FrancophonIA/ELRC3.0 huggingface dataset:
English: Diarrhoea caused by Vibrio cholerae
Slovenian: 5 dni driska, ki jo povzroča Vibrio cholerae
English: The resort to combination therapy, however, should be envisaged according to specific factors (including severe neutropenia).
Slovenian: Odločitev za uporabo ciprofloksacina v kombinaciji z drugimi antibiotiki pa mora biti sprejeta upoštevajoč določene specifične dejavnike (vključno s hudo nevtropenijo).
English: Bayer Pharma, d.o.o., Bravničarjeva 13 SI-1000 Ljubljana Slovenia
Slovenian: Bayer Pharma, d.o.o., Bravničarjeva 13
English: The Applicant/MAH proposed to take the Ciprofloxacin Modified Release Tablets out of this Referral procedure to significantly simplify the exercise of harmonisation.
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom je predlagal, da se tablete ciprofloksacina s prirejenim sproščanjem izvzamejo iz tega napotitvenega postopka, s čimer bi bilo usklajevanje precej enostavnejše.
English: Most reported adverse events were not unexpected, mainly gastro-intestinal disorders or cutaneous disorders.
Slovenian: Najpogosteje objavljeni neželeni dogodki so bili pričakovani in so v glavnem vključevali motnje v prebavilih ali motnje na koži.
English: Therefore, the CHMP asked the applicant/MAH to discuss (PK/PD rational) and make a proposal in this field.
Slovenian: Tako je CHMP predlagatelja/imetnika dovoljenja za promet z zdravilom zaprosil naj predstavi (farmakokinetiko/farmakodinamiko) in na tem področju pripravi predlog.
English: As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.
Slovenian: Kot antibakterijsko zdravilo iz skupine fluorokinolonov ciprofloksacin zavira bakterijska encima topoizomerazo II (DNK girazo) in topoizomerazo IV, ki sta potrebna za podvajanje, prepisovanje, popravljanje in rekombinacijo bakterijske DNK.
English: Importantly, the MR tablet formulation would not gain any new indications.
Slovenian: Tablete s prirejenim sproščanjem pa ne bodo mogle pridobiti nobenih novih indikacij.
English: If such reaction occurs, ciprofloxacin should be discontinued and an adequate medical treatment is required.
Slovenian: Če se pojavi taka reakcija, je treba zdravljenje s ciprofloksacinom prekiniti in ustrezno ukrepati.
English: Subsequently, the CHMP reached an agreement with the Applicant/MAH concerning the new proposals for dose adjustments in case of renal impairment.
Slovenian: Posledično je CHMP s predlagateljem/imetnikom dovoljenja za promet z zdravilom dosegel dogovor o novem predlogu prilagoditve odmerjanja v primeru oslabljenega delovanja ledvic.
English: The mean treatment duration of ciprofloxacin for MEO as reported in the meta-analysis on 13 publications, published by Gehanno (1993) was 3 months (6 months in 3 studies, 2 months in one study).
Slovenian: Meta analiza 13 publikacij, ki jo je objavil Gehanno (1993) je pokazala, da v povprečju trajanje zdravljenja malignega zunanjega otitisa s ciprofloksacinom traja 3 mesece (6 mesecev v treh študijah, 2 meseca v eni študiji).
English: Diarrhoea caused by Shigella dysenteriae type
Slovenian: 1 dan driska, ki jo povzroča Shigella dysenteriae tipa
English: In its original document the applicant/MAH proposed an oral posology of 500 mg QD and an IV posology of 200 mgx2.
Slovenian: V originalnem dokumentu je predlagatelj/imetnik dovoljenja za promet z zdravilom predlagal peroralno odmerjanje z 500 mg QD (enkrat na dan) in IV odmerjanje z 200 mgx2.
English: For treatment of febrile neutropenic patients, when an intravenous antibiotic administration is necessary, ciprofloxacin should be administered at a 400 mg bid or tid regimen.
