natgillin/translations-raw huggingface dataset:
Der er ikke gennemført biokemiske forligelighedsstudier for at vurdere samtidig indgivelse af Zessly med andre midler. 
No physical biochemical compatibility studies have been conducted to evaluate the coadministration of Zessly with other agents.
Studie 1 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. 
Study 1 evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate.
Tabel 1 Bivirkninger i kliniske studier og efter markedsføring 
Table 1 Undesirable effects in clinical studies and from post-marketing experience
I det andet kliniske studie (studie 9) sås forbedring af tegn og symptomer så tidligt som i uge 2. 
In the second clinical study (study 9), improvement in signs and symptoms was observed as early as week 2.
Der var en rapporteret malign sygdom blandt 77 kontrolpatienter (median opfølgningsperiode 0,8 år; incidence 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%]).
Procent forsøgspersoner i klinisk respons og i vedvarende klinisk respons 
Percentage of subjects in clinical response and in sustained clinical response
Samtidig administration af anden biologisk behandling 
Concurrent administration with other biological therapeutics
Den sædvanlige dosis er 3 mg pr. kg kropsvægt. 
The usual dose is 3 mg for every kg of body weight.
• Kredsløbsproblemer såsom for lavt eller for højt blodtryk 
• Circulation problems such as low or high blood pressure,
(≥ 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). 
to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Studie 12 vurderede effekten af infliximab induktionsbehandling hos 249 patienter med plaque psoriasis, som tidligere havde fået PUVA eller systemisk behandling. 
Study 12 evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic 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 CalmetteGuérin (BCG) infection has been reported following administration of BCG vaccine after birth.
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 chimpanzee.
Der foreligger ikke tilstrækkelig information om samtidig brug af infliximab og andre biologiske lægemidler til behandling af de samme lidelser som infliximab. 
There is insufficient information regarding the concomitant use of infliximab with other biological therapeutics used to treat the same conditions as infliximab.
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 C-section section (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).
Tabel 10 Resumé af PASI respons, PGA-respons og andel patienter, hvis negle alle var fri for psoriasis i uge 10, 24 og 50. 
Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at weeks 10, 24, and 50.
Hepatosplenisk T-celle-lymfom (primært hos unge og unge voksne mænd med Crohns sygdom og colitis ulcerosa), Merkelcellekarcinom. 
Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease and ulcerative colitis), Merkel cell carcinoma.
Der blev rapporteret om infektioner hos 31 (51,7 %) af 60 behandlede patienter i studiet med colitis ulcerosa hos børn, og 22 (36,7 %) krævede oral eller parenteral antimikrobiel behandling. 
Infections were reported in 31 (51.7%) of 60 treated patients in the paediatric ulcerative colitis trial and 22 (36.7%) required oral or parenteral antimicrobial treatment.
• Det er vigtigt, at du fortæller dit barns læge og andet sundhedspersonale, at du har fået Zessly, før barnet bliver vaccineret. 
• It is important that you tell your baby's doctors and other health care professionals about your Zessly use before your baby is given any vaccine.
Zessly indeholder det aktive stof infliximab. 
Zessly contains the active substance infliximab.
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.
Abdominalsmerter, kvalme. 
Abdominal pain, nausea.
Zessly indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er i det væsentlige ”natriumfrit”. 
Zessly contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free'.
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.
Tabel 8 Effekt på klinisk respons hos voksne patienter med moderat til svært aktiv ulcerøs colitis, klinisk remission og slimhindeheling i uge 8 og 30. 
Table 8 Effects on clinical response in adult patients with moderately to severely active ulcerative colitis, clinical remission and mucosal healing at weeks 8 and 30.
Zessly leveres som et hætteglas (glasflaske) indeholdende et pulver til koncentrat til infusionsvæske, opløsning (pulver til koncentrat). 
Zessly is supplied as a glass vial containing a powder for concentrate for solution for infusion (powder for concentrate).
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).
Læs indlægssedlen for Zessly grundigt, inden du begynder at tage medicinen. 
Please read the Zessly ‘Package Leaflet' carefully before you start using this medicine.
Når Zessly er taget ud af køleskabet, må det ikke sættes tilbage på køl igen. 
Upon removal from refrigerated storage, Zessly must not be returned to refrigerated storage.
Infliximab er et kimerisk monoklonalt human-murin IgG1-antistof fremstillet i ovarieceller fra kinesiske hamstre (Chinese Hamster Ovary, 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.
• Hvis din læge tror, at du har risiko for at få TB, kan du blive behandlet med lægemidler mod TB, inden du får Zessly. 
• If your doctor feels that you are at risk for TB, you may be treated with medicines for TB
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 mediane 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 concentrationtime curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steady-state drug exposure in adults.
