FrancophonIA/ELRC3.0 huggingface dataset:
English: • Other local anaesthetics.
Croatian: • druge lokalne anestetike.
English: The medical procedure should then start straight away.
Croatian: Nakon toga treba odmah započeti s medicinskim postupkom.
English: If you use more EMLA than you should
Croatian: Ako primijenite više EMLA kreme nego što ste trebali
English: Be careful to avoid getting anything in your eye until feeling returns.
Croatian: Pazite da Vam ništa ne upadne u oko dok Vam se ne vrati osjet.
English: When you apply the cream, it is very important to exactly follow the instructions below:
Croatian: Kad nanosite kremu, vrlo je važno da se točno pridržavate uputa u nastavku:
English: Applied amount of cream
Croatian: Primijenjena količina kreme
English: Clinical data from a longer waiting period are not available.
Croatian: Nisu dostupni klinički podaci za dulje razdoblje čekanja.
English: 4) Application for > 1hour has not been documented.
Croatian: 4) Nije dokumentirana primjena tijekom > 1sata.
English: • Minor skin operations.
Croatian: manjih operacija na koži.
English: Remove the cream with cotton gauze and start cleansing without delay.
Croatian: Uklonite kremu pamučnom gazom i započnite čišćenje bez odlaganja.
English: Tell your doctor about anything else that makes you feel unwell while you are using EMLA.
Croatian: Obavijestite svog liječnika o svemu zbog čega se ne osjećate dobro dok primjenjujete lijek EMLA.
English: The skin thickness decreases over the course of 15 minutes air exposure.
Croatian: Debljina kože smanjuje se tijekom 15 minuta izloženosti zraku.
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria
Croatian: Ovaj lijek je odobren u državama članicama Europskog ekonomskog prostora (EEA) pod sljedećim nazivima:
English: These are normal reactions to the cream and the anaesthetics and will disappear in a short while without any measures being needed.
Croatian: To su normalne reakcije na kremu i anestetike i one će se ubrzo povući bez potrebe za nekim mjerama.
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).
Croatian: Vaš liječnik ili medicinska sestra će skinuti oblog i ukloniti kremu neposredno prije medicinskog postupka (primjerice, neposredno prije uvođenja igle).
English: An application time of 60 minutes may improve the anaesthesia further.
Croatian: Primjena u trajanju od 60 minuta može dodatno pojačati anesteziju.
English: This is the same concentration of local anaesthetics and a similar formulation as for EMLA.
Croatian: To je ista koncentracija lokalnih anaestetika i slična formualcija kao kod lijeka EMLA.
English: The maximum dose is 60 g.
Croatian: Najveća doza je 60 g.
English: These belong to a group of medicines called local anaesthetics.
Croatian: One pripadaju skupini lijekova pod nazivom lokalni anestetici.
English: This ocular reaction may have been influenced by the high pH of the formulation of the emulsion (approximately 9), but is probably also partly a result of the irritative potential of the local anaesthetics themselves.
Croatian: Na ovu očnu reakciju možda je utjecala visoka pH vrijednost formulacije emulzije (približno 9), ali je vjerojatno dijelom i posljedica iritacijskog potencijala samih lokalnih anestetika.
English: This is because EMLA can affect the way some medicines work and some medicines can have an effect on EMLA.
Croatian: To je zato jer EMLA može utjecati na djelovanje nekih lijekova, a neki lijekovi mogu utjecati na lijek EMLA.
English: Application time of the cream on the skin
Croatian: Vrijeme primjene kreme na koži
English: Also the loss of protective reflexes may allow corneal irritation and potential abrasion.
Croatian: Također, gubitak zaštitnih refleksa može omogućiti iritaciju i moguću abraziju rožnice.
English: Other medicines and EMLA
Croatian: Drugi lijekovi i EMLA
English: The usual dose for adults and adolescents over 12 years is 2 g (grams).
Croatian: - Uobičajena doza za odrasle i adolescente starije od 12 godina je 2 g (grama).
English: Tingling of the skin around the mouth and numbness of the tongue.
Croatian: - trnci na koži oko usta i utrnulost jezika.
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.
Croatian: Ako primijenite više EMLA kreme nego što su Vam rekli Vaš liječnik, ljekarnik ili medicinska sestra, odmah se obratite nekome od njih, čak i ako ne osjećate nikakve simptome.
English: What EMLA is and what it is used for
Croatian: Što je EMLA i za što se koristi
English: Table 1 Adults and adolescents 12 years of age and above Indication/Procedure
Croatian: Tablica 1 Odrasli i adolescenti u dobi od 12 i više godina Indikacija/Postupak
English: Adults, Adolescents and Children It can be used to numb the skin before:
Croatian: Odrasli, adolescenti i djeca Može se koristiti za umrtvljivanje osjeta na koži prije:
English: Where to put the cream, how much to use and how long to leave it on for will depend on what it is needed for.
Croatian: Gdje ćete nanijeti kremu, koliko kreme ćete primijeniti i koliko dugo ćete je držati, ovisi o tome za što je trebate.
English: 1 Skin
Croatian: 1 koža
English: No specific disturbances to the reproductive process have so far been reported, e.g. an increased incidence of malformations or other directly or indirectly harmful effects on the foetus.
Croatian: Do sada nisu prijavljeni specifični poremećaji reprodukcije, primjerice povećana incidencija malformacija ili drugi izravni ili neizravni štetni učinci na plod.
English: In serious cases of overdose, symptoms may include fits, low blood pressure, slowed breathing, stopped breathing and altered heartbeat.
Croatian: U ozbiljnim slučajevima predoziranja simptomi mogu uključivati napadaje, nizak krvni tlak, usporeno disanje, prestanak disanja i promjene otkucaja srca.
English: Prior to removal of mollusca in children with atopic dermatitis it is recommended to apply cream for 30 minutes.
Croatian: Prije odstranjivanja moluska kod djece s atopijskim dermatitisom preporučuje se primijeniti kremu tijekom 30 minuta.
English: A shorter application time, 15-30 minutes, may be sufficient (see section 5.1).
Croatian: Možda će biti dovoljno kraće vrijeme primjene, 15-30 minuta (vidjeti dio 5.1).
English: The table is based on adverse events reported during clinical trials, and/or post-marketing use.
Croatian: Tablica se temelji na nuspojavama prijavljenima tijekom kliničkih ispitivanja i/ili nakon stavljanja lijeka u promet.
English: The time needed to achieve reliable anaesthesia of intact skin is 1 to 2 hours, depending on the type of procedure.
Croatian: Vrijeme potrebno za postizanje pouzdane anestezije neoštećene kože iznosi 1 do 2 sata, ovisno o vrsti postupka.
English: Similarly, local anaesthesia of the male genitals is achieved after 15 minutes.
Croatian: Slično tome, lokalna anestezija muških spolnih organa postiže se nakon 15 minuta.
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.
Croatian: Maksimalna koncentracija ne ovisi o dobi bolesnika, ali je u značajnoj korelaciji (p<0,01) s veličinom područja ulkusa.
English: When applied in the vicinity of the eyes, EMLA should be used with particular care since it may cause eye irritation.
Croatian: Kada se nanosi u blizini očiju, EMLA se mora primjenjivati s posebnim oprezom jer može izazvati iritaciju oka.
English: Tests on laboratory animals have shown that EMLA has an ototoxic effect when instilled into the middle ear.
Croatian: Ispitivanja na laboratorijskim životinjama pokazala su da EMLA ima ototoksičan učinak kada se ukapa u srednje uho.
English: Ringing in the ears.
Croatian: - zamagljen vid. - zvonjenje u ušima.
English: The quality of anaesthesia depends upon the application time and the dose.
Croatian: Kvaliteta anestezije ovisi o vremenu primjene i dozi.
English: If any of these problems are present, check with your doctor or pharmacist before using the cream.
Croatian: Ako je prisutan bilo koji od tih problema, provjerite sa svojim liječnikom ili ljekarnikom prije primjene kreme.
English: Due to insufficient data on absorption, EMLA should not be applied to open wounds (excluding leg ulcers).
Croatian: Zbog nedostatnih podataka o apsorpciji, EMLA se ne smije nanositi na otvorene rane (izuzev ulkusa na nogama).
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”).
Croatian: Primjena u trajanju duljem od 30 minuta može izazvati povećan broj lokalnih kožnih reakcija (pogledajte i dio 4 “Moguće nuspojave”).
English: Lidocaine and prilocaine have bacteriocidal and antiviral properties in concentrations above 0.5-2%.
Croatian: Lidokain i prilokain imaju baktericidna i protuvirusna svojstva u koncentracijama iznad 0,5-2%.
English: The details of the Indications or Procedures for use, with Dosage and Application Time are provided in Tables 1 and 2.
Croatian: Pojedinosti o indikacijama ili postupcima kod kojih se primjenjuje te doziranju i vremenu primjene navedene su Tablicama 1 i 2.
