FrancophonIA/ELRC3.0 huggingface dataset:
English: • Severely decreased numbers of white blood cells have been reported in infants born to women treated with Remicade during pregnancy.
Danish: • Alvorligt fald i antal hvide blodlegemer er set hos spædbørn født af kvinder, der er blevet behandlet med Remicade under graviditeten.
English: Key efficacy results for IMPACT and IMPACT 2 are shown in Table 9 below:
Danish: De vigtigste resultater for effekt i IMPACT og IMPACT 2 er vist i tabel 9 nedenfor:
English: Therefore, conventional preclinical safety data with infliximab are limited.
Danish: Derfor er konventionelle prækliniske sikkerhedsdata med infliximab begrænsede.
English: Pregnancy and Vaccinations
Danish: Graviditet og vaccinationer
English: Nine of these patients developed malignancies, including 1 lymphoma.
Danish: Ni af disse patienter udviklede maligne sygdomme, inklusive 1 lymfom.
English: Furthermore, a reduction in corticosteroid use and improvements in quality of life were observed.
Danish: Endvidere blev en reduktion i kortikosteroidanvendelsen og forbedring af livskvalitet observeret.
English: These skin reactions can be accompanied by fever.
Danish: Disse hudreaktioner kan være ledsaget af feber.
English: • Remicade will be given to you by your doctor or nurse.
Danish: • Du vil få Remicade af din læge eller sygeplejerske.
English: Approximately 93% of the patients had previously received antibiotic or immunosuppressive therapy.
Danish: Cirka 93 % af patienterne havde tidligere fået antibiotika eller immunsupprimerende behandling.
English: It is used in adults for the following inflammatory diseases:
Danish: Det bruges til voksne til behandling af følgende betændelsessygdomme:
English: The duration of subsequent infusions could be shortened to not less than 40 minutes in patients who did not experience serious infusion reactions.
Danish: Varigheden af de efterfølgende infusioner kunne forkortes til ikke mindre end 40 minutter hos patienter, som ikke fik alvorlige infusionsreaktioner.
English: If you feel tired, dizzy, or unwell after having Remicade, do not drive or use any tools or machines.
Danish: Hvis du føler dig træt, svimmel eller utilpas efter at have fået Remicade, må du ikke køre bil eller betjene nogen form for maskiner.
English: Adult Crohn's disease Remicade is indicated for:
Danish: Crohns sygdom, voksne Remicade er indiceret til:
English: Isolated cases of liver failure resulting in liver transplantation or death have occurred.
Danish: Isolerede tilfælde af leversvigt resulterende i levertransplantation eller dødsfald er forekommet.
English: An allergic reaction could happen within 2 hours of your injection or later.
Danish: En allergisk reaktion kan opstå inden for 2 timer efter din injektion eller senere.
English: Write the new expiry date on the carton including day/month/year.
Danish: Skriv den nye udløbsdato på æsken med dag/måned/år.
English: Remicade will generally be stored by the health professionals.
Danish: Remicade opbevares normalt af sundhedspersonalet.
English: Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2 IMPACT
Danish: Tabel 9 Effekt på ACR og PASI i IMPACT og IMPACT 2
English: The interval between the last maintenance dose and the first re-induction dose ranged from 35-231 days.
Danish: Intervallet mellem den sidste vedligeholdelsesdosis og den første dosis ved gentagen induktion varierede mellem 35 og 231 dage.
English: Long-term studies have not been performed to evaluate the carcinogenic potential of infliximab.
Danish: Langvarende studier er ikke blevet udført for at vurdere det carcinogene potentiale af infliximab.
English: Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient.
Danish: For nogle patienter kan det være nødvendigt med et kortere doseringsinterval for at opretholde den kliniske fordel, mens det for andre kan være tilstrækkeligt med et længere doseringsinterval.
English: Patients who responded at week 4 were followed to week 12.
Danish: Patienter, der reagerede i uge 4, fulgtes til uge 12.
English: Failure to respond to treatment for Crohn's disease may indicate the presence of a fixed fibrotic stricture that may require surgical treatment.
