FrancophonIA/ELRC3.0 huggingface dataset:
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
Danish: • Unormale værdier for et protein i blodet kaldet 'komplementfaktor', som er en del af immunsystemet.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Serious infections were reported in 12% (7/60) of all treated patients.
Danish: Alvorlige infektioner blev rapporteret hos 12% (7/60) af alle behandlede patienter.
English: If there are any changes in your skin or growths on the skin during or after therapy, tell your doctor.
Danish: Hvis der er forandringer i din hud eller svulster på huden under eller efter behandlingen, skal du fortælle det til lægen.
English: Brand name: Batch number:
Danish: Præparatnavn: Batchnummer:
English: If you are given too much Inflectra
Danish: Hvis du får for meget Inflectra
English: 23 Academy-ro, Yeonsu-gu, Incheon, 22014 Republic of Korea
Danish: 23 Academy-ro Yeonsu-gu, Incheon, 22014 Republikken Korea
English: Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2 IMPACT
Danish: Tabel 9 Virkninger på ACR og PASI i IMPACT og IMPACT 2
English: Approximately 93% of the patients had previously received antibiotic or immunosuppressive therapy.
Danish: Cirka 93% af patienterne havde tidligere fået antibiotika eller immunsupprimerende behandling.
English: The solution may develop a few fine translucent particles, as infliximab is a protein.
Danish: Opløsningen kan udvikle nogle få fine gennemsigtige partikler, da infliximab er et protein.
English: Inflectra is indicated for:
Danish: Inflectra er indiceret til:
English: Your doctor will advise you what other medicines you must keep using while you are having Inflectra.
Danish: Din læge vil rådgive dig om, hvilke andre lægemidler De skal blive ved med at tage, mens du er i behandling med Inflectra.
English: Efficacy was similar in the subgroup of patients that were exposed to previous systemic therapies compared to the overall study population.
Danish: Virkningen var den samme i undergruppen af patienter, der var eksponeret for tidligere systemiske behandlinger sammenlignet med den totale studiepopulation.
English: Foaming of the solution on reconstitution may occur.
Danish: Opskumning af opløsningen ved rekonstitution kan forekomme.
English: The primary endpoint in both studies was the percent of patients who achieved ≥ 75% improvement in PASI from baseline at week 10.
Danish: Det primære endepunkt i begge studier var procenten af patienter, som opnåede ≥ 75% forbedring i PASI fra baseline i uge 10.
English: If you feel tired, dizzy, or unwell after having Inflectra, do not drive or use any tools or machines.
Danish: Hvis du føler dig træt, svimmel eller utilpas efter at have fået Inflectra, må du ikke føre motorkøretøj eller betjene værktøj eller maskiner.
English: It is important that you and your doctor record the brand name and batch number of your medicine.
Danish: Det er vigtigt, at du og din læge noterer præparatnavn og batchnummer på din medicin.
English: Due to a number of treatment withdrawals, the magnitude of the effect difference between infliximab and the methotrexate alone group cannot be defined.
Danish: På grund af et antal behandlingsophør, kan størrelsen af forskellen i virkning mellem infliximab og methotrexat alene ikke defineres.
English: The following side effects have been observed with Inflectra:
Danish: Følgende bivirkninger er observeret med Inflectra:
English: Sustained Steroid-Free Remission b a Reduction in CDAI ≥ 25% and ≥ 70 points.
Danish: Vedblivende steroidfri remission a Reduktion i CDAI ≥ 25% og ≥ 70 point.
English: Further doses
Danish: Yderligere doser
English: b Based on patients with PASI > 2.5 at baseline for IMPACT, and patients with > 3% BSA psoriasis skin involvement at baseline in IMPACT 2.
Danish: b Baseret på patienter med PASI > 2.5 ved baseline for IMPACT, og patienter med > 3% BSA psoriasis hud påvirkning ved baseline af IMPACT 2.
English: • The doctor will decide your dose and how often you will be given Inflectra.
Danish: • Lægen vil bestemme din dosis, og hvor ofte du skal have Inflectra.
