natgillin/translations-raw huggingface dataset:
au Aktiv tuberkulose eller andre alvorlige infektioner, såsom sepsis og opportunistiske infektioner (se punkt 4. 4). re Moderat til alvorlig hjerteinsufficiens (NYHA, klasse III/ IV) (se punkt 4. 4).
Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section lon 4.4).
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen ge
Moderate to severe heart failure (NYHA class III/ IV) (see section 4.4). no
Infektioner æn
Infections t
Patienter skal monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Trudexa.
Patients must be monitored closely for infections, including tuberculosis, before, during and after uc
Behandling med Trudexa bør ikke initieres hos patienter med aktive infektioner, herunder kroniske ke
Because the elimination of adalimumab may take up to five months, monitoring should be continued throughout this period. rod
eller lokaliserede infektioner, før infektionerne er under kontrol.
Treatment with Trudexa should not be initiated in patients with active infections including chronic or localized infections until infections are controlled.
Patienter, der udvikler en ny infektion under behandling med Trudexa, bør monitoreres nøje. r ik
Patients who develop a new infection while undergoing treatment with Trudexa should be monitored lP
Læger bør være forsigtige, når de overvejer brug af Trudexa til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive te
Physicians should exercise caution when considering the use of Trudexa in patients with a history of recurring infection or with underlying conditions which may na
Alvorlige infektioner, sepsis, tuberkulose og andre opportunistiske infektioner, herunder dødelige, er dle
Serious infections, sepsis, tuberculosis and other opportunistic infections, including fatalities, have i
rapporteret ved brug af Trudexa.
been reported with Trudexa. dic
Alvorlige infektioner: mi
Me
Læ
Tuberculosis:
Der har været rapporter om tuberkulose hos patienter, der modtog Trudexa.
67 There have been reports of tuberculosis in patients receiving Trudexa.
lg (latent) tuberkuloseinfektion.
Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
Denne undersøgelse bør omfatte en detaljeret sygdomshistorie med personlig tuberkuloseanamnese eller eventuel tidligere eksponering for patienter med aktiv
This evaluation should include a detailed medical history with a personal history of tuberculosis or possible previous exposure to patients with active tuberculosis and
sa tuberkulose samt tidligere og/ eller samtidig immunsuppressiv behandling.
ed previous and/ or current immunosuppressive therapy.
Den ordinerende læge bør være opmærksom på risikoen for falsk negative resultater af tuberkulinhudtest, særligt hos patienter, der er alvorligt syge eller immunkompromitterede.
ris are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
ret Hvis der diagnosticeres aktiv tuberkulose, må Trudexa- terapi ikke påbegyndes (se punkt 4. 3).
tho If active tuberculosis is diagnosed, Trudexa therapy must not be initiated (see section 4.3).
Hvis der diagnosticeres latent tuberkulose, skal passende antituberkuloseprofylakse initieres i
In this situation, the
I denne situation bør balancen fordele/ ulemper ved behandling med Trudexa overvejes meget nøje.
au benefit/ risk balance of therapy with Trudexa should be very carefully considered.
tor tuberkuloseinfektion (f. eks. vedvarende hoste, tæring/ vægttab, lav temperatur), under eller efter behandling med Trudexa.
r wasting/ weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after
au Andre opportunistiske infektioner:
ge therapy with Trudexa.
Der er rapporteret om alvorlige og svære opportunistiske infektioner associeret med Trudexa behandling, for eksempel pneumocystisk carinii pneumoni, dissemineret histoplasmose, listeria og re aspergillose. ge
Other opportunistic infections: lon There have been reports of serious and severe opportunistic infections associated with Trudexa therapy, for example pneumocystis carinii pneumonia, disseminated histoplasmosis, listeriosis and aspergillosis. no
Hvis en patient, der modtager Trudexa viser forlængede/ atypiske symptomer/ tegn på infektion eller almindelig svækkelse, skal en florerende opportunistisk infektion overvejes. æn
If a patient receiving Trudexa shows prolonged/ atypical symptoms/ signs of infections or general deterioration, prevalent opportunistic conditions must be considered.
