natgillin/translations-raw huggingface dataset:
Nogle af disse reaktioner kan være alvorlige eller livstruende.
Some of these reactions may be serious or life-threatening.
Nogle af disse patienter var under 50 år gamle.
Some of these patients have been under 50 years of age.
Der var herefter ingen forskel mellem grupperne i antallet af sene responderende.
There was no difference between groups in the number of late responders thereafter.
* ITT-analyser med emner med manglende data blev inkluderet som ikke-responderende.
* ITT-analysis where subjects with missing data were included as non-responders.
Lad det rekonstituerede koncentrat stå i 5 minutter.
Allow the reconstituted solution to stand for 5 minutes.
Den eksisterende kliniske erfaring er begrænset.
The available clinical experience is limited.
Da eliminationen af infliximab kan tage op til 6 måneder, bør monitorering fortsættes i denne periode.
Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period.
Skift mellem biologiske DMARDS
Switching between biological DMARDS
Næsten 50 % af rapporterede dødsfald var forbundet med infektion.
Nearly 50% of reported deaths have been associated with infection.
Da du får denne medicin af din læge eller sygeplejerske, er det usandsynligt, at du vil få for meget.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
• Reducere tegn og symptomer på din sygdom
• Reduce the signs and symptoms of your disease
EXP EXP, hvis ikke opbevaret i køleskab ___________________
EXP EXP, if not refrigerated ___________________
Kombinerede resultater fra ACT 1 & 2.
Combined data from ACT 1 & 2
Median varigheden af respons var 12 uger.
The median duration of response was 12 weeks.
Omkring 50 % af patienterne var i funktionsklasse III.
Approximately 50% of patients were in functional Class III.
Der har ikke været rapporteret noget tilfælde af overdosering.
No case of overdose has been reported.
Omtrent halvdelen af tilfældene var lymfomer.
Approximately half the cases were lymphomas.
I denne situation bør Remicade initieres igen som en enkelt dosis efterfulgt af vedligeholdelsesdoser som anbefalet ovenfor.
In this situation, Remicade should be re-initiated as a single dose followed by the maintenance dose recommendations described above.
Disse lægemidler kan give bivirkninger.
These medicines may cause side effects.
Ingen yderligere klinisk relevant akkumulering blev observeret.
No further clinically relevant accumulation was observed.
Fistula Respons (%) Komplet fistula respons (%)
Fistula Response (%) Complete fistula response (%)
Liste over allergier:
List of allergies:
Hvis der opnås tilstrækkelig respons, bør patienten fortsætte på den valgte dosis eller doseringsfrekvens.
If adequate response is achieved, patients should be continued on the selected dose or dose frequency.
ACR respons ( % af patienter)
ACR response (% of patients)
Median terminal halveringstid ved disse doser varierede fra 8 til 9,5 dage.
The median terminal half-life at these doses ranged from 8 to 9.5 days.
Effekten har været demonstreret med eller uden samtidig brug af methotrexat.
Efficacy has been demonstrated with or without concomitant use of methotrexate.
Denne vurdering bør inkludere koloskopi og biopsier ifølge lokale vejledninger.
This evaluation should include colonoscopy and biopsies per local recommendations.
Reduktion i CDAI ≥ 25 % og ≥ 70 point.
Reduction in CDAI ≥ 25% and ≥ 70 points.
Røntgenbilleder af hænder og fødder blev indsamlet ved baseline, uge 24 og 54.
Radiographs of hands and feet were collected at baseline, weeks 24 and 54.
• Kræft hos børn og voksne
• Cancer in children and adults
Hvis du får for meget Remicade
If you are given too much Remicade
Den potentielle indflydelse fra eksponering for infliximab og/eller sværhedsgraden af den underliggende sygdom i disse resultater er fortsat uklar.
The potential contribution of exposure to infliximab and/or the severity of the underlying disease in these outcomes remains unclear.
Bivirkninger kan forekomme lang tid efter sidste dosis.
Side effects may occur a long time after your last dose.
• Lægemidler som påvirker dit immunsystem.
• Medicines that affect your immune system.
I ASPIRE havde mere end 90 % af patienterne mindst to bedømmelsesværdige røntgenbilleder.
