FrancophonIA/ELRC3.0 huggingface dataset:
English: From week 3 onwards
Danish: Fra og med 3. uge
English: In an interaction study of single-dose bedaquiline and multiple-dose lopinavir/ritonavir, exposure (AUC) to bedaquiline was increased by 22% [90% CI (11; 34)].
Danish: I et interaktionsstudie af en enkelt dosis bedaquilin og gentagne doser lopinavir/ritonavir steg eksponeringen (AUC) for bedaquilin med 22 % [90 % CI (11; 34)].
English: • abnormal reading on the electrocardiogram called “QT prolongation”.
Danish: • unormalt hjertediagram med "forlænget QT-interval".
English: SIRTURO contains lactose monohydrate
Danish: SIRTURO indeholder lactosemonohydrat
English: Bedaquiline is also bactericidal against dormant (non-replicating) tubercle bacilli.
Danish: Bedaquilin er også baktericidt mod ikke-replikerende tuberkelose bakterier.
English: In an interaction study of single-dose bedaquiline and once daily rifampicin (strong inducer) in healthy subjects, the exposure (AUC) to bedaquiline was reduced by 52% [90% CI (-57; -46)].
Danish: I et interaktionsstudie af en enkelt dosis bedaquilin og én daglig dosis rifampicin (en potent induktor) hos raske forsøgspersoner blev eksponeringen (AUC) for bedaquilin reduceret med 52 % [90 % CI (-57; -46)].
English: These subjects were excluded from the subgroup analysis by extent of resistance of Mycobacterium tuberculosis strain.
Danish: Disse forsøgspersoner blev udelukket for delgruppeanalysen af graden af resistens for Mycobacterium tuberculosis-stamme.
English: Other antituberculosis medicinal products
Danish: Andre tuberkulostatika
English: Since bedaquiline is highly protein-bound, dialysis is not likely to significantly remove bedaquiline from plasma.
Danish: Da bedaquilin binder til proteiner med høj affinitet, er det usandsynligt, at det kan fjernes fra plasma i et væsentligt omfang ved dialyse.
English: Bedaquiline was a weak OCT1, OATP1B1 and OATP1B3 substrate in vitro, while M2 was not.
Danish: Bedaquilin var et svagt OCT1-, OATP1B1- og OATP1B3-substrat in vitro, mens M2 ikke var. Bedaquilin var ikke et substrat for MRP2 og BCRP in vitro.
English: Co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should, therefore, be avoided (see section 4.5).
Danish: Samtidig administration af bedaquilin og moderate eller potente CYP3A4-induktorer til systemisk brug bør derfor undgås (se pkt.
English: In the randomised phase IIb study (C208, stage 2) a higher rate of deaths was seen in the SIRTURO treatment group (12.7%; 10/79 patients) compared to the placebo treatment group (3.7%; 3/81 patients).
Danish: I det randomiserede fase IIb-studie (C208, trin 2) sås større mortalitet i SIRTURO-gruppen (12,7 %, 10/79 patienter) sammenlignet med placebogruppen (3,7 %, 3/81 patienter).
English: Therefore, the combination of bedaquiline and moderate or strong CYP3A4 inhibitors used systemically for more than 14 consecutive days should be avoided.
Danish: En kombination af bedaquilin administreret sammen med moderate eller stærke CYP3A4-hæmmere til systemisk brug bør derfor ikke gives i længere tid end 14 dage i træk.
English: No relevant bedaquiline-related effects on developmental toxicity parameters were observed in rats and rabbits.
Danish: Hos kaniner og rotter sås ingen relevante bedaquilin-relaterede virkninger på udviklingstoksiske parametre.
English: BOTTLE LABEL
Danish: ETIKET PÅ BEHOLDEREN
English: Patients with MDRH&R-TB Patients infected with pre-XDR-TB Overall non-responder* at Week 120
Danish: Samlet antal respondere i uge 120 Patienter med MDRH&R-TB Patienter inficeret med præ-XDR-TB Samlet antal nonrespondere* i uge 120 Manglende konvertering Recidiv
English: Pre-extensively drug resistant tuberculosis (pre-XDR-TB): isolate resistant to isoniazid, rifampicin, and either any fluoroquinolone or at least one second line injectable agent (but not to both a fluoroquinolone and a second line injectable agent).
Danish: Præ-ekstremt resistent tuberkulose (præ-XDR-TB): isolat, der er resistent over for isoniazid, rifampicin og enten ethvert fluorquinolon eller mindst et injicerbart lægemiddel til andenlinjebehandling (men ikke over for både en fluorquinolon og et andenlinje-injicerbart lægemiddel).
English: • A history of or ongoing bradyarrhythmia;
Danish: • anamnestisk eller aktuel bradyarytmi
English: • The other ingredients are: colloidal anhydrous silica, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polysorbate 20.
Danish: lactosemonohydrat, magnesiumstearat, majsstivelse, mikrokrystallinsk cellulose, polysorbat 20.
English: Cases of intentional or accidental acute overdose with bedaquiline were not reported during clinical trials.
Danish: Under de kliniske studier blev der ikke indberettet tilfælde af overlagt eller utilsigtet akut overdosering med bedaquilin.
English: Store in the original container or package in order to protect from light.
Danish: Opbevares i den originale beholder eller pakning for at beskytte mod lys.
English: Extensively drug resistant tuberculosis (XDR-TB): isolate resistant to isoniazid, rifampicin, any fluoroquinolone, and at least one second line injectable agent.
Danish: Ekstremt resistent tuberkulose (XDR-TB): isolat, der er resistent over for isoniazid, rifampicin, ethvert fluorquinolon og mindst et injicerbart lægemiddel til andenlinjebehandling.
English: • you have a decreased thyroid gland function.
Danish: • hvis du har nedsat funktion af skjoldbruskkirtlen.
English: Walterovo náměstí 329/1 CZ158 00 Praha 5 - Jinonice Tel: +420 227 012 227
Danish: CZ-158 00 Praha 5 - Jinonice Tel: +420 227 012 227
English: If co-administration is required, more frequent electrocardiogram monitoring and monitoring of transaminases is recommended.
Danish: Hvis samtidig administration er nødvendig, anbefales hyppigere monitorering af patienten med optagelse af elektrokardiogram og kontrol af aminotransferaser.
English: In a rat carcinogenicity study, bedaquiline, at the high doses of 20 mg/kg/day in males and 10 mg/kg/day in females, did not induce any treatment-related increases in tumour incidences.
Danish: I et karcinogenicitetsstudie med rotter inducerede bedaquilin ingen behandlingsrelateret stigning i tumorincidensen ved de høje doser på 20 mg/kg/dag hos hanner og 10 mg/kg/dag hos hunner.
English: Transaminases increased*
Danish: Forhøjede aminotransferaser*
English: Furthermore, response rates in patients that completed the bedaquiline treatment period were comparable between different race categories in the clinical trials.
Danish: Endvidere sås der sammenlignelige responsrater i de kliniske forsøg uanset race hos patienter, der gennemførte behandlingsperioden med bedaquilin.
English: Check with your doctor or pharmacist.
Danish: Tal med din læge eller apotekspersonalet om dette.
English: QT prolongation (i.e., gatifloxacin, moxifloxacin and sparfloxacin).
Danish: • ledsagende administration af antibiotika i form af fluorquinoloner, som har potentiale for væsentlig forlængelse af QT-intervallet (d.v.s. gatifloxacin, moxifloxacin og sparfloxacin).
English: In the event that co-administration of clofazimine with bedaquiline is necessary, clinical monitoring, including frequent electrocardiogram assessment, is recommended (see section 4.5).
Danish: Hvis samtidig administration af clofazimin og bedaquilin skønnes nødvendig, anbefales klinisk monitorering, inklusive hyppig EKG-vurdering (se pkt.
English: Refer to the Summary of Product Characteristics of the medicinal products used in combination with SIRTURO for their respective adverse reactions.
Danish: For specifikke dosisanbefalinger for de lægemidler, der anvendes i kombination med SIRTURO, henvises til de respektive produktresuméer.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: SIRTURO tabletter indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp lactase deficiency) eller glucose-/galactosemalabsorption.
English: In female rats, there was no effect on mating or fertility with bedaquiline treatment, however some effects were observed in male rats (see section 5.3).
Danish: Hos hunrotter sås ingen virkninger på parring eller fertilitet af behandling med bedaquilin, mens der blev observeret nogle virkninger hos hanrotter (se pkt.
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion.
English: • Weeks 1-2: 400 mg (4 tablets of 100 mg) once daily
Danish: Den anbefalede dosering er: • Uge 1-2: 400 mg (4 tabletter a 100 mg) en gang dagligt
English: General measures to support basic vital functions including monitoring of vital signs and electrocardiogram (QT interval) monitoring should be taken in case of deliberate or accidental overdose.
Danish: I tilfælde af overlagt eller utilsigtet overdosering bør der træffes generelle forholdsregler med henblik på at understøtte de vitale funktioner med monitorering af disse samt optagelse af EKG (QT-interval).
English: No dose adjustment is necessary for SIRTURO in patients with mild or moderate hepatic impairment (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis af SIRTURO hos patienter med let til moderat nedsat leverfunktion (se pkt.
English: Follow-up monitoring of electrolytes should be performed if QT prolongation is detected (see sections 4.5 and 4.8).
Danish: Ved påvisning af QT-forlængelse bør der udføres opfølgende monitorering af elektrolytter (se pkt.
English: 133-fold increases in bedaquiline MIC, resulting in MICs ranging from 0.25 to 4 mg/l.
Danish: Målbaserede mutationer, der blev genereret i prækliniske studier, førte til 8- til 133-fold-stigninger i bedaquilins MIC-værdi, hvilket medførte MIC-værdier på mellem 0,25 og 4 mg/l.
English: Driving and using machines You may feel dizzy after taking SIRTURO.
Danish: Du kan føle dig svimmel efter at have taget SIRTURO.
English: What SIRTURO contains
Danish: SIRTURO indeholder:
English: If you take more SIRTURO than you should
Danish: Hvis du har taget for mange SIRTURO
English: Bedaquiline exposure may be increased during co-administration with inhibitors of CYP3A4.
Danish: Eksponeringen for bedaquilin kan stige under samtidig administration af CYP3A4-hæmmere.
English: Myalgia * Terms represented by ‘transaminases increased' included AST increased, ALT increased, hepatic enzyme increased,
Danish: Myalgi * 'Forhøjede aminotransferaser' omfattede forhøjet ASAT, forhøjet ALAT, forhøjet leverenzym, abnorm leverfunktion og forhøjede aminotransferaser (se afsnittet nedenfor).
English: If you stop taking SIRTURO Do not stop taking SIRTURO without first talking to your doctor.
Danish: Hvis du holder op med at tage SIRTURO Kontakt lægen, hvis du ønsker at holde pause eller stoppe behandlingen med SIRTURO.
English: In patients with severe renal impairment (creatinine clearance < 30 ml/min) or end-stage renal disease requiring haemodialysis or peritoneal dialysis, SIRTURO should be used with caution (see section 5.2).
Danish: SIRTURO bør anvendes med forsigtighed til patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) eller nyresygdom i terminalstadiet, der kræver hæmodialyse eller peritonealdialyse (se pkt.
English: Electrocardiogram QT prolonged
Danish: QT-forlængelse på EKG
English: Twenty-four of these 24-week responders (14.7%) were considered non-responders at week 120, of which 19 patients had prematurely discontinued the trial while being culture converted and 5 patients had experienced relapse.
Danish: 24 af disse 24-ugers respondere (14,7 %) blev betragtet som non-respondere i uge 120.
English: If co-administration is required, more frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4).
Danish: Hvis samtidig administration er nødvendig, anbefales hyppigere monitorering af patienten med optagelse af elektrokardiogram og kontrol af aminotransferaser (se pkt.
English: When bedaquiline is co-administered with other medicinal products that prolong the QTc interval (including delamanid and levofloxacin), an additive or synergistic effect on QT prolongation cannot be excluded (see section 4.5).
Danish: Det kan ikke udelukkes, at der kan forekomme en additiv eller synergistisk virkning på QTforlængelsen, når bedaquilin administreres samtidig med andre lægemidler, der forlænger QTcintervallet (inklusive delamanid og levofloxacin) (se pkt.
English: 6 cells/l (N = 22; see section 4.5).
Danish: (N = 22, se pkt.
English: What SIRTURO is and what it is used for What you need to know before you take SIRTURO How to take SIRTURO
Danish: Det skal du vide, før du begynder at tage SIRTURO Sådan skal du tage SIRTURO Bivirkninger
English: If you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis du ikke kan tåle eller fordøje visse sukkerarter.
English: • feeling or being sick (nausea or vomiting).
Danish: • kvalme eller opkastning
English: System Organ Class (SOC) Frequency Category
Danish: Systemorganklasse
English: Janssen-Cilag International NV
Danish: Janssen-Cilag B.V.
English: • you have human immunodeficiency virus (HIV) infection.
Danish: • hvis du er hiv-positiv.
English: For example,
Danish: For eksempel kan du tage
English: If you have missed a dose and you are not sure what to do, talk to your doctor or pharmacist.
Danish: Kontakt lægen eller apotekspersonalet, hvis du har glemt en dosis, og du er i tvivl om, hvad du skal gøre.
English: Clinical Breakpoints
Danish: Kliniske grænseværdier
English: The doctor should consider stopping treatment if no improvement has been seen during this time.
Danish: Lægen bør overveje at stoppe behandlingen, hvis der ikke i løbet af denne periode ses en forbedring.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cosentyx on 15 January 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cosentyx den 15. januar 2015.
English: The safety profile was considered reassuring, with the main concern related to mild infections.
Danish: Sikkerhedsprofilen blev anset for betryggende, og den primære bekymring er relateret til milde infektioner.
English: The dose to be used depends on the disease to be treated.
Danish: Dosis afhænger af, hvilken sygdom der behandles.
English: This is a summary of the European public assessment report (EPAR) for Cosentyx.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cosentyx.
English: The full EPAR and risk management plan summary for Cosentyx can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Cosentyx findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Cosentyx is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Cosentyx anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cosentyx's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Cosentyx overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: An improvement is usually seen within 16 weeks of treatment.
Danish: Der ses typisk en forbedring i løbet af 16 ugers behandling.
English: Other information about Cosentyx
Danish: Andre oplysninger om Cosentyx
English: Because Cosentyx may increase the risk of infection, it must not be given to patients with serious active infections such as tuberculosis.
Danish: Da Cosentyx kan øge risikoen for infektion, må det ikke gives ved en alvorlig aktiv infektion såsom tuberkulose.
English: Cosentyx is an anti-inflammatory medicine used to treat adult patients with:
Danish: Cosentyx er et antiinflammatorisk lægemiddel, der anvendes til at behandle voksne patienter med:
English: Most of the side effects are mild to moderate in severity.
Danish: De fleste bivirkninger er lette til moderate.
English: What measures are being taken to ensure the safe and effective use of Cosentyx?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cosentyx?
English: Some patients with an initial partial improvement may see further improvements with continued treatment beyond 16 weeks.
Danish: Nogle patienter oplever indledningsvist en delvis forbedring og kan have gavn af fortsat behandling efter de første 16 uger.
English: The most common side effects with Cosentyx (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds) with inflammation of the nose and throat (nasopharyngitis) and blocked or runny nose (rhinitis).
Danish: De hyppigste bivirkninger med Cosentyx (som optræder hos mere end 1 ud af 10 personer) er forkølelse (øvre luftvejsinfektioner) med inflammation af næse og svælg (nasofaryngitis) og tilstoppet eller løbende næse (rhinitis).
English: The active substance in Cosentyx, secukinumab, is a monoclonal antibody, a type of protein, designed to recognise and attach to a messenger molecule in the immune system called interleukin 17A.
Danish: Det aktive stof i Cosentyx, secukinumab, er et monoklonalt antistof (et protein), der er opbygget, så det genkender og bindes til et signalmolekyle i immunsystemet, der hedder interleukin 17A.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cosentyx, 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 Cosentyx, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: It is not intended to provide practical advice on how to use Cosentyx.
Danish: Det er ikke en praktisk vejledning i, hvordan Cosentyx bør anvendes.
English: In addition, 65% of patients given Cosentyx had clear or nearly clear skin, compared with 27% of patients given etanercept and 2% of those given placebo.
Danish: Derudover opnåede 65 % af de patienter, der fik Cosentyx, klar eller næsten klar hud sammenlignet med 27 % af de patienter, der fik etanercept, og 2 % af dem, der fik placebo.
English: Cosentyx can only be obtained with a prescription and treatment should only be given under the supervision of a doctor with experienced in diagnosing and treating the conditions for which Cosentyx is used.
Danish: Cosentyx fås kun på recept, og behandlingen bør kun iværksættes og overvåges af en læge med erfaring i diagnose og behandling af de lidelser, som Cosentyx anvendes mod.
English: It contains the active substance secukinumab.
Danish: Cosentyx indeholder det aktive stof secukinumab.
English: • moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin) when the patient needs systemic (whole body) treatment;
Danish: • moderat til svær plaque-psoriasis (en sygdom, der medfører røde, skællende hudpartier), når patienten behøver systemisk behandling (af hele kroppen)
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine) when conventional treatments do not work well enough.
Danish: • ankyloserende spondylitis (en sygdom, der forårsager betændelse og smerter i rygleddene), når konventionelle behandlinger ikke virker godt nok.
English: What is Cosentyx and what is it used for?
Danish: Hvad er Cosentyx, og hvad anvendes det til?
English: Why is Cosentyx approved?
Danish: Hvorfor blev Cosentyx godkendt?
English: For the full list of all side effects and restrictions with Cosentyx, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Cosentyx fremgår af indlægssedlen.
English: By attaching to and blocking the action of interleukin 17A, secukinumab reduces the activity of the immune system and the symptoms of the disease.
Danish: Når secukinumab bindes til interleukin 17A og blokerer dets virkning, dæmper det immunsystemets aktivitet og symptomerne på sygdommen.
English: Studies showed that Cosentyx is effective in treating psoriasis, psoriatic arthritis and ankylosing spondylitis, with patients showing greater improvements with Cosentyx than with placebo (a dummy treatment) or with a comparator medicine, etanercept.
Danish: Undersøgelserne viste, at Cosentyx er effektivt til at behandle psoriasis, psoriasis-artritis og ankyloserende spondylitis, og at patienterne oplevede større forbedringer med Cosentyx end med placebo (uvirksomt stof) eller et sammenligningspræparat, etanercept.
English: What are the risks associated with Cosentyx?
Danish: Hvilke risici er der forbundet med Cosentyx?
English: This molecule is involved in the inflammation and other immune system processes that cause psoriasis and are involved in psoriatic arthritis and ankylosing spondylitis.
Danish: Dette molekyle medvirker ved inflammation og andre immunprocesser, der er årsag til psoriasis, og som er involveret i psoriasis-artritis og ankyloserende spondylitis.
English: For more information about treatment with Cosentyx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cosentyx, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • psoriatic arthritis (inflammation of the joints associated with psoriasis) when disease-modifying anti-rheumatic drugs (DMARDs) do not work well enough;
Danish: • psoriasis-artritis (betændelse i leddene, der er relateret til psoriasis), når sygdomsmodificerende antireumatiske lægemidler (DMARD'er) ikke virker godt nok
English: The medicine has been shown to be of substantial clinical benefit in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis.
Danish: Det er påvist, at lægemidlet har væsentlig klinisk fordel for patienter med psoriasis, psoriasis-artritis og ankyloserende spondylitis.
English: The medicine is available as a powder used to make a solution for injection, or as a ready-to-use solution in a pre-filled syringe or pen injector.
Danish: Lægemidlet fås som pulver, der anvendes til fremstilling af en injektionsvæske, og som injektionsvæske i fyldte sprøjter eller penne, der er klar til brug.
English: Cosentyx is given by injection under the skin as four weekly injections followed by monthly maintenance injections.
Danish: Cosentyx injiceres under huden én gang om ugen i fire uger og derefter én gang om måneden (vedligeholdelsesbehandling).
English: In 4 psoriasis studies involving 2,403 patients, 79% of those on Cosentyx achieved a 75% reduction in their PASI scores (a measure of disease severity and area of skin affected) after 12 weeks of treatment.
Danish: I 4 psoriasis-studier med i alt 2 403 patienter opnåede 79 % af dem, der fik Cosentyx, en reduktion på 75 % i deres PASI-score (en skala til måling af sygdommens sværhedsgrad og det berørte hudområde) efter 12 ugers behandling.
English: For practical information about using Cosentyx, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cosentyx, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In a study of 397 patients with psoriatic arthritis, between 51% and 54% of patients on the approved doses of Cosentyx achieved a 20% reduction in ACR scores (painful, swollen joints and other symptoms) after 24 weeks.
Danish: I et studie med 397 patienter med psoriasis-artritis opnåede 51-54 % af de patienter, der fik godkendte doser af Cosentyx en 20 %-reduktion i ACR-score (smertefulde, hævede led og andre symptomer) efter 24 ugers behandling.