FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/013 [10 prolonged-release tablets] EU/1/97/051/014 [30 prolonged-release tablets] EU/1/97/051/015 [100 prolonged-release tablets]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/013 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/014 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/015 [MIRAPEXIN, 100 depottabletter]
English: What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.088 mg tablets are white, of round shape, flat, and without scoring.
Danish: MIRAPEXIN 0,088 mg er hvide, runde, flade tabletter og er uden delekærv.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.52 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 0,52 mg depottabletter pramipexol
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P5, and one side with the Boehringer Ingelheim company symbol).
Danish: Tabletterne er hvide til råhvide, ovale, og er præget med en kode på begge sider (P5 hhv. Boehringer Ingelheim logo).
English: The following dose schedule is suggested:
Danish: Oversigt over indlægssedlen:
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P12, and one side with the Boehringer Ingelheim company symbol).
Danish: Tabletterne er hvide til råhvide, ovale, og er præget med en kode på begge sider (P12 hhv. Boehringer Ingelheim logo).
English: The tablets are white, flat, of round shape, and have a code embossed (one side with the code P6, and one side with the Boehringer Ingelheim company symbol).
Danish: Tabletterne er hvide, flade, runde og præget med en kode på begge sider (P6 hhv. Boehringer Ingelheim logo).
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P13, and one side with the Boehringer Ingelheim company symbol).
Danish: Tabletterne er hvide til råhvide, ovale, og er præget med en kode på begge sider (P13 hhv. Boehringer Ingelheim logo).
English: The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P2, and one side with the Boehringer Ingelheim company symbol).
Danish: Tabletterne er hvide til råhvide, runde med skrå kanter og er præget med en kode på begge sider (P2 hhv. Boehringer Ingelheim logo).
English: Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
Danish: - Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P4, and one side with the Boehringer Ingelheim company symbol).
Danish: Tabletterne er hvide til råhvide, ovale, og er præget med en kode på begge sider (P4 hhv. Boehringer Ingelheim logo).
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.26 mg prolonged-release tablets Pramipexole
Danish: LÆGEMIDLETS NAVN MIRAPEXIN 0,26 mg depottabletter pramipexol
English: (eating more food than normal and more than is needed to satisfy your hunger)* - Delirium (decreased awareness, confusion, loss of reality)
Danish: • Delirium (nedsat bevidsthed, forvirring, manglende realitetsopfattelse)*
English: Dyspnoea hiccups
Danish: • Åndenød (dyspnø)
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P3, and one side with the Boehringer Ingelheim company symbol).
Danish: Tabletterne er hvide til råhvide, ovale, og er præget med en kode på begge sider (P3 hhv. Boehringer Ingelheim logo).
English: When prescribing MIRAPEXIN in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Danish: Hos patienter med Parkinsons sygdom og nedsat nyrefunktion bør dosis reduceres, se pkt.
English: Pramipexole
Danish: Dosering
English: 1 tablet MIRAPEXIN 0.35 mg and 1 tablet MIRAPEXIN 0.18 mg OR
Danish: 1 MIRAPEXIN tablet á 0,35 mg og 1
English: Magnesium stearate
Danish: Nedsat nyrefunktion
English: two MIRAPEXIN 0.52 mg prolonged-release tablets, OR four MIRAPEXIN 0.26 mg prolonged-release tablets.
Danish: 2 MIRAPEXIN 0,52 mg depottabletter, ELLER
English: 40 (1 cartridge x 40) tablets
Danish: 40 (1 patron x 40) tabletter
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration
English: Immediate Packaging Pack size
Danish: Emballage Paknings-størrelse
English: Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage Pakningsstørrelse EU/1/10/665/001 Entacapone Teva 200 mg Filmovertrukket tablet Oral anvendelse Glas (HDPE) 30 tabletter EU/1/10/665/002 Entacapone Teva 200 mg Filmovertrukket tablet Oral anvendelse Glas (HDPE) 60 tabletter EU/1/10/665/003 Entacapone Teva 200 mg Filmovertrukket tablet Oral anvendelse Glas (HDPE) 100 tabletter EU/1/10/665/004 Entacapone Teva 200 mg Filmovertrukket tablet Oral anvendelse Glas (HDPE) 175 tabletter
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: All indications are not authorised in all EU MS.
Danish: Alle indikationer er ikke godkendt i alle EU-medlemsstater.
English: Hypersensitivity reactions
Danish: Hypersensitivitetsreaktioner
English: Only these amendments, adopted and included in the CMDh position, are legally binding and must be implemented by the Member States.
Danish: Kun disse ændringer, der er vedtaget og omfattet af CMDh's standpunkt, er retligt bindende og skal gennemføres af medlemsstaterne.
English: 2 - CMDh revised position
Danish: 2 - CMDh's reviderede standpunkt
English: The PRAC noted that the worldwide estimated exposure of the originator's products alone is over 50 million patient-years and, in the EU over the last decade, around 6.8 million patient-years.
Danish: PRAC bemærkede, at den skønnede eksponering alene for de oprindelige produkter er over 50 mio. patientår på verdensbasis, og i EU cirka 6,8 mio. patientår gennem det seneste tiår.
English: These constitute the majority of the available evidence, in particular in the indications that were first authorised (e.g. secretolytic indication).
Danish: Disse udgør størstedelen af den foreliggende evidens, navnlig ved de indikationer, der blev godkendt først (f.eks. indikationen som sekretolytisk middel).
English: 1 - Overall summary of the scientific evaluation by the PRAC Safety issues
Danish: 1 - Samlet resumé af PRAC's videnskabelige vurdering Spørgsmål vedrørende sikkerhed
English: The PDCO was also of the view that these products are no longer the preferred treatment option in IRDS.
Danish: PDCO var desuden af den opfattelse, at disse produkter ikke længere er den foretrukne behandlingsmulighed ved IRDS.
English: The CMDh position was forwarded to the European Commission.
Danish: CMDh's udtalelse blev overgivet til Europa-Kommissionen.
English: Based on its clinical experience, the PDCO was of the view that there is no need for the use of these products in this indication in children below 2 years of age.
Danish: Ud fra sin kliniske erfaring var PDCO af den opfattelse, at der ikke er behov for disse produkter til denne indikation til børn under 2 år.
English: It is acknowledged that most of the indications are supported by old studies presenting limitations and deficiencies.
Danish: Det vedgås, at størstedelen af indikationerne bygger på gamle undersøgelser, der har begrænsninger og mangler.
English: The level of evidence did not allow for further stratification by age group.
Danish: Evidensens omfang gjorde det ikke muligt at foretage yderligere stratificering efter aldersgruppe.
English: Further, the definition of the relevant clinical endpoints and the measurement of symptoms in these conditions are challenging (Rubin, 2007).
Danish: Desuden er det ved sådanne sygdomme en udfordring at definere de relevante kliniske endepunkter og måle symptomerne (Rubin, 2007).
English: Many drug reactions cannot be distinguished from naturally occurring or infection-induced eruptions, and thus misdiagnosis is common.
Danish: Mange lægemiddelreaktioner kan ikke skelnes fra naturligt forekommende eller infektionsbetingede eruptioner, hvorfor fejldiagnose er almindelig.
English: This is not unexpected considering the methodological challenges inherent to this therapeutic area and evidential standards and requirements at the time when these products were first developed.
Danish: Dette er ikke uventet i betragtning af de metodologiske udfordringer, der kendetegner dette behandlingsområde, og de normer og krav vedrørende evidens, der var gældende, da disse produkter først blev udviklet.
English: During the decision making process, at a meeting of the Standing Committee on Medicinal Products for Human Use, some Member States raised new questions of technical nature which they considered had not been sufficiently addressed in the PRAC recommendation and CMDh position.
Danish: Under et møde i Det Stående Udvalg for Humanmedicinske Lægemidler blev der af nogle medlemsstater under beslutningsprocessen rejst nye spørgsmål af teknisk art, som de ikke fandt tilstrækkeligt behandlet i PRAC's anbefaling og CMDh's udtalelse.
English: Most often these patients receive a number of drugs concomitantly and causality assessment is difficult.
Danish: Oftest får disse patienter flere forskellige lægemidler samtidig, og årsagssammenhængen er vanskelig at vurdere.
English: In light of this, the PRAC recommendation and CMDh position was referred back to the Agency for further consideration.
Danish: På denne baggrund blev PRAC's anbefaling og CMDh's udtalelse henvist til agenturet til fornyet overvejelse.
English: However, prompt recognition of severe reactions and early withdrawal of the causative agent is the most important factor to minimise morbidity and mortality.
Danish: Øjeblikkelig opdagelse af svære reaktioner og tidlig seponering af det udløsende lægemiddel er imidlertid den vigtigste faktor til minimering af morbiditet og mortalitet.
English: It is acknowledged that clinical evidence from studies in children is weak due to their heterogeneity and to the lower number of children enrolled.
Danish: Det vedgås, at den kliniske evidens fra undersøgelser hos børn er svag pga. deres uensartethed og det lavere antal indrullerede patienter.
English: In addition, the PRAC discussed the need to conduct post-authorisation studies, and concluded that such studies would likely not generate new robust information towards more definite conclusions.
Danish: Desuden drøftede PRAC behovet for at udføre undersøgelser efter godkendelse og konkluderede, at sådanne undersøgelser sandsynligvis ikke ville føre til nye holdbare oplysninger eller mere endelige konklusioner.
English: Consequently the PSUR cycle should be shortened to a 3-yearly cycle in order to periodically review these analyses.
Danish: Intervallet mellem PSUR'er bør derfor nedsættes til 3 år for at give mulighed for regelmæssig gennemgang af disse analyser.
English: Ambroxol- and bromhexine-containing medicinal products have first been registered in a European Union (EU) Member State (MS) in 1978 and 1963, respectively, and are currently authorised in all EU MSs (as well as in Norway and Iceland) except the United Kingdom.
Danish: Lægemidler indeholdende ambroxol og bromhexin blev første gang registreret i en EU-medlemsstat i hhv. 1978 og 1963 og er nu godkendt i alle EU-medlemsstater (foruden Norge og Island) bortset fra Det Forenede Kongerige.
English: The PRAC also considered the available data in the paediatric population.
Danish: PRAC gennemgik også de foreliggende data hos den pædiatriske population.
English: It is recognised also that the limitations and uncertainties attached to the dataset hinder the ability to draw robust conclusions on the efficacy.
Danish: Det vedgås også, at begrænsningerne og usikkerhederne ved datasættet står i vejen for at drage holdbare konklusioner om virkningen.
English: Overall conclusion and grounds for the revised PRAC recommendation
Danish: Samlet konklusion og begrundelse for PRAC's reviderede anbefaling Ud fra følgende betragtninger:
English: The clinical studies performed during the development of bromhexine- and ambroxol-containing products between the 1950ies and 1980ies were considerably less standardised than would be necessary today, and would not completely fulfil contemporary requirements with regard to validated endpoints, statistical confirmation, or Good Clinical Practice (GCP).
Danish: De kliniske undersøgelser, der er udført under udviklingen af bromhexin og lægemidler indeholdende ambroxol mellem 1950'erne og 1980'erne, var væsentligt mindre standardiserede, end det ville være nødvendigt i dag, og ville ikke fuldstændig opfylde nutidige krav om validerede endepunkter, statistisk bekræftelse eller god klinisk praksis (GCP).
English: However, when looking at the date of the reports, 40 reports, out of the 119 reported in total for the originator since the first marketing authorisation, appear to have been sent in two batches by the Chinese health authority to the MAH of the originator of these products.
Danish: Af indberetningernes datering fremgår det imidlertid, at 40 af de i alt 119 indberetninger, der er foretaget for det oprindelige lægemiddel siden første markedsføringstilladelse, synes at være sendt i to sæt af de kinesiske sundhedsmyndigheder til indehaveren af markedsføringstilladelsen for det oprindelige lægemiddel.
English: In addition the PRAC recommended harmonising the terms related to hypersensitivity reactions in the product information.
Danish: Derudover anbefalede PRAC harmonisering af begreberne vedrørende hypersensitivitetsreaktioner i produktinformationen.
English: Moreover SCARs cases should be analysed in details in future PSURs.
Danish: Endvidere bør tilfælde af SCAR analyseres nærmere i fremtidige PSUR'er.
English: However, the overall reporting rate is very low when the estimated exposure is considered and many confounders are present in these cases, the evidence supporting this risk is therefore weak.
Danish: Den samlede indberetningsfrekvens er imidlertid meget lav i betragtning af den skønnede eksponering, og der er i disse tilfælde mange konfunderende faktorer til stede, hvorfor evidensen for denne risiko er svag.
English: Many patients with SCARs receive various mucolytic or secretolytic agents in the relevant time period before the onset of their adverse event.
Danish: Mange patienter med SCAR får forskellige mucolytiske eller sekretolytiske midler i det relevante tidsrum før indsætten af bivirkningen.
English: Often a large placebo effect is seen in studies investigating respiratory conditions, particularly in non-serious, self-limiting conditions.
Danish: I undersøgelser af luftvejssygdomme ses ofte en stor placebovirkning, navnlig ved ikke-alvorlige, selvbegrænsende sygdomme.
English: For these reasons studies conducted after the initial marketing authorisation do not provide new significant scientific data on the efficacy of the products.
Danish: Som følge heraf tilfører de undersøgelser, der er udført efter den oprindelige markedsføringstilladelse, ikke nye videnskabelige data af betydning for virkningen af produkterne.
English: However, a shorter PSUR cycle should be introduced to continue to review periodically data that becomes available on the benefit-risk balance of the products.
Danish: Der burde imidlertid indføres kortere mellemrum mellem PSUR'er for jævnligt at fortsætte gennemgangen af data, der bliver til rådighed om produkternes benefit/risk-forhold.
English: Some trials failed to show a significant difference between ambroxol or bromhexine and placebo and other only showed significant difference in some of the studied endpoints.
Danish: I nogle undersøgelser kunne der ikke påvises signifikant forskel mellem ambroxol eller bromhexin og placebo, og i andre var der kun signifikant forskel i nogle af de undersøgte endepunkter.
English: Of note, drugs started less than 4 days or more than 8 weeks before the onset of the reaction are unlikely to be responsible.
Danish: Det må bemærkes, at hvis patienten er sat i behandling med det pågældende lægemiddel mindre end 4 dage før eller mere end 8 uger før indsætten af reaktionen, er det usandsynligt, at lægemidlet er årsag.
English: Four cases of SCARs retrieved from Eudravigilance and 3 others from the literature have been assessed as related to ambroxol.
Danish: Fire tilfælde af SCAR, der er hentet i EudraVigilance, og tre andre fra litteraturen er blevet vurderet til at have sammenhæng med ambroxol.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for ambroxol- and bromhexine-containing medicinal products.
Danish: • PRAC tog stilling til proceduren i medfør af artikel 31 i direktiv 2001/83/EF, der var foranlediget af lægemiddelovervågningsdata for produkter indeholdende ambroxol og bromhexin
English: Taking into account these limitations, together with the weak evidence of a safety issue from the pharmacovigilance data, the PRAC could not conclude from the available evidence that risks outweighed benefits in the different indications.
Danish: I betragtning af disse begrænsninger og den svage evidens for et sikkerhedsproblem baseret på lægemiddelovervågningsdata kunne PRAC imidlertid ikke af den foreliggende evidens konkludere, at risiciene oversteg fordelene ved de forskellige indikationer.
English: Therefore the PRAC concluded that the evidence available did not justify the introduction of further age specific restrictions in the product information.
Danish: PRAC konkluderede derfor, at den foreliggende evidens ikke berettigede indførelse af yderligere aldersspecifikke begrænsninger i produktinformationen.
English: On 25 February 2015, the CMDh, having considered the PRAC recommendation, dated 9 January 2015, reached by majority the position that the marketing authorisations for the concerned medicinal products should be varied.
Danish: Efter gennemgang af PRAC's anbefaling dateret 9. januar 2015 vedtog CMDh den 25. februar 2015 ved en flertalsafgørelse en udtalelse om, at markedsføringstilladelserne for de omfattede lægemidler burde ændres.
English: The PRAC took note of the advice of the paediatric committee (PDCO) that the use of ambroxol and bromhexine varies significantly in paediatric clinical practice across the EU.
Danish: PRAC tog hensyn til bemærkningen fra det pædiatriske udvalg (PDCO) om, at anvendelsen af ambroxol og bromhexin varierer væsentligt i pædiatrisk klinisk praksis i EU.
English: The CMDh considered the PRAC recommendation that the evidence available did not provide sufficient grounds to demonstrate a change to the established benefit-risk balance, provided the recommended amendments to sections 4.4 and 4.8 of the product information, detailed in annex III, are implemented.
Danish: CMDh tog hensyn til PRAC's anbefaling om, at den foreliggende evidens ikke gav tilstrækkeligt grundlag for at påvise en ændring i det fastlagte benefit/risk-forhold, forudsat at der foretages de anbefalede ændringer af produktinformationens afsnit 4.4 og 4.8 som beskrevet i bilag III.
English: Nevertheless, modest but positive results were reported for ambroxol and bromhexine.
Danish: Der blev dog beskrevet beskedne, men positive resultater for ambroxol og bromhexin.
English: Efficacy issues
Danish: Spørgsmål vedrørende virkning
English: This increase in reporting follows the implementation of a new pharmacovigilance regulation in China that might have influenced adverse reaction reporting and does not reflect a new safety concern.
Danish: Stigningen i indberetninger følger efter at der er indført nye bestemmelser om lægemiddelovervågning i Kina, hvilket kan have påvirket bivirkningsindberetningen og ikke afspejler nye sikkerhedsproblemer.
English: An increase was observed in the reporting frequency of anaphylactic reactions over 2012-2014 linked to ambroxol.
Danish: I 2012-2014 blev der iagttaget en stigning i indberetningsfrekvensen for anafylaktiske reaktioner med sammenhæng med ambroxol.
English: As ambroxol is a metabolite of bromhexine and hypersensitivity reactions are not dependent on the dose of the allergenic substance absorbed, the FAMHP considered that any confirmed risk with ambroxol could also be found in bromhexine-containing medicinal products with regards to these reactions.
Danish: Da ambroxol er en metabolit af bromhexin, og da hypersensitivitetsreaktioner ikke afhænger af dosis af det absorberede allergene stof, fandt FAMHP, at enhver bekræftet risiko for sådanne reaktioner med ambroxol også ville gøre sig gældende for lægemidler indeholdende bromhexin.
English: Further to the evaluation of a Worksharing PSUR of ambroxol-containing medicinal products started in January 2012 and of follow-up submissions as well as signal detection activities, the Belgian national competent authority (FAMHP) identified an increase in reporting of hypersensitivity reactions over the years 2012-2014, reports of severe cutaneous adverse reactions (SCARs) and a benefit-risk evaluation in children below 6 years of age concluded that while there was no indication of a different safety profile, insufficient evidence of efficacy was available in secretolytic therapy in this age group, leading to a negative benefit-risk balance.
Danish: Efter at have vurderet en PSUR omfattet af arbejdsdelingsproceduren for lægemidler indeholdende ambroxol, som blev påbegyndt i januar 2012, opfølgende indsendelser og aktiviteter til signaldetektion konstaterede de kompetente belgiske nationale myndigheder (FAMHP) en stigning i indberetningerne af hypersensitivitetsreaktioner i årene 2012-2014, indberetninger om svære kutane bivirkninger (SCAR), og en benefit/risk-vurdering for børn under seks år, hvori det konkluderedes, at der ikke var tegn på, at sikkerhedsprofilen var anderledes, men at der ikke var tilstrækkelig evidens for virkningen til sekretolytisk behandling hos denne aldersgruppe, og at benefit/risk-forholdet derfor var negativt.
English: In light of the above, on 4 April 2014, the FAMHP informed the European Medicines Agency, of their decision to notify a referral procedure to ask for the PRAC's recommendation pursuant to Article 31 of Directive 2001/83/EC, on whether the balance of benefits and risks for these products is still positive in the approved indications, and whether the marketing authorisations for ambroxol- and bromhexinecontaining medicinal products should be maintained, varied, suspended or withdrawn.
Danish: På denne baggrund foretog FAMHP den 4. april 2014 en indbringelse for Det Europæiske Lægemiddelagentur med anmodning om, at PRAC fremsatte en anbefaling i medfør af artikel 31 i direktiv 2001/83/EF om, hvorvidt benefit/risk-forholdet for disse produkter fortsat er positivt til de godkendte indikationer, og om markedsføringstilladelserne for produkter indeholdende ambroxol bør opretholdes, ændres, suspenderes eller inddrages.
English: All the available data submitted, related to the safety and the efficacy of the medicinal products were reviewed by the PRAC to assess the potential impact of the new safety concerns identified on the established benefit-risk balance of the authorised medicinal products.
Danish: PRAC gennemgik alle de indsendte data vedrørende sikkerheden og virkningen af lægemidlerne for at vurdere den potentielle virkning af de nye sikkerhedsmæssige betænkeligheder vedrørende det fastlagte benefit/risk-forhold for de godkendte lægemidler.
English: The PRAC however noted that the observed increase in reporting of anaphylactic reactions for ambroxol-containing products was likely an artefact resulting from the implementation of a new pharmacovigilance regulation in China and did not constitute a new safety concern.
Danish: PRAC bemærkede dog, at den iagttagne stigning i indberetninger af anafylaktiske reaktioner for produkter indeholdende ambroxol måtte antages at være et artefakt, der skyldtes nye bestemmelser om lægemiddelovervågning i Kina og ikke udgjorde et nyt sikkerhedsproblem.