FrancophonIA/ELRC3.0 huggingface dataset:
English: HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/08/WC500170559.pdf" http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/08/WC500170559.pdf]
Danish: [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/08/WC500170559.pdf]
English: <Vaccinated {species} may excrete the vaccine strain up to {x <days> <weeks>} following vaccination.
Danish: <Vaccinerede{arter} kan udskille vaccinestammen i op til {x <dage> <uger>} efter vaccination.
English: <Shelf life of the veterinary medicinal product as packaged for sale: >
Danish: <Opbevaringstid for veterinærlægemidlet i salgspakning:>
English: Name and address of the manufacturer
 responsible for batch release
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig for batchfrigivelse
English: <Pregnancy:> <and lactation:>
Danish: <Drægtighed:> <og laktation:>
English: <Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.>
Danish: <Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinier>
English: <Store and transport frozen.>**
Danish: <Opbevares og transporteres nedfrosset.>**
English: <For use by veterinary surgeons only.>
Danish: <Må kun anvendes af dyrlæger.>
English: <Veterinary medicinal product not subject to prescription.>
Danish: <Lægemidlet er ikke veterinærreceptpligtigt.>
English: <Environmental properties>
Danish: <Miljøoplysninger>
English: <Shelf life after <dilution><reconstitution> according to directions: >
Danish: <Opbevaringstid <efter fortynding><rekonstituering> ifølge anvisning:>
English: PARTICULARS TO APPEAR ON <THE OUTER PACKAGE> <AND> <THE IMMEDIATE PACKAGE>
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE><OG>
English: <Lactation:>
Danish: < Laktation:>
English: <Store and transport frozen {temperature range}.>**
Danish: <Opbevares og transporteres nedfrosset {temperaturinterval}.>**
English: <Safety> <and> <efficacy> data are available which demonstrate that this <vaccine><immunological veterinary medicinal product> can be administered at least {X} <days><weeks> <before><after> the administration of {description of tested product(s).
Danish: immunologiske veterinærelægemiddel> kan gives mindst{X antal}<dage><uger><før><efter> administration af {beskrivelse af det /de testede produkt(er).
English: {(Invented) name of veterinary medicinal product <strength> pharmaceutical form}
Danish: {Lægemidlets (sær)navn, styrke, <lægemiddelform>, <dyrearter, som lægemidlet er beregnet til>}
English: <The use is not recommended during <pregnancy><lactation>.>
Danish: <Anvendelse frarådes (under <drægtighed> > laktation diegivning>.>
English: During this time, the contact of immunosuppressed and unvaccinated {species} with vaccinated {species} should be avoided.>
Danish: I denne periode bør kontakt undgås mellem vaccinerede {arter}, og {arter}som har nedsat immunforsvar, eller som ikke er vaccinerede .>
English: <{adresas}
Danish: Adresse}
English: <The vaccine strain can spread to {species}.Special precautions should be taken to avoid spreading of the vaccine strain to {species}.>
Danish: Der bør træffes særlige sikkerhedsforanstaltninger for at undgå spredning af vaccinestammen til {arter}.>
English: <Adjuvant
:>
Danish: <Adjuvans (Adjuvanser):>
English: <{Adresse/Adres/Anschrift }
Danish: {Navn og adresse}
English: <The excipients (including adjuvants) listed in section 6.1 of the SPC are <either> <allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required> <or> <considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product>.>
Danish: <Hjælpestofferne (inklusive adjuvanter) som er anført i punkt 6.1 af SPC'et er <enten> <tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRL-værdier ikke er påkrævet> <eller> <som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: <The excipients listed in section 6.1 of the SPC are <either> <allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required> <or> <considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product>.>
Danish: <Hjælpestofferne anført under punkt 6.1 i SPC'et er <enten> <tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet> <eller> <som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel >.>
English: <Shelf life after <dilution><reconstitution> according to directions: ….>
Danish: <Opbevaringstid efter fortynding eller rekonstituering ifølge anvisning:…..>
English: <Store and transport refrigerated.>*
Danish: <Opbevares og transporteres nedkølet.>*
English: <(Aadress)
Danish: Adresse
English: <{Osoite/Adress}
Danish: {Navn og adresse}>
English: <Store in a freezer.>
Danish: <Opbevares i dybfryser.>
English: <{Tel.}>
Danish: <{Tlf.}>
English: SE-000 00 {Stad}>
Danish: <{måneder/år}>
English: <{MM/YYYY}>
Danish: <{Tlf..}>
English: <Dispose of waste material in accordance with local requirements.>
Danish: <Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Österreich
Danish: INDIKATIONER
English: {Oraş} {Cod poştal} - RO>
Danish: <Batch>, >Lot>, {nummer}
English: <{E-mail}>France
Danish: <{E-mail}>
English: These effects may be life threatening.
Danish: Disse virkninger kan være livstruende.
English: In that case the doctor will monitor your heart function.
Danish: I dette tilfælde vil din læge følge din hjertefunktion nøje.
English: 4) Application for > 1hour has not been documented.
Danish: 4) Applikationtid > 1 time er ikke dokumenteret.
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Østrig
English: Specific interaction studies in children have not been performed.
Danish: Der er ikke udført specifikke interaktionsstudier hos børn.
English: Interactions are likely to be similar to the adult population.
Danish: Interaktionerne er sandsynligvis de samme som for voksne.
English: Do not rub the cream in. 3.
Danish: Gnid ikke cremen ind. 3.
English: This is more likely when certain medicines have been taken at the same time.
Danish: Der er større sandsynlighed for, at dette opstår, hvis der samtidig er brugt visse andre lægemidler.
English: EMLA Cream is indicated for:
Danish: EMLA creme er indiceret til:
English: However, the amount is so small that there is generally no risk to the child.
Danish: Det er dog i så små mængder, at det generelt ikke udgør nogen risiko for barnet.
English: Plasma concentration [ng/ml]
Danish: Plasmakoncentration [ng/ml]
English: The maximum dose is 60 g.
Danish: Den maksimale dosis er 60 g.
English: Lidocaine Prilocaine
Danish: Lidocain Prilocain
English: Ringing in the ears.
Danish: - Ringen for ørerne.
English: If this happens, the skin becomes bluish-grey due to a lack of oxygen.
Danish: Hvis det sker, bliver huden blå-grå på grund af iltmangel.
English: Table 1 Adults and adolescents 12 years of age and above Indication/Procedure
Danish: Tabel 1 Voksne og unge på 12 år og derover Indikation/procedure
English: This is the same concentration of local anaesthetics and a similar formulation as for EMLA.
Danish: Dette er den samme koncentration af lokalanæstesimidlerne og en tilsvarende formulering som EMLA.
English: An application time of 60 minutes may improve the anaesthesia further.
Danish: En applikationstid på 60 minutter kan eventuelt forbedre anæstesien yderligere.
English: Application time: 30 minutes
Danish: Applikationstid: 30 minutter
English: (especially after longer application times in children with atopic dermatitis or mollusca contagiosa)
Danish: (særligt efter længere applikationstider hos børn med atopisk dermatit eller mollusca contagiosa)
English: The medical procedure should then start straight away.
Danish: Det medicinske indgreb skal starte umiddelbart herefter.
English: Pharmacotherapeutic group: anesthetics, local; amides; ATC code: N01B B20
Danish: Farmakoterapeutisk klassifikation: Lokalanæstetika, amider, ATC-kode: N01B B20
English: This is because EMLA can affect the way some medicines work and some medicines can have an effect on EMLA.
Danish: Det skyldes, at EMLA kan påvirke virkningen af visse andre lægemidler, og at visse lægemidler kan påvirke virkningen af EMLA.
English: A shorter application time, 15-30 minutes, may be sufficient (see section 5.1).
Danish: En kortere applikationstid på 15-30 minutter kan være tilstrækkelig (se pkt.
English: Remove the cream with cotton gauze and start cleansing without delay.
Danish: Fjern cremen med bomuldsgaze og begynd straks rensningen.
English: The maximum concentration does not depend on the patient´s age but is significantly (p<0.01) related to the size of the ulcer area.
Danish: Den maksimale koncentration afhænger ikke af patientens alder, men er i signifikant grad (p<0,01) relateret til sårarealet.
English: These symptoms are unlikely to happen if EMLA is used as recommended.
Danish: Det er usandsynligt, at disse symptomer opstår, hvis EMLA anvendes som anbefalet.
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Danish: Dette produktresumé, denne etikettering og indlægsseddel er resultatet af den referral-procedure, som denne afgørelse fra Kommissionen vedrører.
English: EMLA reduces the postoperative pain for up to 4 hours after debridement.
Danish: EMLA reducerer postoperative smerter i op til 4 timer efter debridering.
English: For further guidance on the appropriate use of the product in such procedures, please refer to Method of administration.
Danish: For yderligere information om den korrekte anvendelse af lægemidlet ved sådanne procedurer, se under Administration.
English: Tingling of the skin around the mouth and numbness of the tongue.
Danish: - Snurren i huden omkring munden og følelsesløshed i tungen.
English: When you apply the cream, it is very important to exactly follow the instructions below:
Danish: Når du påfører cremen, er det meget vigtigt, at du følger nedenstående vejledning nøje:
English: However, animal studies do not indicate any direct or indirect negative effects on pregnancy, embryo-foetal development, parturition or postnatal development.
Danish: Dyrestudier viser imidlertid ingen direkte eller indirekte negative virkninger på graviditet, embryo/føtal udvikling, fødsel eller postnatal udvikling.
English: • Topical anaesthesia of the skin in connection with:
Danish: • Overfladeanæstesi af huden i forbindelse med:
English: Avoid getting EMLA in the eyes, as it may cause irritation.
Danish: Undgå at EMLA kommer i kontakt med øjnene, da det kan medføre irritation.
English: Table 2 Paediatric patients 0-11 years of age
Danish: Tabel 2 Pædiatriske patienter 0-11 år
English: Purpura1, Petechiae1
Danish: Purpura1, Petekkier1
English: Also the loss of protective reflexes may allow corneal irritation and potential abrasion.
Danish: Desuden kan tab af beskyttende reflekser resultere i hornhindeirritation og potentiel abrasion.
English: • Having a needle put in (for example, if you are having an injection or a blood test).
Danish: • Indstik af en kanyle (hvis du eksempelvis skal have en indsprøjtning eller have taget en blodprøve).
English: However, do not put it on more than 5 hours before.
Danish: Du må dog ikke påføre cremen mere end 5 timer før indgrebet.
English: Both active substances were shown to have a low oral acute toxicity, providing a good safety margin in the event that EMLA is inadvertently swallowed.
Danish: Begge aktive stoffer blev påvist at have lav oral akut toksicitet, hvilket giver en god sikkerhedsmargen i tilfælde af, at EMLA uforsætligt bliver indtaget gennem munden.
English: • Minor skin operations.
Danish: • Mindre hudoperationer.
English: Mechanical cleansing/debridement
Danish: Mekanisk rensning/debridering
English: This ocular reaction may have been influenced by the high pH of the formulation of the emulsion (approximately 9), but is probably also partly a result of the irritative potential of the local anaesthetics themselves.
Danish: Den okulære reaktion kan have været påvirket af den høje pH i emulsionsformuleringen (cirka 9), men skyldes formodentligt også delvist det irritative potentiale ved lokalanæstetika i sig selv.
English: Since the rate of absorption from intact skin is slow, a patient showing signs of toxicity should be kept under observation for several hours following emergency treatment.
Danish: Da absorptionshastigheden fra intakt hud er langsom, skal patienter, der udviser tegn på toksicitet, holdes under observation i adskillige timer efter førstehjælpsbehandling.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Avoid contact with eyes.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Undgå kontakt med øjnene.
English: Absorption, distribution, biotransformation and elimination The systemic absorption of lidocaine and prilocaine from EMLA is dependent upon the dose, area of application and application time.
Danish: Absorption, fordeling, biotransformation og elimination Den systemiske absorption af lidocain og prilocain fra EMLA afhænger af dosis, applikationsområde og applikationstid.
English: Additional factors include thickness of the skin (which varies in different areas of the body), other conditions such as skin diseases, and shaving.
Danish: Yderligere faktorer omfatter hudens tykkelse (der er forskellig på forskellige områder af kroppen), andre tilstande, såsom hudsygdomme, og barbering.
English: Then leave it in place for at least 60 minutes.
Danish: Lad forbindingen sidde i mindst 60 minutter.
English: Similarly, local anaesthesia of the male genitals is achieved after 15 minutes.
Danish: Tilsvarende opnås der lokalanæstesi på mandlige kønsorganer efter 15 minutter.
English: Remove the plastic backing.
Danish: Fjern plastfilmen.
English: The table is based on adverse events reported during clinical trials, and/or post-marketing use.
Danish: Tabellen er baseret på bivirkninger, der er indrapporteret under kliniske forsøg og/eller efter markedsføringen.
English: Paediatric patients with atopic dermatitis
Danish: Pædiatriske patienter med atopisk dermatit
English: Prior to cervical curettage
Danish: Inden cervikal curettage
English: The quality of anaesthesia depends upon the application time and the dose.
Danish: Anæstesikvaliteten afhænger af applikationstid og dosis.
English: Reliable anaesthesia for the cleansing of leg ulcers is achieved after an application time of 30 minutes in most patients.
Danish: Der opnås pålidelig anæstesi til rensning af bensår efter en applikationstid på 30 minutter hos de fleste patienter.
English: They both stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby producing local anaesthesia.
Danish: Begge stoffer stabiliserer neuronale membraner ved at hæmme de ionstrømme, som er nødvendige for initiering og overledning af impulser, hvorved de fremkalder lokal anæstesi.
English: • Cimetidine or beta-blockers, which may cause an increase in the blood levels of lidocaine.
Danish: • Cimetidin eller betablokkere, som kan forårsage en stigning i blodniveauet af lidocain.
English: Be careful to avoid getting anything in your eye until feeling returns.
Danish: Indtil du får følelsen tilbage, skal du passe på ikke at få noget i øjet.
English: Adults and Adolescents It can also be used:
Danish: Voksne og unge EMLA kan også anvendes:
English: With large doses of EMLA, consideration should be given to the risk of additional systemic toxicity in patients receiving other local anaesthetics or medicinal products structurally related to local anaesthetics, since the toxic effects are additive.
Danish: Ved brug af høje doser af EMLA skal der tages højde for risikoen for yderligere systemisk toksicitet hos patienter, der får andre lokalanæstetika eller lægemidler, der er strukturelt beslægtet med lokalanæstetika, idet de toksiske virkninger er additive.
English: When lidocaine and prilocaine were combined, only additive effects were seen, with no indication of synergism or unexpected toxicity.
Danish: Når lidocain og prilocain blev kombineret, blev der kun set additive virkninger, og ingen tegn på synergi eller uventet toksicitet.
English: 10 g of cream should be administered in the lateral vaginal fornices for 10 minutes.
Danish: 10 g creme administreres i laterale fornix vaginae i 10 minutter
English: There is also a risk of ‘acute methaemoglobinaemia' (a problem with blood pigment levels).
Danish: - Der er også en risiko for ”akut methæmoglobinæmi” (et problem med niveauet af blodpigment).
English: The details of the Indications or Procedures for use, with Dosage and Application Time are provided in Tables 1 and 2.
Danish: Detaljerne vedrørende dosering og applikationstid for de enkelte indikationer eller procedurer er anført i tabel 1 og 2.
English: Due to insufficient data on absorption, EMLA should not be applied to open wounds (excluding leg ulcers).
Danish: Da der er utilstrækkelige data vedrørende absorption, bør EMLA ikke appliceres på åbne sår (med undtagelse af bensår).
English: Lidocaine and, in all probability, prilocaine are excreted into breast milk, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels.
Danish: Lidocain og højst sandsynligt også prilocain udskilles i human mælk, men i så små mængder, at der generelt ikke er nogen risiko for, at barnet bliver påvirket ved terapeutiske dosisniveauer.
English: These belong to a group of medicines called local anaesthetics.
Danish: Disse stoffer tilhører en gruppe af lægemidler, der kaldes for lokalanæstetika (lokalbedøvende midler).
English: Should other symptoms of systemic toxicity occur, the signs are anticipated to be similar in nature to those following the administration of local anaesthetics by other routes of administration.
Danish: Skulle der opstå andre symptomer på systemisk toksicitet, forventes tegnene at være af samme natur som dem, der optræder efter administration af lokalanæstetika via andre administrationsveje.
English: In serious cases of overdose, symptoms may include fits, low blood pressure, slowed breathing, stopped breathing and altered heartbeat.
Danish: I tilfælde af alvorlig overdosering kan symptomerne omfatte krampeanfald, lavt blodtryk, langsommere vejrtrækning, vejrtrækningsstop og ændrede hjerteslag.
English: In clinical studies of EMLA on intact skin, no differences in safety or efficacy (including anaesthetic onset time) were observed between geriatric patients (aged 65 to 96 years) and younger patients.
Danish: I kliniske studier med EMLA på intakt hud blev der ikke set nogen forskelle i sikkerheden eller virkningen (herunder tid til indsættelse af anæstesi) hos geriatriske patienter (i alderen 65 til 96 år) og yngre patienter.
English: Medicinal products that reduce the clearance of lidocaine (e.g. cimetidine or betablockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period.
Danish: Lægemidler, der reducerer lidocain-clearance (f.eks. cimetidin eller betablokkere), kan forårsage potentielt toksiske plasmakoncentrationer, når lidocain gives i gentagne høje doser i en længere periode.
English: Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine and prilocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use.
Danish: Risikovurderinger, der sammenligner den beregnede maksimale eksponering hos mennesker ved intermitterende brug af lidocain og prilocain med de eksponeringer, der blev brugt i prækliniske studier, viser en bred sikkerhedsmargen for klinisk brug.
English: For adults and adolescents over 12 years put the cream on at least 60 minutes before the procedure (unless the cream is being used on the genitals).
Danish: - Hos voksne og unge over 12 år påføres cremen mindst 60 minutter inden indgrebet (medmindre cremen anvendes på kønsorganerne).
English: This interaction is of no clinical relevance in short-term treatment with EMLA in recommended doses.
Danish: Denne interaktion er ikke af klinisk betydning ved kortvarig behandling med EMLA i de anbefalede doser.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: These metabolites have been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure.
Danish: Disse metabolitter er påvist at have karcinogent potentiale i prækliniske toksikologistudier, der evaluerede kronisk eksponering.
English: The local anaesthetic effect improves with longer application times from 1 to 2 hours in most parts of the body, with the exception of the skin of the face and the male genitals.
Danish: Den lokalanæstetiske virkning øges med længere applikationstider fra 1 til 2 timer for de fleste kropsdele med undtagelse af huden i ansigt og på mandlige kønsorganer.
English: Although topical application is associated with only a low level of systemic absorption, the use of EMLA in pregnant women should be undertaken with care because insufficient data are available concerning the use of EMLA in pregnant women.
Danish: Selv om lokal applikation kun er forbundet med lav systemisk absorption, skal EMLA anvendes med forsigtighed hos gravide kvinder, da der ikke er tilstrækkelige data vedrørende brug af EMLA hos gravide kvinder.
English: 1 Skin
Danish: 1 Hud
English: For children the amount of EMLA used and how long depends on their age.
Danish: - Hos børn afhænger mængden af EMLA og hvor længe den er om at virke af barnets alder.
English: Dosage and Application Time
Danish: Dosering og applikationstid
English: If high levels of accuracy in dosing are required to prevent overdose (ie, at doses approaching the maximum in newborn infants or if two applications may be required in a 24 hour period), a syringe can be used where 1 mL = 1 g.
Danish: Hvis der er brug for meget nøjagtig dosering for at forebygge overdosering (dvs. ved doser, der nærmer sig den maksimale dosis hos nyfødte, eller hvis der er behov for to appliceringer over en 24timers periode), kan der anvendes en sprøjte, idet 1 ml = 1 g.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Danish: Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ} Dato for seneste fornyelse: {DD måned ÅÅÅÅ}
English: The extent of systemic absorption was approximately 10% following application to the face (10 g/100 cm2 for 2 hours).
Danish: Den systemiske absorptionsgrad var cirka 10 % efter påføring i ansigtet (10 g/100 cm2 i 2 timer).
English: Burning sensation1
Danish: Brændende fornemmelse 1
English: EMLA should not be applied to the genital mucosa (e.g. in the vagina) of children (below 12 years of age) owing to insufficient data on absorption of active substances.
Danish: EMLA må ikke anvendes på slimhinder i kønsorganerne (f.eks. i skeden) hos børn (under 12 år) på grund af utilstrækkelige data vedrørende absorption af de aktive stoffer.
English: Do not spread the cream under the dressing.
Danish: Spred ikke cremen under forbindingen.