natgillin/translations-raw huggingface dataset:
Hos patienter med psoriasis arthritis, der modtog 5 mg/kg med og uden methotrexat, forekom der i alt antistoffer hos 15% af patienterne (der forekom antistoffer hos 4% af de patienter, der fik methotrexat og hos 26% af de patienter, der ikke fik methotrexat ved baseline).
In psoriatic arthritis patients who received 5 mg/kg with and without methotrexate, antibodies occurred overall in 15% of patients (antibodies occurred in 4% of patients receiving methotrexate and in 26% of patients not receiving methotrexate at baseline).
Infliximab + AZA Kombinationsterapi
Infliximab + AZA Combination therapy
HÆTTEGLASSET MÅ IKKE RYSTES.
THE VIAL MUST NOT BE SHAKEN.
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 infliximab-treated 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.
I 3 mg/kg infliximab-gruppen 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).
Ud af disse patienter var de fleste teenagedrenge eller unge mænd og de fleste havde enten Crohns sygdom eller colitis ulcerosa.
Of these patients, most were teenage boys or young men and most had either Crohn's disease or ulcerative colitis.
Inflectra bør undersøges visuelt for partikler eller misfarvning før indgivelsen.
Inflectra should be visually inspected for particulate matter or discolouration prior to administration.
4 Medianopfølgning er baseret på behandlede patienter.
3 Number of patients evaluated for ALT. 4 Median follow-up is based on patients treated.
• Det anbefales, at Inflectra anvendes så hurtigt som muligt (inden for 3 timer), efter den er klargjort til infusion.
• It is recommended that when Inflectra is prepared for infusion, it is used as soon as possible (within 3 hours).
Ved baseline fik 53% af patienterne immunmodulerende behandling (6-MP, AZA og/eller MTX), og 62% af patienterne fik kortikosteroider.
At baseline 53% of patients were receiving immunomodulator therapy (6-MP, AZA and/or MTX) and 62% of patients were receiving corticosteroids.
• Før du får Inflectra, skal du fortælle det til din læge, hvis du nogensinde har levet eller rejst i et område, hvor infektioner kaldet histoplasmose, kokcidioidomykose eller blastomykose er almindelige.
• Tell your doctor before you are given Inflectra if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Før du får Inflectra, skal du fortælle det til din læge, hvis du har eller nogensinde har haft lymfom (en type blodkræft) eller enhver anden form for kræft.
• Tell your doctor before you are given Inflectra if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Selvom sammenlignende data mangler, indikerer begrænsede data hos patienter, der initialt responderede på 5 mg/kg, men som mistede respons, at nogle patienter kan genvinde respons med dosisoptrapning (se pkt.
Although comparative data are lacking, limited data in patients who initially responded to 5 mg/kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1).
I genbehandlingsarmen fik 4% (8/219) af patienterne en alvorlig infusionsrelateret reaktion sammenlignet med < 1% (1/222) på vedligeholdelsesbehandling.
In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus < 1% (1/222) on maintenance therapy.
Efter administration af infliximab 5 mg/kg hver 8. uge var den forventede mediane steady-state infliximab-eksponering (arealet under koncentrationstids-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 steady-state medicinal product exposure in adults.
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 6.1.
Placebo (uge 16)
Placebo (Week 16)
EXPRESS vurderede virkningen af infliximab induktions- og vedligeholdelsesbehandling hos 378 patienter med plaque psoriasis.
EXPRESS evaluated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
Fortynd ikke den rekonstituerede Inflectraopløsning med andre infusionsvæsker.
Do not dilute the reconstituted Inflectra solution with any other diluent.
I uge 26, tyve uger efter den sidste induktionsdosis, var 30% af patienterne i 5 mg/kg gruppen og 13,8% af patienterne i 3 mg/kg gruppen PASI 75 respondere.
By week 26, twenty weeks after the last induction dose, 30% of patients in the 5 mg/kg group and 13.8% of patients in the 3 mg/kg group were PASI 75 responders.
I 102. uge var 80 patienter stadig på infliximab-behandling og blandt disse var 71 (89%) ASAS 20 respondere.
At 102 weeks there were 80 subjects still on infliximab treatment and among those, 71 (89%) were ASAS 20 responders.
• Melanom (en type hudkræft).
• Melanoma (a type of skin cancer)
Nogle patienter, der i høj grad udviklede antistoffer mod infliximab, havde tegn på nedsat virkning.
Some patients who developed high titres of antibodies to infliximab had evidence of reduced efficacy.
De 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 tuberculosis (TB) below: Test
Hvis du har glemt eller kommer for sent til din Inflectra-infusion Hvis du glemmer eller kommer for sent til en aftale, hvor Inflectra gives, skal du lave en ny aftale så hurtigt som muligt.
If you forget or miss an appointment to receive Inflectra, make another appointment as soon as possible.
Infliximab er et kimærisk humant-murint monoklonalt antistof, der binder sig med høj affinitet til både opløselige og transmembrane former af TNFα, men ikke til lymphotoxin α (TNFß).
Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ).
Kortikosteroider har tilsyneladende ingen klinisk relevant virkning på infliximabs farmakokinetik.
Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.
• Patienter med KOL og patienter, som er storrygere, kan have en øget risiko for at udvikle kræft under behandling med Inflectra.
• Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Inflectra treatment.
Farmakoterapeutisk klassifikation: immunosuppressiva, tumornekrosefaktor-alfa (TNFα)-hæmmere, ATC-kode: L04AB02.
Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
Infliximab forebyggede sygdom hos transgene mus, der udvikler polyarthritis som resultat af konstitutiv ekspression af human TNFα, og fik ved administration 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.
NAPSI-score ved baseline var hhv. 4,6 og 4,3 i infliximab- og placebogruppen.
scores were 4.6 and 4.3 in infliximab and placebo group.
Kontakt lægen, før eller under behandlingen med Inflectra, hvis du har:
Warnings and precautions Talk to your doctor before or during treatment with Inflectra if you have:
Kombination af infliximabog andre biologiske lægemidler anvendt til behandling af de samme lidelser som infliximab, herunder anakinra og abatacept, kan ikke anbefales (se pkt.
The combination of infliximab with other biological therapeutics used to treat the same conditions as infliximab, including anakinra and abatacept, is not recommended (see section 4.4).
Tilfælde af TB har været rapporteret hos patienter i behandling med infliximab, og også hos patienter, som allerede har været i behandling med lægemidler for TB.
Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for TB.
Ved 54 uger var 44,9% af patienterne i den kombinerede infliximab-behandlingsgruppe i klinisk respons sammenlignet med 19,8% i placebobehandlingsgruppen (p < 0,001).
At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p<0.001).
I alt 573 patienter med moderat til svært aktiv Crohns sygdom (CDAI ≥ 220 ≤ 400) fik en enkelt infusionsdosis på 5 mg/kg ved uge 0.
A total of 573 patients with moderately to severely active Crohn's disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
Hvis opløsningen er klargjort under aseptiske betingelser, kan den dog opbevares i køleskab ved 2°C - 8°C i op til 28 dage og i yderligere 24 timer ved 25°C efter udtagning fra køleskab.
However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2 °C - 8 °C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Hvis en patient udvikler symptomer, der viser tegn på et lupus-lignende syndrom efter behandling med infliximab og er positiv over for antistoffer mod dobbeltstrenget DNA, må behandling med infliximab ikke fortsættes (se pkt.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with infliximab and is positive for antibodies against double-stranded DNA, further treatment with infliximab must not be given (see section 4.8).
• Alvorlige hudproblemer såsom toksisk epidermal nekrolyse, Stevens-Johnsons syndrom og akut generaliseret eksantematøs pustulose
• Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
I dette studie blev 150 patienter med NYHA funktionsklasse III-IV CHF (venstre ventrikels uddrivningsfraktion ≤ 35%) behandlet med 3 infusioner infliximab 5 mg/kg, 10 mg/kg eller placebo i løbet af 6 uger.
In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Samtidig administration af TNF-alfahæmmer og anakinra
Concurrent administration of TNF-alpha inhibitor and anakinra
I et klinisk studie med patienter med Crohns sygdom (SONIC) forekom infusionsrelaterede reaktioner hos 16,6% (27/163) af de patienter, som fik infliximab monoterapi, hos 5% (9/179) af de patienter, som fik infliximab kombineret med AZA, og hos 5,6% (9/161) af de patienter, som fik AZA monoterapi.
In a clinical study of patients with Crohn's disease (SONIC), infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy.
Placebo (uge 24)
Placebo (Week 24)
Det totale perifere antal hvide blodlegemer blev kun påvirket i ubetydeligt omfang hos patienter behandlet med infliximab, omend ændringer i lymfocytter, monocytter og neutrofiler viste skift inden for normalområderne.
Total peripheral white blood cell counts were minimally affected in infliximab-treated patients, although changes in lymphocytes, monocytes and neutrophils reflected shifts towards normal ranges.
