FrancophonIA/ELRC3.0 huggingface dataset:
English: After review of the available data, mainly based on animal models (Giamarellou H et al. 1989), efficacy of pefloxacin cannot be established.
Croatian: Nakon pregleda dostupnih podataka, dobivenih većinom na životinjskim modelima (Giamarellou H i dr. 1989.), nije moguće ustanoviti djelotvornost pefloksacina.
English: Category 4: rewording of indications according to the current medical knowledge
Croatian: 4. kategorija: promjena teksta indikacije u skladu sa sadašnjim medicinskim saznanjima
English: Indication
Croatian: Indikacije
English: In the EU, the indication endocarditis is approved exclusively for pefloxacin.
Croatian: U EU-u indikacija endokarditisa odobrena je isključivo za pefloksacin.
English: Based on the available data, approximately 90% cases of pharyngitis and 70% cases of tonsillitis in adults and children are of viral origin (Zoorob et al 2012).
Croatian: Na temelju dostupnih podataka, približno 90 % slučajeva faringitisa i 70 % slučajeva tonzilitisa u odraslih i djece virusnog su podrijetla (Zoorob i dr., 2012.).
English: The recent study by Gágyor et al (2015) showed that two thirds of women with uncomplicated urinary tract infection treated with ibuprofen recovered without any antibiotics.
Croatian: Novije ispitivanje koje je proveo Gágyor i dr. (2015.) pokazalo je da se dvije trećine žena s nekompliciranom infekcijom urinarnog trakta koja je bila liječena ibuprofenom, oporavilo bez primjene antibiotika.
English: Furthermore, the terminology ‘Infection of cerebrospinal fluid' is considered by the PRAC to be incorrect from a medical perspective.
Croatian: Nadalje, PRAC smatra da je termin „infekcija cerebrospinalne tekućine” netočan iz medicinske perspektive.
English: Risk factors associated with appearance of the assessed ADRs remain one of the main uncertainties and further examination of the risk factors should be further explored.
Croatian: Čimbenici rizika povezani s pojavom procijenjenih nuspojava ostaju jedna od glavnih nesigurnosti pa je potrebno njihovo daljnje istraživanje.
English: Category 2: indications to be restricted
Croatian: 2. kategorija: indikacije koje treba ograničiti
English: Indeed, the PRAC could not identify any solid evidence on the efficacy of (fluoro)quinolone use in this indication.
Croatian: PRAC zapravo nije mogao ustanoviti nijedan čvrst dokaz o djelotvornosti primjene (fluoro)kinolona u toj indikaciji.
English: Indications in this category are amended (please refer to Annex III) as they are either:
Croatian: U ovoj kategoriji izmijenjen je tekst indikacija (pogledajte Prilog III.) jer su one:
English: It should be noted that pefloxacin has a poor antimicrobial activity against P. aeruginosa, thus, the benefit is very limited.
Croatian: Valja napomenuti da pefloksacin ima slabo antimikrobno djelovanje protiv P. aeruginosa, prema tome, korist je vrlo ograničena.
English: Indeed, due to their chemical structure and the related pharmacodynamic and pharmacokinetic profile (very narrow range of antibacterial activity, high minimal inhibitory concentrations) their benefit is limited based on the current available data.
Croatian: Zbog njihove kemijske strukture i s njom povezanog farmakodinamičkog i farmakokinetičkog profila (vrlo uzak raspon antibakterijskog djelovanja, visoke minimalne inhibitorne koncentracije), njihova je korist na temelju trenutačno dostupnih podataka ograničena.
English: While these ADRs are already included in the EU product information of quinolones and fluoroquinolones, the severity and persistence of these known ADRs has not yet been systematically evaluated in the EU.
Croatian: Iako su na području EU-a te nuspojave već uključene u informacije o lijekovima za kinolone i fluorokinolone, težina i ustrajnost tih poznatih nuspojava još nije sustavno procijenjena u EU-u.
English: Inappropriate use of (fluoro)quinolones is associated with rapidly increasing bacterial resistance to these agents (Committee on Infectious Diseases 2006; Murray and Baltimore 2007).
