FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP reviewed the available data on the risk of liver injury and other side effects with orlistat, including post-marketing surveillance, data from the studies supporting the marketing authorisations and population-based studies in the published literature.
Danish: CHMP gennemgik de foreliggende data om risikoen for leverskade og andre bivirkninger med orlistat, herunder data fra overvågning efter markedsføring, fra undersøgelser, der blev anvendt til støtte for ansøgningerne om markedsføringstilladelse, og fra publicerede befolkningsgruppeundersøgelser.
English: The European Medicines Agency has completed a review of orlistat-containing medicines, following concerns about the possible risk of severe liver injury with these medicines.
Danish: Det Europæiske Lægemiddelagentur har foretaget en vurdering af lægemidler indeholdende orlistat, efter at der er rejst betænkeligheder ved den mulige risiko for alvorlige leverskader forårsaget af sådanne lægemidler.
English: The CHMP also noted that published population-based studies suggest that obesity may be associated with a higher risk of liver disease.
Danish: CHMP bemærkede desuden, at befolkningsgruppeundersøgelser tyder på, at fedme i sig selv kan være forbundet med øget risiko for leversygdom.
English: A pattern was not seen in the type of liver problems reported, and in most cases there were other factors which were likely to increase the risk of liver injury such as existing health problems or the use of other medicines.
Danish: I de fleste tilfælde var der desuden andre faktorer til stede, som må forventes at øge risikoen for leverskader, såsom eksisterende helbredsproblemer eller brug af andre lægemidler.
English: The product information for orlistat-containing medicines lists hepatitis, cholelithiasis (gall stones) and a change in liver enzyme levels as potential liver-related side effects.
Danish: Produktinformationen for lægemidler indeholdende orlistat nævner leverbetændelse (hepatitis), galdesten (cholelithiasis) og ændringer i niveauet af leverenzymer som mulige leverrelaterede bivirkninger.
English: Recent safety monitoring showed that from August 2009 to January 2011 four cases of severe liver injury were reported in patients using Xenical where the role of orlistat could not be excluded, including one fatal case of liver failure and one case leading to liver transplantation.
Danish: Den senere tids sikkerhedsovervågning har vist, at der fra august 2009 til januar 2011 var fire tilfælde, hvor patienter, der brugte Xenical, fik svære leverskader, hvor det ikke kunne udelukkes, at orlistat spillede en rolle.
English: The Committee considered that while there may be very rare cases of serious liver injury for which orlistat cannot be excluded as a possible cause, the cases do not provide good evidence of a causal link.
Danish: Udvalget fastslog, at skønt det ikke kan udelukkes, at orlistat i meget sjældne tilfælde er en mulig årsag til leverskader, giver disse tilfælde ikke solidt holdepunkt for en årsagssammenhæng.
English: When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to be passed out in the stools undigested.
Danish: Når disse enzymer blokeres, kan de ikke nedbryde kostens indhold af visse fedtstoffer.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of orlistat continue to outweigh its risks, and therefore recommended that the marketing authorisations be maintained for orlistat-containing medicines.
Danish: Efter vurderingen af de aktuelt foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved lægemidler indeholdende orlistat fortsat er større end risiciene.
English: Therefore, the CHMP considered it necessary to assess whether the evidence gathered over time on the risk of severe liver problems had altered the benefit-risk balance of orlistat-containing medicines.
Danish: CHMP anså det derfor for nødvendigt at vurdere, om benefit/risk-forholdet for lægemidler indeholdende orlistat var ændret på baggrund af den dokumentation om risikoen for alvorlige leverproblemer, der med tiden var blevet indsamlet.
English: The Committee also reviewed information requested from the companies that market orlistat-containing medicines, including the estimated number of people using these medicines and an analysis of the observed number of reports of severe liver problems compared with the expected background rate of liver problems in these people.
Danish: Oplysningerne vedrørte det skønnede antal personer, der anvender lægemidlerne, og en analyse af antallet af indberetninger om alvorlige leverproblemer i forhold til den forventede baggrundsforekomst af leverproblemer hos disse personer.
English: • Patients and prescribers should be aware that certain liver-related problems, including very rare serious reactions such as hepatitis, have been reported and are listed in the product information for orlistat-containing medicines as possible side effects.
