FrancophonIA/ELRC3.0 huggingface dataset:
English: These included changes to the packaging and p recommendations on adjusting the dose for patients with kidney problems and restr medicines' use in certain patients (for instance pati such measures in 1998 and 2006, but concluded in February 2011 that these ha prevent serious side effects from occurring in France.
Slovenian: Ti ukrepi so vključevali spremembe podatkov na embalaži in informacij o zdravilu, priporočila za prilagoditev odmerka za bolnike z ledvičnimi težavami in omejitve pri uporabi zdravila za določene bolnike (na primer bolnike z epilepsijo).
English: Measures to minimise the risks with buflomedil had already been taken in som where the medicine is marketed.
Slovenian: V nekaterih državah članicah, ki zdravilo tržijo, so že sprejeli ukrepe za zmanjšanje tveganj, povezanih z buflomedilom.
English: Patients with PAOD are likely to have kidney problems due to the nature of the e of the Member States roduct information, ictions on the ents with epilepsy).
Slovenian: Bolniki s periferno arterijsko okluzivno boleznijo utegnejo imeti ledvične težave zaradi narave bolezni.
English: It is ition where the body's large arteries become obstructed causing symptoms such as pain and weakness, particularly in ients with stage II PAOD, which means that they experience severe a national , Greece, Italy, me Loftyl and other olution for injection.
Slovenian: Uporablja se za zdravljenje simptomov periferne arterijske okluzivne bolezni, stanja, pri katerem je pretok skozi velike arterije telesa oviran, kar povzroči simptome, kakršna sta bolečina in šibkost, še posebej v nogah.
English: No specific carcinogenicity studies were performed.
Slovenian: Posebne študije kancerogenosti niso bile izvedene.
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.
Slovenian: Informacije o zdravilu se lahko naknadno posodobijo s strani pristojnega organa države članice v povezavi z referenčno državo članico, kot je primerno v skladu s postopki opisanimi v poglavju 4 pod naslovom III Direktive 2001/83/ES.
English: To date, no data are available on humans.
Slovenian: Za človeka za zdaj ni podatkov.
English: The data on this effect remains controversial (see Sections 4.4 and 5.1).
Slovenian: Podatki o tem učinku ostajajo nasprotujoči (glejte poglavji 4.4 in 5.1).
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).
Slovenian: Razvrstitev pogostnosti upošteva naslednji dogovor: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: Additionally, there are important individual variations with regards to the onset and duration of action.
Slovenian: Poleg tega so pomembne razlike med posamezniki tudi glede začetka in trajanja delovanja.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material je treba odvreči v skladu z lokalnimi zahtevami.
English: In severe cases, respiratory arrest may occur.
Slovenian: V hudih primerih lahko pride do zastoja dihanja.
English: This leaflet was last revised in {month YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec YYYY}
English: The higher risk of bleeding is more associated with the procedure, rather than with the medicine.
Slovenian: Večje tveganje za krvavitve je bolj povezano s posegom kot z zdravilom.
English: In the absence of compatibility studies, this medicinal product must not be mixed with any other medicinal products.
Slovenian: Ker kompatibilnostne študije niso bile izvedene, se tega zdravila ne sme mešati z nobenim drugim zdravilom.
English: Frequency “not known”: “not known (cannot be estimated from the available data)”.
Slovenian: Pogostnost “neznana”: “neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)”.
English: Elderly patients: Dosages should be reduced in elderly patients (due to lack of clinical data).
Slovenian: Starejši bolniki: Pri starejših bolnikih je treba zmanjšati odmerek (zaradi pomanjkanja kliničnih podatkov).
English: Limited data of overdose are available.
Slovenian: Na voljo so omejeni podatki o prevelikem odmerjanju.
English: The injection rate shall be very slow (1 ml/min).
Slovenian: Hitrost injiciranja naj bo zelo majhna (1 ml/min).
English: This property could be beneficial when the use of vasoconstrictor is contraindicated.
Slovenian: Ta lastnost je lahko prednost, kadar je uporaba vazokonstriktorja kontraindicirana.
English: Serious adverse experiences are generally systemic.
