FrancophonIA/ELRC3.0 huggingface dataset:
English: • Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Remicade.
Danish: • Din læge vil også udlevere et patientinformationskort til dig, som indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under din behandling med
English: In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines.
Danish: Hos patienter, der får anti-TNF-behandling er der utilstrækkelige data vedrørende respons på vaccinationer med levende vacciner og vedrørende sekundær overførsel af infektion forårsaget af levende vacciner.
English: The antibody titres were notably higher for the 3 mg/kg compared to the 6 mg/kg group.
Danish: Antistoftiter var markant højere for 3 mg/kg gruppen sammenlignet med 6 mg/kg gruppen.
English: In the psoriasis studies, delayed hypersensitivity reactions occurred early in the treatment course.
Danish: I psoriasis studierne forekom forsinkede overfølsomhedsreaktioner tidligt i behandlingsforløbet.
English: If you are 65 or older, you have a greater risk.
Danish: Du har en højere risiko, hvis du er 65 år eller derover.
English: Rare: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Danish: Sjælden: Interstitiel lungesygdom (inklusive hurtigt fremadskridende sygdom, lungefibrose og pneumonitis).
English: Uncommon: Autoantibody positive.
Danish: Ikke almindelig: Positiv for autoantistoffer.
English: 38 weeks
Danish: 38 uger
English: Infliximab inhibits the functional activity of TNF in a wide variety of in vitro bioassays.
Danish: Infliximab hæmmer den funktionelle aktivitet af TNF i en lang række forskellige in vitro bioassays.
English: * P-values represent each infliximab treatment group vs. AZA monotherapy.
Danish: * P-værdier repræsenterer hver infliximab-behandlingsgruppe vs. AZA monoterapi.
English: • Tell your doctor if you have hepatitis B or if you know or suspect you are a carrier of the hepatitis B virus.
Danish: • Fortæl din læge, hvis du har hepatitis B, eller hvis du ved eller har mistanke om, at du er bærer af hepatitis B-virus.
English: Your doctor will test you to see if you have TB.
Danish: Din læge vil teste dig for at se, om du har haft TB.
English: Data to support dose titration in rheumatoid arthritis come from ATTRACT, ASPIRE and the START study.
Danish: Data, som underbygger dosistitrering ved reumatoid arthritis, stammer fra ATTRACT, ASPIRE og START studierne.
English: 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).
Danish: 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.
English: For storage conditions up to 25 °C before reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold op til 25°C før rekonstitution af lægemidlet, se pkt.
English: • Pain in the joints, muscles or back
Danish: • Smerter i leddene, musklerne eller ryggen
English: Common: Conjunctivitis.
Danish: Almindelig: Konjunktivitis.
English: In ASSERT, improvement in signs and symptoms was observed as early as week 2.
Danish: I ASSERT sås forbedring af tegn og symptomer så tidligt som i uge 2.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including infliximab, who are chronic carriers of this virus.
Danish: Reaktivering af hepatitis B er forekommet hos patienter, der fik en TNF-antagonist inklusive infliximab, og som var kroniske bærere af dette virus.
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Danish: Psoriasisarthritis er en betændelsessygdom i leddene, almindeligvis ledsaget af psoriasis.
English: p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Danish: p = 0,030 og < 0,001 for henholdsvis 3 mg/kg og 6 mg/kg behandlingsgruppen mod placebo + MTX.
English: Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions.
Danish: Antistoffer over for infliximab kan udvikles og har været forbundet med en øget frekvens af infusionsreaktioner.
English: • You may get infections more easily when you are being treated with Remicade.
Danish: • Du har lettere ved at få infektioner, når du er i behandling med Remicade.
English: Common: Tachycardia, palpitation.
Danish: Almindelig: Takykardi, palpitation.
English: In addition, bone fracture (6.8%) was reported, however, a causal association has not been established.
Danish: Derudover er knoglebrud (6,8 %) rapporteret.
English: • Fever, increased sweating
Danish: • Feber, øget svedtendens
English: In a 1-year clinical study with repeated infusions in patients with Crohn's disease (ACCENT I study), the incidence of serum sickness-like reactions was 2.4%.
Danish: I et 1-års klinisk studie med gentagne infusioner hos patienter med Crohns sygdom (ACCENT I studie) var hyppigheden af serumsygdoms-lignende reaktioner 2,4 %.
English: Infliximab does not cross react with TNF from species other than human and chimpanzees.
Danish: Infliximab krydsreagerer ikke med TNF fra andre arter end mennesker og chimpanser.
English: • You have tuberculosis (TB) or another serious infection such as pneumonia or sepsis.
