FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus, to ensure that the needle does not penetrate a blood vessel during injection, aspiration should be performed before the local anaesthetic product is injected.
Croatian: Stoga, kako bi se osiguralo da igla ne penetrira u krvnu žilu tijekom injiciranja, potrebno je provesti aspiraciju prije primjene lokalnog anestetika.
English: Concomitant use of the other medicinal products may require thorough monitoring (see section 4.5).
Croatian: Istodobna primjena drugih lijekova može zahtijevati temeljito praćenje (vidjeti dio 4.5).
English: − speech disturbances, excessive talkativeness;
Croatian: − poremećaj govora, pretjerana pričljivost;
English: Sedatives (central nervous system depressants)
Croatian: Sedativi (depresori središnjeg živčanog sustava):
English: Therefore, as a precautionary measure, it is preferable to avoid the use of mepivacaine during pregnancy, unless necessary.
Croatian: Stoga, kao mjera opreza, preporučuje se izbjegavati primjenu mepivakaina tijekom trudnoće, osim ako je neophodno.
English: For poorly controlled epileptic patients, see section 4.3.
Croatian: Za bolesnike sa slabo kontroliranom epilepsijom vidjeti dio 4.3. Bolesnici s bolešću jetre:
English: • Heart disorders due to the abnormality of the electronic impulse triggering the heart beat (severe conduction disturbances);
Croatian: • Poremećaja srca uslijed abnormalnosti električnih impulsa koji pokreću otkucaje srca (teške smetnje u provođenju);
English: As all amide-type local anaesthetics, mepivacaine is largely metabolised in the liver by microsomal enzymes (cytochrome P450 1A2 (CYP1A2)).
Croatian: Kao i svi lokalni anestetici amidnog tipa, mepivakain se u velikoj mjeri metabolizira u jetri pomoću mikrosomalnih enzima (citokrom P450 1A2 (CYP1A2)).
English: The mepivacaine displays slight vasoconstrictive properties leading to a longer duration of action than with most other local anesthetics when administered without a vasoconstrictor.
Croatian: Mepivakain pokazuje blaga vazokonstriktivna svojstva koja vode do dužeg trajanja djelovanja nego kod većine drugih lokalnih anestetika kada se primjenjuju bez vazokonstriktora.
English: Tabulated list of adverse reactions The reported adverse effects come from spontaneous reporting and literature.
Croatian: Prijavljeni štetni događaji potječu od spontanog prijavljivanja i iz literature.
English: CNS toxicity occurs gradually, with symptoms and reactions of progressively increasing severity.
Croatian: Toksičnost središnjeg živčanog sustava pojavljuje se postupno, sa simptomima i reakcijama čija se težina progresivno povećava.
English: Mepivacaine distribution covers all body tissues.
Croatian: Distribucija mepivakaina pokriva sva tkiva tijela.
English: − pain due to nerve damage (neuropathic pain);
Croatian: − bol uslijed oštećenja živca (neuropatska bol);
English: Pulp anaesthesia generally lasts approximately 25 minutes after maxillary infiltration and around 40 minutes after inferior alveolar block, whereas anaesthesia of soft tissue was maintained around up to 90 minutes after maxillary infiltration and approximatively 165 minutes after inferior alveolar nerve block.
Croatian: Anestezija pulpe obično traje otprilike 25 minuta nakon maksilarne infiltracije i oko 40 minuta nakon bloka donjeg alveolarnog živca, dok se anestezija mekog tkiva održava do oko 90 minuta nakon maksilarne infiltracije i otprilike 165 minuta nakon bloka donjeg alveolarnog živca.
English: This medicine is given as an injection in the oral cavity.
Croatian: Ovaj lijek se primjenjuje kao injekcija u usnoj šupljini.
English: As for any cartridge, the diaphragm should be disinfected prior to use.
Croatian: Kao što vrijedi i za bilo koji uložak, dijafragmu je potrebno dezinficirati prije uporabe.
English: Studies revealed, that mepivacaine has vasoconstrictive properties.
Croatian: Istraživanja su otkrila da mepivakain ima vazokonstriktivna svojstva.