English: o superficial surgical procedures; in adults and in the paediatric population
Croatian: o površinskih kirurških zahvata; kod odraslih i u pedijatrijskoj populaciji.
English: • Cimetidine or beta-blockers, which may cause an increase in the blood levels of lidocaine.
Croatian: • Cimetidin ili beta-blokatore, koji mogu uzrokovati porast razina lidokaina u krvi.
English: Always use EMLA exactly as your doctor, pharmacist or nurse has told you.
Croatian: Uvijek primijenite lijek EMLA točno onako kako su Vam rekli Vaš liječnik, ljekarnik ili medicinska sestra.
English: Persons frequently applying or removing cream should ensure that contact is avoided in order to prevent the development of hypersensitivity.
Croatian: Osobe koje često nanose ili uklanjaju kremu moraju se pobrinuti da izbjegavaju kontakt s njom kako bi se spriječio razvoj reakcija preosjetljivosti.
English: months1) 2) 3)
Croatian: 0-2 mjeseca1) 2) 3)
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.
Croatian: Lokalni anestetski učinak poboljšava se s produljenjem vremena primjene od 1 do 2 sata na većini dijelova tijela, osim na koži lica i muških spolnih organa.
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).
Croatian: - Uobičajena doza ovisi o dobi djeteta i primjenjuje se tijekom 30 do 60 minuta (30 minuta ako bolesnik ima atopijski dermatitis).
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).
Croatian: - Kod odraslih i adolescenata starijih od 12 godina krema se stavlja najmanje 60 minuta prije postupka (osim ako se krema ne primjenjuje na spolnim organima).
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.
Croatian: U kliničkim ispitivanjima lijeka EMLA na neoštećenoj koži nisu primijećene razlike u sigurnosti ni djelotvornosti (uključujući vrijeme nastupa anestezije) između starijih bolesnika (u dobi od 65 do 96 godina) i mlađih bolesnika.
English: Children 6-11 years
Croatian: Djeca od 6-11 godina
English: Inside the nose, ear or mouth.
Croatian: - unutar nosa, uha ili usta. - u analnom otvoru (anusu).
English: Irritation of the eyes if EMLA accidentally comes into contact with them during treatment of the skin.
Croatian: - Nadraženost očiju ako EMLA slučajno dođe u kontakt s njima tijekom primjene na koži.
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.
Croatian: Ako primijetite uznemirujuće ili neuobičajene učinke tijekom primjene lijeka EMLA, prestanite ga primjenjivati i što prije provjerite sa svojim liječnikom ili ljekarnikom.
English: The cream is put on under a dressing for 2 to 5 hours.
Croatian: - Krema se primjenjuje pod oblogom tijekom 2 do 5 sati.
English: This is done for 15 minutes on male genital skin and for 60 minutes on female genital skin.
Croatian: Primjena traje 15 minuta na koži muških spolnih organa, a 60 minuta na koži ženskih spolnih organa.
English: A doctor or nurse should supervise the use of EMLA on the genitals.
Croatian: Liječnik ili medicinska sestra moraju nadgledati primjenu lijeka EMLA na spolnim organima.
English: However, animal studies do not indicate any direct or indirect negative effects on pregnancy, embryo-foetal development, parturition or postnatal development.
Croatian: Međutim, ispitivanja na životinjama ne upućuju na izravne ni neizravne učinke na trudnoću, razvoj embrija/fetusa, okot i postnatalni razvoj.
English: It is reasonable to assume that lidocaine and prilocaine have been used in a large number of pregnant women and women of childbearing age.
Croatian: Razumno je pretpostaviti da su lidokain i prilokain primijenjeni velikom broju trudnica i žena reproduktivne dobi.
English: Remove the plastic backing.
Croatian: Skinite plastični okvir.
English: Lidocaine crosses the placental barrier by means of simple diffusion.
Croatian: Lidokain prolazi placentarnu barijeru jednostavnom difuzijom.
English: Paediatric patients with atopic dermatitis
Croatian: Pedijatrijski bolesnici s atopijskim dermatitisom
English: Elderly No dose reduction is necessary in elderly patients (see sections 5.1 and 5.2).
Croatian: Nije potrebno smanjivati dozu kod starijih bolesnika (vidjeti dijelove 5.1 i 5.2).
English: They both stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby producing local anaesthesia.
Croatian: Obje tvari stabiliziraju neuronske membrane inhibirajući protok iona potreban za nastanak i provođenje impulsa te tako ostvaruju lokalnu anesteziju.
English: Neither local anaesthetic showed a genotoxic potential in either in vitro or in vivo genotoxicity tests.
Croatian: Niti jedan od ova dva lokalna anestetika nije pokazao genotoksičan potencijal ni u in vitro ni u in vivo ispitivanjima genotoksičnosti.
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.
Croatian: 5) EMLA je primijenjena za liječenje ulkusa na nogama do 15 puta u razdoblju od 1 do 2 mjeseca bez gubitka djelotvornosti ili povećanja broja i težine nuspojava.
English: When lidocaine and prilocaine were combined, only additive effects were seen, with no indication of synergism or unexpected toxicity.
Croatian: Kada su se lidokain i prilokain davali u kombinaciji, zabilježeni su samo aditivni učinci, bez znakova sinergizma ili neočekivane toksičnosti.
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.
Croatian: Ako je potrebna visoka preciznost doziranja kako bi se spriječilo predoziranje (npr. kod doza blizu maksimalnih kod novorođenčadi ili ako bi mogle biti potrebne dvije primjene unutar 24 sata), može se upotrijebiti štrcaljka gdje je 1 ml = 1 g.
English: EMLA can be used before cleansing of leg ulcers for up to 15 times over a period of 1-2 months.
Croatian: - EMLA se može primijeniti prije čišćenja ulkusa na nogama najviše 15 puta tijekom razdoblja od 1-2 mjeseca.
English: EMLA contains two active substances called lidocaine and prilocaine.
Croatian: EMLA sadrži dvije djelatne tvari koje se zovu lidokain i prilokain.
English: 1) In term newborn infants and infants below 3 months, only one single dose should be applied in any 24
Croatian: 1) Kod terminske novorođenčadi i dojenčadi mlađe od 3 mjeseca, primjenjuje se samo jedna jednokratna doza u razdoblju od 24 sata.
English: • Cleansing or removal of damaged skin of leg ulcers
Croatian: čišćenja ili odstranjivanja oštećene kože s ulkusa na nogama
English: • in preterm newborn infants with a gestational age less than 37 weeks as they are at risk of developing increased methaemoglobin levels.
Croatian: • kod novorođenčadi rođene prije termina u gestacijskoj dobi manjoj od 37 tjedana, jer kod njih postoji rizik za razvoj povišenih razina methemoglobina.
English: This interaction is of no clinical relevance in short-term treatment with EMLA in recommended doses.
Croatian: Ova interakcija nije klinički značajna kod kratkotrajne primjene lijeka EMLA u preporučenim dozama.
English: EMLA reduces the postoperative pain for up to 4 hours after debridement.
Croatian: EMLA ublažava poslijeoperacijsku bol do 4 sata nakon debridmana.
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.
Croatian: Djelotvornost lijeka EMLA prilikom vađenja krvi iz pete novorođenčadi ili za pružanje odgovarajuće analgezije kod obrezivanja nije potvrđena u kliničkim ispitivanjima.
English: It should be assumed that the toxicity of lidocaine and prilocaine are additive.
Croatian: Treba pretpostaviti da je toksičnost lidokaina i prilokaina aditivna.
English: For children aged 3 months and above, a maximum of 2 doses, separated by at least 12 hours can be given within any 24 hour period, see sections 4.4 and 4.8.
Croatian: Djeci u dobi od 3 mjeseca i starijoj mogu se primijeniti najviše 2 doze u razdoblju od 24 sata, s razmakom od najmanje 12 sati; vidjeti dijelove 4.4 i 4.8.
English: if you take particular medicines for heart rhythm disorders (class III antiarrhythmics, such as amiodarone).
Croatian: - ako uzimate određene lijekove za poremećaje srčanog ritma (antiaritmike skupine III, kao što je amiodaron).
English: Specific interaction studies with lidocaine/prilocaine and anti-arrhythmics class III (e.g. amiodarone) have not been performed, but caution is advised (see also section 4.4).
Croatian: Nisu provedena posebna ispitivanja interakcija lidokaina/prilokaina i antiaritmika skupine III (npr. amiodarona), no savjetuje se oprez (vidjeti i dio 4.4).
English: 10 g of cream should be administered in the lateral vaginal fornices for 10 minutes.
Croatian: 10 g kreme primjenjuje se u lateralne dijelove vaginalnog svoda tijekom 10 minuta.
English: With large doses of EMLA, consideration should be given to the risk of additional systemic toxicity in patients receiving other local anaesthetics or medicinal products structurally related to local anaesthetics, since the toxic effects are additive.
