FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or pharmacist straight away.
Danish: Fortæl det til din læge eller apotekspersonalet med det samme.
English: The rate of severe COPD exacerbations and changes in FEV1 were evaluated as key secondary endpoints.
Danish: Hyppigheden af svære KOL-eksacerbationer og ændringer i FEV1 blev evalueret som væsentlige, sekundære endepunkter.
English: A combination of factors, such as in black, non-smoking females, might lead to an increase of exposure and persistent intolerability.
Danish: En kombination af faktorer, såsom hos sorte, ikke-rygende kvinder, kan føre til en øgning i eksponering og vedvarende intolerabilitet.
English: In case of overdose, it is recommended that the appropriate supportive medical care is provided.
Danish: I tilfælde af overdosering anbefales passende understøttende behandling.
English: Swallow the tablet with some water.
Danish: Slug tabletten med vand.
English: If possible take your medicine and this leaflet with you.
Danish: Tag om muligt din medicin og denne indlægsseddel med dig.
English: 28 tablets - 28-day starter pack.
Danish: 28 tabletter - 28 dages startpakning
English: The affinity to the PDE4C splicing variants is 5 to 10-fold lower.
Danish: Affiniteten til splejsningsvarianterne PDE4C er 5 til 10 gange lavere.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: 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: EU/1/10/636/001 10 film-coated tablets EU/1/10/636/002 30 film-coated tablets EU/1/10/636/003 90 film-coated tablets EU/1/10/636/004 14 film-coated tablets EU/1/10/636/005 28 film-coated tablets EU/1/10/636/006 84 film-coated tablets EU/1/10/636/007 98 film-coated tablets
Danish: EU/1/10/636/001 10 filmovertrukne tabletter EU/1/10/636/002 30 filmovertrukne tabletter EU/1/10/636/003 90 filmovertrukne tabletter EU/1/10/636/004 14 filmovertrukne tabletter EU/1/10/636/005 28 filmovertrukne tabletter EU/1/10/636/006 84 filmovertrukne tabletter EU/1/10/636/007 98 filmovertrukne tabletter
English: PVC/PVDC aluminium blisters in packs of 28 tablets.
Danish: PVC/PVDC-aluminium-blister i pakninger med 28 tabletter.
English: Suicidal ideation and behaviour* Depression Nervousness Panic attack
Danish: Selvmordsrelaterede tanker og adfærd* Depression Nervøsitet Panikanfald
English: The primary endpoint was reduction in rate of moderate or severe COPD exacerbations per patient per year.
Danish: Det primære endepunkt var reduktion i hyppigheden af moderate eller svære KOL-eksacerbationer pr. patient pr. år.
English: This starting dose is intended to reduce adverse events and patient discontinuation when initiating therapy, but it is a sub-therapeutic dose.
Danish: Denne startdosis er beregnet til at reducere bivirkninger og patientfrafald i begyndelsen af behandlingen, men det er en subterapeutisk dosis.
English: The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
Danish: Den potentielle risiko for maligne tumorer og den manglende erfaring hos patienter med en tidligere kræftsygdom.
English: The need to inform patients about the risks of Daxas and the precautions for safe use including:
Danish: Nødvendigheden af, at informere patienter om risici ved Daxas og forholdsregler for sikker brug inklusive:
English: You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Daxas may be harmful for the unborn baby.
Danish: Du må ikke blive gravid under behandling med dette lægemiddel, og du skal benytte sikker prævention under behandlingen, da Daxas kan være skadeligt for det ufødte barn.
English: After discontinuation of roflumilast, the majority of patients had regained body weight after 3 months.
Danish: Efter seponering af roflumilast genvandt størstedelen af patienterne vægttabet efter 3 måneder.
English: Roflumilast improved lung function after 4 weeks (sustained over 52 weeks).
Danish: Roflumilast forbedrede lungefunktionen efter 4 uger (fastholdt over 52 uger).
English: Poisson regression
Danish: Poissonregressio
English: In a human spermatogenesis study, roflumilast 500 micrograms had no effects on semen parameters or reproductive hormones during the 3-month treatment period and the following 3-month off-treatment period.
Danish: I et humant spermatogenesestudie havde roflumilast 500 mikrogram hverken effekt på sædparametre eller på reproduktionshormoner i løbet af en 3-måneders behandlingsperiode, og den efterfølgende 3 måneders behandlingsfri periode.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX07
Danish: Farmakoterapeutisk klassifikation: Midler mod obstruktive luftvejssygdomme, andre systemiske midler mod obstruktive luftvejssygdomme, ATC-kode: R03DX07
English: You should check your body weight on a regular basis.
