natgillin/translations-raw huggingface dataset:
Prothrombin time or other suitable anticoagulation test should be used to monitor patients if tigecycline is administered with anticoagulants (see section 4.5).
Bolnike, ki jim dajemo tigeciklin skupaj z antikoagulansi, moramo spremljati s testiranjem protrombinskega časa ali kakim drugim primernim koagulacijskim testom (glejte poglavje 4. 5).
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibacterial agent (see section 4.8).
Zato je pomembno, da pri bolnikih, ki med uporabo ali po uporabi kateregakoli protibakterijskega zdravila dobijo drisko, pomislimo na to diagnozo (glejte poglavje 4. 8).
Patients should be carefully monitored during therapy.
Bolnike moramo med zdravljenjem skrbno spremljati.
If super infection occurs, appropriate measures should be taken (see section 4.8).
Če pride do superinfekcije, so potrebni ustrezni ukrepi (glejte poglavje 4. 8).
Tigecycline may be associated with permanent tooth discolouration in humans if used during tooth development (see section 4.8).
Tigeciklin je lahko povezan s trajnim obarvanjem zob pri ljudeh, če ga dajemo med razvojem zob (glejte poglavje 4. 8).
Tygacil should not be used in children under 8 years of age because of teeth discolouration, and is not recommended in adolescents below 18 years due to the lack of data on safety and efficacy (see sections 4.2 and 4.8).
Tygacila ne smemo uporabljati pri otrocih, mlajših od 8 let, zaradi obarvanja zob, zaradi pomanjkanja podatkov o varnosti in učinkovitosti pa ni priporočljiv pri mladostnikih, mlajših od 18 let (glejte poglavji 4. 2 in 4. 8).
Concomitant administration of tigecycline and warfarin (25 mg single-dose) to healthy subjects resulted in a decrease in clearance of R-warfarin and S-warfarin by 40% and 23%, and an increase in AUC by 68% and 29%, respectively.
Sočasno dajanje tigeciklina in varfarina (v enem samem 25- miligramskem odmerku) zdravim osebam je povzročilo zmanjšanje očistka R- varfarina in S- varfarina za 40% oziroma 23% in zvečanje AUC za 68% oziroma 29%.
Available data does not suggest that this interaction may result in significant INR changes.
Podatki, ki so na voljo, ne kažejo na to, da bi utegnila ta interakcija povzročiti znatne spremembe internacionalnega normaliziranega razmerja (INR).
However, since tigecycline may prolong both prothrombin time (PT) and activated partial thromboplastin time (aPTT), the relevant coagulation tests should be closely monitored when tigecycline is co-administered with anticoagulants (see section 4.4).
Ker pa lahko tigeciklin podaljša tako protrombinski čas (PČ) kot aktivirani parcialni tromboplastinski čas (aPTČ), moramo skrbno spremljati zadevne koagulacijske teste, kadar dajemo tigeciklin sočasno z antikoagulansi (glejte poglavje 4. 4).
4 Tigecycline is not extensively metabolised.
Tigeciklin se ne presnavlja v večji meri.
In vitro, tigecycline is neither a competitive inhibitor nor an irreversible inhibitor of CYP450 enzymes (see section 5.2).
In vitro tigeciklin ni niti kompetitiven inhibitor niti ireverzibilen inhibitor encimov CYP450 (glejte poglavje 5. 2).
Tigecycline in recommended dosage did not affect the rate or extent of absorption, or clearance of digoxin (0.5 mg followed by 0.25 mg daily) when administered in healthy adults.
Ko so tigeciklin v priporočenih odmerkih (0, 5 mg, nato 0, 25 mg na dan) dajali zdravim odraslim, ni vplival na hitrost ali obseg absorpcije, niti na očistek digoksina.
There are no adequate data from the use of tigecycline in pregnant women.
Ni zadostnih podatkov o uporabi tigeciklina pri nosečnicah.
Results from animal studies have shown tigecycline may cause foetal harm when administered during pregnancy (see section 5.3).
Študije na živalih so pokazale, da lahko tigeciklin škoduje plodu, če se ga uporablja med nosečnostjo (glejte poglavje 5. 3).
As it is known for tetracycline class antibiotics, tigecycline may also induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses, exposed in utero during the last half of gestation, and in children under eight years of age due to the enrichment in tissues with a high calcium turnover and formation of calcium chelate complexes (see section 4.4).