Croatian: Neodgovarajuća primjena (fluoro)kinolona povezana je s rezistencijom bakterija na te lijekove koja se brzo povećava (Committee on Infectious Diseases 2006; Murray and Baltimore 2007).
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for medicinal products containing substances related to quinolones and fluoroquinolones for systemic and inhaled use.
Croatian: • Odbor za procjenu rizika u području farmakovigilancije (PRAC) razmotrio je postupak u skladu s člankom 31. Direktive 2001/83/EZ pokrenut na temelju farmakovigilancijskih podataka za lijekove koji sadrže tvari povezane s kinolonima i fluorokinolonima za sistemsku primjenu i inhalaciju.
English: About 80% cases of rhinosinusitis occurring in clinical practice are of viral origin and only a negligible proportion of these cases (i.e. 0,5-2%) develop to bacterial infection (Gwaltney 1996).
Croatian: Oko 80 % slučajeva rinosinusitisa, koji se pojave u kliničkoj praksi, virusnog su podrijetla i tek zanemarivi udio tih slučajeva (tj. 0,5 - 2 %) razvije se u bakterijsku infekciju (Gwaltney 1996).
English: The later ones (starting with norfloxacin) possess an increasingly broader spectrum of activity; they are fluorinated at C-6 carbon of their basic ring structure, hence so-called fluoroquinolones.
Croatian: Kasnije tvari (počevši s norfloksacinom) imaju sve veći spektar djelovanja, fluorirane su na ugljiku C6 svoje osnovne prstenaste strukture te se zbog toga nazivaju fluorokinoloni.
English: Furthermore, activity of ofloxacin against relevant pathogens is too limited to justify use in nosocomial pneumonia.
Croatian: Nadalje, djelovanje ofloksacina protiv relevantnih patogena previše je ograničeno kako bi opravdalo primjenu u nozokomijalnoj pneumoniji.
English: Recurrent UTIs are common among young, healthy women, even though they generally have anatomically and physiologically normal urinary tracts (Hooton 2001).
Croatian: Rekurentne infekcije urinarnog trakta česte se među mladim, zdravim ženama čak i ako je u njih urinarni trakt anatomski i fiziološki normalan (Hooton 2001.).
English: The pathogens associated with pyelonephritis consists mainly of E. coli (75% to 95%), with occasional other species of Enterobacteriaceae, such as P. mirabilis and K. pneumoniae, and of Staphylococci.
Croatian: Patogeni povezani s pijelonefritisom uglavnom su E. coli (od 75 % do 95 %), povremeno druge vrste Enterobacteriaceae, kao što su P. mirabilis i K. pneumoniae te Staphylococci.
English: Therefore fluoroquinolones should be reserved as a last line treatment in patients where other therapeutic options are not effective or not tolerated.
Croatian: Stoga primjena fluorokinolona treba ostati sačuvana kao posljednja linija liječenja u bolesnika u kojih druge terapijske opcije nisu djelotvorne ili ih bolesnici ne podnose.
English: Based on the evaluation of available guidelines and position papers, the prophylaxis of travellers´ diarrhoea should be limited to high-risk short-term travellers only.
Croatian: Na temelju procjene dostupnih smjernica i programskih dokumenata, profilaksu putničkog proljeva treba ograničiti samo na putnike visokog rizika na kratkotrajnim putovanjima.
English: In these infections complicated course as well as high level of the resistant pathogens should be expected.
Croatian: Kod tih infekcija potrebno je očekivati komplicirani tijek i visoku razinu rezistentnih patogena.
English: (1) too broad and encompass too many medical entities in terms of the scientific evidence available for (fluoro)quinolone benefit/risk assessment, in view of the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) and in relation to the (sub) indications mentioned in categories 1, 2 or 3 above.
Croatian: (1) preopširne i obuhvaćaju previše medicinskih entiteta u smislu znanstvenih dokaza dostupnih za procjenu koristi i rizika od primjene (fluoro)kinolona, u pogledu smjernica za ocjenu lijekova indiciranih za liječenje bakterijskih infekcija (Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, CPMP/EWP/558/95 rev 2) te u odnosu na (pod)indikacije prethodno navedene u 1., 2. ili 3. kategoriji.
