FrancophonIA/ELRC3.0 huggingface dataset:
English: • Exacerbations of broncho-pulmonary infections in cystic fibrosis
Croatian: • Egzacerbacije bronhopulmonalnih infekcija u cističnoj fibrozi
English: In view of the above, the PRAC concluded that the benefit-risk balance of the following fluoroquinolone medicinal products, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin remains favourable subject to the agreed amendments to the product information and other risk minimisation measures.
Croatian: U pogledu prethodno navedenoga, PRAC je zaključio da omjer koristi i rizika sljedećih lijekova koji sadrže fluorokinolone, pefloksacin, lomefloksacin, ciprofloksacin, levofloksacin, ofloksacin, moksifloksacin, norfloksacin, prulifloksacin, rufloksacin ostaje pozitivan uz dogovorene izmjene informacija o lijeku i druge mjere za smanjenje rizika.
English: (Fluoro)quinolones have not been extensively studied for the treatment of acute bacterial meningitis and therefore there is only sparse data available regarding the use of pefloxacin in patients with meningitis that do not allow establishing efficacy.
Croatian: Indikacija meningitisa odobrena je u EU-u jedino za pefloksacin. (Fluoro)kinoloni nisu bili opsežno ispitivani u pogledu liječenja akutnog bakterijskog meningitisa pa je dostupno malo podataka o primjeni pefloksacina u bolesnika s meningitisom koji ne omogućavaju da se ustanovi djelotvornost.
English: Malignant otitis externa (MOE), also known as necrotizing otitis externa, is a severe invasive bacterial infection that involves the external auditory canal and skull base.
Croatian: Maligna upala vanjskog uha, poznata i pod nazivom nekrotizirajuća upala vanjskog uha, teška je invazivna bakterijska infekcija koja uključuje vanjski dio zvukovoda i bazu lubanje.
English: Apart from that, same resistance patterns to pefloxacin are shared with other quinolones making pefloxacin not suitable for the use in peri-procedural prophylaxis.
Croatian: Osim toga, obrazac rezistencije na pefloksacin jednak je onome drugih kinolona, zbog čega pefloksacin nije pogodan za primjenu u periproceduralnoj profilaksi.
English: The use of (fluoro)quinolones is not warranted in mild to moderate episodes with alternative treatment options.
Croatian: Primjena (fluoro)kinolona nije potrebna u blagim do umjerenim epizodama za koje postoje zamjenske mogućnosti liječenja.
English: • Prevention of systemic urinary tract infections
Croatian: • Prevencija sistemskih infekcija urinarnog trakta
English: Ear, nose and throat infections Skin and soft tissue infections Genital tract infections
Croatian: Infekcije uha, nosa i grla Infekcije kože i mekog tkiva Infekcije genitalnog sustava
English: For lifting the suspension, the PRAC recommended that the MAH should submit the appropriate scientific evidence to demonstrate a positive benefit-risk of the medicinal product in any indication.
Croatian: Da bi se uklonila obustava, PRAC je preporučio da nositelj odobrenja mora dostaviti odgovarajuće znanstvene dokaze koji će dokazati pozitivan omjer koristi i rizika lijeka u svakoj indikaciji.
English: • Prophylaxis of systemic urinary tract infections Prevention of infection in surgical procedures
Croatian: • Profilaksa sistemskih infekcija urinarnog trakta Prevencija infekcije kod kirurških postupaka
English: Considering potential insufficient coverage of pathogens responsible for meningitis by pefloxacin and risks associated with inappropriate treatment of meningitis, the overall benefit-risk balance of this indication is considered negative and therefore should be deleted.
Croatian: Budući da pefloksacin potencijalno nedovoljno pokriva patogene odgovorne za meningitis i rizike povezane s neodgovarajućim liječenjem meningitisa, ukupni omjer koristi i rizika za ovu indikaciju smatra se negativnim te je indikaciju potrebno izbrisati.
