FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Ocena tveganja glede na izračunano največjo izpostavljenost pri intermitentni uporabi lidokaina in prilokaina pri človeku v primerjavi z izpostavljenostjo v predkliničnih študijah kaže na široko mejo varnosti za klinično uporabo.
English: Do not use this medicine after the expiry date which is stated on the package and tube after “EXP:”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju in na tubi poleg oznake "Uporabno do" in "EXP".
English: 5) EMLA has been used for the treatment of leg ulcers up to 15 times over a period of 1 to 2 months without loss of efficacy or increased number or severity of adverse events.
Slovenian: 5) Zdravilo EMLA so pri zdravljenju ulkusov na nogah uporabili do 15-krat v obdobju 1-2 mesecev, pri čemer ni prišlo do zmanjšanja učinkovitosti ali povečanja števila ali izraženosti neželenih dogodkov.
English: Persons frequently applying or removing cream should ensure that contact is avoided in order to prevent the development of hypersensitivity.
Slovenian: Osebe, ki pogosto nanašajo ali odstranjujejo to kremo, se morajo izogibati stiku z zdravilom, da ne bi prišlo do razvoja preobčutljivosti.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Slovenian: V okviru posameznega organskega sistema so neželeni učinki navedeni po kategorijah pogostnosti: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000).
English: The usual dose depends on the child's age and is used for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis).
Slovenian: Običajen odmerek je odvisen od otrokove starosti, krema pa mora ostati na koži 30-60 minut (30 minut, če ima bolnik atopijski dermatitis).
English: 2) On female genital skin, EMLA alone applied for 60 or 90 minutes does not provide sufficient anaesthesia for thermocautery or diathermy of genital warts.
Slovenian: 2) Na koži ženskih spolovil samo nanos zdravila EMLA za 60 oziroma 90 minut ne zagotavlja zadostne anestezije za termokavterizacijo ali diatermijo genitalnih bradavic.
English: Symptoms of using too much EMLA are listed below.
Slovenian: Simptomi, ki se lahko pojavijo, če uporabite preveč zdravila EMLA, so navedeni spodaj.
English: The cleansing procedure should start within 10 minutes of removal of the cream.
Slovenian: Postopek čiščenja ulkusa je treba začeti v 10 minutah po odstranitvi kreme.
English: Rare cases of clinically significant methaemoglobinaemia have been reported.
Slovenian: Poročali so o redkih primerih klinično pomembne methemoglobinemije.
English: 6.6 Special precautions for disposal and other handling Precautions to be taken before handling or administering the medicinal product Persons frequently applying or removing cream should ensure that contact is avoided in order to prevent the development of hypersensitivity.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Previdnostni ukrepi potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Osebe, ki pogosto nanašajo ali odstranjujejo to kremo, se morajo izogibati stiku z zdravilom, da ne bi prišlo do razvoja preobčutljivosti.
English: Neither local anaesthetic showed a genotoxic potential in either in vitro or in vivo genotoxicity tests.
Slovenian: Nobeden od obeh lokalnih anestetikov ni kazal genotoksičnega potenciala v testih genotoksičnosti in vitro oziroma in vivo.
English: There is also a risk of ‘acute methaemoglobinaemia' (a problem with blood pigment levels).
Slovenian: Obstaja tudi tveganje za "akutno methemoglobinemijo" (motnja koncentracije barvil v krvi).
English: The sum of the maximum plasma concentrations of lidocaine and prilocaine is less than one-third of those associated with toxic reactions, with no apparent accumulation over 10 days.
Slovenian: Vsota najvišjih koncentracij lidokaina in prilokaina v plazmi predstavlja manj kot eno tretjino koncentracije, ki je povezana s toksičnimi reakcijami, pri tem pa v 10 dneh ni prišlo do opaznega kopičenja.
English: Prior to removal of mollusca in children with atopic dermatitis it is recommended to apply cream for 30 minutes.
Slovenian: Pred odstranjevanjem molusk pri otrocih z atopijskim dermatitisom je priporočljivo kremo nanesti za 30 minut.
English: This is the same concentration of local anaesthetics and a similar formulation as for EMLA.
Slovenian: Koncentracija obeh lokalnih anestetikov in sama formulacija sta bili podobni kot pri zdravilu EMLA.
English: 1 Skin
Slovenian: 1 na koži
English: Your doctor or nurse will take the dressing off and remove the cream just before they do the medical procedure (for example just before the needle is put in).
Slovenian: Zdravnik ali medicinska sestra bo odstranil folijo in kremo tik pred posegom (na primer tik pred zabadanjem igle).