Slovenian: Resni neželeni učinki so praviloma sistemski.
English: For poorly controlled epileptic patients, see section 4.3.
Slovenian: Za bolnike s slabo urejeno epilepsijo glejte poglavje 4.3.
English: - Hypotension.
Slovenian: - hipotenzija.
English: However, considering the lack of data for mepivacaine, a risk to the newborns/infants cannot be excluded.
Slovenian: A ker podatkov za mepivakain ni, tveganja za novorojenčke/dojenčke ni mogoče izključiti.
English: The plasma elimination half-life is 2 hours for adults.
Slovenian: Plazemski razpolovni čas izločanja je 2 uri pri odraslem.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate prek nacionalnega sistema poročanja navedenega v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: The maximum plasma level of mepivacaine is achieved approximately after 30-60 minutes.
Slovenian: Največja raven mepivakaina v plazmi je dosežena po približno 30 - 60 minutah.
English: Do not use this medicine if you notice that the solution is not clear and colourless.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da raztopina ni bistra in brezbarvna.
English: Caution should be taken in all patients with porphyria, as this medicinal product may trigger porphyria.
Slovenian: Previdnost je potrebna pri vseh bolnikih s porfirijo, saj lahko to zdravilo izzove porfirijo.
English: Analgesia duration
Slovenian: Trajanje analgezije
English: As patients possess different body weights, each patient possess a different maximum allowed quantity of mepivacaine that can tolerate.
Slovenian: Ker imajo bolniki različne telesne mase, ima vsak bolnik drugačno največjo dovoljeno količino mepivakaina, ki jo lahko prenaša.
English: Clearance of amides is dependent on hepatic blood flow.
Slovenian: Očistek amidov je odvisen od hepatičnega krvnega pretoka.
English: However, the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
Slovenian: Vseeno pa odsotnost krvi v injekcijski brizgi ne zagotavlja, da ni prišlo do intravaskularnega injiciranja.
English: They will determine the appropriate dose taking into account the procedure, your age, your weight and your general health.
Slovenian: Oni bodo določili ustrezni odmerek z upoštevanjem posega, vaše starosti, telesne mase in splošnega zdravstvenega stanja.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila prek nacionalnega sistema poročanja navedenega v Dodatku V.
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.
Slovenian: Trajanje delovanja lokalnega anestetika ni povezano z razpolovnim časom, saj se njegovo delovanje zaključi, ko se zdravilo odstrani z receptorja.
English: H2 antihistaminics (cimetidine)
Slovenian: Antihistaminiki H2 (cimetidin)
English: Recommended therapeutic dose:
Slovenian: Priporočeni terapevtski odmerek:
English: This medicine is given as an injection in the oral cavity.
Slovenian: To zdravilo se da kot injekcija v ustno votlino.
English: Very rare Hypertension Not known Vasodilatation Local/ Regional hyperaemia
Slovenian: zelo redki hipertenzija neznana vazodilatacija lokalna/regionalna hiperemija
English: Elimination can be accelerated by acidifying the urine.
Slovenian: Izločanje se lahko pospeši z nakisanjem urina.
English: The total dose of administered mepivacaine should not exceed the maximum recommended dose.
Slovenian: Celokupni uporabljeni odmerek mepivakaina ne sme preseči največjega priporočenega odmerka.
English: In case a reinjection is required, patient should be monitored, to identify any sign of relative overdose.
Slovenian: V primeru, da je potrebno dodatno injiciranje, je treba bolnika nadzirati, da bi se ugotovilo kakršen koli znak relativnega prekomernega odmerjanja.
English: Unused solution must be discarded.
Slovenian: Neporabljeno raztopino je treba zavreči.
English: X is a local anaesthetic, which numbs a particular region to prevent or minimize pain.
Slovenian: Zdravilo X je lokalni anestetik, ki omrtviči določeno področje za preprečitev ali zmanjšanje bolečine.
English: The cartridges should under no circumstance be dipped into any solution whatsoever.
Slovenian: Vložka pod nobenimi pogoji ne smemo potopiti v kakršno koli raztopino.
English: They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by patient.
