FrancophonIA/ELRC3.0 huggingface dataset:
English: The laboratory studies involved chicks with maternal antibodies against IBD virus.
Danish: Laboratoriestudierne omfattede kyllinger med maternelle antistoffer mod IBD-virus.
English: How is Gumbohatch used?
Danish: Hvordan anvendes Gumbohatch?
English: How does Gumbohatch work?
Danish: Hvordan virker Gumbohatch?
English: What benefits of Gumbohatch have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Gumbohatch?
English: On 28 January 2011, France triggered a referral under Article 31 of Directive 2001/83/EC, as amended.
Danish: Den 28. januar 2011 indbragte Frankrig en sag i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer.
English: Conclusion and recommendations
Danish: Konklusion og anbefalinger
English: While the data from Sweden and Norway appear to be consistent, other factors can explain the observations.
Danish: Skønt dataene fra Sverige og Norge synes at være overensstemmende, kan andre faktorer være forklaringen på iagttagelserne.
English: Pholcodine has been marketed for decades in the European Union, where currently marketing authorisations exist in Belgium, France, Ireland, Lithuania, Luxembourg, Malta, Slovenia, Spain and United Kingdom, either subject to medical prescription or as non-prescription medicines.
Danish: Pholcodin har været markedsført i flere årtier i EU, hvor der nu foreligger markedsføringstilladelser i Belgien, Frankrig, Irland, Litauen, Luxembourg, Malta, Slovenien, Spanien og Det Forenede Kongerige, enten som receptpligtige eller receptfri præparater.
English: Scientific discussion
Danish: Videnskabelig diskussion
English: The draft protocol of the study should be submitted to CHMP within 3 months of the Commission Decision.
Danish: Protokoludkast til denne undersøgelse skal forelægges CHMP senest 3 måneder efter Kommissionens afgørelse.
English: No study has been performed on the long term effects of pholcodine.
Danish: Der ikke udført undersøgelser af langtidsvirkningerne af pholcodin.
English: This coincides with a 9% increase in the consumption of pholcodine-containing products in France between the two periods.
Danish: Dette falder sammen med en stigning på 9 % i forbruget af produkter indeholdende pholcodin i Frankrig i tidsrummet mellem de to perioder.
English: The published data refers mainly to Norway and Sweden, where pholcodine is no longer marketed.
Danish: De offentliggjorte data henviser hovedsageligt til Norge og Sverige, hvor pholcodin ikke længere markedsføres.
English: For this purpose, Marketing Authorisation Holders shall conduct a case-control study as described in annex III of this opinion.
Danish: Til dette formål skal indehaverne af markedsføringstilladelserne udføre en case-kontrolundersøgelse som beskrevet i bilag III til denne udtalelse.
English: 3 Johansson SGO et al. Pholcodine caused anaphylaxis in Sweden 30 years ago.
Danish: Johansson SGO and al. Pholcodine caused anaphylaxis in Sweden 30 years ago.
English: The CHMP was requested to give its opinion on whether the marketing authorisations for medicinal products containing pholcodine-containing medicinal products should be maintained, varied, suspended or withdrawn.
Danish: CHMP blev anmodet om at udtale sig om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende pholcodin burde opretholdes, ændres, suspenderes eller inddrages.
English: Class II and III reactions still represent the majority of the reported cases, same as when pholcodine was still marketed.
Danish: Reaktioner af klasse II og III udgør fortsat størstedelen af de indberettede tilfælde, ligesom da pholcodin endnu var på markedet.
English: Ultimately, even if the prevalence of sensitisation is high, the clinical relevance of these findings is questionable.
Danish: Selv hvis prævalensen af sensibilisering er høj, er den kliniske relevans af disse resultater i sidste instans tvivlsom.
English: A further issue for consideration is that anaphylactic reactions to pholcodine itself appear to be rare.
Danish: Endnu et forhold, der må tages i betragtning, er, at anafylaktiske reaktioner over for selve pholcodinet synes at være sjældne.
English: In countries with small populations such as Norway (4.8 million) and Sweden (9.3 million), confounding factors such as a change in anaesthetic procedures, type of products used in anaesthesia and overall use of NMBAs could play a role in explaining the findings.
Danish: I lande med små befolkninger som Norge (4,8 mio.) og Sverige (9,3 mio.), kan konfunderende faktorer som ændrede anæstesiprocedurer, de anvendte produkttyper ved anæstesi og det totale forbrug af NMBA tænkes at spille en rolle som forklaring på resultaterne.
English: Overall summary of the scientific evaluation of pholcodine-containing products (see Annex I) Background information
Danish: Samlet resumé af den videnskabelige vurdering af produkter indeholdende pholcodin (se bilag I)
English: In France, data from spontaneous reporting suggests a 25% increase in the number of anaphylactic shocks to NMBAs in the period 2008/2009 when compared to the 2003/2004 period.
Danish: I Frankrig tyder data fra spontan indberetning på, at der er sket en stigning på 25 % i antallet af anafylaktiske shock udløst af NMBA i perioden 2008/2009 i forhold til perioden 2003/2004.
English: Very few cases have been described with a substance that has been extensively used for decades and that is even available in some countries without medical prescription.
Danish: Der er beskrevet meget få tilfælde, skønt stoffet har været genstand for omfattende brug i flere årtier og endda i nogle lande udleveres uden recept.
English: There has been extensive use of pholcodine-containing products over the course of several decades, which has allowed the collection of relevant safety data.
Danish: Produkter indeholdende pholcodin har haft stor udbredelse gennem adskillige årtier, hvilket har gjort det muligt at indsamle relevante sikkerhedsdata.
English: Grounds for the maintenance of the marketing authorisations
Danish: Begrundelse for opretholdelsen af markedsføringstilladelsen
English: The existent data seems to indicate that pholcodine is at least as safe as codeine, with the advantage that it does not share the same potential for addiction.
Danish: De foreliggende data synes at pege på, at pholcodin er mindst lige så sikkert som kodein og har den fordel at være uden dettes potentiale for afhængighed.
English: The conditions affecting the marketing authorisations are set out in Annex III.
Danish: Betingelserne for markedsføringstilladelserne fremgår af bilag III.
English: The first clinical studies on efficacy of pholcodine as an antitussive agent are dated 1950.
Danish: De første kliniske undersøgelser af virkningen af pholcodin som antitussivum stammer fra 1950.
English: Annex II Scientific conclusions and grounds for the maintenance of the marketing authorisations presented by the EMA
Danish: Videnskabelige konklusioner og begrundelse for opretholdelse af markedsføringstilladelserne fremlagt af EMA
English: Pholcodine is an opiate with central antitussive action used for treatment of cough and cold symptoms in children and adults.
Danish: Pholcodin er et centralt virkende antitussivt opiat, der anvendes til behandling af hoste og forkølelsessymptomer hos voksne og børn.
English: This could explain the reason why data from countries such as the USA or the Netherlands does not fit with the pholcodine hypothesis: in these countries pholcodine is not marketed, and still prevalence of IgE to pholcodine and morphine was found to be high.
Danish: Dette kan tænkes at være grunden til, at data fra lande som USA og Holland ikke stemmer overens med pholcodin-hypotesen: Pholcodin markedsføres ikke i disse lande, men alligevel er der en høj prævalens af IgE over for pholcodin og morphin.
English: This study has limitations such as a lack of a placebo control arm and the non-validated and subjective nature of the outcomes (cough frequency and intensity), but an effect was observed very early in the treatment.
Danish: Denne undersøgelse har sine begrænsninger i form af manglende placebokontrolarm og den ikke validerede og subjektive karakter af udfaldet (hostefrekvens og -intensitet), men en effekt blev iagttaget meget tidligt i behandlingen.
English: To support this opinion, some experts referred to the data from the USA showing that there is sensitisation even in the absence of pholcodine consumption, which strengthens the view that other substances are able to trigger this kind of cross-sensitisation.
Danish: Til støtte for denne opfattelse henviste nogle af eksperterne til data fra USA, der viser, at sensibilisering forekommer selv uden brug af pholcodin, hvilket styrker antagelsen om, at andre stoffer er i stand til at udløse denne form for krydssensibilisering.
English: In recent years the Norwegian network for anaphylaxis under general anaesthesia, which collects these reports, has been subject to less intense promotion, and therefore it is possible that the observed decrease in reporting does not actually reflect lower occurrence.
Danish: I de senere år har det norske netværk for anafylaksi under general anæstesi, som indsamler disse rapporter, været udsat for en mindre intensiv reklame, hvorfor det iagttagne fald i indberetninger muligvis ikke afspejler en faktisk lavere hyppighed.
English: The concerns of the French Medicines Agency arose from the potential risk that pholcodine may lead to IgEsensitisation to neuromuscular blocking agents (NMBAs).
Danish: Den franske lægemiddelstyrelses betænkeligheder havde baggrund i den potentielle risiko for, at pholcodin kan medføre IgE-sensibilisering over for neuromuskulære blokkere (NMBA).
