FrancophonIA/ELRC3.0 huggingface dataset:
English: EMLA should not be used in children younger than 12 months of age who are being treated at the same time with other medicines that affect blood pigment levels “methaemoglobinaemia” (e.g. sulphonamides, see also Section 2 Other medicines and EMLA).
Slovenian: Zdravila EMLA se ne sme uporabiti pri otrocih, mlajših od 12 mesecev, če hkrati prejemajo še druga zdravila, ki vplivajo na koncentracijo krvnega barvila in bi lahko povzročila "methemoglobinemijo"
English: One gram of EMLA pressed out of a tube of 30 g is approximately 3.5 cm.
Slovenian: En gram zdravila EMLA ustreza približno 3,5 cm kreme, iztisnjene iz 30-gramske tube.
English: If you are applying the cream yourself, make sure that you have been given dressings by your doctor, pharmacist or nurse.
Slovenian: Če kremo nanašate sami, morate poskrbeti, da vam zdravnik, farmacevt ali medicinska sestra dajo material za oblogo.
English: In studies of split-skin grafting in adults application for up to 7hours 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
Slovenian: V študijah presadkov delne debeline kože (split-skin grafting) sta po nanosu na površino do 1500 cm2 na stegnu ali nadlaktu s trajanjem do 7 ur in 40 minut zdravilni učinkovini dosegli najvišjo koncentracijo v plazmi, ki ni presegla 1,1 µg/ml lidokaina oziroma 0,2 µg/ml prilokaina.
English: Use on larger areas of newly shaven skin before outpatient procedures (such as hair removal techniques):
Slovenian: Uporaba kreme na večjih površinah sveže obrite kože pred ambulantnimi posegi (na primer pred postopkom odstranjevanja dlak):
English: Symptoms of local anaesthetic toxicity become increasingly apparent at increasing plasma concentration from 5 to 10 μg/mL of either active substance.
Slovenian: Z zviševanjem koncentracije ene ali druge zdravilne učinkovine v plazmi od 5 do 10 μg/ml postajajo simptomi toksičnosti lokalnega anestetika vedno bolj izraziti.
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.
Slovenian: Sistemska absorpcija lidokaina in prilokaina iz zdravila EMLA je odvisna od apliciranega odmerka in površine ter trajanja nanosa.
English: 10 g of cream should be administered in the lateral vaginal fornices for 10 minutes.
Slovenian: pred abrazijo materničnega vratu v stranska vaginalna forniksa je treba aplicirati 10 g kreme za 10 minut
English: Newborn infants and infants 0-2
Slovenian: novorojenčki in dojenčki v starosti 0-2 meseca1) 2) 3)
English: Hypersensitivity1, 2, 3
Slovenian: Bolezni imunskega sistema preobčutljivost1, 2, 3
English: After the application of 10 g EMLA for 10 minutes to vaginal mucosa, maximum plasma concentrations of lidocaine and prilocaine (mean 0.18 µg/mL and 0.15 µg/mL respectively) were reached after 20-45 minutes.
Slovenian: Po nanosu 10 g zdravila EMLA na nožnično sluznico za 10 minut, sta lidokain in prilokain dosegla najvišjo koncentracijo v plazmi (povprečno 0,18 µg/ml oziroma 0,15 µg/ml) po 20-45 minutah.
English: • Having a needle put in (for example, if you are having an injection or a blood test).
Slovenian: • zabadanjem igle (na primer pred dajanjem injekcije ali odvzemom krvi za preiskave), • manjšimi operacijami na koži.
English: Due to the potentially enhanced absorption on the newly shaven skin, it is important to follow the recommended dosage, skin area and application time.
Slovenian: Na sveže obriti koži je lahko absorpcija zdravila večja, zato je pomembno, da upoštevate priporočila glede velikosti odmerka, velikosti površine kože in trajanja nanosa.
English: Smooth down the edges of the dressing carefully.
Slovenian: Folijo previdno namestite preko kupčka kreme.
English: Posology
Slovenian: Poseg
English: Your doctor, nurse or pharmacist will tell you how much to use and when it should be applied.
Slovenian: medicinska sestra ali farmacevt vam bodo povedali, koliko kreme uporabiti in kdaj jo nanesti.
English: Use on genital skin before injections of local anaesthetics EMLA can be used in this way on adults and adolescents over 12 years only.
