FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Ispitivanja lokalne podnošljivosti uz primjenu mješavine lidokaina i prilokaina u omjeru 1:1 (w/w) u obliku emulzije, kreme ili gela pokazalo je da se te formulacije dobro podnose na neoštećenoj i oštećenoj koži kao i na sluznicama.
English: Contact your doctor or pharmacist if any of the following side effects bother you or do not seem to go away.
Croatian: Javite se svom liječniku ili ljekarniku ako Vas neka od sljedećih nuspojava brine ili ne prolazi.
English: Lidocaine and prilocaine cross the placental barrier and may be absorbed by the foetal tissues.
Croatian: Lidokain i prilokain prolaze placentarnu barijeru i mogu se apsorbirati u tkivima fetusa.
English: • Topical anaesthesia of the skin in connection with:
Croatian: • topikalnu anesteziju kože kod:
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.
Croatian: Kod bolesnika s deficijencijom glukoza-6-fosfat dehidrogenaze antidot metilensko plavilo nije učinkovit u smanjivanju razine methemoglobina a može izazvati oksidaciju samog hemoglobina te se stoga terapija metilenskim plavilom ne smije primjenjivati.
English: However, the rate of metabolism and elimination of the local anaesthetics after topical application of EMLA are governed by the rate of absorption.
Croatian: Međutim, brzina metabolizma i eliminacije lokalnih anestetika nakon topikalne primjene određena je brzinom aporpcije.
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).
Croatian: Ako se preporučena doza prekorači, bolesnika treba nadzirati kako bi se uočile moguće sistemske nuspojave koje su posljedica methemoglobinemije (vidjeti dijelove 4.2, 4.8 i 4.9).
English: Avoid getting EMLA in the eyes, as it may cause irritation.
Croatian: Izbjegavajte kontakt EMLA kreme s očima jer može doći do nadraženosti.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Aluminum Tube 5 g
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Aluminijska tuba 5 g
English: Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive medicinal products; circulatory signs are treated in line with recommendations for resuscitation.
Croatian: moraju se liječiti simptomatski uz potporu disanja i primjenu antikonvulzivnih lijekova; cirkulatorni simptomi liječe se sukladno preporukama za oživljavanje.
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.
Croatian: Mehanizam djelovanja EMLA ostvaruje anesteziju kože otpuštanjem lidokaina i prilokaina iz kreme u epidermalni i dermalni sloj kože u blizini kožnih receptora za bol i živčanih završetaka.
English: The ratio of the embryofetal dose to the maternal serum concentration is 0.4 to
Croatian: Omjer embriofetalne doze i koncentracija u serumu majke je 0,4 prema 1,3.
English: The major elimination pathway of lidocaine and prilocaine is via hepatic metabolism and metabolites are renally excreted.
Croatian: Glavni put elimincije lidokaina i prilokaina je jetreni metabolizam,a metaboliti se izlučuju mokraćom.
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.
Croatian: Učestalost, vrsta i težina nuspojava slični su u pedijatrijskim i odraslim dobnim skupinama, osim methemoglobinemije, koja je primijećena češće u novorođenčadi i dojenčadi u dobi od 0 do 12 mjeseci, često povezana s predoziranjem (vidjeti dio 4.9).
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.
Croatian: povrh okluzivnog obloga treba staviti elastični zavoj kako bi se krema ravnomjerno rasporedila i područje zaštitilo.
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.
Croatian: Primjena na ulkusima na nogama prije čišćenja ili odstranjivanja oštećene kože - Uobičajena doza je 1g do 2 g kreme za svako područje kože veličine 10 cm do ukupno 10 g.
English: Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylene blue (see also section 4.4).
Croatian: Klinički značajnu methemoglobinemiju potrebno je liječiti sporom intravenskom injekcijom metilenskog plavila (vidjeti i dio 4.4).
English: Small dot-shaped bleeding on the treated area (particularly on children with eczema after longer application times) during treatment of the skin.
Croatian: - Lagano točkasto krvarenje na liječenom području (osobito kod djece s ekcemom nakon duljeg vremena primjene) tijekom primjene na koži.