Median (Interkvartilt interval) Patienter uden forværring/patienter evalueret
Patients with no deterioration/patients evaluated (%)
Patienter kan præmedicineres med fx et antihistamin, hydrocortison og/eller paracetamol og infusionshastigheden reduceres for at nedsætte risikoen for infusionsrelaterede reaktioner, især hvis infusionsrelaterede reaktioner er set tidligere (se pkt.
Patients may be pre-treated with e.g. an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
I fase IIIb-studiet med Crohns sygdom, SONIC, fik placebopatienterne AZA 2,5 mg/kg/dag som aktiv kontrol i tillæg til placebo-infliximab-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.
• Du har lettere ved at få infektioner, når du er i behandling med Inflectra.
• You may get infections more easily when you are being treated with Inflectra.
Nogle af disse infektioner har været letale; de opportunistiske infektioner, der oftest er set med en mortalitetsrate > 5%, indbefatter pneumocystose, candidiasis, listeriose og aspergillose.
Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of > 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis.
Foreliggende data 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.
Hos patienter med reumatoid arthritis, der fik det anbefalede regimen med gentagne behandlingsdoser med methotrexat, udviklede 8% af patienterne antistoffer mod infliximab.
In rheumatoid arthritis patients who received the recommended repeated treatment dose regimens with methotrexate, 8% of patients developed antibodies to infliximab.
Patienter bør følges nøje, og infliximab må ikke fortsættes hos patienter, som udvikler nye eller forværrede symptomer på hjerteinsufficiens (se pkt.
Patients should be closely monitored and infliximab must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Læs indlægssedlen for Inflectra grundigt, inden du begynder at tage medicinen.
Please read the Inflectra ‘Package Leaflet' carefully before you start using this medicine.
Der opstod infektioner hos 68% (41/60) af de børn, som fik 3 mg/kg over 52 uger, 65% (37/57) af de børn, som fik infliximab 6 mg/kg over 38 uger og 47% (28/60) af de børn, som fik placebo over 14 uger (se pkt.
Infections occurred in 68% (41/60) of children receiving 3 mg/kg over 52 weeks, 65% (37/57) of children receiving infliximab 6 mg/kg over 38 weeks and 47% (28/60) of children receiving placebo over 14 weeks (see section 4.4).
Hætteglas (type 1 glas) med en (butyl) gummiprop og en aluminiumsforsegling med en flip-off-knap.
Type 1 glass vial with a (butyl) rubber stopper and an aluminium seal with a flip-off button.
Ved den sidste observation efter 12 uger sås stadig virkning hos 13/27 (48%) af patienterne behandlet med infliximab.
At the last observation at 12 weeks, 13/27 (48%) of infliximab-treated patients were still responding.
Hvis du er i tvivl, om noget af ovenstående gælder for dig, skal du kontakte lægen eller apotekspersonalet, før du bruger Inflectra.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Inflectra.
Det lykkedes desuden at lukke alle fistler hos 55% af infliximabbehandlede patientersammenlignet med 13% af patienter behandlet med placebo (p = 0,001).
Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p=0.001).
Alle patienter med colitis ulcerosa, som har forhøjet risiko for dysplasi eller coloncarcinom (for eksempel patienter med langvarig colitis ulcerosa eller primær sklerotisk cholangitis), eller som tidligere har haft dysplasi eller coloncarcinom, bør screenes for dysplasi med reglmæssige 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.
Tabel 6 Procent af patienter, som opnåede kortikosteroidfri klinisk remission i uge 26, SONIC
Table 6 Percent of patients achieving corticosteroid-free clinical remission at Week 26, SONIC AZA Monotherapy
• Det er vigtigt, at du fortæller dit barns læge og andet sundhedspersonale, at du får Inflectra, før barnet bliver vaccineret.
• It is important that you tell your baby's doctors and other healthcare professionals about your Inflectra use before your baby is given any vaccine.
> 40 uger
>40 weeks
• Lavt antal blodceller, herunder svært nedsat antal hvide blodlegemer
• Low blood counts, including a severely decreased number of white blood cells
Psoriasisarthritis, ankyloserende spondylitis (Bechterews sygdom), psoriasis, colitis ulcerosa og Crohns sygdom
Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis and Crohn's disease
I dette studie var der flere patienter i gruppen 12 til 17 år end i gruppen 6 til 11 år (45/60 [75,0%]) vs. 15/60 [25,0%]).
In this study, there were more patients in the 12 to 17 year age group than in the 6 to 11 year age group (45/60 [75.0%]) vs.15/60 [25.0%]).
Samtidig administration af TNF-alfahæmmer og abatacept
Concurrent administration of TNF-alpha inhibitor and abatacept
Inflectra virker ved at binde sig selektivt til TNF-alfa (tumornekrosefaktor alfa) og blokere dets virkning.