Slovenian: Lahko so tudi posledica preobčutljivosti, idiosinkrazije ali bolnikovega zmanjšanega prenašanja.
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,
Slovenian: • preobčutljivost na zdravilno učinkovino (ali kateri koli lokalni anestetik amidnega tipa) ali katero koli pomožno snov, navedeno v poglavju 6.1,
English: For more extensive procedures one or more cartridges may be required, without exceeding the maximum recommended dose.
Slovenian: Za bolj obsežne posege je lahko potreben en ali več vložkov, vendar se ne sme preseči največjega priporočenega odmerka.
English: Concomitant use of the other medicinal products may require thorough monitoring (see section 4.5).
Slovenian: Sočasna uporaba drugih zdravil lahko zahteva temeljit nadzor (glejte poglavje 4.5).
English: If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately.
Slovenian: Če se pojavijo znaki akutne sistemske toksičnosti, je treba injiciranje lokalnega anestetika nemudoma prekiniti.
English: What X is and what it is used for
Slovenian: Kaj je zdravilo X in za kaj ga uporabljamo
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: Ker se anestetično delovanje postopno razvija v živcu, prag za električno vzdražljivost postopoma narašča, hitrost dviga akcijskega potenciala se zmanjšuje in prevajanje impulza se upočasnjuje.
English: Should cardiac arrest occur, a successful outcome may require prolonged resuscitative efforts.
Slovenian: V primeru zastoja srca je lahko za uspešen izid potreben dolgotrajen postopek oživljanja
English: • Poorly controlled epileptic patient.
Slovenian: • bolnik s slabo urejeno epilepsijo.
English: Undesirable toxic effects may appear at plasma concentrations upper than 5 mg/l, and convulsions could appear with 10 mg/l or higher.
Slovenian: Neželeni toksični učinki se lahko pojavijo pri plazemskih koncentracijah nad 5 mg/l, konvulzije pa se lahko pojavijo pri plazemskih koncentracijah nad 10 mg/l.
English: Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.
Slovenian: Optimalna oksigenacija in predihavanje ter podpora obtoka, kot tudi zdravljenje acidoze, so življenjskega pomena.
English: Mepivacaine must be used with caution in:
Slovenian: Mepivakain je treba uporabljati previdno:
English: The rate of injection should not exceed 1 ml of solution per minute.
Slovenian: Hitrost injiciranja ne sme preseči 1 ml raztopine na minuto.
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.
Slovenian: Preko 50 % odmerka se izloči v obliki presnovkov v žolč, toda to je verjetno podvrženo entero-hepatičnemu obtoku, saj se samo majhna količina pojavi v blatu.
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.
Slovenian: Konvulzije lahko trajajo od nekaj sekund do nekaj minut in hitro vodijo do hipoksije in hiperkapnije kot posledica povečane mišične aktivnosti in nezadostne predihanosti.
English: This medicine does not require any special storage condition.
Slovenian: Za shranjevanje tega zdravila niso potrebna posebna navodila.
English: Elimination can be accelerated by acidifying the urine (See section 4.9).
Slovenian: Izločanje se lahko pospeši z nakisanjem urina (glejte poglavje 4.9).
English: What is in this leaflet What X is and what it is used for What you need to know before you use X How to use X
Slovenian: Kaj je zdravilo X in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo X Kako uporabljati zdravilo X
English: Box containing 50 cartridges.
Slovenian: Škatla vsebuje 50 vložkov.
English: * Rounded to the nearest half-cartridge
Slovenian: * Zaokroženo na najbližjo polovico vložka
English: Manifestation of these effects during injection of the product is a warning signal and the injection should be stopped immediately.
Slovenian: Izražanje teh učinkov med injiciranjem zdravila je opozorilni signal in z injiciranjem je treba takoj prenehati.
English: Hypoxaemia and metabolic acidosis may potentiate the cardiovascular toxicity.
Slovenian: Hipoksemija in metabolična acidoza lahko potencirata srčno-žilno toksičnost.
English: Concomitant use of sedatives to reduce patient anxiety:
Slovenian: Sočasna uporaba pomirjeval za zmanjšanje tesnobe bolnika:
English: Mepivacaine binds to plasmatic proteins up to around 75% and can cross placental barrier by simple diffusion.
