with adults who took Remicade for Crohn's disease.
I et toksicitetsstudie vedrørende udvikling udført på mus ved brug af et analogt antistof, der selektivt hæmmer den funktionelle aktivitet af muse TNF, var der ingen tegn på maternal toksicitet, embryotoksicitet eller teratogenicitet.
In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNF, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.