FrancophonIA/ELRC3.0 huggingface dataset:
English: Budesonide/Formoterol Teva is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Croatian: Teva uzima se kao redovita terapija održavanja s posebnim inhalatorom koji sadrži brzodjelujući bronhodilatator za hitno simptomatsko liječenje.
English: Adults (18 years and older): 2 inhalations twice a day.
Croatian: Odrasli (s 18 godina i stariji): 2 inhalacije dvaput dnevno.
English: Adults (18 years and older): 1 inhalation twice daily
Croatian: Odrasli (s 18 godina i više): 1 inhalacija dvaput dnevno
English: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
Croatian: -u bolesnika u kojih astma nije zadovoljavajuće kontrolirana inhalacijskim kortikosteroidima i ″prema potrebi″ inhalacijskim kratkodjelujućim agonistima ß2-adrenergičkih receptora ili -u bolesnika u kojih je astma već zadovoljavajuće kontrolirana primjenom i inhalacijskih kortikosteroida i dugodjelujućih agonista ß2-adrenergičkih receptora.
English: - in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
Croatian: -u bolesnika u kojih astma nije zadovoljavajuće kontrolirana inhalacijskim kortikosteroidima i „prema potrebi“ inhalacijskim kratkodjelujućim agonistima ß2-adrenergičkih receptora. ili -u bolesnika u kojih astma već zadovoljavajuće kontrolirana primjenom i inhalacijskih kortikosteroida i dugodjelujućim agonistima ß2-adrenergičkih receptora.
English: What Budesonide/Formoterol Teva looks like and contents of the pack
Croatian: Teva izgleda i sadržaj pakiranja
English: Budesonide/Formoterol Teva 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Teva 160 mikrograma/4,5 mikrograma prašak inhalata budezonid / formoterolfumarat dihidrat NAVOĐENJE DJELATNE/IH
English: If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler', then seek medical advice.
Croatian: primijenite 'inhalator za brzo ublažavanje simptoma', a zatim zatražite liječnički savjet.
English: Budesonide/Formoterol Teva is not intended for the initial management of asthma.
Croatian: Teva nije namijenjen za početno zbrinjavanje astme.
English: When used for asthma, your doctor will prescribe Budesonide/Formoterol Teva together with a separate ‘reliever inhaler' such as salbutamol.
Croatian: Kada se koristi za astmu, liječnik će Vam propisati Budezonid/Formoterol
English: Do not use Budesonide/Formoterol Teva just before exercise to stop asthma symptoms from occurring, use your separate ‘reliever inhaler'.
Croatian: Teva neposredno prije tjelovježbe kako biste spriječili pojavu simptoma astme, primijenite zasebni „inhalator za brzo ublažavanje simptoma”
English: If you use more Budesonide/Formoterol Teva than you should, contact your doctor, pharmacist or nurse for advice.
Croatian: Teva nego što biste trebali, obratite se za savjet svojem liječniku, ljekarniku ili medicinskoj sestri.
English: Do not use Budesonide/Formoterol Teva 320/9 micrograms as a ‘reliever inhaler'.
Croatian: Teva 320/9 mikrograma kao „inhalator za brzo ublažavanje simptoma“.
English: Adults (18 years and older): • 1 inhalation twice a day.
Croatian: Odrasli (s 18 godina i više) • 1 inhalacija dvaput dnevno.
English: Adults (18 years and older): 2 inhalations twice daily.
Croatian: Odrasli (s 18 godina i više) 2 inhalacije dvaput dnevno.
English: 58, rue du Pont de Créteil 94100 Saint-Maur-Des-Fossés - France
Croatian: 58, rue du Pont de Créteil 94100 Saint-Maur-Des-Fossés - Francuska
English: If you are given more X than you should
Croatian: Ako primite više X nego što ste trebali
English: Additionally, there are important individual variations with regards to the onset and duration of action.
Croatian: Dodatno, postoje važne individualne razlike s obzirom na nastup i trajanje djelovanja.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati ovaj lijek jer sadrži Vama važne podatke.
English: To date, no data are available on humans.
Croatian: Do danas, podaci u ljudi nisu dostupni.
English: Serious adverse experiences are generally systemic.
Croatian: Ozbiljne nuspojave obično su sistemske.
English: The higher risk of bleeding is more associated with the procedure, rather than with the medicine.
Croatian: Povećan rizik od krvarenja je više povezan s postupkom nego s lijekom.
English: They will determine the appropriate dose taking into account the procedure, your age, your weight and your general health.
