FrancophonIA/ELRC3.0 huggingface dataset:
English: The final opinion was converted into a Decision by the European Commission on 6 September 2013.
Danish: Den endelige udtalelse blev den 6. september 2013 omarbejdet til en beslutning af EuropaKommissionen.
English: The referral started on 12 April 2012.
Danish: Indbringelsesproceduren blev indledt den 12. april 2012.
English: The Committee appointed Mr G. J. Schefferlie as rapporteur and Dr B. Kolar as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis hr. G. J. Schefferlie og dr. B. Kolar.
English: Written explanations were provided by the applicants and marketing authorisation holders on 17 September 2012, 3 January 2013 and 9 May 2013.
Danish: Ansøgerne/indehaverne af markedsføringstilladelserne afgav skriftlige redegørelser den 17. september 2012, den 3. januar 2013 og den 9. maj 2013.
English: Doramectin is an antiparasitic agent.
Danish: Doramectin er et middel til bekæmpelse af parasitter.
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Danish: Begge stoffer virker mod et bredt udsnit af parasitter og frembringer samme form for lammelse hos rundorm (nematoder) og leddyr, der optræder som parasitter (parasitære arthropoder).
English: Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to changes of the product information related to harmonisation of the withdrawal periods, inclusion of warning sentences concerning the use in dairy animals and environmental risk mitigation measures.
Danish: På grundlag af de foreliggende data fandt CVMP, at det overordnede forhold mellem fordele og risici for disse produkter fortsat er positivt, forudsat at der foretages ændringer i produktinformationen vedrørende harmonisering af tilbageholdelsestiderne, indsættelse af advarsler om anvendelse hos mælkeproducerende dyr og foranstaltninger til afhjælpning af risikoen for miljøet.
English: The CVMP was requested to give its opinion regarding the adequacy and consumer safety of the withdrawal periods for all injectable and pour-on veterinary medicinal products containing doramectin and whether there is a risk to the environment and the need for risk mitigation measures following use of the products concerned.
Danish: CVMP blev anmodet om at fremsætte en udtalelse om egnetheden og forbrugersikkerheden af tilbageholdelsestiderne for alle veterinærmedicinske injektionspræparater og pour-on-præparater indeholdende doramectin og om, hvorvidt der er risiko for miljøet, og om behovet for risikoafhjælpende foranstaltninger efter anvendelse af de pågældende produkter.
English: On 22 March 2012, the Netherlands presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species.
Danish: Den 22. marts 2012 anmeldte Nederlandene til agenturet en indbringelse i henhold til artikel 35 i direktiv 2011/82/EF vedrørende alle doramectinholdige veterinærmedicinske injektionspræparater og pour-on-præparater, der er bestemt til anvendelse hos fødevareproducerende pattedyrarter.
English: Therefore, the Committee adopted a positive opinion on 12 June 2013, recommending variations to the terms of the marketing authorisations for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species.
Danish: Udvalget vedtog derfor den 12. juni 2013 en positiv udtalelse, der anbefaler ændringer af markedsføringstilladelserne for alle doramectinholdige veterinærmedicinske injektionspræparater og pour-on-præparater, der er bestemt til anvendelse hos fødevareproducerende pattedyrarter.
English: Opinion following an Article 351 referral for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species
Danish: Udtalelse efter en artikel 351-indbringelse vedrørende alle doramectinholdige veterinærmedicinske injektionspræparater og pour-on-præparater, der er bestemt til anvendelse hos fødevareproducerende pattedyrarter
English: Opinion following an Article 350F referral for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species
Danish: Udtalelse efter en artikel 350F-indbringelse vedrørende alle doramectinholdige veterinærmedicinske injektionspræparater og pour-on-præparater, der er bestemt til anvendelse hos fødevareproducerende pattedyrarter EMA/372468/2013
English: Note: You will feel some resistance.
Danish: Bemærk: Du vil mærke lidt modstand.
English: • Then slowly count to 5.
Danish: • Tæl derefter langsomt til 5.
English: Ensure you have the following:
Danish: Sørg for, at du har følgende:
English: The injection can take up to 20 seconds.
Danish: Injektionen kan tage op til 20 sekunder.
English: Date of first authorisation: 26 September 2017
Danish: Dato for første markedsføringstilladelse: 26. september 2017
English: The needle is inside.
Danish: Kanylen er indeni.
English: Subsequent Doses (every other week)
Danish: Efterfølgende doser (hver anden uge)
English: Maintenance and Durability of Response (SOLO CONTINUE study)
Danish: Opretholdelse og varighed af respons (SOLO CONTINUE studie)
English: • You may hear a second click.
