FrancophonIA/ELRC3.0 huggingface dataset:
English: If these medicines do not work well enough, you will be given Zessly to treat your disease.
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Zessly til behandling af din sygdom.
English: Placebo Maintenance (n = 110)
Danish: Placebovedligeholdelse (n = 110)
English: Hypotension, hypertension, ecchymosis, hot flush, flushing.
Danish: Hypotension, hypertension, ekkymose, hedeture, Flushing.
English: In the first clinical study, (study 10), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
Danish: I det første kliniske studie (studie 10) blev effekt og sikkerhed af infliximab undersøgt hos 104 patienter med aktiv polyartikulær psoriasis arthritis.
English: 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).
Danish: 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.
English: Studies in mice deficient in TNFα demonstrated no increase in tumours when challenged with known tumour initiators and/or promoters.
Danish: Studier hos mus, der mangler TNFα, viste ingen stigning i tumorer ved udsættelse for kendte tumorfremkaldere og/eller -fremskyndere.
English: 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."
Danish: 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.
English: Study 13
Danish: Studie 13
English: Limit of Normal (ULN) have been observed (see Table 2).
Danish: Der er set stigninger i ALAT ≥ 5 x øvre grænse for normalområdet (ULN) (se tabel 2).
English: Table 9 Effects on ACR and PASI in patients with active psoriatic arthritis, data from study 10 and study 11
Danish: Tabel 9 Effekt på ACR og PASI hos patienter med aktiv psoriatisk arthritis i studie 10 og studie 11
English: Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Danish: 1 Placebo-patienter fik methotrexat, mens infliximab-patienter fik både infliximab og methotrexat.
English: Infusion reactions following re-administration of infliximab
Danish: Infusionsrelaterede reaktioner efter fornyet indgift af infliximab
English: 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.
Danish: 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.
English: Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have also been reported, some in close temporal association with infusion of infliximab.
Danish: Hændelser (nogle letale) af myokardieiskæmi/-infarkt og arytmi er også set; nogle af hændelserne forekom i tæt tidsmæssig forbindelse med infusionen af infliximab.
English: A patient who requires surgery while on Zessly should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som kræver operation under Zesslybehandling, bør følges nøje for infektioner, og passende forholdsregler bør tages.
English: Zessly is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Danish: Zessly er indiceret til behandling af svær, aktiv ankyloserende spondylitis hos voksne patienter, som har responderet utilstrækkeligt på konventionel behandling.
English: 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.
Danish: 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.
English: 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,
Danish: 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.
English: 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).
Danish: Hvis vedligeholdelsesbehandling afbrydes, og der er behov for genstart af behandlingen, anbefales det ikke at gentage induktionsbehandlingen (se pkt.
English: 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.
Danish: 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.
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and
Danish: Patienter i begge studier havde plaque psoriasis (Body Surface Area [BSA] ≥ 10% og Psoriasis Area and Severity Index [PASI] score ≥ 12).
English: • Tell your doctor before you are given Zessly if you are a carrier of hepatitis B or have ever had it.
Danish: • Fortæl din læge, før du får Zessly, hvis du er bærer af hepatitis B, eller hvis du nogensinde har haft det.
English: 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.
Danish: 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.
English: • You should avoid getting pregnant when you are being treated with Zessly and for 6 months after you stop being treated with it.
Danish: • Du skal undgå at blive gravid, mens du er i behandling med Zessly, og i mindst 6 måneder efter du er stoppet med behandlingen.
English: Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Danish: Toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, erythema multiforme, furunkulose, lineær IgA bulløs dermatose (LABD), akut generaliseret eksantematøs postulose (AGEP), lichenoide reaktioner.
English: Study 13 evaluated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
Danish: Studie 13 vurderede effekten af infliximab induktions- og vedligeholdelsesbehandling hos 378 patienter med plaque psoriasis.
English: • This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 30°C for a single period of up to six months, but not beyond the original expiry date.
