FrancophonIA/ELRC3.0 huggingface dataset:
English: These medicinal products are authorised in the Member States of the EEA under the following names: <{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}> <[See Annex I - To be completed nationally]>
Slovenian: Ti zdravili sta v državah članicah EGP pridobili dovoljenje za promet z naslednjimi imeni: <{Ime države članice}> <{ime zdravila}> <{Ime države članice}> <{ime zdravila }> [<Glejte Prilogo I - Izpolni država članica.>]
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.
Slovenian: Zobozdravnik bo izbral med zdravilom X in zdravilom Y in določil ustrezen odmerek glede na vašo starost, telesno maso, splošno zdravstveno stanje in zobozdravstveni poseg.
English: Appropriate precautions should be taken in all patients with porphyria, as this medicinal product can trigger porphyria.
Slovenian: Pri vseh bolnikih s porfirijo je treba izvajati ustrezne previdnostne ukrepe, saj lahko to zdravilo izzove porfirijo.
English: SN: {number} <NN: {number} >
Slovenian: SN: {številka} <NN: {številka}>
English: If there is any risk of an allergic reaction, your dentist will choose a different medicine for anesthesia.
Slovenian: Če obstaja tveganje za alergijsko reakcijo, bo vaš zobozdravnik izbral drugo zdravilo za anestezijo.
English: Local anaesthetic overdose in the largest sense is often used to describe:
Slovenian: Preveliko odmerjanje lokalnega anestetika se v širšem smislu pogosto uporablja za opis:
English: They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by patient.
Slovenian: Lahko so tudi posledica preobčutljivosti, idiosinkrazije ali bolnikovega zmanjšanega prenašanja zdravila.
English: However, these findings are of little relevance to its clinical use as acute administration.
Slovenian: Vendar pa so te ugotovitve majhnega pomena za klinično uporabo zdravila za akutno dajanje.
English: If any sympathomimetic vasopressor has been used within 24 hours, the planned dental treatment should be postponed.
Slovenian: Če je bolnik v zadnjih 24 urah uporabil kateri koli simpatikomimetični vazopresor, je načrtovani zobozdravstveni poseg treba odložiti.
English: Serum concentrations of articaine measured in newborn infants were approx. 30% of maternal levels.
Slovenian: Serumske koncentracije artikaina, izmerjene pri novorojenčkih, so znašale približno 30 % vrednosti, izmerjenih pri materi.
English: • absolute overdose,
Slovenian: • absolutnega prevelikega odmerjanja,
English: This medicine is given by a slow injection in the oral cavity.
Slovenian: To zdravilo se daje v obliki počasne injekcije v ustno votlino.
English: 3 These neural pathologies may occur with various symptoms of abnormal sensations.
Slovenian: 3 Ta patologija živčevja se lahko pojavi z različnimi simptomi nenormalnih zaznav.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Interakcije z artikainom
English: In case of cardiac arrest, immediate initiation of cardiopulmonary resuscitation should be performed.
Slovenian: V primeru srčnega zastoja je nemudoma treba začeti s kardiopulmonalno reanimacijo.
English: More than 50% of the dose was eliminated in the urine, 95% as articainic acid, within 8 hours of administration.
Slovenian: Več kot 50 % odmerka se je izločilo z urinom, 95 % v obliki artikainske kisline v 8 urah po aplikaciji.
English: Infiltration and perineural use.
Slovenian: Infiltracija in perinevralna uporaba.
English: Distribution: High protein binding of articaine was observed with human serum albumin (68.5-80.8%), and ∝/β-globulins (62.5-73.4%).
Slovenian: Porazdelitev: Veliko vezavo artikaina na proteine so opazili pri humanem serumskem albuminu (68,5 do 80,8 %) in α/β-globulinih (62,5 do 73,4 %).
English: Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis may prevent cardiac arrest.
Slovenian: Optimalna oksigenacija, ventilacija in podpora krvnega obtoka ter zdravljenje acidoze, lahko prepreči srčni zastoj.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted>
Slovenian: PODATKI V BRAILLOVI PISAVI <Sprejeta je utemeljitev, da Braillova pisava ni potrebna.>
English: In this case, caution shall be used for the next injection and reduced dose shall be applied.
Slovenian: V tem primeru je potrebna previdnost pri naslednjem injiciranju, uporabiti pa je treba manjši odmerek.
English: Your dentist or doctor will decide if you can use X / Y during pregnancy.
Slovenian: Zobozdravnik ali zdravnik bo presodil, če lahko med nosečnostjo prejmete zdravilo X/Y.
English: • X is usually used for simple and short dental procedures
Slovenian: • zdravilo X, ki se običajno uporablja pri enostavnih in krajših zobozdravstvenih posegih, ali
English: The reported adverse reactions come from spontaneous reporting, clinical studies and literature.
Slovenian: Navedeni neželeni učinki so bili pridobljeni s spontanimi poročili, kliničnimi študijami in iz podatkov iz literature.
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.
Slovenian: Ta sestoji iz zmanjšanja ali preprečitve velikega prehodnega povečanja permeabilnosti vzdražljivih membran za natrij (Na+), ki je običajno posledica rahle depolarizacije membrane.
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.
Slovenian: Ko se anestetični učinek postopno razvija v živcu, se prag električne vzdražljivosti postopoma povečuje, hitrost naraščanja akcijskega potenciala se zmanjšuje in prevajanje impulzov se upočasnjuje.
English: If you have any further questions on the use of this medicine, ask your dentist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zobozdravnikom.
English: Adrenaline, as vasoconstrictor, acts directly on both α- and β-adrenergic receptors; β-adrenergic effects predominate.
Slovenian: Adrenalin kot vazokonstriktor deluje neposredno na α- in β-adrenergične receptorje, vendar pa prevladujejo β-adrenergični učinki.
English: It is not usually necessary to suspend breast-feeding for short-term use, starting from 5 hours following anesthesia.
Slovenian: Običajno v primeru kratkotrajne uporabe zdravila ni treba prekiniti z dojenjem, ki se lahko začne 5 ur po anesteziji.
English: Other medicines and X / Y
Slovenian: Druga zdravila in zdravilo X/Y
English: Store below 25°C.
Slovenian: Shranjujte pri temperaturi do 25°C.
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.
Slovenian: Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zobozdravnikom ali zdravnikom, preden prejmete to zdravilo.
English: • allergy to articaine or adrenaline or any of the other ingredients of these medicines (listed in section
Slovenian: • alergijo na artikain, adrenalin ali katero koli sestavino teh zdravil (navedeno v poglavju 6).
English: At the discretion of the dentist, more cartridges may be required for more extensive procedures without exceeding the maximum recommended dose.
Slovenian: Po presoji zobozdravnika bo za obsežnejše posege morda potrebnih več vložkov, vendar brez preseganja največjega priporočenega odmerka.
English: doses of up to 20 mg/kg in rats and 12.5 mg/kg in rabbits.
Slovenian: odmerku do 20 mg/kg pri podganah in 12,5 mg/kg pri kuncih.
English: Keep the cartridges in the tightly closed outer carton in order to protect from light .
Slovenian: Vložke shranjujte v tesno zaprti škatli za zagotovitev zaščite pred svetlobo.
English: Infiltration and perineural use in oral cavity.
Slovenian: Infiltracija in perinevralna uporaba v ustni votlini.
English: Very rare side effects: may affect up to 1 in 10,000 people: • persistent loss of sensitivity, extended numbness and loss of taste
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): • trajna izguba občutljivosti, razširjena odrevenelost in izguba čuta za okušanje.
English: Other sources of information <Detailed information on this medicine is available on the website of {name of MS Agency (link)}>
Slovenian: <Podrobne informacije o zdravilu so objavljene na spletni strani {ime agencije v državi članici
English: • Patients with paroxysmal tachycardia or absolute arrhythmias with rapid heart rate
Slovenian: • bolniki s paroksizmalno tahikardijo ali absolutno aritmijo s hitrim srčnim utripom,
English: • allergy to other local anaesthetics;
Slovenian: • alergijo na druge lokalne anestetike.
English: However, the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
Slovenian: Vendar pa odsotnost krvi v injekcijski brizgi ne zagotavlja, da ni prišlo do intravaskularnega injiciranja.
English: If there is any risk of an allergic reaction, choose a different medicine for anesthesia (see section 4.3).
Slovenian: Če obstaja tveganje za alergijsko reakcijo, izberite drugo zdravilo za anestezijo (glejte poglavje 4.3).
English: Local and loco-regional anaesthesia in dental procedures.
Slovenian: Lokalna in regionalna anestezija pri zobozdravstvenih posegih.
English: Persistent paresthesia, mostly following nerve blocks in the mandible, is characterized by slow, incomplete, or lack of recovery.
