natgillin/translations-raw huggingface dataset:
6. 6.
For preparation and administration instructions, see section 6.6.
Voksne (≥ 18 år)
3 Adults (≥ 18 years)
Rheumatoid arthritis Patienter, som ikke tidligere er behandlet med Remicade:
Rheumatoid arthritis Patients not previously treated with Remicade:
Intravenøs infusion med 3 mg/ kg givet over 2 timer efterfulgt af yderligere infusionsdoser på 3 mg/ kg 2 og 6 uger efter den første infusion, og herefter hver 8. uge.
3 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 3 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
3 Hos omhyggeligt udvalgte patienter med rheumatoid arthritis, som har tolereret 3 initiale infusioner af Remicade på 2 timer, kan det overvejes at give efterfølgende infusioner over en periode på ikke mindre end 1 time.
In carefully selected patients with rheumatoid arthritis who have tolerated 3 initial 2-hour infusions of Remicade, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Forkortede infusioner på doser > 6 mg/ kg er ikke blevet undersøgt.
Shortened infusions at doses > 6 mg/ kg have not been studied.
1, 5 mg/ kg op til et maksimum på 7, 5 mg/ kg hver 8. uge.
If a patient has an inadequate response or loses response after this period, consideration may be given to increase the dose step-wise by approximately 1.5 mg/ kg, up to a maximum of 7.5 mg/ kg every 8 weeks.
Alternativt kan administration af 3 mg/ kg så ofte som hver 4 uge overvejes.
Alternatively, administration of 3 mg/ kg as often as every 4 weeks may be considered.
Svær, aktiv Crohns sygdom 5 mg/ kg indgivet som en intravenøs infusion over 2 timer efterfulgt af en yderligere 5 mg/ kg infusion 2 uger efter den første infusion.
Severe, active Crohn’ s disease 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by an additional 5 mg/ kg infusion 2 weeks after the first infusion.
Eksisterende resultater støtter ikke fortsat infliximabbehandling hos patienter, der ikke responderer inden for 6 uger efter den første infusion.
Available data do not support further infliximab treatment, in patients not responding within 6 weeks of the initial infusion.
Hos responderende patienter er der følgende, forskellige strategier for fortsat behandling: • Vedligeholdelsesbehandling:
In responding patients, the alternative strategies for continued treatment are: • Maintenance:
Yderligere infusionsdosis på 5 mg/ kg 6 uger efter den første dosis, efterfulgt af infusionsdoser hver 8. uge eller • Fornyet indgift:
Additional infusion of 5 mg/ kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or • Re-administration:
4. 4).
Infusion of 5 mg/ kg if signs and symptoms of the disease recur (see ‘ Re- administration’ below and section 4.4).
Selvom sammenlignende resultater mangler, indikerer begrænsede data hos patienter, der initialt responderede på 5 mg/ kg, men som mistede respons, at nogle patienter kan genvinde respons med dosisoptrapning (se pkt.
Although comparative data are lacking, limited data in patients who initially responded to 5 mg/ kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1).
Fistulerende, aktiv Crohns sygdom 5 mg/ kg indgivet som en intravenøs infusion over 2 timer følges op med yderligere infusioner på 5 mg/ kg 2 og 6 uger efter den første infusion.
Fistulising, active Crohn’ s disease 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusions at 2 and 6 weeks after the first infusion.
Hos responderende patienter, er de alternative strategier for fortsat behandling: • Vedligeholdelse:
In responding patients, the alternative strategies for continued treatment are: • Maintenance:
Yderligere infusionsdoser på 5 mg/ kg hver 8. uge eller • Fornyet indgift:
Additional infusions of 5 mg/ kg every 8 weeks or • Re-administration:
4. 4).
Infusion of 5 mg/ kg if signs and symptoms of the disease recur followed by infusions of 5 mg/ kg every 8 weeks (see ‘ Re-administration’ below and section 4.4).