English: (Fluoro)quinolones are sometimes recommended in the initial treatment of serious and/or complicated cases of aerobic vaginitis (i.e. to control acute symptoms in severe cases such as staphylococcal or macular streptococcal vaginitis).
Croatian: (Fluoro)kinolone se katkad preporučuje za početno liječenje ozbiljnih i/ili kompliciranih slučajeva aerobnog vaginitisa (tj. za kontrolu akutnih simptoma u teškim slučajevima kao što su stafilokokni ili makularni streptokokni vaginitis).
English: Infectious laryngitis is mostly a self-limiting viral disease (caused by parainfluenza, rhinovirus, influenza and adenovirus) that does not respond to antibiotic therapy (Higgins, 1974).
Croatian: Infektivni laringitis većinom je samoograničavajuća virusna bolest (uzrokovana parainfluencom, rinovirusom, gripom i adenovirusom) koja ne reagira na terapiju antibioticima (Higgins, 1974.).
English: Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catharralis were isolated from sputum samples in up to 45% of patients with acute bronchitis (Macfarlane et al. 1993) but their role is difficult to distinguish because of potential oropharyngeal colonization in healthy individuals (Laurenzi et al. 1961; Smith and Lockwood 1986).
Croatian: Streptococcus pneumoniae, Haemophilus influenzae i Moraxella catharralis izolirane su iz uzoraka sputuma u do 45 % bolesnika s akutnim bronhitisom (Macfarlane i dr. 1993), ali je njihovu ulogu teško razlikovati zbog potencijalne orofaringealne kolonizacije u zdravih osoba (Laurenzi i dr. 1961.; Smith i Lockwood 1986.).
English: The agent used for peri-procedural prophylaxis should ideally not be one that may be required for treatment of infections.
Croatian: Lijek primijenjen za periproceduralnu profilaksu u najboljem slučaju ne smije biti onaj koji bi mogao biti potreban za liječenje infekcije.
English: While the efficacy of topical antibacterial therapy was confirmed in clinical trials, the use of systemic therapy is questionable (Freedman 1978; Yelland 1993; Cannon 1970) and should be limited to persistent otitis externa or local or systemic spread of the infection (Sander 2001).
Croatian: Iako je djelotvornost topikalne antibakterijske terapije potvrđena u kliničkim ispitivanjima, primjena sistemske terapije ostaje upitna (Freedman 1978; Yelland 1993; Cannon 1970) i treba je ograničiti na perzistentnu upalu vanjskog uha ili sistemsko širenje infekcije (Sander 2001).
English: In addition, pefloxacin has low urinary excretion (34% of pefloxacin dose including its active metabolite norfloxacin) (Naber 2001).
Croatian: Osim toga, pefloksacin se slabo izlučuje u mokraći (34 % doze pefloksacina, uključujući njegov aktivni metabolit norfloksacin) (Naber 2001).
English: Furthermore, for pefloxacin PRAC considered that some of the indications mentioned above in Table 1 should be removed as below:
Croatian: Nadalje, za pefloksacin PRAC smatra da neke od indikacija navedene u tablici 1 treba ukloniti kako slijedi:
English: Reviewed European guidelines do not discuss an option of non-antibacterial therapy of urinary tract infections.
Croatian: Pregledane europske smjernice ne razmatraju mogućnost liječenja infekcija urinarnog trakta terapijom koja nije antibakterijska.
English: Antimicrobial prophylaxis can be given only after counselling and behavioural modification has been attempted and when nonantimicrobial measures have been unsuccessful.
Croatian: Antimikrobna profilaksa može se dati samo nakon pokušaja savjetovanja i promjena u ponašanju te kad nisu bile uspješne mjere koje ne uključuju primjenu antimikrobnih lijekova.
English: Fluoroquinolones and quinolones (hereinafter ‘(fluoro)quinolones') are a class of synthetic antibacterial agents that have been used in clinical practice since 1961.
Croatian: Fluorokinoloni i kinoloni (dalje u tekstu „(fluoro)kinoloni” skupina su sintetskih antibakterijskih lijekova koji se u kliničkoj praksi upotrebljavaju od 1961.
