natgillin/translations-raw huggingface dataset:
Samlet set var hyppigheden af bivirkninger og infusionsreaktioner den samme i aldersgrupperne 6-11 år og 12-17 år.
Overall proportions of adverse events and infusion reactions were similar between the 6 to 11 and 12 to 17 year age groups.
Hos nøje udvalgte voksne patienter, som har tålt mindst 3 initiale 2-timers infusioner med Flixabi (induktionsfase) og får vedligeholdelsesterapi, kan det overvejes at indgive de efterfølgende infusioner over en periode på ikke mindre end 1 time.
In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Flixabi (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Uge 10 Uge 24
Week 10 Week 24
Tabel 2 Andel patienter med øget ALAT-aktivitet i kliniske studier Indikation Antal patienter
Table 2 Proportion of patients with increased ALT activity in clinical studies
Interstitiel lungesygdom (inklusive hurtigt fremadskridende sygdom, lungefibrose og pneumonitis).
Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Derudover blev der observeret statistisk og klinisk signifikante forbedringer af livskvalitet og højde såvel som en signifikant reduktion i brug af kortikosteroid i forhold til baseline.
In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed versus baseline.
Opbevar dette kort på dig i 4 måneder, når du har fået din dosis Flixabi, eller i tilfælde af graviditet i mindst 6 måneder, efter du har født.
Keep this card with you for 4 months after your dose of Flixabi, or in case of pregnancy for at least 6 months after the birth of your baby.
Gennemsnitlig NAPSI- score ved baseline var hhv. 4,6 og 4,3 i infliximab- og placebogruppen.
Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Alle patienter, der har fået Flixabi, skal observeres i mindst 1-2 timer efter infusionen for akutte infusionsrelaterede reaktioner.
All patients administered Flixabi are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
I alle tilfælde blev infliximab seponeret og/eller anden behandling igangsat med fuldstændig ophør at tegn og symptomer.
In all cases, infliximab treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Effekten af infliximab til og med uge 54 blev undersøgt i ACT 1 studiet.
The efficacy of infliximab through week 54 was assessed in the ACT 1 study.
Granulomatøs læsion.
Granulomatous lesion.
e HAQ = Health Assessment Questionnaire; større værdier indikerer mindre uarbejdsdygtighed.
e HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Hvis du har holdt pause i behandlingen med infliximab 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 treatment with infliximab of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Kombinationen af Flixabi og abatacept anbefales ikke.
The combination of Flixabi and abatacept is not recommended.
Behandling med Flixabi må ikke fortsættes, hvis en patient udvikler en alvorlig infektion eller sepsis.
Further treatment with Flixabi must not be given if a patient develops a serious infection or sepsis.
Komplementfaktorabnormitet.
Complement factor abnormal.
Hvis det ikke anvendes straks, er opbevaringstiderne og -betingelserne efter anbrud indtil anvendelse brugerens ansvar, og de bør ikke overskride 24 timer ved 2 °C til 8 °C.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
Følgende bivirkninger er observeret med infliximab:
The following side effects have been observed with infliximab:
Eksperimentelle data viser, at TNFα er afgørende for at bekæmpe intracellulære infektioner.
Experimental data show that TNFα is essential for the clearing of intracellular infections.
Ud fra et mikrobiologisk synspunkt bør præparatet anvendes snarest muligt, og inden for 3 timer efter rekonstitution og fortynding.
From a microbiological point of view, the product should be used as soon as possible but within 3 hours of reconstitution and dilution.
(Interkvartil interval) Patienter uden forværring/patienter evalueret c
Median (Interquartile range) Patients with no deterioration/patients evaluated (%)
Din læge vil rådgive dig om, hvilke andre lægemidler du skal blive ved med at tage, mens du er i behandling med Flixabi.
Your doctor will advise you what other medicines you must keep using while you are having Flixabi.
Den rekonstituerede opløsnings kemiske og fysiske stabilitet efter anbrud er påvist i 24 timer ved 25 °C.
Chemical and physical in use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C.
• Du vil få Flixabi af din læge eller sygeplejerske.
• Flixabi will be given to you by your doctor or nurse.
Langvarende studier er ikke blevet udført for at vurdere karcinogenicitet af infliximab.
Long-term studies have not been performed to evaluate the carcinogenic potential of infliximab.
Flixabi virker ved selektivt at binde sig til TNF alfa og blokere dets virkning.
Flixabi works by selectively attaching to TNF alpha and blocking its action.
Derfor kan kombination af Flixabi og anakinra ikke anbefales.