Kot je znano za antibiotike tetraciklinske skupine, lahko tudi tigeciklin povzroči trajne okvare zob (obarvanje in okvare sklenine) in zakasnitev zakostenevanja pri plodovih, ki so bili zdravilu izpostavljeni in utero v drugi polovici nosečnosti, in pri otrocih, mlajših od osem let, zaradi kopičenja v tkivih z velikim obratom kalcija in nastajanja kompleksov kalcijevega kelata (glejte poglavje 4. 4).
Tigecycline should not be used during pregnancy unless clearly necessary.
Tigeciklina ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
It is not known whether this medicinal product is excreted in human milk.
Ni znano, če se to zdravilo izloča v materino mleko.
In animal studies tigecycline is excreted into milk of lactating rats.
V raziskavah na živalih se je tigeciklin izločal v mleko doječih podgan.
Because a potential risk to the breast-feeding infant cannot be ruled out, when treating with tigecycline, caution should be exercised and interruption of breast-feeding should be considered (see section 5.3).
Ker ni mogoče izključiti možnega tveganja za dojenega otroka, moramo biti pri zdravljenju s tigeciklinom previdni in razmisliti o možnost prekinitve dojenja (glejte poglavje 5. 3).
No studies on the effects of tigecycline on the ability to drive and use machines have been performed.
Študij o vplivu tigeciklina na sposobnost vožnje in upravljanja s stroji niso izvedli.
Dizziness may occur and this may have an effect on driving and use of machines (see section 4.8).
Lahko se pojavi omotica, ki utegne vplivati na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4. 8).
The total number of patients treated with tigecycline in Phase 3 clinical studies was 1415.
Celotno število bolnikov, zdravljenih s tigeciklinom v kliničnih študijah 3. faze, je bilo 1415.
Adverse reactions were reported in approximately 41% of patients treated with tigecycline.
O neželenih učinkih so poročali pri približno 41% bolnikov, zdravljenih s tigeciklinom.
Treatment was discontinued due to adverse reactions in 5% of patients.
Zaradi neželenih učinkov so prekinili zdravljenje pri 5% bolnikov.
In clinical trials, the most common drug-related treatment emergent adverse reactions were reversible nausea (20%) and vomiting (14%), which usually occurred early (on treatment days 1-2) and were generally mild or moderate in severity.
V kliničnih preskušanjih sta bila najpogostejša neželena učinka, ki sta se pojavila v zvezi z zdravljenjem z zdravilom, reverzibilna navzea (20%) in bruhanje (14%), ki sta se navadno pojavila v začetku zdravljenja (prvi ali drugi dan zdravljenja) in sta bila na splošno blaga do zmerna.
Adverse reactions reported with Tygacil, including clinical trials and post-marketing experience, are listed below:
Neželeni učinki, o katerih so poročali pri uporabi zdravila Tygacil, vključno s kliničnimi preskušanji in izkušnjami po prihodu zdravila na trg, so navedeni spodaj:
Very common (≥ 1/ 10); Common (≥ 1/ 100 to < 1/ 10); Uncommon (≥ 1/ 1,000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1,000); Very Rare (< 1/ 10,000)
Pogostnosti pojavljanja neželenih učinkov so opredeljene po naslednjih skupinah: zelo pogosti (≥1/ 10); pogosti (≥1/ 100 do < 1/ 10); občasni (≥1/ 1. 000 do < 1/ 100); redki (≥1/ 10. 000 do < 1/ 1. 000); zelo redki (< 1/ 10. 000).
5 For adverse reactions identified from post-marketing experience with Tygacil derived from spontaneous reports for which the frequency cannot be estimated, the frequency grouping is categorized as not known.
Neželeni učinki, ugotovljeni iz spontanih poročil v okviru izkušenj po prihodu zdravila Tygacil na trg, za katere pogostnosti ni mogoče oceniti, so uvrščeni v skupino pogostnosti “ neznano ”.
Sepsis/ septic shock
Pogosti: absces, okužbe Občasni: sepsa/ septični šok
In Phase 3 clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with tigecycline (6.7%) vs comparators (4.6%).
V kliničnih študijah 3. faze so pri bolnikih, zdravljenih s tigeciklinom, pogosteje poročali o resnih neželenih učinkih, povezanih z okužbami (6, 7%) kot pri primerjalnih osebah (4, 6%).
Significant differences in sepsis/ septic shock with tigecycline (1.5%) vs comparators (0.5%) were observed.
Opazili so pomembne razlike glede sepse/ septičnega šoka med tigeciklinom (1, 5%) in primerjalnimi zdravili (0, 5%).
Increased International Normalised Ratio (INR) Not known: thrombocytopenia
Pogosti: podaljšan aktivirani parcialni tromboplastinski čas (aPTČ), podaljšan protrombinski čas (PČ) Občasni: zvečano internacionalno normalizirano razmerje (INR) Neznano: trombocitopenija
Anaphylaxis/ anaphylactoid reactions (see sections 4.3 and 4.4)
Neznano: anafilaksija/ anafilaktoidne reakcije (glejte poglavji 4. 3 in 4. 4)
Metabolism and nutrition disorders:
5 Presnovne in prehranske motnje:
Hypoproteinaemia
Občasni: hipoproteinemija
Vascular disorders:
Pogosti: omotica
Thrombophlebitis
Žilne bolezni:
Gastrointestinal disorders:
Pogosti: flebitis Občasni: tromboflebitis
Very Common:
Bolezni prebavil:
Acute pancreatitis
Zelo pogosti: navzea, bruhanje, driska Pogosti: bolečina v trebuhu, dispepsija, anoreksija Občasni: akutni pankreatitis
Elevated aspartate aminotransferase (AST) in serum, and elevated alanine aminotransferase (ALT) in serum, hyperbilirubinaemia
Pogosti: zvišanje aspartat- aminotransferaze (AST) v serumu in zvišanje alanin - aminotransferaze (ALT) v serumu, hiperbilirubinemija
AST and ALT abnormalities in Tygacil-treated patients were reported more frequently in the post therapy period than in those in comparator-treated patients, which occurred more often on therapy.
O nenormalnostih AST in ALT pri bolnikih, zdravljenih s Tygacilom, so pogosteje poročali v obdobju po končanem zdravljenju kot pri bolnikih, zdravljenih s primerjalnim zdravilom, pri katerih so se le- te pogosteje pojavljale med zdravljenjem.
6 Skin and subcutaneous tissue disorders:
Občasni: zlatenica, okvara jeter, večinoma holestatska
Pruritus, rash
Bolezni kože in podkožja:
General disorders and administration site conditions:
Pogosti: pruritus, izpuščaj
Headache Uncommon:
Splošne težave in spremembe na mestu aplikacije:
Injection site reaction, injection site inflammation, injection site pain, injection site oedema, injection site phlebitis
Pogosti: glavobol Občasni: reakcija na mestu injiciranja, vnetje na mestu injiciranja, bolečina na mestu injiciranja, edem na mestu injiciranja, flebitis na mestu injiciranja
Common:
Preiskave:
Elevated amylase in serum, increased blood urea nitrogen (BUN)
Pogosti: zvišana serumska amilaza, zvišan dušik sečnine v krvi (BUN).
In Phase 3 cSSSI and cIAI studies, death occurred in 2.3% (32/ 1383) of patients receiving tigecycline and 1.6% (22/ 1375) of patients receiving comparator drugs.
V študijah cIAI in cSSSI 3. faze je umrlo 2, 3% (32/ 1383) bolnikov, ki so prejemali tigeciklin, in 1, 6% (22/ 1375) bolnikov, ki so prejemali primerjalna zdravila.
Antibiotic Class Effects:
Učinki antibiotične skupine:
Pseudomembranous colitis which may range in severity from mild to life threatening (see section 4.4)
Psevdomembranski kolitis, katerega stopnja izraženosti lahko sega od blagega do smrtno nevarnega (glejte poglavje 4. 4).
Overgrowth of non-susceptible organisms, including fungi (see section 4.4)
Razraščanje neobčutljivih mikroorganizmov, vključno z glivicami (glejte poglavje 4. 4).
Tetracycline Class Effects:
Učinki tetraciklinske skupine:
Tetracycline class adverse reactions may include photosensitivity, pseudotumour cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.4).
Med neželenimi učinki tetraciklinske skupine so lahko preobčutljivost za svetlobo, benigna intrakranialna hipertenzija, pankreatitis in antianabolno delovanje, ki lahko povzroči zvišan dušik sečnine v krvi, azotemijo, acidozo in hiperfosfatemijo (glejte poglavje 4. 4).
Tigecycline may be associated with permanent tooth discolouration if used during tooth development (see section 4.4).
Tigeciklin je lahko povezan s trajnim obarvanjem zob, če ga dajemo med razvojem zob (glejte poglavje 4. 4).
Intravenous administration of tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting.
Intravensko dajanje tigeciklina zdravim prostovoljcem v enem samem 300- miligramskem odmerku v času 60 minut je bilo povezano v večjo pojavnostjo navzee in bruhanja.
Tetracyclines, ATC code:
Farmakoterapevtska skupina: tetraciklini, oznaka ATC:
Tigecycline, a glycylcycline antibiotic, inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome.
Način delovanja Glicilciklinski antibiotik tigeciklin inhibira prepisovanje beljakovin z ribonukleinske kisline (RNA) pri bakterijah, tako da se veže na ribosomsko podenoto 30S in blokira vstop aminoacilnih molekul tRNA na mesto A na ribosomu.
7 In general, tigecycline is considered bacteriostatic.
Na splošno velja, da je tigeciklin bakteriostatik.
At 4 times the minimum inhibitory concentration (MIC), a 2-log reduction in colony counts was observed with tigecycline against Enterococcus spp., Staphylococcus aureus, and Escherichia coli.
V koncentraciji, ki je bila štirikrat višja od minimalne inhibicijske koncentracije (MIC), so s tigeciklinom opazovali zmanjšanje 2- log števila kolonij proti Enterococcus spp., Staphylococcus aureus in Escherichia coli.
Tigecycline is able to overcome the two major tetracycline resistance mechanisms, ribosomal protection and efflux.
Mehanizem odpornosti Tigeciklin je sposoben premagati dva poglavitna mehanizma odpornosti proti tetraciklinom, ribosomsko zaščito in iztok.
However, it is vulnerable to chromosomally-encoded multidrug efflux pumps of Proteeae (see below) and Pseudomonas aeruginosa (MexXY-OprM efflux system).
Občutljiv pa je za kromosomsko kodirane iztočne črpalke za več zdravil, ki jih imajo Proteeae (glejte spodaj) in Pseudomonas aeruginosa (iztočni sistem MexXY- OprM).
In addition, some acquired resistance has been detected in Klebsiella pneumoniae, Enterobacter aerogenes, and Enterobacter cloacae.
Poleg tega so odkrili nekaj pridobljene odpornosti pri bakterijah Klebsiella pneumoniae, Enterobacter aerogenes in Enterobacter cloacae.
Decreased susceptibility in Acinetobacter baumannii has been attributed to the overexpression of the AdeABC efflux pump.
Zmanjšano občutljivost pri Acinetobacter baumannii so pripisali čezmerni eskpresiji AdeABC iztočne črpalke..
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Mejne vrednosti Mejne vrednosti minimalnih inhibicijskih koncentracij (MIC), ki jih je ugotovil Evropski odbor za testiranje občutljivosti za protimikrobna zdravila (EUCAST), so naslednje:
S ≤ 0.5 mg/ L and R > 0.5 mg/ L Streptococcus spp. other than S. pneumoniae S ≤ 0.25 mg/ L and R > 0.5 mg/ L Enterococcus spp.
S ≤ 0, 5 mg/ l in R > 0, 5 mg/ l Streptococcus spp., razen S. pneumoniae, S ≤ 0, 25 mg/ l in R > 0, 5 mg/ l Enterococcus spp.
S ≤ 0.25 mg/ L and R > 0.5 mg/ L Enterobacteriaceae S ≤ 1(^) mg/ L and R > 2 mg/ L (^) Tigecycline has decreased in vitro activity against Proteus, Providencia, and Morganella spp.
S ≤ 0, 25 mg/ l in R > 0, 5 mg/ l Enterobacteriaceae S ≤ 1 (^) mg/ l in R > 2 mg/ l () ^ Tigeciklin ima zmanjšano aktivnost in vitro proti družinam Proteus, Providencia in Morganella spp.
For anaerobic bacteria there is clinical evidence of efficacy in polymicrobial intra-abdominal infections, but no correlation between MIC values, PK/ PD data and clinical outcome.
Za anaerobne bakterije obstajajo klinični dokazi o učinkovitosti pri polimikrobnih intraabdominalnih okužbah, vendar ni nikakršne korelacije med vrednostmi MIC, podatki o farmakokinetiki in farmakodinamiki in kliničnim izidom.
It should be noted that the MIC distributions for organisms of the genera Bacteroides and Clostridium are wide and may include values in excess of 2 mg/ L tigecycline.
Opozarjamo, da so porazdelitve MIC za organizme rodov Bacteroides in Clostridium široke in lahko vključujejo vrednosti, ki presegajo 2 mg/ l tigeciklina.
However, polymicrobial intra-abdominal infections have shown to respond to treatment with tigecycline in clinical trials.
Vendar se je pokazalo, da se v kliničnih preskušanjih polimikrobne intraabdominalne infekcije odzivajo na zdravljenje s tigeciklinom.
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.
Informacije z lokalnega območja o odpornosti mikroorganizmov so zaželene predvsem pri zdravljenju težkih okužb.
Staphylococcus haemolyticus Streptococcus agalactiae* Streptococcus anginosus group* (includes S. anginosus, S. intermedius and S. constellatus) Streptococcus pyogenes* Viridans group streptococci Citrobacter freundii* Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae* Escherichia coli* Klebsiella oxytoca* Klebsiella pneumoniae* Serratia marcescens Clostridium perfringens† Peptostreptococcus spp .† Prevotella spp.
Običajno občutljive vrste Enterococcus spp. † Staphylococcus aureus * Staphylococcus epidermidis Staphylococcus haemolyticus Streptococcus agalactiae * Skupina Streptococcus anginosus * (vključuje S. anginosus, S. intermedius in S. constellatus) Streptococcus pyogenes * Streptokoki skupine viridans Citrobacter freundii * Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca * Klebsiella pneumoniae * Serratia marcescens Clostridium perfringens † Peptostreptococcus spp. † Prevotella spp.
Species for which acquired resistance may be a problem Acinetobacter baumannii Bacteroides fragilis group† Burkholderia cepacia Morganella morganii Providencia spp.
Vrste, pri katerih utegne biti problem pridobljena odpornost Acinetobacter baumannii Skupina Bacteroides fragilis † Burkholderia cepacia Morganella morganii Providencia spp.
Inherently resistant organisms Pseudomonas aeruginosa * denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies. † see section 5.1, Breakpoints above.
Naravno odporni organizmi Pseudomonas aeruginosa * označuje vrsto, za katero velja, da je bila aktivnost proti njej zadovoljivo prikazana v kliničnih študijah. † glejte poglavje 5. 1, Mejne vrednosti zgoraj.
Tigecycline is administered intravenously and therefore has 100% bioavailability.
Absorpcija Tigeciklin se daje intravensko in ima zato 100- odstotno biološko uporabnost.
The in vitro plasma protein binding of tigecycline ranges from approximately 71% to 89% at concentrations observed in clinical studies (0.1 to 1.0 µg/ ml).
Porazdelitev Vezava tigeciklina na plazemske beljakovine in vitro sega od približno 71% do 89% v koncentracijah, ki so jih opazovali v kliničnih študijah (0, 1 do 1, 0 μg/ ml).
In rats receiving single or multiple doses of 14C-tigecycline, radioactivity was well distributed to most tissues, with the highest overall exposure observed in bone marrow, salivary glands, thyroid gland, spleen, and kidney.
Pri podganah, ki so prejele bodisi en sam odmerek bodisi po več odmerkov 14C- tigeciklina, se je radioaktivnost dobro porazdelila v večino tkiv, pri čemer so največjo celotno izpostavljenost izmerili v
In humans, the steady-state volume of distribution of tigecycline averaged 500 to 700 L (7 to 9 L/ kg), indicating that tigecycline is extensively distributed beyond the plasma volume and concentrates into tissues.
Pri ljudeh je bil volumen porazdelitve tigeciklina v stanju dinamičnega ravnovesja povprečno 500 do 700 l (7 do 9 l/ kg), kar kaže, da se tigeciklin obsežno prerazporedi iz plazemskega prostora in se kopiči v tkivih.
9 No data are available on whether tigecycline can cross the blood-brain barrier in humans.
Ni podatkov o morebitnem prehajanju tigeciklina skozi krvno- možgansko pregrado pri ljudeh.
In clinical pharmacology studies using the therapeutic dosage regimen of 100 mg followed by 50 mg q12h, serum tigecycline steady-state Cmax was 866±233 ng/ ml for 30-minute infusions and 634±97 ng/ ml for 60-minute infusions.
V kliničnofarmakoloških študijah, v katerih so uporabljali shemo terapevtskega odmerjanja 100 mg, nato pa 50 mg vsakih 12 ur, je bila serumska Cmax tigeciklina v stanju dinamičnega ravnovesja 866±233 ng/ ml pri 30- minutnih infuzijah in 634±97 ng/ ml pri 60- minutnih infuzijah.
The steady-state AUC0-12h was 2349±850 ng• h/ ml.
AUC0- 12h v stanju dinamičnega ravnovesja je bila 2349±850 ng• h/ ml.
On average, it is estimated that less than 20% of tigecycline is metabolised before excretion.
Presnova Ocenjujejo, da se povprečno manj kot 20% tigeciklina presnovi, preden se izloči.
In healthy male volunteers, following the administration of 14C-tigecycline, unchanged tigecycline was the primary 14 C-labelled material recovered in urine and faeces, but a glucuronide, an N-acetyl metabolite and a tigecycline epimer were also present.
Pri zdravih moških prostovoljcih je bil, potem ko so prejeli 14C- tigeciklin, primarna snov, označena s 14C, ki so jo prestregli iz urina in blata, nespremenjeni tigeciklin, prisotni pa so bili tudi glukuronid, N- acetilni presnovek in tigeciklinov epimer.
In vitro studies in human liver microsomes indicate that tigecycline does not inhibit metabolism mediated by any of the following 6 cytochrome P450 (CYP) isoforms:
Raziskave v mikrosomih človeških jeter in vitro kažejo, da tigeciklin ne zavira presnove, ki jo posreduje katerakoli od naslednjih šestih izoencimov citokroma P450 (CYP):
1A2, 2C8, 2C9, 2C19, 2D6, and 3A4 by competitive inhibition.
1A2, 2C8, 2C9, 2C19, 2D6, in 3A4, s kompetitivno inhibicijo.
In addition, tigecycline did not show NADPH-dependency in the inhibition of CYP2C9, CYP2C19, CYP2D6 and CYP3A, suggesting the absence of mechanism-based inhibition of these CYP enzymes.
Poleg tega tigeciklin pri inhibiciji CYP2C9, CYP2C19, CYP2D6 in CYP3A ni kazal odvisnosti od NADPH, kar kaže na to, da inhibicija teh encimov s CYP ne temelji na mehanizmu.
The recovery of the total radioactivity in faeces and urine following administration of 14C-tigecycline indicates that 59% of the dose is eliminated by biliary/ faecal excretion, and 33% is excreted in urine.
Izločanje Prestrežena celotna radioaktivnost v blatu in urinu po danem odmerku 14C- tigeciklina kaže, da se 59% odmerka izloči iz telesa z žolčem in blatom, 33% pa se ga izloči z urinom.
The total clearance of tigecycline is 24 L/ h after intravenous infusion.
Celotni očistek tigeciklina po intravenskem infundiranju je 24 l/ h.
Renal clearance is approximately 13% of total clearance.
Ledvični očistek predstavlja približno 13% celotnega očistka.
Hepatic Insufficiency The single-dose pharmacokinetic disposition of tigecycline was not altered in patients with mild hepatic impairment.
Insuficienca jeter Pri bolnikih z blago okvaro jeter se farmakokinetika tigeciklina po enkratnem odmerku ni spremenila.
However, systemic clearance of tigecycline was reduced by 25% and 55% and the half-life of tigecycline was prolonged by 23% and 43% in patients with moderate or severe hepatic impairment (Child Pugh B and C), respectively (see section 4.2).
Pri bolnikih z zmerno oziroma s hudo okvaro jeter (razred B oziroma C po Child- Pughovi lestvici) pa se je sistemski očistek tigeciklina zmanjšal za 25% oziroma 55%, razpolovni čas tigeciklina pa podaljšal za 23% oziroma 43% (glejte poglavje 4. 2).
Renal Insufficiency The single dose pharmacokinetic disposition of tigecycline was not altered in patients with renal insufficiency (creatinine clearance < 30 ml/ min, n=6).
Insuficienca ledvic Pri bolnikih z insuficienco ledvic (očistek kreatinina < 30 ml/ min, n=6) se farmakokinetika tigeciklina po enkratnem odmerku ni spremenila.