natgillin/translations-raw huggingface dataset:
Therefore, the use of ciprofloxacin in children is generally not recommended, except for cystic fibrosis patients (see section 4.1).
Glede uporabe ciprofloksacina pri otrocih in mladostnikih ni dovolj podatkov, zato uporaba ciprofloksacina pri otrocih na splošno ni priporočljiva, razen za bolnike s cistično fibrozo (glejte poglavje 4. 1).
Musculoskeletal system:
Mišično- skeletni sistem:
If there is any indication of tendinitis (e. g. painful swelling) the administration of ciprofloxacin or other fluoroquinolones must immediately be discontinued, the affected extremity should not be strained and a physician must be consulted.
Posvetovati se je treba z zdravnikom.
Very rarely, a partial or total rupture (in particular of the
Zelo redko so poročali o delnem ali popolnem pretrganju (zlasti Ahilove kite), predvsem pri starejših bolnikih, ki so se pred tem sistemsko zdravili z glukokortikoidi.
Ciprofloxacin may cause an exacerbation of Myastenia gravis symptoms.
20 Ciprofloksacin lahko poslabša simptome miastenije gravis.
Therefore, it is recommended to avoid prolonged exposure to sunlight or UV light during treatment with ciprofloxacin.
Ciprofloksacin in drugi fluorokinoloni lahko povzročijo fotosenzibilnost, zato naj se bolniki med zdravljenjem s ciprofloksacinom izogibajo dolgotrajni izpostavljenosti sončni svetlobi ali UV žarkom.
Anaphylactic/ anaphylactoid reactions can in very rare cases develop into life-threatening shock, sometimes even after the first administration of ciprofloxacin.
Anafilaktične/ anafilaktoidne reakcije se lahko v zelo redkih primerih razvijejo v smrtno nevaren šok, včasih celo že po prvi uporabi ciprofloksacina.
Ciprofloxacin Kabi contains 15.1 mmol (347 mg) sodium per 100 ml solution for infusion.
Ciprofloxacin Kabi vsebuje 15, 1 mmol (347 mg) natrija v 100 ml raztopine za infundiranje.
Probenecid Probenecid inhibits the renal excretion of ciprofloxacin resulting in an increase in the plasma concentration of ciprofloxacin.
Probenecid Probenecid inhibira izločanje ciprofloksacina skozi ledvica kar ima za posledico povečanje koncentracije ciprofloksacina v plazmi.
CYP1A2 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e. g. theophylline, clozapine, tacrine, ropinirol, tizanidine).
CYP1A2 Ciprofloksacin zavira CYP1A2 in tako lahko zviša serumsko koncentracijo tistih sočasno uporabljenih zdravil, ki se presnavljajo s tem encimom (npr. teofilin, klozapin, takrin, ropinirol, tizanidin).
Determination of serum concentrations, especially of theophylline, and dose adjustments may be necessary.
Bolnike, ki hkrati s ciprofloksacinom jemljejo takšna zdravila, je zato treba natančno nadzirati glede kliničnih znakov prevelikega odmerjanja; potrebna utegne biti določitev koncentracije v serumu, še zlasti za teofilin.
Other xanthine derivatives On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.
Drugi ksantinski derivati Ob sočasnem dajanju ciprofloksacina in kofeina ali pentoksifilina (oksipentifilina) so poročali o zvišanju koncentracij ksantinskih derivatov v serumu.
Phenytoin Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
Fenitoin Sočasno dajanje ciprofloksacina in fenitoina lahko ima za posledico povečanje ali zmanjšanje ravni fenitoina v serumu zato se priporoča nadziranje ravni zdravila.
Methotrexate Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate.
Metotreksat Renalni tubularni transport metotreksata je lahko inhibiran s sočasnim dajanjem ciprofloksacina kar potencialno vodi do povečanja koncentracije metotreksata v plazmi.
23 Cylosporine Following concomitant administration of ciprofloxacin and cyclosporine a transient increase of the serum creatinine concentration has been observed in separate cases.
