FrancophonIA/ELRC3.0 huggingface dataset:
English: 5) Injecting Imraldi
Danish: 5) Injektion af Imraldi
English: Surgery or dental procedure
Danish: Operation eller tandbehandling
English: Fatty areas are easier to pinch and are good for inserting the needle correctly.
Danish: Fedtholdige områder er lettere at klemme sammen og er gode til korrekt indføring af kanylen.
English: Initial dose of 40 mg, followed by
Danish: Startdosis på 40 mg, efterfulgt af
English: • high blood pressure;
Danish: • højt blodtryk;
English: The decision to stop using Imraldi should be discussed with your child's doctor.
Danish: Beslutningen om at stoppe med at bruge Imraldi skal diskuteres med dit barns læge.
English: This could bend or damage the needle.
Danish: Dette kan bøje eller beskadige kanylen.
English: Induction of clinical remission (defined as CDAI <150) was evaluated in two studies, CD study I (CLASSIC I) and CD study II (GAIN).
Danish: Induktion af klinisk remission (defineret som CDAI < 150) blev undersøgt i to studier, CD-studie I (CLASSIC I) og CD-studie II (GAIN).
English: • neuropathy (nerve damage);
Danish: • neuropati (nervebeskadigelse);
English: Imraldi is intended for treatment of:
Danish: Imraldi er beregnet til behandling af:
English: • If you received Imraldi during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Hvis du har fået Imraldi, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion.
English: By attaching to TNFα, Imraldi decreases the process of inflammation in these diseases.
Danish: Ved at binde til TNFα reducerer Imraldi betændelsesprocessen ved disse sygdomme.
English: • To reduce the chance of infection, wipe the injection site with the other alcohol pad.
Danish: • For at reducere risikoen for infektion skal du tørre injektionsstedet af med den anden spritserviet.
English: DO NOT set the syringe down at any time.
Danish: Læg IKKE sprøjten fra dig på noget tidspunkt.
English: Before initiation of therapy with Imraldi, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Danish: Før behandling med Imraldi påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: • Choose a site on your thigh or abdomen (except the area around the navel).
Danish: • Vælg et sted på lår eller mave (bortset området omkring navlen).
English: Carriers of HBV who require treatment with Imraldi should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Bærere af HBV, som kræver behandling med Imraldi, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
English: Treatment with Imraldi should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Danish: Behandling med Imraldi bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: Always take the outer carton of the medicine with you, even if it is empty.
Danish: Tag altid den ydre karton fra medicinen med, også selvom den er tom.
English: Tuberculosis can develop during therapy even if your child has received preventative treatment for tuberculosis.
Danish: Tuberkulose kan udvikles under behandlingen, også selv om dit barn har fået forebyggende behandling mod tuberkulose.
English: The decision to stop using Imraldi should be discussed with your doctor.
Danish: Beslutningen om at stoppe med at bruge Imraldi skal diskuteres med din læge.
English: Uncommon Deafness, tinnitus
Danish: Ikke almindelig Døvhed, tinnitus
English: During the study, most subjects used concomitant MTX, with fewer reporting use of corticosteroids or NSAIDs.
Danish: I løbet af studiet fik de fleste patienter samtidig MTX, og et mindre antal rapporterede brug af kortikosteroider eller NSAID.
English: c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Danish: c Ankylosing Spondylitis Disease Activity Score d Delvis opblussen af sygdom er defineret som ASDAS ≥ 1,3 men < 2,1 ved 2 på hinanden følgende besøg.
English: The adjusted OR (accounting for baseline differences) was 1.10 (95 % CI 0.45-2.73) with RA and CD combined.
Danish: Den korrigerede OR (som tager højde for baseline forskelle) var 1,10 (95% KI 0,45-2,73) for RA og CD kombineret.
English: After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after administration.
Danish: Efter subkutan administration af en enkelt 40 mg dosis var absorption og fordeling af adalimumab langsom, og maksimal serumkoncentration blev nået omkring 5 dage efter administration.
English: The following instructions explain how to inject Imraldi.
Danish: Følgende er en vejledning i, hvordan man injicerer Imraldi.
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Danish: Af de forsøgspersoner, som blev behandlet med adalimumab uden at vise progression radiografisk fra baseline til uge 48 (n = 102), viste 84 % fortsat ingen progression radiografisk i løbet af de 144 ugers behandling.
English: • Check to see that the fluid remaining in the syringe is at least the prescribed dose volume.
Danish: • Kig efter at væsken i sprøjten mindst svarer til det foreskrevne dosisvolumen.
English: Week 26 Placebo-Controlled
Danish: Uge 26 Placebo- kontrolleret
English: Check with your child's doctor or pharmacist if you are not sure about any of the instructions or if you have any questions.
Danish: Spørg dit barns læge eller apotekspersonalet, hvis du er i tvivl om noget med hensyn til anvisningerne, eller hvis du har spørgsmål.
English: If your medication is not clear, free of particles, or expired, do not use it.
Danish: Hvis din medicin ikke er klar og fri for partikler, eller udløbsdatoen er overskredet, må den ikke anvendes.
English: • Imraldi should only be used during a pregnancy if needed.
Danish: • Imraldi bør kun anvendes under graviditet, hvis det er tydeligvis nødvendigt.
English: Excess liquid may come out of the needle while the white plunger rod is being pushed.
Danish: Overskudsvæske kan komme ud af kanylen mens du skubber den hvide stempelstang.
English: Failure to perform the following steps as described may cause contamination which may lead to infection of your child.
Danish: Hvis nedenstående instruktioner ikke følges er der risiko for forurening, som kan medføre at dit barn får en infektion.
English: Patients should be tested for HBV infection before initiating treatment with Imraldi.
Danish: Patienter bør testes for HBV-infektion inden behandling med Imraldi.
English: • When you push down, the injection starts.
Danish: • Injektionen starter, når du trykker ned.
English: Imraldi has not been studied in these patient populations.
Danish: Imraldi er ikke undersøgt hos disse patientpopulationer.
English: • With the other hand, hold syringe at 45-degree angle to skin.
Danish: • Hold sprøjten med den anden hånd i en vinkel på 45° mod huden.
English: solution for injection Contains 2 cartons each for a single injection only
Danish: injektionsvæske, opløsning Indeholder 2 kartoner, der hver kun er til en enkelt injektion
English: • hepatitis;
Danish: • hepatit;
English: For instructions for use, refer to section 7.
Danish: For en brugsanvisning henvises til punkt 7.
English: Adverse Reaction alopecia1), pruritus
Danish: Hyperhidrose alopeci1), pruritus
English: Very common Headache Common
Danish: Meget almindelig Hovedpine Almindelig
English: Tuberculosis can develop during therapy even if you have received preventative treatment for tuberculosis.
Danish: Tuberkulose kan udvikles under behandlingen, også selv om du har fået forebyggende behandling mod tuberkulose.
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Paediatric ACR 50 response, and Paediatric ACR 70 response.
Danish: Selvom det ikke var statistisk signifikant, viste størstedelen af patienterne klinisk bedring i sekundære endepunkter, såsom antallet af steder med entesopatirelateret artrit, antallet af ømme led (TJC), antallet af hævede led (SJC), pædiatrisk ACR50-respons og pædiatrisk ACR 70-respons.
English: Imraldi is used to treat
Danish: Imraldi bruges til at behandle
English: • a bump or open sore that doesn't heal;
Danish: • en bule eller åbent sår, som ikke vil hele;
English: Fatty areas are good for inserting the needle correctly.
Danish: Fedtholdige områder er gode til korrekt indføring af kanylen.
English: Never reuse a syringe.
Danish: Genbrug aldrig en sprøjte.
English: 2) Preparing the Imraldi dose for injection
Danish: 2) Forberedelse af Imraldi-dosis til injektion
English: Treatment with Imraldi must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med Imraldi skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
English: In patients who develop HBV reactivation, Imraldi should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Hos patienter, der udvikler reaktivering af HBV, bør Imraldi seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres.
English: Very common Abdominal pain, nausea and vomiting
Danish: Meget almindelig Abdominalsmerter, kvalme og opkastning
English: In patients with Crohn's disease, a reduction of the number of cells expressing inflammatory markers in the colon including a significant reduction of expression of TNFα was seen.
Danish: Hos patienter med Crohns sygdom sås en reduktion i antallet af celler med ekspression af inflammatoriske markørere i colon, inklusive en betydelig reduktion i antallet af celler med TNFαekspression.
English: 14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
Danish: 14 uger a Pædiatrisk ACR 30/50/70-responser ved uge 48 er signifikant bedre end responserne for placebobehandlede patienter b p = 0,015 c p = 0,031
English: • severe rash, hives or other signs of allergic reaction;
Danish: • kraftigt udslæt, nældefeber eller andre tegn på en allergisk reaktion;
English: Patients receiving MTX who achieved a ≥PASI 50 response at week 8 and/or 12 did not receive further dose increases.
Danish: Patienter, som fik methotrexat, og som opnåede et ≥ PASI 50-respons ved uge 8 og/eller 12, fik ikke yderligere dosisøgning.
English: Patients who develop a new infection while undergoing treatment with Imraldi, should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, der udvikler en ny infektion under behandling med Imraldi, bør monitoreres nøje og gennemgå en fuldstænding diagnostisk evaluering.
English: The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Danish: Mediantiden til behandlingssvigt var 24,1 uger for patienter behandlet med placebo, mens mediantiden til behandlingssvigt hos patienter behandlet med adalimumab ikke var målbar, da mindre end halvdelen af disse patienter oplevede behandlingssvigt.
English: Always make sure your medicine is clear, free of particles, and has not expired.
Danish: Kontrollér altid, at medicinen er klar og fri for partikler, og udløbsdatoen ikke er overskredet.
English: A single Imraldi pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 28 days.
Danish: En enkelt fyldt Imraldi-injektionssprøjte eller fyldt pen kan opbevares ved temperaturer på op til maksimalt 25 °C i en periode på op til 28 dage.
English: Treatment with Imraldi can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Danish: Behandling med Imraldi kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
English: Do not touch the area again before the injection.
Danish: Undlad at berøre området igen før injektionen.
English: If active tuberculosis is diagnosed, Imraldi therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må Imraldi-terapi ikke påbegyndes (se pkt.
English: Hypersensitivity, allergies (including seasonal allergy) Uncommon Sarcoidosis1),
Danish: Hypersensitivitet, allergier (inklusive sæsonbestemt allergi) Ikke almindelig Sarkoidose1),
English: Standard dose
Danish: Standard-dosis
English: Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Danish: Farmakokinetiske populationsanalyser med data fra flere end 1.300 RA patienter viste en tendens til en tilsyneladende højere clearance af adalimumab med stigende legemsvægt.
English: - The active substance is adalimumab.
Danish: - Aktivt stof: adalimumab.
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Danish: Der er en forøget baggrundsrisiko for lymfomer og leukæmi hos reumatoid artrit patienter med længerevarende, højaktiv, inflammatorisk sygdom, hvilket komplicerer risikoestimeringen.
English: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);
Danish: • Stevens-Johnsons syndrom (tidlige symptomer inkluderer utilpashed, feber, hovedpine og udslæt);
English: • serious infections (including blood poisoning and influenza);
Danish: • alvorlige infektioner (inklusive blodforgiftning og influenza);
English: • In some patients the body may fail to produce enough of the blood cells to fight off infections or help you to stop bleeding.
Danish: • Hos nogle patienter vil kroppen ikke producere tilstrækkeligt af de blodlegemer, som bekæmper infektioner eller hjælper dig med at stoppe blødninger.
English: Use a plaster if you want to.
Danish: Brug evt. et plaster.
English: After 5 years of adalimumab therapy, 74.0 % (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0 % (46/50) of patients continued to be in clinical response per PCDAI.
Danish: Efter 5 års adalimumab-behandling var 74,0 % (37/50) af de 50 patienter, som stadig var i studiet, fortsat i klinisk remission, og 92,0 % (46/50) af patienterne havde fortsat klinisk respons i henhold til PCDAI.
English: • Certain vaccines contain weakened but live forms of disease-causing bacteria or viruses, and these vaccines should not be given while receiving Imraldi.
Danish: • Visse vacciner indeholder svækkede men levende former af sygdomsfremkaldende bakterier eller vira.
English: • reactivation of hepatitis B;
Danish: • genopblussen af hepatitis B;
English: • reduction in blood platelets which increases risk of bleeding or bruising;
Danish: • nedsat antal blodplader med forøget risiko for blødning eller blå mærker;
English: The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab:
Danish: Ovennævnte symptomer kan være tegn på følgende bivirkninger, som er observeret ved brug af adalimumab:
English: The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Danish: Infektionerne var primært nasofaryngitis, øvre luftvejsinfektioner, og sinuitis.
English: • blood in urine;
Danish: • blod i urinen;
English: One hundred patients (n=100) from the Paediatric CD study continued in an open-label long-term extension study.
Danish: Ethundrede patienter (n = 100) fra det pædiatriske Crohn-studie fortsatte i langtidsbehandling i et åbent forlængelsesstudie.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Imraldi in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Inden start af behandling med Imraldi skal profylaktisk behandling mod tuberkulose også overvejes hos patienter med adskillige eller signifikante risikofaktorer for tuberkulose på trods af en negativ test for tuberkulose samt hos patienter, der tidligere har haft latent eller aktiv tuberkulose, hvor det ikke har kunnet bekræftes, at behandlingen har været tilstrækkelig.
English: NEVER pull past the 0.9 ml position regardless of prescribed dose.
Danish: Træk ALDRIG stemplet længere ud end til 0,9 ml uanset hvad den ordinerede dosis er.
English: This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Danish: Inflammationen kan føre til nedsat syn og/eller fluer i øjet (sorte pletter eller svage linjer, som bevæger sig i synsfeltet).
English: Lupus-like syndrome
Danish: Lupus-lignende syndrom
English: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning).
Danish: Disse infektioner kan være alvorlige og inkluderer tuberkulose, infektioner forårsaget af virus, svampe, parasitter eller bakterier, andre opportunistiske infektioner (usædvanlige infektioner i forbindelse med et svækket immunforsvar) og sepsis (blodforgiftning).
English: Clinical response * p value for Standard Dose versus Low Dose comparison
Danish: Klinisk respons * p-værdi for sammenligning af standard-dosis versus lav-dosis.
English: • Merkel cell carcinoma (a type of skin cancer);
Danish: • Merkelcelle karcinom (en type hudkræft);
English: DO NOT put these items into regular household waste.
Danish: Disse dele må IKKE lægges i husholdningsaffaldet.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Danish: Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbeltblindede, placebokontrollerede AS-studie II på 82 voksne patienter med aktiv ankyloserende spondylitis.
English: Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Danish: Plaque-psoriasis er en betændelsestilstand i huden, som forårsager røde, skællende, skorpede pletter på huden dækket med sølvfarvede skæl.
English: It is important that you tell your baby's doctors and other health care professionals about your Imraldi use during your pregnancy so they can decide when your baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik Imraldi under graviditeten, så de kan beslutte, hvornår dit spædbarn bør vaccineres.
English: Patients who had been randomised to placebo in Period A were assigned to receive placebo in Period B.
Danish: Patienter, som var randomiseret til placebo i periode A, blev tildelt placebo i periode B.
English: Always take the outer carton or the vial of the medicine with you, even if it is empty.
Danish: Tag altid den ydre karton eller hætteglasset fra medicinen med, også selvom det er tomt.
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker ud fra studier af toksicitet efter en enkelt dosis, toksicitet efter gentagne doser og genotoksicitet.
English: Carefully pull off the clear needle cap with a metal center from the pen.
Danish: Træk forsigtigt den klare kanylehætte af med en metalmidterdel fra pennen.
English: Adalimumab treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Danish: Patienter i behandling med adalimumab havde signifikant større forbedringer ved uge 12, som blev opretholdt frem til uge 24, i både SF 36 og ankyloserende spondylitis livskvalitetsspørgeskema (ASQoL).
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96 % of those in serum.
Danish: Koncentrationen af adalimumab i synovialvæsken fra adskillige reumatoid artritpatienter målt i serum var 31-96 %.
English: Adalimumab significantly decreased the risk of treatment failure by 75 % relative to placebo, as shown by the hazard ratio (HR = 0.25 [95 % CI: 0.12, 0.49]).
Danish: Adalimumab nedsætter signifikant risikoen for behandlingssvigt med 75 %, som vist med hazard ratio sammenlignet med placebo (HR = 0,25 [95% CI: 0,12; 0,49]).
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX- treated.
Danish: I den åbne indkøringsfase blev patienterne stratificeret i to grupper - MTX-behandlede (methotrexat-behandlede) og ikke-MTXbehandlede.
English: • impotence;
Danish: • impotens;
English: • asthma;
Danish: • astma;
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Imraldi should be promptly discontinued.
Danish: For patienter, som udvikler tegn og symptomer såsom feber, utilpashed, vægttab, svedeture, hoste, dyspnø, og/eller pulmonale infiltrater eller anden alvorlig systemisk sygdom med eller uden samtidig shock, bør en invasiv svampeinfektion mistænkes, og administration af Imraldi skal omgående afbrydes.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Imraldi and is positive for antibodies against double-stranded DNA, further treatment with Imraldi should not be given (see section 4.8).
Danish: Hvis en patient efter behandling med Imraldi udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbelt-strenget DNA, bør der ikke gives yderligere behandling med Imraldi (se pkt.
English: Clean your injection site with an alcohol pad.
Danish: Rens injektionsstedet med en spritserviet.
English: • There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
Danish: • Der har været tilfælde af kræft, der er forskellig fra lymfom, hos patienter med en specifik lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL), der var i behandling med en anden TNFα-hæmmer.
English: Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50 % reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Danish: Reduktion af inflammatoriske læsioner og forebyggelse af forværring af abscesser og suppurerende fistler blev evalueret ved hjælp af ”Hidrosadenitis Suppurativa Clinical Response” (HiSCR; mindst 50 % reduktion i det totale antal abscesser og inflammatoriske noduli og uden stigning i antallet af abscesser og suppurerende fistler i forhold til baseline).
English: Set the package down with the clear side of the package facing up.
Danish: Læg pakningen ned så den klare side af emballagen er opad.