FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the divergent national decisions taken by Member States concerning the authorisation of nBDPcontaining products, Italy notified the CHMP/European Medicines Agency on 19 June 2015 of a referral under Article 30 of Directive 2001/83/EC for Clenil and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise its divergent product information across the EU.
Danish: På grund af de forskellige nationale beslutninger i medlemsstaterne vedrørende godkendelse af produkter indeholdende nBDP indgav Italien meddelelse til CHMP/Det Europæiske Lægemiddelagentur den 19. juni 2015 om en officiel indbringelse af Clenil og relaterede navne i henhold til artikel 30 i direktiv 2001/83/EF med senere ændringer for at løse divergenser mellem de nationalt godkendte produktresuméer og dermed harmonisere de divergerende produktresuméer i EU.
English: BDP nebuliser (nBDP) suspension products are authorised in five EU member states including France, Germany, Greece, Ireland and Italy under different invented names: Sanasthmax, Becloneb, Beclospin, Clenil.
Danish: Suspensionsprodukter med BDP-nebulisering (nBDP) er tilladt i de fem EU-medlemsstater Frankrig, Tyskland, Grækenland, Irland og Italien under forskellige navne: Sanasthmax, Becloneb, Beclospin, Clenil.
English: The cumulative prevalence of wheeze is almost 50% at the age of 6 years.
Danish: Den kumulative forekomst af hvæsende vejrtrækning er næsten 50 % i seksårsalderen.
English: As such reference is not made to a brand rather to a “jet nebuliser” in the product information.
Danish: Der henvises ikke til et bestemt mærke, men til "jetnebulisator" i produktinformationen.
English: 4 Allergic Rhinitis and its Impact on Asthma (ARIA) guideline 2015: Available from http://www.whiar.org/Documents&Resources.php
Danish: Allergic Rhinitis and its Impact on Asthma (ARIA) guideline 2015: Kan rekvireres på http://www.whiar.org/Documents&Resources.php.
English: The evidence provided by the MAH in support of this indication consisted of 4 studies, only one of which is a randomised clinical trial (Profita et al., 2013)3.
Danish: Dokumentation fra indehaveren af markedsføringstilladelsen til støtte for denne indikation bestod af fire undersøgelser, hvoraf kun den ene er et randomiseret klinisk forsøg (Profita et al., 2013)3.
English: The studies in allergic rhinitis were actually carried out using intranasal spray.
Danish: Undersøgelserne af allergisk rhinitis blev faktisk udført med intranasal spray.
English: The most supportive evidence for the treatment of recurrent wheezing children (Papi et al., 2009)2 enrolled children aged 1-4 years.
Danish: Den mest støttende dokumentation for behandling af tilbagevendende hvæsende vejrtrækning hos børn (Papi et al., 2009)2 omfattede børn i alderen 1-4 år.
English: Finally, recent evidence reports that distribution of topical solution to the unoperated sinuses is limited, with nebulization being also ineffective with <3% sinus penetration.
Danish: Endelig viser de seneste dokumentationsrapporter, at distribution af topisk opløsning til uopererede bihuler er begrænset, idet nebulisering også er ineffektiv med en sinuspenetration på < 3 %.
English: In addition, the duration of treatment of recurrent wheezing should not exceed 3 months, unless diagnosis of asthma is confirmed to avoid an unnecessary long-term exposure.
Danish: Desuden bør behandlingen af tilbagevendende hvæsende vejrtrækning ikke overstige tre måneder, medmindre der stilles en diagnose af astma, for at undgå unødig eksponering på langt sigt.
English: For the recurrent wheezing indication in young children, the CHMP concluded that if no treatment benefit of is observed within 2-3 months, Clenil should be discontinued.
Danish: Med hensyn til indikationen for tilbagevendende hvæsende vejrtrækning hos små børn konkluderede CHMP, at hvis der ikke observeres nogen fordele ved behandlingen inden for 2-3 måneder, bør behandlingen med Clenil afsluttes.