English: Based on the efficacy data, current treatment guideline, known risks related to the use of (fluoro)quinolones including disabling ADRs the PRAC considered that benefit-risk balance of (fluoro)quinolones in vaginitis is negative.
Croatian: Na temelju podataka o djelotvornosti, sadašnjih smjernica za liječenje, poznatih rizika povezanih s primjenom (fluoro)kinolona uključujući onesposobljujuće nuspojave, PRAC smatra da je omjer koristi i rizika od primjene (fluoro)kinolona kod vaginitisa negativan.
English: • The PRAC concluded that some of the serious adverse drug reactions associated with the use of quinolones and fluoroquinolones could very rarely be long-lasting, disabling and potentially irreversible and that these risks are a class effect.
Croatian: • PRAC je zaključio da neke ozbiljne nuspojave povezane s primjenom kinolona i fluorokinolona mogu vrlo rijetko biti dugotrajne, onesposobljujuće i potencijalno ireverzibilne te da su ti rizici učinci skupine lijekova.
English: Therefore in view of the risk related to the use of (fluoro)quinolones, including the risk of long-lasting, disabling or potentially permanent ADRs, the overall benefit-risk balance in the indication of otitis media (acute) has changed and should be only used in patients who have no alternative treatment option.
Croatian: Stoga se u pogledu rizika povezanog s upotrebom (fluoro)kinolona, uključujući rizik od pojave dugotrajnih, onesposobljujućih i potencijalno trajnih ozbiljnih nuspojava, ukupni omjer koristi i rizika u indikaciji upale srednjeg uha (akutne) promijenio i smije se primjenjivati samo u bolesnika kod kojih ne postoji zamjenska mogućnost liječenja.
English: Taking into consideration the risk of long-lasting, disabling and potentially irreversible ADRs the benefit-risk balance of (fluoro)quinolones in the indication of prevention of exacerbations in women with recurring urinary tract infection is considered negative.
Croatian: Uzimajući u obzir rizik od dugotrajnih, onesposobljujućih i potencijalno ireverzibilnih nuspojava, omjer koristi i rizika (fluoro)kinolona u indikaciji prevencije egzacerbacija u žena s rekurentnom infekcijom urinarnog trakta smatra se negativnim.
English: Preoperative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone
Croatian: Predoperativne pripreme za kroničnu upalu srednjeg uha s kolesteatomom i kronični otitis koji se širi na kost
English: • The PRAC considered the totality of the data submitted for quinolones and fluoroquinolones medicinal products with regard to long-lasting, disabling and potentially irreversible ADRs.
Croatian: • PRAC je razmotrio ukupne podatke dostavljene za lijekove koji sadrže kinolone i fluorokinolone u pogledu dugotrajnih, onesposobljujućih i potencijalno ireverzibilnih nuspojava.
English: Infections of kidney, urinary tract and genitals Urinary tract infection
Croatian: Infekcije bubrega, urinarnog trakta i genitalija Infekcija urinarnog trakta Respiratorne infekcije
English: In view of the above, the benefit-risk balance for this indication is considered negative.
Croatian: S obzirom na prethodno navedeno, omjer koristi i rizika u ovoj indikaciji smatra se negativnim.
English: Based on the increasing resistance of pathogenic microorganisms to (fluoro)quinolones, the association of (fluoro)quinolones with C. difficile-associated diarrhoea, their other well-known risks in addition to the risk of rare, nevertheless persistent and disabling ADRs, the benefit/risk balance of (fluoro)quinolones in the prophylaxis of travellers´ diarrhoea is considered negative.
Croatian: Na temelju sve veće rezistencije patogenih mikroorganizama na (fluoro)kinolone, povezanost (fluoro)kinolona s proljevom koji uzrokuje C. difficile, ostalih dobro poznatih rizika od njihove primjene osim rizika od rijetkih, ali ustrajnih i onesposobljujućih nuspojava, omjer koristi i rizika za (fluoro)kinolone u profilaksi putničkog proljeva smatra se negativnim.
