natgillin/translations-raw huggingface dataset:
Ketek is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4 (see section 4.5).
Ketek je zaviralec CYP3A4, zato se ga sme le v posebnih okoliščinah uporabiti med zdravljenjem z drugimi zdravili, ki se presnavljajo s CYP3A4 (glejte poglavje 4. 5).
Experience of treatment of infections caused by penicillin/ or erythromycin resistant S. pneumoniae is limited, but so far, clinical efficacy and eradication rates have been similar compared with the treatment of susceptible S. pneumoniae.
Izkušnje z zdravljenjem okužb, ki jih povzroča na penicilin ali eritromicin odporni S. pneumoniae, so omejene, vendar so bili klinična učinkovitost in deleži eradikacije doslej podobni kot pri zdravljenju dovzetnega S. pneumoniae.
• Effect of Ketek on other medicinal product
• Vpliv zdravila Ketek na druga zdravila
Hence, Ketek should not be used during treatment with medicinal products that are CYP3A4 substrates, unless plasma concentrations of the CYP3A4 substrate, efficacy or adverse events can be closely monitored.
Zato se zdravila Ketek ne sme uporabljati med zdravljenjem z zdravili, ki so substrati CYP3A4, razen kadar je mogoče natančno nadzorovati plazemske koncentracije, učinkovitost ali neželene učinke takšnega substrata.
Medicinal products with a potential to prolong QT interval Ketek is expected to increase the plasma levels of cisapride, pimozide, astemizole and terfenadine.
Zdravila, ki lahko podaljšajo interval QT Pričakovati je, da zdravilo Ketek zviša plazemske koncentracije cisaprida, pimozida, astemizola in terfenadina.
Concomitant administration of Ketek and any of these medicinal products is contraindicated (see section 4.3).
Sočasna uporaba zdravila Ketek in katerega od teh zdravil je kontraindicirana (glejte poglavje 4. 3).
Caution is warranted when Ketek is administered to patients taking other medicinal products with the potential to prolong QT interval (see section 4.4).
Previdnost je potrebna med uporabo zdravila Ketek pri bolnikih, ki jemljejo druga zdravila s potencialom za podaljšanje QT intervala (glejte poglavje 4. 4).
Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Ketek and alkaloid derivatives could lead to severe vasoconstriction (“ ergotism”) with possibly necrosis of the extremities.
Derivati alkaloidov ergot (kot sta ergotamin in dihidroergotamin) Po ekstrapolaciji z eritromicina A in josamicina bi lahko sočasno zdravljenje z zdravilom Ketek in alkaloidnimi derivati povzročilo hudo vazokonstrikcijo ("ergotizem") z možno nekrozo okončin.
The combination is contraindicated (see section 4.3).
Ta kombinacija je kontraindicirana (glejte poglavje 4. 3).
Statins When simvastatin was coadministered with Ketek, there was a 5.3 fold increase in simvastatin Cmax, an 8.9 fold increase in simvastatin AUC, a 15-fold increase in simvastatin acid Cmax and an 11-fold increase in simvastatine acid AUC.
Statini Med sočasno uporabo simvastatina in zdravila Ketek so ugotovili 5, 3- kratno zvišanje Cmax simvastatina in 8, 9- kratno zvišanje njegove AUC ter 15- kratno zvišanje Cmax simvastatinske kisline in 11- kratno zvišanje njene AUC.
In vivo interaction studies with other statins have not been performed, but Ketek may produce a similar interaction with lovastatin and atorvastatin, a lesser interaction with cerivastatin and little or no interaction with pravastatin and fluvastatin.
Raziskav medsebojnega delovanja z drugimi statini in vivo ni bilo, vendar lahko zdravilo Ketek povzroči podobne interakcije z lovastatinom in atorvastatinom, manjše interakcije s cerivastatinom ter majhne ali sploh nobenih s pravastatinom in fluvastatinom.
Ketek should not be used concomitantly with simvastatin, atorvastastin and lovastatin.
Zdravila Ketek se ne sme uporabljati sočasno s simvastatinom, atorvastatinom in lovastatinom.
Cerivastatin should be used with caution and patients should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis.
Cerivastatin je treba uporabljati previdno in bolnike skrbno nadzorovati, da bi odkrili znake in simptome miopatije in rabdomiolize.
Benzodiazepins When midazolam was coadministered with Ketek, midazolam AUC was increased 2.2-fold after intravenous administration of midazolam and 6.1-fold after oral administration.
