FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of dimethyl fumarate at oral doses of 25, 100, and 250 mg/kg/day to pregnant rats during the period of organogenesis resulted in maternal adverse effects at 4 times the recommended dose on an AUC basis, and low fetal weight and delayed ossification (metatarsals and hindlimb phalanges) at 11 times the recommended dose on an AUC basis.
Danish: Oral administration af dimethylfumarat i doser på 25, 100 og 250 mg/kg/dag til drægtige rotter under organogenesen resulterede i negative virkninger hos moderdyret ved 4 gange den anbefalede dosis baseret på AUC samt lav fostervægt og forsinket ossifikation (metatarsal og posterior ekstremitet falanks) ved 11 gange den anbefalede dosis baseret på AUC.
English: In the majority of patients who experienced flushing, it was mild or moderate in severity.
Danish: Hos hovedparten af de patienter, der oplevede rødme, var sværhedsgraden let til moderat.
English: The benefit of breast-feeding for the child and the benefit of therapy for the woman should be taken into account.
Danish: Det skal besluttes, om amning eller behandling med Tecfidera skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Prescribers and patients should be alert to this possibility in the event of severe flushing reactions (see sections 4.2, 4.5 and 4.8).
Danish: Ordinerende læger og patienter skal være opmærksomme på dette i tilfælde af svær blussen eller rødme (se pkt.
English: Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate
Danish: Hver hård enterokapsel indeholder 120 mg dimethylfumarat
English: Tecfidera 120 mg gastro-resistant hard capsules are green and white and printed with ‘BG-12 120 mg' and are available in packs containing 14 capsules.
Danish: Tecfidera 120 mg hårde enterokapsler er grønne og hvide og præget med ‘BG-12 120 mg'.
English: Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate
Danish: Hver hård enterokapsel indeholder 240 mg dimethylfumarat
English: How Tecfidera works
Danish: Sådan virker Tecfidera
English: Gastrointestinal
Danish: Gastrointestinale gener
English: Clinical Endpointsa
Danish: Kliniske endepunktera
English: Each capsule contains 120 mg dimethyl fumarate Read the package leaflet before use Keep out of the sight and reach of children
Danish: Hver hårde enterokapsel indeholder 120 mg dimethylfumarat Læs indlægssedlen inden brug
English: Tecfidera was evaluated in a prospective open-label, uncontrolled study in 22 paediatric patients with
Danish: Tecfidera blev evalueret i et prospektivt, åbent, ikke kontrolleret studie med 22 pædiatriske patienter i alderen 13 til 17 år (4 patienter ≤ 14 år) med RRMS.
English: If you take more Tecfidera than you should
Danish: Hvis du har taget for meget Tecfidera
English: Tecfidera 120mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate.
Danish: Tecfidera 120 mg enterokapsler, hårde Hver hård enterokapsel indeholder 120 mg dimethylfumarat.
English: Common White blood cell count decreased Common 1 Adverse reactions derived only during post marketing experience
Danish: 1Bivirkninger kun fra erfaring efter markedsføring
English: - medicines that affect the body's immune system including other medicines used to treat
Danish: - medicin, der påvirker nyrerne, herunder nogle antibiotika (til behandling af infektioner),
English: Thu.
Danish: Tors.
English: In patients with flushing, the majority had flushing events that were mild or moderate in severity.
Danish: Hos patienter med rødme var bivirkningen let til moderat hos flertallet.
English: Talk to your doctor before taking Tecfidera if you have: - severe kidney disease - severe liver disease - a disease of the stomach or bowel - a serious infection (such as pneumonia)
Danish: - en alvorlig nyresygdom - en alvorlig leversygdom - en sygdom i maven eller tarmsystemet
English: If you forget or miss a dose, do not take a double dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: If you have a serious infection (such as pneumonia), talk to your doctor immediately proteins (albumin) in urine increase in levels of liver enzymes (ALT, AST) in the blood
Danish: - protein i urinen - forhøjet niveau af leverenzymer (ALAT, ASAT) i blodet
English: Tecfidera 240 mg gastro-resistant hard capsules are green and printed with ‘BG-12 240 mg' and are available in packs containing 56 or 168 capsules.