Croatian: Kod primjene visokih doza lijeka EMLA treba uzeti u obzir rizik od dodatne sustavne toksičnosti kod bolesnika koji primaju druge lokalne anestetike ili lijekove strukturno slične lokalnim anesteticima jer su toksični učinci aditivni.
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.
Croatian: Djelotvornost analgezije povećavala se s vremenom primjene od 15 do 90 minuta na normalnoj koži, ali na krvožilnim lezijama primjena u trajanju od 90 minuta nije pružila dodatnu korist u odnosu na primjenu od 60 minuta.
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.
Croatian: Lidokain, i najvjerojatnije i prilokain, izlučuju se u majčino mlijeko, ali u tako malim količinama da pri terapijskoj razini doza općenito ne postoji rizik od utjecaja na dijete.
English: Additional factors include thickness of the skin (which varies in different areas of the body), other conditions such as skin diseases, and shaving.
Croatian: Dodatni faktori su debljina kože (koja je različita na pojedinim dijelovima tijela), druga stanja poput kožnih bolesti te brijanje.
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.
Croatian: Apsorpcija, distribucija, biotransformacija i eliminacija Sistemska apsorpcija lidokaina i prilokaina iz lijeka EMLA ovisi o dozi, području primjene i vremenu primjene.
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.
Croatian: U istraživanjima na životinjama, toksičnost primijećena nakon primjene visokih doza lidokaina ili prilokaina, samih ili u kombinaciji, obuhvaćala je učinke na središnji živčani i kardiovaskularni sustav.
English: EMLA can be used during breastfeeding if clinically needed.
Croatian: EMLA se smije primjenjivati tijekom dojenja ako postoji klinička potreba.
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.
Croatian: EMLA se ne smije primjenjivati na sluznici spolnih organa (npr. rodnice) kod djece (mlađe od 12 godina) zbog nedostatnih podataka o apsorpciji djelatnih tvari.
English: When EMLA is used on the genitals, a doctor or nurse should supervise its use.
Croatian: Kada se EMLA primjenjuje na spolnim organima, liječnik ili medicinska sestra će nadzirati primjenu.
English: Tell your doctor or pharmacist if you are using / taking, have recently used / taken or might use / take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate / primjenjujete ili ste nedavno uzeli / primijenili ili biste mogli uzeti / primijeniti bilo koje druge lijekove.
English: Infants 3-11 months2)
Croatian: Dojenčad od 3-11 mjeseci2)
English: The extent of systemic absorption was approximately 10% following application to the face (10 g/100 cm2 for 2 hours).
Croatian: Opseg sistemske apsorpcije nakon primjene na licu iznosio je približno 10% (10 g/100 cm2 tijekom 2 sata).
English: Squeeze the cream into a mound where it is needed on your skin (for example where the needle is going to be put in).
Croatian: Istisnite kremu na potrebno mjesto na koži (primjerice na mjestu gdje će se uvesti igla).
English: Since the rate of absorption from intact skin is slow, a patient showing signs of toxicity should be kept under observation for several hours following emergency treatment.
Croatian: S obzirom da je apsorpcija kroz neoštećenu kožu spora, bolesnika koji pokazuje znakove toksičnosti potrebno je nadzirati više sati nakon hitnog liječenja.
English: Approx. 1g/10 cm2 for one hour (see details below)
Croatian: Približno 1g/10 cm2 tijekom jednog sata (vidjeti pojedinosti u nastavku)
English: The cleansing procedure should start within 10 minutes of removal of the cream.
Croatian: Postupak čišćenja treba započeti unutar 10 minuta od uklanjanja kreme.
English: 6 - 8 years
Croatian: 6 - 8 godina
English: A dressing is not used.
Croatian: Oblog se ne stavlja.
English: If eye contact occurs, the eye should immediately be rinsed with water or sodium chloride solution and protected until sensation returns.
Croatian: Dođe li do kontakta s očima, oko treba odmah isprati vodom ili otopinom natrijeva klorida i zaštititi do povrata osjeta.
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.
Croatian: Nisu provedena ispitivanja kancerogenosti ni s lidokainom ni s prilokainom, samima ili u kombinaciji, zbog indikacije i trajanja terapijske primjene tih djelatnih tvari.
English: if you or your child have an itchy skin condition called ‘atopic dermatitis', a shorter application time may be sufficient.
Croatian: - ako Vi ili Vaše dijete imate ‘atopijski dermatitis' - kožnu bolest praćenu svrbežom, možda će biti dovoljno kraće vrijeme primjene.