21 Ciklosporin V posameznih primerih so po sočasni uporabi ciprofloksacina in ciklosporina opazili prehodno zvišanje koncentracije kreatinina v serumu.
Oral anticoagulants (e. g. warfarin) Ciprofloxacin, like other quinolones, may enhance the effect of coumarin derivates including warfarin.
Peroralni antikoagulanti (tj. varfarin) Ciprofloksacin tako kot ostali kinoloni lahko poveča učinek kumarinskih derivatov vključno z varfarinom.
Glibenclamide When used simultaneously, ciprofloxacin may, in certain cases, increase the effect of glibenclamide (hypoglycaemia).
Glibenklamid Sočasno uporabljeni ciprofloksacin lahko v določenih primerih poveča učinek glibenklamida (hipoglikemija).
NSAIDs Animal trials have shown that the concurrent administration of very high doses of fluoroquinolones and certain NSAIDs (but not acetylsalicylic acid) may provoke convulsions.
NSAID Poskusi na živalih so pokazali, da lahko sočasna uporaba zelo velikih odmerkov fluorokinolonov in nekaterih nesteroidnih protivnetnih zdravil (vendar ne acetilsalicilne kisline) povzroči konvulzije.
Mexiletine Simultaneous administration of ciprofloxacin and mexiletine can lead to increased plasma concentrations of mexiletine.
Meksiletin Sočasno dajanje ciprofloksacina in meksiletina lahko vodi do povečanja koncentracije meksiletina v plazmi.
Pregnancy Use during pregnancy is contraindicated.
Nosečnost Uporaba ciprofloksacina med nosečnostjo je kontraindicirana.
Since the risks for humans are unknown Ciprofloxacin Kabi must not be administered during pregnancy (see section 4.3).
Ker tveganja za človeka niso znana, se Ciprofloxacina Kabi ne sme uporabljati med nosečnostjo (glejte poglavje 4. 3).
Due to the risk of arthropathy and other potentially severe toxicity in the infant, ciprofloxacin is contraindicated during lactation (see section 4.3).
Zaradi tveganja za artropatijo in druge potencialno hude toksične učinke pri otroku je dojenje med zdravljenjem s ciprofloksacinom kontraindicirano (glejte poglavje 4. 3).
Adverse reactions have been reported in 5-14% of patients receiving ciprofloxacin.
O neželenih učinkih so poročali pri 5– 14% bolnikov, ki so prejemali ciprofloksacin.
The following adverse reactions have been observed:
Poročali so o naslednjih neželenih učinkih.
24 In this section undesirable effects are defined as follows:
Pogostnost neželenih učinkov je razvrščena v naslednje skupine:
very common common uncommon rare very rare, including isolated reports
zelo pogosti pogosti občasni
(> 1/ 10) (> 1/ 100 ,< 1/10) (> 1/1000 ,< 1/100) (> 1/10 000, < 1/ 1000) (< 1/10 000)
(> 1/ 10) (> 1/ 100, < 1/ 10) (> 1/ 1. 000, < 1/ 100)
Rare: tinnitus, transient hearing loss (particularly high frequencies).
Redki: tinitus, prehodna izguba sluha (zlasti v področju visokih frekvenc).
In very rare cases ventricular arrhythmia, QT interval prolongation and torsades de pointes have been reported.
V zelo redkih primerih so poročali o ventrikularni aritmiji, podaljšanju QT intervala in “ torsades de pointes ”.
(thrombo)phlebitis.
(trombo) flebitis.
25 Rare: dyspnoea, laryngeal oedema.
Redki: dispneja, edem grla.
Common: nausea, diarrhoea.
Pogosti: navzea, driska.
Rare: pseudomembranous colitis, moniliasis (oral).
23 Občasni: bruhanje, dispepsija, flatulenca, anoreksija, abdominalna bolečina Redki: psevdomembranski kolitis, kandidoza (oralna).
Very rare: erythema nodosum, erythema multiforme (minor), Stevens-Johnson syndrome, epidermal necrolysis (Lyell Syndrome).