English: • Your doctor should test you for hepatitis B virus.
Danish: • Din læge skal teste dig for hepatitis B-virus.
English: Prior therapy with PUVA, methotrexate, ciclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Danish: Tidligere behandling med PUVA, methotrexat, ciclosporin eller acitretin var modtaget af 71,4% af patienterne, selv om de ikke nødvendigvis var behandlingsresistente.
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
Danish: Patienter i begge studier havde plaque psoriasis (Body Surface Area [BSA] ≥ 10% og Psoriasis Area and Severity Index [PASI] score ≥ 12).
English: Inflectra is a biosimilar medicinal product.
Danish: Inflectra er et biosimilært lægemiddel.
English: Inflectra infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Danish: Inflectra-infusioner skal administreres af kvalificeret sundhedspersonale, som er trænet i at detektere infusionsrelaterede problemer.
English: Inflectra should be administered
Danish: Inflectra bør administreres
English: Do not use Inflectra if any of the above applies to you.
Danish: Du må ikke få Inflectra, hvis noget af ovenstående passer på dig.
English: Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Danish: Inflectra, i kombination med methotrexat, er indiceret til reduktion af sygdomstegn og symptomer samt forbedring af fysisk funktionsevne hos:
English: Before reconstitution
Danish: Før rekonstitution:
English: Any unused portion of the infusion solution should not be stored for reuse.
Danish: Rester af den ikke anvendte infusionsopløsning må ikke opbevares til fornyet brug.
English: Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment.
Danish: Tidlig erkendelse af atypiske kliniske forekomster af alvorlige infektioner og typiske kliniske forekomster af sjældne og usædvanlige infektioner er afgørende for at begrænse forsinkelse i diagnosticering og behandling.
English: Inflectra is also used in adults and children 6 years of age or older for:
Danish: Inflectra bruges også til voksne og børn fra 6 år og opefter til behandling af:
English: Inflectra belongs to a group of medicines called ‘TNF blockers'.
Danish: Inflectra tilhører en medicingruppe kaldet ”TNF-blokkere”.
English: • In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Danish: • Hos nogle patienter, som får infliximab, kan kroppen måske ikke lave nok af de blodlegmer, der skal hjælpe med at bekæmpe infektioner eller stoppe blødninger.
English: The efficacy of infliximab through week 54 was assessed in the ACT 1 study.
Danish: Virkningen af infliximab i uge 54 blev undersøgt i ACT 1 studiet.
English: Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Danish: Infliximab passerer placenta og er blevet sporet i i serum hos spædbørn op til 6 måneder efter fødslen.
English: placebo inflixim ab placebo inflixim ab placebo inflixim ab placebo inflixim ab
Danish: placebo infliximab placebo Infliximab placebo infliximab placebo infliximab
English: The safety and efficacy of re-administration after an infliximab-free interval of more than 16 weeks has not been established.
Danish: Sikkerhed og virkning ved fornyet administration efter en infliximab-fri periode på over 16 uger er ikke klarlagt.
English: Patients who did not respond to infliximab at week 8 (n=15) received no further medicinal product and returned for safety follow-up.
Danish: Patienter, der ikke havde responderet på infliximab i uge 8 (n=15) fik ikke yderligere doser og gik tilbage til sikkerhedsopfølgning.
English: Elevations of ALT ≥5 x Upper 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: Side effects may also occur after your treatment with Inflectra has stopped.
Danish: Bivirkninger kan også opstå efter ophør af din behandling med Inflectra.
English: A response was observed within 2 weeks, with a maximum response at 4 weeks.
Danish: Der konstateredes en virkning inden for 2 uger med maksimal virkning efter 4 uger.
English: In REACH, 17.5% of randomised patients experienced 1 or more infusion reactions.
Danish: 17,5% af de randomiserede patienter i REACH oplevede 1 eller flere infusionsreaktioner.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret i {MM/YYYY}.
