FrancophonIA/ELRC3.0 huggingface dataset:
English: The doses of Avaglim may need to be adjusted when given with certain other medicines such as gemfibrozil or rifampicin.
Danish: Det kan endvidere også være nødvendigt at justere doseringen af Avaglim, når det gives sammen med andre lægemidler såsom gemfibrozil eller rifampicin.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Type 2-diabetes er en sygdom, hvor bugspytkirtlen enten ikke danner tilstrækkeligt insulin til at regulere glukoseniveauet (sukkeret) i blodet, eller når kroppen ikke er i stand til at udnytte insulinet effektivt.
English: The marketing authorisation is valid for five years, after
Danish: Markedsføringstilladelsen er gyldig i
English: It must not be used in patients who have heart failure (an inability of the heart to pump enough blood around the body), an ‘acute coronary syndrome' such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, problems with their liver, severe problems with their kidneys, type 1 diabetes, or complications of diabetes (diabetic ketoacidosis or diabetic coma).
Danish: Det må ikke anvendes til patienter med hjerteinsufficiens (hjertets manglende evne til at pumpe tilstrækkeligt blod rundt i kroppen), akut koronarsyndrom såsom ustabil angina (en svær form for brystsmerter, der varierer i intensitet), visse typer af hjertetilfælde, leverproblemer, alvorlige nyreproblemer, type 1-diabetes eller diabeteskomplikationer (diabetisk ketoacidose eller diabetisk koma).
English: Avaglim is a medicine that contains two active substances, rosiglitazone and glimepiride.
Danish: Avaglim er et lægemiddel, der indeholder de to aktive stoffer rosiglitazon og glimepirid.
English: The patient can start with separate tablets containing only rosiglitazone or a sulphonylurea, before switching to the combination tablet once control is achieved.
Danish: Patienten kan påbegynde behandlingen med særskilte tabletter, som kun indeholder rosiglitazon eller et sulfonylurinstof, og dernæst skifte til en kombinationstablet, når der er opnået kontrol.
English: Doctors must be careful when switching patients who are at risk of developing hypoglycaemia (low blood sugar levels) to Avaglim, such as elderly patients, patients with low weight or those who have been taking certain
Danish: Lægen skal være forsigtig, når patienter, som har risiko for at udvikle hypoglykæmi (for lavt blodsukkerniveau), skifter til Avaglim, såsom ældre patienter, patienter med lav vægt eller patienter, som har fået visse
English: How does Avaglim work?
Danish: Hvordan virker Avaglim?
English: The most common side effects with Avaglim (seen in more than 1 patient in 10) are hypoglycaemia and oedema (swelling).
Danish: De hyppigste bivirkninger ved Avaglim (som ses hos flere end 1 ud af 10 patienter) er hypoglykæmi (lavt blodsukkerniveau) og ødem (hævelse).
English: Avaglim should not be used in people who may be hypersensitive (allergic) to rosiglitazone, glimepiride or any of the other ingredients.
Danish: Avaglim bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for rosiglitazon, glimepirid eller andre af indholdsstofferne.
English: Because they have been used in the EU for a number of years, studies of rosiglitazone and glimepiride used on their own were used as the basis for Avaglim.
Danish: Da rosiglitazon og glimepirid har været godkendt i EU i en række år, blev undersøgelserne af de to stoffer anvendt hver for sig brugt som grundlag for Avaglim.
English: • rosiglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces;
Danish: • Rosiglitazon gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder,
English: What benefit has Avaglim shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Avaglim?
English: Avaglim is used in patients who cannot satisfactorily control their blood glucose (sugar) when using an adequate dose of a sulphonylurea (a type of antidiabetes medicine) on its own, and for whom metformin (another antidiabetes medicine) is
Danish: Avaglim anvendes til patienter, hvis blodsukker ikke på tilfredsstillende måde kan holdes under kontrol, når den rette dosis sulfonylurinstof (en form for lægemiddel mod sukkersyge) anvendes alene, og for hvem metformin (en anden form for
English: The CHMP concluded that Avaglim's benefits are greater than its risks and recommended that it be
Danish: Udvalget konkluderede, at fordelene ved Avaglim er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Avaglim.
English: For the full list of all side effects reported with Avaglim, see the Package
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Avaglim fremgår af indlægssedlen.
English: For glimepiride, the information came from
Danish: Oplysningerne om glimepirid stammede
English: Idacio can also be given alone.
Danish: Idacio kan også tages alene.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 2 April 2019
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 2. april 2019
English: Label area (Idacio, dose, expiration date)
Danish: Etiketområde (Idacio, dosis, udløbsdato)
English: 1) including spontaneous reporting data
Danish: 1) inklusive spontane rapporter
English: Idacio is available in other presentations.
Danish: Idacio er tilgængelig i andre præsentationer.
English: Step 2 Wash your Hands
Danish: Trin 2 Vask dine hænder
English: Side effects may occur up to 4 months or more after the last Idacio injection.
Danish: Bivirkninger kan forekomme op til 4 måneder eller mere efter den sidste Idacio injektion.
English: Detailed instructions on how to inject Idacio are provided in section 7 ‘Instructions for use'.
Danish: Detaljeret vejledning om, hvordan Idacio injiceres, gives i punkt 7 ”Brugsvejledning”.
English: Idacio may be available in other presentations depending on the individual treatment needs.
Danish: Idacio er tilgængelig i andre præsentationer afhængigt af individuelt behandlingsbehov.
English: • On rare occasions, treatment with Idacio could result in lupus-like syndrome.
Danish: • I sjældne tilfælde kan behandling med Idacio resultere i lupus-lignende syndrom.
English: Patients were allowed to continue on study medication beyond Week 78 until they had access to adalimumab.
Danish: Patienterne fik lov til at fortsætte med studiemedicin udover 78 uger, indtil de havde adgang til adalimumab.
English: Your doctor may prescribe another strength of Idacio if your child needs a different dose.
Danish: Din læge kan ordinere en anden styrke af Idacio, hvis dit barn behøver en anderledes dosis.
English: The recommended doses for Idacio in each of the approved uses are shown in the following table.
Danish: De anbefalede doser af Idacio, til hver af de godkendte anvendelser, er vist i følgende tabel:
English: Pack sizes of:
Danish: Pakningsstørrelse af:
English: Idacio is a biosimilar medicinal product.
Danish: Idacio er et biosimilært lægemiddel.
English: You should continue to inject Idacio for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere Idacio i så lang tid, som din læge har fortalt dig.
English: Vertigo and visual impairment may occur following administration of Idacio (see section 4.8).
Danish: Vertigo og svækket syn kan forekomme efter administration af Idacio (se pkt 4.8).
English: Idacio should only be used during a pregnancy if needed.
Danish: Idacio bør kun anvendes under graviditet, hvis det nødvendigt.
English: You and your doctor should pay special attention to signs of infection while you are being treated with Idacio.
Danish: Du og din læge bør være særligt opmærksomme på tegn på infektion, mens du er i behandling med Idacio.
English: Idacio is intended for the treatment of the following inflammatory diseases:
Danish: Idacio er beregnet til behandlingen af følgende inflammatoriske sygdomme:
English: Idacio in combination with methotrexate, is indicated for:
Danish: Idacio i kombination med methotrexat er indiceret til:
English: If retreatment with Idacio is indicated, the above guidance on dose and treatment duration should be followed.
Danish: Hvis genbehandling med Idacio er indiceret, bør ovenstående vejledning for dosering og behandligsvarighed følges.
English: • If you are over 65 years you may be more susceptible to infections while taking Idacio.
Danish: • Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager Idacio.
English: Idacio should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Idacio bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
English: Warning: Do not use the pre-filled pen if the name on the label is not Idacio and/or the expiration date on the label has passed.
Danish: Advarsel: Du må ikke bruge den fyldte pen, hvis der ikke står Idacio på etiketten, og/eller hvis udløbsdatoen på etiketten er overskredet.
English: Idacio works by reducing this inflammation.
Danish: Idacio virker ved at reducere denne inflammation.
English: By attaching to TNFα, Idacio blocks its action and reduces the inflammation in these diseases.