English: Chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis
Croatian: Infekcije genitalnog trakta / ginekološke infekcije Kronične plućne infekcije zbog bakterije Pseudomonas aeruginosa u odraslih bolesnika s cističnom fibrozom
English: To lift the suspension the MAH should submit the appropriate scientific evidence to demonstrate a positive benefit-risk of the medicinal product.
Croatian: Da bi se ukinula obustava, nositelj odobrenja mora dostaviti odgovarajuće znanstvene dokaze koji će dokazati pozitivan omjer koristi i rizika lijeka.
English: Therefore, septicaemia is not acceptable as a stand-alone indication as per the Note for Guidance (CPMP/EWP/558/95 rev 2).
Croatian: Stoga, prema Napomeni sa smjernicama (CPMP/EWP/558/95 rev 2), septikemija nije prihvatljiva kao samostalna indikacija.
English: • Prophylaxis of frequently repeating infections of urinary tract infections
Croatian: • Profilaksa često ponavljajućih infekcija urinarnog trakta
English: Considering potential insufficient coverage of pathogens responsible for endocarditis by pefloxacin and risks associated with inappropriate treatment of endocarditis, the benefit-risk balance of this indication is considered negative.
Croatian: S obzirom na to da pefloksacin ne pokriva u dovoljnoj mjeri patogene odgovorne za endokarditis te rizike povezane s neodgovarajućim liječenjem endokarditisa, ukupni omjer koristi i rizika u ovoj indikaciji smatra se negativnim.
English: However, lack of symptoms relief and risk of complications (specifically pyelonephritis) have been found to be higher in non-antibiotic group.
Croatian: No, ustanovljeno je da je u skupini koja nije primala antibiotike ublažavanje simptoma bilo manje, a rizik od komplikacija veći (posebice pijelonefritisa).
English: • Acute bacterial sinusitis Acute otitis media
Croatian: • Akutni bakterijski sinusitis Akutna upala srednjeg uha
English: The PRAC also concluded that the benefit-risk balance of the following quinolone medicinal products, nalidixic acid, pipemidic acid, cinoxacin and flumequine is no longer favourable and should be suspended.
Croatian: PRAC je također zaključio da omjer koristi i rizika sljedećih lijekova koji sadrže kinolone, nalidiksičnu kiselinu, pipemidičnu kiselinu, cinoksacin i flumekin, više nije povoljan te je njihovu primjenu potrebno obustaviti.
English: To lift the suspension, the MAH should submit appropriate scientific evidence to demonstrate a positive benefit-risk balance of these medicinal products.
Croatian: Da bi se prekinula obustava, nositelj odobrenja mora dostaviti odgovarajuće znanstvene dokaze koji će dokazati pozitivan omjer koristi i rizika tih lijekova.
English: • Long term prophylaxis of recurrent urinary infections
Croatian: • Dugoročna profilaksa rekurentnih urinarnih infekcija
English: Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis Community acquired pneumonia
Croatian: Bronhopulmonalne infekcije kod cistične fibroze ili kod bronhoektazije
English: Taking into consideration the predominant viral aetiology of laryngitis, its mostly self-limiting nature, increasing resistance of common microorganisms to (fluoro)quinolones and the identified risk of occurrence of long-lasting, disabling and potentially irreversible adverse drug reactions, the benefit-risk balance of (fluoro)quinolone use in laryngitis is considered negative.
Croatian: Uzimajući u obzir prevladavajuću virusnu etiologiju laringitisa, njegovu samoograničavajuću narav, sve veću rezistenciju uobičajenih mikroorganizama na (fluoro)kinolone te identificirani rizik od pojave dugotrajnih, onesposobljujućih i potencijalno ireverzibilnih nuspojava, omjer koristi i rizika kod primjene (fluoro)kinolona u liječenju laringitisa smatra se negativnim.