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.
Croatian: Pedijatrijska populacija Maksimalne koncentracije lidokaina i prilokaina u plazmi nakon primjene EMLA kreme kod pedijatrijskih bolesnika različite dobi također su bile ispod potencijalno toksičnih razina.
English: The active substances in EMLA (lidocaine and prilocaine) are excreted into breast milk.
Croatian: Djelatne tvari u lijeku EMLA (lidokain i prilokain) izlučuju se u majčino mlijeko.
English: Symptoms of using too much EMLA are listed below.
Croatian: Simptomi primjene prekomjerne količine lijeka EMLA navedeni su u nastavku.
English: EMLA is applied to intact skin under an occlusive dressing.
Croatian: EMLA se primjenjuje na neoštećenu kožu pod okluzivnim oblogom.
English: Skin of male genital organs Prior to injection of local anaesthetics
Croatian: Primjena na kožu spolnih organa prije injekcije lokalnih anestetika
English: Use on larger areas of newly shaven skin before outpatient procedures (such as hair removal techniques):
Croatian: Primjena na većim površinama svježe obrijane kože prije ambulantnih zahvata (poput tehnika uklanjanja dlaka):
English: Available paediatric data do not demonstrate adequate efficacy for circumcision.
Croatian: Dostupni podaci u pedijatrijskoj populaciji ne pokazuju odgovarajuću djelotvornost za obrezivanje.
English: if you are allergic to lidocaine or prilocaine, other similar local anaesthetics or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati lijek EMLA - ako ste alergični na lidokain ili prilokain, druge slične lokalne anestetike ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač [Vidjeti Dodatak I - ispunjava država članica]
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).
Croatian: Primijećena je reproduktivna toksičnost kod supkutane/intramuskularne primjene visokih doza lidokaina ili prilokaina, kojima se postiže puno veća izloženost nego kod topikalne primjene (vidjeti dio 5.3).
English: EMLA diminished the pain of both needle insertion and injection of vaccines.
Croatian: EMLA je ublažila bol i kod uvođenja igle i kod ubrizgavanja cjepiva.
English: No negative effects on ulcer healing or bacterial flora have been observed.
Croatian: Nisu primijećeni negativni učinci na zacjeljivanje ulkusa niti na baketrijsku floru.
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.
Croatian: U ispitivanjima reproduktivne toksičnosti utvrđeni su embriotoksični i fetotoksični učinci: lidokaina pri supkutanoj dozi od 25 mg/kg u kunića, a prilokaina počevši od intramuskularne doze od 100 mg/kg u štakora.
English: What EMLA looks like and contents of the pack [To be completed nationally]
Croatian: Kako EMLA izgleda i sadržaj pakiranja
English: For procedures related to genital mucosa, no occlusive dressing is required.
Croatian: Kod postupaka na genitalnoj sluznici nije potreban okluzivni oblog.
English: Maximum recommended dose: 60 g. Maximum recommended treated area; 600 cm2 for a minimum of 1 hour, maximum 5 hours1).
Croatian: Najveće preporučeno područje primjene: 600 cm2 tijekom najmanje 1 sata, a najviše 5 sati1).
English: A line of cream of about 3.5 cm from the 30 g tube is equal to 1 g of cream.
Croatian: Traka kreme duga oko 3,5 cm iz tube od 30 g odgovara količini od 1 g kreme.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava methemoglobinemija1
English: Cuts, grazes or wounds, excluding leg ulcers.
Croatian: ogrebotine ili druge otvorene rane, osim ulkusa na nogama.
English: If you are applying the cream yourself, make sure that you have been given dressings by your doctor, pharmacist or nurse.
Croatian: Ako kremu nanosite sami, obavezno provjerite jesu li Vam liječnik, ljekarnik ili medicinska sestra dali obloge.
English: Lidocaine and prilocaine are amide-type local anaesthetics.
Croatian: Lidokain i prilokain su lokalni anestetici iz skupine amida.
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).
