natgillin/translations-raw huggingface dataset:
In a randomised active-controlled trial 18.2% (126/693) of microbiologically evaluable (ME) patients had complicated lower urinary tract infection, including 60/126 patients who were treated with ceftolozane/tazobactam.
V randomiziranem, z zdravilno učinkovino nadzorovanem preskušanju, se je pri 18,2 % (126/693) mikrobiološko ocenljivih bolnikov pojavila zapletena okužba spodnjih sečil, vključno s 60/126 bolnikov, ki so bili zdravljeni s ceftolozanom/tazobaktamom.
One of the active ingredients, ceftolozane, may have harmful effects if it reaches the aquatic environment (see section 5.3).
Ena od učinkovin, ceftolozan, ima lahko škodljiv učinek, če pride v vodno okolje (glejte poglavje 5.3).
It is not known if ceftolozane crosses the placenta.
Ni znano, ali ceftolozan prehaja skozi placento.
In subjects with end stage renal disease on haemodialysis, approximately two-thirds of the administered ceftolozane/tazobactam dose is removed by haemodialysis.
Pri bolnikih s končno odpovedjo ledvic na hemodializi se med hemodializo odstranita približno dve tretjini uporabljenega odmerka ceftolozana/tazobaktama.
Approximately 66% of ceftolozane, 56% of tazobactam, and 51% of the M1 metabolite of tazobactam were removed by dialysis.
Z dializo so odstranili približno 66 % ceftolozana, 56 % tazobaktama in 51 % presnovka tazobaktama M1.
A dose of 300 mg/kg/day to rats was associated with a ceftolozane plasma exposure (AUC) value lower than the ceftolozane plasma AUC value at the highest recommended human dose of 2 grams every 8 hours.
Odmerek 300 mg/kg/dan je bil pri podganah povezan s plazemsko izpostavljenostjo ceftolozanu (AUC), ki je bila nižja kot je plazemska AUC ceftolozana ob največjem priporočenem odmerku za človeka, ki je 2 grama na 8 ur.
After reconstitution with 10 mL diluent, the total volume of the solution in the vial is 11.4 mL, which contains 88 mg/mL of ceftolozane and 44 mg/mL of tazobactam.
Po rekonstituciji z 10 ml vehikla je celotni volumen raztopine v viali 11,4 ml in vsebuje 88 mg/ml ceftolozana in 44 mg/ml tazobaktama.
The effects of ceftolozane and tazobactam on fertility in humans have not been studied.
Vplivi ceftolozana in tazobaktama na plodnost pri človeku niso raziskani.
2, liver function test abnormal
2, nepravilnosti testov jetrne funkcije
Ceftolozane belongs to the cephalosporin class of antimicrobials.
Ceftolozan spada v skupino cefalosporinskih protimikrobnih zdravil.
No dose adjustment is recommended based on gender.
Prilagoditev odmerka glede na spol ni potrebna.
It is unknown whether ceftolozane and tazobactam are excreted in human milk.
Ni znano, ali se ceftolozan in tazobaktam izločata v materino mleko.
It is an inhibitor of many molecular Class A beta-lactamases, including CTX-M, SHV, and TEM enzymes.
Je zaviralec številnih betalaktamaz molekulske skupine A, med drugim encimov CTX-M, SHV in TEM.
In clinical trials of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis, the efficacy of ceftolozane/tazobactam was lower in patients with moderate renal impairment compared with those with normal or mildly impaired renal function at baseline.
V kliničnih preskušanjih pri zapletenih okužbah v trebušni votlini in zapletenih okužbah sečil, vključno s pielonefritisom, je bila učinkovitost ceftolozana/tazobaktama pri bolnikih z zmerno okvaro ledvic manjša v primerjavi z bolniki z normalnim delovanjem ledvic ali blago okvaro ledvic v izhodišču.
For doses above 1 g ceftolozane and 0.5 g tazobactam, two vials are used.
Za odmerke, večje od 1 g ceftolozana in 0,5 g tazobaktama, je treba uporabiti dve viali.
Studies with ceftolozane in mice and rats have not shown evidence of reproductive toxicity or teratogenicity.
