FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe infections and mixed infections with Gram-positive and anaerobic pathogens Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens.
Slovenian: Hude okužbe in mešane okužbe s po Gramu pozitivnimi in anaerobnimi patogeni Ciprofloksacin ni primeren kot monoterapija za zdravljenje hudih okužb in okužb, ki jih povzročajo po Gramu pozitivni ali anaerobni patogeni.
English: • theophylline (for breathing problems)
Slovenian: − teofilin (za lajšanje težav pri dihanju)
English: In patients with impaired liver function no dose adjustment is required.
Slovenian: Bolnikom z okvarjenim delovanjem jeter odmerkov ni treba prilagajati.
English: Posology for the treatment of uncomplicated cystitis The CHMP asked the applicant/MAH to provide reassurance that a 100 mg BID dose for 3 days (currently validated in some EU countries) is adequate for treating uncomplicated cystitis in young women with regards to the epidemiological figure pertaining to the bacteria potentially involved and with regards to the treatment response as compared to the proposed higher dose of 250 mg- 500 mg BID.
Slovenian: CHMP je predlagatelja/imetnika dovoljenja za promet z zdravilom zaprosil naj zagotovi potrditev, da je odmerek 100 mg BID v treh dneh (trenutno odobreno v nekaterih državah članicah EU) ustrezen za zdravljenje nezapletenih cist pri mladih ženskah, upoštevajoč epidemiološko sliko o bakterijah, ki so potencialno vpletene in odziv na zdravljenje v primerjavi s predlaganim večjim odmerkom 250 mg500 mg BID.
English: Breakpoints separate susceptible strains from strains with intermediate susceptibility and the latter from resistant strains:
Slovenian: Mejne vrednosti ločujejo občutljive seve od sevov z vmesno občutljivostjo in nato od odpornih sevov:
English: 08970 Sant Joan Despí Barcelona
Slovenian: Av. Baix Llobregat, 3-5 08970 Sant Joan Despí Barcelona
English: Some medicines reduce the effect of Ciprofloxacin Bayer.
Slovenian: Nekatera zdravila zmanjšajo učinek zdravila Ciprofloksacin Bayer.
English: 7 to 21 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)
Slovenian: 7 do 21 dni, v posebnih primerih je lahko podaljšano za več kot 21 dni (npr. absces)
English: Impermeability and/or active substance efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance.
Slovenian: Neprepustnosti in/ali mehanizmi odpornosti, kjer gre za prenos zdravilne učinkovine iz celice z membransko črpalko, vplivata na različno občutljivost za fluorokinolone, kar je odvisno od fizikalnokemijskih lastnosti različnih zdravilnih učinkovin znotraj skupine ter afinitete do transportnih sistemov vsake posamezne zdravilne učinkovine.
English: After a careful review of the data submitted the CHMP considered that the therapeutic indication of ciprofloxacin in prophylaxis of invasive infections due to Neisseria meningitidis in adults was well substantiated by publications and corresponded to the current practice.
Slovenian: Po natančnem pregledu predloženih podatkov je CHMP menil, da je terapevtska indikacija ciprofloksacina za profilakso invazivnih okužb z bakterijo Neisseria meningitidis pri odraslih ustrezno utemeljena z objavami in skladna s trenutno prakso.
English: - exacerbations of chronic obstructive pulmonary disease
Slovenian: - eksacerbacije kronične obstruktivne pljučne bolezni
English: Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including pain, burning, tingling, numbness, and/or weakness in order to prevent the development of an irreversible condition (see section 4.8).
Slovenian: Zdravljenje s ciprofloksacinom je treba prekiniti pri bolnikih s simptomi nevropatije, ki vključuje bolečino, žarenje, ščemenje, odrevenelost in/ali oslabelost; da bi preprečili nastanek ireverzibilnega stanja (glejte poglavje 4.8).
English: Treatment of infections caused by Bacillus Anthracis The CHMP asked the Applicant/MAH to provide an updated review of the non clinical data (including animal data) and on the clinical experience gained up to now in the use of ciprofloxacin in inhalation anthrax.
Slovenian: Zdravljenje okužb povzročenih z bakterijo Bacillus Anthracis CHMP je od predlagatelja/imetnika dovoljenja za promet z zdravilom zahteval predložitev posodobljenih nekliničnih podatkov (vključno s podatki pri živalih) in podatkov o kliničnih izkušnjah, pridobljenih do sedaj o uporabi ciprofloksacina pri vdihavanju antraksa.