Slovenian: Za persistentno parestezijo, ki se je večinoma pojavila po blokadi živcev v spodnji čeljustnici, je značilno počasno in nepopolno okrevanje ali izostanek okrevanja.
English: What you need to know before you are given X / Y 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo X/Y
English: • epilepsy, not adequately controlled by drug treatment.
Slovenian: • epilepsijo, ki ni ustrezno nadzorovana z zdravili.
English: The safety of {(Invented) name and associated names (see Annex I)} in children aged 4 years and below has not been established.
Slovenian: Varnost zdravila {(izmišljeno) ime in povezana imena (glejte Prilogo I)} pri otrocih, starih 4 leta ali manj, ni bila ugotovljena.
English: X / Y is a clear and colourless solution.
Slovenian: Zdravilo X/Y je bistra in brezbarvna raztopina.
English: In case of relative overdose, patients generally present symptoms within the first minutes.
Slovenian: V primeru relativnega prevelikega odmerka se pri bolnikih običajno pokažejo prvi simptomi v prvih minutah po injiciranju.
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.
Slovenian: Da bi se izognili injiciranju v živec in da bi preprečili poškodbe živcev pri živčnih blokadah, je treba iglo vedno nekoliko izvleči, če bolnik ob vbodu občuti električni tresljaj ali če je vbod še posebej boleč.
English: • numbness or reduced sense of touch in and around the mouth
Slovenian: • odrevenelost ali zmanjšanje čuta za dotik v ustih in okoli ust,
English: Not known: frequency cannot be estimated from the available data
Slovenian: Neželeni učinki neznane pogostnosti (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: There is a risk of adrenergic toxicity.
Slovenian: Obstaja tveganje za adrenergične toksične učinke.
English: • Hypersensitivity to articaine (or any local anaesthetic agent of the amide type), to adrenaline or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost za artikain (ali kateri koli lokalni anestetik amidnega tipa), adrenalin ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: The necessary dosage must be determined on an individual basis.
Slovenian: Potreben odmerek je treba določiti pri vsakem bolniku posebej.
English: If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor, and/or inotropic agents should be considered.
Slovenian: Če pride do kardiovaskularne depresije (hipotenzija, bradikardija), je potrebno premisliti o ustreznem zdravljenju z intravenskimi tekočinami, vazopresorji in/ali inotropnimi učinkovinami.
English: Adrenaline prolongs the effect duration of the articaine, and reduces the risk of excessive uptake of articaine into the systemic circulation.
Slovenian: Adrenalin podaljša trajanje delovanja artikaina in zmanjša tveganje za prekomerno absorpcijo artikaina v sistemski krvni obtok.
English: Animal studies have shown that adrenaline is toxic to reproduction at doses higher than maximal recommended dose (see section 5.3).
Slovenian: Študije na živalih so pokazale reproduktivno toksičnost adrenalina v odmerkih, višjih od priporočenega dnevnega odmerka (glejte poglavje 5.3).
English: Breast-feeding can be resumed after 5 hours following anaesthesia.
Slovenian: Z dojenjem lahko nadaljujete 5 ur po prejemu anestezije.
English: • Patients with epilepsy not controlled by treatment.
Slovenian: • Bolniki z epilepsijo, ki ni nadzorovana z zdravljenjem.
English: Biotransformation: Articaine is subject to hydrolysis of its carboxyl group by unspecific esterases in the tissue and in blood.
Slovenian: Biotransformacija: Karboksilne skupine artikaina so hidrolizirane z nespecifičnimi esterazami v tkivu in krvi.
English: In embryotoxicity studies with articaine, no increase in the foetal mortality rate or malformations were observed at daily i.v.
Slovenian: V študijah embriotoksičnosti z artikainom niso opazili povečane umrljivosti ploda ali deformacij pri dnevnem i.v.
English: • metallic taste, taste disturbance or loss of taste function
Slovenian: • kovinski okus, motnje okusa ali izguba čuta za okušanje,
English: In the event of inadvertent intravascular administration in the mother, adrenaline can reduce uterine perfusion.
Slovenian: V primeru nenamerne intravaskularne uporabe pri materi lahko adrenalin zmanjša perfuzijo maternice.
English: There is the danger of a hypertensive crisis (very high blood pressure) or severe slowing of the pulse (see section other medicines);
Slovenian: Obstaja nevarnost za hipertenzivno krizo (zelo visok krvni tlak) ali hudo upočasnitev srčnega utripa (glejte poglavje Druga zdravila in zdravilo X/Y),
English: What X / Y is and what it is used for
Slovenian: Kaj je zdravilo X/Y in za kaj ga uporabljamo
English: Patient body weight (kg)
Slovenian: Telesna masa bolnika (kg)
English: Adrenaline and articaine cross the placental barrier, although articaine does so to a lesser extent than other local anaesthetics.
Slovenian: Adrenalin in artikain prehajata skozi placento, čeprav artikain prehaja v manjši meri kot drugi lokalni anestetiki.
English: • coronary artery bypass surgery in the last 3 months;
Slovenian: • obvodno operacijo koronarnih arterij v zadnjih 3 mesecih,
English: You will be given X or Y by a dentist.
Slovenian: Zdravilo X/Y vam bo dal zobozdravnik.
English: Children (4 to 11 years of age)
Slovenian: Otroci (stari od 4 do 11 let)
English: Local anaesthetics should be injected with caution when there is inflammation and/or infection at the site of the injection.
Slovenian: Lokalne anestetike je treba injicirati previdno v primeru vnetja in/ali okužbe na mestu injiciranja.
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.
Slovenian: Pri rutinskih posegih je običajen odmerek za odrasle bolnike 1 vložek, vendar lahko za učinkovito anestezijo zadostuje vsebina, manjša od enega vložka.
English: Articaine, a local amide anaesthetic, reversibly blocks nerve conduction through a well-known mechanism commonly observed with other local amide anaesthetics.
Slovenian: Artikain, lokalni amidni anestetik, reverzibilno zavre prevajanje živčnih impulzov preko dobro poznanega mehanizma, pogosto opaženega pri drugih lokalnih amidnih anestetikih.
English: X / Y with food
Slovenian: Zdravilo X/Y skupaj s hrano
English: • worsening of the neuromuscular symptoms in Kearns-Sayre syndrome
Slovenian: • poslabšanje nevromuskularnih simptomov pri Kearns-Sayrejevem sindromu,
English: • very high blood pressure;
Slovenian: • zelo visok krvni tlak,
English: Dose of adrenaline (mg)
Slovenian: Odmerek adrenalina (mg)
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.
Slovenian: Pri živalih, ki so jih zdravili z adrenalinom, so teratogenost opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
English: 4 Several adverse events, like agitation, anxiety / nervousness, tremor, speech disorder may be warning signs before CNS depression.
Slovenian: 4 Več neželenih učinkov, kot so agitacija, anksioznost/živčnost, tremor, motnje govora, lahko predstavlja opozorilne znake depresije osrednjega živčevja.
English: The cartridges are intended for single use.
Slovenian: Vložki so namenjeni za enkratno uporabo.
English: {(Invented) name and associated names (see Annex I)} contains 0.804 mg sodium per 1 ml of solution i.e. 1.44 mg/1.7 ml.
Slovenian: {(Izmišljeno) ime in povezana imena (glejte Prilogo I)} vsebuje 0,804 mg natrija na en ml raztopine tj. 1,44 mg/1,7 ml.
English: ● Children (4 to 11 years of age)
Slovenian: • Otroci (stari od 4 do 11 let)
English: Only physicians or dentists are trained to use X/Y.
Slovenian: Kako uporabljati zdravilo X/Y Samo zdravniki ali zobozdravniki so usposobljeni za uporabo zdravila X/Y.
English: • sedatives (such as benzodiazepine, opioids), for example to reduce your apprehension before the dental procedure;
Slovenian: • pomirjevala (kot so benzodiazepini, opioidi), na primer za zmanjšanje strahu pred zobozdravstvenim posegom;
English: • increased amount of blood in a part of the body leading to congestion of blood vessels
Slovenian: • povečana količina krvi v delu telesa, kar povzroči zasičenost krvnih žil,
English: • serious problems with your liver
Slovenian: • resne težave z jetri,
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.
Slovenian: Parestezijo lahko opredelimo kot spontane, običajno neboleče, nenormalne zaznave (npr. žarenje, zbadanje, ščegetanje ali srbenje), ki trajajo veliko dlje od pričakovanega trajanja anestezije.
English: • wheezing (bronchospasm), asthma
Slovenian: • piskajoče dihanje (bronhospazem), astma,
English: Avoid eating, included chewing-gum, until normal sensation is restored because there is a risk that you may bite your lips, cheeks or tongue, especially in children.
Slovenian: Izognite se uživanju hrane in žvečenju žvečilnih gumijev, dokler se ne povrne normalna čutna zaznava, saj v nasprotnem primeru, zlasti pri otrocih, obstaja tveganje, da se ugriznete v ustnice, lica ali jezik.
English: Articaine is additionally metabolised in the liver microsomes.
Slovenian: Artikain se dodatno presnavlja v jetrnih mikrosomih.
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.
Slovenian: Pri uporabi zdravila {(izmišljeno) ime in povezana imena (glejte Prilogo I)} za infiltracijo ali regionalno anestezijo z blokado je treba injiciranje vedno izvesti počasi in ob predhodni aspiraciji.
English: If you experience side effects, including dizziness, blurred vision or fatigue, you should not drive or operate machinery until you recover your abilities (generally within 30 minutes following the dental procedure).
Slovenian: V primeru pojava neželenih učinkov, vključno z omotico, zamegljenim vidom ali utrujenostjo, ne smete voziti vozil ali upravljati strojev, dokler se vam ne povrnejo vaše sposobnosti (običajno v roku
English: • Porphyria which causes either neurological complications or skin problems;
Slovenian: • stanje, imenovano porfirija, ki lahko povzroči nevrološke zaplete ali težave s kožo,
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.
Slovenian: Subkutano injiciranje artikaina v kombinaciji z adrenalinom je povzročilo neželene učinke pri odmerjanju od 50 mg/kg/dan pri podganah in 80 mg/kg/dan pri psih po 4 tednih ponavljajoče se dnevne uporabe.
English: • taking medications called antiplatelets or anticoagulants, to prevent narrowing or hardening of your blood vessels in the arms and legs;
Slovenian: • jemljete zdravila, imenovana protitrombocitna zdravila ali antikoagulanti, za preprečevanje zoženja ali otrditve krvnih žil v rokah in nogah),
English: As a result of the rapid drop in serum levels and rapid elimination, clinically relevant quantities of articaine are not found in breast milk.
Slovenian: Artikaina, zaradi hitrega padca serumskih vrednosti in hitrega izločanja, v materinem mleku niso našli v klinično pomembnih količinah.
English: In a clinical trial, plasma concentrations of articaine and articainic acid were shown to decrease rapidly following submucosal injection.
Slovenian: Klinično preskušanje je pokazalo, da se koncentraciji artikaina in artikainske kisline v plazmi po submukoznem injiciranju hitro zmanjšata.
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)
Slovenian: Pred in med uporabo tega zdravila je pomembno: seznaniti se z bolnikovim trenutnim in predhodnim zdravljenjem, ohraniti verbalni stik z bolnikom, imeti pripravljeno vso potrebno opremo za oživljanje (glejte poglavje 4.9).
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Odmerjanje
English: (hypersensitivity) reaction.
Slovenian: (preobčutljivostne) reakcije,
English: • adrenaline, a vasoconstrictor which narrows the blood vessels at the site of injection, and thereby prolongs the effect of articaine.
Slovenian: • adrenalin, vazokonstriktor, ki na mestu injiciranja zoži krvne žile in s tem podaljša učinek artikaina.
English: No difference was observed in pharmacodynamic properties between the adult and the paediatric population.
Slovenian: Pri odrasli in pediatrični populaciji niso opazili razlik glede farmakodinamičnih lastnosti.
English: • lacking of a natural chemical substance called cholinesterase in your blood (plasma cholinesterase deficiency);
Slovenian: • pomanjkanje naravne kemične snovi v krvi, imenovane holinesteraza (pomanjkanje plazemske holinesteraze),
English: • neuroleptic drugs (for example phenothiazines).
Slovenian: • nevroleptična zdravila (npr. fenotiazini).
English: • widening or narrowing of blood vessels
Slovenian: • razširjenje ali zoženje krvnih žil,
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.
Slovenian: Zdravilo {(izmišljeno) ime in povezana imena (glejte Prilogo I)} se sme pri bolnikih z akutno porfirijo uporabljati samo v primeru, da ni na voljo varnejše možnosti.
English: • epilepsy;
Slovenian: • epilepsijo,
English: Whereas in case of absolute overdose, signs of toxicity, depending on the injection site, appear later after the injection.
Slovenian: V primeru absolutnega prevelikega odmerka pa se znaki toksičnosti pojavijo pozneje, odvisno od mesta injiciranja.