Benzodiazepini Med sočasno uporabo midazolama in zdravila Ketek se je AUC midazolama po intravenski aplikaciji midazolama zvišala za 2, 2- krat, po peroralni pa za 6, 1- krat.
The midazolam half- life was increased about 2.5-fold.
Razpolovni čas midazolama se je podaljšal za približno 2, 5- krat.
For those benzodiazepins which are not metabolized by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Ketek is unlikely.
Pri benzodiazepinih, ki se ne presnavljajo s CYP3A4 (temazepam, nitrazepam, lorazepam), medsebojno delovanje z zdravilom Ketek ni verjetno.
Cyclosporin, tacrolimus, sirolimus Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these CYP34A4 substrates.
Ciklosporin, takrolimus, sirolimus Zaradi potenciala za zaviranje CYP3A4 lahko telitromicin zviša koncentracije teh substratov CYP3A4 v krvi.
5 Metoprolol When metoprolol (a CYP2D6 substrate) was coadministered with Ketek, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
Metoprolol Med sočasno uporabo metoprolola (substrata CYP2D6) in zdravila Ketek, sta se Cmax in AUC metoprolola zvišali za okrog 38%, vendar ni bilo učinka na razpolovno dobo izločanja metoprolola.
The increase exposure to metoprolol may be of clinical importance in patients with heart failure treated with metoprolol.
5 popuščanjem, zdravljenih z metoprololom.
Digoxin Ketek has been shown to increase the plasma concentrations of digoxin.
Digoksin Dokazano je, da Ketek zviša koncentracije digoksina v plazmi.
Theophylline There is no clinically relevant pharmacokinetic interaction of Ketek and theophylline administered as extended release formulation.
Teofilin Med zdravilom Ketek in teofilinom, uporabljenim v obliki s podaljšanim sproščanjem, ni klinično pomembnih farmakokinetičnih interakcij.
Oral anticoagulants Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin.
Peroralni antikoagulanti Pri bolnikih, ki so istočasno prejemali antikoagulante in antibiotike, vključno s telitromicinom, so poročali o povečani aktivnosti antikoagulantov.
Although Ketek has no clinically relevant pharmacokinetic or pharmacodynamic interaction with warfarin after single dose administration, more frequent monitoring of prothrombin time/ INR (International Normalised Ratio) values should be considered during concomitant treatment.
Čeprav po uporabi enega odmerka Ketek nima klinično pomembnih farmakokinetičnih ali farmakodinamičnih interakcij z varfarinom, je potrebno razmisliti o pogostejšem nadziranju protrombinskega časa/ INR (» International Normalised Ratio «) med sočasnim zdravljenjem.
Oral contraceptives There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose triphasic oral contraceptives in healthy subjects.
Peroralni kontraceptivi Pri zdravih preiskovankah ni farmakodinamičnih ali klinično pomembnih farmakokinetičnih interakcij z nizkoodmernimi trifaznimi peroralnimi kontraceptivi.
• Effect of other medicinal products on Ketek
• Vpliv drugih zdravil na zdravilo Ketek
Therefore, concomitant administration of CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John’ s wort) is likely to result in subtherapeutic levels of telithromycin and loss of effect.
Med sočasno uporabo induktorjev CYP3A4 (kot so rifampicin, fenitoin, karbamazepin, fenobarbital, šentjanževka) zato obstaja možnost za pojav subterapevtskih koncentracij telitromicina in izgubo učinka.
Interaction studies with itraconazole and ketoconazole, two CYP3A4 inhibitors, showed that maximum plasma concentrations of telithromycin were increased respectively by 1.22 and 1.51 fold and AUC by respectively 1.54 fold and 2.0 fold.
V raziskavah interakcij z itrakonazolom in ketokonazolom, zaviralcema CYP3A4, se je najvišja koncentracija telitromicina v plazmi s prvim zvišala za 1, 22- krat in z drugim za 1, 51- krat, AUC pa s prvim za 1, 54- krat in z drugim za 2, 0- krat.
6 Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Telitromicin se izloča z mlekom doječih živali v koncentracijah, ki so približno 5- krat tolikšne kot v materini plazmi.
Ketek may cause undesirable effects such as visual disturbances, confusion or hallucination which may reduce the capacity for the completion of certain tasks.
Ketek lahko povzroči neželene učinke, kot so motnje vida, zmedenost ali halucinacije, ki lahko zmanjšajo zmožnost za opravljanje nekaterih nalog.
In addition, rare cases of transient loss of consciousness, which may be preceded by vagal symptoms, have been reported (see section 4.8).
Poročali so tudi o redkih primerih prehodne izgube zavesti, pred katero se lahko pojavijo vagalni simptomi (glejte poglavje 4. 8).
If patients experience visual disorders, loss of consciousness, confusion or hallucination while taking Ketek, patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities (see sections 4.4 and 4.8).
Če se med zdravljenjem z zdravilom Ketek pri bolnikih pojavijo motnje vida, izguba zavesti, zmedenost ali halucinacije, bolniki ne smejo voziti motornih vozil, upravljati s težkimi stroji ali se vključevati v druge nevarne aktivnosti (glejte poglavji 4. 4 in 4. 8).
Patients should be informed that these undesirable effects may occur as early as after the first dose of medication.
Bolnike je treba seznaniti, da seti neželeni učinki lahko pojavijo že po prvem odmerku zdravila.
This is shown below.
Pri 2461 bolnikih, zdravljenih z zdravilom Ketek v kliničnih preskušanjih III. faze in med postmarketinško izkušnjo, so bili opisani naslednji neželeni učinki, ki so morda ali verjetno povezani s telitromicinom in so navedeni spodaj.
System organ class
Zelo redki Neznana
Very common (≥ 1/ 10)
pogosti (≥ 1/ 100 do (≥ 1/ 10) < 1/ 10)
Common (≥ 1/ 100 to < 1/ 10)
(≥ 1/ 1. 000 do < 1/ 100)
Uncommon Rare (≥ 1/ 1,000 (≥ 1/ 10,000 to to < 1/ 100) < 1/ 1,000)
(≥ 1/ 10. 000 do < 1/ 1. 000)
Very rare (< 1/ 10,000)
(< 1/ 10. 000)
Frequency unknown (cannot be estimated from available data)*
pogostnost (ni mogoče oceniti iz razpoložljivih podatkov) * podaljšanje
Flush Atrial Palpitations arrhythmia, hypotension, bradycardia
aritmija, hipotenzija, bradikardija
QT/ QTc interval prolongation
intervala
Dizziness, headache, disturbance of taste
omotica, glavobol, motnje okusa
Vertigo somnolence, nervousness, insomnia,
vrtoglavica, somnolenca, živčnost, nespečnost
Transient loss Parosmia of consciousness, paraesthesia
prehodna izguba zavesti, parestezije
Ageusia, anosmia,
poročali so o primerih hitrega pojava poslabšanja miastenije gravis (glejte poglavji 4. 3 in 4. 4), agevzija, anozmija
Eye disorders
Očesne bolezni Srčno- žilne bolezni
Blurred vision
zamegljen vid pordevanje palpitacije oralna okužba
Diplopia
diplopija atrijska aritmija, hipotenzija, bradikardija
7 System organ class
psevdomem - pankreatitis
Very common (≥ 1/ 10)
Bolezni
Common (≥ 1/ 100 to < 1/ 10)
driska
Uncommon Rare (≥ 1/ 1,000 (≥ 1/ 10,000 to to < 1/ 100) < 1/ 1,000)
navzea,
Very rare (< 1/ 10,000)
s Candido,
Frequency unknown (cannot be estimated from available data)*
branski
Gastro-intestinal Diarrhoea Nausea, disorders vomiting, gastrointestin al pain, flatulence
prebavil
Oral Candida infection, stomatitis anorexia, constipation
bruhanje, bolečine v prebavilih, flatulenca
Pseudo- membranous colitis
stomatitis, anoreksija, zaprtje
Pancreatitis
kolitis
Skin and subcutaneous tissue disorders
7 Bolezni kože in podkožja
Rash, urticaria, pruritus
izpuščaj, urtikarija, pruritus
Muscle cramps
mišični krči
Angioneurotic oedema, anaphylactic reactions including anaphylactic shock, hypersensitivity
angionevrotični edem, anafilaktične reakcije vključno z anafilaktičnim šokom, preobčutljivost
Hepato-biliary Increase in disorders liver enzymes (AST, ALT, alkaline phosphatase) Reproductive Vaginal system disorders Candida infection
Bolezni jeter, žolčnika in
Hepatitis
hepatitis
Severe hepatitis and liver failure (see section 4.4)
hud hepatitis in odpoved jeter (glejte poglavje
Psychiatric disorders * postmarketing experience.
Bolezni reprodukcijskih organov Psihiatrične motnje * postmarketinška izkušnja
Confusion, hallucination
zmedenost, halucinacije
Visual disturbances (< 1%) associated with the use of Ketek, including blurred vision, difficulty focusing and diplopia, were mostly mild to moderate.
Motnje vida (< 1%), povezane z uporabo zdravila Ketek, vključno z nejasnim vidom, težavami pri fokusiranju in diplopijo, so bile večinoma blage do zmerne.
These events have not been associated with signs of ocular abnormality (see sections 4.4 and 4.7).
Ti dogodki niso bili povezni z znaki abnormalnosti na očeh (glejte poglavji 4. 4 in 4. 7).
In comparative trials, similar effects to those observed with clarithromycin were seen with an on-therapy Δ QTc > 30 msec in 7.6% and 7.0% of cases, respectively.
7, 0% primerov.
No patient in either group developed a Δ QTc > 60 msec.
Pri nobenem bolniku se ni niti v eni niti v drugi skupini pojavil ΔQTc > 60 milisekund.
Pharmacotherapeutic group: macrolides, lincosamides and streptogramins, ATC Code:
Farmakoterapevtska skupina: makrolidi, linkozamidi in streptogramini, oznaka ATC:
Telithromycin is a semisynthetic derivative of erythromycin A belonging to the ketolides, a class of antibacterial agents related to macrolides.
8 Telitromicin je polsintetični derivat eritromicina A in spada med ketolide, skupino makrolidom sorodnih protibakterijskih zdravil.
The affinity of telithromycin for the 50S bacterial subunit of ribosome is 10 fold higher than that of erythromycin A when the strain is susceptible to erythromycin A.
Afiniteta telitromicina za podenoto 50S bakterijskega ribosoma je 10- krat večja kot afiniteta eritromicina A, kadar je sev občutljiv za eritromicin A.
Against erythromycin A resistant strains, due to an MLSB mechanism of resistance, telithromycin shows a more than 20 fold affinity compared to erythromycin A in the 50S bacterial subunit.
Pri sevih, ki so zaradi mehanizma odpornosti MLSB odporni proti eritromicinu A, pa ima telitromicin v primerjavi z eritromicinom A več kot 20 - kratno afiniteto za bakterijsko podenoto 50S.
The recommended MIC breakpoints for telithromycin, separating susceptible organisms from intermediately susceptible organisms and intermediately susceptible organisms from resistant organisms, are: susceptible ≤ 0.5 mg/ l, resistant > 2 mg/ l.
Priporočeni mejni vrednosti MIK za telitromicin, ki ločita občutljive organizme od srednje občutljivih ter srednje občutljive od odpornih, sta: občutljivi ≤ 0, 5 mg/ l, odporni > 2 mg/ l.
9 Commonly susceptible species Aerobic Gram-positive bacteria Staphylococcus aureus methicillin susceptible (MSSA)* Lancefield group C and G (ß haemolytic) streptococci Streptococcus agalactiae Streptococcus pneumoniae * Viridans group streptococci Aerobic Gram- negative bacteria
Ponavadi občutljive vrste Aerobne grampozitivne bakterije Staphylococcus aureus občutljiv za meticilin (MSSA) * streptokoki skupine C in G po Lancefieldovi (ß - hemolitični) Streptococcus agalactiae Streptococcus pneumoniae * Streptokoki skupine Viridans Aerobne gramnegativne bakterije
Legionella pneumophila Moraxella catarrhalis* Other Chlamydophila pneumoniae* Chlamydia psittaci Mycoplasma pneumoniae*
Legionella pneumophila Moraxella catarrhalis * Druge Chlamydophila pneumoniae * Chlamydia psittaci Mycoplasma pneumoniae *
Species for which acquired resistance may be a problem Aerobic Gram-positive bacteria Staphylococcus aureus methicillin resistant (MRSA)+ Streptococcus pyogenes* Aerobic Gram- negative bacteria Haemophilus influenzae$* Haemophilus parainfluenzae$ Inherantly resistant organisms Aerobic Gram- negative bacteria Acinetobacter Enterobacteriaceae Pseudomonas
9 Vrste, pri katerih je pridobljena odpornost lahko problem Aerobne grampozitivne bakterije Staphylococcus aureus odporen za meticilin (MRSA) + Streptococcus pyogenes * Aerobne gramnegativne bakterije Haemophilus influenzae$ * Haemophilus parainfluenzae$ Inherentno odporni organizmi Aerobne gramnegativne bakterije Acinetobacter Enterobacteriaceae Pseudomonas
∗ Clinical efficacy has been demonstrated for susceptible isolates in the approved clinical indications. $natural intermediate susceptibility +Among MRSA the rate of MLSBc resistant strains is more than 80%, telithromycin is not active against MLSBc.
* Klinična učinkovitost je bila dokazana za občutljive izolate pri odobrenih kliničnih indikacijah. $naravna intermediarna občutljivost + Med MRSA je delež MLSBc odpornih sevov več kot 80%, telitromicin ni aktiven proti MLSBc.
Telithromycin does not induce MLSB resistance in vitro to Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus pyogenes, an attribute related to its 3 keto function.
Telitromicin in vitro ne inducira odpornosti MLSB pri Staphylococcus aureusu, Streptococcus pneumoniae in Streptococcus pyogenesu; ta lastnost je povezana z njegovo 3- keto funkcijo.
For Streptococcus pneumoniae, there is no cross- or co-resistance between telithromycin and other antibacterial classes including erythromycin A and/ or penicillin resistance.
Pri Streptococcus pneumoniae ni navzkrižne odpornosti ali soodpornosti med telitromicinom in drugimi skupinami protibakterijskih zdravil, vključno z eritromicinsko A in/ ali penicilinsko rezistenco.
10 Effect on oral and faecal flora
Učinek na oralno in fekalno floro
A mean maximum plasma concentration of about 2 mg/ l is reached within 1-3 hour after dose with once-daily dosing of telithromycin 800 mg.
Med uporabo 800 mg telitromicina enkrat na dan doseže povprečno najvišjo koncentracijo v plazmi približno 2 mg/ l v 1 do 3 urah po odmerku.
Mean steady-state trough plasma concentrations of between 0.04 and 0.07 mg/ l are reached within 3 to 4 days with once-daily dosing of telithromycin 800 mg.
Povprečne najnižje plazemske koncentracije v stanju dinamičnega ravnovesja, ki znašajo od 0, 04 do 0, 07 mg/ l, so dosežene po 3 do 4 dneh uporabe 800 mg telitromicina enkrat na dan.
At steady-state AUC is approximately 1.5 fold increased compared to the single dose.
AUC v stanju dinamičnega ravnovesja se v primerjavi s posamičnim odmerkom zviša za približno 1, 5- krat.
Mean peak and trough plasma concentrations at steady state in patients were 2.9±1.6 mg/ l (range 0.02- 7.6 mg/ l) and 0.2±0.2 mg/ l (range 0.010 to 1.29 mg/ l), during a therapeutic 800 mg once-daily dose regimen.
10 Med terapevtskim režimom odmerjanja 800 mg enkrat na dan sta bili pri bolnikih povprečna najvišja in najnižja plazemska koncentracija v stanju dinamičnega ravnovesja 2, 9 ± 1, 6 mg/ l (razpon 0, 02 - 7, 6 mg/ l) in 0, 2 ± 0, 2 mg/ l (razpon 0, 010- 1, 29 mg/ l).
The in vitro protein binding is approximately 60% to 70%.
In vitro je vezava na beljakovine približno 60 do 70%.
The volume of distribution is 2.9±1.0 l/ kg.
Volumen porazdelitve je 2, 9 ± 1, 0 l/ kg.
The maximum total tissue concentration in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 14.9±11.4 mg/ l, 318.1±231 mg/ l, 3.88±1.87 mg/ kg, 3.95±0.53 mg/ kg and 6.96±1.58 mg/ kg, respectively.
Najvišje celokupne tkivne koncentracije so bile 14, 9 ± 11, 4 mg/ l v epitelijski tekočini, 318, 1 ± 231 mg/ l v alveolnih makrofagih, 3, 88 ± 1, 87 mg/ kg v bronhialni sluznici, 3, 95 ± 0, 53 mg/ kg v tonzilah in 6, 96 ± 1, 58 mg/ kg v sinusih.
The total tissue concentration 24 h after dose in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 0.84±0.65 mg/ l, 162±96 mg/ l, 0.78±0.39 mg/ kg, 0.72±0.29 mg/ kg and 1.58±1.68 mg/ kg, respectively.
Celokupne tkivne koncentracije 24 ur po odmerku so bile 0, 84 ± 0, 65 mg/ l v epitelijski tekočini, 162 ± 96 mg/ l v alveolnih makrofagih, 0, 78 ± 0, 39 mg/ kg v bronhialni sluznici, 0, 72 ± 0, 29 mg/ kg v tonzilah in 1, 58 ± 1, 68 mg/ kg v sinusih.
The mean maximum white blood cell concentration of telithromycin was 83±25 mg/ l.
Povprečna najvišja koncentracija telitromicina v belih krvnih celicah je bila 83 ± 25 mg/ l.
Telithromycin is metabolized both by CYP450 isoenzymes and non-CYP enzymes.
Telitromicin se presnavlja tako z izoencimi CYP450 kot z ne- CYP encimi.
After oral administration of radiolabelled telithromycin, 76% of the radioactivity was recovered from faeces, and 17% from the urine.
Po peroralni uporabi radioaktivno označenega telitromicina so določili 76% radioaktivnosti v blatu in 17% v urinu.
The total clearance (mean ±SD) is 11 approximately 58±5 l/ h after an intravenous administration with renal clearance accounting for about 22% of this.
Skupni očistek (povprečje ± SD) po intravenski uporabi je približno 58 ± 5 l/ h, pri čemer gre okoli 22% tega na račun ledvičnega očistka.
Telithromycin displays a tri-exponential decay from plasma, with a rapid distribution half-life of 0.17 h.
Padec koncentracije telitromicina v plazmi je eksponenten v treh fazah s kratkim razpolovnim časom porazdelitve 0, 17 ure.
-Renal impairment In a multiple-dose study, 36 subjects with varying degrees of renal impairment, a 1.4-fold increase in Cmax, ss, and a 2-fold increase in AUC (0-24)ss at 800 mg multiple doses in the severe renally impaired group (CLCR < 30 mL/ min) compared to healthy volunteers were observed and a reduced dosage of Ketek is recommended (See Section 4.2.).
V raziskavi z večkratnimi odmerki, v katero so vključili 36 oseb z različno stopnjo okvare ledvic, so v skupini bolnikov s hudo okvaro ledvic (očistek kreatinina < 30 ml/ min) v primerjavi z zdravimi prostovoljci pri večkratnih odmerkih po 800 mg ugotovili 1, 4- kratno povečanje Cmax, ss in 2- kratno povečanje AUC (0- 24h) ss, zato je priporočeno zmanjšanje odmerka zdravila Ketek (glejte poglavje 4. 2).
Based on simulation data, an alternating daily dosing regimen of 800 mg and 400 mg in patients with severe renal impairment can approximate the AUC (0-48h) in healthy subjects receiving 800 mg once daily.
Izmeničen dnevni režim odmerjanja po 800 mg in 400 mg pri bolnikih s hudo okvaro ledvic približa AUC (0- 48) zdravim prostovoljcem glede na podatke, pridobljene s simulacijo.
The effect of dialysis on the elimination of telithromycin has not been assessed.
- Okvara jeter
-Hepatic impairment In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with mild to severe hepatic insufficiency (Child Pugh Class A, B and C), the Cmax, AUC and t1/ 2 of telithromycin were similar compared to those obtained in age- and sex-matched healthy subjects.
V študiji posamičnega odmerka (800 mg) pri 12 bolnikih in študiji večkratnih odmerkov (800 mg) pri 13 bolnikih z blago do hudo insuficienco jeter (razred A, B in C po Child- Pughu), so bili Cmax, AUC in t1/ 2 telitromicina podobni kot pri zdravih preiskovancih, po starosti in spolu usklajenih z bolniki.
Due to limited experience in patients with decreased metabolic capacity of the liver, Ketek should be used with caution in patients with hepatic impairment (see also section 4.4).
Zaradi omejenih izkušenj pri bolnikih z zmanjšano presnovno kapaciteto jeter je treba zdravilo Ketek pri bolnikih z jetrno okvaro uporabljati previdno (glejte tudi poglavje 4. 4).
-Elderly subjects In subjects over 65 (median 75 years), the maximum plasma concentration and AUC of telithromycin were increased approximately 2 fold compared with those achieved in young healthy adults.
Pri preiskovancih, starejših od 65 let (mediana 75 let), sta bili najvišja plazemska koncentracija in AUC telitromicina približno 2- krat višji kot pri mladih zdravih odraslih.
-Paediatric patients The pharmacokinetics of telithromycin in paediatric population less than 12 years old have not yet been studied.
Farmakokinetika telitromicina v skupini pediatričnih bolnikov do 12. leta starosti še ni raziskana.