natgillin/translations-raw huggingface dataset:
Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Zdravljenje s ciprofloksacinom lahko začne le zdravnik, ki ima izkušnje z zdravljenjem cistične fibroze/ hudih okužb pri otrocih in mladostnikih.
173 n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years) revealed an incidence of suspected drug-related arthropathy (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%.
4, 6%.
Treatment should be initiated only after a careful benefit/risk evaluation, due to possible adverse events related to joints and/or surrounding tissue.
Zaradi možnih neželenih učinkov na sklepe in/ ali sosednja tkiva, se zdravljenje lahko začne samo po skrbni oceni koristnosti zdravljenja in tveganja.
Musculoskeletal System Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment.
Mišičnoskeletni sistem Ciprofloksacin se praviloma ne sme uporabljati pri bolnikih z boleznimi/ poškodbami kit v anamnezi, ki so bile povezane z zdravljenjem s kinoloni.
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.
V zelo redkih primerih, glede na mikrobiološke izvide o povzročiteljih in oceni tveganja in koristi, se lahko ciprofloksacin predpiše tudi tem bolnikom za 178 zdravljenje posebno hudih okužb, predvsem če je bilo standardno zdravljenje neuspešno ali odpornost bakterije opravičuje uporabo ciprofloksacina.
174 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).
Resistance During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection.
179 Odpornost Med ali po zdravljenju s ciprofloksacinom se lahko izolirajo bakterije odporne na ciprofloksacin, z ali brez klinično izražene superinfekcije.
There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.
Tveganje je večje posebno med dolgotrajnim zdravljenjem, pri zdravljenju nozokomialnih okužb in/ ali kadar so povzročitelji iz vrst Staphylococcus in Pseudomonas.
Cytochrome P450 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, ropinirole, tizanidine).
Citokrom P450 Ciprofloksacin zavira encimski sistem CYP1A2, kar lahko povzroči zvišanje serumskih koncentracij sočasno danih zdravil, ki se presnavljajo s pomočjo tega encima (npr. teofilin, klozapin, ropinirol, tizanidin).
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).
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).
Injection Site Reaction Local intravenous site reactions have been reported with the intravenous administration of ciprofloxacin.
Reakcije na mestu injiciranja Po intravenski uporabi ciprofloksacina se lahko pojavijo lokalne reakcije.
175 Glucose Load Ciprofloxacin Bayer solution for infusion contains 5 g glucose in 100 mL solution for infusion.
Vsebnost glukoze Raztopina za infundiranje Ciprofloksacin Bayer vsebuje 5 g glukoze v 100 ml raztopine za infundiranje.
Effects of other medicinal products on ciprofloxacin:
Vpliv drugih zdravil na ciprofloksacin
Methotrexate
180 Metotreksat
Pregnancy The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin.
Nosečnost Podatki o uporabi ciprofloksacina pri nosečnicah, ki so na voljo, ne kažejo malformacij ali feto/ neonatalne toksičnosti.
Lactation Ciprofloxacin is excreted in breast milk.
