FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-REVEAL) in 405 adult patients with active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite non-steroidal anti-inflammatory (NSAID) or DMARD therapy.
Danish: Simponis sikkerhed og effekt blev vurderet i et, randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie (GO-REVEAL) hos 405 voksne patienter med aktiv psoriasisartrit (≥ 3 hævede led og ≥ 3 ømme led) på trods af non-steroid anti-inflammatorisk (NSAID) eller DMARD-behandling.
English: If you use more Simponi than you should
Danish: Hvis du har taget for meget Simponi
English: Excipient with known effect Each pre-filled pen contains 18.45 mg sorbitol (E420) per 45 mg dose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver fyldt pen indeholder 18,45 mg sorbitol (E420) per 45 mg dosis.
English: Check the liquid in the pre-filled syringe
Danish: Tjek væsken i den fyldte injektionssprøjte
English: Patients treated with golimumab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and 4.6).
Danish: Patienter i behandling med golimumab kan vaccineres samtidigt undtagen med levende vacciner (se pkt.
English: Inject the medicine
Danish: Indsprøjt medicinen
English: • Taste disturbances
Danish: • Smagsforstyrrelser
English: Solution for injection in pre-filled pen (injection), VarioJect
Danish: Injektionsvæske, opløsning i fyldt pen (injektion), VarioJect
English: Key results for the Simponi 50 mg dose at week 52 are presented in Table 5.
Danish: Nøgleresultater for Simponi 50 mg-dosen i uge 52 er vist i tabel 5.
English: • Tell your doctor if you are a carrier or if you have or have had HBV before you are given
Danish: • Inden du får Simponi, skal du fortælle din læge, hvis du er bærer af, eller hvis du har eller har haft HBV.
English: It is recommended that therapeutic infectious agents not be given concurrently with golimumab.
Danish: Terapeutiske smitstoffer bør ikke gives samtidig med golimumab.
English: Use a cotton ball or gauze
Danish: Anvend en vatrondel eller gaze
English: If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away.
Danish: Kontakt straks din læge, hvis du udvikler feber, der ikke forsvinder, nemt får blå mærker, bløder eller ser meget bleg ud.
English: Orange Needle Guard
Danish: Orange nålebeskyttelse
English: Common: Dyspepsia, gastrointestinal and abdominal pain, nausea, gastrointestinal inflammatory disorders (such as gastritis and colitis), stomatitis Uncommon: Constipation, gastro-oesophageal reflux disease
Danish: Almindelig: Dyspepsi, gastrointestinal og abdominal smerte, kvalme, inflammatorisk gastrointestinal sygdom (såsom gastrit og colitis), stomatitis Ikke almindelig: Obstipation, gastroøsofagal refluks
English: Preparing for use of the pre-filled syringe Choosing and preparing the injection site Injecting the medicine After the injection
Danish: Forberedelse til anvendelse af den fyldte injektionssprøjte Valg og forberedelse af indsprøjtningssted Indsprøjtning af medicinen
English: Simponi belongs to a group of medicines called ‘TNF blockers'.
Danish: Simponi tilhører en medicingruppe kaldet ”TNF-blokkere”, som bruges til voksne til behandling af følgende betændelsessygdomme:
English: Metabolism and nutrition disorders Uncommon: Blood glucose increased, lipids increased
Danish: Ikke almindelig: Forhøjet niveau af blodglucose, forhøjede lipider Psykiske forstyrrelser
English: Part 1 of the study consisted of a 16-week open-label phase in which 173 enrolled children received Simponi 30 mg/m
Danish: Studiets del 1 bestod af en 16-ugers åben fase, hvor de 173 inkluderede børn fik Simponi 30 mg/m (højst 50 mg) subkutant hver 4. uge og MTX.
