FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients under treatment with levofloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition (see section 4.8).
Croatian: Bolesnicima koji se liječe levofloksacinom treba savjetovati da prije nastavka liječenja obavijeste liječnika ako imaju simptome neuropatije poput boli, žarenja, trnaca, utrnulosti ili slabosti kako bi se spriječio razvoj potencijalno ireverzibilnog stanja (vidjeti dio 4.8).
English: These two placebo-controlled studies showed that 28 days of treatment with Quinsair 240 mg twice daily resulted in significant improvement in relative change from baseline in FEV1 percent predicted compared to placebo (see Table 1).
Croatian: Ova dva placebom kontrolirana ispitivanja pokazala su da je 28-dnevno liječenje Quinsairom 240 mg dva puta na dan rezultiralo značajnim poboljšanjem relativne promjene u odnosu na početni postotak FEV1 predviđene vrijednosti u usporedbi s placebom (pogledati tablicu 1).
English: Therefore, if levofloxacin has to be used in these patients, potential occurrence of haemolysis should be monitored.
Croatian: Stoga, ako se u ovih bolesnika mora primjenjivati levofloksacin, potrebno je paziti na moguću pojavu hemolize.
English: If you notice any changes in your eyesight or any other problems with your eyes whilst using Quinsair, contact an eye specialist immediately.
Croatian: Ako primijetite promjene vida ili neki drugi problem s očima dok koristite Quinsair, obratite se odmah specijalistu za očne bolesti.
English: The safety of the recommended dose of Quinsair was evaluated in 472 patients with CF from two double-blind, single-cycle, placebo-controlled trials and from an active-comparator study with an optional uncontrolled extension.
Croatian: Sigurnost primjene preporučene doze Quinsaira procijenjena je na 472 bolesnika s CF u dva dvostruko slijepa, jednociklusna, placebom kontrolirana ispitivanja i jednom ispitivanju s aktivnim komparatorom i opcionalnim nekontroliranim produljenjem ispitivanja.
English: Do not inhale the contents of more than one ampoule to make up for a missed dose.
Croatian: Nemojte inhalirati sadržaj više od jedne ampule kako biste nadoknadili zaboravljenu dozu.
English: Population pharmacokinetic analysis results showed no differences in systemic exposure of levofloxacin due to gender following administration of Quinsair.
Croatian: Rezultati analize populacijske farmakokinetike nisu pokazali razlike u sustavnoj izloženosti levofloksacinu zbog spola nakon primjene Quinsaira.
English: Quinsair is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment.
Croatian: Quinsair se uzima u naizmjeničnim ciklusima od 28 dana liječenja nakon čega slijedi 28 dana bez terapije.
English: What you need to know before you use Quinsair
Croatian: Što morate znati prije nego počnete primjenjivati Quinsair
English: Levofloxacin did not show any genotoxic potential in a photomutagenicity assay.
Croatian: Levofloksacin nije pokazao genotoksični potencijal u testovima fotomutagenosti.
English: After it has completely turned itself off and when you are ready to restart, press and hold the on/off button for one second again.
Croatian: Kada se uređaj sam potpuno ugasi i kada ste spremni ponovo započeti postupak, ponovno pritisnite tipku za uključivanje (on/off) i držite je pritisnutom jednu sekundu.
English: Levofloxacin did not induce gene mutations in bacterial or mammalian cells but did induce chromosome aberrations in Chinese hamster lung cells in vitro.
Croatian: Levofloksacin nije inducirao mutacije gena u bakterijama ili stanicama sisavaca, ali je inducirao kromosomske aberacije u stanicama pluća kineskog hrčka in vitro.
English: Clostridium difficile-associated disease
Croatian: Bolest povezana s Clostridium difficile
English: Other relevant information
Croatian: Ostali važni podaci
English: and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Croatian: antiaritmici klase IA i III, triciklički antidepresivi, makrolidi, antipsihotici).
English: Effect of levofloxacin on other medicinal products
Croatian: Učinak levofloksacina na druge lijekove
English: This means that Quinsair should not be used to prevent lung infections.
Croatian: To znači da se Quinsair ne smije primjenjivati za sprečavanje plućne infekcije.
English: Levofloxacin is an antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic active substance ofloxacin.
Croatian: Levofloksacin je antibakterijsko sredstvo iz skupine fluorokinolona i predstavlja S (-) enantiomer racemične djelatne tvari ofloksacina.
English: If for any reason you must stop the treatment before it's finished, press and hold the controller's on/off button for one second.
Croatian: Ako iz bilo kojeg razloga morate prekinuti postupak prije nego je dovršen, pritisnite tipku za uključivanje (on/off) kontrolora protoka i držite je pritisnutom jednu sekundu.
English: The Zirela Nebuliser System was used to administer Quinsair in the clinical studies described in section 5.1.
Croatian: Naprava za inhalaciju Zirela Nebuliser System korištena je za primjenu Quinsaira u kliničkim ispitivanjima opisanim u dijelu 5.1.
English: Levofloxacin concentrations were about 13% higher in the presence of fenbufen than when administered alone.
Croatian: Koncentracije levofloksacina bile su oko 13% više u prisutnosti fenbufena nego kad se levofloksacin primjenjivao sam.
English: Tabulated list of adverse reactions reported with Quinsair
Croatian: Tablični prikaz nuspojava prijavljenih s Quinsairom
English: Table 2: Results for the primary and key secondary endpoints in the active-controlled efficacy and safety study of Quinsair in patients with CF
Croatian: Tablica 2: Rezultati za primarne i ključne sekundarne krajnje točke ishoda u aktivno kontroliranom ispitivanju djelotvornosti i sigurnosti primjene Quinsaira u bolesnika s CF
English: Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.
Croatian: Tendinitis i ruptura tetive (osobito Ahilove, ali i drugih tetiva), ponekad bilateralna, može se javiti već unutar 48 sati od početka liječenja kinolonima i fluorokinolonima, a prijavljeno je da nastaju čak i do nekoliko mjeseci nakon prestanka liječenja.
English: If aerosol mist does not begin to flow, please refer to the Zirela Manufacturer's Instructions for Use for help.
Croatian: Ako maglica aerosola ne počne protjecati, potražite pomoć u Uputama proizvođača za uporabu uređaja Zrela.
English: Patients with glucose-6-phosphate dehydrogenase deficiency
Croatian: Bolesnici s deficitom glukoza-6-fosfat-dehidrogenaze
English: As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g. glibenclamide) or with insulin.
Croatian: Kao i kod svih kinolona zabilježeni su poremećaji razine glukoze u krvi, uključujući hipoglikemiju i hiperglikemiju, obično u bolesnika s dijabetesom koji su istodobno liječeni oralnim hipoglikemikom (npr. glibenklamidom) ili inzulinom.
English: Ventricular tachycardia, Ventricular arrhythmia and torsade de pointes
Croatian: Srčani poremećaji palpitacije ventrikularna tahikardija, ventrikularna aritmija i torsade de pointes
English: Arthralgia, Myalgia*
Croatian: artralgija, mialgija*
English: The doses should be inhaled as close as possible to 12 hours apart.
Croatian: Ove se doze moraju inhalirati u što točnijim 12-satnim vremenskim razmacima.
English: - Theophylline (used to treat breathing problems) or non-steroidal anti-inflammatory medicines (NSAIDs) such as fenbufen, acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting) or ibuprofen.
Croatian: - Teofilin (koristi se za liječenje problema s disanjem) ili nesteroidne protuupalne lijekove (NSAIL) poput fenobufena, acetilsalicilatne kiseline (tvari koja je prisutna u mnogim lijekovima protiv bolova i za snižavanje tjelesne temperature, kao i za sprečavanje zgrušavanja krvi) ili ibuprofena.
English: The following side effects have also been reported after taking tablets or an intravenous infusion containing levofloxacin, so they might possibly occur after using Quinsair:
Croatian: Sljedeće nuspojave prijavljene su nakon uzimanja tableta ili intravenske infuzije koja je sadržavala levofloksacin, tako da se mogu javiti nakon korištenja Quinsaira:
English: Administration of Quinsair in patients with clinically significant haemoptysis should be undertaken only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Croatian: Primjena Quinsaira u bolesnika s klinički značajnom hemoptizom mora uslijediti samo ako je korist od njegove primjene veća od rizika od izazivanja daljnjeg krvarenja.
English: Active substances known to prolong the QT interval Levofloxacin should be used with caution in patients receiving active substances known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Croatian: Djelatne tvari za koje je poznato da produljuju QT-interval Levofloksacin se mora koristiti s oprezom u bolesnika koji primaju djelatne tvari za koje je poznato da produljuju QT-interval (npr. antiaritmici klase IA i III, triciklički antidepresivi, makrolidi, antipsihotici).
English: If you forget a dose, use it as soon as you remember as long as there is an 8-hour interval before inhaling the next dose.
Croatian: Ako ste zaboravili primijeniti dozu, primijenite je čim se sjetite, ali samo ako do inhalacije sljedeće doze bude interval od 8 sati.
English: Median time to pulmonary exacerbation
Croatian: Median vremena do plućne egzacerbacije
English: Efficacy was not evaluated in the 14 children with CF (≥ 6 to < 12 years old) and 13 adolescents with CF (≥ 12 to < 17 years old) who participated in Study 206.
Croatian: Djelotvornost nije procjenjivana u 14 djece s CF (u dobi ≥ 6 do < 12 godina) i 13 adolescenata s CF (u dobi ≥ 12 do < 17 godina) koji su sudjelovali u Ispitivanju 206.
English: Quinsair contains an antibiotic medicine called levofloxacin.
Croatian: Quinsair sadrži antibiotik koji se naziva levofloksacin.
English: Non-clinical studies conducted with levofloxacin using the inhalation route revealed no special hazard for humans based on conventional studies of safety pharmacology (respiratory), single dose toxicity and repeated dose toxicity.
Croatian: Neklinička ispitivanja provedena s levofloksacinom primijenjenim putem inhalacije nisu ukazala na posebne rizike za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije (respiratorne), toksičnosti jednokratne doze i toksičnosti ponovljenih doza.
English: Tell your doctor if you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obavijestite o tome svog liječnika.
English: The maximal plasma concentration (Cmax) of levofloxacin following administration by inhalation occurred at approximately 0.5-1 hour post-dose.
Croatian: Maksimalna koncentracija (Cmax) levofloksina u plazmi nakon inhalacijske primjene nastupila je oko 0,5 - 1 sat nakon primijenjene doze.
English: Do not take any medicines to treat your diarrhoea without first checking with your doctor.
Croatian: Ne uzimajte nikakve lijekove za liječenje proljeva a da se prethodno niste posavjetovali s liječnikom.
English: - Vision problems
Croatian: - probleme s vidom
English: An in vitro study indicated a low potential for interaction between levofloxacin and CYP2C9 substrates.
Croatian: Supstrati CYP2C9 In vitro ispitivanja ukazuju na niski potencijal za interakciju levofloksacina i supstrata CYP2C9.
English: These medicines may interfere with the effects of Quinsair.
Croatian: Ti bi lijekovi mogli utjecati na učinke Quinsaira.
English: Rhabdomyolysis, Tendon rupture, Ligament rupture, Muscle rupture, Arthritis
Croatian: mišićna slabost rabdomioliza, ruptura tetive, ruptura ligamenta, ruptura mišića, artritis
English: - Severe skin reactions
Croatian: - teške kožne reakcije
English: If this becomes severe or persistent, or you notice blood in your stools, you should stop using Quinsair immediately and talk to your doctor.
Croatian: Ako je težak i uporan ili primijetite krv u stolici, odmah morate prestati primjenjivati Quinsair i obratiti se svom liječniku.
English: ECG monitoring should be undertaken because of the possibility of QT interval prolongation.
Croatian: Potrebno je uspostaviti elektrokardiografski nadzor zbog mogućnosti pojave produljenja QT-intervala.
English: - Do not use Quinsair if you notice that the sealed foil sachet or ampoules have been tampered with.
Croatian: - Ne koristite Quinsair ako primijetite da su vrećica od zavarene folije ili ampule oštećene.
English: Clinical efficacy was demonstrated in two placebo-controlled studies and one active-comparator study in 448 patients randomised to receive Quinsair 240 mg twice daily.
Croatian: Klinička djelotvornost dokazana je u dva placebom kontrolirana ispitivanja i jednom ispitivanju s aktivnim komparatorom na 448 bolesnika randomiziranih u skupine koje su primale Quinsair 240 mg dva puta na dan.
English: If this happens, stop taking Quinsair and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
Croatian: Ako se to dogodi, odmah prestanite uzimati Quinsair i obratite se liječniku kako bi se spriječio razvoj oštećenja s potencijalno trajnim učincima.
English: The weight-based dosing scheme resulted in consistent serum and sputum PK exposure across the range of ages (7 to 16 years old) and weights (22 to 61 kg) observed in the study.
Croatian: Shema doziranja prema tjelesnoj težini imala je za rezultat konzistentnu farmakokinetičku izloženost u serumu i sputumu u rasponu dobi (7 do 16 godina) i tjelesne težine (22 do 61 kg) zabilježenih u ispitivanju.
English: OFF Quinsair Do not use it for the next 28 days
Croatian: BEZ TERAPIJE Quinsairom Nemojte primjenjivati sljedećih 28 dana
English: Resistance to levofloxacin, other antibacterial agents and treatment-emergent microorganisms
Croatian: Rezistencija na levofloksacin, drugi antibakterijski lijekovi i mikroorganizmi koji se pojavljuju zbog liječenja
English: If you forget to use Quinsair
Croatian: Ako ste zaboravili primijeniti Quinsair
English: In diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).
Croatian: U bolesnika s dijabetesom preporučuje se pažljivo praćenje razine glukoze u krvi (vidjeti dio 4.8).
English: Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
Croatian: Fluorokinoloni, uključujući levofloksacin, imaju blokirajuće djelovanje na neuromuskulanu spojnicu i mogu pogoršati mišićnu slabost kod miastenije gravis.
English: Hearing loss*
Croatian: gubitak sluha*
English: b LS Mean difference for Quinsair minus placebo.
Croatian: b LS srednja razlika za Quinsair minus placebo po metodi Last-square.
English: Figure 1 3) Close the medicine reservoir by aligning the tabs of the medicine cap with the slots of the reservoir (a).
Croatian: Slika 1 3) Zatvorite spremnik za lijek tako da poravnate oznake na poklopcu spremnika s urezima na samom spremniku (a).
English: Bronchospasm**, Bronchial hyper-reactivity, Obstructive airways disorder
Croatian: disfonija bronhospazam**, hiperreaktivnost bronhija, opstruktivni poremećaj dišnih puteva
English: CI = Confidence interval; FEV1 = forced expiratory volume in 1 second; ITT = intent-to-treat (all patients randomised); P = P-value; SD = standard deviation; SE = standard error; TIS = tobramycin inhalation solution.
Croatian: CI = interval pouzdanosti; FEV1 = forsirani ekspiratorni volumen u 1 sekundi; ITT = namjera liječenja (svih randomiziranih bolesnika); P = P vrijednost; SD = standardna devijacija; SE = standardna pogreška; TIS = otopina tobramicina za inhalaciju.
English: Weight decreased**, Forced expiratory volume decreased*
Croatian: Pretrage pad tjelesne težine**, smanjeni forsirani ekspiratorni volumen*
English: Bronchospasm is a complication associated with inhaled therapies including Quinsair (see section 4.8).
Croatian: Bronhospazam je komplikacija koja se javlja kod primjene inhalacijskih lijekova uključujući Quinsair (vidjeti dio 4.8).
English: a Treatment difference for Quinsair minus TIS, or Hazard ratio for Quinsair/TIS.
Croatian: a Razlika prema vrsti liječenja za Quinsair minus TIS ili omjer hazarda za Quinsair/TIS.
English: Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval (see sections 4.5, 4.8 and 4.9) such as, for example:
Croatian: Potreban je oprez pri primjeni fluorokinolona, uključujući levofloksacin, u bolesnika s poznatim čimbenicima rizika za produljenje QT-intervala (vidjeti dijelove 4.5, 4.8 i 4.9) poput npr.:
English: Tinnitus*
Croatian: tinitus*
English: Levofloxacin is systemically absorbed following inhalation of Quinsair and eliminated similarly to levofloxacin following systemic administration.
Croatian: Levofloksacin se sustavno apsorbira nakon inhalacije Quinsaira i eliminira slično levofloksacinu nakon sistemske primjene.
English: Resistance to levofloxacin is most often acquired through a stepwise process by target site mutations in DNA gyrase and topoisomerase IV.
Croatian: Rezistencija na levofloksacin najčešće se stječe postupno mutacijama na ciljnim mjestima DNA-giraze i topoizomeraze IV.
English: Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin.
Croatian: Psihotične reakcije zabilježene su u bolesnika koji su primali kinolone, uključujući levofloksacin.
English: This comprises an inner carton box containing 56 ampoules and a Package Leaflet.
Croatian: Ono uključuje unutarnju kartonsku kutiju koja sadrži 56 ampula i uputu o lijeku.
English: The mean apparent total body clearance of levofloxacin following systemic administration of a 500 mg single dose was 175 +/- 29.2 ml/min.
Croatian: Srednji prividni ukupni klirens levofloksacina nakon sistemske primjene jednokratne doze od 500 mg iznosio je 175 +/- 29,2 ml/min.
English: Treatment of these patients with levofloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).
Croatian: Ove se bolesnike smije početi liječiti levofloksacinom samo ako ne postoje alternativne mogućnosti liječenja te nakon pažljive procjene omjera koristi i rizika (vidjeti također dio 4.3).
English: Quinolone antibiotics, including Quinsair, may cause levels of glucose in the blood to be either too high or too low.
Croatian: Kinolonski antibiotici, uključujući Quinsair, mogu uzrokovati razine glukoze u krvi koje su ili previsoke ili preniske.
English: Effect of other medicinal products on levofloxacin
Croatian: Učinci drugih lijekova na levofloksacin
English: Cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with systemic administration of levofloxacin (see section 4.8).
Croatian: Slučajevi teške bulozne kožne reakcije poput Stevens-Johnsonovog sindroma ili toksične epidermalne nekrolize prijavljeni su pri sistemskoj primjeni levofloksacina (vidjeti dio 4.8).
English: Each 28-day pack of Quinsair contains one box of 56 (14 sachets of 4) ampoules and one box holding a Zirela Nebuliser Handset with the Manufacturer's Instructions for Use.
Croatian: Svako pakiranje Quinsaira za 28 dana terapije sadrži jednu kutiju s 56 ampula (14 vrećica sa po 4 ampule) i jednu kutiju s napravom za inhalaciju Zirela Nebuliser Handset s Uputama proizvođača za uporabu.
English: - The other ingredients are magnesium chloride hexahydrate and water for injections.
Croatian: - Drugi sastojci su magnezijev klorid heksahidrat i voda za injekcije.
English: Insomnia*
Croatian: insomnija*
English: CDAD may range in severity from mild to life-threatening, the most severe form of which is pseudomembranous colitis.
Croatian: Težina CDAD može varirati od blage do po život opasne, a najteži njen oblik je pseudomembranozni kolitis.
English: Caution is recommended if levofloxacin is used in psychotic patients or in patients with a history of psychiatric disease.
Croatian: Preporučuje se oprez kada se levofloksacin primjenjuje u psihotičnih bolesnika ili bolesnika s psihijatrijskom bolešću u anamnezi.
English: Levofloxacin caused no impairment of fertility or reproductive performance in rats (see section 5.3).
Croatian: Levofloksacin nije uzrokovao oštećenje plodnosti ili reproduktivne sposobnosti u štakora (vidjeti dio 5.3).
English: All patients had also received a minimum of 3 courses of inhaled anti-pseudomonal antimicrobial therapy in the 12 months (Study 204) or 18 months (Study 207) prior to entry into the study, but none in the 28 days immediately preceding study entry.
Croatian: Svi su bolesnici također primili najmanje 3 serije inhalacijske antipseudomonalne antimikrobne terapije tijekom 12 (Ispitivanje 204) ili 18 mjeseci (Ispitivanje 207) prije uključivanja u ispitivanje, ali ništa 28 dana neposredno prije početka ispitivanja.
English: Levofloxacin is contraindicated in patients with a history of epilepsy (see section 4.3) and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures or on concomitant treatment with active substances that lower the cerebral seizure threshold, such as theophylline (see section 4.5).
Croatian: Levofloksacin je kontraindiciran u bolesnika s epilepsijom u anamnezi (vidjeti dio 4.3) i, i kao i kod drugih kinolona, mora se primjenjivati s krajnjim oprezom u bolesnika s predispozicijom za napadaje ili onih koji istodobno uzimaju lijekove čija djelatna tvar snizuje cerebralni prag za napadaje, poput teofilina (vidjeti dio 4.5).
English: Nervous system disorders1
Croatian: Poremećaji živčanog sustava1
English: - Inflammation of a tendon causing pain, stiffness and/or swelling in the joints (tendonitis).
Croatian: - upalu tetive koja uzrokuje bol, ukočenost i/ili oteknuće zglobova (tendinitis)
English: - Medicines such as probenecid (used to prevent gout) or cimetidine (used to treat ulcers).
Croatian: - Lijekovi poput probenecida (koristi se za sprečavanje gihta) ili cimetidina (koristi se za liječenje čira na želucu).
English: 8) Once treatment is complete, disconnect the controller and take apart the Zirela Nebuliser Handset for cleaning and disinfecting.
Croatian: 8) Kada je postupak dovršen, odvojite kontrolor protoka i rastavite napravu za inhalaciju Zirela Nebuliser Handset radi čišćenja i dezinfekcije.
English: Quinolone antibiotics, including Quinsair, may cause seizures or convulsions (fits).
Croatian: Kinolonski antibiotici, uključujući Quinsair, mogu izazvati napadaje i konvulzije.
English: However, a pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, non-steroidal anti-inflammatory drugs, or other substances which lower the seizure threshold.
Croatian: Međutim, može doći do naglašenog snižavanja cerebralnog praga za napadaje kada se kinoloni primjenjuju paralelno s teofilinom, nesteroidnim protuupalnim lijekovima i drugim tvarima koje snizuju prag za napadaje.
English: 3) After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset.
Croatian: 3) Nakon nekoliko sekundi maglica aerosola će početi protjecati kroz komoru naprave za inhalaciju Zirela Nebuliser Handset.
English: 500 mg Oral QD*
Croatian: 500 mg peroralno QD*