181 Dojenje Ciprofloksacin se izloča v materino mleko.
Common ≥ 1/100 to <
Občasni
Uncommon ≥ 1/1 000 to <
Zelo redki < 1/ 10. 000
Rare ≥ 1/10 000 to <
≥ 1/ 1. 000 do
Very Rare < 1/ 10 000
≥ 1/ 10. 000 do <
Frequency not known
oceniti iz
1/1 000
1/ 1. 000
177
in
System Organ Class
edem/ angioedem
Common ≥ 1/100 to <
hiperglikemija
Blood and Lymphatic System Disorders
Psihiatrične
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia
motnje
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
na
Immune System Disorders
dezorientiranost
Psychiatric Disorders
periferna
Psychomotor hyperactivity / agitation
živčevja
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
omotica
Psychotic reactions (see section 4.4)
disestezija
Nervous System Disorders
nevropatija
Vascular Disorders
pankreatitis
Vasodilatation Hypotension Syncope
bolečine v trebuhu dispepsija flatulenca
Vasculitis
jetrna okvara
178 System Organ Class
jetrna nekroza
Common ≥ 1/100 to <
žolčnika in
Respiratory, Thoracic and Mediastinal Disorders
žolčevodov
Dyspnoea (including asthmatic condition)
zvišanje vrednosti bilirubina
Gastrointestinal Disorders
nevarno jetrno odpoved)
Nausea Diarrhoea
Bolezni
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
izpuščaji
Pancreatitis
fotosenzitivne
Hepatobiliary Disorders
petehije
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
Erythema
Skin and Subcutaneous Tissue Disorders
podkožja
Musculoskeletal, Connective Tissue and Bone Disorders
mišičnega tonusa
Musculoskeletal pain (e.g. extremity pain, back pain, chest pain) Arthralgia
(predvsem
179
edem
System Organ
težave in
Common
zvišana
Uncommon
hidroza)
Very Rare
zvišanje
Frequency
nenormalne
Class
Pogosti
≥ 1/ 100 to <
Občasni
≥ 1/1 000 to <
Zelo redki < 1/ 10. 000
≥ 1/10 000 to <
≥ 1/ 1. 000 do
< 1/ 10 000
≥ 1/ 10. 000 do <
Asthenia Fever
krvi
Investigations
vrednosti amilaze
Vomiting, Transient increase in transaminases, Rash Thrombocytopenia, Thrombocytaemia, Confusion and disorientation, Hallucinations, Par- and dysaesthesia, Seizures, Vertigo, Visual disturbances, Hearing loss, Tachycardia, Vasodilatation, Hypotension, Transient hepatic impairment, Cholestatic icterus, Renal failure, Oedema
bruhanje, prehodno zvišanje vrednosti transaminaz, izpuščaj trombocitopenija, trombocitemija, zmedenost in dezorientiranost, halucinacije, parestezija in disestezija, krči, vrtoglavica, motnje vida, oglušitev, tahikardija, vazodilatacija, hipotenzija, prehodna jetrna okvara, holestatska zlatenica, ledvična odpoved, edem
Pancytopenia, Bone marrow depression, Anaphylactic shock, Psychotic reactions, Migraine, Olfactory nerve disorders, Hearing impaired, Vasculitis, Pancreatitis, Liver necrosis, Petechiae, Tendon rupture
pancitopenija, depresija kostnega mozga, anafilaktični šok, psihotične reakcije, migrena, motnje vonja, okvara sluha, vaskulitis, pankreatitis, jetrna nekroza, petehije, pretrganje kite
180 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.
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.
PK/PD relationship:
Razmerje farmokokinetike/ farmoakodinamike
Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.
185 Učinek je odvisen predvsem od razmerja med največjo serumsko koncentracijo (Cmax) in minimalno inhibitorno koncentracijo (MIK) ciprofloksacina proti bakterijam oziroma razmerja med področjem pod krivuljo (AUC) in MIK.
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 fizikalno - kemijskih lastnosti različnih zdravilnih učinkovin znotraj skupine ter afinitete do transportnih sistemov vsake posamezne zdravilne učinkovine.
S ≤ 0.5 mg/L S ≤ 0.5 mg/L S ≤ 1 mg/L S ≤ 1 mg/L
S < 0, 5 mg/ l S < 0, 5 mg/ l S < 1 mg/ l S < 1 mg/ l S < 0, 5 mg/ l S < 0, 03 mg/ l S < 0, 03 mg/ l S < 0, 5 mg/ l
R > 1 mg/L R > 1 mg/L R > 1 mg/L R > 1 mg/L
R > 1 mg/ l R > 1 mg/ l R > 1 mg/ l R > 1 mg/ l R > 0, 5 mg/ l R > 0, 06 mg/ l R > 0, 06 mg/ l R > 1 mg/ l
1 Staphylococcus spp. - breakpoints for ciprofloxacin relate to high dose therapy. * Non-species-related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species.
1 Staphylococcus spp. – mejne vrednosti za ciprofloksacin povezane z zdravljenjem z visokimi odmerki. * Mejne vrednosti za nespecifične vrste so določili na podlagi farmakokinetičnih in farmakodinamičnih podatkov in so neodvisne od distribucije MIK- a za specifične vrste.
181 COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
186 SPLOŠNO OBČULJIVE VRSTE aerobni, po Gramu pozitivni mikroorganizmi Bacillus anthracis( 1) aerobni, po Gramu negativni mikroorganizmi Aeromonas spp.
Yersinia pestis Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Aerobic Gram-positive micro-organisms Enterococcus faecalis ($) Staphylococcus spp. *(2) Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia +* Campylobacter spp.+* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae * Escherichia coli* Klebsiella oxytoca Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp.
Yersinia pestis anaerobni mikroorganizmi Mobinculus drugi mikroorganizmi Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) VRSTE, PRI KATERIH JE PRIDOBLJENA ODPORNOST LAHKO DVOMLJIVA aerobni, po Gramu pozitivni mikroorganizmi Enterococcus faecalis ($) Staphylococcus spp. * (2) aerobni, po Gramu negativni mikroorganizmi Acinetobacter baumannii+ Burkholderia cepacia + * Campylobacter spp. + * Citrobacter freundii * Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Klebsiella pneumoniae * Morganella morganii * Neisseria gonorrhoeae * Proteus mirabilis * Proteus vulgaris * Providencia spp.
Natural intermediate susceptibility in the absence of acquired mechanism of resistance (1):
187 aerobni, po Gramu negativni mikroorganizmi Stenotrophomonas maltophilia anaerobni mikroorganizmi razen mikroorganizmov navedenih zgoraj drugi mikroorganizmi Mycoplasma genitalium Ureaplasma urealitycum * klinično učinkovitost so dokazali pri občutljivih izolatih za odobrene klinične indikacije + stopnja odpornosti ≥ 50% v eni ali več državah Evropske unije ($) naravna vmesna občutljivost v odsotnosti pridobljene odpornosti (1):
The treating physician should refer to national and /or international consensus documents regarding treatment of anthrax.
Lečeči zdravnik mora upoštevati nacionalne in/ ali mednarodne smernice glede zdravljenja vraničnega prisada.
Pharmacokinetics of ciprofloxacin were linear over the dose range up to 400 mg administered intravenously.
Farmakokinetika ciprofloksacina je linearna pri i. v. odmerkih do 400 mg.
Comparison of the pharmacokinetic parameters for a twice a day and three times a day intravenous dose regimen indicated no evidence of drug accumulation for ciprofloxacin and its metabolites.
Primerjava farmakokinetičnih parametrov pri i. v. uporabi zdravila dvakrat in trikrat na dan ne potrjuje kopičenja ciprofloksacina in njegovih presnovkov.
A 60-minute intravenous infusion of 200 mg ciprofloxacin or the oral administration of 250 mg ciprofloxacin, both given every 12 hours, produced an equivalent area under the serum concentration time curve (AUC).
Pri 60- minutnem intravenskem infundiranju 200 mg ciprofloksacina ali po peroralni uporabi 250 mg ciprofloksacina na 12 ur je AUC enaka.
A 60-minute intravenous infusion of 400 mg ciprofloxacin every 12 hours was bioequivalent to a 500 mg oral dose every 12 hours with regard to AUC.
60- minutno infuzija 400 mg ciprofloksacina na vsakih 12 ur je bioekvivalentna 500 mg peroralnemu odmerku na 12 ur glede na AUC.
The 400 mg intravenous dose administered over 60 minutes every 12 hours resulted in a Cmax similar to that observed with a 750 mg oral dose.
Cmax je po i. v. uporabi 400 mg ciprofloksacina v 60 minutah na vsakih 12 ur podobna kot pri peroralni uporabi odmerka 750 mg.
A 60-minute infusion of 400 mg ciprofloxacin every 8 hours is equivalent with respect to AUC to 750 mg oral regimen given every 12 hours.
AUC je po 60- minutnem infundiranju 400 mg ciprofloksacina na vsakih 8 ur enaka kot pri 750 mg peroralnem odmerku na vsakih 12 ur.
Ciprofloxacin
Ravnotežni volumen porazdelitve je velik, 2 – 3 l/ kg telesne mase.
183 reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflamed lesions (cantharides blister fluid), and the urogenital tract (urine, prostate, endometrium) where total concentrations exceeding those of plasma concentrations are reached.
Ciprofloksacin doseže visoke koncentracije v določenih tkivih kot so pljuča (epitelijska tekočina, alveolarni makrofagi, biopsijska tkiva), sinusi in vnetne lezije in urogenitalni trakt (seč, prostata, endometrij), kjer skupna koncentracija preseže dosežene plazemske koncentracije.
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).
To so desetilenciprofloksacin (M1), sulfociprofloksacin (M2), oksociprofloksacin (M3) in 188 formilciprofloksacin (M4).
Excretion of ciprofloxacin (% of dose) Intravenous Administration
izločanje ciprofloksacina (% odmerka)
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.
No notable increase in Cmax and AUC upon multiple dosing (10 mg/kg three times daily) was observed.
Pri večkratnem odmerjanju (10 mg/ kg trikrat dnevno) niso opazili značilnega povečanja Cmax in AUC.
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.
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).
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.
16, 5 mg * / l (med 11, 0 in 23, 8 mg * / l) glede na starostno skupino.
184 Articular tolerability:
Vplivi zdravila na sklepe:
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
[To be completed nationally]
Raztopini za intravensko infundiranje se ne sme dodajati nobenih dodatkov.
Since the infusion solution is photosensitive, the infusion bags should be removed from the box only immediately before use.
Ker je raztopina za infundiranje občutljiva za svetlobo, je treba vreče z raztopino za infundiranje vzeti iz škatle tik pred uporabo.
{Name and address} < {tel} > < {fax} > < {e-mail} >
{Ime in naslov} < {tel} > < {fax} > < {e- mail} >
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally]
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 400 mg/ 200 ml raztopina za infundiranje [Glejte Dodatek I – Izpolni država članica]
Ciprofloxacin Bayer 400 mg/200 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Zdravilo Ciprofloksacin Bayer 400 mg/ 200 ml raztopina za infundiranje se uporablja za zdravljenje naslednjih okužb (glejte poglavji 4. 4 in 5. 1)..
• Infections of the skin and soft tissue caused by Gram-negative bacteria
192 • okužbe kože in mehkih tkiv, ki jih povzročajo po Gramu negativne bakterije
187 • Infections of the bones and joints
• okužbe kosti in sklepov
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 mora začeti zdravnik, ki ima izkušnje z zdravljenjem cistične fibroze in/ ali hudih okužb pri otrocih in mladostnikih (glejte poglavji 4. 4 in 5. 1).
Epididymo-orchitis and pelvic inflamm atory diseases
epididimo- orhitis in medenična vnetna bolezen
Treatment of infections or prophylaxis of infections in neutropenic patients Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance.
zdravljenje okužb ali preprečevanje
400 mg twice daily to 400 mg three times a day
400 mg dvakrat na dan 194
Therapy should be continued over the entire period of neutropenia
skupno trajanje zdravljenja (tudi peroralno zdravljenje takoj, ko je možno)
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons requiring parenteral treatment Drug administration should begin as soon as possible after suspected or confirmed exposure.
okužb pri bolnikih z nevtropenijo; ciprofloksacin je treba dati hkrati z ustreznim antibakterijskim zdravilom( i) v skladu z veljavnimi smernicami
400 mg twice daily
do 400
Total duration of
skupno trajanje zdravljenja (tudi peroralno zdravljenje takoj, ko je možno)
treatment (including switch to oral therapy as soon as possible) Cystic fibrosis
cistična fibroza
10 mg/kg body weight three times a day with a maximum of 400 mg per dose.