Danish: Tecfidera 240 mg hårde enterokapsler er grønne og præget med ‘BG-12 240 mg'.
English: Hepatic impairment
Danish: Hård enterokapsel
English: Potential risks associated with acetylsalicylic acid therapy should be considered prior to co-administration with Tecfidera in patients with Relapsing Remitting MS. Long term (> 4 weeks) continuous use of acetylsalicylic acid has not been studied (see sections 4.4 and 4.8).
Danish: Langvarig (> 4 uger) vedvarende brug af acetylsalicylsyre er ikke blevet undersøgt (se pkt.
English: Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate
Danish: Tecfidera 240 mg hårde enterokapsler dimethylfumarat
English: Tecfidera 120 mg gastro-resistant hard capsules dimethyl fumarate
Danish: Tecfidera 120 mg hårde enterokapsler dimethylfumarat
English: Side effects which may show up in your blood or urine tests low levels of white blood cells (lymphopenia, leucopenia) in the blood.
Danish: Bivirkninger, som kan påvises i blod- eller urinprøver
English: Tecfidera 240mg gastro-resistant hard capsules
Danish: Tecfidera 240 mg enterokapsler, hårde
English: Proportion with 12-week confirmed disability progression
Danish: Gennemsnitligt antal (medianværdi) Gdlæsioner efter 2 år
English: Tecfidera 120mg gastro-resistant hard capsules
Danish: Tecfidera 120 mg enterokapsler, hårde
English: Tecfidera 240mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate For the full list of excipients, see section 6.1.
Danish: Tecfidera 240 mg enterokapsler, hårde Hver hård enterokapsel indeholder 240 mg dimethylfumarat.
English: Abdominal pain upper
Danish: Smerter i den øverste del af abdomen
English: MRI Endpointsb
Danish: Endepunkter ved MRskanningb
English: Appropriate measures to manage and minimize the risks, including the need for close monitoring during and after administration of BRINAVESS.
Danish: Hensigtsmæssige forholdsregler til at håndtere og minimere risici herunder behovet for tæt monitorering under og efter administration af BRINAVESS.
English: • Acute coronary syndrome (including myocardial infarction) within the last 30 days
Danish: • Akut koronarsyndrom (herunder myokardieinfarkt) inden for de seneste 30 dage.
English: Patient selection criteria, including contraindications, special warnings and precautions for use and information about patient populations with limited information from clinical trials.
Danish: Kriterier til udvælgelse af patienter herunder kontraindikationer, særlige advarsler og forholdsregler for anvendelse og information om patientpopulationer, hvor der er begrænset information fra kliniske undersøgelser.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller restriktioner vedrørende sikker og effektiv anvendelse af lægemidlet som beskrevet nedenfor, bliver implementeret:
English: The Marketing Authorisation Holder shall ensure that all Healthcare Professionals (HCP) involved in the administration of BRINAVESS are provided with a healthcare professional information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle i sundhedspersonalet, der er involveret i administration af BRINAVESS, får informationspakken til læger og sundhedspersonale, som indeholder følgende:
English: The number of vials of BRINAVESS concentrate required to prepare the appropriate quantity of solution for the treatment of an individual patient will depend on the patient's weight, and the vial size.
Danish: Det antal hætteglas af BRINAVESS-koncentrat, der er nødvendigt for at tilberede den rigtige mængde opløsning til behandling af den enkelte patient, afhænger af patientens vægt og størrelsen på hætteglasset.
English: Only a well-qualified healthcare professional should administer BRINAVESS and should frequently monitor the patient for the duration of the infusion and for at least 15 minutes after the completion of the infusion for signs and symptoms of a sudden decrease in blood pressure or heart rate (see section 4.4).
Danish: Kun en velkvalificeret læge må administrere BRINAVESS, og patienten skal monitoreres hyppigt under hele infusionsforløbet og i mindst 15 minutter efter afsluttet infusion for tegn og symptomer på pludseligt fald i blodtryk eller hjertefrekvens (se pkt.