English: Prophylaxis of travellers´ diarrhoea
Croatian: Profilaksa putničkog proljeva
English: • Acute exacerbation of chronic obstructive pulmonary disease including chronic bronchitis
Croatian: • Akutna egzacerbacija kronične opstruktivne plućne bolesti uključujući kronični bronhitis
English: Taking into consideration the frequently viral aetiology of acute bronchitis, its mostly self-limiting nature, increasing resistance of common microorganisms to (fluoro)quinolones and the potential risk of disabling ADRs, the benefit-risk balance of (fluoro)quinolone use in acute bronchitis is considered negative.
Croatian: Uzimajući u obzir čestu virusnu etiologiju akutnog bronhitisa, njegovu samoograničavajuću narav, sve veću rezistenciju uobičajenih mikroorganizama na (fluoro)kinolone te potencijalni rizik od pojave onesposobljujućih nuspojava, omjer koristi i rizika kod primjene (fluoro)kinolona u liječenju akutnog bronhitisa smatra se negativnim.
English: Nosocomial pneumonia External otitis
Croatian: Nozokomijalna pneumonija Upala vanjskog uha
English: In majority of cases, otitis externa is caused by bacterial infection (Dibb 1991; Rosenfeld et al. 2014), however, also other causative agents such as fungal infection or non-infectious dermatologic processes should be considered.
Croatian: 2014), međutim, u obzir je potrebno uzeti i druge uzročne agense kao što su gljivična infekcija ili neinfektivni dermatološki procesi.
English: • Malignant external otitis
Croatian: • Maligna upala vanjskog uha
English: For these indications, the recommendation for the deletion of the indication is based on the below:
Croatian: Za ove indikacije, preporuka o brisanju indikacije temelji se na sljedećem: Faringitis - tonzilitis
English: Bone and joint infections
Croatian: Infekcije kosti i zglobova
English: Prevention of exacerbations in women with recurring urinary tract infections (UTI)
Croatian: Prevencija egzacerbacija u žena s rekurentnim infekcijama urinarnog trakta
English: Mainly CRS is caused by the following pathogens: Streptococcus pneumoniae, Haemophilus influenza, Staphylococcus spp., Streptococcus pyogenes, Moraxella catarrhalis, Klebsiella pneumoniae, anaerobes, and Chlamydia spp.
Croatian: Kronični sinusitis uglavnom uzrokuju sljedeći patogeni: Streptococcus pneumoniae, Haemophilus influenza, Staphylococcus spp., Streptococcus pyogenes, Moraxella catarrhalis, Klebsiella pneumoniae, anaerobi i Chlamydia spp. Imajući u vidu slabu osjetljivost pneumokoka na pefloksacin te potencijalne rizike, PRAC je zaključio da primjenu pefloksacina za liječenje akutnih egzacerbacija kroničnog sinusitisa treba ograničiti na one bolesnike u kojih se primjena drugih antibakterijskih lijekova za liječenje tih infekcija (posljednja terapijska opcija) smatra neodgovarajućom.
English: The benefit-risk balance is therefore negative and the indication should be deleted.
Croatian: Stoga se omjer koristi i rizika smatra negativnim te je indikaciju potrebno izbrisati.
English: Having considered the above, the PRAC considered that the benefit-risk balance of (fluoro)quinolones in preoperative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone is negative.
Croatian: Na temelju prethodno opisanoga, PRAC smatra da je za upalu srednjeg uha s kolesteatomom i kronični otitis koji se proširio na kost, omjer koristi i rizika od primjene (fluoro)kinolona u predoperativnim pripremama negativan.
English: • The PRAC concluded that for patients with a serious infection that is susceptible to these antibiotics fluoroquinolones remain an important treatment option despite the very rare risk of long-lasting, disabling and potentially irreversible adverse reactions.