Danish: Manglende respons på behandling for Crohns sygdom kan indikere tilstedeværelsen af en fikseret fibrotisk striktur, der kan kræve kirurgisk indgreb.
English: Efficacy was similar in the subgroup of patients that were exposed to previous systemic therapies compared to the overall study population.
Danish: Effekten var den samme i undergruppen af patienter, der var eksponeret for tidligere systemiske behandlinger sammenlignet med den totale studiepopulation.
English: No serious infusion reactions were reported.
Danish: Der blev ikke rapporteret om alvorlige infusionsreaktioner.
English: The primary endpoint in both studies was the percent of patients who achieved ≥ 75% improvement in PASI from baseline at week 10.
Danish: Det primære endepunkt i begge studier var procenten af patienter, som opnåede ≥ 75 % forbedring i PASI fra baseline i uge 10.
English: Telephone number doctor:
Danish: Lægens telefonnummer:
English: • Eye problems, including red eyes and infections
Danish: • Øjenproblemer inklusive røde øjne og øjeninfektioner
English: • Hepatitis B infection when you have had hepatitis B in the past
Danish: • Hepatitis B-infektion, hvis du tidligere har haft hepatitis B
English: Patients with a PGA score ≥ 3 were eligible to receive an additional infusion of the same treatment at week 26.
Danish: Patienter med en PGA score ≥ 3 havde mulighed for at få en yderligere infusion af den samme behandling i uge 26.
English: The long half-life of infliximab should be taken into consideration if a surgical procedure is planned.
Danish: Infliximabs lange halveringstid bør tages i betragtning, hvis et kirurgisk indgreb er planlagt.
English: The potential risk with the combination of AZA or 6-MP and Remicade should be carefully considered.
Danish: Den potentielle risiko ved kombinationen af AZA eller 6-MP og Remicade bør overvejes omhyggeligt.
English: After reconstitution and dilution:
Danish: Efter rekonstitution og fortynding:
English: There are no known side effects of having too much of Remicade.
Danish: Der kendes ikke til bivirkninger efter at have fået for meget Remicade.
English: Twenty four of these patients (75.0%) regained clinical response after crossing over.
Danish: Fireogtyve af disse patienter (75,0 %) genvandt klinisk respons efter cross-over.
English: Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Danish: Remicade, i kombination med methotrexat, er indiceret til reduktion af sygdomstegn og symptomer samt forbedring af fysisk funktionsevne hos:
English: Due to a number of treatment withdrawals, the magnitude of the effect difference between infliximab and the methotrexate alone group cannot be defined.
Danish: På grund af et antal behandlingsophør, kan størrelsen af forskellen i effekt mellem infliximab og methotrexat alene ikke defineres.
English: Patients who have inflammatory diseases already take medicines to treat their problem.
Danish: Patienter, som har betændelsessygdomme, tager allerede medicin for at behandle deres lidelse.
English: Remicade belongs to a group of medicines called ‘TNF blockers'.
Danish: Remicade tilhører en medicingruppe kaldet ”TNF-blokkere”.
English: Remicade has been studied only in combination with conventional immunosuppressive therapy.
Danish: Remicade er kun blevet undersøgt i kombination med konventionel immunsuppressiv behandling.
English: Shortened infusions across adult indications
Danish: Kortere infusionstid ved indikationer hos voksne
English: The majority of the malignancies developed in the lung or head and neck.
Danish: De fleste af de maligne sygdomme udvikledes i lungerne eller hoved og nakke.
English: These infections are caused by specific types of fungi that can affect the lungs or other parts of your body.
Danish: Disse infektioner forårsages af særlige svampetyper, som kan påvirke lungerne eller andre dele af kroppen.
English: Periodic screening should continue in women treated with Remicade, including those over 60 years of age.
Danish: Periodisk screening bør fortsætte hos kvinder, der er blevet behandlet med Remicade, inklusive kvinder over 60 år.
English: It should be noted that suppression of TNF may mask symptoms of infection such as fever.
Danish: Vær opmærksom på, at suppression af TNF kan maskere symptomer på infektion såsom feber.
English: Use of live vaccines can result in clinical infections, including disseminated infections.
Danish: Anvendelse af levende vacciner kan medføre kliniske infektioner herunder disseminerede infektioner.
English: In all situations described below, the benefit/risk balance of Remicade therapy should be very carefully considered.
Danish: I alle situationer beskrevet nedenfor bør benefit/risk-balancen af Remicadebehandling vurderes meget nøje.
English: • Provision to record the type, date, and result of TB screenings
Danish: • Mulighed for at notere type, dato og resultater af TB-screeninger.
English: Remicade infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Danish: Remicadeinfusioner skal administreres af kvalificeret sundhedspersonale, som er trænet i at detektere infusionsrelateredeproblemer.
English: List of other medicines:
Danish: Liste over anden medicin:
English: It should be noted that in the majority of these reports tuberculosis was extrapulmonary, presenting as either local or disseminated disease.
Danish: Det bør bemærkes, at i størstedelen af disse tilfælde var der tale om tuberkulose med ekstrapulmonal placering i form af enten lokal eller dissemineret sygdom.
English: Nail psoriasis was assessed using the Nail Psoriasis Severity Index (NAPSI).
Danish: Neglepsoriasis blev vurderet ved brug af Nail Psoriasis Severity Index (NAPSI).
English: It is not known whether this finding was due to effects on the males and/or the females.
Danish: Det vides ikke, om dette fund skyldes virkninger på hannerne og/eller hunnerne.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Inden for systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not use Remicade if any of the above applies to you.
Danish: Du må ikke få Remicade, hvis noget af ovenstående passer på dig.
English: Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Remicade treatment.
Danish: Da humane immunglobuliner udskilles i mælk, må kvinder ikke amme i mindst 6 måneder efter Remicadebehandling.
English: Your doctor will record these tests on your patient reminder card.
Danish: Din læge vil notere disse tests på dit patientinformationskort.
English: Week-14 responders (195/282) were analysed for the primary endpoint, which was time from randomisation to loss of response (see Table 7).
Danish: Uge 14-responderende (195/282) blev analyseret for det primære endepunkt, som var tiden fra randomisering til tab af respons (se tabel 7).
English: The solution may develop a few fine translucent particles, as infliximab is a protein.
Danish: Der kan opstå nogle få fine gennemsigtige partikler i koncentratet, da infliximab er et protein.
English: Patients with ACR20 response/ Patients evaluated (%)
Danish: Patienter med ACR20 respons /Patienter evalueret
English: Prior therapy with PUVA, methotrexate, ciclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Danish: Tidligere behandling med PUVA, methotrexat, ciclosporin eller acitretin var modtaget af 71,4 % af patienterne, selv om de ikke nødvendigvis var behandlingsresistente.
English: If you have had a break in your Remicade treatment of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Danish: Hvis du har holdt pause i Remicade-behandlingen i over 16 uger, er der en højere risiko for at få en allergisk reaktion, når du starter behandlingen igen.
English: Result:
Danish: Resultat:
English: • Slow down the damage in your joints
Danish: • Forsinke skaden i dine led
English: This applies to both Crohn's disease patients and rheumatoid arthritis patients.
Danish: Dette gælder både for patienter med Crohns sygdom og patienter med reumatoid arthritis.
English: Key results are presented in Table 10.
Danish: Nøgleresultater præsenteres i tabel 10.
English: Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Danish: Infliximab passerer placenta og er blevet sporet i serum hos spædbørn op til 6 måneder efter fødslen.
English: Hepatitis B (HBV) reactivation
Danish: Reaktivering af hepatitis B (HBV)
English: Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment.
Danish: Tidlig erkendelse af atypiske kliniske forekomster af alvorlige infektioner og typiske kliniske forekomster af sjældne og usædvanlige infektioner er afgørende, for at begrænse forsinkelse i diagnosticering og behandling.
English: Therefore, the combination of Remicade and anakinra is not recommended.
Danish: Derfor kan kombination af Remicade og anakinra ikke anbefales.
