FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label (cartridge)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica (uložak)
English: Paresthesia3 (persistent hypoesthesia and gustatory loss) after mandibular or inferior alveolar nerve blocks
Croatian: Vrlo rijetko Parestezija3 (perzistentna hipoestezija i gubitak osjeta okusa) nakon mandibularnog bloka ili bloka donjeg alveolarnog živca
English: • pain in the neck or at the site of the injection
Croatian: • osip, svrbež • bol u vratu ili na mjestu primjene injekcije
English: 50 x 1.7 ml cartridges 50 x 1.7 ml cartridges, selfaspirating 4 (50 x 1.7 ml) cartridges 8 (50 x 1.7 ml) cartridges
Croatian: 4 x (50 x 1,7 ml) ulošci 8 x (50 x 1,7 ml) ulošci
English: • exfoliation of the injection site
Croatian: • ljuštenje na mjestu primjene injekcije
English: Particular precaution should be used in order to administer the lowest dose leading to efficient anaesthesia in patients with hepatic impairment, in particular after repeated use, although 90% of articaine is first inactivated by unspecific plasma esterases in the tissue and blood.
Croatian: Osobit je oprez potreban kako bi se u bolesnika s oštećenjem funkcije jetre primijenila najniža doza dovoljna za učinkovitu anesteziju, naročito u slučaju ponavljane primjene, iako se 90 % artikaina inaktivira nespecifičnim plazmatskim esterazama u tkivu i krvi.
English: Ergot-type oxytocic drugs (e.g., methysergide, ergotamine, ergonovine):
Croatian: Oksitocinski lijekovi tipa ergot (npr. metisergid, ergotamin, ergonovin):
English: oxymetazoline), used to raise the blood pressure: if used within the past 24 hours, the planned dental treatment has to be postponed.
Croatian: korištene za povišenje krvnog tlaka: ako su korišteni u protekla 24 sata planirani stomatološki zahvat mora se odgoditi.
English: − If you have any further questions, ask your dentist, doctor or pharmacist.
Croatian: Ako imate dodatnih pitanja, obratite se stomatologu, liječniku ili ljekarniku.
English: • use other local anaesthetics, medicines that cause reversible loss of sensation (including volatile anaesthetics such as halothane);
Croatian: • primjenjujete druge lokalne anestetike, lijekove koji uzrokuju prolazni gubitak osjeta (uključujući hlapljive anestetike kao što je halotan);
English: • Burning mouth syndrome
Croatian: • sindrom pečenja usta
English: • nausea, vomiting, diarrhea
Croatian: • mučnina, povraćanje, proljev
English: (hypersensitivity) reaction.
Croatian: (preosjetljivosti).
English: How to store X / Y
Croatian: Kako primjenjivati X/Y
English: Patients receiving treatment with antiplatelets / anticoagulants: {(Invented) name and associated names (see Annex I)} should be administered with caution in patients, who are using antiplatelet/anticoagulant medicines or are suffering from coagulation disorder, because of higher risk of bleeding.
Croatian: {(Novoizumljeno) ime i pridružena imena (vidjeti Prilog I.)} treba primjenjivati oprezno u bolesnika koji uzimaju antitrombocitne/antikoagulantne lijekove ili pate od poremećaja koagulacije zbog većeg rizika od krvarenja.
English: • double vision, temporary blindness
Croatian: • nevoljne kretnje očiju • dvoslike, privremena sljepoća
English: This medicine is given by a slow injection in the oral cavity.
Croatian: Ovaj se lijek daje sporom injekcijom u usnoj šupljini.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: It is not usually necessary to suspend breast-feeding for short-term use, starting from 5 hours following anesthesia.
Croatian: Kod kratkotrajne primjene obično nije potrebno prestati s dojenjem koje se može nastaviti kad protekne 5 sati od primjene.
English: Hypotension (with possible circulatory collapse) Uncommon Hypertension Rare
Croatian: Hipotenzija (s mogućim cirkulatornim kolapsom)
English: At the discretion of the dentist, more cartridges may be required for more extensive procedures without exceeding the maximum recommended dose.
Croatian: Prema procjeni stomatologa, za opsežnije zahvate može biti potrebno i više uložaka pri čemu se ne smije prekoračiti maksimalna preporučena doza.
