FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no significant differences in levofloxacin pharmacokinetics between young and elderly subjects, except those associated with differences in creatinine clearance.
Slovenian: V farmakokinetiki levofloksacina med mlajšimi in starejšimi bolniki ni pomembnih razlik, razen tistih, ki so povezane z razlikami v očistku kreatinina.
English: Prescribers are advised to take into account the local prevalence of resistance in E. coli to fluoroquinolones.
Slovenian: Zdravnikom svetujemo, da upoštevajo lokalno prevalenco odpornosti E. coli proti fluorokinolonom.
English: • The length of your treatment will depend on how serious your infection is.
Slovenian: • Čas zdravljenja je odvisen od resnosti okužbe
English: alteration of the heart rhythm (called ‘prolongation of QT interval', seen on ECG, electrical activity of the heart)
Slovenian: spreminjanje srčnega ritma (t.i. ‘podaljšanje intervala QT', vidno na EKG, zapisu električne aktivnosti srca)
English: Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant.
Slovenian: Dokler ni dokazov o kliničnem odgovoru potrjenih izolatov z MIK nad trenutno mejno vrednostjo za odpornost, jih je treba poročati kot odporne seve.
English: The degree of the bactericidal activity of levofloxacin depends on the ratio of the maximum concentration in serum (Cmax) or the area under the curve (AUC) and the minimal inhibitory concentration (MIC).
Slovenian: Stopnja baktericidnega delovanja levofloksacina je odvisna od razmerja med maksimalno koncentracijo v serumu (Cmax) ali površino pod krivuljo (AUC - area under curve) in minimalno inhibitorno koncentracijo (MIK).
English: Macrogol
Slovenian: Makrogol
English: • Low number of white blood cells (neutropenia)
Slovenian: • Majhno število belih krvnih celic (nevtropenija)
English: If your doctor has prescribed a urine test, tell your doctor you are taking Tavanic.
Slovenian: Če vam zdravnik namerava narediti urinske teste, mu povejte, da jemljete zdravilo Tavanic.
English: It most frequently involves the Achilles tendon and may lead to tendon rupture.
Slovenian: Najpogosteje prizadene Ahilovo tetivo in lahko povzroči pretrganje tetive.
English: With decreasing renal function renal elimination and clearance are decreased, and elimination half-lives increased as shown in the table below:
Slovenian: Z zmanjševanjem delovanja ledvic se zmanjšujeta izločanje in očistek, razpolovni čas izločanja pa se podaljša, kot prikazuje naslednja preglednica:
English: Due to the mechanism of action, there is generally no cross-resistance between levofloxacin and other classes of antibacterial agents.
Slovenian: Zaradi mehanizma delovanja na splošno ni nobene navzkrižne odpornosti med levofloksacinom in drugimi vrstami antibiotikov.
English: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see sections 4.7 and 4.8).
Slovenian: Če se pojavijo motnje vida ali se pojavijo kakršnikoli učinki na očeh, se je treba nemudoma posvetovati s specialistom za oči (glejte poglavji 4.7 in 4.8).
English: • Temporary loss of consciousness or posture (syncope)
Slovenian: • Začasna izguba zavesti ali padec (sinkopa)
English: These could be signs of a severe bowel problem
Slovenian: To so lahko znaki hude težave s črevesjem
English: For the above-mentioned infections Tavanic should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Slovenian: Za zgoraj omenjene okužbe se lahko zdravilo Tavanic uporablja samo, če uporaba protibakterijskih zdravil, ki so običajno priporočena za začetno zdravljenje teh okužb, ni primerna.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Slovenian: V primeru razširjene lokalne odpornosti je treba poiskati nasvet strokovnjaka, če se izkaže, da je pričakovana korist zdravljenja v vsaj nekaj primerih okužb vprašljiva.
English: (E 172) and red ferric oxide (E 172)
Slovenian: (E 172) in rdeči železov oksid (E 172)
English: • Blood tests may show unusual results due to liver (bilirubin increased) or kidney (creatinine increased) problems
Slovenian: • Preiskave krvi lahko pokažejo neobičajne rezultate zaradi težav z jetri (povišan bilirubin) ali ledvicami (kreatinin)
English: The renal clearance of levofloxacin was reduced by cimetidine (24%) and probenecid (34%).
Slovenian: Oba zmanjšata ledvični očistek kreatinina, in sicer cimetidin za 24 % in probenecid za 34 %.
English: Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with levofloxacin (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (CDAD).
Slovenian: Driska (zlasti če je huda, dolgotrajna in/ali krvava) med zdravljenjem z levofloksacinom ali po njem (vključno še nekaj tednov po zaključku zdravljenja) lahko pomeni bolezen, povezano s Clostridium difficile (CDAD - Clostridium difficile-associated disease).
English: Anti-peristaltic medicinal products are contraindicated in this clinical situation.
Slovenian: Zdravila, ki zavirajo peristaltiko, so v takšnih kliničnih okoliščinah kontraindicirana.
English: Stop taking Tavanic and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Slovenian: Nehajte uporabljati zdravilo Tavanic tablete in nemudoma povejte zdravniku, če opazite katerega od naslednjih resnih neželenih učinkov - morda boste potrebovali nujno zdravniško zdravljenje:
English: Low-level fluoroquinolone resistance (ciprofloxacin MICs of 0.12-0.5 mg/l) may occur but there is no evidence that this resistance is of clinical importance in respiratory tract infections with H. influenzae.
Slovenian: Lahko se pojavi nizka raven odpornosti proti fluorokinolonom (ciprofloksacin MIK od 0,12-0,5 mg / l), vendar ni dokazov, da je ta odpornost klinično pomembna pri okužbah dihal s H. influenzae.
English: The daily dose should be adjusted in elderly patients based on creatinine clearance (see section 4.2).
Slovenian: Dnevni odmerek je treba prilagoditi pri starejših bolnikih na osnovi očistka kreatinina (glejte poglavje 4.2).
English: • Inflammation of the vessels that carry blood around your body due to an allergic reaction (vasculitis)
Slovenian: • Vnetje žil, ki dovajajo krvi po telesu, zaradi alergijske reakcije (vaskulitis)
English: If you stop taking the tablets too soon, the infection may return, your condition may get worse or the bacteria may become resistant to the medicine.
Slovenian: Če se z jemanjem zdravila prehitro preneha, se lahko okužba povrne ali postane bakterija odporna na zdravilo.
English: • Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest,
Slovenian: • Neobičajno hiter ritem srca, življenje ogrožajoči neredni srčni ritem vključno s srčnim zastojem,
English: • You have ever had epilepsy
Slovenian: • Ste kdaj imeli epilepsijo
English: This belongs to a group of medicines called antibiotics.
Slovenian: Spada v skupino antibiotikov.
English: • Warfarin - used to thin the blood.
Slovenian: • Varfarin, ki se uporablja za redčenje krvi.
English: Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body.
Slovenian: Hemodializa (vključno s peritonealno dializo in CAPD) ni učinkovita za odstranjevanje levofloksacina iz telesa.
English: Levofloxacin may be used in the treatment of Acute Bacterial Sinusitis and Acute Exacerbation of Chronic Bronchitis when these infections have been adequately diagnosed.
Slovenian: Levofloksacin se lahko uporablja za zdravljenje akutnega bakterijskega sinuzitisa in akutnega poslabšanja kroničnega bronhitisa, ko so bile te okužbe ustrezno diagnosticirane.
English: Adults and the elderly with kidney problems Your doctor may need to give you a lower dose.
Slovenian: Odrasli in starejši z okvaro ledvic Zdravnik vam lahko predpiše nižji odmerek.
English: Separate analysis for male and female subjects showed small to marginal gender differences in levofloxacin pharmacokinetics.
Slovenian: Ločena analiza je pri moških in ženskih bolnikih pokazala majhne do nepomembne razlike v farmakokinetiki levofloksacina.
English: These may be signs of liver problems which may include a fatal failure of the liver
Slovenian: To so lahko znaki težav z jetri, ki lahko vključujejo usodno jetrno odpoved.
English: Probenecid and cimetidine had a statistically significant effect on the elimination of levofloxacin.
Slovenian: Probenecid in cimetidin statistično značilno vplivata na eliminacijo levofloksacina.
English: • Ciclosporin - used after organ transplants.
Slovenian: • Ciklosporin, ki se uporablja pri transplantacijah organov.
English: In a pharmacokinetic interaction study, levofloxacin did not affect the pharmacokinetics of theophylline (which is a probe substrate for CYP1A2), indicating that levofloxacin is not a CYP1A2 inhibitor.
Slovenian: V študiji farmakokinetičnih interakcij levofloksacin ni vplival na farmakokinetiko teofilina (ki je substrat za CYP1A2), kar kaže na to, da levofloksacin ni zaviralec CYP1A2.
English: In vivo tests (micronucleus, sister chromatid exchange, unscheduled DNA synthesis, dominant lethal tests) did not show any genotoxic potential.
Slovenian: Testi in vivo (mikronukleusi, izmenjave sestrskih kromatid, nenačrtna sinteza DNA, testi dominantni smrtnosti) niso pokazali genotoksičnega potenciala.
English: • Lungs, in people with long-term breathing problems or pneumonia
Slovenian: • Pljuč, pri ljudeh z dolgotrajnimi težavami z dihanjem ali s pljučnico
English: Do not stop taking Tavanic just because you feel better.
Slovenian: Če ste prenehali jemati zdravilo Tavanic tablete Ne prenehajte z jemanjem zdravila Tavanic le zato, ker se počutite bolje.
English: Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.
Slovenian: Lečeči zdravnik mora upoštevati nacionalna in/ali mednarodna priporočila za zdravljenje antraksa.
English: Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
Slovenian: Previdnost se priporoča ob uporabi levofloksacina pri psihotičnih bolnikih ali pri bolnikih s psihiatrično boleznijo v anamnezi.
English: Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs
Slovenian: Teofilin, fenbufen in podobna nesteroidna protivnetna zdravila
English: • Unusual fast beating of your heart (tachycardia) or low blood pressure (hypotension)
Slovenian: • Nenavadno hitro bitje srca (tahikardija) ali nizek krvni tlak (hipotenzija)
English: Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.
Slovenian: Levofloksacin lahko zavira rast Mycobacterium tuberculosis, zato so pri bakteriološki diagnostiki tuberkuloze rezultati lahko lažno negativni.
English: Patients with G-6-phosphate dehydrogenase deficiency
Slovenian: Bolniki s pomanjkanjem G-6-fosfat-dehidrogenaze
English: This medicine does not require any special storage conditions but it is best to keep Tavanic tablets in the original strips and box in a dry place.
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila, vendar je zdravilo Tavanic tablete najbolje hraniti v originalni ovojnini na suhem mestu.
English: • Changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis.
Slovenian: • Spremembe v delovanju ledvic in občasna odpoved ledvic, ki je lahko posledica alergijske reakcije ledvic, imenovane intersticijski nefritis
English: • Pain and inflammation in your tendons or ligaments, which could lead to rupture.
Slovenian: • Bolečine in vnetje v kitah ali vezeh, ki lahko vodi v pretrganje kite.
English: • Theophylline - used for breathing problems.
Slovenian: • Teofilin, ki se uporablja pri težavah z dihanjem.
English: • Changes in the number of other bacteria or fungi, infection by fungi named Candida, which may need to be treated
Slovenian: • Spremembe števila drugih bakterij ali glivic, okužba z glivico imenovano Candida, kar lahko zahteva zdravljenje
English: • Prostate gland, where you have a long lasting infection
Slovenian: • Prostate, pri dolgotrajni okužbi
English: Levofloxacin concentrations were about 13% higher in the presence of fenbufen than when administered alone.
Slovenian: Koncentracije levofloksacina so bile v prisotnosti fenbufena približno 13 % večje kot tedaj, ko je bil levofloksacin uporabljen sam.
English: Renal failure acute (e.g. due to interstitial nephritis)
Slovenian: Akutna odpoved ledvic (npr. zaradi intersticijskega nefritisa)
English: • Lowering in red blood cells (anemia): this can make the skin pale or yellow due to damage of the red blood cells; lowering in the number of all types of blood cells (pancytopenia)
Slovenian: • Zmanjšanje števila rdečih krvnih celic (anemija): zaradi poškodbe rdečih krvnih celic je koža lahko bleda ali rumena, zmanjšanje števila vseh vrst krvnih celic (pancitopenija)
English: Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).
Slovenian: Levofloksacina zato ne priporočamo za zdravljenje znanih okužb z MRSA ali ob sumu nanje, razen če so laboratorijski rezultati potrdili občutljivost organizma na levofloksacin (in antibiotiki, ki se običajno uporabljajo za zdravljenje okužb z MRSA, niso primerni).
English: Vitamin K antagonists
Slovenian: Antagonisti vitamina K
English: Tavanic tablets may therefore be administered regardless of food intake.
Slovenian: Zdravilo Tavanic tablete je zato mogoče jemati ne glede na obroke.
English: Strains with MIC values above the susceptible breakpoint are very rare or not yet reported.
Slovenian: Sevi z vrednostmi MIK nad mejnimi vrednostmi za občutljivost (dovzetnost) so zelo redki ali pa o njih še niso poročali.
English: Psychotic reactions
Slovenian: Psihotične reakcije
English: These effects can be attributed to inhibition of topoisomerase II.
Slovenian: Ti učinki so posledica zaviranja topoizomeraze II.
English: There are limited amount of data from the use of levofloxacin in pregnant women.
Slovenian: Podatkov o uporabi levofloksacina pri nosečnicah je malo.
English: • Changes in the number of white blood cells shown up in the results of some blood tests (leukopenia,
Slovenian: • Sprememba števila belih krvnih celic na nekaterih laboratorijskih preiskavah (levkopenija,
English: In some special situations, Tavanic tablets may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax.
Slovenian: V nekaterih posebnih okoliščinah se lahko Tavanic tablete uporablja za zmanjšanje možnosti za razvoj pljučne bolezni z imenom antraks oz. poslabšanje bolezni po izpostavitvi bakteriji, ki povzroča antraks.
English: • You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • Ste alergični na levofloksacin, katerikoli drugi kinolonski antibiotik kot moksifloksacin, ciprofloksacin ali ofloksacin, ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: This leaflet was last revised in MM/YYYY [To be completed nationally]
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/LLLL [izpolni država članica]
English: In patients treated with levofloxacin, determination of opiates in urine may give false-positive results.
Slovenian: Pri bolnikih, ki jemljejo levofloksacin, lahko testi ugotavljanja prisotnosti opiatov v urinu dajo lažne pozitivne rezultate.
English: You may be more likely to have inflammation and/or rupture of your tendons.
Slovenian: Verjetneje je, da boste imeli več vnetij in/ali pretrgano tetivo.
English: Bronchospasm Pneumonitis allergic
Slovenian: Bronhospazem Alergijski pnevmonitis
English: • Increase in the level of some liver enzymes in your blood
Slovenian: • Zvišanje nekaterih jetrnih encimov v krvi
English: Cross-resistance between levofloxacin and other fluoroquinolones is observed.
Slovenian: Ugotovljena je navzkrižna odpornost med levofloksacinom in drugimi fluorokinoloni.
English: These may be signs of something called ‘neuropathy'
Slovenian: To so lahko znaki motnje, ki jo imenujemo "nevropatija".
English: The mean volume of distribution of levofloxacin is approximately 100 l after single and repeated 500 mg doses, indicating widespread distribution into body tissues.
Slovenian: Povprečni volumen porazdelitve levofloksacina je približno 100 l po enkratnem in večkratnem 500 mg odmerku, kar kaže na obsežno porazdelitev v telesnih tkivih.
English: • You have something known as ‘glucose - 6 - phosphate dehydrogenase deficiency'.
Slovenian: • Imate bolezen, znano kot pomanjkanje glukoza-6-fosfat-dehidrogenaze.
English: There is insufficient information on the excretion of levofloxacin in human milk; however other fluoroquinolones are excreted in breast milk.
Slovenian: Ni dovolj podatkov o izločanju levofloksacina v materino mleko, vendar se drugi fluorokinoloni izločajo v materino mleko.
English: The mean apparent total body clearance of levofloxacin following a 500 mg single dose was 175 +/-29.2 ml/min.
Slovenian: Povprečni celotni telesni očistek levofloksacina po enkratnem 500 mg odmerku je 175 +/- 29,2 ml/ min.
English: Food has little effect on the absorption of levofloxacin.
Slovenian: Hrana le malo vpliva na absorpcijo levofloksacina.
English: Stop taking Tavanic and see a doctor or go to a hospital straight away if you notice the following side effect:
Slovenian: Nehajte uporabljati zdravilo Tavanic in nemudoma povejte zdravniku ali pojdite v bolnišnico, če opazite naslednji neželen učinek:
English: Levofloxacin is a ‘quinolone' antibiotic.
Slovenian: Levofloksacin je »kinolonski« antibiotik.
English: • Impairment or loss of hearing
Slovenian: • Oslabitev ali izguba sluha
English: Breakpoints apply to an oral dose of 500 mg x 1 to 500 mg x 2 and an intravenous dose of 500 mg x 1 to 500 mg x 2.
Slovenian: Mejne vrednosti veljajo za peroralne odmerke 500 mg x 1 do 500 mg x 2 in intravenski odmerek 500 mg x 1 do 500 mg x 2.
English: Dosage in patients with normal renal function (creatinine clearance >50 ml/min)
Slovenian: Odmerjanje pri bolnikih z normalnim delovanjem ledvic (očistek kreatinina> 50 ml/min)
English: Tavanic tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin; given the bioequivalence of the parenteral and oral forms, the same dosage can be used.
Slovenian: Zdravilo Tavanic tablete se lahko uporabi za dokončanje zdravljenja pri bolnikih, pri katerih je bil v začetnem obdobju zdravljenja z intravenozno obliko levofloksacina dosežen napredek; glede na bioekvivalenco parenteralne in peroralne oblike je mogoče uporabiti isto odmerjanje.
English: This is because it can increase the chance of you getting side effects, when taken with Tavanic:
Slovenian: To pa zato, ker se lahko poveča možnost za razvoj neželenih učinkov, če jih jemljete sočasno z zdravilom Tavanic:
English: Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.
Slovenian: Bolniki z latentnimi ali dejanskimi motnjami aktivnosti glukoza-6-fosfat-dehidrogenaze so med zdravljenjem s kinolonskimi protibakterijskimi zdravili nagnjeni k hemolitičnim reakcijam.
English: You are more likely to have serious problems with your blood when taking this medicine
Slovenian: boste imeli v tem primeru bolj verjetno resne težave s krvjo
English: Convulsion (see sections 4.3 and 4.4) Paraesthesia
Slovenian: Konvulzije (glejte poglavji 4.3 in 4.4) Parestezija
English: 7 - 14 days
Slovenian: 7-14 dni pielonefritis
English: If tendinitis is suspected, treatment with levofloxacin must be halted immediately, and appropriate treatment (e.g. immobilisation) must be initiated for the affected tendon (see sections 4.3 and 4.8).
Slovenian: Če obstaja sum na tendinitis, je treba zdravljenje z zdravilom Tavanic takoj prekiniti in začeti ustrezno zdravljenje (npr. imobilizacijo) prizadete tetive (glejte poglavji 4.3 in 4.8).
English: Tavanic tablets can be used to treat infections of the:
Slovenian: Zdravilo Tavanic tablete se uporablja za zdravljenje okužb:
English: Steady state conditions are reached within 48 hours following a 500 mg once or twice daily dosage regimen.
Slovenian: Stanje dinamičnega ravnovesja so dosegli v 48 urah po odmerjanju 500 mg enkrat ali dvakrat na dan.
English: Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations.
Slovenian: Zato je ob uporabi fluorokinolonov, vključno z levofloksacinom, pri tej populaciji potrebna previdnost.
English: Special care should be taken when taking either of these medicines with Tavanic.
Slovenian: Posebna pozornost je potrebna, če katerokoli od navedenih zdravil jemljete z zdravilom Tavanic.
English: The tablets may be taken during meals or between meals.
Slovenian: Tablete se lahko zaužijejo z obroki ali med enim in drugim obrokom.
English: In case of convulsive seizures (see section 4.8), treatment with levofloxacin should be discontinued.
Slovenian: Če se pojavijo konvulzivni napadi (glejte poglavje 4.8) je treba zdravljenje z levofloksacinom prekiniti.
English: Resistance to fluoroquinolones of E. coli - the most common pathogen involved in urinary tract infections - varies across the European Union.
Slovenian: Odpornost E. coli - najpogostejšega povzročitelja okužb urinarnega trakta - proti fluorokinolonom je v Evropski uniji različna.
English: Tavanic is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
Slovenian: Zdravilo Tavanic je pri odraslih indicirano za zdravljenje naslednjih okužb (glejte poglavji 4.4 in 5.1)
English: Clostridium difficile-associated disease
Slovenian: Bolezen, povezana s Clostridium difficile
English: Abnormal dreams Nightmares
Slovenian: Agitiranost Nenormalne sanje Nočne more
English: Some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Nekateri neželeni učinki (npr. omotica/ vrtoglavica, zaspanost, motnje vida) lahko oslabijo bolnikovo sposobnost koncentracije in reagiranja in so torej nevarni v okoliščinah, v katerih so te sposobnosti posebej pomembne (npr. pri vožnji vozila ali upravljanju s stroji).
English: • Allergic lung reactions
Slovenian: • Alergijske pljučne reakcije
English: Concurrent administration of fluoroquinolones with multi-vitamins containing zinc appears to reduce their oral absorption.
Slovenian: Sočasna uporaba fluorokinolonov z multivitaminskimi pripravki, ki vsebujejo zink, naj bi zmanjšala njihovo peroralno absorbcijo.
English: • Medicines known to affect the way your heart beats.
Slovenian: • Zdravila, ki uravnavajo način bitja srca.
English: Your doctor may need to take regular blood tests to check how well your blood can clot.
Slovenian: Vaš zdravnik vam mora s krvni mi testi redno nadzirati parametre strjevanja krvi.
English: • Fever, sore throat and a general feeling of being unwell that does not go away.
Slovenian: • Zvišana telesna temperatura, vneto grlo in splošno slabo počutje, ki ne izgine.