Juvenil idiopatisk arthritis, psoriasis arthritis og ankyloserende spondylitis 
Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis
• Behandling med TNF-blokkere, såsom Zessly, kan medføre, at hepatitis B igen bliver aktiv hos patienter, som bærer denne virus. 
• Treatment with TNF blockers such as Zessly may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
Hvis du er i tvivl, så tal med din læge, før du får Zessly. 
If you are not sure, talk to your doctor before you are given Zessly.
De vigtigste resultater for effekt i studie 10 og studie 11 hos patienter med aktiv psoriatisk arthritis er vist i tabel 9 nedenfor: 
Key efficacy results for study 10 and study 11 in patients with active psoriatic arthritis are shown in Table 9 below:
Zessly administreres intravenøst. 
Zessly should be administered intravenously.
EU/1/18/1280/001 1 hætteglas 100 mg EU/1/18/1280/002 2 hætteglas 100 mg EU/1/18/1280/003 3 hætteglas 100 mg EU/1/18/1280/004 4 hætteglas 100 mg EU/1/18/1280/005 5 hætteglas 100 mg 
EU/1/18/1280/001 1 vial 100 mg EU/1/18/1280/002 2 vials 100 mg EU/1/18/1280/003 3 vials 100 mg EU/1/18/1280/004 4 vials 100 mg EU/1/18/1280/005 5 vials 100 mg
Klinisk respons i uge 8a Klinisk respons i uge 30a Vedvarende respons (klinisk respons både i uge 8 og uge 30)a 
Clinical response at week 8a Clinical response at week 30a Sustained response (clinical response at both week 8 and week 30)a
2 Placebo-patienter i de to fase III-studier med Crohns sygdom fik som startdosis 5 mg/kg infliximab ved studiets begyndelse og var på placebo i vedligeholdelsesfasen. 
Placebo patients in the two Phase III studies in Crohn's disease, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
I uge 16 blev 47 placebopatienter med < 10 % forbedring fra udgangspunktet i både hævede og ømme led flyttet til infliximab-induktion (tidlig overflytning). 
At week 16, 47 placebo patients with < 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
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.
Reduktionen i hyppigheden af kolektomi blev også undersøgt i et anden randomiseret, dobbelblind studie 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 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.
Effekten blev også vurderet i et randomiseret, dobbeltblind, placebokontrolleret studie hos 94 patienter med fistulerende Crohns sygdom, som havde fistler af mindst 3 måneders varighed. 
The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulas that were of at least 3 months' duration.
I uge 24 blev alle placebobehandlede patienter flyttet over til infliximab-induktion. 
At week 24, all placebo-treated patients crossed over to infliximab induction.
Infliximab er et monoklonalt antistof - en type protein, der binder sig til et specifikt mål i kroppen kaldet TNF (tumornekrosefaktor) alfa. 
Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Infliximab blev undersøgt i et klinisk studie med 120 patienter (alder: 4-17 år) med aktiv juvenil reumatoid arthrithis 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.
Hvis alvorlige reaktioner opstår, skal symptomatisk behandling gives, og der må ikke gives yderligere Zesslyinfusioner (se pkt. 
If serious reactions occur, symptomatic treatment must be given and further Zessly infusions must not be administered (see section 4.8).
b Baseret på patienter med PASI > 2.5 ved baseline for studie 10, og patienter med > 3 % BSA psoriasis hud påvirkning ved baseline af studie 11. 
b Based on patients with PASI ≥ 2.5 at baseline for study 10, and patients with ≥ 3% BSA
I fase IIIb-studiet med Crohns sygdom 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, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
I Crohns sygdom er erfaring med fornyet indgift efter genopdukkende sygdomstegn og symptomer begrænset, og sammenlignende data vedrørende gavn versus risici på de forskellige strategier savnes. 
In Crohn's disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Patienter bør følges nøje, og Zessly må ikke fortsættes hos patienter, som udvikler nye eller forværrede symptomer på hjerteinsufficiens (se pkt. 
Patients should be closely monitored and Zessly must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Kontroller at koncentratet er farveløst til lysebrunt og opaliserende. 
Check that the solution is colourless to light brown and opalescent.
Mediantiden, 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.
• Tal med din læge, hvis du fornylig 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 you 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).
Infliximab forbedrede livskvaliteten i studie 6 og studie 7, hvilket bekræftedes ved statistisk signifikant forbedring i både et sygdomsspecifikt mål, IBDQ, og ved forbedring i den almindelige 36-punkt korte udgave af spørgeskema SF-36. 
In study 6 and study 7, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF-36.
Ændring fra baseline i total van der Heijde modificeret Sharp scoreb Gennemsnit ± SDa 
Change from baseline in total van der Heijde-modified Sharp scoreb Mean ± SDa
Tabel 3 Virkninger på ACR20, strukturel ledskade og fysisk funktionsevne ved uge 54, studie 1 
Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, study 1
Tuberkulose, svampeinfektioner (fx candidiasis, onychomykose). 
Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis ).
Forsigtighed bør udvises, når brug af Zessly overvejes hos patienter med kronisk infektion eller med en sygdomshistorie med tilbagevendende infektioner, inklusive samtidig behandling med immunsuppressive lægemidler. 
Caution should be exercised when considering the use of Zessly in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Hvis disse lægemidler ikke virker godt nok, vil du få Zessly til behandling af din sygdom. 
If these medicines do not work well enough, you will be given Zessly to treat your disease.
Placebovedligeholdelse (n = 110) 
Placebo Maintenance (n = 110)
Hypotension, hypertension, ekkymose, hedeture, Flushing. 
Hypotension, hypertension, ecchymosis, hot flush, flushing.
I det første kliniske studie (studie 10) blev effekt og sikkerhed af infliximab undersøgt hos 104 patienter med aktiv polyartikulær psoriasis arthritis. 
In the first clinical study, (study 10), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
Begrænset erfaring fra fornyet indgift med en enkelt infliximab dosis ved psoriasis efter et interval på 20 uger tyder på nedsat effekt og en højere incidens af lette til moderate infusionsreaktioner sammenlignet med det initiale induktionsregime (se pkt. 
Limited experience from re-treatment with one single infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Studier hos mus, der mangler TNFα, viste ingen stigning i tumorer ved udsættelse for kendte tumorfremkaldere og/eller -fremskyndere. 
Studies in mice deficient in TNFα demonstrated no increase in tumours when challenged with known tumour initiators and/or promoters.
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-TNF-behandling. 
However,studies from the published literature in variousindications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggestthat 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."
Studie 13 
Study 13
Der er set stigninger i ALAT ≥ 5 x øvre grænse for normalområdet (ULN) (se tabel 2). 
Limit of Normal (ULN) have been observed (see Table 2).
Tabel 9 Effekt på ACR og PASI hos patienter med aktiv psoriatisk arthritis i studie 10 og studie 11 
Table 9 Effects on ACR and PASI in patients with active psoriatic arthritis, data from study 10 and study 11
1 Placebo-patienter fik methotrexat, mens infliximab-patienter fik både infliximab og methotrexat. 
Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Infusionsrelaterede reaktioner efter fornyet indgift af infliximab 
Infusion reactions following re-administration of infliximab
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. 
Mean ± SDc 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.
Hændelser (nogle letale) af myokardieiskæmi/-infarkt og arytmi er også set; nogle af hændelserne forekom i tæt tidsmæssig forbindelse med infusionen af infliximab. 
Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have also been reported, some in close temporal association with infusion of infliximab.
En patient, som kræver operation under Zesslybehandling, bør følges nøje for infektioner, og passende forholdsregler bør tages. 
A patient who requires surgery while on Zessly should be closely monitored for infections, and appropriate actions should be taken.
Zessly er indiceret til behandling af svær, aktiv ankyloserende spondylitis hos voksne patienter, som har responderet utilstrækkeligt på konventionel behandling. 
Zessly is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Hos patienter, der har boet i eller rejst til områder, hvor invasive svampeinfektioner såsom histoplasmose, kokcidioidomykose eller blastomykose er endemiske, skal fordele og risici ved Zesslybehandling overvejes omhyggeligt, før Zesslybehandling initieres. 
For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of Zessly treatment should be carefully considered before initiation of Zessly therapy.
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) erytrocyt-sedimentationshastighed 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,
Hvis vedligeholdelsesbehandling afbrydes, og der er behov for genstart af behandlingen, anbefales det ikke at gentage induktionsbehandlingen (se pkt. 
In case maintenance therapy is interrupted, and there is a need to restart treatment, use of a reinduction regimen is not recommended (see section 4.8).
Af de 22 personer som havde fistler ved baseline, var henholdsvis 63,6 % (14/22), 59,1 % (13/22) og 68,2 % (15/22) i fuldstændig fistelrespons i uge 10, 30 og 54 i de kombinerede 8-ugers og 12-ugers vedligeholdelsesgrupper. 
Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at week 10, 30, and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
Patienter i begge studier havde plaque psoriasis (Body Surface Area [BSA] ≥ 10% og Psoriasis Area and Severity Index [PASI] score ≥ 12). 
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and
• Fortæl din læge, før du får Zessly, hvis du er bærer af hepatitis B, eller hvis du nogensinde har haft det. 
• Tell your doctor before you are given Zessly if you are a carrier of hepatitis B or have ever had it.
I et klinisk studie med patienter med Crohns sygdom 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, 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.
• Du skal undgå at blive gravid, mens du er i behandling med Zessly, og i mindst 6 måneder efter du er stoppet med behandlingen. 
• You should avoid getting pregnant when you are being treated with Zessly and for 6 months after you stop being treated with it.