Danish: • Lægemidlet kan også opbevares i den originale pakning uden for køleskab ved højst 30 °C i en enkelt periode på op til 6 måneder, men den oprindelige udløbsdato må ikke overskrides.
English: The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (clinical Study 5).
Danish: Effekten af gentagne infusioner med infliximab hos patienter med fistulerende Crohns sygdom blev undersøgt i et 1-års klinisk studie (klinisk studie 5).
English: Placebo → infliximab 5 mg/kg (at week 24)
Danish: Placebo → infliximab 5 mg/kg (i uge 24)
English: Visually inspect Zessly for particulate matter or discolouration prior to administration.
Danish: Undersøg Zessly visuelt for partikler eller misfarvning før indgivelsen.
English: 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 (TNFß).
Danish: Infliximab er et kimerisk human-murin monoklonalt antistof, der binder sig med høj affinitet til både opløselige og transmembrane former af TNFα, men ikke til lymphotoxin α (TNFβ).
English: * including bovine tuberculosis (disseminated BCG infection), see section 4.4
Danish: herunder kvægtuberkulose (dissemineret BCG-infektion), se pkt.
English: Upper respiratory tract infection, sinusitis.
Danish: Øvre luftvejsinfektion, sinuitis.
English: For women taking Zessly including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Danish: Lægen kan tilråde, at kvinder, der får Zessly, herunder kvinder over 60 år, bliver regelmæssigt screenet for livmoderhalskræft.
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, study 2
Danish: Tabel 4 Effekter på ACRn, strukturel ledskade og fysisk funktion ved uge 54, studie 2
English: Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one fifth of placebo-treated patients.
Danish: I kliniske studier udviklede cirka halvdelen af infliximab-behandlede patienter, som var ANA negative ved baseline, en positiv ANA i løbet af studiet sammenlignet med cirka en femtedel af placebobehandlede patienter.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at øge sporbarheden af biologiske lægemidler skal præparatnavnet og lot-nummeret på det administrerede lægemiddel tydeligt noteres.
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Zessly.
Danish: Hvis du er i tvivl, om noget af ovenstående passer på dig, skal du tale med din læge eller apotekspersonalet, før du får Zessly.
English: Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNFα-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
Danish: Der blev observeret alvorlige infektioner og neutropeni i kliniske studier ved samtidig anvendelse af anakinra og et andet TNFα -blokerende middel, etanercept, uden nogen øget klinisk fordel sammenlignet med etanercept indgivet alene.
English: • Do not breast-feed when you are being treated with Zessly or for 6 months after your last treatment with Zessly.
Danish: • Du må ikke amme, mens du er i behandling med Zessly og i mindst 6 måneder efter din sidste behandling med Zessly.
English: A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab (maximum of four infusions at 0, 2, 6, and 14 weeks) following disease flare.
Danish: Der var designet et klinisk studie med patienter med moderat til svær psoriasis for at undersøge effekt og sikkerhed af langtidsvedligeholdelsesbehandling i forhold til fornyet indgift med et induktionsregime med infliximab (højst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom.
English: There are insufficient data on the incidence of delayed hypersensitivity reactions after infliximabfree intervals of more than 1 year but limited data from clinical studies suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval (see section 4.4).
Danish: Der er utilstrækkelige resultater vedrørende forekomst af forsinkede overfølsomhedsreaktioner efter infliximab-fri perioder på mere end 1 år, men begrænsede resultater fra kliniske studier tyder på en øget risiko for overfølsomhed ved stigende infliximab-fri periode (se pkt.
English: • Some children and teenage patients who have received TNF-blockers such as infliximab have developed cancers, including unusual types, which sometimes resulted in death.
Danish: • Nogle børn og unge, som har fået TNF-blokkere såsom infliximab, har udviklet kræft inklusive usædvanlige typer kræft, som i visse tilfælde har været dødelige.
English: Study 2 evaluated responses at 54 weeks in 1,004 methotrexate naive patients with early (≤ 3 years disease duration, median 0.6 years) active rheumatoid arthritis (median swollen and tender joint count of 19 and 31, respectively).