English: Solution for injection in pre-filled pen (injection), SmartJect
Danish: Injektionsvæske, opløsning i fyldt pen (injektion), SmartJect
English: Solution for injection in pre-filled pen (SmartJect) Multipack: 3 (3 packs of 1) pre-filled pens
Danish: Injektionsvæske, opløsning i fyldt pen (SmartJect) Multipakke: 3 (3 pakker a 1) fyldte penne
English: Set prescribed dose
Danish: Indstil den ordinerede dosis
English: 155 to < 165
Danish: 155 til < 165
English: Symptoms can include yellowing of the skin and eyes, dark brown-coloured urine, right-sided abdominal pain, fever, feeling sick, being sick, and feeling very tired.
Danish: Symptomerne kan være gulfarvning af hud og øjne, mørkebrun urin, smerte i højre side af maven, feber, kvalme og opkastning eller udpræget træthed.
English: The solution is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein.
Danish: Opløsningen er klar til let opaliserende, farveløs til lys gul og kan indeholde få små gennemsigtige eller hvide partikler af protein.
English: If you have active psoriatic arthritis you will first be given other medicines.
Danish: Hvis du har aktiv psoriasisartrit, vil du først få andre lægemidler.
English: Allow the pen to sit at room temperature outside the box for 30 minutes before use.
Danish: Opbevar pennen ved stuetemperatur uden for æsken i 30 minutter inden brug.
English: Keep the pre-filled pen in the outer carton in order to protect from light Can be stored at room temperature (up to 25°C) for a single period up to 30 days, but not exceeding the original expiry date
Danish: Opbevar den fyldte pen i den ydre karton for at beskytte mod lys Kan opbevares ved stuetemperatur (op til 25 °C) i en enkelt periode på op til 30 dage, men den oprindelige udløbsdato må ikke overskrides
English: Instructions for Use Simponi 45 mg/0.45 mL solution for injection in pre-filled pen, VarioJect For paediatric use
Danish: Brugsvejledning Simponi 45 mg/0,45 ml injektionsvæske, opløsning, i fyldt pen, VarioJect Til pædiatrisk brug
English: EU/1/09/546/009 1 pre-filled pen
Danish: EU/1/09/546/009 1 fyldt pen
English: Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn.
Danish: Administration af golimumab hos gravide kan påvirke det normale immunforsvar hos den nyfødte, da golimumab hæmmer TNF.
English: Therapeutic infectious agents should not be given concurrently with golimumab (see section 4.4).
Danish: Terapeutiske smitstoffer bør ikke gives samtidig med golimumab (se pkt.
English: Key results for the Simponi 50 mg dose at week 52 are presented in Table 3.
Danish: Nøgleresultater for Simponi 50 mg-dosen i uge 52 er vist i tabel 3.
English: • Do not use the pre-filled pen if it is dropped without the cap in place.
Danish: • Anvend ikke den fyldte pen, hvis den tabes uden hætten.
English: The incidence of serious infections per 100 subject-years of follow-up in the controlled period of RA, PsA, AS, and nr-Axial SpA trials was 7.3; 95% CI: 4.6, 11.1 for the golimumab 100 mg group, 2.9; 95% CI: 1.2, 6.0 for the golimumab 50 mg group and 3.6; 95% CI: 1.5, 7.0 for the placebo group.
Danish: Hyppigheden af alvorlige infektioner per 100 forsøgspersonår med follow-up i den kontrollerede periode af RA-, PsA-, AS- og nr-aksial SpA-studierne var 7,3 (95% CI: 4,6; 11,1) for golimumab 100 mg gruppen; 2,9 (95% CI: 1,2; 6,0) for golimumab 50 mg gruppen og 3,6 (95% CI: 1,5; 7,0) for placebogruppen.
English: Patients with mucosal healing at week 6
Danish: Patienter med heling af slimhinde i uge 6
English: The incidence per 100 subject-years of all serious infections was 4.1; 95% CI: 3.6, 4.5, in patients receiving golimumab 100 mg and 2.5; 95% CI: 2.0, 3.1, in patients receiving golimumab 50 mg.
Danish: Hyppigheden per 100 forsøgspersonår for alle alvorlige infektioner var 4,1 (95% CI: 3,6; 4,5) hos patienter, som fik golimumab 100 mg, og 2,5 (95% CI: 2,0; 3,1) hos patienter, som fik golimumab 50 mg.
English: • Sensation of heart beating irregularly
Danish: • Følelse af uregelmæssig hjerterytme
English: Within the RA, PsA, AS, and nr-Axial SpA pivotal trials, one patient in an RA trial with pre-existing liver abnormalities and confounding medicinal products treated with golimumab developed non-infectious fatal hepatitis with jaundice.
Danish: I de pivotale RA-, PsA-, AS- og nr-aksial SpA-studier var der i golimumab-armen i et RA-studie en patient, der havde eksisterende leverlidelse og fik flere lægemidler, som udviklede ikke-infektiøs, dødeligt forløbende hepatitis med gulsot.
English: • Low white blood cell counts
Danish: • Lavt antal hvide blodceller
English: Among patients remaining in the study and treated with Simponi, similar rates of patients showed no progression from baseline from week 104 through week 256.
Danish: Blandt de patienter, der blev i studiet og fik behandling med Simponi, viste et lignende antal patienter ingen progression i forhold til baseline fra uge 104 til og med uge 256.
English: In the controlled period of RA, PsA, AS, and nr-Axial SpA trials, serious infections were observed in 1.2% of golimumab-treated patients and 1.2% of control-treated patients.
Danish: I den kontrollerede periode af RA-, PsA-, AS- og nr-aksial SpA-studier blev der observeret alvorlige infektioner hos 1,2% af de golimumab-behandlede patienter og hos 1,2% af kontrolpatienterne.
English: Table 2 Tabulated list of ARs
Danish: Tabel 2 Tabel over bivirkninger
English: Do not use the pre-filled syringe if it is dropped without the needle cover in place.
Danish: Anvend ikke den fyldte injektionssprøjte, hvis du har tabt den uden nålebeskyttelseshætten på.
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, DAS28 and HAQ DI responses were maintained through week 104.
Danish: Blandt de patienter, som forblev på den Simponibehandling, som de var randomiseret til ved studiestart, blev DAS28- og HAQ DI-respons bibeholdt til uge 104.
English: The 154 children who achieved an American College of Rheumatology (ACR) Ped 30 response at week 16 entered Part 2 of the study, the randomised withdrawal phase, and received Simponi 30 mg/m2 (maximum
Danish: De 154 børn, der opnåede et pædiatrisk American College of Rheumatology (ACR) 30-respons ved uge 16, fortsatte i studiets del 2, den randomiserede seponeringsfase, og fik Simponi 30 mg/m2 (højst 50 mg) + MTX eller placebo + MTX hver 4. uge.
English: If needed, cover injection site with a bandage.
Danish: Om nødvendigt kan du eventuelt sætte et plaster over indsprøjtningsstedet.
English: Among patients remaining in the study and treated with Simponi, similar rates of change from baseline in BASDAI were observed from week 24 through week 256.
Danish: Blandt de patienter, der blev i studiet og fik behandling med Simponi, sås samme hyppighed af forandringer i BASDAI i forhold til baseline fra uge 24 til og med uge 256.
English: Symptoms of TB include persistent cough, weight loss, tiredness, fever or night sweats.
Danish: Symptomer inkluderer vedvarende hoste, vægttab, træthedsfølelse, feber eller nattesved.
English: With concomitant use of MTX, treatment with 50 mg golimumab subcutaneously every 4 weeks resulted in a mean ( standard deviation) steady-state trough serum concentration of approximately 0.6  0.4 g/mL in RA patients with active RA despite MTX therapy, and approximately 0.5  0.4 g/mL in patients with active PsA and approximately 0.8  0.4 g/mL in patients with AS. Steady-state trough mean serum golimumab concentrations in patients with nr-Axial SpA were similar to those observed in patients with AS following subcutaneous administration of 50 mg golimumab every 4 weeks.
Danish: Ved samtidig administration af MTX resulterede 50 mg golimumab subkutant hver 4. uge i en gennemsnitlig (± standardafvigelse) steady-state-dal-serum-koncentration på ca. 0,6 ± 0,4 µg/ml hos RA-patienter med aktiv RA på trods af MTX-behandling, og på ca. 0,5 ± 0,4 µg/ml hos patienter med aktiv PsA og ca. 0,8 ± 0,4 µg/ml hos patienter med AS.
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis:
Danish: Reumatoid artrit, psoriasisartrit og aksial spondylartrit, herunder ankyloserende spondylit og nonradiografisk aksial spondylartrit:
English: Among patients remaining in the study and treated with Simponi, radiographic effects were similar from week 104 through week 256.
Danish: Blandt de patienter, der blev i studiet og fik behandling med Simponi, var de radiografiske virkninger de samme fra uge 104 til og med uge 256.
English: Keep the pre-filled syringe in the outer carton in order to protect from light Can be stored at room temperature (up to 25°C) for a single period up to 30 days, but not exceeding the original expiry date
Danish: Opbevar den fyldte injektionssprøjte i den ydre karton for at beskytte mod lys Kan opbevares ved stuetemperatur (op til 25 °C) i en enkelt periode på op til 30 dage, men den oprindelige udløbsdato må ikke overskrides
English: 145 to < 155
Danish: 145 til < 155
English: • Hold the pre-filled syringe by its body with the covered needle pointing downward.
Danish: • Hold på kappen af den fyldte injektionssprøjte med nålebeskyttelseshætten vendt nedad.
English: Symptoms of heart failure can include shortness of breath or swelling of your feet.
Danish: Symptomer på hjertesvigt kan være åndenød eller hævede fødder.
English: • Do not shake the pre-filled pen at any time.
Danish: • Ryst på intet tidspunkt den fyldte pen.
English: Among patients remaining in the study and treated with Simponi, the proportion of patients with an ASAS 20 and ASAS 40 response were similar from week 24 through week 256.
Danish: Blandt de patienter, der blev i studiet og fik behandling med Simponi, var andelen af patienter med ASAS 20- og ASAS 40-respons den samme fra uge 24 til og med uge 256.
English: Patients receiving golimumab should be monitored closely for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis,
Danish: Patienter, som får golimumab, skal følges tæt for tegn og symptomer på aktiv tuberkulose, herunder patienter som er testet negative for latent tuberkulose, patienter i behandling for latent tuberkulose og patienter, som tidligere har været behandlet for tuberkulose.
English: Position the pre-filled syringe to inject
Danish: Placering af den fyldte injektionssprøjte til indsprøjtning
English: • Vision disturbances
Danish: • Synsforstyrrelser
English: b < 1.3 BASDAI 50 Inhibition of inflammation in sacroiliac (SI) joints as measured by MRI Placebo Simponi 50 mg Placebo Simponi 50 mg
Danish: Hæmning af inflammation i led med sakroiliit (SI) målt ved MRI Placebo Simponi 50 mg Placebo Simponi 50 mg n
English: Among patients remaining in the study and treated with Simponi, improvement in HAQ DI was similar from week 104 through week 256.
Danish: Blandt de patienter, der blev i studiet og fik behandling med Simponi, var forbedringen i HAQ DI den samme fra uge 104 til og med uge 256.
English: • Tell your surgeon or dentist performing the procedure that you are having treatment with
Danish: • Fortæl kirurgen eller tandlægen, som foretager indgrebet, at du er i behandling med Simponi ved at vise dem patientinformationskortet.
English: In the controlled period of the UC pivotal trials of golimumab induction, mild ALT elevations (> 1 and < 3 x ULN) occurred in similar proportions of golimumabtreated and control patients (8.0% to 6.9%, respectively).