Danish: • Du hører muligvis endnu et klik.
English: However, there were only 61 patients over 65 years of age included in this analysis.
Danish: Der var dog kun 61 patienter over 65 år inkluderet i denne analyse.
English: A: Prepare A1.
Danish: A: Forberedelse A1.
English: Important information
Danish: Vigtige oplysninger
English: These effects were sustained throughout treatment.
Danish: Disse virkninger blev opretholdt gennem hele behandlingsforløbet.
English: ≥ 2 points on a 0-4 IGA scale.
Danish: ≥ 2 point på en 0-4 IGA skala.
English: Note: You may see an air bubble; this is normal.
Danish: Bemærk: Du vil muligvis se en luftboble; det er normalt.
English: Wash your hands.
Danish: Vask hænder.
English: Recommended injection sites are:
Danish: De anbefalede injektionssteder er:
English: - if you have recently had or are due to have a vaccination.
Danish: - hvis du for nylig har fået, eller det er tid til, at du skal have en vaccination.
English: Thereafter, resume dosing at the regular scheduled time.
Danish: Genoptag derefter dosering på det sædvanlige planlagte tidspunkt.
English: Your doctor will decide how much Dupixent you need and for how long.
Danish: Din læge vil beslutte, hvor meget Dupixent du har brug for og hvor længe.
English: Oral Corticosteroid Reduction Study (VENTURE)
Danish: Oral kortikosteroid-reduktionsstudie (VENTURE)
English: Such signs are listed under “Serious side effects” in section 4.
Danish: Sådanne tegn er angivet i punkt 4 under ”Alvorlige bivirkninger”.
English: • Check that you have the correct product and dose.
Danish: • Tjek at du har det korrekte produkt og den korrekte dosis.
English: Exacerbations per Year
Danish: Eksacerbationer pr. år
English: *Items not included in the carton
Danish: *Ikke inkluderet i kartonen
English: • There will be a “click” when the injection starts.
Danish: • Du vil høre et “klik”, når injektionen begynder.
English: Similar results were observed in VENTURE.
Danish: Lignende resultater blev observeret i VENTUREstudiet.
English: • fainting, dizziness, feeling lightheaded (low blood pressure)
Danish: • besvimelse, svimmelhed, føle sig ør (lavt blodtryk)
English: • cold sores (on lips and skin)
Danish: • forkølelsessår (på læber og hud)
English: Endpoints were assessed at weeks 51 or 52.
Danish: Endepunkter blev vurderet ved uge 51 eller 52.
English: Efficacy and safety in this age group were similar to the overall study population.
Danish: Sikkerhed og virkning i denne aldersgruppe var den samme som i den samlede studiepopulation.
English: Component of a multipack, can't be sold separately.
Danish: Komponenter i en multipakning kan ikke sælges separat.
English: • The window will start to turn yellow.
Danish: • Vinduet vil begynde at skifte farve til gul.
English: If a dose is missed, administer the dose as soon as possible.
Danish: Hvis en dosis glemmes, skal dosen tages snarest muligt.
English: Most patients with conjunctivitis recovered or were recovering during the treatment period.
Danish: Størstedelen af patienterne med conjunctivitis kom sig eller oplevede bedring i behandlingsperioden.
English: less than 60 kg
Danish: under 60 kg
English: A total of 305 patients were treated with dupilumab for at least 1 year.
Danish: I alt 305 patienter blev behandlet med dupilumab i mindst 1 år.
English: EXP Date of removal from the refrigerator: / / /
Danish: EXP Dato taget ud af køleskab: / / /
English: • Check that the entire window has turned to yellow.
Danish: • Tjek at hele vinduet nu er gult.
English: Dupilumab should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Dupilumab bør kun tages under graviditet, hvis den potentielle fordel berettiger den potentielle risiko for fosteret.
English: • swelling of the face, mouth, and tongue
Danish: • hævelse af ansigt, mund og tunge
English: Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Danish: Visse patienter, som indledningsvist udviser delvist respons, kan efterfølgende opnå bedring ved at fortsætte behandlingen ud over 16 uger.
English: Stop using Dupixent and tell your doctor or get medical help immediately if you notice any signs of an allergic reaction.
Danish: Stop brug af Dupixent og fortæl din læge eller søg lægehjælp med det samme, hvis du bemærker tegn på en allergisk reaktion.
