FrancophonIA/ELRC3.0 huggingface dataset:
English: Enurev Breezhaler capsules, which contain a powder for inhalation, are only used with the Enurev Breezhaler inhaler and must not be swallowed.
Danish: Enurev Breezhaler-kapsler, som indeholder et pulver til inhalation, anvendes udelukkende med Enurev Breezhaler-inhalatoren og må ikke sluges.
English: Therefore, the Agency decided that Enurev Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet afgjorde, at fordelene ved Enurev Breezhaler opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Enurev Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Danish: De bivirkninger, der er indberettet for Enurev Breezhaler, vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule.
Danish: Dosis tages ved, at patienten anbringer en kapsel i inhalatoren og indånder pulveret fra kapslen gennem munden.
English: The European Medicines Agency noted that Enurev Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD.
Danish: Agenturet bemærkede, at Enurev Breezhaler havde en beskeden, men relevant gavnlig virkning hos patienterne med hensyn til forbedring af lungefunktionen og også viste sig at forbedre symptomerne på KOL.
English: What is Enurev Breezhaler and what is it used for?
Danish: Hvad er Enurev Breezhaler, og hvad anvendes det til?
English: Enurev Breezhaler is used for maintenance (regular) treatment.
Danish: Enurev Breezhaler anvendes til (regelmæssig) vedligeholdelsesbehandling.
English: Enurev Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Enurev Breezhaler er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: Why is Enurev Breezhaler authorised in the EU?
Danish: Hvorfor er Enurev Breezhaler godkendt i EU?
English: An overview of Enurev Breezhaler and why it is authorised in the EU
Danish: Oversigt over Enurev Breezhaler, og hvorfor det er godkendt i EU
English: Enurev Breezhaler (glycopyrronium bromide)
Danish: Enurev Breezhaler (glycopyrroniumbromid)
English: What are the risks associated with Enurev Breezhaler?
Danish: Hvilke risici er der forbundet med Enurev Breezhaler?
English: The active substance in Enurev Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Danish: Det aktive stof i Enurev Breezhaler, glycopyrroniumbromid, er en muskarin receptorantagonist.
English: Enurev Breezhaler can only be obtained with a prescription.
Danish: Enurev Breezhaler udleveres kun på recept.
English: For the full list of side effects and restrictions with Enurev Breezhaler, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Enurev Breezhaler fremgår af indlægssedlen.
English: Other information about Enurev Breezhaler
Danish: Andre oplysninger om Enurev Breezhaler
English: Enurev Breezhaler contains the active substance glycopyrronium bromide.
Danish: Enurev Breezhaler indeholder det aktive stof glycopyrroniumbromid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enurev Breezhaler have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Enurev Breezhaler.
English: How is Enurev Breezhaler used?
Danish: Hvordan anvendes Enurev Breezhaler?
English: What benefits of Enurev Breezhaler have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Enurev Breezhaler?
English: Enurev Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Danish: Det blev i to hovedundersøgelser med i alt 1 888 patienter med KOL påvist, at Enurev Breezhaler er mere effektivt end placebo (en uvirksom behandling) til at lindre symptomerne på KOL.
English: How does Enurev Breezhaler work?
Danish: Hvordan virker Enurev Breezhaler?
English: Content (concentration)
Danish: Indhold (Koncentrati on)
English: Cartridge (glass) 3 ml (3.5 mg/ml) 1 cartridge
Danish: 1 cylinderampul
English: For all indications
Danish: For alle indikationer
English: There is no need to rush your injection - 5 minutes gives you enough time.
Danish: Det er ingen grund til, at du skynder dig med injektionen - 5 minutter giver dig rigeligt tid.
English: • Wash your hands thoroughly.
Danish: • Vask dine hænder grundigt.
English: The time left is shown on screen.
Danish: Den tilbageværende tid vises på skærmen.
English: Your doctor can provide advice.
Danish: Lægen kan rådgive dig.
English: Not known (frequency cannot be estimated from the available data):
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data):
English: These data are reasonably in agreement with observed data.
Danish: Disse data er i rimelig overensstemmelse med observerede data.
English: Component of a multipack, cannot be sold separately
Danish: Del af multipakning, kan ikke sælges separat
English: - Certain vaccinations may cause infections.
Danish: - Visse vaccinationer kan medføre infektion.
English: The value of these data to the evaluation of human risk may be limited.
