FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents Libertek should not be used by children and adolescents under 18 years of age.
Danish: Børn og teenagere Libertek bør ikke bruges til børn og teenagere under 18 år.
English: Date of first authorisation: 28 February 2011 Date of latest renewal: 24 April 2015
Danish: Dato for første markedsføringstilladelse: 28. februar 2011 Dato for seneste fornyelse: 24. april 2015
English: Libertek has been studied in clinical trials for up to one year.
Danish: Libertek er undersøgt i kliniske studier i op til et år.
English: There is a lack of relevant experience with Libertek under these conditions.
Danish: Der mangler relevante erfaringer med Libertekbehandling under disse omstændigheder.
English: It is important to continue taking Libertek for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.
Danish: Det er vigtigt at fortsætte med at tage Libertek så længe, som din læge har foreskrevet, selv når du ingen symptomer har, for at fastholde kontrollen over din lungefunktion.
English: The tablet can be taken with or without food.
Danish: Tabletter kan tages med eller uden føde.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Tag ikke en dobbeltdosis som erstatning for den glemte dosis.
English: If on one day you have forgotten to take a tablet of Libertek, just carry on the next day with the next tablet as usual.
Danish: Hvis du en dag har glemt at tage en tablet Libertek, fortsætter du bare den næste dag med den næste tablet som sædvanligt.
English: You may need to take Libertek for several weeks to achieve its beneficial effect.
Danish: Det kan være nødvendigt at tage Libertek i flere uger, for at opnå den ønskede virkning.
English: Post-implantation losses were not seen in rabbits.
Danish: Post-implantative tab blev ikke observeret hos kanin.
English: Tell your doctor or pharmacist straight away.
Danish: Fortæl det til din læge eller apoteket med det samme.
English: Thus Libertek eases breathing problems.
Danish: Dermed vil Libertek lette åndedrætsbesvær.
English: There is no relevant use of Libertek in the paediatric population (under 18 years) in the indication COPD.
Danish: Det er ikke relevant at anvende Libertek i den pædiatriske population (under 18 år) til indikationen KOL.
English: The need to inform patients about the risks of Libertek and the precautions for safe use including:
Danish: Nødvendigheden af, at informere patienter om risici ved Libertek og forholdsregler for sikker brug inklusive:
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Danish: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Libertek may be harmful for the unborn baby.
Danish: Du bør ikke blive gravid under behandling med dette lægemiddel, og du skal benytte sikker prævention under behandlingen, da Libertek kan være skadeligt for det ufødte barn.
English: Libertek should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Danish: Libertekbehandling bør ikke påbegyndes eller bør stoppes hos patienter med kræft (bortset fra basalcellekarcinom).
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 negroide, ikke-rygende kvinder, kan føre til en øgning i eksponering og vedvarende intolerabilitet.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Libertek kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Libertek may need to be taken for several weeks to achieve its effect (see section 5.1).
Danish: Libertek skal muligvis tages i flere uger for at opnå effekt (se pkt.
English: Suicidal ideation and behaviour* Depression Nervousness Panic attack
Danish: Selvmordsrelaterede tanker og adfærd* Nervøsitet Depression Panikanfald
English: Warnings and precautions Talk to your doctor or pharmacist before taking Libertek
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteket, før du tager Libertek
English: Interim Study Reports - with each PSUR
Danish: Interime studierapportermed hver PSUR
English: The potential risk of infections: Libertekshould not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Danish: Den potentielle risiko for infektioner: Libertekbehandling bør ikkepåbegyndes eller skal stoppes hos patienter med svære akutte smitsomme sygdomme.
English: The fact that Libertek 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 Libertek 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: If you stop taking Libertek
Danish: Hvis du holder op med at tage Libertek
English: • Copies of the patient card to be given to patients or caregivers before they receive Libertek
Danish: • Kopier af patientkortet, der skal udleveres til patienter eller plejere ved udskrivning af Libertek
English: If you forget to take Libertek
Danish: Hvis du har glemt at tage Libertek
English: The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Libertek are provided with an updated Educational pack.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der forventes at ordinere Libertek, er forsynet med en opdateret uddannelsespakke.
English: Do not take Libertek - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Libertek - hvis du er allergisk over for roflumilast eller et af de øvrige indholdsstoffer i Libertek (angivet i afsnit 6).
English: Following intravenous or oral administration of radiolabeled 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: 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: A total of 2,690 patients were included and randomized 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: Libertek contains lactose
Danish: Libertek indeholder lactose
English: Before starting treatment with Libertek, 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 Libertek, 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: PVC/PVDC aluminum blisters in packs of 10, 30, or 90 film-coated tablets.
Danish: PVC/PVDC-aluminium-blister i pakninger med 10, 30 eller 90 filmovertrukne tabletter.
English: These studies in rats with radiolabeled 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 Libertek and the potential risk of suicide.
Danish: Risikoen for psykiske forstyrrelser, såsom søvnløshed, angst eller depression hos patienter, der tager Libertek og den potentielle risiko for selvmord.
English: What Libertek contains - The active substance is roflumilast.
Danish: Libertek indeholder: - Det aktive stof er roflumilast.
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 gnaver og med særlig bindingsaffinitet i disse arter (dvs. mus, rotte og hamster).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Moderate or severe Moderate
Danish: Moderat eller svær
English: Libertek is to be used in addition to bronchodilators.
Danish: Libertek skal anvendes som tillæg til bronkodilatatorer.
English: Libertek is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms).
Danish: Libertek er ikke beregnet til behandling af et pludseligt anfald af åndenød (akutte bronkospasmer).
English: Libertek has no influence on the ability to drive and use machines.
Danish: Libertek påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Each pack contains 10, 30, or 90 film-coated tablets.
Danish: Hver pakning indeholder 10, 30 eller 90 filmovertrukne tabletter.
English: Libertek may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Danish: Libertek kan tages sammen med andre lægemidler, der anvendes til behandling af KOL såsom inhalerede eller orale steroider eller bronkodilatatorer.
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, salmeterol i studie M2-127 og tiotropium i studie M2-128.
English: The potential cardiac risk: Libertek has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Danish: Den potentielle kardielle risiko: Liberteker ikke undersøgt hos patienter med kongestiv hjerteinsufficiens (NYHA grad 3 og 4) og derfor ikke anbefales til denne population.
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 diare (5,9%), vægttab (3,4%), kvalme (2,9%), abdominalsmerter (1,9%) og hovedpine (1,7%).
English: Plasma protein binding of roflumilast and its N-oxide metabolite is approximately 99% and 97%, respectively.
Danish: Plasmaproteinbindingen af roflumilast og dens N-oxidmetabolit er henholdsvis ca. 99% og 97%.
English: In Phase I studies, the following symptoms were observed at an increased rate after single oral doses of 2,500 micrograms and one single dose of 5,000 micrograms (ten times the recommended dose): headache, gastrointestinal disorders, dizziness, palpitations, light-headedness, clamminess and arterial hypotension.
Danish: I fase I-studier blev følgende symptomer observeret med øget hyppighed ved oral enkeltdosis på 2.500 mikrogram og en enkeltdosis på 5.000 mikrogram (ti gange anbefalet dosis): Hovedpine, mavebesvær, svimmelhed, palpitationer, uklarhed, klamsved og arteriel hypotension.
English: Each film-coated tablet contains 188.72 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 188,72 mg lactose (som monohydrat).
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 roflumiast eller dets metabolitter udskilles i mælk.
English: The effect of Libertek 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 Libertek 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: 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 dens N-oxidmetabolit er dosisproportionale over et dosisinterval fra 250 mikrogram til 1.000 mikrogram.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere information om lægemidlet på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
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 versus KOL-patienter, der ikke behandlesmed roflumilast.
English: A total of 1935 patients were randomised to double-blind 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: • 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: Libertek 500 micrograms
Danish: Libertek 500 mikrogram
English: Other medicines and Libertek
Danish: Brug af anden medicin sammen med Libertek
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 dens N-oxid-metabolit opnås efter ca. 4 dage for roflumilast og ca. 6 dage for roflumilast N-oxid efter dosering 1 gang dagligt.
English: In case of an allergic reaction, stop taking Libertek 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 Libertek og straks kontakte læge eller skadestue.
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 indsende resultater af studier med roflumilast i alle undergrupper af den pædiatriske population for kronisk obstruktiv lungesygdom (se pkt.
English: Rescue medicinal products Libertek is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Danish: Anfaldsmedicin Libertek er ikke indiceret som anfaldsmedicin til lindring af akutte bronkospasmer.
English: Takeda GmbH Production Site Oranienburg Lehnitzstrasse 70-98
Danish: Takeda GmbH Produktionssite Oranienburg Lehnitzstrasse 70-98
English: Libertek 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: Libertek 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: In two confirmative replicate one-year studies (M2-124 and M2-125) and two supplementary six-month studies (M2-127 and M2-128), a total number of 4,768 patients were randomized and treated of whom 2,374 were treated with roflumilast.
Danish: I to pivotale bekræftende 1-års-studier med samme studiedesign (M2-124 og M2-125) og to supplerende 6 måneders-studier (M2-127 og M2-128) blev i alt 4.768 patienter randomiseret og behandlet, heraf blev 2.374 patienter behandlet med roflumilast.
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 for mange Libertek tabletter Hvis du har taget flere tabletter, end du skulle, kan du opleve følgende symptomer: hovedpine, kvalme, diare, svimmelhed, hjertebanken, uklarhed, klamsved og lavt blodtryk.
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: 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: 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 dens N-oxidmetabolit er medieret af CYP1A2 og 3A4.
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 % (risikoratio: 0,86; 95 % CI: 0,74-0,99).
English: The numbers of patients who died due to any reason were equal for those treated with placebo or roflumilast (42 deaths each group; 2.7% each group; pooled analysis).
Danish: Antallet af patienter der døde af en vilkårlig årsag, var ens i placebo- og roflumilastgruppen (42 (2,7%) døde i hver gruppe; poolet analyse).
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, tumor 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.
English: OUTER CARTON FOR BLISTER
Danish: Ydre blisterkarton
English: Libertek contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Danish: Libertek indeholder det aktive stof roflumilast, som er et anti-inflammatorisk lægemiddel, der kaldes fosfodiesterase 4-hæmmer.
English: Gamma-GT increased Aspartate aminotransferase (AST) increased
Danish: Lever og galdeveje γ-GT forøget Forøget aspartat-transaminase (AST)
English: Lactose monohydrate Maize starch Povidone (K90) Magnesium stearate
Danish: Tabletkerne Lactosemonohydrat Majsstivelse Povidon (K90) Magnesiumstearat
English: That Libertek may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Danish: At Libertek kan forårsage vægttab, og patienter regelmæssigt skal kontrollere og registrere deres vægt på patientkortet.
English: In addition, in vitro studies demonstrated no induction of the CYP1A2, 2A6, 2C9, 2C19, or 3A4/5 and only a weak induction of CYP2B6 by roflumilast.
Danish: Endvidere viste in vitro-studier med roflumilast ingen induktion af CYP1A2, 2A6, 2C9, 2C19, eller 3A4/5, og kun en svag induktion af CYP2B6.
English: Since both roflumilast and roflumilast N-oxide contribute to PDE4 inhibitory activity in vivo, pharmacokinetic considerations are based on total PDE4 inhibitory activity (i.e. total exposure to roflumilast and roflumilast N-oxide).
Danish: Da både roflumilast og roflumilast N-oxid bidrager til den PDE4-hæmmende aktivitet i in vivo, er de farmakokinetiske overvejelser baseret på den samlede PDE4-hæmmende aktivitet (dvs. den samlede eksponering af roflumilast og roflumilast N-oxid).
English: 10 film-coated tablets 30 film-coated tablets 90 film-coated tablets
Danish: 10 filmovertrukne tabletter 30 filmovertrukne tabletter 90 filmovertrukne tabletter
English: 2 What you need to know before you take Libertek
Danish: Det skal du vide, før du begynder at tage Libertek
English: The recommended dose is one 500 micrograms tablet once daily.
Danish: Den anbefalede dosis er 1 tablet med 500 mikrogram en gang daglig.
English: The rate (per patient per year) of moderate exacerbations (requiring intervention with systemic glucocorticosteroids) or severe exacerbations (resulting in hospitalisation and/or leading to death) after 1 year was 1.142 with roflumilast and 1.374 with placebo corresponding to a relative risk reduction of 16.9% (95%CI: 8.2% to 24.8%) (primary endpoint, p=0.0003).
Danish: Antallet (pr. patient pr. år) af moderate eksacerbationer (krævende intervention med systemiske glukokortikosteroider) eller svære eksacerbationer (resulterende i indlæggelse og/eller førende til dødsfald) efter 1 år var 1,142 med roflumilast og 1,374 med placebo; svarende til en relativ risikoreduktion på 16,9% (95%KI: 8,2% til 24,8%) (primært endepunkt, p=0,0003).
English: The rate of severe exacerbations was reduced in the overall patient group (rate ratio: 0.76; 95% CI: 0.60 to 0.95) with a rate of 0.24 per patient/year compared to a rate of 0.32 per patient/year in patients treated with placebo.
Danish: Hyppigheden af svære eksacerbationer blev reduceret i den samlede patientgruppe (risikoratio: 0,76; 95% CI: 0,60-0,95) med en hyppighed på 0,24 pr. patient/år sammenlignet med en hyppighed på 0,32 pr. patient/år hos patienter, der fik placebo.