English: Instructions for use and handling - storage conditions
Danish: Instruktion i anvendelse og håndtering - opbevaring
English: In post-marketing spontaneous reporting, infections are the most common serious adverse reaction.
Danish: Ved spontan postmarketing rapportering er infektioner den mest almindelige alvorlige bivirkning.
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
Danish: Patienter i begge studier havde plaque psoriasis (Body Surface Area [BSA] ≥ 10 % og Psoriasis Area and Severity Index [PASI] score ≥ 12).
English: Remicade is also used in adults and children 6 years of age or older for:
Danish: Remicade bruges også til voksne og børn fra 6 år og opefter til behandling af:
English: Instructions for use and handling - reconstitution, dilution and administration
Danish: Instruktion i anvendelse og håndtering - rekonstitution, fortynding og administration
English: The median AUCss in paediatric patients aged 2 years to less than 6 years was predicted to be approximately 40% lower than that in adults, although the number of patients supporting this estimate is limited.
Danish: Den mediane AUCss hos pædiatriske patienter i alderen 2 år til under 6 år var forventet at være ca. 40 % lavere end hos voksne, selvom antallet af patienter, der bekræfter dette estimat, er begrænset.
English: Before starting treatment with Remicade, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Danish: Før initiering af behandling med Remicade skal alle patienter vurderes for både aktiv og inaktiv (“latent”) tuberkulose.
English: Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer.
Danish: Aktuelle data indikerer ikke, at infliximab-behandling påvirker risikoen for at udvikle dysplasi eller colon cancer.
English: Forty six percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
Danish: 46 % af patienterne fortsatte på stabile doser methotrexat (≤ 25 mg/uge).
English: Patients with no deterioration/patients evaluated
Danish: Median (Interkvartil interval) Patienter uden forværring/patienter evalueret
English: • Lack of interest or emotion
Danish: • Mangel på interesse eller følelser
English: The new expiry date must be written on the carton.
Danish: Den nye udløbsdato skal skrives på æsken.
English: Other paediatric indications
Danish: Andre pædiatriske indikationer
English: All infusion reactions were mild or moderate in intensity.
Danish: Alle infusionsreaktioner var lette eller moderate.
English: Janssen Biotech Inc., 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, United States of America
Danish: Janssen Biotech Inc. 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, USA
English: It is unknown whether infliximab is excreted in human milk or absorbed systemically after ingestion.
Danish: Det er ukendt, om infliximab udskilles i human mælk eller optages systemisk efter indtagelse.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: • Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: The efficacy of Remicade through week 54 was assessed in the ACT 1 study.
Danish: Effekten af Remicade i uge 54 blev undersøgt i ACT 1 studiet.
English: The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Danish: Det beskedne antal prospektivt indsamlede graviditeter eksponeret for infliximab, som resulterede i levendefødsel med kendte resultater, inklusive ca. 1.100 graviditeter, der blev eksponeret under første trimester, indikerer ikke en stigning i hyppigheden af misdannelser hos den nyfødte.
English: Additional information on special populations
Danish: Yderligere information om særlige populationer Ældre
English: Patients who did not respond to infliximab at week 8 (n = 15) received no further medicinal product and returned for safety follow-up.
Danish: Patienter, der ikke havde responderet på infliximab i uge 8 (n = 15) fik ikke yderligere doser og gik tilbage til sikkerhedsopfølgning.
English: Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
Danish: Kasser lægemidlet, hvis det ikke er brugt før den nye udløbsdato eller den dato, der er trykt på æsken, alt efter, hvilken dato der kommer først.
English: Subjects randomised Percentage ACR improvement Mean ± SD
Danish: Forsøgspersoner randomiseret Procentvis ACR forbedring Gennemsnit ± SD
English: After the first year of the study, 53 patients continued into an open-label extension to week 102.
Danish: Efter studiets første år fortsatte 53 patienter i en open-label forlængelse til uge 102.
English: Remicade should be administered intravenously over a 2 hour period.
Danish: Remicade skal administreres intravenøst over en 2-timers periode.
English: In IMPACT and IMPACT 2, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
Danish: I IMPACT og IMPACT 2 blev klinisk respons observeret så tidligt som uge 2 og blev bibeholdt henholdsvis til og med uge 98 og uge 54.
English: Warnings and precautions Talk to your doctor before or during treatment with Remicade if you have:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før eller under behandlingen med Remicade, hvis du har:
English: A response was observed within 2 weeks, with a maximum response at 4 weeks.
Danish: Der konstateredes en effekt inden for 2 uger med maksimal effekt efter 4 uger.
English: Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse reactions, including infection.
Danish: Der bør udvises forsigtighed, og patienterne skal fortsat monitoreres, ved skift fra et biologisk lægemiddel til et andet, da overlappende biologisk aktivitet kan øge risikoen for bivirkninger yderligere, herunder for infektioner.
English: Elevations of ALT ≥ 5 x Upper Limit of Normal (ULN) have been observed (see Table 2).
Danish: Der er set stigninger i ALAT ≥5 x øvre grænse for normalområdet (ULN) (se tabel 2).
English: The elimination pathways for infliximab have not been characterised.
Danish: Eliminationsvejene for infliximab er ikke karakteriseret.
English: Data about fistulas were derived from PCDAI scores.
Danish: Data om fistler blev uddraget fra PCDAI-score.
English: • Do not use this medicine if it is discoloured or if there are particles present.
Danish: • Brug ikke dette lægemiddel, hvis det er misfarvet, eller hvis det indeholder partikler.
English: Side effects may also occur after your treatment with Remicade has stopped.
Danish: Bivirkninger kan også opstå efter ophør af din behandling med Remicade.
English: Remicade has not been studied in these patient populations.
Danish: Remicade er ikke undersøgt hos denne patientpopulation.
English: Median time to loss of response through week 54
Danish: Median tid til tab af respons frem til uge 54
English: Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy.
Danish: Cirka 3 % af patienterne afbrød behandlingen på grund af infusionsrelaterede reaktioner, og alle patienter kom sig med eller uden behandling.
English: • Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma.
Danish: • Patienter med alvorlig reumatoid arthritis, som har haft sygdommen i lang tid, kan have en større risiko for at udvikle lymfom.
English: In REACH, 17.5% of randomised patients experienced 1 or more infusion reactions.
Danish: 17,5 % af de randomiserede patienter i REACH oplevede 1 eller flere infusionsreaktioner.
English: Delayed hypersensitivity
Danish: Forsinket overfølsomhed
English: There were no serious infusion reactions, and 2 subjects in REACH had non-serious anaphylactic reactions.
Danish: Der var ingen alvorlige infusionsreaktioner, og 2 personer i REACH fik ikke alvorlige anafylaktiske reaktioner.
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Danish: Eksisterende resultater tyder på, at det kliniske respons sædvanligvis nås inden for 12 ugers behandling.
English: AZA was given at a dose of 2.5 mg/kg daily.
Danish: AZA blev givet med en dosis på 2,5 mg/kg dagligt.
English: It is important that you and your doctor record the brand name and batch number of your medicine.
Danish: Det er vigtigt, at du og din læge noterer produktnavn og lot-nummer på din medicin.
English: Reports of lupus and lupus-like syndromes, however, remain uncommon (see section 4.4).
Danish: Rapporter om lupus og lupus-lignende syndromer er imidlertid stadig usædvanlige (se pkt.
English: • The doctor will decide your dose and how often you will be given Remicade.
Danish: • Lægen vil bestemme din dosis og hvor ofte, du skal have Remicade.
English: Similar trends in the achievement of corticosteroid-free clinical remission were observed at week 50.
Danish: En tilsvarende tendens til opnåelse af kortikosteroidfri klinisk remission blev observeret i uge 50.
English: Remicade should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Danish: Remicade må kun anvendes til børn, hvis de behandles for Crohns sygdom eller colitis ulcerosa.
English: • adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
Danish: • voksne patienter med alvorlig, aktiv og progressiv sygdom, der ikke tidligere er behandlet med methotrexat eller andre DMARD.
English: Results from week 54 are shown in Table 4.
Danish: Resultaterne fra uge 54 er vist i tabel 4.