FrancophonIA/ELRC3.0 huggingface dataset:
English: However in severe asthmatics, a 12 week study has shown that a dose of 640µg/d (given 320µg/d twice daily) has demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function (see section 5.1).
Danish: Ved en 12-ugers undersøgelse er det dog blevet påvist, at en dosis på 640 µg dagligt (320 µg to gange dagligt) hos personer med svær astma kan mindske hyppigheden af akut forværring, men forbedrer ikke lungefunktionen (se afsnit 5.1).
English: How to store Alvesco
Danish: SÅDAN OPBEVARER DU ALVESCO
English: HOW TO STORE ALVESCO
Danish: Sådan opbevarer du Alvesco
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Mikrogramm Dosieraerosol
Danish: Amavio 40 Mikrogramm Dosieraerosol
English: the CHMP has recommended the granting of the Marketing Authorisation(s) for Alvesco and associated names, with amendments to the relevant sections of the Product Information and with commitments to be fulfilled.
Danish: - Indehaveren af markedsføringstilladelsen foreslog, at der udføres en passende undersøgelse med henblik på at løse det uafklarede spørgsmål om langvarig brug af 320 µg og 640 µg dagligt anbefalede CHMP udstedelse af markedsføringstilladelse(r) for Alvesco og tilknyttede navne med ændringer af de relevante afsnit i produktoplysningerne og med forpligtelser, der skal opfyldes.
English: Alvesco 80 Inhalátor 80 µg
Danish: Alvesco 80 Inhalátor
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Alvesco 40, 80 and 160 micrograms pressurised inhalation, solution Ciclesonide
Danish: Alvesco 40, 80 og 160 mikrogram inhalationsspray, opløsning Ciclesonid
English: Freathe 160 mcg/Dose 160 µg
Danish: Freathe 160 mcg/Dose 160 µg Inhalationsspray, opløsning
English: Alvesco 40 innúdalyf 40 µg
Danish: Alvesco 40 innúdalyf
English: Alvesco 40 Inhalátor 40 µg
Danish: Alvesco 40 Inhalátor
English: Alvesco 160 Inhalátor 160 µg
Danish: Alvesco 160 Inhalátor 160 µg Inhalationsspray, opløsning
English: Mikrogramm Druckgasinhalation, Lösung
Danish: Alvesco 80 Mikrogramm Druckgasinhalation, Lösung
English: You should check with your doctor or pharmacist if you are not sure.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
English: Alvesco 160 Inalador 160 µg
Danish: Alvesco 160 Inalador
English: Alvesco 160 mcg/Dose 160 µg
Danish: Alvesco 160 mcg/Dose 160 µg Inhalationsspray, opløsning
English: Alvesco 80 innúdalyf 80 µg
Danish: Alvesco 80 innúdalyf
English: Alvesco 160 innúdalyf 160 µg
Danish: Alvesco 160 innúdalyf 160 µg Inhalationsspray, opløsning
English: Alvesco 160 inhalators 160 µg
Danish: Alvesco 160 inhalators 160 µg Inhalationsspray, opløsning
English: Alvesco 160 Inhaler 160 µg
Danish: Alvesco 160 Inhaler
English: 160 µg/dose Pressurised inhalation, solution
Danish: 160 µg/dose Inhalationsspray, opløsning
English: Alvesco 40 Inhaler 40 µg
Danish: Alvesco 40 Inhaler
English: Amavio 160 mcg/Dose 160 µg
Danish: Amavio 160 mcg/Dose 160 µg Inhalationsspray, opløsning
English: Alvesco 160 Inhalator 160 µg
Danish: Alvesco 160 Inhalator 160 µg Inhalationsspray, opløsning
English: 40 µg/dose Pressurised inhalation, solution
Danish: 40 µg/dose Inhalationsspray, opløsning
English: 80 µg/dose Pressurised inhalation, solution
Danish: 80 µg/dose Inhalationsspray, opløsning
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Alvesco 80 Inhaler 80 µg
Danish: Alvesco 80 Inhaler
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
Danish: TILFØJELSER DER SKAL IND I DEN ENDELIGE VERSION AF INDLÆGSSEDLEN
English: Alvesco 40 Inhalator 40 µg
Danish: Alvesco 40 Inhalator
English: ANNEX
Danish: BILAG
English: The monitoring of NO2 formation
Danish: Monitorering af dannelse af NO2
English: Educational material for Healthcare Professionals
Danish: Informationsmateriale for sundhedspersonale.
English: The monitoring of Methaemoglobin level
Danish: Monitorering af metæglobinniveauet<0}
English: The educational material should be a pocket size guide that includes information on the following key elements:
Danish: Uddannelsesmaterialet skal være en vejledning i lommestørrelse som indeholder oplysninger om følgende centrale punkter:
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch of the new indication, all Healthcare Professionals who are expected to use and/or prescribe INOmax as part of the treatment of peri- or post- operative pulmonary hypertension in adults and children in conjunction to heart surgery are provided with an Educational pack.
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal ved lanceringen af den nye indikation sikre, at alt sundhedspersonale, som forventes at bruge og/eller ordinere INOmax som led i behandlingen af peri- eller postoperativ pulmonar hypertension hos voksne eller børn i forbindelse med hjerteoperation, modtager en informationspakke.
English: The educational pack should contain the following: Summary of Product Characteristics and Patient Information Leaflet for INOmax
Danish: Informationspakken skal indeholde følgende: Opsummering af produktkarakteristika og patientinformationshæfte for INOmax.
English: The potential risk of bleeding and haemostasis disorders The potential risks if used in combination with other vasodilators which act on cGMP or cAMP
Danish: Den potentielle risiko for blødning og hæmostaselidelser De potentielle risici ved anvendelse samtidig med andre vasodilaterende midler der virker efter cGMP- eller cAMP-systemerne
English: The risk of rebound effect and the precautions to take when discontinuing the treatment The risk of abrupt discontinuation of Inomax therapy in the event of critical failure of the delivery system and how to prevent it
Danish: Risikoen ved akut seponering af INOmax-behandlingen i tilfælde af kritisk svigt i indgivelsessystemet og hvordan dette forhindres
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG.
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented in their national territory: Prior to launch of the new indication of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder
Danish: Før lanceringen af produktets nye indikation i medlemslandet skal indehaveren af markedsføringstilladelsen aftale indhold og format for undervisningsprogrammet med de relevante nationale myndigheder.
English: This product has never been marketed.
Danish: Dette lægemiddel er aldrig blevet markedsført.
English: This effect is known as ‘dose-dumping'.
Danish: Denne effekt kaldes "dosisdumping".
English: The CHMP's conclusions were arbitrary.
Danish: CHMP's konklusioner var vilkårlige.
English: This aspect is outside the scope of this procedure and it does not provide any relevant information to the issue at stake.
Danish: Dette aspekt ligger uden for denne procedures anvendelsesområde og giver ikke nogen relevante informationer i det spørgsmål, der er tale om.
English: The new formulation must be approved by the National Competent Authorities of the concerned Member States (see Annex IV).
Danish: Den nye formulering skal godkendes af de nationale kompetente myndigheder i de berørte medlemsstater (se bilag IV).
English: About 20% of the responders reported chronic pain (>6 months).
Danish: Cirka 20 % af respondenterne indberettede kroniske smerter (>6 måneder).
English: This further illustrates the limitations of the data presented.
Danish: Dette illustrerer ligeledes de fremlagte datas begrænsning.
English: The Opinion was not properly reasoned.
Danish: Udtalelsen var ikke ordentligt begrundet.
English: The remaining systems were not significantly affected by alcohol.
Danish: De resterende systemer blev ikke signifikant påvirket af alkohol.
English: Grounds for suspension of the marketing authorisation
Danish: Begrundelser for suspendering af markedsføringstilladelsen
English: This may be further aggravated by the fact that many patients with chronic pain will also suffer from depression.
Danish: Dette kan yderligere forværres af den kendsgerning, at mange patienter med kroniske smerter også lider af depression.
English: Re-examination procedure
Danish: Revurderingsprocedure
English: Benefit-Risk balance
Danish: Benefit/risk-forholdet
English: In its assessment, the Committee took into consideration data submitted for the different timepoints.
Danish: I sin vurdering tog udvalget de data i betragtning, der var fremsendt i forbindelse med de forskellige tidsfrister.
English: Pain at baseline was a significant predictive factor for alcohol use in the 3-years follow-up period.
Danish: Smerte ved baseline var en væsentlig prædiktiv faktor for alkoholforbrug i den treårige opfølgningsperiode.
English: It is well known that food can have an effect on the pharmacokinetic parameters of medicinal products.
Danish: Det er velkendt, at fødevarer kan have en indvirkning på et lægemiddels farmakokinetiske parametre.
English: Quality issues
Danish: Kvalitetsspørgsmål
English: Further to that, the IVIV correlation is, at present time, uncertain for most products.
Danish: Hertil kommer, at IVIV-sammenhængen på nuværende tidspunkt er usikker for de fleste lægemidler.
English: The question under discussion is, however, whether the magnitude of the interaction is such that it can be assumed to have clinical significance and represent a significant risk for the patient.
Danish: Det spørgsmål, der drøftes, er dog, om interaktionen er af et sådant omfang, at den kan antages at have klinisk signifikans og udgøre en signifikant risiko for patienten.
English: This will be related to the specificities of each formulation, namely the physical characteristics of the excipients and the manufacturing process.
Danish: Dette vil hænge sammen med de enkelte formuleringers særlige kendetegn, nemlig hjælpestoffernes fysiske karakteristika og fremstillingsprocessen.
English: Given the type of products and patient population involved, it is acknowledged that underreporting is considerable.
Danish: I betragtning af, hvilken type lægemidler og patientpopulation der er berørt, anerkendes det, at der sker en betydelig underindberetning.
English: The association between chronic pain and alcohol use is summarized in the table below.
Danish: Sammenhængen mellem kroniske smerter og alkoholforbrug opsummeres i tabellen nedenfor.
English: The question of what could be considered as a clinical significant interaction with alcohol was left for the EWP to consider.
Danish: Spørgsmålet om, hvad der kunne betragtes som en klinisk signifikant interaktion med alkohol, blev det overladt til EWP at overveje.
English: On 18 September 2009, the European Commission triggered a referral under Article 31 of Directive 2001/83/EC, as amended.
Danish: Den 18. september 2009 indbragte Europa-Kommissionen en sag i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer.
English: When adopting its 22 July 2010 opinion on this procedure, CHMP was fully aware of the positions of the different working parties.
Danish: Da CHMP vedtog sin udtalelse af 22. juli 2010 om denne procedure, var udvalget fuldstændigt klar over de forskellige arbejdsgruppers holdninger.
English: The Committee is therefore of the opinion that its 22 July 2010 opinion should be maintained.
Danish: CHMP er således af den opfattelse, at udvalgets udtalelse af 22. juli 2010 bør fastholdes.
English: The Opinion did not take account of the earlier advice of its own working parties, namely the EWP and QWP, which had been requested by the CMD(h); nor did it provide any proper reasons for discounting that advice.
Danish: I udtalelsen var der ikke taget højde for den tidligere rådgivning fra CHMP's egne arbejdsgrupper, nemlig EWP og QWP, som CMD(h) havde anmodet om, og den indeholdt heller ikke nogen rimelige grunde til at se bort fra denne rådgivning.
English: Where not possible, the QWP recommended the inclusion of differential wording in the Product Information.
Danish: Hvis dette ikke er muligt, rådede QWP til medtagelsen af en anden ordlyd i produktinformationen.
English: However, a significant percentage of the patients with chronic pain who uses opioids still reports high alcohol intake (10.8%) and binge drinking at least once a month (22.3%), despite existing warnings.
Danish: En væsentlig procentdel af patienterne med kroniske smerter, og som bruger opioider, indberetter imidlertid stadig et højt alkoholforbrug (10,8 %) og druk mindst én gang om måneden (22,3 %), på trods af de eksisterende advarsler.
English: Patients being treated with opioids tend to drink less alcohol than patients who do not use opioids at all.
Danish: Patienter, der behandles med opioider, har tendens til at drikke mindre alkohol end patienter, som slet ikke bruger opioider.
English: It is important to note in this regard that the effects of food related interactions are measured in vivo, and therefore the data on food effect reflects, as accurately as possible, the real extent of the interaction.
Danish: I den forbindelse er det vigtigt at bemærke, at virkningerne af fødevarerelaterede interaktioner måles in vivo, og derfor afspejler dataene for fødevareindvirkninger interaktionens reelle omfang så nøjagtigt som muligt.
English: In this context, the fact that the product is meant for use once or twice a day may be of importance given the higher dose usually contained in once a day formulations.
Danish: I den forbindelse kan den kendsgerning, at lægemidlet skal bruges én eller to gange om dagen, være vigtig i betragtning af den højere dosis, der som regel er indeholdt i formuleringer beregnet til indtagelse én gang om dagen.
English: In its initial Opinion, the CHMP did not conclude that the formulations analysed were unaffected by alcohol.
Danish: I sin oprindelige udtalelse konkluderede CHMP ikke, at de analyserede formuleringer ikke blev påvirket af alkohol.
English: A significant effect was observed also in a hydromorphone once a day formulation which is not marketed in the EU.
Danish: Der blev også observeret en signifikant effekt i en hydromorphonformulering beregnet til indtagelse én gang daglig, som ikke markedsføres i EU.
English: The Committee is also of the opinion that further minimisations measures would not adequately address the concern.
Danish: Udvalget mener endvidere, at yderligere minimeringsforanstaltninger ikke i tilstrækkelig grad ville afhjælpe denne betænkelighed.
English: The advice of the QWP was that formulations should, if possible, be developed such that a physicochemical incompatibility with alcohol is avoided.
Danish: QWP rådede til, at formuleringerne om muligt skulle udvikles på en sådan måde, at den fysisk-kemiske uforenelighed med alkohol undgås.
English: Modified-release products are complex dosage forms designed to release drugs in a controlled manner to achieve desired efficacy and safety profiles.
Danish: Lægemidler med modificeret udløsning er komplekse doseringsformer, der er udviklet til at frigive lægemidler på en kontrolleret måde for at opnå den ønskede effekt og de ønskede sikkerhedsprofiler.
English: In addition, the CHMP agreed on the inclusion for all other products in the European market of a pharmacodynamic warning.
Danish: Desuden vedtog CHMP, at der for alle andre lægemidler på det europæiske marked skulle medtages en farmakodynamisk advarsel.
English: While it may be argued that patients may use less alcohol as a self-medication strategy if they are sufficiently treated with analgesics like opioids, the results of a recently published Danish Health survey (Ekholm et al. Eur J Pain 2009; 13: 606-12) reveal a different pattern of behavior.
Danish: Selv om det kan fremføres, at patienter måske i mindre grad bruger alkohol som selvmedicinering, hvis de modtager tilstrækkelig behandling med analgetika som opioider, afslører resultaterne af en nyligt offentliggjort dansk sundhedsundersøgelse (Ekholm et al. Eur J Pain 2009; 13: 606-12) et andet adfærdsmønster.
English: The Committee also discussed the possibility of the introduction of a pharmacokinetic warning in those cases where some degree of additional formulation interaction could be suspected.
Danish: Udvalget drøftede ligeledes muligheden for at medtage en farmakokinetisk advarsel i de tilfælde, hvor der kunne være mistanke om en vis grad af yderligere formuleringsinteraktion.
English: The advice of the EWP was to consider the worst case scenario, including gastric residence times of 1-2 to hours and potential exposure to high concentrations of alcohol.
Danish: EWP rådede til at tage det værst tænkelige scenario i betragtning, herunder en opholdstid i maven på 1-2 timer og en potentiel eksponering for høje koncentrationer af alkohol.
English: It is therefore concluded that the approach is not inconsistent, firstly because in the case of alcohol, a recommendation not to take the product with alcohol will always exist regardless of the formulation.
Danish: Det konkluderes således, at tilgangen ikke er inkonsekvent, for det første fordi der for alkohols vedkommende altid vil være en anbefaling om ikke at indtage lægemidlet sammen med alkohol, uanset formulering.
English: The association between pain and drinking was evaluated by Brennan et al in a cohort of 401 elderly with different drinking behavior (Brennan, Addiction.
Danish: Sammenhængen mellem smerter og druk blev evalueret af Brennan et al. i en kohorte med 401 ældre patienter med forskellig drikkeadfærd (Brennan, Addiction.
English: Both problem drinkers as non-problem drinkers reported to use alcohol to manage pain, although in the latter group to less extent (see figure 1).
Danish: Både alkoholikere og ikkealkoholikere indberettede at bruge alkohol til at håndtere smerte, i sidstnævnte gruppe dog i mindre grad (se figur 1).
English: For most of the products assessed, only in vitro data was submitted.
Danish: Der blev for de fleste af de vurderede lægemidlers vedkommende kun indsendt in vitro-data.
English: Dissolution data was submitted for two different controlled release systems of hydromorphone, four different controlled release systems of oxycodone, and seven different controlled release systems containing morphine.
Danish: Der blev indsendt opløsningsdata for to forskellige systemer til kontrolleret udløsning af hydromorphon, fire forskellige systemer til kontrolleret udløsning af oxycodon og syv forskellige systemer til kontrolleret udløsning af morfin.
English: In this study, subjects were interviewed about their number of alcohol consumptions of the last week and frequency of binge drinking in the last month (5292 responders).
Danish: Deltagerne i denne undersøgelse blev bedt om at oplyse, hvor mange alkoholgenstande de havde indtaget i løbet af den seneste uge, og hvor hyppigt de havde været på druk i løbet af den seneste måned (5 292 respondenter).
English: Concurrent depression and pain have a much greater impact than either disorder alone and, in patients with pain, depression is associated to more pain sites, greater pain intensity, longer duration of pain, and greater likelihood of poor treatment response (Bair, J et al., Psychosom Med. 2008 October; 70(8): 890-897).
Danish: Samtidig tilstedeværelse af depression og smerter har en langt større indvirkning end hver af disse lidelser alene, og hos patienter med smerter er depression forbundet med flere smertesteder, større smerteintensitet, længerevarende smerter og større sandsynlighed for ringe respons på behandling (Bair, J et al., Psychosom Med. 2008 october; 70(8): 890-897).
English: Both problem drinkers and non-problem drinkers were included.
Danish: Der indgik både alkoholikere og ikkealkoholikere.
English: This is demonstrated by measurements of gastric-duodenal ethanol levels after consumption of alcohol in healthy volunteers.
Danish: Dette fremgår af målinger af de gastriske og duodenale ethanolniveauer efter indtagelsen af alkohol hos raske frivillige.
English: The assessment within this procedure provided an overview of the modified-release systems used in the European Union in oral opioid products.
Danish: Vurderingen inden for rammerne af denne procedure gav et overblik over de systemer til modificeret udløsning, der anvendes i orale opioide lægemidler i EU.
English: However, for all of these products, a pharmacodynamic interaction may occur and should be mentioned in the Product information of all products in a consistent manner.
Danish: For alle disse lægemidler kan der imidlertid forekomme en farmakodynamisk interaktion, og dette bør på konsekvent vis fremgå af produktinformationen for alle lægemidlerne.
English: The effect of alcohol on the dissolution rate was mild in most cases, except for one morphine formulation (morphine once-daily capsules).
Danish: Alkoholens effekt på opløsningshastigheden var i de fleste tilfælde mild, bortset fra én morfinformulering (morfinkapsler til indtagelse én gang daglig).
English: In addition, as the medicinal product based on this release-mechanism is intended for once a day dosing, the content of morphine is high and therefore the risk of adverse events following dose-dumping is also higher.
Danish: Idet lægemidlet baseret på denne mekanisme til udløsning er beregnet til dosering én gang daglig, er indholdet af morfin desuden højt, hvorfor risikoen for utilsigtede hændelser som følge af dosisdumping også er højere.
English: Alcohol use is common in patients with chronic pain due to the fact that it reduces pain perception.
Danish: Indtagelse af alkohol er almindeligt blandt patienter med kroniske smerter, idet det reducerer smerteopfattelsen.
English: Secondly, the CHMP's approach to alcohol interaction is inconsistent with its approach to food interactions.
Danish: For det andet er CHMP's tilgang til interaktionen med alkohol ikke konsekvent i betragtning af dens tilgang til interaktionerne med fødevarer.
English: It is however clear that, in the cases where the highest degree of in vitro interaction was observed, the high alcohol solubility of the excipients provided a clear explanation for the observation.
Danish: Det står dog klart, at i de tilfælde, hvor der blev observeret den højeste grad af in vitro-interaktion, gav hjælpestoffernes høje opløselighed i alkohol en tydelig forklaring på det observerede resultat.
English: Gastric ethanol concentrations dropped rapidly after the consumption of alcohol by 70% in 10 min (Levitt et all, Am J Physiol Gastrointest Liver Physiol 273:951-957, 1997).
Danish: De gastriske ethanolkoncentrationer faldt hurtigt efter indtagelsen af alkohol, nemlig med 70 % på 10 minutter (Levitt et al., Am J Physiol Gastrointest Liver Physiol 273:951-957, 1997).
English: For alcohol, the majority of the data available relates to in vitro testing only, and therefore cannot be assumed, for the reasons previously explained, to be directly reproduced in vivo.
Danish: Hvad alkohol angår, vedrører størstedelen af de tilgængelige data udelukkende in vitro-undersøgelser, og derfor kan det - af de grunde, der forklares ovenfor - ikke antages, at de bliver direkte gengivet in vivo.
English: In this respect, it was noted that the in vitro - in vivo correlation is unclear in most cases, and therefore it would be inappropriate to assume a pharmacokinetic interaction.
Danish: Det blev i den forbindelse bemærket, at in vitro/in vivo-sammenhængen er uklar i de fleste tilfælde, og derfor ville det være forkert at antage, at der er en farmakokinetisk interaktion.