FrancophonIA/ELRC3.0 huggingface dataset:
English: In vivo tests (micronucleus, sister chromatid exchange, unscheduled DNA synthesis, dominant lethal tests) did not show any genotoxic potential.
Croatian: Testiranja in vivo (mikronukleus, razmjena sestrinskih kromatida, nepredviđena sinteza DNA, dominanti letalni testovi) nisu pokazali genotoksični potencijal.
English: Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (e.g. including angioedema and anaphylactic shock).
Croatian: Levofloksacin može uzrokovati ozbiljne, potencijalno fatalne reakcije preosjetljivosti (npr. koje uključuju angioedem i anafilaktički šok).
English: • Hypersensitivity to the active substance, other quinolones or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar, druge kinolone ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The recommended dosage is 240 mg (one ampoule) administered by inhalation twice daily (see section 5.2).
Croatian: Preporučena doza je 240 mg (jedna ampula) primijenjena inhalacijom dva puta na dan (vidjeti dio 5.2).
English: Cross-resistance between levofloxacin and other fluoroquinolones is observed.
Croatian: Primjećena je unakrsna rezistencija između levofloksacina i drugih fluorokinolona.
English: Quinsair may make you feel dizzy, tired or weak, or cause problems with your eyesight.
Croatian: Quinsair Vam može izazvati omaglicu, umor ili slabost ili Vam može uzrokovati probleme s vidom.
English: Keep the Zirela Instructions for Use in a safe place as they give full details on assembling the device.
Croatian: Držite Upute za uporabu naprave Zirela na sigurnom mjestu jer se u njima nalazi detaljan opis kako sastaviti uređaj.
English: In common with other fluoroquinolones, levofloxacin showed effects on cartilage (blistering and cavities) in rats and dogs.
Croatian: Slično ostalim fluorokinolonima, levofloksacin je pokazao učinke na hrskavicu (izbočenja i udubljenja) u štakora i pasa.
English: Inhale the contents of one ampoule (240 mg) twice a day using the Zirela Nebuliser System.
Croatian: Inhalirajte sadržaj jedne ampule (240 mg) dva puta na dan pomoću naprave za inhalaciju Zirela Nebuliser System.
English: You use Quinsair every day for 28 days, then take a 28-day break, during which you do not inhale any Quinsair.
Croatian: Quinsair primjenjujte svaki dan tijekom 28 dana, zatim napravite pauzu od 28 dana tijekom koje nećete inhalirati Quinsair.
English: You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms.
Croatian: Rijetko možete osjetiti simptome oštećenja živaca (neuropatije) kao što su bol, žarenje, trnci, utrnulost i/ili slabost osobito u stopalima i nogama ili šakama i rukama.
English: if you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
Croatian: ako vam je dijagnosticirano proširenje ili „napuhivanje“ velike krvne žile (aneurizma aorte ili aneurizma periferne velike krvne žile).
English: This is because both active substances are capable of blocking the renal tubular secretion of levofloxacin.
Croatian: To je zato što obje djelatne tvari imaju sposobnost blokiranja bubrežne tubularne sekrecije levofloksacina.
English: Furthermore, clinical data do not suggest interaction with P-glycoprotein (P-gp) substrates such as digoxin.
Croatian: Nadalje, klinički podaci ne upućuju na interakciju sa supstratima P-glikoproteina (P-gp) poput digoksina.
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.
Croatian: U ispitivanju farmakokinetičke interakcije, levofloksacin nije utjecao na farmakokinetiku teofilina (koji je probni supstrat CYP1A2) što ukazuje da levofloksacin nije inhibitor CYP1A2.
English: Bacteria can become resistant to treatment with an antibiotic over time.
Croatian: Bakterije mogu s vremenom postati rezistentne (otporne) na liječenje antibiotikom.
English: Stop using Quinsair and tell your doctor immediately: - if you experience pain, stiffness and/or swelling in your joints - if you develop problems with your liver.
