natgillin/translations-raw huggingface dataset:
To date, ciprofloxacin has been the fluoroquinolone that has been used most extensively in adolescents.
Do danes je ciprofloksacin fluorokinolon, ki je pri mladostnikih uporabljen v največjem obsegu.
The ready-to-use suspension is stable for 14 days when stored in a refrigerator or at ambient temperatures below 30°C.
Pripravljena suspenzija je stabilna 14 dni, če jo shranjujete pri temperaturi do 30 °C ali v hladilniku.
However, after careful deliberations, an agreement was reach to include a statement in section 4.1 to cover the possible resort of ciprofloxacin in severe infections with a cross reference in section 4.4 that details such situations.
Po preudarni razpravi je bil sklenjen dogovor o vključitvi izjave v poglavje 4.1, ki govori o možni uporabi ciprofloksacina pri hudih okužbah z navzkrižnim sklicevanjem na poglavje 4.4, kjer so takšne situacije podrobno opisane.
In addition, taking into account the large use of ciprofloxacin in post-marketing, no safety signal was identified with long-term use of ciprofloxacin in PSURs.
Poleg tega tudi v obširni uporabi ciprofloksacina po začetku trženja, v poročilih o varnosti zdravila niso bili opaženi nobeni varnostni znaki pri dolgotrajni uporabi ciprofloksacina.
Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture.
Izogibajte se nepotrebni telesni dejavnosti, ker se lahko zveča tveganje za raztrganje kite.
Renal clearance is between 180-300 mL/kg/h and the total body clearance is between 480-600 mL/kg/h.
Ledvični očistek je 180 - 300 ml/kg/h, celotni telesni očistek pa 480 - 600 ml/kg/h.
The extent of the cartilage damage varies according to age, species and dose; the damage can be reduced by taking the weight off the joints.
Obseg poškodbe hrustanca je različen in je odvisen od starosti, živalske vrste in odmerka; poškodba se lahko zmanjša z razbremenitvijo sklepa.
The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups.
Pogostnost pojava z zdravilom domnevno povezane artropatije čez čas v nobeni skupini ni bila statistično značilna.
The CHMP had concerns with regards to the therapeutic indication “single dose treatment of uncomplicated UTI”.
CHMP je izrazil zadržke glede terapevtske indikacije „zdravljenje nezapletenih okužb sečil z enkratnim odmerkom“.
With regards to the treatment of febrile patients with neutropenia, the CHMP considered that, despite the lack of robustness of the available data (limited number of patients included in these studies), the use of ciprofloxacin remained well admitted in the scientific community and had become part of the clinical practice.
Glede zdravljenja vročinskih bolnikov z nevtropenijo je CHMP menil, da je navkljub pomanjkanju celovitosti razpoložljivih podatkov (omejeno število bolnikov sodelujočih v študijah) uporaba ciprofloksacina v znanstveni skupnosti dobro sprejeta in je postala del klinične prakse.
Like a number of other quinolones, ciprofloxacin is phototoxic in animals at clinically relevant exposure levels.
Podobno kot drugi kinoloni, je ciprofloksacin fototoksičen za živali pri klinično pomembni izpostavljenosti.
They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended.
Uporabljajo se samo za vrste, pri katerih mejne vrednosti niso bile določene in se ne uporabljajo za vrste, pri katerih se test občutljivosti ne priporoča.
Serum Creatinine [µmol/L]
serumske vrednosti kreatinina [µmol/l]
The infusion solution can be infused either directly or after mixing with other compatible infusion solutions (see section 6.2).
Raztopino za infundiranje se lahko infundira neposredno ali v dodatku z drugimi kompatibilnimi raztopinami za infundiranje (glejte poglavje 6.2).
Avoid exposure to strong sunlight or artificial UV light such as sunbeds.
Izogibajte se izpostavljanju močni sončni ali umetni UV svetlobi (npr. solarij).
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
− metotreksat (za zdravljenje nekaterih vrst raka, luskavice, revmatoidnega artritisa)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CIPROFLOXACIN BAYER AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA CIPROFLOKSACIN BAYER IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Do not take Ciprofloxacin Bayer during breast feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.
Ne jemljite zdravila Ciprofloksacin Bayer med dojenjem, ker se ciprofloksacin izloča v materino mleko in je lahko škodljiv za vašega otroka.
The degree of cross-resistance between ciprofloxacin and other fluoroquinolones that results is variable.
Stopnja navzkrižne odpornosti med ciprofloksacinom in ostalimi fluorokinoloni je različna.
Referring to the lack of clinical data to support the use of ciprofloxacin in anthrax, the applicant/MAH proposed a statement in section 5.1.
V zvezi s pomanjkanjem kliničnih podatkov glede uporabe ciprofloksacina pri antraksu je predlagatelj/imetnik dovoljenja za promet z zdravilom predlagal izjavo v poglavju 5.1.