Hepatitis B- reaktivering
Hepatitis B Reactivation t uc
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 Trudexa should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Tilstrækkelige data for behandling af patienter, som er r ik
Adequate data of treating patients who are carriers of HBV with anti-viral therapy in lP
bærere af HBV med anti- viral behandling i forbindelse med TNF- antagonister til forebyggelse af HBV- reaktivering, er ikke tilgængelige.
conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Hos patienter, der udvikler reaktivering af HBV, bør Trudexa stoppes og effektiv anti- viral behandling med passende understøttende behandling bør initieres. te
In patients who develop HBV reactivation, Trudexa should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. na
TNF- antagonister, herunder Trudexa, er i sjældne tilfælde blevet forbundet med nyt udbrud eller dle
TNF-antagonists including Trudexa have been associated in rare cases with new onset or exacerbation i dic
Lægen bør udvise forsigtighed, når behandling med Trudexa overvejes til patienter med allerede eksisterende eller nyligt opståede demyeliniserende sygdomme i centralnervesystemet. mi
Me
Alvorlige allergiske reaktioner er ikke rapporteret under de kliniske forsøg ved subkutan ge
Serious allergic adverse reactions have not been reported with subcutaneous administration of Trudexa during clinical trials.
Hvis der opstår en anafylaktisk Læ
If an anaphylactic reaction or other serious allergic
reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Trudexa straks ophøre og egnet behandling påbegyndes.
68 reaction occurs, administration of Trudexa should be discontinued immediately and appropriate therapy initiated.
71 Kanylens beskyttelseshætte indeholder naturgummi (latex).
The needle cover of the syringe contains natural rubber (latex).
lg Immunsuppression
ed Immunosuppression
til effektor T - og B- celler, NK- celler, monocytter/ makrofager og neutrofiler.
ris evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-and B cells and NK-cells, monocyte/ macrophages, and neutrophils.
Maligniteter og lymfeproliferative sygdomme
tho Malignancies and lymphoproliferative disorders
ret I de kontrollerede dele af de kliniske forsøg med TNF- antagonister, blev der observeret flere tilfælde af maligniteter inklusiv lymfomer blandt de patienter, som modtog TNF- antagonister, sammenlignet med kontrol patienterne.
In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including
Imidlertid, var forekomsten sjælden.
au lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Ydermere findes der en forøget
However, the occurrence was rare.
ise baggrundsrisiko for lymfomer hos reumatoid artrit patienter med længerevarende, højaktiv, inflammatorisk sygdom, som komplicerer estimeringen af risiko.
Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Med den nuværende viden, kan det ikke udelukkes, at der findes en mulig risiko for udvikling af lymfomer eller andre maligniteter hos
With the current knowledge, a possible risk for the
tor patienter, der behandles med TNF- antagonister.
r development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be
Der er ikke gennemført nogen forsøg med patienter, der tidligere har haft maligniteter, eller hvor
ge excluded.
au behandling fortsættes af patienter, der udvikler maligniteter under behandling med Trudexa.
No studies have been conducted that include patients with a history of malignancy or that continue lon treatment in patients who develop malignancy while receiving Trudexa.
Der bør derfor udvises ekstra forsigtighed, hvis behandling med Trudexa overvejes til sådanne patienter (se punkt 4. 8). re I et eksplorativt klinisk forsøg, hvor anvendelsen af et andet anti- TNF- stof infliximab blev undersøgt hos patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL), blev der rapporteret om ge
Thus additional caution should be exercised in considering Trudexa treatment of these patients (see section 4.8).
flere maligniteter, primært i lunger eller hoved og hals, hos infliximab- behandlede patienter end hos kontrol- patienter.
with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Der bør derfor udvises forsigtighed, når der anvendes TNF- antagonister til KOL- patienter og til patienter med en forøget æn
Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to t
risiko for malignitet på grund af massiv rygning.
heavy smoking. uc
Hæmatologiske reaktioner l
Haematologic reactions rod
Hæmatologiske bivirkninger herunder klinisk signifikant cytopeni (f. eks. ke
All patients should lP
Hos patienter r ik
be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e. g. persistent fever, bruising, bleeding, pallor) while on Trudexa.