English: Apr; 65 (4): 498-502.
Danish: Allergy 2010 Apr; 65 (4): 498-502.
English: Divergent opinions were expressed on the strength of the epidemiological evidence, based on the Swedish and the Norwegian experiences and the quasi experiment resulting from the discontinuation of the drug in the two countries at different timings and the biological plausibility of the hypothesis.
Danish: Der blev udtrykt divergerende opfattelser af styrken af den epidemiologiske evidens, der var baseret på de svenske og norske erfaringer, det forsøgslignende forløb bestående i seponeringen af lægemidlet i de to lande til forskellig tid og den biologiske plausibilitet af hypotesen.
English: If indeed other substances containing quaternary ammonium ions have the ability to induce cross-sensitisation to NMBAs, and if such substances can be found in numerous household products, the specificity of IgE to pholcodine has to be questioned.
Danish: Hvis andre stoffer, der indeholder kvaternære ammoniumforbindelser, i praksis kan inducere krydssensibilisering for NMBA, og hvis sådanne stoffer findes i mange husholdningsprodukter, må der sættes spørgsmålstegn ved specificiteten af IgE over for pholcodin.
English: The evidence in support of this derives from ecological studies conducted by a single research team relying on spontaneously reported adverse reactions to NMBAs.
Danish: Dokumentationen til støtte herfor er uddraget af økologiske undersøgelser, der er foretaget af et enkelt forskerhold, som har baseret sig på spontant indberettede reaktioner mod NMBA.
English: Even assuming that there is some biological plausibility for the pholcodine-sensitisation and that the spontaneously reported cases reflect the actual prevalence of anaphylactic reactions during surgery, a broad range of other agents may also be responsible.
Danish: Selv hvis man antager, at pholcodin-sensibilisering har en vis biologisk plausibilitet, og at de spontant indberettede tilfælde afspejler den faktiske prævalens af anafylaktiske reaktioner under kirurgiske indgreb, kan en lang række andre midler også være ansvarlige.
English: As a consequence, the French Medicines Agency changed the prescription status of pholcodine-containing medicines to prescription only and triggered this referral.
Danish: I konsekvens heraf har den franske lægemiddelstyrelse ændret udleveringsbestemmelserne for lægemidler indeholdende pholcodin, således at de nu udelukkende er receptpligtige, og har indledt denne indbringelse.
English: The Committee therefore recommended the maintenance of the marketing authorisation for pholcodinecontaining products.
Danish: Udvalget anbefalede derfor opretholdelse af markedsføringstilladelsen for produkter indeholdende pholcodin.
English: There is a large body of literature demonstrating the existence of centrally-acting cough suppressant properties of opiates, and pholcodine in particular has been used in this indication since the 1950's.
Danish: I litteraturen findes omfattende dokumentation for opiaters centralt betingede hostestillende egenskaber, og specielt pholcodin har været brugt til denne indikation siden 1950'erne.
English: The majority of the experts considered that although sensitisation to pholcodine and development of allergic reactions to NMBAs is a possibility, the existing evidence is weak mainly due to inconsistencies and methodological bias.
Danish: Størstedelen af eksperterne var af den opfattelse, at skønt sensibilisering for pholcodin og udvikling af allergiske reaktioner over for NMBA er en mulighed, er den foreliggende dokumentation svag, hovedsageligt på grund af uoverensstemmelser og metoderelateret bias.
English: The experts also considered that the decision to use a NMBA is based on clinical need and cannot be avoided, regardless of history of pholcodine use.
Danish: Eksperterne tog desuden i betragtning, at beslutningen om at bruge et NMBA bliver taget på grundlag af det kliniske behov og er uundgåelig, uanset hvordan pholcodin tidligere har været anvendt.
English: Most studies were not adequately controlled, either with active or placebo medications, and some were performed using combination products, which makes it difficult to isolate and measure the efficacy of the single component pholcodine.
Danish: De fleste undersøgelser var ikke tilstrækkeligt kontrollerede, og i nogle af dem anvendtes kombinationsprodukter, hvilket gør det vanskeligt at udskille og fastlægge virkningen af pholcodin isoleret.
English: Data from Sweden where pholcodine has not been marketed since the 80's is indicative, like in Norway, that the level of IgE-sensitisation to pholcodine has been decreasing over time in parallel to a decrease in the number of NMBA-related anaphylaxis cases3.
Danish: Data fra Sverige, hvor pholcodin ikke har været markedsført siden 80'erne, tyder ligesom i Norge på, at niveauet af IgE-sensibilisering over for pholcodin med tiden har været aftagende, sideløbende med faldet i antallet af tilfælde af NMBA-relateret anafylaksi3.
