FrancophonIA/ELRC3.0 huggingface dataset:
English: The necessary dosage must be determined on an individual basis.
Croatian: Potrebna doza mora se odrediti za svaku osobu pojedinačno.
English: Tell your dentist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog stomatologa ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Very little articaine was detected in plasma from 12 to 24 hours following injection.
Croatian: Vrlo malo artikaina otkriveno je u plazmi 12 do 24 sata nakon injiciranja.
English: • ringing of the ears, over-sensitivity of hearing
Croatian: • zvonjava u ušima, pretjerana osjetljivost na zvuk
English: • epilepsy;
Croatian: • epilepsije;
English: Mechanism of action and pharmacodynamic effects:
Croatian: Mehanizam djelovanja i farmakodinamički učinci:
English: It is not likely that you will be given too much of this injection but if you should begin to feel unwell, tell your dentist.
Croatian: Nije vjerojatno da će Vam biti primijenjena prevelika količine lijeka, ali ako se počenete osjećati loše, obratite se stomatologu.
English: Your dentist or doctor will decide if you can use X / Y during pregnancy.
Croatian: Vaš stomatolog ili liječnik odlučit će možete li primiti X/Y tijekom trudnoće.
English: Store below 25°C.
Croatian: Čuvati na temperaturi ispod 25 °C.
English: 4.8 Undesirable effects a) Summary of the safety profile
Croatian: 4.8 Nuspojave a) Sažetak sigurnosnog profila
English: The higher risk of bleeding is more associated with the procedure, rather than with the medicine.
Croatian: Veći rizik od krvarenja je više povezan sa zahvatom nego s lijekom.
English: Most cases of paresthesia reported following dental treatment are transient and resolve within days, weeks or months.
Croatian: Najveći broj slučajeva parestezije prijavljenih nakon dentalnog liječenja je prolazan i rješava se u roku od nekoliko dana, tjedana ili mjeseci.
English: • extremely good mood (euphoria)
Croatian: • pretjerano dobro raspoloženje (euforija)
English: The safety profile was similar in children and adolescents from 4 to 18 years old compared to adults.
Croatian: Sigurnosni profil u djece i adolescenata od 4 do 18 godina sličan je onome u odraslih.
English: Other sources of information <Detailed information on this medicine is available on the website of {name of MS Agency (link)}>
Croatian: Ostali izvori informacija <Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici {naziv nadležnog tijela države članice (poveznica)}>
English: Since this hydrolysis is very fast, about 90% of articaine is inactivated by this way.
Croatian: Budući da je ta hidroliza vrlo brza, njome se inaktivira otprilike 90 % artikaina.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your dentist or doctor for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom stomatologu ili liječniku za savjet prije primjene ovog lijeka.
English: Within 24 hours, approximately 57% (68 mg) and 53% (204 mg) of the dose was eliminated in the urine.
Croatian: Unutar 24 sata otprilike 57 % (68 mg) i 53 % (204 mg) doze eliminirano je mokraćom.
English: X / Y with food
Croatian: X/Y s hranom
English: • Porphyria which causes either neurological complications or skin problems;
Croatian: • porfiriju koje uzrokuje neurološke komplikacije ili kožne probleme;
English: • allergy to other local anaesthetics;
Croatian: • alergije na druge lokalne anestetike;
English: The table below illustrates the maximum recommended dose:
Croatian: Tablica u nastavku prikazuje maksimalne preporučene doze:
English: Preclinical data reveal no special hazard for humans at therapeutic doses, based on conventional studies of safety pharmacology, chronic toxicity, reproductive toxicity and genotoxicity.
Croatian: Neklinčki podaci ne ukazuju na poseban rizik za ljude pri terapijskim dozama, na temelju konvencionalnih ispitivanja sigurnosne farmakologije, kronične toksičnosti, reproduktivne toksičnosti i genotoksičnosti.
English: Only physicians or dentists are trained to use X/Y.
Croatian: Samo su liječnici ili stomatolozi obučeni za primjenu X/Y.
