natgillin/translations-raw huggingface dataset:
Hos psoriasis patienter resulterede behandling med infliximab i fald i epidermal inflammation og normalisering af keratinocytdifferenciering i psoriasis plaques.
In psoriasis patients, treatment with infliximab resulted in decreases in epidermal inflammation and normalisation of keratinocyte differentiation in psoriatic plaques.
• Små røde eller lilla pletter, der skyldes blødning under huden
• Small red or purple spots caused by bleeding under the skin
Hos patienter behandlet med Remicade bør en invasiv svampeinfektion såsom aspergillose, candidiasis, pneumocystose, histoplasmose, kokcidioidomykose eller blastomykose mistænkes, hvis en alvorlig systemisk sygdom udvikles, og en læge med ekspertise i diagnosticering og behandling af invasive svampeinfektioner bør konsulteres på et tidligt stadie, når disse patienter undersøges.
In patients treated with Remicade, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Under Remicadebehandling bør anden samtidig behandling såsom kortikosteroider og immunsuppressiva optimeres.
During Remicade treatment, other concomitant therapies, e.g., corticosteroids and immunosuppressants should be optimised.
• Virusinfektioner såsom herpes eller influenza
• Viral infections such as herpes or flu
I kliniske studier med infliximab hvori 5.780 patienter blev behandlet, svarende til 5.494 patientår, sås 5 tilfælde af lymfomer og 26 non-lymfom maligniteter sammenlignet med ingen lymfom og 1 nonlymfom malignitet hos 1.600 placebobehandlede patienter svarende til 941 patientår.
In clinical studies with infliximab in which 5,780 patients were treated, representing 5,494 patient years, 5 cases of lymphomas and 26 non-lymphoma malignancies were detected as compared with no lymphomas and 1 non-lymphoma malignancy in 1,600 placebo-treated patients representing 941 patient years.
Fortæl straks din læge, hvis du bemærker noget af ovenstående.
Tell your doctor straight away if you notice any of the above.
* herunder kvægtuberkulose (dissemineret BCG-infektion), se pkt.
* including bovine tuberculosis (disseminated BCG infection), see section 4.4
• Fortæl din læge, hvis du tror, du kan have en risiko for at blive smittet med hepatitis B.
• Tell your doctor if you think you might be at risk of contracting hepatitis B.
• Patienter med KOL og patienter, som er storrygere, kan have en øget risiko for at udvikle kræft under behandling med Remicade.
• Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remicade treatment.
Patientinformationskortet skal indeholde følgende væsentlige elementer:
The patient reminder card shall contain the following key messages:
Patienterne fulgtes indtil uge 26.
Patients were followed up to 26 weeks.
Din læge kan anbefale en midlertidig pause med Remicade.
Your doctor may recommend temporarily stopping Remicade.
Studier fra den publicerede litteratur i forskellige indikationer (fx reumatoid arthritis, psoriasis, Crohns sygdom) tyder dog på, at ikke-levende vacciner givet under anti-TNFbehandling, herunder Remicade, kan fremkalde et lavere immunrespons end hos patienter, der ikke får anti-TNF-behandling.
However, studies from the published literature in various indications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggest that non-live vaccinations received during treatment with anti-TNF therapies, including Remicade, may elicit a lower immune response than in patients not receiving anti-TNF therapy.
Kræft og lymfom
Cancer and lymphoma
I en af armene (gruppe 2, n = 329) blev patienter med utilstrækkeligt respons tilladt dosisjustering med 1,5 mg/kg intervaller fra 3 op til 9 mg/kg.
In one of the study arms (group 2, n = 329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Af de patienter, som ikke fik en infusionsreaktion under induktionsfasen, fik 9 % en infusionsreaktion under vedligeholdelsesfasen.
Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period.
Nogle patienter, der i høj grad udviklede antistoffer mod infliximab, havde tegn på nedsat effekt.
Some patients who developed high titres of antibodies to infliximab had evidence of reduced efficacy.