med bekræftede signifikante hæmatologiske abnormiteter bør det overvejes at afbryde behandlingen med Trudexa. te
Discontinuation of Trudexa therapy should be considered in patients with confirmed significant haematologic abnormalities. na
Der blev observeret et lignede antistof respons på den 23- valente standard pneumokok vaccine og den dle
Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent i dic
Patienter i Trudexa behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner. mi
Me
Hjerteinsufficiens ge
Congestive heart failure
I et klinisk forsøg med en anden TNF- antagonist er der observeret forværring af hjerteinsufficiens og Læ
In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
72 alvorlig hjerteinsufficiens (se punkt 4. 3).
69 heart failure (see section 4.3).
lg Autoimmune processer
Autoimmune processes
Hvis en
The impact of long-
ret Samtidig administration af TNF antagonister og anakinra
ris given (see section 4.8).
ise anakinra og en anden TNF- antagonist, etanercept, uden yderligere klinisk virkning end ved anvendelse af etanercept alene.
tho Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
På grund af typen af bivirkningerne observeret ved kombinationen af etanercept og anakinra er der risiko for lignende toksicitet ved kombination af anakinra og andre TNF -
Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar
tor antagonister.
au toxicities may also result from the combination of anakinra and other TNF-antagonists.
au Der er begrænset erfaring med sikkerhed efter kirurgiske indgreb hos patienter i behandling med Trudexa.
r ge There is limited safety experience of surgical procedures in patients treated with Trudexa.
En patient, som har behov for et kirurgisk indgreb under behandling med Trudexa, re bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
A patient who requires surgery while on Trudexa should be closely monitored for infections, and lon appropriate actions should be taken.
Der er begrænset erfaring med sikkerhed for patienter, som får artroplastik under behandling med Trudexa. ge
There is limited safety experience in patients undergoing arthroplasty while receiving Trudexa.
Tyndtarms- obstruktion
Small bowel obstruction no
Manglende respons på behandling for Crohns sygdom kan være tegn på tilstedeværelse af en fikseret æn
Failure to respond to treatment for Crohn’ s disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment.
Foreliggende data tyder ikke på, at Trudexa forværrer eller forårsager forsnævringer.
Available data suggest that Trudexa does not worsen or cause strictures. t uc
4. 5 Interaktion med andre lægemidler og andre former for interaktion l ke
4.5 Interaction with other medicinal products and other forms of interaction
Trudexa er blevet undersøgt hos patienter med reumatoid artrit og psoriasis artrit, der udelukkende blev behandlet med Trudexa, og hos patienter, der også samtidigt tog methotrexat.
Trudexa has been studied both in rheumatoid arthritis and psoriatic arthritis patients taking Trudexa as rod
Antistofdannelsen var lavere ved Trudexa i kombination med methotrexat i forhold til ved behandling med Trudexa r ik
Antibody formation was lower when Trudexa was given together with methotrexate in comparison with use as monotherapy.
Administration af Trudexa uden methotrexat øgede antistofdannelsen, clearance og reducerede effekten af adalimumab (se punkt 5. 1).
Administration of Trudexa without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1). lP
4. 6 Graviditet og amning te
4.6 Pregnancy and lactation na
I et toksicitetforsøg, hvor man undersøgte udviklinger 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, i
Prækliniske data for adalimumab om postnatal toksicitet og virkning på fertilitet findes ikke (se punkt 5. 3). mi
Preclinical data on postnatal toxicity and fertility effects of dic
På grund af sin TNFα- hæmmende virkning kan adalimumab administreret under graviditet påvirke normal immunrespons hos nyfødte.
Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal Me
Læ
Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last Trudexa treatment.
Det vides ikke, om adalimumab udskilles i modermælken eller absorberes systemisk efter indgift.
70 It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion.
lg fem måneder efter den sidste Trudexa- behandling.
However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Trudexa treatment.
sa 4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
ed 4.7 Effects on ability to drive and use machines
4. 8 Bivirkninger
ris 4.8 Undesirable effects
ret Kliniske forsøg
tho Clinical Trials
ise Trudexa blev undersøgt hos 5293 patienter i kontrolleredeog åbne forsøg i op til 60 måneder.
Trudexa was studied in 5293 patients in controlled and open label trials for up to 60 months.
Data i tabel 1 er baseret på de kontrollerede forsøg (I- IX, CLASSIC I, GAIN og CHARM) (beskrevet i punkt 5. 1), som omfatter
These trials included rheumatoid arthritis patients with short term and long standing disease as well as
tor 3271 patienter, der fik Trudexa, og 1809 patienter, der fik enten placebo eller aktiv kontrol i den kontrollerede behandlingsperiode.
The data in Table 1 is based on the controlled Studies (I− IX, CLASSIC I, GAIN AND CHARM) (described in section 5.1) involving 3271 patients receiving Trudexa and 1809 patients receiving placebo or active comparator during the controlled period.
au Den del af patienterne, som ophørte med behandling på grund af bivirkninger i løbet af den dobbeltblindede, kontrollerede del af forsøg I- IX, CLASSIC I, GAIN og CHARM udgjorde 5. 7% for patienter, der fik Trudexa, og 5. 3% for kontrolbehandlede patienter. re Bivirkninger, hvor kausaliteten er mindst muligt relateret til adalimumab for forsøgne I- IX, CLASSIC I, GAIN og CHARM både klinisk og laboratoriemæssigt, er opført efter organklassesystem og ge
r ge The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of Studies I− IX, CLASSIC I, GAIN and CHARM was 5.7% for patients taking Trudexa and 5.3% for control treated patients. lon Adverse events at least possibly causally-related to adalimumab for Studies I− IX, CLASSIC I, GAIN and CHARM, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/ 10; common≥ 1/ 100 < 1/ 10; uncommon≥ 1/ 1000 to ≤ 1/ 100) and rare < 1/ 1000 in Table no
hyppighed (meget almindelig ≥ 1/ 10; almindelig ≥ 1/ 100 < 1/ 10; usædvanlig ≥ 1/ 1. 000 til ≤ 1/ 100 og sjælden < 1/ 1000) i tabel 1 nedenfor.
1 below.
Inden for hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed. æn
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Tabel 1 Bivirkninger i kliniske forsøg l ke
Table 1 t uc
Systemorganklasser Infektiøse og parasitære sygdomme r ik
Undesirable Effects in Clinical Studies
Bivirkning nedre luftvejsinfektioner (herunder pneumoni, bronkitis), virusinfektioner (herunder influenza,
lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections),
herpesinfektioner), candidiasis, bakterielle infektioner (herunder urinvejsinfektioner), øvre luftvejsinfektioner te
candidiasis, bacterial infections (including urinary tract infections), upper respiratory infection na
dle
dic
sepsis, opportunistiske infektioner (såsom tuberkulose eller histoplasmose) abscesser,
opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess, joint infection, wound infection, skin infection
ledinfektion, sårinfektion, hudinfektion (herunder cellulitis og impetigo),, superficielle svampeinfektioner (herunder i hud, negle og mi
(including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot) Me
ret (herunder cyster og polypper)
71 cysts and polyps)
tor
ed
au
ris
Forstyrrelser i immunsystemet
tho Immune system disorders
Stofskiftesygdomme og ernæringsbetingede sygdomme
r ge Metabolism and nutrition disorders
Almindelig
Common t uc
Læ
lP
Sygdomme i det ydre og det
Ear and labyrinth disorders i dic
tinnitus, øre- ubehag (herunder smerte og
tinnitus, ear discomfort (including pain and swelling)
høre- tab
hearing loss
sa Hjertesygdomme
Cardiac disorders Me
ret Karsygdomme
Vascular disorders
Gastrointestinale sygdomme
ris Gastrointestinal disorders
l æn ke
au
Sygdomme i lever og
r Hepato-biliary disorders
galdeveje
Rare
Sjælden
lon
hepatisk nekrose, hepatitis
ge hepatic necrosis, hepatitis
Sygdomme i hud og te
Skin and subcutaneous tissue disorders
mi
no
76
rod
til
lP
Lidelser i det reproduktive
Reproductive system and breast disorders na
forstyrrelser i menstruationscyklus og blødning fra
menstrual cycle and uterine bleeding disorders
Almene lidelser og reaktioner på
General disorders and administration site conditions i dic
forhøjet blod- keratin- fosforkinase, forlænget aktiveret partiel thromboplastin tid, re tilstedeværelse af autoantistoffer ge
blood creatine phosphokinase increased, activated partial thromboplastin time prolonged, autoantibodies present
Reaktioner ved injektionsstedet
73 Injection site reactions
ved injektionsstedet (erythem og/ eller kløe, blødning, smerter eller hævelse) sammenlignet med 10% af de patienter, som fik placebo eller aktiv kontrol. Reaktioner ved injektionsstedet gjorde det normalt ke
In the twelve controlled trials, 16% of patients treated with Trudexa developed injection site reactions (erythema and/ or itching, haemorrhage, pain or swelling), compared to 10% of patients receiving
Infektioner r ik
ris Infections
Infektionerne var te
In the twelve controlled trials, the rate of infection was 1.49 per patient year in the Trudexa treated
primært øvre luftvejsinfektioner, bronkitis, og urinvejsinfektioner.