English: − failure of the heart to contract effectively (myocardial depression);
Croatian: − nemogućnost učinkovite kontrakcije srca (depresija miokarda);
English: wheezing/asthma, hives (urticaria): these might be symptoms of hypersensitivity reactions (allergic or allergy-like reactions);
Croatian: koprivnjača (urtikarija): ovo mogu biti simptomi reakcija preosjetljivosti (alergijskih ili onih sličnih alergijskim reakcijama);
English: Respiratory depression Bradypnoea
Croatian: Rijetko Respiratorna depresija Bradipneja
English: Mepivacaine has a rapid onset, a high potency of anaesthesia and a low toxicity.
Croatian: Mepivakain ima brz nastup djelovanja, visoko je potentan anestetik i niske je toksičnosti.
English: In vitro and in vivo testing carried out on mepivacaine hydrochloride did not reveal any genotoxic effect of this product.
Croatian: In vitro i in vivo ispitivanja provedena s mepivakainkloridom nisu otkrila nikakve genotoksične učinke ovog lijeka.
English: Equivalent* in cartridge numbers (1.7 ml)
Croatian: Ekvivalent* u broju uložaka (1,7 ml)
English: In order to avoid intraneural injection and to prevent nerve injuries in connection with nerve blockades, the needle should always be slightly withdrawn if electric shock sensation is felt by the patient during injection or if the injection is particularly painful.
Croatian: Da bi se izbjeglo intraneuralno injiciranje i da bi se spriječila ozljeda živca povezana s blokadama živca, iglu treba uvijek lagano izvući ukoliko se tijekom injiciranja bolesniku javi osjećaj strujnog udara ili ako je injiciranje naročito bolno.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na reprodukciju.
English: Risk of biting trauma (lips, cheeks, mucosa, and tongue) exists, especially in children; the patient should be told to avoid chewing gum or eating until normal sensation is restored.
Croatian: Postoji rizik od ugrizne ozljede (usana, obraza, sluznice i jezika), posebno u djece; bolesnika treba upozoriti da ne smije žvakati žvakaće gume niti jesti dok mu se ne vrati normalan osjet.
English: If sedative medication is administered, the maximum safe dose of mepivacaine may be reduced due to an additive effect of the combination on central nervous system depression (see section 4.5).
Croatian: Ukoliko je primijenjeno liječenje sedativom, maksimalna sigurna doza mepivakaina može se smanjiti zbog aditivnog učinka kombinacije na depresiju središnjeg živčanog sustava (vidjeti dio 4.5).
English: • Children below 4 years of age (ca. 20 kg body weight),
Croatian: • Djeca mlađa od 4 godine (tjelesne težine manje od približno 20 kg),
English: The maximum recommended dose in pediatric population is 3 mg of mepivacaine/kg (0.1 ml mepivacaine/kg).
Croatian: Maksimalna preporučena doza u pedijatrijskoj populaciji iznosi 3 mg mepivakaina/kg (0,1 ml mepivakaina/kg).
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted.>
Croatian: <Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.>
English: If there is any risk of an allergic reaction, choose different medicine for anaesthesia (see Section 4.3).
Croatian: Ukoliko postoji bilo koji rizik od alergijske reakcije, potrebno je primijeniti drugi lijek za anesteziju (vidjeti dio 4.3).
English: Epileptic patients:
Croatian: Bolesnici s epilepsijom:
English: • Epilepsy not adequately controlled by treatment; - In children below 4 years of age (ca. 20 kg in body weight).
Croatian: • Epilepsije koja nije odgovarajuće kontrolirana liječenjem; - U djece mlađe od 4 godine (tjelesne težine manje od približno 20 kg).
English: Mepivacaine reversibly inhibits the conduction of nerve impulses by decreasing or blocking sodium (Na+) flow during propagation of the nerve action potential.
Croatian: Mepivakain reverzibilno inhibira provođenje živčanih impulsa na način da smanjuje ili blokira protok natrija (Na+) tijekom propagacije akcijskog potencijala živca.
English: Do not use this medicine after the expiry date, which is stated on the cartridge label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici uloška i kutiji iza oznake EXP.
English: In attendance of these signs, patients should be requested to hyperventilate and surveillance should be instituted (see Section 4.9.)
Croatian: U slučaju prisutnosti ovih znakova, bolesnike je potrebno zatražiti da hiperventiliraju te je potrebno uspostaviti nadzor (vidjeti dio 4.9)
English: Delay in proper management of dose-related toxicity, under ventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death.
Croatian: Odgađanje odgovarajućeg liječenja toksičnosti vezane uz dozu, hipoventilacija zbog bilo kojeg uzroka i/ili izmijenjena osjetljivost mogu dovesti do razvoja acidoze, srčanog zastoja i moguće smrti.
English: Paediatric population {Scandonest and associated names} is contraindicated in children below 4 years of age (ca. 20 kg body weight) (see section 4.3).
Croatian: Pedijatrijska populacija {Scandonest i pridružena imena} je kontraindiciran u djece mlađe od 4 godine (tjelesne težine manje od približno 20 kg) (vidjeti dio 4.3).
English: If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor, and/or inotropic agents should be considered.
Croatian: Ukoliko se pojavi depresija kardiovaskularnog sustava (hipotenzija, bradikardija), potrebno je razmotriti odgovarajuće liječenje primjenom intravenskih tekućina, vazopresorom i/ili inotropnim sredstvima.
English: The medicine is used in local dental procedures in adults, adolescents and children above 4 years of age (ca. 20 kg in body weight).
Croatian: Lijek se primjenjuje u lokalnim stomatološkim zahvatima u odraslih, adolescenata i djece starije od 4 godine (tjelesne težine od približno 20 kg i veće).
English: Caution should be exercised when mepivacaine is administered concomitantly with propranolol.
Croatian: Oprez je potreban kada se mepivakain primjenjuje istodobno s propranololom.
English: It is packed in a glass cartridge with a rubber seal kept in place by an aluminium cap.
Croatian: Opremljen je u stakleni uložak s gumenim zatvaračem kojeg pridržava aluminijska kapica.
English: Patients who are being treated with antiarrhythmic drugs may encounter an accumulation of side effects after the use of mepivacaine due the similarity of structures (such as Class I drug i.e. lidocaine).
Croatian: Bolesnici koji se liječe antiaritmicima mogu iskusiti nakupljanje nuspojava nakon primjene mepivakaina zbog sličnosti u strukturama (kao što je lijek I.skupine tj. lidokain).
English: − vision blurred, problems clearly focusing an object, visual impairment;
Croatian: − zamagljen vid, poteškoće u jasnom fokusiranju predmeta, oštećenje vida;
English: Mepivacaine should be administered with caution in patients, who are using antiplatelet/anticoagulant medicines or are suffering from a coagulation disorder, because of higher risk of bleeding.
Croatian: Mepivakain treba primjenjivati s oprezom u bolesnika koji koriste antitrombocitne/antikoagulacijske lijekove ili boluju od poremećaja koagulacije, zbog većeg rizika od krvarenja.
English: No relevant data reported any toxic effects on fertility in animals with mepivacaine.
Croatian: Niti jedan relevantni podatak ne ukazuje na bilo kakve toksične učinke na plodnost kod životinja pri primjeni mepivakaina.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Posebna upozorenja
English: Toxicity of local anaesthetics is additive.
Croatian: Toksičnost lokalnih anestetika je aditivna.
English: These include inadvertent intravascular injection or abnormal rapid absorption into the systemic circulation, or delayed metabolism and elimination of the product.
Croatian: To uključuje nehotično injiciranje u krvne žile ili abnormalno brzu apsorpciju u sistemsku cirkulaciju ili odgođeni metabolizam i eliminaciju lijeka.
English: Very rare Hypertension Not known Vasodilatation Local/ Regional hyperaemia
Croatian: Nepoznato Vazodilatacija Lokalna/ regionalna hiperemija
English: Given this fact, inhibitors of P450 isoenzymes may decrease its metabolism and increase the risk of adverse effects (see section 4.5.).
Croatian: S obzirom na tu činjenicu, inhibitori P450 izoenzima mogu smanjiti metabolizam mepivakaina i povećati rizik od nuspojava (vidjeti dio 4.5).
English: Contains sodium, see package leaflet for further information.
Croatian: Sadrži natrij, vidjeti uputu o lijeku za dodatne informacije.
English: Equivalent* in cartridge numbers (2.2 ml)
Croatian: Ekvivalent* u broju uložaka (2,2 ml)
English: The medicinal product should only be used by or under the supervision of dentists, stomatologists or other clinicians sufficiently trained and familiar with diagnosis and treatment of systemic toxicity.
Croatian: Lijek se smije koristiti samo od strane ili pod nadzorom stomatologa ili drugih kliničara dovoljno osposobljenih i s iskustvom u dijagnosticiranju i liječenju sistemske toksičnosti.
English: The patient's state of consciousness should be monitored after each local anaesthetic injection.
Croatian: Potrebno je pratiti stanje svijesti bolesnika nakon svakog injiciranja lokalnog anestetika.
English: Overdose of local anaesthetics may be absolute, resulting from the injection of excessive doses, or relative, resulting from the injection of a normally non-toxic dose under particular circumstances.
Croatian: Tipovi predoziranja Predoziranja lokalnim anesteticima mogu biti apsolutna, koja su posljedica injiciranja prekomjernih doza, ili relativna, koja su posljedica injiciranja inače netoksične doze u određenim okolnostima.
English: If needle nerve injuries occur, the neurotoxic effect could be aggravated by mepivacaine's potential chemical neurotoxicity as it may impair the perineural blood supply and prevent mepivacaine local wash-out.
Croatian: Ukoliko se dogodi ozljeda živca iglom, neurotoksični učinak može se pogoršati potencijalnom kemijskom neurotoksičnosti mepivakaina jer može pogoršati perineuralnu opskrbu krvlju te spriječiti lokalno ispiranje mepivakaina.
English: 4.1 Therapeutic indications {Scandonest and associated names (see Annex I) strength pharmaceutical form} is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, adolescents and children above 4 years of age (c.a.
Croatian: 4.1 Terapijske indikacije {Scandonest i pridružena imena (vidjeti Prilog I.) jačina farmaceutski oblik} je lokalni anestetik indiciran za lokalnu i lokoregionalnu anesteziju kod stomatoloških operativnih zahvata u odraslih, adolescenata i djece starije od 4 godine (tjelesne težine od približno 20 kg i veće).
English: Local anaesthetics should only be employed by healthcare professionals who are well versed in diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed.
Croatian: Lokalne anestetike smiju primjenjivati samo zdravstveni radnici s iskustvom u dijagnosticiranju i liječenju toksičnosti vezane uz dozu i ostalih akutnih hitnih stanja koja mogu nastati od bloka koji će se primijeniti.
English: If you experience any of these, administration should immediately be stopped and emergency medical assistance should be summoned.
Croatian: Ako osjetite bilo koji od navedenih simptoma, potrebno je odmah zaustaviti primjenu lijeka i pozvati hitnu medicinsku pomoć.
English: If any of these situations applies to you, tell your dentist.
Croatian: Ukoliko se bilo koje navedeno stanje odnosi na Vas, obavijestite svog stomatologa.
English: Of note, the maximum quantity has to take into account the patient's body weight.
Croatian: Napomena, maksimalna količina lijeka ovisi o bolesnikovoj tjelesnoj težini.
English: Adverse reactions following administration of {Scandonest and associated names} are similar to those observed with other local amide anaesthetics.
Croatian: Nuspojave nakon primjene lijeka {Scandonest i pridružena imena} slične su onima uočenim kod drugih lokalnih amidnih anestetika.
English: − failure of the heart to contract effectively (cardiac arrest), rapid and erratic heartbeats (ventricular fibrillation), severe and crushing chest pain (angina pectoris);
Croatian: − nemogućnost učinkovite kontrakcije srca (srčani zastoj), brzi i nepravilni srčani otkucaji (ventrikularna fibrilacija), teška i pritiskajuća bol u prsnom košu (angina pektoris);
English: Mepivacaine maximum concentrations were reported to be between 0.4 - 1.2 µg/ml at around 30 minutes post-intraoral injection with one cartridge and between 0.95-1.70 µg/ml with two cartridges.