English: Being an old product, the methodology used in most efficacy studies with pholcodine would be considered poor by modern standards.
Danish: Da pholcodin er et gammel produkt, ville metodologien i størstedelen af undersøgelserne af stoffets virkning blive anset for at være ringe, vurderet efter en moderne standard.
English: In recent years, observations in Norway led one team of researchers to raise the possibility that high consumption of cough mixtures in these countries was related to increased prevalence of IgE antibodies to pholcodine, morphine and suxamethonium, and ultimately higher incidence of IgE-mediated anaphylactic reactions to NMBAs1,2
Danish: I de senere år har observationer i Norge fået et team af forskere til at rejse muligheden af, at et højt forbrug af hostestillende miksturer i disse lande er forbundet med øget prævalens af IgEantistoffer mod pholcodin, morphin og suxamethonium, og ultimativt med højere incidens af IgEmedierede anafylaktiske reaktioner over for NMBA1,2.
English: Based on immunological analyses determining the prevalence of antibodies to these active substances in different populations, and reporting rates for NMBA-related anaphylaxis during anaesthesia, researchers concluded that withdrawal of pholcodine from the market in Norway significantly lowered within 1-2 years levels of IgE and IgE antibodies to pholcodine and, within 3 years, the frequency of NMBA suspected anaphylaxis.
Danish: På grundlag af immunologiske analyser anvendt til bestemmelse af prævalensen af antistoffer mod disse aktive stoffer i forskellige populationer samt indberetningsrater for NMBA-relateret anafylaksi under anæstesi har forskerne konkluderet, at tilbagetrækningen af pholcodin fra markedet i Norge i løbet af 1-2 år førte til et væsentligt fald i IgE- og IgE-antistoffer mod pholcodin og, i løbet af tre år, i frekvensen af formodet anafylaksi over for NMBA.
English: The majority of the adverse events reported in clinical trials, literature and post-marketing experience are gastrointestinal disorders and psychiatric disorders, which are adverse events known and commonly reported with opiates.
Danish: Hovedparten af de indberettede bivirkninger fra kliniske undersøgelser, litteraturen og erfaringer efter markedsføring er af gastrointestinal og psykiatrisk art og er velkendte og hyppigt indberettede i forbindelse med opiater.
English: The group had split views about the strength of the evidence of an association between pholcodine exposure and allergic reactions to NMBAs, although it was agreed that this is an issue that warrants further investigation.
Danish: I gruppen var der delte meninger om styrken af dokumentationen for en sammenhæng mellem eksponering for pholcodin og allergiske reaktioner over for NMBA, men der var dog enighed om, at spørgsmålet kræver yderligere undersøgelse.
English: The Committee reviewed the available data on the safety and efficacy of pholcodine, particularly the data in support of a link between pholcodine use and development of NMBA-related anaphylaxis.
Danish: Udvalget gennemgik de foreliggende data om sikkerheden og virkningen af pholcodin, navnlig data, der støtter en sammenhæng mellem brug af pholcodin og udviklingen af NMBA-relateret anafylaksi.
English: The absence of any report of IgE-mediated anaphylactic reaction to NMBAs in Sweden since 1990 raises further questions on the reliability of the data, as regardless of pholcodine use NMBAs would still be expected to cause anaphylactic reactions and the Swedish data does not appear to reflect this expected background rate.
Danish: De manglende indberetninger om IgE-medierede anafylaktiske reaktioner over for NMBA i Sverige siden 1990 sætter yderligere spørgsmålstegn ved pålideligheden af dataene, da NMBA, uanset brugen af pholcodin, under alle omstændigheder må forventes at medføre anafylaktiske reaktioner, og de svenske data således ikke synes at afspejle den forventede baggrundsforekomst.
English: The most recent study conducted by Zambon and published in 2006, comparing pholcodine and dextrometorphan in a randomised and blinded design, showed they had similar efficacy in reducing day and night-time cough frequencies in adult patients suffering with acute non-productive cough.
Danish: Den nyeste undersøgelse, der blev udført af Zambon og offentliggjort i 2006, var en sammenligning af pholcodin og dextromethorphan i et randomiseret, blindet design og viste, at de to stoffer svarede til hinanden i virkning hvad angår hostefrekvens om dagen og om natten hos voksne patienter med akut, uproduktiv hoste.
English: Considering that as a part of this procedure: - The CHMP already assessed the evidence available to date from across the Member States on this topic, and during the assessment has been able to identify its shortcomings - The preliminary proposals for the study protocol submitted by different MAHs have already been reviewed by the CHMP during this referral procedure
Danish: I betragtning af, at der som en del af denne procedure er foretaget følgende: - CHMP har allerede foretaget en vurdering af den dokumentation om emnet, som indtil videre er stillet til rådighed fra alle medlemsstater, og har under gennemgangen kunnet konstatere manglerne.
English: Nevertheless, the existing data is consistent and supportive of the efficacy of pholcodine in the treatment of acute non-productive cough.
Danish: De eksisterende data er imidlertid sammenhængende og understøtter virkningen af pholcodin til behandling af akut, uproduktiv hoste.
English: The results support the efficacy of pholcodine in the treatment of acute non-productive cough.
Danish: Resultatet understøtter virkningen af pholcodin til behandling af akut, uproduktiv hoste.
English: The Committee recommended the maintenance of the marketing authorisations for the medicinal products referred to in Annex I.
Danish: Udvalget anbefalede opretholdelse af markedsføringstilladelserne for de i bilag I omhandlede produkter.
English: The Committee therefore concluded that, based on currently available information, the benefits of pholcodine in the treatment of non-productive cough outweigh the risks, and that the benefit-risk balance of pholcodinecontaining products in the treatment of non-productive cough is positive under normal conditions of use.
Danish: Udvalget konkluderede derfor, at fordelene ved pholcodin til behandling af uproduktiv hoste på grundlag af de aktuelt foreliggende oplysninger opvejer risiciene, og at benefit/risk-forholdet for produkter indeholdende pholcodin til behandling af uproduktiv hoste er positivt under normale anvendelsesbetingelser.
English: Taking into account all of the above, the CHMP concluded that the evidence of a link between pholcodine and NMBA-related anaphylaxis is circumstantial, not entirely consistent and does not support the conclusion that there is a significant risk of cross-sensitisation to NMBAs and subsequent development of anaphylaxis during surgery.
Danish: På baggrund af alt det ovenstående konkluderede CHMP, at evidensen for en sammenhæng mellem pholcodin og NMBA-relateret anafylaksi er indirekte og ikke fuldstændig sammenhængende og ikke støtter en konklusion om, at der er nævneværdig risiko for krydssensibilisering over for NMBA og efterfølgende udviklingen af anafylaksi under kirurgiske indgreb.
English: Further data needs to be generated to clarify the possibility of an association between pholcodine use and NMBA-related anaphylaxis.
Danish: Det vil kræve yderligere data at klarlægge den mulige sammenhæng mellem brug af pholcodin og NMBA-relateret anafylaksi.
English: The Committee considered that evidence of an association between pholcodine use and development of NMBA-related anaphylaxis is circumstantial, not entirely consistent and therefore does not support the conclusion that there is a significant risk of cross-sensitisation to NMBAs and subsequent development of anaphylaxis during surgery.
Danish: Udvalget fandt, at evidensen for en sammenhæng mellem brug af pholcodin og NMBA-relateret anafylaksi er indirekte og ikke fuldstændig sammenhængende og derfor ikke støtter en konklusion om, at der er nævneværdig risiko for krydssensibilisering over for NMBA og efterfølgende udvikling af anafylaksi under kirurgiske indgreb.
English: An ad-hoc expert group composed mainly of immunologists and anaesthesiologists was consulted to provide advice to CHMP on this issue.
Danish: CHMP har søgt rådgivning om dette spørgsmål hos en ad hoc-ekspertgruppe hovedsagelig bestående af immunologer og anæstesiologer.
English: Nevertheless the Committee considered that the possibility of an association between pholcodine use and NMBA-related anaphylaxis needs to be further investigated.
Danish: Udvalget fandt imidlertid, at den mulige sammenhæng mellem brug af pholcodin og NMBArelateret anafylaksi kræver nærmere undersøgelse.
English: The Committee therefore concluded that, based on currently available information, the benefit-risk balance of pholcodine-containing products in the treatment of non-productive cough is positive under normal conditions of use.
Danish: Udvalget konkluderede derfor, at benefit/risk-forholdet for lægemidler indeholdende pholcodin til behandling af uproduktiv hoste er gunstigt under normale anvendelsesbetingelser.
English: Literature has been published suggesting a link between pholcodine consumption and cross sensitisation to NMBAs, resulting in anaphylactic reactions during surgery.
Danish: Offentliggjorte data tyder på, at der er sammenhæng mellem indtagelse af pholcodin og krydssensibilisering over for NMBA resulterende i anafylaktiske reaktioner under kirurgiske indgreb.