Uge 54
Week 54
Tabel 6 Procent af patienter, som opnåede kortikosteroidfri klinisk remission i uge 26, SONIC AZA Monoterapi
Table 6 Percent of patients achieving corticosteroid-free clinical remission at week 26, SONIC
Der er også, ligeledes efter markedsføring, modtaget rapporter om nyopstået hjerteinsufficiens, inklusive hjerteinsufficiens hos patienter uden tidligere kendt hjerte-kar sygdom.
There have also been post-marketing reports of new onset heart failure, including heart failure in patients without known pre-existing cardiovascular disease.
Placebo-patienter i de 2 fase III-studier med Crohns sygdom, ACCENT I og ACCENT II, fik som startdosis 5 mg/kg infliximab ved studiets begyndelse og var på placebo i vedligeholdelsesfasen.
Placebo patients in the 2 Phase III studies in Crohn's disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Remicade findes i pakninger med 1, 2, 3, 4 eller 5 hætteglas.
Remicade is available in packs of 1, 2, 3, 4 or 5 vials.
Af disse 108 patienter blev 27 behandlet med den anbefalede dosis på 5 mg/kg infliximab.
Of these 108 patients, 27 were treated with the recommended dosage of infliximab 5 mg/kg.
I et fase II studie, der skulle vurdere Remicade ved CHF, sås højere forekomst af dødsfald på grund af forværret hjerteinsufficiens hos patienter behandlet med Remicade, især hos patienter behandlet med den højere dosis på 10 mg/kg (svarende til to gange den maksimale godkendte dosis).
In a Phase II study aimed at evaluating Remicade in CHF, higher incidence of mortality due to worsening of heart failure were seen in patients treated with Remicade, especially those treated with the higher dose of 10 mg/kg (i.e. twice the maximum approved dose).
Anden anvendelse af terapeutiske smitstoffer såsom levende svækkede bakterier (fx instillation af BCG i blæren ved behandling af cancer) kan medføre kliniske infektioner herunder disseminerede infektioner.
Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Placebo-patienter fik methotrexat, mens infliximab-patienter fik både infliximab og methotrexat.
Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Der blev rapporteret om infektioner hos 31 (51,7 %) af 60 behandlede patienter i C0168T72, og 22 (36,7 %) krævede oral eller parenteral antimikrobiel behandling.
Infections were reported in 31 (51.7%) of 60 treated patients in C0168T72 and 22 (36.7%) required oral or parenteral antimicrobial treatment.
Farmakoterapeutisk klassifikation: Immunsuppressiva, tumor nekrose faktor alfa (TNF)-hæmmere, ATC-kode: L04AB02.
Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF) inhibitors, ATC code: L04AB02.
Enogtredive af disse patienter blev behandlet med infliximab 5 mg/kg.
Thirty one of these patients were treated with infliximab 5 mg/kg.
Stigninger i aminotransferaser blev set (ALAT mere almindeligt end ASAT) i en større del af patienter, der fik Remicade, end hos kontrolpersoner, både når Remicade blev givet i monoterapi, og når det blev brugt i kombination med andre immunsuppressive stoffer.
Elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving Remicade than in controls, both when Remicade was given as monotherapy and when it was used in combination with other immunosuppressive agents.
Infliximab er et monoklonalt antistof - en type protein, der binder sig til et specifikt mål i kroppen kaldet TNF (tumor nekrose faktor) alfa.
Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Kombination af Remicade og andre biologiske lægemidler anvendt til behandling af de samme lidelser som Remicade, herunder anakinra og abatacept, kan ikke anbefales (se pkt.
The combination of Remicade with other biological therapeutics used to treat the same conditions as Remicade, including anakinra and abatacept, is not recommended (see section 4.4).
