FrancophonIA/ELRC3.0 huggingface dataset:
English: • Some patients receiving infliximab via injection under the skin have experienced local injection site reactions.
Danish: • Nogle patienter, der modtager infliximab via injektion under huden, har oplevet lokale reaktioner på injektionsstedet.
English: • The abdomen except for the 5 cm around the belly button (navel).
Danish: • Maven, bortset fra 5 cm omkring navlen.
English: Remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Danish: Remsima er indiceret til behandling af aktiv og progressiv psoriasis arthritis hos voksne patienter, hvor respons på tidligere DMARD-behandling har været utilstrækkelig.
English: • The initial two intravenous infusions will be given to you by your doctor or nurse.
Danish: • De første to intravenøse infusioner vil du få af din læge eller sygeplejerske.
English: • Tell your doctor before you are given Remsima if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Danish: • Fortæl din læge, før du får Remsima, hvis du har eller nogensinde har haft lymfom (en type blodkræft) eller enhver anden form for kræft.
English: • Sharps disposal container* *Items not included in the carton.
Danish: • Beholder til bortskaffelse af skarpe genstande* *Genstande ikke inkluderet i kartonen.
English: • It is recommended that when Remsima is prepared for infusion, it is used as soon as possible (within 3 hours).
Danish: • Det anbefales, at Remsima anvendes så hurtigt som muligt (inden for 3 timer), efter det er klargjort til infusion.
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Danish: Anden anvendelse af terapeutiske smitstoffer såsom levende svækkede bakterier (f.eks. instillation af BCG i blæren ved behandling af cancer) kan medføre kliniske infektioner herunder disseminerede infektioner.
English: If you are 65 years of age or older, you have a greater risk.
Danish: Du har en højere risiko, hvis du er 65 år eller derover.
English: All systemic injection reactions were mild to moderate.
Danish: Alle systemiske injektionsreaktioner var lette til moderate.
English: Acute reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following administration of infliximab.
Danish: Akutte reaktioner inklusive anafylaktiske reaktioner kan opstå under (inden for sekunder) eller få timer efter administration af infliximab.
English: • Tell your doctor before you are given Remsima if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Danish: • Fortæl din læge, før du får Remsima, hvis du nogensinde har boet eller rejst i et område, hvor infektioner kaldet histoplasmose, kokcidioidomykose eller blastomykose er almindelige.
English: • In case you have received Remsima while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Danish: • Hvis du har fået Remsima, mens du var gravid, er det vigtigt, at du informerer dit barns læge om det, før dit barn bliver vaccineret.
English: Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: Test:
Danish: Du skal bede din læge om at notere type og dato for seneste screening(er) for tuberkulose (TB) nedenfor:
English: Remsima should be administered intravenously.
Danish: Remsima administreres intravenøst.
English: Remsima contains sodium
Danish: Remsima indeholder natrium
English: • Children should receive recommended vaccinations before starting Remsima treatment.
Danish: • Børn skal have de anbefalede vaccinationer, før behandling med Remsima påbegyndes.
English: Inspect the pen.
Danish: Inspicér pennen.
English: ≥75% improvement
Danish: ≥ 75 % forbedring
English: 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%]).
Danish: Der var en rapporteret malign sygdom blandt 77 kontrolpatienter (median opfølgningsperiode 0,8 år; incidens 1.3 % [95 % CI 0,03 %-7,0 %]).
English: This Patient Reminder Card contains important safety information that you need to be aware of before and during treatment with Remsima.
Danish: Dette patient informationskort indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Remsima.
English: Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C to 8 °C and for an additional 24 hours at 25°C after removal from refrigeration.
Danish: Den fortyndede infusionsvæskes kemiske og fysiske stabilitet efter anbrud er påvist i op til 28 dage ved 2°C til 8°C og i yderligere 24 timer ved 25°C efter udtagning fra køleskab.
English: You may receive some vaccines during treatment with Remsima but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Remsima because they may cause infections.
Danish: Der er visse vaccinationer, du kan få, mens du er i behandling med Remsima, men du må ikke få levende vacciner (vacciner der indeholder et levende men svækket smitstof), da de kan give infektioner.
English: Discontinuation of infliximab should be considered if these disorders develop.
Danish: Det bør overvejes at afbryde Remsima-behandlingen, hvis disse sygdomme udvikles.
English: Because human immunoglobulins are excreted in milk, women must not breast-feed for at least 6 months after infliximab treatment.
Danish: Da humane immunglobuliner udskilles i mælk, må kvinder ikke amme i mindst 6 måneder efter infliximab-behandling.
English: Remsima contains the active substance infliximab.
Danish: Remsima indeholder det aktive stof infliximab.
English: ≥90% improvement
Danish: N ≥ 90 % forbedring
English: • You may get infections more easily when you are being treated with Remsima.