Danish: Du skal tjekke din vægt regelmæssigt.
English: Most relevant findings in safety pharmacology and toxicology studies occurred at higher doses and exposure than that intended for clinical use.
Danish: De mest relevante fund i sikkerhedsfarmakologiske og toksikologiske studier forekom ved højere doser og eksponering end den, der er beregnet til klinisk brug.
English: The relevance of these findings to humans is unknown.
Danish: Det er usikkert, om disse observationer er relevante for mennesker.
English: Talk to your doctor if these side effects do not resolve within the first weeks of treatment.
Danish: Tal med din læge, hvis sådanne bivirkninger ikke fortager sig inden for de første uger af behandlingen.
English: No dose adjustment is recommended in these patients.
Danish: Dosisjustering anbefales ikke hos disse patienter.
English: The limited or missing information in patients with liver impairment.
Danish: De begrænsede eller manglende data hos patienter med nedsat leverfunktion.
English: There is no evidence for a specific accumulation or retention of roflumilast or its metabolites in organs and fatty tissue.
Danish: Der er ingen evidens for specifik akkumulering eller retention af roflumilast eller dets metabolitter i organer og fedtvæv.
English: In one of three rat studies on fertility and embryofetal development, post-implantation losses were observed.
Danish: I et af tre studier af fertilitet og embryoføtal udvikling hos rotter observeredes post-implantative tab.
English: Daxas should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Danish: Daxasbehandling bør ikke påbegyndes eller bør stoppes hos patienter med kræft (bortset fra basalcellekarcinom).
English: There is no relevant use of Daxas in the paediatric population (under 18 years) in the indication COPD.
Danish: Pædiatrisk population Det er ikke relevant at anvende Daxas i den pædiatriske population (under 18 år) til indikationen KOL.
English: • infection with tuberculosis, herpes, hepatitis, HIV
Danish: • Tuberkulose, herpes, hepatitis eller hiv
English: Women of childbearing age should be advised to use an effective method of contraception during treatment.
Danish: Kvinder i den fertile alder skal rådes til at anvende sikker kontraception under behandlingen.
English: In the event of an unexplained and clinically concerning weight decrease, the intake of roflumilast should be stopped and body weight should be further followed-up.
Danish: I tilfælde af et uforklarligt og klinisk betydende vægttab, bør behandling med roflumilast afbrydes, og kropsvægten bør følges yderligere.
English: The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daxas are provided with an updated Educational pack.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der forventes at ordinere Daxas, er forsynet med en opdateret uddannelsespakke.
English: No interactions were observed with inhaled salbutamol, formoterol, budesonide and oral montelukast, digoxin, warfarin, sildenafil and midazolam.
Danish: Der er ikke observeret interaktioner med inhaleret salbutamol, formoterol, budesonid, oral montelukast, digoxin, warfarin, sildenafil og midazolam.
English: Patient Card
Danish: Patientkort
English: The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease.
Danish: Risikoen for vægttab hos undervægtige patienter og behovet for at kontrollere kropsvægt ved hvert besøg, og at behandlingen skal stoppes i tilfælde af et uforklarligt og klinisk bekymrende vægttab.
English: Each pack contains 10, 14, 28, 30, 84 , 90 or 98 film-coated tablets.
Danish: Hver pakning indeholder 10, 14, 28, 30, 84, 90 eller 98 filmovertrukne tabletter.
English: Thus Daxas eases breathing problems.
Danish: Dermed vil Daxas lette åndedrætsbesvær.
English: Both studies included moderate to severe patients with a non-reversible airway obstruction and a FEV1 of 40% to 70% of predicted.
Danish: Begge studier inkluderede patienter med moderat til svær KOL med en ikke-reversibel luftvejsobstruktion og en FEV1 på 40% til 70% af forventet.
English: Rescue medicinal products (salbutamol or albuterol) were allowed on an as-needed basis.
Danish: Anfaldsmedicin (salbutamol og albuterol) var tilladt efter behov.
English: In older people, females and in non-Caucasians, total PDE4 inhibitory activity was increased.
Danish: Hos ældre, kvinder og hos ikke-kaukasere, var den totale PDE4-hæmmende aktivitet øget.
English: No epididymal toxicity or changes in semen parameters were present in any other rodent or non-rodent species including monkeys in spite of higher exposures.
Danish: Ingen toksisk påvirkning af bistestikler eller ændringer i sædparametre var til stede hos nogen anden gnaver eller ikke-gnaverart inklusive abe og på trods af højere eksponering.
English: Following intravenous or oral administration of radiolabelled roflumilast, about 20% of the radioactivity was recovered in the faeces and 70% in urine as inactive metabolites.
Danish: Efter intravenøs eller oral administration af radioaktivt mærket roflumilast genfindes ca. 20% af radioaktiviteten i fæces og 70% i urinen som inaktive metabolitter.
English: Total PDE4 inhibitory activity decreased by 9% in patients with severe renal impairment (creatinine clearance 10-30 ml/min).
Danish: Den totale PDE4-hæmmende aktivitet faldt med 9% hos patienter med svært nedsat nyrefunktion (kreatininclearance 10-30 ml/min).
English: Take all your medicines and this leaflet with you and provide full information of your current medications.
Danish: Medbring al din medicin og denne indlægsseddel og videregiv al information om din aktuelle medicinske behandling.
English: The rate of exacerbations (as defined in the protocols) were not significantly reduced by roflumilast in the individual studies (relative risk reduction: 13.5% in Study M2-111 and 6.6% in Study M2-112; p= not significant).
Danish: Antallet af eksacerbationer (som defineret i protokollerne) blev ikke signifikant reduceret af roflumilast i de enkelte studier (relativ risikoreduktion 13,5% i studie M2-111 og 6,6% i studie M2-112; p= ikke-signifikant).
English: The patient card should contain the following key elements:
Danish: Patientkortet bør indeholde følgende nøgleelementer:
English: Patients with no history of exacerbations were excluded.
Danish: Patienter uden tidligere eksacerbationer blev ekskluderet.
English: The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
Danish: Manglen på kliniske data til at understøtte kombination med theophyllin og at en sådan kombination derfor ikke anbefales.
English: Roflumilast is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, nervousness and depression.
Danish: Roflumilast er associeret med en øget risiko for psykiatriske forstyrrelser, såsom søvnløshed, angst, nervøsitet og depression.
English: The fact that Daxas is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency.
Danish: Den omstændighed, at Daxas hverken er indiceret til behandling af KOL-patienter uden for den godkendte indikation eller er til brug til patienter med astma eller alfa-1-antitrypsinmangel.
English: At screening, patients were required to have had at least one exacerbation in the previous year and on standard of care COPD maintenance treatment for at least 12 weeks.
Danish: Ved screeningen skulle patienterne have haft mindst en eksacerbation i det foregående år og været på standard KOL-vedligeholdelsesbehandling i mindst 12 uger.
English: The potential risk of infections: Daxas should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Danish: Den potentielle risiko for infektioner: Daxasbehandling bør ikke påbegyndes eller skal stoppes hos patienter med svære akutte smitsomme sygdomme.
English: No dose adjustment is necessary in patients receiving these active substances.
Danish: Dosisjustering er ikke nødvendig hos patienter, der behandles med disse virksomme stoffer.
English: Inhaled corticosteroids were used in 809 (61%) of the roflumilast treated patients, whereas the use of LABAs and theophylline was prohibited.
Danish: Inhalerede kortikosteroider blev brugt af 809 (61%) af de roflumilastbehandlede patienter, hvorimod anvendelse af LABA og theofyllin ikke var tilladt.
English: Before starting treatment with Daxas, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects.
Danish: Før du begynder behandling med Daxas, skal du fortælle din læge, hvis du allerede har sådanne symptomer, eller hvis du tager anden medicin, da noget af denne medicin måske kan øge risikoen for, at disse symptomer opstår.
English: Each film-coated tablet contains 188.72 mg lactose (as monohydrate).
Danish: Hver filmovertrukken tablet indeholder 188,72 mg lactose (som monohydrat).
English: Roflumilast is extensively metabolised via Phase I (cytochrome P450) and Phase II (conjugation) reactions.
Danish: Roflumilast metaboliseres i udstrakt grad via fase I-(cytokrom P450) og fase II-(konjugerings)reaktioner.
English: Due to the physico-chemical properties, roflumilast is readily distributed to organs and tissues including fatty tissue of mice, hamster and rat.