English: From the data submitted the CHMP considered that 500 mg bid could be used in the oral treatment of upper respiratory tract infections such as acute exacerbations of chronic sinusitis and chronic suppurative otitis media.
Slovenian: Na podlagi predloženih podatkov je CHMP menil, da bi 500 mg bid lahko bilo uporabljeno pri peroralnem zdravljenju okužb zgornjega dela dihal, kot so na primer akutne eksacerbacije kroničnega sinuzitisa in kronično supurativno vnetje srednjega ušesa (otitis media).
English: Therefore, the CHMP and the Applicant/MAH were in agreement with the proposal to adapt the national SPCs of Ciprofloxacin MR tablets in those European Member States where the product is approved, to the outcome of the referral procedure for the other Ciprofloxacin Bayer formulations by submitting adequate national variations.
Slovenian: CHMP in predlagatelj/imetnik dovoljenja za promet z zdravilom sta se tako strinjala s predlogom, da se nacionalni povzetki glavnih značilnosti zdravila v tistih državah članicah EU, ki so odobrile ciprofloksacin tablete s prirejenim sproščanjem, priredijo v skladu z rezultati tega napotitvenega postopka za druge farmacevtske oblike zdravila Ciprofloxacin Bayer s predložitvijo ustreznih nacionalnih različic.
English: Ventricular arrhythmia, QT prolongation, torsades de pointes *
Slovenian: Srčne bolezni tahikardija ventrikularne aritmije, podaljšanje intervala QT, torsade de pointes *
English: 2 to 4 weeks (acute)
Slovenian: 2 do 4 tedne (akutni)
English: Swallow the tablets with plenty of fluid.
Slovenian: Tablete pogoltnite cele, z dovolj tekočine.
English: Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).
Slovenian: Zdravljenje naj pričenjajo le zdravniki z izkušnjami pri zdravljenju cističnih fibroz in/ali hudih okužb pri otrocih in mladostnikih (glejte poglavji 4.4 in 5.1).
English: However, after extensive discussions, the CHMP considered that ciprofloxacin still remains a useful therapeutic option in uncomplicated cystitis.
Slovenian: Kljub temu pa je CHMP po obsežni razpravi menil, da je ciprofloksacin uporabna terapevtska možnost pri zdravljenju nezapletenih cist.
English: Reclose the large bottle properly according to the instructions on the cap and shake vigorously for about 15 seconds.
Slovenian: Zaprite stekleničko točno po navodilu na zaporki in močno stresajte približno 15 sekund.
English: Following concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively.
Slovenian: Po sedemdnevni sočasni uporabi ciprofloksacina v odmerku 250 mg so se zvečale serumske koncentracije klozapina in N-desmetilklozapina za 29 % oz. 31 %.
English: The occurrence of severe and persistent diarrhoea during or after treatment (including several weeks after treatment) may indicate an antibiotic-associated colitis (life-threatening with possible fatal outcome), requiring immediate treatment (see section 4.8).
Slovenian: Če se med zdravljenjem s ciprofloksacinom ali po njem (tudi več tednov po koncu zdravljenja) pojavi huda in trdovratna driska, so ti simptomi lahko povezani s kolitisom, ki nastane zaradi jemanja antibiotikov (življenjsko nevarno stanje z možnim smrtnim izidom), ki zahteva takojšnje zdravljenje (glejte poglavje 4.8).
English: If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin Bayer.
Slovenian: Če ste depresivni ali imate psihoze, se simptomi lahko poslabšajo med zdravljenjem z zdravilom Ciprofloksacin Bayer.
English: 6.6 Special precautions for disposal and other handling Since the infusion solution is photosensitive, the infusion bags should be removed from the box only immediately before use.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ker je raztopina za infundiranje občutljiva za svetlobo, je treba vreče z raztopino za infundiranje vzeti iz škatle tik pred uporabo.
English: The infusion solution can be infused either directly or after mixing with other compatible infusion solutions.
Slovenian: Raztopino za infundiranje se lahko infundira neposredno ali v dodatku z drugimi kompatibilnimi raztopinami za infundiranje.