Croatian: EMLA se ne smije primjenjivati kod djece mlađe od 12 mjeseci koja se istodobno liječe drugim lijekovima koji utječu na razine krvnog pigmeta pod nazivom “methemoglobinemija” (npr.
English: For procedures related to leg ulcers, a thick layer of EMLA should be applied under an occlusive dressing.
Croatian: Kod postupaka povezanih s ulkusima na nogama, nanosi se debeli sloj EMLA kreme pod okluzivnim oblogom.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING UNITS Aluminum Tube -30 g
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Aluminijska tuba 30 g
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.
Croatian: Nakon primjene na bedro kod odraslih (60 g kreme/400 cm2 tijekom 3 sata), opseg apsorpcije lidokaina i prilokaina iznosio je približno 5%.
English: 1) After a longer application time anaesthesia decreases.
Croatian: 1) Nakon duljeg trajanja primjene anestezija se smanjuje.
English: o needle insertion, e.g. intravenous catheters or blood sampling;
Croatian: o uvođenja igle, primjerice intavenskog katetera ili za uzimanje uzoraka krvi;
English: An initially mild sensation of burning, itching or warmth at the treated area during treatment of the skin.
Croatian: Početni blag osjećaj peckanja, svrbeža ili topline na liječenom području tijekom primjene na koži.
English: Do not rub the cream in. 3.
Croatian: Nemojte utrljavati kremu.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Avoid contact with eyes.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Dermal surgical procedures on larger areas in a hospital setting, e.g. split-skin grafting.
Croatian: Dermatološki kirurški postupci na većim područjima u bolničkom okruženju, npr. presađivanje kože u djelomičnoj debljini.
English: 2 g (approx. half a 5 g tube) or approx. 1.5g/10 cm2 for 1 to 5 hours1).
Croatian: 2 g (približno pola tube od 5 g) ili približno 1,5 g/10 cm2 tijekom 1 do 5 sati1).
English: 1 g/10 cm2 for 15 minutes
Croatian: 1 g/10 cm2 tijekom 15 minuta
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.
Croatian: Methemoglobinemija, poremećaj krvi, koja je opažena češće kod novorođenčadi i dojenčadi u dobi od
English: Remove the covers of the dressing.
Croatian: Odstranite pokrove s obloga.
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.
Croatian: 2) Zbog sigurnosnih razloga EMLA se ne smije primjenjivati kod dojenčadi u dobi do 12 mjeseci koja se liječe lijekovima koji induciraju stvaranje methemoglobina, vidjeti dijelove 4.4 i 4.8.
English: Patients with defective glucose-6-phosphate dehydrogenase hereditary or idiopathic methaemoglobinaemia are more susceptible to active-substance-induced signs of methaemoglobinaemia.
Croatian: Bolesnici s poremećajem glukoza-6-fosfat dehidrogenaze, nasljednom ili idiopatskom methemoglobinemijom podložniji su razvoju znakova methemoglobinemije izazvane djelatnom tvari.
English: An impairment of the fertility of male or female rats by lidocaine or prilocaine was not observed.
Croatian: Nije primijećen poremećaj plodnosti mužjaka ni ženki štakora uslijed djelovanja lidokaina ili prilokaina.
English: Surgical treatment of localised lesions, e.g. removal of genital warts (condylomata acuminata) and prior to injection of local anaesthetics
Croatian: odstranjivanje genitalnih bradavica (condylomata acuminata) i prije injekcije lokalnih anestetika
English: These symptoms are unlikely to happen if EMLA is used as recommended.
Croatian: Oni se vjerojatno neće pojaviti ako se EMLA primjenjuje sukladno preporukama.
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.
Croatian: Nakon ponovljene primjene 2-10 g EMLA kreme na ulkusima na nogama, na području do 62 cm2 tijekom 30-60 minuta, 3-7 puta tjedno do ukupno 15 doza u razdoblju od mjesec dana, nije primijećena kumulacija lidokaina i njegovih metabolita monoglicineksilidida i 2,6-ksilidina niti prilokaina i njegova metabolita orto-toluidina u plazmi.
English: Do not use EMLA on areas with skin rash, cuts, grazes or other open wounds, with the exception of a leg ulcer.
Croatian: Ne smijete primjenjivati EMLA kremu na sljedećim područjima: - posjekotinama, ogrebotinama ili ranama, osim ulkusa na nogama.
English: 6) After longer application time anaesthesia decreases.
Croatian: 6) Nakon duljeg trajanja primjene anestezija se smanjuje.
English: EMLA contains castor oil polyoxyl hydrogenated, which may cause skin reactions.
Croatian: EMLA sadrži ricinusovo ulje, polioksil hidrogenirano, koje može uzrokovati kožne reakcije.
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.
Croatian: Prilokain u visokim dozama može uzrokovati porast razina methemoglobina, osobito ako se primjenjuje zajedno s lijekovima koji induciraju stvaranje methemoglobina (npr. sulfonamidi, nitrofurantoin, fenitoin, fenobarbital).
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.
Croatian: Primjetna reakcija nadraženosti zabilježena je u jednom ispitivanju na životinjama, nakon jednokratne okularne primjene emulzije lidokaina + prilokaina 1:1 (w/w) u dozi od 50 mg/g.
English: Maximum plasma concentrations (mean 0.12 and 0.07 µg/mL) were reached approximately 2-6 hours after application.
Croatian: Maksimalne koncentracije u plazmi (srednja vrijednost 0,12 i 0,07 µg/mL) postignute su približno 2 do 6 sati nakon primjene.
English: Your doctor, nurse or pharmacist will tell you how much cream to use.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra reći će Vam koliko kreme trebate primijeniti.
English: EMLA contains castor oil polyoxyl hydrogenated Castor oil polyoxyl hydrogenated may cause skin reactions.
Croatian: EMLA sadrži polioksil hidrogenirano ricinusovo ulje Polioksil hidrogenirano ricinusovo ulje može izazvati kožne reakcije.
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).
Croatian: Prilokain u visokim dozama može uzrokovati porast razina methemoglobina, osobito kod podložnih pojedinaca (dio 4.4), u slučaju prečestog doziranja kod novorođenčadi i dojenčadi mlađe od 12 mjeseci (dio 4.2) te ako se primjenjuje zajedno s lijekovima koji induciraju stvaranje methemoglobina (npr. sulfonamidi,
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.
Croatian: Iz toga je razloga potrebno pratiti rezultate intrakutanih injekcija živih cjepiva, iako jedno kliničko ispitivanje upućuje na to da ELMA ne utječe na odgovor na cijepljenje, ocijenjen s obzirom na razvoj lokalne papule, kada se primijeni prije BCG cjepiva.
English: 1-2 g/10 cm2 for 60 minutes
Croatian: 1 - 2 g/10 cm2 tijekom 60 minuta
English: Maximum plasma concentrations (mean 0.16 and 0.06 µg/mL) were reached after approximately 1.5-3 hours.
Croatian: Maksimalne koncentracije u plazmi (srednja vrijednost 0,16 and 0,06 µg/mL) postignute su približno 1,5-3 sata nakon primjene.
English: Approx. 1-2 g/10 cm2 up to a total of 10 g to the leg ulcer(s)3) 5).
Croatian: Približno 1-2 g/10 cm2 do ukupno 10 g na ulkus(e) na nozi3) 5).
English: Renal impairment A dose reduction is not necessary among patients with restricted renal function.
Croatian: Nije potrebno smanjivati dozu kod bolesnika s oslabljenom bubrežnom funkcijom.
English: The cream is put on under a dressing.
Croatian: - Krema se primjenjuje pod oblogom.
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.
Croatian: Kod novorođenčadi/dojenčadi mlađe od 3 mjeseca često je zabilježen prolazan, klinički beznačajan porast razina methemoglobina do 12 sati nakon primjene EMLA kreme u preporučenim dozama.
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”.
Croatian: Primjena na kožu prije odstranjivanja bradavicama sličnih promjena koje se zovu “moluske” - EMLA se može primjenjivati kod djece i adolescenata koji imaju kožnu bolest koja se zove
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.
Croatian: Nakon ponovljene primjene 10 g EMLA kreme na kroničnim ulkusima na nogama, na području između 62-160 cm2 tijekom 60 minuta, jedanput dnevno tijekom 10 uzastopnih dana, srednja maksimalna plazmatska koncentracija zbrojenih koncentracija lidokaina i prilokaina bila je 0,6 µg/ml.
English: • in newborn infants/infants up to 12 months of age receiving concomitant treatment with methaemoglobin-inducing agents.
Croatian: • kod novorođenčadi/dojenčadi do navršenih 12 mjeseci života koji se istodobno liječe lijekovima koji induciraju stvaranje methemoglobina.
English: Smooth down the edges of the dressing carefully.
Croatian: Pažljivo izravnajte rubove obloga.
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.
Croatian: Nakon primjene 10 g EMLA kreme na vaginalnoj sluznici tijekom 10 minuta, maksimalne koncentracije lidokaina i prilokaina u plazmi (srednja vrijednost 0,18 µg/ml, odnosno 0,15 µg/ml) postignute su nakon 20-45 minuta.
English: EMLA produces a biphasic vascular response involving initial vasoconstriction followed by vasodilatation at the application site (see section 4.8).
Croatian: Krvožilni odgovor na lijek EMLA odvija se u dvije faze, gdje nakon početne vazokonstrikcije slijedi vazodilatacija na mjestu primjene (vidjeti dio 4.8).
English: Peel the ‘centre cut-out' from the dressing.
Croatian: Odlijepite ‘središnji isječak' obloga.
English: Peel the paper layer from the dressing.
Croatian: Odlijepite papirnati sloj s obloga.
English: 3) EMLA should not be used at less than 37 weeks gestational age, because of safety concerns, see section
Croatian: Zbog sigurnosnih razloga EMLA se ne smije primjenjivati u gestacijskoj dobi manjoj od 37 tjedana,
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.
Croatian: Nakon primjene na ulkusima na nogama u trajanju od 24 sata na području do 50-100 cm2, maksimalne plazmatske koncentracije lidokaina (0,19-0,71 µg/ml) i prilokaina (0,06-0,28 µg/ml) obično su se postigle unutar 2 do 4 sata.
English: The protective membrane of the tube is perforated by applying the cap.
Croatian: Zaštitna opna tube probija se tako da se na nju natakne zatvarač.
English: The use of EMLA prior to measles-mumps-rubella or intramuscular diphtheria-pertussis-tetanusinactivated poliovirus-Haemophilus influenzae b or Hepatitis B vaccines did 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.
Croatian: U usporedbi s bolesnicima koji su primili placebo, primjena lijeka EMLA prije cjepiva protiv ospicazaušnjaka-rubele ili intramuskuranog cjepiva protiv difterije-pertusisa-tetanusa-inaktiviranog polio virusa-bakterije Haemophilus influenzae tipa b ili cjepiva protiv hepatitisa B nije utjecala na srednji titar protutijela, stopu serokonverzije niti udio bolesnika koji su nakon cijepljenja postigli zaštitni ili pozitivan titar protutijela.
English: The maximum observed plasma concentrations for prilocaine and ortho-toluidine were 0.08 µg/mL and 0.01 µg/mL respectively.
Croatian: Maksimalna opažena plazmatska koncentracija prilokaina bila je 0,08 µg/ml, a ortotoluidina 0,01 µg/ml.
English: Do not use EMLA on the following areas:
Croatian: EMLA se ne smije primjenjivati:
English: Approx. 1.5-2 g/10 cm2 for 2 to 5 hours1).
Croatian: Približno 1,5 - 2 g/10 cm2 tijekom 2 do 5 sati1).
English: An initially mild sensation of burning, itching or warmth at the treated area during treatment of genital mucosa or leg ulcers.
Croatian: Početni blag osjećaj peckanja, svrbeža ili topline na liječenom području tijekom primjene na sluznici spolnih organa ili ulkusima na nogama.
English: Your doctor, nurse or pharmacist will tell you how much to use and when it should be applied.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra reći će Vam koliko kreme primijeniti i kada je trebate nanijeti.