English: Due to the difficulty to set a lower age limit for the treatment of asthma/wheezing condition in the paediatric population, the CHMP considered more appropriate to leave it open.
Danish: Da det er vanskeligt at fastsætte en lavere aldersgrænse for behandling af astma/hvæsende vejrtrækning hos den pædiatriske gruppe, mente CHMP, at det var mere hensigtsmæssig at lade den stå åben.
English: Overall, the CHMP agreed on the final indication wording "treatment of wheezing in children up to 5 years of age".
Danish: Generelt var CHMP enig i den endelige indikation med ordlyden "behandling af hvæsende vejrtrækning hos børn op til fem år".
English: • The committee considered the divergences identified in the notification for Clenil and associated names, as well as the remaining sections of the product information.
Danish: • Udvalget behandlede de divergenser, der er konstateret i anmeldelsen vedrørende Clenil og relaterede navne, samt de øvrige punkter i produktinformationen.
English: This indication of the maintenance treatment of asthma when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate is currently approved in all five member states where the product is authorised.
Danish: Denne indikation til vedligeholdelsesbehandling af astma, når brug af trykinhalator eller inhalator med tørpulver er utilfredsstillende eller uhensigtsmæssig, er i dag godkendt i alle fem medlemsstater, hvor produktet er godkendt.
English: Beclometasone dipropionate (BDP) is a glucocorticoid and a prodrug of the active metabolite, beclometasone-17-monopropionate.
Danish: Beclometason dipropionat (BDP) er et glukokortikoid og et pro-drug for det aktive metabolit beclometason-17-monopropionat.
English: According to the most recent guidelines4, the use of corticosteroids is recommended for mild-moderate rhinitis via intranasal route.
Danish: de nyeste retningslinjer4 anbefales det at bruge kortikosteroider til mild til moderat rhinitis via intranasal indgivelse.
English: In the clinical managing of asthma, patient adherence to long-term inhaled therapy is of extreme importance and the possibility of a once daily administration should not be precluded.
Danish: I den kliniske håndtering af astma er det ekstremt vigtigt, at patienten følger en inhalationsbehandling på langt sigt, og muligheden for én daglig administration bør ikke udelukkes.
English: More importantly, ICS therapy is always patient-tailored and closely monitored by the physician in terms of symptom controls, thus precluding the occurring of prolonged unsatisfactory symptom control because of once-daily administration.
Danish: Hvad der er endnu vigtigere, er, at ICS-behandling altid skræddersyes til patienterne og nøje overvåges af lægen med hensyn til at kontrollere symptomer og dermed udelukke, at der forekommer langvarig, uønsket symptomkontrol på grund af administration én gang dagligt.
English: Beclometasone dipropionate exerts local anti-inflammatory action in the control of bronchial asthma.
Danish: Beclometason dipropionat udøver lokal anti-inflammatorisk aktion ved kontrol af bronkial astma.
English: A confident diagnosis of asthma in children < 5 years of age is difficult, because episodic respiratory symptoms such as wheezing and cough are also common in children without asthma, particularly in those 0-2 years old.
Danish: Det er vanskeligt at stille en sikker astmadiagnose hos børn i alderen < fem år, fordi episoder med luftvejssymptomer som hvæsende vejrtrækning og hoste også er almindeligt forekommende hos børn uden astma, navnlig hos 0-2-årige.
English: Sections 4.3 Contraindications to 5.3 Preclinical safety data have been harmonised to include the relevant available information, or amend wording according to the attest QRD template.
Danish: Punkt 4.3 (kontraindikationer) til 5.3 (prækliniske sikkerhedsdata) er blevet harmoniseret, så de omfatter de relevante tilgængelige oplysninger eller ændrer ordlyden i overensstemmelse med QRDmodellen.
English: In GINA guideline, low dose ICS (controller treatment) is recommended as the preferred initial treatment to control asthma in children 5 years and younger.