Danish: • Du har lettere ved at få infektioner, når du er i behandling med Remsima.
English: 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).
Danish: I uge 16 blev 47 placebopatienter med < 10 % forbedring fra udgangspunktet i både hævede og ømme led flyttet til infliximab induktion (tidlig overflytning).
English: Take your next dose on the next originally planned date and thereafter biweekly.
Danish: Tag din næste dosis på den næste oprindeligt planlagte dato og derefter hver anden uge.
English: The combination of infliximab with other biological therapeutics used to treat the same conditions as infliximab, including anakinra and abatacept, is not recommended (see section 4.4).
Danish: Kombination af infliximab og andre biologiske lægemidler anvendt til behandling af de samme lidelser som infliximab, herunder anakinra og abatacept, kan ikke anbefales (se pkt.
English: There is insufficient information regarding the switching of patients who received the intravenous infusions of infliximab higher than 3 mg/kg every 8 weeks to the subcutaneous formulation of Remsima.
Danish: Der foreligger ikke tilstrækkelige oplysninger vedrørende skifte af patienter, som modtog intravenøse infusioner af infliximab højere end 3 mg/kg hver 8. uge, til den subkutane formulering med Remsima.
English: Clinical remission at Week 8a Clinical remission at Week 30a Sustained remission(in remission at both Week 8 and Week 30)a
Danish: Klinisk remission i uge 8a Klinisk remission i uge 30a Vedvarende remission (i remission både i uge 8 og uge 30)a
English: INSTRUCTIONS ON USE
Danish: Instruktioner i anvendelse
English: Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4).
Danish: Patienter skal søge øjeblikkelig lægehjælp, hvis de udvikler symptomer på alvorlige allergiske reaktioner (se pkt.
English: Remsima should be visually inspected for particulate matter or discolouration prior to administration.
Danish: Remsima bør undersøges visuelt for partikler eller misfarvning før indgivelsen.
English: • After proper training, if you feel you are well-trained and confident to inject Remsima yourself, your doctor may allow you to inject subsequent doses of Remsima yourself at home.
Danish: • Hvis du, efter passende træning, føler, at du er godt trænet og sikker nok til selv at injicere, kan din læge lade dig injicere efterfølgende doser Remsima derhjemme.
English: 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: Hypersensitivity to the active substance, to other murine proteins or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, over for andre murine proteiner eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: Systemic injection reaction/ localised injection site reaction/ hypersensitivity
Danish: Systemisk injektionsreaktion/lokaliseret reaktion på injektionsstedet/overfølsomhed
English: a. Pull the cap straight off and set it aside.
Danish: a. Træk hætten lige af og læg den til side.
English: Remsima treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Remsima is indicated.
Danish: Behandling med Remsima skal initieres og holdes under opsyn af kvalificerede læger med erfaring i diagnostik og behandling af lidelser, som Remsima er indiceret til.
English: At the last observation at 12 weeks, 13/27 (48%) of infliximab-treated patients were still responding.
Danish: Ved den sidste observation efter 12 uger sås stadig virkning hos 13/27 (48 %) af patienterne behandlet med infliximab.
English: Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Remsima in the infusion bag only.
Danish: Opbevaring i mere end 24 timer ved 2 °C - 8 °C gælder udelukkende for klargøring af Remsima i infusionsposen.
English: The bioavailability of infliximab subcutaneous, estimated in a population PK model, is 58% (95% CI:
Danish: Biotilgængeligheden af infliximab subkutant, estimeret i en populationsfarmakokinetisk model, er 58 % (95 % CI: 54 % - 62 %).
English: a. Clean the injection site with an alcohol swab.
Danish: a. Rens injektionsstedet med en alkoholserviet.
English: For intravenous use after reconstitution and dilution
Danish: Til intravenøs anvendelse efter rekonstitution og fortynding.
English: The estimate of treatment difference was 0.27 with corresponding lower limit of the two-sided 95% confidence interval [CI] of 0.02 (95% CI: 0.02, 0.52), which was greater than the pre-specified non-inferiority margin of -0.6 indicating non-inferiority of Remsima subcutaneous formulation to Remsima intravenous formulation.
Danish: Estimatet af behandlingsforskellen var 0,27 med tilsvarende lavere grænse for det tosidede 95 % konfidensinterval [CI] på 0,02 (95 % CI: 0,02; 0,52), hvilket var større end den forudbestemte noninferioritetsmargen på -0,6, hvilket indikerer noninferioritet af Remsima subkutan formulering sammenlignet med Remsima intravenøs formulering.
English: Mean ± SDc a control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Danish: SDc a Kontrol = Alle patienter havde aktiv RA på trods af behandling med stabile methotrexat doser i 6 måneder før inklusion og skulle fortsætte på stabile doser gennem studiet.