In ASPIRE, more than 90% of patients had at least two evaluable X-rays.
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.
Nogle patienter kan dog opleve alvorlige bivirkninger, som kan kræve behandling.
However some patients may experience serious side effects and may require treatment.
Medianopfølgning er baseret på behandlede patienter.
Median follow-up is based on patients treated.
Tal med din læge, hvis du er på en diæt med et lavt saltindhold.
Talk to your doctor if you are on a low salt diet.
Uge 26 Alle randomiserede patienter
Week 26 All randomised patients
Skulle du få brug for information omkring opbevaring, gælder følgende:
The storage details should you need them are as follows:
HAQ = Health Assessment Questionnaire; højere værdier indikerer mindre handicap.
HAQ = Health Assessment Questionnaire; greater values indicate less disability.
• Du vil blive overvåget, mens du får Remicade og i 1-2 timer derefter.
• You will be monitored while you are given Remicade and also for 1 to 2 hours afterwards.
• Din læge eller sygeplejerske vil klargøre medicinen til infusion.
• Your doctor or nurse will prepare the medicine for infusion.
• Alvorlig allergisk reaktion, som kan medføre tab af bevidsthed og kan være livstruende
• Severe allergic reaction that may cause loss of consciousness and could be life-threatening
De virkninger, der sås ved 54 uger, blev opretholdt i 102 uger.
The effects observed at 54 weeks were maintained through 102 weeks.
Denne type kræft har oftest haft dødelig udgang.
This type of cancer has usually resulted in death.
• eller alene hos patienter, der udviser intolerance over for methotrexat, eller for hvem methotrexat er kontraindiceret
• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated
• i kombination med methotrexat
• in combination with methotrexate
Hvis akutte infusionsreaktioner opstår, skal infusionen afbrydes øjeblikkeligt.
If acute infusion reactions occur, the infusion must be interrupted immediately.
Dette vil afhænge af din sygdom, vægt og hvor godt, du reagerer på Remicade.
This will depend on your disease, weight and how well you respond to Remicade.
Forbedring fra baseline i HAQ gennemsnitligt over tid fra uge 30 til uge 54
Improvement from baseline in HAQ averaged over time from week 30 to week 54
Hos responderende patienter, er de alternative strategier for fortsat behandling:
In responding patients, the alternative strategies for continued treatment are:
• Du er allergisk over for infliximab eller et af de øvrige indholdsstoffer i Remicade (angivet i punkt 6).
• You are allergic to infliximab or to any of the other ingredients in Remicade (listed in section 6).
A ≥ 50 % reduktion fra baseline i antallet af drænede fistulaer over en periode på ≥ 4 uger.
A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks.
Periodisk undersøgelse af huden anbefales hos patienter, især hos patienter med risikofaktorer for hudcancer.
Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Mellem uge 6 og 26 vendte symptomerne på psoriasis gradvis tilbage med en median tid til sygdomsrelaps på > 20 uger.
Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of > 20 weeks.
En lille del af infusionsreaktionerne var alvorlige allergiske reaktioner.
A low proportion of the infusion reactions was serious allergic reactions.
• Blodprøveresultater, der viser ‘antistoffer' mod din egen krop.
• Blood test result showing ‘antibodies' against your own body.
Følgende bivirkninger er observeret med Remicade:
The following side effects have been observed with Remicade:
• Hos nogle patienter, som får Remicade, kan kroppen måske ikke lave nok af de blodlegemer, der skal hjælpe med at bekæmpe infektioner eller stoppe blødning.
• In some patients receiving Remicade, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Tabel 2 Andel patienter med øget ALAT-aktivitet i kliniske studier
Table 2 Proportion of patients with increased ALT activity in clinical studies
• Unormale værdier for et protein i blodet kaldet ‘komplementfaktor', som er en del af immunsystemet.
• Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
Der blev rapporteret 3 tilfælde af lungebetændelse (1 alvorlig) og 2 tilfælde af herpes zoster (begge ikke alvorlige).
Three cases of pneumonia (1 serious) and 2 cases of herpes zoster (both non-serious) were reported.
