natgillin/translations-raw huggingface dataset:
Trudexa, 40 mg injektionsvæske, opløsning i engangshætteglas (type 1- glas) med gummiprop, aluminiumklemmer og letaftagelig forsegling. æn
Trudexa 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, dic
En blisterpakning indeholdende et hætteglas (0, 8 ml steril opløsning), 1 tom steril injektionssprøjte i pose og 2 alkoholservietter. l ke
1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe in pouch and 2 alcohol pads, all in a blister.
Ikke anvendt lægemiddel eller affald heraf bør bortskaffes i overensstemmelse med lokale r ik
Any unused product or waste material should be disposed of in accordance with local requirements.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN te
MARKETING AUTHORISATION HOLDER
Kent ME11 5EL England mi
Queenborough Kent ME11 5EL United Kingdom
EU/ 1/ 03/ 257/ 001 ge
ris EU/ 1/ 03/ 257/ 001
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN Læ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
1 september 2003
1 September 2003
22 10.
au 10.
lg {MM/ ÅÅÅÅ}
r {MM/ YYYY}
sa til ret ise tor au re ge l æn ke r ik te dle mi ge Læ
ge lon not uc rod lP i na dic Me
lg Trudexa, 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte
Trudexa 40 mg solution for injection in pre-filled syringe
Hver fyldte 0, 8 ml enkeltdosisinjektionssprøjte indeholder 40 mg adalimumab.
ed Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
til Adalimumab er et rekombinant humant monoklonalt antistof fremstillet ved ekspression i ovarieceller
ris Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
ise 4.
tho 3.
KLINISKE OPLYSNINGER
PHARMACEUTICAL FORM
tor 4. 1 Terapeutiske indikationer
au Solution for injection in pre-filled syringe.
Reumatoid artrit
CLINICAL PARTICULARS
au Trudexa i kombination med methotrexat er indiceret til:
r ge 4.1 Therapeutic indications
• behandling af moderat til alvorlig aktiv reumatoid artrit hos voksne patienter, hvor responsen på re sygdomsmodificerende antireumatiske lægemidler, herunder methotrexat, har været utilstrækkelig.
Rheumatoid arthritis lon Trudexa in combination with methotrexate, is indicated for:
behandling af alvorlig, aktiv og progressiv reumatoid artrit hos voksne patienter, som ikke ge • tidligere er blevet behandlet med methotrexat.
the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the no
Trudexa kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat æn
response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. t uc
behandling med methotrexat er uhensigtsmæssig.
Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. rod
Trudexa har vist sig at hæmme udviklingen af leddestruktion bedømt ved måling med røntgen og at forbedre den fysiske funktion, når det gives i kombination med methotrexat. l ke
Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Psoriasisartrit
Psoriatic arthritis lP
responset på forudgående behandling med sygdomsmodificerende antireumatiske lægemidler har været utilstrækkelig.
Trudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. na
Ankyloserende spondylitis te
Ankylosing spondylitis i
Trudexa er indiceret til behandling af voksne med alvorlig aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på konventionel behandling. dle
Trudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have dic
Crohns sygdom mi
Crohn’ s disease Me
Trudexa er indiceret til behandling af svær, aktiv Crohns sygdom hos patienter, som på trods af en adækvat behandling med glukokortikoid og/ eller et andet immunosuppressivum ikke har responderet tilfredsstillende, eller som er intolerante over for eller har medicinske kontraindikationer mod sådanne ge
Trudexa is indicated for treatment of severe, active Crohn’ s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/ or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Trudexa kan gives Læ
For induction treatment, Trudexa should be given in combination with corticosteroids.
som monoterapi i tilfælde af intolerance over for kortikosteroider, eller når forsat behandling med kortikosteroider er uhensigtsmæssig (se punkt 4. 2).
Trudexa can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).
24 4. 2 Dosering og indgivelsesmåde
23 4.2 Posology and method of administration
lg Behandling med Trudexa bør initieres og overvåges af speciallæger med erfaring i diagnosticering og behandling af reumatoid artrit, psoriasisartrit, ankolyserende spondylitis eller Crohns sygdom.
Trudexa treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or Crohn’ s disease.
sa Patienter i Trudexa- behandling bør få udleveret et særligt patientkort.
Patients treated with Trudexa should be given the special alert card.