English: BRINAVESS should be administered by intravenous infusion in a monitored clinical setting appropriate for cardioversion.
Danish: BRINAVESS skal administreres som intravenøs infusion under monitorering i et klinisk miljø, der er egnet til konvertering.
English: Educational material for Healthcare Professionals Summary of Product Characteristics, Package Leaflet and Labelling
Danish: Undervisningsmateriale til læger og sundhedspersonale Produktresumé, indlægsseddel og etikettering
English: Instructions on dose calculation, preparation of the solution for infusion, and method of administration.
Danish: Instruktion i dosisberegning, tilberedning af opløsning til infusion samt indgivelsesmåde.
English: • Resumption or initiation of oral-maintenance antiarrhythmic therapy can be considered 2 hours after BRINAVESS administration.
Danish: - Genoptagelse eller initiering af oral vedligeholdelsesbehandling med antiarytmika kan overvejes 2 timer efter administration af BRINAVESS.
English: Risk of atrial flutter may be increased in patients receiving class I AADs.
Danish: Risikoen for atrieflagren kan være forøget hos patienter, der får klasse I antiarytmika.
English: • Patients with severe aortic stenosis, patients with systolic blood pressure <100 mm Hg, and patients with heart failure class NYHA III and NYHA IV.
Danish: • Patienter med svær aortastenose, patienter med systolisk blodtryk <100 mm Hg og patienter med hjerteinsufficiens NYHA III og NYHA IV
English: • Patients with prolonged QT at baseline (uncorrected > 440 msec), or severe bradycardia, sinus node dysfunction or second degree and third degree heart block in the absence of a pacemaker.
Danish: • Patienter med forlænget QT-interval ved baseline (ukorrigeret >440 ms) eller svær bradykardi, sinusknudedysfunktion eller 2. grads og 3. grads AV-blok uden pacemaker.
English: • BRINAVESS should be used with caution in patients on oral AADs (class I and III), due to limited experience.
Danish: - BRINAVESS bør anvendes med forsigtighed hos patienter, der får orale antiarytmika (klasse I og III) pga. begrænset erfaring.
English: • Use of intravenous rhythm control anti-arrhythmics (class I and class III) within 4 hours prior, as well as in the first 4 hours after, to BRINAVESS administration.
Danish: • Brug af intravenøe antiarytmika til rytmekontrol (klasse I og III) op til 4 timer før samt i de første 4 timer efter administration af BRINAVESS.
English: - Alert HCP for adverse events, which may occur after BRINAVESS administration, including hypotension, bradycardia, atrial flutter, or ventricular arrhythmia.
Danish: - Læger og sundhedspersonale skal gøres opmærksom på bivirkninger, der kan forekomme efter administration af BRINAVESS herunder hypotension, bradykardi, atrieflagren eller ventrikulær arytmi.
English: - Alert HCP about the need of precautions when using BRINAVESS in haemodynamically stable patients with congestive heart failure NYHA I and NYHA II and the need to monitor patients with valvular heart disease closely.
Danish: - Læger og sundhedspersonale skal gøres opmærksom på behovet for forholdsregler, når BRINAVESS anvendes til hæmodynamisk stabile patienter med venstresidig hjerteinsufficiens NYHA I og NYHA II, og behovet for tæt monitorering af patienter med valvulær hjertesygdom.
English: • BRINAVESS can not be recommended in patients previously administered intravenous AADs (class I and III) 4-24 hours prior to vernakalant, due to lack of data.
Danish: - BRINAVESS bør ikke gives til patienter, der tidligere har fået intravenøse antiarytmika (klasse I og III) 4-24 timer før vernakalant pga. manglende data.
English: - Alert HCP about BRINAVESS special warnings and precautions in patients with, clinically meaningful valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis, previously documented LVEF ≤ 35%, advanced hepatic impairment.
Danish: - Læger og sundhedspersonale skal gøres opmærksom på særlige advarsler og forsigtighedsregler for BRINAVESS hos patienter med klinisk betydningsfuld valvulær stenose, hypertrofisk obstruktiv kardiomyopati, restriktiv kardiomyopati eller konstriktiv perikaridit, tidligere dokumenteret venstre ventrikel ejektionsfraktion ≤35%, fremskreden leverinsufficiens.
English: • Intravenous rhythm control AADs should not be used in the first 4 hours after BRINAVESS administration.
Danish: - Intravenøs rytmekontrol med antiarytmika bør ikke anvendes i de første 4 timer efter administration af BRINAVESS.
English: - Alert HCP for use of AADs (anti-arrhythmic drugs) prior to or after BRINAVESS.
Danish: - Læger og sundhedspersonale skal gøres opmærksom på anvendelse af antiarytmika før og efter BRINAVESS.
English: - Alert HCP on BRINAVESS contraindications:
Danish: - Læger og sundhedspersonale skal gøres opmærksom på kontraindikationerne for BRINAVESS:
English: BRINAVESS may be available in different vial sizes [available vial sizes to be inserted locally].
Danish: BRINAVESS vil måske kunne fås i forskellige hætteglasstørrelser.
English: The study lasted six months.
Danish: Undersøgelsen varede seks måneder.
English: Similar results were seen in the second study after a year.
Danish: Der blev observeret lignende resultater i den anden undersøgelse efter et år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adenuric on 21 April 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Adenuric den 21. april 2008.
English: The full EPAR for Adenuric can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Adenuric findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (80 and 120 mg).
Danish: Det fås som tabletter (80 og 120 mg).
English: This is a summary of the European public assessment report (EPAR) for Adenuric.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Adenuric.
English: A risk management plan has been developed to ensure that Adenuric is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Adenuric anvendes så sikkert som muligt.
English: Patients received either Adenuric or allopurinol for 7 to 9 days.
Danish: Patienterne modtog enten Adenuric eller allopurinol i 7-9 dage.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adenuric.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Adenuric.
English: For more information about treatment with Adenuric, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Adenuric, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This usually reduces blood uric acid levels within two weeks, but the dose can be increased to 120
Danish: Dette reducerer normalt blodets indhold af urinsyre inden for to uger, men dosen kan øges til 120 mg en
English: Adenuric should be started two days before chemotherapy and continued for at least 7 days.
Danish: Behandling med Adenuric skal påbegyndes to dage før kemoterapi og fortsætte i mindst 7 dage.
English: These side effects were mostly mild or moderate in severity.
Danish: Disse bivirkninger var oftest af let til moderat sværhedsgrad.
English: Adenuric is a medicine that contains the active substance febuxostat.
Danish: Adenuric er et lægemiddel, der indeholder det aktive stof febuxostat.
English: Rare serious hypersensitivity (allergic) reactions to Adenuric have occurred post-marketing.
Danish: Der er forekommet sjældne alvorlige overfølsomhedsreaktioner (allergiske reaktioner) over for Adenuric efter markedsføringen.
English: Blood uric acid levels were measured every month.
Danish: Niveauet af urinsyre i blodet blev målt hver måned.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after two to four weeks.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom gang dagligt, hvis blodets indhold af urinsyre forbliver højt (over 6 mg pr. deciliter) efter to til fire uger.
English: Other information about Adenuric
Danish: Øvrige oplysninger om Adenuric
English: The Committee decided that Adenuric's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget fandt, at fordelene ved Adenuric er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Adenuric.
English: The main measure of effectiveness was the number of patients whose final three blood uric acid levels were below 6 mg/dl.
Danish: Det primære effektmål var antallet af patienter, hvis sidste tre målinger af urinsyre i blodet var under 6 mg/dl.
English: What measures are being taken to ensure the safe and effective use of Adenuric?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Adenuric?
English: When this happens in the joints and causes pain, it is known as ‘gout'.
Danish: Når det sker i leddene og forårsager smerter, kaldes det ”podagra” eller ”urinsyregigtanfald”.
English: In both studies, allopurinol was used at a dose of 300 mg once a day, except in patients with kidney problems, who took 100 mg.
Danish: I begge undersøgelser blev allopurinol anvendt i en dosis på 300 mg en gang dagligt undtagen hos patienter med nyreproblemer, som fik 100 mg.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Adenuric, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Adenuric herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.
Danish: Hos patienter, der får kemoterapi, forventes en formindskelse af niveauerne af urinsyre at reducere risikoen for tumorlysis-syndrom.
English: This was compared with 22% of the patients taking allopurinol (60 out of 268) and none of the 134 patients taking placebo.
Danish: Det blev sammenlignet med 22 % af de patienter, som modtog allopurinol (60 ud af 268) og ingen af de 134 patienter, som modtog placebo.
English: Adenuric treatment should not be stopped if an attack of gout occurs.
Danish: Behandlingen med Adenuric skal ikke ophøre, hvis der kommer et urinsyregigtanfald.
English: It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Danish: Det virker ved at blokere et enzym kaldet ”xanthinoxidase”, som er nødvendigt for, at kroppen kan producere urinsyre.
English: By reducing the production of uric acid, Adenuric can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Danish: Ved at reducere produktionen af urinsyre kan Adenuric reducere niveauet af urinsyre i blodet og holde det lavt og derved standse opbygningen af krystaller.
English: For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, Adenuric has been studied in one main study involving 346 adult patients undergoing chemotherapy for blood cancer.
Danish: Til behandling og forebyggelse af hyperurikæmi hos patienter, der gennemgik kemoterapi, er Adenuric blevet undersøgt i en hovedundersøgelse, hvori der deltog 346 voksne patienter, der fik kemoterapi mod blodkræft.
English: For the full list of all side effects and restrictions with Adenuric, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Adenuric fremgår af indlægssedlen.
English: Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys.
Danish: Hyperurikæmi kan medføre, at der dannes og opbygges uratkrystaller i leddene og nyrerne.
English: Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Adenuric.
Danish: Derfor anbefales det, at patienter tager andre lægemidler for at forebygge urinsyregigtanfald i mindst de første seks måneder af behandlingen med Adenuric.
English: For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, the recommended dose is 120 mg once a day.
Danish: Til behandling og forebyggelse af hyperurikæmi hos patienter, der gennemgår kemoterapi, er den anbefalede dosis 120 mg én gang dagligt.
English: Adenuric is used in patients who already have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones', larger deposits of urate crystals that can cause joint and bone damage).
Danish: Adenuric anvendes til patienter, som allerede har symptomer på opbygning af krystaller, herunder arthrose (smerter og inflammation i leddene) eller tophi (”sten”, større aflejringer af uratkrystaller, som kan medføre led- og knogleskader).
English: Adenuric was more effective than allopurinol and placebo in treating hyperuricaemia by reducing blood uric acid levels.
Danish: Adenuric var mere effektivt end allopurinol og placebo til at behandle hyperurikæmi ved at nedsætte niveauet af urinsyre i blodet.
English: Adenuric is used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Danish: Adenuric anvendes til behandling af voksne med langvarig hyperurikæmi (et højt indhold af urinsyre eller ”urat” i blodet).
English: The active substance in Adenuric, febuxostat, reduces the formation of uric acid.
Danish: Det aktive stof i Adenuric, febuxostat, reducerer dannelsen af urinsyre.
English: The first study, carried out in 1,072 patients, compared three doses of Adenuric (80, 120 and 240 mg once a day) with placebo (a dummy treatment) and allopurinol (another medicine used to treat hyperuricaemia).
Danish: Den første undersøgelse, som omfattede 1 072 patienter, sammenlignede tre doser Adenuric (80, 120 og 240 mg en gang dagligt) med placebo (en virkningsløs behandling) og med allopurinol (et andet lægemiddel til behandling af hyperurikæmi).
English: In the first study, 48% of the patients taking 80 mg Adenuric once a day (126 out of 262) and 65% of the patients taking 120 mg once a day (175 out of 269) had levels of uric acid below 6 mg/dl in the final three measurements.
Danish: I den første undersøgelse havde 48 % af patienterne, som modtog 80 mg Adenuric en gang dagligt (126 ud af 262), og 65 % af de patienter, som modtog 120 mg en gang dagligt (175 ud af 269), et urinsyreniveau under 6 mg/dl i de sidste tre målinger.