Slovenian: Zdravilo EMLA se sme na ta način uporabiti le pri odraslih in mladostnikih, starejših od 12 let.
English: 5) No clinically significant increase in methaemoglobin levels has been observed after an application time of up to 4 hours on 16 cm2.
Slovenian: 5) Po nanosu zdravila na površino 16 cm2 s trajanjem do 4 ure niso opažali klinično pomembnega zvišanja koncentracije methemoglobina.
English: Paediatric patients with atopic dermatitis
Slovenian: "atopijski dermatitis".
English: The usual dose is 1.5 g to 2 g of cream for each of area of skin that is 10 cm2 (10 square centimetres) in size.
Slovenian: Običajen odmerek je 1,5 g do 2 g kreme na vsakih 10 cm2 (10 kvadratnih centimetrov) kožne površine.
English: Reproduction toxicity has been shown with subcutaneous/intramuscular administration of high doses of lidocaine or prilocaine much exceeding the exposure from topical application (see section 5.3).
Slovenian: Pri subkutanem oziroma intramuskularnem odmerjanju velikih odmerkov lidokaina ali prilokaina, po katerem je izpostavljenost zdravilu precej presegala tisto po lokalni aplikaciji, so opažali škodljiv vpliv na sposobnost razmnoževanje (glejte poglavje 5.3)
English: Clinical studies involved more than 2,300 paediatric patients of all age groups and demonstrated efficacy for needle pain (venipuncture, cannulation, sc and im vaccinations, lumbar puncture), laser treatment of vascular lesions, and curettage of molluscum contagiousum.
Slovenian: Rezultati teh študij dokazujejo učinkovitost anestezije za bolečino pri zabadanju igle (za venepunkcijo, vstavljanje kanile, subkutano ali intramuskularno cepljenje in lumbalno punkcijo), pri laserskem zdravljenju žilnih sprememb in odstranjevanju molusk (mollusca contagiosa) s kireto.
English: The maximum observed plasma concentrations for prilocaine and ortho-toluidine were 0.08 µg/mL and 0.01 µg/mL respectively.
Slovenian: Pri prilokainu sta bili najvišji izmerjeni koncentraciji v plazmi 0,08 µg/ml za prilokain in 0,01 µg/ml za orto-toluidin.
English: Following repeated application of 2-10 g EMLA to leg ulcers with an area of up to 62 cm2 for 30-60 minutes 3-7 times a week for up to 15 doses during a period of one month, there was no apparent accumulation in plasma of lidocaine and its metabolites monoglycinexylidide and 2,6-xylidine or of prilocaine and its metabolite ortho-toluidine.
Slovenian: 3-7-krat na teden do skupno 15 odmerkov v obdobju enega meseca v plazmi ni bilo opaznega kopičenja lidokaina in njegovih presnovkov monoglicinksilidida in 2,6-ksilidina oziroma prilokaina in njegovega presnovka orto-toluidina.
English: 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.
Slovenian: Pri novorojenčkih/dojenčkih, mlajših od 3 mesecev, so v obdobju do 12 ur po uporabi zdravila EMLA v priporočenih odmerkih pogosto opažali prehodno in klinično nepomembno zvišanje koncentracije methemoglobina.
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Prilogo I - izpolni država članica]
English: The cream is put on under an airtight dressing such as plastic wrap.
Slovenian: Kremo je treba nanesti pod oblogo (npr. plastično folijo), ki ne prepušča zraka.
English: After an application time of 24 hours to leg ulcers with an area of up to 50-100 cm2, the maximum plasma concentrations of lidocaine (0.19-0.71 µg/mL) and of prilocaine (0.06-0.28 µg/mL) were usually reached within 2 to 4 hours.
Slovenian: Po 24-urnem nanosu na ulkusih na nogah s površino od 50 do 100 cm2 sta lidokain in prilokain običajno dosegla najvišjo koncentracijo v plazmi v 2 do 4 urah (lidokain od 0,19 do 0,71 µg/ml in prilokain od 0,06 do 0,28 µg/ml).
English: o needle insertion, e.g. intravenous catheters or blood sampling;
Slovenian: o zabadanja igle, npr. pri vstavljanju intravenskih katetrov ali pri odvzemih krvi),
English: Cancer studies have not been performed with either lidocaine or prilocaine alone or in combination, due to the indication and duration of therapeutic use of these active substances.