Efter passende oplæring i injektionsteknik kan patienter selv injicere Trudexa, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
ed After proper training in injection technique, patients may self-inject with Trudexa if their physician determines that it is appropriate and with medical follow-up as necessary.
til Under behandling med Trudexa, bør andre samtidige behandlinger (f. eks., kortikosteroider og/ eller immunmodulerende midler) optimeres.
ris During treatment with Trudexa, other concomitant therapies (e. g., corticosteroids and/ or immunomodulatory agents) should be optimised.
ret Voksne
tho Adults
ise Den anbefalede dosis af Trudexa til voksne patienter med reumatoid artrit er 40 mg adalimumab givet som enkeltdosis ved subkutan injektion hver anden uge.
au The recommended dose of Trudexa for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
tor Der kan fortsættes med glukokortikoider, salicylater, non- steroide antiinflammatoriske eller analgetiske lægemidler under behandling med Trudexa.
r Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued
au med andre sygdomsmodificerende antireumatiske lægemidler end methotrexat.
Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1. lon In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week.
Ved behandling med Trudexa alene kan det være en fordel for visse patienter, der oplever faldende respons, at øge dosis til 40 mg adalimumab hver uge. re Psoriasisartrit og ankyloserende spondylitis ge
Psoriatic arthritis and ankylosing spondylitis no
Den anbefalede dosis af Trudexa til patienter med psoriaris artrit er 40 mg adalimumab givet som enkeltdosis subkutan injektion hver anden uge. æn
The recommended dose of Trudexa for patients with psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. t
Fortsat behandling bør overvejes nøje, hvis patienten ikke responderer inden for denne periode. l
Continued therapy should be carefully reconsidered in a patient not responding within this time period. rod
Crohns sygdom ke
Crohn’ s disease
behandlingen, kan regimet 160 mg i uge 0 (dosis kan administreres som fire injektioner på en dag eller som to injektioner pr. dag i to på hinanden følgende dage), 80 mg i uge 2, anvendes med erkendelse af, at risikoen for bivirkninger er højere under induktionen. te
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. na
Alternativt, kan Trudexa gen- administreres, hvis patienten er stoppet behandling med Trudexa, og dle
Alternatively, if a patient has stopped Trudexa and signs and symptoms of disease recur, i dic
tegn og symptomer på sygdommen kommer igen.
Trudexa may be re-administered.
Under vedligeholdelsesbehandling kan kortikosteroider nedtrappes i overenstemmelse med mi
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice Me
mg Trudexa hver uge.
guidelines.
Nogle patienter, som ikke har responderet ved uge 4, kan have fordel af fortsat Læ
Some patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg Trudexa every week.
vedligeholdelsesbehandling i 12 uger.
24 Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
25 Ældre patienter
Elderly patients
lg Dosisjustering er ikke nødvendig.
ed No dose adjustment is required.
sa Børn og unge
Children and adolescents
Der er ingen erfaring med børn.
ris There is no experience in children.
til Svækket nyre - og/ eller leverfunktion
tho Impaired renal and/ or hepatic function
ret Trudexa er ikke undersøgt i disse patientpopulationer, hvor dosisanbefaling ikke kan gives.
No dose recommendations can be made.
4. 3 Kontraindikationer
au 4.3 Contraindications
ise Overfølsomhed over for den aktive substans eller over for ét eller flere af hjælpestofferne.
Hypersensitivity to the active substance or to any of the excipients.
Aktiv tuberkulose eller andre alvorlige infektioner, såsom sepsis og opportunistiske infektioner (se
r Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section
tor punkt 4. 4).
ge 4.4).
Moderat til alvorlig hjerteinsufficiens (NYHA, klasse III/ IV) (se punkt 4. 4).
Moderate to severe heart failure (NYHA class III/ IV) (see section 4.4). lon 4.4 Special warnings and precautions for use
au 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
Infections no
Infektioner re 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 treatment with Trudexa.
fortsættes i hele denne periode.
Because the elimination of adalimumab may take up to five months, monitoring should be continued throughout this period. t uc
Behandling med Trudexa bør ikke initieres hos patienter med aktive infektioner, herunder kroniske æn
Treatment with Trudexa should not be initiated in patients with active infections including chronic or localized infections until infections are controlled. rod
Administration af Trudexa bør ophøre, hvis en patient udvikler en ny alvorlig infektion, indtil denne l
Administration of Trudexa should be discontinued if a patient develops a new serious infection until infections are controlled.
Læger bør være forsigtige, når de overvejer brug af Trudexa til patienter ke
Physicians should exercise caution when considering the use of Trudexa in patients with a history of recurring infection or with underlying conditions which may lP
med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler. r ik
predispose patients to infections, including the use of concomitant immunosuppressive medications.
Alvorlige infektioner, sepsis, tuberkulose og andre opportunistiske infektioner, herunder dødelige, er rapporteret ved brug af Trudexa. te
Serious infections, sepsis, tuberculosis and other opportunistic infections, including fatalities, have na
Alvorlige infektioner:
been reported with Trudexa.