English: Food and drink does not affect your treatment with Ciprofloxacin Bayer.
Slovenian: Hrana in pijača nimata vpliva na zdravljenje z zdravilom Ciprofloksacin Bayer.
English: After evaluating the data presented by the Applicant/MAH, the CHMP considered that the therapeutic indication related to the empiric ciprofloxacin treatment of Shigellosis or the traveller's diarrhoea was acceptable with the wording “infections of the gastro-intestinal tract (e.g. travellers' diarrhoea)” and restricted its use in “severe” cases in section 4.2, with the following schedule regimens:
Slovenian: Po ovrednotenju predloženih podatkov predlagatelja/imetnika dovoljenja za promet z zdravilom je CHMP menil, da je terapevtska indikacija v zvezi z empiričnim zdravljenjem šigeloze s ciprofloksacinom ali potovalne driske sprejemljiva z ubeseditvijo „okužbe prebavil (na primer potovalna driska)“ ter omejil uporabo na „hude“ primere v poglavju 4.2 z naslednjim načinom:
English: Ciprofloxacin has been shown to cause photosensitivity reactions.
Slovenian: Ciprofloksacin povzroča fotosenzitivnostne reakcije.
English: Indications approved for children and adolescents in most European countries include acute pulmonary exacerbations of patients with cystic fibrosis caused by Pseudomonas aeruginosa, complicated urinary tract infections, pyelonephritis, and post-exposure prophylaxis of inhalational anthrax.
Slovenian: Odobrene indikacije za otroke in mladostnike v večini evropskih držav vključujejo akutne pljučne eksacerbacije pri bolnikih s cistično fibrozo, povzročeno z Pseudomonas aeruginosa, zapletenimi infekcijami sečil, pielonefritisom in zaščito po izpostavljenosti zaradi vdihavanja antraksa.
English: Non-renal clearance of ciprofloxacin is mainly due to active trans-intestinal secretion and metabolism.
Slovenian: Neledvični očistek ciprofloksacina je v glavnem posledica njegovega aktivnega izločanja skozi črevesje in presnove.
English: After careful evaluation, the CHMP agreed with the Applicant/MAH to delete the dose regimen “100 mg bid for 3 days” allocated to the treatment of uncomplicated cystitis.
Slovenian: Po natančnem pregledu se je CHMP strinjal s predlagateljem/imetnikom dovoljenja za promet z zdravilom o izbrisu načina odmerjanja „100 mg bid v treh dneh“, določenega za zdravljenje nezapletenih cist.
English: This will depend on the type of infection you have and how bad it is.
Slovenian: To je odvisno od vrste in resnosti okužbe.
English: Not authorised
Slovenian: Ni registrirano
English: It is an often intractable bacterial infection of the ear, mastoid and skull base caused by Pseudomonas aeruginosa.
Slovenian: Pogoste trdovratne bakterijske okužbe ušesa, mastoida in baze lobanje, ki jih povzroča bakterija Pseudomonas aeruginosa.
English: If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin Bayer.
Slovenian: Če imate hudo okužbo ali okužbo, ki jo povzroča več vrst bakterij, boste mogoče hkrati z zdravilom Ciprofloksacin Bayer dobili še dodaten antibiotik.
English: Always use the measuring spoon provided.
Slovenian: Vedno uporabite merilno žličko.
English: Dose adjustments for patients with impaired renal function The CHMP reviewed the Applicant/MAH's initial proposal for dose adjustment in case of renal impairment and considered it incomplete and poorly substantiated.
Slovenian: Prilagoditev odmerkov bolnikom z oslabljenim delovanjem ledvic CHMP je preučil prvoten predlog predlagatelja/imetnika dovoljenja za promet z zdravilom glede prilagoditve odmerjanja v primeru oslabljenega delovanja ledvic in menil, da je predlog nepopoln in neustrezno utemeljen.
English: In a study in young beagle dogs, ciprofloxacin caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.
Slovenian: V študijah na mladih slednih psih, ki so dobivali ciprofloksacin v terapevtskih odmerkih, je le ta po dveh tednih zdravljenja povzročil hude spremembe v sklepih, ki so bile opazne tudi po 5 mesecih.
English: As it is not compulsory to specify the recommended antibiotic strategy in the wording of the therapeutic indication in the Marketing Authorisation, the CHMP recommended that the proposed 4.1 SPC wording “prophylaxis of invasive infections due to Neisseria meningitidis” remain, and accepted the adult posology: PO: 1 x 500 mg/d (single dose).
Slovenian: Ker v besedilu o terapevtskih indikacijah v dovoljenju za promet z zdravilom natančna opredelitev priporočene strategije z antibiotiki ni obvezna, je CHMP priporočil, da predlagano besedilo poglavja 4.1 povzetka glavnih značilnosti zdravila ostane nespremenjeno in sprejel odmerjanje pri odraslih: PO: 1 x 500 mg/d (enkraten odmerek).
English: Berkshire RG14 1JA United Kingdom Trading as: Bayer plc, Bayer Schering Pharma
Slovenian: Berkshire RG14 1JA Velika Britanija Ime družbe, ki trži: Bayer plc,
English: Shake vigorously each time before use for approximately 15 seconds.
Slovenian: Pred vsako uporabo jo močno stresajte približno 15 sekund!
English: The CHMP raised concerns on the potential uncontrolled use of ciprofloxacin in the empirical treatment of shigellosis or traveller's diarrhoea and questioned its effectiveness, especially in the mild form, pointing out the high risk of resistance induction.
Slovenian: Odbor za zdravila za uporabo v humani medicini je izrazil zadržke o možni nenadzorovani uporabi ciprofloksacina pri empiričnem zdravljenju šigeloze ali potovalne driske ter izpostavil vprašanje o učinkovitosti, zlasti pri zdravljenju zmernih oblik, ki lahko povzroči visoko tveganje nastanka odpornosti.
English: • have myasthenia gravis (a type of muscle weakness)
Slovenian: − imate miastenijo gravis (vrsta mišične oslabelosti)
English: During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection.
Slovenian: Med ali po zdravljenju s ciprofloksacinom se lahko izolirajo bakterije odporne na ciprofloksacin, z ali brez klinično izražene superinfekcije.
English: Ciprofloxacin Bayer should be checked visually prior to use.
Slovenian: ZdraviloCiprofloksacin Bayer je treba pred uporabo vizualno preveriti.
English: Apart from routine emergency measures, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria.
Slovenian: Poleg običajnih ukrepov nujne medicinske pomoči se priporoča nadzor ledvičnega delovanja, in če je potrebno za zaščito pred kristalurijo tudi nadzor pH in kislosti seča.
English: It was shown in a clinical study that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively.
Slovenian: V kliničnih študijah so ugotovili, da se zaradi sočasne uporabe ropinirola in ciprofloksacina, ki je srednje močni zaviralec izoencima CYP450 1A2, zvečata Cmax in AUC ropinirola za 60 % oz. 84 %.
English: However, the recommendation of the administration of 750 mg tid and 1g bid by oral route in severe infections (respiratory tract infections, bone and joint infections) was not supported by the data submitted and the CHMP considered that none of the proposed posologies could be included in the Marketing Authorisation.
Slovenian: Predloženi podatki niso utemeljili priporočila za uporabo 750 mg tid in 1 g bid na peroralen način pri hudih okužbah (okužbe dihal, kosti in sklepov) in CHMP je menil, da nobeno od predlaganih odmerjanj ne more biti vključeno v dovoljenje za promet z zdravilom.
English: Belgium BAYER SA-NV Avenue Louise 143
Slovenian: BAYER SA-NV Avenue Louise 143
English: The recommended dosage can be higher (750 mg bid) depending on the severity and the microorganism.
Slovenian: Predlagan odmerek je glede na okužbo in mikroorganizme lahko večji (750 mg bid).
English: Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.
Slovenian: Učinek je odvisen predvsem od razmerja med največjo serumsko koncentracijo (Cmax) in minimalno inhibitorno koncentracijo (MIK) ciprofloksacina proti bakterijam oziroma razmerja med področjem pod krivuljo (AUC) in MIK.
English: Package Leaflet and Labelling
Slovenian: Navodila za uporabo in označevanje
English: Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Slovenian: Zdravljenje s ciprofloksacinom lahko začne le zdravnik, ki ima izkušnje z zdravljenjem cistične fibroze/hudih okužb pri otrocih in mladostnikih.
English: Spectrum of antibacterial activity:
Slovenian: Spekter protibakterijske učinkovitosti
English: Pseudomonas aeruginosa* Pseudomonas fluorescens Serratia marcescens* Anaerobic micro-organisms Peptostreptococcus spp.
Slovenian: Pseudomonas aeruginosa* Pseudomonas fluorescens Serratia marcescens * anaerobni mikroorganizmi Peptostreptococcus spp.
English: Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
Slovenian: Ciprofloksacin je treba uporabljati v kombinaciji z drugimi antibakterijskimi zdravili, odvisno od mikrobioloških izvidov.
English: Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, ropinirole, tizanidine).
Slovenian: Ciprofloksacin zavira encimski sistem CYP1A2, kar lahko povzroči zvišanje serumskih koncentracij sočasno danih zdravil, ki se presnavljajo s pomočjo tega encima (npr. teofilin, klozapin, ropinirol, tizanidin).
English: Any calcium you take as part of a meal will not seriously affect uptake.
Slovenian: Kalcij, ki ga zaužijete kot del obroka, ne bo pomembno vplival na jemanje zdravila.
English: Treatment of some infections (e.g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.
Slovenian: Pri zdravljenju nekaterih okužb (npr. medenične vnetne bolezni, intraabdominalnih okužb, okužb pri bolnikih z nevtropenijo in okužbah kosti in sklepov) je lahko potrebno sočasno zdravljenje z drugimi ustreznimi antibakterijskimi zdravili, odvisno od povzročitelja.
English: If it becomes severe or persistent or you notice that your stool contains blood or mucus tell your doctor immediately.
Slovenian: Če je huda in trdovratna ali če v blatu opazite kri ali sluz, takoj obvestite svojega zdravnika.
English: Prophylaxis of invasive infections of adults due to Neisseria meningitides Ciprofloxacin is used in clinical practice in prophylaxis of invasive infections of adults due to Neisseria meningitidis when rifampicin is contra-indicated or after microbiologically documentation when Neisseria meningitidis is resistant to rifampicin, in line with some therapeutic guidelines.
Slovenian: Profilaksa invazivnih okužb pri odraslih zaradi bakterije Neisseria meningitides Ciprofloksacin se uporablja v klinični praksi, v profilaksi invazivnih okužb pri odraslih zaradi bakterije Neisseria meningitidis v primeru, kadar je rifampicin kontraindiciran ali po mikrobiološki dokumentaciji, ko je bakterija Neisseria meningitidis odporna na rifampicin v skladu z nekaterimi terapevtskimi smernicami.
English: The CHMP asked the applicant/MAH to provide a substantiated discussion on the use of ciprofloxacin in prophylaxis of invasive infections of adults, to harmonize the therapeutic management of patients.
Slovenian: CHMP je predlagatelja/imetnika dovoljenja za promet z zdravilom zaprosil, naj predloži ustrezno utemeljeno razpravo o uporabi ciprofloksacina za profilakso invazivnih okužb pri odraslih za uskladitev terapevtskega vodenja bolnikov.
English: The changes to the SPC have been taken into account in the amendments to the Package Leaflet and Labelling.
Slovenian: Spremembe v povzetku glavnih značilnosti zdravila so bile upoštevane tudi pri spremembah v navodilih za uporabo in označevanju.
English: Administering the infusion slowly helps prevent immediate side effects occurring.
Slovenian: Počasno infundiranje zmanjša nevarnost takojšnjih neželenih učinkov.
English: Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.
Slovenian: Bolniki, ki jemljejo ciprofloksacin morajo biti primerno hidrirani; izogibati se je treba preveliki alkalnosti seča.
English: • If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system.
Slovenian: − Če imate epilepsijo ali kakšne druge nevrološke motnje (npr. zmanjšana prekrvavitev možganov ali možganska kap), se lahko pojavijo neželeni učinki, ki so povezani z osrednjim živčnim sistemom.
English: Pour the granules completely into the large bottle with the suspension fluid.
Slovenian: Stresite zrnca v celoti v stekleničko s suspenzijo.
English: - the CHMP concluded that the Marketing Authorisation could be harmonised on the following indications for oral and intravenous formulations in children and adolescents:
Slovenian: - da je CHMP sklenil, da se dovoljenja za promet z zdravilom lahko uskladijo pri naslednjih indikacijah za peroralne in intravenozne pripravke pri otrocih in mladostnikih: