FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC was of the view that the risk of SCARs should be addressed by its inclusion in the product information accompanied by a warning in order for patients and caregivers to recognise the prodromes of SCARs and discontinue treatment immediately in the event of such signs.
Danish: • PRAC var af den opfattelse, at risikoen for SCAR bør håndteres ved, at den nævnes i produktinformationen ledsaget af en advarsel, der gør patienter og omsorgsgivere opmærksomme på prodromerne til SCAR med henblik på øjeblikkelig seponering af behandlingen hvis sådanne tegn optræder
English: • The PRAC reviewed the totality of the data submitted in support of the safety and efficacy of ambroxol- and bromhexine-containing products, including submissions from the marketing authorisation holders and expert input.
Danish: • PRAC gennemgik samtlige indsendte data vedrørende sikkerheden og virkningen af produkter indeholdende ambroxol og bromhexin, herunder materiale indsendt af indehaverne af markedsføringstilladelsesindehaverne og ekspertbidrag
English: The safety information submitted by the MAHs, from Eudravigilance and from the literature, comprises in total around 300 case reports of suspected SCARs, many of which have possible confounders.
Danish: Sikkerhedsoplysningerne fra indehaverne af markedsføringstilladelse, fra EudraVigilance og fra litteraturen omfatter i alt omkring 300 case-rapporter om formodede SCAR, hvor der i mange tilfælde kan have været konfunderende faktorer.
English: In addition, ambroxol and bromhexine have been approved in some EU MS in airway diseases indications in fixed dose combinations with various active substances.
Danish: Ambroxol og bromhexin er i nogle medlemsstater desuden godkendt til luftvejssygdomme i fast kombination med forskellige aktive stoffer.
English: The CMDh, having considered the revised PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and reached the position that the marketing authorisations for ambroxol- and bromhexine-containing medicinal products should be varied.
Danish: Efter gennemgang af PRAC's reviderede anbefaling tilslutter CMDh sig PRAC's overordnede videnskabelige konklusioner og nåede til den opfattelse, at markedsføringstilladelserne for lægemidler indeholdende ambroxol- og bromhexin bør ændres.
English: The PRAC considered all these elements in its review of the available data on the efficacy of ambroxol- and bromhexine-containing products.
Danish: PRAC tog alle disse elementer i betragtning i sin gennemgang af de foreliggende data om virkningen af produkter indeholdende ambroxol og bromhexin.
English: Hypersensitivity reactions are dose and formulation independent, therefore the possible risk of developing hypersensitivity reactions including SCARs is inherent to all ambroxol- and bromhexinecontaining products.
Danish: Hypersensitivitetsreaktioner er uafhængige af dosis og formulering, hvorfor den mulige risiko for hypersensitivitetsreaktioner, herunder SCAR, er knyttet til alle produkter indeholdende ambroxol eller bromhexin.
English: Based on these data it is considered that the susceptibility of all age groups (paediatric, adults and elderly) to putative hypersensitivity-related undesirable effects of ambroxol or bromhexine is likely similar.
Danish: På dette grundlag anses der for at være lige stor følsomhed i alle aldersgrupper (pædiatriske, voksne og ældre) over for formodede hypersensitivitetsrelaterede uønskede virkninger af ambroxol eller bromhexin.
English: In relation to the efficacy of ambroxol- and bromhexine-containing products, the PRAC concluded that although modest positive results were reported, the evidence of efficacy of ambroxol and bromhexine suffered from a number of limitations and deficiencies.
Danish: Vedrørende virkningen af produkter indeholdende ambroxol og bromhexin konkluderede PRAC, at der var opnået moderat positive resultater, men at evidensen for virkningen af ambroxol og bromhexin var behæftet med en række begrænsninger og mangler.
English: However, these adverse reactions are already listed in the product information of most ambroxol- and bromhexinecontaining products and the analysis of the most frequently reported adverse events selected by the SMQ Hypersensitivity (broad) did not identify any new safety concerns.
Danish: Disse bivirkninger er imidlertid allerede er anført i produktinformationen for de fleste produkter indeholdende ambroxol og bromhexin, og analysen af de hyppigst indberettede bivirkninger, udvalgt ved søgning med den standardiserede (brede) MedDRA-søgeterm "Hypersensitivity", viste ingen nye sikkerhedsproblemer.
English: The PRAC was of the view that the possible risk of SCARs can be adequately addressed by the proposed amendments to the PI to inform caregivers and patients of the risk and allow early identification of signs of SCARs and immediate discontinuation of treatment should they occur.
Danish: PRAC var af den opfattelsen, at den mulige risiko for SCAR kan håndteres tilstrækkeligt ved de foreslåede ændringer af produktinformationen, der informerer omsorgsgivere og patienter om risikoen og giver mulighed for tidlig påvisning af tegn på SCAR og øjeblikkelig seponering af behandlingen, hvis de indtræder.
English: With regards to delayed hypersensitivity reactions associated with SCARs, a few cases have been assessed as certainly related to ambroxol.
Danish: Vedrørende forsinkede hypersensitivitetsreaktioner forbundet med SCAR er enkelte tilfælde blevet vurderet til at have sikker sammenhæng med ambroxol.
English: • The PRAC considered that ambroxol and bromhexine are associated with an increased risk of hypersensitivity reactions.
Danish: • PRAC fandt, at ambroxol og bromhexin er forbundet med øget risiko for hypersensitivitetsreaktioner
English: Based on the evaluation of the individual case reports, considering the nature of these events the PRAC was of the view that there is a reasonable possibility that all ambroxol and bromhexine-containing products are associated with an increased risk of SCARs including combination products.
Danish: Ved vurderingen af de individuelle case-rapporter fandt PRAC, at det i betragtning af arten af disse hændelser er rimelig sandsynligt, at alle produkter indeholdende ambroxol og bromhexin er forbundet med øget risiko for SCAR, herunder kombinationsprodukter.
English: Analysis of the safety information submitted by the MAH, from Eudravigilance and from the literature, demonstrates that ambroxol and bromhexine formulations in their different indications have been associated with reports of serious immediate hypersensitivity reactions.
Danish: Analyse af sikkerhedsoplysningerne fra indehaveren af markedsføringstilladelsen, fra EudraVigilance og fra litteraturen viser, at formuleringer af ambroxol og bromhexin til forskellige indikationer er blevet sat i forbindelse med indberettede svære hypersensitivitetsreaktioner af straks-typen.
English: Taking all of the above into consideration, the PRAC concluded that the data reviewed supported amendments of the product information to reflect the risk of severe cutaneous adverse reactions, and that further age restrictions to reflect the concerns about the benefit-risk balance of ambroxol- and bromhexine-containing products are not justified on the basis of the data available.
Danish: I betragtning af alt det ovennævnte konkluderede PRAC, at de gennemgåede data støttede ændring af produktinformationen vedrørende risikoen for svære kutane bivirkninger, og at de foreliggende data ikke begrunder yderligere aldersbegrænsninger, der afspejler betænkelighederne ved benefit/riskforholdet for produkter indeholdende ambroxol og bromhexin.
English: The authorised indications of bromhexine, as listed in the Company Core Data Sheet of the originator, are secretolytic therapy, alteration in the production or elimination of mucus (acute and chronic sinusitis) and Sjögren's syndrome.
Danish: De godkendte indikationer for bromhexin i henhold til det centrale datablad for originalproduktet er sekretolytisk behandling, ændret slimproduktion eller -udskillelse (akut og kronisk sinuitis) og Sjögrens syndrom.
English: These products are contra-indicated in different subsets of the paediatric population in the EU MS. Ambroxol and bromhexine are marketed in several formulations for oral, nasal, oromucosal, intravenous or rectal administration under various invented names.
Danish: Ambroxol og bromhexin markedsføres i en række formuleringer til oral, nasal, oromucosal, intravenøs og rektal administration under forskellige handelsnavne.
English: The authorised indications of ambroxol, as listed in the Company Core Data Sheet of the originator, are secretolytic therapy, prophylaxis and treatment of Infant Respiratory Distress Syndrome (IRDS), prophylaxis and treatment of post-operative bronchopulmonary complications (PPC) and pain relief in acute sore throat.
Danish: De godkendte indikationer for ambroxol i henhold til virksomhedens centrale datablad for originalproduktet er sekretolytisk behandling, forebyggelse og behandling af akut lungesvigtsyndrom hos børn (Infant Respiratory Distress Syndrome, IRDS), forebyggelse og behandling af postoperative bronkopulmonale komplikationer (PPC) samt smertelindring ved akut ondt i halsen.
English: In addition, ambroxol formulations indicated in secretolytic therapy and prophylaxis or treatment of IRDS and PPC have been associated with delayed-onset hypersensitivity reactions without severe skin injury.
Danish: Ambroxolformuleringer indiceret til sekretolytisk behandling og forebyggelse eller behandling af akut lungesvigtsyndrom hos børn (IRDS) og postoperative bronkopulmonale komplikationer (PPC) er desuden blevet sat i forbindelse med forsinkede hypersensitivitetsreaktioner uden svære hudskader.
English: When considering data in support of the safety issues, the PRAC was of the view that ambroxol- and bromhexine-containing products are associated with case reports of immediate and delayed hypersensitivity including hypersensitivity reactions, anaphylactic reactions including anaphylactic shock, angioedema, pruritus, rash and urticaria.
Danish: Ved gennemgang af data til støtte for sikkerhedsproblemerne var PRAC af den opfattelse, at produkter indeholdende ambroxol og bromhexin er forbundet med case-rapporter om hypersensitivitet af strakstypen og forsinket hypersensitivitet, herunder hypersensitivitetsreaktioner, anafylaktiske reaktioner inkl.
English: The PRAC considered that there was a reasonable possibility that ambroxol and bromhexine are associated with serious delayed-type hypersensitivity reactions associated with SCARs.
Danish: PRAC fandt det rimelig sandsynligt, at ambroxol og bromhexin har sammenhæng med alvorlige hypersensitivitetsreaktioner af forsinket type med ledsagende SCAR.
English: As SCARs sometimes start with flu-like symptoms some patients might also start taking ambroxol or bromhexine to alleviate these symptoms whereas the typical skin reactions appear later and ambroxol or bromhexine might be considered as suspect drug.
Danish: Da SCAR undertiden sætter ind med influenzalignende symptomer, kan nogle patienter desuden tænkes at begynde at tage ambroxol eller bromhexin for at dæmpe disse symptomer.
English: • The PRAC considered that there is a reasonable possibility of a risk of SCARs associated with ambroxol and bromhexine.
Danish: • PRAC fandt det rimelig sandsynligt, at der er en risiko for SCAR knyttet til ambroxol og bromhexin
English: Ambroxol- and bromhexine-containing medicines are available as over-the-counter (OTC) as well as prescription-only medicines (POM).
Danish: Lægemidler indeholdende ambroxol og bromhexin fås som håndkøbsmedicin og som receptpligtig medicin.
English: In addition, all studies conducted more recently submitted by the MAHs were also considered by the PRAC.
Danish: Derudover tog PRAC hensyn til alle undersøgelser, der senere er indsendt af markedsføringstilladelsesindehaverne.
English: The PRAC considered that the evidence of risk of SCARs associated with ambroxol and bromhexine is weak.
Danish: PRAC fandt, at der kun var svag evidens for en risiko for SCAR i forbindelse med ambroxol og bromhexin.
English: Therefore, the PRAC recommends the variation to the terms of the marketing authorisations, for all ambroxol- and bromhexine-containing medicinal products identified in Annex I and for which the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III of the revised PRAC recommendation.
Danish: • PRAC fandt de foreliggende data utilstrækkelige til at begrunde nye aldersbegrænsninger anbefaler PRAC ændring af markedsføringstilladelserne for alle de i bilag I omhandlede lægemidler indeholdende ambroxol og bromhexin, for hvilke de relevante afsnit af produktresuméet og indlægssedlen fremgår af bilag III til PRAC's reviderede udtalelse konkluderede PRAC, at benefit/risk-forholdet for lægemidler indeholdende ambroxol og bromhexin fortsat er positivt under forudsætning af, at ovennævnte ændringer indføres i produktinformationen.
English: They will tell you what to do.
Danish: De vil fortælle Dem, hvad De skal gøre.
English: It is also likely to lower the amount of milk you produce.
Danish: Det vil sandsynligvis også nedsætte den mængde mælk, De producerer.
English: Augmentation may occur.
Danish: Augmentation kan forekomme.
English: If this happens, do not drive.
Danish: Hvis det sker, må De ikke føre motorkøretøj.
English: This is because the medicine may be released faster.
Danish: Dette skyldes, at medicinen derved kan frigives hurtigere.
English: Allée de la Recherche 60 B-1070 Bruxelles Belgium
Danish: Allée de la Recherche 60 B-1070 Bruxelles Belgien
English: The effect was maintained over a 6 months period.
Danish: Effekten blev opretholdt i en periode på 6 måneder.
English: The right dose for you will depend on your needs.
Danish: Den passende dosis for Dem afhænger af Deres behov.
English: Periodic assessment of efficacy should be performed, along with evaluation of safety, including augmentation.
Danish: Der bør udføres periodisk vurdering af virkningen sammen med evaluering af sikkerheden, herunder augmentation.
English: Comparable skin tolerability was reported for both formulations.
Danish: Der blev rapporteret sammenlignelig tolerabilitet for begge formuleringer.
English: Treatment of overdose may require general supportive measures to maintain the vital signs.
Danish: Behandling af overdosis kan kræve generelle understøttende tiltag for at opretholde de vitale tegn.
English: Both treatments showed improvements in early morning motor function and sleep.
Danish: Begge behandlinger viste forbedringer i motorisk funktion tidligt om morgenen og søvn.
English: Interactions with other forms of hormonal contraception have not been investigated.
Danish: Interaktioner med andre former for hormonel kontraception er ikke undersøgt.
English: These may irritate your skin.
Danish: Det kan irritere huden.
English: This is when you and your doctor agree that the symptoms are being controlled well enough and the side effects of the medicines are acceptable.
Danish: Dette er, når De og Deres læge er enige om, at symptomerne er tilstrækkeligt kontrolleret, og bivirkningerne af lægemidlerne er acceptable.
English: The primary outcome assessment was the reduction in “off” time (hours).
Danish: Den primære resultatvurdering var reduktion i “off”-tid (timer).
English: The information on metabolites is incomplete.
Danish: Informationen om metabolitter er ufuldstændig.
English: Contains E223.
Danish: Indeholder E 223.
English: None of these patients discontinued therapy because of augmentation.
Danish: Ingen af disse patienter seponerede behandlingen på grund af augmentation.
English: MULTIPACKS ONLY
Danish: KUN MULTIPACKS
English: The safety profile was comparable, with the exception of application site reactions.
Danish: Sikkerhedsprofilerne var sammenlignelige, med undtagelse af reaktioner relateret til applikationsstedet.
English: Loss of consciousness can occur
Danish: Bevidsthedstab kan forekomme
English: You can put a new patch on afterwards.
Danish: De kan sætte et nyt plaster på bagefter.
English: Date of first authorisation: 16 June 2011 Date of latest renewal: 14 January 2016
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 16 juni 2011 Dato for seneste fornyelse: 14 januar 2016
English: All differences between the active treatments and placebo were statistically significant.
Danish: Alle forskelle mellem de aktive behandlinger og placebo var statistisk signifikante.
English: (see Special populations)
Danish: (se Særlige populationer)
English: Wash your hands with soap and water straight after handling the patch.
Danish: Vask hænderne med vand og sæbe umiddelbart efter håndtering af plasteret.
English: In both cases, use a new patch at the usual time on the following day.
Danish: I begge tilfælde skal De bruge et nyt plaster på det sædvanlige tidspunkt den følgende dag.
English: The same site should not be used within 14 days.
Danish: Samme sted bør ikke anvendes inden for 14 dage.
English: This is because it may change the colour of the skin.
Danish: Det skyldes, at det kan give ændringer i hudens farve.
English: However, there is no indication of a relevant impact on the clinical outcome.
Danish: Der er imidlertid ingen indikation for relevant påvirkning af det kliniske resultat.
English: The majority of erythema observed was mild and none severe.
Danish: Størstedelen af observerede erytemtilfælde var milde og ikke alvorlige.
English: Additional studies to further evaluate the specific pathology have not been performed.
Danish: Der har ikke været foretaget flere studier for yderligere at vurdere den specifikke patologi.
English: • altered or increased sexual interest and behaviour which causes significant concern to you or others - for example, an increased sex drive
Danish: • ændret eller øget seksuel interesse og opførsel, som er til betydelig bekymring for Dem eller andre - for eksempel øget sexlyst
English: • Keep it pressed for about 30 seconds.
Danish: • Hold fast i omkring 30 sekunder.
English: Leganto with food, drink and alcohol
Danish: Brug af Leganto sammen med mad, drikke og alkohol
English: Any used or unused patches should be disposed of in accordance with local requirements or returned to the pharmacy.
Danish: Brugte eller ubrugte plastre skal bortskaffes i henhold til lokale retningslinjer eller returneres til apoteket.
English: Patients should be regularly monitored for the development of impulse control disorders.
Danish: Patienter skal kontrolleres regelmæssigt for udvikling af impulskontrolforstyrrelser.
English: The absolute bioavailability after transdermal application is approximately 37%.
Danish: Den absolutte biotilgængelighed efter transdermal applikation er ca. 37%.
English: Not known: it is not known how often these happen
Danish: Ikke kendt: hyppigheden er ikke kendt
English: The apparent volume of distribution in humans is approximately 84 l/kg.
Danish: Det tilsyneladende distributionsvolumen hos mennesker er ca. 84 l/kg.
English: For example, put it on the right side of your body one day, then on the left side of your body the next day.
Danish: For eksempel, kan De sætte det på højre side af kroppen den ene dag og på venstre side af kroppen den næste dag.
English: While these complications may resolve when treatment is discontinued, complete resolution does not always occur.
Danish: Selvom disse komplikationer kan fortage sig, når behandlingen ophører, er det ikke altid, de forsvinder fuldstændigt.
English: CPK levels have not been routinely measured in other populations.
Danish: Der er ikke blevet målt CKniveauer rutinemæssigt hos andre populationer.
English: Also do not use them on or near a patch you are already wearing.
Danish: Anvend derudover ikke disse på eller nær et plaster, De allerede har på.
English: You can also use a little baby oil to remove any stickiness that will not wash off.
Danish: De kan også anvende en smule babyolie for at fjerne eventuelt klæbemiddel, som ikke kan vaskes af.
English: • The reactions normally go away after a few hours - once you remove the patch.
Danish: • Reaktionerne forsvinder normalt nogle få timer efter, De har fjernet plasteret.
English: It is thin and has three layers.
Danish: Det er tyndt og har tre lag.
English: This is normally reached within 3 to 7 weeks.
Danish: Dette nås normalt inden for 3 til 7 uger.
English: If you are treated with Leganto and levodopa at the same time, some side effects may get more serious.
Danish: Hvis De bliver behandlet med Leganto og levodopa samtidig, kan visse bivirkninger blive mere alvorlige.
English: Approximately 45% of the active substance within the patch is released to the skin in 24 hours.
Danish: Ca. 45% af det aktive stof i plasteret frigives til huden på 24 timer.
English: Do not give this medicine to children below 18 years of age because it is not known if it is safe or effective in this age group.
Danish: Lægemidlet må ikke anvendes til børn under 18 år, da sikkerhed og virkning ikke er kendt i denne aldersgruppe.
English: This is normally reached within 3 to 4 weeks.
Danish: Dette nås normalt inden for 3 til 4 uger.
English: • Gently wash the area with warm water and mild soap.
Danish: • Vask forsigtigt området med varmt vand og mild sæbe.
English: Rotigotine has not been investigated in this patient group.
Danish: Rotigotin er ikke undersøgt hos denne patientgruppe.
English: The patient should be monitored closely, including heart rate, heart rhythm and blood pressure.
Danish: Patienten bør monitoreres nøje, herunder puls, hjerterytme og blodtryk.
English: • abnormal thoughts about reality
Danish: • unormale tanker omkring virkeligheden
English: Contact your doctor if you notice signs of an allergic reaction - these can include swelling of the face, tongue or lips.
Danish: Kontakt lægen, hvis De bemærker tegn på allergiske reaktioner - disse kan omfatte hævelse af ansigtet, tungen eller læberne.
English: Fibrotic complications
Danish: Fibrotiske komplikationer
English: 30 seconds.
Danish: 30 sekunder.
English: • Used patches still contain the active substance ‘rotigotine', which may be harmful to others.
Danish: • Brugte plastre indeholder stadig det aktive stof, ‘rotigotin' som kan være skadeligt for andre.
English: • your symptoms of Restless Legs Syndrome may start earlier than usual, be more intense and involve other limbs.
Danish: • Deres symptomer på restless legs-syndrom kan begynde tidligere end sædvanligt, være mere intense og omfatte andre lemmer.
English: It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of orthostatic hypotension associated with dopaminergic therapy.
Danish: Det anbefales at monitorere blodtryk, især i begyndelsen af behandlingen, på grund af den generelle risiko for ortostatisk hypotension, som forbindes med dopaminbehandling.
English: Efficacy was demonstrated in controlled trials in patients treated for up to 29 weeks.
Danish: Virkningen blev demonstreret i kontrollerede studier med patienter behandlet i op til 29 uger.
English: Also do not use tools or machines if you feel very sleepy - or do anything else which may put others or yourself at risk of serious injury.
Danish: Derudover må De ikke bruge værktøj eller maskiner, hvis De føler dem meget træt - eller gøre andet der kan udsætte Dem selv eller andre for alvorlige skader.
English: Because patients with clinically relevant cardiovascular disease were excluded in these studies, patients with severe cardiovascular disease should be asked about symptoms of syncope and pre-syncope.
Danish: Da patienter med klinisk relevant kardiovaskulær sygdom blev ekskluderet i disse studier, bør patienter med alvorlig kardiovaskulær sygdom adspørges om symptomer på synkope og præsynkope.
English: Efficacy/safety data is insufficient to establish a relation between exposure and response (see also paediatric information in section 4.2).
Danish: Data vedrørende sikkerhed og virkning er ikke tilstrækkelige til at fastlægge en sammenhæng mellem eksponering og respons (se også pædiatrisk information under pkt.