Slovenian: Zaradi indikacij in trajanja terapevtske uporabe obeh zdravilnih učinkovin niso izvajali študij o povezavi z rakom niti z lidokainom oziroma prilokainom posamezno niti s kombinacijo obeh zdravilnih učinkovin.
English: What EMLA looks like and contents of the pack [To be completed nationally]
Slovenian: Izgled zdravila EMLA in vsebina pakiranja
English: 3) Plasma concentrations have not been determined in patients treated with doses of >10 g (see also Section 4) In adolescents weighing less than 20 kg the maximum dose of EMLA on genital mucosa should be proportionally reduced.
Slovenian: 4) Pri mladostnikih s telesno maso pod 20 kg je treba sorazmerno zmanjšati največji odmerek zdravila
English: Plasma concentrations of lidocaine and prilocaine in paediatric age groups from 0 months to 8 years of age
Slovenian: Preglednica 4 Koncentraciji lidokaina in prilokaina v plazmi pri pediatričnih bolnikih v starosti od
English: The Netherland
Slovenian: Nizozemska
English: 2 Genital mucosa 3 Leg ulcer
Slovenian: 2 na sluznici spolovil 3 na ulkusih na nogah
English: Your doctor, pharmacist or nurse will tell you where to put it.
Slovenian: Zdravnik, farmacevt ali medicinska sestra vam bodo povedali, kam morate kremo nanesti.
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] INSTRUCTIONS ON USE Read the package leaflet before use.
Slovenian: NAVODILA ZA UPORABO Pred uporabo preberite priloženo navodilo!
English: Peel the paper layer from the dressing.
Slovenian: Odlepite papirnato plast s folije.
English: The usual dose is 1 g of cream for each area of skin that is 10 cm² (10 square centimetres) in size, applied for 1 to 5 hours under a dressing.
Slovenian: Običajen odmerek je 1 g kreme na vsakih 10 cm2 (10 kvadratnih centimetrov) kožne površine, pri čemer krema ostane na koži pod folijo 1 do 5 ur.
English: EMLA is applied to intact skin under an occlusive dressing.
Slovenian: Koža Zdravilo EMLA je treba nanesti na nepoškodovano kožo in ga pokriti z okluzivno oblogo.
English: Application site warmth 2, 3
Slovenian: srbenje na mestu aplikacije2, 3
English: (especially after longer application times in children with atopic dermatitis or mollusca contagiosa)
Slovenian: Bolezni kože in podkožja purpura1, petehije1 (zlasti po daljšem trajanju nanosa pri otrocih z atopijskim dermatitisom ali moluskami (mollusca contagiosa)
English: EMLA should not be applied to an impaired eardrum.
Slovenian: Zdravila EMLA se ne sme uporabljati pri nedonošenčkih.
English: However, animal studies do not indicate any direct or indirect negative effects on pregnancy, embryo-foetal development, parturition or postnatal development.
Slovenian: Pri lokalni uporabi je sistemska absorpcija zdravila sicer majhna, vendar je pri uporabi pri nosečnicah potrebna previdnost, saj o uporabi zdravila EMLA pri nosečnicah ni na voljo dovolj podatkov, čeprav rezultati študij na živalih niso pokazali neposrednih ali posrednih neugodnih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
English: 2 g/16 cm2
Slovenian: 3 - 12 mesecev 2 g/16 cm2
English: PHARMACEUTICAL FORM AND CONTENTS [To be completed nationally] METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: In infants/newborn infants younger than 3 months a transient, clinically not relevant increase in blood pigment levels “methaemoglobinaemia” is commonly observed up to 12 hours after EMLA is put on.
Slovenian: Pri dojenčkih in novorojenčkih, mlajših od 3 mesecev, se do 12 ur po nanosu zdravila EMLA pogosto pojavi prehodno zvišanje koncentracije krvnega barvila, kar imenujemo "methemoglobinemija"; to zvišanje ni klinično pomembno.
English: For procedures related to genital mucosa, no occlusive dressing is required.
Slovenian: Za posege na sluznici spolovil okluzivna obloga ni potrebna.
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.
Slovenian: lahko povzročijo tolikšne koncentracije lidokaina v plazmi, da ta pri ponavljajočem odmerjanju velikih odmerkov v daljšem časovnem obdobju lahko deluje toksično.
English: The extent of systemic absorption was approximately 10% following application to the face (10 g/100 cm2 for 2 hours).
Slovenian: Po nanosu na obraz (10 g/100 cm2 za 2 uri) je znašala sistemska absorpcija približno 10 %.
English: Application site irritation3
Slovenian: draženje na mestu aplikacije3
English: For procedures related to leg ulcers, a thick layer of EMLA should be applied under an occlusive dressing.
Slovenian: Za posege na ulkusih na nogah je treba nanesti debelo plast zdravila EMLA in jo pokriti z okluzivno oblogo.
English: Dosage and Application Time
Slovenian: Odmerjanje in trajanje nanosa
English: 1 g/10 cm2 for 15 minutes
Slovenian: 1 g/10 cm2 za 15 minut 1-2 g/10 cm2 za 60 minut
English: The usual dose is 1 g of cream (1g to 2 g for female genital skin) for each area of skin that is 10 cm2 (10 square centimetres) in size.
Slovenian: Običajen odmerek je 1 g kreme (1 do 2 grama za kožo na ženskih spolovilih) na vsakih 10 cm2
English: • Cleansing or removal of damaged skin of leg ulcers
Slovenian: Uporaba na razjedah na nogah pred čiščenjem ali odstranjevanjem poškodovane kože
English: Maximum plasma concentrations (mean 0.16 and 0.06 µg/mL) were reached after approximately 1.5-3 hours.
Slovenian: Najvišjo koncentracijo v plazmi (povprečno 0,16 oziroma 0,06 µg/ml) sta zdravilni učinkovini dosegli po približno
English: Using EMLA
Slovenian: Uporaba zdravila EMLA
English: A doctor or nurse should supervise the use of EMLA on the genitals.
Slovenian: Uporabo zdravila EMLA na spolovilih mora nadzirati zdravnik ali medicinska sestra.
English: There was no benefit of EMLA versus placebo for liquid nitrogen cryotherapy of common warts No adequate efficacy for circumcision could be demonstrated.
Slovenian: Zdravilo EMLA v primerjavi s placebom ni prineslo dodatne koristi pri krioterapiji navadnih bradavic s tekočim dušikom.
English: EMLA reduces the number of cleansing sessions required to achieve a clean ulcer compared to debridement with placebo cream.
Slovenian: V primerjavi s čiščenjem z uporabo placebo kreme zdravilo EMLA zmanjša število čiščenj, ki so potrebna za očiščenje ulkusa.
English: Burning sensation2, 3 Application site pruritus 2, 3
Slovenian: Splošne težave in spremembe na mestu aplikacije pekoč občutek2, 3
English: Application site pallor 1,
Slovenian: srbenje na mestu aplikacije1
English: Surgical treatment of localised lesions, e.g. removal of genital warts (condylomata acuminata) and prior to injection of local anaesthetics
Slovenian: Sluznica spolovil kirurško zdravljenje lokaliziranih sprememb, npr. odstranjevanje genitalnih bradavic (condylomata acuminata) in pred injiciranjem lokalnega anestetika približno 5-10 g kreme za 5-10 minut1) 3) 4)
English: 1 g/10 cm2
Slovenian: 0 - 3 mesece 1 g/10 cm2
English: Due to insufficient data on absorption, EMLA should not be applied to open wounds (excluding leg ulcers).
Slovenian: Zdravila EMLA se ne sme nanesti na odprte rane (z izjemo ulkusov na nogah), ker podatkov o absorpciji v takšnem primeru ni dovolj.
English: if you or your child have a problem with blood pigment levels called ‘methaemoglobinaemia'.
Slovenian: če imate vi ali ima vaš otrok težave s koncentracijo krvnega barvila; to motnjo imenujemo
English: Eleven clinical studies in newborn infants and infants showed that peak methaemoglobin concentrations occur about 8 hours after epicutaneous EMLA administration, are clinically insignificant with recommended dosage, and return to normal values after about 12-13 hours.
Slovenian: Rezultati enajstih kliničnih študij pri novorojenčkih in dojenčkih kažejo, da do najvišje koncentracije methemoglobina pride približno 8 ur po uporabi zdravila EMLA na površini kože.
