natgillin/translations-raw huggingface dataset:
Uddannelsesprogrammet består af et patientinformationskort, som patienten skal have på sig.
The educational programme consists of a patient reminder card to be held by the patient.
6 uger efter din 1. dosis
6 weeks after your 1
Du skal bede din læge om at notere type og dato for din(e) seneste screening(er) for TB på kortet.
Ask your doctor to record the type and date of your last screening(s) for TB on the card
Akutte infusionsreaktioner inklusive anafylaktiske reaktioner kan opstå under (inden for sekunder) eller få timer efter infusionen.
Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion.
Enkelte intravenøse infusioner på 1, 3, 5, 10 eller 20 mg/kg infliximab udviste dosis-proportionale stigninger i den maksimale serumkoncentration (Cmax) samt området under koncentrationstidskurven (AUC).
Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC).
• Nogle patienter, der er blevet behandlet med infliximab, har udviklet visse former for hudkræft.
• Some patients treated with infliximab have developed certain kinds of skin cancer.
I denne situation må det ikke sættes tilbage i køleskab.
In this situation, do not return to refrigerated storage again.
I 102. uge var 49 patienter stadig på infliximabbehandling, og blandt disse var 30 (61 %) BASDAI 50 responders.
At 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
• Fortæl din læge, før du får Remicade, hvis du har eller nogensinde har haft lymfom (en type blodkræft) eller enhver anden form for kræft.
• Tell your doctor before you are given Remicade if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Et fald i tegn og symptomer var defineret som værende mindst en 20 % forbedring (ACR20) i antallet af både ømme og hævede led og i 3 af de følgende 5 kriterier: (1) Evaluators samlede vurdering, (2) patientens samlede vurdering, (3) funktions/handicap mål, (4) visuel analog smerteskala og (5) erytrocytsedimentationshastighed eller C-reaktiv protein.
A reduction in signs and symptoms was defined to be at least a 20% improvement (ACR20) in both tender and swollen joint counts, and in 3 of the following 5 criteria: (1) evaluator's global assessment, (2) patient's global assessment, (3) functional/disability measure, (4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
Da der ikke er anvendt konserveringsmiddel, anbefales det, at indgivelsen af infusionsvæsken begyndes så hurtigt som muligt og inden for 3 timer efter rekonstitution og fortynding.
Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution.
højere værdier indikerer mere ledskade.
greater values indicate more joint damage.
Hos infliximabbehandlede personer var signifikant PASI 50 respons tydelig ved det første besøg (uge 2) og PASI 75 respons ved det andet besøg (uge 6).
In infliximab treated subjects, significant PASI 50 responses were apparent at the first visit (week 2) and PASI 75 responses by the second visit (week 6).
På grund af hæmningen af TNF kan infliximab indgivet under graviditet påvirke det normale immunrespons hos den nyfødte.
Due to its inhibition of TNF, infliximab administered during pregnancy could affect normal immune responses in the newborn.
Børn kan få visse vacciner under behandlingen med Remicade, men må ikke få levende vacciner, mens de får Remicade.
Children may receive some vaccines during treatment with Remicade but should not receive live vaccines while using Remicade.
Remicade påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
Remicade may have a minor influence on the ability to drive and use machines.
Patienter, som var randomiseret til placebo-vedligeholdelsesgruppen og senere blev krydset over til infliximab, er inkluderet i infliximab-gruppen i ALAT-analysen.
Patients who were randomised to the placebo maintenance group and then later crossed over to infliximab are included in the infliximab group in the ALT analysis.
Tilfælde af TB har været rapporteret hos patienter i behandling med Remicade, også hos patienter, der allerede har været i behandling med medicin mod TB.
Cases of TB have been reported in patients treated with Remicade, even in patients who have already been treated with medicines for TB.
Passende screeningundersøgelser (fx tuberkulintest, røntgen af thorax og/eller Interferon Gamma Relase Assay, bør udføres hos alle patienter (lokale vejledninger kan være gældende).
Appropriate screening tests (e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
Højere grader af klinisk respons (ACR50 og ACR70) blev set i alle infliximab-grupper ved 30 og 54 uger sammenlignet med methotrexat alene.
Higher degrees of clinical response (ACR50 and ACR70) were observed in all infliximab groups at 30 and 54 weeks compared with methotrexate alone.
• 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
• 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.
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.
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.
Antistoftiter var markant højere for 3 mg/kg gruppen sammenlignet med 6 mg/kg gruppen.
The antibody titres were notably higher for the 3 mg/kg compared to the 6 mg/kg group.
I psoriasis studierne forekom forsinkede overfølsomhedsreaktioner tidligt i behandlingsforløbet.
In the psoriasis studies, delayed hypersensitivity reactions occurred early in the treatment course.
Du har en højere risiko, hvis du er 65 år eller derover.
If you are 65 or older, you have a greater risk.
