FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended oral single dose in adults and adolescents aged 15 years or over is also 500 to 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Croatian: Preporučena pojedinačna peroralna doza kod odraslih i adolescenata u dobi od 15 i više godina također je 500 do 1 000 mg.
English: Based on the data assessed, the Committee recommended a parenteral single dose in adults and adolescents aged 15 years or over of 500 - 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Croatian: Odbor je preporučio parenteralnu pojedinačnu dozu od 5001 000 mg kod odraslih i adolescenata u dobi od 15 i više godina.
English: Try not to breathe through your nose.
Croatian: Nastojte ne disati kroz nos.
English: No specific antidote exists.
Croatian: Specifični antidot ne postoji.
English: This is ok.
Croatian: To je u redu.
English: Cumulative intermediate analyses - annually.
Croatian: Kumulativne intermedijalne analize - godišnje.
English: Elderly patients (≥ 65 years old)
Croatian: Stariji bolesnici (≥ 65 godina)
English: Always use this medicine exactly as your doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako je Vam je rekao Vaš liječnik.
English: Your doctor will explain more.
Croatian: Vaš će Vam liječnik to dodatno objasniti.
English: These findings were more marked in young animals.
Croatian: Nalazi su bili izraženiji u mladih životinja.
English: c Tested using alpha of 0.05.
Croatian: c Provjera korištenjem alfa 0,05.
English: Symptoms are listed in section 4.
Croatian: Simptomi su navedeni u dijelu 4.
English: (See sections 4.2 and 5.3.)
Croatian: (Vidjeti dijelove 4.2 i 5.3)
English: Currently available data are described in sections 4.8, 5.1, 5.2 and 5.3 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 , 5.2 i 5.3, ali ne mogu se dati preporuke o doziranju.
English: - Depression or mental health problems.
Croatian: - depresiju ili probleme s mentalnim zdravljem
English: The ampoule is labelled in English only.
Croatian: Ampule su označene samo na engleskom jeziku.
English: If this happens to you, do not drive or use any tools or machines.
Croatian: Ako se to dogodi, nemojte upravljati vozilima niti koristiti ikakve alate ili strojeve.
English: What if I need to stop my treatment before I've finished?
Croatian: Što ako prekinem postupak prije nego je dovršen?
English: Quinsair should not be given to children and adolescents less than 18 years old as there is not enough information about its use in this age group.
Croatian: Quinsair se ne smije davati djeci i adolescentima mlađim od 18 godina jer nema dovoljno podataka o njegovoj primjeni u toj dobnoj skupini.
English: Women who take these types of medicines may be more likely to be affected.
Croatian: Žene koje uzimaju ove lijekove vjerojatno će biti više pogođene.
English: Your doctor may need to give you regular blood tests to check how well your blood can clot.
Croatian: Može biti potrebno da Vam liječnik odredi redovite krvne pretrage kako bi se provjerilo koliko se gruša Vaša krv.
English: Dornase alfa;
Croatian: Dornaza alfa;
English: - Resistance to antibiotics
Croatian: - rezistencija na antibiotike
English: Important information to know before you start - Each ampoule is for single use only.
Croatian: Važni podaci koje morate znati prije početka primjene - Svaka ampula je samo za jednokratnu uporabu.
English: - A severe allergic reaction.
Croatian: - tešku alergijsku reakciju.
English: Each ampoule is for single use only.
Croatian: Svaka ampula je samo za jednokratnu uporabu.
English: Other side effects can include:
Croatian: Ostale nuspojave mogu uključivati:
English: Tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: 1) When you start your treatment, sit in a relaxed, upright position.
Croatian: 1) Kad započnete s postupkom, sjednite u uspravnom, opuštenom položaju.
English: Quinsair may make your skin become more sensitive to sunlight.
Croatian: Zbog Quinsaira Vaša koža može postati osjetljivija na sunčevu svjetlost.
English: e P-value determined using a log-rank test.
Croatian: e P-vrijednost određena je pomoću log-rang testa.
English: In this situation, you should inform your doctor as soon as possible.
Croatian: U toj situaciji morate što prije obavijestiti svog liječnika o tome.
English: Inhaling Quinsair at the same time each day will help you remember when to take your medicine.
Croatian: Inhalirajući Quinsair svakoga dana u isto vrijeme pomoći će Vam da zapamtite kada morate uzeti lijek.
English: Results obtained for the primary and key secondary endpoints are provided in Table 2.
Croatian: Dobiveni rezultati za primarne i ključne sekundarne krajnje točke ishoda prikazane su u tablici 2.
English: A few drops of medicine may remain at the bottom of the reservoir at the end of treatment.
Croatian: Nekoliko kapi lijeka može zaostati na dnu spremnika na kraju terapije.
English: Probenecid and cimetidine
Croatian: Probenecid i cimetidin
English: If the infection is not properly treated it will continue to damage the lungs, causing further problems with breathing.
Croatian: Ako se infekcija odgovarajuće ne liječi, nastavit će oštećivati pluća uzrokujući tako daljnje probleme s disanjem.
English: Pivotal Study - Study 209 (Core Phase; ITT)
Croatian: Glavno ispitivanje - Ispitivanje 209 (središnja faza; ITT)
English: Interactions mediated by effects on transporters
Croatian: Interakcije posredovane učinkom na transportere
English: Once opened, use immediately.
Croatian: Nakon otvaranja odmah upotrijebiti.
English: The patient should be observed and appropriate hydration maintained.
Croatian: Bolesnika se mora nadzirati i održavati odgovarajuća hidracija.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/03/2015
Croatian: Datum prvog odobrenja: 26/03/2015
English: Prevention of photosensitisation
Croatian: Prevencija fotosenzibilizacije
English: Pain (including pain in back, chest and extremities)
Croatian: bol (uključujući bol u leđima, prsnom košu i ekstremitetima)
English: Patients who experience such symptoms should be advised not to drive or use machines.
Croatian: Bolesnicima koji dobiju ove simptome mora se savjetovati da ne upravljaju vozilima i ne rade sa strojevima.
English: You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.
Croatian: Zajedno s liječnikom odlučit ćete o nastavku liječenja, a također ćete razmotriti i primjenu antibiotika iz neke druge skupine.
English: What if I am using several different inhalers and other therapies for cystic fibrosis?
Croatian: Što ako koristim nekoliko različitih inhalatora i druge lijekove za cističnu fibrozu?
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Moraju se uzeti u obzir službene smjernice za adekvatnu primjenu antibakterijskih lijekova.
English: - False test results
Croatian: - Lažni rezultati pretraga
English: FEV1 percent predicted
Croatian: Predviđeni postotak FEV1
English: Interactions with CYP inhibitors or inducers are thus not expected.
Croatian: Interakcije s inhibitorima ili induktorima CYP se stoga ne očekuju.
English: Sit the patient in a relaxed, upright position.
Croatian: Posjednite bolesnika u uspravan i opušten položaj.
English: Treatment will restart.
Croatian: Postupak će se ponovno započeti.
English: Weight decrease was reported as an adverse event during clinical studies, but was primarily thought to be disease rather than drug-related.
Croatian: Gubitak tjelesne težine prijavljen je kao štetni događaj tijekom kliničkih ispitivanja, ali se prvenstveno smatra da je to povezano s bolešću a ne s lijekom.
English: Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Italy
Croatian: Adare Pharmaceuticals S.r.l. Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Italija
English: If superinfection occurs during therapy, appropriate measures should be taken.
Croatian: Ako se tijekom liječenja pojavi superinfekcija, moraju se poduzeti odgovarajuće mjere.
English: Cyclical therapy may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
Croatian: Terapijski ciklusi mogu se nastaviti sve dok liječnik smatra da bolesnik od toga ima kliničke koristi.
English: Study 204 (ITT) a
Croatian: Ispitivanje 204 (ITT) a
English: Therefore, concomitant use of corticosteroids should be avoided.
Croatian: Stoga je potrebno izbjegavati istodobnu primjenu kortikosteroida.
English: The information that appears on the ampoule is:
Croatian: Podaci koji se nalaze na ampuli su:
English: How much do I use?
Croatian: Koliko lijeka moram primijeniti?
English: • Epilepsy.
Croatian: • Epilepsija.
English: The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su prema sljedećoj konvenciji: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Treatment Difference a
Croatian: Razlika prema vrsti liječenja a
English: What Quinsair is and what it is used for
Croatian: Što je Quinsair i za što se koristi
English: Approximately 30 to 40% of levofloxacin is bound to serum protein.
Croatian: Oko 30 do 40% levofloksacina veže se na proteine plazme.
English: You then start another treatment course.
Croatian: Tada ćete započeti sljedeći ciklus terapije.
English: Inhale this medicine at least 15 minutes or up to 4 hours before your next dose of Quinsair.
Croatian: Inhalirajte ovaj lijek najmanje 15 minuta ili sve do 4 sata prije sljedeće doze Quinsaira.
English: Their frequency cannot be estimated from available data.
Croatian: Njihova se učestalost ne može procijeniti na temelju dostupnih podataka.
English: Elimination is primarily by the renal route (> 85% of the dose following oral or intravenous administration).
Croatian: Eliminacija se primarno odvija putem bubrega (> 85% doze nakon peroralne ili intravenske primjene).
English: Sometimes lengthy treatment with antibiotics can mean that you get another infection caused by other bacteria which are not affected by the antibiotic (superinfection).
Croatian: Ponekad dugotrajno liječenje antibiotikom može značiti da ćete dobiti drugu infekciju uzrokovanu drugom bakterijom na koju primjenjivani antibiotik ne djeluje (superinfekcija).
English: Ensure that you completely empty the ampoule, gently tapping it against the side of the reservoir if necessary.
Croatian: Provjerite da ste ampulu potpuno ispraznili nježno kuckajući njome o rub spremnika ako je potrebno.
English: In the “crimped area” on either side of the ampoule tail LOT
Croatian: Na "naboranom dijelu" svake strane repa ampule Lot
English: These effects can be attributed to inhibition of topoisomerase II.
Croatian: Ovi se učinci mogu pripisati inhibiciji topoizomeraze II.
English: It may be necessary to confirm positive opiate screens by more specific methods.
Croatian: Stoga može biti potrebno potvrditi pozitivni nalaz na opijate pomoću osjetljivijih metoda.
English: Sputum PK exposure in children aged 7 to 16 years old was approximately one-third of adult exposure.
Croatian: Farmakokinetička izloženost u sputumu u djece u dobi od 7 do 16 godina bila je približno jedna trećina izloženosti u odraslih.
English: 6) When all of the medicine has been delivered, you will hear two ‘beeps', which means the treatment is complete.
Croatian: 6) Kada je sav lijek inhaliran čut ćete dva tona, što znači da je postupak dovršen.
English: If you are diabetic, you should monitor your blood glucose levels carefully.
Croatian: Ako ste dijabetičar potrebno je da pažljivo nadzirete razinu glukoze u vašoj krvi.
English: Basic instructions for use are given below.
Croatian: Osnovne upute za uporabu navedene su u nastavku.
English: You will hear one ‘beep' and the status light will turn green.
Croatian: Čut čete jedan ton i upalit će se zeleno svjetlo.
English: In the event of overdose, symptomatic treatment should be implemented.
Croatian: U slučaju predoziranja potrebno je primijeniti simptomatsko liječenje.
English: You must inhale and exhale through the mouthpiece as before.
Croatian: Možete udisati i izdisati kroz usnik kao i ranije.
English: • Congenital long QT syndrome.
Croatian: • Kongenitalnog sindroma dugog QT-intervala.
English: However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance.
Croatian: Međutim, pri dozama ispitanim u ispitivanju nije vjerojatno da će dobivene statistički značajne kinetičke razlike biti od kliničke važnosti.
English: Talk to your doctor if you have any questions about this.
Croatian: Obratite se svom liječniku ako imate pitanja u vezi s tim.
English: Once an ampoule is opened, the contents should be used immediately (see section 6.6).
Croatian: Nakon otvaranja ampule odmah se mora primijeniti njezin sadržaj (vidjeti dio 6.6)
English: c Non-inferiority was tested using a pre-specified, fixed non-inferiority margin of 4% at Day 28 of Cycle 1. d Estimates were obtained from a Cox proportional hazards regression model.
Croatian: c Neinferiornost je provjerena pomoću prethodno specificirane fiksne granice neinferiornosti od 4% 28. dana ciklusa 1. d Procjene su dobivene pomoću Coxovog regresijskog modela proporcionalnog hazarda.
English: Other medicines and Quinsair
Croatian: Drugi lijekovi i Quinsair
English: Elderly patients and women may be more sensitive to QTc-prolonging medicinal products.
Croatian: Stariji bolesnici i žene mogu biti podložniji QT-prolongaciji uzrokovanoj lijekovima.
English: Quinsair can interfere with the effects of these medicines.
Croatian: Quinsair može utjecati na učinke tih lijekova.
English: 4) Keeping the handset level, place the mouthpiece in your mouth and close your lips around it (Figure 3).
Croatian: 4) Držeći uređaj u ravnini stavite usnik u usta i stisnute usne oko njega (slika 3).
English: These metabolites account for ˂ 5% of the dose following systemic administration and are excreted in urine.
Croatian: Na ove metabolite otpada ˂ 5% doze nakon sistemske primjene i izlučuju se urinom.
English: Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids.
Croatian: Rizik Vam je povećan ako ste starije dobi (stariji od 60 godina), imate presađen organ, tegobe s bubrezima ili se liječite kortikosteroidima.