Croatian: Pokazalo se da su maksimalne koncentracije mepivakaina između 0,4 i 1,2 μg/ml oko 30 minuta nakon intraoralnog injiciranja s jednim uloškom i između 0,95-1,70 μg/ml s dva uloška.
English: Cardiovascular symptoms occur at plasma levels exceeding those inducing CNS toxicity and are therefore generally preceded by signs of CNS toxicity, unless the patient is under general anaesthesia or is heavily sedated (e.g. by a benzodiazepine or barbiturate).
Croatian: Kardiovaskularni simptomi pojavljuju se pri razinama u plazmi koja nadmašuje razine koje izazivaju toksičnost središnjeg živčanog sustava te su stoga obično prethođeni znakovima toksičnosti središnjeg živčanog sustava, osim ako bolesnik nije u općoj anesteziji ili je u dubokoj sedaciji (npr., primjenom benzodiazepina ili barbiturata).
English: Caution should be used in case of acidosis such as worsened of renal insufficiency or poorly control of type 1 diabetes mellitus.
Croatian: Potreban je oprez u slučaju acidoze poput pogoršanja bubrežne insuficijencije ili loše kontrole dijabetes melitusa tipa
English: Risk associated with intraneural injection
Croatian: Rizik od slučajnog intraneuralnog injiciranja
English: Nursing mothers are advised not to breastfeed 10 hours following anaesthesia with this product.
Croatian: Dojiljama se ne preporučuje dojiti 10 sati nakon anestezije s ovim lijekom.
English: Peak plasma levels of mepivacaine 30 mg/ml solution following peri-oral injections during dental usual procedures were determined in various clinical studies.
Croatian: Apsorpcija Vršne razine u plazmi otopine mepivakaina koncentracije 30 mg/ml nakon perioralnih injiciranja tijekom uobičajenih stomatoloških postupaka utvrđene su u raznim kliničkim ispitivanjima.
English: As a precautionary measure, it is preferrable to avoid the use of this product during pregnancy, unless necessary.
Croatian: Kao mjera predostrožnosti, poželjno je izbjegavati primjenu ovog lijeka tijekom trudnoće, osim ukoliko je lijek neophodan.
English: Accidental intraneural injection may lead the drug to move in retrograde manner along the nerve.
Croatian: Slučajno intraneuralno injiciranje može rezultirati retrogradnim kretanjem lijeka duž živac.
English: This medicine contains 24.67 mg sodium per 10 ml (maximum recommended dose).
Croatian: Ovaj lijek sadrži 24,67 mg natrija u 10 ml (maksimalna preporučena doza).
English: The average dosage is 0.75 mg/kg = 0.025 ml of mepivacaine solution per kg body weight: ~ ¼ cartridge (15 mg of mepivacaine hydrochloride) for a 20 kg child.
Croatian: Prosječna doza iznosi 0,75 mg/kg = 0,025 ml otopine mepivakaina po kilogramu tjelesne težine: ~ ¼ uloška (15 mg mepivakainklorida) za dijete tjelesne težine od 20 kg.
English: The following symptoms may be signs of toxicity due to excessive doses of local anaesthetics: agitation, a sensation of numbness in the lips and tongue, prickling and tingling around the mouth, dizziness, visual and hearing disturbances, and buzzing in the ears, muscle stiffness and twitching, low blood pressure, low or irregular heart rate.
Croatian: Sljedeći simptomi mogu biti znakovi toksičnosti uslijed prekomjernih doza lokalnih anestetika: uznemirenost, osjećaj utrnulosti usana i jezika, peckanje i trnci oko usta, omaglica, smetnje vida i sluha i zujanje u ušima, ukočenost mišića i trzanje, niski krvni tlak, niska ili nepravilna brzina otkucaja srca.
English: Increased serum levels of amide anaesthetics have also been reported after concomitant administration of cimetidine, which is probably due to the inhibitory effect of cimetidine on CYP1A2.
