FrancophonIA/ELRC3.0 huggingface dataset:
English: Quofenix tablets should be taken at least 2 hours before or 6 hours after:
Croatian: Quofenix tablete treba uzeti najmanje 2 sata prije ili 6 sati nakon:
English: Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Quofenix affects you.
Croatian: Nemojte voziti, upravljati strojevima ili sudjelovati u drugim aktivnostima koje zahtijevaju mentalnu pozornost ili koordinaciju dok ne znate kakav učinak Quofenix ima na Vas.
English: Unchanged parent drug is the predominant component in plasma.
Croatian: Nepromijenjeni izvorni lijek je dominantna komponenta u plazmi.
English: If you miss a dose, you should take it as soon as possible anytime up to 8 hours prior to the next scheduled dose.
Croatian: Ako propustite dozu, trebate je uzeti čim prije moguće, u bilo koje vrijeme najkasnije do 8 sati prije sljedeće planirane doze.
English: This medicine must not be used in children and adolescents as it has not been studied enough in these groups.
Croatian: Ovaj lijek se ne smije primjenjivati u djece i adolescenata jer nije dovoljno ispitivan u tim skupinama.
English: • You had sometimes long treatment with antibiotics; it can mean that you get another infection caused by other bacteria (superinfection) which cannot be treated by the antibiotic.
Croatian: • ako ste bili dugotrajno liječeni antibioticima; to može značiti da ćete dobiti drugu infekciju uzrokovanu drugom bakterijom (superinfekcija) koja ne može biti liječena tim antibiotikom.
English: • High blood pressure
Croatian: • visoki krvni tlak
English: It belongs to a group of medicines called fluoroquinolones.
Croatian: Pripada skupini lijekova koji se zovu fluorokinoloni.
English: These may be signs and symptoms of a hypersensitivity (allergic) reaction and may be life-threatening.
Croatian: Ovo mogu biti znakovi i simptomi reakcije preosjetljivosti (alergijske reakcije) i mogu biti opasni po život.
English: Gram-negative micro-organisms:
Croatian: Gram-negativni mikroorganizmi:
English: The following information is intended for healthcare professionals only: For single use only.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
English: Frequencies are defined as: 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).
Croatian: Učestalosti su definirane kao: vrlo često (≥1/10); često (≥ 1/100 i < 1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i
English: If you stop taking Quofenix without the advice of your doctor, your symptoms may get worse.
Croatian: Ako prestanete uzimati Quofenix bez savjeta Vašeg liječnika, Vaši simptomi bi se mogli pogoršati.
English: This medicinal product does not require any special storage conditions if kept unopened in the original container.
Croatian: Ovaj lijek ne zahtijeva posebne uvjete čuvanja ako je neotvoren i u originalnom spremniku.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije uporabe odgovornost su korisnika te obično ne smiju biti duži od 24 sata na 2 do 8°C, osim ako su rekonstitucija i razrjeđivanje provedeni u kontroliranim i validiranim aseptičkim uvjetima.
English: If you accidentally take more tablets than you should, tell a doctor or get other medical advice.
Croatian: Ako slučajno uzmete više tableta nego što ste trebali, obavijestite liječnika ili zatražite drugi medicinski savjet.
English: • Swollen, red, irritated veins
Croatian: • otečene, crvene, iritirane vene
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Potrebno je uzeti u obzir službene smjernice o ispravnoj primjeni antibakterijskih lijekova.
English: SX Via Morolense 5 03013 Ferentino (FR) Italy or
Croatian: SX Via Morolense 5 03013 Ferentino (FR) Italija ili
English: It is used to treat adults with serious short-term infections of the skin and tissues under the skin caused by certain bacteria when usual antibiotics cannot be used or have not worked.
Croatian: Koristi se za liječenje odraslih s ozbiljnim kratkotrajnim infekcijama kože i tkiva ispod kože uzrokovanih određenim bakterijama kada se uobičajeni antibiotici ne mogu primijeniti ili nisu djelovali.
English: Contents of the pack and other information What Quofenix contains
Croatian: Sadržaj pakiranja i druge informacije Što Quofenix sadrži
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije komplikacija rane
English: The patient should drink a sufficient amount of fluids while taking Quofenix.