Croatian: Oni će odrediti odgovarajuću dozu uzimajući u obzir postupak, Vašu dob, tjelesnu težinu i opće zdravlje.
English: Limited data of overdose are available.
Croatian: Dostupni su ograničeni podaci o predoziranju.
English: X with food
Croatian: X s hranom
English: No specific carcinogenicity studies were performed.
Croatian: Nisu provedena nikakva specifična ispitivanja kancerogenosti.
English: Frequency “not known”: “not known (cannot be estimated from the available data)”.
Croatian: Učestalost “nepoznato”: “nepoznato (ne može se procijeniti na temelju dostupnih podataka)”.
English: This property could be beneficial when the use of vasoconstrictor is contraindicated.
Croatian: Ova svojstva mogu biti korisna kada je uporaba vazokonstriktora kontraindicirana.
English: The injection rate shall be very slow (1 ml/min).
Croatian: Injiciranje mora biti vrlo sporo (1 ml/min).
English: − low blood pressure;
Croatian: − nizak krvni tlak;
English: However, considering the lack of data for mepivacaine, a risk to the newborns/infants cannot be excluded.
Croatian: Međutim, zbog nedostatka podataka za mepivakain, ne može se isključiti rizik za novorođenče/dojenče.
English: It should be carefully swabbed either with 70% ethyl alcohol or with 90% pure isopropyl alcohol for pharmaceutical use.
Croatian: Potrebno ju je pažljivo obrisati ili sa 70% etilnim alkoholom ili s 90% čistim izopropilnim alkoholom za farmaceutsku upotrebu.
English: What you need to know before you use X
Croatian: Što morate znati prije nego počnete primati X
English: This medicine does not require any special storage condition.
Croatian: Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: The frequencies classification follows the convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000) and Very rare (<1/10,000).
Croatian: Kategorije učestalosti definirane su kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i i vrlo rijetko (<1/10 000).
English: Do not throw away any medicines via wastewater or household.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Ask your dentist, doctor or pharmacist how to throw away medicines you no longer use.
Croatian: liječnika ili ljekarnika kako baciti lijekove koje više ne koristite.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu naknadno ažurirati informacije o lijeku, gdje je prikladno u suradnji s referentnom državom članicom, sukladno postupcima navedenima u Poglavlju 4 Glave III Direktive 2001/83/EZ.
English: Elderly patients: Dosages should be reduced in elderly patients (due to lack of clinical data).
Croatian: Dozu je potrebno smanjiti u starijih bolesnika (zbog nedostatka kliničkih podataka).
English: − excessive sweating;
Croatian: − pretjerano znojenje;
English: In case of relative overdose, patients generally present symptoms within 1-3 minutes.
Croatian: U slučaju relativnog predoziranja, bolesnici obično razviju simptome unutar 1-3 minute.
English: Metabolites are excreted in the urine with less than 10% of unchanged mepivacaine.
Croatian: Metaboliti se izlučuju putem urina s manje od 10% nepromijenjenog mepivakaina.
English: * Rounded to the nearest half-cartridge
Croatian: *Zaokruženo na najbližu polovicu uloška
English: Should cardiac arrest occur, a successful outcome may require prolonged resuscitative efforts.
Croatian: Ukoliko dođe do srčanog zastoja, uspješan ishod može zahtijevati produžene napore pri oživljavanju.
English: Hypotension (with possible circulatory collapse)
Croatian: Rijetko Hipotenzija (s mogućim kolapsom cirkulacije)
English: The maximum plasma level of mepivacaine is achieved approximately after 30-60 minutes.
Croatian: Maksimalna razina mepivakaina u plazmi postiže se otprilike nakon 30-60 minuta.
English: They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by patient.
Croatian: Također mogu biti posljedica preosjetljivosti, idiosinkrazije ili smanjene tolerancije bolesnika.
English: In severe cases, respiratory arrest may occur.
Croatian: U težim slučajevima, može doći do zastoja disanja.
English: In the absence of compatibility studies, this medicinal product must not be mixed with any other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, dentist or pharmacist 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 liječniku, stomatologu ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: H2 antihistaminics (cimetidine)
Croatian: H2-antihistaminici (cimetidin)
English: Hyperhidrosis (sweating or perspiration)
Croatian: Hiperhidroza (znojenje ili perspiracija)
English: For more extensive procedures one or more cartridges may be required, without exceeding the maximum recommended dose.
Croatian: Za opsežnije postupke može biti potrebno jedan ili više uložaka bez prekoračivanja maksimalne preporučene doze.
English: Loss of consciousness Coma
Croatian: Gubitak svijesti Koma
English: The ratio of the average plasma levels following one and two cartridges were approximately 50%, evidencing a dose proportionality at these dose levels.
Croatian: Omjer prosječnih razina u plazmi nakon jednog i dva uloška iznosi približno 50%, što dokazuje proporcionalnost doza pri tim razinama doza.
English: What X looks like and contents of the pack
Croatian: Kako X izgleda i sadržaj pakiranja
English: Because of their convulsive actions, all local anaesthetics should be used very cautiously.
Croatian: Zbog konvulzivnog učinka, svi lokalni anestetici se trebaju koristiti vrlo oprezno.
English: The total dose of administered mepivacaine should not exceed the maximum recommended dose.
Croatian: Ukupna doza primijenjenog mepivakaina ne smije prekoračiti maksimalnu preporučenu dozu.
English: As patients possess different body weights, each patient possess a different maximum allowed quantity of mepivacaine that can tolerate.
Croatian: Kako bolesnici imaju različitu tjelesnu težinu, svaki bolesnik ima različitu maksimalnu dozvoljenu količinu mepivakaina koju može podnijeti.
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 injiciranje u krvnu žilu.
English: Caution should be taken in all patients with porphyria, as this medicinal product may trigger porphyria.
Croatian: Potreban je oprez u svih bolesnika s porfirijom jer ovaj lijek može uzrokovati porfiriju.
English: Analgesia duration
Croatian: Trajanje analgezije
English: The bioavailability is 100% at the action site.
Croatian: Bioraspoloživost Bioraspoloživost iznosi 100% na mjestu djelovanja.
English: Maximum recommended dosage:
Croatian: Maksimalna preporučena doza:
English: Higher concentrations are found in highly perfused tissues such as liver, lungs, heart and brain.
Croatian: Više koncentracije pronalaze se u visoko prokrvljenim tkivima kao što su jetra, pluća, srce i mozak.
English: • Hypersensitivity to the active substance (or any local anaesthetics agent of the amide type) or to any of the excipients listed in section 6.1,
Croatian: • Preosjetljivost na djelatnu tvar (ili bilo koji lokalni anestetik amidnog tipa) ili neku od pomoćnih tvari navedenih u dijelu 6.1,
English: Mepivacaine binds to plasmatic proteins up to around 75% and can cross placental barrier by simple diffusion.
Croatian: Mepivakain se veže na proteine plazme do oko 75% i može prelaziti placentarnu barijeru jednostavnom difuzijom.
English: These data originated in post-marketing reports, mostly following nerve blocks in mandible, involving various branches of the trigeminal nerve;
Croatian: Ovi podaci proizlaze iz post-marketinških izvješća, uglavnom nakon blokade živaca u mandibuli, koji uključuju razne grane trigeminalnog živca:
English: − loss of consciousness, fit (convulsion), coma;
Croatian: − gubitak svijesti, napadaj (konvulzije), koma;
English: Box containing 50 cartridges.
Croatian: Kutija s 50 uložaka.
English: Undesirable toxic effects may appear at plasma concentrations upper than 5 mg/l, and convulsions could appear with 10 mg/l or higher.
Croatian: Neželjeni toksični učinci mogu nastati pri koncentracijama u plazmi višim od 5 mg/l, a konvulzije se mogu javiti pri koncentraciji od 10 mg/l ili višoj.
English: Children should be given doses commensurate with age and weight.
Croatian: Djeci je potrebno osigurati dozu u skladu s njihovom dobi i težinom.
English: What X contains
Croatian: Što X sadrži
English: Concomitant use of sedatives to reduce patient anxiety:
Croatian: Istodobna primjena sedativa za smanjenje anksioznosti bolesnika:
English: If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately.
Croatian: Ukoliko se pojave znakovi akutne sistemske toksičnosti, injiciranje lokalnog anestetika mora se odmah prekinuti.
English: When a dental peripheral nerve block is performed, mepivacaine effect occurs rapidly (generally within 3 to 5 minutes).
Croatian: Kada se izvodi blok zubnog perifernog živca, učinak mepivakaina se javlja brzo (obično unutar 3 do 5
English: Very rare side effects (may affect up to 1 in 10,000 people): − high blood pressure.
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba): − visoki krvni tlak.
English: The duration of the local anaesthetic is unrelated to the half-life as its action is terminated when the drug is removed from the receptor.
Croatian: Trajanje učinka lokalnog anestetika nije povezano s poluvremenom jer njegovo djelovanje prestaje kada se lijek odvoji od receptora.
English: Whereas in case of absolute overdose, signs of toxicity, depending on the injection site, appear about 20-30 minutes after the injection.
Croatian: Dok se u slučaju apsolutnog predoziranja, znakovi toksičnosti, ovisno o mjestu injiciranja, pojave oko 20-30
English: Mepivacaine must be used safely and effectively under appropriate conditions: The local anaesthetic effects may be reduced when {Scandonest and associated names} is injected into an inflamed or infected area.
Croatian: Mepivakain se mora primjenjivati sigurno i učinkovito uz odgovarajuće uvjete: Učinci lokalne anestezije mogu se smanjiti kada se {Scandonest i pridružena imena} injicira u upaljeno ili inficirano područje.
English: This medicine may have a minor influence on the ability to drive and use machines.
Croatian: Ovaj lijek može imati mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Izbjegavajte jesti, uključujući i žvakanje žvakaće gume, dok se ne vrati normalan osjet jer postoji rizik da se ugrizete za usne, obraze ili jezik, osobito u djece.
English: Do not use this medicine if you notice that the solution is not clear and colourless.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da otopina nije bistra i bezbojna.
English: One or more of the following side effects may occur following administration of X.
Croatian: Jedna ili više sljedećih nuspojava mogu se javiti nakon primjene lijeka X.
English: Elimination can be accelerated by acidifying the urine (See section 4.9).
Croatian: Eliminacija se može ubrzati povećanjem kiselosti urina (vidjeti dio 4.9).
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 učinak anestetika progresivno razvija u živcu, prag električne podražljivosti postupno raste, brzina porasta akcijskog potencijala opada i provođenje impulsa usporava.
English: In case a reinjection is required, patient should be monitored, to identify any sign of relative overdose.
Croatian: U slučaju da je potrebna ponovljena primjena lijeka, bolesnika je potrebno pratiti kako bi se otkrio bilo koji znak relativnog predoziranja.
English: Conduction disorders (atrioventricular block)
Croatian: Poremećaji provođenja (atrioventrikularni blok)
English: The plasma elimination half-life is 2 hours for adults.
Croatian: Poluvrijeme eliminacije mepivakaina iz plazme iznosi 2 sata u odraslih osoba.
English: Presyncope, syncope;
Croatian: Presinkopa, sinkopa;
English: Hypoxaemia and metabolic acidosis may potentiate the cardiovascular toxicity.
Croatian: Hipoksemija i metabolička acidoza mogu potencirati kardiovaskularnu toksičnost.
English: The cartridges should under no circumstance be dipped into any solution whatsoever.
Croatian: Uložak se ni u kom slučaju ne smije umočiti u bilo kakvu otopinu.
English: Elimination can be accelerated by acidifying the urine.
Croatian: Eliminacija se može ubrzati povećanjem kiselosti urina.
English: This medicine is a clear and colourless solution.
Croatian: Ovaj lijek je bistra i bezbojna otopina.
English: The following table lists the maximum allowed dose in children and the equivalent in number of cartdriges:
Croatian: Sljedeća tablica prikazuje maksimalne dozvoljene doze u djece te ekvivalent u broju uložaka:
English: The immediate availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies should be considered (see section 4.2).
Croatian: Treba razmotriti neposrednu dostupnost kisika, drugih lijekova za oživljavanje, opreme za kardiopulmonalno oživljavanje te osoblja potrebnog za odgovarajuće liječenje toksičnih reakcija i povezanih hitnih stanja (vidjeti dio 4.2).
English: Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.
Croatian: Optimalna oksigenacija i ventilacija te potpora cirkulacije kao i liječenje acidoze su od vitalne važnosti.
English: 4 neural pathologies that may occur with the various symptoms of abnormal sensations (i.e., paresthesia,
Croatian: 4. neuralne patologije koje se mogu javiti uz razne simptome abnormalnih osjeta (tj. parestezija,
English: Seizures may last from a few seconds to several minutes and rapidly lead to hypoxia and hypercapnia, as a result of increased muscular activity and insufficient ventilation.
Croatian: Napadaji mogu trajati od nekoliko sekundi do nekoliko minuta i brzo vode u hipoksiju i hiperkapniju, što je posljedica povećane mišićne aktivnosti te nedovoljne ventilacije.
English: − quick or difficult breathing, drowsiness, headache, inability to think and sleepiness, which may be the signs of a high concentration of carbon dioxide in your blood (hypercapnia);
Croatian: − brzo ili otežano disanje, omamljenost, glavobolja, nemogćnost razmišljanja i pospanost, koji mogu biti znakovi visoke koncentracije ugljikovog dioksida u krvi (hiperkapnija);
English: Convulsion (including tonic-clonic seizure)
Croatian: Konvulzije (uključujući toničko-klonički napadaj)
English: Manifestation of these effects during injection of the product is a warning signal and the injection should be stopped immediately.
Croatian: Pojava ovih učinaka tijekom injiciranja lijeka je znak upozorenja te je potrebno odmah zaustaviti injiciranje.
English: The plasma half-life is prolonged if the patient is suffering from liver and renal insufficiency.
Croatian: Poluvrijeme u plazmi produžuje se ako bolesnik pati od jetrene i bubrežne insuficijencije.
English: General toxicity studies (Single dose toxicity, Repeat-dose toxicity) were performed with mepivacaine demonstrating a good safety margin.
Croatian: Ispitivanja opće toksičnosti (toksičnost pojedinačne doze, toksičnost ponovljene doze) provedena s mepivakainom pokazala su dobru granicu sigurnosti.
English: PH: 6.1-6.7
Croatian: Bistra i bezbojna otopina. pH: 6,1-6,7
English: Acidosis exacerbates the toxic effects of local anaesthetics.
Croatian: Acidoza pogoršava toksične učinke lokalnih anestetika.
English: Each ml contains 0.11 mmol of sodium (2.467 mg/ml).
Croatian: Jedan ml sadrži 0,11 mmol natrija (2,467 mg/ml).
English: Clinical studies were not performed in pregnant women and no cases of pregnant women injected with mepivacaine 30 mg/ml were reported in the literature.
Croatian: Trudnoća Nisu provedena klinička ispitivanja u trudnica i u literaturi nisu zabilježeni slučajevi trudnica kojima je injicirano 30 mg/ml mepivakaina.
English: You should not leave the dental office until you recover your abilities (generally within 30 minutes) following the dental procedure.
Croatian: Ne smijete napustiti stomatološku ordinaciju dok Vam se ne vrate Vaše sposobnosti (uglavnom unutar 30 minuta) nakon stomatološkog postupka.
English: Pharmacotherapeutic group: Nervous System/Anaesthetics/Local anaesthetics/Amides/Mepivacaine ATC code: N01 BB 03
Croatian: Farmakoterapijska skupina: Živčani sustav/Anestetici/Lokalni anestetici/Amidi/Mepivakain ATK oznaka: N01 BB 03
English: The rate of injection should not exceed 1 ml of solution per minute.
Croatian: Brzina injiciranja ne smije prelaziti 1 ml otopine u minuti.
English: Not known Myocardial depression
Croatian: Nepoznato Depresija miokarda
English: X is a local anaesthetic, which numbs a particular region to prevent or minimize pain.
Croatian: X je lokalni anestetik kojim se postiže neosjetljivost određenog područja kako bi se spriječila ili smanjila bol.
English: For adults, the maximum recommended dose is of 4.4 mg/kg of body weight with an absolute maximum recommended dose of 300 mg for the individuals above 70 kg of body weight corresponding to 10 ml of solution.
Croatian: Za odrasle, maksimalna preporučena doza iznosi 4,4 mg/kg tjelesne težine s apsolutnom maksimalnom preporučenom dozom od 300 mg za osobe tjelesne težine iznad 70 kg što odgovara 10 ml otopine.
English: So, patients should not leave the dental office until they recover their abilities (generally within 30 minutes) following the dental procedure.
Croatian: Stoga bolesnici ne bi smjeli napustiti stomatološku ordinaciju dok im se ne vrate njihove sposobnosti (uglavnom unutar 30 minuta) nakon stomatološkog postupka.
English: Not known Nerve injury
Croatian: Nepoznato Ozljeda živca
English: - The other ingredients are: sodium chloride, sodium hydroxide and water for injection.
Croatian: - Drugi sastojci su: natrijev klorid, natrijev hidroksid i voda za injekcije.
English: Over 50% of a dose is excreted as metabolites into the bile but these probably undergo entero-hepatic circulation as only small amounts appear in the faeces.
Croatian: Preko 50% doze izlučuje se u obliku metabolita putem žuči, ali su vjerojatno podvrgnuti enterohepatičkoj cirkulaciji, budući da se u fecesu pojavljuju samo male količine.