natgillin/translations-raw huggingface dataset:
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.
In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism / foetus (see section 5.3).
Pri mladih in prenatalnih živalih, ki so bile izpostavljene kinolonom, so opažali učinke na nerazvitem hrustancu, zato se možnosti poškodb sklepnega hrustanca pri nerazvitih organizmih/ fetusih ne da zanesljivo izključiti (glejte poglavje 5. 3).
Lactation Ciprofloxacin is excreted in breast milk.
Dojenje Ciprofloksacin se izloča v materino mleko.
29 Due to its neurological effects, ciprofloxacin may affect reaction time.
Zaradi nevroloških učinkov zdravilo ciprofloksacin lahko vpliva na odzivne sposobnosti.
ADRs derived from clinical studies and post-marketing surveillance with Ciprofloxacin Bayer (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below.
Neželeni učinki, ki so jih opazili v kliničnih študijah in v obdobju trženja z zdravilom Ciprofloksacin Bayer (peroralno, intravensko in sekvenčno zdravljenje) so razvrščeni po pogostnosti.
System Organ
29 Organski
Very Rare
Zelo redki < 1/ 10. 000
Frequency
Neznana (ni mogoče
Class
sistem
≥ 1/ 100
≥ 1/ 100
≥ 1/ 1 000 to <
≥ 1/ 1. 000 do
≥ 1/ 10 000 to <
≥ 1/ 10. 000 do <
not known
oceniti iz
to < 1/ 10
do < 1/ 10
1/ 1 000
1/ 1. 000
(cannot be estimated from available data)
razpoložljivi h podatkov)
Mycotic superinfections
glivične okužbe
Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)
kolitis, ki nastane zaradi jemanja antibiotikov (zelo redko z možnim smrtnim izidom) (glejte poglavje 4. 4)
Blood and Lymphatic System Disorders
agranulocitoza
Eosinophilia
pancitopenija
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia
trombocitopenij a trombocitemija
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
(smrtno nevarna) depresija kostnega mozga (smrtno nevarna)
Immune System Disorders
anafilaktični
Allergic reaction Allergic oedema / angiooedema
edem/ angio - edem
Anaphylactic reaction Anaphylactic shock (life- threatening) (see section 4.4) Serum sickness- like reaction
šok (smrtno nevaren) (glejte poglavje 4. 4) reakcija, podobna serumski bolezni
Psychiatric Disorders
psihomotorična
Psychomotor hyperactivity / agitation
hiperaktivnost /
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
koordinacije motnje ravnotežja motnje vohanja zvišan intrakranialni tlak
Psychotic reactions (see section 4.4)
(glejte poglavje 4. 4)
30 System Organ
30
Nervous System Disorders
Očesne bolezni Ušesne bolezni, vključno z motnjami labirinta
Headache Dizziness Sleep disorders Taste disorders
motnje vida zvonjenje v ušesih oglušitev/ motnj e sluha
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
ventrikularne aritmije, podaljšanje intervala QT, torsade de pointes *
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
Žilne bolezni Bolezni dihal, prsnega koša in mediastinal nega prostora
Peripheral neuropathy (see section 4.4)
vazodilatacija hipotenzija sinkopa dispneja (tudi astmatsko stanje)
Eye Disorders Ear and Labyrinth Disorders
vaskulitis
Visual disturbances Tinnitus Hearing loss / Hearing impaired
slabost
Visual colour distortions
bruhanje
Cardiac Disorders
pankreatitis
Tachycardia
prebavil
Ventricular arrhythmia, QT prolongation, torsades de pointes *
bolečine v trebuhu dispepsija flatulenca
Vascular Disorders
jetrna okvara
Vasodilatation Hypotension Syncope
jetrna nekroza
Vasculitis
zvišanje
Respiratory, Thoracic and Mediastinal Disorders
holestatski
Dyspnoea (including asthmatic condition)
(zelo redko
Gastrointestinal Disorders
žolčevodov
Nausea Diarrhoea
smrtno nevarno
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
zvišanje vrednosti bilirubina
Pancreatitis
izpuščaji
Hepatobiliary Disorders
fotosenzitivne
Increase in transaminases Increased bilirubin
kože in
Hepatic impairment Cholestatic icterus Hepatitis
reakcije (glejte
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
multiforme minor Erythema nodosum Stevens - Johnsonov sindrom (lahko smrtno nevaren) toksična epidermalna nekroliza (lahko smrtno nevarna)
Skin and Subcutaneous Tissue Disorders
bolečine (npr.