Študije ceftolozana na miših in podganah niso pokazale znakov vpliva na sposobnost razmnoževanja ali teratogenosti.
The European Medicines Agency has deferred the obligation to submit the results of studies with Zerbaxa in one or more subsets of the paediatric population in complicated intra-abdominal infection, complicated urinary tract infection, and hospital-acquired pneumonia, including ventilator-associated pneumonia (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Zerbaxa za eno ali več podskupin pediatrične populacije pri zapletenih okužbah v trebušni votlini, zapletenih okužbah sečil in bolnišnični pljučnici, vključno s pljučnico, povezano z umetnim predihavanjem (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Table 3: Adverse reactions identified during clinical trials with ceftolozane/tazobactam System organ class
Preglednica 3: Neželeni učinki, ugotovljeni v kliničnih preskušanjih ceftolozana/tazobaktama Organski sistem
In this situation, you should not take medicines that stop or slow bowel movement
V tem primeru ne smete jemati zdravil, ki povzročajo zaprtje ali upočasnijo prebavo.
Following administration of a single 1 g / 0.5 g IV dose of ceftolozane/tazobactam to healthy male adults greater than 95% of ceftolozane was excreted in the urine as unchanged parent substance.
Po intravenski uporabi enkratnega odmerka 1 g/0,5 g ceftolozana/tazobaktama pri zdravih odraslih moških se je več kot 95 % ceftolozana izločilo v urinu v obliki nespremenjene matične spojine.
After a single dose of ceftolozane/tazobactam, renal clearance of ceftolozane (3.41 - 6.69 L/h) was similar to plasma clearance (4.10 - 6.73 L/h) and similar to the glomerular filtration rate for the unbound fraction, suggesting that ceftolozane is eliminated by the kidney via glomerular filtration.
Po enkratnem odmerku ceftolozana/tazobaktama je bil ledvični očistek ceftolozana (3,41 - 6,69 l/h) podoben plazemskemu očistku (4,10 - 6,73 l/h) in podoben hitrosti glomerulne filtracije nevezane frakcije, kar kaže, da se ceftolozan izloča skozi ledvice z glomerulno filtracijo.
Table 2: Recommended intravenous dose regimens for Zerbaxa in patients with creatinine clearance ≤ 50 mL/min
Preglednica 2: Priporočene sheme intravenskega odmerjanja zdravila Zerbaxa pri bolnikih z očistkom kreatinina ≤ 50 ml/min
No dose adjustment is recommended based on race.
Prilagoditev odmerka glede na raso ni potrebna.
1, flatulence 1, ileus paralytic
1, paralitični ileus
Zerbaxa is for intravenous infusion.
Zdravilo Zerbaxa je namenjeno za intravensko infundiranje.
The respective tazobactam dose normalized geometric mean AUC increased approximately up to 1.3-fold, 2-fold, and 4-fold.
Geometrična sredina AUC tazobaktama, normalizirana na odmerek, se je v teh treh skupinah povečala za približno 1,3-krat, 2-krat in 4-krat.
Patients treated for an infection of the lungs called “pneumonia” Common side effects (may affect up to 1 in 10 people): Inflammation of the large intestine due to C. difficile bacteria, diarrhoea, vomiting, increase in liver enzymes (from blood tests)
Bolniki, zdravljeni zaradi okužbe pljuč, ki jo imenujemo "pljučnica” Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): vnetje debelega črevesa zaradi bakterije C. difficile, driska, bruhanje, zvišanje jetrnih encimov (na preiskavah krvi)
The recommended intravenous dose regimen for patients with creatinine clearance > 50 mL/min is shown by infection type in Table 1.
Priporočena shema intravenskih odmerkov za bolnike z očistkom kreatinina > 50 ml/min je prikazana v preglednici 1 glede na vrsto okužbe.
Driving and using machines Zerbaxa may cause dizziness, which can affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Zerbaxa lahko povzroči omotico, ki ima lahko vpliv na sposobnost upravljanja vozil in strojev.
Precautions to be taken before handling or administering the product See section 6.2 for incompatibilities.