Disse patienter blev klassificeret som uge-2 responderende og blev inkluderet i den primære analyse (se tabel 5).
These patients were classified as week-2 responders and were included in the primary analysis (see Table 5).
• Depression, problemer med at sove
• Depression, problems sleeping
Ikke kendt: Forværring af dermatomyositis-symptomer.
Not known: Worsening of symptoms of dermatomyositis.
Hvis dit barn hyppigt får feber eller infektioner, skal du omgående kontakte barnets læge.
If your baby has continual fevers or infections, contact your baby's doctor immediately.
Enkelte doser på op til 20 mg/kg har været indgivet uden toksiske virkninger.
Single doses up to 20 mg/kg have been administered without toxic effects.
Alvorlige infektioner blev rapporteret hos 12 % (7/60) af alle behandlede patienter.
Serious infections were reported in 12% (7/60) of all treated patients.
Fravær af alle drænede fistulaer.
Absence of any draining fistulas.
De fleste tilfælde af unormale aminotransferaser var forbigående; et lille antal patienter oplevede imidlertid mere langvarige stigninger.
Most aminotransferase abnormalities were transient; however, a small number of patients experienced more prolonged elevations.
De fleste alvorlige infusionsrelaterede reaktioner opstod i forbindelse med den 2 infusion i uge 2.
The majority of serious infusion reactions occurred during the second infusion at week 2.
Hvis latent tuberkulose er under mistanke, bør en læge med ekspertise i behandling af tuberkulose konsulteres.
If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Hvis der er forandringer i huden eller svulster på huden under eller efter behandlingen, skal du fortælle det til lægen.
If there are any changes in your skin or growths on the skin during or after therapy, tell your doctor.
(anafylaktisk shock)
(anaphylactic shock)
• Alvorligt fald i antal hvide blodlegemer er set hos spædbørn født af kvinder, der er blevet behandlet med Remicade under graviditeten.
• Severely decreased numbers of white blood cells have been reported in infants born to women treated with Remicade during pregnancy.
De vigtigste resultater for effekt i IMPACT og IMPACT 2 er vist i tabel 9 nedenfor:
Key efficacy results for IMPACT and IMPACT 2 are shown in Table 9 below:
Derfor er konventionelle prækliniske sikkerhedsdata med infliximab begrænsede.
Therefore, conventional preclinical safety data with infliximab are limited.
Graviditet og vaccinationer
Pregnancy and Vaccinations
Ni af disse patienter udviklede maligne sygdomme, inklusive 1 lymfom.
Nine of these patients developed malignancies, including 1 lymphoma.
Endvidere blev en reduktion i kortikosteroidanvendelsen og forbedring af livskvalitet observeret.
Furthermore, a reduction in corticosteroid use and improvements in quality of life were observed.
Disse hudreaktioner kan være ledsaget af feber.
These skin reactions can be accompanied by fever.
• Du vil få Remicade af din læge eller sygeplejerske.
• Remicade will be given to you by your doctor or nurse.
Cirka 93 % af patienterne havde tidligere fået antibiotika eller immunsupprimerende behandling.
Approximately 93% of the patients had previously received antibiotic or immunosuppressive therapy.
Det bruges til voksne til behandling af følgende betændelsessygdomme:
It is used in adults for the following inflammatory diseases:
Varigheden af de efterfølgende infusioner kunne forkortes til ikke mindre end 40 minutter hos patienter, som ikke fik alvorlige infusionsreaktioner.
The duration of subsequent infusions could be shortened to not less than 40 minutes in patients who did not experience serious infusion reactions.
Hvis du føler dig træt, svimmel eller utilpas efter at have fået Remicade, må du ikke køre bil eller betjene nogen form for maskiner.
If you feel tired, dizzy, or unwell after having Remicade, do not drive or use any tools or machines.
Crohns sygdom, voksne Remicade er indiceret til:
Adult Crohn's disease Remicade is indicated for:
Isolerede tilfælde af leversvigt resulterende i levertransplantation eller dødsfald er forekommet.
Isolated cases of liver failure resulting in liver transplantation or death have occurred.
En allergisk reaktion kan opstå inden for 2 timer efter din injektion eller senere.