English: Patient body weight (kg)
Croatian: Tjelesna težina bolesnika (kg)
English: In case of relative overdose, patients generally present symptoms within the first minutes.
Croatian: U slučaju relativnog predoziranja, simptomi se u bolesnika obično javljaju unutar prvih nekoliko minuta.
English: Your dentist will choose between X and Y, and determine the appropriate dose taking into account your age, your weight, your general health and the dental procedure.
Croatian: Vaš stomatolog odabrat će između X i Y te će odrediti odgovarajuću dozu uzimajući u obzir Vašu dob, težinu i opće zdravstveno stanje te stomatološki zahvat.
English: • metallic taste, taste disturbance or loss of taste function
Croatian: • metalni okus, poremećaj okusa ili gubitak osjeta okusa
English: • increased, unpleasant or abnormal sense of touch
Croatian: • pojačan, neugodan ili neuobičajen osjet dodira
English: Not known Local / Regional hyperaemia Vasodilatation
Croatian: Nepoznato Lokalna/regionalna hiperemija Vazodilatacija
English: There is a risk of adrenergic toxicity.
Croatian: Postoji rizik od adrenergičke toksičnosti.
English: They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by patient.
Croatian: One također mogu nastati kao posljedica preosjetljivosti, idiosinkrazije ili smanjene podnošljivosti u bolesnika.
English: However, accidental soft tissue injury was observed more frequently, especially in 3 to 7 year old children, due to the prolonged soft tissue anaesthesia.
Croatian: Međutim, slučajna ozljeda mekog tkiva zabilježena je češće, posebice u djece u dobi od 3 do 7 godina, zbog produljene anestezije mekog tkiva.
English: You will be given X or Y by a dentist.
Croatian: X ili Y će Vam dati stomatolog.
English: Other medicines and X / Y
Croatian: Drugi lijekovi i X/Y
English: Renal elimination of unchanged articaine accounted for only about 2% of total elimination.
Croatian: Na bubrežnu eliminaciju nepromijenjenog artikaina otpada samo 2 % ukupne eliminacije.
English: • numbness or reduced sense of touch in and around the mouth
Croatian: • obamrlost ili smanjen osjet dodira unutar i oko usta
English: The reported adverse reactions come from spontaneous reporting, clinical studies and literature.
Croatian: Navedene nuspojave temelje se na spontanom prijavljivanju, kliničkim ispitivanjima i literaturi.
English: In case of cardiac arrest, immediate initiation of cardiopulmonary resuscitation should be performed.
Croatian: U slučaju srčanog aresta treba odmah započeti kardiopulmonalnu reanimaciju.
English: Adrenaline passes into breast milk but also has a short half-life.
Croatian: Adrenalin prelazi u majčino mlijeko, ali također ima kratak polvijek.
English: Children should be given doses commensurate with age and weight.
Croatian: U djece treba primijeniti doze prilagođene dobi i težini.
English: • increased sensitivity to heat
Croatian: • pojačana osjetljivost na toplinu
English: What X / Y is and what it is used for 2.
Croatian: Što je X/Y i za što se koristi 2.
English: While you are in your dentist's office, your dentist will carefully follow the effects of X / Y.
Croatian: Dok ste u ordinaciji Vašeg stomatologa, on će pažljivo pratiti učinke lijeka X/Y na Vas.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Croatian: 9 DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: The dose must also be reduced in case of hypoxia, hyperkalaemia and metabolic acidosis.
Croatian: Doza se mora smanjiti i u slučaju hipoksije, hiperkalijemije i metaboličke acidoze.
English: X / Y is for children over 4 years of age (ca. 20 kg in body weight), adolescents and adults.
Croatian: X/Y namijenjen je djeci starijoj od 4 godine (približno 20 kg tjelesne težine), adolescentima i odraslima.
English: Adrenaline exhibits sympathomimetic effects.
Croatian: Adrenalin pokazuje simpatomimetičke učinke.