The infections consisted primarily of upper respiratory tract infections, bronchitis and urinary tract infections.
Incidensen af alvorlige infektioner var 0, 03 pr. patientår hos Trudexa- behandlede patienter og 0, 03 pr. dle
au The incidence of serious infections was 0.03 per patient year in Trudexa treated patients and 0.03 per patient year in placebo and active control− treated patients.
patientår hos placebo - og aktiv kontrolbehandlede patienter.
In controlled and open label studies with Trudexa, serious infections (including fatal infections, which
I kontrollerede og åbne forsøg med Trudexa blev der rapporteret alvorlige infektioner (herunder mi
r occurred rarely) have been reported, which include reports of tuberculosis (including miliary and
De fleste ge
ge extra-pulmonary locations) and invasive opportunistic infections (e. g. disseminated histoplasmosis, pneumocystis carinii pneumonia, aspergillosis and listeriosis).
Læ
Most of the cases of tuberculosis occurred within the first eight months after initiation of therapy and may reflect recrudescence of lon latent disease.
Maligniteter og lymfeproliferative sygdomme
Malignancies and lymphoproliferative disorders no
77 I de kontrollerede dele af ti Trudexa- forsøg af mindst 12 ugers varighed (I- IX og CHARM) hos patienter med moderat til svær aktiv reumatoid artrit, psoriasis artrit, ankyloserende spondylitis og
During the controlled portions of ten Trudexa trials at least 12 weeks in duration (I-IX and CHARM) in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’ s disease, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 5.7 (3.3, 10.1) per 1000 patient-years among t
1000 patient- år blandt 2887
2887 Trudexa treated patients versus a rate of 4.1 (1.5, 10.9) 1 per 1000 patient-years among 1570 uc
1000 patient- år blandt 1570 kontrolpatienter (gennemsnitlig varighed af behandlingen var 5. 7 måneder for Trudexa og 5. 5 måneder for de kontro- lbehandlede patienter).
control patients (median duration of treatment was 5.7 months for Trudexa and 5.5 months for control- treated patients).
Hyppigheden (95% konfidensinterval) af ikke- melanom
The rate (95% confidence interval) of non-melanoma skin cancers was 7.6 (4.7, 12.4) per 1000 patient-years among Trudexa-treated patients and 2.0 (0.5, 8.2) per 1000 patient-years rod
1000 patient- år blandt kontrolpatienterne.
Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.4 (1.0, 5.7) per 1000 patient-years among Trudexa-treated patients and 0 per 1000 patient-years among control patients.
1000 patient- år blandt de
The rate (95% confidence interval) of lymphomas was 1.0 lP
Hyppigheden (95% konfidensinterval) af lymfomer var 1. 0 (0, 2, 3, 8) pr.
(0.2, 3.8) per 1000 patient-years among Trudexa-treated patients and 1.0 (0.1, 7.3) per 1000 patient- years among control patients.
1000 patient- år blandt kontrolpatienterne.
When combining controlled portions of ten trials (I-IX and CHARM) and ongoing open label na