English: Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for TB.
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: In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus <1% (1/222) on maintenance therapy.
Danish: I genbehandlingsarmen fik 4 % (8/219) af patienterne en alvorlig infusionsrelateret reaktion sammenlignet med < 1 % (1/222) på vedligeholdelsesbehandling.
English: • Do not shake the pen at any time.
Danish: • Pennen må ikke rystes på noget tidspunkt.
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Remsima use before your baby is given any vaccine.
Danish: • Det er vigtigt, at du fortæller dit barns læge og andet sundhedspersonale, at du har fået Remsima, før barnet bliver vaccineret.
English: At 102 weeks there were 80 subjects still on infliximab treatment and among those, 71 (89%) were ASAS 20 responders.
Danish: I 102. uge var 80 patienter stadig på infliximab-behandling og blandt disse var 71 (89 %) ASAS 20 respondere.
English: If you forget to use Remsima
Danish: Hvis du har glemt at tage Remsima
English: Improvement from baseline in HAQ averaged over time from week 30 to week 54c Mean ± SDd a p <0.001, for each infliximab treatment group vs control.
Danish: Median Forbedring fra baseline i HAQ gennemsnitligt over tid fra uge 30 til uge 54c Gennemsnit ± SDd a p < 0,001, for hver infliximab-behandlingsgruppe mod kontrol.
English: Date of first authorisation: DD month YYYY
Danish: Dato for første markedsføringstilladelse: DD måned ÅÅÅÅ
English: However, studies from the published literature in various indications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggest that 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-TNFbehandling.
English: • you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (serious bacterial infection of the blood),
Danish: • du har tuberkulose (TB) eller en anden alvorlig infektion, såsom lungebetændelse eller blodforgiftning (sepsis, en alvorlig bakterieinfektion i blodet),
English: Remsima is produced in packs of 1, 2, 3, 4 or 5 vials.
Danish: Remsima fremstilles i pakninger med 1, 2, 3, 4 eller 5 hætteglas.
English: (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Danish: (≥ 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).
English: The safety profile of Remsima subcutaneous formulation (evaluated in 168 and 175 patients for the subcutaneous infliximab group and the intravenous infliximab group, respectively) from active rheumatoid arthritis patients was overall similar to the safety profile of the intravenous formulation.
Danish: Sikkerhedsprofilen for Remsima subkutan formulering (evalueret hos 168 og 175 patienter for henholdsvis den subkutane infliximab-gruppe og den intravenøse infliximab-gruppe) fra aktive reumatoid artritpatienter svarede generelt til sikkerhedsprofilen for den intravenøse formulering.
English: At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p<0.001).
Danish: Ved 54 uger var 44,9 % af patienterne i den kombinerede infliximab-behandlingsgruppe i klinisk respons sammenlignet med 19,8 % i placebobehandlingsgruppen (p < 0,001).
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-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).
Danish: På basis af et observationsstudie fra Nordeuropa blev der observeret øget risiko (OR, 95 % CI; pværdi) 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; 1,412,94; 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).
English: The safety and efficacy of Remsima subcutaneous therapy in children aged below 18 years of age have not yet been established.
Danish: Sikkerheden og effekten af Remsima subkutan behandling hos børn under 18 år er endnu ikke klarlagt.
English: In Part 2 of this study, among 357 patients who were enrolled to receive 2 doses of Remsima 3 mg/kg intravenously at Weeks 0 and 2, 167 patients were randomised to receive Remsima 120 mg subcutaneously at Week 6 and every 2 weeks up to Week 54, while 176 patients were randomised to receive Remsima 3 mg/kg intravenously at Weeks 6, 14 and 22 and then switched to Remsima 120 mg subcutaneous at Week 30 once-every 2 weeks up to Week 54.
Danish: I del 2 af dette studie, blandt 357 patienter, der blev indskrevet til at modtage 2 doser Remsima 3 mg/kg intravenøst i uge 0 og 2, blev 167 patienter randomiseret til at modtage Remsima 120 mg subkutant i uge 6 og hver 2. uge op til uge 54, mens 176 patienter blev randomiseret til at modtage Remsima 3 mg/kg intravenøst i uge 6, 14 og 22 og derefter skiftet til Remsima 120 mg subkutant i uge 30 én gang hver 2. uge op til uge 54.
English: The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight.
Danish: Den normale anbefalede dosis Remsima subkutan injektion er 120 mg hver 2. uge uanset kropsvægt.
English: The co-primary endpoints were the proportion of patients in clinical remission (CDAI <150) at week 30 and time to loss of response through week 54.
Danish: De co-primære endepunkter var forholdet af patienter i klinisk remission (CDAI < 150) ved uge 30 og tiden til tab af respons efter uge 54.
English: Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis.
Danish: Nogle af disse infektioner har været letale; de opportunistiske infektioner, der oftest er set med en mortalitetsrate > 5 %, indbefatter pneumocystose, candidiasis, listeriose og aspergillose.
English: A total of 573 patients with moderately to severely active Crohn's disease (CDAI ≥220 ≤400) received a single infusion of 5 mg/kg at week 0.
Danish: I alt 573 patienter med moderat til svært aktiv Crohns sygdom (CDAI ≥ 220 ≤ 400) fik en enkelt infusionsdosis på 5 mg/kg ved uge 0.
English: When switching from the maintenance therapy of infliximab intravenous formulation to the subcutaneous formulation of Remsima, the subcutaneous formulation may be administered 8 weeks after the last administration of the intravenous infusions of infliximab 3 mg/kg given every 8 weeks.
Danish: Når der skiftes fra vedligeholdelsesbehandling med infliximab intravenøs formulering til subkutan formulering med Remsima, kan den subkutane formulering administreres 8 uger efter den sidste administration af de intravenøse infusioner af infliximab på 3 mg/kg givet hver 8. uge.
English: • Do not use the pen if it has been dropped or is visibly damaged.
Danish: • Pennen må ikke bruges, hvis den er tabt eller synligt beskadiget.
English: If you miss a dose of Remsima for 8 days or more, after the original scheduled dose, you should not take the missed dose.
Danish: Hvis du glemmer en dosis Remsima i 8 dage eller mere efter den oprindeligt planlagte dosis, skal du ikke tage den glemte dosis.
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT
Danish: Tabel 3 Virkninger på ACR20, strukturel ledskade og fysisk funktionsevne ved uge 54, ATTRACT
English: In a clinical study of patients with Crohn's disease (SONIC), infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy.
Danish: I et klinisk studie med patienter med Crohns sygdom (SONIC) forekom infusionsrelaterede reaktioner hos 16,6 % (27/163) af de patienter, som fik infliximab monoterapi, hos 5 % (9/179) af de patienter, som fik infliximab kombineret med AZA, og hos 5,6 % (9/161) af de patienter, som fik AZA
English: Following administration of 5 mg/kg infliximab every 8 weeks, the predicted median steady-state infliximab exposure (area under concentration-time curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steady-state medicinal product exposure in adults.
Danish: Efter administration af infliximab 5 mg/kg hver 8. uge var den forventede mediane steady-state infliximab-eksponering (arealet under koncentrations-tids-kurven ved steady-state, AUCss) hos pædiatriske patienter i alderen 6 til 17 år ca. 20 % lavere end den forventede median steady-state lægemiddel-eksponering hos voksne.
English: In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Danish: I dette studie blev 150 patienter med NYHA funktionsklasse III-IV CHF (venstre ventrikels uddrivningsfraktion ≤ 35 %) behandlet med 3 infusioner infliximab 5 mg/kg, 10 mg/kg eller placebo i løbet af 6 uger.
English: • Treatment with TNF blockers such as Remsima may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
Danish: • Behandling med TNF-blokkere, såsom Remsima, kan medføre, at hepatitis B igen bliver aktiv hos patienter, som bærer denne virus.
English: Infections occurred in 68% (41/60) of children receiving 3 mg/kg over 52 weeks, 65% (37/57) of children receiving infliximab 6 mg/kg over 38 weeks and 47% (28/60) of children receiving placebo over 14 weeks (see section 4.4).
Danish: Der opstod infektioner hos 68 % (41/60) af de børn, som fik 3 mg/kg over 52 uger, 65 % (37/57) af de børn, som fik infliximab 6 mg/kg over 38 uger og 47 % (28/60) af de børn, som fik placebo over 14 uger (se pkt.
English: a. Put the used pen in an approved sharps disposal container immediately after use.
Danish: a. Læg den brugte pen i en godkendt beholder til bortskaffelse af skarpe genstande straks efter brug.
English: Remsima contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Remsima indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er i det væsentlige ”natriumfrit”.
English: Patients with ACR20 response/Patients evaluated (%)
Danish: ACR20 respon s /Patienter evalueret (%)
English: Total scored (van der Heijde-modified Sharp score) Change from baseline (Mean ± SDc)
Danish: Total scored (van der Heijde-modified Sharp score) Ændring fra baseline
English: Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI <150) and clinical response over time.
Danish: Sekundære endepunkter omfattede andelen af patienter i klinisk remission i uge 4 (CDAI < 150) og den kliniske respons på længere sigt.
English: Consult your healthcare provider if you have questions about using the Remsima pen.
Danish: Kontakt sundhedspersonalet, hvis du har spørgsmål om brug af Remsima pen.