Sjælden: Interstitiel lungesygdom (inklusive hurtigt fremadskridende sygdom, lungefibrose og pneumonitis).
Rare: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Ikke almindelig: Positiv for autoantistoffer.
Uncommon: Autoantibody positive.
38 uger
38 weeks
Infliximab hæmmer den funktionelle aktivitet af TNF i en lang række forskellige in vitro bioassays.
Infliximab inhibits the functional activity of TNF in a wide variety of in vitro bioassays.
* P-værdier repræsenterer hver infliximab-behandlingsgruppe vs. AZA monoterapi.
* P-values represent each infliximab treatment group vs. AZA monotherapy.
• Fortæl din læge, hvis du har hepatitis B, eller hvis du ved eller har mistanke om, at du er bærer af hepatitis B-virus.
• Tell your doctor if you have hepatitis B or if you know or suspect you are a carrier of the hepatitis B virus.
Din læge vil teste dig for at se, om du har haft TB.
Your doctor will test you to see if you have TB.
Data, som underbygger dosistitrering ved reumatoid arthritis, stammer fra ATTRACT, ASPIRE og START studierne.
Data to support dose titration in rheumatoid arthritis come from ATTRACT, ASPIRE and the START study.
Patienter med fistulerende Crohns sygdom med akut pusdannende fistler må ikke påbegynde Remicade-behandling, før en kilde til mulig infektion, specielt abscesser, er blevet udelukket (se pkt.
Patients with fistulising Crohn's disease with acute suppurative fistulas must not initiate Remicade therapy until a source for possible infection, specifically abscess, has been excluded (see section 4.3).
Opbevaringsforhold op til 25°C før rekonstitution af lægemidlet, se pkt.
For storage conditions up to 25 °C before reconstitution of the medicinal product, see section 6.3.
• Smerter i leddene, musklerne eller ryggen
• Pain in the joints, muscles or back
Almindelig: Konjunktivitis.
Common: Conjunctivitis.
I ASSERT sås forbedring af tegn og symptomer så tidligt som i uge 2.
In ASSERT, improvement in signs and symptoms was observed as early as week 2.
Reaktivering af hepatitis B er forekommet hos patienter, der fik en TNF-antagonist inklusive infliximab, og som var kroniske bærere af dette virus.
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including infliximab, who are chronic carriers of this virus.
Psoriasisarthritis er en betændelsessygdom i leddene, almindeligvis ledsaget af psoriasis.
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
p = 0,030 og < 0,001 for henholdsvis 3 mg/kg og 6 mg/kg behandlingsgruppen mod placebo + MTX.
p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Antistoffer over for infliximab kan udvikles og har været forbundet med en øget frekvens af infusionsreaktioner.
Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions.
• Du har lettere ved at få infektioner, når du er i behandling med Remicade.
• You may get infections more easily when you are being treated with Remicade.
Almindelig: Takykardi, palpitation.
Common: Tachycardia, palpitation.
Derudover er knoglebrud (6,8 %) rapporteret.
In addition, bone fracture (6.8%) was reported, however, a causal association has not been established.
• Feber, øget svedtendens
• Fever, increased sweating
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 %.
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%.
Infliximab krydsreagerer ikke med TNF fra andre arter end mennesker og chimpanser.
Infliximab does not cross react with TNF from species other than human and chimpanzees.
• Du har tuberkulose (TB) eller en anden alvorlig infektion, såsom lungebetændelse eller blodforgiftning (sepsis).
• You have tuberculosis (TB) or another serious infection such as pneumonia or sepsis.
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.
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.
Ved baseline fik 27,4 % af patienterne systemiske kortikosteroider, 14,2 % af patienterne fik budesonid, og 54,3 % af patienterne fik 5-ASA-stoffer.
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.
2 uger efter din 1. dosis
2 weeks after your 1
Den almindeligste utilsigtede hændelse var forværring af colitis ulcerosa, hvor hyppigheden var større hos patienter i 12-ugers behandlingsregime vs. 8-ugers behandlingsregime.
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.
Hvis du har moderat til svær plaque psoriasis, vil du først få andre lægemidler eller behandlinger, såsom lysterapi.
If you have moderate to severe plaque psoriasis, you will first be given other medicines or treatments, such as phototherapy.
Der er en øget baggrundsrisiko for lymfomer og leukæmi hos reumatoid arthritis patienter med længerevarende, højaktiv inflammatorisk sygdom, hvilket vanskeliggør risikovurderingen.
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.
≥ 90 % forbedring ≥ 75 % forbedring ≥ 50 % forbedring
≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
• 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.
• 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.
Infliximab-behandling af patienter med Crohns sygdom var også forbundet med en betydelig reduktion af den ofte forhøjede serum betændelsesmarkør, CRP.