Therefore, the combination of Flixabi and anakinra is not recommended.
• Brug ikke lægemidlet, hvis det er misfarvet, eller hvis det indeholder partikler.
• Do not use this medicine if it is discoloured or if there are particles present.
Forsøgspersoner randomiseret Procentvis ACR forbedring Gennemsnit ± SDa
Subjects randomised Percentage ACR improvement Mean ± SD
ACR respons (% af patienter)
ACR response (% of patients) N
N ≥ 90 % forbedring ≥ 75 % forbedring ≥ 50 % forbedring
N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
Kvinder i den fertile alder skal overveje at anvende sikker kontraception for at undgå graviditet og fortsætte med anvendelsen heraf i mindst 6 måneder efter den sidste behandling med Flixabi.
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Flixabi treatment.
• Infektion, der skyldes en levende vaccine som følge af et svækket immunsystem.
• Infection due to a live vaccine because of a weakened immune system.
• Fortæl din læge, hvis du tidligere har været i behandling med lægemidler indeholdende infliximab og nu starter behandling med Flixabi igen.
• Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Flixabi treatment again.
Opbevaringsforhold på 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.
Vedvarende remission (i remission både i uge 8 og uge 30)a
Sustained remission (in remission at both week 8 and week 30)
Næsten alle patienterne havde også fået medicin, der indeholder azathioprin eller 6-mercaptopurin ud over den TNF-blokerende behandling.
Almost all patients had also received medicines containing azathioprine or 6mercaptopurine in addition to TNF-blockers.
Ved enkeltdoser på 3, 5 eller 10 mg/kg var median værdier for Cmax henholdsvis 77, 118 og 277 mikrogram/ml.
At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/mL, respectively.
Positiv for autoantistoffer.
Autoantibody positive.
Tilfælde af tuberkulose, undertiden dødelige, inklusive miliær tuberkulose og tuberkulose med ekstrapulmonal placering har været rapporteret (se pkt.
Cases of tuberculosis, sometimes fatal, including miliary tuberculosis and tuberculosis with extrapulmonary location have been reported (see section 4.4).
• En påmindelse til patienterne om, at de skal vise patientinformationskortet til alle behandlende sundhedspersoner, herunder i nødstilfælde, og en besked til sundhedspersoner om, at patienten anvender Flixabi.
• A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Flixabi
Patienter, der får seponeret immunsuppressiva før eller under infliximabbehandling, har større risiko for at udvikle disse antistoffer.
Patients who discontinue immunosuppressants prior to or during infliximab treatment are at greater risk of developing these antibodies.
Hvis du får for meget Flixabi
If you are given too much Flixabi
Endoftalmitis.
Endophthalmitis.
Advarsler og forsigtighedsregler Kontakt lægen, før eller under behandlingen med Flixabi, hvis du har:
Warnings and precautions Talk to your doctor before or during treatment with Flixabi if you have:
Flixabi må kun anvendes til børn og unge, hvis de behandles for Crohns sygdom eller colitis ulcerosa.
Flixabi should only be used in children and adolescents if they are being treated for Crohn`s disease or ulcerative colitis.
Hos infliximab- behandlede 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).
• Forværring af en sygdom, der kaldes dermatomyositis (observeres som hududslæt ledsaget af muskelsvaghed)
• Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
Fornyet indgift ved Crohns sygdom og reumatoid arthritis Hvis tegn og symptomer på sygdom vender tilbage, kan Flixabi indgives på ny inden for 16 uger efter den seneste infusion.
Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Flixabi can be re-administered within 16 weeks following the last infusion.
I et klinisk studie hos patienter med reumatoid arthritis (ASPIRE) skulle de 3 første infusioner indgives over 2 timer.
In a clinical study of patients with rheumatoid arthritis (ASPIRE), infusions were to be administered over 2 hours for the first 3 infusions.
Patienter skal følges tæt for infektioner, inklusive tuberkulose før, under og efter behandling med Flixabi.
Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Flixabi.
Bivirkninger kan også opstå efter ophør af din behandling med Flixabi.
Side effects may also occur after your treatment with Flixabi has stopped.
Da muligheden for øget risiko for udvikling af cancer hos patienter med nydiagnosticeret dysplasi behandlet med infliximab ikke er vist, bør risiko og gavn af fortsat behandling for de individuelle patienter nøje overvejes af lægen.
Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with infliximab is not established, the risk and benefits of continued therapy to the individual patients should be carefully considered by the clinician.
• Det er meget vigtigt, at du fortæller din læge, hvis du nogensinde har haft tuberkulose (TB), eller hvis du har været i tæt kontakt med en person, som har haft TB.
