FrancophonIA/ELRC3.0 huggingface dataset:
English: Posology The recommended dose is 500 micrograms (one tablet) roflumilast once daily.
Danish: Dosering Den anbefalede dosis er 500 mikrogram (én tablet) roflumilast en gang dagligt.
English: Rare instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression, usually within the first weeks of treatment (see section 4.8).
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 (se pkt.
English: If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended to discontinue treatment with Libertek.
Danish: Hvis patienten får nye psykiske symptomer eller de forværres, eller hvis selvmordstanker ellerforsøg opdages, anbefales det at afbryde behandling med Libertek.
English: Concomitant treatment with long acting muscarinic antagonists (LAMA) A higher incidence of weight decrease, decreased appetite, headache and depression was observed during Study RO-2455-404-RD in patients receiving concomitant roflumilast and long-acting muscarinic antagonists (LAMA) plus concomitant inhaled corticosteroids (ICS) and long acting B2 agonists (LABA) compared to those treated only with concomitant roflumilast, ICS and LABA.
Danish: Samtidig behandling med langtidsvirkende muskarinreceptor-antagonister (LAMA) I studie RO-2455-404-RD blev der observeret en højere forekomst af vægttab, appetitløshed, hovedpine og depression hos patienter, der samtidig fik roflumilast og en langtidsvirkende muskarinreceptor-antagonist (LAMA) plus inhalationskortikosteroid (ICS) og langtidsvirkende 2agonist (LABA), sammenlignet med gruppen, som kun fik samtidig behandling med roflumilast, ICS og LABA.
English: In the subgroup of patients with history of frequent exacerbations (at least 2 exacerbations during the last year), the rate of exacerbations was 1.526 with roflumilast and 1.941 with placebo corresponding to a relative risk reduction of 21.3% (95%CI: 7.5% to 33.1%).
Danish: For subgruppen af patienter med tidligere gentagne eksacerbationer (mindst 2 eksacerbationer i det forgangne år) var antallet af eksacerbationer 1,526 med roflumilast og 1,941 med placebo svarende til en relativ risikoreduktion på 21,3% (95% KI: 7,5% til 33,1%).
English: You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with Libertek.
Danish: Du kan måske opleve diare, kvalme, mavesmerter eller hovedpine i løbet af de første uger af behandlingen med Libertek.
English: Common side effects (may affect up to 1 in 10 people) - diarrhoea, nausea, stomach ache - weight decrease, decreased appetite - headache
Danish: Almindelige bivirkninger (forekommer hos 1 ud af 10 personer) - diaré, kvalme, mavesmerter - vægttab, nedsat appetit - hovedpine
English: Due to lack of relevant experience, treatment with roflumilast should not be initiated or existing treatment with roflumilast should be stopped in patients with severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma), or patients being treated with immunosuppressive medicinal products (i.e.: methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids).
Danish: På grund af manglende relevant erfaring bør behandling med roflumilast ikke påbegyndes og igangværende behandling med roflumilast bør afbrydes hos patienter med svære immunologiske sygdomme (f.eks. HIV-infektion, dissemineret sklerose, lupus erythematosus, progressiv multifokal leukoencefalopati), alvorlige akutte smitsomme sygdomme, kræftsygdomme (undtagen basalcellekarcinom), og hos patienter, der behandles med immunosuppressive lægemidler (f.eks. methotrexat, azathioprin, infliximab, etanercept eller orale kortikosteroider til langtidsbehandling; undtagen systemiske kortikosteroider til korttidsbehandling).
English: • Summary of Product Characteristics and Patient Information Leaflet for Libertek
Danish: • Produktresumé og indlægsseddel for Libertek.
English: In contrast to the two confirmative studies, a history of chronic bronchitis and of COPD exacerbations was not requested for patients' inclusion.
Danish: I modsætning til de to pivotale bekræftende studier var kronisk bronkitis og tidligere KOL-eksacerbationer ikke et inklusionskriterium.
English: The per-protocol Poisson regression analysis and the non-significant sensitivity to drop-out Poisson regression intention-to-treat analysis rate ratios were 0.81 (95% CI: 0.69 to 0.94) and 0.89 (95% CI: 0.77 to 1.02), respectively.
Danish: Risikoratioer ved den protokolmæssige Poisson-regressionsanalyse og ved Poisson-regression intention-to-treat-analysen uden signifikant følsomhed over for drop-out var henholdsvis 0,81 (95 % CI: 0,69-0,94) og 0,89 (95 % CI: 0,77-1,02).
English: Libertek is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Danish: Liberteker kontraindiceret til patienter med moderat eller svær nedsat leverfunktion (Child-Pugh B eller
English: A similar reduction was achieved in the subgroup of patients concomitantly treated with LAMA (rate ratio: 0.77; 95% CI: 0.60 to 0.99) and in the subgroup not treated with LAMA (rate ratio: 0.71; 95% CI: 0.42 to 1.20).
Danish: En tilsvarende reduktion blev opnået i undergruppen af patienter, som var i samtidig behandling med LAMA (risikoratio: 0,77; 95 % CI: 0,60-0,99) og i undergruppen, som ikke blev behandlet med LAMA (risikoratio: 0,71; 95 % CI: 0,42-1,20).
English: Reductions were achieved in the subgroup of patients concomitantly treated with LAMA (rate ratio: 0.88; 95% CI: 0.75 to 1.04) and in the subgroup not treated with LAMA (rate ratio: 0.83; 95% CI: 0.62 to 1.12).
Danish: Reduktioner blev opnået i undergruppen af patienter i samtidig behandling med LAMA (rate ratio: 0,88; 95 % CI: 0,75-1,04) og i undergruppen, som ikke blev behandlet med LAMA (risikoratio: 0,83; 95 % CI: 0,62-1,12).
English: In the two six-month studies, pre-bronchodilator FEV1 was significantly improved by 49 ml (primary endpoint, p<0.0001) beyond the bronchodilator effect of concomitant treatment with salmeterol in study M2-127 and by 80 ml (primary endpoint, p<0.0001) incremental to concomitant treatment with tiotropium in study M2-128.
Danish: I studie M2-127 blev FEV1 før bronkodilatation signifikant forbedret med 49 ml (primært endepunkt, p<0,0001) sammenlignet med den bronkodilaterende effekt af salmeterol givet alene og i studie M2-128 med 80 ml (primært endepunkt, p<0,0001) sammenlignet med tiotropium givet alene.
English: All patients should be informed about the risks of Libertek and the precautions for safe use and should be given a patient card before starting Libertek.
Danish: Alle patienter skal informeres om risici forbundet med behandling med Libertek og om forholdsregler for sikkert brug.
English: Manufacturer Takeda GmbH Production site Oranienburg Lehnitzstraße 70-98
Danish: Takeda GmbH Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg Tyskland
English: While adverse reactions like diarrhoea, nausea, abdominal pain and headache mainly occur within the first weeks of therapy and mostly resolve on continued treatment, roflumilast treatment should be reassessed in case of persistent intolerability.
Danish: Bivirkninger som diare, kvalme, mavesmerter og hovedpine opstår hovedsageligt inden for de første ugers behandling og aftager for det meste ved fortsat behandling.
English: What Libertek looks like and contents of the pack Libertek 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Danish: Libertek 500 mikrogram filmovertrukne tabletter er gule, D-formede filmovertrukne tabletter, mærket med ”D” på den ene side.
English: In study RO-2455-404-RD when compared with the overall population, the total PDE4 inhibitory activity determined from ex vivo unbound fractions was found to be 15% higher in patients ≥75 years of age, and 11% higher in patients with baseline body weight <60 kg (refer to section 4.4).
Danish: Sammenlignet med den generelle population blev den samlede PDE4-hæmmende aktivitet, bestemt ud fra ex vivo ubundne fraktioner, i studie RO-2455-404-DR fundet at være 15 % højere hos patienter ≥ 75 år og 11 % højere hos patienter med kropsvægt < 60 kg ved baseline (se pkt.
English: Roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 51 ml (pre-bronchodilator FEV1, p<0.0001), and by 53 ml (post-bronchodilator FEV1, p<0.0001).
Danish: Libertek 500 mikrogram 1 gang daglig forbedrede lungefunktionen (FEV1) signifikant med, gennemsnitligt 51 ml før bronkodilatation (p<0,0001) og 53 ml efter bronkodilatation (p<0,0001) sammenlignet med placebo.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially the following: - a medicine containing theophylline (a medicine to treat respiratory diseases), or - a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term.
Danish: Fortæl det til lægen, før du begynder at tage Libertek, hvis du allerede tager: - medicin, der indeholder theofyllin (medicin til behandling af luftvejssygdomme), eller - medicin, der bruges til behandling af immunologiske sygdomme, som methotrexat, azathioprin,
English: Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Danish: Libertek anvendes som vedligeholdelsesbehandling hos voksne patienter med svær, kronisk obstruktiv lungesygdom (KOL) (FEV1 efter bronkodilatation mindre end 50% af forventet) associeret med kronisk bronkitis og med tidligere gentagne eksacerbationer.
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g..multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Libertekshould not be initiated or should be stopped in these patients.
Danish: Den manglende erfaring hos patienter med HIV-infektion eller aktiv hepatitis, med alvorlige immunologiske sygdomme (multipel sklerose, lupus erythematosus, multifokal leukoenkefalopati) eller patienter i immunsupprimerende behandling (andre end korttids-systemiske kortikosteroider).
English: - The other ingredients are: - Core: lactose monohydrate, maize starch, povidone (K90), magnesium stearate, - Coating: hypromellose, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow (E172).
Danish: Filmovertræk: Hypromellose, Macrogol 4000, titandioxid (E171), gul jernoxid (E172)
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Libertek (see section 4.3).
Danish: Patienter med moderat eller svært nedsat leverfunktion klassificeret som Child-Pugh B eller C må ikke tage Libertek (se pkt.
English: Patients and caregivers should be instructed to notify the prescriber of any suicidal ideation (see also section 4.4).
Danish: Patienter, pårørende og plejere skal informeres om at kontakte læge ved enhver tanke om selvmord (se også pkt.
English: EU/1/11/666/001 EU/1/11/666/002 EU/1/11/666/003
Danish: EU/1/11/666/002
English: Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation.
Danish: Patienter, pårørende og plejere skal informeres om at kontakte læge ved enhver ændring i adfærd eller humør og ved selvmordslignende tanker.
English: Driving and using machines Libertek has no influence on the ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Libertek påvirker ikke arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Libertek til dig personligt.
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,
English: Gastrointestinal disorders Diarrhoea
Danish: Opkastning Gastroesofagal refluks Dyspepsi
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Libertek tabletter indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (lapp lactase deficiency) eller glucose/galactose malabsorption.
English: Libertek is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Danish: Libertek anbefales ikke til patienter, der tidligere har haft depression forbundet med selvmordstanker eller selvmordslignende adfærd.
English: 3 How to take Libertek
Danish: Sådan skal du tage Libertek
English: (LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Danish: Libertek anbefales ikke, hvis du har en eller flere af følgende sygdomme: - svære immunologiske sygdomme som HIV-infektion, multipel sklerose (MS), lupus erythematosus (LE) eller progressiv multifokal leukoenkefalopati, (PML) - alvorlige akutte infektionssygdomme som tuberkulose eller akut hepatitis - kræft (bortset fra basalcellekarcinom, en langsomt voksende form for hudkræft) - eller alvorlig forringelse af hjertefunktionen.
English: These findings consisted mainly of gastrointestinal findings (i.e. vomiting, increased gastric secretion, gastric erosions, intestine inflammation) and cardiac findings
Danish: Disse fund bestod hovedsageligt af gastrointestinale fund (dvs. opkastning, øget gastrisk sekretion, gastriske erosioner, tarmbetændelse) og kardielle fund (dvs. fokale blødninger, hæmosiderinaflejringer og infiltration af lymfocytter og histiocytter i højre atrium hos hund, og nedsat blodtryk og øget hjertefrekvens i rotte, marsvin og hund).
English: The clinical data with Libertek in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Libertek should be used with caution in these patients.
Danish: De kliniske data for patienter med let nedsat leverfunktion klassificeret som Child-Pugh A, og som blev behandlet med Libertek, er utilstrækkelige til at anbefale en dosisjustering (se pkt.
English: Libertek 500 micrograms tablets roflumilast
Danish: Libertek 500 mikrogram tabletter roflumilast
English: What Libertek is and what it is used for What you need to know before you take Libertek How to take Libertek
Danish: Det skal du vide, før du begynder at tage Libertek Sådan skal du tage Libertek Bivirkninger
English: BLISTERS
Danish: Blisterkort
English: Libertek 500 micrograms film-coated tablets
Danish: Libertek 500 mikrogram filmovertrukne tabletter
English: Hepatobiliary disorders
Danish: Negativ binomial regression
English: Vomiting Gastro-esophageal reflux disease Dyspepsia
Danish: Mave-tarm-kanalen Diare
English: Method of administration
Danish: Analysemodel
English: Libertek 500 micrograms film-coated tablets Roflumilast
Danish: Libertek 500 mikrogram filmovertrukne tabletter roflumilast
English: Libertek 500 micrograms film-coated tablets roflumilast
Danish: Libertek 500 mikrogram filmovertrukne tabletter Roflumilast
English: Each film-coated tablet (tablet) contains 500 micrograms roflumilast.
Danish: Hver filmovertrukken tablet indeholder 500 mikrogram roflumilast - De øvrige indholdsstoffer er:
English: This will reduce the risk of possible problems.
Danish: Dette vil nedsætte risikoen for eventuelle problemer.
English: Ask your doctor for advice.
Danish: Spørg lægen til råds.
English: • if you are pregnant, think you might be pregnant or are planning to become pregnant
Danish: • hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid hvis du ammer.
English: Symptoms of these reactions include:
Danish: Symptomer på disse reaktioner inkluderer:
English: Protein binding has been stated as 33 to 50%, depending on the methodology used.
Danish: Proteinbinding er blevet fastlagt til at være fra 33 % til 50 % afhængigt af den anvendte metodologi.
English: S=susceptible, R=resistant.
Danish: S = følsom, R = resistent.
English: • positive Coomb's test.
Danish: • positiv Coombs' test.
English: Amount of water to be added (ml)
Danish: Mængde vand, der skal tilsættes (ml)
English: Renal impairment has been reported during use of these combinations.
Danish: Nyrefunktionsnedsættelse er rapporteret ved anvendelse af disse kombinationer.
English: If you are having tests:
Danish: Hvis du skal have taget prøver:
English: Zinacef is an antibiotic used in adults and children.
Danish: Zinacef er et antibiotikum, der anvendes til voksne og børn.
English: See (‘Conditions you need to look out for') in section 4.
Danish: Se ('Tilstande, du skal holde øje med') under punkt 4.
English: If you have a kidney problem, your doctor may change your dose.
Danish: Hvis du har nyreproblemer, vil lægen måske ændre din dosis.
English: Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms:
Danish: Bakteriel resistens over for cefuroxim kan skyldes en eller flere af følgende mekanismer:
English: Other Interactions
Danish: Andre interaktioner
English: It works by killing bacteria that cause infections.
Danish: Det virker ved at dræbe bakterier, som forårsager infektioner.
English: This may have significance in the interference in clinical laboratory tests in humans.
Danish: Dette kan have betydning ved interferens med kliniske laboratorieanalyser hos mennesker.
English: Maximum dose: 6 g per day.
Danish: Højeste dosis er 6 g om dagen.
English: Streptococcus A, B, C and G
Danish: Streptococcus A,B,C og G
English: • severe allergic reaction.
Danish: • alvorlig allergisk reaktion.
English: Repeat steps 4 to 6 to rinse the inside of the vial.
Danish: Gentag trin 4 til 6 for at skylle hætteglasset.
English: Approximate cefuroxime concentration (mg/mL)**
Danish: Omtrentlig cefuroximkoncentration (mg/ml)**
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Danish: Grænseværdierne for den mindste hæmmende koncentration (MIC), fastlagt af European Committee on Antimicrobial Susceptibility Testing (EUCAST), er følgende:
English: The following convention has been utilised for the classification of frequency: 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 and not known (cannot be estimated from the available data).
Danish: Der er benyttet følgende konvention til klassificering af hyppigheden: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Overgrowth of non-susceptible microorganisms
Danish: Overvækst af ikke-følsomme mikroorganismer
English: In many areas, ESBL detection and characterization is recommended or mandatory for infection control purposes.
Danish: I mange områder er ESBL detektion og bestemmelse anbefalet eller obligatorisk af hensyn til infektionskontrol.
English: Microorganism
Danish: Mikroorganisme
English: Zinacef is used to treat infections of:
Danish: Zinacef anvendes til at behandle infektioner i:
English: Interference with diagnostic tests
Danish: Interferens med diagnostiske analyser
English: Don't drive or use machines if you do not feel well.
Danish: Trafik- og arbejdssikkerhed Kør ikke bil og betjen ikke maskiner, hvis du ikke føler dig godt tilpas.
English: Check that the powder has dissolved, and that the bag has no leaks.
Danish: Kontroller, at pulveret er opløst, og at der ikke er hul på posen.
English: The majority of the cefuroxime is excreted within the first 6 hours.
Danish: Størstedelen af cefuroxim udskilles inden for de første 6 timer.
English: However, in older infants (aged >3 weeks) and in children, the serum half-life of 60 to 90 minutes is similar to that observed in adults.
Danish: Hos ældre spædbørn (> 3 uger gamle) og børn svarer halveringstiden i serum på 6090 minutter til, hvad der er observeret hos voksne.
English: Zinacef should be prescribed to pregnant women only if the benefit outweighs the risk.
Danish: Zinacef må kun ordineres til gravide kvinder, hvis fordelene opvejer risici.
English: Other side effects Other side effects have occurred in a very small number of people but their exact frequency is unknown:
Danish: Andre bivirkninger Andre bivirkninger er set hos meget få personer, men den nøjagtige hyppighed kendes ikke:
English: Cefuroxime is usually active against the following microorganisms in vitro.
Danish: Cefuroxim er normalt aktivt over for de følgende mikroorganismer in vitro.
English: Use of cefuroxime may result in the overgrowth of Candida.
Danish: Anvendelse af cefuroxim kan resultere i overvækst af Candida.
English: Reproductive studies in animals have shown no effects on fertility.
Danish: Reproduktionsstudier i dyr har ikke vist påvirkning af fertilitet.
English: Concomitant use with oral anticoagulants may give rise to increased international normalised ratio (INR).
Danish: Samtidig anvendelse af orale antikoagulantia kan medføre forhøjet International Normalised Ratio (INR).
English: Zinacef is also used:
Danish: Zinacef anvendes desuden:
English: Cefuroxime is excreted in human milk in small quantities.
Danish: Cefuroxim udskilles i human mælk i små mængder.
English: It will retain potency for up to 24 hours at room temperature in:
Danish: Aktiviteten vil være bevaret i op til 24 timer ved stuetemperatur i:
English: No carcinogenicity studies have been performed; however, there is no evidence to suggest carcinogenic potential.
Danish: Karcinogenicitetsstudier er ikke udført, men der er ikke evidens for karcinogent potentiale.
English: The frequencies assigned to all other adverse reactions (i.e. those occurring at <1/10,000) were mainly determined using post-marketing data, and refer to a reporting rate rather than a true frequency.
Danish: Hyppigheder fastsat for alle andre bivirkninger (dvs. bivirkninger observeret hos < 1/10.000), er overvejende fastlagt ved anvendelse af data efter markedsføring og refererer til en indberetningshyppighed snarere end til en reel hyppighed.
English: It belongs to a group of medicines called cephalosporins.
Danish: Det tilhører en gruppe lægemidler, der kaldes cefalosporiner.
English: France - Zinnat
Danish: Frankrig - Zinnat
English: • to prevent infections during surgery.
Danish: • til forebyggelse af infektioner i forbindelse med operationer.
English: Cefuroxime is not metabolised.
Danish: Cefuroxim metaboliseres ikke.
English: It can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle.
Danish: Det kan gives som drop (intravenøs infusion) eller som en injektion direkte i en blodåre (vene) eller i en muskel.
English: Your doctor will consider the benefit of treating you with Zinacef against the risk to your baby.
Danish: Lægen vil afveje fordelene ved at behandle dig med Zinacef over for risikoen for barnet.