FrancophonIA/ELRC3.0 huggingface dataset:
English: The indication “topical anaesthesia of the skin” is approved in all countries where EMLA has a marketing authorisation.
Danish: Indikationen “overfladeanalgesi af hud” er godkendt i alle lande, hvor EMLA har en markedsføringstilladelse.
English: The Committee also noted that data on efficacy in adults in this indication can be extrapolated to adolescents.
Danish: Udvalget bemærkede desuden, at data vedrørende virkning hos voksne ved denne indikation kan ekstrapoleres til unge.
English: The SmPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Danish: Harmoniseringen af produktresuméerne skete under hensyntagen til alle relevante terapeutiske og regulatoriske retningslinjer i EU.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation
Danish: Bilag II Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelsen
English: Interactions are likely to be similar to the adult population” is preferred.
Danish: Der forventes samme interaktioner som hos den voksne population”.
English: This dosage was previously approved and supported by the clinical study program.
Danish: Denne dosering var tidligere godkendt og underbyggedes af det kliniske undersøgelsesprogram.
English: • Skin of male & female genital organs - prior to injection of local anaesthetics
Danish: • Hud på mandlige og kvindelige kønsorganer - før injektion af lokalanæstetika
English: This was endorsed by the CHMP.
Danish: Dette blev godkendt af CHMP.
English: The wording was improved for clarity to include “self-application by patient”.
Danish: Ordlyden blev af klarhedshensyn forbedret med tilføjelsen “påføres af patienten selv”.
English: A statement like “Specific interaction studies in children have not been performed.
Danish: Der foretrækkes en angivelse såsom “Der er ikke foretaget specifikke interaktionsundersøgelser hos børn.
English: The proposed dosage and application time for each of the above procedures was also endorsed and was in line with the approved wording in most of the countries.
Danish: Den foreslåede dosering og påføringstid for hver af ovennævnte procedurer blev ligeledes godkendt og var i overensstemmelse med den godkendte ordlyd i størstedelen af landene.
English: 1.5-2 g/10 cm2 for 2-5 hours” was previously approved and is in line with the CSP agreed in 2012.
Danish: 1,5-2 g/10 cm2 i 2-5 timer” var tidligere godkendt og er i overensstemmelse med de centrale sikkerhedsoplysninger, der blev godkendt i 2012.
English: The CHMP requested the inclusion of a warning for the paediatric population as regards the maximum number of doses in 24 hours.
Danish: CHMP anmodede om, at der blev indsat en advarsel for den pædiatriske population vedrørende det maksimale antal doser i løbet af 24 timer.
English: In view of this, Germany (BfArM) notified the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised Products Information (PIs) and thus to harmonise its divergent PIs across the EU.
Danish: På denne baggrund foretog Tyskland (BfArM) officielt en indbringelse til CHMP/EMA's sekretariat i medfør af artikel 30 i direktiv 2001/83/EF for at ophæve afvigelserne mellem de nationalt godkendte produktinformationer og dermed harmonisere de divergerende produktinformationer i EU.
English: In addition it was recommended that this section should include a list of the most commonly concomitantly used medicines relevant to the population in which they are prescribed making also clear that this list is not exhaustive.
Danish: Desuden anbefaledes det, at dette punkt indeholder en liste over de hyppigste samtidigt anvendte lægemidler, der er relevante for den population, de ordineres til, idet det nævnes, at listen ikke er udtømmende.
English: Section 4.6 - Fertility, pregnancy and lactation
Danish: Punkt 4.6 - Fertilitet, graviditet og amning
English: In general, the CHMP was in agreement with the proposed wording with some minor amendments.
Danish: Overordnet var CHMP enig i den foreslåede ordlyd med visse mindre ændringer.
English: In addition, since no adequate data are available on the use of EMLA in pregnant women, a more careful wording is suggested and animal data - although not relating to dermal application- should nevertheless be cited.
Danish: Da der ikke foreligger tilstrækkelige data om anvendelse af EMLA hos gravide kvinder, foreslås der desuden en mere forsigtig ordlyd, og at dyreundersøgelser omtales, selv om de ikke vedrører dermal påføring.
English: Grounds for the variation to the terms of the marketing authorisation(s) Whereas
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelsen (-tilladelserne) Eftersom
English: This text was endorsed by the CHMP with the addition of the below paragraph.
Danish: Denne tekst blev godkendt af CHMP med tilføjelse af nedenstående afsnit.
English: Data on vascular response and ease of venepuncture including skin thickness was included in this section mainly to address frequent questions on the effect of EMLA on the technical performance of vascular punctures.
Danish: Data om vaskulær respons og lethed af venepunktur, herunder hudtykkelse, indgik hovedsagelig i dette punkt for at svare på ofte stillede spørgsmål om virkningen af EMLA på den tekniske udførelse af karpunktur.
English: As a result the CHMP endorsed the MAH's proposal for this indication with the addition of the related population (i.e. adults only).
Danish: CHMP godtog derfor markedsføringstilladelsesindehaverens forslag til denne indikation med tilføjelse af den pågældende population (dvs. kun voksne).
English: However, there were some divergences in the national SmPCs with regard to the youngest age group, and the presence of a minimum recommended dose-interval.
Danish: Der var dog visse afvigelser mellem de nationale produktresuméer hvad angår den yngste aldersgruppe og angivelse af et mindste anbefalet dosisinterval.
English: If the recommended dose is exceeded the patient should be monitored for system adverse reactions secondary to methaemoglobinaemia (see sections 4.2, 4.8 and 4.9).”
Danish: Hvis den anbefalede dosis overskrides, bør patienterne overvåges for systemiske bivirkninger sekundære til methæmoglobinæmi (se punkt 4.2, 4.8 og 4.9).”
English: Section 4.9 - Overdose
Danish: Punkt 4.9 - Overdosering
English: The proposed dose and application time were previously approved and well-established.
Danish: Den foreslåede dosering og påføringstid er tidligere godkendt og veldokumenteret.
English: For female genital skin a footnote was added stating that EMLA alone applied for 60 or 90 min does not provide sufficient anaesthesia for thermocautery or diathermy of genital warts.
Danish: For hud på kvindelige kønsorganer blev der tilføjet en fodnote om, at påføring af EMLA alene i 60 eller 90 minutter ikke giver tilstrækkelig anæstesi til termokauterisation eller diatermi af genitale vorter.
English: The proposed text for fertility and breast-feeding was endorsed by the CHMP.
Danish: Den foreslåede tekst vedrørende fertilitet og amning blev godkendt af CHMP.
English: The MAH agreed that “anaphylactic reaction” should not be used for allergic reactions; however as there is no Preferred Term (PT) for “allergic reactions” in the current MedDRA coding (version 17) the PT term “hypersensitivity” will be used instead.
Danish: Indehaveren af markedsføringstilladelsen vedgik, at “anafylaktisk reaktion” ikke burde anvendes i stedet for allergiske reaktioner; da der imidlertid ikke er nogen foretrukken term (PT) for “allergiske reaktioner” i det gældende MedDRA-kodesystem (version 17), vil PT-termen “hypersensitivitet” blive anvendt i stedet.
English: The agreed dosage and application time was “2g (approx. half a 5g tube) or approx. 1.5g/10 cm2 for 1 to 5 hours”.
Danish: Den godkendte dosering og påføringstid var “2 g (ca. halvdelen en 5 g tube) eller ca. 1,5 g/10 cm2 i 1-5 timer”.
English: “Consideration should be given to the fact that pulse oximeter values may overestimate the actual oxygen saturation in case of increased methaemoglobin fraction; therefore, in cases of suspected methaemoglobinaemia, it may be more helpful to monitor oxygen saturation by co-oximetry”.
Danish: “Der gøres opmærksom på, at pulsoxymetri kan overvurdere den faktiske iltmætning ved øget andel af methæmoglobin; ved mistanke om methæmoglobinæmi kan co-oxymetri derfor være mere velegnet til overvågning af iltmætningen”.
English: • The committee reviewed the data submitted by the MAH on clinical studies, post-marketing data and published literature justifying the proposed harmonisation of the product information
Danish: • udvalget gennemgik de data, der er forelagt af indehaverne af markedsføringstilladelsen om kliniske undersøgelser, data efter markedsføring og den publicerede litteratur som begrundelse for den foreslåede harmonisering af produktinformationen,
English: A reference for section 4.4 was also added in section 4.9 as follows: “Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylene blue (see also section 4.4)”.
Danish: I punkt 4.9 blev der desuden indsat følgende henvisning til punkt 4.4: “Klinisk betydningsfuld methæmoglobinæmi bør behandles med langsom intravenøs injektion af methylenblåt (se også pkt.
English: However, the Committee flagged that as per the SmPC Guideline, this section should be presented in the simplest possible way to highlight the interactions resulting in a practical recommendation regarding the use of the medicinal product.
Danish: Udvalget påpegede dog, at dette punkt i henhold til vejledningen om produktresuméer burde fremlægges på en så enkelt måde som muligt, så at det fremhæver interaktionerne og munder ud i en praktisk anbefaling om lægemidlets anvendelse.
English: For the paediatric population the CHMP agreed to the inclusion of the paragraph describing the interaction of EMLA with vaccines.
Danish: For den pædiatriske population vedtog CHMP at indsætte et afsnit om interaktionen mellem EMLA og vacciner.
English: The active substances are both local anaesthetics of the amide type with long-standing clinical experience.
Danish: Begge aktive indholdsstoffer er lokalanæstetika af amidtypen, som længe har været anvendt i klinikken.
English: • The committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet proposed by the marketing authorisation holder the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for EMLA and associated names (see Annex I).
Danish: • udvalget godtog den harmonisering af produktresuméet, etiketteringen og indlægssedlen, der er foreslået af indehaveren af markedsføringstilladelse, anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for EMLA og relaterede navne (se bilag I).
English: The CHMP did not fully support the proposal for the paragraph on pregnancy as it was not aligned with the wording given in the SmPC guideline.
Danish: CHMP støttede ikke fuldstændigt forslaget til afsnittet om graviditet, da det ikke var i overensstemmelse med ordlyden i vejledningen om produktresuméer.
English: The labelling and the package leaflet were revised and brought in line with the adopted harmonised SmPC as discussed above and reflected in Annex III.
Danish: Etiketteringen og indlægssedlen blev revideret og bragt i overensstemmelse med det vedtagne harmoniserede produktresumé som er omhandlet ovenfor og fremgår af bilag III.
English: The MAH provided an updated text for pregnancy taking into consideration the comments of CHMP and the new wording was endorsed by the Committee.
Danish: Indehaveren af markedsføringstilladelsen forelagde en ajourført tekst vedrørende graviditet under hensyntagen til kommentarerne fra CHMP, og den nye ordlyd blev godkendt af udvalget.
English: Finally, the age ranges were amended in line with the Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population - CPMP/ICH/2711/99 and also to reflect the degree of maturity of NADH reductase in paediatric patients.
Danish: Endelig blev aldersgrupperne rettet i overensstemmelse med vejledningen om klinisk undersøgelse af lægemidler hos den pædiatriske population (CPMP/ICH/2711/99) og for at afspejle graden af modenhed af NADH-reduktase hos pædiatriske patienter.
English: Lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby producing local anaesthesia.
Danish: Lidocain og prilocain stabiliserer neuronernes membraner ved at hæmme den ionfluks, der er nødvendig til initiering og ledning af impulser, og bevirker derved lokalanæstesi.
English: The proposed wording for use on newly shaven skin on large body areas as well as the proposed dosage are previously approved and are in line with the CSP agreed in 2012.
Danish: Den foreslåede ordlyd vedrørende anvendelse på nybarberet hud på store kropsoverflader og den foreslåede dosering er tidligere godkendt og er i overensstemmelse med de centrale sikkerhedsoplysninger (CSP), der er godkendt i 2012.
English: The agreed wording was: “Safety and efficacy for the use of EMLA on genital skin and genital mucosa have not been established in children younger than 12 years.
Danish: Den vedtagne ordlyd var: “Sikkerheden og virkningen af EMLA på genital hud og genital slimhinde er ikke godtgjort hos børn under 12 år.
English: The MAH's proposal included results of a single study for the paediatric population but the CHMP stated that the information for the paediatric population should not consist of a single study data.
Danish: Forslaget fra indehaveren af markedsføringstilladelsen indeholdt resultater af en enkelt undersøgelse hos den pædiatriske population, men CHMP anførte, at oplysninger vedrørende den pædiatriske population ikke kun burde bestå i data fra en enkelt undersøgelse.
English: • Dermal procedures on newly shaven skin of large body areas, e.g. laser hair removal (selfapplication by patient)
Danish: • Dermale indgreb på nybarberet hud på store kropsoverflader (f.eks. fjernelse af hår med laser (påføres af patienten selv)
English: For children aged 3 months and above, a maximum of 2 doses, separated by at least 12 hours can be given within any 24 hour period, see sections 4.4 and 4.8.”
Danish: Til børn over 3 måneder kan der gives højst 2 doser med mindst 12 timers mellemrum i løbet af en 24-timers periode, se punkt 4.4 og
English: The CHMP agreed to display the note on “heel lancing” in section 4.4 according to the agreed CSP from 24 September 2012.
Danish: CHMP vedtog at medtage bemærkningen om “hælblodprøve” i punkt 4.4 i overensstemmelse med de vedtagne centrale sikkerhedsoplysninger af 24. september 2012.
English: As a result, the final agreed wording was: “In term newborn infants and infants below 3 months, only one single dose should be applied in any 24 hour period.
Danish: Den vedtagne endelige ordlyd var således: “Hos fuldbårne nyfødte og spædbørn under 3 måneder må kun påføres en enkelt dosis i løbet af en 24-timers periode.
English: The CHMP also recommended shortening the detailed study descriptions for the paediatric population to provide a more comprehensive overview about the relevant paediatric study program and the relevant paediatric features.
Danish: CHMP anbefalede desuden at afkorte de detaljerede beskrivelser af de kliniske undersøgelser hos den pædiatriske population for at give et mere dækkende overblik over det kliniske pædiatriske undersøgelsesprogram og de relevante egenskaber ved pædiatrisk anvendelse.
English: Following the paediatric work sharing procedure SE/W/008/pdWS/001, the use of EMLA in “topical anaesthesia of the skin” in paediatric patients has been implemented nationally in the vast majority of the member states.
Danish: Efter den pædiatriske arbejdsdelingsprocedure SE/W/008/pdWS/001 er anvendelsen af EMLA til “overfladeanalgesi af hud” hos pædiatriske patienter indført nationalt i langt størstedelen af medlemsstaterne.
English: As a result of the implementation of the outcome of the paediatric work sharing procedure SE/W/008/pdWS/001 (Article 45 of Regulation (EC) No1901/2006) several divergences between the summaries of product characteristics (SmPCs) of this product, namely in sections 4.1 and 4.2 and respective sections of the package leaflet (PL) have been identified.
Danish: Som resultat af gennemførelsen af udfaldet af den pædiatriske arbejdsdelingsprocedure SE/W/008/pdWS/001 (artikel 45 i forordning (EF) nr. 1901/2006) er der fundet afvigelser mellem produktresuméerne for dette produkt i punkt 4.1 og 4.2 samt de tilsvarende afsnit i indlægssedlen.
English: • The committee considered the identified divergences for EMLA and associated names regarding the therapeutic indications, posology and method of administration, as well as in the remaining sections of the SmPCs
Danish: • udvalget behandlede de konstaterede divergenser for EMLA og relaterede navne vedrørende terapeutiske indikationer, dosering, administrationsvej og de øvrige afsnit af produktresuméerne,
English: The wording “mechanical cleansing/debridement” is consistent with one approved in the majority of the countries.
Danish: Ordlyden “mekanisk rensning/debridering” svarer til ordlyden i størstedelen af landene.
English: The CMHP agreed with the 15 minute application time for male genital organs as the thin male genital skin enables faster absorption than other skin.
Danish: CHMP tilsluttede sig en påføringstid på 15 minutter for de mandlige kønsorganer, da den tynde hud på de mandlige kønsorganer giver hurtigere absorption end anden hud.
English: EMLA is a fixed combination product consisting of an oil/water emulsion and eutectic mixture of lidocaine and prilocaine in equal quantities (by weight) with 2.5% of each active substance included.
Danish: EMLA er et fast kombinationsprodukt bestående af en olie i vand-emulsion og eutektisk blanding af lige dele (efter vægt) lidocain og prilocain, hvert af dem i en koncentration på 2,5 %.
English: Available paediatric data do not demonstrate adequate efficacy for circumcision.”
Danish: De foreliggende pædiatriske data viser ikke tilfredsstillende virkning ved omskæring.”
English: The following text was agreed: “In studies of split-skin grafting in adults application for up to 7 hours 40 minutes to the thigh or upper arm to an area of up to 1,500 cm2 resulted in maximum plasma concentrations not exceeding 1.1 µg/mL lidocaine and 0.2 µg/mL prilocaine.”
Danish: Der blev vedtaget følgende ordlyd: “I undersøgelser ved delhudtransplantationer hos voksne medførte påføring i op til 7 timer og 40 minutter på låret eller overarmen på et areal på op til 1 500 cm2 spidsplasmakoncentrationer på ikke over 1,1 µg/ml lidocain og 0,2 µg/ml prilocain.”
English: Finally, the CHMP was of the view that the non-recommendation for the use of EMLA on genital skin for children should be introduced in section 4.4 as well in accordance with the wording in 4.2.
Danish: Endelig fandt CHMP, at det i punkt 4.4 ligeledes burde frarådes at anvende EMLA på genital hud hos børn i overensstemmelse med ordlyden i punkt 4.2.
English: Section 4.1 - Therapeutic indications
Danish: Afsnit 4.1 - Terapeutiske indikationer
English: The CHMP agreed with the wording proposed by the MAH, as follows: “EMLA has no or negligible influence on the ability to drive and use machines when used at the recommended doses”.
Danish: CHMP godkendte følgende ordlyd, som blev foreslået af markedsføringstilladelsesindehaveren: “EMLA påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner, når det anvendes i de anbefalede doser”.
English: The final wording is “Studies have been unable to demonstrate the efficacy of EMLA for heel lancing in newborn infants”.
Danish: Den endelige ordlyd er “De foretagne undersøgelser har ikke kunnet godtgøre virkningen af EMLA ved hælblodprøvetagning hos nyfødte”.
English: There are some linguistic differences on the national texts but the CHMP considered “topical anaesthesia of the genital mucosa” to be the optimal description.
Danish: Der er visse sproglige forskelle mellem de nationale tekster, men CHMP fandt, at “overfladeanalgesi af den genitale slimhinde” var den optimale beskrivelse.
English: Thus, the agreed wording was “topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement in adults only.”
Danish: Den vedtagne ordlyd var således “overfladeanalgesi af bensår for at lette mekanisk rensning/debridering kun hos voksne.”
English: Section 4.3 - Contraindications
Danish: Afsnit 4.3 - Kontraindikationer
English: Regarding adolescents ≥12 years, no wording has been previously implemented in the SmPCs with the exception of two countries.
Danish: Unge ≥ 12 år har ikke tidligere været omfattet af produktresuméerne bortset fra to lande.
English: The harmonised paediatric wording has been taken from the UK SmPC.
Danish: Den harmoniserede pædiatriske ordlyd er uddraget af produktresuméet for Det Forenede Kongerige
English: In addition, no safety concerns could be identified in the population younger than 12 years using EMLA on genital mucosa provided appropriate dosage was applied.
Danish: Der blev i øvrigt ikke fundet sikkerhedsmæssige problemer hos populationen under 12 år ved anvendelse af EMLA på den genitale slimhinde, forudsat at der blev anvendt den korrekte dosis.
English: The efficacy of EMLA for mechanical (sharp) debridement of leg ulcers has been demonstrated in a number of clinical studies.
Danish: Virkningen af EMLA ved mekanisk (skarp) debridering af bensår er dokumenteret i en række kliniske undersøgelser.
English: There is a clinical need for the use of EMLA as a topical anaesthetic of the genital mucosa in this population.
Danish: Der er klinisk behov for anvendelse af EMLA til overfladeanalgesi af den genitale slimhinde hos denne population.
English: There were some divergences in the wording used in some countries (e.g. injuries or lesions and superficial surgical procedures, minor abnormalities) but the CHMP agreed on the above wording as it was consistent with the one approved in the majority of the countries.
Danish: Der var visse afvigelser mellem ordlyden i nogle lande (f.eks. traumer eller læsioner og superficielle kirurgiske indgreb, mindre abnormiteter), men CHMP vedtog ovenstående ordlyd, der nøje svarer til, hvad der er godkendt i størstedelen af landene.
English: The posology used for minor procedures like needle insertion and surgical treatment of localised lesions in the paediatric population has previously been harmonised in most countries.
Danish: Den anvendte dosering til mindre indgreb såsom indføring af kanyler og kirurgisk behandling af lokale læsioner hos den pædiatriske population er tidligere harmoniseret i de fleste lande.
English: • Minor procedures, e.g. needle insertion and surgical treatment of localised lesions
Danish: • Mindre indgreb, f.eks. indføring af kanyle og kirurgisk behandling af lokale læsioner
English: The following wording was agreed: “In newborn infants/infants younger than 3 months a transient, clinically insignificant increase in methaemoglobin levels is commonly observed up to 12 hours after an application of EMLA within the recommended dosing.
Danish: Der blev vedtaget følgende ordlyd: “Hos nyfødte/småbørn under 3 måneder ses ofte forbigående, klinisk ubetydelig stigning i methæmoglobin i op til 12 timer efter påføring af EMLA i den anbefalede dosering.
English: There are some linguistic differences between the countries, such as “local anaesthesia”, “topical analgesia” and “topical anaesthesia”.
Danish: Der er visse sproglige afvigelser mellem landene såsom “lokalanæstesi”, “overfladeanalgesi” og “topikal anæstesi”.