English: Use on the skin prior to removal of wart-like spots called “mollusca” EMLA can be used on children and adolescents with a skin condition called “atopic dermatitis”.
Slovenian: Zdravilo EMLA je mogoče uporabiti pri otrocih in mladostnikih s kožno boleznijo, imenovano
English: How to store EMLA
Slovenian: Shranjevanje zdravila EMLA
English: Animals with an intact tympanic membrane, however, show no abnormality when exposed to EMLA in the external auditory canal.
Slovenian: Pri živalih z nepoškodovanim bobničem, ki so jim zdravilo EMLA aplicirali v sluhovod, pa niso ugotovili nobenih nepravilnosti.
English: NAME OF THE MEDICINAL PRODUCT EMLA and associated names (see Annex I) 25mg/g + 25mg/g cream [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA EMLA in povezana imena (glejte Prilogo I) 25 mg/g + 25 mg/g krema
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION EMLA and associated names (see Annex I) 25mg/g + 25mg/g cream [See Annex I - To be completed nationally] lidocaine / prilocaine
Slovenian: IME ZDRAVILA IN POT(I) UPORABE EMLA in povezana imena (glejte Prilogo I) 25 mg/g + 25 mg/g krema
English: The maximum observed plasma concentration for lidocaine, monoglycinexylidide and 2,6-xylidine were 0.41, 0.03 and 0.01 µg/mL respectively.
Slovenian: Pri lidokainu so bile najvišje izmerjene koncentracije v plazmi 0,41 µg/ml za lidokain, 0,03 µg/ml za monoglicinksilidid in 0,01 µg/ml za 2,6-ksilidin.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN [Izpolni država članica]
English: A mild reaction (paleness or redness of the skin, slight puffiness, initial burning or itching) may occur on the area on which EMLA is used.
Slovenian: Na predelih, na katerih uporabljate zdravilo EMLA, lahko pride do blage reakcije (do bledice ali rdečine kože, rahle otekline, pekočega občutka na začetku nanosa ali do srbenja).
English: EMLA should not be applied to an impaired tympanic membrane.
Slovenian: Zdravila EMLA se ne sme nanesti na poškodovan ušesni bobnič.
English: Prior to removal of mollusca
Slovenian: pediatrični bolniki z atopijskim dermatitisom pred odstranjevanjem molusk (mollusca contagiosa)
English: Application site oedema 1, 2, 3
Slovenian: rdečina na mestu aplikacije1, 2, 3 edem na mestu aplikacije1, 2, 3
English: Mechanical cleansing/debridement
Slovenian: lidokain/prilokain dermalna uporaba
English: Prilocaine in high doses may cause an increase in methaemoglobin levels particularly in conjunction with methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofuradantin, phenytoin, phenobarbital).This list is not exhaustive.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Prilokain v velikih odmerkih lahko zvišuje koncentracijo methemoglobina, zlasti v povezavi z drugimi zdravili, ki povzročajo nastajanje methemoglobina (npr. sulfonamidi, nitrofuradantin, fenitoin,
English: Up to 2 g and 20 cm2 for one hour5)
Slovenian: 20 cm2 površine; za eno uro5)
English: Allergic reactions, which in rare cases may develop into anaphylactic shock (skin rash, swelling, fever, respiratory difficulties and fainting) during treatment of skin, genital mucosa or leg ulcers.
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) alergijske reakcije, ki se v redkih primerih lahko razvijejo v anafilaktični šok (izpuščaj na koži, otekanje, vročina, težave z dihanjem in izguba zavesti) med uporabo na koži, sluznici spolovil ali razjedah na nogah methemoglobinemija (krvna motnja) med uporabo na koži majhne pikčaste krvavitve na mestu nanosa (zlasti pri otrocih z ekcemom po dolgotrajnejšem nanosu) med uporabo na koži draženje oči, če zdravilo EMLA po nesreči pride v stik z njimi med uporabo na koži Dodatni neželeni učinki pri otrocih
English: An initially mild sensation of burning, itching or warmth at the treated area during treatment of genital mucosa or leg ulcers.
Slovenian: blag pekoč občutek ob začetku nanosa, srbenje ali občutek toplote na mestu nanosa na kožo odrevenelost (mravljinčenje) na mestu nanosa med uporabo na sluznici spolovil draženje kože med nanosom na razjede na nogah
English: Tingling of the skin around the mouth and numbness of the tongue.
