FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric population Studies have been unable to demonstrate the efficacy of EMLA for heel lancing in newborn infants.
Slovenian: Pediatrična populacija S študijami niso uspeli dokazati učinkovitosti zdravila EMLA pri odvzemu krvi iz pete pri novorojenčkih.
English: Safety and efficacy for the use of EMLA on genital skin and genital mucosa have not been established in children younger than 12 years.
Slovenian: Varnost in učinkovitost uporabe zdravila EMLA na koži in sluznici spolovil pri otrocih, starih manj kot 12 let, nista bili dokazani.
English: EMLA contains two active substances called lidocaine and prilocaine.
Slovenian: Zdravilo EMLA vsebuje dve zdravilni učinkovini, imenovani lidokain in prilokain.
English: o superficial surgical procedures; in adults and in the paediatric population
Slovenian: pri odraslih in v pediatrični populaciji;
English: Analgesic efficacy increased from 15 to 90 minutes application on normal skin but on vascular lesions 90 minutes provided no benefit over 60 min.
Slovenian: Analgetična učinkovitost se je s podaljšanjem trajanja nanosa na normalni koži od 15 na 90 minut izboljšala, na žilnih spremembah pa 90-minuten nanos ni povzročil močnejše anestezije kot 60-minuten nanos.
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.
Slovenian: V kliničnih študijah uporabe zdravila EMLA na nepoškodovani koži niso opažali nobenih razlik v varnosti in učinkovitosti zdravila (vključno s hitrostjo nastopa anestezije) med geriatričnimi bolniki (starimi od
English: Tests on laboratory animals have shown that EMLA has an ototoxic effect when instilled into the middle ear.
Slovenian: Poskusi na laboratorijskih živalih so pokazali, da zdravilo EMLA, ki so jim ga v obliki kapljic vnesli v srednje uho, deluje ototoksično.
English: Remove the covers of the dressing.
Slovenian: Odstranite pokrivni del folije.
English: Irrespective of the vascular response, EMLA facilitates the needle procedure compared to placebo cream.
Slovenian: Ne glede na žilni odgovor zdravilo EMLA olajša zabadanje igle v kožo bolj kot placebo krema.
English: These belong to a group of medicines called local anaesthetics.
Slovenian: Obe zdravilni učinkovini sodita v skupino zdravil, ki jih imenujemo lokalni anestetiki.
English: 1) After a longer application time anaesthesia decreases.
Slovenian: 1) Po daljšem trajanju nanosa je anestetično delovanje manjše.
English: The time needed to achieve reliable anaesthesia of intact skin is 1 to 2 hours, depending on the type of procedure.
Slovenian: Na nepoškodovani koži zdravilo povzroči zadostno anestezijo v roku 1 do 2 ur, kar je odvisno od vrste posega.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema methemoglobinemija1
English: Do not use EMLA on areas with skin rash, cuts, grazes or other open wounds, with the exception of a leg ulcer.
Slovenian: zdravila EMLA ne uporabljajte na predelih kože, kjer so izpuščaj, vreznine, odrgnine ali druge odprte rane; izjema so razjede na nogah.
English: EMLA diminished the pain of both needle insertion and injection of vaccines.
Slovenian: Zdravilo EMLA je zmanjšalo bolečino zaradi vboda igle in zaradi injiciranja cepiva.
English: Cutaneous use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Slovenian: dermalna uporaba POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom!
English: For this reason, although one clinical study suggests that the immunization response, as assessed by local wheal formation, is not affected when EMLA is used prior to BCG vaccination, the results of intracutaneous injections of live vaccines should be monitored.
Slovenian: Čeprav rezultati ene klinične študije kažejo, da zdravilo EMLA, uporabljeno pred cepljenjem proti tuberkulozi, ne zmoti odziva na imunizacijo (ocenjenega z lokalnim nastankom urtike), je treba rezultate intradermalnega injiciranja živih cepiv preveriti in spremljati.
English: Lidocaine and prilocaine cross the placental barrier and may be absorbed by the foetal tissues.
Slovenian: Lidokain in prilokain prehajata preko placente in se lahko absorbirata v plodova tkiva.
English: In 90% of patients the anaesthesia is sufficient for the insertion of a biopsy punch (4 mm diameter) to a depth of 2 mm after 60 minutes and 3 mm after 120 minutes EMLA treatment.
Slovenian: Pri 90 % bolnikov 60 minut po nanosu zdravila EMLA anestezija zadošča za vbod biopsijske igle (premera 4 mm) do globine 2 mm, 120 minut po nanosu pa do globine 3 mm.
English: 2) EMLA should not be used in infants up to 12 months of age receiving treatment with methaemoglobin inducing agents, because of safety concerns, see sections 4.4 and 4.8.
Slovenian: 2) Zdravila EMLA se iz varnostnih razlogov ne sme uporabljati pri dojenčkih, ki so stari do 12 mesecev in prejemajo zdravila, ki lahko povzročajo nastajanje methemoglobina, glejte poglavji 4.4 in 4.8.
English: Prilocaine in high doses may cause an increase in methaemoglobin levels, particularly in susceptible individuals (section 4.4), with too frequent dosing in newborn infants and infants below 12 months of age (section 4.2) and in conjunction with methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofuradantin, phenytoin and phenobarbital).
Slovenian: Prilokain v velikih odmerkih lahko zviša koncentracijo methemoglobina, zlasti pri za to dovzetnih osebah (glejte poglavje 4.4), v primeru prepogoste uporabe pri novorojenčkih in dojenčkih do 12. meseca starosti (glejte poglavje 4.2) ali skupaj z zdravili, ki povzročajo nastanek methemoglobina (npr. sulfonamidi, nitrofuradantin, fenitoin in fenobarbital).
English: EMLA contains castor oil polyoxyl hydrogenated, which may cause skin reactions.
Slovenian: Zdravilo EMLA vsebuje polietoksilirano hidrogenirano ricinusovo olje, ki lahko povzroča kožne reakcije.
English: Intact skin Following application to the thigh in adults (60 g cream/400 cm2 for 3 hours), the extent of absorption was approximately 5% of lidocaine and prilocaine.
Slovenian: Po nanosu na stegno pri odraslih (60 g kreme/400 cm2 za 3 ure) je znašala absorpcija lidokaina in prilokaina približno 5 %.
English: This is done for 15 minutes on male genital skin and for 60 minutes on female genital skin.
Slovenian: Na koži moških spolovil mora krema ostati 15 minut, na koži ženskih spolovil pa 60 minut.
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.
Slovenian: Pri otrocih (mlajših od 12 let) se zdravila EMLA ne sme nanesti na sluznico spolovil (npr. v nožnico), ker pri njih ni dovolj podatkov o absorpciji zdravilne učinkovine.
English: Be careful to avoid getting anything in your eye until feeling returns.
Slovenian: Dokler se vam v očesu ne vrne občutek za dotik, bodite zelo previdni in pazite, da vam ne bi v oko zašlo še kaj drugega.
English: Use on the skin before small procedures (such as having a needle put in or minor skin operations):
Slovenian: Uporaba kreme na koži pred manjšimi posegi (pred zabadanjem igle ali pred manjšo operacijo na koži):
English: Local tolerance studies using a 1:1 (w/w) mixture of lidocaine and prilocaine as an emulsion, cream or gel indicated that these formulations are well tolerated by intact and damaged skin and mucosal membranes.
Slovenian: Rezultati študij lokalne prenosljivosti, v katerih so uporabljali mešanico lidokaina in prilokaina v razmerju 1:1 (m/m) v obliki emulzije, kreme ali gela, kažejo, da bolniki dobro prenašajo uporabo teh oblik tako na nepoškodovani koži kot na poškodovani koži in sluznicah.
English: Available paediatric data do not demonstrate adequate efficacy for circumcision.
Slovenian: Razpoložljivi podatki o uporabi pri pediatričnih bolnikih ne kažejo, da bi bilo zdravilo lahko dovolj učinkovito za izvajanje cirkumcizije.
English: Renal impairment A dose reduction is not necessary among patients with restricted renal function.
Slovenian: Pri bolnikih z zmanjšanim delovanjem ledvic zmanjševanje odmerkov ni potrebno.
English: When applied in the vicinity of the eyes, EMLA should be used with particular care since it may cause eye irritation.
Slovenian: Pri nanašanju zdravila EMLA v bližini oči je potrebna posebna previdnost, saj zdravilo lahko draži oči.
English: Because of thin facial skin and high tissue blood flow, maximal local anaesthetic effect is obtained after 30-60 minutes on the forehead and on the cheeks.
Slovenian: Ker je koža na obrazu tanka in dobro prekrvljena, pride na čelu in licih do največjega anestetičnega učinka že po 30-60 minutah.
English: • in newborn infants/infants up to 12 months of age receiving concomitant treatment with methaemoglobin-inducing agents.
Slovenian: • pri novorojenčkih/dojenčkih, ki so stari do 12 mesecev in sočasno prejemajo zdravila, ki lahko povzročajo nastajanje methemoglobina,
English: Peel the ‘centre cut-out' from the dressing.
Slovenian: Odlepite osrednji "izrezani" del s folije.
English: Dermal surgical procedures on larger areas in a hospital setting, e.g. split-skin grafting.
Slovenian: kirurški posegi na večjih predelih kože, izvedeni v bolnišnici, npr. odvzem kožnega presadka delne debeline kože (angl. split-skin grafting)
English: EMLA may cause a transient increase in skin thickness, partly caused by hydration of the skin under the occlusive dressing.
Slovenian: Zdravilo EMLA lahko povzroči prehodno zadebelitev kože, ki je deloma posledica hidracije kože pod okluzivno oblogo in se zmanjša v 15 minutah, ko je koža izpostavljena zraku.
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.
Slovenian: Zdravilo EMLA povzroča anestezijo kože s sproščanjem lidokaina in prilokaina iz kreme v pokožnično in usnjično (epidermalno in dermalno) plast kože ter v bližino bolečinskih receptorjev in živčnih končičev v koži.
English: Animal studies have shown no impairment of male or female fertility.
Slovenian: Študije na živalih ne kažejo, da bi zdravilo zmanjševalo plodnost samcev ali samic.
English: The duration of anaesthesia following the application of EMLA for 1 to 2 hours is at least 2 hours after removal of the dressing, except in the face where the duration is shorter.
Slovenian: Po 1- do 2-urnem nanosa zdravila EMLA traja anestezija najmanj 2 uri po odstranitvi pokritja, razen na obrazu, kjer traja manj časa.
English: PHARMACEUTICAL FORM Cream [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Izpolni država članica]
English: Lidocaine Prilocaine
Slovenian: lidokain/prilokain
English: The depth of cutaneous anaesthesia increases with application time.
Slovenian: Globina kožne anestezije se povečuje s trajanjem nanosa.
English: The procedure should be commenced immediately after removal of the cream.
Slovenian: Poseg je treba izvesti takoj po odstranitvi kreme.
English: In studies on reproduction toxicity, embryotoxic or fetotoxic effects of lidocaine were detected at doses of 25 mg/kg s.c. in the rabbit and for prilocaine starting at doses of 100 mg/kg i.m.
Slovenian: študijah vpliva na sposobnost razmnoževanja so embriotoksične ali fetotoksične učinke lidokaina ugotavljali pri odmerkih 25 mg/kg subkutano pri kuncih, za prilokain pa so se začeli pri odmerkih
English: The cream is then covered by a dressing [plastic wrap].
Slovenian: Kremo je nato treba pokriti z oblogo [plastično folijo].
English: Methaemoglobinaemia, a blood disorder, which is more frequently observed, often in connection with overdose in newborn infants and infants aged 0 to 12 months.
Slovenian: Methemoglobinemija, krvna motnja, ki jo pogosteje opažajo pri novorojenčkih in dojenčkih od rojstva od
English: Avoid getting EMLA in the eyes, as it may cause irritation.
Slovenian: Pazite, da zdravilo EMLA ne pride v oči, ker jih lahko draži.
English: Methaemoglobinaemia1
Slovenian: pekoč občutek1
English: This interaction is of no clinical relevance in short-term treatment with EMLA in recommended doses.
Slovenian: To medsebojno delovanje med kratkotrajno uporabo zdravila EMLA v priporočenih odmerkih ni klinično pomembno.
English: 6) After longer application time anaesthesia decreases.
Slovenian: 6) Po daljšem trajanju nanosa je anestetično delovanje manjše.
English: If eye contact occurs, the eye should immediately be rinsed with water or sodium chloride solution and protected until sensation returns.
Slovenian: Če zdravilo pride v stik z očesom, ga je treba takoj izprati z vodo ali raztopino natrijevega klorida in oko zaščititi,
English: The maximum plasma concentrations of lidocaine and prilocaine after application of EMLA in paediatric patients of different ages were also below potentially toxic levels.
Slovenian: Najvišji koncentraciji lidokaina in prilokaina v plazmi sta bili po uporabi zdravila EMLA tudi pri pediatričnih bolnikih različnih starosti precej nižji od potencialno toksičnih koncentracij.
English: A line of cream of about 3.5 cm from the 30 g tube is equal to 1 g of cream.
Slovenian: Približno 3,5 cm dolga črta kreme iz 30-gramske tube ustreza 1 gramu kreme.
English: Your doctor, nurse or pharmacist will tell you how much cream to use.
Slovenian: Zdravnik, medicinska sestra ali farmacevt vam bodo povedali, koliko kreme je treba uporabiti.
English: An impairment of the fertility of male or female rats by lidocaine or prilocaine was not observed.
Slovenian: Motenj plodnosti zaradi lidokaina ali prilokaina pri podganjih samcih in samicah niso opažali.
English: This is taken off just before the procedure starts.
Slovenian: Oblogo je treba odstraniti tik pred začetkom posega.
English: 2 g (approx. half a 5 g tube) or approx. 1.5g/10 cm2 for 1 to 5 hours1).
Slovenian: 2 g (približno pol 5-gramske tube) ali približno 1,5 g/10 cm2; za 1 do 5 ur1)
English: Lidocaine and prilocaine have bacteriocidal and antiviral properties in concentrations above 0.5-2%.
Slovenian: Lidokain in prilokain v koncentracijah nad 0,5 do 2 % delujeta baktericidno in protivirusno.
English: EMLA produces a biphasic vascular response involving initial vasoconstriction followed by vasodilatation at the application site (see section 4.8).
Slovenian: Zdravilo EMLA na mestu aplikacije povzroči dvofazni žilni odgovor z začetno vazokonstrikcijo in kasnejšo vazodilatacijo (glejte poglavje 4.8).
English: Patients with defective glucose-6-phosphate dehydrogenase hereditary or idiopathic methaemoglobinaemia are more susceptible to active-substance-induced signs of methaemoglobinaemia.
Slovenian: Pri bolnikih s pomanjkanjem glukoza-6-fosfat dehidrogenaze oziroma s prirojeno ali idiopatsko methemoglobinemijo so znaki methemoglobinemije, ki jo povzročata zdravilni učinkovini, lahko bolj izraženi.
English: EMLA contains castor oil polyoxyl hydrogenated Castor oil polyoxyl hydrogenated may cause skin reactions.
Slovenian: Zdravilo EMLA vsebuje polietoksilirano hidrogenirano ricinusovo olje Polietoksilirano hidrogenirano ricinusovo olje lahko povzroči kožne reakcije.
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.
Slovenian: ampak je statistično značilno (p<0,01) povezana z velikostjo površine ulkusov.
English: Their frequency of Adverse Reactions is listed by MedDRA System Organ Class (SOC) and at the preferred term level.
Slovenian: Pogostnosti neželenih učinkov so navedene po organskih sistemih in na ravni posameznih prednostnih izrazov v okviru klasifikacije MedDRA.
English: 3) EMLA should not be used at less than 37 weeks gestational age, because of safety concerns, see section
Slovenian: Zdravila EMLA se iz varnostnih razlogov ne sme uporabljati pri nedonošenčkih gestacijske starosti manj kot 37 tednov, glejte poglavje 4.4.
English: How to use EMLA
Slovenian: Kako uporabljati zdravilo EMLA
English: Plasma concentrations of lidocaine and prilocaine in both geriatric and non-geriatric patients following application of EMLA to intact skin are very low and well below potentially toxic levels.
Slovenian: Koncentraciji lidokaina in prilokaina v plazmi sta bili po uporabi zdravila EMLA na nepoškodovani koži tako pri geriatričnih kot pri mlajših bolnikih zelo nizki in tudi precej nižji od potencialno toksičnih koncentracij.
English: Inside the nose, ear or mouth.
Slovenian: v nosu, ušesih ali ustih, v zadnjiku (anusu), na spolovilih pri otrocih.
English: Cleansing should start without delay after removal of the cream.
Slovenian: S čiščenjem je treba začeti takoj po odstranitvi kreme.
English: Increasing the ulcer area by 1 cm2 results in an increased Cmax for the sum of lidocaine and prilocaine concentrations of 7.2 ng/mL.
Slovenian: Povečanje površine ulkusov za 1 cm2 je pomenilo zvišanje najvišje koncentracije lidokaina in prilokaina v plazmi skupaj za 7,2 ng/ml.
English: EMLA reduces the postoperative pain for up to 4 hours after debridement.
Slovenian: Zdravilo EMLA zmanjšuje bolečine po odstranjevanju nekrotičnega tkiva do 4 ure po posegu.
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).
Slovenian: Po nanosu odmerka, ki presega priporočeno odmerjanje, je bolnika treba spremljati glede morebitnega pojavljanja sistemskih neželenih učinkov zaradi methemoglobinemije (glejte poglavja 4.2, 4.8 in 4.9).
English: Reliable anaesthesia for the cleansing of leg ulcers is achieved after an application time of 30 minutes in most patients.
Slovenian: Zadostna anestezija za čiščenje ulkusov na nogah pri večini bolnikov nastopi po 30-minutnem nanosu zdravila.
English: Skin of male genital organs Prior to injection of local anaesthetics
Slovenian: Uporaba na koži spolovil pred injiciranjem lokalnega anestetika
English: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo
English: Minor procedures, e.g. needle insertion and surgical treatment of localised lesions.
Slovenian: Koža manjši posegi, npr. zabadanje igle in kirurško zdravljenje lokaliziranih sprememb
English: Methaemoglobin formation is related to the cumulative amount of prilocaine percutaneously absorbed, and may therefore increase with prolonged application times of EMLA.
Slovenian: Nastajanje methemoglobina je povezano s kumulativno količino prilokaina, ki se absorbira skozi kožo, zato pri dolgotrajnem nanosu zdravila EMLA lahko nastane še več methemoglobina.
English: Due to the potentially enhanced absorption on the newly shaven skin, it is important to adhere to the recommended dosage, area and time of application (see section 4.2).
Slovenian: Na sveže obriti koži je lahko absorpcija zdravila večja, zato je pomembno upoštevati priporočila glede odmerjanja, površine kože in trajanja nanosa (glejte poglavje 4.2).
English: The use of EMLA prior to measles-mumps-rubella or intramuscular diphtheria-pertussis-tetanusinactivated poliovirus-Haemophilus influenzae b or Hepatitis B vaccines does not affect mean antibody titres, rate of seroconversion, or the proportion of patients achieving protective or positive antibody titres post immunization, as compared to placebo treated patients.
Slovenian: V primerjavi s placebom uporaba zdravila EMLA pred uporabo cepiva proti ošpicam, mumpsu in rdečkam, intramuskularnega cepiva proti davici, tetanusu in oslovskemu kašlju, inaktiviranemu poliovirusu, okužbi z bakterijo Haemophilus influenzae b ali proti hepatitisu B ne vpliva na povprečne vrednosti titrov protiteles, stopnje serokonverzije oziroma delež bolnikov, ki po cepljenju dosežejo zaščitne ali pozitivne titre protiteles.
English: Skin of female genital organs Prior to injection of local anaesthetics2)
Slovenian: na koži moških spolovil pred injiciranjem lokalnega anestetika na koži ženskih spolovil pred injiciranjem lokalnega anestetika2)
English: The major elimination pathway of lidocaine and prilocaine is via hepatic metabolism and metabolites are renally excreted.
Slovenian: Glavna pot odstranjevanja lidokaina in prilokaina je presnova v jetrih, presnovki pa se izločijo skozi ledvice.
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 cooximetry.
Slovenian: Upoštevati je treba, da lahko s pulznim oksimetrom izmerjene vrednosti nasičenosti hemoglobina s kisikom presegajo dejanske vrednosti, če je frakcija methemoglobina povečana.
English: Maximum plasma concentrations (mean 0.12 and 0.07 µg/mL) were reached approximately 2-6 hours after application.
Slovenian: Najvišjo koncentracijo v plazmi (povprečno 0,12 oziroma 0,07 µg/ml) sta zdravilni učinkovini dosegli približno 2-6 ur po nanosu.
English: Similarly, local anaesthesia of the male genitals is achieved after 15 minutes.
Slovenian: Podobno pride na moških spolovilih do največjega anestetičnega učinka po 15 minutah.
English: Hepatic impairment A reduction of a single dose is not necessary in patients with impaired hepatic function (see section 5.2).
Slovenian: Pri bolnikih z zmanjšanim delovanjem jeter ni treba zmanjšati posameznega odmerka (glejte poglavje 5.2).
English: When EMLA is used on the genitals, a doctor or nurse should supervise its use.
Slovenian: Če zdravilo EMLA uporabljate na spolovilih, mora to nadzirati zdravnik ali medicinska sestra.
English: Approx. 1.5-2 g/10 cm2 for 2 to 5 hours1).
Slovenian: približno 1,5-2 g/10 cm2 za 2 do 5 ur1)
English: EMLA should not be used
Slovenian: Zdravila EMLA se ne sme uporabljati:
English: The protective membrane of the tube is perforated by applying the cap.
Slovenian: Zaščitno folijo na tubi je treba prebosti s pokrovčkom tube.
English: PHARMACEUTICAL FORM AND CONTENTS [To be completed nationally] 30 g cream METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: 30 g krema POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: Do not rub the cream in. 3.
Slovenian: Kreme ne vtirajte v kožo.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila EMLA Vsebina pakiranja in dodatne informacije
English: In or near the eyes.
Slovenian: kjer je na koži izpuščaj ali ekcem, v očeh ali v okolici oči,
English: A marked irritative reaction was seen after single ocular administration of a 50 mg/g lidocaine + prilocaine 1:1 (w/w) emulsion, in an animal study.
Slovenian: Po enkratnem odmerjanju emulzije 50 mg/g lidokaina + prilokaina v razmerju 1:1 (m/m) v oko so v študiji na živalih zabeležili izrazito reakcijo draženja očesa.
English: Therefore, a decrease in clearance, such as in patients with severely impaired liver function, has limited effects on the systemic plasma concentrations after a single dose of EMLA, and after single doses repeated once daily short term (up to 10 days).
Slovenian: Po lokalni uporabi zdravila EMLA je hitrost presnove in izločanja lokalnega anestetika odvisna od hitrosti absorpcije, zato zmanjšano izločanje, na primer pri bolnikih s hudo okvaro jeter, le malo vpliva na sistemsko koncentracijo v plazmi po aplikaciji enkratnega odmerka zdravila EMLA oziroma po več posameznih odmerkih z odmerjanjem enkrat na dan v kratkem obdobju (do 10 dni).
English: The effectiveness of EMLA when drawing blood from the heel of newborn infants or to provide adequate analgesia for circumcision could not be confirmed in clinical studies.
Slovenian: V študijah ni bilo mogoče potrditi učinkovitosti zdravila EMLA pri odvzemu krvi iz pete pri novorojenčkih in pri zagotavljanju zadostne analgezije pri obrezovanju (cirkumciziji).