10 mg/ kg telesne mase trikrat na dan; največ 400 mg na odmerek
6 mg/kg body weight three times a day to 10 mg/kg body weight three times a day with a maximum of 400 mg per dose.
6 mg/ kg trikrat na dan do 10 mg/ kg telesne mase trikrat na dan; največ 400 mg na odmerek
Inhalation anthrax
inhalacijski vranični prisad (zdravljenje po izpostavitvi povzročitelju) pri osebah, ki potrebujejo parenteralno zdravljenje; zdravljenje je treba začeti takoj po domnevni ali potrjeni izpostavitvi povzročitelju
10 mg/kg body weight twice daily to 15 mg/kg body
10 mg/ kg telesne mase dvakrat na dan do 15 mg/ kg telesne mase dvakrat na dan; največ 400 mg na odmerek
Creatinine Clearance [mL/min/1.73 m²]
očistek kreatinina [ml/ min/ 1, 73m²]
Serum Creatinine [µmol/L]
serumske vrednosti kreatinina [µmol/ l]
200-400 mg every 12 h
200 – 400 mg vsakih 12 h 200 – 400 mg vsakih 24 h
200-400 mg every 24 h (after dialysis)
200 – 400 mg vsakih 24 h (po dializi)
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.
190 Method of administration
Način uporabe
Ciprofloxacin should be administered by intravenous infusion.
Ciprofloksacin je treba infundirati intravensko.
In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin Bayer and 30 minutes for 200 mg Ciprofloxacin Bayer.
Pri odraslih bolnikih traja infundiranje zdravila Ciprofloksacin Bayer 400 mg/ 200 ml raztopina za infundiranje 60 minut oz.
Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation.
30 minut, če se infundira zdravilo Ciprofloksacin Bayer 200 mg/ 100 ml raztopina za infundiranje.
The infusion solution can be infused either directly or after mixing with other compatible infusion solutions (see section 6.2).
Počasno infundiranje v veliko veno bo zmanjšalo tveganje za vnetje vene, postopek bo za bolnika bolj primeren.
Travellers’ diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
196 Pri zdravljenju bolnikov s potovalno drisko je potrebno upoštevati podatke o odpornosti povzročiteljev na ciprofloksacin v državah, v katere so potovali.
191 Ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals.
Ciprofloksacin povzroča artropatijo v nosilnih sklepih nerazvitih živali.
Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
Včasih se lahko po zdravljenju s ciprofloksacinom (v 197 prvih 48 urah zdravljenja) pojavi tendinitis ali ruptura kite (predvsem Ahilove tetive), včasih obojestransko.
If seizures occur Ciprofloxacin should be discontinued (see section 4.8).
Če se pojavijo krči, je treba zdravljenje s ciprofloksacinom prekiniti (glejte poglavje 4. 8).
Psychiatric reactions may occur even after the
Psihiatrične reakcije se lahko pojavijo že po prvem odmerku ciprofloksacina.
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).
Cytochrome P450 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, ropinirole, tizanidine).
198 Citokrom P450 Ciprofloksacin zavira encimski sistem CYP1A2, kar lahko povzroči zvišanje serumskih koncentracij sočasno danih zdravil, ki se presnavljajo s pomočjo tega encima (npr. teofilin, klozapin, ropinirol, tizanidin).
193 Injection Site Reaction Local intravenous site reactions have been reported with the intravenous administration of ciprofloxacin.
Reakcije na mestu injiciranja Po intravenski uporabi ciprofloksacina se lahko pojavijo lokalne reakcije.
Glucose Load Ciprofloxacin Bayer solution for infusion contains 10 g glucose in 200 mL solution for infusion.
Vsebnost glukoze Raztopina za infundiranje Ciprofloksacin Bayer vsebuje 5 g glukoze v 100 ml raztopine za infundiranje.
Other xanthine derivatives
199 Drugi derivati ksantina