Zelo redki: nodozni eritem, multiformni eritem (minor), Stevens- Johnsonov sindrom, epidermalna nekroliza (Lyellov sindrom).
Musculoskeletal, conective tissue and bone disorders:
Bolezni mišično- skeletnega sistema in vezivnega tkiva:
Very rare: increment of amylase/ lipase levels.
Zelo redki: povišane vrednosti amilaze/ lipaze.
At haemodialysis or peritoneal dialysis only a modest amount of ciprofloxacin (less than 10%) is eliminated.
S hemodializo ali peritonealno dializo se izloči le malo (manj kot 10%) ciprofloksacina.
Quinolone antibacterials (ATC code:
Farmakoterapevtska skupina: kinolinske protimikrobne učinkovine (oznaka ATC:
Mode of action:
Mehanizem delovanja:
26 Ciprofloxacin is effective in vitro against a large number of Gram-negative aerobic bacteria including P. aeruginosa.
Ciprofloksacin je in vitro učinkovit proti številnim gramnegativnim aerobnim bakterijam, vključno s P. aeruginosa.
It is also effective against Gram-positive organisms, such as staphylococci and streptococci.
Učinkovit je tudi proti grampozitivnim mikroorganizmom, npr. stafilokokom in
The enzyme DNA-gyrase plays a crucial role in this process.
Ključno vlogo v tem dogajanju ima encim DNA- giraza.
Ciprofloxacin inhibits DNA-gyrase, resulting in inhibition of DNA synthesis.
Ciprofloksacin zavre DNA - girazo in s tem sintezo DNA.
Transferable plasmid-mediated quinolone resistance associated with qnr has been detected in quinolone-resistant clinical strains of E. coli and Klebsiella spp.
Pri kinolonih niso opazili pojava odpornosti prek plazmidov, kakršna se razvije v primeru betalaktamskih antibiotikov, aminoglikozidov in tetraciklinov.
Development of resistance to ciprofloxacin and other fluoroquinolones has been observed in staphylococci, especially methicillin- resistant S. aureus, P. aeruginosa, E. coli and E. faecalis (see the sensitivity table).
Pojav odpornosti proti ciprofloksacinu in drugim fluorokinolonom so zabeležili pri stafilokokih, zlasti za meticilin odporne S. aureus, P. aeruginosa, E. coli in E. faecalis (glejte desni stolpec v tabeli občutljivosti).
Especially patients undergoing long-term treatment (e. g. in cystic fibrosis, osteomyelitis), or patients who are extremely susceptible to infections (e. g. in selective prophylaxis in certain groups of neutropenic patients, artificial ventilation) show the highest risk.
Tveganje je največje še posebno pri bolnikih, ki so podvrženi dolgotrajnemu zdravljenju (npr. bolniki s cistično fibrozo, osteomielitisom), in bolnikih, ki so izredno dovzetni za okužbe (npr. selektivna profilaksa pri določenih skupinah nevtropeničnih bolnikov, umetna ventilacija).
Regular determination of resistance is therefore recommended.
Odstotek odpornih sevov se lahko lokalno zelo razlikuje, zato je priporočljivo redno določanje odpornosti.
According to EUCAST the following breakpoints for aerobic bacteria have been defined for ciprofloxacin:
Po priporočilih EUCAST so določene naslednje mejne vrednosti za aerobne bakterije za ciprofloksacin:
- Enterobacteriaceae: ≤ 0.5 µg/ ml for susceptible, > 1 µg/ ml for resistant;
- Enterobacteriaceae: ≤0, 5 µg/ ml za občutljive, > 1 µg/ ml za rezistentne;
- Pseudomonas spp. ≤ 0.5 µg/ ml for susceptible, > 1 µg/ ml for resistant;
- Pseudomonas spp. ≤0, 5 µg/ ml za občutljive, > 1 µg/ ml za rezistentne;
- Acinetobacter spp. ≤ 1 µg/ ml for susceptible, > 1 µg/ ml for resistant;
- Acinetobacter spp. ≤1 µg/ ml za občutljive, > 1 µg/ ml za rezistentne;
- S. pneumonia ≤ 0.125 µg/ ml for susceptible, > 2 µg/ ml for resistant;
- S. pneumonia ≤0, 125 µg/ ml za občutljive, > 2 µg/ ml za rezistentne;
- Staphylococcus spp. ≤ 1 µg/ ml for susceptible, > 1 µg/ ml for resistant;
- Staphylococcus spp. ≤1 µg/ ml za občutljive, > 1 µg/ ml za rezistentne;
- H. influenza and M. catarrhalis ≤ 0.5 µg/ ml for susceptible, > 0.5 µg/ ml for resistant;
- H. influenza in M. catarrhalis ≤0, 5 µg/ ml za občutljive, > 0, 5 µg/ ml za rezistentne;
- Neisseria gonorrhoeae: ≤ 0.03 µg/ ml for susceptible, > 0.06 µg/ ml for resistant;
- Neisseria gonorrhoeae: ≤0, 03 µg/ ml za občutljive, > 0, 06 µg/ ml za rezistentne;
- N. meningitides: ≤ 0.03 µg/ ml for susceptible, > 0.06 µg/ ml for resistant;
- N. meningitides: ≤0, 03 µg/ ml za občutljive, > 0, 06 µg/ ml za rezistentne;
Non-species related breakpoints are ≤ 0.5 µg/ ml for susceptible, and > 1 µg/ ml for resistant organisms.
Neodvisno od vrste so mejne vrednosti ≤0, 5 µg/ ml za občutljive, in > 1 µg/ ml za rezistentne organizme.
27 Proteus vulgaris Salmonella spp.
25 Salmonella spp.
Species for which acquired resistance may be a problem Gram-positive aerobes Coagulase-negative Staphylococcus Enterococcous faecalis MRSA* Staphylococcus aureus Staphylococcus aureus (methicillin susceptible) Streptococcus spp.
Vrste za katere je pridobljena rezistenca lahko problematična Grampozitivni aerobi Coagulase- negative Staphylococcus Enterococcous faecalis MRSA * Staphylococcus aureus Staphylococcus aureus (methicillin susceptible) Streptococcus spp.
Streptococcus agalactiae Streptococcus pneumoniae S. pneumoniae PEN-R Streptococcus pyogenes Gram-negative aerobes Acinetobacter spp.
Streptoococus agalactiae Streptococcus pneumoniae S. pneumoniae PEN- R Streptococcus pyogenes Gramnegativni aerobi Acinetobacter spp.
Amp-C producing Escherichia coli E. coli ESBL producing Klebsiella pneumoniae Klebsiella oxytoca Klebsiella pneumoniae ESBL producing Neisseria gonorrhoeae Pseudomonas aeruginosa
Amp- C producing Escherichia coli E. coli ESBL producing Klebsiella pneumoniae Klebsiella oxytoca Klebsiella pneumoniae ESBL producing Neisseria gonorrhoeae Pseudomonas aeruginosa
Enterococcus faecium Staphylococcus epidermidis Staphylococcus haemolyticus Gram-negative aerobes E. coli multi-resistant Providencia spp.
Enterococcus faecium Staphylococcus epidermidis Staphylococcus haemolyticus Gramnegativni aerobi E. coli multi- resistant Providencia spp.
Stenotrophomonas maltophilia Other pathogens Ureaplasma urealyticum Anaerobes Bacteroides fragilis
Stenotrophomonas maltophilia Ostali povzročitelji Ureaplasma urealyticum Anaerobi Bacteroides fragilis
* MRSA are very likely to be resistant to ciprofloxacin and ciprofloxacin should not be used to treat presumed or known MRSA infections unless the organism is known to be susceptible.
* Obstaja velika verjetnost, da je MRSA rezistentna na ciprofloksacin in ciprofloksacin se ne sme uporabljati za zdravljenje domnevnih ali znanih okužb z MRSA razen če je mikroorganizem ocenjen za občutljivega.
28 Abbreviations:
26 Okrajšave:
Methicillin-resistant Staphylococcus aureus
ESBL: beta- laktamaze razširjenega spektra MRSA: proti meticilinu odporni Staphylococcus aureus
A study on Rhesus-monkeys that were exposed to anthrax by inhalation revealed that 8/ 9 animals survived the experiment when these animals were treated from 1 day after anthrax exposure with ciprofloxacin twice daily for a period of 30 days.
Študija na opicah Rhesus, izpostavljenih vdihanemu antraksu, je pokazala, da je 8 od 9 živalih poskus preživelo, če so te živali od 1. dne po izpostavljenosti antraksu zdravili s ciprofloksacinom dvakrat na dan 30 dni.
The MIC of the Bacillus anthrax strain that was applied in this study was 0.08 µg/ ml.
MIK za sev bakterije Bacillus anthrax, uporabljen v tej študiji, je bila 0, 08 µg/ ml.
Because the MIC90 for ciprofloxacin of 70 other Bacillus anthrax strains varied between 0.03-0.06 µg/ ml, it seems likely that ciprofloxacin would also be effective in other strains than the one that was applied in this study.
Ker je bila MIK90 ciprofloksacina za 70 drugih sevov bakterije Bacillus anthrax od 0, 03 do 0, 06 µg/ ml, bi bil ciprofloksacin verjetno učinkovit tudi pri drugih sevih od tistega, ki je bil uporabljen v tej študiji.
Physicians are recommended to follow current national and/ or international consensus documents regarding the treatment of anthrax.
Zdravniki naj upoštevajo veljavne nacionalne in/ ali mednarodne dokumente o soglasju glede zdravljenja antraksa.
The peak plasma concentration is reached 0.5 - 2 hours after taking 50 - 1000 mg p. o. and varies from 0.3 - 5.9 mg/ l.
Največjo koncentracijo v plazmi doseže od 0, 5 do 2 uri po peroralni uporabi od 50 do 1000 mg in sega od 0, 3 do 5, 9 mg/ l.
The bioavailability of ciprofloxacin after oral administration is between 70% and 85%.
Po peroralni uporabi je biološka uporabnost ciprofloksacina med 70 in 85%.
The bioavailability is lower if antacids that contain aluminium and/ or magnesium hydroxide, and calcium and iron salts are used concomitantly.
Biološka uporabnost je manjša, če so sočasno uporabljeni antacidi, ki vsebujejo aluminijev in/ ali magnezijev hidroksid, ali soli kalcija ali železa.
Twelve hours after i. v. administration of 200 mg the plasma concentration is still higher than the MIC values of the majority of clinically relevant pathogens (approximately 0.1 µg/ ml).
Dvanajst ur po intravenski uporabi 200 mg je koncentracija v plazmi še vedno večja od MIK za večino klinično pomembnih patogenov (približno 0, 1 µg/ ml).
In steady-state conditions the apparent distribution volume of ciprofloxacin is situated between 1,7 and 2,7 l/ kg.
Navidezni volumen porazdelitve ciprofloksacina v stanju dinamičnega ravnovesja je med 1, 7 in 2, 7 l/ kg.
The ciprofloxacin concentration in the sputum consists of 50-70% of the serum concentration.
Koncentracija ciprofloksacina v sputumu je od 50 do 70% tiste v serumu.
The plasma protein binding of ciprofloxacin is situated between 16% and 28% and is not dependent on the concentration and pH (determined by means of ultrafiltration).
Vezava ciprofloksacina na beljakovine v plazmi je med 16 in 28% ter ni odvisna od koncentracije in pH (določeno z ultrafiltracijo).
Biotransformation:
Presnova:
Part of it is converted into desethylene-, sulpho-, oxo- and formylciprofloxacin.
Del se ga spremeni v dezetilen -, sulfo -, okso in formilciprofloksacin.
77%.
Po peroralni uporabi se ciprofloksacin izloči nespremenjen v približno 70%, po intravenski uporabi pa v približno 77%.
After oral administration 45% is excreted unchanged in the urine and 25% is excreted in the faeces.
Po peroralni uporabi se ga 45% izloči nespremenjenega v urinu, 25% pa se ga izloči v blatu.
After i. v. administration 62% is excreted unchanged in the urine and 15% is excreted in the faeces.
Po intravenski uporabi se ga 62% izloči nespremenjenega v urinu, 15% pa se ga izloči v blatu.
After oral administration 19% and after i. v. administration 12% of ciprofloxacin is excreted in the urine and faeces in the form of metabolites.
Po peroralni uporabi se v obliki presnovkov v urinu in blatu izloči 19% ciprofloksacina, po intravenski uporabi pa 12%.
The renal clearance constitutes 60%-70% of the total body clearance and is approximately 3 times higher than the creatinine clearance.
Na račun ledvičnega očistka gre od 60 do 70% celotnega telesnega očistka in je približno 3 -
The renal clearance occurs through glomerular filtration and active tubular secretion.
Ledvični očistek poteka z glomerulno filtracijo in aktivno tubulno sekrecijo.
The elimination half-life of ciprofloxacin after single or multiple oral dosage is between 3,4 and 6,9 hours.
Eliminacijski razpolovni čas ciprofloksacina po posamičnem ali večkratnem peroralnem odmerjanju je med 3, 4 in 6, 9 ure.
After single and multiple i. v. dosage the elimination half-life is between 3 – 4,6 hours.
Po posamičnem in večkratnem intravenskem odmerjanju je eliminacijski razpolovni čas med 3 in 4, 6 ure.
In patients with severely impaired renal function (creatinine clearance < 30 ml/ min) the elimination half-life may be prolonged by a factor of 2.
Pri bolnikih z zelo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/ min) je eliminacijski razpolovni čas lahko podaljšan za faktor 2.
The pharmacokinetics of ciprofloxacin in children with cystic fibrosis differs from that in children without cystic fibrosis, and dosing recommendations are only applicable for children with cystic fibrosis.
Odmerjanje je primerno navesti samo za otroke s cistično fibrozo.
Oral administration of 20 mg/ kg twice daily to children with cystic fibrosis gives an exposure that is comparable to that in adults following an oral dose of 750 mg twice daily.
Peroralno dajanje je 20 mg/ kg dvakrat dnevno pri otrocih s cistično fibrozo, ki je primerljivo z odmerjanjem pri odraslih peroralnega odmerka 750 mg dvakrat dnevno.
Other preclinical effects were observed only at exposures that were sufficiently in excess of the maximum human exposure so that concern for human safety is negligible.
Klinični pomen teh izsledkov je torej majhen.
Sodium chloride Sulphuric acid Sodium hydroxide for pH adjustment Water for injections
natrijev klorid žveplova kislina natrijev hidroksid za uravnavanje pH voda za injekcije
30 6.3 Shelf life
6. 3 Rok uporabnosti
18 months From a microbiological point of view, the product should be used immediately.
18 mesecev Zaradi možne mikrobiološke kontaminacije je treba raztopino uporabiti takoj.
[Ciprofloxacin Kabi 100 mg/ 50 ml solution for infusion: pack sizes:
[Ciprofloxacin Kabi 100 mg/ 50 ml raztopina za infundiranje: velikosti pakiranj:
1, 5, 10, 20, 30 or 40 bags.
1, 5, 10, 20, 30 ali 40 vrečk.
Ciprofloxacin Kabi 200 mg/ 100 ml solution for infusion: pack sizes:
Ciprofloxacin Kabi 200 mg/ 100 ml raztopina za infundiranje: velikosti pakiranj:
Ciprofloxacin Kabi 400 mg/ 200 ml solution for infusion: pack sizes:
Ciprofloxacin Kabi 400 mg/ 200 ml raztopina za infundiranje: velikosti pakiranj:
1, 5, 10, 20, 30 or 40 bags.]
1, 5, 10, 20, 30 ali 40 vrečk]
Ciprofloxacin Kabi is compatible with isotonic sodium chloride solution, Ringer’ s solution, Ringer’ s lactate solution, 50 mg/ ml (5%) or 100 mg/ ml (10%) glucose solution and 50 mg/ ml (5%) glucose s olution with 2.25 mg/ ml (0.225%) or 4.5 mg/ ml (0.45%) sodium chloride solution.
Ciprofloxacin Kabi je združljiv z izotonično raztopino natrijevega klorida, Ringerjevo raztopino, raztopino Ringerjevega laktata, 50 mg/ ml (5%) ali 100 mg/ ml (10%) raztopine glukoze in 50 mg/ ml (5%) raztopine glukoze z 2, 25 mg/ ml (0, 225%) ali 4, 5 mg/ ml (0, 45%) raztopine natrijevega klorida.
Compatibility with these solutions has been proven in the dilution range of 1+1 and 1+4, corresponding to ciprofloxacin concentrations of 0.4 to 1 mg/ ml.
Združljivost s temi raztopinami so dokazali pri redčenju 1+1 in 1+4, kar ustreza koncentracijam ciprofloksacina 0, 4 do 1 mg/ ml.
Unless compatibility is proven, the solution for infusion should always be administered separately (see also section 6.2).
Če združljivost ni dokazana, je treba raztopino za injiciranje vedno uporabljati posebej (glejte tudi poglavje 6. 2).
32 LABELLING
29 OZNAČEVANJE
33 PARTICULARS TO APPEAR ON THE OUTER PACKING
30 PODATKI NA ZUNANJI OVOJNINI
Ciprofloxacin Kabi and associated names (See Annex I) 100 mg/ 50 ml solution for infusion [See Annex I – To be completed nationally]
Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 100 mg/ 50 ml raztopina za infundiranje [glejte Dodatek I – izpolni država članica]
Each bag with 50 ml contains 100 mg ciprofloxacin.
Vsaka vrečka s 50 ml vsebuje 100 mg ciprofloksacina.
Sodium chloride, sulphuric acid, sodium hydroxide, water for injections
Natrijev klorid, žveplova kislina, natrijev hidroksid, voda za injekcije.
Contains sodium compounds.
Vsebuje natrijeve spojine.
Solution for infusion 1, 5, 10, 20, 30, 40 x 50 ml
Rztopina za infundiranje 1, 5, 10, 20, 30, 40 x 50 ml
Keep infusion bag in the overpouch until ready to use in order to protect from light.
31 Infuzijsko vrečko shranjujte v zunanjem ovoju do uporabe za zagotovitev zaščite pred svetlobo.
35 PARTICULARS TO APPEAR ON THE OUTER PACKING
32 PODATKI NA ZUNANJI OVOJNINI
Ciprofloxacin Kabi and associated names (See Annex I) 200 mg/ 100 ml solution for infusion [See Annex I – To be completed nationally]
Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 200 mg/ 100 ml, raztopina za infundiranje [glejte Dodatek I – izpolni država članica]
Solution for infusion 1, 5, 10, 20, 30, 40 x 100 ml
Rztopina za infundiranje 1, 5, 10, 20, 30, 40 x 100 ml
Keep infusion bag in the overpouch until ready to use in order to protect from light.
33 Infuzijsko vrečko shranjujte v zunanjem ovoju do uporabe za zagotovitev zaščite pred svetlobo.
37 PARTICULARS TO APPEAR ON THE OUTER PACKING
34 PODATKI NA ZUNANJI OVOJNINI
Ciprofloxacin Kabi and associated names (See Annex I) 400 mg/ 200 ml solution for infusion [See Annex I – To be completed nationally]
Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 400 mg/ 200 ml, raztopina za infundiranje [glejte Dodatek I – izpolni država članica]
Each bag with 200 ml contains 400 mg ciprofloxacin.
Vsaka vrečka s 400 ml vsebuje 200 mg ciprofloksacina.