Croatian: • PRAC je zaključio da unatoč vrlo rijetkom riziku od dugotrajnih, onesposobljujućih i potencijalno ireverzibilnih nuspojava, fluorokinoloni ostaju važna terapijska opcija za bolesnike s ozbiljnom infekcijom koja je osjetljiva na te antibiotike.
English: The overall benefit-risk ratio for this indication for is therefore considered negative.
Croatian: Stoga se ukupni omjer koristi i rizika u ovoj indikaciji smatra negativnim.
English: • Prevention of traveller's diarrhoea Preoperative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone Septicaemia Selective decontamination of gastrointestinal tract in patients with compromised immune system Prevention of exacerbations in women with recurring urinary tract
Croatian: • Prevencija putničkog proljeva Predoperativne pripreme za kroničnu upalu srednjeg uha s kolesteatomom i kronični otitis koji se širi na kost Septikemija
English: Malignant external otitis
Croatian: Maligna upala vanjskog uha
English: Therefore, the benefit-risk in using pefloxacin in this indication is negative.
Croatian: Stoga je u ovoj indikaciji omjer koristi i rizika od primjene pefloksacina negativan.
English: Therefore, the benefit risk-balance of this indication is considered negative for pefloxacin.
Croatian: Stoga se u ovoj indikaciji omjer koristi i rizika od primjene pefloksacina smatra negativnim.
English: Acute exacerbation of chronic bronchitis (AECB) and COPD
Croatian: Akutna egzacerbacija kroničnog bronhitisa i KOPB
English: Septicaemia
Croatian: Septikemija
English: Respiratory infections
Croatian: Vaginalne infekcije
English: As for the cases of pharyngitis of bacterial aetiology, the most common pathogen causing bacterial acute pharyngitis is Streptococcus pyogenes.
Croatian: Kao i u slučajevima faringitisa bakterijske etiologije, najčešći patogen koji uzrokuje bakterijski akutni faringitis je Streptococcus pyogenes. (Fluoro)kinoloni ne pokrivaju u dovoljnoj mjeri spektar patogena koje se obično identificira u bolesnika s faringitisom i/ili tonzilitisom.
English: • Exacerbation of chronic obstructive pulmonary disease Acute bacterial sinusitis
Croatian: • Egzacerbacija kronične opstruktivne plućne bolesti
English: • Chronic sinusitis (CRS)
Croatian: • Kronični sinusitis
English: • Frequent, recurrent urinary infection prophylaxis
Croatian: • Profilaksa čestih, rekurentnih urinarnih infekcija
English: Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets
Croatian: 90 (3x30) tableta
English: Doses should be taken at the same time each day with a light meal.
Croatian: Doze lijeka treba uzimati svakog dana u isto vrijeme uz lagani obrok.
English: The full EPAR for Stivarga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Stivarga nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: All patients also received supportive care.
Croatian: Svi bolesnici također su primali potpornu skrb.
English: Stivarga is available as tablets (40 mg).
Croatian: Lijek Stivarga dostupan je u obliku tableta (40 mg).
English: What is Stivarga and what is it used for?
Croatian: Što je Stivarga i za što se koristi?
English: Treatment may need to be interrupted or stopped, or the dose reduced, if the patient experiences certain side effects.
Croatian: Liječenje će možda trebati prekinuti ili zaustaviti ili će biti potrebno smanjiti dozu ako kod bolesnika nastupe određene nuspojave.
English: What measures are being taken to ensure the safe and effective use of Stivarga?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Stivarga?
English: This is a summary of the European public assessment report (EPAR) for Stivarga.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni lijeka (EPAR) Stivarga.
English: • hepatocellular carcinoma (HCC, a cancer of the liver).
Croatian: • hepatocelularni karcinom (HCC, rak jetre).
English: Treatment should continue for as long as the patient benefits from treatment or until the side effects become too severe.