Danish: • Patienter og ordinerende læger bør have for øje, at der er indberettet visse leverproblemer, herunder meget sjældne reaktioner som hepatitis.
English: There were 9 reports of liver failure in people using Alli since it was marketed in May 2007 until January 2011, although in some cases there were other possible explanations and in some cases there was insufficient information to assess the cause.
Danish: Der er indberettet 9 tilfælde af leversvigt hos personer, der har anvendt Alli, fra det kom på markedet i maj 2007 og indtil januar 2011.
English: The Committee also agreed on minor amendments to the package leaflet for all orlistat-containing medicines to ensure they give the same information, including a description of the symptoms of hepatitis to alert patients to these symptoms.
Danish: Udvalget fastlagde endvidere mindre ændringer af indlægssedlen for alle lægemidler indeholdende orlistat for at sikre, at de indeholder samme oplysninger.
English: It noted that the product information for Xenical already listed ‘hepatitis that may be serious' as a side effect of unknown frequency, and recommended that the product information for all orlistat-containing medicines should be harmonised to include this information.
Danish: Udvalget bemærkede, at produktinformationen for Xenical i forvejen nævner “hepatitis, som kan være alvorlig” som en bivirkning med ikke kendt hyppighed.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of orlistat continue to outweigh its risks, and recommended that the marketing authorisations be maintained with minor amendments to the product information to ensure the same information on very rare liver-related side effects is provided for all orlistat-containing medicines.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved orlistat fortsat overstiger risiciene, og anbefalede opretholdelse af markedsføringstilladelserne.
English: (Invented) name Strength Pharmaceutical form Route of administration
Danish: Styrke Lægemiddelform
English: Date of first authorisation: 28 September 2012 Date of latest renewal: 13 July 2017
Danish: Dato for første markedsføringstilladelse: 28. september 2012 Dato for seneste fornyelse: 13. juli 2017
English: There are no data from the use of Enurev Breezhaler in pregnant women.
Danish: Der er ingen data fra anvendelse af Enurev Breezhaler til gravide kvinder.
English: Infections and infestations Nasopharyngitis1)
Danish: Infektioner og parasitære sygdomme Nasofaryngitis1)
English: Dental caries
Danish: Dental karies
English: Acute intoxication by inadvertent oral ingestion of Enurev Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Danish: Akut forgiftning ved utilsigtet oral indtagelse af Enurev Breezhaler-kapsler er ikke sandsynlig pga. den lave orale biotilgængelighed (omkring 5 %).
English: There is no relevant use of Enurev Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Danish: Det er ikke relevant at anvende Enurev Breezhaler hos den pædiatriske population (under 18 år) ved indikationen KOL.
English: Enurev Breezhaler once daily has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ).
Danish: Enurev Breezhaler én gang dagligt har ligeledes vist en statistisk signifikant virkning på helbredsrelateret livskvalitet målt ved hjælp af St. George's Respiratory Questionnaire (SGRQ).
English: Please read the full Instructions for Use before using the Enurev Breezhaler.
Danish: Læs venligst den fulde anvisning for brug inden du bruger Enurev Breezhaler.
English: The recommended dose is the inhalation of the content of one capsule once daily using the Enurev Breezhaler inhaler.
Danish: Den anbefalede dosis er inhalation af indholdet i en kapsel én gang dagligt ved hjælp af Enurev Breezhaler-inhalatoren.
English: Do not use Enurev Breezhaler - if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine
Danish: Brug ikke Enurev Breezhaler - hvis du er allergisk over for glycopyrroniumbromid eller et af de øvrige indholdsstoffer i
English: Enurev Breezhaler 44 micrograms once daily can be safely used in all age and body weight groups.
Danish: Enurev Breezhaler 44 mikrogram én gang dagligt kan anvendes sikkert i alle alders- og vægtgrupper.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Enurev Breezhaler and to contact their doctor immediately should any of these signs or symptoms develop.
Danish: Patienter skal informeres om tegn og symptomer på akut snævervinklet glaukom og skal informeres om øjeblikkelig seponering af Enurev Breezhaler og kontakte lægen, hvis patienten udvikler nogle af disse tegn eller symptomer.
English: • One or more blister cards, each containing either 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
Danish: • Et eller flere blisterkort, som hver indeholder enten 6 eller 10 Enurev Breezhaler kapsler til brug i inhalatoren
English: Enurev Breezhaler should be used with caution in these patient groups.
Danish: Enurev Breezhaler bør derfor bruges med forsigtighed i disse patientgrupper.
English: During treatment with Enurev Breezhaler, stop taking this medicine and tell your doctor immediately: - if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Enurev Breezhaler (signs of bronchospasm).
Danish: Under behandling med Enurev Breezhaler, stop med at tage medicinen og fortæl det øjeblikkeligt til din læge: - hvis du oplever trykken for brystet, hoste, hvæsen eller åndenød umiddelbart efter, du har taget Enurev Breezhaler (tegn på bronkospasme).
English: • Enurev Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
Danish: • Enurev Breezhaler kapsler skal altid opbevares i den originale blister og må først tages ud umiddelbart inden anvendelse.
English: - When you start a new pack, use the new Enurev Breezhaler inhaler that is supplied in the pack.
Danish: - Når du starter på en ny pakning, skal du bruge den nye Enurev Breezhaler-inhalator, som er vedlagt pakningen.
English: Following oral inhalation using the Enurev Breezhaler inhaler, glycopyrronium was rapidly absorbed and reached peak plasma levels at 5 minutes post dose.
Danish: Efter oral inhalation med Enurev Breezhaler-inhalatoren blev glycopyrronium hurtigt absorberet og nåede maksimale plasmaniveauer 5 minutter efter dosis.
English: Enurev Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8).
Danish: Enurev Breezhaler kan bruges ved den anbefalede dosis til ældre patienter (75 år eller ældre) (se pkt.
English: Enurev Breezhaler 44 micrograms once daily provided consistently statistically significant improvement in lung function (forced expiratory volume in one second, FEV1, forced vital capacity, FVC, and inspiratory capacity, IC) in a number of clinical studies.
Danish: Enurev Breezhaler 44 mikrogram én gang dagligt medførte konsekvent, statistisk signifikant forbedring af lungefunktionen (forceret udåndingsvolumen i et sekund, FEV1, forceret vitalkapacitet, FVC, og inspiratorisk kapacitet, IC) i en række kliniske studier.
English: Immediate hypersensitivity reactions have been reported after administration of Enurev Breezhaler.
Danish: Der er rapporteret øjeblikkelige overfølsomhedsreaktioner efter administration af Enurev Breezhaler.
English: The long duration of action can be partly attributed to sustained concentrations of active substance in the lung as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Enurev Breezhaler inhaler in contrast to the half life after intravenous administration (see section 5.2).
Danish: Den lange virkningsvarighed kan delvist tillægges vedvarende koncentrationer af det aktive stof i lungerne, som afspejles af den forlængede terminale eliminationshalveringstid for glycopyrronium efter inhalation via Enurev Breezhaler-inhalatoren i modsætning til halveringstiden efter intravenøs administration (se pkt.
English: How to inhale Enurev Breezhaler - In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Danish: Sådan skal du inhalere Enurev Breezhaler - Denne pakning indeholder en inhalator og kapsler (i blister), som indeholder medicinen i form af et inhalationspulver.
English: The absolute bioavailability of glycopyrromium inhaled via Enurev Breezhaler was estimated to be about 45% of the delivered dose.
Danish: Den absolutte biotilgængelighed for glycopyrronium, inhaleret med Enurev Breezhaler, blev estimeret til ca. 45 % af leveret dosis.
English: Enurev Breezhaler is a once-daily, long-term maintenance treatment and is not indicated for the initial treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Danish: Enurev Breezhaler er til langtidsvedligeholdelsesbehandling én gang daglig, og er ikke indiceret til initialbehandling af akutte tilfælde af bronkospasmer, dvs som anfaldsbehandling.
English: No change in mean heart rate or QTc interval was observed with Enurev Breezhaler in doses up to 176 micrograms in COPD patients.
Danish: Der blev ikke observeret ændringer i middelhjertefrekvens eller QTc-interval med Enurev Breezhaler i doser på op til 176 mikrogram hos KOL-patienter.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Enurev Breezhaler in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Enurev Breezhaler i alle undergrupper af den pædiatriske population med KOL (se pkt.
English: This includes medicines similar to Enurev Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
Danish: Det gælder også for medicin tilsvarende Enurev Breezhaler, som bruges i forbindelse med din lungelidelse, f.eks. ipratropium, oxitropium eller tiotropium (såkaldte antikolinerge lægemidler).
English: Talk to your doctor before using Enurev Breezhaler, if any of the following applies to you: - you have kidney problems.
Danish: Kontakt lægen, før du bruger Enurev Breezhaler, hvis nogen af nedenstående forhold gælder for dig: - hvis du har nyreproblemer.
English: If you use more Enurev Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Danish: Hvis du har inhaleret for meget af dette lægemiddel, eller hvis andre personer ved et uheld bruger dine kapsler, skal du øjeblikkeligt fortælle det til din læge eller henvende dig til den nærmeste skadestue.
English: • Do not use the Enurev Breezhaler capsules with any other inhaler.
Danish: • Brug ikke Enurev Breezhaler kapsler med nogen anden inhalator.
English: Enurev Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Danish: Enurev Breezhaler skal bruges med forsigtighed til patienter med snævervinklet glaukom eller urinretention.
English: In a 3-week study where exercise tolerance was tested via cycle ergometer at submaximal (80%) workload (submaximal exercise tolerance test), Enurev Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
Danish: I et studie på 3 uger, hvor fysisk udholdenhed blev undersøgt ved cykelergometri ved submaksimal (80 %) arbejdsbelastning (submaksimal fysisk udholdenhedstest), reducerede Enurev Breezhaler givet om morgenen dynamisk hyperinflation og forbedrede varigheden af den tid patienten kunne motionere fra første dosis og frem.
English: Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Enurev Breezhaler er indiceret som bronkodilaterende vedligeholdelsesbehandling til symptomlindring hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) Enurev Breezhaler can be used at the recommended dose.
Danish: Hos KOL-patienter med mildt og moderat nedsat nyrefunktion (estimeret glomerulær filtrationshastighed, eGFR ≥30 ml/min/1,73 m2) kan Enurev Breezhaler anvendes ved den anbefalede dosis.
English: Enurev Breezhaler administered at 44 micrograms once daily statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI).
Danish: Enurev Breezhaler administreret som 44 mikrogram én gang dagligt reducerer åndenød statistisk signifikant evalueret ved TDI (Transitional Dyspnoea Index).
English: The co-administration of Enurev Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended.
Danish: Samtidig behandling med Enurev Breezhaler og andre antikolinerge lægemidler er ikke undersøgt og anbefales derfor ikke.
English: • Do not use the Enurev Breezhaler inhaler to take any other capsule medicine.
Danish: • Brug ikke Enurev Breezhaler inhalatoren til at tage anden kapselmedicin.
English: Enurev Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Danish: Enurev Breezhaler kan bruges ved den anbefalede dosis hos patienter med let til moderat nedsat nyrefunktion.
English: Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Enurev Breezhaler and were well tolerated.
Danish: Maksimale plasmaniveauer og samlet systemisk eksponering efter intravenøs administration af 150 mikrogram glycopyrroniumbromid (svarende til 120 mikrogram glycopyrronium) hos raske frivillige var henholdsvis omkring 50 og 6 gange højere end det maksimale plasmaniveau og den samlede eksponering ved steady state, som blev opnået med den anbefalede dosis (44 mikrogram én gang dagligt) af Enurev Breezhaler, og var veltolereret.
English: In the pooled 6-month database the frequency of dry mouth was 2.2% versus 1.1%, of insomnia 1.0% versus 0.8%, and of gastroenteritis 1.4% versus 0.9%, for Enurev Breezhaler and placebo respectively.
Danish: I den samlede database for 6 måneder var hyppigheden for mundtørhed 2,2 % vs. 1,1 %, for søvnløshed 1,0 % vs. 0,8 % og for gastroenteritis 1,4 % vs. 0,9 %, for henholdsvis Enurev Breezhaler og placebo.
English: Enurev Breezhaler once daily statistically significantly reduced the use of rescue medication (salbutamol) by 0.46 puffs per day (p=0.005) over 26 weeks and by 0.37 puffs per day (p=0.039) over 52 weeks, compared to placebo for the 6- and 12-month studies, respectively.
Danish: Enurev Breezhaler én gang dagligt reducerede brugen af anfaldsmedicin (salbutamol) statistisk signifikant med 0,46 sug pr. dag (p=0,005) i løbet af 26 uger og med 0,37 sug pr. dag (p=0,039) i løbet af 52 uger sammenlignet med placebo i henholdsvis studierne på 6 og 12 måneder.
English: When to inhale Enurev Breezhaler Use this medicine at the same time each day.
Danish: Tidspunkt for inhalering af Enurev Breezhaler Brug dette lægemiddel på samme tidspunkt hver dag.
English: In the 12-month study, Enurev Breezhaler produced statistically significant improvements in FEV1 compared to tiotropium in the first 4 hours after dosing on day 1 and at week 26, and numerically greater values for FEV1 in the first 4 hours after dosing than tiotropium at week 12 and week 52.
Danish: I studiet på 12 måneder viste Enurev Breezhaler statistiske signifikante forbedringer i FEV1 sammenlignet med tiotropium i de første 4 timer efter dosering på dag 1 og ved uge 26 samt numerisk højere værdier for FEV1 i de første 4 timer efter dosering end tiotropium ved uge 12 og uge 52.
English: Enurev Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index.
Danish: Enurev Breezhaler reducerede ligeledes åndenød i hvile målt ved Transitional Dyspnoea Index.
English: Enurev Breezhaler contains lactose
Danish: Enurev Breezhaler indeholder lactose
English: Enurev Breezhaler is a single-dose inhaler.
Danish: Enurev Breezhaler er en inhalator til enkeltdosering.
English: Enurev Breezhaler is used as a maintenance treatment for your COPD.
Danish: Enurev Breezhaler anvendes som vedligeholdelsesbehandling af din KOL.
English: After three weeks of treatment the improvement in inspiratory capacity with Enurev Breezhaler was similar to the first day (200 ml), exercise endurance time however had increased by 89 seconds (an increase of 21%) compared to placebo.
Danish: Efter tre ugers behandling var forbedringen i inspiratorisk kapacitet med Enurev Breezhaler svarende til den første dag (200 ml), mens fysisk udholdenhedstid var forøget med 89 sekunder (en forøgelse på 21 %) sammenlignet med placebo.
English: At 12 weeks (primary endpoint), Enurev Breezhaler increased trough FEV1 by 72 ml in patients with the lowest degree of reversibility (<5%) and by 113 ml in those patients with a higher degree of reversibility at baseline (≥5%) compared to placebo (both p<0.05).
Danish: Ved 12 uger (primært endepunkt) øgede Enurev Breezhaler dal-FEV1 med 72 ml hos patienter med den laveste grad af reversibilitet (<5 %) and med 113 ml i de patienter med en højere grad af reversibilitet ved baseline (≥5 %) sammenlignet med placebo (begge p<0,05).
English: The capsules must be administered only using the Enurev Breezhaler inhaler (see section 6.6).
Danish: Kapslerne må kun tages ved hjælp af Enurev Breezhaler-inhalatoren (se pkt.
English: Show the pack of Enurev Breezhaler.
Danish: Vis dem pakken med Enurev Breezhaler.
English: The pooled analysis also showed fewer patients treated with Enurev Breezhaler than with placebo experienced an exacerbation requiring hospitalisation (1.7% versus 4.2%, p=0.003).
Danish: Den samlede analyse viste også, at færre patienter på Enurev Breezhaler sammenlignet med placebo oplevede en eksacerbation, der krævede indlæggelse (1,7 % vs. 4,2 %, p=0,003).
English: In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Enurev Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Enurev Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
Danish: I 6-måneders-studiet var procentdelen af patienter, der oplevede moderate til svære eksacerbationer, 17,5 % for Enurev Breezhaler og 24,2 % for placebo (hazard ratio: 0,69, p=0,023), og i 12-måneders-studiet var det 32,8 % for Enurev Breezhaler og 40,2 % for placebo (hazard ratio: 0,66, p=0,001).