Slovenian: občutek, da boste izgubili zavest, ali občutek omotičnost mravljinčenje v koži okrog ust in omrtvičenost jezika nenormalen okus zamegljen vid zvenenje v ušesih
English: minutes, the maximum plasma concentrations of lidocaine (range 0.05-0.25 µg/mL, one individual value of 0.84 µg/mL) and of prilocaine (0.02-0.08 µg/mL) were reached within 1 to 2.5 hours.
Slovenian: Po enkratnem nanosu od 5 do 10 g zdravila EMLA na ulkuse na nogah s površino do 64 cm2 za 30 minut sta lidokain in prilokain dosegla najvišjo koncentracijo v plazmi v 1 do 2,5 ure (lidokain v okviru od 0,05 do 0,25 µg/ml, z eno posamezno vrednostjo 0,84 µg/ml, in prilokain od 0,02 do 0,08 µg/ml).
English: The active substances are: lidocaine and prilocaine [To be completed nationally]
Slovenian: Zdravilni učinkovini sta: lidokain in prilokain.
English: Application site pruritus1
Slovenian: Očesne bolezni draženje roženice1
English: Do not pass it on to others.
Slovenian: Pokritja pri tem ne nameščamo.
English: Up to 20 g and 200 cm2 for 1-5 hours6)
Slovenian: 200 cm2 površine; za 1-5 ur6)
English: Use on leg ulcers before cleaning or removal of damaged skin The usual dose is 1g to 2 g of cream for each area of skin that is 10 cm2 up to a total of 10 g.
Slovenian: En ali več ulkusov na nogah samo pri odraslih mehansko čiščenje/odstranjevanje nekrotičnega tkiva približno 1-2 g/10 cm2 do skupaj 10 g na en ali več ulkusov na nogah3) 5)
English: Following repeated application of 10 g EMLA to chronic leg ulcers with an area between 62-160 cm2 for 60 minutes once daily during 10 consecutive days, the mean maximum plasma concentration of the sum of lidocaine and prilocaine concentrations was 0.6 µg/mL.
Slovenian: 60 minut enkrat na dan 10 zaporednih dni je znašala povprečna najvišja koncentracija lidokaina in prilokaina skupaj 0,6 µg/ml.
English: PACKAGE LEAFLET
Slovenian: Okvara ledvic
English: Up to 10 g and 100 cm2 for 1-5 hours6)
Slovenian: 100 cm2 površine; za 1-5 ur6)
English: o Medical procedures such as removal of warts.
Slovenian: o dajanjem injekcije, o posegi, kot je odstranjevanje bradavic.
English: EMLA and associated names (see Annex I) 25mg/g + 25mg/g cream [See Annex I - To be completed nationally]
Slovenian: Navodilo za uporabo EMLA in povezana imena (glejte Prilogo I) 25 mg/g + 25 mg/g krema
English: Leg ulcer Following a single application of 5 to 10 g of EMLA to leg ulcers with an area of up to 64 cm2 for 30
Slovenian: Po ponavljanju nanosa 10 g zdravila EMLA na kronične ulkuse na nogah s površino do 62-160 cm2 za
English: Use on the skin before hospital procedures (such as split-skin grafting) that require deeper skin anaesthesia: EMLA can be used in this way on adults and adolescents over 12 years.
Slovenian: Na kožo (velja tudi za kožo spolovil) je treba nanesti debelo plast zdravila EMLA in jo pokriti z okluzivno oblogo.
English: 6.4 Special precautions for storage [To be completed nationally]
Slovenian: 6.4 Posebna navodila za shranjevanje
English: Up to 1 g and 10 cm2 for one hour4)
Slovenian: 10 cm2 površine; za eno uro4)
English: Toddlers and children 1-5 years
Slovenian: malčki in otroci v starosti 1-5 let največ 10 g kreme na največ
English: • Minor skin operations.
Slovenian: o površinskih kirurških posegov,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Aluminum Tube 5 g
Slovenian: Aluminijasta tuba 5 g
English: Table 3 Adverse reactions System Organ Class
Slovenian: Preglednica 3 Neželeni učinki
English: The European Commission issued a decision on 20 June 2017.
Slovenian: Evropska komisija je sklep izdala 20. junija 2017.