Danish: Værdien af denne dokumentation for evalueringen af risikoen for mennesker kan være begrænset.
English: • spontaneous abortion.
Danish: • spontan abort.
English: For each injection you will need:
Danish: Til hver injektion skal du bruge:
English: Medication level indicator 3.
Danish: Indikator for medicinniveau 3.
English: CH-1630 Bulle Switzerland
Danish: CH-1630 Bulle Schweiz
English: Micro-USB Port
Danish: Mikro-USB-port
English: - You can change this speed using the “scroll wheel” on the side of your ava.
Danish: - Du kan ændre denne hastighed ved at anvende ”rullehjulet” på siden af ava.
English: • general physical health deterioration.
Danish: • generel svækkelse af den fysiske helbredstilstand.
English: • after 16 weeks if you have plaque psoriasis.
Danish: • efter 16 uger, hvis du har plaque psoriasis.
English: • AutoClicks pre-filled pen is designed to work accurately and safely.
Danish: • AutoClicks fyldte pen er lavet til at fungere præcist og sikkert.
English: The device is provided separately.
Danish: Anordningen udleveres separat.
English: This can take up to 15 seconds.
Danish: Dette kan tage op til 15 sekunder.
English: Antibodies are proteins that specifically recognise and bind to other proteins.
Danish: Antistoffer er proteiner, der genkender og binder sig til visse andre proteiner.
English: As this medecine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Danish: Da du får denne medicin af din læge eller sygeplejerske, er det usandsynligt, at du vil få for meget.
English: All patients had a history of heavy smoking.
Danish: Alle patienter havde en fortid med massiv rygning.
English: - Try to relax as this will make the injection more comfortable.
Danish: - Prøv at slappe af, det vil gøre injektionen mere behagelig.
English: Injection device: ava
Danish: Injektionsanordning: ava
English: * Hodges-Lehmann point estimate of shift and 95% asymptotic (Moses) confidence interval.
Danish: * Hodges-Lehmann punktestimat af skift og 95% asymptotisk (Moses) konfidensinterval.
English: Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Danish: Regelmæssig undersøgelse af huden anbefales, især hos patienter med risikofaktorer for hudcancer.
English: The C-EARLY trial met its primary and key secondary endpoints.
Danish: C-EARLY-studiet mødte dets primære og vigtigste sekundære endepunkter.
English: It can take up to 10 seconds to empty the syringe.
Danish: Det kan tage op til 10 sekunder at tømme sprøjten.
English: • multiple sclerosis*
Danish: • multipel sclerose*
English: This will make sure you are giving the injection correctly.
Danish: Dette sikrer, at du indgiver injektionen korrekt.
English: •The needle safety device will not activate unless the entire dose is given.
Danish: • Nålens sikkerhedsanordning aktiveres ikke, medmindre hele dosen er injiceret.
English: This will take 30 minutes.
Danish: Dette tager 30 minutter.
English: The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Danish: De øvrige tilfælde repræsenterede en række forskellige maligniteter, herunder sjældne maligniteter, der som regel er forbundet med immunsuppression.
English: PASI 90 at Week 16 was a key secondary endpoint in all 3 studies.
Danish: PASI 90 i uge 16 var et vigtigt sekundært effektmål i alle 3 studier.
English: ASAS 40 was a secondary endpoint.
Danish: ASAS 40 var et sekundært endepunkt.
English: (Stevens-Johnson syndrome)
Danish: (Stevens-Johnsons syndrom)
English: Percentage response based upon number of subjects contributing data (n) to that endpoint and time point which may differ from N
Danish: Procentrespons er baseret på antallet af deltagere, der bidrager (n) til dette effektmål og tidspunkt, hvilket kan være forskelligt fra N
English: The CIMPACT study evaluated 559 patients.
Danish: CIMPACT-studiet evaluerede 559 patienter.
English: Non-responder imputation was used for missing data.
Danish: Nonrespondent imputation blev brugt til manglende data.
English: This medicinal product is for single use only.
Danish: Dette lægemiddel er kun til engangsanvendelse.
English: • antibody directed against normal tissue
Danish: • antistof rettet mod normalt væv
English: Do not try to touch the needle as it could activate the pre-filled pen.
Danish: Forsøg ikke at berøre nålen, da det kan aktivere den fyldte pen.
English: It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Danish: Det er meget vigtigt, at du fortæller det til lægen, hvis du nogensinde har haft tuberkulose, eller hvis du har været i tæt kontakt med en person, som har haft tuberkulose.
English: - In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
Danish: - Hos nogle patienter producerer kroppen ikke tilstrækkeligt af de blodlegemer, som hjælper kroppen med at bekæmpe infektioner eller stoppe blødninger.
English: Cimzia has not been studied in these patient populations.
Danish: Cimzia er ikke blevet undersøgt hos disse patientpopulationer.
English: - You can choose “slowest”, “slow”, “fast” or “fastest” - this controls how fast the medicine will be injected and should be selected (and adjusted) as per your personal comfort preference.
Danish: - Du kan vælge ”langsomst”, ”langsom”, ”hurtig” eller ”hurtigst” - dette angiver hvor hurtigt medicinen bliver injiceret og bør vælges (og justeres) i forhold den hastighed, du personligt foretrækker.
English: Radiographic set with linear extrapolation.
Danish: Radiografisk sæt med lineær ekstrapolation.
English: Take care not to touch the needle or let the needle touch any surface.
Danish: Vær omhyggelig med ikke at berøre nålen eller lade nålen røre nogen overflade.
English: Hold the pre-filled pen straight (at a 90° degree angle) against the skin, that previously has been cleaned (the “injection site”).
Danish: Hold den fyldte pen lodret (i en 90 graders vinkel) mod huden, som tidligere er blevet renset (”injektionsstedet”).
English: • You must also carefully read the full instructions in the ava User Manual.
Danish: • Du skal også læse hele vejledningen i ava brugermanualen nøje.
English: At this time, the injection will be complete.
Danish: Injektionen vil nu være afsluttet.
English: This will take 30 to 45 minutes.
Danish: Dette tager 30 til 45 minutter.
English: The results at week 34 are shown in Table 7.
Danish: Resultaterne ved uge 34 er vist i tabel 7.
English: The baseline PGA score ranged from moderate (70%) to severe (30%).
Danish: Baseline PGA-scoren gik fra moderat (70 %) til svær (30 %).
English: Hepatitis B virus (HBV) reactivation
Danish: Reaktivering af Hepatitis B-virus (HBV)
English: • Release the skin with the first hand.
Danish: • Slip huden med den første hånd.
English: - The medication contains 1ml of Cimzia and is not completely full - this is normal.
Danish: - Medicinen indeholder 1 ml Cimzia og er ikke helt fuld - dette er normalt.
English: Frequency categories are defined as follows: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1000 to < 1/100); Rare (≥ 1/10,000 to < 1/1000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvensgrupperne er defineret som følger: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Therefore, early detection of any infection, particularly atypical clinical presentations of a serious infection, is critical to minimise delays in diagnosis and initiation of treatment.
Danish: Derfor er tidlig påvisning af enhver infektion, især kliniske atypiske tegn på en alvorlig infektion, afgørende for at mindske forsinkelser af diagnosticering og initiering af behandling.
English: In vitro functional studies of human vacuolated macrophages indicated all functions tested were retained.
Danish: In vitrofunktionsstudier af humane vakuoliserede makrofager indikerede, at alle testede funktioner blev bevaret.
English: - If you have moderate to severe HEART FAILURE.
Danish: - Hvis du har moderat til alvorligt HJERTESVIGT.
English: • Do not remove the needle cap until ava instructs you to do so.
Danish: • Tag ikke nålehætten af, før ava instruerer dig i at gøre det.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Danish: Denne sjældne type af T-celle-lymfom har et meget aggressivt sygdomsforløb og er sædvanligvis dødelig.
English: The pH of the solution is approximately 4.7.
Danish: Opløsningens pH er ca. 4,7.
English: Patient numbers
Danish: Patient antal
English: This number decreases with increasing doses of concomitant MTX treatment.
Danish: Dette antal falder med stigende doser af samtidig behandling med MTX.
English: Check that the red “medication level indicator” is at the top of the cartridge.
Danish: Kontroller at den røde ”medicinniveau-indikator” er i toppen af kassetten.
English: • The needle will automatically move back into the empty pen.
Danish: • Nålen vil automatisk trækkes tilbage i den tømte pen.
English: The primary efficacy variable was the Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) response at Week 52.
Danish: Den primære effektvariabel var Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) respons ved uge 52.
English: The terminal elimination phase half-life (t1/2) was approximately 14 days for all doses tested.
Danish: Den terminale eliminationsfasehalveringstid (t1/2) var tilnærmelsesvis 14 dage for alle doser, som blev undersøgt.
English: • Merkel cell carcinoma (a type of skin cancer)*
Danish: • Merkelcellekarcinom (en type hudkræft)*
English: There is no evidence of an increased risk of infections with continued exposure over time.
Danish: Der er ingen evidens for en øget risiko for infektioner med fortsat eksponering over tid.
English: **These events have been related to the class of TNF-antagonists.
Danish: **Disse hændelser er relateret til gruppen af TNF-antagonister.
English: Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
Danish: Forsøg ikke at selv-injicere før du er sikker på, at du er klar over, hvordan du skal forberede og give injektionen.
English: ASDAS-MI Week 52
Danish: ASDAS-MI Uge 52
English: Do not inject until the skin is dry.
Danish: - Injicér ikke, før huden er tør.
English: As clearance decreases with decreasing body weight, females may generally obtain somewhat higher systemic exposure of certolizumab pegol.
Danish: Eftersom clearance aftager med faldende legemsvægt, kan kvinder generelt opnå en noget højere systemisk eksponering for certolizumab pegol.
English: If the viewing window turns orange and you hear a second click this means the injection has been completed.
Danish: Hvis kontrolvinduet bliver orange, og du hører et yderligere klik, betyder det, at injektionen er afsluttet.
English: In rare occasions tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis.
Danish: I sjældne tilfælde kan tuberkulose udvikles under behandlingen, også selv om du har fået forebyggende behandling mod tuberkulose.
English: Response rates and p-values based on a logistic regression model.
Danish: Responsrater og p-værdier baseret på en logistisk regressionsmodel.
English: Subject who escaped or withdrew (based on not achieving PASI 50 response) were treated as non-responders at Week 48.
Danish: Forsøgspersoner, der forsvandt eller trak sig ud (baseret på ikke at opnå PASI 50 respons) blev behandlet som non-respondenter i uge 48.
English: Other aPTT assays may be affected as well.
Danish: Andre APTT-analyser kan muligvis også være påvirket.
English: The injection begins when a first “click” is heard and the orange band at the bottom of the pre-filled pen disappears.
Danish: Injektionen begynder, når det første ”klik” lyder, og det orange bånd i bunden af den fyldte pen forsvinder.
English: • Store ava in the storage case after use.
Danish: • Opbevar ava i opbevaringskassen efter brug.
English: (On/Off button) for 1 second, or until the screen lights up and you hear sound - “Hello” is displayed for 2 seconds - this means ava is switched on.
Danish: (Tænd/sluk-knappen) i 1 sekund, eller indtil skærmen tænder og du hører lyden - ”Hej” vises på skærmen i 2 sekunder - dette betyder at ava er tændt.
English: - Avoid removing ava from the skin during the injection to ensure that you receive the full dose.
Danish: - Undgå at fjerne ava fra huden under injektionen, for at sikre, at du får hele dosen.
English: 87.7% of patients received concomitant NSAIDs.
Danish: 87,7% af patienter fik samtidig NSAID.
English: Vaccinations - Talk to your doctor if you have had, or are due to have a vaccine.
Danish: Vaccinationer - Tal med lægen hvis du har fået eller skal have en vaccination.
English: If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Danish: Hvis du har KOL eller er storryger, skal du drøfte med lægen, om behandling med en TNF-blokker er hensigtsmæssig for dig.
English: Do not stop using Cimzia without talking to your doctor first.
Danish: Du må ikke stoppe med at bruge Cimzia uden at tale med lægen først.
English: • trouble breathing, swallowing (multiple causes for these symptoms)
Danish: • besvær med at trække vejret, synke (adskillige årsager til disse symptomer)
English: Study RA-II Methotrexate combination (24 weeks)
Danish: Studie RA-II Methotrexat kombination (24 uger)
English: ASDAS-MI response was defined as an ASDAS reduction (improvement) ≥ 2.0 relative to baseline or as reaching the lowest possible score.
Danish: ASDAS-MI-respons var defineret som en ASDAS-reduktion (forbedring) ≥ 2,0 sammenlignet med baseline eller opnåelse af den lavest mulige score.
English: Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Danish: Visse patienter, som indledningsvist udviste delvis respons, kan efterfølgende blive bedre ved at fortsætte behandling i længere tid end 16 uger.
English: These 3 groups were well balanced with regards to clinical response following the active run-in period (ACR 20: 83-84% at week 18).
Danish: Disse 3 grupper var velafbalancerede i forhold til klinisk respons efter den aktive indkøringsperiode (ACR20: 83-84% ved uge 18).
English: The mean PASI score at baseline was 20 and ranged from 12 to 69.
Danish: Den gennemsnitlige PASI score ved baseline var 20 og gik fra 12 til 69.
English: The maximum duration of the study was 204 weeks.
Danish: Studiets maksimale varighed var 204 uger.
English: You can inject yourself or the injection can be given by someone else (caregiver).
Danish: Du kan selv injicere eller injektionen kan gives af en anden (omsorgsperson).
English: The Fab' fragment comprises protein compounds and is expected to be degraded to peptides and amino acids by proteolysis.
Danish: Fab'fragmentet omfatter proteinstoffer og forventes at blive nedbrudt til peptider og aminosyrer ved proteolyse.
English: - If you have a nervous system disorder, such as multiple sclerosis, your doctor will decide whether you should use Cimzia.
Danish: - Hvis du har en sygdom i nervesystemet, såsom multipel sklerose, vil din læge beslutte, om du skal bruge Cimzia.
English: • bacterial infections in any site (a collection of pus)
Danish: • bakterieinfektioner på et hvilket som helst sted (pusansamling)
English: • increased iron levels in the body
Danish: • forhøjet indhold af jern i kroppen
English: Eighteen percent of patients reported a history of psoriatic arthritis at baseline.
Danish: Atten procent af patienterne rapporterede en historik med psoriasis artritis ved baseline.
English: • swollen face, hands, feet (angioedema)
Danish: • hævelser i ansigt, hænder, fødder (angioødem)
English: Date of latest renewal: 16 May 2014
Danish: Dato for første markedsføringstilladelse: 1. oktober 2009 Dato for seneste fornyelse: 16. maj 2014
English: However, the available clinical experience is too limited to, with a reasonable certainty, conclude that there is no increased risk associated with Cimzia administration during pregnancy.
Danish: Tilgængelig klinisk erfaring er imidlertid for begrænset til, at det med rimelig sikkerhed kan konkluderes, at der ikke er nogen forøget risiko forbundet med administration af Cimzia under graviditet.
English: Patients were predominantly men (64%) and Caucasian (94%), with a mean age of 45.7 years (18 to 80 years); of these, 7.2% were ≥ 65 years of age.
Danish: Patienter var hovedsagligt mænd (64 %) og kaukasiske (94 %), med en gennemsnitsalder på 45,7 år (18 til 80 år); af disse var 7,2 % ≥ 65 år.
English: Needle (inside cap) 7.
Danish: Nål (inde i hætten) 7.
English: Study AS0006, performed in subjects without radiographic signs of inflammation in the SI joints, confirmed the effect previously demonstrated in this subgroup in the AS001 study.
Danish: Studie AS0006, udført hos personer uden radiografiske tegn på inflammation i SI-leddene, bekræftede den virkning, der tidligere var påvist i denne undergruppe i AS001-studiet.
English: Mean baseline BSA was 25% and ranged from 10% to 96%.
Danish: Gennemsnitlig baseline BSA var 25 % og gik fra 10 % til 96 %.
English: • Turn on ava:
Danish: • Tænd ava:
English: • Firmly push the flat end cap into the medication/injection port at the bottom of ava - push until you hear a click.
Danish: • Skub den flade endehætte ind i medicin-/injektionsporten i bunden af ava - skub indtil du hører et klik.
English: 1: Orange band 2: Viewing window 3: Black handle 4: Clear cap
Danish: 1: Orange bånd 2: Kontrolvindue 3: Sort håndtag 4: Klar kanylehætte
English: Information screen
Danish: Informationsskærm
English: - Position ava at a right angle on your skin with the screen facing you.
Danish: - Anbring ava på huden i en ret vinkel med skærmen vendt imod dig.
English: In the clinical trials, there was an apparently higher incidence of infections among subjects ≥ 65 years of age, compared to younger subjects, although experience is limited.
Danish: I de kliniske studier var der en tydeligt højere forekomst af infektioner blandt personer ≥ 65 år sammenlignet med yngre personer, selvom erfaringen er begrænset.