An allergic reaction could happen within 2 hours of your injection or later.
Skriv den nye udløbsdato på æsken med dag/måned/år.
Write the new expiry date on the carton including day/month/year.
Remicade opbevares normalt af sundhedspersonalet.
Remicade will generally be stored by the health professionals.
Tabel 9 Effekt på ACR og PASI i IMPACT og IMPACT 2
Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2 IMPACT
Intervallet mellem den sidste vedligeholdelsesdosis og den første dosis ved gentagen induktion varierede mellem 35 og 231 dage.
The interval between the last maintenance dose and the first re-induction dose ranged from 35-231 days.
Langvarende studier er ikke blevet udført for at vurdere det carcinogene potentiale af infliximab.
Long-term studies have not been performed to evaluate the carcinogenic potential of infliximab.
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.
Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient.
Patienter, der reagerede i uge 4, fulgtes til uge 12.
Patients who responded at week 4 were followed to week 12.
Manglende respons på behandling for Crohns sygdom kan indikere tilstedeværelsen af en fikseret fibrotisk striktur, der kan kræve kirurgisk indgreb.
Failure to respond to treatment for Crohn's disease may indicate the presence of a fixed fibrotic stricture that may require surgical treatment.
Effekten var den samme i undergruppen af patienter, der var eksponeret for tidligere systemiske behandlinger sammenlignet med den totale studiepopulation.
Efficacy was similar in the subgroup of patients that were exposed to previous systemic therapies compared to the overall study population.
Der blev ikke rapporteret om alvorlige infusionsreaktioner.
No serious infusion reactions were reported.
Det primære endepunkt i begge studier var procenten af patienter, som opnåede ≥ 75 % forbedring i PASI fra baseline i uge 10.
The primary endpoint in both studies was the percent of patients who achieved ≥ 75% improvement in PASI from baseline at week 10.
Lægens telefonnummer:
Telephone number doctor:
• Øjenproblemer inklusive røde øjne og øjeninfektioner
• Eye problems, including red eyes and infections
• Hepatitis B-infektion, hvis du tidligere har haft hepatitis B
• Hepatitis B infection when you have had hepatitis B in the past
Patienter med en PGA score ≥ 3 havde mulighed for at få en yderligere infusion af den samme behandling i uge 26.
Patients with a PGA score ≥ 3 were eligible to receive an additional infusion of the same treatment at week 26.
Infliximabs lange halveringstid bør tages i betragtning, hvis et kirurgisk indgreb er planlagt.
The long half-life of infliximab should be taken into consideration if a surgical procedure is planned.
Den potentielle risiko ved kombinationen af AZA eller 6-MP og Remicade bør overvejes omhyggeligt.
The potential risk with the combination of AZA or 6-MP and Remicade should be carefully considered.
Efter rekonstitution og fortynding:
After reconstitution and dilution:
Der kendes ikke til bivirkninger efter at have fået for meget Remicade.
There are no known side effects of having too much of Remicade.
Fireogtyve af disse patienter (75,0 %) genvandt klinisk respons efter cross-over.
Twenty four of these patients (75.0%) regained clinical response after crossing over.
Remicade, i kombination med methotrexat, er indiceret til reduktion af sygdomstegn og symptomer samt forbedring af fysisk funktionsevne hos:
Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
På grund af et antal behandlingsophør, kan størrelsen af forskellen i effekt mellem infliximab og methotrexat alene ikke defineres.
Due to a number of treatment withdrawals, the magnitude of the effect difference between infliximab and the methotrexate alone group cannot be defined.
Patienter, som har betændelsessygdomme, tager allerede medicin for at behandle deres lidelse.
Patients who have inflammatory diseases already take medicines to treat their problem.
Remicade tilhører en medicingruppe kaldet ”TNF-blokkere”.
Remicade belongs to a group of medicines called ‘TNF blockers'.
Remicade er kun blevet undersøgt i kombination med konventionel immunsuppressiv behandling.
Remicade has been studied only in combination with conventional immunosuppressive therapy.
Kortere infusionstid ved indikationer hos voksne
Shortened infusions across adult indications
De fleste af de maligne sygdomme udvikledes i lungerne eller hoved og nakke.
The majority of the malignancies developed in the lung or head and neck.
Disse infektioner forårsages af særlige svampetyper, som kan påvirke lungerne eller andre dele af kroppen.
These infections are caused by specific types of fungi that can affect the lungs or other parts of your body.
Periodisk screening bør fortsætte hos kvinder, der er blevet behandlet med Remicade, inklusive kvinder over 60 år.
Periodic screening should continue in women treated with Remicade, including those over 60 years of age.
Vær opmærksom på, at suppression af TNF kan maskere symptomer på infektion såsom feber.
It should be noted that suppression of TNF may mask symptoms of infection such as fever.
Anvendelse af levende vacciner kan medføre kliniske infektioner herunder disseminerede infektioner.
Use of live vaccines can result in clinical infections, including disseminated infections.
I alle situationer beskrevet nedenfor bør benefit/risk-balancen af Remicadebehandling vurderes meget nøje.
In all situations described below, the benefit/risk balance of Remicade therapy should be very carefully considered.
• Mulighed for at notere type, dato og resultater af TB-screeninger.
• Provision to record the type, date, and result of TB screenings
Remicadeinfusioner skal administreres af kvalificeret sundhedspersonale, som er trænet i at detektere infusionsrelateredeproblemer.
Remicade infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Liste over anden medicin:
List of other medicines:
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.
It should be noted that in the majority of these reports tuberculosis was extrapulmonary, presenting as either local or disseminated disease.
Neglepsoriasis blev vurderet ved brug af Nail Psoriasis Severity Index (NAPSI).
Nail psoriasis was assessed using the Nail Psoriasis Severity Index (NAPSI).
Det vides ikke, om dette fund skyldes virkninger på hannerne og/eller hunnerne.
It is not known whether this finding was due to effects on the males and/or the females.
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).
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).
Du må ikke få Remicade, hvis noget af ovenstående passer på dig.
Do not use Remicade if any of the above applies to you.
Da humane immunglobuliner udskilles i mælk, må kvinder ikke amme i mindst 6 måneder efter Remicadebehandling.
Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Remicade treatment.
Din læge vil notere disse tests på dit patientinformationskort.
Your doctor will record these tests on your patient reminder card.
Uge 14-responderende (195/282) blev analyseret for det primære endepunkt, som var tiden fra randomisering til tab af respons (se tabel 7).
Week-14 responders (195/282) were analysed for the primary endpoint, which was time from randomisation to loss of response (see Table 7).
Der kan opstå nogle få fine gennemsigtige partikler i koncentratet, da infliximab er et protein.
The solution may develop a few fine translucent particles, as infliximab is a protein.
Patienter med ACR20 respons /Patienter evalueret
Patients with ACR20 response/ Patients evaluated (%)
Tidligere behandling med PUVA, methotrexat, ciclosporin eller acitretin var modtaget af 71,4 % af patienterne, selv om de ikke nødvendigvis var behandlingsresistente.
Prior therapy with PUVA, methotrexate, ciclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
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.
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.
• Forsinke skaden i dine led
• Slow down the damage in your joints
Dette gælder både for patienter med Crohns sygdom og patienter med reumatoid arthritis.
This applies to both Crohn's disease patients and rheumatoid arthritis patients.
Nøgleresultater præsenteres i tabel 10.
Key results are presented in Table 10.
Infliximab passerer placenta og er blevet sporet i serum hos spædbørn op til 6 måneder efter fødslen.
Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Reaktivering af hepatitis B (HBV)
Hepatitis B (HBV) reactivation
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.
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.
Derfor kan kombination af Remicade og anakinra ikke anbefales.
Therefore, the combination of Remicade and anakinra is not recommended.
Instruktion i anvendelse og håndtering - opbevaring
Instructions for use and handling - storage conditions
Ved spontan postmarketing rapportering er infektioner den mest almindelige alvorlige bivirkning.
In post-marketing spontaneous reporting, infections are the most common serious adverse reaction.
Patienter i begge studier havde plaque psoriasis (Body Surface Area [BSA] ≥ 10 % og Psoriasis Area and Severity Index [PASI] score ≥ 12).
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).