Danish: • Du har tuberkulose (TB) eller en anden alvorlig infektion, såsom lungebetændelse eller blodforgiftning (sepsis).
English: Administration of Remicade should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Behandling med Remicade bør seponeres, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling bør initieres, indtil infektionen er under kontrol.
English: At baseline 27.4% of patients were receiving systemic corticosteroids, 14.2% of patients were receiving budesonide, and 54.3% of patients were receiving 5-ASA compounds.
Danish: Ved baseline fik 27,4 % af patienterne systemiske kortikosteroider, 14,2 % af patienterne fik budesonid, og 54,3 % af patienterne fik 5-ASA-stoffer.
English: 2 weeks after your 1
Danish: 2 uger efter din 1. dosis
English: The most common adverse event was worsening of ulcerative colitis, the incidence of which was higher in patients on the q12 week vs. the q8 week dosing regimen.
Danish: Den almindeligste utilsigtede hændelse var forværring af colitis ulcerosa, hvor hyppigheden var større hos patienter i 12-ugers behandlingsregime vs. 8-ugers behandlingsregime.
English: If you have moderate to severe plaque psoriasis, you will first be given other medicines or treatments, such as phototherapy.
Danish: Hvis du har moderat til svær plaque psoriasis, vil du først få andre lægemidler eller behandlinger, såsom lysterapi.
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.
Danish: Der er en øget baggrundsrisiko for lymfomer og leukæmi hos reumatoid arthritis patienter med længerevarende, højaktiv inflammatorisk sygdom, hvilket vanskeliggør risikovurderingen.
English: ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
Danish: ≥ 90 % forbedring ≥ 75 % forbedring ≥ 50 % forbedring
English: • Tell your doctor before you are given Remicade if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Danish: • Fortæl din læge, før du får Remicade, hvis du nogensinde har boet eller rejst i et område, hvor infektioner kaldet histoplasmose, kokcidioidomykose eller blastomykose er almindelige.
English: Infliximab treatment of Crohn's disease patients was also associated with a substantial reduction of the commonly elevated serum inflammatory marker, CRP.
Danish: Infliximab-behandling af patienter med Crohns sygdom var også forbundet med en betydelig reduktion af den ofte forhøjede serum betændelsesmarkør, CRP.
English: • You are allergic (hypersensitive) to proteins that come from mice.
Danish: • Du er allergisk over for proteiner, som stammer fra mus.
English: In both studies, physical function and quality of life as measured by the BASFI and the physical component score of the SF-36 were also improved significantly.
Danish: I begge studier blev fysisk funktion og livskvalitet målt ved BASFI og den fysiske delscore af SF-36 blev også signifikant forbedret.
English: This includes multiple sclerosis, Guillain-Barre syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
Danish: Dette inkluderer dissemineret sklerose, Guillain-Barré syndrom, hvis du har krampeanfald eller har fået stillet diagnosen ”optisk neuritis”
English: • Your doctor will test you to see if you have TB.
Danish: • Din læge vil teste dig for at se, om du har TB.
English: • It is recommended that when Remicade is prepared for infusion, it is used as soon as possible (within 3 hours).
Danish: • Det anbefales, at Remicade anvendes så hurtigt som muligt (inden for 3 timer), efter det er klargjort til infusion.
English: All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Danish: Alle patienterne skulle være på en stabil dosis af 6MP, AZA eller MTX (35 % fik også kortiokosteroid ved baseline).
English: The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of < 150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose > 6 mg/day.
Danish: Studiets primære endepunkt var kortikosteroidfri klinisk remission i uge 26, defineret som patienter i klinisk remission (CDAI < 150), som i mindst 3 uger ikke havde taget orale systemiske kortikosteroider (prednison eller lignende) eller budesonid i en dosis på > 6 mg/dag.
English: While the numbers of patients in each subgroup are too small to draw definitive conclusions about the effect of age, there was a higher number of patients in the younger age group who stepped up in dose or discontinued treatment due to inadequate efficacy.
Danish: Antallet af patienter i hver undergruppe er for lille til at drage definitive konklusioner omkring alderens indflydelse, men der var flere patienter i den yngre aldersgruppe, der fik øget deres dosis eller stoppede behandlingen på grund af utilstrækkelig virkning.
English: • 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 or has TB.
Danish: • Det er meget vigtigt, at du fortæller din læge, hvis du nogensinde har haft TB, eller hvis du har været i tæt kontakt med en person, som har eller har haft TB.
English: You may receive some vaccines during treatment with Remicade but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Remicade because they may cause infections.
Danish: Der er visse vaccinationer, du kan få, mens du er i behandling med Remicade, men du må ikke få levende vacciner (vacciner der indeholder et levende men svækket smitstof), da de kan give infektioner.