English: Anxiety*, Depression*
Croatian: anksioznost*, depresija*
English: b LS Mean (SE).
Croatian: b Srednja LS (SE).
English: Following oral and intravenous administration, levofloxacin is eliminated relatively slowly from the plasma (t1/2: 6 to 8 hours).
Croatian: Nakon peroralne i intravenske primjene levofloksacin se relativno sporo eliminira iz plazme (t1/2: 6 do 8 sati).
English: - Difficulty in breathing which can range from mild to severe (bronchospasm).
Croatian: - teškoće s disanjem koje se mogu kretati od blagih do teških (bronhospazam)
English: Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.
Croatian: Levofloksacin može inhibirati rast Mycobacterium tuberculosis i stoga može dati lažno negativne rezultate kod bakteriološkog dokazivanja tuberkuloze.
English: - Seizures and convulsions
Croatian: - napadaje i konvulzije
English: When the treatment is complete, the controller will ‘beep' twice.
Croatian: Kad je tretman dovršen kontrolor će se oglasiti tonom dva puta.
English: The medicine comes in small 3 ml plastic ampoules.
Croatian: Lijek se isporučuje u malim plastičnim ampulama od 3 ml.
English: This should be connected to either an eBase Controller or an eFlow rapid Control Unit.
Croatian: On mora biti spojen na kontrolor protoka ili eBase Controller eFlow rapid Control Unit.
English: Reduced bacterial permeability (common in P. aeruginosa) and efflux mechanisms may also confer or contribute to resistance.
Croatian: Smanjena bakterijska permeabilnost (česta kod P. aeruginosa) i mehanizmi efluksa mogu također biti uzrok ili doprinijeti rezistenciji.
English: If the contents of the ampoule are swallowed, don't worry but tell your doctor as soon as possible.
Croatian: Ako se sadržaj ampule proguta, nemojte se brinuti ali se obratite svom liječniku što je prije moguće.
English: Psychotic reactions
Croatian: Psihotične reakcije
English: - Superinfections
Croatian: - superinfekcije
English: Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones ATC code: J01MA12
Croatian: Farmakoterapijska skupina: antibakterijski lijekovi za sustavnu primjenu, fluorokinoloni ATK oznaka: J01MA12
English: - Do not swallow the liquid in the ampoule.
Croatian: - Tekućinu iz ampule nemojte progutati.
English: The renal clearance of levofloxacin was reduced by cimetidine (24%) and probenecid (34%).
Croatian: Bubrežni klirens levofloksacina bio je smanjen cimetidinom (24%) i probenecidom (34%).
English: Any unused product must be thrown away.
Croatian: Sav neiskorišteni lijek mora se baciti.
English: Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations.
Croatian: Stoga je potreban oprez kada se fluorokinoloni, uključujući levofloksacin, koriste u tim populacijama.
English: Studies in the mouse showed levofloxacin to have phototoxic activity only at very high doses.
Croatian: Ispitivanja na miševima pokazala su da levofloksacin ima fototoksičku aktivnost samo u vrlo visokim dozama.
English: Quinsair can cause changes to your heart rhythm, especially if you are taking any medicines to treat heart problems or low levels of potassium or magnesium in the blood.
Croatian: Quinsair može izazvati promjene Vašeg srčanog ritma, osobito ako uzimate lijekove za srce ili za snižavanje razine kalija ili magnezija u krvi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/973/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/973/001
English: Final study report - by Q2 2022.
Croatian: Konačno izvješće o rezultatu ispitivanja - 2. tromjesečje 2022.
English: In vitro studies demonstrated that inhibition of the key transporters associated with drug disposition in the kidney (organic anion-transporting polypeptide-1B1 (OATP1B1), OATP1B3, organic anion transporter-1 (OAT1), OAT3 and organic cationic transporter-2 (OCT2)) at exposures following inhalation of 240 mg levofloxacin twice daily is low.
Croatian: In vitro ispitivanja pokazala su da je inhibicija ključnih transportera povezanih s dispozicijom lijeka u bubregu (organskog anionskog transportnog polipeptida 1B1 (OATP1B1), OATP1B3, organskog anionskog transportera-1 (OAT1), OAT3 i organskog kationskog transportera -2 (OCT2)) pri ekspoziciji nakon inhalacije 240 mg levofloksacina dva puta dnevno niska.
English: If you use more Quinsair than you should
Croatian: Ako primijenite više Quinsaira nego što ste trebali
English: Pharmacokinetic parameter
Croatian: Farmakokinetički parametar
English: 7) Once complete, open the medicine cap to ensure all of the medicine has been used.
Croatian: 7) Nakon dovršetka, otvorite poklopac spremnika kako biste provjerili je li iskorišten sav lijek.
English: What Quinsair is and what it is used for What you need to know before you use Quinsair How to use Quinsair
Croatian: Što je Quinsair i za što se koristi Što morate znati prije nego počnete primjenjivati Quinsair Kako primjenjivati Quinsair
English: The parameters associated with the antibacterial effects of levofloxacin are the Cmax/MIC and AUC/MIC ratios (Cmax = maximum concentration at the site of infection, AUC = area under the curve and MIC = minimal inhibitory concentration).
Croatian: Parametri povezani s antibakterijskim učinkom levofloksacina su omjeri Cmax/MIC i AUC/MIC (Cmax = maksimalna koncentracija na mjestu infekcije, AUC = površina ispod krivulje i MIC = minimalna inhibitorna koncentracija).
English: if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Croatian: ako ste već prethodno doživjeli epizodu disekcije aorte (razdvajanje stijenki aorte).
English: Ask the patient to inhale and exhale through the mouthpiece until the treatment is finished.
Croatian: Zatražite od bolesnika da udiše i izdiše kroz usnik dok tretman ne bude gotov.
English: It takes about 5 minutes to inhale the medicine using the nebuliser.
Croatian: Potrebno je oko 5 minuta da bi se lijek inhalirao pomoću sustava za inhalaciju.
English: * Adverse events with uncertain relatedness to Quinsair but which are known to be associated with systemic administration of levofloxacin and/or are plausibly associated with Quinsair and were reported more frequently than with placebo in clinical studies.
Croatian: * Štetni događaji koji se ne mogu sa sigurnošću povezati s Quinsairom, ali za koje je poznato da su povezani sa sistemskom primjenom levofloksacina i/ili su vjerojatno povezani s Quinsairom i u kliničkim ispitivanjima su prijavljeni češće nego u skupini placebo.
English: Hyposmia*, Somnolence*
Croatian: hipozmija*, somnolencija*
English: Levofloxacin is stereochemically stable and does not undergo chiral inversion.
Croatian: Levofloksacin je stereokemijski stabilan i ne podliježe kiralnoj inverziji.
English: • Uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia).
Croatian: • Nekorigiranog disbalansa elektrolita (npr. hipokalijemija, hipomagnezijemija).
English: In patients treated with levofloxacin, determination of opiates in urine may give false-positive results.
Croatian: U bolesnika koji se liječe levofloksacinom, određivanje opijata u urinu može dati lažno pozitivne rezultate.
English: How do I prepare my Nebuliser System to inhale the medicine?
Croatian: Kako ću pripremiti svoju napravu Nebuliser System za inhalaciju lijeka?
English: You should avoid prolonged exposure to sunlight or strong sunlight and should not use sunbeds or any other UV lamps whilst using Quinsair and for 48 hours after stopping treatment.
Croatian: Morate izbjegavati produljeno izlaganje sunčevoj svjetlosti ili jaku sunčevu svjetlost i ne smijete koristiti solarij ili bilo koju UV-lampu svo vrijeme dok koristite Quinsair i 48 sati nakon prestanka liječenja.
English: Quinsair must not be used whilst pregnant or breast-feeding.
Croatian: Quinsair se ne smije koristiti tijekom trudnoće i dojenja.
English: How long do I use it for?
Croatian: Koliko ću dugo primjenjivati lijek?
English: The most frequently reported adverse reactions were cough/productive cough (54%), dysgeusia (30%) and fatigue/asthenia (25%).
Croatian: Najčešće prijavljene nuspojave bile su kašalj/produktivni kašalj (54%), disgeuzija (30%) i umor/astenija (25%).
English: It belongs to the group of antibiotics called fluoroquinolones.
Croatian: Pripada skupini antibiotika koje nazivamo fluorokinoloni.
English: Four ampoules are sealed in a foil sachet and each box contains 14 sachets.
Croatian: Četiri ampule zavarene su u vrećici od folije i svaka kutija sadrži 14 vrećica.
English: In very rare cases, these have progressed to suicidal thoughts and self-endangering behavioursometimes after only a single dose of levofloxacin (see section 4.8).
Croatian: U vrlo rijetkim slučajevima ove su reakcije progredirale do suicidalnih misli i samougrožavajućeg ponašanja - ponekad nakon samo jedne doze levofloksacina (vidjeti dio 4.8).
English: Inner box
Croatian: Unutarnja kutija