Croatian: Bolesnik treba piti dovoljno tekućine dok uzima Quofenix.
English: • The vial should be vigorously shaken until contents are completely dissolved.
Croatian: • Bočicu treba dobro protresti dok se sadržaj u potpunosti ne otopi.
English: 10 single-dose vials
Croatian: 10 jednodoznih bočica
English: Therefore, concomitant use of corticosteroids should be avoided.
Croatian: Stoga se istodobnu primjenu kortikosteroida mora izbjegavati.
English: The tablets are swallowed whole with a sufficient amount of water, and can be taken with or without food.
Croatian: Tablete se gutaju cijele, s dovoljnom količinom vode, i mogu se uzimati sa ili bez hrane.
English: • Dizziness or loss of balance (vertigo)
Croatian: • omaglica ili gubitak ravnoteže (vrtoglavica)
English: Talk to your doctor or pharmacist before you stop taking your medicine.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego prestanete uzimati Vaš lijek.
English: • Feeling lightheaded or faint, usually because of a drop in blood pressure
Croatian: • osjećaj ošamućenosti ili nesvjestice, obično zbog pada krvnog tlaka
English: It works by blocking bacteria enzymes needed to copy and to repair their DNA.
Croatian: Djeluje tako da blokira enzime bakterija koji su potrebni za umnažanje i popravak njihove DNK.
English: • Worsening of a wound
Croatian: • pogoršanje rane
English: • You or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase.
Croatian: • ako znate da Vi ili član Vaše obitelji ima deficit glukoza-6-fosfat dehidrogenaze.
English: The pharmacokinetics of delafloxacin is not significantly altered with age; therefore, dose adjustment is not necessary based on age.
Croatian: Farmakokinetika delafloksacina nije se značajno mijenjala s dobi; prema tome, nije potrebno prilagođavanje doza na temelju dobi.
English: Contact your doctor straight away if you have diarrhoea during or after your treatment.
Croatian: Odmah obavijestite svog liječnika ako dobijete proljev za vrijeme ili nakon Vašeg liječenja.
English: • If you are allergic to delafloxacin or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na delafloksacin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • Night sweat
Croatian: • noćno znojenje
English: If superinfection occurs during therapy, appropriate measures should be taken.
Croatian: Ako se pojavi superinfekcija za vrijeme liječenja, potrebno je poduzeti odgovarajuće mjere.
English: Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Croatian: U epidemiološkim ispitivanjima prijavljen je povećan rizik od aneurizme i disekcije aorte nakon uzimanja fluorokinolona, posebno u starijoj populaciji.
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 starija osoba (stariji od 60 godina), presađen Vam je organ, imate tegobe s bubrezima ili se liječite kortikosteroidima.
English: By blocking these enzymes, Quofenix kills bacteria that cause the infection.
Croatian: Blokirajući te enzime, Quofenix ubija bakterije koje uzrokuju infekciju.
English: • You have a myasthenia gravis (a type of muscle weakness), because symptoms can become worse.
Croatian: • ako imate miasteniju gravis (vrstu mišićne slabosti), jer se simptomi mogu pogoršati.
English: Patheon Italia S.p.A. 2° Trav.
Croatian: Patheon Italia S.p.A.
English: - Abdominal (belly) pain with possible severe diarrhoea; fever and nausea.
Croatian: - Bol u abdomenu (trbuhu) s mogućim teškim proljevom; vrućica i mučnina.
English: • an antacid, multivitamin, or other product that has magnesium, aluminium, iron, or zinc
Croatian: • antacida, multivitamina ili drugog proizvoda koji sadrži magnezij, aluminij, željezo ili cink
English: Please, inform your doctor or nurse immediately if you get any of these symptoms, as the medicine should be stopped and you may need urgent medical attention:
Croatian: Odmah obavijestite Vašeg liječnika ili medicinsku sestru ako primijetite neki od ovih simptoma jer treba prekinuti primjenu lijeka i možda će Vam biti potrebna hitna medicinska pomoć:
English: • didanosine buffered tablets for oral suspension or the paediatric powder for oral solution
Croatian: • didanozina u obliku puferiranih tableta za oralnu suspenziju ili pedijatrijskog praška za oralnu otopinu
English: Treatment of overdose with delafloxacin should consist of observation and general supportive measures.