Previdnostni ukrepi, potrebni pred rokovanjem z zdravilom ali dajanjem zdravila Glede inkompatibilnosti glejte poglavje 6.2.
The ceftolozane/tazobactam dose should be adjusted based on renal function (see section 4.2, Table 2).
Odmerek ceftolozana/tazobaktama je treba prilagoditi glede na delovanje ledvic (glejte poglavje 4.2, preglednico 2).
Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to Zerbaxa in vitro:
V kliničnih študijah je bila dokazana učinkovitost proti patogenom, ki so našteti pri posamezni indikaciji in so bili in vitro občutljivi na zdravilo Zerbaxa:
In vitro studies demonstrated that ceftolozane, tazobactam and the M1 metabolite of tazobactam did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 and did not induce CYP1A2, CYP2B6, or CYP3A4 at therapeutic plasma concentrations.
Študije in vitro so pokazale, da ceftolozan, tazobaktam in presnovek tazobaktama M1 v terapevtskih plazemskih koncentracijah ne zavirajo CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4 in ne inducirajo CYP1A2, CYP2B6 ali CYP3A4.
20 mL vial (Type I clear glass) with stopper (bromobutyl rubber) and flip-off seal.
20 ml viala (steklo tipa I) z zamaškom (brombutilna guma) in snemno zaporko.
Ceftolozane/tazobactam should be used with caution in patients with a history of any other type of hypersensitivity reaction to penicillins or other beta-lactam antibacterial agents.
Ceftolozan/tazobaktam je treba previdno uporabljati pri bolnikih, ki so kdaj imeli kakršno koli drugo vrsto preobčutljivostne reakcije na peniciline ali druge betalaktamske antibiotike.
Patients with kidney problems
Bolniki, ki imajo težave z ledvicami
Zerbaxa can be removed by haemodialysis.
Zdravilo Zerbaxa se lahko odstrani s hemodializo.
Do not throw away any unused medicinal product or waste material via wastewater.
Neuporabljenega zdravila ali odpadnega materiala ne smete odvreči med odpadne vode.
The beta-lactam ring of tazobactam is hydrolyzed to form the pharmacologically inactive, tazobactam metabolite M1.
Betalaktamski obroč tazobaktama hidrolizira do farmakološko neaktivnega presnovka tazobaktama M1.
- Complicated intra-abdominal infections (see section 4.4); - Acute pyelonephritis; - Complicated urinary tract infections (see section 4.4); - Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).
- zapletenih okužb v trebušni votlini (glejte poglavje 4.4), - akutnega pielonefritisa, - zapletenih okužb sečil (glejte poglavje 4.4), - bolnišnične pljučnice (HAP - hospital-acquired pneumonia), vključno s pljučnico, povezano z umetnim predihavanjem (VAP - ventilator-associated pneumonia).
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: ceftolozane administered to rats during pregnancy and lactation was associated with a decrease in auditory startle response in postnatal day (PND) 60 male pups at maternal doses of 300 and 1,000 mg/kg/day.
Neželeni učinki, ki jih niso opazili v kliničnih študijah, opaženi pa so bili pri živalih pri izpostavljenostih, podobnih klinični stopnji izpostavljenosti, in bi lahko bili pomembni za klinično uporabo, so: uporaba ceftolozana pri podganjih samicah v odmerkih 300 in 1.000 mg/kg/dan med brejostjo in laktacijo je bila pri mladičih - samcih povezana z zmanjšanjem zdrznitve na slušni dražljaj 60. dan po skotitvi.
Effect on renal function
Vpliv na delovanje ledvic
Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to Zerbaxa in the absence of acquired mechanisms of resistance:
Klinična učinkovitost proti naslednjim patogenom ni bila dokazana, čeprav študije in vitro nakazujejo, da so občutljivi na zdravilo Zerbaxa, če nimajo pridobljenih mehanizmov odpornosti: Citrobacter freundii
Zerbaxa is used in adults to treat complicated infections within the abdomen, kidney and urinary system infections, and an infection of the lungs called “pneumonia”.
Zdravilo Zerbaxa se uporablja pri odraslih za zdravljenje zapletenih okužb v trebuhu, zapletenih okužb ledvic in sečil ter okužbe pljuč, imenovane "pljučnica".
