FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the MAH proposed a new comprehensive overview including the statement on circumcision procedures which was endorsed by the CHMP with some minor amendments.
Danish: Overordnet foreslog indehaveren af markedsføringstilladelsen en ny fyldestgørende oversigt, herunder erklæringen om omskæring, hvilket godkendtes af CHMP med visse mindre ændringer.
English: An introductory paragraph describing the differences in distribution and subsequent plasma concentrations between lidocaine and prilocaine, and a description of the effect of absorption-dependent rate of metabolism and elimination have also been added.
Danish: Desuden er tilføjet et indledende afsnit om forskellene mellem lidocain og prilocain i fordeling og efterfølgende plasmakoncentrationer og en beskrivelse af virkningen af absorptionsafhængig metaboliserings- og udskillelseshastighed.
English: The specified use on genital mucosa in adolescents is included in the SmPC of two countries.
Danish: Den specificerede anvendelse på den genitale slimhinde hos unge er omfattet af produktresuméet i to lande.
English: The CHMP agreed to introduce this information in tabular format as this would be more clearly represented and easier to read.
Danish: CHMP tilsluttede sig at medtage disse oplysninger i tabelformat for at gøre dem klare og letlæselige.
English: The CHMP considered “topical anaesthesia” to be the optimal description.
Danish: CHMP anså “topikal analgesi” for den optimale beskrivelse.
English: It is the view of the CHMP that this age group should only be dosed once in 24 hours and as a result the CHMP was of the view that a restriction in this regard should be introduced in this SmPC section.
Danish: CHMP finder, at der hos denne aldersgruppe kun bør doseres én gang hver 24 timer, og at denne begrænsning bør angives i dette punkt i produktresuméet.
English: In general the proposed paediatric posology was considered acceptable by the CHMP except for the frequency of dosing in the population between 0-3 months.
Danish: Generelt kunne CHMP godkende den foreslåede dosering til pædiatrisk anvendelse bortset fra doseringshyppigheden hos populationen mellem 0 og 3 måneder.
English: Section 5.3 - Preclinical safety data
Danish: Punkt 5.3 - Prækliniske sikkerhedsdata
English: Section 5.2 - Pharmacokinetic properties
Danish: Punkt 5.2 - Farmakokinetiske egenskaber
English: It is hereafter summarised the main points discussed for the harmonisation of the different sections of the SmPC.
Danish: Hovedpunkterne i drøftelserne af harmoniseringen af de forskellige punkter i produktresuméet er sammenfattet nedenfor.
English: The MAH proposed to include the medicinal products more commonly used in paediatric practice (e.g. sulphonamides, nitrofuradantin, phenytoin, phenobarbital) which was endorsed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen foreslog at nævne sædvanligt anvendte lægemidler i pædiatrisk praksis (f.eks. sulfonamider, nitrofuradantin, phenytoin, phenobarbital), hvilket godkendtes af CHMP.
English: An additional subheading section on repeated application to leg ulcers was proposed compared to the CDS; this was discussed during the PSUR work sharing procedure and agreed to be included in this section.
Danish: Der blev foreslået, at et supplerende underafsnit om gentagen påføring på bensår skulle sammenholdes med det centrale datablad; dette blev drøftet under PSUR-arbejdsdelingen, og det vedtoges at indsætte det i dette punkt.
English: The wording in section 5.3 is based on the MAH's CDS expect for a change from “mutagenic” to “genotoxic” and the addition of fertility data.
Danish: Ordlyden i punkt 5.3 bygger på markedsføringstilladelsesindehaverens centrale datablad bortset fra en ændring fra “mutagent” til “genotoksisk” og tilføjelse af oplysninger om fertilitet.
English: The dosage was previously approved and is in line with the CSP agreed in 2012.
Danish: Doseringen var tidligere godkendt og er i overensstemmelse med de centrale sikkerhedsoplysninger vedtaget i 2012.
English: For the paediatric population, the MAH proposed a text stating the plasma concentrations of lidocaine and prilocaine per age group including the applied amount of cream and the application time of the cream on the skin.
Danish: Til den pædiatriske population foreslog indehaveren af markedsføringstilladelsen en angivelse af plasmakoncentrationerne af lidocain og prilocain for hver aldersgruppe, herunder den påførte mængde creme og påføringstiden for cremen på huden.
English: The CHMP agreed to harmonise the indication in the genital mucosa to include the use in adolescents.
Danish: CHMP vedtog at harmonisere indikationen for den genitale slimhinde, så anvendelse hos unge indgår.
English: The CHMP agreed with the non-inclusion of the maximum dose or maximum area to be treated in section 4.2 but proposed to briefly introduce the available information in section 5.2 as this may be helpful for the prescriber.
Danish: CHMP tilsluttede sig, at der ikke angives en maksimal dosis eller et maksimalt behandlet areal i punkt 4.2, men foreslog en kortfattet angivelse af de foreliggende oplysninger i punkt 5.2, da dette kan være nyttigt for den ordinerende læge.
English: The proposed harmonised wording from the MAH for both procedures, i.e. “surgical treatment of localised lesions, e.g. removal of genital warts (condylomata acuminata) and prior to injection of local anaesthetics” and “prior to cervical curettage” was considered acceptable by the CHMP as it was consistent with the one in the majority of the countries.
Danish: Markedsføringstilladelsesindehaverens forslag til en harmoniseret ordlyd for de to procedurer, dvs. “kirurgisk behandling af lokale læsioner, f.eks.. fjernelse af kønsvorter (condylomata acuminata) og før injektion af lokalanæstetika” samt “før cervikal abrasio” kunne godkendes af CHMP, da det svarede til ordlyden i størstedelen af landene.
English: The proposal presented by the MAH reflected the latest scientific information using as basis the MAH's Core Data Sheet (CDS), the Core Safety Profile (CSP) agreed wording from the last PSUR work sharing procedure (IE/H/PSUR/0019/002) and the result of the paediatric work sharing procedure (SE/W/008/pdWS/001).
Danish: Forslaget fra indehaveren af markedsføringstilladelsen afspejlede den nyeste videnskabelige viden og var baseret på markedsføringstilladelsesindehaverens centrale datablad (CDS), den vedtagne ordlyd af den centrale sikkerhedsprofil (CSP) ved den seneste PSUR-arbejdsdelingsprocedure (IE/H/PSUR/0019/002) og resultatet af den pædiatriske arbejdsdelingsprocedure (SE/W/008/pdWS/001).
English: The CHMP commented that in the CSP and in the German SmPC “allergic reactions (in the most severe cases anaphylactic shock)” is listed instead.
Danish: CHMP kommenterede, at der i de centrale sikkerhedsoplysninger og i det tyske produktresumé i stedet står “allergiske reaktioner (i de sværeste tilfælde anafylaktisk shock)”.
English: Also, due to the off label use of EMLA in paediatric circumcision procedures it was agreed to introduce the statement of SE/W/008/pdWS/001 that the available paediatric data do not demonstrate adequate efficacy during circumcision procedures.
Danish: På baggrund af den ikke godkendte anvendelse af EMLA til pædiatrisk omskæring blev det derudover vedtaget at indsætte en angivelse fra SE/W/008/pdWS/001 af, at de foreliggende pædiatriske data ikke godtgør tilfredsstillende virkning ved omskæring.
English: The contraindication proposed by the MAH and endorsed by the CHMP was “Hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of the amide type or to any of the excipients listed in section 6.1.”.
Danish: CHMP godkendte den af markedsføringstilladelsesindehaveren foreslåede kontraindikation: “Overfølsomhed over for lidocain og/eller prilocain eller lokalanæstetika af amidtypen eller for nogen af hjælpestofferne i punkt 6.1.”.
English: The CHMP addressed a list of questions to the MAH, pointing out the sections of the products SmPC where divergences existed.
Danish: CHMP stillede en række spørgsmål til indehaveren af markedsføringstilladelsen og påpegede de afsnit i produktresuméerne, hvor der var afvigelser.
English: However, there was a discrepancy in the table of adverse reactions, in the section “immune system disorders”.
Danish: Der var dog en afvigelse i afsnittet “immunsystemet” i tabellen over bivirkninger.
English: The wording in section 5.1 is based on the MAH's Core Data Sheet (CDS) with some minor rearrangements to present the text per respective indication (i.e. skin, genital mucosa, leg ulcers).
Danish: Ordlyden i punkt 5.1 er baseret på markedsføringstilladelsesindehaverens centrale datablad (CDS), dog er der foretaget mindre redaktionelle ændringer, så teksten anføres for hver indikation (dvs. hud, genital slimhinde, bensår).
English: Section 4.7 - Effects on ability to drive and use machines The MAH proposed the following harmonised SmPC text in line with the agreed CSP.
Danish: Punkt 4.7 - Virkning på evnen til at føre motorkøretøj og betjene maskiner Indehaveren af markedsføringstilladelsen foreslog følgende harmoniserede tekst til produktresuméet svarende til de vedtagne centrale sikkerhedsoplysninger.
English: The MAH's proposal was supported by the CHMP as it was consistent with the wording in the majority of the countries.
Danish: CHMP tilsluttede sig forslaget fra indehaveren af markedsføringstilladelsen, da det var i overensstemmelse med ordlyden i størstedelen af landene.
English: Section 5.1 - Pharmacodynamic properties
Danish: Afsnit 5.1 - Farmakodynamiske egenskaber
English: The CHMP was also of the view that similar to the dose recommendations that are given for adults and adolescents for the use on genital skin, information regarding the non-recommendation of EMLA on genital skin for children should be introduced in this section.
Danish: CHMP fandt desuden, at der i lighed med dosisanbefalingerne til anvendelse på genital hud hos voksne og unge bør indsættes en bemærkning om, at EMLA frarådes anvendt på genital hud på børn.
English: The dosage “Approx.
Danish: Doseringen “Ca.
English: The CHMP noted that from the data available no maximum area to be treated may be derived but agreed to briefly introduce the available information in section 5.2 as this may be helpful for the prescriber.
Danish: CHMP bemærkede, at der ikke kan udledes et maksimalt behandlet areal, men vedtog en kortfattet angivelse af de foreliggende oplysninger i punkt 5.2, da dette kan være nyttigt for den ordinerende læge.
English: No maximum dose or maximum area to be treated was specified in the harmonised proposed text.
Danish: Den foreslåede harmoniserede tekst foreskriver ikke en maksimal dosis eller et maksimalt behandlet areal.
English: The wording in section 5.2 is based on the MAH's CDS with some amendments.
Danish: Ordlyden i punkt 5.2 bygger på markedsføringstilladelsesindehaverens centrale datablad med visse ændringer.
English: “Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia in adults and adolescents ≥12 years.”
Danish: “Overfladeanalgesi af genital slimhinde, f.eks. før superficielle kirurgiske indgreb eller før infiltrationsanæstesi, hos voksne og unge ≥ 12 år.”
English: The efficacy in intact skin indications such as “needle insertion” and “superficial surgical procedures” has been demonstrated in a number of clinical studies and is considered acceptable.
Danish: Virkningen ved indikationer i forbindelse med intakt hud såsom “indføring af kanyle ” og “superficielle kirurgiske procedurer” er påvist i en række kliniske undersøgelser og kan godtages.
English: EMLA provides dermal anaesthesia through the release of lidocaine and prilocaine from the cream into the epidermal and dermal layers of the skin and the vicinity of dermal pain receptors and nerve endings.
Danish: EMLA frembringer dermal anæstesi ved at frigive lidocain og prilocain fra cremen til epidermis og dermis og til de dermale smertereceptorer og nerveterminaler.
English: • Dermal procedures on larger areas in a hospital setting, e.g. split-skin grafting
Danish: • Dermale indgreb på større overflader i hospitalsomgivelser f.eks. delhudtransplantation
English: The wording proposed by the MAH was the CSP agreed wording from the last PSUR work sharing procedure (IE/H/PSUR/0019/002) with additions to be in accordance with the latest QRD template and to provide a recommendation for pregnant and breast feeding women.
Danish: Markedsføringstilladelsesindehaverens forslag til ordlyden var den samme som den vedtagne ordlyd af de centrale sikkerhedsoplysninger fra den seneste PSUR-arbejdsdelingsprocedure (IE/H/PSUR/0019/002) med tilføjelser, der retter den ind efter den nyeste QRD-skabelon, og med en anbefaling for gravide og ammende kvinder.
English: The MAH listed as rare undesirable effect “anaphylactic reaction (in the most severe cases anaphylactic shock)”.
Danish: Indehaveren af markedsføringstilladelsen angav som en sjælden bivirkning “anafylaktisk reaktion (i de sværeste tilfælde anafylaktisk shock)”.
English: Section 4.8 - Undesirable effects
Danish: Afsnit 4.8 - Bivirkninger
English: Regarding the posology and the application time for paediatric patients the information was presented by the MAH per age group and per related procedure in a tabular format.
Danish: Vedrørende dosering og påføringstid for pædiatriske patienter forelagde markedsføringstilladelsesindehaveren i tabelform oplysninger for hver aldersgruppe og hvert tilknyttet indgreb.
English: The harmonised information on posology and on application time was presented by the MAH per indication (i.e. skin, genital mucosa, leg ulcers) and per related procedure in a tabular format.
Danish: De harmoniserede oplysninger om dosering og påføringstid blev af markedsføringstilladelsesindehaveren forelagt i tabelform for hver indikation (dvs. hud, genital slimhinde, bensår) og hver tilsvarende procedure.
English: The MAH made a proposal in line with the agreed CSP wording (IE/H/PSUR/0019/002) which in general was considered acceptable by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen fremsatte et forslag, der var i overensstemmelse med den vedtagne ordlyd af de centrale sikkerhedsoplysninger (IE/H/PSUR/0019/002), og som CHMP generelt kunne godtage.
English: Most countries include the examples “needle insertion, e.g. intravenous catheters or blood sampling” and “superficial surgical procedures”.
Danish: I de fleste lande anføres som eksempler “indføring af kanyler, f.eks. til intravenøse katetre eller blodprøvetagning” og “superficielle kirurgiske indgreb”.
English: Efficacy and safety in intact skin indications such as venipuncture and vaccination has been demonstrated in a number of clinical studies in children and was considered acceptable.
Danish: For indikationer til intakt hud såsom venepunktur og vaccination er virkningen og sikkerheden dokumenteret i en række kliniske undersøgelser hos børn og kunne godkendes.
English: The CHMP noted that there are several clinical data supporting the inclusion of “topical anaesthesia of the skin in connection with needle insertion e.g. intravenous catheters or blood sampling and in superficial surgical procedures” in paediatric population.
Danish: CHMP bemærkede, at der er en del kliniske data til støtte for “overfladeanalgesi af hud ved indføring af kanyler, f.eks. til intravenøse katetre eller blodprøvetagning, og ved superficielle kirurgiske procedurer” hos den pædiatriske population.
English: An additional sentence describing the ceiling plasma concentration for symptoms of local anaesthetic toxicity was present in several national SmPCs, and was also proposed to be included to put the ranges of concentrations reported in context.
Danish: Flere af de nationale produktresuméer indeholdt derudover et loft for plasmakoncentrationen med henblik på toksiske symptomer fra lokalanæstetika, og dette blev også foreslået medtaget for at sætte de angivne koncentrationer i sammenhæng Alle disse ændringer blev anset for relevante af CHMP og blev godkendt.
English: The final agreed wording for the indication “topical anaesthesia of the skin” was: “Topical anaesthesia of the skin in connection with - needle insertion, e.g. intravenous catheters or blood sampling - superficial surgical procedures in adults and in the paediatric population.”
Danish: Den endelige vedtagne ordlyd af indikationen “overfladeanalgesi af hud” var: “Overfladeanalgesi af hud ved - indføring af kanyler, f.eks. til intravenøse katetre eller blodprøvetagning - superficielle kirurgiske indgreb hos voksne og hos den pædiatriske population.”
English: The CHMP agreed that the use in adolescents is specifically supported by clinical studies which provide evidence for the similarity of the thickness of the stratum corneum (the rate-limiting barrier for percutaneous absorption) in adults and adolescents.
Danish: CHMP fandt, at anvendelsen hos unge specifikt underbygges af kliniske undersøgelser med evidens for ligheden hos voksne og unge i tykkelsen af stratum corneum (den hastighedsbegrænsende barriere for perkutan absorption).
English: This wording was in line with the wording of the latest work sharing CSP.
Danish: Denne ordlyd var i nøje overensstemmelse med de seneste centrale sikkerhedsoplysninger (CSP) fra arbejdsdelingsproceduren.
English: The wording proposed for other warnings and precautions (e.g. application on open wounds, atopic dermatitis, application in the vicinity of the eyes or to an impaired tympanic membrane) was considered acceptable by the CHMP.
Danish: CHMP kunne godtage den foreslåede ordlyd af øvrige vejledninger og forholdsregler (f.eks. påføring på åbne sår, atopisk dermatitis, påføring nær øjnene eller på en defekt trommehinde).
English: Topical anaesthesia of the genital mucosa
Danish: Overfladeanalgesi af den genitale slimhinde
English: Genital mucosa
Danish: Genital slimhinde
English: Section 4.2 - Posology and method of administration Adults and adolescents
Danish: Punkt 4.2 - Dosering og administration
English: The clinical justification for the dosage in adolescents referring to the similarity of the thickness of the stratum corneum (the ratelimiting barrier for percutaneous absorption) in adults and adolescents was considered acceptable by the CHMP.
Danish: CHMP kunne godtage den kliniske begrundelse for doseringen hos unge, der henviser til ligheden i tykkelsen af stratum corneum (den hastighedsbegrænsende barriere for perkutan absorption) hos voksne og unge.
English: The MAH made a proposal in line with the wording of the latest work sharing CSP. Additionally, information on pulse oximetry and antidotes in glucose-6-phosphate dehydrogenase deficiency has been agreed.
Danish: Desuden er der vedtaget oplysninger om pulsoxymetri og modgift ved glucose-6-phosphat-dehydrogenasemangel.