Slovenian: Za zdravljenje bolnikov z vročinsko nevtropenijo, v primeru kadar je potrebna uporaba intravenoznega antibiotika, naj se ciprofloksacin uporablja z odmerkom 400 mg z bid ali tid načinom odmerjanja.
English: However, 500 mg bid PO was considered inadequate for the treatment of malignant external otitis, and a dose of 750 mg bid PO was recommended for oral administration.
Slovenian: Kljub temu pa odmerjanje s 500 mg bid ni ustrezno pri zdravljenju malignega zunanjega otitisa, medtem ko je odmerjanje s 750 mg bid priporočeno za peroralno uporabo.
English: In summary, the CHMP was of the opinion that anthrax should remain part of the indications to avoid any confusion for prescribers and to be consistent with EU and international guidelines including a recommendation on ciprofloxacin as a first line treatment.
Slovenian: CHMP je tako menil, da naj antraks ostane del indikacije, saj se lahko tako prepreči kakršna koli zmedenost pri zdravnikih, ki predpisujejo ciprofloksacin in zagotovi skladnost z mednarodnimi smernicami in smernicami EU, vključno z navedbo, da je zdravljenje s ciprofloksacinom primarno.
English: More limited experience is available in treating children between 1 and 5 years of age.
Slovenian: Izkušnje pri otrocih starih med 1 in 5 let so bolj omejene.
English: • suffer from epilepsy or other neurological conditions
Slovenian: − imate epilepsijo ali kakšne druge nevrološke težave
English: If possible, take your tablets or the box with you to show the doctor.
Slovenian: Če je mogoče, vzemite s seboj tablete ali škatlo in jih pokažite zdravniku.
English: Recommended starting and maintenance doses for patients with impaired renal function:
Slovenian: Priporočeni začetni in vzdrževalni odmerki pri bolnikih z okvarjenim delovanjem ledvic:
English: Posology for severe respiratory tract infections, severe bone and joint infections In severe respiratory tract infections as well as in severe bone and joint infections, higher doses than that currently recommended (such as 750 mg x 3/day or 1000 mg x 2/day) for oral route are currently used in clinical practice given the known decreased susceptibility of the main pathogens involved (including Pseudomonas aeruginosa, Acinetobacter, Staphylococcus aureus) and the severity of the disease (as well as the difficulties in reaching optimal concentration at the bone level).
Slovenian: Odmerjanje pri hudih okužbah dihal, hudih okužbah kosti in sklepov Pri hudih okužbah dihal in pri hudih okužbah kosti in sklepov se v sodobni klinični praksi uporabljajo večji odmerki od trenutno priporočenih za peroralno uporabo (na primer 750 mg x3/dan ali 1000 mg x 2/dan), upoštevajoč znano zmanjšano občutljivost glavnih sodelujočih patogenov (vključno z Pseudomonas aeruginosa, Acinetobacter, Staphylococcus aureus) in resnost bolezni (ter težave pri doseganju optimalne koncentracije na ravni kosti).
English: Nevertheless the CHMP noted that consideration should be given to the precautions of use in ciprofloxacin treatment of such infections.
Slovenian: Kljub temu pa je CHMP menil, da je pri zdravljenju takšnih okužb s ciprofloksacinom potrebna posebna previdnost.
English: 2 - Strictly follow the prescription.
Slovenian: Natančno upoštevati navodila.
English: The ready-to-use suspension is now finished.
Slovenian: Suspenzija je tako pripravljena za uporabo.
English: Your doctor will decide whether treatment with Ciprofloxacin Bayer needs to be stopped.
Slovenian: Zdravnik se bo odločil, če je treba zdravljenje z zdravilom Ciprofloksacin Bayer prekiniti.
English: ¾ Take the normal dose as soon as possible and then continue as prescribed.
Slovenian: Če ste pozabili vzeti zdravilo, vzemite običajni odmerek takoj, ko se spomnite in nato nadaljujte kot vam je predpisal zdravnik.