English: Adrenaline, as vasoconstrictor, acts directly on both α- and β-adrenergic receptors; β-adrenergic effects predominate.
Croatian: Adrenalin, kao vazokonstriktor, izravno djeluje i na α- i na β-adrenergičke receptore; prevladavaju βadrenergički učinci.
English: This medicinal product should only be used by or under the supervision of physicians or dentists sufficiently trained and familiar with diagnosis and treatment of systemic toxicity.
Croatian: Ovaj lijek smije se primjenjivati samo od strane ili pod nadzorom liječnika ili stomatologa koji su dovoljno obučeni i upoznati s dijagnosticiranjem i liječenjem sistemske toksičnosti.
English: ● Adults and adolescents (12 to 18 years of age)
Croatian: ● Odrasli i adolescenti (12 do 18 godina)
English: Serum concentrations of articaine measured in newborn infants were approx. 30% of maternal levels.
Croatian: Koncentracije artikaina u serumu mjerene kod novorođenčadi bile su oko 30 % majčinih razina.
English: Distribution: High protein binding of articaine was observed with human serum albumin (68.5-80.8%), and ∝/β-globulins (62.5-73.4%).
Croatian: Distribucija: Zabilježena je visoka razina vezanja artikaina na albumin u ljudskom serumu (68,5 - 80,8 %) i na ∝/β-globulin (62,5 - 73,4 %).
English: This medicinal product must be used with caution in patients with the following disorders:
Croatian: Ovaj se lijek mora koristiti oprezno u bolesnika sa sljedećim poremećajima:
English: Neuropathy:
Croatian: Neuropatija:
English: The cartridges are intended for single use.
Croatian: Ulošci su namijenjeni za jednokratnu uporabu.
English: ● Children (4 to 11 years of age)
Croatian: ● Djeca (4 do 11 godina)
English: 1 Allergic reactions should not be mistaken with syncopal episodes (cardiac palpitations due to adrenaline).
Croatian: 1 Alergijske reakcije ne smiju se krivo protumačiti kao sinkopalne epizode (palpitacije zbog djelovanja adrenalina).
English: This consists in decreasing or preventing the large transient increase in the permeability of excitable membranes to sodium (Na+) that is normally produced by slight depolarisation of the membrane.
Croatian: To obuhvaća smanjivanje ili sprječavanje prolaznog velikog povećanja permeabilnosti podražljive membrane za natrij (Na+) koji se obično proizvodi laganom depolarizacijom membrane.
English: For instructions on the handling of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rukovanju s lijekom prije primjene vidjeti dio 6.6.
English: If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately.
Croatian: Ako se pojave znakovi akutne sistemske toksičnosti, injiciranje lokalnog anestetika mora se odmah prekinuti.
English: If there is any risk of an allergic reaction, your dentist will choose a different medicine for anesthesia.
Croatian: Ako postoji ikakav rizik od alergijske reakcije, Vaš će stomatolog izabrati drugi lijek za anesteziju.
English: • Y is more adapted to procedures lasting longer or with possible significant bleeding.
Croatian: • Y je prikladniji za zahvate koji traju dulje ili mogu biti praćeni značajnim krvarenjem.
English: Depending on the kind of dental procedure performed, the dentist will choose between the two medicines:
Croatian: Ovisno o vrsti stomatološkog zahvata, stomatolog će izabrati jedan od dva lijeka:
English: The local anaesthetic effects may be reduced when this medicinal product is injected into an inflamed or infected area.
Croatian: Učinci lokalne anestezije mogu biti smanjeni kada se ovaj lijek injicira u upaljeno ili inficirano područje.
English: 3 These neural pathologies may occur with various symptoms of abnormal sensations.
Croatian: 3 Ovi poremećaji živaca mogu se javiti uz razne simptome abnormalnih osjeta.
