FrancophonIA/ELRC3.0 huggingface dataset:
English: Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: Simponi er indiceret til behandling af moderat til svær, aktiv colitis ulcerosa hos voksne patienter, som har haft utilstrækkelig respons på konventionel behandling herunder kortikosteroider og 6-mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kliniske kontraindikationer for sådanne behandlinger.
English: After the injection
Danish: Efter indsprøjtningen
English: You will find detailed “Instructions for Use” included with this leaflet.
Danish: Der følger en detaljeret ”Brugsvejledning” med denne indlægsseddel.
English: Discontinuation of golimumab therapy should be considered in patients with confirmed significant haematologic abnormalities.
Danish: Seponering af golimumab bør overvejes hos patienter med bekræftede signifikante hæmatologiske anormaliteter.
English: • if the dose is less than 2 weeks late, the patient should inject the forgotten dose and stay on the original schedule.
Danish: • hvis dosis gives mindre end 2 uger for sent, skal patienten injicere den glemte dosis og fortsætte med den oprindelige behandlingsplan.
English: Remove the cap (figure 4)
Danish: Fjern hætten (figur 4)
English: • Check the expiration date printed or written on the carton.
Danish: • Tjek udløbsdatoen, der er trykt eller skrevet på pakningen.
English: • Talk to your doctor if you are going to have any operations or dental procedures.
Danish: • Fortæl din læge, hvis du skal have foretaget en operation eller en tandbehandling.
English: Polyarticular juvenile idiopathic arthritis in children with body weight less than 40 kg The recommended dose of Simponi for children with a body weight less than 40 kg with polyarticular juvenile idiopathic arthritis is 30 mg/m2 body surface area up to maximum single dose of 40 mg administered once a month, on the same date each month.
Danish: Polyartikulær juvenil idiopatisk artrit hos børn med en kropsvægt under 40 kg Den anbefalede dosis Simponi til børn med en kropsvægt under 40 kg med polyartikulær juvenil idiopatisk artrit er 30 mg/m2 kropsoverflade op til en enkeltdosis på maksimalt 40 mg administreret en gang om måneden på samme dato hver måned.
English: Patients who have an inadequate response may benefit from continuing with 100 mg at week 6 and every 4 weeks thereafter (see section 5.1).
Danish: Patienter med utilstrækkeligt respons kan have fordel af at fortsætte med 100 mg i uge 6 og derefter hver 4. uge (se pkt.
English: These changes were observed at the first assessment (week 4) after the initial Simponi administration and were generally maintained through week 24.
Danish: Disse ændringer blev observeret ved første evaluering (uge 4) efter administration af Simponi og var generelt opretholdt til uge 24.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og addresse på den fremstiller, der er anvarlig for batchfrigivelse
English: • Severely decreased number of white blood cells
Danish: • Alvorligt nedsat antal hvide blodceller
English: Table 2 Key efficacy outcomes from the controlled portions of GO-FORWARD, GO-AFTER and GO-BEFORE.
Danish: Tabel 2 Nøgleresultater for effekt fra de kontrollerede dele af GO-FORWARD, GO-AFTER og GO-BEFORE
English: In at-risk patients treated with golimumab, an invasive fungal infection should be suspected if they develop a serious systemic illness.
Danish: Hos patienter i risikogruppe, der bliver behandlet med golimumab, skal invasiv svampeinfektion mistænkes, hvis patienten udvikler en alvorlig systemisk sygdom.
English: Each 0.05 mL medicine contains 2.05 mg sorbitol (E420).
Danish: Hver 0,05 ml lægemiddel indeholder 2,05 mg sorbitol (E420).
English: Rare: Bladder disorders, renal disorders Reproductive system and breast disorders
Danish: Sjælden: Blæresygdomme, nyresygdomme Det reproduktive system og mammae
English: • Bacterial infections (such as cellulitis)
Danish: • Bakterielle infektioner (såsom betændelse i hudens bindevæv)
English: Simponi should not be used if the solution is discoloured, cloudy or containing visible foreign particles.