English: Elevated product plasma levels may occur in these patients in particular after repeated use.
Croatian: U tih bolesnika može doći do povećane razine lijeka u plazmi, osobito nakon ponavljane primjene.
English: Allergic1, anaphylactic / anaphylactoid reactions
Croatian: Alergijske1, anafilaktičke / anafilaktoidne reakcije
English: CNS symptoms (convulsions, CNS depression) must promptly be treated with appropriate airway/respiratory support and the administration of anticonvulsant drugs.
Croatian: Simptomi SŽS-a (konvulzije, depresija SŽS-a) moraju se hitno liječiti odgovarajućim osiguranjem prohodnosti dišnih puteva/disanja te primjenom antikonvulziva.
English: If the concurrent use of these agents cannot be avoided, the dose and rate of administration of this product should be reduced, and the product should be used under strict medical supervision due to possible potentiation of the effects of adrenaline leading to the risk of hypertensive crisis.”
Croatian: Ako se istodobna primjena ne može izbjeći, treba smanjiti dozu i brzinu primjene te lijek primjenjivati pod strogim medicinskim nadzorom zbog mogućeg pojačavanja učinka adrenalina što dovodi do rizika od hipertenzivne krize.
English: • Cardiac impulse formation and conduction disturbances (e.g. 2nd or 3rd degree atrioventricular block,
Croatian: • poremećaja stvaranja srčanih impulsa i provodljivosti (npr. 2. ili 3. stupanj atrioventrikularnog bloka, izražena bradikardija);
English: Elevated product plasma levels may occur in elderly patients in particular after repeated use.
Croatian: U starijih bolesnika može doći do povećanih razina lijeka u plazmi, osobito nakon ponavljane primjene.
English: • serious problems with your liver
Croatian: • ozbiljne probleme s jetrom;
English: • MAO inhibitors used to treat depressive or anxiety disorders (such as moclobemide, phenelzine,
Croatian: • MAO inhibitore korištene za liječenje depresije ili tjeskobe (kao što su moklobemid, fenelzin,
English: Sodium metabisulfite (E223) Sodium hydroxide (for pH-adjustment) Water for injections
Croatian: Natrijev metabisulfit (E223) Natrijev hidroksid (za podešavanje pH) Voda za injekcije
English: • heart and blood pressure medicines (such as guanadrel, guanethidine, propranolol, nadolol,)
Croatian: • lijekove za reguliranje rada srca i krvnog tlaka (kao što su gvanadrel, gvanetidin, propranolol, nadolol);
English: Accidental intravascular injection may cause sudden high levels of adrenaline and articaine in the systemic circulation.
Croatian: Rizik povezan s nehotičnim intravaskularnim injiciranjem: Nehotično intravaskularno injiciranje može uzrokovati iznenadne visoke razine adrenalina i artikaina u sistemskoj cirkulaciji.
English: • tumour called pheochromocytoma;
Croatian: • tumor koji se naziva feokromocitom;
English: Infiltration and perineural use in oral cavity.
Croatian: Infiltracija i perineuralna primjena u usnoj šupljini.
English: Adrenaline impairs the flow of blood in the gums, potentially causing local tissue necrosis.
Croatian: Adrenalin dovodi do poremećaja protoka krvi u desnima i može uzrokovati nekrozu lokalnog tkiva.
English: • recession displacement of the eyeball into the orbit (Enophthalmos)
Croatian: • povlačenje očne jabučice u očnu šupljinu (enoftalmus)
English: • Concomitant treatment with tricyclic antidepressants, as these active substances can intensify the cardiovascular effects of adrenaline.
Croatian: • istodobne terapije tricikličkim antidepresivima jer te djelatne tvari mogu pojačati kardiovaskularne učinke adrenalina (vidjeti dio 4.5)
English: (bronchospasm).
Croatian: (metabolička acidoza).
English: In case of required reinjection, patient should be strictly monitored, to identity any sign of relative overdose (see section 4.9).
Croatian: U slučaju potrebe za ponovnim ubrizgavanjem bolesnike treba strogo nadzirati kako bi se uočio svaki znak relativnog predoziranja (vidjeti dio 4.9).