Inflectra works by selectively attaching to TNF alpha (tumour necrosis factor alpha) and blocking its action.
Hovedpine.
and headache.
ACR 20 respons* 5(10%) ACR 50 respons* 0(0%) ACR 70 respons* 0(0%) PASI respons (% af patienter)
ACR 20 response* ACR 50 response* ACR 70 response* PASI response (% of patients)b
Der er begrænset erfaring med sikkerheden af infliximab-behandling hos patienter, som har gennemgået kirurgiske indgreb inklusive artroplastik.
There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty.
Stigninger i aminotransferaser blev set (ALAT mere almindeligt end ASAT) hos 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.
Hvis alvorlige reaktioner opstår, skal symptomatisk behandling gives, og der må ikke gives yderligere infliximabinfusioner (se pkt.
If serious reactions occur, symptomatic treatment must be given and further infliximab infusions must not be administered (see section 4.8).
En farmakokinetisk populationsanalyse baseret på data fra patienter med colitis ulcerosa (N=60), Crohns sygdom (N=112), juvenil reumatoid arthritis (N=117) og Kawasakis sygdom (N=16) med et overordnet aldersinterval fra 2 måneder til 17 år indikerede, at eksponering for infliximab var afhængig af legemsvægt på en ikke-lineær måde.
Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N=60), Crohn's disease (N=112), juvenile rheumatoid arthritis (N=117) and Kawasaki disease (N=16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Før behandling med Inflectra
Before treatment with Inflectra
Hos patienter behandlet med methotrexat alene var hyppigheden af alvorlige infektioner 5,2% hos patienter på 65 år og derover sammenlignet med 2,7% hos patienter under 65 år (se pkt.
In patients treated with methotrexate alone, the incidence of serious infections was 5.2% in patients 65 years and older compared to 2.7% in patients under 65 (see section 4.4).
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.
En patient, som kræver operation under infliximabbehandling, bør følges nøje for infektioner, og passende forholdsregler bør tages.
A patient who requires surgery while on infliximab should be closely monitored for infections, and appropriate actions should be taken.
Spædbørn, der har været eksponeret for infliximab i uterus, kan have en øget risiko for infektioner, herunder svær dissemineret infektion, som kan blive letal.
After in utero exposure to infliximab, infants may be at increased risk of infection, including serious disseminated infection that can become fatal.
Gentagen administration af infliximab (5 mg/kg ved 0, 2 og 6 uger i fistulerende Crohns sygdom, 3 eller 10 mg/kg hver 4. eller 8. uge i reumatoid arthritis) resulterede i en let akkumulering af infliximab i serum efter den anden dosis.
Repeated administration of infliximab (5 mg/kg at 0, 2 and 6 weeks in fistulising Crohn's disease, 3 or 10 mg/kg every 4 or 8 weeks in rheumatoid arthritis) resulted in a slight accumulation of infliximab in serum after the second dose.
Der opstod infusionsreaktioner hos 35% af patienterne med juvenil reumatoid arthrithis, som fik 3 mg/kg sammenlignet med 17,5% af patienterne som fik 6 mg/kg.
Infusion reactions occurred in 35% of patients with juvenile rheumatoid arthritis receiving 3 mg/kg compared with 17.5% of patients receiving 6 mg/kg.
I en undergruppe med 90 voksne patienter med reumatoid arthritis fra ASPIRE-studiet kom en tilsvarende andel af patienterne i hver behandlingsgruppe (methotrexat plus: placebo [n=17], 3 mg/kg [n=27] eller 6 mg/kg infliximab [n=46]) op på en effektiv fordobling i titer med en polyvalent pneumokokvaccine, som indikerer, at infliximab ikke påvirkede det T-celle uafhængige humorale immunrespons.
In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titres to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses.
Opløsningen blandes forsigtigt ved at vende hætteglasset for at opløse pulveret.
The solution has to be gently swirled by rotating the vial to dissolve the powder.
Toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, erythema multiforme, furunkulose, lineær IgA bulløs dermatose (LABD), akut generaliseret eksantematøs pustulose (AGEP), lichenoide reaktioner.
Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Brug af TNF-blokerende midler, inklusive infliximab har været forbundet med tilfælde af frembrud af eller forværring af kliniske symptomer og/eller radiografiske tegn på demyeliniseringssygdomme i centralnervesystemet, inklusive dissemineret sklerose og perifere demyeliniseringssygdomme, inklusive Guillain-Barré syndrom.
Use of TNF-blocking agents, including infliximab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis, and peripheral demyelinating disorders, including Guillain-Barré syndrome.