Staphylococci or Pseudomonas aeruginosa are the main bacteria involved in these infections and ciprofloxacin bacterial activity had to be taken into account regarding these targeted species.
Stafilokoki ali Pseudomonas aeruginosa so glavne bakterije, vključene v te okužbe in bakterijsko dejavnost ciprofloksacina v zvezi s temi bakterijami je potrebno upoštevati.
Haemophilus influenzae and Moraxella catarrhalis
Haemophilus influenzae in Moraxella catarrhalis
Take the prescribed amount of suspension by using the measuring spoon.
Jemljite predpisano količino suspenzije z merilno žličko.
Do not take medicines that stop or slow down bowel movements and contact your doctor.
Ne uporabljajte zdravil, ki zavirajo gibanje prebavil in se posvetujte z zdravnikom.
500 mg twice daily to 750 mg twice daily at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)
500 mg do 750 mg dvakrat na dan najmanj 10 dni, v posebnih primerih je lahko podaljšano za več kot 21 dni (npr. absces)
• Tell your doctor if you or a member of your family is known to have a deficiency in glucose-6phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin.
− Obvestite zdravnika, če imate vi ali katerikoli član vaše družine pomanjkanje glukoza-6fosfat dehidrogenaze (G6PD), ker obstaja ob jemanju ciprofloksacina tveganje za anemijo.
The proposed wording of the therapeutic indications was as follows: “Inhalation anthrax (post exposure prophylaxis and curative treatment)” for oral and IV pharmaceutical presentations.
Predlagano je bilo naslednje besedilo za terapevtske indikacije: „Vdihavanje antraksa (profilaksa po izpostavitvi in kurativno zdravljenje)“ za peroralno in IV farmacevtsko predstavitev.
- pneumonia
- pljučnica
After treatment has been completed, it should not be reused.
Ko je zdravljenje zaključeno, suspenzije ne smete ponovno uporabiti.
Glucose-6-phosphate dehydrogenase deficiency
Pomanjkanje glukoza-6-fosfat dehidrogenaze
After a long discussion, an agreement was achieved to using precautionary statements for downgrading the recommendation of the single dose regimen as compared to the 3-day regimen and by restricting this possible option to uncomplicated cystitis in pre-menopausal women.
Po dolgi razpravi je bil sprejet dogovor, da se s previdnostno izjavo ublaži priporočilo glede zdravljenja z uporabo enkratnega odmerka v primerjavi s tridnevnim načinom zdravljenja ter da se ta možnost zdravljenja omeji na zdravljenje nezapletenih cist pri ženskah v predmenopavznem obdobju.
In this case, potential occurrence of haemolysis should be monitored.
Ob tem je potrebno spremljati možnost pojava hemolize.
• tizanidine (for muscle spasticity in multiple sclerosis)
− tizanidin (za zdravljenje mišičnih krčev pri multipli sklerozi)
Withdrawn Indications
Izbrisane indikacije
Clinical trials have included children and adolescents aged 5-17 years.
V klinična preskušanja so bili vključeni otroci in mladostniki, v starosti od 5 do 17 let.
Always use the graduated measuring spoon to obtain the exact dose for administering the suspension.
Vedno je treba vzeti graduirano merilno žličko, da se doseže točen odmerek pri jemanju suspenzije.
In particular, the Applicant/MAH did not discuss its benefit-risk ratio in comparison to the other longer treatment duration (3 day treatment).
Predlagatelj/imetnik dovoljenja za promet z zdravilom prav tako ni obrazložil razmerja koristi/tveganje v primerjavi z drugim, daljšim načinom zdravljenja (tridnevno zdravljenje).
A glass of water may be taken after taking the dose.
Po odmerku zdravila lahko spijete kozarec vode.
Ciprofloxacin is approved for the treatment of uncomplicated and complicated infections caused by ciprofloxacinsusceptible bacteria and thus a broad variety of infections in adults.
Ciprofloksacin je odobren za zdravljenje nezapletenih in zapletenih okužb, povzročenih z bakterijami, dovzetnimi za ciprofloksacin in tako za obsežno raznovrstnost okužb pri odraslih.
Consequently, ciprofloxacin should be administered either 1-2 hours before or at least 4 hours after these preparations.
Ciprofloksacin je treba vzeti 1 do 2 uri pred uživanjem teh pripravkov ali vsaj 4 ure po njem.
Resistance mechanisms that inactivate other antibiotics such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may affect susceptibility to ciprofloxacin.
Mehanizmi odpornosti, ki inaktivirajo druge antibiotike npr. prepustne pregrade (običajno pri Pseudomonas aeruginosa) in membranske črpalke lahko vplivajo na občutljivost za ciprofloksacin.
The AUC values were 17.4 mg*h/L (range 11.8-32.0 mg*h/L) and 16.5 mg*h/L (range 11.0-23.8 mg*h/L) in the respective age groups.
Vrednosti AUC so bile 17,4 mg*h/l (med 11,8 in 32,0 mg*/l) oz. 16,5 mg*/l (med 11,0 in 23,8 mg*/l) glede na starostno skupino.
Epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae.
Epididimo-orhitis in medenično vnetno bolezen lahko povzroča za fluorokinolone odporna Neisseria gonorrhoeae.
BAYER HELLAS ΑΒΕΕ 18-20 Sorou Street 15125 Marousi , Athens, Greece
BAYER HELLAS ΑΒΕΕ 18-20 Sorou Street 15125 Marousi , Athens, Grčija
Consequently ciprofloxacin should be used only after microbiological documentation and empirical treatment was not recommended.
Iz tega izhaja, da naj se ciprofloksacin uporablja le po mikrobiološki dokumentaciji in kadar empirično zdravljenje ni priporočljivo.
• warfarin or other oral anti-coagulants (to thin the blood)
− varfarin ali katerikoli drugi peroralni antikoagulant (proti strjevanju krvi)
Patients on peritoneal dialysis
bolniki na peritonealni dializi
Clinical trials have included children and adolescents aged 1-17 years.
V klinična preskušanja so bili vključeni otroci in mladostniki, v starosti od 1 do 17 let.
The Applicant/MAH subsequently proposed to follow the same proposal for other diarrhoea indications, taking into account data supporting oral 500 mg bid daily dose and considering bioavailability purposes, the corresponding IV dosage should be 400 mg bid.
Predlagatelj/imetnik dovoljenja za promet z zdravilom je posledično predlagal upoštevanje enakega predloga za druge indikacije driske, upoštevajoč podatke, ki podpirajo peroralno uporabo 500 mg bid na dan in upoštevajoč biološko razpoložljivost, bi bil ustrezen IV odmerek 400 mg bid.
In most cases, ciprofloxacin should be administered in combination with another appropriate (beta-lactam) antibiotic.
V večini primerov se naj ciprofloksacin uporablja v kombinaciji z drugim, ustreznim (beta laktam) antibiotikom.
Dosing in children with impaired renal and/or hepatic function has not been studied.
Odmerjanja pri otrocih z okvarjenim delovanjem ledvic in/ali jeter niso proučevali.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
• clozapine (an antipsychotic)
− klozapin (antipsihotik)
Intravenous Dose [mg] See Usual Dosage.
intravenski odmerki [mg] glej običajno odmerjanje
Quinolones are known to trigger seizures or lower the seizure threshold.
Znano je, da kinoloni povzročajo krče in znižujejo prag zanje.
In studies supporting the use of oral ciprofloxacin in acute exacerbation of chronic sinusitis and exacerbation of chronic otitis media, the treatment duration was 10 days and efficacy results have shown that this duration was sufficient.
V študijah, ki podpirajo uporabo peroralnega ciprofloksacina pri akutni eksacerbaciji kroničnega sinuzitisa in eksacerbaciji kroničnega vnetja srednjega ušesa (otitis media), je zdravljenje potekalo 10 dni in rezultati učinkovitosti so pokazali, da je takšna dolžina zdravljenja zadostna.
If you stop using this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse.
Če boste prekmalu prenehali uporabljati zdravilo, se vaša okužba ne bo popolnoma pozdravila in simptomi okužbe se lahko ponovijo oz. poslabšajo.
The following oral and intravenous formulations are currently approved and marketed in different EU countries: - Immediate release film-coated tablets: 100 mg, 250 mg, 500 mg, 750 mg - Granules and solvent for oral suspension: 250 mg/5 ml, 500 mg/5 ml - Solution for infusion (glass bottles and flexibags): 100 mg/50 ml, 200 mg/100 ml and 400 mg/200 ml - Modified release film-coated tablets: 500 mg, 1000 mg. - Sachets: 250mg, 500mg
V različnih državah EU so trenutno odobreni in trženi naslednji peroralni in intravenozni pripravki: - filmsko obložene tablete s takojšnjim sproščanjem: 100 mg, 250 mg, 500 mg, 750 mg - zrnca in topila za peroralno raztopino: 250 mg/5 ml, 500 mg/5 ml - raztopina za infundiranje (steklenice in prilagodljive vrečke) 100 mg/50 ml, 200 mg/100 ml in 400 mg/200 ml - filmsko obložene tablete s prirejenim sproščanjem: 500 mg, 1000 mg - vrečke: 250 mg, 500 mg
Tell your doctor if you take or wish to take:
Obvestite svojega zdravnika, če nameravate jemati ali jemljete:
If you stop taking this medicine too soon, your infection may not be completely cured and the symptoms of the infection may return or get worse.
Če boste prekmalu prenehali jemati zdravilo, se vaša okužba ne bo popolnoma pozdravila in simptomi okužbe se lahko ponovijo oz. poslabšajo.
• ropinirole (for Parkinson's disease)
− ropinirol (za zdravljenje Parkinsonove bolezni)
The small bottle contains granules which you add to the solvent in the larger bottle.
Steklenička vsebuje zrnca, ki jih dodate v vehikel v plastenki.
The CHMP therefore recommended the following wording to distinguish, by specific indications, the prophylactic and curative uses of ciprofloxacin in neutropenic patients with the following wording: -treatment of infections in neutropenic patients, -prophylaxis of infections in neutropenic patients.
CHMP je tako predlagal naslednje besedilo, s katerim želi razlikovati med posameznimi indikacijami za profilaktično in kurativno uporabo ciprofloksacina pri bolnikih z nevtropenijo z naslednjo ubeseditvijo: - zdravljenje okužb pri nevtropeničnih bolnikih, - profilaksa okužb pri nevtropeničnih bolnikih.
• Malignant external otitis
• zunanji maligni otitis
Consequently, the following wording was recommended in section 4.1, and subsequently section 4.2 was amended accordingly: - acute exacerbations of chronic sinusistis especially if these are caused by Gram-negative bacteria - gonococcal urethritis and cervicitis - epididymo-orchitis including cases due to Neisseria gonorrhoeae - pelvic inflammatory disease including cases due to Neisseria gonorrhoeae - malignant external otitis
Tako je bilo za poglavje 4.1 in posledično poglavje 4.2 priporočeno naslednje besedilo: - akutna eksacerbacija kroničnega sinuzitisa, zlasti če je povzročena z Gram negativnimi bakterijami - gonoroični uretritis in cervicitis - epididimis-orhitis, vključno s primeri zaradi bakterije Neisseria gonorrhoeae - bolezni vnetja medenice, vključno s primeri zaradi bakterije Neisseria gonorrhoeae - zunanji maligni otitis
The pharmacokinetic data in paediatric patients are limited.
Podatki o farmakokinetiki pri otrocih, so zelo omejeni.
Streptococcal Infections (including Streptococcus pneumoniae) Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
Okužbe, ki jih povzročajo streptokoki (tudi Streptococcus pneumonie) Zaradi nezadostne učinkovitosti se ciprofloksacin ne priporoča za zdravljenje streptokoknih okužb.
* Non-species-related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species.
* Mejne vrednosti za nespecifične vrste so določili na podlagi farmakokinetičnih in farmakodinamičnih podatkov in so neodvisne od distribucije MIK-a za specifične vrste.
The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin.
Podatki o uporabi ciprofloksacina pri nosečnicah, ki so na voljo, ne kažejo malformacij ali feto/neonatalne toksičnosti.
at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)
najmanj 10 dni, v posebnih primerih je lahko podaljšano za več kot 21 dni (npr. absces)
Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.
Zaradi možnega tveganja za poškodbe sklepov se ciprofloksacina med dojenjem ne sme uporabljati.
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.
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.
• theophylline (for breathing problems)
− teofilin (za lajšanje težav pri dihanju)
In patients with impaired liver function no dose adjustment is required.
Bolnikom z okvarjenim delovanjem jeter odmerkov ni treba prilagajati.
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.
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.
Breakpoints separate susceptible strains from strains with intermediate susceptibility and the latter from resistant strains:
Mejne vrednosti ločujejo občutljive seve od sevov z vmesno občutljivostjo in nato od odpornih sevov:
Some medicines reduce the effect of Ciprofloxacin Bayer.
Nekatera zdravila zmanjšajo učinek zdravila Ciprofloksacin Bayer.
7 to 21 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)
7 do 21 dni, v posebnih primerih je lahko podaljšano za več kot 21 dni (npr. absces)
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.
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.
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.
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.
- exacerbations of chronic obstructive pulmonary disease
- eksacerbacije kronične obstruktivne pljučne bolezni
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).
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).
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.
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.
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.
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).
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.
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.
Ventricular arrhythmia, QT prolongation, torsades de pointes *
Srčne bolezni tahikardija ventrikularne aritmije, podaljšanje intervala QT, torsade de pointes *
2 to 4 weeks (acute)
2 do 4 tedne (akutni)
Swallow the tablets with plenty of fluid.
Tablete pogoltnite cele, z dovolj tekočine.
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).
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).
However, after extensive discussions, the CHMP considered that ciprofloxacin still remains a useful therapeutic option in uncomplicated cystitis.
Kljub temu pa je CHMP po obsežni razpravi menil, da je ciprofloksacin uporabna terapevtska možnost pri zdravljenju nezapletenih cist.