English: Reversible renal toxicity has been reported.
Slovenian: Poročali so tudi o reverzibilni nefrotoksičnosti.
English: Patients taking ciprofloxacin should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment (see section 4.8).
Slovenian: Bolnikom, ki jemljejo ciprofloksacin, je treba odsvetovati daljše izpostavljanje neposredni sončni svetlobi ali ultravijoličnemu sevanju med zdravljenjem (glejte poglavje 4.8)
English: Data on photomutagenicity/photocarcinogenicity show a weak photomutagenic or phototumorigenic effect of ciprofloxacin in-vitro and in animal experiments.
Slovenian: Podatki o fotomutagenosti/fotokarcinogenosti kažejo na šibak fotomutageni ali fototumorogeni učinek ciprofloksacina in vitro in v poskusih na živalih.
English: Non-species-related breakpoints *
Slovenian: Mejne vrednosti za nespecifične vrste*
English: The Applicant/MAH did not provide any data or scientific discussion to support the single dose oral ciprofloxacin treatment of uncomplicated cystitis.
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom ni predložil nobenih podatkov ali znanstvenih razprav, ki bi potrdile zdravljenje nezapletenih cist z enkratnim odmerkom peroralnega ciprofloksacina.
English: Psychiatric reactions may occur even after the first administration of ciprofloxacin.
Slovenian: Psihiatrične reakcije se lahko pojavijo že po prvem odmerku ciprofloksacina.
English: When a switch down to oral therapy is possible, a 750 mg bid ciprofloxacin regimen is recommended.
Slovenian: Kadar je možna sprememba terapije na peroralno, se priporoča 750 mg odmerek bid odmerjanja ciprofloksacina.
English: These may appear as local skin reactions which resolve rapidly upon completion of the infusion.
Slovenian: Lokalne kožne reakcije izginejo hitro po koncu infundiranja.
English: Ciprofloxacin should be used in combination with other antimicrobial agents, such as rifampicin in infections due to Staphylococci, and beta-lactams or aminoglycosides in infections due to Pseudomonas aeruginosa.
Slovenian: Ciprofloksacin naj se uporablja v kombinaciji z drugimi protimikrobnimi snovmi, kot so na primer rifampicin pri okužbah s stafilokoki in beta laktami ali aminoglikozidi pri okužbah s Pseudomonas aeruginosa.
English: Therefore, the CHMP and the Applicant/MAH were in agreement that a duration up to 3 months with ciprofloxacin was justified for the treatment of malignant external otitis.
Slovenian: CHMP in predlagatelj/imetnik dovoljenja za promet z zdravilom sta soglašala, da je uporaba ciprofloksacina do treh mesecev upravičena pri zdravljenju malignega zunanjega otitisa.
English: Even with the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up.
Slovenian: Že po prvi uporabi zdravila obstaja možnost, da se pojavijo hude alergijske reakcije z naslednjimi simptomi: stiskanje v prsnem košu, vrtoglavica, oslabelost, omedlevica ali vrtoglavica ob vstajanju.
English: Respectively, an incidence of drug-related arthropathy by 1-year follow-up was 9.0% and 5.7%.
Slovenian: Pri spremljanju bolnikov do enega leta se je z zdravilom domnevno povezana artropatija pojavila v 9 % oz. 5,7 %.
English: The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.
Slovenian: Odmerek je odvisen od vrste, stopnje in mesta okužbe, občutljivosti povzročitelja(ev) na ciprofloksacin, delovanja ledvic in pri otrocih in mladostnikih od telesne mase.
English: Shake before use applying slight pressure to the wall.
Slovenian: Pred uporabo pretresite vsebino z rahlim pritiskanjem na steno vrečice.
English: Long-term safety profile of ciprofloxacin to treat bone and joint infections Since a treatment duration of up to 3 months may be required in clinical practice to treat bone and joints infections, the CHMP requested that the applicant/MAH provide long term safety data to substantiate the safety profile of the drug in such a prolonged use.