English: Septicaemia is a severe and life-threatening disease associated with high mortality.
Croatian: Septikemija je teška i životno opasna bolest povezana s visokom smrtnošću.
English: Boader-spectrum antibiotics should not be used for peri-procedural prophylaxis or only cautiously in very selective cases (The 2015 European Association of Urology (EAU) guidelines on Urological infections).
Croatian: Antibiotike šireg spektra ne smije se primjenjivati u profilaksi prije i poslije postupaka (periproceduralno) ili samo oprezno u vrlo selektivnim slučajevima (smjernice o urološkim infekcijama Europskog udruženja za urologiju (EAU), 2015).
English: Streptococcus species have only moderate sensitivity to pefloxacin, with MIC90 values ranging from 3.1 to 32 mg/L (Gonzalez JP, Henwood JM.
Croatian: Vrste Streptococcus imaju tek umjerenu osjetljivost na pefloksacin, pri čemu su vrijednosti MIK90 u rasponu od 3,1 do 32 mg/L (Gonzalez JP, Henwood JM.
English: Acute bronchitis
Croatian: Akutni bronhitis
English: Table 5 - Category 4 indications to be reworded according to accurate medical terms
Croatian: Tablica 5 - indikacije 4. kategorije čiji tekst treba promijeniti u skladu s točnim medicinskim pojmovima
English: These substances inhibit synthesis of bacterial DNA via binding to intracellular topoisomerase enzymes and forming drug-enzyme-DNA complexes.
Croatian: Te tvari inhibiraju sintezu bakterijske DNK putem vezivanja na unutarstanične enzime topoizomeraze i stvaranja kompleksa lijek-enzim-DNK.
English: Local antibiotics most suitable are preferably non-absorbed and broad spectrum, especially covering enteric gram-positive and gram-negative aerobes, like kanamycin.
Croatian: Najpogodniji lokalni antibiotici jesu oni širokog spektra, po mogućnosti neapsorbirajući, a osobito oni koji pokrivaju enterične gram-pozitivne i gram-negativne aerobne bakterije poput kanamicina.
English: Apart from that, the available data shows a poor antimicrobial activity of pefloxacin against Pseudomonas (King and Phillips 1986) and no updated susceptibility data on pefloxacin are available as the European Committee on Antimicrobial Susceptibility Testing (EUCAST) has not defined clinical breakpoints for pefloxacin (http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Rationale_documents/Ciproflo xacin_rationale_1.9.pdf).
Croatian: Osim toga, dostupni podatci pokazuju slabo antimikrobno djelovanje pefloksacina protiv Pseudomonasa (King and Phillips 1986) i nema ažuriranih podataka o osjetljivosti na pefloksacin jer Europski odbor za testiranje antimikrobne osjetljivosti (EUCAST) nije definirao kliničke granične vrijednosti za pefloksacin (http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Rationale_documents/Ciproflo xacin_rationale_1.9.pdf).
English: This included the responses submitted by the marketing authorisation holders in writing as well as the outcomes of consultations with the Infectious Disease Working Party.
Croatian: To uključuje i odgovore koje su napismeno dostavili nositelji odobrenja za stavljanje lijeka u promet i zaključke konzultacija s radnom skupinom za zarazne bolesti (Infectious Disease Working Party, IDWP).
English: Infective endocarditis is a severe and life-threatening disease associated with high mortality.
Croatian: Infektivni endokarditis teška je i životno opasna bolest povezana s visokom smrtnošću.
English: The therapy should be targeted to the primary infection taking into account PK/PD characteristics of the treatment and site of the infection.
Croatian: Terapiju treba usmjeriti na primarnu infekciju, uzimajući u obzir farmakokinetičke/farmakodinamičke karakteristike liječenja i mjesto infekcije.
English: ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Croatian: Akutni bakterijski rinosinusitis uglavnom je infekcija koja nije teška i povezana je s visokim stopama spontanog izlječenja (90 %).
English: AOM is regarded as a multifactorial and polymicrobial disease, which usually occurs as a complication of viral upper respiratory tract infection (Marom et al 2012).
Croatian: Akutna upala srednjeg uha smatra se multifaktorskom i polimikrobnom bolešću koja se obično razvije kao komplikacija virusne infekcije gornjih dišnih putova (Marom et al 2012).
English: The benefit of systemic antibiotic prophylaxis in general in the clean-contaminated ear surgery is currently not sufficiently substantiated and the benefit over topical antibiotics is not proven.
Croatian: Kod čistih-kontaminiranih kirurških zahvata na uhu, korist od sistemske antibiotske profilakse općenito nije trenutačno dovoljno potvrđena i korist u odnosu na topikalne antibiotike nije dokazana.
English: Being one of the most common paediatric diseases, AOM with its spontaneous cure rate above 80% might be considered as a non-serious and inmost cases self-limited infection.
Croatian: Kao jedna od najčešćih pedijatrijskih bolesti, akutna upala srednjeg uha sa stopom spontanog izlječenja većom od 80 % može se smatrati infekcijom koja nije ozbiljna i u većini je slučajeva samoograničavajuća.
English: It is considered that uncomplicated cystitis constitutes a non-severe, non-life-threatening indication for which the potential risk outweighs the benefit when using (fluoro)quinolones as first line treatment.
Croatian: Smatra se da nekomplicirani cistitis predstavlja indikaciju koja nije teška i ne ugrožava život, a za koju potencijalni rizik nadmašuje korist kada se (fluoro)kinoloni koriste kao prva linija liječenja.
English: The research should focus on current gaps and uncertainties in knowledge, including but not exclusive to, risk factors associated with these specific ADRs, treatments for the ADRs, identification of possible biomarkers to predict these ADRs and underlying mechanisms of action that could lead to the respective reactions.
Croatian: Istraživanje se treba usredotočiti na postojeće praznine i neizvjesnosti u spoznajama, uključujući između ostalog čimbenike rizika povezane s tim specifičnim nuspojavama, identifikaciju mogućih bioloških markera kako bi se predvidjele te nuspojave i osnovne mehanizme djelovanja koji mogu dovesti do takvih reakcija.
English: In case of atypical sexually transmitted pathogens, such as Mycoplasma hominis and Chlamydia trachomatis or Ureaplasma urealyticum, pefloxacin antimicrobial activity is low (Gonzales and Henwood 1989).
Croatian: U slučaju atipičnih spolno prenosivih patogena, kao što su Mycoplasma hominis i Chlamydia trachomatis ili Ureaplasma urealyticum, pefloksacin ima malo antimikrobno djelovanje (Gonzales i Henwood 1989.).
English: Acute bacterial rhinosinusitis (ABS)
Croatian: Akutni bakterijski rinosinusitis (ABR)
English: • Category 2: The newly identified safety concern necessitates a restriction of (fluoro)quinolone use in these indications.
Croatian: • 2. kategorija: Novoidentificirano sigurnosno pitanje zahtijeva ograničenje primjene (fluoro)kinolona u tim indikacijama.
English: Rhinosinusitis is a group of disorders characterized by inflammation of the mucosa of the nose and the paranasal sinuses.
Croatian: Rinosinusitis skupina je poremećaja koju karakterizira upala sluznice nosa i paranazalnih sinusa.
English: Therefore, the risks outweigh the benefits in this indication and the indication should be deleted.
Croatian: Stoga rizici nadmašuju koristi u ovoj indikaciji i tu indikaciju valja izbrisati.
English: The earliest substances of this class (starting with nalidixic acid) are non-fluorinated, possess only a narrow spectrum of activity against Gram-negative bacteria and have generally been replaced in clinical practices by more recent antibiotics.
Croatian: Prve tvari iz te skupine (počevši s nalidiksičnom kiselinom) nisu fluorirane, imaju uski spektar djelovanja protiv gram-negativnih bakterija i u kliničkoj praksi uglavnom su zamijenjene novijim antibioticima.
English: For the indications falling within this category 1, the PRAC considered that their benefit overweighs the risks, in particular the identified risk of occurrence of long-lasting, disabling and potentially irreversible adverse drug reactions.
Croatian: Za indikacije koje spadaju u ovu 1. kategoriju, PRAC smatra da njihova korist nadmašuje rizike, a posebno identificirani rizik od pojave dugotrajnih, onesposobljujućih i potencijalno ireverzibilnih nuspojava lijeka.
English: Prophylaxis of invasive infections due to Neisseria meningitidis Inhalation anthrax (post-exposure prophylaxis and curative treatment) Infection in immunocompromised patients
Croatian: Profilaksa invazivnih infekcija zbog bakterije Neisseria meningitidis Inhalacija antraksa (profilaksa poslije izlaganja i kurativno liječenje) Infekcija u imunokompromitiranih bolesnika
English: The poor pefloxacin antimicrobial activity against indication specific pathogen precludes its use in this indication as there is a high risk of inadequate coverage and resistance development.
Croatian: Zbog slabog antimikrobnog djelovanja pefloksacina protiv patogena specifičnog za ovu indikaciju, njegova se primjena u ovoj indikaciji isključuje jer postoji visoki rizik od neodgovarajuće pokrivenosti i razvoja rezistencije.
English: Table 1 - Category 1 indications: no modification of the indications
Croatian: Tablica 1 - Indikacije 1. kategorije: nema promjene indikacija
English: • Intra-abdominal infections
Croatian: • Intraabdominalne infekcije
English: • Category 3: The newly identified safety concern changes benefit risk to negative and these indications shall be deleted.
Croatian: • 3. kategorija: Novoidentificirano sigurnosno pitanje mijenja omjer koristi i rizika u negativan i te će se indikacije izbrisati.
English: Pefloxacin antimicrobial activity against bacterial strains relevant for this indication is low (Hoogkamp-Korstanje 1997).
Croatian: Protiv sojeva bakterija relevantnih za ovu indikaciju antimikrobno je djelovanje pefloksacina slabo (Hoogkamp-Korstanje 1997).
English: Group B streptococci (GBS), Escherichia coli, Staphylococcus aureus and Enterococcus faecalis are the organisms most frequently associated with Aerobic Vagnitis (Rampersaud et al 2012).
Croatian: Organizmi streptococci skupine B, Escherichia coli, Staphylococcus aureus i Enterococcus faecalis najčešće su povezani s aerobnim vaginitisom (Rampersaud i dr., 2012.).
English: Indication heading Complicated urinary tract infections/pyelonephritis
Croatian: Naziv indikacije Komplicirane infekcije urinarnog trakta/pijelonefritis
English: Selective decontamination of gastrointestinal tract in patients with compromised immune system
Croatian: Selektivna dekontaminacija gastrointestinalnog trakta u bolesnika s kompromitiranim imunološkim sustavom
English: Prostatitis, epididymo-orchitis
Croatian: Prostatitis, epididimoorhitis
English: The benefit-risk balance remains positive and its incremental change does not warrant any amendment to the indication.
Croatian: Omjer koristi i rizika ostaje pozitivan i njegova mala promjena ne zahtijeva izmjenu indikacije.
English: Considering the limited benefit and in view of the overall risk related to the use of these medicinal products including the risk of long-lasting, disabling and potentially irreversible reactions, the benefit-risk balance of these medicinal products is negative.
Croatian: Imajući u vidu ograničenu korist te s obzirom na ukupni rizik povezan s primjenom tih lijekova uključujući rizik od dugotrajnih, onesposobljujućih i potencijalno ireverzibilnih reakcija, omjer koristi i rizika tih lijekova je negativan.
English: However, for pefloxacin PRAC considered that some of the indications mentioned above in Table 1 should be restricted as below:
Croatian: Međutim, PRAC smatra da za pefloksacin treba neke od indikacija navedene u tablici 1 ograničiti kako slijedi:
English: Indication heading
Croatian: Naziv indikacije
English: Acute otitis externa is a cellulitis of the ear canal skin and sub-dermis, with acute inflammation and variable oedema.
Croatian: Akutna upala vanjskog uha je celulitis kože ušnog kanala i sloja ispod kože, uz akutnu upalu i varijabilni edem.