natgillin/translations-raw huggingface dataset:
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: 
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.:
Tinnitus* 
tinitus*
Levofloxacin is systemically absorbed following inhalation of Quinsair and eliminated similarly to levofloxacin following systemic administration. 
Levofloksacin se sustavno apsorbira nakon inhalacije Quinsaira i eliminira slično levofloksacinu nakon sistemske primjene.
Resistance to levofloxacin is most often acquired through a stepwise process by target site mutations in DNA gyrase and topoisomerase IV. 
Rezistencija na levofloksacin najčešće se stječe postupno mutacijama na ciljnim mjestima DNA-giraze i topoizomeraze IV.
Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin. 
Psihotične reakcije zabilježene su u bolesnika koji su primali kinolone, uključujući levofloksacin.
This comprises an inner carton box containing 56 ampoules and a Package Leaflet. 
Ono uključuje unutarnju kartonsku kutiju koja sadrži 56 ampula i uputu o lijeku.
The mean apparent total body clearance of levofloxacin following systemic administration of a 500 mg single dose was 175 +/- 29.2 ml/min. 
Srednji prividni ukupni klirens levofloksacina nakon sistemske primjene jednokratne doze od 500 mg iznosio je 175 +/- 29,2 ml/min.
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). 
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).
Quinolone antibiotics, including Quinsair, may cause levels of glucose in the blood to be either too high or too low. 
Kinolonski antibiotici, uključujući Quinsair, mogu uzrokovati razine glukoze u krvi koje su ili previsoke ili preniske.
Effect of other medicinal products on levofloxacin 
Učinci drugih lijekova na levofloksacin
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). 
Slučajevi teške bulozne kožne reakcije poput Stevens-Johnsonovog sindroma ili toksične epidermalne nekrolize prijavljeni su pri sistemskoj primjeni levofloksacina (vidjeti dio 4.8).
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. 
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.
- The other ingredients are magnesium chloride hexahydrate and water for injections. 
- Drugi sastojci su magnezijev klorid heksahidrat i voda za injekcije.
Insomnia* 
insomnija*
CDAD may range in severity from mild to life-threatening, the most severe form of which is pseudomembranous colitis. 
Težina CDAD može varirati od blage do po život opasne, a najteži njen oblik je pseudomembranozni kolitis.
Caution is recommended if levofloxacin is used in psychotic patients or in patients with a history of psychiatric disease. 
Preporučuje se oprez kada se levofloksacin primjenjuje u psihotičnih bolesnika ili bolesnika s psihijatrijskom bolešću u anamnezi.
Levofloxacin caused no impairment of fertility or reproductive performance in rats (see section 5.3). 
Levofloksacin nije uzrokovao oštećenje plodnosti ili reproduktivne sposobnosti u štakora (vidjeti dio 5.3).
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. 
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.
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). 
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).
Nervous system disorders1 
Poremećaji živčanog sustava1
- Inflammation of a tendon causing pain, stiffness and/or swelling in the joints (tendonitis). 
- upalu tetive koja uzrokuje bol, ukočenost i/ili oteknuće zglobova (tendinitis)
- Medicines such as probenecid (used to prevent gout) or cimetidine (used to treat ulcers). 
- Lijekovi poput probenecida (koristi se za sprečavanje gihta) ili cimetidina (koristi se za liječenje čira na želucu).
8) Once treatment is complete, disconnect the controller and take apart the Zirela Nebuliser Handset for cleaning and disinfecting. 
8) Kada je postupak dovršen, odvojite kontrolor protoka i rastavite napravu za inhalaciju Zirela Nebuliser Handset radi čišćenja i dezinfekcije.
Quinolone antibiotics, including Quinsair, may cause seizures or convulsions (fits). 
Kinolonski antibiotici, uključujući Quinsair, mogu izazvati napadaje i konvulzije.
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. 
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.
3) After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset. 
3) Nakon nekoliko sekundi maglica aerosola će početi protjecati kroz komoru naprave za inhalaciju Zirela Nebuliser Handset.
500 mg Oral QD* 
500 mg peroralno QD*
Established susceptibility breakpoints for systemic (oral or intravenous) administration of levofloxacin are not applicable to delivery by inhalation. 
Utvrđene granične vrijednosti osjetljivosti za sistemsku (peroralnu ili intravensku) primjenu levofloksacina nisu primjenjive za primjenu u obliku inhalacije.
N = 93 90.5 days 
N = 93 90,5 dana
- Glucose-6-phosphate dehydrogensae deficiency Quinolone antibiotics, such as Quinsair, can cause patients with glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease) to be prone to blood complications leading to a sudden rise in body temperature, yellowing of the skin and mucous membranes, dark coloured urine, paleness, tiredness, heavy, fast breathing and a weak, rapid pulse. 
Kinolonski antibiotici, poput Quinsaira, mogu u bolesnika s deficitom glukoza-6-fosfatdehidrogenaze (rijetkom nasljednom bolešću) uzrokovati sklonost krvnim komplikacijama koje dovode do iznenadnog porasta tjelesne temperature, žuto obojene kože i sluznica, tamne mokraće, bljedoće, umora, teškog, ubrzanog disanja i slabog, ubrzanog pulsa.
Serious haematological adverse reactions such as pancytopenia, agranulocytosis and haemolytic anaemia have been reported following systemic administration of levofloxacin. 
Ozbiljne hematološke nuspojave poput pancitopenije, agranulocitoze i hemolitičke anemije prijavljeni su nakon sistemske primjene levofloksacina.
Clinical pharmacology studies have shown that the pharmacokinetics of levofloxacin were not affected to any clinically relevant extent when levofloxacin was administered together with the following active substances: calcium carbonate, digoxin, glibenclamide and ranitidine. 
Klinička farmakološka ispitivanja pokazala su da, u klinički značajnoj mjeri, nema utjecaja na farmakokinetiku levofloksacina kada se levofloksacin primjenjuje zajedno sa sljedećim djelatnim tvarima: kalcijev karbonat, digoksin, glibenklamid i ranitidin.
On the front of the ampoule tail Quinsair 240 mg 
Na prednjoj strani „repa“ ampule Quinsair 240 mg
ON Quinsair Use it twice a day for 28 days 
POD TERAPIJOM Quinsairom Primijenite dva puta na dan kroz 28 dana
Therefore, doses of Quinsair do not need to be adjusted in patients with mild to moderate renal impairment. 
Stoga nije potrebno prilagođavanje doze Quinsaira u bolesnika s blagim do umjerenim oštećenjem bubrega.
Fluoroquinolones have been shown to cause arthropathy in weight-bearing joints of immature animals. 
Utvrđeno je da fluorokinoloni uzrokuju artropatiju u težinom opterećenim zglobovima nezrelih životinja.
If you experience palpitations or an irregular heart beat whilst using Quinsair you should tell your doctor immediately. 
Ako osjetite lupanje srca ili nepravilne otkucaje srca dok koristite Quinsair, morate o tome obavijestiti svog liječnika.
At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with levofloxacin should be discontinued and alternative treatment should be considered. 
Kod prvog znaka tendinitisa (npr. bolan otok, upala) treba prekinuti liječenje levofloksacinom i razmotriti primjenu druge terapije.
Transient vision loss 
prolazni gubitak vida
Tabulated list of additional adverse reactions reported following systemic administration of levofloxacin 
Tablični prikaz dodatnih nuspojava prijavljenih nakon sistemske primjene levofloksacina
Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists (see section 4.4). 
Stoga je potrebno pratiti parametre koagulacije u bolesnika liječenih antagonistima vitamina K (vidjeti dio 4,4).
Once an ampoule is opened, the contents should be used immediately. 
Nakon otvaranja ampule, njezin sadržaj se mora odmah iskoristiti.
Multiple dose administration of Quinsair 240 mg twice daily by inhalation results in levofloxacin systemic exposure approximately 50% lower than that observed following systemic administration of comparable doses (see Table 3). 
Višekratna primjena Quinsair 240 mg dva puta na dan putem inhalacije rezultirala je sustavnom izloženošću levofloksacinu oko 50% nižom od one primijećene nakon sistemske primjene usporedivih doza (pogledati tablicu 3).
Studies using systemic administration of levofloxacin show that the pharmacokinetics of levofloxacin are affected by renal impairment; with decreasing renal function (estimated creatinine clearance < 50 ml/min), renal elimination and clearance are decreased, and elimination half-life increased. 
Ispitivanja u kojima se koristila sistemska primjena levofloksacina pokazala su da oštećenje bubrega utječe na farmakokinetiku levofloksacina; smanjenjem bubrežne funkcije (procijenjen klirens kreatinina < 50 ml/min), bubrežna eliminacija i klirens se smanjuju a poluvijek eliminacije produljuje.
Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen. 
Bolesnicima je potrebno savjetovati da prekinu liječenje i obrate se svom liječniku ako se kod njih pojave znakovi i simptomi bolesti jetre, poput anoreksije, žutice, tamne mokraće, svrbeža ili osjetljivog abdomena.
5th Inhaled steroids 
Quinsair inhalacijske steroide
However, there is variability in the systemic exposures observed which means that serum levels of levofloxacin following inhalation of Quinsair may sometimes fall within the range of levels observed following systemic administration of comparable doses. 
Međutim, primijećena sustavna izloženost je varijabilna, što znači da razina levofloksacina u serumu nakon inhalacije Quinsaira može biti unutar raspona razina primijećenih nakon sistemske primjene usporedivih doza.
Patients weighing 22 to 30 kg received 180 mg levofloxacin/day and patients weighing ˃ 30 kg received 240 mg levofloxacin/day. 
Bolesnici tjelesne težine 22 do 30 kg primala su 180 mg levofloksacina/dan a bolesnici tjelesne težine ˃ 30 kg primala su 240 mg levofloksacina/dan.
The apparent clearance (CL/F) of levofloxacin following inhalation of Quinsair 240 mg twice daily is 31.8 +/- 22.4 L/hour. 
Prividni klirens (CL/F) levofloksacina nakon inhalacije Quinsaira 240 mg dva puta na dan iznosi 31,8 +/- 22,4 l/sat.
INFORMATION IN BRAILLE Quinsair 
16. PODACI NA BRAILLEOVOM PISMU Quinsair
More detailed instructions are available in the Package Leaflet and device Manufacturer's Instructions for Use. 
Detaljnije upute dostupne su u Uputi o lijeku i Uputama proizvođača za uporabu sustava za inhalaciju.
Taking Quinsair at the same time as these medicines could affect how your kidneys deal with the medicine which is particularly important if you suffer from kidney problems. 
Istodobno korištenje Quinsaira i tih lijekova može utjecati na izlučivanje lijeka bubrezima, što je osobito važno ako patite od problema s bubrezima.
Please refer to the Manufacturer's Instructions for Use for cleaning and storage advice. 
Molimo potražite u Uputama proizvođača za uporabu savjete kako čistiti i čuvati sustav za inhalaciju.
Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin). 
Povećanje parametara koagulacije (PT/INR) i/ili krvarenja, koje može biti ozbiljno, zabilježeno je u bolesnika koji su liječeni levofloksacinom u kombinaciji s antagonistima vitamina K (npr. varfarinom).
Table 3: Comparison of mean (SD) multiple dose levofloxacin pharmacokinetic parameters following Quinsair administration by inhalation to patients with CF and following oral and intravenous administration of levofloxacin to healthy adult volunteers 
Tablica 3: Usporedba farmakokinetičkih parametara srednje (SD) višekratne doze levofloksacina nakon inhalacijske primjene Quinsaira u bolesnika s CF i nakon peroralne i intravenske primjene levofloksacina u zdravih odraslih dobrovoljaca
Do not use this medicine after the expiry date which is stated on the ampoule, the foil sachet and the boxes after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na ampuli, vrećici i kutijama iza oznaka „Rok valjanosti“ ili „EXP“.
However, dose adjustments were not employed in clinical studies of Quinsair which allowed for the inclusion of patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 20 ml/min using the Cockcroft-Gault formula in adult patients and ≥ 20 ml/min/1.73 m2 using the Bedside Schwartz formula in patients < 18 years old). 
Međutim, prilagodbe doze nisu primjenjivane tijekom kliničkih ispitivanja Quinsaira što je omogućilo uključivanje bolesnika s blagim do umjerenim oštećenjem bubrega (klirens kreatinina ≥ 20 ml/min procijenjen pomoću Cockcroft--Gaultove formule u odraslih bolesnika i ≥ 20 ml/min/1,73 m2 procijenjenog pomoću Bedside Schwartzove formule u bolesnika u dobi od
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). 
Dijareja koja se javi tijekom ili nakon liječenja levofloksacinom (uključujući i nekoliko tjedana nakon liječenja), osobito ako je teška, uporna i/ili krvava, može biti simptom bolesti povezane s Clostridium difficile (engl.
Quinsair is used to treat lung infections caused by Pseudomonas aeruginosa in adults with cystic fibrosis. 
Quinsair se koristi za liječenje infekcija pluća uzrokovanih Pseudomonas aeruginosa u odraslih koji imaju cističnu fibrozu.
2) Squeeze all of the contents of one ampoule into the medicine reservoir of the Zirela Nebuliser Handset (Figure 1). 
2) Istisnite sadržaj jedne ampule u spremnik naprave za inhalaciju Zirela Nebuliser Handset (slika 1).
Quinsair should be taken by inhalation using a Zirela Nebuliser Handset (including a Zirela Aerosol Head). 
Quinsair se mora primjenjivati inhalacijom pomoću naprave za inhalaciju Zirela Nebuliser Handset (uključujući Zirela Aerosol Head).
- Photosensitivity 
- Fotoosjetljivost
N = 93 110 days 
N = 93 110 dana
Uncommon: may affect up to 1 in 100 people - Fungal infection of the mouth - Low numbers of red cells in the blood (anaemia) or the cells in the blood that help it clot 
Manje često: mogu se javiti kod najviše 1 na 100 osoba - gljivične infekcije u ustima - nizak broj crvenih krvnih stanica u krvi (anemija) ili stanica koje sudjeluju u zgrušavanju krvi
** See paragraph below for further details. 
** Za više podataka pogledati paragraf u nastavku.
However if there are more than a few drops left, replace the medicine cap and restart treatment. 
Međutim, ako je zaostalo više od nekoliko kapljica, vratite poklopac spremnika na mjesto i ponovite postupak.
Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF, see section 5.1). 
Quinsair je indiciran za liječenje kroničnih plućnih infekcija uzrokovanih Pseudomonas aeruginosa u odraslih bolesnika s cističnom fibrozom (CF, vidjeti dio 5.1).
Airway clearance techniques; 
Tehnike za pročišćavanje dišnih puteva;
Study 207 (ITT) 
Potporna ispitivanja Ispitivanje 207 (ITT)
N = 189 141 days 
N = 189 141 dana
Table 1: FEV1 Percent predicted relative change from baseline to Day 28 in placebo-controlled efficacy and safety studies of Quinsair in patients with CF 
Tablica 1: Relativna promjena od početne vrijednosti postotka predviđene vrijednosti FEV1 do 28. dana u placebom kontroliranom ispitivanju djelotvornosti i sigurnosti primjene Quinsaira u bolesnika s CF
In addition, 14 children with CF (≥ 6 to < 12 years old) and 13 adolescents with CF (≥ 12 to < 17 years old) received Quinsair 180 mg or 240 mg once daily for 14 days. 
Nadalje, 14 djece s CF (u dobi od ≥ 6 do < 12 godina) i 13 adolescenata s CF (u dobi od ≥ 12 do < 17 godina) primala su Quinsair 180 mg ili 240 mg jedan put na dan tijekom 14 dana.
2) Hold the handset level, press and hold the on/off button on the controller for a few seconds. 
2) Pridržavajte uređaj u razini, pritisnite i držite nekoliko sekundi pritisnutom tipku za uključivanje (on/off) na kontroloru protoka.
If a dose is missed, it should be taken as soon as the patient remembers providing that at least an 8 hour interval is allowed before inhaling the next dose. 
Ako se doza preskoči, lijek se treba uzeti čim se bolesnik toga sjeti, pod uvjetom da mora proći najmanje 8 sati prije sljedeće doze.
For the subgroup of patients who received TIS during the Core Phase and switched to Quinsair in the Extension Phase, the improvement in FEV1 percent predicted was more marked on Quinsair than on TIS (LS Mean change in FEV1 percent predicted on TIS ranged between 0.97% to 3.60% across Cycles 1 to 3 and between 4.00% to 6.91% across Cycles 4 to 6 on Quinsair). 
U podskupini bolesnika koji su primali TIS tijekom središnje faze ispitivanja i prebačeni su na Quinsair u produljenoj fazi, poboljšanje postotka FEV1 predviđene vrijednosti bilo je izraženije u skupini Quinsair nego u skupini TIS (srednja LS promjena postotka predviđene vrijednosti FEV1 u skupini TIS kretala se između 0,97% i 3,60% od 1. do 3. ciklusa i između 4,00% i 6,91% od 4. do 6. ciklusa terapije Quinsairom).
It reduced tumour development in a photocarcinogenicity study. 
U ispitivanju fotokancerogenosti smanjio je razvoj tumora.
Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study. 
Teofilin, fenbufen ili slični nesteroidni protuupalni lijekovi U kliničkom ispitivanju nisu utvrđene farmakokinetičke interakcije levofloksacina s teofilinom.
How to use Quinsair 
Kako koristiti Quinsair
Patients predisposed to seizures 
Bolesnici s predispozicijom za napadaje
Adult and adolescent (≥ 12 to < 18 years old and weighing ≥ 30 kg) patients who had a FEV1 percent predicted between 25% and 85% were enrolled. 
U ispitivanje su bili uključeni odrasli bolesnici i adolescenti (u dobi od ≥ 12 do < 18 godina i tjelesne težine ≥ 30 kg) kod kojih je postotak FEV1 bio između 25% i 85% predviđene vrijednosti.
• Concomitant use of active substances that are known to prolong the QT interval (e.g. Class IA 
• Istodobne primjene djelatnih tvari za koje je poznato da produljuju QT-interval (npr.
Levofloxacin is metabolised to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide. 
Levofloksacin se metabolizira u vrlo malom opsegu, a metaboliti su mu desmetil-levofloksacin i levofloksacin-N-oksid.
What Quinsair contains - The active substance is levofloxacin. 
Što Quinsair sadrži - Djelatna tvar je levofloksacin.
- Coughing up blood or blood-stained mucus from the airways. 
- iskašljavanje krvi ili sluzi s tragovima krvi iz dišnih puteva
The proportion of patients who received Quinsair throughout Study 209 Core and Extension Phases (with a highest levofloxacin MIC P. aeruginosa isolate exceeding 1 µg/ml) was similar at the end of treatment during Cycles 1 and 3 in the Core Phase (76.6% to 83.3%) and at the end of treatment during Cycles 4 to 6 in the Extension Phase (77.8% to 87.5%). 
Omjer bolesnika koji su primali Quinsair tijekom čitave središnje i produljene faze Ispitivanja 209 (i imali najvišu MIC levofloksacina za izolat P. aeruginosa koja je prelazila 1 µg/ml), bio je sličan na kraju liječenja tijekom 1. i 3. ciklusa u središnjoj fazi ispitivanja (76,6% do 83,3%) i na kraju liječenja tijekom 4. do 6. ciklusa u produljenoj fazi ispitivanja (77,8% do 87,5%).
Hazard ratio [95% CI] d: P = 0.154 e 
Omjer hazarda [95% CI] d: P = 0,154 e
3 ml, Low density polyethylene ampoule. 
Ampula od 3 ml od polietilena niske gustoće.
Post-marketing serious adverse reactions, including deaths and the requirements for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. 
Ozbiljne nuspojave zabilježene nakon stavljanja lijeka na tržište, koje su uključivale smrt i potrebu za respiratornom potporom, smatrale su se povezane s primjenom fluorokinolona u bolesnika s miastenijom gravis.
Symptoms include: - Loss of appetite - Yellowing of the skin and eyes (jaundice) - Dark coloured urine - Itching - Tenderness (pain) around the stomach (abdomen) 
Simptomi uključuju: - gubitak apetita - žutu boju kože i očiju (žuticu) - tamno obojenu mokraću - svrbež - osjetljivost (bol) u području želuca (trbuha)
During the Extension Phase, the LS Mean change for FEV1 percent predicted ranged between 4.83% to 1.46% across the 3 additional treatment cycles. 
Tijekom produljene faze ispitivanja srednja promjena postotka predviđene vrijednosti FEV1 dobivena metodom najmanjih kvadrata kretala se između 4,83% i 1,46% u sva 3 dodatna terapijska ciklusa.