Danish: På grund af de fysisk-kemiske egenskaber fordeles roflumilast let til organer og væv, herunder fedtvævet hos mus, hamster og rotte.
English: Maximum concentrations of the N-oxide metabolite are reached after about eight hours (ranging from 4 to 13 hours).
Danish: Maksimale koncentrationer af N-oxidmetabolitten opnås efter ca. 8 timer (varierende fra 4 til 13 timer).
English: Physicians should carefully assess the benefit risk balance of this treatment in patients with existing psychiatric symptoms or with history of depression.
Danish: Læger skal nøje opveje benefit/risk-balancen af denne behandling hos patienter med eksisterende psykiske symptomer eller med tidligere depression.
English: Total PDE4 inhibitory activity was slightly decreased in smokers.
Danish: Den totale PDE4-hæmmende aktivitet var lidt lavere hos rygere.
English: ANX 2.1 - The MAH commits to conduct a long-term comparative observational safety study.
Danish: ANX 2.1 - Indehaveren af markedsføringstilladelsen forpligter sig til at gennemføre et komparativt observationsstudie med henblik på vurdering af sikkerheden.
English: That patients or their caregivers should tell their doctor if the patient develops symptoms indicative of:
Danish: At patienter eller plejere skal informere læge, hvis patienten udvikler symptomer som:
English: The improvement in lung function was apparent at the first visit after 4 weeks and was maintained up to one year (end of treatment period).
Danish: Forbedringen i lungefunktion sås ved første kontrol efter 4 ugers behandling og var vedvarende i op til 1 år (slut på behandlingsperioden).
English: Roflumilast did not significantly reduce the rate of exacerbations compared with placebo in the subgroup of patients with moderate COPD.
Danish: Roflumilast reducerede ikke antallet af eksacerbationer signifikant sammenlignet med placebo i subgruppen af patienter med moderat KOL.
English: Since roflumilast is highly protein bound, haemodialysis is not likely to be an efficient method of its removal.
Danish: Da roflumilast er stærkt proteinbundet, vil hæmodialyse næppe være effektivt til at fjerne det.
English: - The starting dose is a low dose used to help your body get used to the medicine before you start taking the full dose.
Danish: o Startdosis er en lav dosis, der skal hjælpe din krop med at vænne sig til medicinen, før du begynder at tage den fulde dosis.
English: That patients should tell their doctor if they are taking any other medicines.
Danish: At patienter skal fortælle deres læge, hvis de tager anden medicin.
English: The Marketing Authorisation Holder shall agree the content and format of the updated educational material with the national competent authority.
Danish: Indehaveren af markedsføringstilladelsen skal blive enig med den nationale myndighed om indholdet og udformningen af det opdaterede undervisningsmateriale.
English: Please talk to your doctor if you have one of these diseases.
Danish: Tal med din læge, hvis du har en af disse sygdomme.
English: Short-acting anticholinergics (SAMAs) were allowed for those patients not taking LABAs.
Danish: Korttidsvirkende antikolinergika (SAMA) var tilladt for de patienter, der ikke tog LABA.
English: These studies in rats with radiolabelled roflumilast also indicate low penetration across the blood-brain barrier.
Danish: Disse rottestudier med radioaktivt mærket roflumilast indikerede også en lav penetration via blod-hjerne-barrieren.
English: The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daxas and the potential risk of suicide.
Danish: Risikoen for psykiske forstyrrelser, såsom søvnløshed, angst eller depression hos patienter, der tager Daxas og den potentielle risiko for selvmord.
English: Do not take Daxas - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Daxas - hvis du er allergisk over for roflumilast eller et af de øvrige indholdsstoffer i Daxas (angivet i afsnit 6).
English: Daxas has no influence on the ability to drive and use machines.
Danish: Daxas påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: Tremor Vertigo Dizziness
Danish: Tremor Vertigo Svimmelhed
English: A total of 2,690 patients were included and randomised in two supportive 1-year studies (M2-111 and M2-112).
Danish: I alt 2.690 patienter blev inkluderet og randomiseret til 2 supplerende 1-års-studier (M2-111 og M2-112).
English: Analysis model
Danish: Analysemodel
English: This effect seems to be due to an ADCP (4-Amino-3,5-dichloro-pyridine) N-oxide intermediate specifically formed in rodent olfactory mucosa, with special binding affinity in these species (i.e. mouse, rat and hamster).
