natgillin/translations-raw huggingface dataset:
Molenberglei 7 B-2627 Schelle, Belgium Tel-No.:
Molenberglei 7 B- 2627 Schelle, Belgija Tel- No.:
Fresenius Kabi N. V. Molenberglei 7B-2627 Schelle, Belgium Tel-No.:
Fresenius Kabi N. V. Molenberglei 7B- 2627 Schelle, Belgija Tel- No.:
3 Cyprus
Ciper
Ciprofloxacin Kabi 100 mg/ 50 ml,
Ciprofloxacin Kabi 100 2 mg/ ml mg/ 50 ml,
2 mg/ ml
Raztopina za infundiranje
Solution for infusion Intravenous use
Za intravensko uporabo
GR 153-41 Agia Paraskevi solution for infusion Attica, Greece Tel-No.:
GR 153- 41 Agia Paraskevi solution for infusion Attica, Grčija Tel- No.:
0030 210 654 8909 Cyprus
0030 210 654 8909 Ciper
0030 210 654 8909 Czech Republic
0030 210 654 8909 Češka
Fresenius Kabi Nederland Ciprofloxacin Kabi 100 B. V. mg/ 50 ml, Postbus 2379 solution for infusion NL-5202 CJ´s Hertogenbosch, Netherlands Tel-No.:
Fresenius Kabi Nederland Ciprofloxacin Kabi 100 B. V. mg/ 50 ml, Postbus 2379 solution for infusion NL- 5202 CJ´s Hertogenbosch, Nizozemska Tel- No.:
4 Czech Republic
Češka
Fresenius Kabi Nederland Ciprofloxacin Kabi 200 2 mg/ ml B. V. mg/ 100 ml, Postbus 2379 solution for infusion NL-5202 CJ´s Hertogenbosch, Netherlands Tel-No.:
Fresenius Kabi Nederland Ciprofloxacin Kabi 200 B. V. mg/ 100 ml, Postbus 2379 solution for infusion NL- 5202 CJ´s Hertogenbosch, Nizozemska Tel- No.:
Czech Republic
4 Češka
Fresenius Kabi Nederland Ciprofloxacin Kabi 400 2 mg/ ml B. V. mg/ 200 ml, Postbus 2379 solution for infusion NL-5202 CJ´s Hertogenbosch, Netherlands Tel-No.:
Postbus 2379 NL- 5202 CJ´s Hertogenbosch, Nizozemska Tel- No.:
Solution for infusion Intravenous use
Ciprofloxacin Kabi 400 2 mg/ ml mg/ 200 ml, solution for infusion
Fresenius Kabi Deutschland Ciprofloxacin Kabi 100 2 mg/ ml GmbH, D-61346 Bad mg/ 50 ml, solution for Homburg infusion v. d. H. ,GermanyTel-No.:
Fresenius Kabi Deutschland GmbH, D- 61346 Bad Homburg v. d. H., Nemčija Tel- No.:
Solution for infusion Intravenous use
Ciprofloxacin Kabi 100 2 mg/ ml mg/ 50 ml, solution for infusion
Fresenius Kabi Deutschland Ciprofloxacin Kabi 200 2 mg/ ml GmbH, mg/ 100 ml, D-61346 Bad Homburg solution for infusion v. d. H., Germany Tel-No.:
Fresenius Kabi Deutschland GmbH, D- 61346 Bad Homburg v. d. H., Nemčija Tel- No.:
Solution for infusion Intravenous use
Ciprofloxacin Kabi 200 2 mg/ ml mg/ 100 ml, solution for infusion
5 Germany
Nemčija
Fresenius Kabi Deutschland GmbH, D-61346 Bad Homburg v. d. H., Germany Tel-No.:
Fresenius Kabi Deutschland GmbH, D- 61346 Bad Homburg v. d. H., Nemčija Tel- No.:
Denmark
5 Danska
Fresenius Kabi AB SE-75174 Uppsala Sweden Tel-No.:
Fresenius Kabi AB SE- 75174 Uppsala Švedska Tel- No.:
0030 210 654 8909
Ciprofloxacin Kabi 100 2 mg/ ml mg/ 50 ml,
Ciprofloxacin Kabi 100 2 mg/ ml mg/ 50 ml, solution for infusion
Raztopina za infundiranje
Greece
GR 153- 41 Agia Paraskevi solution for infusion Attica, Grčija Tel- No.:
354 Messoghoin Avenue GR 153-41 Agia Paraskevi Attica, Greece Tel-No.:
Ciprofloxacin Kabi 200 354 Messoghoin Avenue mg/ 100 ml, GR 153- 41 Agia Paraskevi solution for infusion Attica, Grčija Tel- No.:
Ciprofloxacin Kabi 200 2 mg/ ml mg/ 100 ml, solution for infusion
Raztopina za infundiranje
6 Greece
Grčija
Ciprofloxacin Kabi 400 2 mg/ ml 354 Messoghoin Avenue mg/ 200 ml, GR 153-41 Agia Paraskevi solution for infusion Attica, Greece Tel-No.:
Ciprofloxacin Kabi 400 354 Messoghoin Avenue mg/ 200 ml, GR 153- 41 Agia Paraskevi solution for infusion Attica, Grčija Tel- No.:
Fresenius Kabi España Ciprofloxacin Kabi 2 2 mg/ ml S. A. c. / Marina 16-18, planta mg/ ml, solution for 17, E-08005 infusion Barcelona, SpainTel-No.:
Fresenius Kabi España Ciprofloxacin Kabi 2 S. A. c. / Marina 16- 18, planta mg/ ml, solution for 17, E- 08005 Barcelona, infusion Španija Tel- No.:
Finland
6 Finska
Fresenius Kabi AB Ciprofloxacin Fresenius 2 mg/ ml SE-75174 Uppsala Kabi 2 mg/ ml, solution Sweden for infusion Tel-No.:
Fresenius Kabi AB SE- 75174 Uppsala Švedska Tel- No.:
Solution for infusion Intravenous use
Ciprofloxacin Fresenius 2 mg/ ml Kabi 2 mg/ ml, solution for infusion
7 Hungary
Madžarska
Fresenius Kabi Italia S. r. L. via Camagre 41 I-37063 Isola della Scala (VR), Italy Tel-No.:
Fresenius Kabi Italia S. r. L. via Camagre 41 I- 37063 Isola della Scala (VR), Italija Tel- No.:
Italy
7 Italija
8 Poland
Poljska
Fresenius Kabi Deutschland GmbH, D-61346 Bad Homburg v. d. H. ,GermanyTel-No.:
Fresenius Kabi Deutschland GmbH, D- 61346 Bad Homburg v. d. H., Nemčija Tel- No.:
Poland
8 Poljska
Fresenius Kabi Deutschland GmbH, D-61346 Bad Homburg v. d. H., Germany Tel-No.:
Fresenius Kabi Deutschland Ciprofloxacin Kabi 400 2 mg/ ml GmbH, mg/ 200 ml, D- 61346 Bad Homburg solution for infusion v. d. H., Nemčija Tel- No.:
Ciprofloxacin Kabi 400 2 mg/ ml mg/ 200 ml, solution for infusion
Raztopina za infundiranje
100 mg/ 50 ml
Portugalska
Forte 3, Edifício Suécia IV, Piso 3, 2794-039 Carnaxide, Portugal Tel-No.:
Fresenius Kabi Pharma Ciprofloxacin Kabi 100 2 mg/ ml Portugal Lda., Avenida do mg/ 50 ml, Forte 3, Edifício Suécia IV, solution for infusion Piso 3, 2794- 039 Carnaxide, Portugalska Tel- No.:
solution for infusion
Raztopina za infundiranje
Fresenius Kabi Pharma
Za intravensko uporabo
200 mg/ 100 ml
Portugalska
Portugal Lda., Avenida do mg/ 100 ml, Forte 3, Edifício Suécia IV, solution for infusion Piso 3, 2794-039 Carnaxide, Portugal Tel-No.:
Fresenius Kabi Pharma Ciprofloxacin Kabi 200 2 mg/ ml Portugal Lda., Avenida do mg/ 100 ml, Forte 3, Edifício Suécia IV, solution for infusion Piso 3, 2794- 039 Carnaxide, Portugalska Tel- No.:
Fresenius Kabi Pharma
Raztopina za infundiranje
Ciprofloxacin Kabi 400 2 mg/ ml
Za intravensko uporabo
Solution for infusion Intravenous use
200 mg/ 100 ml
400 mg/ 200 ml
Portugalska
Portugal Lda., Avenida do mg/ 200 ml, Forte 3, Edifício Suécia IV, solution for infusion Piso 3, 2794-039 Carnaxide, Portugal Tel-No.:
Fresenius Kabi Pharma Ciprofloxacin Kabi 400 2 mg/ ml Portugal Lda., Avenida do mg/ 200 ml, Forte 3, Edifício Suécia IV, solution for infusion Piso 3, 2794- 039 Carnaxide, Portugalska Tel- No.:
200 mg/ 100 ml, 400 mg/ 200 ml
Raztopina za infundiranje
Slovak Republic
Za intravensko uporabo
100 mg/ 50 ml
Slovaška
Homburg v. d. H. ,Germany infusion Tel-No.:
Fresenius Kabi Deutschland GmbH, D- 61346 Bad Homburg v. d. H., Nemčija Tel- No.:
10 Slovak Republic
Za intravensko uporabo
Fresenius Kabi Limited Cestrian Court, Eastgate Way Manor Park, Runcorn Cheshire WA7 1NT, UK, Tel-No.:
Fresenius Kabi Limited Cestrian Court, Eastgate Way Manor Park, Runcorn Cheshire WA7 1NT, Velika Britanija Tel- No.:
0044 1928 594221 Fax. No.:
0044 1928 594221
Ciprofloxacine Kabi 100 2 mg/ ml mg/ 50 ml, solution for infusion
Ciprofloxacine Kabi 100 2 mg/ ml mg/ 50 ml, solution for infusion
100 mg/ 50 ml
Za intravensko uporabo
Solution for infusion Intravenous use
0044 1928 594314
200 mg/ 100 ml
Velika Britanija
Way Manor Park, Runcorn solution for infusion Cheshire WA7 1NT, UK, Tel-No.:
Fresenius Kabi Limited Cestrian Court, Eastgate Way Manor Park, Runcorn Cheshire WA7 1NT, Velika Britanija Tel- No.:
11 United Kingdom
Ciprofloxacine Kabi 200 2 mg/ ml mg/ 100 ml, solution for infusion
Fresenius Kabi Limited Cestrian Court, Eastgate
Raztopina za infundiranje
Ciprofloxacine Kabi 400 2 mg/ ml mg/ 200 ml,
Za intravensko uporabo
400 mg/ 200 ml
Velika Britanija
12 ANNEX II
12 ZNANSTVENI ZAKLJUČKI
Ciprofloxacin exerts a rapid bactericidal effect by inhibiting DNA-gyrase, resulting in inhibition of DNA synthesis.
Ciprofloksacin ima hiter baktericidni učinek zaradi zaviranja DNA- giraze in s tem posledično sinteze DNA.
Ciprofloxacin is rapidly and effectively absorbed after oral administration.
Ciprofloksacin se po peroralnemu dajanju hitro in učinkovito absorbira.
In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient’ s compliance and dosing need to be adequate.
Da bi se izognili pojavu odpornosti in neuspehu pri zdravljenju, sta predpogoja za zdravljenje primerno sodelovanje bolnika in ustrezno odmerjanje.
During the referral procedure the Applicant/ Marketing Authorisation Holder was requested to submit:
Med napotitvenim postopkom je moral vlagatelj/ imetnik dovoljenja za promet predložiti:
1. clinical data and discuss the risk/ benefit of the proposed dose in urinary tract infections (UTI).
Klinične podatke in razpravo o tveganjih in koristnih učinkih predlaganega odmerka pri okužbah sečil.
The applicant/ MAH should discuss both the 100 mg twice daily (bid) dose and the 200 – 400 mg bid dose from a safety and efficacy point of view.
Vlagatelj/ imetnik dovoljenja za promet bi moral v razpravi preučiti varnost in učinkovitost odmerka 100 mg dvakrat na dan (bid) kot tudi odmerka 200- 400 mg dvakrat dnevno.
In doing so the applicant/ MAH should discuss the data in relation to complicated and uncomplicated, upper and lower urinary tract infections.
Pri tem bi moral vlagatelj/ imetnik dovoljenja za promet podatke obravnavati tudi glede na zapletene in nezapletene oblike okužb ter okužb zgornjih in spodnjih sečil.
2. clinical data and discuss the risk/ benefit of the maximum adult daily dose, i. e. whether it should be 400 mg bid or 400 mg three times daily.
Klinične podatke in razpravo o tveganjih/ koristnih učinkih največjega dnevnega odmerka pri odraslih, t. j. ali naj slednji znaša 400 mg dvakrat dnevno ali 400 mg trikrat na dan.
The applicant/ MAH did not submit any clinical data to address the questions related to the risk/ benefit of the proposed dose in UTIs and the maximum adult daily dose, as this application is a so called ″ generic″ application (reference product/ originator Ciproxin from Bayer).
Ker gre za t. i. "generično" vlogo (referenčno zdravilo in originator je Ciproxin podjetja Bayer), vlagatelj/ imetnik dovoljenja za promet ni predložil kliničnih podatkov za reševanje vprašanj, povezanih s tveganji in koristnimi učinki pri predlaganem odmerku za zdravljenje okužb sečil in največjim dnevnim odmerkom pri odraslih.
The applicant/ MAH performed a review of published clinical studies from the mid 1990’ s to date, to support the recommended posology of 200-400 mg ciprofloxacin twice daily in the treatment of complicated urinary tract infections.
Vlagatelj/ imetnik dovoljenja za promet je opravil pregled objavljenih kliničnih raziskav od sredine 1990- ih let do današnjega dne, da bi podprl predlagani način odmerjanja z odmerki od 200 do 400 mg ciprofloksacina dvakrat dnevno za zdravljenje zapletenih primerov okužbe sečil.
In the majority of studies a regimen of 500 mg b. i. d. p. o. was used.
Pri večini raziskav je predpisani način zdravljenja vključeval odmerke po 500 mg dvakrat dnevno, dane po peroralni poti.
As ciprofloxacin is 70– 85% bioavailable, the oral doses of 250-500mg bid. used in most of the published studies presented are equivalent to the 200-400mg b. id. intravenous dose.
Ker znaša biološka razpoložljivost ciprofloksacina 70 – 85%, je višina peroralnih odmerkov od 250 - 500 mg dvakrat dnevno, ki so jih uporabljali v večini objavljenih raziskav, enakovredna intravenoznemu odmerku 200- 400 mg dvakrat dnevno.
Two studies of oral doses of 100 mg b. i. d. demonstrated clinical efficacy of 93% and bacterial eradication of 89%, but this was for the treatment of uncomplicated UTI (3) and efficacy of 91% (n=23) without development of resistance (2).
Dve raziskavi peroralnih 100 mg odmerkov dvakrat dnevno sta pokazali 93% klinično učinkovitost in 89% eradikacijo bakterij, vendar le pri zdravljenju nezapletenih okužb sečil (3), in 91% učinkovitost (n=23) brez pojava odpornosti (2).
No clinical study using 100 mg i. v. twice daily for the treatment of complicated urinary tract infections was identified.
Ne obstaja nobena raziskava, pri kateri bi za zdravljenje zapletenih okužb sečil uporabljali 100 mg intravenozni odmerek dvakrat dnevno.
An additional factor for consideration is the emergence of increasing ciprofloxacin resistance, particularly in the last 10-15 years.
Dodatni dejavnik, ki ga je treba upoštevati, je pojav naraščajoče odpornosti na ciprofloksacin, ki je še posebej prisoten v zadnjih 10- 15 letih.
To maintain the activity of the fluoroquinolone class, clinicians need to implement an evidence-based approach to antimicrobial selection, particularly a strategy in which the most pharmacodynamically potent fluoroquinolone is matched, on an empiric basis when required, to anticipated bacterial pathogens.
Da bi ohranili aktivnost fluorokinolonov, morajo klinični zdravniki pri izbiri antimikrobiotikov uporabiti pristop, ki temelji na dokazih, zlasti pa strategijo, pri kateri se za
14 Medical practice in the treatment of complicated UTI’ s with ciprofloxacin has developed and changed since the time of first licensing in 1987 and the proposed dosing is in line with current medical practice (5) and supported by the published literature.
Zdravstvena praksa zdravljenja zapletenih okužb sečil s ciprofloksacinom se je razvila in spremenila od tiste, ki je veljala v času prve podelitve licence leta 1987, predlagano odmerjanje pa je usklajeno s trenutno medicinsko prakso (5) in ga podpira tudi objavljena literatura.
The frequencies of probably and/ or possibly drug-related adverse events did not differ significantly between ciprofloxacin-treated patients and the comparator groups.
Pogostost neželenih učinkov, ki so verjetno in/ ali morda povezani z zdravili, pri bolniki zdravljenih s ciprofloksacinom ni kazala znatnih odstopanj glede na primerjalne skupine.
GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
14 PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
- The body of published literature and resistance data presented provide adequate justification, both
- Predstavljena objavljena literatura in podatki o odpornosti so s stališča učinkovitosti in varnosti
from an efficacy and safety viewpoint, for the dosing regimen of 200-400 mg ciprofloxacin twice daily for the treatment of complicated UTI.
zadostna utemeljitev za zdravljenje zapletenih okužb sečil z odmerki 200- 400 mg ciprofloksacina dvakrat dnevno.
- From the published data, which have demonstrated for the proposed maximum dose 400 mg i. v. three
- Ni razloga, da bi na podlagi objavljenih podatkov, ki so za predlagani najvišji odmerek 400 mg
times daily as a maximum dose, a superior prevention of antibiotic resistance without a significant increase in adverse reactions in serious and life-threatening infections of other organ systems, there is 15 no reason to conclude that this favourable risk/ benefit profile would differ significantly in the treatment of complicated UTIs.
intravensko trikrat dnevno pokazali prednosti pri preprečevanju antibiotične odpornosti brez znatnega povečanja neželenih učinkov pri resnih in življenjsko nevarnih okužbah drugih organskih sistemov, zaključili, da bo ta profil tveganj/ koristi znatno odstopal od tistega pri zdravljenju zapletenih okužb sečil.
- The applicant submitted in addition to the proposed Summary of Product Characteristics, a proposal
- Vlagatelj je poleg predloga Povzetka glavnih značilnosti zdravila predložil tudi predlog za usklajeno
for harmonised labelling and package leaflet.
označevanje in Navodila za uporabo.
The CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Ciprofloxacin Kabi and associated names (see Annex I).
CHMP je za Ciprofloxacin Kabi in z njim povezana imena (glej Dodatek I) priporočil odobritev dovoljenj( a) za promet, katerih Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo so opredeljeni v Dodatku III.
16 ANNEX III
16 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Ciprofloxacin Kabi and associated names (See Annex I) 100 mg/ 50 ml, solution for infusion Ciprofloxacin Kabi and associated names (See Annex I) 200 mg/ 100 ml, solution for infusion Ciprofloxacin Kabi and associated names (See Annex I) 400 mg/ 200 ml, solution for infusion
Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 100 mg/ 50 ml raztopina za infundiranje Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 200 mg/ 100 ml raztopina za infundiranje Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 400 mg/ 200 ml raztopina za infundiranje
[See Annex I – To be completed nationally]
[glejte Dodatek I – izpolni država članica]
Each ml of solution for infusion contains 2 mg ciprofloxacin (as hydrogen sulphate)
1 ml raztopine za infundiranje vsebuje 2 mg ciprofloksacina (v obliki ciprofloksacinijevega hidrogensulfata).
[Each bag with 50 ml contains 100 mg ciprofloxacin.
[Vsaka vrečka s 50 ml vsebuje 100 mg ciprofloksacina.
Each bag with 200 ml contains 400 mg ciprofloxacin.] Excipient: sodium
Vsaka vrečka z 200 ml vsebuje 400 mg ciprofloksacina.] Pomožna snov: natrij
Solution for infusion Clear, colourless solution pH of the solution:
Bistra, brezbarvna raztopina. pH raztopine:
4.0 to 4.9
4, 0 do 4, 9
Ciprofloxacin Kabi is indicated for the treatment of serious and/ or life-threatening infections caused by ciprofloxacin-susceptible pathogens.
Ciprofloxacin Kabi je indiciran za zdravljenje resnih in/ ali smrtno nevarnih okužb, ki jih povzročajo za ciprofloksacin občutljivi mikroorganizmi.
The following indications can be considered for treatment with Ciprofloxacin Kabi when oral therapy is not possible or not reliable:
Zdravljenje s Ciprofloxacinom Kabi pride v poštev pri naslednjih indikacijah, če peroralno zdravljenje ni mogoče ali ni zanesljivo:
- complicated urinary tract infections
- zapletenih okužbah sečil,
- infections of the lower respiratory tract including pneumonia caused by aerobic gram-negative
- okužbe spodnjih dihal, vključno s pljučnicami, ki jih povzročajo aerobne gramnegativne
bacteria, in case of Streptococcus pneumoniae infections ciprofloxacin is not the substance of first choice.
bakterije; v primeru okužb s Streptococcus pneumoniae, ciprofloksacin ni zdravilo prve izbire.
- complicated skin and soft tissue infections
- zapletenih okužbah kože in mehkih tkiv,
- osteomyelitis
- osteomielitisu.
20 Due to the increased risk of local reactions, higher intravenous doses in particular should only be administered via a large vein or a central line.
18 Zaradi povečanega tveganja za lokalne reakcije, je treba posebej večje intravenske odmerke aplicirati v veliko veno ali centralno linijo.
Mixing with other solutions: see sections 6.2 and 6.6.
Mešanje z drugimi raztopinami: glejte poglavji 6. 2 in 6. 6.
Generally, acute and chronic infections (e. g. osteomyelitis and prostatitis, etc), where the causative organism is known to be sensitive to ciprofloxacin, should be treated for at least three days after the signs and symptoms of the infection have disappeared.
Za akutne in kronične okužbe (tj. osteomielitis in prostatitis, itd.), kjer je znano, da je povzročitelj občutljiv za ciprofloksacin, splošno velja, da jih je treba zdravljenje nadaljevati najmanj tri dni po izginotju znakov in simptomov okužb.
The adult dosage is 200 – 400 mg ciprofloxacin twice daily.
Odmerjanje za odrasle je od 200 do 400 mg dvakrat na dan.
As with all other antibiotics, the patient should be monitored during therapy for the development of resistant strains of initially sensitive bacteria, especially P. aeruginosa and S. aureus (see the relevant statements in section 5.1).
Tako kot pri zdravljenju z drugimi antibiotiki je treba bolnika med terapijo nadzirati glede pojava odpornih sevov uvodoma občutljivih bakterij, zlasti P. aeruginosa in S. aureus (glejte zadevne navedbe v poglavju 5. 1).
Average duration of treatment can be 4-6 weeks.
Povprečno trajanje zdravljenja je 4 – 6 tednov.
In patients with a creatinine clearance in the range 31 – 60 ml/ minute/ 1.73 m2 or a serum creatinine concentration in the range 124 – 174 µmol/ l, the maximum daily intravenous dose is 800 mg.
Pri bolnikih z očistkom kreatinina od 31 - 60 ml/ min/ 1, 73 m2 ali koncentracijo kreatinina v serumu v obsegu 124 - 174 µmol/ l, je največji dnevni intravenski odmerek 800 mg.
If creatinine clearance is ≤ 30 ml/ minute/ 1.73 m2 or the serum creatinine concentration is ≥ 175 µmol/ l, the maximum daily intravenous dose is 400 mg.
Če je očistek kreatinina ≤ 30 ml/ min/ 1, 73 m2 ali je koncentracija kreatinina v serumu ≥ 175 µmol/ l, je največji dnevni intravenski odmerek 400 mg.
In patients on haemodialysis or CAPD, the maximum daily intravenous dose is also 400 mg.
Tudi pri bolnikih na hemodializi ali kontinuirani ambulantni peritonealni dializi je venski odmerek 400 mg.
On the dialysis days, the dose is given after the haemodialysis session.
Na dan dialize mora bolnik odmerek dobiti po hemodializi.
In case of impaired hepatic function it is not necessary to adjust the dosage.
V primeru okvarjenega delovanja jeter odmerka ni potrebno prilagoditi.
Acute lower respiratory tract infections caused by Pseudomonas aeruginosa in children and adolescents (5-17years) with cystic fibrosis:
Akutne okužbe spodnjih dihal, ki jih povzroča Pseudomonas aeruginosa, pri otrocih in mladostnikih (5– 17 let) s cistično fibrozo:
Twice daily intravenous administration of 15 mg/ kg bodyweight, or 10 mg/ kg bodyweight three times daily (maximum of 1200 mg per day).
Intravenska aplikacija 15 mg/ kg telesne mase dvakrat na dan ali 10 mg/ kg telesne mase trikrat na dan (največ 1200 mg na dan).
Dosage as follows:
Odmerjanje je:
Twice daily intravenous administration of 15 mg/ kg bodyweight, or 10 mg/ kg bodyweight three times daily (maximum of 1200 mg per day), then twice daily oral administration.
Intravenska aplikacija 15 mg/ kg telesne mase dvakrat na dan ali 10 mg/ kg telesne mase trikrat na dan (največ 1200 mg na dan), nato peroralna uporaba dvakrat dnevno.
The dosage in children with impaired renal and/ or hepatic function has not been investigated.
Odmerjanje pri otrocih z okvarjenim delovanjem ledvic in/ ali jeter ni raziskano.
Ciprofloxacin Kabi is contraindicated in:
19 4. 3 Kontraindikacije Ciprofloxacin Kabi je kontraindiciran pri:
- patients with a hypersensitivity to ciprofloxacin, chinolin carboxylic acid derivatives or to any of
- bolnikih s preobčutljivostjo za ciprofloksacin, derivate kinolinkarboksilne kisline ali
the excipients
katerokoli pomožno snov v zdravilu,
- children under 5 years of age.
- otrocih mlajših od 5 let starosti.
With regard to the safety and use of ciprofloxacin in children, see
Glede varnosti in uporabe ciprofloksacina pri otrocih
also section 4.4
glejte tudi poglavje 4. 4,
- Children and growing adolescents except for the treatment of acute pulmonary exacerbations of
- otrocih in odraščajočih mladostnikih, starih od 5- 17 let, razen za zdravljenje akutnega
cystic fibrosis in children aged 5 to 17 years.
poslabšanja pljučne cistične fibroze,
- pregnancy and lactation
- nosečnosti in dojenju,
- patients with a history of tendon disorder related to fluoroquinolone administration
- bolnikih z anamnezo poškodbe kite povezane z dajanjem fluorokinolona.
Patients with a family history of or actual defects in glucose-6-phosphate dehydrogenase activity are prone to haemolytic reactions with quinolones, and so ciprofloxacin should be used with caution in these patients.
Bolniki z družinsko anamnezo motenj aktivnosti glukoza- 6- fosfat dehidrogenaze so nagnjeni k hemolitičnim reakcijam s kinoloni in zato je treba ciprofloksacin pri teh bolnikih dajati s previdnostjo.
In patients with epilepsy or other lesions of the central nervous system (e. g. reduced convulsion threshold, a history of epileptic seizures, diminished cerebral bloodflow, changes in brain structure or stroke), ciprofloxacin is only to be used after carefully weighing the benefits against the risk, because the possibility of central nervous side effects puts these patients at increased risk.
Ti bolniki so namreč zaradi možnosti neželenih učinkov na osrednjem živčevju bolj ogroženi.
Since ciprofloxacin is associated with very rare cases of QT prolongation (see section 4.8) caution should be exercised when treating patients at risk for torsade de pointes arrhythmia.
Ker je ciprofloksacin povezan z zelo redkimi primeri QT podaljšanja (glejte poglavje 4. 8) je potrebna previdnost pri zdravljenu bolnikov s tveganjem za aritmijo “ torsade de pointes ”.