natgillin/translations-raw huggingface dataset:
for hvem doseringsintervallet er afkortet til under 8 uger, kan have større risiko for bivirkninger.
Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions.
Autoimmun hepatitis, gulsot.
Autoimmune hepatitis, jaundice.
Behandling med Flixabi 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 Flixabi 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.
Anvendelsen af anti-tuberkulosebehandling bør også overvejes før initieringen af Flixabi hos patienter med en tidligere sygdomshistorie med latent eller aktiv tuberkulose, hos hvem et passende behandlingsprogram ikke kan bekræftes.
Use of anti-tuberculosis therapy should also be considered before the initiation of Flixabi in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
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.
1 Placebo-patienter fik methotrexat, mens infliximab-patienter fik både infliximab og methotrexat.
1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
2 Placebo-patienter i de 2 fase III-studier med Crohns sygdom, ACCENT I og ACCENT II, fik som startdosis 5 mg/kg infliximab ved studiets begyndelse og var på placebo i vedligeholdelsesfasen.
2 Placebo patients in the 2 Phase III studies in Crohn's disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Dette inkluderer dissemineret sklerose, Guillain-Barré syndrom, hvis du har krampeanfald eller har fået stillet diagnosen ”optisk neuritis” (betændelse i synsnerven).
This includes multiple sclerosis, Guillain-Barre syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
• Børn og voksne i behandling med Flixabi kan have en øget risiko for at udvikle lymfom eller anden form for kræft.
• Children and adults taking Flixabi may have an increased risk of developing lymphoma or another cancer.
Flixabi indeholder det aktive stof infliximab.
Flixabi contains the active substance infliximab.
Du skal bede din læge om at notere type og dato for seneste screening(er) for tuberkulose (TB) nedenfor:
Ask your doctor to record the type and date of last screening(s) for TB below:
I en af armene (gruppe 2, n = 329) blev patienter med utilstrækkeligt respons tilladt dosisjustering med 1,5 mg/kg intervaller fra 3 op til 9 mg/kg.
In one of the study arms (group 2, n=329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Der sås intet reboundfænomen.
No rebound was observed.
Beregn det samlede påkrævede volumen rekonstitueret Flixabi-opløsning.
Calculate the total volume of reconstituted Flixabi solution required.
Hos patienter behandlet med Flixabi bør en invasiv svampeinfektion såsom aspergillose, candidiasis, pneumocystose, histoplasmose, kokcidioidomykose eller blastomykose mistænkes, hvis en alvorlig systemisk sygdom udvikles, og en læge med ekspertise i diagnosticering og behandling af invasive svampeinfektioner bør konsulteres på et tidligt stadie, når disse patienter undersøges.
In patients treated with Flixabi, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Lymfom, non-Hodgkins lymfom, Hodgkins sygdom, leukæmi, melanom, livmoderhalskræft.
Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
• Melanom (en type hudkræft)
• Melanoma (a type of skin cancer).
På basis af et observationsstudie fra Nordeuropa blev der observeret øget risiko (OR, 95 % CI; p-værdi) for kejsersnit (1,50; 1,14-1,96; p = 0,0032), for tidligt fødte børn (1,48; 1,05-2,09; p = 0,024), børn født små i forhold til gestationsalder (2,79; 1,54-5,04; p = 0,0007) og lav fødselsvægt (2,03; 1,41-2,94; p = 0,0002) hos kvinder, som blev eksponeret for infliximab under graviditeten (med eller uden immunmodulatorer/kortikosteroider, 270 graviditeter) sammenlignet med kvinder, som udelukkende blev eksponeret for immunmodulatorer/kortikosteroider (6.460 graviditeter).
Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for Csection (1.50, 1.14-1.96; p=0.0032), preterm birth (1.48, 1.05-2.09; p=0.024), small for gestational age (2.79, 1.54-5.04; p=0.0007), and low birth weight (2.03, 1.41-2.94; p=0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Kombination af Flixabi og andre biologiske lægemidler anvendt til behandling af de samme lidelser som Flixabi, herunder anakinra og abatacept, kan ikke anbefales (se pkt.
The combination of Flixabi with other biological therapeutics used to treat the same conditions as Flixabi, including anakinra and abatacept, is not recommended (see section 4.4).