English: • Tell your doctor if you have had treatment with Remicade in the past and are now starting Remicade treatment again.
Danish: • Fortæl din læge, hvis du tidligere har været i behandling med Remicade og nu starter behandling med Remicade igen.
English: Symptoms included, but were not limited to, dyspnea, urticaria, facial oedema, and hypotension.
Danish: Symptomerne inkluderede, men var ikke begrænset til dyspnø, urticaria, ødemer i ansigtet og hypotension.
English: SPIRIT evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy.
Danish: SPIRIT vurderede effekten af infliximab induktionsbehandling hos 249 patienter med plaque psoriasis, som tidligere havde fået PUVA eller systemisk behandling.
English: Sustained Steroid-Free Remission
Danish: Vedblivende steroidfri remission
English: The pooled data analysis from the ACT 1 and ACT 2 studies and their extensions, analysed from baseline through 54 weeks, demonstrated a reduction of ulcerative colitis-related hospitalisations and surgical procedures with infliximab treatment.
Danish: Den samlede data analyse for ACT 1 og ACT 2 studierne og deres forlængelser, som blev analyseret fra baseline til uge 54, viste en reduktion af colitis ulcerosa-relaterede hospitalsindlæggelser og kirurgiske indgreb med infliximab-behandling.
English: If you received Remicade while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Danish: Hvis du har fået Remicade under graviditeten, kan vaccination af dit barn med BCG-vaccine (bruges til at forebygge tuberkulose) inden for 6 måneder efter fødslen medføre infektion med alvorlige komplikationer herunder død.
English: At 38 weeks, 9 of 101 patients treated with Remicade (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo.
Danish: Efter 38 uger var 9 af 101 patienter behandlet med Remicade (2 med 5 mg/kg og 7 med 10 mg/kg) døde sammenlignet med et dødsfald blandt de 49 patienter på placebo.
English: At week 2, all patients were assessed for clinical response and randomised to one of 3 treatment groups; a placebo maintenance group, 5 mg/kg maintenance group and 10 mg/kg maintenance group.
Danish: I uge 2 blev alle patienter bedømt til klinisk respons og randomiseret til en af 3 behandlingsgrupper; en placebovedligeholdelsesgruppe, en 5 mg/kg vedligeholdelsesgruppe og en 10 mg/kg vedligeholdelsesgruppe.
English: Slowly add the total volume of reconstituted Remicade solution to the 250-ml infusion bottle or bag.
Danish: Tilføj langsomt det samlede volumen af rekonstitueret Remicade-koncentrat til 250 ml infusionsflasken eller -posen.
English: • Circulation problems such as low or high blood pressure
Danish: • Kredsløbsproblemer såsom for lavt eller for højt blodtryk
English: The ATTRACT study evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate.
Danish: ATTRACT studiet evaluerede responset ved ugerne 30, 54 og 102 i en placebokontrolleret studie hos 428 patienter med aktiv reumatoid arthrit på trods af behandling med methotrexat.
English: The antibody incidence was 2-3 fold higher for patients treated episodically.
Danish: Hyppigheden af antistoffer var 2-3 gange højere hos patienter, der blev behandlet periodevist.
English: • Abnormal tissue swelling or growth
Danish: • Unormal vævshævelse eller -vækst
English: Week 54 Clinical Response
Danish: Uge 54 Klinisk respons
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with Remicade at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Danish: I et uddybende klinisk studie omfattende patienter, som havde moderat til svær COPD og var enten nuværende eller tidligere rygere, var 157 voksne patienter behandlet med Remicade i doser svarende til dem, der anvendes ved reumatoid arthritis og Crohns sygdom.
English: What you need to know before you use Remicade
Danish: Det skal du vide, før du får Remicade
English: • Psoriasis, skin problems such as eczema and hair loss
Danish: • Psoriasis, hudproblemer såsom eksem og hårtab
English: • Some patients receiving Remicade have developed symptoms of an immune system disorder called lupus.
Danish: • Nogle patienter, der får Remicade, har udviklet symptomer på en sygdom i immunsystemet kaldet lupus.
English: For volumes greater than 250 ml, either use a larger infusion bag (e.g. 500 ml, 1000 ml) or use multiple 250 ml infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/ml.
Danish: Brug enten en større infusionspose (fx 500 ml, 1.000 ml) til voluminer over 250 ml eller brug flere 250 ml infusionsposer for at sikre, at koncentrationen af infusionsvæsken ikke overstiger 4 mg/ml.
English: Infliximab should only be used during pregnancy if clearly needed.
Danish: Infliximab bør kun anvendes på tvingende indikation under graviditet.