Danish: Studie 2 evaluerede respons ved uge 54 hos 1.004 methotrexat naive patienter med tidlig (≤ 3 års sygdomsvarighed, median 0,6 år) aktiv reumatoid arthritis (median antallet af hævede og ømme led var henholdsvis 19 og 31).
English: Chemical and physical in use stability of the reconstituted solution has been demonstrated for 24 hours at 2 °C - 30 °C.
Danish: Det rekonstituerede koncentrat og den fortyndede infusionsvæskes kemiske og fysiske stabilitet efter anbrud er påvist i 24 timer ved 2 °C - 30 °C.
English: If these medicines do not work well enough, you will be given Zessly to:
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Zessly for at:
English: Zessly treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Danish: Behandling med Zessly skal initieres og holdes under opsyn af kvalificerede læger med erfaring i diagnostik og behandling af reumatoid arthritis, inflammatoriske tarmsygdomme, ankyloserende spondylitis, psoriasis arthritis eller psoriasis.
English: • Signs of a nervous system problem (including eye problems) such as fits, tingling or numbness in any part of your body, weakness in arms or legs, changes in eyesight such as double vision or other eye problems.
Danish: • Tegn på et problem i nervesystemet (inklusive øjenproblemer) såsom krampeanfald, prikken eller følelsesløshed et sted i kroppen, svaghed i arme eller ben, ændringer i synet såsom dobbeltsyn eller andre øjenproblemer.
English: Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for
Danish: Tilfælde af TB har været rapporteret hos patienter i behandling med infliximab, også hos patienter, der allerede har været i behandling med medicin mod TB.
English: • Tell your doctor before you are given Zessly if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
Danish: • Fortæl din læge, før du får Zessly, hvis du har en lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL, rygerlunger), eller hvis du er storryger.
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Zessly.
Danish: Fortyndingen kan opnås ved at udtrække et volumen af natriumchlorid 9 mg/ml (0,9 %) infusionsvæske fra 250 ml glasflasken eller infusionsposen svarende til voluminet af det rekonstituerede Zessly-koncentrat.
English: Calculate the total volume of reconstituted Zessly solution required.
Danish: Beregn det samlede påkrævede volumen rekonstitueret Zessly-koncentrat.
English: In a subset of 90 adult patients with rheumatoid arthritis from the study 2 a similar proportion of patients in each treatment group (methotrexateplus: placebo [n=17], 3mg/kg [n=27] or 6mg/kg infliximab [n=46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses.
Danish: I en undergruppe med 90 voksne patienter med reumatoid arthritis fra studie 2 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.
English: If active tuberculosis is diagnosed, Zessly therapy must not be initiated (see section 4.3).
Danish: Ved aktiv tuberkulose, må Zesslybehandling ikke påbegyndes (se pkt.
English: • Tell your doctor before you are given Zessly if you have an infection, even if it is a very minor one.
Danish: • Fortæl din læge, før du får Zessly, hvis du har en infektion, også selvom det er en meget let infektion.
English: Of infliximab-treated patients who had an infusion reaction during the induction period, through week 6, 27% experienced an infusion reaction during the maintenance period, week 7 through week 54.
Danish: Af de infliximab-behandlede patienter, som fik en infusionsreaktion under induktionsfasen til og med uge 6, fik 27 % en infusionsreaktion i vedligeholdelsesfasen uge 7 til og med uge 54.
English: • That treatment with Zessly may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP
Danish: • Information om at behandling med Zessly kan øge risikoen for alvorlige infektioner/sepsis, opportunistiske infektioner, tuberkulose, reaktivering af hepatitis B og BCGgennembrudsinfektion hos spædbørn, der i uterus er blevet eksponeret for infliximab, samt information om, hvornår patienten skal søge hjælp hos en sundhedsperson.
English: • Some patients receiving treatment with medicines containing infliximab have developed serious liver problems.