English: Inform your dentist, doctor or pharmacist immediately if you experience one of the following serious side effects:
Croatian: Odmah obavijestite stomatologa, liječnika ili ljekarnika ako imate bilo koju od sljedećih ozbiljnih nuspojava:
English: Due to an overdose (absolute or relative), since excitement may be transient or absent, the first manifestations may be drowsiness merging into unconsciousness and respiratory arrest.
Croatian: U slučaju predoziranja (apsolutnog ili relativnog), budući da ekscitiranost može biti prolazna ili odsutna, prva manifestacija može biti omamljenost koja se produbljuje u nesvjesticu i respiratorni arest.
English: Unused solution must be discarded.
Croatian: Neiskorištena otopina mora se baciti.
English: Whereas in case of absolute overdose, signs of toxicity, depending on the injection site, appear later after the injection.
Croatian: U slučaju apsolutnog predoziranja znakovi toksičnosti, ovisno o mjestu injekcije, pojavljuju se kasnije nakon injekcije.
English: • allergy to articaine or adrenaline or any of the other ingredients of these medicines (listed in section
Croatian: • alergije na artikain ili adrenalin ili neki drugi sastojak ovih lijekova (naveden u dijelu 6.);
English: Thermohyperesthesia Headache
Croatian: Termohiperesteziju Glavobolju
English: These medicines may intensify the effects of adrenaline.
Croatian: Ovi lijekovi mogu pojačati djelovanje adrenalina.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Interakcije s artikainom
English: • lacking of a natural chemical substance called cholinesterase in your blood (plasma cholinesterase deficiency);
Croatian: • nedostatak prirodne kemijske tvari u Vašoj krvi koja se zove kolinesteraza (nedostatak kolinesteraze u plazmi);
English: tranylcypromine, linezolide);
Croatian: tranilcipromin, linezolid);
English: Local anaesthetic overdose in the largest sense is often used to describe:
Croatian: Predoziranje lokalnim anestetikom u najširem smislu često se odnosi na:
English: • very high blood pressure;
Croatian: • vrlo visok krvni tlak;
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Cardboard carton
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kartonska kutija
English: Acidosis exacerbates the toxic effects of local anaesthetics.
Croatian: Acidoza pojačava toksične učinke lokalnih anestetika.
English: Not known Conduction disorders (atrioventricular block)
Croatian: Nepoznato Poremećaji provođenja (atrioventrikularni blok)
English: As the anaesthetic action progressively develops in the nerve, the threshold for electrical excitability gradually increases, the rate of rise of the action potential declines and impulse conduction slows.
Croatian: Kako se anestetsko djelovanje u živcu progresivno pojačava, prag električne podražljivosti postupno raste, brzina rasta akcijskih potencijala opada i provođenje impulsa se usporava.
English: Dose of adrenaline (mg)
Croatian: Doza adrenalina (mg)
English: Very rare side effects: may affect up to 1 in 10,000 people: • persistent loss of sensitivity, extended numbness and loss of taste
Croatian: Vrlo rijetke nuspojave: mogu se javiti u do 1 na 10 000 osoba: • trajni gubitak osjetljivosti, produljena obamrlost i gubitak osjeta okusa
English: Risk associated with intraneural injection:
Croatian: Rizik povezan s intraneuralnim injiciranjem:
English: The total dose of all local anaesthetics administered should not exceed the maximum recommended dose of the drugs used.
Croatian: Ukupna doza svih primijenjenih lokalnih anestetika ne smije prekoračiti maksimalnu preporučenu dozu korištenih lijekova.
English: Phenothiazines (and other neuroleptics):
Croatian: Fenotiazini (i drugi neuroleptici):
English: What X / Y look like and contents of the pack
Croatian: Kako X/Y izgleda i sadržaj pakiranja?
English: • Articaine
Croatian: • Artikain
English: Paresthesia can be defined as spontaneous abnormal usually non-painful sensation (e.g., burning, pricking, tingling or itching) well beyond the expected duration of anesthesia.
Croatian: Parestezija se može definirati kao spontan, abnormalan, obično bezbolan osjet (npr. pečenje, bockanje, trnci ili svrbež) daleko dulje od očekivanog trajanja anestezije.
English: Breast-feeding can be resumed after 5 hours following anaesthesia.
Croatian: Dojenje se može nastaviti nakon što je prošlo 5 sati od anestezije.
English: Articaine is additionally metabolised in the liver microsomes.
Croatian: Artikain se dodatno metabolizira u mikrosomima jetre.
English: • wheezing (bronchospasm), asthma
Croatian: • piskanje (bronhospazam), astma
English: There is the danger of a hypertensive crisis (very high blood pressure) or severe slowing of the pulse (see section other medicines);
Croatian: Postoji opasnost od hipertenzivne krize (vrlo visok krvni tlak) ili izrazitog usporavanja pulsa (pogledajte dio „Drugi lijekovi i X/Y”);
English: When using {(Invented) name and associated names (see Annex I)} for infiltration or regional block anaesthesia, injection should always be made slowly and with prior aspiration.
Croatian: Kada se {(Novoizumljeno) ime i pridružena imena (vidjeti Prilog I.)} primjenjuje za infiltraciju ili regionalne blokove injekcija uvijek treba biti spora i uz prethodnu aspiraciju.
English: These adverse reactions are, in general, dose-related.
Croatian: Te nuspojave, općenito, ovise o dozi.
English: In clinical trials performed in children, Cmax was 1382 ng/ml and Tmax 7.78 min following infiltration of a dose of 2 mg/kg body weight.
Croatian: U kliničkim ispitivanjima koja su provedena u djece, Cmax je bio 1382 ng/ml i Tmax 7,78 minuta nakon infiltracije dozom od 2 mg/kg tjelesne težine.
English: Careful aspiration prior to administration is recommended.
Croatian: Prije davanja lijeka preporučuje se pažljiva aspiracija.
English: • taking some medicines for blood pressure called beta blockers, such as propranolol.
Croatian: • uzimate neke lijekove za krvni tlak koji se zovu beta blokatori, primjerice propranolol.
English: The maximum articaine dose of 500 mg corresponds to a healthy adult of more than 70 kg body weight.
Croatian: Maksimalna doza artikaina od 500 mg odgovara maksimalnoj dozi za zdravu odraslu osobu tjelesne težine veće od 70 kg.
English: • Patients taking non-cardioselective beta-blockers (e.g. propranolol) (risk of hypertensive crisis or severe bradycardia), (see section 4.5)
Croatian: • bolesnika koji uzimaju nekardioselektivne beta blokatore (npr. Propranolol) (rizik od hipertenzivne krize ili teške bradikardije), (vidjeti dio 4.5)
English: However, the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
Croatian: Međutim, odsutnost krvi u štrcaljki ne jamči da je izbjegnuto intravakularno injiciranje.
English: Before using this medicinal product, it is important: - To make inquiries into the patient's current therapies and history; - To maintain verbal contact with the patient - To have resuscitative equipment at hand (see section 4.9)
Croatian: Prije primjene ovog lijeka, važno je: - saznati koje lijekove bolesnik trenutno uzima i uzeti anamnezu bolesniku - održavati verbalni kontakt s bolesnikom - imati pri ruci opremu za reanimaciju (vidjeti dio 4.9)
English: • abnormally increased sweating,
Croatian: • neuobičajeno pojačano znojenje
English: Infections and infestations
Croatian: Infekcije i infestacije Često
English: • taking medications called antiplatelets or anticoagulants, to prevent narrowing or hardening of your blood vessels in the arms and legs;
Croatian: • uzimate lijekove koji se nazivaju antitrombocitni lijekovi ili antikoagulansi, namijenjene za sprečavanje sužavanja ili otvrdnjavanja krvnih žila u rukama i nogama;
English: This medicinal product must be used with special caution in patients with the following disorders and postponement of dental surgery should be considered if the condition is severe and/or unstable.
Croatian: Ovaj se lijek mora koristiti naročito oprezno u bolesnika sa sljedećim poremećajima, te treba razmotriti odgodu dentalnog zahvata ako je stanje teško i/ili nestabilno.
English: • Patients with unstable angina or a history of recent (less than 6 months) myocardial infarction
Croatian: • bolesnika s nestabilnom anginom ili nedavnim (manje od 6 mjeseci) infarktom miokarda u anamnezi
English: For a routine procedure, the normal dose for adult patients is of 1 cartridge, but the contents of less of a cartridge may be sufficient for effective anaesthesia.
Croatian: Za rutinske zahvate uobičajena doza za odrasle bolesnike je jedan uložak, ali i manje sadržaja može biti dovoljno za učinkovitu anesteziju.
English: Biotransformation: Articaine is subject to hydrolysis of its carboxyl group by unspecific esterases in the tissue and in blood.
Croatian: Biotransformacija: Artikain podliježe hidrolizi karboksilne skupine nespecifičnim esterazama u tkivu i krvi.
English: This medicinal product contains sodium metabisulfite, a sulfite that may rarely cause hypersensitivity reactions and bronchospasm.
Croatian: Ovaj lijek sadrži natrijev metabisulfit, sulfit koji rijetko može uzrokovati reakcije preosjetljivosti i bronhospazam.
English: If any sympathomimetic vasopressor has been used within 24 hours, the planned dental treatment should be postponed.
Croatian: Ako je unutar 24 sata korišten bilo koji simpatomimetik, planirani stomatološki zahvat treba odgoditi.
English: Patients with porphyria {(Invented) name and associated names (see Annex I)} should only be used in patients with acute porphyria when no safer alternative is available.
Croatian: Bolesnici s porfirijom {(Novoizumljeno) ime i pridružena imena (vidjeti Prilog I.)} se smije primjenjivati u bolesnika s akutnom porfirijom samo kada nije dostupna sigurnija alternativa.
English: If there is any risk of an allergic reaction, choose a different medicine for anesthesia (see section 4.3).
Croatian: Ako postoji ikakav rizik od alergijske reakcije, izaberite drugi lijek za anesteziju (vidjeti dio 4.3).
English: At therapeutic doses, adverse effects on human fertility are not expected.
Croatian: Pri terapijskim se dozama ne očekuje neželjeni učinci na ljudsku plodnost.
English: Local and loco-regional anaesthesia in dental procedures.
Croatian: Lokalna i lokoregionalna anestezija kod stomatoloških zahvata.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake EXP.
English: What X / Y is and what it is used for
Croatian: Što je X/Y i za što se koristi?
English: Patients with plasma cholinesterase deficiency
Croatian: Bolesnici s nedostatkom plazmatske kolinesteraze
English: In this case, caution shall be used for the next injection and reduced dose shall be applied.
Croatian: U tom je slučaju potreban oprez kod sljedećeg injiciranja te je potrebno primijeniti manju dozu.
English: Animal studies have shown that adrenaline is toxic to reproduction at doses higher than maximal recommended dose (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost adrenalina kod doza viših od maksimalne preporučene doze (vidjeti dio 5.3).
English: Teratogenecity was observed in animals treated with adrenaline only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: Teratogenost je uočena u životinja liječenih samo adrenalinom pri izloženosti koja se smatra dostatno većom od maksimalne izloženosti u ljudi što ukazuje na mali značaj za kliničku primjenu.
English: Use with caution in patients taking phenothiazines considering the risk of hypotension due to possible inhibition of adrenaline effect.
Croatian: Koristite oprezno u bolesnika koji uzimaju fenotiazine uzimajući u obzir rizik od hipotenzije zbog moguće inhibicije učinka adrenalina.
English: Use immediately after the opening of the cartridge.
Croatian: Upotrijebiti odmah nakon otvaranja uloška.
English: X / Y is a clear and colourless solution.
Croatian: X/Y je prozirna i bezbojna otopina.
English: • widening or narrowing of blood vessels
Croatian: • širenje ili sužavanje krvnih žila
English: • Hypotension
Croatian: • hipotenzije