Danish: Ved at binde sig til TNF blokerer Idacio dets virkning og reducerer inflammationen ved disse sygdomme.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Idacio.
Danish: Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Idacio.
English: Treatment with Idacio may result in the formation of autoimmune antibodies.
Danish: Behandling med Idacio kan medføre dannelse af autoimmune antistoffer.
English: Erosion score JSNd score amethotrexate b95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
Danish: Erosion score JSNd score amethotrexat b95% Konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab.
English: Administration of Idacio 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 Idacio 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: After proper training in injection technique, patients may self-inject with Idacio 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 Idacio, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Idacio.
Danish: Det anbefales, at børn såvidt som muligt får alle de planlagte vaccinationer for deres alder, før behandlingen med Idacio indledes.
English: Hepatitis, reactivation of hepatitis B1), autoimmune hepatitis1)
Danish: Hepatit reaktivering af hepatitis B1) autoimmun hepatit1)
English: Treatment with Idacio should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Danish: Behandling med Idacio bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Danish: Patientkortet (voksne og børn) indeholder følgende hovedelementer: - infektioner, inklusive tuberkulose - cancer - problemer med nervesystemet - vaccinationer
English: Carriers of HBV who require treatment with Idacio 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 Idacio, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
English: The decision to stop using Idacio should be discussed with your child's doctor.
Danish: Beslutningen om at stoppe med at bruge Idacio skal diskuteres med dit barns læge.
English: Your doctor will decide if your child should receive Idacio.
Danish: Din læge vil beslutte, om dit barn skal have Idacio.
English: Idacio contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Danish: Idacio indeholder det aktive stof adalimumab; en medicin, som virker på din krops immunsystem.
English: Before initiation of therapy with Idacio, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Danish: Før behandling med Idacio påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: Week 26 Week 52 1 p value for Standard Dose versus Low Dose comparison.
Danish: Uge 26 Uge 52, 1 p-værdi for sammeligning af standard-dosis versus lav-dosis.
English: Treatment with Idacio can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Danish: Behandling med Idacio kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
English: Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
Danish: Længere tids behanding med adalimumab 40 mg ugentlig viste ingen nye sikkerhedsfund.
English: In patients who develop HBV reactivation, Idacio should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Hos patienter, der udvikler reaktivering af HBV, bør Idacio seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres.
English: Idacio treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Idacio is indicated.
Danish: Behandling med Idacio bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Idacio er indiceret til.
English: The decision to stop using Idacio should be discussed with your doctor.
Danish: Beslutningen om at stoppe med at bruge Idacio skal diskuteres med din læge.
English: If you use less Idacio than you should
Danish: Hvis du har givet mindre Idacio, end du skulle
English: Taking these results into consideration, Idacio 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 adalimumab 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: Patients who develop a new infection while undergoing treatment with Idacio, should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, der udvikler en ny infektion under behandling med Idacio, bør monitoreres nøje og gennemgå en fuldstænding diagnostisk evaluering.
English: The active ingredient in Idacio, adalimumab, is a monoclonal antibody.
Danish: Det aktive stof i Idacio, adalimumab, er et monoklonalt antistof.
English: Idacio can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Danish: Idacio kan nedsætte antallet af knuder og bylder og lindre den smerte, som ofte er forbundet med sygdommen.
English: Be sure that you read, understand, and follow these Instructions for Use before injecting Idacio.
Danish: Sørg for at læse, forstå og følge denne brugsvejledning, før du injicerer Idacio.
English: Patients should be tested for HBV infection before initiating treatment with Idacio.
Danish: Patienter bør testes for HBV-infektion inden behandling med Idacio.
English: Your doctor may recommend temporarily stopping Idacio.
Danish: Din læge kan anbefale midlertidig afbrydelse af Idacio.