Danish: • Nogle patienter, der får behandling med lægemidler, der indeholder infliximab, har udviklet alvorlige leverproblemer.
English: The efficacy of repeated infusions with infliximab was studied in a 1-year clinical study (study 4).
Danish: Effekten af gentagne infusioner med infliximab blev undersøgt i et 1-års klinisk studie 4.
English: In the paediatric Crohn's disease study, 17.5% of randomised patients experienced 1 or more infusion reactions.
Danish: 17,5 % af de randomiserede patienter i studiet med Crohns sygdom hos børn oplevede 1 eller flere infusionsreaktioner.
English: Zessly may be stored at temperatures up to a maximum of 30°C for a single period of up to 6 months, but not exceeding the original expiry date.
Danish: Zessly kan opbevares ved temperaturer på op til højst 30 °C i en enkelt periode på op til 6 måneder, men den oprindelige udløbsdato må ikke overskrides.
English: In psoriatic arthritis, short-term treatment with infliximab reduced the number of T-cells and blood vessels in the synovium and psoriatic skin.
Danish: Ved psoriasis arthritis reducerede korttidsbehandling med infliximab antallet af T-celler og blodkar i synovium og hud med psoriasis.
English: • You should receive recommended vaccinations before starting Zessly treatment.
Danish: • Du skal have de anbefalede vaccinationer, før du starter behandling med Zessly.
English: Table 7 Effects on response rate in patients with fistulising Crohn's disease, data from study 5 (week14 responders)
Danish: Tabel 7 Effekter på responshastighed hos patienter med fistulerende Crohns sygdom, data fra studie 5 (uge-14 responderende)
English: Slowly add the total volume of reconstituted Zessly solution to the 250-ml infusion bottle or bag.
Danish: Tilføj langsomt det samlede volumen af rekonstitueret Zessly-koncentrat til 250 ml infusionsflasken eller -posen.
English: Concurrent administration of TNF-alpha inhibitor and anakinra
Danish: Samtidig indgift af TNF-alfahæmmer og anakinra
English: In the paediatric ulcerative colitis trial, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache.
Danish: I studiet med colitis ulcerosa hos børn var de almindeligste bivirkninger øvre luftvejsinfektion, faryngitis, abdominalsmerter, feber og hovedpine.
English: In study 12 in patients with plaque psoriasis, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p < 0.001).
Danish: I studie 12 hos patienter med plaque psoriasis var andelen af patienter, der opnåede PASI 75 i uge 10 71,7 % i 3 mg/kg infliximab-gruppen, 87,9 % i 5 mg/kg infliximab-gruppen og 5,9 % i placebogruppen (p < 0,001).
English: There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty.
Danish: Der er begrænset erfaring med sikkerheden af infliximabbehandling hos patienter, som har gennemgået kirurgiske indgreb inklusive atroplastik.
English: Zessly is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Zessly fortyndes dog med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning.
English: Study 10
Danish: Studie 10
English: The powder is a freeze-dried white pellet.
Danish: Pulveret er frysetørrede, hvide pellets.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet, der indeholder infliximab, i alle undergrupper af den pædiatriske population med reumatoid arthritis, juvenil idiopatisk arthritis, psoriasis arthritis, ankyloserende spondylitis, psoriasis og Crohns sygdom (se pkt.
English: Zessly and Orencia should not be used together.
Danish: Du må ikke få Zessly og Orencia samtidig.
English: • Some patients who have received TNF-blockers, including infliximab, have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Danish: • Nogle patienter, som har fået TNF-blokerende behandling, herunder infliximab, har udviklet en sjælden kræftform kaldet hepatosplenisk T-celle-lymfom.
English: In an exploratory clinical study evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximabtreated patients compared with control patients.
Danish: I et uddybende klinisk studie, der vurderede anvendelsen af infliximab hos patienter med moderat til svær kronisk obstruktiv lungesygdom (COPD), blev der rapporteret flere maligne sygdomme hos patienter behandlet med infliximab sammenlignet med kontrolpatienter.