Infliximab treatment of Crohn's disease patients was also associated with a substantial reduction of the commonly elevated serum inflammatory marker, CRP.
• Du er allergisk over for proteiner, som stammer fra mus.
• You are allergic (hypersensitive) to proteins that come from mice.
I begge studier blev fysisk funktion og livskvalitet målt ved BASFI og den fysiske delscore af SF-36 blev også signifikant forbedret.
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.
Dette inkluderer dissemineret sklerose, Guillain-Barré syndrom, hvis du har krampeanfald eller har fået stillet diagnosen ”optisk neuritis”
This includes multiple sclerosis, Guillain-Barre syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
• Din læge vil teste dig for at se, om du har TB.
• Your doctor will test you to see if you have TB.
• Det anbefales, at Remicade anvendes så hurtigt som muligt (inden for 3 timer), efter det er klargjort til infusion.
• It is recommended that when Remicade is prepared for infusion, it is used as soon as possible (within 3 hours).
Alle patienterne skulle være på en stabil dosis af 6MP, AZA eller MTX (35 % fik også kortiokosteroid ved baseline).
All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
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.
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.
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.
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.
• 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.
• 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.
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.
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.
• Fortæl din læge, hvis du tidligere har været i behandling med Remicade og nu starter behandling med Remicade igen.
• Tell your doctor if you have had treatment with Remicade in the past and are now starting Remicade treatment again.
Symptomerne inkluderede, men var ikke begrænset til dyspnø, urticaria, ødemer i ansigtet og hypotension.
Symptoms included, but were not limited to, dyspnea, urticaria, facial oedema, and hypotension.
SPIRIT vurderede effekten af infliximab induktionsbehandling hos 249 patienter med plaque psoriasis, som tidligere havde fået PUVA eller systemisk behandling.
SPIRIT evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy.
Vedblivende steroidfri remission
Sustained Steroid-Free Remission
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.
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.
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.
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.
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.
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.
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.
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.
Tilføj langsomt det samlede volumen af rekonstitueret Remicade-koncentrat til 250 ml infusionsflasken eller -posen.
Slowly add the total volume of reconstituted Remicade solution to the 250-ml infusion bottle or bag.
• Kredsløbsproblemer såsom for lavt eller for højt blodtryk
• Circulation problems such as low or high blood pressure
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.
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.
Hyppigheden af antistoffer var 2-3 gange højere hos patienter, der blev behandlet periodevist.
The antibody incidence was 2-3 fold higher for patients treated episodically.
• Unormal vævshævelse eller -vækst
• Abnormal tissue swelling or growth
Uge 54 Klinisk respons
Week 54 Clinical Response
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.
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.
Det skal du vide, før du får Remicade
What you need to know before you use Remicade
• Psoriasis, hudproblemer såsom eksem og hårtab
• Psoriasis, skin problems such as eczema and hair loss
• Nogle patienter, der får Remicade, har udviklet symptomer på en sygdom i immunsystemet kaldet lupus.
• Some patients receiving Remicade have developed symptoms of an immune system disorder called lupus.
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.
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.
Infliximab bør kun anvendes på tvingende indikation under graviditet.
Infliximab should only be used during pregnancy if clearly needed.
Tal med lægen om anvendelse af prævention i denne tidsperiode.
Discuss the use of contraception during this time with your doctor.
Ikke kendt: Hepatosplenisk T-celle-lymfom (primært hos unge og unge voksne mænd med Crohns sygdom eller colitis ulcerosa), Merkelcellekarcinom.
Not known: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease or ulcerative colitis), Merkel cell carcinoma.
Median tiden til der registreredes en effekt i gruppen behandlet med infliximab var 2 uger.
The median time to onset of response in the infliximab-treated group was 2 weeks.
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.
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.
Du må kun få Remicade under graviditeten, hvis lægen finder det nødvendigt.
Remicade should only be used during pregnancy if your doctor feels it is necessary for you.
I de fleste patienter med fistulerende Crohns sygdom blev infliximab påvist i serum i 12 uger (interval 428 uger) efter indgift af regimen.
In most fistulising Crohn's disease patients, infliximab was detected in serum for 12 weeks (range 4-28 weeks) after administration of the regimen.
Almene symptomer og reaktioner på administrationsstedet Meget almindelig: Infusionsrelaterede reaktioner, smerter.
General disorders and administration site conditions Very common: Infusion-related reaction, pain.
Det anbefales, at patienterne, om muligt, bringes up to date med alle vaccinationer i overensstemmelse med gældende vaccinationsvejledninger før initiering af behandling med Remicade.
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.
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.
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.
Herudover viste perifere blodlymfocytter intet signifikant fald i antal eller i proliferativt respons af in vitro mitogenisk stimulation sammenlignet med ubehandlede patienters celler.
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.
Remicade skal anvendes sammen med methotrexat.
Remicade must be given concomitantly with methotrexate.