English: 16-Week Monotherapy Studies (SOLO 1 and SOLO 2)
Danish: 16-ugers studier med monoterapi (SOLO 1 og SOLO 2)
English: If the window does not turn completely yellow, remove the pen and call your healthcare provider.
Danish: Hvis vinduet ikke bliver helt gult, skal du fjerne pennen og ringe til lægen eller sundhedspersonalet.
English: A5: Wait 30 minutes
Danish: A5: Vent 30 minutter
English: Although no differences in safety or efficacy were observed between older and younger adult atopic dermatitis patients, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.
Danish: Selvom der ikke blev set nogen forskelle i sikkerhed eller effekt mellem ældre og yngre voksne patienter med atopisk dermatitis, var antallet af patienter på 65 år eller derover ikke tilstrækkeligt til at fastslå, om de reagerer anderledes end yngre patienter.
English: Pull the needle out of the skin at the same angle it was inserted.
Danish: Træk kanylen ud af huden i samme vinkel, som den blev indført.
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis.
Danish: Det skal overvejes at stoppe behandling hos patienter, som ikke har udvist respons efter 16 ugers behandling af atopisk dermatitis.
English: It is not known whether this is caused by Dupixent.
Danish: Man ved ikke, om denne tilstand forårsages af Dupixient.
English: Dupixent may weaken your resistance to infections caused by parasites.
Danish: Dupixent kan svække din modstandsevne over for infektioner forårsaget af parasitter.
English: These medicines (especially ones called corticosteroids) must be stopped gradually, under the direct supervision of your doctor and dependent on your response to Dupixent.
Danish: Disse lægemidler (især typen, der kaldes kortikosteroider) skal nedtrappes gradvist under direkte overvågning af din læge og afhænger af, hvordan du reagerer på Dupixent.
English: Less than 0.4 % of patients exhibited high titer ADA responses associated with reduced exposure and efficacy.
Danish: Mindre end 0,4 % af patienterne udviste et respons med høje titre af ADA, der var forbundet med reduceret eksponering og effekt.
English: These events usually, but not always, may be associated with the reduction of oral corticosteroid therapy.
Danish: Disse tilstande kan ofte, men ikke altid, være forbundet med reduktion af oral kortikosteroiddosis.
English: Mean age (years) (SD) % Female % White
Danish: Gennemsnitsalder (år) (SD) % Kvinder % Hvide
English: No adverse interactions between either of the non-live vaccines and dupilumab were noted in the study.
Danish: Ingen problematiske interaktioner mellem nogen af de ikke-levende vacciner og dupilumab blev rapporteret i studiet.
English: In CHRONOS, efficacy was also evaluated at week 52.
Danish: I CHRONOS blev effekt også evalueret ved uge 52.
English: If you live in a region where these infections are common or if you are travelling to such a region check with your doctor.
Danish: Hvis du bor i et område, hvor disse infektioner er almindelige, eller hvis du rejser til et sådant område, skal du spørge din læge til råds.
English: Dupilumab is intended for long-term treatment.
Danish: Dupilumab er beregnet til langtidsbehandling.
English: Conjunctivitis and related events
Danish: Conjunctivitis og relaterede hændelser
English: It is unknown whether dupilumab is excreted in human milk or absorbed systemically after ingestion.
Danish: Det er ukendt, om dupilumab udskilles i human mælk eller absorberes systemisk efter indtagelse.
English: Talk to your doctor if you have any new or worsening eye problems, including eye pain or changes in vision.
Danish: Tal med din læge, hvis du har nogen nye eller forværrede øjenproblemer, herunder øjensmerter eller synsændringer.
English: • Check with your healthcare professional how often you will need to inject the medicine.
Danish: • Tjek med dit sundhedspersonale, hvor ofte du skal injicere lægemidlet.
English: PRO Treatment
Danish: PRO Behandling
English: A total of 325 patients were enrolled, with 210 patients who were previously exposed to ciclosporin and 115 patients who have never been exposed to ciclosporin because ciclosporin treatment was medically inadvisable.
Danish: I alt blev 325 patienter inkluderet, heraf var 210 patienter tidligere blevet eksponeret for ciclosporin og 115 patienter var aldrig blevet eksponeret for ciclosporin, fordi behandling med ciclosporin ikke var tilrådeligt fra et lægeligt synspunkt.
English: Look at the label:
Danish: Se på etiketten:
English: This should be taken into consideration to determine type 2 status in patients taking oral corticosteroids (see section
Danish: Dette bør tages i betragtning ved vurdering af type 2-status hos patienter, der tager oral kortikosteroid (se pkt.