Danish: I den kontrollerede periode af de pivotale UC-studier med golimumab-induktion forekom let forhøjet ALAT (> 1 og < 3 x ULN) i samme omfang hos golimumab- og kontrolbehandlede patienter (henholdsvis 8% og 6,9%).
English: Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems or a burning feeling when urinating.
Danish: Tegn på infektion inkluderer feber, hoste, åndenød, influenzalignende symptomer, diarré, sår, tandproblemer eller en brændende smerte, når du lader vandet.
English: • The recommended dose is 50 mg (the content of 1 pre-filled pen) given once a month, on the same date each month.
Danish: • Den anbefalede dosering er 50 mg (indholdet af 1 fyldt pen) en gang om måneden på den samme dato hver måned.
English: Simponi has minor influence on your ability to ride bicycles, drive and use tools or machines.
Danish: Simponi påvirker i mindre grad din evne til at køre på cykel, køre bil og betjene værktøj eller maskiner.
English: Golimumab has not been studied in patients with CHF.
Danish: Golimumab er endnu ikke undersøgt hos patienter med kongestivt hjertesvigt.
English: Polyarticular juvenile idiopathic arthritis:
Danish: Polyartikulær juvenil idiopatisk artrit:
English: Key ACR results for the Simponi 50 mg dose at weeks 14, 24 and 52 for GO-FORWARD, GO-AFTER and GO-BEFORE are shown in Table 2 and are described below.
Danish: De vigtigste ACR-resultater for Simponi 50 mg dosis ved uge 14, 24 og 52 i GO-FORWARD, GO-AFTER og GO-BEFORE er vist i tabel 2 og beskrevet nedenfor.
English: • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Danish: • Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig, herunder medicin til behandling af reumatoid artrit, polyartikulær juvenil idiopatisk artrit, psoriasisartrit, ankyloserende spondylit, non-radiografisk aksial spondylartrit eller colitis ulcerosa.
English: • While you are waiting you can get the rest of your equipment ready, including an alcohol swab,
Danish: • Mens du venter, kan du klargøre resten af udstyret, som inkluderer en alkoholserviet, en vatrondel eller gaze og en nålebeholder.
English: By study design, patients in the long-term extension may have switched between the 50 mg and 100 mg Simponi doses at the discretion of the study physician.
Danish: I henhold til studiedesign kan patienterne i langtidsopfølgningsperioden have skiftet mellem doserne 50 mg og 100 mg Simponi efter studielægens skøn.
English: Solution for injection in pre-filled syringe Multipack: 3 (3 packs of 1) pre-filled syringes
Danish: Injektionsvæske, opløsning i fyldt injektionssprøjte Multipakke: 3 (3 pakker a 1) fyldte injektionssprøjter
English: If you have not been trained, please contact your doctor, nurse or pharmacist to schedule a training session.
Danish: Kontakt din læge, sygeplejerske eller apotekspersonalet for at aftale en træningskonsultation, hvis du ikke er blevet oplært.
English: Key ACR results for the Simponi 50 mg dose at weeks 14, 24 and 52 for GO-FORWARD, GO-AFTER and GO-BEFORE are shown in Table 4 and are described below.
Danish: De vigtigste ACR-resultater for Simponi 50 mg dosis ved uge 14, 24 og 52 i GO-FORWARD, GO-AFTER og GO-BEFORE er vist i tabel 4 og beskrevet nedenfor.
English: Signs and symptoms Key results for the 50 mg dose at weeks 14 and 24 are shown in Table 6 and described below.
Danish: Tegn og symptomer De vigtigste resultater for 50 mg dosis ved uge 14 og 24 er vist i tabel 6 og beskrevet nedenfor.
English: For the 50 mg dose, see section 3 “How to use Simponi” of the Simponi 50 mg pre-filled pen or pre-filled syringe package leaflet.
Danish: Se punkt 3 “Sådan skal du tage Simponi” i indlægssedlen for Simponi 50 mg fyldt pen eller fyldt injektionssprøjte for oplysninger om 50 mg dosis.