Danish: Simponi må ikke anvendes, hvis opløsningen er misfarvet, uklar eller indeholder synlige fremmede partikler.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with TNF-blockers cannot be excluded.
Danish: Risiko for udvikling af hepatosplenisk T-celle-lymfom hos patienter, der behandles med TNF-blokkere, kan ikke udelukkes.
English: Comprehensive instructions for the preparation and administration of Simponi in a pre-filled pen are included in the pack.
Danish: En detaljeret vejledning for klargøring og administration af Simponi i en fyldt pen er vedlagt i pakningen.
English: In a single and swift motion, insert the needle through the skin as far as it will go (see figure 6).
Danish: Stik nålen gennem huden så langt den kan, i en enkel og hurtig bevægelse (se figur 6).
English: In GO-BEFORE the primary analysis in patients with moderate to severe rheumatoid arthritis (combined Simponi 50 and 100 mg + MTX groups vs MTX alone for ACR50) was not statistically significant at week 24 (p = 0.053).
Danish: I GO-BEFORE var de primære analyser af ACR 50 hos patienter med moderat til svær reumatoid artrit (kombineret Simponi 50 mg og 100 mg + MTX-grupper versus MTX alene) ikke statistisk signifikante i uge 24 (p = 0,053).
English: • Some of these reactions occurred after the first administration of Simponi.
Danish: • Nogle af disse reaktioner forekom efter den første injektion af Simponi.
English: If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines.
Danish: Hvis du har ankyloserende spondylit eller non-radiografisk aksial spondylartrit, vil du først få andre lægemidler.
English: Simponi 50 mg given once a month, on the same date each month.
Danish: Simponi 50 mg indgives en gang om måneden på den samme dato hver måned.
English: • Failure of the bone marrow to produce blood cells
Danish: • Knoglemarv, der ikke kan producere blodceller
English: Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Danish: Fortsat behandling bør genovervejes hos patienter, som ikke viser tegn på terapeutisk virkning inden for denne periode.
English: The presence of antibodies to golimumab may increase the risk of injection site reactions (see section 4.4).
Danish: Tilstedeværelsen af antistoffer mod golimumab kan øge risikoen for reaktioner på injektionsstedet (se pkt.
English: The active substance is golimumab.
Danish: Aktivt stof: Golimumab.
English: Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with an increased risk of malignancy due to heavy smoking.
Danish: Forsigtighed bør derfor udvises, når TNF-blokerende behandling overvejes, hos patienter med øget risiko for KOL samt patienter med en øget risiko for maligne sygdomme på grund af kraftig rygning.
English: There were no patients age 45 and over in the nr-Axial SpA study.
Danish: Der var ingen patienter i alderen 45 år eller derover i nraksial SpA-studiet.
English: Gently, press the plunger up with your thumb until it stops.
Danish: Tryk forsigtigt stemplet hele vejen ned med din tommelfinger, indtil det stopper.
English: In GO-AFTER, the primary endpoint was the percentage of patients achieving an ACR 20 response at week 14.
Danish: I GO-AFTER var det primære endepunkt den procentdel af patienterne, der opnåede et ACR 20-respons i uge 14.
English: Patients who completed the maintenance study through week 54 continued treatment in a study-extension, with efficacy evaluated through week 216.
Danish: Patienter, som havde gennemført vedligeholdelsesstudiet til og med uge 54, fortsatte behandlingen i en studieforlængelse, hvor virkning blev vurderet til og med uge 216.
English: In UC patients treated with 50 mg or 100 mg golimumab subcutaneously every 4 weeks, concomitant use of immunomodulators did not have a substantial effect on steady-state trough levels of golimumab.
Danish: Hos patienter med UC, der blev behandlet med 50 mg eller 100 mg golimumab subkutant hver 4. uge, havde samtidig behandling med immunmodulerende lægemidler ingen større indvirkning på golimumabs steady-state-dalserumkoncentration.
English: You must stop breast-feeding if you are to be given Simponi.
Danish: Du skal stoppe med at amme, hvis du skal i behandling med Simponi.
English: * p ≤ 0.001 for all comparisons n reflects randomised patients; actual number of patients evaluable for each endpoint may vary by timepoint
Danish: * p ≤ 0,001 for alle sammenligninger n reflekterer randomiserede patienter; det reelle antal af patienter til vurdering ved hvert endepunkt kan variere med tidspunkterne
English: Do not lift the pre-filled pen up yet.
Danish: Undlad at løfte den fyldte pen endnu.
English: Gently, press the plunger until it stops.
Danish: Tryk forsigtigt på stemplet, indtil det stopper.
English: If you have lived in or travelled to an area where infections caused by specific type of fungi that can affect the lungs or other parts of the body (called histoplasmosis, coccidioidomycosis, or blastomycosis), are common, tell your doctor straight away.
Danish: Fortæl det straks til din læge, hvis du har boet eller rejst i et område, hvor infektioner forårsaget af særlige svampetyper (kaldet histoplasmose, kokcidioidomykose eller blastomykose), som kan påvirke lungerne eller andre dele af kroppen, er almindelige.
English: Following induction doses of 200 mg and 100 mg golimumab at week 0 and 2, respectively, and maintenance doses of 50 mg or 100 mg golimumab subcutaneously every 4 weeks thereafter to patients with UC, serum golimumab concentrations reached steady state approximately 14 weeks after the start of therapy.
Danish: Efter induktionsdoser på 200 mg og 100 mg golimumab i henholdsvis uge 0 og 2 og vedligeholdelsesdoser på 50 mg eller 100 mg subkutant hver 4. uge derefter til patienter med UC nåede serumkoncentrationen af golimumab steady-state ca. 14 uger efter behandlingsstart.
English: Objective signs of inflammation population (OSI) Placebo Simponi 50 mg Placebo Simponi 50 mg
Danish: Objective signs of inflammationpopulation (OSI) Placebo Simponi 50 mg Placebo Simponi 50 mg
English: At week 52, 15% of patients in the Simponi 50 mg + MTX group achieved a major clinical response compared with 7% of patients in the placebo + MTX group (p = 0.018).
Danish: I uge 52 opnåede 15% af patienterne i Simponi 50 mg + MTX-gruppen et major klinisk respons sammenlignet med 7% af patienterne i placebo + MTX-gruppen (p = 0,018).
English: • cancer of the lymph nodes (lymphoma) (rare).
Danish: • Kræft i lymfeknuderne (lymfom) (sjælden).
English: If you do not respond well enough to these medicines, you may be given Simponi which you will take in combination with another medicine called methotrexate to:
Danish: Hvis du ikke reagerer godt nok på disse lægemidler, vil du få Simponi, som du skal tage sammen med et andet lægemiddel, der hedder methotrexat, for at:
English: • Feeling numb or having a tingling feeling
Danish: • Følelsesløshed eller en prikkende fornemmelse i huden
English: Call your doctor or pharmacist for a new pre-filled pen.
Danish: Kontakt lægen eller apotekspersonalet for at få en ny fyldt pen.
English: Non-radiographic axial spondyloarthritis
Danish: Non-radiografisk aksial spondylartrit
English: • Inject all of the medicine by pushing in the plunger until the plunger head is completely between the needle guard wings (see figure 7).
Danish: • Indsprøjt al medicinen ved at trykke på stemplet indtil stempelhovedet er fuldstændig nede mellem nålebeskyttelsesafskærmningen (se figur 7).
English: • Do not inject into areas where the skin is tender, bruised, red, scaly, hard or has scars or stretch marks.
Danish: • Du må ikke indsprøjte i områder, hvor huden er øm, rød, skællet, hård, eller hvor der er blå mærker, ar eller strækmærker.
English: Malignancies and lymphoproliferative disorders
Danish: Maligne og lymfoproliferative sygdomme
English: • Do not remove the pre-filled pen's cap while allowing it to reach room temperature.
Danish: • Fjern ikke den fyldte pens hætte, mens den får lov til at nå stuetemperatur.
English: Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2.
Danish: Simponi gives med en initialdosis på 200 mg efterfulgt af 100 mg i uge 2.
English: Hold pressure on your skin with a cotton ball or gauze pad until any bleeding stops.
Danish: Pres en vatrondel eller gaze mod huden, og hold trykket, indtil en eventuel blødning stopper.
English: For placebo subjects, the incidence (95% CI) per 100 subject-years of follow-up of these malignancies was 0.00 (0.00, 2.94).
Danish: For forsøgspersoner i placebogruppen var hyppigheden (95% CI) per 100 forsøgspersonårs opfølgning af disse maligne sygdomme 0,00 (0,00; 2,94).
English: Treatment with 50 mg or 100 mg golimumab subcutaneous every 4 weeks during maintenance resulted in a mean steady-state trough serum concentration of approximately 0.9 ± 0.5 g/mL and 1.8 ± 1.1 g/mL, respectively.
Danish: Behandling med 50 mg eller 100 mg golimumab subkutant hver 4. uge i vedligeholdelsesperioden medførte en gennemsnitlig steady-state-dalserumkoncentration på henholdsvis ca. 0,9 ± 0,5 µg/ml og 1,8 ± 1,1 µg/ml.
English: Keep Simponi pre-filled pen and all medicines out of the sight and reach of children.
Danish: Simponi fyldt pen og alle lægemidler skal opbevares utilgængeligt for børn.
English: Check the expiration date (‘EXP') printed or written on the back panel of the carton.
Danish: Kontroller udløbsdatoen (‘EXP'), der er trykt eller skrevet på kartonens bagside.
English: Renal and hepatic impairment Simponi has not been studied in these patient populations.
Danish: Nedsat nyre- og/eller leverfunktion Simponi er ikke undersøgt hos denne patientpopulation.
English: In a fertility and general reproductive function study in mouse, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, the number of pregnant mice was reduced.
Danish: I et studie af fertilitet og generel reproduktiv funktion hos mus blev antallet af gravide mus reduceret ved brug af et tilsvarende antistof som selektivt hæmmede den funktionelle aktivitet af TNFα.
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including golimumab (see section 4.8).
Danish: Der er rapporteret om melanom og Merkelcellekarcinom hos patienter, der har fået TNF-blokerende behandling, herunder golimumab (se pkt.
English: This will cause any air bubbles to rise to the top.
Danish: Bank for at samle luftboblerne i toppen
English: Read the package leaflet before use Subcutaneous use
Danish: Læs indlægssedlen inden brug Til subkutan anvendelse
English: * p < 0.05 for all comparisons; n reflects randomised patients; actual number of patients evaluable for each endpoint may vary by timepoint
Danish: * p < 0,05 for alle sammenligninger n reflekterer randomiserede patienter; det reelle antal af patienter til vurdering ved hvert endepunkt kan variere med tidspunkterne
English: In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Danish: I et uddybende klinisk studie, der vurderede anvendelsen af et andet TNF-blokerende middel, infliximab, hos patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL), blev der rapporteret flere maligne sygdomme, hovedsageligt i lungerne eller hoved og hals hos patienter behandlet med infliximab sammenlignet med kontrolgruppen.
English: • Do not pull back on the plunger at any time.
Danish: • Træk på intet tidspunkt tilbage i stemplet.
English: • The medicine should be injected within 5 minutes after the cap has been removed.
Danish: • Medicinen skal indsprøjtes inden for 5 minutter efter at hætten er fjernet.
English: Through approximately 4 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar to the general population.
Danish: I løbet af opfølgningsperioden på ca. 4 år var hyppigheden af non-lymfome maligne sygdomme (eksklusive non-melanom hudkræft) den samme som hos befolkningen generelt.
English: Thin Hidden Needle
Danish: Tynd skjult nål
English: Population pharmacokinetic/pharmacodynamic modelling and simulation in children with pJIA confirmed the relationship between golimumab serum exposures and clinical efficacy and supports the dosing regimen of golimumab 30 mg/m2 every 4 weeks in children with pJIA.
Danish: Farmakokinetisk/farmakodynamisk populationsanalyse og simulering hos børn med pJIA bekræftede forholdet mellem serumeksponering af golimumab og klinisk effekt og understøtter doseringsregimet for golimumab 30 mg/m2 hver 4. uge hos børn med pJIA.
English: Patients who developed anti-golimumab antibodies generally had low trough steady-state serum concentrations of golimumab (see section 5.1).
Danish: Patienter, der udviklede anti-golimumab-antistoffer, havde generelt en lav steady-state-dal-serumkoncentration af golimumab (se pkt.
English: All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after golimumab treatment.
Danish: Alle patienter skal opfordres til at søge læge, hvis sygdomstegn/symptomer, der tyder på tuberkulose (fx vedvarende hoste, skranten/vægttab, let feber), forekommer under eller efter golimumabbehandling.
English: Nervous system disease
Danish: Sygdom i nervesystemet
English: If you have polyarticular juvenile idiopathic arthritis you will first be given other medicines.
Danish: Hvis du har polyartikulær juvenil idiopatisk artrit, vil du først få andre lægemidler.
English: Simponi is available in packs containing 1 pre-filled pen.
Danish: Simponi er tilgængelig i en pakke indeholdende 1 fyldt pen.
English: Patients should be instructed to inject the full amount of Simponi according to the comprehensive instructions for use provided in the package leaflet.
Danish: Patienterne skal instrueres i at injicere den fulde mængde af Simponi i henhold til den detaljerede brugsvejledning, som findes i indlægssedlen.
English: Cases of leukaemia have been reported in patients treated with golimumab.
Danish: Der er set tilfælde af leukæmi hos patienter, der er blevet behandlet med golimumab.
English: Treatment with concomitant immunomodulators (azathioprine, 6-mercaptopurine and MTX) resulted in a lower proportion of patients with antibodies to golimumab than patients receiving golimumab without immunomodulators (1% (4/308) versus 3% (22/638), respectively).
Danish: Samtidig behandling med immunmodulerende lægemidler (azathioprin, 6-mercaptopurin og MTX) resulterede i en mindre andel af patienter med antistoffer mod golimumab i forhold til patienter, der fik golimumab uden immunmodulerende lægemidler (hhv. 1% (4/308) versus 3% (22/638)).
English: At week 16, all ACR Ped components demonstrated clinically relevant improvement from baseline (see Table 3).
Danish: Ved uge 16 udviste alle pædiatriske ACR-komponenter klinisk relevant forbedring i forhold til baseline (se tabel 3).
English: Following a single SC dose in healthy subjects, approximately dose-proportional pharmacokinetics were also observed over a dose range of 50 mg to 400 mg.
Danish: Efter en enkelt subkutan dosis hos raske forsøgspersoner sås også tilnærmelsesvis dosisproportional farmakokinetik i et interval på 50 mg til 400 mg.
English: Table 4 Key efficacy outcomes from the controlled portions of GO-FORWARD, GO-AFTER and GO-BEFORE.
Danish: Tabel 4 Nøgleresultater for effekt fra de kontrollerede dele af GO-FORWARD, GO-AFTER og GO-BEFORE
English: The safety and efficacy of Simponi was evaluated in a randomised, double-blind, placebo-controlled, withdrawal study (GO-KIDS) in 173 children (2 to 17 years of age) with active pJIA with at least 5 active joints and an inadequate response to MTX.
Danish: Simponis sikkerhed og virkning blev vurderet i et randomiseret, dobbeltblindet, placebokontrolleret seponeringsstudie (GO-KIDS) hos 173 børn (i alderen 2 til 17 år) med aktiv pJIA med mindst 5 aktive led og utilstrækkeligt respons på MTX.
English: At week 16, all ACR Ped components demonstrated clinically relevant improvement from baseline (see Table 8).
Danish: Ved uge 16 udviste alle pædiatriske ACR-komponenter klinisk relevant forbedring i forhold til baseline (se tabel 8).
English: • blood cancer (leukaemia) (rare).
Danish: • Blodkræft (leukæmi) (sjælden).
English: In the dose confirming portion of the study, 761 patients were randomised to receive either 400 mg Simponi SC at week 0 and 200 mg at week 2, 200 mg Simponi SC at week 0 and 100 mg at week 2, or placebo SC at weeks 0 and 2.
Danish: I doseringsdelen af studiet blev 761 patienter randomiseret til at få enten 400 mg Simponi subkutant i uge 0 og 200 mg i uge 2 eller 200 mg Simponi subkutant i uge 0 og 100 mg i uge 2 eller placebo subkutant i uge 0 og 2.
English: Remove cap Keep holding the pre-filled pen upright, then twist and pull the cap to remove.
Danish: Fjern hætten Hold fortsat den fyldte pen opad, drej og træk herefter hætten af.
English: In an exploratory clinical study, patients with severe persistent asthma received a golimumab loading dose (150% of the assigned treatment dose) subcutaneously at week 0 followed by golimumab 200 mg, golimumab 100 mg or golimumab 50 mg every 4 weeks subcutaneously through week 52.
Danish: I et uddybende klinisk studie omfattende patienter med svær persisterende astma, som fik golimumab startdosis (150% af behandlingsdosis) subkutant i uge 0 efterfulgt af golimumab 200 mg, golimumab 100 mg eller golimumab 50 mg hver 4. uge subkutant til uge 52.
English: While you are waiting you can get the rest of your equipment ready, including an alcohol swab, a cotton ball or gauze and a sharps container.
Danish: Mens du venter kan du klargøre resten af udstyret, som inkluderer en alkoholserviet, en vatrondel eller gaze og en nålebeholder.
English: Uncommon: Neoplasms (such as skin cancer, squamous cell carcinoma and melanocytic naevus) Rare: Lymphoma, leukaemia, melanoma, Merkel cell carcinoma Not known: Hepatosplenic T-cell lymphoma* Blood and lymphatic system disorders
Danish: Ikke almindelig: Tumorer (såsom hudkræft, planocellulært karcinom og melanocytisk naevus) Sjælden: Lymfom, leukæmi, melanom, Merkelcellekarcinom Ikke kendt: Hepatosplenisk T-celle-lymfom*
English: • For patients weighing at least 40 kg, the recommended dose is 50 mg given once a month, on the same date each month.
Danish: • Til patienter, der vejer mindst 40 kg, er den anbefalede dosering 50 mg en gang om måneden på den samme dato hver måned.
English: • Cases of TB have been reported in patients treated with Simponi, in rare occasions even in patients who have been treated with medicines for TB.
Danish: • Der er set tilfælde af TB hos patienter i behandling med Simponi, i sjældne tilfælde er
English: Serious infections observed in golimumab-treated patients included tuberculosis, bacterial infections including sepsis and pneumonia, invasive fungal infections and other opportunistic infections.
Danish: Alvorlige infektioner, som blev observeret hos golimumab-behandlede patienter, var tuberkulose, bakterieinfektioner som sepsis og pneumoni, invasive svampeinfektioner og andre opportunistiske infektioner.
English: • skin cancer (uncommon).
Danish: • Hudkræft (ikke almindelig).
English: • Cancers, including skin cancer and non-cancerous growths or lumps, including skin moles
Danish: • Kræft, inklusive hudkræft og godartede svulster eller knuder, inklusive modermærker