English: Topical anaesthesia of the skin
Danish: Overfladeanalgesi af hud
English: The CHMP did generally agree with the text proposed by the MAH.
Danish: CHMP kunne generelt tilslutte sig markedsføringstilladelsesindehaverens forslag til teksten.
English: The wording proposed by the MAH was the CSP agreed wording from the last PSUR work sharing procedure.
Danish: Markedsføringstilladelsesindehaverens forslag til ordlyden var den vedtagne ordlyd i de centrale sikkerhedsoplysninger fra den seneste PSUR-arbejdsdelingsprocedure.
English: The wording of the CSP from the last work-sharing procedure as well as the recent PSURs served as basis for the harmonised text proposed by the MAH.
Danish: Markedsføringstilladelsesindehaverens forslag til ordlyden af en harmoniseret tekst byggede på den seneste arbejdsdelingsprocedure og de nylige PSUR.
English: In addition, efficacy in genital mucosa indications such as application prior to superficial surgical procedures or infiltration anaesthesia has been demonstrated in a number of clinical studies.
Danish: I en række kliniske undersøgelser er der desuden påvist virkning ved indikationer vedrørende genital slimhinde, således anvendelse før superficielle kirurgiske procedurer eller før infiltrationsanæstesi.
English: The CHMP was of the view that efficacy in genital mucosa indications such as application prior to superficial surgical procedures or infiltration anaesthesia when used in adults has been demonstrated in a number of clinical studies.
Danish: CHMP fandt, at virkningen hos voksne var godtgjort i en række kliniske undersøgelser for indikationer vedrørende den genitale slimhinde såsom påføring før superficielle kirurgiske indgreb og før infiltrationsanæstesi.
English: It works in a different way to other authorised treatments.
Danish: Det virker anderledes end andre godkendte behandlinger.
English: The dose for adolescents and children depends on their body weight.
Danish: Dosis til unge og børn afhænger af deres kropsvægt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Firazyr on 11 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Firazyr den 11. juli 2008.
English: If needed, treatment can be repeated for a third time after an additional 6 hours.
Danish: Hvis det er nødvendigt, kan behandlingen gentages en tredje gang efter yderligere 6 timer.
English: This is a summary of the European public assessment report (EPAR) for Firazyr.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Firazyr.
English: Other information about Firazyr
Danish: Andre oplysninger om Firazyr
English: This blocks the activity of bradykinin, helping to relieve the symptoms of the disease.
Danish: Dette blokerer bradykinins aktivitet og bidrager til at lindre symptomerne på sygdommen.
English: If symptoms continue or come back, a second injection can be given after 6 hours.
Danish: Hvis symptomerne varer ved eller vender tilbage, kan der gives endnu en injektion efter 6 timer.
English: The doctor may decide that the patient or their caregiver can inject the medicine themselves, after they have been properly trained by a healthcare professional.
Danish: Lægen kan træffe beslutning om, at patienten eller dennes plejer selv må indsprøjte lægemidlet, når de er blevet behørigt instrueret heri af en sundhedsfaglig person.
English: No more than three injections should be given in any 24-hour period.
Danish: Der må højst gives tre injektioner i løbet af en 24-timers periode.
English: The main measure of effectiveness was how long it took for the patient's symptoms to be relieved.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor lang tid det tog at lindre patientens symptomer.
English: The recommended dose of Firazyr in adults is one injection (3 ml).
Danish: Den anbefalede dosis af Firazyr hos voksne er én injektion (3 ml).
English: What measures are being taken to ensure the safe and effective use of Firazyr?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Firazyr?
English: Attacks of hereditary angioedema can be life threatening when they involve the throat.
Danish: Anfald af arveligt angioødem kan være livstruende, når de omfatter halsen.
English: The European Medicines Agency decided that Firazyr's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Firazyr opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Firazyr.
English: Firazyr can only be obtained with a prescription.
Danish: Firazyr udleveres kun efter recept.
English: Why is Firazyr approved?
Danish: Hvorfor blev Firazyr godkendt?
English: Each pre-filled syringe of Firazyr contains 30 mg icatibant in 3 ml.
Danish: Hver fyldt sprøjte med Firazyr indeholder 30 mg icatibant i 3 ml.
English: What is Firazyr and what is it used for?
Danish: Hvad er Firazyr, og hvad anvendes det til?
English: Because the number of patients with angioedema is low, the disease is considered ‘rare', and Firazyr was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 February 2003.
Danish: Da antallet af patienter med angioødem er lavt, betragtes sygdommen som "sjælden", og Firazyr blev udpeget som "lægemiddel til sjældne sygdomme" den 17. februar 2003.