Danish: Denne virkning synes at være et resultat af et ADCP (4-amino-3,5-dichlor-pyridin)N-oxid-intermediat, som dannes specifikt i næseslimhinden hos gnavere og med særlig bindingsaffinitet i disse arter (dvs. mus, rotte og hamster).
English: The use of inhaled corticosteroids and theophylline was prohibited during the studies.
Danish: Anvendelse af inhalerede kortikosteroider og theofyllin var ikke tilladt i studierne.
English: Roflumilast reduces the activity of phosphodiesterase-4, a protein occurring naturally in body cells.
Danish: Roflumilast nedsætter aktiviteten af fosfodiesterase 4, der er et protein, der forekommer naturligt i kroppens celler.
English: An early distribution phase with marked penetration into tissues is followed by a marked elimination phase out of fatty tissue most probably due to pronounced break-down of parent compound to roflumilast N-oxide.
Danish: En tidlig distributionsfase med markant penetrering i væv er efterfulgt af en markant eliminationsfase ud af fedtvæv sandsynligvis på grund af en udtalt nedbrydning af roflumilast til roflumilast N-oxid.
English: Ratio Roflumilast/Placebo
Danish: Ratio Roflumilast/Placebo 2-sidet pværdi
English: 10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Danish: 10 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter
English: The absolute bioavailability of roflumilast following a 500 micrograms oral dose is approximately 80%.
Danish: Den absolutte biotilgængelighed af roflumilast efter en 500 mikrogram oral dosis er ca. 80%.
English: Pregnancy There are limited amount of data from the use of roflumilast in pregnant women.
Danish: Graviditet Der er ingen eller utilstrækkelige data fra anvendelse af roflumilast til gravide kvinder.
English: If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure.
Danish: Hvis du har taget flere tabletter, end du skulle, kan du opleve følgende symptomer: hovedpine, kvalme, diarré, svimmelhed, hjertebanken, uklarhed, klamsved og lavt blodtryk.
English: Summary of COPD exacerbation endpoints in Study RO-2455-404-RD
Danish: Oversigt over endepunkter for KOL-eksacerbation i studie RO-2455-404-RD
English: Interim Study Reports - with each PSUR.
Danish: Interime studierapportermed hver PSUR
English: COPD is a chronic disease of the lungs that results in tightening of the airways (obstruction) and swelling and irritation of the walls of the small air passages (inflammation).
Danish: KOL er en kronisk lungesygdom, som medfører en forsnævring af luftvejene (obstruktion) samt hævelse og irritation af væggene i de mindre luftveje (inflammation).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: I hver frekvensgruppe er bivirkninger opstillet i rækkefølge efter faldende alvorlighed.
English: The educational material for the prescriber should include information on the following key elements:
Danish: Undervisningsmaterialet til den ordinerende læge skal indeholde oplysninger om følgende centrale elementer:
English: Food intake does not affect the total PDE4 inhibitory activity, but delays time to maximum concentration (tmax) of roflumilast by one hour and reduces Cmax by approximately 40%.
Danish: Fødeindtag påvirker ikke den totale PDE4-hæmmende aktivitet, men forlænger tiden til maksimumkoncentration (tmax) af roflumilast med 1 time og reducerer Cmax med ca. 40%.
English: PVC/PVDC aluminium blisters in packs of 10, 14, 28, 30, 84, 90 or 98 film-coated tablets.
Danish: PVC/PVDC-aluminium-blister i pakninger med 10, 14, 28, 30, 84, 90 eller 98 filmovertrukne tabletter.
English: Roflumilast has been demonstrated to cross the placenta in pregnant rats.
Danish: Det er påvist, at roflumilast passerer placenta hos drægtige rotter.
English: This mechanism of action and the selectivity also apply to roflumilast N-oxide, which is the major active metabolite of roflumilast.
Danish: Denne virkningsmekanisme og selektivitet omfatter også roflumilast N-oxid, som er den mest aktive metabolit af roflumilast.
English: What Daxas contains The active substance is roflumilast.
Danish: Daxas indeholder: Det aktive stof er roflumilast.
English: The respective reduction in exacerbations seen in patients without concomitant LABAs was on average 15% (p=0.0387).
Danish: Den tilsvarende reduktion i eksacerbationer hos patienter som var i samtidig LABA-behandling var gennemsnitligt 15% (p=0,0387).