Croatian: Liječenje treba nastaviti sve dok bolesnik ima koristi od terapije ili dok nuspojave ne postanu preozbiljne.
English: Other information about Stivarga
Croatian: Ostale informacije o lijeku Stivarga
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stivarga on 26 August 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Stivarga u promet koje je vrijedi na prostoru Europske unije od 26. kolovoza 2013.
English: By blocking the action of these enzymes, Stivarga helps to stop the growth and spread of the cancer.
Croatian: Blokiranjem djelovanja tih enzima, lijek Stivarga pomaže u zaustavljanju rasta i širenja raka.
English: The most common side effects with Stivarga (which may affect more than 3 in 10 people) are pain, weakness, tiredness, loss of appetite and eating less, hand-foot syndrome (rash and numbness affecting the palms and soles), diarrhoea, infection and hypertension (high blood pressure).
Croatian: Najčešće nuspojave lijeka Stivarga (koje se mogu javiti u više od 3 na 10 osoba) su bolovi, slabost, umor, gubitak apetita i slabije uzimanje hrane, sindrom dlanova i stopala (osip i utrnulost dlanova i stopala), proljev, infekcije i hipertenzija (visok krvni tlak).
English: The most serious side effects are severe liver injury, bleeding, gastrointestinal perforation (development of a hole in the wall of the gut) and infection.
Croatian: Najozbiljnije nuspojave su teška oštećenja jetre, krvarenje, gastrointestinalna perforacija (stvaranje rupe u stijenci crijeva) i infekcije.
English: The Committee noted that in colorectal cancer the benefits in terms of extending patient survival were modest, but considered that they outweighed the risks in patients for whom there are no other remaining treatment options.
Croatian: Odbor je primijetio da su kod kolorektalnog karcinoma koristi u smislu produljenja preživljavanja bolesnika skromne, ali je zaključio da nadmašuju rizike u bolesnika kojima nije preostala druga mogućnost liječenja.
English: It is not intended to provide practical advice on how to use Stivarga.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Stivarga.
English: All patients also received supportive care, including pain medicines and treatment for infections.
Croatian: Svi bolesnici također su primali potpornu skrb, uključujući lijekove protiv bolova i terapiju za liječenje infekcija.
English: The European Medicines Agency decided that Stivarga's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Stivarga nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za njegovu primjenu u EU-u.
English: For colorectal cancer, these include chemotherapy based on medicines called fluoropyrimidines and treatment with other cancer medicines known as anti-VEGF and anti-EGFR therapies.
Croatian: Za liječenje kolorektalnog karcinoma, one uključuju kemoterapiju na temelju lijekova pod nazivom fluoropirimidini i liječenje drugim lijekovima za liječenje raka naziva anti-VEGF i anti-EGFR terapije.
English: This means that it blocks several enzymes that are important for the development of a blood supply to tumours and the growth and development of cancer cells.
Croatian: To znači da blokira nekoliko enzima koji su važni za razvoj opskrbe krvlju tumora te rast i razvoj stanica raka.
English: It is taken in 4-week treatment cycles at a recommended starting dose of 160 mg (4 tablets) once every day for three weeks, followed by a week without taking the medicine.
Croatian: Lijek se uzima u ciklusima liječenja u trajanju od četiri tjedna u preporučenoj početnoj dozi od 160 mg (četiri tablete) jednom dnevno tijekom tri tjedna,
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stivarga have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Stivarga nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Treatment with Stivarga must be prescribed by a doctor who is experienced in treating cancer.
Croatian: Liječenje lijekom Stivarga mora propisati liječnik s iskustvom u liječenju raka.
English: It is used on its own to treat the following cancers:
Croatian: Koristi se kao monoterapija za liječenje sljedećih karcinoma:
English: • colorectal cancer (cancer of the bowel and rectum) that has spread to other parts of the body;
Croatian: • kolorektalni karcinom (rak crijeva i rektuma) koji se proširio na ostale dijelove tijela;