På basis af et observationsstudie fra Nordeuropa blev der observeret øget risiko (OR, 95 % CI; pværdi) for kejsersnit (1,50; 1,14-1,96; p = 0,0032), for tidligt fødte børn (1,48; 1,05-2,09; p = 0,024), børn født små i forhold til gestationsalder (2,79; 1,54-5,04; p = 0,0007) og lav fødselsvægt (2,03; 1,41-2,94; p = 0,0002) hos kvinder, som blev eksponeret for infliximab under graviditeten (med eller uden immunmodulatorer/kortikosteroider, 270 graviditeter) sammenlignet med kvinder, som udelukkende blev eksponeret for immunmodulatorer/kortikosteroider (6.460 graviditeter).
Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Tabel 8 Effekt på klinisk respons, klinisk remission og slimhindeheling i uge 8 og 30.
Table 8 Effects on clinical response, clinical remission and mucosal healing at weeks 8 and 30.
Remicade fremstilles i pakninger med 1, 2, 3, 4 eller 5 hætteglas.
Remicade is produced in packs of 1, 2, 3, 4 or 5 vials.
Den fortyndede infusionsvæskes kemiske og fysiske stabilitet efter anbrud er påvist i op til 28 dage ved 2°C til 8°C og i yderligere 24 timer ved 25°C efter udtagning fra køleskab.
Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C to 8 °C and for an additional 24 hours at 25 °C after removal from refrigeration.
Klinisk respons i uge 8 var den samme hos dem, som fik immunmodulator og hos dem, som ikke fik immunmodulator ved baseline.
Clinical response at week 8 was similar between those with or without concomitant immunomodulator use at baseline.
I uge 16 blev 47 placebopatienter med < 10 % forbedring fra udgangspunktet i både hævede og ømme led flyttet til infliximab induktion (tidlig overflytning).
At week 16, 47 placebo patients with < 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
• Nogle kvinder, der er blevet behandlet for reumatoid arthritis med Remicade, har udviklet livmoderhalskræft.
• Some women being treated for rheumatoid arthritis with Remicade have developed cervical cancer.
Opbevar ikke rester af den ikke anvendte infusionsvæske til fornyet brug.
Do not store any unused portion of the infusion solution for reuse.
I 3 mg/kg Remicade gruppen fik 4 ud af 60 patienter en alvorlig infusionsreaktion og 3 patienter rapporterede en mulig anafylaktisk reaktion (ud af disse var 2 blandt de alvorlige infusionsreaktioner).
In the 3 mg/kg Remicade group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions).
Reduktion i parametrene for perifere aktivitetskarakteristika på psoriasis arthritis (såsom antal hævede led, antal smertefulde/ømme led, dactylitis og tilstedeværelse af entesopati) sås hos infliximab-behandlede patienter.
Decreases in parameters of peripheral activity characteristic of psoriatic arthritis (such as number of swollen joints, number of painful/tender joints, dactylitis and presence of enthesopathy) were seen in the infliximab-treated patients.
Tabel 10 Resumé af PASI respons, PGA-respons og andel patienter, hvis negle alle var fri for psoriasis i uge 10, 24 og 50.
Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at weeks 10, 24 and 50.
Vedvarende respons (klinisk respons både i uge 8 og uge 30)
Sustained response (clinical response at both week 8 and week 30)
Tilfælde af gulsot og ikke-infektiøs hepatitis, nogle med tegn på autoimmun hepatitis, er set efter markedsføring af Remicade.
Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of Remicade.
Hos de patienter, der blev behandlet med infliximab, og 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.
Hos patienter med psoriasis arthritis, der modtog 5 mg/kg med og uden methotrexat, forekom der i alt antistoffer hos 15 % af patienterne (der forekom antistoffer hos 4 % af de patienter, der fik methotrexat og hos 26 % af de patienter, der ikke fik methotrexat ved baseline).
In psoriatic arthritis patients who received 5 mg/kg with and without methotrexate, antibodies occurred overall in 15% of patients (antibodies occurred in 4% of patients receiving methotrexate and in 26% of patients not receiving methotrexate at baseline).
Hos de fleste patienter kunne infliximab påvises i serum i mindst 8 uger efter den anbefalede enkeltdosis på 5 mg/kg til Crohns sygdom og reumatoid arthritis vedligeholdelsesdosis på 3 mg/kg hver 8. uge.
In most patients, infliximab could be detected in the serum for at least 8 weeks after the recommended single dose of 5 mg/kg for Crohn's disease and the rheumatoid arthritis maintenance dose of 3 mg/kg every 8 weeks.
• Hvis du har fået Remicade, mens du var gravid, er det vigtigt, at du informerer dit barns læge om det, før dit barn bliver vaccineret.
• In case you have received Remicade while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
• Alvorlige lungeproblemer (såsom interstitiel lungesygdom)
• Serious lung problems (such as interstitial lung disease)
Dette patientinformationskort indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Remicade.
This patient reminder card contains important safety information that you need to be aware of before and during treatment with Remicade.
Forsigtighed bør også udvises hos patienter med psoriasis og tidligere ekstensiv immunsupprimerende behandling eller forlænget PUVA behandling.
Caution should also be exercised in patients with psoriasis and a medical history of extensive immunosuppressant therapy or prolonged PUVA treatment.
Hvis en patient udvikler symptomer, der viser tegn på et lupus-lignende syndrom efter behandling med Remicade og er positiv over for antistoffer mod dobbeltstrenget DNA, må behandling med Remicade ikke fortsættes (se pkt.
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).
> 54 uger
> 54 weeks
Seponering af immunmodulatorer og nedtrapning af kortikosteroid-dosis var tilladt efter uge 0.
Discontinuation of immunomodulators and corticosteroid taper were permitted after week 0.
N/A 49,4 N/A 6,7 % N/A 1,7 %
N/A 6.7% N/A 1.7%
Uomdannet infliximab blev ikke påvist i urin.
Unchanged infliximab was not detected in urine.
Ved baseline fik 53 % af patienterne immunmodulerende behandling (6-MP, AZA og/eller MTX), og 62 % af patienterne fik kortikosteroider.
At baseline 53% of patients were receiving immunomodulator therapy (6-MP, AZA and/or MTX) and 62% of patients were receiving corticosteroids.
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.
• Det er meget vigtigt, at du fortæller din læge, hvis du nogensinde har haft tuberkulose (TB), eller hvis du har været i tæt kontakt med en person, som har haft TB.
• It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB.
Andelen af patienter med infektioner var også større i den yngre aldersgruppe, men andelen af patienter med alvorlige infektioner var ens i de to aldersgrupper.
While the proportion of patients with infections was also higher in the younger age group, for serious infections, the proportions were similar in the two age groups.
Lægens navn:
Name doctor:
Almindelig: Depression, søvnløshed.
Common: Depression, insomnia.
• Glemsomhed, irritabilitet, forvirring, nervøsitet
• Feeling forgetful, irritable, confused, nervous
Overfølsomhed over for det aktive stof, over for andre murine proteiner eller over for et eller flere af hjælpestofferne anført under pkt.
Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 6.1.
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.
Klinisk erfaring viser, at modtagerens forsvar mod infektion er nedsat hos nogle patienter behandlet med infliximab.
Clinical experience shows that host defence against infection is compromised in some patients treated with infliximab.
Studier hos patienter med lever- eller nyresygdom er ikke blevet udført.
Studies have not been performed in patients with liver or renal disease.
Ved den sidste observation efter 12 uger sås stadig effekt hos 13/27 (48 %) af patienterne behandlet med infliximab.
At the last observation at 12 weeks, 13/27 (48%) of infliximab-treated patients were still responding.
• Nogle børn og unge, som har fået TNF-blokkere såsom Remicade, har udviklet kræft inklusive usædvanlige typer kræft, som i visse tilfælde har været dødelige.
• Some children and teenage patients who have received TNF-blockers such as Remicade have developed cancers, including unusual types, which sometimes resulted in death.
Du skal bede din læge om at notere type og dato for seneste screening(er) for tuberkulose (TB) nedenfor:
Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: Test
• Ansamling af immunceller som følge af et inflammatorisk respons (granulomatøse læsioner)
• Collections of immune cells resulting from an inflammatory response (granulomatous lesions)
Ændring fra baseline i total van der Heijde modificeret Sharp score Gennemsnit ± SD
Change from baseline in total van der Heijde-modified Sharp score Mean ± SD
En patient, som kræver operation under Remicadebehandling, 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.
Placebo (uge 16)
Placebo (week 16)
I genbehandlingsarmen fik 4 % (8/219) af patienterne en alvorlig infusionsrelateret reaktion sammenlignet med < 1 % (1/222) på vedligeholdelsesbehandling.
In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus < 1% (1/222) on maintenance therapy.
Næsten alle disse patienter havde fået behandling med AZA eller 6-MP samtidig med eller umiddelbart før TNF-blokerende behandling.
Almost all patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to a TNF-blocker.
Infliximab er et kimerisk monoklonalt human-murin IgG1-antistof fremstillet i murine hybridomaceller ved rekombinant DNA-teknologi.
Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Alle patienter med colitis ulcerosa, som har forhøjet risiko for dysplasi eller colon cancer (for eksempel patienter med langvarig colitis ulcerosa eller primær sklerotisk cholangitis), eller som tidligere har haft dysplasi eller colon cancer, bør screenes for dysplasi med reglmæssige intervaller før behandling og under deres sygdomsforløb.
All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Hos patienter behandlet med methotrexat alene var hyppigheden af alvorlige infektioner 5,2 % hos patienter på 65 år og derover sammenlignet med 2,7 % hos patienter under 65 år (se pkt.
In patients treated with methotrexate alone, the incidence of serious infections was 5.2% in patients 65 years and older compared to 2.7% in patients under 65 (see section 4.4).
I 102. uge var 80 patienter stadig på infliximab-behandling og blandt disse var 71 (89 %) ASAS 20 responders.
At 102 weeks there were 80 subjects still on infliximab treatment and among those, 71 (89%) were ASAS 20 responders.
Infusionsreaktioner og overfølsomhed
Infusion reactions and hypersensitivity
• Betændelsestilstand i leveren forårsaget af et problem med immunsystemet (autoimmun hepatitis)
• Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)
N/A 53,0 N/A 4,4 % N/A 1,5 %
N/A 4.4% N/A 1.5%
Andelen af patienter med infektioner i C0168T72 svarede til andelen i studiet med børn med Crohns sygdom (REACH), men var højere end andelen i studierne med voksne med colitis ulcerosa (ACT 1 og ACT 2).
The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn's disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2).
• Tal med din læge, hvis du fornylig har fået eller det er planlagt, at du skal have behandling med et terapeutisk smitstof (fx instillation af BCG til behandling af kræft).
• Talk to you doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Forbedring af målene for livskvalitet, reduktion i sygdomsrelateret hospitaliseringer og brug af kortikosteroid sås for infliximab-vedligeholdelsesgrupperne sammenlignet med placebovedligeholdelsesgruppen ved ugerne 30 og 54.
Improvements in quality of life measures, a reduction in disease-related hospitalisations and corticosteroid use were seen in the infliximab maintenance groups compared with the placebo maintenance group at weeks 30 and 54.
I uge 26, tyve uger efter den sidste induktionsdosis, var 30 % af patienterne i 5 mg/kg gruppen og 13,8 % af patienterne i 3 mg/kg gruppen PASI 75 respondere.
By week 26, twenty weeks after the last induction dose, 30% of patients in the 5 mg/kg group and 13.8% of patients in the 3 mg/kg group were PASI 75 responders.
I dette studie blev 150 patienter med NYHA funktionsklasse III-IV CHF (venstre ventrikels uddrivningsfraktion ≤ 35 %) behandlet med 3 infusioner Remicade 5 mg/kg, 10 mg/kg eller placebo i løbet af 6 uger.
In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of Remicade 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.