• It is very important that you tell your doctor if you have ever had tuberculosis (TB), or if you have been in close contact with someone who has had TB.
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.
• Forsinke skaden i dit led
• Slow down the damage in your joints,
Under Flixabi-behandling bør anden samtidig behandling såsom kortikosteroider og immunsuppressiva optimeres.
During Flixabi treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Overfølsomhed over for det aktive stof, over for andre murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section
Hvis der opstår gulsot og/eller ALAT- forhøjelser ≥ 5 gange øvre grænse af normalområdet, bør Flixabi seponeres, og et omhyggelig studie af hændelsen bør foretages.
If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), Flixabi should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Patienter, som udvikler en ny infektion, imens de er under behandling med Flixabi, bør monitoreres tæt og gennemgå en komplet diagnostisk evaluering.
Patients who develop a new infection while undergoing treatment with Flixabi, should be monitored closely and undergo a complete diagnostic evaluation.
Flixabi kan evt. i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
Flixabi may have a minor influence on the ability to drive and use machines.
Kontroller at opløsningen er farveløs til lysegul og opaliserende.
Check that the solution is colourless to light yellow and opalescent.
• Fortæl kirurgen eller tandlægen, at du er i behandling med Flixabi ved at vise dem dit patientinformationskort.
• Tell your surgeon or dentist that you are having treatment with Flixabi by showing them your patient reminder card.
På grund af hæmningen af TNFα kan infliximab indgivet under graviditet påvirke det normale immunrespons hos den nyfødte.
Due to its inhibition of TNFα, infliximab administered during pregnancy could affect normal immune responses in the newborn.
I de fleste patienter med fistulerende Crohns sygdom blev infliximab påvist i serum i 12 uger (interval 4- 28 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.
Placebo Vedligeholdelse (n = 99)
Placebo Maintenance (n=99)
N ≥ 90 % forbedring
N ≥ 90% improvement
Median opfølgningsperioden var 0,8 år (incidens 5,7 % [95 % CI 2,65 %-10,6 %].
The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%].
Flixabi påvirker sandsynligvis ikke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
Flixabi is not likely to affect your ability to drive or use tools or machines.
In vivo danner infliximab hurtigt stabile komplekser med human TNFα, en proces der svarer til tabet af TNFα bioaktivitet.
In vivo, infliximab rapidly forms stable complexes with human TNFα, a process that parallels the loss of TNFα bioactivity.
Der kendes ikke til nogen bivirkninger efter at have fået for meget Flixabi.
There are no known side effects of having too much of Flixabi.
Under kliniske studier med infliximab over alle godkendte indikationer var forekomsten af lymfom hos infliximab-behandlede patienter højere end forventet i den generelle befolkningsgruppe, men forekomsten af lymfom var sjælden.
During clinical studies of infliximab across all approved indications the incidence of lymphoma in infliximab-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Hvis inaktiv (“latent”) tuberkulose diagnosticeres, skal behandling for latent tuberkulose påbegyndes med behandling mod tuberkulose før initiering af Flixabibehandling i henhold til lokale vejledninger.
If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Flixabi, and in accordance with local recommendations.
Det er vigtigt, at du fortæller dit barns læger og andet sundhedspersonale, at du får Flixabi, så de kan finde frem til, hvornår dit barn skal vaccineres; det gælder også levende vacciner som BCG (bruges til at forebygge tuberkulose).
It is important that you tell your baby's doctors and other health care professionals about your Flixabi use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
I længerevarende sikkerhedsopfølgninger af kliniske studier med infliximab på op til 5 år, svarende til 6.234 patientår (3.210 patienter), blev der rapporteret 5 tilfælde af lymfom og 38 tilfælde af nonlymfom maligniteter.
In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patientsyears (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Flixabi indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er i det væsentlige ”natriumfrit”.
Flixabi contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Vedblivende steroidfri remissionb a Reduktion i CDAI ≥ 25 % og ≥ 70 point.
a Reduction in CDAI ≥ 25% and ≥ 70 points.
Analyse af lamina propria mononukleære celler udtaget ved biopsi fra den intestinale mucosa viste, at infliximab-behandling forårsagede en reduktion i antallet af celler, som var i stand til at udtrykke TNFα og interferon-γ.
Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferon γ.
Hos patienter, der har adskillige eller signifikante risikofaktorer for tuberkulose og har en negativ test for latent tuberkulose, bør anti-tuberkulosebehandling overvejes før initieringen af Flixabi.
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of Flixabi.
Infliximab er ikke undersøgt hos denne patientpopulation.
Infliximab has not been studied in these patient populations.
≥ 50 % forbedring PGA helt væk (0) eller minimale (1)
≥ 50% improvement PGA of cleared (0) or minimal (1)
Der er ikke udført specifikke studier af infliximab hos ældre patienter.
Specific studies of infliximab in elderly patients have not been conducted.
Den almindeligste utilsigtede hændelse var forværring af colitis ulcerosa, hvor hyppigheden var større hos patienter i 12-ugers behandlingsregimen vs. 8-ugers behandlingsregimen.
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.
d p = 0,030 og < 0,001 for henholdsvis 3 mg/kg og 6 mg/kg behandlingsgruppen mod placebo + MTX.
d p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Histologisk evaluering af biopsier fra colon, som er udtaget før og 4 uger efter indgivelse af infliximab, viste en betydelig reduktion i påviseligt TNFα.
Histological evaluation of colonic biopsies, obtained before and 4 weeks after administration of infliximab, revealed a substantial reduction in detectable TNFα.
Flixabi bør anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/II).
Flixabi should be used with caution in patients with mild heart failure (NYHA class I/II).
Alle patienterne skulle være på en stabil dosis af 6- MP, 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).
* Infliximab er et kimerisk monoklonalt human-murin IgG1-antistof fremstillet i celler fra kinesiske hamsterovarier (CHO) ved rekombinant DNA-teknologi.
* Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
• Det anbefales, at Flixabi anvendes så hurtigt som muligt (inden for 3 timer), efter det er klargjort til infusion.
• It is recommended that when Flixabi is prepared for infusion, it is used as soon as possible (within 3 hours).
ATTRACT studiet evaluerede responset ved ugerne 30, 54 og 102 i en placebokontrolleret studie hos 428 patienter med aktiv reumatoid arthritis 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.
For instruktioner om tilberedning og administration, se pkt.
For preparation and administration instructions, see section 6.6.
Generelt var patienter, der udviklede ALAT og ASAT stigninger, asymptomatiske, og hændelserne bedredes eller forsvandt med enten fortsættelse eller afbrydelse af infliximab, eller justering af samtidig behandling.
In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant therapy.
Været i behandling med lægemidler indeholdende infliximab tidligere
Had treatment with any medicine containing infliximab before
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).
• Lave blodtal, herunder svært nedsat antal hvide blodlegemer.
• Low blood counts, including a severely decreased number of white blood cells.
Symptomerne inkluderede, men var ikke begrænset til dyspnø, urticaria, ødemer i ansigtet og hypotension.
Symptoms included, but were not limited to, dyspnoea, urticaria, facial oedema, and hypotension.
Infliximab krydsreagerer ikke med TNFα fra andre arter end mennesker og chimpanser.
Infliximab does not cross react with TNFα from species other than human and chimpanzees.
Det bør overvejes at afbryde Flixabibehandlingen, hvis disse forstyrrelser fortsætter.
Discontinuation of Flixabi should be considered if these disorders develop.
Strukturel ledskade (erosioner og forsnævring af ledspalte) i begge hænder og fødder blev målt som ændringen fra baseline i total van der Heijdemodified Sharp score (0-440).
Structural joint damage (erosions and joint space narrowing) in both hands and feet was measured by the change from baseline in the total van der Heijde-modified Sharp score (0-440).
• Hvis du har fået Flixabi, mens du var gravid, kan dit barn også have en større risiko for at få en infektion med levende vacciner i op til 6 måneder efter fødslen.
• If you received Flixabi while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth.
Hvis disse lægemidler eller behandlinger ikke virker godt nok, vil du få Flixabi for at reducere tegn og symptomer på din sygdom.
If these medicines or treatments do not work well enough, you will be given Flixabi to reduce the signs and symptoms of your disease.
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).
Tilsæt langsomt det samlede volumen af rekonstitueret Flixabi-opløsning til 250 ml infusionsflasken eller -posen.
Slowly add the total volume of reconstituted Flixabi solution to the 250-ml infusion bottle or bag.
Hvis disse lægemidler ikke virker godt nok, vil du få Flixabi, som du skal tage sammen med et andet lægemiddel, der hedder methotrexat, for at:
If these medicines do not work well enough, you will be given Flixabi which you will take in combination with another medicine called methotrexate to:
Patienter med fistulerende Crohns sygdom med akut pusdannende fistler må ikke påbegynde Flixabibehandling, 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 Flixabi therapy until a source for possible infection, specifically abscess, has been excluded (see section 4.3).