Croatian: Liječenje predoziranja delafloksacinom treba uključivati promatranje i opće potporne mjere.
English: No dose adjustment is recommended based on gender.
Croatian: Nije potrebno prilagođavanje doze na temelju spola.
English: Quofenix can make you feel dizzy and lightheaded.
Croatian: Quofenix može učiniti da osjećate omaglicu i ošamućenost.
English: However, Quofenix should not be given together with any solution containing substances such as calcium and magnesium, through the same intravenous line.
Croatian: Međutim, Quofenix se ne smije istodobno primjenjivati s bilo kojom otopinom koja sadrži tvari poput kalcija i magnezija, putem iste intravenske linije.
English: • Dry eye
Croatian: • suho oko
English: Other medicines and Quofenix
Croatian: Drugi lijekovi i Quofenix
English: Staphylococcus aureus Streptococcus pyogenes Streptococcus dysgalactiae Streptococcus agalactiae Streptococcus anginosus group Escherichia coli
Croatian: Staphylococcus aureus Streptococcus pyogenes Streptococcus dysgalactiae Streptococcus agalactiae Skupina Streptococcus anginosus Escherichia coli
English: • 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: The European Medicines Agency has waived the obligation to submit the results of studies with Quofenix in all subsets of the paediatric population in the treatment of local infections of skin and subcutaneous tissues (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Quofenix u svim skupinama pedijatrijske populacije za liječenje lokalnih infekcija kože i potkožnih tkiva (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Therefore, delafloxacin should be taken at least 2 hours before or 6 hours after these agents.
Croatian: Stoga, delafloksacin treba uzeti najmanje 2 sata prije ili 6 sati nakon tih preparata.
English: Serious bullous skin reactions
Croatian: Ozbiljne bulozne kožne reakcije
English: If you have diabetes, you should monitor your blood glucose levels carefully.
Croatian: Ako imate dijabetes potrebno je pažljivo nadzirati razinu glukoze u Vašoj krvi.
English: Quofenix is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1).
Croatian: Quofenix je indiciran za liječenje akutnih bakterijskih infekcija kože i kožnih struktura (engl. acute bacterial skin and skin structure infections, ABSSSI) u odraslih kad se upotreba drugih antibakterijskih lijekova koji se obično preporučuju za početno liječenje tih infekcija smatra neprikladnom (vidjeti dijelove 4.4 i 5.1).
English: Clostridioides difficile-associated disease
Croatian: Bolest povezana s Clostridioides difficile
English: Cross-resistance between delafloxacin and other fluoroquinolones may be observed, although some isolates resistant to other fluoroquinolone may retain susceptibility to delafloxacin.
Croatian: Može biti primijećena križna rezistencija između delafloksacina i drugih fluorokinolona, iako neki izolati koji su rezistentni na druge fluorokinolone mogu zadržati osjetljivost na delafloksacin.
English: Fluoroquinolone/quinolone antibacterial medicines 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: Fluorokinolonski/kinolonski antibiotici povezani su s vrlo rijetkim, ali ozbiljnim nuspojavama, od kojih su neke dugotrajne (traju mjesecima ili godinama), onesposobljavajuće ili potencijalno nepopravljive.
English: Delafloxacin tablets can be taken with or without food.
Croatian: Tablete delafloksacina mogu se uzimati sa ili bez hrane.
English: Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”.
Croatian: Nemojte upotrijebiti ovaj lijek nakon isteka roka valjanosti navedenog na kutiji ili blisteru iza oznake „EXP“.
English: Fluoroquinolones have been associated with an increased risk of central nervous system (CNS) reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) and toxic psychosis.
Croatian: Fluorokinoloni su bili povezani s povećanim rizikom od reakcija središnjeg živčanog sustava (CNS), uključujući: konvulzije i povišeni intrakranijalni tlak (uključujući pseudotumor cerebri) te toksičnu psihozu.
English: Delafloxacin inhibits bacterial topoisomerase IV and DNA gyrase (topoisomerase II), enzymes required for bacterial DNA replication, transcription, repair, and recombination.
Croatian: Delafloksacin inhibira bakterijsku topoizomerazu IV i DNK girazu (topoizomeraza II), enzime koji su potrebni za replikaciju, transkripciju, popravak i rekombinaciju bakterijske DNK.
English: • Abnormal hair loss
Croatian: • neuobičajen gubitak kose
English: Administration of oral delafloxacin in patients with severe renal impairment and low body weight may lead to increased systemic exposures.
Croatian: Primjena peroralnog delafloksacina u bolesnika s teškim oštećenjem bubrežne funkcije i niskom tjelesnom težinom može dovesti do povećane sistemske izloženosti.
English: Delafloxacin is a probable substrate of BCRP.
Croatian: Delafloksacin je vjerojatan supstrat BCRP-a.
English: • You are suffering from diarrhoea, or have previously suffered from diarrhoea while taking antibiotics or up to 2 months afterwards.
Croatian: • ako imate proljev, ili ste ranije imali proljev tijekom uzimanja antibiotika ili do 2 mjeseca nakon uzimanja.
English: Medicinal products inhibiting the peristalsis are contraindicated if Clostridioides difficile-associated disease is suspected.
Croatian: Lijekovi koji inhibiraju peristaltiku su kontraindicirani ako se sumnja na bolest povezanu s Clostridioides difficile.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 20 to 25ºC or at 2 to 8°C.
Croatian: Dokazana je kemijska i fizikalna stabilnost lijeka u primjeni tijekom 24 sata na 20 do 25ºC ili na 2 do 8°C.
English: Talk to your doctor if you have any concerns or questions about this and using Quofenix.
Croatian: Obratite se Vašem liječniku ako ste zabrinuti ili imate pitanja u vezi s tim i u vezi primjene lijeka Quofenix.
English: Quofenix has moderate influence on the ability to drive and use machines.
Croatian: Quofenix umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: What Quofenix is and what it is used for 2.
Croatian: Što je Quofenix i za što se koristi 2.
English: Tablets should be swallowed and can be taken with or without food.
Croatian: Tablete treba progutati i mogu se uzimati sa ili bez hrane.
English: Accumulation of the intravenous vehicle sulfobutylbetadex sodiumoccurs in patients with moderate to severe renal impairment; therefore serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to switch to Quofenix 450 mg tablet every 12 hours.
Croatian: Akumulacija intravenskog vehikuluma sulfobutilbetadeksnatrija pojavljuje se u bolesnika s umjerenim do teškim oštećenjem bubrežne funkcije; stoga treba pažljivo nadzirati razine kreatinina u serumu tih bolesnika te, porastu li, razmotriti prelazak na tabletu Quofenixa od 450 mg svakih 12 sati.
English: • Staphylococcus aureus (including methicillin-resistant [MRSA])
Croatian: • Staphylococcus aureus (uključujući meticilin rezistentni [MRSA])
English: Delafloxacin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk.
Croatian: Delafloksacin smiju uzimati samo oni bolesnici kod kojih je očekivana klinička korist veća od potencijalnog rizika.
English: However, no such effects and no other developmental abnormalities occurred in the progeny of mothers exposed up to a level about 2-fold higher than observed in humans.
Croatian: Međutim, ni takvi učinci niti drugi razvojni poremećaji nisu se pojavili u potomaka majki izloženih do razine oko 2 puta veće nego u ljudi.
English: The following adverse reactions have been identified in four comparative ABSSSI Phase 2 and 3 studies classified by preferred term and System Organ Class, and by frequency.
Croatian: Sljedeće nuspojave su zabilježene u četiri komparativna ispitivanja ABSSSI faze 2 i 3, klasificirane prema preporučenom izrazu i organskom sustavu, te prema učestalosti.
English: Organism
Croatian: Organizam
English: If Clostridioides difficile-associated disease is suspected or confirmed treatment with delafloxacin should be discontinued and appropriate supportive measures together with the specific antibacterial treatment of C. difficile should be considered.
Croatian: Ako se sumnja na bolest povezanu s Clostridioides difficile ili se ona potvrdi, potrebno je prekinuti primjenu delafloksacina i razmotriti prikladne potporne mjere uz specifično antibiotsko liječenje C. difficile.
English: Aortic dissection and aneurysm
Croatian: Disekcija aorte i aneurizma
English: • 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: As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported (see section 4.8), 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 (vidjeti dio 4.8), obično u bolesnika s dijabetesom koji su istodobno liječeni oralnim hipoglikemikom (npr. glibenklamidom) ili inzulinom.