Slovenian: Dolgoročni varnostni profil ciprofloksacina pri zdravljenju okužb kosti in sklepov Ker lahko zdravljenje okužb kosti in sklepov v klinični praksi traja tudi do treh mesecev, je Odbor za zdravila za uporabo v humani medicini predlagatelja/imetnika dovoljenja za promet z zdravilom zaprosil, naj zagotovi dolgoročne varnostne podatke v potrditev varnostnega profila zdravila v tako podaljšani uporabi.
English: Creatinine Clearance
Slovenian: očistek kreatinina
English: It can also increase the probability of experiencing side effects.
Slovenian: Hkrati se lahko poveča možnost pojava neželenih učinkov.
English: Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e.g. of theophylline) may be necessary (see section 4.5).
Slovenian: Bolnike, ki jemljejo ta zdravila sočasno s ciprofloksacinom je treba skrbno nadzorovati glede pojava kliničnih znakov prevelikega odmerjanja in če je potrebno, določiti serumske koncentracije (npr. teofilina) (glejte poglavje 4.5).
English: Like all medicines, Ciprofloxacin Bayer can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Ciprofloksacin Bayer neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Rare ≥ 1/10 000 to <
Slovenian: Redki ≥ 1/10.000 do <
English: There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
Slovenian: Podatki o učinkovitosti ciprofloksacina pri zdravljenju intraabdominalnih okužb po kirurških posegih so omejeni.
English: In 10 children with severe sepsis Cmax was 6.1 mg/L (range 4.6-8.3 mg/L) after a 1-hour intravenous infusion of 10 mg/kg in children aged less than 1 year compared to 7.2 mg/L (range 4.7-11.8 mg/L) for children between 1 and 5 years of age.
Slovenian: Pri desetih otrocih s hudo sepso, mlajših od enega leta, je bila po 60-minutnem intravenskem infundiranju odmerka 10 mg/kg, Cmax 6,1 mg/l (med 4,6 in 8,3 mg/l); pri otrocih v starosti od 1 do 5 let je bila Cmax 7,2 mg/l (med 4,7 in 11,8 mg/l).
English: Mechanism of resistance:
Slovenian: Mehanizen odpornosti
English: Psychomotor hyperactivity / agitation
Slovenian: − hiperaktivnost ali vznemirjenost
English: Overall, the CHMP considered that the therapeutic indication “acute sinusitis” could not be accepted, as the most commonly involved pathogen in this infection, Streptococcus pneumoniae, is only intermediately susceptible to ciprofloxacin and its efficacy in this indication is poorly substantiated by the submitted data.
Slovenian: CHMP je menil, da indikacija „akutni sinuzitis“ ne more biti sprejemljiva, saj je najbolj pogost patogen pri tej okužbi Streptococcus pneumoniae, ki pa je le začasno dovzeten na ciprofloksacin, tako da učinkovitost pri tej indikaciji s predloženimi podatki ni ustrezno utemeljena.
English: Typically, the infection spreads to the basis of the skull and mastoid, resulting in cranial neuropathies, and rarely, brain abscess, sphenoidal sinusitis.
Slovenian: Ponavadi se okužba razširi na bazo lobanje in mastoid, kar povzroča kranialne nevropatije in redkeje abscese v možganih, sfenoidalni sinuzitis.
English: Ciprofloxacin undergoes both glomerular filtration and tubular secretion.
Slovenian: Ciprofloksacin se izloča z glomerulno filtracijo in tubulno sekrecijo.
English: The single dose treatment of uncomplicated UTI should not be approved unless scientifically justified (comparative benefit/risk assessment with the 3 day treatment regimen is provided).
Slovenian: Enkraten odmerek pri zdravljenju nezapletenih okužb sečil se lahko potrdi le na podlagi ustrezne strokovne utemeljitve (priložena je primerjalna ocena razmerja koristi/tveganja s tridnevnim načinom zdravljenja).