Hvis du har fået Flixabi 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 Flixabi 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.
Der var en rapporteret malign sygdom blandt 77 kontrolpatienter (median opfølgningsperiode 0,8 år; incidens 1,3 % [95 % CI 0,03 %-7,0 %]).
There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]).
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 infliximab 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 infliximab at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Liste over allergier
List of allergies:
Hepatosplenisk T-celle-lymfom (primært hos unge og unge voksne mænd med Crohns sygdom eller colitis ulcerosa), Merkelcellekarcinom.
Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease or ulcerative colitis), Merkel cell carcinoma.
Alle patienter med colitis ulcerosa, som har forhøjet risiko for dysplasi eller colon cancer (for eksempel patienter med langvarig colitis ulcerosa eller primær sklerotisk cholangitis), eller som tidligere har haft dysplasi eller colon cancer, bør screenes for dysplasi med regelmæssige intervaller før behandling og under deres sygdomsforløb.
All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Autoimmune processer Den relative mangel på TNFα som følge af anti-TNF-behandling kan medføre initiering af en autoimmun proces.
The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Ændring fra baseline i total van der Heijde modificeret Sharp scoreb
Change from baseline in total van der Heijde-modified Sharp score b
Flixabi skal administreres intravenøst over en 2-timers periode.
Flixabi should be administered intravenously over a 2-hour period.
Der er visse vaccinationer, du kan få, mens du er i behandling med Flixabi, 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 Flixabi but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Flixabi because they may cause infections.
• Hvis du fik Flixabi under graviditeten, kan dit barn have en øget risiko for at få en infektion.
• If you received Flixabi during your pregnancy, your baby may have a higher risk for getting an infection.
Farmakoterapeutisk klassifikation: Immunsuppressiva, tumor nekrose faktor alfa (TNFα)-hæmmere, ATC-kode: L04AB02.
Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
• Patienter med KOL og patienter, som er storrygere, kan have en øget risiko for at udvikle kræft under behandling med Flixabi.
• Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Flixabi treatment.
Dette patientinformationskort indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Flixabi.
This patient reminder card contains important safety information that you need to be aware of before and during treatment with Flixabi.
Hos de patienter, der blev behandlet med infliximab, og som fik mindst en kort infusion, opstod infusionsrelaterede reaktioner hos 15 % af patienterne, og alvorlige infusionsreaktioner opstod hos 0,4 % af patienterne.
Of the infliximabtreated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients.
Tilfælde af TB har været rapporteret hos patienter i behandling med Flixabi, også hos patienter, der allerede har været i behandling med medicin mod
Cases of TB have been reported in patients treated with Flixabi, even in patients who have already been treated with medicines for TB.
Læs indlægssedlen for Flixabi grundigt, inden du begynder at tage medicinen.
Please read the Flixabi ‘Package Leaflet' carefully before you start using this medicine.
Efter 38 uger var 9 af 101 patienter behandlet med infliximab (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 infliximab (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo.
PGA helt væk (0) eller minimale (1) PGA helt væk (0), minimale (1) eller lette (2) Alle negle fri for psoriasis c
PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2) All nails cleared c
Grundet egenskaberne af bivirkningerne set ved kombinationsbehandlingen med etanercept og anakinra, kan lignende toksiciteter muligvis forekomme ved kombination af anakinra med andre TNFα-blokerende midler.
Because of the nature of the adverse reactions seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNFα-blocking agents.
I 3 mg/kg infliximabgruppen fik 4 ud af 60 patienter en alvorlig infusionsreaktion, og 3 patienter rapporterede en mulig anafylaktisk reaktion (ud af disse var 2 blandt de alvorlige infusionsreaktioner).
In the 3 mg/kg infliximab group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions).
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
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).
• Fortæl din læge, før du får Flixabi, 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 Flixabi if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Bakterielle infektioner (fx sepsis, cellulitis, absces).
Bacterial infections (e.g. sepsis, cellulitis, abscess).
• Hvis du har fået Flixabi, mens du var gravid, er det vigtigt, at du informerer dit barns læge om det, før dit barn bliver vaccineret.
• In case you have received Flixabi while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
• Dette lægemiddel kan også opbevares i den originale karton uden for køleskab ved maksimalt 25 °C i en enkelt periode på op til seks måneder, men den oprindelige udløbsdato må ikke overskrides.
• This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 25°C for a single period of up to six months.
• Tal med din læge, hvis du for nylig har fået eller det er planlagt, at du skal have behandling med et terapeutisk smitstof (fx instillation af BCG til behandling af kræft).
• Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Efter administration af infliximab 5 mg/kg hver 8. uge var den forventede mediane steady-state infliximab-eksponering (arealet under koncentrations- tids-kurven ved steady-state, AUCss) hos pædiatriske patienter i alderen 6 til 17 år ca. 20 % lavere end den forventede median steady-state lægemiddel-eksponering hos voksne.
Following administration of 5 mg/kg infliximab every 8 weeks, the predicted median steady-state infliximab exposure (area under concentration-time curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steadystate drug exposure in adults.
Studier fra den publicerede litteratur i forskellige indikationer (fx reumatoid arthritis, psoriasis, Crohns sygdom) tyder dog på, at ikke-levende vacciner givet under anti-TNF-behandling, herunder infliximab kan fremkalde et lavere immunrespons end hos patienter, der ikke får anti-TNFbehandling.
However, studies from the published literature in various indications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggest that non-live vaccinations received during treatment with anti-TNF therapies, including infliximab, may elicit a lower immune response than in patients not receiving anti-TNF therapy.
I fase IIIb-studiet med Crohns sygdom, SONIC, fik placebo-patienterne AZA 2,5 mg/kg/dag som aktiv kontrol i tillæg til placeboinfliximab-infusioner.
In the Phase IIIb trial in Crohn's disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
Det anbefales, at patienterne, om muligt, bringes up to date med alle vaccinationer i overensstemmelse med gældende vaccinationsvejledninger før initiering af behandling med Flixabi.
It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Flixabi therapy.
I et fase II studie, der skulle vurdere infliximab ved CHF, sås højere forekomst af dødsfald på grund af forværret hjerteinsufficiens hos patienter behandlet med infliximab, især hos patienter behandlet med den højere dosis på 10 mg/kg (svarende til to gange den maksimale godkendte dosis).
In a Phase II study aimed at evaluating infliximab in CHF, higher incidence of mortality due to worsening of heart failure were seen in patients treated with infliximab, especially those treated with the higher dose of 10 mg/kg (i.e. twice the maximum approved dose).
Patienter bør følges nøje, og Flixabi må ikke fortsættes hos patienter, som udvikler nye eller forværrede symptomer på hjerteinsufficiens (se pkt.
Patients should be closely monitored and Flixabi must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Næsten alle disse patienter havde fået behandling med AZA eller 6-MP samtidig med eller umiddelbart før TNF- blokerende behandling.
Almost all patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to a TNF-blocker.
Hvis alvorlige reaktioner opstår, skal symptomatisk behandling gives, og der må ikke gives yderligere Flixabi-infusioner (se pkt.
If serious reactions occur, symptomatic treatment must be given and further Flixabi infusions must not be administered (see section 4.8).
Indsæt sprøjtekanylen i hætteglasset gennem midten af gummiproppen og ret strålen med vand til injektionsvæsker mod glasvæggen i hætteglasset.
Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
• Fortæl din læge, hvis du har en infektion, også selvom det er en meget let infektion.
• Tell your doctor if you have an infection even if it is a very minor one.
Da der ikke er anvendt konserveringsmiddel, anbefales det, at indgivelsen af infusionsvæsken, opløsningen, påbegyndes 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.
• Fortæl din læge, før du får Flixabi, hvis du har eller nogensinde har haft lymfom (en type blodkræft) eller enhver anden form for kræft.
• Tell your doctor before you are given Flixabi if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Anafylaktisk shock, vasculitis, sarkoid-lignende reaktioner.
Anaphylactic shock, vasculitis, sarcoid-like reaction.
• Du har lettere ved at få infektioner, når du er i behandling med Flixabi.
• You may get infections more easily when you are being treated with Flixabi.
Flixabi er indiceret til behandling af aktiv og progressiv psoriasis arthritis hos voksne patienter, hvor respons på tidligere DMARD-behandling har været utilstrækkelig.
Flixabi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Flixabi indeholder natrium
Flixabi contains sodium
Tabel 7 Effekter på responshastighed, data fra ACCENT II (uge-14 responderende) ACCENT II (uge-14 responderende)
Table 7 Effects on response rate, data from ACCENT II (week-14 responders)
Forhøjede koncentrationer af TNFα er blevet fundet i leddene hos reumatoid arthritis patienter og korrelerer med øget sygdomsaktivitet.
Elevated concentrations of TNFα have been found in the joints of rheumatoid arthritis patients and correlate with elevated disease activity.
Liste over anden medicin
List of other medicines:
Eksisterende resultater tyder på en øget risiko for forsinket overfølsomhed ved længerevarende infliximab-fri periode.
Available data suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval.
b Alle infliximab doser er givet i kombination med methotrexat og folat samt eventuelt kortikosteroider og/eller NSAIDs c p < 0,001, for hver infliximab-behandlingsgruppe versus kontrol d Større værdier indikerer mere uarbejdsdygtighed.
b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs c p < 0.001, for each infliximab treatment group vs. control d greater values indicate more joint damage.
Infliximab blev undersøgt i et klinisk studie med 120 patienter (alder: 4-17 år) med aktiv juvenil reumatoid arthritis til trods for behandling med methotrexat.
Infliximab was studied in a clinical study in 120 patients (age range: 4-17 years old) with active juvenile rheumatoid arthritis despite methotrexate.
Når rekonstitution og fortynding er udført under aseptiske forhold, kan Flixabi infusionsvæske anvendes inden for 24 timer, hvis den opbevares ved 2 °C til 8 °C.
When reconstitution and dilution are performed under aseptic conditions, Flixabi infusion solution can be used within 24 hours if stored at 2°C to 8°C.
Reduktionen i hyppigheden af kolektomi blev også undersøgt i et andet randomiseret, dobbelblindt studie (C0168Y06) af hospitaliserede patienter (n = 45) med moderat til svær aktiv colitis ulcerosa, som ikke responderede på intravenøse kortikosteroider, og som derfor havde større risiko for kolektomi.
The reduction in incidence of colectomy was also examined in another randomised, double-blind study (C0168Y06) in hospitalised patients (n=45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy.
Undersøg Flixabi visuelt for partikler eller misfarvning før indgivelsen.
Visually inspect Flixabi for particulate matter or discolouration prior to administration.
Flixabi findes i pakninger, der indeholder 1, 2, 3, 4 og 5 hætteglas.
Flixabi is available in packs containing 1, 2, 3, 4, and 5 vial(s).
Infliximab forebyggede sygdom hos transgene mus, der udvikler polyarthritis som resultat af konstitutiv ekspression af human TNFα, og fik ved indgift efter sygdomsstart eroderede led til at heles.
Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα and when administered after disease onset, it allowed eroded joints to heal.
Tuberkulose, svampeinfektioner (fx candidiasis, onychomykose).
Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis).
Hætteglas (type 1 glas med en gummiprop og aluminiumshætte beskyttet med et plastiklåg).
Type 1 glass vial with a rubber stopper and aluminium crimp protected by a plastic cap.
Hvis en patient udvikler symptomer, der viser tegn på et lupus-lignende syndrom efter behandling med Flixabi og er positiv over for antistoffer mod dobbeltstrenget DNA, må behandling med Flixabi ikke fortsættes (se pkt.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Flixabi and is positive for antibodies against double-stranded DNA, further treatment with Flixabi must not be given (see section 4.8).
• Besværet eller smertefuldt åndedræt, smerter i brystet
• Difficult or painful breathing, chest pain
Anafylaktiske reaktioner, Lupus-lignende syndrom, serumsygdom eller serumsygdoms-lignende reaktioner.
Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Din læge kan anbefale en midlertidig pause med Flixabi.
Your doctor may recommend temporarily stopping Flixabi.
Stigninger i aminotransferaser blev set (ALAT mere almindeligt end ASAT) i en større del af patienter, der fik infliximab, end hos kontrolpersoner, både når infliximab blev givet i monoterapi, og når det blev brugt i kombination med andre immunsuppressive stoffer.
Elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving infliximab than in controls, both when infliximab was given as monotherapy and when it was used in combination with other immunosuppressive agents.