English: Care should be taken when applying EMLA to patients with atopic dermatitis.
Slovenian: Previdnost je potrebna v primeru uporabe zdravila EMLA pri bolnikih z atopijskim dermatitisom.
English: When lidocaine and prilocaine were combined, only additive effects were seen, with no indication of synergism or unexpected toxicity.
Slovenian: Pri uporabi lidokaina in prilokaina v kombinaciji so opažali samo aditivne učinke, ne pa znakov sinergije ali nepričakovane toksičnosti.
English: Lidocaine crosses the placental barrier by means of simple diffusion.
Slovenian: Lidokain prehaja skozi placento z enostavno difuzijo.
English: The most frequently observed adverse drug reactions (ADRs) are related to administration site conditions (transient local reactions at the application site), reported as common.
Slovenian: Neželeni učinki zdravila, ki so jih najpogosteje opažali, so bili povezani s spremembami na mestu aplikacije (prehodne lokalne reakcije na mestu aplikacije), opisali so jih kot pogoste.
English: 1) In term newborn infants and infants below 3 months, only one single dose should be applied in any 24
Slovenian: 1) Pri donošenih novorojenčkih in dojenčkih v starosti do 3 mesece se sme v obdobju 24 ur uporabiti samo en odmerek.
English: If you experience any troublesome or unusual effects while you are using EMLA, stop using it and check with your doctor or pharmacist as soon as possible.
Slovenian: Če med uporabo zdravila EMLA opazite kakšne moteče ali neobičajne učinke, prenehajte uporabljati zdravilo in se čim prej posvetujte z zdravnikom ali farmacevtom.
English: An application time of 60 minutes may improve the anaesthesia further.
Slovenian: Daljše trajanje nanosa (60 minut) lahko dodatno izboljša anestezijo.
English: No negative effects on ulcer healing or bacterial flora have been observed.
Slovenian: Negativnih učinkov na celjenje ulkusov ali bakterijsko floro niso opažali.
English: • Medicines used to treat infections, called ‘sulphonamides' and nitrofuradantin.
Slovenian: • zdravila za zdravljenje okužb, imenovana "sulfonamidi", ali nitrofuradantin,
English: It can also be used to numb the skin before:
Slovenian: Zdravilo lahko uporabljamo za omrtvičenje kože pred:
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.
Slovenian: Če je potrebno zelo natančno odmerjanje, da bi preprečili preveliko odmerjanje (kar je potrebno pri novorojenčkih pri odmerkih, ki so blizu največjim priporočenim odmerkom, ali v primeru, da je zdravilo treba uporabiti dvakrat v obdobju 24 ur), je mogoče uporabiti brizgo, pri čemer velja, da 1 ml ustreza 1 g zdravila.
English: Contact your doctor or pharmacist if any of the following side effects bother you or do not seem to go away.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, če vas kateri od naslednjih neželenih učinkov začne motiti ali če ne mine.
English: Absorption from the genital mucosa is more rapid and onset time is shorter than after application to the skin.
Slovenian: Absorpcija iz sluznice spolovil je hitrejša, čas do začetka delovanja pa krajši kot po uporabi na koži.
English: The table is based on adverse events reported during clinical trials, and/or post-marketing use.
Slovenian: Podatki v preglednici temeljijo na poročilih o neželenih dogodkih med potekom kliničnih študij in/ali v času uporabe zdravila po njegovem prihodu na trg.
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.
Slovenian: Lokalni anestetični učinek se z daljšim trajanjem nanosa v okviru 1 do 2 ur okrepi na večini delov telesa, razen na koži obraza in moških spolovil.
English: In animal studies the toxicity noted after high doses of either lidocaine or prilocaine, alone or in combination, consisted of effects on the central nervous and cardiovascular systems.
Slovenian: V študijah na živalih je toksično delovanje, ki so ga opažali pri velikih odmerkih lidokaina ali prilokaina posamezno ali v kombinaciji, obsegalo učinke na centralno živčevje in kardiovaskularni sistem.
English: • Cimetidine or beta-blockers, which may cause an increase in the blood levels of lidocaine.
Slovenian: • cimetidin ali zaviralce adrenergičnih receptorjev beta, ki lahko povzročijo zvišanje koncentracije lidokaina v krvi.
English: The EMLA tube is intended for single use when used on leg ulcers: The tube with any remaining contents should be discarded after each occasion that a patient has been treated.
Slovenian: Tuba zdravila EMLA je pri uporabi za razjede na nogah namenjena za enkratno uporabo: Tubo z morebitnim neporabljenim ostankom kreme je treba zavreči po vsaki posamezni obravnavi bolnika.
English: Lidocaine and prilocaine are amide-type local anaesthetics.
Slovenian: Lidokain in prilokain sta lokalna anestetika amidnega tipa.
English: Half a 5 g tube corresponds to about 2 g EMLA.
Slovenian: Polovica 5-gramske tube ustreza približno 2 gramoma zdravila EMLA.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi
English: The cream is put on to the skin in a thick layer.
Slovenian: Kremo je treba nanesti na kožo v debeli plasti.
English: It should be assumed that the toxicity of lidocaine and prilocaine are additive.
Slovenian: Treba je predpostaviti, da je toksično delovanje lidokaina in prilokaina aditivno.
English: Patients treated with anti-arrhythmics of class III (e.g. amiodarone) should be carefully monitored and ECG monitoring considered, as cardiac effects may be additive.
Slovenian: Bolnike, ki prejemajo antiaritmike skupine III (npr. amiodaron), je treba skrbno opazovati in pretehtati možnost snemanja EKG, saj lahko pride do aditivnega delovanja na srce.
English: Following application to leg ulcers, the characteristics of the ulcers may also affect the absorption.
Slovenian: Po nanosu na ulkuse na nogah lahko na absorpcijo vplivajo tudi lastnosti ulkusov.
English: EMLA should not be used on an area of newly shaven skin larger than 600 cm² (600 square centimetres, e.g. 30 cm by 20 cm) in size.
Slovenian: Zdravila EMLA se ne sme uporabljati na predelih sveže obrite kože, ki so večji od 600 cm2 (600 kvadratnih centimetrov, tj. 30 cm krat 20 cm).
English: • Medicines to treat an uneven heartbeat, such as amiodarone.
Slovenian: • zdravila za zdravljenje nerednega bitja srca, na primer amiodaron,
English: For application to larger areas, such as split-skin grafting, an elastic bandage should be applied on top of the occlusive dressing to give an even distribution of cream and protect the area.
Slovenian: Pri uporabi na velikih površinah, na primer pri odvzemu kožnega presadka delne debeline kože, je treba preko okluzivne obloge namestiti elastičen povoj, da se krema enakomerno porazdeli in je predel zaščiten.
English: Application time: 30-60 minutes.
Slovenian: trajanje nanosa: 30-60 minut
English: If you accidentally get EMLA in your eye, you should immediately rinse it well with lukewarm water or salt (sodium chloride) solution.
Slovenian: Če zdravilo EMLA slučajno pride v oko, morate oko nemudoma temeljito sprati z mlačno vodo ali raztopino soli (natrijevega klorida).
English: Maximum recommended dose: 60 g. Maximum recommended treated area; 600 cm2 for a minimum of 1 hour, maximum 5 hours1).
Slovenian: največji priporočeni odmerek: 60 g; največja priporočena površina predela za nanos: 600 cm2; za najmanj 1 uro in največ 5 ur1)
English: if you take particular medicines for heart rhythm disorders (class III antiarrhythmics, such as amiodarone).
Slovenian: če jemljete določena zdravila proti motnjam srčnega ritma (antiaritmična zdravila iz skupine III,
English: These metabolites have been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure.
Slovenian: Za ta dva presnovka so v predkliničnih toksikoloških študijah, v katerih so ocenjevali kronično izpostavljenost, dokazali karcinogeni potencial.
English: • Topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement in adults only
Slovenian: • lokalno anestezijo ulkusov na nogah za olajšanje mehanskega čiščenja/odstranjevanja nekrotičnega tkiva (debridement) samo pri odraslih.
English: If you use more EMLA than your doctor, pharmacist or nurse has told you to, talk to one of them straight away, even if you do not feel any symptoms.
Slovenian: Če ste uporabili večji odmerek zdravila EMLA, kot bi smeli Če ste uporabili več zdravila EMLA, kot vam je naročil zdravnik, farmacevt ali medicinska sestra, se takoj posvetujte z enim od njih, tudi če nimate nobenih simptomov.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Avoid contact with eyes.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Pazite, da zdravilo ne pride v stik z očmi.
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.
Slovenian: Lidokain, najverjetneje pa tudi prilokain, se izločata v materinem mleku, vendar v tako majhni količini, da med uporabo terapevtskih odmerkov načeloma ni tveganja za vpliv na otroka.
English: Fertility Animal studies have shown no impairment of the fertility of male or female rats (see section 5.3).