English: The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1,100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Danish: Det beskedne antal prospektivt indsamlede graviditeter eksponeret for infliximab, som resulterede i levendefødsel med kendte resultater, inklusive ca. 1.100 graviditeter, der blev eksponeret under første trimester, tyder ikke på en stigning i hyppigheden af misdannelser hos den nyfødte.
English: START was a randomised, multicentre, double-blind, 3-arm, parallel-group safety study.
Danish: START var et randomiseret, multicenter, dobbelblindet, 3-armet, parallel-gruppe sikkerhedsstudie.
English: Forty-six percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
Danish: 46% af patienterne fortsatte på stabile doser methotrexat (≤ 25 mg/uge).
English: There are no known side effects of having too much of Inflectra.
Danish: Der kendes ikke til nogen bivirkninger efter at have fået for meget Inflectra.
English: The card is aimed at both serving as a reminder to record the dates and outcomes of specific tests and to facilitate the patient sharing of special information with healthcare professionals (HCPs) treating the patient about on-going treatment with the product.
Danish: Kortet fungerer både som en påmindelse om at registrere datoer for og resultater af specifikke test og gør det lettere for patienten at dele særlige oplysninger med de sundhedspersoner, der behandler patienten, om den igangværende behandling med lægemidlet.
English: The required total volume of reconstituted Inflectra solution has to be calculated.
Danish: Det påkrævede samlede volumen rekonstitueret Inflectraopløsning beregnes.
English: Infliximab should be administered intravenously over a 2 hour period.
Danish: Infliximab skal administreres intravenøst over en 2-timers periode.
English: Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy.
Danish: Cirka 3% af patienterne afbrød behandlingen på grund af infusionsrelaterede reaktioner, og alle patienter kom sig med eller uden behandling.
English: In all situations described below, the benefit/risk balance of infliximab therapy should be very carefully considered.
Danish: I alle situationer beskrevet nedenfor bør benefit/risk-balancen af infliximab-behandling vurderes meget nøje.
English: The potential risk with the combination of AZA or 6-MP and infliximab should be carefully considered.
Danish: Den potentielle risiko ved kombinationen af AZA eller 6-MP og infliximab skal overvejes omhyggeligt.
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Danish: Foreliggende data tyder på, at det kliniske respons sædvanligvis nås inden for 12 ugers behandling.
English: The majority (67%) of these patients did not require any dose titration.
Danish: Størstedelen af patienterne (67%) behøvede ingen dosisjustering.
English: 5 years at 2 °C - 8 °C.
Danish: 5 år ved 2°C - 8°C.
English: • you are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6),
Danish: • du er allergisk over for infliximab eller et af de øvrige indholdsstoffer i Inflectra (angivet i punkt 6),
English: Pack sizes of 1, 2, 3, 4, 5 vials.
Danish: Pakningsstørrelser på 1, 2, 3, 4, 5 hætteglas.
English: ** PASI 75 response for IMPACT not included due to low N; p<0.001 for infliximab vs. placebo at week 24 for IMPACT 2.
Danish: ** PASI 75 respons for IMPACT ikke inkluderet som følge af lav N; p < 0.001 for infliximab vs. placebo i uge 24 for IMPACT 2.
English: • reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery.
Danish: • sænke antallet af unormale åbninger (fistler) mellem din tarm og hud, der ikke har kunnet behandles tilfredsstillende med andre lægemidler eller operation.
English: In a fertility and general reproductive function study, the number of pregnant mice was reduced following administration of the same analogous antibody.
Danish: I et fertilitets- og generelt reproduktionsfunktionsstudie var antallet af drægtige mus reduceret efter administration af det samme analoge antistof.
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: Inflectra will generally be stored by the health professionals at the hospital or clinic.
Danish: Inflectra opbevares af sundhedspersonalet på hospitalet eller klinikken.
English: Inflectra should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Danish: Inflectra bør kun anvendes til børn, hvis de behandles for Crohns sygdom eller colitis ulcerosa.
English: Before starting treatment with infliximab, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Danish: Før initiering af behandling med infliximab skal alle patienter vurderes for både aktiv og inaktiv (“latent”) tuberkulose.
English: The usual dose is 5 mg for every kg of body weight.
Danish: Den normale dosis er 5 mg for hver kg legemsvægt.
English: Infusion reactions following re-administration of infliximab
Danish: Infusionsrelaterede reaktioner efter fornyet administration af infliximab
English: In post-marketing spontaneous reporting, infections are the most common serious adverse reaction.
Danish: Ved spontan rapportering efter markedsføring er infektioner den mest almindelige alvorlige bivirkning.
English: The combination of infliximab and abatacept is not recommended.
Danish: Kombinationen af infliximab og abatacept anbefales ikke.
English: Of the 573 patients randomised, 335 (58%) achieved clinical response by week 2.
Danish: Af de 573 randomiserede patienter, opnåede 335 (58%) klinisk respons ved uge 2.
English: • Your doctor or nurse will prepare the medicine for infusion.
Danish: • Din læge eller sygeplejerske vil klargøre medicinen før infusionen.
English: This should be taken into consideration for patients on a controlled sodium diet (see section 6.6).
Danish: Dette skal tages med i overvejelserne for patienter på kontrolleret natriumdiæt (se pkt.
English: Sustained remission(in remission at both week 8 and week 30)
Danish: Vedvarende remission (i remission både i uge 8 og uge 30)
English: • If you experience reactivation of hepatitis B, your doctor may need to stop your treatment and may give you medicines such as effective antiviral therapy with supportive treatment.
Danish: • Hvis du oplever reaktivering af hepatitis B, kan det blive nødvendigt, at lægen stopper din behandling og giver dig medicin som fx effektiv antiviral terapi med understøttende behandling.
English: • Inflectra will be given to you by your doctor or nurse, in a hospital or clinic.
Danish: • Du vil få Inflectra af din læge eller sygeplejerske på et hospital eller en klinik.
English: In all cases, infliximab treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Danish: I alle tilfælde blev infliximab seponeret og/eller anden behandling igangsat med fuldstændigt ophør af tegn og symptomer.
English: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of infliximab (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Danish: Hos nøje udvalgte voksne patienter, som har tålt mindst 3 initiale 2-timers infusioner med infliximab (induktionsfase) og får vedligeholdelsesterapi, kan det overvejes at indgive de efterfølgende infusioner over en periode på ikke mindre end 1 time.
English: Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Inflectra in the infusion bag only.
Danish: Opbevaring ud over 24 timer ved 2C - 8C gælder kun for tilberedning af Inflectra i infusionspose.
English: Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections.
Danish: Øvre luftvejsinfektion (7/60 [12%]) og faryngitis (5/60 [8%]) var de hyppigst rapporterede luftvejsinfektioner.
English: In children (6 years of age or older) treated for Crohn's disease or ulcerative colitis, the recommended dose is the same as for adults.
Danish: Hos børn (i alderen 6 år eller derover), der behandles for Crohns sygdom eller colitis ulcerosa, er den anbefalede dosis den samme som for voksne.
English: Significant improvements from baseline were demonstrated in DLQI (p<0.001) and the physical and mental component scores of the SF 36 (p<0.001 for each component comparison).
Danish: Der blev registreret signifikante forbedringer fra baseline i DLQI (p < 0,001) og de fysiske og mentale del-scorer af SF 36 (p < 0,001 for hver enkelt delsammenligning).
English: If visibly opaque particles, discolouration or foreign particles are observed it should not be used.
Danish: Hvis der observeres synligt uigennemsigtige partikler, misfarvning eller fremmedlegemer må det ikke anvendes.
English: At baseline, 87% of the patients had perianal fistulae, 14% had abdominal fistulae, 9% had rectovaginal fistulae.
Danish: Ved baseline havde 87% af patienterne perianale fistler, 14% havde abdominale fistler, 9% havde rektovaginale fistler.
English: Inflectra contains the active substance infliximab, which is of human and mouse origin.
Danish: Inflectra indeholder det aktive stof infliximab, der stammer fra mennesker og mus.
English: The proportion of patients in clinical response at week 8 was 73.3% (44/60).
Danish: Andelen af patienter med klinisk respons i uge 8 var 73,3% (44/60).
English: All patients had experienced an inadequate response to prior conventional therapies.
Danish: Alle patienter havde haft utilstrækkelig virkning af tidligere konventionel behandling.
English: Rheumatoid arthritis The usual dose is 3 mg for every kg of body weight.
Danish: Rheumatoid artritis Den normale dosis er 3 mg for hver kg legemsvægt.
English: Your doctor may recommend temporarily stopping Inflectra.
Danish: Din læge kan anbefale en midlertidig pause med Inflectra.
English: Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. three doses.
Danish: Foreliggende data tyder på, at det kliniske respons sædvanligvis opnås inden for 14 ugers behandling, svarende til tre doser.
English: In most fistulising Crohn's disease patients, infliximab was detected in serum for 12 weeks (range 4-28 weeks) after administration of the regimen.
Danish: I de fleste patienter med fistulerende Crohns sygdom blev infliximab påvist i serum i 12 uger (interval 4-28 uger) efter administration af regimen.
English: Further treatment with infliximab must not be given if a patient develops a serious infection or sepsis.
Danish: Behandling med infliximab må ikke fortsættes, hvis en patient udvikler en alvorlig infektion eller sepsis.
English: Therefore, the combination of infliximab and anakinra is not recommended.
Danish: Derfor kan kombination af infliximab og anakinra ikke anbefales.
English: Appropriate screening tests (e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
Danish: Passende screeningundersøgelser (f.eks. tuberkulintest, røntgen af thorax og/eller Interferon Gamma Release Assay), bør udføres hos alle patienter (lokale vejledninger kan være gældende).
English: • A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Inflectra
Danish: • En påmindelse til patienterne om, at de skal vise patientinformationskortet til alle behandlende sundhedspersoner, herunder i nødstilfælde, og en besked til sundhedspersoner om, at patienten anvender Inflectra.
English: It is important that you tell your baby's doctors and other healthcare professionals about your Inflectra use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Danish: Det er vigtigt, at du fortæller dit barns læger og andet sundhedspersonale, at du får Inflectra, så de kan finde frem til, hvornår dit barn skal vaccineres; det gælder også levende vacciner som BCG (bruges til at forebygge tuberkulose).
English: b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Danish: b N = 292. c Analysen var baseret på patienter med neglepsoriasis ved baseline (81,8% af patienterne).
English: Keep this card with you for 4 months after your last dose of Inflectra, or in case of pregnancy, for at least 6 months after the birth of your baby.
Danish: Opbevar dette kort på dig i 4 måneder efter du har fået din sidste dosis Inflectra, eller i tilfælde af graviditet i mindst 6 måneder, efter du har født.
English: Inflectra is produced in packs of 1, 2, 3, 4, or 5 vials.
Danish: Inflectra fremstilles i pakninger med 1, 2, 3, 4 eller 5 hætteglas.
English: Clinical remission at week 8 was 33.3% (17/51) as measured by the Paediatric Ulcerative Colitis Activity Index (PUCAI) score.
Danish: Klinisk remission i uge 8 var 33,3% (17/51) målt ved pædiatrisk colitis ulcerosa aktivitets-indeks (PUCAI) scoren.
English: Talk to your doctor if you are on a low salt diet.
Danish: Fortæl det til lægen, hvis du får en diæt med lavt saltindhold.
English: Inflectra is not likely to affect your ability to drive or use tools or machines.
Danish: Inflectra påvirker sandsynligvis ikke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
English: • If you have had a break in your treatment with infliximab of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Danish: • Hvis du har holdt pause i behandlingen med infliximab i over 16 uger, er der en højere risiko for at få en allergisk reaktion, når du starter Inflectra-behandlingen igen.
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: Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last infusion.
Danish: Fornyet administration ved Crohns sygdom og reumatoid arthritis Hvis tegn og symptomer på sygdom vender tilbage, kan infliximab indgives på ny inden for 16 uger efter den seneste infusion.