English: After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 20 to 25ºC or at 2 to 8°C.
Croatian: Nakon rekonstitucije: Dokazana je kemijska i fizikalna stabilnost lijeka u primjeni tijekom 24 sata na 20 do 25ºC ili na 2 do 8°C.
English: From a microbiological point of view, the product should be used immediately after reconstitution and dilution.
Croatian: S mikrobiološkog stajališta lijek treba primijeniti odmah nakon rekonstitucije i razrjeđivanja.
English: The steady state volume of distribution of delafloxacin is about 40 L which approximates total body water.
Croatian: Volumen distribucije delafloksacina u stanju dinamičke ravnoteže je oko 40 l što približno odgovara ukupnom volumenu tjelesnih tekućina.
English: Patients under treatment with delafloxacin 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: Bolesnike koji se liječe delafloksacinom mora se savjetovati da prije nastavka liječenja obavijeste svog liječnika ako se pojave simptomi neuropatije kao što su bol, pečenje, trnci, utrnulost ili slabost kako bi se spriječio razvoj potencijalno ireverzibilnog stanja (vidjeti dio 4.8).
English: 10x1 tablets 20x1 tablets 30x1 tablets 50x1 tablets 60x1 tablets 100x1 tablets
Croatian: 10x1 tableta 20x1 tableta 30x1 tableta 50x1 tableta 60x1 tableta 100x1 tableta
English: • Swelling, redness or pain around the needle where the medicine is given into a vein (infusion site reaction)
Croatian: • oticanje, crvenilo ili bol oko igle kroz koju je lijek dan u venu (reakcija na mjestu infuzije)
English: • Irregular or rapid heart beats, feeling your heart beat (palpitation), decrease of heart beat
Croatian: • nepravilni ili brzi otkucaji srca, osjećaj lupanja srca (palpitacije), usporeni otkucaji srca
English: This is equivalent to 8.8% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 8,8% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.
Croatian: Vašeg liječnika ako imate probleme s bubrezima jer će možda biti potrebno prilagoditi
English: In the two major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only.
Croatian: U dva veća ispitivanja ABSSSI, vrste liječenih infekcija bile su ograničene samo na celulitis/erizipel, apscese i infekcije rana.
English: There are no available data concerning specific effects of other medicinal products on delafloxacin.
Croatian: Nema dostupnih podataka o specifičnim učincima drugih lijekova na delafloksacin.
English: What Quofenix looks like and contents of the pack
Croatian: Kako Quofenix izgleda i sadržaj pakiranja
English: Importantly, gastrointestinal effects and slightly elevated liver enzymes in dogs were not associated with histopathological changes of gastrointestinal and annexed tissues (pancreas, liver).
Croatian: Važno je to što gastrointestinalni učinci i blago povišeni jetreni enzimi u pasa nisu bili povezani s histopatološkim promjenama gastrointestinalnih i pridruženih tkiva (gušterača, jetra).
English: • Seasonal allergy
Croatian: • sezonska alergija
English: • Cloudy urine because of the presence of solid component
Croatian: • zamućena mokraća zbog prisustva čestica
English: In the absence of human data and findings in non-clinical studies at human therapeutic exposures, delafloxacin is contraindicated during pregnancy and in women of childbearing potential not using contraception (see sections 4.3 and 4.4).
Croatian: U nedostatku podataka za ljude i nedostatku nalaza iz nekliničkih ispitivanja pri terapijskoj izloženosti u ljudi, delafloksacin je kontraindiciran tijekom trudnoće i u žena u reproduktivnoj dobi koje ne koriste kontracepciju (vidjeti dijelove 4.3 i 4.4).
English: There are no data concerning an interaction of intravenous delafloxacin with multivitamins, other supplements or didanosine.
Croatian: Nema podataka o interakciji intravenskog delafloksacina s multivitaminima, drugim pripravcima ili didanozinom.
English: The effects of delafloxacin on fertility in humans have not been studied.
Croatian: Učinak delafloksacina na plodnost u ljudi nije ispitivan.
English: The plasma protein binding of delafloxacin is approximately 84%; it primarily binds to albumin.
Croatian: Vezanje delafloksacina na proteine plazme je približno 84%; primarno se veže na albumin.