English: At week 52 in the overall population, the percentage of patients in the Simponi 50 mg + MTX group who achieved an ACR response was generally higher but not significantly different when compared with MTX alone (see Table 2).
Danish: I den samlede population var procentdelen af patienter, som opnåede et ACR-respons ved uge 52, generelt højere i Simponi 50 mg + MTX-gruppen sammenlignet med MTX alene, men forskellen var ikke signifikant (se tabel 2).
English: • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Danish: • Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig, herunder medicin til behandling af reumatoid artrit, psoriasisartrit, ankyloserende spondylit, non-radiografisk aksial spondylartrit eller colitis ulcerosa.
English: Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100 mg.
Danish: Hvis der ikke er tegn på terapeutisk virkning efter 3 til 4 ekstra doser af 100 mg, bør fortsat behandling revurderes.
English: Simponi 45 mg/0.45 mL injection golimumab
Danish: Simponi 45 mg/0,45 ml injektionsvæske golimumab s.c.
English: Preparing for use of the pre-filled syringe
Danish: Forberedelse til anvendelse af den fyldte injektionssprøjte
English: At week 52 in the overall population, the percentage of patients in the Simponi 50 mg + MTX group who achieved an ACR response was generally higher but not significantly different when compared with MTX alone (see Table 4).
Danish: I den samlede population var procentdelen af patienter, som opnåede et ACR-respons ved uge 52, generelt højere i Simponi 50 mg + MTX-gruppen sammenlignet med MTX alene, men forskellen var ikke signifikant (se tabel 4).
English: o If your dose is 200 mg, you will get four 50 mg pre-filled syringes and you will need to give yourself four injections.
Danish: o Hvis din dosis er 200 mg, vil du få fire 50 mg fyldte injektionssprøjter, og du skal give dig selv fire indsprøjtninger.
English: It should be clear to slightly opalescent (having pearl-like shine) and colourless to light yellow and may contain a few small translucent or white particles of protein.
Danish: Den skal være klar til let opaliserende (en perlelignende glans) og farveløs til lysegul og kan indeholde få, små halvgennemsigtige eller hvide partikler af protein.
English: Signs and symptoms Key results for the 50 mg dose at weeks 14 and 24 are shown in table 4 and described below.
Danish: Tegn og symptomer De vigtigste resultater for 50 mg dosis ved uge 14 og 24 er vist i tabel 4 og beskrevet nedenfor.
English: • Do not remove the needle cover from the pre-filled syringe until instructed to do so.
Danish: • Fjern ikke nålebeskyttelseshætten fra den fyldte injektionssprøjte, før det er beskrevet i vejledningen.
English: 50 mg) subcutaneously every 4 weeks, had median steady-state trough golimumab concentrations which were similar across different age groups, and which were also similar to or slightly higher than those seen in adult RA patients who received 50 mg golimumab every 4 weeks.
Danish: I pJIA-studiet havde de børn, der fik golimumab 30 mg/m2 (højst 50 mg) subkutant hver 4. uge, en gennemsnitlig dal-golimumabkoncentration i serum ved steady state, som var den samme på tværs af forskellige aldersgrupper, og som også var lig med eller lidt højere end dalkoncentrationen hos voksne RApatienter, som fik 50 mg golimumab hver 4. uge.
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, improvement in HAQ DI was maintained through week 104.
Danish: Hos de patienter, som blev i samme behandling med Simponi, som de var randomiseret til fra studiestart, blev en forbedring i HAQ DI opretholdt til og med uge 104.
English: o If your dose is 200 mg, you will get four 50 mg pre-filled pens and you will need to give yourself four injections.
Danish: o Hvis din dosis er 200 mg, vil du få fire 50 mg fyldte penne, og du skal give dig selv fire indsprøjtninger.
English: Solution for injection in pre-filled syringe (injection)
Danish: Injektionsvæske, opløsning i fyldt injektionssprøjte (injektion)