Croatian: Prestanite primjenjivati Quinsair i odmah se obratite svom liječniku: - ako osjetite bol, ukočenost i/ili oticanje zglobova - ako Vam se jave problemi s jetrom.
English: At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Quinsair, contact your doctor and rest the painful area.
Croatian: Kod prvog znaka boli ili upale tetive (na primjer, u gležnju, zapešću, laktu, ramenu ili koljenu), prestanite uzimati Quinsair, obratite se liječniku i poštedite bolno područje.
English: Press down and turn the cap clockwise as far as it will go (b, Figure 2).
Croatian: Pritisnite prema dolje i zakrenite poklopac do kraja u smjeru kazaljki na satu (b, slika 2).
English: Continue to inhale and exhale comfortably until the treatment is finished.
Croatian: Nastavite opušteno udisati i izdisati dok postupak ne bude gotov.
English: Reduced susceptibility to levofloxacin can also result from acquisition of plasmids encoding proteins that protect these targets from inhibition.
Croatian: Smanjena osjetljivost na levofloksacin može također biti rezultat preuzimanja plazmida koji kodiraju proteine koji štite ta ciljna mjesta od inhibicije.
English: Taking these medicines with Quinsair may lead to an increase in bleeding.
Croatian: Uzimanje ovih lijekova zajedno s Quinsairom može dovesti do pojačanog krvarenja.
English: Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Quinsair therapy.
Croatian: Upala i puknuće tetiva mogu nastati unutar prvih 48 sati liječenja pa sve do nekoliko mjeseci nakon prestanka liječenja lijekom Quinsair.
English: The Manufacturer's Instructions for Use will give full details on cleaning and disinfecting.
Croatian: U Uputama proizvođača za uporabu naći ćete detaljan opis čišćenja i dezinfekcije.
English: The use of inhaled medicinal products may induce a cough reflex.
Croatian: Primjena inhalacijskog lijeka može izazvati refleks kašlja.
English: It is important that you keep using the medicine twice a day during your 28 days on treatment and that you keep to the 28-days on, 28-days off cycle for as long as your doctor tells you to.
Croatian: Važno je da nastavite primjenjivati lijek dva puta na dan tijekom 28 dana terapije i da se pridržavate ciklusa od 28 dana terapije i 28 dana bez terapije onoliko dugo koliko Vam je to rekao liječnik.
English: Interference with laboratory tests
Croatian: Utjecaj na rezultate laboratorijskih pretraga
English: If you are treated with Quinsair, you may have a severe skin reaction such as blistering or lesions.
Croatian: Ako se liječite Quinsairom, možete imati teške kožne reakcije poput stvaranja mjehura i rana.
English: There is a limited amount of data from the use of levofloxacin in pregnant women.
Croatian: Količina podataka o primjeni levofloksacina u trudnica je ograničena.
English: Two randomised, double-blind, single-cycle, placebo-controlled clinical trials (Studies 204 and 207) in patients with CF chronically infected with P. aeruginosa were conducted.
Croatian: Provedena su dva randomizirana, dvostruko slijepa, jednociklusna, placebom kontrolirana ispitivanja (Ispitivanje 204 i Ispitivanje 207) na bolesnicima s CF i kroničnom infekcijom P. aeruginosa.
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).
Croatian: Ako se javi oslabljeni vid ili neki drugi učinak na oči, potrebno je odmah potražiti savjet specijalista za bolesti očiju (vidjeti dijelove 4.7 i 4.8).
English: A total of 88 patients received at least 1 dose of Quinsair in Study 209 (Extension Phase), 32 of these had received TIS and 56 of these had received Quinsair in the Core Phase.
Croatian: Ukupno 88 bolesnika primilo je najmanje 1 dozu Quinsaira u Ispitivanju 209 (produljena faza), 32 od njih je primilo TIS i 56 je primilo Quinsair u središnjoj fazi ispitivanja.
English: Levofloxacin is primarily excreted unchanged in the urine and metabolism is minimal (see section 5.2).
Croatian: Levofloksacin se primarno izlučuje nepromijenjen urinom i minimalno se metabolizira (vidjeti dio 5.2).
English: If you experience breathing difficulties after using Quinsair, your doctor may prescribe you an inhaler containing a bronchodilator medicine (e.g. salbutamol).
Croatian: Ako osjetite poteškoće s disanjem nakon primjene Quinsaira, Vaš Vam liječnik može propisati inhalator koji sadrži lijek bronhodilatator (npr. salbutamol).
English: Following systemic administration, there were no significant differences in levofloxacin pharmacokinetics between young and elderly subjects except those associated with age-related decreases in creatinine clearance.
Croatian: Nakon sistemske primjene nije bilo značajne razlike u farmakokinetici levofloksacina između mladih i starijih ispitanika osim one povezane sa sniženim klirensom kreatinina zbog dobi.
English: Inhaled steroids.
Croatian: Inhalacijski steroidi.
English: 1) Make sure that the Zirela Nebuliser Handset is on a flat and stable surface.
Croatian: 1) Provjerite da je naprava za inhalaciju Zirela Nebuliser Handset položena na ravnu i čvrstu površinu.
English: Keeping the handset level, place the mouthpiece in the patient's mouth making sure their lips are closed around it.
Croatian: Držeći uređaj u ravnini stavite usnik u usta bolesnika pazeći da su usne stisnute oko njega.
English: Study 209 (Core Phase) was a randomised, open-label, parallel group, active-controlled, non-inferiority study comparing Quinsair to tobramycin inhalation solution (TIS) over 3 treatment cycles.
Croatian: Ispitivanje 209 (središnja faza) bilo je randomizirano, otvoreno, aktivno kontrolirano ispitivanje neinferiornosti na paralelnim skupinama u kojem se Quinsair usporedio s otopinom tobramicina za inhaliranje (tobramycin inhalation solution - TIS) kroz 3 terapijska ciklusa.
English: Talk to your doctor if you have any concerns or questions about this.
Croatian: Obratite se svom liječniku ako ste zabrinuti ili imate pitanja u vezi s tim.
English: Inhale your medicine as follows: - 1 ampoule in the morning using the Zirela Nebuliser - 1 ampoule in the evening using the Zirela Nebuliser It is best to leave close to 12 hours between your doses.
Croatian: Inhalirajte lijek kako slijedi: - 1 ampula ujutro pomoću naprave za inhalaciju Zirela Nebuliser - 1 ampula navečer pomoću naprave za inhalaciju Zirela Nebuliser Najbolje je da između doza protekne točno 12 sati.
English: The mean post-dose sputum concentrations were approximately 500-1900 µg/ml and were approximately 400-1700 times higher than those observed in serum.
Croatian: Srednja koncentracija u sputumu nakon primijenjene doze bila je oko 500-1900 µg/ml i oko 400-1700 viša od onih primijećenih u serumu.
English: If you have used more Quinsair than you should, tell your doctor as soon as possible.
Croatian: Ako primijenite više Quinsaira nego što ste trebali, obratite se svom liječniku što je prije moguće.
English: Respiratory domain of Cystic Fibrosis Questionnaire - Revised (CFQ-R)
Croatian: Dio koji se odnosi na respiraciju revidiranog Upitnika o cističnoj fibrozi (Cystic Fibrosis Questionnaire - Revised - CFQR)
English: The mechanism of action of levofloxacin and other fluoroquinolone antimicrobials involves inhibition of bacterial DNA gyrase and topoisomerase IV enzymes.
Croatian: Mehanizam djelovanja levofloksacina i drugih fluorokinolonskih antimikrobnih lijekova uključuje inhibiciju bakterijskih enzima DNA-giraze i topoizomeraze IV.
English: Patients should not inhale the contents of more than one ampoule to compensate for the missed dose.
Croatian: Bolesnici ne smiju inhalirati sadržaj više od jedne ampule kako bi nadoknadili propuštenu dozu.
English: - A disease causing muscle weakness and fatigue called myasthenia gravis.
Croatian: - bolest koja uzrokuje mišićnu slabost i umor, a koja se naziva mijastenija gravis.
English: When do I use it?
Croatian: Kada da primijenim lijek?
English: Haemodialysis, including peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD), are not effective in removing levofloxacin from the body.
Croatian: Hemodijaliza, uključujući peritonealnu dijalizu i kontinuiranu ambulatornu peritonealnu dijalizu (CAPD), nisu učinkovite u odstranjivanju levofloksacina iz tijela.
English: How do I use the Zirela Nebuliser System?
Croatian: Kako ću koristiti napravu za inhalaciju Zirela Nebuliser System?
English: 500 mg IV QD*
Croatian: 500 mg i.v. QD*
English: - Check that your Zirela Nebuliser System works properly before starting your treatment.
Croatian: Vaša naprava za inhalaciju Zirela Nebuliser System ispravno radi prije nego započnete terapiju.
English: The outer carton box also contains one Zirela Nebuliser Handset packaged in its own carton box with the Manufacturer's Instruction for Use.
Croatian: Vanjska kartonska kutija sadrži također i jednu napravu za inhalaciju Zirela Nebuliser Handset pakiranu u vlastitoj kartonskoj kutiji s uputama proizvođača za uporabu.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti jednokratne doze, toksičnosti ponovljenih doza, kancerogenosti te reproduktivne i razvojne toksičnosti.
English: Median time to administration of anti-pseudomonal antimicrobials
Croatian: Medijan vremena do primjene antipseudomonalnog antimikrobnog lijeka
English: Some adverse reactions (e.g. fatigue, asthenia, visual disturbances, dizziness) may impair patient's ability to concentrate and react.
Croatian: Neke nuspojave (npr. umor, astenija, smetnje vida, omaglica) mogu negativno utjecati na bolesnikovu sposobnost koncentracije i reakcije.
English: Animal studies with levofloxacin do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja levofloksacina na životinjama ne ukazuju na izravne ili neizravne štetne učinke u smislu reproduktivne toksičnosti (vidjeti dio 5.3).
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.
Croatian: Bolesnici s latentnim ili stvarnim oštećenjem aktivnosti glukoza-6-fosfat-dehidrogenaze mogu biti skloni hemolitičkim reakcijama kada se liječe kinolonskim antibakterijskim tvarima.
English: Higher sputum concentrations were observed in adults compared to paediatric patients in Study 207; similar sputum concentrations were observed in adult and paediatric patients in Study 209.
Croatian: U Ispitivanju 207 primijećene su više koncentracije u sputumu u usporedbi s pedijatrijskim bolesnicima; slične koncentracije u sputumu odraslih i pedijatrijskih bolesnika primijećene su u Ispitivanju 209.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Quinsair in one or more subsets of the paediatric population in cystic fibrosis patients with P. aeruginosa pulmonary infection/colonisation (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Quinsair u jednoj ili više podskupina pedijatrijske populacije u bolesnika s cističnom fibrozom i pulmonalnom infekcijom/kolonizacijom P. aeruginosa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: - Nerve damage
Croatian: - oštećenje živaca
English: • Cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
Croatian: • Srčanih bolesti (npr. zatajenje srca, infarkt miokarda, bradikardija).
English: It should only be used to treat lung infections caused by Pseudomonas aeruginosa.
Croatian: Smije se primjenjivati samo za liječenje plućnih infekcija uzrokovanih Pseudomonas aeruginosa.
English: One nebuliser handset should be used for one 28-day treatment course.
Croatian: Jedna naprava za inhalaciju treba se koristiti za jedan 28-dnevni ciklus terapije.
English: In addition to study drug, patients remained on standard of care treatment for chronic pulmonary infection.
Croatian: Uz ispitivani lijek bolesnici su nastavili standardno liječenje kronične plućne infekcije.
English: Hepatic impairment No dose adjustment is required (see section 5.2).
Croatian: Nije potrebno prilagođavanje doze (vidjeti dio 5.2).
English: Patients who completed Study 209 (Core Phase) could continue in an optional Extension Phase for 3 additional cycles (i.e. 28 days of treatment with Quinsair 240 mg twice daily followed by 28 days off treatment).
Croatian: Bolesnici koji su dovršili Ispitivanje 209 (središnju fazu) mogli su nastaviti opcionalnu produljenu fazu ispitivanja s 3 dodatna ciklusa (tj. 28 dana liječenja Quinsairom 240 mg dva puta na dan nakon čega je slijedilo 28 dana bez terapije).
English: To conduct a non-interventional post-authorisation safety study in a registry of patients with cystic fibrosis to investigate the long term safety profile of Quinsair in normal clinical practice in the European Union.
Croatian: Provođenje neintervencijskog ispitivanja sigurnosti primijene lijeka, nakon dobivanja odobrenja, na temelju registra bolesnika s cističnom fibrozom radi ispitivanja sigurnosnog profila dugotrajne primjene Quinsaira u standardnoj kliničkoj praksi u Europskoj uniji.
English: Tell your doctor if you notice any skin reactions after using Quinsair.
Croatian: Obavijestite svog liječnika ako primijetite bilo kakvu kožnu reakciju nakon primjene Quinsaira.
English: Levofloxacin caused no impairment of fertility or reproductive performance in rats and its only effect on foetuses was delayed maturation as a result of maternal toxicity.
Croatian: Levofloksacin nije izazvao oštećenje plodnosti ili reproduktivne sposobnosti u štakora i jedini njegov učinak na fetuse bilo je zakašnjelo sazrijevanje kao posljedica maternalne toksičnosti.
English: Ciclosporin The half-life of ciclosporin was increased by 33% when coadministered with levofloxacin.
Croatian: Ciklosporin Poluvijek ciklosporina bio je produžen za 33% kada je primjenjivan istodobno s levofloksacinom.
English: Following systemic administration, levofloxacin obeys linear pharmacokinetics over a range of 50 to 1000 mg.
Croatian: Nakon sistemske primjene levofloksacin slijedi linearnu farmakokinetiku u rasponu od 50 do 1000 mg.
English: Following systemic administration, the effect of race on levofloxacin pharmacokinetics was examined through a covariate analysis performed on data from 72 subjects: 48 white and 24 non-white.
Croatian: Učinci rase na farmakokinetiku levofloksacina nakon sistemske primjene provjereni su analizom kovarijance na podacima 72 ispitanika: 48 bjelačka i 24 nebjelačka.
English: The affected limb(s) should be appropriately treated (e.g. immobilisation).
Croatian: Zahvaćeni ud(ove) treba liječiti na odgovarajući način (npr. imobilizacijom).
English: Quinsair is supplied as a 28-day pack.
Croatian: Quinsair se isporučuje kao pakiranje za 28-dnevnu terapiju.
English: - Ciclosporin (used after organ transplants) or medicines that affect your heart beat (such as antiarrhythmics, tricyclic antidepressants, macrolide antibiotics or antipsychotics).
Croatian: - Ciklosporin (koristi se nakon presađivanja organa) ili lijekovi koji utječu na otkucaje srca (poput antiaritmika, tricikličkih antidepresiva, makrolidnih antibiotika ili antipsihotika).
English: If you experience breathing difficulties when you use Quinsair what additional medicine may your doctor prescribe for you?
Croatian: Ako za vrijeme korištenja Quinsaira osjetite poteškoće s disanjem, koje Vam druge lijekove Vaš liječnik smije propisati?
English: The safety and efficacy of Quinsair in elderly patients with CF have not been established.
Croatian: Sigurnost i djelotvornost Quinsaira u starijih bolesnika s CF nisu još ustanovljene.
English: The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, patients receiving daily doses of 1000 mg levofloxacin, and those treated concurrently with corticosteroids.
Croatian: Rizik od tendinitisa i rupture tetive povećan je u starijih bolesnika, bolesnika s oštećenjem funkcije bubrega, bolesnika s presađenim solidnim organima, bolesnika koji primaju dnevnu dozu od 1000 mg levofloksacina i u onih koji se istodobno liječe kortikosteroidima.
English: There is insufficient information on the excretion of levofloxacin in human milk; however, other fluoroquinolones are excreted in breast milk.
Croatian: Nema dovoljno podataka o izlučivanju levofloksacina u majčino mlijeko; međutim ostali se fluorokinoloni izlučuju u majčino mlijeko.
English: * Note: One adolescent randomised to Quinsair 240 mg twice daily did not receive study drug.
Croatian: * Napomena: jedan adolescent koji je randomiziran u skupinu koja je primala Quinsair 240 mg dva puta na dan nije primio ispitivani lijek.
English: IV = intravenous; QD = quaque die (once a day); BID = bis in die (twice a day) * Predicted value from population PK analysis in CF patients ** Healthy males 18-53 years old
Croatian: i.v. = intravenski; QD = quaque die (jedanput na dan); BID = bis in die (dva puta na dan) * Predviđena vrijednost na temelju analize populacijske farmakokinetike u bolesnika s CF ** Zdravi muškarci u dobi od 18 do 53 godine
English: Tell your doctor before using Quinsair if you have or have ever had any of the following: - Prolonged, disabling and potentially irreversible serious side effects Fluoroquinolone/quinolone antibacterial medicines, including Quinsair, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible.
Croatian: Obavijestite svog liječnika prije nego primijenite Quinsair ako imate ili ste ikad imali nešto od sljedećeg: - Dugotrajne, onesposobljavajuće i potencijalno ozbiljne nuspojave čiji su učinci trajni Fluorokinolonski/kinolonski antibiotici, uključujući Quinsair, povezani su s vrlo rijetkim, ali ozbiljnim nuspojavama od kojih su neke dugotrajne (traju mjesecima ili godinama), onesposobljavajuće ili s potencijalno trajnim učincima.
English: All patients had also received at least 3 courses of TIS in the 12 months prior to entry into the study, but none in the 28 days immediately preceding study entry.
Croatian: Svi bolesnici su također primili najmanje 3 ciklusa TIS tijekom 12 mjeseci prije uključivanja u ispitivanje, ali ništa 28 dana neposredno prije početka ispitivanja.
English: LS Mean (SE) Treatment Difference at Day 28 [95% CI] b
Croatian: Srednja LS (SE) Razlika prema vrsti liječenja 28. dana [95% CI] b
English: The development of fluoroquinolone-resistant P. aeruginosa and superinfection with fluoroquinolone-insusceptible microorganisms represent potential risks associated with the use of Quinsair.
Croatian: Razvoj P. aeruginosa rezistentnog na fluorokinolone i superinfekcija mikroorganizmima neosjetljivim na fluorokinolone predstavljaju potencijalni rizik udružen s primjenom Quinsaira.
English: Each treatment cycle included 28 days of treatment with Quinsair 240 mg twice daily or TIS 300 mg twice daily followed by 28 days without inhaled antibiotics.
Croatian: Svaki terapijski ciklus uključivao je 28 dana liječenja Quinsairom 240 mg dva puta na dan ili TIS 300 mg dva puta na dan, nakon čega je sljedilo 28 dana bez inhalacije antibiotika.