English: • tricyclic antidepressants used to treat depression (such as amitriptyline, desipramine, imipramine,
Croatian: • tricikličke antidepresive korištene za liječenje depresije (npr. amitriptilin, desipramin, imipramin,
English: Common side effects: may affect up to 1 in 10 people:
Croatian: Česte nuspojave: mogu se javiti u do 1 na 10 osoba:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per cartridge, i.e. it is considered as essentially “sodium free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po ulošku, tj. zanemarive količine natrija.
English: • decreased amounts of oxygen in the body's tissues (hypoxia), high blood potassium (hyperkalaemia)
Croatian: • smanjenu količinu kisika u tkivima u tijelu (hipoksija), visoku razinu kalija u krvi (hiperkalijemija) i metaboličke poremećaje nastale kao posljedica viška kiseline u krvi
English: Disodium edetate
Croatian: Dinatrijev edetat
English: Change patient position to supine position if necessary.
Croatian: Po potrebi polegnite bolesnika na leđa.
English: Single use cylindrical class I glass cartridge sealed at its base by a mobile rubber plunger and at the top by a rubber seal kept in place by an aluminium cap.
Croatian: Cilindrični stakleni uložak (staklo tipa I) za jednokratnu primjenu zatvoren na dnu pomičnim gumenim klipom, a na vrhu gumenim zatvaračem kojeg pridržava aluminijska kapica.
English: • Patients with susceptibility of acute angle-closure glaucoma: This medicinal product should be used cautiously due to the presence of adrenaline.
Croatian: • Bolesnika s predispozicijom za akutni glaukom zatvorenog kuta Ovaj lijek treba koristiti oprezno zbog prisutnosti adrenalina.
English: The anaesthetic duration of articaine 40 mg/mL with adrenaline 1: 200 000 is of 45 to 60 minutes for pulpal anaesthesia and 120 to 300 minutes for soft tissue anaesthesia.
Croatian: Trajanje anestezije nakon primjene artikaina 40 mg/ml s adrenalinom 1:200 000 je 45 do 60 minuta u slučaju anestezije pulpe te 120 do 300 minuta u slučaju anestezije mekog tkiva.
English: Adrenaline is a vasoconstrictor added to articaine to slow down absorption into the systemic circulation and thus prolong maintenance of active articaine tissue concentration.The volume of distribution in plasma was about 4 l/kg.
Croatian: Adrenalin je vazokonstriktor dodan artikainu kako bi usporio apsorpciju u sistemsku cirkulaciju i time produljio održavanje aktivne koncentracije artikaina u tkivu.
English: 4 Several adverse events, like agitation, anxiety / nervousness, tremor, speech disorder may be warning signs before CNS depression.
Croatian: 4 Nekoliko štetnih događaja kao što su agitacija, anksioznost/nervoza, tremor, poremećaji govora,
English: Diplopia (paralysis of oculomotor muscles)4
Croatian: Diplopija (paraliza okulomotornih mišića) Poremećaj vida (privremena sljepoća)4
English: Vasoconstriction
Croatian: Vazokonstrikcija
English: Dysgeusia (e.g., taste metallic, taste disturbance)
Croatian: Disgeuziju (npr. metalni okus,
English: Other side effects not listed above may also occur in some patients.
Croatian: U nekih se bolesnika mogu pojaviti i druge nuspojave koje nisu navedene u prethodnom tekstu.
English: Reproductive toxicity studies conducted with articaine 40 mg/ml + adrenaline 10 micrograms/ml administered by the subcutaneous route at doses up to 80 mg/kg/day revealed no adverse effects on fertility, embryonal/foetal development, or pre- and postnatal development.
Croatian: adrenalinom 10 mikrograma/ml primijenjenima supkutanim putem u dozama do 80 mg/kg/dan nisu otkriveni štetni učinci na plodnost, embriofetalni razvoj ili pre- i post-natalni razvoj.
English: The anaesthetic duration of articaine 40 mg/mL with adrenaline 1: 100 000 is of 60 to 75 minutes for pulpal anaesthesia and 180 to 360 minutes for soft tissue anaesthesia.
Croatian: Trajanje anestezije nakon primjene artikaina 40 mg/ml s adrenalinom 1:100 000 je 60 do 75 minuta u slučaju anestezije pulpe te 180 do 360 minuta u slučaju anestezije mekog tkiva.
English: 4.9 Overdose
Croatian: 4.9 Predoziranje Vrste predoziranja
English: Patients with myasthenia gravis treated by acetylcholinesterase inhibitors: The lowest dose leading to effective anaesthesia should be used.
Croatian: Bolesnici s miastenijom gravis liječeni inhibitorima acetilkolinesteraze Treba koristiti najnižu dozu koja omogućava učinkovitu anesteziju.
English: (TCAs) Tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine, nortriptyline, maprotiline and protriptyline):
Croatian: Triciklički antidepresivi (npr. amitriptilin, desipramin, imipramin, nortriptilin, maprotilin i protriptilin):
English: • a disease called angle-closure glaucoma which affects your eyes;
Croatian: • bolest zvanu glaukom zatvorenog kuta koja pogađa
English: The symptoms are dose-dependent and have progressive severity in the realm of neurological manifestations (presyncope, syncope, headache, restlessness, agitation, confusional state, disorientation, dizziness (lightheadedness), tremor, stupor, deep CNS depression, loss of consciousness, coma, convulsion (including tonic-clonic seizure), speech disorder (e.g., dysarthria, logorrhea), vertigo, balance disorder (disequilibrium)), eyes manifestations (mydriasis, vision blurred, accommodation disorder) followed by vascular (pallor (local, regional, general)), respiratory (apnoea (respiratory arrest), bradypnoea, tachypnoea, yawning, respiratory depression) and finally cardiac (cardiac arrest, myocardial depression) toxicity.
Croatian: poremećaj govora (npr. dizartrija, logoreja), vrtoglavica, poremećaj ravnoteže) i očnih manifestacija (midrijaza, zamagljen vid, poremećaj akomodacije) te praćeno vaskularnom (bljedilo (lokalno, regionalno, opće)), respiratornom (apneja (respiratorni arest), bradipneja, tahipneja, zijevanje, respiratorna depresija) i naposljetku kardijalnom (srčani arest, depresija miokarda) toksičnošću.
English: • drooping of the eyelid, and constriction of the pupil (Horner's syndrome)
Croatian: • spuštanje očnog kapka i sužavanje zjenice (Hornerov sindrom)
English: Due to the lack of clinical data, particular precaution should be used in order to administer the lowest dose leading to effective anaesthesia in elderly patients and in patients with renal disorders.
Croatian: Zbog nedostatka kliničkih podataka, poseban oprez potreban je prilikom davanja minimalne doze koja uzrokuje učinkovitu anesteziju u starijih bolesnika te u bolesnika s poremećajem funkcije bubrega
English: Psychiatric disorders Rare
Croatian: Psihijatrijski poremećaji
English: • Patients with paroxysmal tachycardia or absolute arrhythmias with rapid heart rate
Croatian: • bolesnika s paroksizmalnom tahikardijom ili fibrilacijom atrija s brzim odgovorom ventrikla
English: Ptosis
Croatian: Ptoza
English: Talk to your dentist before using X / Y if you suffer from any of the following conditions:
Croatian: Upozorenja i mjere opreza Obratite se stomatologu prije primjene lijeka X/Y ako imate bilo koje od niže navedenih stanja:
English: Elevated product plasma levels may occur in patients with cholinesterase deficiency or under acetylcholinesterase inhibitors treatment since the product is inactivated at 90% by plasmatic esterases.
Croatian: U bolesnika s nedostatkom kolinesteraze ili na terapiji inhibitorima acetilkolinesteraze može doći do povećane razine lijeka u plazmi jer se i do 90 % lijeka inaktivira plazmatskim esterazama.
English: Symptoms of overdose include severe weakness, paleness of the skin, headache, feeling agitated or restless, feeling disorientated, losing your balance, involuntary trembling or quivering, dilation of the pupil, blurred vision, problems clearly focusing an object, speech disorders, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid breathing which could lead to temporarily stopping breathing, failure of the heart to contract effectively (called cardiac arrest).
Croatian: Simptomi predoziranja uključuju tešku slabost, blijedu kožu, glavobolju, osjećaj uznemirenosti ili nemira, dezorijentiranost, gubitak ravnoteže, nevoljno drhtanje ili tresenje, širenje zjenica, zamagljen vid, otežano jasno fokusiranje predmeta, poremećaje govora, omaglicu,
English: Total volume (ml) and equivalent in number of cartridges (1.7 ml) (2.1 cartridges) (3.1 cartridges) (4.1 cartridges) (5.6 cartridges)
Croatian: (1,7 ml) (2,1 uloška) (3,1 uloška) (4,1 uloška) (5,6 uložaka)
English: Subcutaneous injections of articaine combined with adrenaline induced adverse effects from 50 mg/kg/day in rats and 80 mg/kg/day in dogs after 4 weeks daily repeated administrations.
Croatian: 50 mg/kg/dan u štakora te 80 mg/kg/dan u pasa nakon 4 tjedna svakodnevne ponavljane primjene.
English: Patients with epileptic disease: Because of their convulsive actions, all local anaesthetics should be used very cautiously.
Croatian: Zbog konvulzivnog učinka, lokalni anestetici trebaju se koristiti vrlo oprezno.
English: • absolute overdose,
Croatian: • apsolutno predoziranje • relativno predoziranje:
English: The availability of appropriate resuscitation equipment and medication should be ensured before induction of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.
Croatian: Prije uvođenja regionalne anestezije lokalnim anesteticima potrebno je osigurati dostupnost odgovarajuće opreme i lijekova za reanimaciju kako bi se u slučaju potrebe odmah moglo započeti s liječenjem bilo kakvih respiratornih i kardiovaskularnih hitnih stanja.
English: The safety of {(Invented) name and associated names (see Annex I)} in children aged 4 years and below has not been established.
Croatian: Sigurnost primjene {(Novoizumljeno) ime i pridružena imena (vidjeti Prilog I.)} u djece u dobi od
English: Contradictory findings were raised from in-vitro and in-vivo genotoxicity studies with adrenaline.
Croatian: In vitro i in vivo ispitivanja genotoksičnosti adrenalina dala su kontradiktorne rezultate.
English: • Sodium: less than 23 mg sodium per cartridge, meaning it is essentially "sodium free".
Croatian: • Natrij: manje od 23 mg natrija po ulošku, tj. zanemarive količine natrija.
English: The combination articaine hydrochloride with adrenaline tartrate solution for injection may have a minor influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Primjena kombinacije artikainklorida i adrenalintartarata u obliku otopine za injekciju mogla bi malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: • inflammation of the tongue and mouth
Croatian: • visok krvni tlak • upala jezika i usta
English: Dental use.
Croatian: Dentalno.
English: • sympathomimetic vasopressors (such as cocaine, amphetamines, phenylephrine, pseudoephedrine,
Croatian: • simpatomimetike (kao što su kokain, amfetamini, fenilefrin, pseudoefedrin, oksimetazolin)
English: The availability of resuscitation equipment and medication should be ensured before administration of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.
Croatian: Prije primjene regionalne anestezije lokalnim anesteticima mora se osigurati dostupnost opreme i lijekova za reanimaciju kako bi se u slučaju potrebe moglo odmah započeti s liječenjem bilo kakvih respiratornih i kardiovaskularnih hitnih stanja.
English: Total volume (ml) and equivalent in number of cartridges (1.7 ml) (4.1 cartridges) (5.2 cartridges) (6.2 cartridges)
Croatian: (1,7 ml) (4,1 uloška) (5,2 uložaka) (6,2 uložaka)
English: • Patients with cardiovascular diseases (e.g. heart failure, coronary heart disease, history of myocardial infarction, cardiac arrhythmia, hypertension)
Croatian: • Bolesnika s kardiovaskularnim bolestima (npr. zatajenje srca, koronarna bolest srca, infarkt miokarda u anamnezi, srčana aritmija, hipertenzija) • Bolesnika s poremećajem cerebralne cirkulacije, moždani udar u anamnezi
English: Reduced doses of this medicinal product should be used due to sensitization of the heart to the arrhythmogenic effects of catecholamines: risk of severe ventricular arrhythmia.
Croatian: Treba koristiti manje doze ovog lijeka zbog senzibilizacije srca na aritmogene učinke katekolamina:
English: No genotoxicity effect was observed during in-vitro and in-vivo studies conducted with articaine alone or in an in vivo study conducted with articaine in combination with adrenaline.
Croatian: Tijekom in vitro i in vivo ispitivanja provedenih sa samim artikainom ili tijekom in vivo ispitivanja kombinacije artikaina s adrenalinom nisu uočeni genotoksični učinci.
English: In attendance of these signs, patients should be requested to hyperventilate and surveillance should be instituted (see Section 4.9 of SmPC).
Croatian: Ako se pojave ti znakovi, od bolesnika treba zahtijevati da hiperventilira te je potrebno uspostaviti nadzor (vidjeti dio 4.9).
English: 10 DATE OF REVISION OF THE TEXT [To be completed nationally]
Croatian: 10 DATUM REVIZIJE TEKSTA
English: Patients with severe hepatic disease:
Croatian: Bolesnici s teškom bolešću jetre
English: Total volume (ml) and equivalent in number of cartridges (1.7 ml)
Croatian: Ukupan volumen (ml) i odgovarajući broj uložaka
English: Special precautions for disposal and other handling
Croatian: Posebne mjere opreza pri zbrinjavanju i rukovanju
English: A reduced amount of adrenaline in dental anaesthesia should be given to patients on COMT inhibitors.
Croatian: Bolesnicima koji uzimaju COMT inhibitore treba dati manju količinu adrenalina pri dentalnoj anesteziji.
English: The maximum safe dose of local anaesthetic may be reduced in sedated patients due to an additive effect on central nervous system depression.
Croatian: Istodobna primjena sedativa za smanjenje anksioznosti u bolesnika: Maksimalna sigurna doza lokalnog anestetika može biti manja u sediranih bolesnika zbog aditivnog učinka na depresiju središnjeg živčanog sustava.
English: Persistent paresthesia, mostly following nerve blocks in the mandible, is characterized by slow, incomplete, or lack of recovery.
Croatian: Perzistentna parestezija, najčešće nakon blokada živaca u donjoj čeljusti, karakterizirana je sporim,
English: • muscle twitch, involuntary muscle contraction
Croatian: • koprivnjača (urtikarija) • trzaji mišića, nevoljno stezanje mišića
English: For more complex procedures, such as requiring pronounced hemostasis, it is preferable to use {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml.
Croatian: Za složenije zahvate, kod kojih je važna optimalna hemostaza, bolje je primijeniti {(Novoizumljeno) ime i pridružena imena (vidjeti Prilog I.)} 40 mg/ml + 10 mikrograma/ml.
English: The maximum safe dose of local anaesthetics may be reduced in sedated patients due to an additive effect on central nervous system depression (see section 4.5).
Croatian: Istodobna primjena sedativa za smanjenje anksioznosti u bolesnika: Maksimalna sigurna doza lokalnog anestetika može biti manja u sediranih bolesnika zbog aditivnog učinka na depresiju središnjeg živčanog sustava (vidjeti dio 4.5).
English: • feeling hot or feeling cold
Croatian: • osjećaj vrućine ili hladnoće • nemogućnost otvaranja usta
English: Excipients with known effect: sodium metabisulfite (E223), sodium chloride, disodium edetate, sodium hydroxide.
Croatian: Pomoćne tvari s poznatim učinkom: natrijev metabisulfit (E223), natrijev klorid, dinatrijev edetat, natrijev hidroksid.
English: Dental use
Croatian: Dentalno
English: (see section 4.5)
Croatian: (dio 4.4 i 5.2).
English: Clear colourless solution.
Croatian: Prozirna, bezbojna otopina.
English: Gingival / oral mucosal exfoliation (sloughing) / ulceration Not known Dysphagia Swelling of cheeks Glossodynia
Croatian: Eksfolijacija (ljuštenje) / ulceracija sluznice gingive/usta Nepoznato Disfagija Oticanje obraza
English: Hot flush
Croatian: Navale vrućine
English: 8 MARKETING AUTHORISATION NUMBER [To be completed nationally]
Croatian: 8 BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET