FrancophonIA/ELRC3.0 huggingface dataset:
English: In this case, roflumilast treatment should be reassessed (see section 4.4).
Danish: I et sådan tilfælde bør roflumilastbehandling revurderes (se pkt.
English: Co-administration with an antacid (combination of aluminium hydroxide and magnesium hydroxide) did not alter the absorption or pharmacokinetics of roflumilast or its N-oxide.
Danish: Samtidig administration af et antacidum (en kombination af aluminiumhydroxid og magnesiumhydroxid) ændrede hverken absorptionen eller farmakokinetikken af roflumilast eller dets N-oxid.
English: There is no evidence for an immunotoxic, skin sensitising or phototoxic potential.
Danish: Der er ikke evidens for immunotoksicitet, hudsensibilisering eller fototoksicitet.
English: Daxas is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms).
Danish: Daxas er ikke beregnet til behandling af et pludseligt anfald af åndenød (akutte bronkospasmer).
English: Allergic reactions may affect the skin and in rare cases cause swelling of the eyelids, face, lips and tongue, possibly leading to difficulties in breathing and/or a drop in blood pressure and accelerated heartbeat.
Danish: Allergiske reaktioner kan påvirke huden og i sjældne tilfælde forårsage hævelse af øjenlåg, ansigt, læber og tunge, hvilket muligvis kan medføre vejrtrækningsbesvær og/eller blodtryksfald og øget hjerterytme (puls).
English: Blood creatine phosphokinase (CPK) increased
Danish: Forhøjet kreatinfosfokinase (CPK) i blodet
English: Therefore, the 250-micrograms dose should be used only as a starting dose (see sections 5.1 and 5.2).
Danish: Derfor bør 250 mikrogram dosis kun anvendes som startdosis (se pkt 5.1 og 5.2).
English: • Obligation to conduct post-authorisation measures
Danish: •Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Danish: Titandioxid (E171) Jernoxid, gul (E172)
English: Roflumilast targets the PDE4A, 4B and 4D splicing variants with similar potency in the nanomolar range.
Danish: Roflumilast virker med samme potens på splejsningsvarianterne PDE4A, 4B og 4D i det nanomolære område.
English: Clinical data are considered insufficient to recommend dose adjustment and caution should be observed in patients with mild liver impairment (Child-Pugh A).
Danish: De kliniske data anses for utilstrækkelige til at anbefale dosisjustering og forsigtighed bør udvises hos patienter med let nedsat leverfunktion (Child-Pugh A).
English: Adverse reactions with roflumilast in clinical COPD studies and post-marketing experience
Danish: Bivirkninger ved roflumilast i kliniske KOL-studier og post marketing erfaring.
English: The most commonly reported adverse reactions were diarrhoea (5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%) and headache (1.7%).
Danish: De hyppigst rapporterede bivirkninger var diarré (5,9%), vægttab (3,4%), kvalme (2,9%), abdominalsmerter (1,9%) og hovedpine (1,7%).
English: The design of the studies was parallel-group, double-blind and placebo-controlled.
Danish: Studierne var designet som dobbeltblindede og placebokontrollerede studier med parallelgruppebehandling.
English: Plasma protein binding of roflumilast and its N-oxide metabolite is approximately 99% and 97%, respectively.
Danish: Plasmaproteinbindingen af roflumilast og dets N-oxidmetabolit er henholdsvis ca. 99% og 97%.
English: Available pharmacokinetic data in animals have shown excretion of roflumilast or its metabolites in milk.
Danish: De tilgængelige farmakokinetiske data fra dyrestudier viser, at roflumilast eller dets metabolitter udskilles i mælk.
English: The educational pack should contain the following:
Danish: Uddannelsespakken skal indeholde følgende:
English: Maximum plasma concentrations of roflumilast typically occur approximately one hour after dosing (ranging from 0.5 to 2 hours) in the fasted state.
Danish: Maksimal plasmakoncentration af roflumilast opnås typisk ca. 1 time efter dosering (varierende fra 0,5 til 2 timer) i fastende tilstand.
English: Long-term administration at the 250 micrograms dose level may not induce sufficient PDE4 inhibition to exert clinical efficacy.
Danish: Langtidsbehandling med 250 mikrogram doseringen kan ikke inducere en tilstrækkelig PDE4-inhibition til at opnå klinisk effekt.
English: The potential cardiac risk: Daxas has not been studied in patients in congestive heart failure (NYHA grade3 and 4); hence, it is not recommended in this population.
Danish: Den potentielle kardielle risiko: Daxas er ikke undersøgt hos patienter med kongestiv hjerteinsufficiens (NYHA grad 3 og 4) og derfor ikke anbefales til denne population.
English: Maintenance dose
Danish: Vedligeholdelsesdosering
English: • Copies of the patient card to be given to patients or caregivers before they receive Daxas
Danish: • Kopier af patientkortet, der skal udleveres til patienter eller plejere ved udskrivning af Daxas
English: Prolongation of gestation was seen in mice.
Danish: Forlængelse af drægtighedsperioden blev observeret hos mus.
English: Daxas may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Danish: Daxas kan tages sammen med andre lægemidler, der anvendes til behandling af KOL såsom inhalerede eller orale steroider eller bronkodilatatorer.
English: You may also experience sleeplessness (common), anxiety (uncommon), nervousness (rare), panic attack (rare) or depressive mood (rare).
Danish: Du kan også opleve søvnløshed (almindelig), angst (ikke almindelig), nervøsitet (sjælden), panikanfald (sjælden) eller nedtrykthed/depressivt humør (sjælden).
English: The plasma AUC of the N-oxide metabolite on average is about 10-fold greater than the plasma AUC of roflumilast.
Danish: AUC for N-oxidmetabolitten i plasma er gennemsnitligt omkring 10 gange større end plasma AUC for roflumilast.
English: That Daxas may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Danish: At Daxas kan forårsage vægttab, og patienter regelmæssigt skal kontrollere og registrere deres vægt på patientkortet.
English: Daxas 500 micrograms may need to be taken for several weeks to achieve its full effect (see sections 5.1 and 5.2).
Danish: Daxas 500 mikrogram skal muligvis tages i flere uger for at opnå fuld effekt (se pkt.
English: Thus, the N-oxide metabolite is considered to be the main contributor to the total PDE4 inhibitory activity in vivo.
Danish: Således anses N-oxidmetabolitten for at være den væsentligste bidragsyder til den samlede PDE4-hæmmende aktivitet in vivo.
English: This helps to stop narrowing of airways occurring in chronic obstructive pulmonary disease (COPD).
Danish: Dette hjælper til at stoppe den forsnævring af luftvejene, der opstår ved kronisk obstruktiv lungesygdom (KOL).
English: 250 micrograms once a day is a sub-therapeutic dose, and should be used only as a starting dose for the first 28 days (see sections 4.2 and 5.2).
Danish: 250 mikrogram én gang dagligt er en subterapeutisk dosering, der kun bør anvendes som startdosis de første 28 dage (se punkt 4.2 og
English: The pharmacokinetics of roflumilast and its N-oxide metabolite are dose-proportional over a range of doses from 250 micrograms to 1,000 micrograms.
Danish: Farmakokinetikken for roflumilast og dets N-oxidmetabolit er dosisproportionale over et dosisinterval fra 250 mikrogram til 1.000 mikrogram.
English: There was a trend towards a reduction in moderate or severe exacerbations in subjects treated with roflumilast compared with placebo over 52 weeks, which did not achieve statistical significance (Table 2).
Danish: Der var en tendens til en reduktion af moderate og svære eksacerbationer hos forsøgspersoner, der blev behandlet over 52 uger med roflumilast sammenlignet med placebo; statistisk signifikans blev ikke nået (tabel 2).
English: Roflumilast is a PDE4 inhibitor, a non-steroid, anti-inflammatory active substance designed to target both the systemic and pulmonary inflammation associated with COPD.
Danish: Roflumilast er en PDE4-inhibitor, et non-steroidt, anti-inflammatorisk aktivt stof rettet mod både den systemiske og den pulmonale inflammation, som er associeret med KOL.
English: The risks and benefits of starting or continuing treatment with roflumilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended.
Danish: Risici og fordele skal nøje vurderes ved opstart eller ved fortsat behandling med roflumilast hos patienter, der fortæller om tidligere eller eksisterende psykiske forstyrrelser, eller hvis der er påtænkt samtidig behandling med andre lægemidler, der har en kendt psykiatrisk bivirkningsprofil.
English: Daxas contains lactose
Danish: Daxas indeholder lactose
English: However, Cmax and tmax of roflumilast N-oxide are unaffected.
Danish: Men Cmax og tmax for roflumilast N-oxid er uændrede.
English: Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied and therefore treatment of these patients is not recommended.
Danish: Patienter med hjerteinsufficiens (NYHA grad 3 og 4) er ikke undersøgt, hvorfor behandling af den type patienter ikke kan anbefales.
English: Roflumilast is extensively metabolised in humans, with the formation of a major pharmacodynamically active metabolite, roflumilast N-oxide.
Danish: Roflumilast metaboliseres i udstrakt grad hos mennesker under dannelse af en væsentlig farmakodynamisk aktiv metabolit, roflumilast N-oxid.
English: In one of two rat embryofetal development studies, a higher incidence of incomplete skull bone ossification was seen at a dose producing maternal toxicity.
Danish: I et af to studier af embryoføtal udvikling hos rotter, observeredes en højere incidens af ufuldstændig ossifikation af kranieknogler ved en dosis, som forårsagede toksicitet hos moderen.
English: That they should tell their doctor if they have a history of any of the following conditions
Danish: At de skal informere læge, hvis de har en medicinsk historie med en af følgende tilstande:
English: This study should be appropriate to compare the incidences of all-cause mortality, major cardiovascular events, new diagnosis of cancer, all-cause hospitalisation, hospitalisation related to respiratory disease, suicide or hospitalisation for suicide attempt, and new diagnosis of depression, tuberculosis or viral hepatitis B or C in roflumilast treated COPD patients compared with COPD patients not treated with roflumilast.
Danish: Dette studie skal være hensigtsmæssigt til at sammenligne hyppigheden af alle dødsfald, større kardiovaskulære hændelser, nydiagnostiserede tilfælde af cancer, hospitalsindlæggelser uanset årsag, hospitalsindlæggelser relateret til luftvejslidelser, selvmord eller hospitalsindlæggelser pga. selvmordsforsøg samt nydiagnostiserede tilfælde af depression, tuberkulose og viral hepatitis B eller C hos roflumilastbehandlede KOL-patienter versusKOL-patienter, der ikke behandles med roflumilast.
English: Daxas is to be used in addition to bronchodilators.
Danish: Daxas skal anvendes som tillæg til bronkodilatatorer.
English: Volume of distribution for single dose of 500 micrograms roflumilast is about 2.9 l/kg.
Danish: Fordelingsvolumen for en enkelt dosis på 500 mikrogram roflumilast er ca. 2,9 l/kg.
English: Steady state plasma concentrations of roflumilast and its N-oxide metabolite are reached after approximately 4 days for roflumilast and 6 days for roflumilast N-oxide following once-daily dosing.
Danish: Steady state plasmakoncentrationer af roflumilast og dets N-oxid-metabolit opnås efter ca. 4 dage for roflumilast og ca. 6 dage for roflumilast N-oxid efter dosering 1 gang dagligt.
English: The effect of Daxas may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy).
Danish: Virkningen af Daxas kan forringes, hvis det tages sammen med rifampicin (antibiotika) eller sammen med fenobarbital, karbamazepin eller fenytoin (medicin der normalt gives til behandling af epilepsi).
English: Patients should be advised to check their body weight on a regular basis.
Danish: Patienter bør rådes til regelmæssigt selv at kontrollere deres kropsvægt.
English: In clinical studies and post-marketing experience, rare instances of suicidal thinking and behaviour (including suicide) were reported.
Danish: I kliniske studier og efter markedsføring af lægemidlet er der i sjældne tilfælde rapporteret om selvmordstanker og selvmordslignende adfærd (inklusive selvmord).
English: • insomnia, anxiety, depression, changes in behaviour or mood, suicidal ideation or behaviour
Danish: • Søvnløshed, angst, depression, ændringer i adfærd eller humør, selvmordslignende tanker eller adfærd
English: The plasma clearance after short-term intravenous infusion of roflumilast is about 9.6 l/h.
Danish: Plasmaclearance efter en kortvarig intravenøs infusion af roflumilast er omkring 9,6 l/t.
English: D-16515 Oranienburg Germany
Danish: D-16515 Oranienburg Tyskland
English: The study assessed the effect of roflumilast on COPD exacerbation rate in patients treated with fixed combinations of LABA and inhaled corticosteroids, compared to placebo.
Danish: Studiet vurderede effekten af roflumilast på hyppigheden af KOL-eksacerbationer hos patienter, der blev behandlet med en fast kombination af LABA og inhalationskortikosteroid, versus placebo.
English: The N-oxide metabolite is the major metabolite observed in the plasma of humans.
Danish: N-oxidmetabolitten er den mest aktive metabolit observeret i human plasma.
English: Seventeen (1.8%) patients in the roflumilast group and 18 (1.9%) patients in the placebo group died during the double-blind treatment period due to any reason and 7 (0.7%) patients in each group due to a COPD exacerbation.
Danish: 17 (1,8 %) af patienterne i roflumilast-gruppen og 18 (1,9 %) af patienterne i placebo-gruppen døde i løbet af den dobbeltblinde behandlingsperiode af forskellige årsager og 7 (0,7 %) af patienterne i hver gruppe på grund af en KOL-eksacerbation.
English: The European Medicines Agency has waived the obligation to submit the results of studies with roflumilast in all subsets of the paediatric population in chronic obstructive pulmonary disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med roflumilast i alle undergrupper af den pædiatriske population for kronisk obstruktiv lungesygdom (se pkt.
English: The patient card should include an area where patients can record their weight and the date they weighed themselves and they should be asked to bring the patient card with them at each visit.
Danish: Patientkortet skal indeholde et skema, hvor vægt og dato for vægt kan noteres, når patienten kontrolvejer sig selv og de skal bedes om, at bringe patientkortet med til hver konsultation.
English: If you stop taking Daxas
Danish: Hvis du holder op med at tage Daxas
English: Rare instances of suicidal ideation and behaviour, including completed suicide, have been observed in patients with and without a history of depression, usually in the first weeks of treatment.
Danish: Sjældne tilfælde af selvmordsrelaterede tanker og adfærd, herunder fuldførte selvmord, er observeret hos patienter med eller uden tidligere depression, ofte inden for de første uger af behandlingen.
English: Therefore, the concomitant treatment with theophylline is not recommended.
Danish: Derfor kan samtidig behandling med theofyllin ikke anbefales.
English: 16515 Oranienburg Germany
Danish: 16515 Oranienburg Tyskland
English: The observed adverse reactions for roflumilast in Study RO-2455404-RD were in line with those already included in section 4.8.
Danish: De observerede bivirkninger for roflumilast i studie RO-2455-404-RD var i overensstemmelse med dem, der allerede indgår under pkt.
English: A total of 1935 patients were randomised to doubleblind medication and approximately 70% were also using a long-acting muscarinic antagonist (LAMA) through the course of the trial.
Danish: I alt 1.935 patienter blev randomiseret til dobbeltblind medicinering, og ca. 70 % fik også en langtidsvirkende muskarinreceptor-antagonist (LAMA) gennem studieforløbet.
English: Adverse events rates were independent of concomitant treatment with inhaled corticosteroids.
Danish: Bivirkningsfrekvenser var uafhængige af samtidig behandling med inhalerede kortikosteroider.
English: Special clinical conditions
Danish: Særlige kliniske tilstande
English: Warnings and precautions Talk to your doctor or pharmacist before taking Daxas.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Daxas.
English: Takeda GmbH Production Site Oranienburg Lehnitzstrasse 70-98
Danish: Takeda GmbH Production site Oranienburg Lehnitzstraße 70-98
English: In case of an allergic reaction, stop taking Daxas and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital.
Danish: Hvis du får en allergisk reaktion, skal du stoppe med at tage Daxas og straks kontakte læge eller skadestue.
English: Roflumilast or placebo treatment was added to continuous treatment with a long-acting bronchodilator, in particular salmeterol in Study M2-127 or tiotropium in Study M2-128.
Danish: Roflumilast eller placebo blev lagt oven i fast behandling med en langtidsvirkende bronkodilatator, særligt salmeterol i studie M2-127 og tiotropium i studie M2-128.
English: This leads to symptoms such as coughing, wheezing, chest tightness or difficulty in breathing.
Danish: Dette fører til symptomer som hoste, hvæsen, trykken for brystet eller vejrtrækningsbesvær.
English: Sudden attack of breathlessness
Danish: Pludseligt anfald af åndenød
English: Rodent-specific toxicity in the nasal mucosa was observed in repeat-dose toxicity and carcinogenicity studies.
Danish: Gnaver-specifik toksicitet i næseslimhinden blev observeret i repeat-dose-toksicitetsstudier og carcinogenicitetsstudier.
English: If you forget to take Daxas
Danish: Hvis du har glemt at tage Daxas
English: There are no clinical data to support the concomitant treatment with theophylline for maintenance therapy.
Danish: Der findes ikke kliniske data, som understøtter samtidig behandling med theofyllin som vedligeholdelsesbehandling.
English: The other ingredients are lactose monohydrate (see section 2 under “Daxas contains lactose”), maize starch, povidone, magnesium stearate.
Danish: De øvrige indholdsstoffer er: lactosemonohydrat (se punkt 2 under ”Daxas indeholder lactose”), majsstivelse, povidon, magnesiumstearat.
English: In vitro studies and clinical interaction studies suggest that the metabolism of roflumilast to its N-oxide metabolite is mediated by CYP1A2 and 3A4.
Danish: In vitro-studier og kliniske interaktionsstudier tyder på, at metabolisering af roflumilast til dets N-oxidmetabolit er medieret af CYP1A2 og 3A4.
English: Inhibition of PDE4 leads to elevated intracellular cAMP levels and mitigates COPD-related malfunctions of leukocytes, airway and pulmonary vascular smooth muscle cells, endothelial and airway epithelial cells and fibroblasts in experimental models.
Danish: Hæmning af PDE4 fører til forhøjede intracellulære cAMP-niveauer og mindsker KOL-associerede dysfunktioner af leukocytter, glatte muskelceller i luftvejenes og lungernes kar, endotelceller og luftvejsepitelceller og fibroblaster i eksperimentelle modeller.
English: More patients in the roflumilast group (27.6%) than placebo (19.8%) withdrew study medication due to any reason (risk ratio: 1.40; 95% CI: 1.19 to 1.65).
Danish: Flere patienter i roflumilast-gruppen (27,6 %) end i placebo-gruppen (19,8 %) seponerede studiemedicineringen af forskellige årsager (risikoratio: 1,40; 95 % CI: 1,19-1,65).
English: Roflumilast is not recommended in women of childbearing potential not using contraception.
Danish: Roflumilast frarådes til kvinder i den fertile alder, der ikke anvender kontraception.
English: A pre-specified sensitivity analysis using the negative binomial regression model treatment showed a statistically significant difference of -14.2% (rate ratio: 0.86; 95% CI: 0.74 to 0.99).
Danish: I en præspecificeret følsomhedsanalyse med anvendelse af den negative binomiale regressionsmodel viste behandling en statistisk signifikant forskel på -14,2 % (risiko ratio: 0,86; 95 % CI: 0,74-0,99).
English: Daxas is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Danish: Daxas anvendes til vedligeholdelsesbehandling af svær KOL hos voksne, der tidligere har haft hyppige forværringer af symptomerne på sygdommen KOL (dette kaldes eksacerbationer), og som lider af kronisk bronkitis.
English: Post-bronchodilator FEV1 showed a clinically significant improvement in favour of roflumilast by 56 mL over placebo (95% CI: 38, 73 mL).
Danish: Post-bronkodilatator-FEV1 viste en klinisk signifikant forbedring til fordel for roflumilast med 56 ml over placebo (95 % CI: 38-73 ml).
English: Following an oral dose, the median plasma effective half-life of roflumilast and its N-oxide metabolite are approximately 17 and 30 hours, respectively.
Danish: Efter en oral dosis, er medianværdien af den effektive plasmahalveringstid for roflumilast og dens N-oxidmetabolit henholdsvis ca. 17 og 30 timer.
English: Roflumilast is not recommended during pregnancy.
Danish: Roflumilast bør ikke anvendes under graviditet.
English: Treatment with roflumilast may lead to a higher risk of sleep disorders (mainly insomnia) in patients with a baseline body weight of <60 kg, due to a higher total PDE4 inhibitory activity found in these patients (see section 4.8).
Danish: Behandling med roflumilast kan medføre en større risiko for søvnforstyrrelser (hovedsageligt søvnløshed) hos patienter med en kropsvægt < 60 kg ved baseline på grund af en højere samlet PDE4-hæmmende aktivitet, som er konstateret hos disse patienter (se pkt.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne (anført i pkt 6.1).
English: Furthermore, roflumilast attenuated influx of neutrophils and eosinophils into the airways of endotoxin challenged healthy volunteers.
Danish: Desuden svækkede roflumilast tilstrømning af neutrofile og eosinofile granolucytter i luftvejene i raske forsøgspersoner udsat for endotoksin.
English: Therefore, following administration of roflumilast, the total PDE4 inhibition is considered to be the combined effect of both roflumilast and roflumilast N-oxide.
Danish: Efter administration af roflumilast anses den samlede PDE4-hæmning derfor at være den samlede effekt af både roflumilast og roflumilast N-oxid.
English: Upon in vitro stimulation of human neutrophils, monocytes, macrophages or lymphocytes, roflumilast and roflumilast N-oxide suppress the release of inflammatory mediators e.g. leukotriene B4, reactive oxygen species, tumour necrosis factor α, interferon γ and granzyme B.
Danish: Efter in vitro-stimulering af humane neutrofile granulocytter, monocytter, makrofager eller lymfocytter hæmmer roflumilast og roflumilast-N-oxid frigivelsen af inflammatoriske mediatorer f.eks leukotrin B4, reaktive oxygenforbindelser, tumornekrosefaktor α, γ-interferon og granzym B.