English: CHRONOS at Week 52
Danish: CHRONOS ved uge 52
English: Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with dupilumab.
Danish: Immunogenicitet Som med alle terapeutiske proteiner er immunogenicitet en mulighed med dupilumab.
English: An enhanced pre- and post-natal developmental study revealed no adverse effects in maternal animals or their offspring up to 6 months post-partum/post-birth.
Danish: Et udvidet udviklingsstudie før og efter fødslen viste ingen bivirkninger hos hunner og deres afkom i op til 6 måneder post-partum/efter-fødslen.
English: Step 5: Choose
Danish: Trin 5: Vælg
English: QUEST was a 52-week confirmatory study which included 1,902 patients (12 years of age and older).
Danish: QUEST var et 52 ugers bekræftende studie, som inkluderede 1.902 patienter (12 år og derover).
English: A caregiver may also give you your Dupixent injection after proper training.
Danish: En omsorgsperson kan også give dig din injektion af Dupixent efter passende undervisning.
English: Biomarkers of type 2 inflammation may be suppressed by systemic corticosteroid use.
Danish: Biomarkører for type 2-inflammation kan undertrykkes ved anvendelse af systemisk kortikosteroid.
English: Dupilumab elimination is mediated by parallel linear and nonlinear pathways.
Danish: Elimination af dupilumab medieres af parallelle lineære og non-lineære pathways.
English: Talk to your doctor before you stop Dupixent or if your asthma remains uncontrolled or worsens during treatment with this medicine.
Danish: Tal med din læge, inden du stopper Dupixent, eller hvis din astma forbliver ukontrolleret eller forværres under behandling med dette lægemiddel.
English: You must not try to give yourself or someone else the injection unless you have received training from your healthcare professional.
Danish: Du må ikke forsøge at give dig selv eller en anden person injektionen, medmindre du har fået undervisning af dit sundhedspersonale.
English: You must look out for signs of these conditions (i.e. breathing problems, swelling of the face, mouth, and tongue, fainting, dizziness, feeling lightheaded (low blood pressure), fever, general ill feeling, swollen lymph nodes, hives, itching, joint pain, skin rash) while you are taking Dupixent.
Danish: Du skal se efter tegn på disse tilstande (dvs. vejrtrækningsproblemer, hævelse af ansigt, mund og tunge, besvimelse, svimmelhed, føle sig ør (lavt blodtryk), feber, generel utilpashed, hævede lymfekirtler, nældefeber, kløe, ledsmerter, hududslæt), mens du tager Dupixent.
English: Eye problems (if you have atopic dermatitis)
Danish: Øjenproblemer (hvis du har atopisk dermatitis)
English: If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of dupilumab should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der forekommer en systemisk overfølsomhedsreaktion (umiddelbar eller forsinket), skal administration af dupilumab straks afbrydes og passende behandling indledes.
English: How much Dupixent is given and for how long
Danish: Hvor meget Dupixent skal du have og hvor længe
English: These markers were near maximal suppression after 2 weeks of treatment, except for IgE which declined more slowly.
Danish: Efter 2 ugers behandling var disse markører tæt på maksimal hæmning, med undtagelse af IgE, som var langsommere aftagende.
English: Therefore, patients receiving dupilumab may receive concurrent inactivated or non-live vaccinations.
Danish: Patienter, som får dupilumab, kan derfor få samtidige inaktiverede eller ikke-levende vaccinationer.
English: There is no specific treatment for dupilumab overdose.
Danish: Der er ingen specifik behandling for overdosis af dupilumab.
English: Look at the label
Danish: Se på etiketten
English: Push the plunger rod down slowly and steadily as far as it will go until the syringe is empty.
Danish: Tryk langsomt og støt stemplet helt ned, så langt det kan komme, indtil injektionssprøjten er tom.
English: Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.
Danish: Lokalbehandling med calcineurin-hæmmere kan anvendes, men det skal forbeholdes problemområder, såsom ansigtet, halsen, intertriginøse og genitale områder.
English: Dupilumab is expected to degrade to small peptides and individual amino acids.
Danish: Dupilumab forventes at nedbrydes til små peptider og individuelle aminosyrer.
English: • Check the expiration date.
Danish: • Tjek udløbsdatoen.
English: Keep holding the pre-filled pen firmly against your skin.
Danish: Bliv ved med at holde den fyldte pen fast mod huden.
English: There are limited amount of data from the use of dupilumab in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af dupilumab til gravide kvinder.