I Crohns sygdom er erfaring med fornyet indgift efter genopdukkende sygdomstegn og symptomer begrænset og sammenlignende data vedrørende gavn versus risici på de forskellige strategier savnes.
In Crohn’ s disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/ risk of the alternative strategies for continued treatment are lacking.
Colitis ulcerosa Intravenøs infusion med 5 mg/ kg givet over 2 timer efterfulgt af yderligere infusionsdoser på 5 mg/ kg 2 og 6 uger efter den første infusion, og herefter hver 8. uge.
4 Ulcerative colitis 5 mg/ kg given as an intravenous infusion over a 2 hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Eksisterende resultater tyder på, at det kliniske respons sædvanligvis opnås inden for 14 ugers behandling, svarende til tre doser.
Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i. e. three doses.
4 Ankyloserende spondylitis 5 mg/ kg givet som en intravenøs infusion over en 2- timers periode efterfulgt af yderligere infusionsdoser på 5 mg/ kg 2 og 6 uger efter den første infusion, herefter hver 6. til 8. uge.
Ankylosing spondylitis 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks.
Hvis en patient ikke responderer ved uge 6 (det vil sige efter 2 doser), bør der ikke gives yderligere behandling med infliximab.
If a patient does not respond by 6 weeks (i. e. after 2 doses), no additional treatment with infliximab should be given.
Psoriasis arthritis 5 mg/ kg givet som en intravenøs infusion over en 2- timers periode efterfulgt af yderligere infusionsdoser på 5 mg/ kg 2 og 6 uger efter den første infusion, herefter hver 8. uge.
Psoriatic arthritis 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Psoriasis 5 mg/ kg givet som en intravenøs infusion over en 2- timers periode efterfulgt af yderligere infusionsdoser på 5 mg/ kg 2 og 6 uger efter den første infusion, herefter hver 8. uge.
Psoriasis 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Hvis en patient ikke viser respons efter 14 uger (det vil sige efter 4 doser), bør der ikke gives yderligere behandling med infliximab.
If a patient shows no response after 14 weeks (i. e. after 4 doses), no additional treatment with infliximab should be given.
Fornyet indgift ved Crohns sygdom og rheumatoid arthritis Hvis tegn og symptomer på sygdom vender tilbage, kan Remicade indgives på ny inden for 16 uger efter den seneste infusion.
Re-administration for Crohn’ s disease and rheumatoid arthritis If the signs and symptoms of disease recur, Remicade can be re-administered within 16 weeks following the last infusion.
4. 4 og 4. 8:
In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after Remicade-free intervals of less than 1 year (see section 4.4 and 4.8: delayed hypersensitivity).
Sikkerhed og effekt ved fornyet indgift efter en Remicade- fri periode på over 16 uger er ikke kendt.
The safety and efficacy of re-administration after a Remicade-free interval of more than 16 weeks has not been established.
Dette gælder både for patienter med Crohns sygdom og patienter med rheumatoid arthritis.
This applies to both Crohn’ s disease patients and rheumatoid arthritis patients.
Fornyet indgift ved colitis ulcerosa Sikkerhed og effekt ved fornyet indgift, udover hver 8. uge, er ikke vist.
Re-administration for ulcerative colitis The safety and efficacy of re-administration, other than every 8 weeks, has not been established.
Fornyet indgift ved ankyloserende spondylitis Sikkerhed og effekt ved fornyet indgift, udover hver 6. til 8. uge, er ikke vist.
Re-administration for ankylosing spondylitis The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established.
Fornyet indgift ved psoriasis arthritis Sikkerhed og effekt ved fornyet indgift, udover hver 8. uge, er ikke vist.
Re-administration for psoriatic arthritis The safety and efficacy of re-administration, other than every 8 weeks, has not been established.
5. 1).
Re-administration for psoriasis Limited experience from re-treatment with one single Remicade dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Crohns sygdom (6 til 17 år) 5 mg/ kg gives som en intravenøs infusion over en 2 timers periode efterfulgt af yderligere 5 mg/ kg infusionsdoser 2 og 6 uger efter den første infusiion, derefter hver 8. uge.
Crohn’ s disease (6 to 17 years) 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Nogle patienter kan behøve et kortere doseringsinterval for at vedligeholde den klinisk fordel, mens det for andre kan være tilstrækkeligt med et længere doseringsinterval.
Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient.
De tilgængelige data understøtter ikke yderligere infliximab behandling af børn, som ikke responderer inden for de første 10 ugers behandling.
Available data do not support further infliximab treatment in paediatric patients not responding within the first 10 weeks of treatment.
4. 3 Kontraindikationer
5 4.3 Contraindications
4. 4).
Patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see section 4.4).
4. 4 og 4. 8).
Patients with moderate or severe heart failure (NYHA class III/ IV) (see sections 4.4 and 4.8).
4. 8), over for andre murine proteiner eller over for et eller flere af hjælpestofferne.
Patients with a history of hypersensitivity to infliximab (see section 4.8), to other murine proteins, or to any of the excipients.
4. 8).
Infusion reactions and hypersensitivity Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Patienter kan forbehandles med for eksempel et antihistamin, hydrokortison og/ eller paracetamol for at forebygge lette og forbigående reaktioner.
Patients may be pre-treated with e. g., an antihistamine, hydrocortisone and/ or paracetamol to prevent mild and transient effects.
Antistoffer overfor infliximab kan udvikles og har været forbundet med en øget frekvens af infusionsreaktioner.
Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions.
En sammenhæng mellem udvikling af antistoffer overfor infliximab og reduceret varighed af respons er også blevet observeret.
An association between development of antibodies to infliximab and reduced duration of response has also been observed.
Samtidig administration af immunmodulatorer er blevet forbundet med en lavere hyppighed af antistoffer overfor infliximab og en reduktion i frekvensen af infusionsreaktioner.
Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and a reduction in the frequency of infusion reactions.
Effekten af samtidig behandling med immunmodulatorer var mere udtalt hos patienter behandlet periodevist i forhold til patienter i vedligeholdelsesbehandling.
The effect of concomitant immunomodulator therapy was more profound in episodically treated patients than in patients given maintenance therapy.
Patienter, der får seponeret immunsuppressiva før eller under Remicade behandling, har større risiko for at udvikle disse antistoffer.
Patients who discontinue immunosuppressants prior to or during Remicade treatment are at greater risk of developing these antibodies.
Antistoffer overfor infliximab kan ikke altid påvises i serumprøver.
Antibodies to infliximab cannot always be detected in serum samples.
4. 8:
If serious reactions occur, symptomatic treatment must be given and further Remicade infusions must not be administered (see section 4.8:
"Immunogenicitet").
"Immunogenicity").
I kliniske undersøgelser har forsinkede overfølsomhedsreaktioner været rapporteret.
In clinical studies, delayed hypersensitivity reactions have been reported.
Eksisterende resultater tyder på en øget risiko for forsinket overfølsomhed ved længerevarende Remicade- fri periode.
Available data suggest an increased risk for delayed hypersensitivity with increasing Remicade-free interval.
4. 8: “ Forsinket overfølsomhedsreaktion ”).
Advise patients to seek immediate medical advice if they experience any delayed adverse event (see section 4.8: “ Delayed hypersensitivity”).
Infektioner Patienter skal følges tæt for infektioner inklusive tuberkulose før, under og efter behandling med Remicade.
Infections Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Remicade.
Forsigtighed bør udvises når brug af Remicade overvejes hos patienter med kronisk infektion eller med en sygdomshistorie med tilbagevendende infektioner, inklusive samtidig behandling med immunosuppressive lægemidler.
Caution should be exercised when considering the use of Remicade in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Det bør bemærkes, at suppression af TNFα kan skjule symptomer på infektion så som feber.
It should be noted that suppression of TNFα may mask symptoms of infection such as fever.
Tidlig genkendelse af atypiske kliniske forekomster af alvorlige infektioner er afgørende for at begrænse forsinkelser i diagnose og behandling.
Early recognition of atypical clinical presentations of serious infections is critical in order to minimize delays in diagnosis and treatment.
Patienter, som tager TNF- blokkere, er mere modtagelige over for alvorlige infektioner.
6 Patients taking TNF-blockers are more susceptible to serious infections.
Tuberkulose, bakterieinfektioner, inklusive sepsis og pneumoni, invasive svampeinfektioner og andre opportunistiske infektioner er set hos patienter behandlet med infliximab.
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal infections, and other opportunistic infections have been observed in patients treated with infliximab.
Nogle af disse infektioner har været fatale.
Some of these infections have been fatal.
6 Patienter, som udvikler en ny infektion, imens de er under behandling med Remicade, bør monitoreres tæt og gennemgå en komplet diagnostisk evaluering.
Patients who develop a new infection while undergoing treatment with Remicade, should be monitored closely and undergo a complete diagnostic evaluation.
For patienter, som har boet, eller rejst i områder, hvor invasive svampeinfektioner såsom histoplasmose, kokcidioidomykose eller blastomykose er endemiske, bør fordele og risici ved Remicadebehandling overvejes omhyggeligt, før Remicadebehandling initieres.
For patients who have resided in or traveled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of Remicade treatment should be carefully considered before initiation of Remicade therapy.
Rapporterede opportunistiske infektioner hos patienter, der fik Remicade, har inkluderet, men er ikke begrænset til, pneumocystose, histoplasmose, cytomegalovirus infektion, atypiske mycobakterielle infektioner, listeriose og aspergillose.
Opportunistic infections reported in patients on Remicade have included, but are not limited to pneumocystosis, histoplasmosis, cytomegalovirus infection, atypical mycobacterial infections, listeriosis and aspergillosis.
4. 8).
In clinical studies, infections have been reported more frequently in paediatric patient populations than in adult patient populations (see section 4.8).
Før initiering af behandling med Remicade, skal alle patienter vurderes for både aktiv og inaktiv (“ latent ”) tuberkulose.
Before starting treatment with Remicade, all patients must be evaluated for both active and inactive (‘ latent’) tuberculosis.
Denne vurdering skal omfatte en detaljeret anamnese vedrørende eventuel tidligere tuberkulose eller mulig tidligere kontakt med personer med tuberkulose samt tidligere og/ eller nuværende immunsuppressiv behandling.
This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/ or current immunosuppressive therapy.
Passende screeningundersøgelser, såsom tuberkulin test og røntgen af thorax, bør udføres hos alle patienter (lokale vejledninger kan være gældende).
Appropriate screening tests, i. e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Det anbefales, at udførelsen af disse undersøgelser registreres på patientens informationskort.
It is recommended that the conduct of these tests should be recorded in the patient’ s alert card.
4. 3).
If active tuberculosis is diagnosed, Remicade therapy must not be initiated (see section 4.3).
I alle situationer beskrevet nedenfor, bør benefit / risk balancen af Remicadebehandling vurdere meget nøje.
In all situations described below, the benefit/ risk balance of Remicade therapy should be very carefully considered.
Hvis inaktiv (“ latent ”) tuberkulose diagnosticeres, skal behandling for latent tuberkulose påbegyndes med behandling mod tuberkulose før initiering af Remicadebehandling i henhold til lokale vejledninger.
If inactive (‘ latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Remicade, and in accordance with local recommendations.
Hos patienter, der har adskillige eller signifikante risikofaktorer for tuberkulose og har en negativ test for latent tuberkulose, bør anti- tuberkulosebehandling overvejes før initieringen af Remicade.
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, anti-tuberculosis therapy should be considered before the initiation of Remicade.
Anvendelsen af anti- tuberkulosebehandling bør også overvejes før initieringen af Remicade hos patienter med en tidligere sygdomshistorie med latent eller aktiv tuberkulose, hos hvem et passende behandlingsprogram ikke kan bekræftes.
Use of anti-tuberculosis therapy should also be considered before the initiation of Remicade in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Alle patienter skal informeres om at søge læge, hvis sygdomstegn/ symptomer, der tyder på tuberkulose (vedvarende hoste, skranten/ vægttab, let feber), forekommer under eller efter Remicade behandling.
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.
Patienter med fistulerende Crohns sygdom med akut pusdannende fistler må ikke påbegynde Remicade- behandling før en kilde til mulig infektion, specielt abscesser, er blevet udelukket (se pkt.
Patients with fistulising Crohn’ s disease with acute suppurative fistulas must not initiate Remicade therapy until a source for possible infection, specifically abscess, has been excluded (see section 4.3).
4. 3).
Hepatitis B Reactivation
Reaktivering af hepatitis B Reaktivering af hepatitis B er forekommet hos patienter, der fik en TNF- antagonist inklusive Remicade, og som var kroniske bærere af dette virus.
7 Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Remicade, who are chronic carriers of this virus.
Patienter, som har risiko for HBV- infektion, bør undersøges for forudgående tegn på HBV- infektion,
Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Remicade therapy.
Bærere af HBV, som kræver behandling med Remicade, bør følges for at registere tegn og symptomer på aktiv HBV- infektion i løbet af behandlingen og i adskillige måneder efter afslutning af behandlingen.
Carriers of HBV who require treatment with Remicade should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Der er ikke tilgængelige data om antiviral behandling af patienter, som er bærere af HBV, i forbindelse med TNF- antagonist- behandling for at undgå HBV- reaktivering.
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.
Remicade- behandling bør stoppes hos patienter, som udvikler HBV - reaktivering, og effektiv antiviral behandling med passende understøttende behandling bør igangsættes.
In patients who develop HBV reactivation, Remicade should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Lever - og galdevejshændelser Meget sjældne tilfælde af gulsot og ikke- infektiøs hepatitis, nogle med tegn på autoimmun hepatitis, er set efter markedsføring af Remicade.
Hepatobiliary events Very rare cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of Remicade.
Hvis der opstår gulsot og/ eller ALT- forhøjelser ≥ 5 gange øvre grænse af normalområdet, bør Remicade afbrydes, og en omhyggelig undersøgelse af hændelsen foretages.
If jaundice and/ or ALT elevations ≥ 5 times the upper limit of normal develop(s), Remicade should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Samtidig indgift af TNF- alfa hæmmer og anakinra Der blev observeret alvorlige infektioner i kliniske undersøgelser ved samtidig anvendelse af anakinra og et andet TNFα- blokerende middel, etanercept, uden nogen øget klinisk fordel sammenlignet med etanercept indgivet alene.
Concurrent administration of TNF-alpha inhibitor and anakinra Serious infections were seen in clinical studies with concurrent use of anakinra and another TNFα - blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
Grundet egenskaberne af bivirkningerne set ved kombinationsbehandlingen med etanercept og anakinra, kan lignende toksiciteter muligvis forekomme ved kombination af anakinra med andre TNFα- blokerende midler.
Because of the nature of the adverse events seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNFα -blocking agents.
Vaccinationer Der er ingen tilgængelige resultater om respons på vaccinationer med levende vacciner eller den sekundære overførelse af infektion med levende vacciner hos patienter, der er i anti- TNF behandling.
Vaccinations No data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines in patients receiving anti-TNF therapy.
Det anbefales, at der ikke gives levende vacciner samtidigt.
It is recommended that live vaccines not be given concurrently.
Det anbefales at pædiatriske patienter med Crohns sygdom bliver vaccineret i overensstemmelse med gældende vaccinationsvejledninger før Remicadebehandling påbegyndes, hvis dette er muligt.
It is recommended that paediatric Crohn’ s disease patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remicade therapy.