The most common adverse reactions (≥ 5% in a Phase 3 trial of hospital-acquired pneumonia, including ventilator-associated pneumonia) occurring in patients receiving Zerbaxa were diarrhoea, alanine aminotransferase increased, and aspartate aminotransferase increased and were generally mild or moderate in severity.
Najpogostejši neželeni učinki (≥ 5 % v preskušanju 3. faze pri bolnišnični pljučnici, vključno s pljučnico, povezano z umetnim predihavanjem) pri bolnikih, ki so prejemali zdravilo Zerbaxa, so bili diareja, zvišana alanin-aminotransferaza in zvišana aspartat-aminotransferaza ter so bili večinoma blagi ali zmerni.
Zerbaxa is available in packs containing 20 mL Type I clear glass vial with stopper (bromobutyl rubber) and flip-off seal.
Zdravilo Zerbaxa je na voljo v pakiranjih, ki vsebujejo 20 ml vialo iz prozornega stekla tipa I z zamaškom (brombutilna guma) in snemno zaporko.
62%, respectively and are similar to those in healthy subjects (approximately 61% and 63%, respectively) receiving 1 g / 0.5 g ceftolozane/tazobactam.
ter podobno kot pri zdravih preiskovancih (približno 61 % oz. 63 %), ki so prejeli 1 g/0,5 g ceftolozana/tazobaktama.
The recommended dose of Zerbaxa is 1 g of ceftolozane and 0.5 g of tazobactam or 2 g of ceftolozane and 1 g of tazobactam every 8 hours, which is given into one of your veins (directly into the bloodstream).
Priporočeni odmerek zdravila Zerbaxa je 1 g ceftolozana in 0,5 g tazobaktama ali 2 g ceftolozana in 1 g tazobaktama na 8 ur v veno (neposredno v krvni obtok).
*To be used in combination with metronidazole when anaerobic pathogens are suspected.
*V primeru suma na anaerobne patogene je treba zdravilo uporabiti v kombinaciji z metronidazolom.
The development of a positive direct antiglobulin test (DAGT) may occur during treatment with ceftolozane/tazobactam (see section 4.8).
Med zdravljenjem s ceftolozanom/tazobaktamom lahko pride do pozitivnega direktnega antiglobulinskega testa (DAGT - direct antiglobulin test) (glejte poglavje 4.8).
**To be used in combination with an antibacterial agent active against Gram-positive pathogens when these are known or suspected to be contributing to the infectious process.
**V primeru, ko je znano oziroma v primeru suma, da grampozitivne bakterije pripomorejo k vnetnim procesom, je treba zdravilo uporabiti v kombinaciji z antibiotikom, ki deluje proti grampozitivnim bakterijam.
For ceftolozane the time that the plasma concentration exceeds the minimum inhibitory concentration of ceftolozane for the infecting organism has been shown to be the best predictor of efficacy in animal models of infection.
Za ceftolozan se je pokazalo, da je najboljši napovednik njegove učinkovitosti v živalskih modelih okužb čas, v katerem plazemska koncentracija preseže minimalno inhibitorno koncentracijo ceftolozana za organizem, ki je povzročil okužbo.
The highest single dose of Zerbaxa used in clinical trials was 3 g / 1.5 g of ceftolozane/tazobactam administered to healthy volunteers.
Največji enkratni odmerek zdravila Zerbaxa, uporabljen v kliničnih preskušanjih pri zdravih prostovoljcih, je bil 3 g/1,5 g ceftolozana/tazobaktama.
Infection due to C. difficile bacteria, C. difficile test positive (from stool test), Coombs test positive (a blood test that looks for antibodies that may fight against your red blood cells)
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): okužba z bakterijo C. difficile, pozitiven izvid za C. difficile (na preiskavi blata), pozitiven Coombsov test (preiskava krvi za odkrivanje protiteles, ki lahko delujejo proti rdečim krvnim celicam)
Dizziness may occur following administration of Zerbaxa (see section 4.8).
Po uporabi zdravila Zerbaxa se lahko pojavi omotica (glejte poglavje 4.8).
Gram-negative bacteria Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens
Gramnegativne bakterije Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens
When the powder is reconstituted with 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, the vial contains 11.5 mmol (265 mg) of sodium.
Če se prašek rekonstituira z 10 ml natrijevega klorida 0,9 % (9 mg/ml) raztopino za injiciranje, vsebuje viala 11,5 mmol (265 mg) natrija.
Respiratory, thoracic, and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja
Metallo-beta-lactamases (e.g., New Delhi metallo-beta-lactamase [NDM]) iv. Ambler Class D beta-lactamases (OXA-carbapenemases)
serinskih karbapenemaz (npr. karbapenemaz Klebsiella pneumoniae [KPC]) iii. metalo-betalaktamaz (npr. metalo-betalaktamaze New Delhi [NDM]) iv. betalaktamaz razreda D po Amblerju (OXA-karbapenemaz)
Table 1: Intravenous dose of Zerbaxa by type of infection in patients with creatinine clearance > 50 mL/min
Preglednica 1: Intravenski odmerek zdravila Zerbaxa glede na vrsto okužbe pri bolnikih z očistkom kreatinina > 50 ml/min
Ceftolozane/tazobactam is also contraindicated in patients with severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems) (see section 4.3).
Kombinacija ceftolozana/tazobaktama je kontraindicirana tudi pri bolnikih s hudo preobčutljivostjo (npr. anafilaktično reakcijo, hudo kožno reakcijo) na katero koli vrsto betalaktamskih antibiotikov (npr. na peniciline ali karbapeneme) (glejte poglavje 4.3).
- The other excipients are sodium chloride, arginine, and citric acid, anhydrous.
- Druge sestavine zdravila so natrijev klorid, arginin in brezvodna citronska kislina.
The mean (coefficient of variation CV%) steady-state volume of distribution of ceftolozane/tazobactam in healthy adult males (n=51) following a single 1 g / 0.5 g IV dose was 13.5 L (21%) and 18.2 L (25%) for ceftolozane and tazobactam, respectively, similar to extracellular fluid volume.
Povprečni (koeficient variacije KV %) volumen porazdelitve ceftolozana/tazobaktama v stanju dinamičnega ravnovesja po enkratnem intravenskem odmerku 1 g/0,5 g pri zdravih odraslih moških (n = 51) je bil za ceftolozan 13,5 l (21 %) in za tazobaktam 18,2 l (25 %), kar je podobno volumnu zunajcelične tekočine.
The most common adverse reactions (≥ 3% in pooled Phase 3 trials of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis) occurring in patients receiving Zerbaxa were nausea, headache, constipation, diarrhoea, and pyrexia and were generally mild or moderate in severity.
Najpogostejši neželeni učinki (≥ 3 % v združenih preskušanjih 3. faze pri zapletenih okužbah v trebušni votlini in zapletenih okužbah sečil, vključno s pielonefritisom) pri bolnikih, ki so prejemali zdravilo Zerbaxa, so bili navzea, glavobol, zaprtje, diareja in zvišana telesna temperatura ter so bili večinoma blagi ali zmerni.
Ceftolozane and tazobactam were not substrates for P-gp or BCRP, and tazobactam was not a substrate for OCT2, in vitro at therapeutic plasma concentrations.
Ceftolozan in tazobaktam v terapevtskih plazemskih koncentracijah in vitro nista bila substrata P-gp ali BCRP in tazobaktam ni bil substrat OCT2.
Blood and the lymphatic system disorders
Bolezni krvi in limfatičnega sistema trombocitoza anemija
The development of a positive direct Coombs test may occur during treatment with Zerbaxa.
Med zdravljenjem z zdravilom Zerbaxa se lahko pojavi pozitiven izvid direktnega Coombsovega testa.
Ceftolozane/tazobactam contains 230 mg sodium per vial, equivalent to 11.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Kombinacija ceftolozana/tazobaktama vsebuje 230 mg natrija na vialo, kar ustreza 11,5 % največjega priporočenega dnevnega vnosa (po WHO) 2 g natrija za odrasle.
How to take Zerbaxa
Kako uporabljati zdravilo Zerbaxa
Ceftolozane/tazobactam is not active against bacteria that produce beta-lactamase enzymes which are not inhibited by tazobactam.
Kombinacija ceftolozana/tazobaktama ni učinkovita proti bakterijam, ki tvorijo encime betalaktamaze, katerih pa tazobaktam ne zavira.
Ceftolozane, tazobactam and the tazobactam metabolite M1 are eliminated by the kidneys.
Ceftolozan, tazobaktam in presnovek tazobaktama M1 se izločijo skozi ledvice.
The powder for concentrate for solution for infusion for each vial is reconstituted with 10 mL of water for injections or sodium chloride 9 mg/mL (0.9%) solution for injection per vial; following reconstitution the vial should be shaken gently to dissolve the powder.
Prašek za koncentrat za raztopino za infundiranje v eni viali je treba rekonstituirati z 10 ml vode za injekcije ali 0,9 % (9 mg/ml) raztopine natrijevega klorida za injiciranje na vialo; po rekonstituciji je treba vialo rahlo pretresti, da se prašek raztopi.
**Based on 2 g ceftolozane / 1 g tazobactam intravenously every 8 hours.
**Na podlagi 2 g ceftolozana/1 g tazobaktama intravensko na 8 ur.
With haemodialysis, the dose should be administered immediately following completion of dialysis (see section 4.2).
Pri hemodializi je treba odmerek dati takoj po koncu dialize (glejte poglavje 4.2).
Complicated urinary tract infections, including pyelonephritis
Zapletene okužbe sečil, vključno s pielonefritisom
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions and would normally not be longer than 24 hours at 2 to 8°C.
Čas običajno ne sme presegati 24 ur pri temperaturi od 2 do 8 °C, razen če sta rekonstitucija/redčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
In a population pharmacokinetic analysis of ceftolozane/tazobactam, no clinically relevant differences in exposure were observed with regard to age.
Populacijska farmakokinetična analiza ceftolozana/tazobaktama ni pokazala klinično pomembnih razlik v izpostavljenosti glede na starost.
Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see section 5.2).
Okvara jeter Prilagoditev odmerka pri bolnikih z okvaro jeter ni potrebna (glejte poglavje 5.2).
Gram-negative bacteria Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
Gramnegativne bakterije Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
Ceftolozane/tazobactam is contraindicated in patients with a history of hypersensitivity to ceftolozane, tazobactam, or cephalosporins (see section 4.3).
Kombinacija ceftolozana/tazobaktama je kontraindicirana pri bolnikih, ki imajo v anamnezi preobčutljivost na ceftolozan, tazobaktam ali cefalosporine (glejte poglavje 4.3).
Following a single 1-hour intravenous infusion of 2 g / 1 g ceftolozane/tazobactam to critically ill patients with CrCL greater than or equal to 180 mL/min (N=10), mean terminal half-life values of ceftolozane and tazobactam were 2.6 hours and 1.5 hours, respectively.
Po enkratni 1-urni intravenski infuziji 2 g/1 g ceftolozana/tazobaktama pri kritično bolnih bolnikih z očistkom kreatinina večjim ali enakim 180 ml/min (n = 10) je bil povprečni terminalni razpolovni čas ceftolozana 2,6 ure in tazobaktama 1,5 ure.
No dose adjustment of ceftolozane/tazobactam based on age alone is recommended.
Prilagoditev odmerka ceftolozana/tazobaktama zgolj zaradi starosti ni potrebna.
As ceftolozane/tazobactam does not undergo hepatic metabolism, the systemic clearance of ceftolozane/tazobactam is not expected to be affected by hepatic impairment.
Ker se ceftolozan in tazobaktam ne presnavljata v jetrih, ni pričakovati, da bi okvara jeter vplivala na sistemski očistek ceftolozana/tazobaktama.
In clinical studies, there was no evidence of haemolysis in patients who developed a positive direct Coombs test in any treatment group.
V kliničnih študijah pri bolnikih, pri katerih se je pojavil pozitiven izvid direktnega Coombsovega testa, v nobeni terapevtski skupini niso ugotovili znakov hemolize.