English: In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued.
Slovenian: V primeru znakov ali simptomov jetrne bolezni (npr. anoreksija, zlatenica, temen seč, srbenje ali napet trebuh), je treba zdravljenje prekiniti.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: 60 days from the confirmation of Bacillus anthracis exposure
Slovenian: 60 dni od potrjene izpostavljenosti Bacillus anthracis
English: Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications.
Slovenian: * klinično učinkovitost so dokazali pri občutljivih izolatih za odobrene klinične indikacije
English: Additionally, the use of ciprofloxacin in prophylaxis of neutropenia was further supported by a recent trial with other fluoroquinolones (levofloxacin).
Slovenian: Uporabo ciprofloksacina pri profilaksi nevtropenije je potrdil tudi nedavni preskus z uporabo drugega fluorokinolona (levofloksacin).
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet.
Slovenian: - da je bil obseg napotitve uskladitev povzetkov glavnih značilnosti zdravil, označevanja in navodil za uporabo,
English: Nevertheless, in very rare instances, after microbiological documentation of the causative organism and evaluation of the risk/benefit balance, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where the microbiological data may justify the use of ciprofloxacin.
Slovenian: V zelo redkih primerih, glede na mikrobiološke izvide o povzročiteljih in oceni tveganja in koristi, se lahko ciprofloksacin predpiše tudi tem bolnikom za zdravljenje posebno hudih okužb, predvsem če je bilo standardno zdravljenje neuspešno ali odpornost bakterije opravičuje uporabo ciprofloksacina.
English: - the CHMP concluded that the Marketing Authorisation could be harmonised on the following indications for oral and intravenous formulations in adults:
Slovenian: - da je CHMP sklenil, da se dovoljenja za promet z zdravilom lahko uskladijo pri naslednjih indikacijah za peroralne in intravenozne pripravke pri odraslih:
English: Close the bottle with the solvent and added granules, turn it on its side and shake vigorously for about 15 seconds.
Slovenian: Zaprite plastenko, ki vsebuje vehikel in dodana zrnca in močno stresajte približno 15 sekund.
English: There have been many reports of increases in oral anticoagulant activity in patients receiving antibacterial agents, including fluoroquinolones.
Slovenian: V večih primerih so poročali o zvečanem antikoagulacijskem učinku pri bolnikih, ki so dobivali antibakterijska zdravila, predvsem fluorokinolone.
English: In these cases, ciprofloxacin should be discontinued.
Slovenian: V takih primerih je treba zdravljenje s ciprofloksacinom prekiniti.
English: The CHMP agreed with this last Applicant/MAH proposal which is in line with the bioequivalence data.
Slovenian: Odbor za zdravila za uporabo v humani medicini se je strinjal s predlogom predlagatelja/imetnika dovoljenja za promet z zdravilom, ki je usklajen s podatki o biološki enakovrednosti.
English: Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4)
Slovenian: Specifične vrste bakterij razvrščenih glede na občutljivost za ciprofloksacin (za streptokoke glejte poglavje 4.4).
English: Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk.
Slovenian: V takih primerih se je treba izogibati zdravljenju s ciprofloksacinom, razen če je korist zdravljenja večja od tveganja.
English: Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4).
Slovenian: To so desetilenciprofloksacin (M1), sulfociprofloksacin (M2), oksociprofloksacin (M3) in formilciprofloksacin (M4).
English: Taking Ciprofloxacin Bayer together with these medicines can influence the therapeutic effect of those medicines.
Slovenian: Jemanje zdravila Ciprofloksacin Bayer sočasno s temi zdravili lahko vpliva na terapevtski učinek teh zdravil.
English: Other xanthine derivatives
Slovenian: Drugi derivati ksantina
English: other than Shigella dysenteria type 1and empirical treatment of traveller's diarrhoea (per os : 2 x 500 mg/d - 1 day, i.v : 2 x 400 mg/d - 1 day) -Diarrhoea caused by Shigella dysenteriae type 1 (per os : 2 x 500 mg/d - 5 days, i.v : 2x400 mg/d- 5 days)
Slovenian: - driska povzročena z bakterijskimi patogeni, vključno s Shigella spp., razen Shigella dizenterija vrste 1 in empirično zdravljenje potovalne driske (P.O.: 2 x 500 mg/d - 1 dan, i.v : 2 x 400 mg/d - 1 dan) - driska povzročena z Shigella dizenterija vrste 1 (P.O.: 2 x 500 mg/d - 5 dni, i.v : 2 x 400 mg/d- 5 dni)
English: Central Nervous System
Slovenian: Osrednje živčevje
English: The simultaneous administration of ciprofloxacin (oral) and multivalent cation-containing drugs and mineral supplements (e.g. calcium, magnesium, aluminium, iron), polymeric phosphate binders (e.g. sevelamer), sucralfate or antacids, and highly buffered drugs (e.g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of ciprofloxacin.
Slovenian: Pri hkratni uporabi ciprofloksacina (peroralno) in zdravil, ki vsebujejo večvalentne katione in mineralne dodatke (npr. kalcij, magnezij, aluminij, železo), polimerov, ki vežejo fosfat (npr. sevelamer), sukralfata ali antacidov in močno puferiranih zdravil (npr. tablete, ki vsebujejo didanozin), ki vsebujejo magnezij, aluminij ali kalcij, se zmanjša absorpcija ciprofloksacina.
English: Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin, potentially leading to increased plasma levels of methotrexate and increased risk of methotrexate-associated toxic reactions.
Slovenian: Ledvično tubulno izločanje metotreksata je pri sočasni uporabi ciprofloksacina zavrto, zato se lahko zveča njegova plazemska koncentracija in tveganje za pojav z metotreksatom povezanih toksičnih reakcij.
English: Tell your doctor if you are taking:
Slovenian: Obvestite svojega zdravnika, če jemljete:
English: Posology in the treatment of upper respiratory tract infections The CHMP asked the applicant/MAH to further substantiate the efficacy/risk of the lower dosage proposed (500 mg BID) in the treatment of upper respiratory tract infection, especially with regard to malignant external otitis.
Slovenian: Odmerjanje pri zdravljenju okužb zgornjega dela dihal CHMP je predlagatelja/imetnika dovoljenja za promet z zdravilom zaprosil, naj še dodatno utemelji učinkovitost/tveganje pri manjših predlaganih odmerkih (500 mg bid) pri zdravljenju okužb zgornjega dela dihal, zlasti v zvezi z malignim zunanjim otitisom.
English: Ciprofloxacin is excreted in breast milk.
Slovenian: Ciprofloksacin se izloča v materino mleko.
English: • ropinirole (for Parkinson's disease) • phenytoin (for epilepsy)
Slovenian: − ropinirol (za zdravljenje Parkinsonove bolezni) − fenitoin (za zdravljenje epilepsije)
English: 2 to 4 weeks (acute) to 4 to 6 weeks (chronic)
Slovenian: 2 do 4 tednov (akutni) do 4 do 6 tednov (kronični)
English: Therefore, the following wording was proposed for section 4.1: Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.
Slovenian: Tako je bilo za poglavje 4.1 predlagano naslednje besedilo: Ciprofloksacin se lahko po potrebi uporablja tudi za zdravljenje hudih okužb pri otrocih in mladostnikih.
English: The CHMP asked the applicant/MAH to discuss the extent to which ciprofloxacin could be viewed as an acceptable option for treating bone and joints infections due to Gram-positive bacteria (in particular Staphyloccocus species).
Slovenian: CHMP je predlagatelja/imetnika dovoljenja za promet z zdravilom zaprosil za pojasnitev, v kolikšni meri je zdravljenje s ciprofloksacinom sprejemljiva možnost zdravljenja okužb kosti in sklepov, nastalih zaradi Gram-pozitivne bakterije (zlasti vrste stafilokok).