Croatian: Povišene razine amidnih anestetika u serumu su također utvrđene nakon istodobne primjene s cimetidinom, a koje su vjerojatno posljedica inhibitornog učinka cimetidina na CYP1A2.
English: − confusion, disorientation;
Croatian: − smetenost, dezorijentiranost;
English: 5 mostly in patients with underlying cardiac disease or those receiving certain drugs; 6 in predisposed patients or those with risk factors of ischemic heart disease; 7 hypoxia and hypercapnia are secondary to respiratory depression and / or to seizures and sustained muscular exertion; 8 by accidental biting or chewing of the lips or tongue while the anaesthesia persists.
Croatian: 5. uglavnom u bolesnika s podležećom srčanom bolesti ili u onih koji primaju određene lijekove; 6. u predisponiranih bolesnika ili u onih s faktorima rizika ishemijske bolesti srca; 7. hipoksija i hiperkapnija posljedica su respiratorne depresije i/ili napadaja i kontinuiranog mišićnog napora;
English: The drug administration should take place immediately after opening.
Croatian: Lijek se mora primijeniti odmah nakon otvaranja.
English: Mepivacaine should be administered with caution in patients with impaired cardiac function since they may be less able to compensate or worsen changes due to prolongation of atrio-ventricular conduction.
Croatian: Mepivakain se mora primjenjivati uz oprez u bolesnika sa smanjenom funkcijom srca s obzirom da su manje sposobni kompenzirati ili može doći do pogoršanja promjena izazvanih produženjem u atrio ventrikularnom provođenju.
English: Mepivacaine is metabolized by the liver and can lead to elevated plasma levels in patients with hepatic impairment, in particular after repeated use.
Croatian: Mepivakain se metabolizira u jetri i može dovesti do povišenih vrijednosti u plazmi u bolesnika s oštećenjem funkcije jetre, posebno nakon ponovljene primjene.
English: These adverse reactions are, in general, dose-related and may result from high plasma levels caused by overdose, rapid absorption or unintended intra-vascular injection.
Croatian: Te su nuspojave uglavnom povezane s dozom i mogu biti posljedica visokih razina u plazmi uzrokovanih predoziranjem, brzom apsorpcijom ili nenamjernim intravaskularnim injiciranjem.
English: The clearance of mepivacaine may be reduced when associated with propranolol and it may result in higher serum concentrations of the anaesthetic.
Croatian: Klirens mepivakaina može biti smanjen kada je pridružen propranololu te može rezultirati višim koncentracijama anestetika u serumu.
English: − a feeling of spinning (vertigo);
Croatian: − vrtoglavica (vertigo);
English: Sodium chloride, sodium hydroxide (for pH-adjustment),water for injection.
Croatian: Natrijev klorid, natrijev hidroksid (za podešavanje pH), voda za injekcije.
English: Dialysis is not effective in treating an overdose of Mepivacaine.
Croatian: Dijaliza nije učinkovita u liječenju predoziranja mepivakainom.
English: − ear disturbances, such as ringing in the ears, oversensitivity of hearing;
Croatian: − poremećaji uha kao što je zujanje u ušima, preosjetljivost sluha;
English: X should only be used by or under the supervision of dentists, stomatologists or other, trained clinicians by a slow local injection.
Croatian: X se smije primjenjivati samo od strane ili pod nadozorom stomatologa ili drugih obučenih kliničara, sporom lokalnom injekcijom.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
Croatian: OBLIK I SADRŽAJ Otopina za injekciju.
English: Initial symptoms include agitation, a feeling of intoxication, a sensation of numbness in the lips and tongue, paraesthesia around the mouth, dizziness, visual and hearing disturbances, and buzzing in the ears.
Croatian: Inicijalni simptomi uključuju agitaciju, osjećaj intoksikacije, osjećaj utrnulosti usana i jezika, paresteziju oko usta, omaglicu, smetnje vida i sluha i zujanje u ušima.
English: Cartridges of 1.7 ml or 2.2 ml.
Croatian: Ulošci s 1,7 ml ili 2,2 ml.