natgillin/translations-raw huggingface dataset:
Autoimmune processer Den relative mangel på TNFα som følge af anti- TNF behandling kan medføre initiering af en autoimmun proces.
Autoimmune processes The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process.
4. 8 ” Anti- nukleare antistoffer (ANA) / dobbeltstrenget DNA (dsDNA) antistoffer ”).
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Remicade and is positive for antibodies against double-stranded DNA, further treatment with Remicade must not be given (see section 4.8: “ Anti-nuclear antibodies (ANA)/ Double- stranded DNA (dsDNA) antibodies”).
Neurologiske lidelser Infliximab og andre lægemidler, der hæmmer TNFα, har i sjældne tilfælde været forbundet med optisk neuritis, kramper og indsættelse eller forværring af kliniske symptomer og/ eller radiografiske tegn på demyelinisationsforstyrrelser i centralnervesystemet, inklusive dissemineret sklerose og perifere demyelinisationsforstyrrelser, inklusive Guillain- Barré syndrom.
Neurological events Infliximab and other agents that inhibit TNFα have been associated in rare cases with optic neuritis, seizure and new onset or exacerbation of clinical symptoms and/ or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis, and peripheral demyelinating disorders, including Guillain-Barré syndrome.
Hos patienter med allerede eksisterende eller nyligt indtruffede demyelinisationssygdomme, skal vurdering af forventet gavn og risiko ved Remicade behandlingen overvejes omhyggeligt før initiering af Remicade terapien.
In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of Remicade treatment should be carefully considered before initiation of Remicade therapy.
Maligne og lymfoproliferative sygdomme I de kontrollerede dele af kliniske undersøgelser med TNF- blokerende midler er der set flere maligne tilfælde, inklusive lymfom, blandt patienter, som fik en TNF- blokker sammenlignet med patienter i kontrolgruppen.
Malignancies and lymphoproliferative disorders 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.
Under kliniske undersøgelser med Remicade over alle godkendte indikationer var forekomsten af lymfom hos Remicade- behandlede patienter højere end forventet i den generelle befolkningsgruppe, men forekomsten af lymfom var sjælden.
During clinical studies of Remicade across all approved indications the incidence of lymphoma in Remicade-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Herudover er der en øget baggrundsrisiko for lymfomer hos rheumatoid arthrit patienter med længerevarende, højaktiv inflammatorisk sygdom, som vanskeliggør risikovurderingen.
Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with longstanding, highly active, inflammatory disease, which complicates the risk estimation.
I en uddybende klinisk undersøgelse, der vurderede anvendelsen af Remicade hos patienter med moderat til svær kronisk obstruktiv lungesygdom (COPD), blev der rapporteret flere maligne
8 In an exploratory clinical study evaluating the use of Remicade in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in Remicade-treated patients compared with control patients.
Forsigtighed bør udvises hos patienter med øget risiko for maligne sygdomme på grund af kraftig rygning, når TNF- blokerende behandling overvejes.
Caution should be exercised in considering treatment of patients with increased risk for malignancy due to heavy smoking.
(se pkt.
With the current knowledge, a risk for the development of lymphomas or other malignancies in patients treated with a TNF-blocking agent cannot be excluded (see Section 4.8).
Når TNF- blokerende behandling overvejes bør forsigtighed udvises hos patienter med en fortid med maligne sygdomme eller når fortsat behandling overvejes hos patienter, der udvikler maligne sygdomme.
Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
Efter markedsføring har sjældne tilfælde af hepatosplenisk T- celle- lymfom været rapporteret hos patienter behandlet med TNF- blokerende lægemidler inklusive Remicade.
Rare postmarketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNF-blocking agents including Remicade.
Denne sjældne type af T - celle- lymfom har et meget aggressivt sygdomsforløb og er sædvanligvis fatal.
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Hos patienter, som tog Remicade, er alle tilfælde forekommet hos patienter med Crohns sygdom eller colitis ulcerosa, og størstedelen blev rapporteret hos teenagere og unge voksne mænd.
All Remicade cases have occurred in patients with Crohn’ s disease or ulcerative colitis and the majority were reported in adolescent or young adult males.
Alle disse patienter havde modtaget behandling med azathioprin eller 6- mercaptopurin samtidig med eller umiddelbart før Remicade.
All of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with or immediately prior to Remicade.
Den potentielle risiko ved kombinationen af AZA eller 6- MP og Remicade bør overvejes omhyggeligt.
The potential risk with the combination of AZA or 6-MP and Remicade should be carefully considered.
4. 2 og 4. 8).
A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Remicade cannot be excluded (see sections 4.2 and 4.8).
4. 8).
With current data it is not known if infliximab treatment influences the risk for developing dysplasia or colon cancer (see section 4.8).
Hjerteinsufficiens Remicade bør anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/ II).
Heart failure Remicade should be used with caution in patients with mild heart failure (NYHA class I/ II).
4. 3 og 4. 8).
Patients should be closely monitored and Remicade must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Børn På grund af utilstrækkelige sikkerheds - og effektdata anbefales Remicade ikke til børn ≤17 år bortset fra til Crohns sygdom.
Paediatrics Due to insufficient data on safety and efficacy, Remicade is not recommended for use in children ≤ 17 years, except in Crohn’ s disease.
Remicade er ikke blevet undersøgt hos børn under 6 år.
Remicade has not been studied in patients with Crohn’ s disease below the age of 6 years.
Andet Farmakokinetik for infliximab hos ældre patienter er ikke undersøgt.
Others The pharmacokinetics of infliximab in elderly patients has not been studied.
5. 2).
Studies have not been performed in patients with liver or renal disease (see section 5.2).
5. 3).
There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see section 5.3).
Der er begrænset erfaring om sikkerheden ved kirurgiske procedurer hos Remicade behandlede patienter.
There is limited safety experience of surgical procedures in Remicade treated patients.
Den lange halveringstid ved infliximab bør tages i betragtning, hvis en kirurgisk procedure er planlagt.
The long half- life of infliximab should be taken into consideration if a surgical procedure is planned.
En patient, som kræver operation under Remicade behandling, bør følges nøje for infektioner, og passende forholdsregler bør tages.
A patient who requires surgery while on Remicade should be closely monitored for infections, and appropriate actions should be taken.
Der er begrænset erfaring med hensyn til sikkerheden af Remicade behandling hos patienter, som har gennemgået artroplastik.
There is limited safety experience of Remicade treatment in patients who have undergone arthroplasty.
9 Manglende respons over for behandling for Crohns sygdom kan indikere tilstedeværelsen af en fixeret fibrotisk striktur, der kan kræve kirurgisk indgreb.
9 Failure to respond to treatment for Crohn’ s disease may indicate the presence of a fixed fibrotic stricture that may require surgical treatment.
Tilgængelige data antyder at infliximab ikke forværrer eller forårsager strikturer.
Available data suggest that infliximab does not worsen or cause strictures.
Hos patienter med rheumatoid arthritis, psoriasis arthritis og Crohns sygdom tyder det på, at samtidig anvendelse af methotrexat og andre immunmodulatorer reducerer dannelsen af antistoffer mod infliximab og forøger plasmakoncentrationerne af infliximab.
In rheumatoid arthritis, psoriatic arthritis and Crohn's disease patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab.
4. 4 - ” Samtidig indgift af TNF - alfahæmmer og anakinra ”).
The combination of Remicade and anakinra is not recommended (see section 4.4 - "Concurrent administration of TNF-alpha inhibitor and anakinra”).
Ingen information er til rådighed angående mulige interaktioner mellem infliximab og andre aktive stoffer.
Nothing is known regarding possible interactions between infliximab and other active substances.
4. 4 ” Vaccinationer ”).
It is recommended that live vaccines not be given concurrently with Remicade (see section 4.4 - “ Vaccinations”).
Graviditet Rapporter efter markedsføring fra omkring 300 graviditeter eksponeret for infliximab viser ikke uventede virkninger på graviditetens udfald.
Pregnancy Post-marketing reports from approximately 300 pregnancies exposed to infliximab, do not indicate unexpected effects on pregnancy outcome.
På grund af hæmningen af TNFα, kan infliximab indgivet under graviditet påvirke de normale immunrespons hos den nyfødte.
Due to its inhibition of TNFα, infliximab administered during pregnancy could affect normal immune responses in the newborn.
I en toksicitetsundersøgelse vedrørende udvikling udført på mus med et analogt antistof, som selektivt hæmmer den funktionelle aktivitet af muse- TNFα, var der ingen tegn på maternal toksicitet, embryotoksicitet eller teratogenicitet (se pkt.
In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity (see section 5.3).
Fertile kvinder Fertile kvinder skal anvende sikker antikonception for at undgå graviditet og fortsætte med anvendelsen heraf i mindst 6 måneder efter den sidste behandling med Remicade.
Women of childbearing potential Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Remicade treatment.
Amning Det vides ikke, om infliximab udskilles i modermælk eller optages systemisk efter indtagelse.
Lactation It is not known whether infliximab is excreted in human milk or absorbed systemically after ingestion.
Da humane immunglobuliner udskilles i modermælk, må kvinder ikke amme i mindst 6 måneder efter Remicade behandling.
Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Remicade treatment.
4. 7 Virkninger på evnen til at føre motor køretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motor køretøj eller betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
I kliniske undersøgelser med infliximab blev der observeret bivirkninger hos cirka 60% af infliximabbehandlede patienter og 40% af placebobehandlede patienter.
In clinical studies with infliximab, adverse reactions were observed in approximately 60% of infliximab-treated patients and 40% of placebo-treated patients.
Infusionsrelaterede reaktioner var de mest almindeligt rapporterede bivirkninger.
Infusion-related reactions were the most common adverse reactions reported.
Infusionsrelaterede reaktioner (dyspnø, nældefeber og hovedpine) var de mest almindelige årsager til seponering.
Infusion-related reactions (dyspnoea, urticaria and headache) were the most common cause for discontinuation.
Tabel 1 viser de bivirkninger, som er set i kliniske undersøgelser, såvel som de bivirkninger, som er set efter markedsføring, heraf er nogle dødelige.
10 Table 1 lists the adverse reactions based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience.
Inden for systemorganklasserne er bivirkningerne 10 opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥1/ 10); almindelig (≥1/ 100 til < 1/ 10); usædvanlig (≥1/ 1. 000 til < 1/ 100); sjælden (≥1/ 10. 000 til < 1/ 1. 000); meget sjælden (< 1/ 10. 000).
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
Idet bivirkninger efter markedsføring er indrapporteret frivilligt fra en population af en ukendt størrelse, er det ikke muligt at estimere hyppigheden.
Because post-marketing events are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency.
Derfor er hyppigheden af disse bivirkninger kategoriseret som ukendt.
Therefore, the frequency of these adverse reactions is categorised as unknown.
Indenfor hver frekvensgruppering er uønskede effekter præsenteret i rækkefølge efter faldende alvorlighed.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Tabel 1 Bivirkninger i kliniske undersøgelser og efter markedsføring
Table 1 Undesirable Effects in Clinical Studies and from Post-Marketing Experience
Virusinfektion (f. eks. influenza, herpes virus infektioner) Usædvanlig:
Viral infection (e. g. influenza, herpes virus infection) Uncommon:
Sepsis, tuberkulose, absces, bakterieinfektion, svampeinfektion, cellulitis, candidiasis Ukendt:
Sepsis, tuberculosis, abscess, bacterial infection, fungal infection, cellulitis, candidiasis Unknown:
Opportunistiske infektioner (såsom atypiske mykobakter, pneumocystosis, histoplasmosis, coccidioidomycosis, cryptococosis, aspergillosis, listeriosis), reaktivering af hepatitis B, salmonellaforgiftning Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper) Ukendt:
Opportunistic infections (such as atypical mycobacterial infection, pneumocystosis, histoplasmosis, coccidioidomycosis, cryptococcosis, aspergillosis and listeriosis), hepatitis B reactivation, salmonellosis Neoplasms benign, malignant and unspecified (including cysts and polyps) Unknown:
Hepatosplenisk T- celle- lymfom (primært hos teenagere og unge voksne med Crohns sygdom og colitis ulcerosa), lymfom (inklusive non- Hodgkins lymfom og Hodgkins sygdom) Blod- og lymfesystem Usædvanlig:
Hepatosplenic T-cell lymphoma (primarily in adolescents and young adults with Crohn’ s disease and ulcerative colitis), lymphoma (including non-Hodgkin’ s lymphoma and Hodgkin’ s disease) Blood and lymphatic system disorders Uncommon:
Neutropeni, leukopeni, thrombocytopeni, anæmi, lymfopeni, lymphadenopati, lymphocytose Ukendt:
Neutropenia, leukopenia, thrombocytopenia, anaemia, lymphopenia, lymphadenopathy, lymphocytosis Unknown:
Agranulocytose, thrombotisk thrombocytopenisk purpura, pancytopeni, hæmolytisk anæmi, idiopatisk thrombocytopenisk purpura Immunsystemet Almindelig:
Agranulocytosis, thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura Immune system disorders Common:
Serumsygdoms- lignende reaktioner Usædvanlig:
Serum sickness-like reaction Uncommon:
Anafylaktiske reaktioner, Lupus- lignende syndrom, allergisk luftvejssymptom Ukendt:
Anaphylactic reaction, lupus-like syndrome, allergic respiratory symptom Unknown:
Anafylaktisk shock, serumsygdom, vasculitis Psykiske forstyrrelser Usædvanlig:
Anaphylactic shock, serum sickness, vasculitis Psychiatric disorders Uncommon:
Depression, amnesi, uro, forvirring, søvnløshed, søvnighed, nervøsitet, apati Nervesystemet Almindelig:
Depression, amnesia, agitation, confusion, insomnia, somnolence, nervousness, apathy Nervous system disorders Common:
Hovedpine, svimmelhed Usædvanlig:
Headache, vertigo, dizziness Uncommon:
Demyelinisationsforstyrrelser i centralnervesystemet (der minder om dissemineret sklerose) Sjælden:
Central nervous system demyelinating disorders (multiple sclerosis-like disease) Rare:
Meningitis Ukendt:
Meningitis Unknown:
Perifere demyelinisationsforstyrrelser (såsom Guillain- Barré syndrom, kronisk inflammatorisk demyelinerende polyneuropati og multifokal bevægelses neuropati), demyelinisationsforstyrrelser i centralnervesystemet (såsom optisk neuritis), transvers myelitis, kramper, neuropatier, følelsesløshed, prikkende fornemmelse Øjne Usædvanlig:
Peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy), central nervous system demyelinating disorders (such as optic neuritis), transverse myelitis, seizure, neuropathy, hypoaesthesia, paraesthesia Eye disorders Uncommon:
Endophthalmitis, keratitis, konjunktivitis, periorbitalt ødem, bygkorn Hjerte Usædvanlig:
Endophthalmitis, keratitis, conjunctivitis, periorbital oedema, hordeolum Cardiac disorders
11 Vaskulære sygdomme Almindelig:
Tachycardia Unknown:
Ansigtsrødmen Usædvanlig:
Cardiac failure, pericardial effusion Vascular disorders Common:
Hypotension, perifer iskæmi, hypertension, thrombophlebitis, hæmatom, ecchymosis, petekkier, vasospasme, hedeture Sjælden:
Hypotension, peripheral ischaemia, hypertension, thrombophlebitis, haematoma, ecchymosis, petechia, vasospasm, hot flush Rare:
Kredsløbssvigt Luftveje, thorax og mediastinum Almindelig:
Circulatory failure Respiratory, thoracic and mediastinal disorders Common:
Nedre luftvejsinfektion (f. eks. bronchitis, pneumoni), øvre luftvejsinfektion, sinuitis, dyspnø Usædvanlig:
Lower respiratory tract infection (e. g. bronchitis, pneumonia), upper respiratory tract infection, sinusitis, dyspnoea Uncommon:
Lungeødem, bronchospasme, pleuritis, næseblod Sjælden:
Pulmonary oedema, bronchospasm, pleurisy, epistaxis Rare:
Pleural effusion Ukendt:
Pleural effusion Unknown:
Interstitiel lungesygdom (inklusive hurtigt fremadskridende sygdom, lungefibrose og pneumonitis) Mave- tarmkanalen Almindelig:
Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis) Gastrointestinal disorders Common:
Abdominal smerte, diarré, kvalme, dyspepsi Usædvanlig:
Abdominal pain, diarrhoea, nausea, dyspepsia Uncommon:
Diverticulitis, gastroøsofagal refluks, forstoppelse, cheilitis Sjælden:
Diverticulitis, gastroesophageal reflux, constipation, cheilitis Rare:
Tarmperforation, gastrointestinal blødning, tarmstenose Ukendt:
Intestinal perforation, gastrointestinal haemorrhage, intestinal stenosis Unknown:
Pancreatitis Lever og galdeveje Almindelig:
Pancreatitis Hepatobiliary disorders Common:
Forhøjede levertransaminaser Usædvanlig:
Transaminases increased Uncommon:
Cholecystitis, unormal leverfunktion Sjælden:
Cholecystitis, hepatic function abnormal Rare:
Hepatitis Ukendt:
Hepatitis Unknown:
Leversvigt, autoimmun hepatitis, hepatocellulær skade, gulsot Hud og subkutane væv Almindelig:
Liver failure, autoimmune hepatitis, hepatocellular damage, jaundice Skin and subcutaneous tissue disorders Common:
Urticaria, udslæt, pruritus, øget svedtendens, tør hud Usædvanlig:
Urticaria, rash, pruritus, hyperhidrosis, dry skin Uncommon:
Bulløst udslæt, furunkulosis, svampedermatitis, onychomycosis, eksem, seborrhoea, rosacea, hudpapilom, hyperkeratose, alopecia, unormal hudpigmentering Ukendt:
Bullous eruption, furunculosis, fungal dermatitis, onychomycosis, eczema, seborrhoea, rosacea, skin papilloma, hyperkeratosis, alopecia, abnormal skin pigmentation Unknown:
Toksisk epidermal nekrolyse, Stevens- Johnsons syndrom, psoriasis, inklusive debuterende og pustuløs (primært pustulosis palmoplantaris), erythem multiforme Knogler, led, muskler og bindevæv Usædvanlig:
Toxic epidermal necrolysis, Stevens-Johnson-Syndrome, psoriasis, including new onset and pustular (primarily palm & soles), erythema multiforme Musculoskeletal and connective tissue disorders Uncommon:
Ledsmerter, muskelsmerter, rygsmerter Nyrer og urinveje Usædvanlig:
Arthralgia, myalgia, back pain Renal and urinary disorders Uncommon:
Pyelonefritis, urinvejsinfektion Det reproduktive system og mammae Usædvanlig:
Pyelonephritis, urinary tract infection Reproductive system and breast disorders Uncommon:
Vaginitis Almene symptomer og reaktioner på administrationsstedet Almindelig:
Vaginitis General disorders and administration site conditions Common:
Infusionsrelateret reaktion, brystsmerte, træthed, feber Usædvanlig:
Infusion-related reaction, chest pain, fatigue, fever Uncommon:
Forringet heling, reaktioner på injektionsstedet, kulderystelser, ødem, smerte Sjælden:
Impaired healing, injection site reaction, chills, oedema, pain Rare:
Granulomatøs læsion Undersøgelser Usædvanlig:
Granulomatous lesion Investigations Uncommon:
Positiv for autoantistoffer, komplementfaktorabnormalitet
Autoantibody positive, complement factor abnormal
Infusionsrelaterede reaktioner:
12 Infusion-related reactions:
En infusionsrelateret reaktion blev i kliniske undersøgelser defineret som enhver bivirkning, der forekom under en infusion eller inden for 1 til 2 timer efter en infusion.
An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 to 2 hours after an infusion.
I kliniske undersøgelser oplevede cirka 20% af infliximabbehandlede patienter sammenlignet med cirka 10% af placebobehandlede patienter en infusionsrelateret reaktion.
In clinical studies, approximately 20% of infliximab-treated patients compared with approximately 10% of placebo- treated patients experienced an infusion-related effect.
Cirka 3% af patienterne afbrød behandling på grund af infusionsreaktioner, og alle patienter kom sig med eller uden medicinsk behandling.
Approximately 3% of patients discontinued treatment due to infusions reactions and all patients recovered with or without medical therapy.
Hos de patienter,
In a clinical study of patients with rheumatoid arthritis (ASPIRE), sixty six percent of the patients (686 out of 1040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1040) received at least one shortened infusion of 60 minutes or less.
12 der blev behandlet med infliximab, som fik mindst en kort infusion, opstod infusionsrelaterede reaktioner hos 15% af patienterne, og alvorlige infusionsreaktioner opstod hos 0, 4% af patienterne.
Of the infliximab-treated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients.
Efter markedsføring er hændelser af anafylaktisk lignende reaktioner, inklusive strube/ spiserørs ødemer og alvorlige bronkospasmer, og kramper blevet forbundet med administrering af Remicade.
In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/ pharyngeal oedema and severe bronchospasm, and seizure have been associated with Remicade administration.
Forsinket overfølsomhed:
Delayed hypersensitivity:
I kliniske undersøgelser har forsinkede overfølsomhedsreaktioner været usædvanlige og er forekommet efter Remicade- fri perioder på mindre end 1 år.
In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after Remicade-free intervals of less than 1 year.
I psoriasis undersøgelserne forekom forsinkede overfølsomhedsreaktioner tidligt i behandlingsforløbet.
In the psoriasis studies, delayed hypersensitivity reactions occurred early in the treatment course.