English: Discuss the use of contraception during this time with your doctor.
Danish: Tal med lægen om anvendelse af prævention i denne tidsperiode.
English: Not known: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease or ulcerative colitis), Merkel cell carcinoma.
Danish: Ikke kendt: Hepatosplenisk T-celle-lymfom (primært hos unge og unge voksne mænd med Crohns sygdom eller colitis ulcerosa), Merkelcellekarcinom.
English: The median time to onset of response in the infliximab-treated group was 2 weeks.
Danish: Median tiden til der registreredes en effekt i gruppen behandlet med infliximab var 2 uger.
English: Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one fifth of placebo-treated patients.
Danish: Anti-nukleare antistoffer (ANA)/Anti-dobbeltstrengede DNA (dsDNA) antistoffer I kliniske studier udviklede cirka halvdelen af infliximab-behandlede patienter, som var ANA negative ved baseline, en positiv ANA i løbet af studiet sammenlignet med cirka en femtedel af placebobehandlede patienter.
English: Remicade should only be used during pregnancy if your doctor feels it is necessary for you.
Danish: Du må kun få Remicade under graviditeten, hvis lægen finder det nødvendigt.
English: In most fistulising Crohn's disease patients, infliximab was detected in serum for 12 weeks (range 4-28 weeks) after administration of the regimen.
Danish: I de fleste patienter med fistulerende Crohns sygdom blev infliximab påvist i serum i 12 uger (interval 428 uger) efter indgift af regimen.
English: General disorders and administration site conditions Very common: Infusion-related reaction, pain.
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: Infusionsrelaterede reaktioner, smerter.
English: It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remicade therapy.
Danish: Det anbefales, at patienterne, om muligt, bringes up to date med alle vaccinationer i overensstemmelse med gældende vaccinationsvejledninger før initiering af behandling med Remicade.
English: In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus Calmette-Guérin (BCG) infection has been reported following administration of BCG vaccine after birth.
Danish: Hos spædbørn, der i uterus er blevet eksponeret for infliximab, er der rapporteret om letalt udfald på grund af dissemineret infektion forårsaget af Calmette-Guérins bakterie (BCG) efter administration af BCG-vaccine efter fødslen.
English: Peripheral blood lymphocytes further showed no significant decrease in number or in proliferative responses to in vitro mitogenic stimulation when compared with untreated patients' cells.
Danish: Herudover viste perifere blodlymfocytter intet signifikant fald i antal eller i proliferativt respons af in vitro mitogenisk stimulation sammenlignet med ubehandlede patienters celler.
English: Remicade must be given concomitantly with methotrexate.
Danish: Remicade skal anvendes sammen med methotrexat.
English: In psoriasis patients, treatment with infliximab resulted in decreases in epidermal inflammation and normalisation of keratinocyte differentiation in psoriatic plaques.
Danish: Hos psoriasis patienter resulterede behandling med infliximab i fald i epidermal inflammation og normalisering af keratinocytdifferenciering i psoriasis plaques.
English: • Small red or purple spots caused by bleeding under the skin
Danish: • Små røde eller lilla pletter, der skyldes blødning under huden
English: 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.
Danish: 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.
English: During Remicade treatment, other concomitant therapies, e.g., corticosteroids and immunosuppressants should be optimised.
Danish: Under Remicadebehandling bør anden samtidig behandling såsom kortikosteroider og immunsuppressiva optimeres.
English: • Viral infections such as herpes or flu
Danish: • Virusinfektioner såsom herpes eller influenza
English: 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.
Danish: 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.
English: Tell your doctor straight away if you notice any of the above.
Danish: Fortæl straks din læge, hvis du bemærker noget af ovenstående.
English: * including bovine tuberculosis (disseminated BCG infection), see section 4.4
Danish: * herunder kvægtuberkulose (dissemineret BCG-infektion), se pkt.
English: • Tell your doctor if you think you might be at risk of contracting hepatitis B.
Danish: • Fortæl din læge, hvis du tror, du kan have en risiko for at blive smittet med hepatitis B.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remicade treatment.
Danish: • Patienter med KOL og patienter, som er storrygere, kan have en øget risiko for at udvikle kræft under behandling med Remicade.
English: The patient reminder card shall contain the following key messages:
Danish: Patientinformationskortet skal indeholde følgende væsentlige elementer:
English: Patients were followed up to 26 weeks.
Danish: Patienterne fulgtes indtil uge 26.
English: Your doctor may recommend temporarily stopping Remicade.
Danish: Din læge kan anbefale en midlertidig pause med Remicade.
English: 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.
Danish: 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.
English: Cancer and lymphoma
Danish: Kræft og lymfom