natgillin/translations-raw huggingface dataset:
194 and general status of the patient so that the contribution of the fluoroquinolone to the increase in INR (international normalised ratio) is difficult to assess.
Tveganje je odvisno od okužbe, starosti in splošnega stanja bolnikov, zato je v teh pogojih težko oceniti vpliv fluorokinolonov na spremembe INR (International Normalised Ratio).
4.8 Undesirable effects
200 4. 8 Neželeni učinki
Rare ≥ 1/10 000 to <
Organski
Very Rare < 1/ 10 000
Pogosti
1/ 10
Občasni
1/100
Redki
1/1 000
Zelo redki < 1/ 10. 000
Immune System Disorders
Neznana (ni mogoče
Anorexia
sistem
Common ≥ 1/100 to <
≥ 1/ 100 do
Uncommon ≥ 1/1 000 to <
≥ 1/ 1. 000 do
Rare ≥ 1/10 000 to <
≥ 1/ 10. 000 do <
Very Rare < 1/ 10 000
oceniti iz
Cardiac Disorders
Infekcijske
Tachycardia
glivične
Vascular Disorders
kolitis, ki nastane
Vasodilation Hypotension Syncope
in parazitske bolezni
Vasculitis
okužbe
Respiratory, Thoracic and Mediastinal Disorders
zaradi jemanja antibiotikov (zelo redko z možnim smrtnim izidom) (glejte poglavje 4. 4)
Nausea Diarrhoea
Bolezni krvi
Pancreatitis
eozinofilija
Hepatobiliary Disorders
levkopenija
Rash Pruritus Urticaria
hemolitična
Photosensitivity reactions (see section 4.4)
in
197 System Organ Class
anemija
Common ≥ 1/100 to <
anemija
Rare ≥ 1/10 000 to <
limfatičnega
Very Rare < 1/ 10 000
nevtropenija
Frequency not known
agranulocitoza
1/ 10
sistema
1/100
levkocitoza
1/1 000
pancitopenija
(cannot be estimated from available data)
trombocitopenija trombocitemija
Musculoskeletal, Connective Tissue and Bone Disorders
(smrtno nevarna) depresija kostnega mozga (smrtno nevarna)
Renal and Urinary Disorders
Bolezni
Renal impairment
alergijska
Asthenia Fever
anafilaktična
Oedema Sweating (hyperhidrosis)
imunskega
Investigations
reakcija
Common Uncommon
reakcija
Rare
sistema
Paediatric patients
alergijski
4.9 Overdose
anafilaktični
Reversible renal toxicity has been reported.
edem/ angioedem
Only a small quantity of ciprofloxacin (< 10%) is eliminated by haemodialysis or peritoneal dialysis.
šok (smrtno nevaren) (glejte poglavje 4. 4) reakcija, podobna serumski bolezni
5.1 Pharmacodynamic properties
Presnovne in prehranske motnje
J01MA02
anoreksija
Mechanism of action:
hiperglikemija
PK/PD relationship:
Psihiatrične
Mechanism of resistance:
psihomotorič
All in-vitro mechanisms of resistance are commonly observed in clinical isolates.
zmedenost in
Spectrum of antibacterial activity:
psihotične
EUCAST Recommendations
motnje
Microorganisms
na
Susceptible
dezorientiranost
Resistant
reakcije
Enterobacteria Pseudomonas Acinetobacter Staphylococcus spp.1
hiperaktivnos t / agitacija
S ≤ 0.5 mg/L S ≤ 0.5 mg/L S ≤ 1 mg/L S ≤ 1 mg/L
anksiozna reakcija nočne more depresija halucinacije
R > 1 mg/L R > 1 mg/L R > 1 mg/L R > 1 mg/L
(glejte poglavje 4. 4)
S ≤ 0.5 mg/L
Bolezni
R > 0.5 mg/L
glavobol
S ≤ 0.03 mg/L S ≤ 0.03 mg/L S ≤ 0.5 mg/L
parestezija in
R R
migrena
> 0.06 mg/L > 0.06 mg/L R > 1 mg/L
periferna
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.
živčevja
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.
omotica
Brucella spp.
disestezija
(2):
motnje
Absorption
nevropatija
201 Following an intravenous infusion of ciprofloxacin the mean maximum serum concentrations were achieved at the end of infusion.
201
Metabolism
Organski
Faeces
Pogosti
61.5 9.5
Občasni
15.2 2.6
Redki
DATE OF REVISION OF THE TEXT
Zelo redki < 1/ 10. 000
[To be completed nationally]
Neznana (ni mogoče
204 1.
sistem
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/50 mL solution for infusion [See Annex I - To be completed nationally]
≥ 1/ 100 do
QUALITATIVE AND QUANTITATIVE COMPOSITION
≥ 1/ 1. 000 do
PHARMACEUTICAL FORM
≥ 1/ 10. 000 do <
Solution for infusion.
oceniti iz
4.
< 1/ 10
Ciprofloxacin Bayer 100 mg/50 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
< 1/ 100
Adults
1/ 1. 000
• Urinary tract infections
razpoložljivih podatkov)
Children and adolescents
motnje spanja motnje okusa
IV treatment should be followed by oral route as soon as possible.
hipoestezija tremor krči (glejte poglavje 4. 4) vrtoglavica
Total duration of treatment (including switch to oral therapy as soon as possible)
koordinacije motnje ravnotežja motnje vohanja zvišan intrakranialni tlak
to 4 weeks (acute)
(glejte poglavje 4. 4)
Epididymo-orchitis and pelvic inflamm atory diseases
Očesne bolezni Ušesne bolezni, vključno z motnjami labirinta
400 mg twice daily to 400 mg three times a day
motnje vida zvonjenje v ušesih oglušitev/ motnje sluha
at least 14 days
motnje zaznavanja barv
400 mg twice daily
Srčne bolezni
400 mg twice daily
tahikardija
Diarrhoea caused by Vibrio cholerae
ventrikularne aritmije, podaljšanje intervala QT, torsade de pointes *
Typhoid fever Intra-abdominal infections due to Gram-negative bacteria
Žilne bolezni Bolezni dihal, prsnega koša in mediastinal nega prostora
400 mg twice daily 400 mg twice daily to 400 mg three times a day
vazodilatacija hipotenzija sinkopa dispneja (tudi astmatsko stanje)
7 days 5 to 14 days
vaskulitis
7 to 14 days
Bolezni
Bone and joint infections
slabost
max. of 3 months
bruhanje
400 mg twice daily to 400 mg three times a day
pankreatitis
mg twice daily
prebavil
207
driska
Indications as possible after suspected or confirmed exposure.
bolečine v trebuhu dispepsija flatulenca
Daily dose in mg
Bolezni
Indication
prehodno
Daily dose in mg
jetrna okvara
Total duration of
jetrna nekroza
10 to 14 days
jeter,
10 to 21 days
zvišanje
Inhalation anthrax
holestatski
days from the
(zelo redko
Geriatric patients
žolčnika in
Intravenous Dose [mg]
vrednosti
< 124
ikterus
See Usual Dosage.
napreduje v
30-60
žolčevodov
124 to 168
transaminaz
200-400 mg every 12 h
hepatitis
> 169
smrtno
200-400 mg every 24 h
zvišanje vrednosti bilirubina
Patients on haemodialysis
nevarno jetrno odpoved)
> 169
Bolezni
200-400 mg every 24 h (after dialysis)
izpuščaji
Patients on peritoneal dialysis
fotosenzitivne
> 169
petehije
200-400 mg every 24 h
kože in
Method of administration
srbenje
It must not be used if cloudy.
reakcije (glejte
4.3 Contraindications
Erythema
Probenecid
podkožja
Tizanidine
koprivnica
4 to 21-fold; AUC increase:
poglavje 4. 4)
The concomitant use is not recommended (see section 4.4).
multiforme minor Erythema nodosum
Theophylline
202
Phenytoin
Organski
212 Oral anticoagulants
Pogosti
Ropinirole
Občasni
Clozapine
Redki
4.6 Pregnancy and lactation
Zelo redki < 1/ 10. 000
4.8 Undesirable effects
Neznana (ni mogoče
213 System Organ Class
sistem
Common ≥ 1/100 to < 1/10
≥ 1/ 100 do
Uncommon ≥ 1/1 000 to < 1/100
≥ 1/ 1. 000 do
Very Rare < 1/10 000
≥ 1/ 10. 000 do <
Eosinophilia
oceniti iz
Anorexia
< 1/ 10
Common ≥ 1/100 to < 1/10
< 1/ 100
Uncommon ≥ 1/1 000 to < 1/100
1/ 1. 000
Rare ≥ 1/10 000 to < 1/1 000
Stevens - Johnsonov sindrom (lahko smrtno nevaren) toksična epidermalna nekroliza (lahko smrtno nevarna)
Very Rare < 1/10 000
razpoložljivih podatkov)
Frequency not known (cannot be estimated from available data)
Bolezni
Eye Disorders
mišično -
Visual disturbances
mialgija
Visual colour distortions
mišična
Ear and Labyrinth Disorders
mišično -
Tinnitus Hearing loss / Hearing impaired
skeletne
Cardiac Disorders
artritis
Tachycardia
oslabelost
Ventricular arrhythmia, QT prolongation, torsades de pointes *
skeletnega
Vascular Disorders
bolečine
Vasodilatation Hypotension Syncope
zvečanje
Vasculitis
tendinitis
Respiratory, Thoracic and Mediastinal Disorders
sistema in
Dyspnoea (including asthmatic condition)
(npr.
Gastrointestin al Disorders
mišičnega tonusa
Nausea Diarrhoea
raztrganine
Pancreatitis
vezivnega
Hepatobiliary Disorders
bolečine v
Increase in transaminases Increased bilirubin
in krči
Hepatic impairment Cholestatic icterus Hepatitis
tetiv
Liver necrosis (very rarely progressing to life- threatening hepatic failure) (see section 4.4)
tkiva
215 System Organ Class
okončinah,
Common ≥ 1/100 to < 1/10
(predvsem
Uncommon ≥ 1/1 000 to < 1/100
hrbtu, prsnem košu) artralgija
Rare ≥ 1/10 000 to < 1/1 000
Ahilove tetive) (glejte poglavje 4. 4) poslabšanje miastenije gravis (glejte poglavje 4. 4)
Very Rare < 1/10 000
Bolezni sečil
Skin and Subcutaneous Tissue Disorders
ledvična
Rash Pruritus Urticaria
ledvična odpoved
Photosensitivity reactions (see section 4.4)
okvara
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
hematurija kristalurija (glejte poglavje 4. 4) tubulointersticijs ki nefritis
Musculoskelet al, Connective Tissue and Bone Disorders
Splošne
Musculoskelet al pain (e.g. extremity pain, back pain, chest pain) Arthralgia
astenija
Myalgia Arthritis Increased muscle tone and cramping
edem
Muscular weakness Tendinitis Tendon rupture (predominan tly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
težave in
Renal and Urinary Disorders
zvišana
Renal impairment
znojenje (hiper -
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
spremembe na mestu aplikacije
General Disorders and Administration Site Conditions
telesna temperatura
Injection and infusion site reactions (only intravenous administration)
hidroza)
216 The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment:
V podskupini bolnikov, ki so se zdravili intravensko ali sekvenčno (intravensko, nato peroralno), so se pogosteje pojavili naslednji neželeni učinki:
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
203 halucinacije, parestezija in disestezija, krči, vrtoglavica, motnje vida, oglušitev, tahikardija, vazodilatacija, hipotenzija, prehodna jetrna okvara, holestatska zlatenica, ledvična odpoved, edem
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.
217 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.
Resistance mechanisms that inactivate other antibiotics such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may affect susceptibility to ciprofloxacin.
204 pregrade (običajno pri Pseudomonas aeruginosa) in membranske črpalke lahko vplivajo na občutljivost za ciprofloksacin.
Susceptible
občutljiva (mg/ l)
Resistant
odporna (mg/ l)
S ≤ 0.5 mg/L S ≤ 0.5 mg/L S ≤ 1 mg/L S ≤ 1 mg/L
S < 0, 5 S < 0, 5 S < 1 S < 1 S < 0, 5 S < 0, 03 S < 0, 03
R > 1 mg/L R > 1 mg/L R > 1 mg/L R > 1 mg/L
R > 1 R > 1 R > 1 R > 1 R > 0, 5 R > 0, 06 R > 0, 06
S ≤ 0.5 mg/L
S < 0, 5
R > 0.5 mg/L
R > 1
> 0.06 mg/L > 0.06 mg/L R > 1 mg/L
1.
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.
Staphylococcus spp. – mejne vrednosti za ciproflokscin 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.
They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended.
Uporabljajo se samo za vrste, pri katerih, mejne vrednosti niso bile določene in se ne uporabljajo za vrste, pri katerih se test občutljivosti ne priporoča.
COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
205 aerobni, po Gramu negativni mikroorganizmi Aeromonas spp.
Citrobacter koseri Francisella tularensis Haemophilus ducreyi Haemophilus influenzae* Legionella spp.
Francisella tularensis Haemophilus ducreyi Haemophilus influenzae * Legionella spp.
Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($)
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 ($) Staphylococcus spp.
Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia +* Campylobacter spp.+* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae * Escherichia coli* Klebsiella oxytoca Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp.
(2) aerobni, po Gramu negativni mikroorganizmi Acinetobacter baumannii+ Burkholderia cepacia + * Campylobacter spp. + * Citrobacter freundii * Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Klebsiella pneumoniae * Morganella morganii * Neisseria gonorrhoeae * Proteus mirabilis * Proteus vulgaris * Providencia spp.
Propionibacterium acnes
Propionibacterium acnes ODPORNI ORGANIZMI aerobni, po Gramu pozitivni mikroorganizmi Actinomyces Enteroccus faecium Listeria monocytogenes aerobni, po Gramu negativni mikroorganizmi Stenotrophomonas maltophilia anaerobni mikroorganizmi razen mikroorganizmov navedenih zgoraj
Natural intermediate susceptibility in the absence of acquired mechanism of resistance (1):
206 drugi mikroorganizmi Mycoplasma genitalium Ureaplasma urealitycum * klinično učinkovitost so dokazali pri občutljivih izolatih za odobrene klinične indikacije + stopnja odpornosti ≥ 50% v eni ali več državah Evropske unije ($) naravna vmesna občutljivost v odsotnosti pridobljene odpornosti (1):
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.
Ciprofloksacin se slabo veže na plazemske beljakovine (20 - 30%) in je v plazmi prisoten pretežno v neionizirani obliki.
Ciprofloxacin reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages,
Ravnotežni volumen porazdelitve je velik, 2 – 3 l/ kg telesne mase.
220 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 (kantaridin blister tekočina) ali urogenitalni trakt (seč, prostata, endometrij), kjer skupna koncentracija preseže dosežene plazemske koncentracije.
Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.
207 Ciprofloksacin je srednje močni zaviralec encimskega sistema CYP450 1A2.
Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, faecally.–
Razpolovni čas izločanja v serum je pri ljudeh z normalnim ledvičnim delovanjem približno 4 do 7 ur.
221 Articular tolerability:
Vplivi zdravila na sklepe:
In a study in young beagle dogs, ciprofloxacin caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.
208 ciprofloksacin v terapevtskih odmerkih, je le ta po dveh tednih zdravljenja povzročil hude spremembe v sklepih, ki so bile opazne tudi po 5 mesecih.
For ease of use the infusion vial stopper should be penetrated in the central ring.
Ker je raztopina za infundiranje občutljiva za svetlobo, je treba vreče z raztopino za infundiranje vzeti iz škatle tik pred uporabo.
Penetration of the outer ring may result in damage to the vial stopper.
Pri dnevni svetlobi je njena učinkovitost zagotovljena 3 dni.
222 [To be completed nationally]
[Izpolni država članica]
{MM/YYYY}
209 {MM/ LLLL}
223 1.
210 1.
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/100 mL solution for infusion [See Annex I - To be completed nationally]
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 100 mg/ 50 ml raztopina za infundiranje [Glejte Dodatek I – Izpolni država članica]
Ciprofloxacin Bayer 200 mg/100 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Zdravilo Ciprofloksacin Bayer 100 mg/ 50 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
211 • okužbe kože in mehkih tkiv, ki jih povzročajo po Gramu negativne bakterije
224 • Infections of the bones and joints
• okužbe kosti in sklepov
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)
• preprečevanje invazivnih okužb, ki jih povzroča Neisseria meningitidis
Adults
212 Odrasli
Infections of the upper respiratory tract
okužbe zgornjih akutno poslabšanje dihal kroničnega sinusitisa
uncomplicated pyelonephritis
okužbe sečil zapleten in nezapleten pielonefritis
Epididymo-orchitis and pelvic inflamm atory diseases
okužbe spolovil epididimo- orhitis in medenična vnetna bolezen
400 mg twice daily to 400 mg three times a day
400 mg dvakrat na dan do 400 mg trikrat na 213
Children and adolescents
inhalacijski vranični prisad (zaščita in zdravljenje po izpostavitvi povzročitelju) pri osebah, ki se lahko zdravijo peroralno, če je to klinično primerno; zdravljenje je treba začeti takoj po domnevni ali potrjeni izpostavitvi povzročitelju.
400 mg twice daily 226
400 mg dvakrat na dan
Indication
Otroci in mladostniki
Daily dose in mg
indikacije
10 mg/kg body weight twice daily to 15 mg/kg body
10 mg/ kg telesne mase dvakrat na dan do 15mg/ kg telesne mase dvakrat na dan; največ 400 mg na odmerek
Recommended starting and maintenance doses for patients with impaired renal function:
214 Priporočeni začetni in vzdrževalni odmerki pri bolnikih z okvarjenim delovanjem ledvic:
227 Ciprofloxacin should be administered by intravenous infusion.
Zdravilo ciprofloksacin je treba infundirati intravensko.
Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
215 Intraabdominalne okužbe Podatki o učinkovitosti ciprofloksacina pri zdravljenju intraabdominalnih okužb po kirurških posegih so omejeni.
Safety data from a randomised double-blind study on ciprofloxacin use in children (ciprofloxacin: n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years)
4, 6%.
Musculoskeletal System Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment.
216 Mišičnoskeletni sistem Ciprofloksacin se praviloma ne sme uporabljati pri bolnikih z boleznimi/ poškodbami kit v anamnezi, ki so bile povezane z zdravljenjem s kinoloni.
Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including
Pri bolnikih, ki so prejemali ciprofloksacin, so poročali o polinevropatiji (na osnovi nevroloških simptomov, npr. bolečina, žarenje, senzorične motnje ali mišična oslabelost; bodisi posamezen simptom ali kombinacija simptomov).
229 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.
217 Odpornost Med ali po zdravljenju s ciprofloksacinom se lahko izolirajo bakterije odporne na ciprofloksacin, z ali brez klinično izražene superinfekcije.
230 NaCl Load In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.), the additional sodium load should be taken into account (for sodium chloride content, see section 2).
Vsebnost natrijevega klorida Zdravilo vsebuje natrija, kar je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija (npr. bolniki s kongestivnim srčnim popuščanjem, ledvičnim popuščanjem, nefrotskim sindromom) (za vsebnost natrijevega klorida glejte poglavje 2).
Theophylline
218 Teofilin
4.7 Effects on ability to drive and use machines
219 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
232
Bolezni krvi
System Organ Class
eozinofilija
Common ≥ 1/100 to <
levkopenija
Uncommon ≥ 1/1 000 to <
hemolitična
Rare ≥ 1/10 000 to <
anemija
Very Rare < 1/ 10 000
anemija
Frequency not known
limfatičnega
1/ 10
nevtropenija
1/100
agranulocitoza
1/1 000
sistema
(cannot be estimated from available data)
levkocitoza
Blood and Lymphatic System Disorders
pancitopenija
Eosinophilia
trombocitopenija trombocitemija
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
Bolezni
Immune System Disorders
alergijska
Allergic reaction Allergic oedema / angiooedema
anafilaktična
Anaphylactic reaction Anaphylactic shock (life- threatening) (see section 4.4) Serum sickness- like reaction
imunskega
Metabolism and Nutrition Disorders
reakcija
Nervous System Disorders
anoreksija
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Psihiatrične
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
psihomotorič
Peripheral neuropathy (see section 4.4)
zmedenost in
Eye Disorders Ear and Labyrinth Disorders
psihotične
Visual disturbances Tinnitus Hearing loss / Hearing impaired
motnje
Visual colour distortions
na
Cardiac Disorders
dezorientiranost
Tachycardia
reakcije
Ventricular arrhythmia, QT prolongation, torsades de pointes *
hiperaktivnos t / agitacija
Vascular Disorders
anksiozna reakcija
Vasodilatation Hypotension Syncope
(glejte poglavje 4. 4)
Vasculitis
Organski
233 System Organ Class
Pogosti
1/1 000
1/ 1. 000 nočne more depresija halucinacije
Respiratory, Thoracic and Mediastinal Disorders
glavobol
Dyspnoea (including asthmatic condition)
parestezija in
Gastrointestinal Disorders
živčevja
Nausea Diarrhoea
disestezija
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
motnje
Pancreatitis
nevropatija
Hepatobiliary Disorders
motnje spanja motnje okusa
Increase in transaminases Increased bilirubin
hipoestezija tremor krči (glejte poglavje 4. 4) vrtoglavica
Hepatic impairment Cholestatic icterus Hepatitis
koordinacije motnje ravnotežja motnje vohanja zvišan intrakranialni tlak
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
Očesne bolezni Ušesne bolezni, vključno z motnjami labirinta
Skin and Subcutaneous Tissue Disorders
motnje vida zvonjenje v ušesih oglušitev/ motnje sluha
Rash Pruritus Urticaria
motnje zaznavanja barv
Photosensitivity reactions (see section 4.4)
Srčne bolezni