Danish: I GINA's vejledning anbefales en lav dosis ICS (kontrolbehandling) som den foretrukne indledende behandling til kontrol af astma hos børn i alderen fem år og derunder.
English: Most wheezing in preschool children (<5 years of age) is associated with viral upper respiratory tract infections, which recur frequently in this age group.
Danish: De fleste tilfælde af hvæsende vejrtrækning hos børn i førskolealderen (< fem år) forbindes med infektioner i de øvre luftveje, som ofte forekommer i denne aldersgruppe.
English: The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and in line with GINA guidelines.
Danish: Indehaveren af markedsføringstilladelsen foreslog harmoniserede dosisanbefalinger baseret på de undersøgte doser i kliniske forsøg og i overensstemmelse med GINA's retningslinjer.
English: Sections 6.3 (shelf life), 6.4 (special precautions for storage) 6.5 (nature and contents of container) and 6.6 (Special precautions for disposal and other handling) have been updated in line with the recommendation for multi-use of the 800 ug ampoule.
Danish: Punkt 6.3 (opbevaringstid), 6.4 (særlige opbevaringsforhold) 6.5 (emballagetype og pakningsstørrelser) og 6.6 (regler for bortskaffelse og anden håndtering) er blevet ajourført i overensstemmelse med anbefalingen til multibrug af 800 ug-ampullen.
English: Indeed, the CHMP noted that restricting the indication to only "asthma" might lead to an under-treatment of children < 5 years of age with recurrent wheezing without any other apparent risk factors for asthma.
Danish: CHMP bemærkede, at en begrænsning af indikationen udelukkende til "astma" kan medføre underbehandling af børn < fem år med tilbagevendende hvæsende vejrtrækning uden andre åbenlyse risikofaktorer for astma.
English: The CHMP agreed with the indication "in the maintenance treatment of asthma" in line with the available scientific evidence and guideline recommendations where inhaled corticosteroids are considered the firstline treatment when a diagnosis of asthma has been done and nebulizers are recommended when the use of other hand-held inhalers is not appropriate.
Danish: CHMP accepterede indikationen "til vedligeholdelsesbehandling af astma" i overensstemmelse med den tilgængelige videnskabelige dokumentation og vejledende anbefalinger, hvor inhalerede kortikosteroider anses for at være førstevalgsbehandling, når astma er diagnosticeret, og der anbefales nebulisering, hvis andre håndholdte inhalatorer ikke er hensigtsmæssige.
English: In France nBDP is indicated as anti-inflammatory treatment of severe persistent asthma in children.
Danish: I Frankrig er nBDP indikeret til anti-inflammatorisk behandling af svær vedvarende astma hos børn.
English: The MAH proposed to revise the SmPC section 4.2 to include more detailed information on the nebuliser systems.
Danish: Indehaveren af markedsføringstilladelsen foreslog at revidere produktresuméets punkt 4.2, så det indeholdt mere detaljerede oplysninger om nebuliseringssystemer.
English: The nBDP indication in wheezing would allow paediatricians to treat young children suffering from recurring wheezing when a clear asthma diagnosis is not achievable, in line with GINA guideline1.
Danish: Indikationen for nBDP ved hvæsende vejrtrækning vil give børnelæger mulighed for at behandle små børn, der lider af tilbagevendende hvæsende vejrtrækning, når der ikke kan opnås en klar astmadiagnose, i overensstemmelse med GINA's retningslinjer1.
English: Section 1, (name of the medicial product) Sections 2 (qualitative and quantitative composition), 6.1 (list of excipients), and 6.2 (incompatibilities) have been updated with minor changes to be in line with QRD template.
Danish: Punkt 1 (lægemidlets navn), punkt 2 (kvalitativ og kvantitativ sammensætning), 6.1 (hjælpestoffer) og 6.2 (uforligeligheder) er blevet ajourført med mindre ændringer, så de opfylder QRD-modellen.
English: Following the negative position of the CHMP on the broad indication, the MAH proposed a narrowed one "symptomatic treatment of recurrent wheezing in preschool children" that was agreed with some changes.
Danish: Efter CHMP's negative holdning til den brede indikation foreslog indehaveren af markedsføringstilladelsen en mere snæver indikation, nemlig "systematisk behandling af tilbagevendende hvæsende vejrtrækning hos børn i førskolealderen", som blev vedtaget med visse ændringer.
English: Clenil is currently indicated for the treatment of other respiratory conditions with the narrowing of the airways in the lungs (bronchostenotic condition) in Italy.
Danish: Clenil er i dag indikeret til behandling af andre luftvejslidelser med forsnævring af luftvejene i lungerne (bronkostenose) i Italien.
English: Once daily vs twice daily administration
Danish: Administration henholdsvis én eller to gange dagligt
English: The CHMP considered that the inclusion of the brand nebulisers in section SmPC 4.2 was not acceptable as the data to support this were not available.
Danish: CHMP mente, at det ikke kunne accepteres at indarbejde nebulisatorer af et bestemt mærke i produktresuméets punkt 4, da der ikke forelå data til støtte for dette.
English: The evidence and argumentation provided by the MAH on the beneficial effect of nBDP in the treatment of the broad proposed indications (bronchostenotic condition as initial one, inflammatory disorders of the respiratory tract in particular associated with wheezing as second one) was considered by the CHMP unsatisfactory in identifying the medical need and the target population (lack of adequately designed and sized trials).
Danish: Dokumentationen og argumenterne fra indehaveren af markedsføringstilladelsen om de gavnlige virkninger af nBDP i behandlingen af de bredspektrede indikationer (indledningsvist bronkostenose, inflammatoriske luftvejslidelser, navnlig i forbindelse med hvæsende vejrtrækning som den anden) blev af CHMP anset for at være utilfredsstillende i forbindelse med identificering af det medicinske behov og målgruppen (manglende tilstrækkeligt udformede og tilpassede forsøg).
English: Other respiratory conditions with the narrowing of the airways in the lungs (bronchostenotic condition)
Danish: Andre luftvejslidelser med forsnævring af luftvejene i lungerne (bronkostenose)
English: In Ireland, Germany and Greece nBDP is indicated in both adults and children for the treatment of bronchial asthma where use of a pressurised or dry powder inhaler is unsatisfactory or inappropriate.
Danish: I Irland, Tyskland og Grækenland er nBDP indikeret til behandling af bronkial astma hos både børn og voksne, hvor brug af trykinhalator eller inhalator til tørpulver er utilfredsstillende eller uhensigtsmæssig.
English: Asthma and wheezing
Danish: Astma og hvæsende vejrtrækning
English: • The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Danish: • Udvalget gennemgik alle data, som indehaveren af markedsføringstilladelsen har forelagt til underbygning af den foreslåede harmonisering af produktinformationen.
English: In conclusion, the CHMP considered that the available evidence does not support the proposed indications in "allergic and idiopathic rhinitis, inflammatory and allergic affections of the nasal cavities and of the rhino-pharyngeal tract" for nBDP.
Danish: CHMP konkluderede, at den tilgængelige dokumentation ikke støtter de foreslåede indikationer for "allergisk og idiopatisk rhinitis, inflammatorisk og allergisk påvirkning af næsehulen og svælget" for nBDP.
English: The package leaflet has been amended to reflect the changes of the SmPC
Danish: Indlægsseddel Indlægssedlen er blevet ændret for at afspejle ændringerne i produktresuméet.
English: The MAH stated that nebulisation is able to deliver drugs to paranasal sinuses while nasal sprays are not.
Danish: Indehaveren af markedsføringstilladelsen anførte, at nebulisering kan indgive lægemidler til næsens bihuler, mens næsespray ikke kan.
English: It is acknowledged that the scientific evidence on the benefit of nBDP in the treatment of recurrent wheezing in pre-schooler is limited (the only supportive scientific evidence comes from Papi and colleagues (2009) in which methodological bias is noted); however, high standard studies, as per today criteria, are not expected to be available for nBDP to support indication that has been granted in Italy many years ago.
Danish: Det anerkendes, at den videnskabelige dokumentation om fordelene ved nBDP til behandling af tilbagevendende hvæsende vejrtrækning hos børn i førskolealderen er begrænset (den eneste understøttende videnskabelige dokumentation kommer fra Papi og kolleger (2009), hvor der bemærkes metodologisk ensidighed).
English: Grounds for the CHMP opinion
Danish: Begrundelse for CHMP's udtalelse ud fra følgende betragtninger:
English: Allergic and idiopathic rhinitis, inflammatory and allergic affections of the nasal cavities and of the rhinopharyngeal tract
Danish: Allergisk og idiopatisk rhinitis, inflammatoriske og allergiske påvirkninger af næsehulen og svælget
English: In Italy nBDP is currently indicated in both adults and children for the treatment of asthma, and other respiratory conditions with the narrowing of the airways in the lungs (brochostenotic condition), specifically when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate.
Danish: I Italien er nBDP i dag indikeret til behandling af astma og andre luftvejslidelser med forsnævring af luftvejene i lungerne (bronkostenose) hos både børn og voksne, navnlig når brugen af trykinhalatorer eller inhalatorer med tørpulver er utilfredsstillende eller uhensigtsmæssig.
English: As regards the indication in wheezing, the term “preschool” as proposed by the MAH was not considered as informative by the CHMP and not in line with the SmPC guideline.
Danish: Hvad angår indikationen for hvæsende vejrtrækning, anså CHMP ikke termen "førskolealderen", som indehaveren af markedsføringstilladelsen foreslog, for at være informativ og i overensstemmelse med produktresuméets vejledning.
English: In fact, pharmaceutical formulations for nebulization are intended for asthma treatment as they deliver particles with particle size distribution less than 5 microns that can reach lower airways using facial masks; the fact that a nebuliser suspension administered through the facial mask is not suitable for administration to the nasal cavity is also proven by the cited article by Profita and colleagues where no differences were observed between the nBDP provided by facial mask and the placebo group for symptom score of rhinitis.
Danish: En nebuliseringssuspension, der administreres gennem en maske, egner sig ikke til administration til næsehulen, og dette er også dokumenteret i den nævnte artikel af Profita et al., hvor der ikke blev observeret forskelle mellem nBDP administreret af masken og placebogruppen for symptomer på rhinitis.
English: Pre-schoolers with recurrent wheezing are at high risk of developing asthma during school age; in this population asthma and wheezing do not always overlap and deciding when recurrent wheezing is the initial presentation of asthma is difficult.
Danish: I denne gruppe overlapper astma og hvæsende vejrtrækning ikke altid, og det er vanskeligt at bestemme, hvornår tilbagevendende hvæsen er en forløber for astma.
English: The CHMP concluded that for asthma treatment no indication of duration of therapy should be reported in the SmPC; the duration of treatment should be based on clinical judgement on the basis on the severity and frequency of symptoms and patient conditions on a case-by-case basis.
Danish: Behandlingens varighed bør baseres på en klinisk vurdering på grundlag af symptomernes sværhed og hyppighed og den enkelte patients tilstand.
English: nBDP is also indicated in allergic and idiopathic rhinitis, inflammatory and allergic affections of the nasal cavities and of the rhino-pharyngeal tract.
Danish: nBDP er også indikeret til behandling af allergisk og idiopatisk rhinitis i næsehulen og i svælget.
English: The CHMP also agreed that there is a need to give adequate information in the PI on the risk of long-term exposure in children below the age of 5 years.
Danish: CHMP var også enig i, at der er behov for at give passende information i produktinformationen om risikoen ved langtidseksponering hos børn under fem år, eftersom sådanne anbefalinger vedrørende behandlingens varighed og behovet for overvågning fremgår af punkt 4.2 og 4.4 i produktresuméet.
English: Paediatric age range
Danish: Pædiatrisk population
English: The Netherlands ratiopharm Nederland bv
Danish: Nederlandene ratiopharm Nederland bv
English: CC Zaandam, The
Danish: CC Zaandam,
English: POSSIBLE SIDE EFFECTS Like all medicines, Fentanyl-ratiopharm can cause side effects, although not everybody gets them.
Danish: BIVIRKNINGER Fentanyl-ratiopharm kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt den { MM/ÅÅÅÅ } [Udfyldes nationalt]
English: the CHMP has recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet which are set out in Annex III for Fentanyl-ratiopharm and associated names (see Annex I).
Danish: anbefalede CHMP på grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, og den faglige drøftelse i udvalget udstedelse af de markedsføringstilladelse(r) og ændring af det produktresumé og den etikettering og indlægsseddel, der fremgår af bilag III, for Fentanyl "ratiopharm" og tilknyttede navne - se bilag I.
English: WHAT FENTANYL-RATIOPHARM IS AND WHAT IT IS USED FOR
Danish: FENTANYL-RATIOPHARMS VIRKNING OG HVAD DE SKAL BRUGE DET TIL
English: Albert-SchweitzerGasse 3, 1140 WIEN, Austria transdermales Matrixpflaster
Danish: Albert-SchweitzerGasse 3, 1140 WIEN, Østrig µg/h transdermales Matrixpflaster mikrogram per time
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FENTANYLRATIOPHARM AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMMENDRAG AF DEN FAGLIGE VURDERING AF FENTANYL "RATIOPHARM" OG TILKNYTTEDE NAVNE (SE BILAG I)
English: - asthma, respiratory depression or any lung disease - low blood pressure - impaired liver function - impaired kidney function - if you have had a head injury, a brain tumour, signs of increased intracranial pressure (e.g.
Danish: - nedsat leverfunktion - nedsat nyrefunktion - hvis De har haft hovedet beskadiget, hjernesvulst, symptomer på øget tryk i kraniet (f.eks.
English: Fentanyl ratiopharm 100 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 100 µg/uur, pleister voor transdermaal gebruik United Kingdom Telfanyl 100 microgram/hr Transdermal patch
Danish: Fentanilo Matrix ratiopharm 100 microgramos/h parches transdérmicos EFG Storbritannien Telfanyl 100 microgram/hr Transdermal patch Tyskland
English: Fentanyl-ratiopharm 100 µg/h Matrixpflaster and associated names (see Annex I)
Danish: Fentanyl-ratiopharm 100 µg/h Matrixpflaster og andre berørte navne (se Vedlæg I)
English: Fentanyl-ratiopharm 75 µg/h Matrixpflaster and associated names (see Annex I)
Danish: Fentanyl-ratiopharm 75 µg/h Matrixpflaster og andre berørte navne (se Vedlæg I)
English: Fentanyl ratiopharm 75 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 75 µg/uur, pleister voor transdermaal gebruik United Kingdom Telfanyl 75 microgram/hr Transdermal patch
Danish: Fentanilo Matrix ratiopharm 75 microgramos/h parches transdérmicos EFG Storbritannien Telfanyl 75 microgram/hr Transdermal patch Tyskland
English: Fentanyl-ratiopharm 25 µg/h Matrixpflaster and associated names (see Annex I)
Danish: Fentanyl-ratiopharm 25 µg/h Matrixpflaster og andre berørte navne (se Vedlæg I)
English: BEFORE YOU USE FENTANYL-RATIOPHARM
Danish: Brug ikke Fentanyl-ratiopharm
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 100 µg/h Matrixpflaster and associated names (see Annex I) [See Annex I - To be completed nationally]
Danish: Fentanyl-ratiopharm 100 µg/h Matrixpflaster og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt]