FrancophonIA/ELRC3.0 huggingface dataset:
English: • that Halimatoz treatment may increase the potential risks of o infections, including tuberculosis o cancer o nervous system problems o vaccinations
Danish: • at behandling med Halimatoz kan øge de mulige risici for o infektioner, inklusive tuberkulose o cancer o problemer med nervesystemet o vaccinationer
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Halimatoz.
Danish: Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Halimatoz.
English: You should continue to inject Halimatoz for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere Halimatoz så længe, din læge har fortalt dig.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Halimatoz.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med adalimumab, vil lægen undersøge dig for tegn og symptomer på tuberkulose, før behandling med Halimatoz påbegyndes.
English: • inject Halimatoz 15-30 minutes after taking it out of the refrigerator for a more comfortable injection.
Danish: • injicer Halimatoz 15-30 minutter efter, at du har taget det ud af køleskabet for at få en mere behagelig injektion.
English: If you take Halimatoz the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når du tager Halimatoz, kan risikoen for at få et lymfom, leukæmi eller andre former for kræft øges.
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given Halimatoz and during treatment with Halimatoz.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under din behandling med Halimatoz.
English: Halimatoz works by reducing this inflammation.
Danish: Halimatoz virker ved at reducere denne inflammation.
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Halimatoz and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.
Danish: • Hvis du får allergiske reaktioner med symptomer som trykken for brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så undlad at injicere mere Halimatoz, og kontakt straks lægen, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: A single Halimatoz pre-filled syringe / pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: En enkelt Halimatoz fyldt injektionssprøjte/fyldt pen kan opbevares ved temperaturer på op til maksimalt 25°C i en periode på op til 14 dage.
English: Patients on Halimatoz may receive concurrent vaccinations, except for live vaccines.
Danish: Patienter i Halimatoz-behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner.
English: After proper training in injection technique, patients may self-inject with Halimatoz if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Efter passende oplæring i injektionsteknik kan patienter selv injicere Halimatoz, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: Administration of Halimatoz should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Administration af Halimatoz bør ophøre, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling iværksættes, indtil infektionen er under kontrol.
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Halimatoz treatment.
Danish: • Du bør overveje brugen af passende prævention for at forhindre graviditet og fortsætte brugen mindst 5 måneder efter den sidste behandling med Halimatoz.
English: Before initiation of therapy with Halimatoz, all patients must be evaluated for both active and inactive (“latent”) tuberculosis infection.
Danish: Før behandling med Halimatoz påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: If you receive Halimatoz while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Danish: Hvis du har fået Halimatoz, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion i op til ca. fem måneder efter din sidste dosis under graviditeten.
English: • Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Halimatoz in case they cause infections.
Danish: • Visse vacciner indeholder levende men svækkede former for sygdomsfremkaldende bakterier eller virusser og bør ikke gives under Halimatoz-behandling i tilfælde af, at de giver infektioner.
English: By attaching to TNFα, Halimatoz blocks its action and reduces the inflammation in these diseases.
Danish: Ved at binde sig til TNFα blokerer Halimatoz dennes virkning og reducerer den inflammatoriske proces i disse sygdomme.
English: • It is important that you tell your baby's doctors and other health care professionals about your Halimatoz use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
Danish: • Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner om din brug af Halimatoz under graviditeten, før dit barn får nogen vaccinationer (for mere information om vacciner, se afsnittet vedrørende "Advarsler og forsigtighedsregler").
English: If you have mild heart failure and you are being treated with Halimatoz, your heart failure status must be closely monitored by your doctor.
Danish: Hvis du har lettere hjerteinsufficiens og bliver behandlet med Halimatoz, skal status for din hjerteinsufficiens følges nøje af din læge.
English: Treatment with Halimatoz should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Danish: Behandling med Halimatoz bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: Halimatoz is used to treat
Danish: Halimatoz bruges til at behandle
English: Carriers of HBV who require treatment with Halimatoz 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 Halimatoz, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
English: Treatment with Halimatoz may result in the formation of autoimmune antibodies.
Danish: Behandling med Halimatoz kan medføre dannelse af autoimmune antistoffer.
English: Halimatoz contains sodium
Danish: Halimatoz indeholder natrium
English: Taking these results into consideration, Halimatoz is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Danish: I betragtning af disse resultater anbefales Halimatoz til anvendelse i kombination med MTX og til anvendelse som monoterapi til patienter, som ikke egner sig til behandling med MTX (se afsnit 4.2).
English: Halimatoz treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Halimatoz is indicated.
Danish: Behandling med Halimatoz bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Halimatoz er indiceret til.
English: Halimatoz is a biosimilar medicinal product.
Danish: Halimatoz er et biosimilært lægemiddel.
English: If you accidentally inject Halimatoz more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required.
Danish: Hvis du ved en fejltagelse injicerer Halimatoz hyppigere end forskrevet af lægen eller apotekspersonalet, kontakt lægen eller apotekspersonalet og forklar, at du har taget mere medicin end nødvendigt.
English: Treatment with Halimatoz can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Danish: Behandling med Halimatoz kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
English: • If you are about to have surgery or dental procedures tell your doctor that you are taking Halimatoz.
Danish: • Hvis du skal opereres eller have tandbehandling, skal du fortælle din læge, at du tager Halimatoz.
English: Keep Halimatoz and all medicines out of the reach of children.
Danish: Halimatoz og andre lægemidler skal opbevares uden for børns rækkevidde.
English: Treatment with Halimatoz must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med Halimatoz skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
English: Vertigo and visual impairment may occur following administration of Halimatoz (see section 4.8).
Danish: Vertigo og svækket syn kan forekomme efter administration af Halimatoz (se pkt.
English: In patients who develop HBV reactivation, Halimatoz should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Hos patienter, der udvikler reaktivering af HBV, bør Halimatoz seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres.
English: Your doctor may recommend temporarily stopping Halimatoz.
Danish: Din læge kan anbefale midlertidig afbrydelse af Halimatoz.
English: Patients should be tested for HBV infection before initiating treatment with Halimatoz.
Danish: Patienter bør testes for HBV-infektion inden behandling med Halimatoz.
English: Patients who develop a new infection while undergoing treatment with Halimatoz should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, der udvikler en ny infektion under behandling med Halimatoz, bør monitoreres nøje og gennemgå en fuldstændig diagnostisk evaluering.
English: If active tuberculosis is diagnosed, Halimatoz therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må Halimatoz-terapi ikke påbegyndes (se pkt.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Halimatoz 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 Halimatoz 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: Be sure that you read, understand, and follow these Instructions for Use before injecting Halimatoz.
Danish: Sørg for at læse, forstå og følge denne brugsvejledning, før du injicerer Halimatoz.
English: Patients who were in the non-MTX stratum were either naïve to or had been withdrawn from MTX at least two weeks prior to study drug administration.
Danish: Patienter i stratummet af ikke-MTX-behandlede var enten aldrig blevet behandlet medMTX eller havde fået seponeret MTX mindst to uger før administration af studielægemidlet.
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 Halimatoz 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 Halimatoz skal omgående afbrydes.
English: Halimatoz contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Danish: Halimatoz indeholder det aktive stof adalimumab, et lægemiddel, som reagerer på din krops immunforsvar.
English: Tell your doctor if you are taking azathioprine or mercaptopurine with Halimatoz.
Danish: Fortæl din læge, hvis du får lægemidlerne azathioprin eller mercaptopurin sammen med Halimatoz.
English: During treatment with Halimatoz, other concomitant therapies (e.g., corticosteroids and / or immunomodulatory agents) should be optimised.
Danish: Under behandling med Halimatoz bør andre samtidige behandlinger (f.eks. kortikosteroider og/eller immunmodulerende midler) optimeres.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Halimatoz should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Halimatoz straks ophøre, og egnet behandling påbegyndes.
English: Halimatoz is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Danish: Halimatoz bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6-17 år.
English: • If you receive Halimatoz during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Hvis du får Halimatoz, mens du er gravid, kan dit spædbarn have en højere risiko for at få en infektion.
English: It is important that you tell your baby's doctors and other health care professionals about your Halimatoz 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 Halimatoz under graviditeten, så de kan beslutte, hvornår dit spædbarn bør vaccineres.
English: It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Halimatoz.
Danish: Det anbefales, at børn så vidt som muligt får alle vaccinationer i overensstemmelse med gældende retningslinjer for deres alder, før behandlingen med Halimatoz indledes.
English: Halimatoz can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Danish: Halimatoz kan nedsætte antallet af knuder og bylder og lindre den smerte, som ofte er forbundet med sygdommen.
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Halimatoz should be considered prior to initiating therapy (see Other opportunistic infections).
Danish: Hos patienter, som har været eksponeret for tuberkulose, og patienter, som har rejst i områder med høj risiko for tuberkulose eller endemisk mykose, såsom histoplasmose, kokcidioidomykose eller blastomykose, skal risiko og fordele ved behandling med Halimatoz overvejes, inden behandlingen iværksættes (se Andre opportunistiske infektioner).
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Halimatoz and is positive for antibodies against double-stranded DNA, further treatment with Halimatoz should not be given (see section 4.8).
Danish: Hvis en patient efter behandling med Halimatoz udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbeltstrenget DNA, bør der ikke gives yderligere behandling med Halimatoz (se pkt.
English: Physicians should exercise caution when considering the use of Halimatoz in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Danish: Læger bør være forsigtige, når de overvejer brug af Halimatoz til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler.
English: The active ingredient in Halimatoz, adalimumab, is a monoclonal antibody.
Danish: Det aktive stof i Halimatoz, adalimumab, er et humant monoklonalt antistof.
English: Contents of the pack and other information What Halimatoz contains
Danish: Pakningsstørrelser og yderligere oplysninger Halimatoz indeholder
English: Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Halimatoz kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Halimatoz treatment.
Danish: Kvinder i den fertile alder bør overveje at anvende passende prævention for at forebygge graviditet og fortsætte med at anvende prævention i mindst fem måneder efter den sidste Halimatoz- behandling.
English: When Halimatoz therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Danish: Når Halimatoz behandlingen påbegyndes kan en induktionsdosis på 40 mg til patienter < 30 kg eller 80 mg til patienter ≥ 30 kg administreres en uge før start af vedligeholdelsesbehandling.
English: • If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Halimatoz.
Danish: • Hvis du har eller udvikler demyeliniserende sygdom (en sygdom, der påvirker det isolerende lag rundt om nerverne som dissemineret sklerose), vil din læge afgøre, om du skal have eller fortsætte med at få Halimatoz.
English: Halimatoz can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Halimatoz kan anvendes sammen med methotrexat eller visse sygdomsmodificerende antireumatiske lægemidler (sulfasalazin, hydroxychloroquin, leflunomid og guldpræparater til injektion), kortikosteroider eller smertemedicin, herunder non-steroide anti-inflammatoriske lægemidler (NSAIDs).
English: Patients treated with Halimatoz should be given the Patient Reminder Card.
Danish: Patienter i Halimatoz-behandling bør få udleveret et patientkort.
English: A patient who requires surgery while on Halimatoz should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som har behov for et kirurgisk indgreb under behandling med Halimatoz, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Halimatoz, and in accordance with local recommendations.
Danish: Hvis der diagnosticeres latent tuberkulose, skal profylaktisk behandling mod tuberkulose påbegyndes i overensstemmelse med lokale anbefalinger, inden behandling med Halimatoz startes.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Halimatoz.
Danish: I overensstemmelse med klinisk praksis kan samtidig kortikosteroidbehandling nedtrappes med start to uger efter initiering af Halimatoz-behandling.
English: If your doctor considers that methotrexate is inappropriate, Halimatoz can be given alone.
Danish: Hvis din læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan Halimatoz anvendes alene.
English: Halimatoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Danish: Halimatoz er i kombination med methotrexat indiceret til behandling af aktiv polyartikulær juvenil idiopatisk artrit hos patienter fra 2 år, som har haft et utilstrækkeligt respons på en eller flere sygdomsmodificerende anti-reumatiske lægemidler (DMARDs).
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Halimatoz cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-cellelymfom hos patienter, der bliver behandlet med Halimatoz kan ikke udelukkes (se pkt.
English: • Halimatoz should only be used during a pregnancy if needed.
Danish: • Halimatoz bør kun anvendes under graviditeten, hvis det er tydeligvis nødvendigt.
English: Usually, Halimatoz is used with methotrexate.
Danish: Normalt gives Halimatoz sammen med methotrexat.
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Halimatoz.
Danish: Der kan fortsættes med glukokortikoider, salicylater, non-steroide antiinflammatoriske eller analgetiske lægemidler under behandling med Halimatoz.
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Halimatoz.
Danish: Ved ikke-infektiøs uveitis kan du fortsætte med at bruge kortikosteroider eller andre lægemidler, som påvirker immunsystemet, mens du tager Halimatoz.
English: Your healthcare provider should show you how to prepare and inject Halimatoz properly using the prefilled pen before you use it for the first time.
Danish: Din læge viser dig, hvordan du skal forberede og injicere Halimatoz korrekt med den fyldte pen, inden du bruger det for første gang.
English: • If you have an infection, including long-term or localised infection (for example leg ulcer), consult your doctor before starting Halimatoz.
Danish: • Hvis du har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), skal du kontakte din læge, før du begynder at bruge Halimatoz.
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of Halimatoz is an initial dose of 40 mg, followed by 40 mg one week later.
Danish: Børn og unge fra 4 til 17 år, der vejer 30 kg eller mere Den anbefalede startdosis af Halimatoz er 40 mg, efterfulgt af 40 mg en uge senere.
English: Halimatoz is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Danish: Halimatoz bruges til at behandle hidrosadenitis suppurativa hos voksne og unge fra 12 år.
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Halimatoz therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.
Danish: Hvis du har reumatoid artrit og ikke får methotrexat i kombination med din Halimatoz-behandling, kan lægen vælge at ordinere 40 mg adalimumab hver uge eller 80 mg hver anden uge.
English: What you need to know before you use Halimatoz Do not use Halimatoz
Danish: Det skal du vide, før du begynder at tage Halimatoz Tag ikke Halimatoz