Rash Pruritus Urticaria
raztrganine tetiv
Photosensitivity reactions (see section 4.4)
(predvsem
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
tkiva
Musculoskeletal, Connective Tissue and Bone Disorders
hrbtu, prsnem
Musculoskeletal pain (e. g. extremity pain, back pain, chest pain) Arthralgia
Ahilove tetive)
Myalgia Arthritis Increased muscle tone and cramping
košu) artralgija
Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
(glejte poglavje 4. 4) poslabšanje miastenije gravis (glejte poglavje 4. 4)
Renal impairment
ledvična
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
odpoved hematurija kristalurija (glejte poglavje 4. 4) tubulointersticij ski nefritis
General Disorders and Administration Site Conditions
spremembe na mestu aplikacije
Asthenia Fever
temperatura
Oedema Sweating (hyperhidrosis)
hidroza)
Investigations
nenormalne
Increase in blood alkaline phosphatase
vrednosti alkalne fosfataze v krvi
Prothrombin level abnormal Increased amylase
vrednosti protrombina zvišanje vrednosti amilaze
* These events were reported during the postmarketing period and were observed predominantly among patients with further risk factors for QT prolongation (see section 4.4).
* O teh neželenih učinkih so poročali v obdobju trženja in so jih opazili pretežno pri bolnikih pri katerih obstaja tveganje za podaljšanje intervala QT (glejte poglavje 4. 4).
Paediatric patients The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults.
Pediatrični bolniki Pogostnost pojava zgoraj omenjene artropatije, je podana na podlagi zbranih podatkov iz študij pri odraslih.
In children, arthropathy is reported to occur commonly (see section 4.4).
Artropatija se pri otrocih pojavlja pogosteje (glejte poglavje 4. 4).
32 An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Prekomerni odmerek 12 g je povzročil blage simptome toksičnosti.
Only a small quantity of ciprofloxacin (< 10%) is eliminated by haemodialysis or peritoneal dialysis.
S hemodializo ali peritonealno dializo se lahko iz telesa odstrani le manjša količina ciprofloksacina (< 10%).
Fluoroquinolones, ATC code:
Farmakoterapevtska skupina: fluorokinoloni, oznaka ATC:
PK/ PD relationship:
Razmerje farmokokinetike/ farmoakodinamike
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.
Plasmid-mediated resistance encoded by qnr-genes has been reported.
Poročali so tudi o odpornosti, pridobljeni s plazmidi, ki imajo qnr gene.
Microorganisms
mikroorganizmi
Susceptible
občutljiva
Resistant
odporna
Enterobacteria Pseudomonas Acinetobacter Staphylococcus spp.1
Enterobacteria Pseudomonas Acinetobacter Staphylococcus spp. 1 Haemophilus influenzae in Moraxella catarrhalis Neisseria gonorrhoeae Neisseria meningitidis
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
R > 1 mg/ L R > 1 mg/ L R > 1 mg/ L R > 1 mg/ L
> 1 mg/ l > 1 mg/ l > 1 mg/ l > 1 mg/ l > 0, 5 mg/ l > 0, 06 mg/ l > 0, 06 mg/ l
33 Haemophilus influenzae and Moraxella catarrhalis
33
S ≤ 0.5 mg/ L
Mejne vrednosti za nespecifične vrste *
R > 0.5 mg/ L
S < 0, 5 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.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Predvsem pri zdravljenju hudih okužb je pomembno poznati lokalne podatke o odpornosti; predvsem za zdravljenje hujših okužb.
Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4) COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
34 SPLOŠNO OBČULJIVE VRSTE aerobni, po Gramu pozitivni mikroorganizmi Bacillus anthracis( 1) aerobni, po Gramu negativni mikroorganizmi Aeromonas spp.
Moraxella catarrhalis* Neisseria meningitidis Pasteurella spp.
Moraxella catarrhalis * Neisseria meningitidis Pasturella 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 ($) Staphylococcus spp. * (2) Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia+* Campylobacter spp. +* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae* Escherichia coli* Klebsiella oxytoca
Yersinia pestis anaerobni mikroorganizmi Mobinculus drugi mikroorganizmi Chlamydia trachomatis ($) 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.
Pseudomonas aeruginosa* Pseudomonas fluorescens Serratia marcescens* Anaerobic micro-organisms Peptostreptococcus spp.
Pseudomonas aeruginosa * Pseudomonas fluorescens Serratia marcescens * anaerobni mikroorganizmi Peptostreptococcus spp.
Propionibacterium acnes INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Actinomyces Enteroccus faecium Listeria monocytogenes Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia
Propionibacterium acnes ODPORNI ORGANIZMI aerobni, po Gramu pozitivni mikroorganizmi Actinomyces Enteroccus faecium Listeria monocytogenes 35 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):
Studies have been conducted in experimental animal infections due to inhalations of Bacillus anthracis spores; these studies reveal that antibiotics starting early after exposition avoid the occurrence of the disease if the treatment is made up to the decrease of the number of spores in the organism under the infective dose.
Študije so izvedli pri eksperimentalnih okužbah živali po inhalaciji spor Bacillus anthracis; te študije so odkrile, da antibiotiki dani čimprej po izpostavitvi, preprečijo pojav bolezni, če zdravljenje zmanjša število spor v organizmu po infektivnem odmerku.
The recommended use in human subjects is based primarily on in-vitro susceptibility and on animal experimental data together with limited human data.
Uporaba pri ljudeh se priporoča primarno na osnovi in vitro podatkov o občutljivosti in podatkov iz preskušanj na živalih ter omejenih podatkov pridobljenih pri ljudeh.
Two-month treatment duration in adults with oral ciprofloxacin given at the following dose, 500 mg bid, is considered as effective to prevent anthrax infection in humans.
Dvomesečno zdravljenje s peroralnimi oblikami ciprofloksacina pri ljudeh v odmerkih 500 mg dvakrat na dan, naj bi bila učinkovita zaščita pred okužbo z vraničnim prisadom pri ljudeh.
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.
Methicillin-resistant S. aureus very commonly express co-resistance to fluoroquinolones.
Meticilin- odporni S. aureus zelo pogosto izraža koodpornost na flurokinolone.
The rate of resistance to methicillin is around 20 to 50% among all staphylococcal species and is usually higher in nosocomial isolates.
Stopnja odpornosti do meticilina je približno 20 do 50% med vsemi stafilokoki in je običajno višja pri nozokomialnih izolatih.
Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later.
Najvišja serumska koncentracija je dosežena eno do dve uri po zaužitju zdravila.
Single doses of 100-750 mg produced dose-dependent maximum serum concentrations (Cmax) between 0.56 and 3.7 mg/ L.
Po enkratnih odmerkih od 100 do 750 mg so najvišje serumske koncentracije med 0, 56 in 3, 7 mg/ l.
The absolute bioavailability is approximately 70-80%.
Absolutna biološka uporabnost je približno 70 do 80%.
A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration-time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours.
Peroralni odmerki 500 mg dani vsakih 12 ur so pokazali da je površina pod krivuljo serumska koncentracija/ čas (AUC) enaka kot po 60- minutnem intravenskem infundiranju ciproflaksacina v odmerku 400 mg vsakih 12 ur.
Protein binding of ciprofloxacin is low (20-30%).
Ciprofloksacin se slabo veže na plazemske beljakovine (20 - 30%) in je v plazmi prisoten pretežno v neionizirani obliki.
Ciprofloxacin is present in plasma largely in a non- ionised form and has a large steady state distribution volume of 2-3 L/ kg body weight.
Ravnotežni volumen porazdelitve je velik, 2 – 3 l/ kg telesne mase.
Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.
In vitro presnovki delujejo protibakterijsko vendar je njihova učinkovitost manjša od učinkovitosti ciprofloksacina.
Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, faecally.
Ciprofloksacin je srednje močni zaviralec izoencimskega sistema CYP450 1A2.
36 Excretion of ciprofloxacin (% of dose) Oral Administration
36 Izločanje
Urine
seč
Faeces
blato
Ciprofloxacin Metabolites (M1-M4)
ciprofloksacin presnovki (M1 – M4)
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.
1% of the dose is excreted via the biliary route.
Z žolčem se izloči 1% odmerka.
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.
4-5 hours and the bioavailability of the oral suspension ranges from 50 to 80%.
Na podlagi analize farmakokinetike pri pediatričnih bolnikih z različnimi okužbami, je pričakovana povprečna razpolovna doba 4 do 5 ur, biološka uporabnost peroralne suspenzije pa med 50 in 80%.
Data on photomutagenicity/ photocarcinogenicity show a weak photomutagenic or phototumorigenic effect of ciprofloxacin in-vitro and in animal experiments.
Podatki o fotomutagenosti/ fotokarcinogenosti kažejo na šibak fotomutageni ali fototumorogeni učinek ciprofloksacina in vitro in v poskusih na živalih.
Articular tolerability:
Vplivi zdravila na sklepe:
37 [To be completed nationally]
[Izpolni država članica]
[See Annex I - To be completed nationally.]
[Glejte Dodatek I – Izpolni država članica]
{Name and address }< {tel }> < {fax }> < {e-mail }>
{Ime in naslov} < {tel} > < {fax} > < {e- mail} >
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally]
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 250 mg filmsko obložene tablete [Glejte Dodatek I – Izpolni država članica]
Ciprofloxacin Bayer 250 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Zdravilo Ciprofloksacin Bayer 250 mg filmsko obložene tablete 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
• okužbe prebavil
39 • Malignant external otitis
39 • intraabdominalne okužbe
Acute exacerbation of chronic sinusitis
okužbe zgornjih akutno poslabšanje dihal kroničnega sinusitisa
tract
40 indikacije
Daily dose in mg
okužbe sečil
Infections of the gastro-intestinal tract and intra- abdominal infections
okužbe prebavil in intraabdominalne okužbe
Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea
driska, ki jo povzročajo bakterije, tudi iz vrste Shigella spp., ne pa Shigella dysenteriae tipa 1 in empirično zdravljenje hude potovalne driske
500 mg twice daily to 750 mg twice daily
250 mg do 500 mg dvakrat na dan 41
10 mg/ kg body weight twice daily to 20 mg/ kg body weight twice daily with a maximum of 750 mg per dose.
do 20 mg/ kg telesne mase dvakrat na dan; največ 750 mg na odmerek
Inhalation anthrax
10 mg/ kg
10 mg/ kg body weight twice daily to 15 mg/ kg body
do 15 mg/ kg telesne mase dvakrat na dan; največ 500 mg na odmerek
42
42 Okvarjeno delovanje ledvic in jeter
30-60
30 – 60 < 30
124 to 168
124 do 168 > 169
250-500 mg every 12 h
250 – 500 mg vsakih 12 h 250 – 500 mg vsakih 24 h
> 169
bolniki
250-500 mg every 24 h
na hemodializi
250-500 mg every 24 h (after dialysis)
250 – 500 mg vsakih 24 h (po dializi)
In severe cases or if the patient is unable to take tablets (e. g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.
V hudih primerih ali če bolnik ne more jemati tablet (npr. bolniki na enteralni prehrani), je priporočena uporaba intravenskih oblik ciprofloksacina, dokler ni možna uporaba peroralnih oblik ciprofloksacina.
43 Travellers’ diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
43 Potovalna driska Pri zdravljenju bolnikov s potovalno drisko je potrebno upoštevati podatke o odpornosti povzročiteljev na ciprofloksacin v državah, v katere so potovali.
Infections of the bones and joints Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
Inhalacijski vranični prisad Uporaba pri ljudeh je odvisna od in- vitro občutljivosti in podatkov pridobljenih iz preskušanj na živalih ter omejenih podatkov pridobljenih pri ljudeh.
Children and adolescents The use of ciprofloxacin in children and adolescents should follow available official guidance.
Otroci in mladostniki Pomembno je, da se pri uporabi ciprofloksacinapri otrocih in mladostnikih upoštevajo veljavne smernice.
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.
More limited experience is available in treating children between 1 and 5 years of age.
Izkušnje pri otrocih starih med 1 in 5 let so bolj omejene, zato je pri njih potrebna posebna previdnost.
Other specific severe infections Other severe infections in accordance with official guidance, or after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.
Druge specifične hude okužbe Za zdravljenje drugih hudih okužb je treba upoštevati veljavne smernice ali natančno oceniti razmerje tveganja in koristi, ko druga zdravljenja ne pridejo v poštev, ali ko je bilo običajno zdravljenje neuspešno in mikrobiološki izvidi opravičujejo uporabo zdravila Ciprofloksacin Bayer.
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.
Včasih se lahko po zdravljenju s ciprofloksacinom (v prvih 48 urah zdravljenja) pojavi tendinitis ali ruptura kite (predvsem Ahilove tetive), včasih
44 Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
44 obojestransko.
Cardiac disorders Since ciprofloxacin is associated with cases of QT prolongation (see section 4.8), caution should be exercised when treating patients at risk for torsades de pointes arrhythmia.
Srčne bolezni Ciprofloksacin lahko povzroči podaljšanje intervala QT (glejte poglavje 4. 8), zato je potrebna previdnost pri bolnikih pri katerih obstaja tveganje za aritmije torsade de pointes.
Hepatobiliary system Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin (see section 4.8).
Hepatobiliarni sistem Pri zdravljenju s ciprofloksacinom so poročali o primerih jetrne nekroze in življenjsko nevarne jetrne okvare (glejte poglavje 4. 8).