I kliniske forsøg er der vist en forøget risiko for alvorlige infektioner hos patienter, der modtog dle
Serious infections: i dic
Trudexa, og rapporter fra post- marketing støtter disse fund.
In clinical trials an increased risk of serious infections in patients receiving Trudexa has been shown, and reports from the post-marketing setting support this finding.
Af særlig vigtighed er infektioner som pneumoni, pyelonefritis, septisk artrit og sepsis. mi
Me
størstedelen af disse rapporter var tuberkulose ekstra- pulmonær, med andre ord dissemineret.
It should be noted that in the majority of those reports, tuberculosis was extra-pulmonary, i. e. disseminated.
(latent) tuberkuloseinfektion.
25 Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
Passende
This evaluation should include a detailed medical history with a personal history of tuberculosis or possible previous exposure to patients with active tuberculosis and previous and/ or current immunosuppressive therapy.
26 screeningsundersøgelser, dvs. hudtest med tuberkulin og røntgen af thorax, bør foretages for alle patienter (i henhold til lokale anbefalinger).
Appropriate screening tests, i. e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
sa Hvis der diagnosticeres aktiv tuberkulose, må Trudexa- terapi ikke påbegyndes (se punkt 4. 3).
ris If active tuberculosis is diagnosed, Trudexa therapy must not be initiated (see section 4.3).
til Hvis der diagnosticeres latent tuberkulose, skal passende antituberkuloseprofylakse initieres i overensstemmelse med lokale anbefalinger, før behandling med Trudexa påbegyndes.
If latent tuberculosis is diagnosed, appropriate anti-tuberculosis prophylaxis in accordance with local
ret Patienter bør instrueres i at søge læge, hvis der opstår sygdomstegn/ symptomer, der tyder på tuberkuloseinfektion (f. eks. vedvarende hoste, tæring/ vægttab, lav temperatur), under eller efter
Patients should be instructed to seek medical advice if signs/ symptoms (e. g., persistent cough,
ise behandling med Trudexa.
au wasting/ weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with Trudexa.
Andre opportunistiske infektioner:
r Other opportunistic infections:
tor Der er rapporteret om alvorlige og svære opportunistiske infektioner associeret med Trudexa behandling, for eksempel pneumocystisk carinii pneumoni, dissemineret histoplasmose, listeria og aspergillose.
ge There have been reports of serious and severe opportunistic infections associated with Trudexa therapy, for example pneumocystis carinii pneumonia, disseminated histoplasmosis, listeriosis and lon aspergillosis.
au Hvis en patient, der modtager Trudexa viser forlængede/ atypiske symptomer/ tegn på infektion eller almindelig svækkelse, skal en florerende opportunistisk infektion overvejes. re Hepatitis B- reaktivering ge
If a patient receiving Trudexa shows prolonged/ atypical symptoms/ signs of infections or general deterioration, prevalent opportunistic conditions must be considered. no
Patienter med risiko for HBV- infektion bør undersøges for tidligere tegn på HBV- infektion inden æn
Patients at risk for HBV t uc
initiering af behandling med Trudexa.
infection should be evaluated for prior evidence of HBV infection before initiating Trudexa therapy.
Bærere af HBV, som kræver behandling med Trudexa, 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 Trudexa should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination rod
HBV- reaktivering, er ikke tilgængelige.
Adequate data of treating patients who are carriers of HBV with anti-viral therapy in 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. ke
In patients who develop HBV reactivation, Trudexa should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. lP
Neurologiske tilfælde r ik
Neurological events
TNF- antagonister, herunder Trudexa, er i sjældne tilfælde blevet forbundet med nyt udbrud eller forværring af kliniske symptomer og/ eller radiografiske tegn på demyeliniserende sygdom.
TNF-antagonists including Trudexa have been associated in rare cases with new onset or exacerbation na
nyligt opståede demyeliniserende sygdomme i centralnervesystemet.
Prescribers should exercise caution in considering the use of Trudexa in patients with pre-existing or recent-onset central nervous system demyelinating disorders. i dic
Allergiske reaktioner dle
Allergic reactions
Alvorlige allergiske reaktioner er ikke rapporteret under de kliniske forsøg ved subkutan administration af Trudexa.
Serious allergic adverse reactions have not been reported with subcutaneous administration of Trudexa Me
Ikkealvorlige allergiske reaktioner relateret til Trudexa var ualmindelige under de kliniske forsøg.
during clinical trials.
Postmarketing er der meget sjældent rapporteret om alvorlige allergiske mi
Non-serious allergic reactions associated with Trudexa were uncommon during clinical trials.
reaktioner, inklusive anafylaksi, efter administration af Trudexa.
In postmarketing, serious allergic reactions including anaphylaxis have been reported very rarely following Trudexa administration.
Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Trudexa straks ophøre og egnet behandling påbegyndes. ge
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Trudexa should be discontinued immediately and appropriate therapy initiated.
Kanylens beskyttelseshætte indeholder naturgummi (latex).
26 The needle cover of the syringe contains natural rubber (latex).
Læ
This may cause severe allergic reactions in patients sensitive to latex.
27 I et forsøg, hvor 64 patienter med reumatoid artrit blev behandlet med Trudexa, var der ingen tegn på nedsat forsinket hypersensitivitet, nedsatte immunglobulinniveauer eller forandring i antallet af
In a study of 64 patients with rheumatoid arthritis that were treated with Trudexa, there was no
lg effektor T - og B- celler, NK- celler, monocytter/ makrofager og neutrofiler.
ed 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.
sa Maligniteter og lymfeproliferative sygdomme
ris Malignancies and lymphoproliferative disorders
I de kontrollerede dele af de kliniske forsøg med TNF- antagonister, blev der observeret flere tilfælde
tho In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Ydermere findes der en forøget baggrundsrisiko for lymfomer hos reumatoid artrit patienter med længerevarende, højaktiv,
Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory
ret inflammatorisk sygdom, som komplicerer estimeringen af risiko.
au disease, which complicates the risk estimation.
Der bør derfor udvises ekstra forsigtighed, hvis behandling med Trudexa overvejes til sådanne patienter (se
r No studies have been conducted that include patients with a history of malignancy or that continue
I et eksplorativt klinisk forsøg, hvor anvendelsen af et andet anti- TNF- stof infliximab blev undersøgt
ge treatment in patients who develop malignancy while receiving Trudexa.
au hos patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL), blev der rapporteret om flere maligniteter, primært i lunger eller hoved og hals, hos infliximab- behandlede patienter end hos kontrol- patienter.
Thus additional caution should be exercised in considering Trudexa treatment of these patients (see section 4.8). lon In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients 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 re risiko for malignitet på grund af massiv rygning. ge
TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
Hæmatologiske reaktioner
Haematologic reactions t uc
Sjældne tilfælde af pancytopeni herunder aplastisk anæmi er rapporteret efter behandling med TNF - æn
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF blocking agents.
Hæmatologiske bivirkninger herunder klinisk signifikant cytopeni (f. eks. thrombocytopeni, leukopeni) er rapporteret i sjældne tilfælde efter behandling med Trudexa.
thrombocytopaenia, leucopaenia) have been infrequently reported with Trudexa.
Hos patienter l
All patients should 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. ke
Discontinuation of Trudexa therapy should be considered in patients with confirmed significant haematologic lP
Vaccinationer r ik
abnormalities.
Der blev observeret et lignede antistof respons på den 23- valente standard pneumokok vaccine og den trivalente influenza virus vaccine i et forsøg med 226 voksne individer med reumatoid artrit, som blev behandlet med adalimumab eller placebo.
virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
overførsel af infektion med levende vacciner hos patienter, der modtager Trudexa.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Trudexa.
Patienter i Trudexa behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner. dle
Patients on Trudexa may receive concurrent i dic
Hjerteinsufficiens mi
vaccinations, except for live vaccines.
patienter med let hjerteinsufficiens (NYHA, klasse I/ II).
Trudexa should be used with caution in patients with mild heart failure (NYHA class I/ II).
Trudexa kontraindikeres ved moderat til alvorlig hjerteinsufficiens (se punkt 4. 3).
Trudexa is contraindicated in moderate to severe heart failure (see section 4.3).
Læ
Treatment with Trudexa must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Autoimmune processer
27 Autoimmune processes
28 Behandling med Trudexa kan medføre dannelse af autoimmune antistoffer.
Treatment with Trudexa may result in the formation of autoimmune antibodies.
lg patient efter behandling med Trudexa udvikler symptomer, der tyder på et lupus- lignende syndrom, og er positiv for antistoffer mod dobbelt- strenget DNA, bør der ikke gives yderligere behandling med
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Trudexa and is positive for antibodies against double-stranded DNA, further treatment with Trudexa should not be
sa Trudexa (se punkt 4. 8).
ed given (see section 4.8).
til I kliniske forsøg er der observeret alvorlige infektioner i forbindelse med samtidig administration af anakinra og en anden TNF- antagonist, etanercept, uden yderligere klinisk virkning end ved anvendelse
Because of