English: Do not stop using Dupixent without speaking to your doctor first.
Danish: Stop ikke brugen af Dupixent uden først at tale med din læge.
English: Clinical Response in Patients Not Adequately Controlled with, Intolerant to, or for whom Ciclosporin Treatment was Inadvisable (CAFE study)
Danish: Klinisk respons hos patienter, som ikke opnåede tilstrækkelig kontrol med, var intolerante over for, eller for hvem behandling med ciclosporin ikke var tilrådeligt (CAFE studie)
English: If you develop an allergic reaction, stop using Dupixent and talk to your doctor right away.
Danish: Hvis du udvikler en allergisk reaktion, skal du stoppe brugen af Dupixent og tale med din læge med det samme.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity (including safety pharmacology endpoints) and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen specifik risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser (herunder endepunkter for sikkerhedsfarmakologi) samt reproduktionsog udviklingstoksicitet.
English: In SOLO CONTINUE, a trend for increased treatment-emergent ADA positivity with increased dosing intervals was observed.
Danish: I SOLO CONTINUE blev der observeret en tendens til øget behandlingsrelateret ADA-positivitet med øget doseringsintervaller.
English: The data gathered from this study did not indicate clinically relevant effects of dupilumab on CYP1A2, CYP3A, CYP2C19, CYP2D6, or CYP2C9 activity.
Danish: Data indsamlet under studiet angav ingen klinisk relevante effekter af dupilumab på CYP1A2-, CYP3A-, CYP2C19-, CYP2D6-, eller CYP2C9-aktivitet.
English: Industriepark Hoechst 65926 FRANKFURT AM MAIN GERMANY
Danish: Industriepark Hoechst 65926 Frankfurt am Main Tyskland
English: Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician.
Danish: Reduktion af kortikosteroiddosis skal, om nødvendigt, ske gradvist og foregå under direkte opsyn af en læge.
English: 52-Week Concomitant TCS Study (CHRONOS)
Danish: 52-ugers studie med samtidig TKS (CHRONOS)
English: In adolescents 12 years and older, it is recommended that Dupixent be administered by or under supervision of an adult.
Danish: Hos unge på 12 år og derover anbefales det, at Dupixent gives af en voksen eller under opsyn af en voksen.
English: - if you are allergic to dupilumab or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for dupilumab eller et af de øvrige indholdsstoffer i dupilumab (angivet i punkt 6).
English: The responder rate was defined as an improvement in score of 0.5 or more (scale range 0-6 for ACQ-5 and 1-7 for AQLQ(S)).
Danish: Responsraten blev defineret som en forbedring i score på 0,5 eller derover (skala fra 0 til 6 for ACQ-5 og 1 til 7 for AQLQ(S)).
English: In addition, Dupixent helps improve your sleep disturbance and overall quality of life.
Danish: Dupixent hjælper desuden med at forbedre dine søvnforstyrrelser og den generelle livskvalitet.
English: IL-4 and IL-13 are major drivers of human type 2 inflammatory disease, such as atopic dermatitis and asthma.
Danish: IL-4 og IL-13 er hovedaktører i human type 2-inflammatorisk sygdom, såsom atopisk dermatitis og astma.
English: No age-related pharmacokinetic difference was observed in adolescent patients after correction for body weight.
Danish: Der blev ikke observeret aldersrelaterede farmakokinetiske forskelle hos unge patienter efter korrektion for legemsvægt.
English: Co-Primary Endpoints
Danish: Co-primære endepunkter
English: After a single subcutaneous (SC) dose of 75-600 mg dupilumab, median times to maximum concentration in serum (tmax) were 3-7 days.
Danish: Efter en enkelt subkutan dosis af 75-600 mg dupilumab var den gennemsnitlige tid til maksimal koncentration i serum (tmax) 3-7 dage.
English: • 1 alcohol wipe*
Danish: • 1 alkoholserviet*
English: For information on live vaccines see section 4.4.
Danish: 4.4 for information om levende vacciner.
English: If you already have a parasitic infection it should be treated before you start treatment with Dupixent.
Danish: Hvis du allerede har en parasitinfektion, skal den behandles, inden du begynder behandling med Dupixent.
English: Week 52 (FAS Week 52)b
Danish: Uge 52 (FAS uge 52)b
English: Table 7: Results of the primary and secondary endpoints in SOLO CONTINUE study Placebo
Danish: Tabel 7: Resultater af primære og sekundære endepunkter i SOLO CONTINUE studiet Placebo