English: 2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion 3 defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post
Danish: 2 immunmodulerende lægemidler kunne kun seponeres ved eller efter uge 26 efter investigators skøn, hvis patienten opfyldte det kliniske respons-kriterium 3 defineret som lukning af alle fistler, som var åbne ved baseline, ved mindst 2 på hinanden følgende besøg efter baseline-besøget
English: Hidradenitis Suppurativa clinical response (HiSCR)a
Danish: Hidradenitis Suppurativa Clinical Respons (HiSCR)a
English: Treatment with Idacio must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med Idacio skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
English: • signs of skin cancer such as a bump or open sore that doesn't heal;
Danish: • tegn på hudkræft som en bule eller åbent sår, som ikke vil hele
English: The combination of Idacio and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Danish: Kombination af Idacio og abatacept anbefales ikke (se pkt.t 4.4 “Samtidig administration af biologiske DMARDs eller TNF-antagonister”).
English: ≥30% Reduction in skin painb
Danish: ≥30% reduktion af hudsmerterb
English: If active tuberculosis is diagnosed, Idacio therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må Idacio-terapi ikke påbegyndes (se pkt.
English: During treatment with Idacio, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Danish: Under behandling med Idacio, 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 Idacio should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Idacio straks ophøre og egnet behandling påbegyndes.
English: There is insufficient evidence of the efficacy of Idacio in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Danish: Der foreligger utilstrækkelig evidens for virkningen af Idacio hos patienter med ankyloserende spondylitis-lignende psoriasis-artropati, da kun få patienter er blevet undersøgt.
English: CD study II: Infliximab experienced patients
Danish: CD-Studie II: Infliximab erfarne patienter
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Idacio 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 Idacio 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: Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1), lichenoid skin reaction1)
Danish: Erythema multiforme1), Stevens-Johnsons syndrom1), angioødem1), kutan vaskulitis1), lichenoid hudreaktion1)
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies 1) including spontaneous reporting data
Danish: 4.3, 4.4 og 4.8 ** inklusive åben-label forlængelsesstudier 1) inklusive spontane rapporter
English: • Vaccinations: if possible children should be up to date with all vaccinations before using Idacio.
Danish: • Vaccinationer: hvis det er muligt, skal dit barn føres ajour med alle vaccinationer, før behandling med Idacio startes.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med referencelægemidlet indeholdende adalimumab i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa, se pkt.
English: b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine.
Danish: b Blandt patienter med HS-relateret evaluering af hudsmerte ≥ 3 ved baseline, baseret på en numerisk vurderingsskala 0-10; 0 = ingen hudsmerte, 10 = hudsmerte så slem, som du kan forestille dig.
English: Table 25 Maintenance regimen
Danish: Tabel 25 Vedligeholdelsesregime Patient vægt
English: Idacio is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Danish: Idacio bruges til at behandle polyartikulær juvenil idiopatisk artrit hos børn og unge i alderen fra 2 til 17 år og entesopatirelateret artrit hos børn og unge i alderen 6-17 år.
English: Table 19 Maintenance regimen
Danish: Tabel 19 Vedligeholdelsesregime Patient vægt
English: b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders.
Danish: b Patienter, som opfyldte protokol-specifikke kriterier for tab af respons eller ingen forbedring, udgik af studierne og blev talt som nonrespondere.
English: INFORMATION IN BRAILLE Idacio 40 mg
Danish: INFORMATION I BRAILLE-SKRIFT Idacio 40 mg
English: Idacio contains sodium
Danish: Idacio indeholder natrium
English: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B -, NK-cells, monocyte/macrophages, and neutrophils.
Danish: I et studie, hvor 64 patienter med reumatoid artrit blev behandlet med adalimumab, var der ingen tegn på nedsat forsinket hypersensitivitet, nedsatte immunglobulinniveauer eller forandring i antallet af effektor T-, B-, NK-celler, monocytter/makrofager og neutrofiler.
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Idacio.
Danish: Der kan fortsættes med glukokortikoider, salicylater, non-steroide antiinflammatoriske eller analgetiske lægemidler under behandling med Idacio.
English: Syringe Warning: Do not use if damaged.
Danish: Sprøjte Advarsel: Må ikke bruges, hvis beskadiget.
English: The impact of long- term treatment with adalimumab on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning langtidsbehandling med adalimumab har på udviklingen af autoimmune sygdomme.