Slovenian: Mepivakain se veže na plazemske proteine v približno 75 % in lahko prehaja placentno bariero z enostavno difuzijo.
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.
Slovenian: Preveliko odmerjanje lokalnega anestetika je lahko absolutno, zaradi injiciranja prevelikega odmerka, ali relativno, zaradi injiciranja normalnega ne-toksičnega odmerka v določenih okoliščinah.
English: Acidosis exacerbates the toxic effects of local anaesthetics.
Slovenian: Acidoza poslabša toksične učinke lokalnih anestetikov.
English: It should be carefully swabbed either with 70% ethyl alcohol or with 90% pure isopropyl alcohol for pharmaceutical use.
Slovenian: 70 % etilnim alkoholom ali s čistim izopropilnim alkoholom (90 %) za farmacevtsko uporabo.
English: The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation.
Slovenian: Količino za injiciranje je treba določiti glede na starost in telesno maso otroka ter velikost posega.
English: Do not throw away any medicines via wastewater or household.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Each ml contains 0.11 mmol of sodium (2.467 mg/ml).
Slovenian: En ml vsebuje 0,11 mmol natrija (2,467 mg/ml).
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov, kar zadeva toksične vplive na sposobnost razmnoževanja.
English: Convulsion (including tonic-clonic seizure)
Slovenian: konvulzije (vključno s tonično-kloničnimi napadi)
English: As all amide-type local anaesthetics, mepivacaine is largely metabolised in the liver by microsomal enzymes (cytochrome P450 1A2 (CYP1A2)).
Slovenian: Kot vsi lokalni anestetiki amidnega tipa se tudi mepivakain obširno presnavlja v jetrih z mikrosomalnimi encimi (citokrom P450 1A2 (CYP1A2)).
English: If there is any risk of an allergic reaction, choose different medicine for anaesthesia (see Section 4.3).
Slovenian: Če obstaja kakršno koli tveganje za alergijsko reakcijo, je treba izbrati drugo zdravilo za anestezijo (glejte poglavje 4.3).
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.
Slovenian: Kliničnih študij pri nosečnicah niso izvedli, v literaturi pa ni opisanih primerov nosečnic, ki bi jim injicirali mepivakain 30 mg/ml.
English: Nursing mothers are advised not to breastfeed 10 hours following anaesthesia with this product.
Slovenian: Doječim materam se svetuje, da ne dojijo 10 ur po anesteziji s tem zdravilom.
English: No nursing mothers were included in the clinical studies with {Scandonest and associated names}.
Slovenian: Doječe matere niso bile vključene v klinične študije zdravila {Scandonest in povezana imena (glejte
English: Children should be given doses commensurate with age and weight.
Slovenian: Otrokom je treba dati odmerke, ki ustrezajo njihovi starosti in telesni masi.
English: − nerve injury.
Slovenian: poškodba živca.
English: This medicine is a clear and colourless solution.
Slovenian: To zdravilo je bistra in brezbarvna raztopina.
English: Mepivacaine reversibly inhibits the conduction of nerve impulses by decreasing or blocking sodium (Na+) flow during propagation of the nerve action potential.
Slovenian: Mepivakain reverzibilno zavira prevajanje živčnih impulzov z zmanjšanjem ali blokiranjem pretoka natrija (Na+) med širjenjem živčnega akcijskega potenciala.
English: The following table lists the maximum allowed dose in children and the equivalent in number of cartdriges:
Slovenian: V naslednji preglednici so navedeni največji dovoljeni odmerki pri otrocih in ustrezajoče število vložkov:
English: Caution should be exercised when mepivacaine is administered concomitantly with propranolol.
Slovenian: Previdnost je potrebna, kadar se mapivakain uporablja sočasno s propranololom.
English: He/she may decide to give you reduced dose.
Slovenian: Lahko se odloči, da uporabi manjši odmerek.
English: Risk associated with intraneural injection
Slovenian: Tveganje, povezano z injiciranjem v živec
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, kadar je prisotno vnetje in/ali okužba na mestu injiciranja.
English: So, patients should not leave the dental office until they recover their abilities (generally within 30 minutes) following the dental procedure.
Slovenian: Zato bolniki zobozdravniške ordinacije ne smejo zapustiti, dokler si ne opomorejo (običajno v 30 minutah) po zobozdravstvenem posegu.
English: Do not use X: - If you are allergic to mepivacaine or any of the other ingredients of this medicine (listed in section 6); - if you are allergic to other local anaesthetics of the same group (e.g. lidocaine, bupivacaine); - If you suffer from:
Slovenian: če ste alergični na mepivakain ali katero koli sestavino tega zdravila (navedeno v poglavju 6), če ste alergični na druge lokalne anestetike iz iste skupine (npr. lidokain, bupivakain), če imate:
English: Epileptic patients:
Slovenian: Bolniki z epilepsijo:
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 okvaro živcev pri živčnih blokadah, je treba iglo vedno rahlo izvleči, če bolnik občuti električni tresljaj med injiciranjem ali če je injiciranje posebno boleče.
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).
Slovenian: To zdravilo se uporablja za lokalne zobozdravstvene posege pri odraslih, mladostnikih in otrocih nad 4. letom starosti (približno 20 kg telesne mase).
English: The following table lists the maximum allowed doses in adults for the most commonly used anaesthetic techniques and the equivalent in number of cartridges:
Slovenian: V naslednji preglednici so navedeni največji dovoljeni odmerki za odrasle za najpogosteje uporabljane anestetične tehnike in ustrezajoče število vložkov:
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.
Slovenian: Za odrasle je največji priporočeni odmerek 4,4 mg/kg telesne mase z absolutno največjim priporočenim odmerkom 300 mg za posameznike nad 70 mg telesne mase, kar ustreza 10 ml raztopine.
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.
Slovenian: Obstaja tveganje za poškodbe zaradi ugriza (ustnice, lica, sluznica in jezik), zlasti pri otrocih; bolniku je treba povedati, naj se izogiba žvečenju žvečilnega gumija ali uživanju hrane, dokler se ne povrnejo normalni občutki.
English: Higher concentrations are found in highly perfused tissues such as liver, lungs, heart and brain.
Slovenian: Večje koncentracije so izmerili v dobro prekrvljenih tkivih, kot so jetra, pljuča, srce in možgani.
English: When a dental peripheral nerve block is performed, mepivacaine effect occurs rapidly (generally within 3 to 5 minutes).
Slovenian: Začetek delovanja V primeru dentalne periferne blokade živca se učinek mepivakaina pojavi hitro (na splošno v 3 do
English: If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor, and/or inotropic agents should be considered.
Slovenian: Če se pojavi srčno-žilna depresija (hipotenzija, bradikardija), je treba pretehtati ustrezno zdravljenje z intravenskimi tekočinami, vazopresorji in/ali inotropnimi učinkovinami.
English: • Children below 4 years of age (ca. 20 kg body weight),
Slovenian: • otroci do 4. leta starosti (približno 20 kg telesne mase),
English: If you experience any of these, administration should immediately be stopped and emergency medical assistance should be summoned.
Slovenian: Če občutite kar koli od tega, je treba injiciranje takoj prekiniti in začeti z nujno medicinsko pomočjo.
English: Caution should be used in case of acidosis such as worsened of renal insufficiency or poorly control of type 1 diabetes mellitus.
Slovenian: Previdnost je potrebna v primeru acidoze, npr. ob poslabšanju ledvične insuficience ali slabo urejeni sladkorni bolezni tipa I.
English: Method of administration Infiltration and perineural use For single use
Slovenian: Način uporabe infiltiranje in perinevralna uporaba za enkratno uporabo
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.
Slovenian: Mepivakain izraža rahle vazokonstriktorne lastnosti, kar vodi do daljšega delovanja kot pri mnogih drugih lokalnih anestetikih, kadar se uporabijo brez vazokonstriktorja.
English: CYP1A2 inhibitors
Slovenian: Zaviralci CYP1A2
English: Cimetidine reduces the clearance of mepivacaine.
Slovenian: Cimetidin zmanjša očistek mepivakaina.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted.>
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.