Slovenian: Študije na živalih ne kažejo na škodljiv vpliv zdravila na plodnost podganjih samcev in samic (glejte poglavje 5.3).
English: The details of the Indications or Procedures for use, with Dosage and Application Time are provided in Tables 1 and 2.
Slovenian: Podrobnejši podatki o indikacijah oziroma posegih, pri katerih je indicirana uporaba zdravila, ter o odmerjanju in trajanju nanosa so navedeni v preglednicah 1 in 2.
English: Hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of the amide type or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na lidokain in/ali prilokain, lokalne anestetike amidnega tipa ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: • Medicines used to treat epilepsy, called phenytoin and phenobarbital.
Slovenian: • zdravili, ki ju uporabljamo pri zdravljenju epilepsije in ju imenujemo fenitoin in fenobarbital,
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.
Slovenian: Če pride do drugih simptomov sistemske toksičnosti, so znaki predvidoma podobni kot pri uporabi lokalnih anestetikov z drugimi načini vnosa.
English: Application time: 30 minutes
Slovenian: trajanje nanosa: 30 minut
English: EMLA is equally effective and has the same anaesthetic onset time across the range of light to dark pigmented skin (skin types I to VI).
Slovenian: Zdravilo EMLA je enako učinkovito in povzroči anestezijo enako hitro na vseh tipih kože, od zelo svetle do temno pigmentirane kože (na kožnih tipih od I do VI).
English: At doses below the maternal toxic range in the rat, lidocaine has no effect on the postnatal development of the offspring.
Slovenian: V odmerkih, ki so bili pri podganah izpod okvirja toksičnosti za matere, lidokain ni vplival na postnatalni razvoj mladičev.
English: The quality of anaesthesia depends upon the application time and the dose.
Slovenian: Jakost anestezije je odvisna od trajanja nanosa in višine odmerka.
English: Plasma concentrations after treatment with EMLA are 20-60% lower for prilocaine than for lidocaine, because of a larger volume of distribution and more rapid clearance.
Slovenian: Po uporabi zdravila EMLA je koncentracija prilokaina v plazmi od 20 do 60 % nižja od koncentracije lidokaina, in sicer zaradi večjega volumna porazdelitve in hitrejšega izločanja.
English: Then leave it in place for at least 60 minutes.
Slovenian: Potem pustite nanos z oblogo na mestu najmanj 60 minut.
English: Additional factors include thickness of the skin (which varies in different areas of the body), other conditions such as skin diseases, and shaving.
Slovenian: Poleg tega na absorpcijo lahko med drugim vplivajo še debelina kože (ki se na različnih delih telesa razlikuje) in druge spremembe na koži, kot so kožne bolezni ali stanje po britju.
English: Also the loss of protective reflexes may allow corneal irritation and potential abrasion.
Slovenian: Zaradi odsotnosti zaščitnih refleksov lahko pride do draženja roženice in možnosti abrazije.
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).
Slovenian: Pri odraslih in mladostnikih, starejših od 12 let, je treba kremo nanesti najmanj 60 minut pred posegom (razen v primeru, da kremo uporabljate na spolovilih), vendar kreme ne nanašajte več kot 5 ur pred posegom.
English: 2 - 3 years
Slovenian: 2 - 3 leta
English: For children the amount of EMLA used and how long depends on their age.
Slovenian: Pri otrocih sta količina zdravila EMLA in čas nanosa odvisna od njihove starosti.
English: In serious cases of overdose, symptoms may include fits, low blood pressure, slowed breathing, stopped breathing and altered heartbeat.
Slovenian: V resnih primerih prevelikega odmerjanja lahko simptomi vključujejo napad krčev, nizek krvni tlak,
English: The usual dose is 5 g to 10 g of cream for 10 minutes.
Slovenian: Običajen odmerek je od 5 do 10 g kreme za 10 minut.
English: Your doctor, pharmacist or nurse will put the cream on or show you how to do it yourself.
Slovenian: Zdravnik, farmacevt ali medicinska sestra vam bo nanesel kremo ali vam bo pokazal, kako to naredite sami.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING UNITS Aluminum Tube -30 g
Slovenian: PODATKI NA PRIMARNI OVOJNINI Aluminijasta tuba - 30 g
English: In glucose-6-phosphate dehydrogenase deficient patients the antidote methylene blue is ineffective at methaemoglobin reduction, and is capable of oxidising haemoglobin itself, and therefore methylene blue therapy cannot be given.
Slovenian: Pri bolnikih s pomanjkanjem glukoza-6-fosfat dehidrogenaze antidot metilensko modrilo ni učinkovit za znižanje koncentracije methemoglobina in lahko celo oksidira sam hemoglobin, zato z metilenskim modrilom ni mogoče zdraviti takih bolnikov.
English: See table 4.
Slovenian: Glejte preglednico 4.
English: After a 5-10 minute application of EMLA to female genital mucosa the average duration of effective analgesia to an argon laser stimulus, which produced a sharp, pricking pain was 15-20 minutes (individual variations in the range 5-45 minutes).
Slovenian: Po 5- do 10-minutni aplikaciji zdravila EMLA na sluznici ženskih spolovil je učinkovita analgezija na dražljaj z argonskim laserjem, ki povzroča ostro, zbadajočo bolečino, povprečno trajala od 15 do 20 minut (z različnim trajanjem odziva pri posameznih bolnicah v okviru od 5 do 45 minut).
English: In the presence of atopic dermatitis, the application time should be reduced.
Slovenian: V primeru atopijskega dermatitisa je potrebno skrajšati trajanje nanosa.
English: • Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia; in adults and adolescents ≥12 years
Slovenian: • lokalno anestezijo sluznice spolovil, na primer pred površinskimi kirurškimi posegi ali infiltracijsko anestezijo, pri odraslih in mladostnikih, starih 12 let ali več;
English: A metabolite of lidocaine, 2,6-dimethylaniline, and a metabolite of prilocaine, σ-toluidine, showed evidence of genotoxic activity.
Slovenian: Za presnovek lidokaina 2,6-dimetilanilin in presnovek prilokaina σ-toluidin so dokazali znake genotoksičnega delovanja.
English: Application times of longer than 30 minutes in patients with atopic dermatitis may result in an increased incidence of local vascular reactions, particularly application site redness and in some cases petechia and purpura (see section 4.8).
Slovenian: Če pri bolnikih z atopijskim dermatitisom trajanje nanosa presega 30 minut, se lahko poveča pogostnost lokalnih žilnih reakcij, zlasti rdečine na mestu nanosa ter v nekaterih primerih petehij in purpure (glejte poglavje 4.8).
English: Do not spread the cream under the dressing.
Slovenian: Kreme pod folijo ne razmažite.
English: EMLA works by numbing the surface of the skin for a short time.
Slovenian: Zdravilo EMLA deluje tako, da za krajši čas omrtviči površino kože.
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.
Slovenian: Pri obeh zdravilnih učinkovinah je ugotovljena majhna peroralna akutna toksičnost, kar pomeni, da je v primeru naključnega zaužitja zdravila EMLA meja varnosti zelo široka.
English: EMLA can be used before cleansing of leg ulcers for up to 15 times over a period of 1-2 months.
Slovenian: Zdravilo EMLA se lahko uporabi za čiščenje razjed na nogah do 15-krat v obdobju 1 do
English: Infants 3-11 months2)
Slovenian: 3-11 mesecev2)
English: Frequency, type and severity of adverse reactions are similar in the paediatric and adult age groups, except for methaemoglobinaemia, which is more frequently observed, often in connection with overdose (see Section 4.9), in newborn infants and infants aged 0 to 12 months.
Slovenian: Pogostnost, vrsta in resnost neželenih učinkov so pri pediatričnih starostnih skupinah podobne kot pri odraslih, razen v primeru methemoglobinemije, ki so jo pogosteje opažali pri novorojenčkih in dojenčkih v starosti od 0 do 12 mesecev, pogosto v povezavi s prevelikim odmerjanjem (glejte poglavje 4.9).
English: Dermal procedures on newly shaven skin of large body areas, e.g. laser hair removal (self-application by patient)
Slovenian: kožni posegi na sveže obriti koži velikih predelov telesa, npr. lasersko odstranjevanje dlak (bolnik si sam nanese zdravilo)
English: Application times of longer than 30 minutes may result in an increased incidence of local skin reaction (see also section 4 “Possible side effects”).
Slovenian: pogosteje pride do lokalnih kožnih reakcij (glejte tudi poglavje 4 "Možni neželeni učinki").
English: The ratio of the embryofetal dose to the maternal serum concentration is 0.4 to
Slovenian: Razmerje med embriofetalnim odmerkom in koncentracijo v materinem serumu je od 0,4 do 1,3.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: [glejte Prilogo I - izpolni država članica] Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: If any of these problems are present, check with your doctor or pharmacist before using the cream.
Slovenian: Če imate katerokoli od navedenih težav, se pred uporabo kreme posvetujte z zdravnikom ali farmacevtom.