natgillin/translations-raw huggingface dataset:
Following 1 hour intravenous infusions of 2 g / 1 g ceftolozane/tazobactam or adjusted based on renal function every 8 hours in ventilated patients with confirmed or suspected pneumonia (N=22), ceftolozane and tazobactam concentrations in pulmonary epithelial lining fluid were greater than 8 mcg/mL and 1 mcg/mL, respectively, over 100% of the dosing interval.
Po enourni intravenski infuziji 2 g/1 g ceftolozana/tazobaktama (ali prilagojeno delovanju ledvic) na 8 ur pri ventiliranih bolnikih, s potrjeno pljučnico ali sumom nanjo (n = 22), je bila v 100 % odmernega intervala koncentracija ceftolozana v tekočini pljučne epitelijske sluznice večja od 8 mcg/ml in tazobaktama večja od 1 mcg/ml.
The Cmax and AUC of ceftolozane/tazobactam increase approximately in proportion to dose within ceftolozane single-dose range of 250 mg to 3 g and tazobactam single-dose range of 500 mg to 1.5 g. No appreciable accumulation of ceftolozane/tazobactam is observed following multiple 1-hour IV infusions of 1 g / 0.5 g ceftolozane/tazobactam or 2 g / 1 g ceftolozane/tazobactam administered every 8 hours for up to 10 days in healthy adults with normal renal function.
Cmax in AUC ceftolozana/tazobaktama naraščata približno sorazmerno odmerku v razponu enkratnega odmerka ceftolozana od 250 mg do 3 g in v razponu enkratnega odmerka tazobaktama od 500 mg do 1,5 g. Pri zdravih odraslih z normalnim delovanjem ledvic niso opazili pomembnega kopičenja ceftolozana/tazobaktama po večkratnih 1-urnih intravenskih infuzijah 1 g/0,5 g ceftolozana/tazobaktama ali 2 g/1 g ceftolozana/tazobaktama, uporabljenih na 8 ur do 10 dni.
Ceftolozane administered to rats during pregnancy and lactation was associated with a decrease in auditory startle response in postnatal day (PND) 60 male pups (see section 5.3).
Uporaba ceftolozana pri podganah med brejostjo in laktacijo je bila pri podganjih mladičih - samcih povezana z zmanjšanjem zdrznitve na slušni dražljaj 60. dan po skotitvi (glejte poglavje 5.3).
Applies across all indications: complicated intra-abdominal infections, acute pyelonephritis, complicated urinary tract infections, and hospital-acquired pneumonia, including ventilator-associated pneumonia.
Velja za vse indikacije: zapletene okužbe v trebušni votlini, akutni pielonefritis, zapletene okužbe sečil in bolnišnično pljučnico, vključno s pljučnico, povezano z umetnim predihavanjem.
What Zerbaxa contains - The active substances are ceftolozane and tazobactam.
Kaj vsebuje zdravilo Zerbaxa - Zdravilni učinkovini sta ceftolozan in tazobaktam.
No significant medicinal product interactions are anticipated between ceftolozane/tazobactam and substrates, inhibitors, and inducers of cytochrome P450 enzymes (CYPs) based on in vitro and in vivo studies.
Med ceftolozanom/tazobaktamom in substrati, zaviralci in induktorji encimov citokroma P450 (CYP) glede na študije in vitro in vivo ni pričakovati pomembnih medsebojnih delovanj z zdravili.
Fertility studies in rats showed no effect on fertility and mating after intraperitoneal administration of tazobactam or intravenous administration of ceftolozane (see section 5.3).
Študije plodnosti na podganah po intraperitonealni uporabi tazobaktama ali intravenski uporabi ceftolozana niso pokazale vpliva na plodnost in parjenje (glejte poglavje 5.3).
White to yellowish powder.
bel do rumenkast prašek
Zerbaxa contains sodium
Zdravilo Zerbaxa vsebuje natrij
500 mg ceftolozane / 250 mg tazobactam intravenously every 8 hours
500 mg ceftolozana/250 mg tazobaktama intravensko na 8 ur
Sodium chloride, arginine, citric acid, anhydrous
natrijev klorid, arginin, brezvodna citronska kislina
250 mg ceftolozane / 125 mg tazobactam intravenously every 8 hours
250 mg ceftolozana/125 mg tazobaktama intravensko na 8 ur
Ceftolozane/tazobactam and the tazobactam metabolite M1 are eliminated by the kidneys.
Ceftolozan/tazobaktam in presnovek tazobaktama M1 se izločijo skozi ledvice.
In vitro data indicate that ceftolozane did not inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, MRP, BSEP, OAT1, OAT3, MATE1, or MATE2-K in vitro at therapeutic plasma concentrations.
Podatki in vitro kažejo, da ceftolozan v terapevtskih plazemskih koncentracijah in vitro ni zavrl P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, MRP, BSEP, OAT1, OAT3, MATE1 ali MATE2-K.
Specific for the hospital-acquired pneumonia, including ventilator-associated pneumonia indication treated with Zerbaxa (2 g / 1 g intravenously every 8 hours) for up to 14 days.
Značilno za indikacijo bolnišnična pljučnica, vključno s pljučnico, povezano z umetnim predihavanjem, zdravljeno z zdravilom Zerbaxa (2 g/1 g intravensko na 8 ur) do 14 dni.
Hospital-acquired pneumonia, including ventilator-associated pneumonia** *Based on 1 g ceftolozane / 0.5 g tazobactam intravenously every 8 hours.
H. influenzae bolnišnična pljučnica, vključno s pljučnico, povezano z umetnim predihavanjem** *Na podlagi 1 g ceftolozana/0,5 g tazobaktama intravensko na 8 ur.
The reconstituted vial with 10 mL of 0.9% sodium chloride (normal saline) for injection contains 265 mg sodium per vial, equivalent to 13.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Viala, pripravljena (rekonstituirana) z 10 ml 0,9 % natrijevega klorida (fiziološke raztopine) za injiciranje, vsebuje 265 mg natrija na vialo, kar ustreza 13,3 % največjega priporočenega dnevnega vnosa (po WHO) 2 g natrija za odrasle.
There are no data on the use of ceftolozane/tazobactam in pregnant women.
Podatkov o uporabi ceftolozana/tazobaktama pri nosečnicah ni. Tazobaktam prehaja skozi placento.
Mean pulmonary epithelial-to-free plasma AUC ratios of ceftolozane and tazobactam were approximately 50% and
Povprečno razmerje med AUC v pljučnem epiteliju in AUC proste učinkovine v plazmi je bilo za ceftolozan približno 50 % in za tazobaktam približno 62 %
Clostridioides difficile-associated diarrhoea
Diareja, povezana s Clostridioides difficile
Headache, stomach ache, constipation, diarrhoea, nausea, vomiting, increase in liver enzymes (from blood tests), rash, fever (high temperature), decrease in blood pressure, decrease in potassium (from blood tests), increase in the number of certain types of blood cells known as platelets, dizziness, anxiety, difficulty sleeping, infusion site reactions
Bolniki, zdravljeni zaradi zapletenih okužb v trebuhu, ledvicah in drugih delih sečil Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): glavobol, bolečine v trebuhu, zaprtje, driska, slabost s siljenjem na bruhanje, bruhanje, zvišanje jetrnih encimov (na preiskavah krvi), izpuščaj, zvišana telesna temperatura, znižanje krvnega tlaka, znižanje kalija (na preiskavah krvi), zvečanje števila določene vrste krvnih celic, ki jih imenujemo trombociti, omotica, tesnoba, težave s spanjem, reakcija na mestu infundiranja
Each vial contains ceftolozane sulfate equivalent to 1 g ceftolozane and tazobactam sodium equivalent to 0.5 g tazobactam.
Ena viala vsebuje ceftolozan sulfat, kolikor ga ustreza 1 g ceftolozana, in natrijev tazobaktamat, kolikor ga ustreza 0,5 g tazobaktama.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftolozane/tazobactam.
Pri bolnikih, pri katerih se med uporabo ceftolozana/tazobaktama ali po njej pojavi diareja, je zato pomembno pomisliti na to diagnozo.
In a population pharmacokinetic analysis of ceftolozane/tazobactam, no clinically relevant differences in AUC were observed for ceftolozane and tazobactam.
Populacijska farmakokinetična analiza ceftolozana/tazobaktama ni pokazala klinično pomembnih razlik AUC ceftolozana in tazobaktama.
Ischemic stroke
Okvara ledvic
The recommended dose in complicated intra-abdominal infections, complicated urinary tract infections, and acute pyelonephritis subjects with end stage renal disease on haemodialysis is a single loading dose of 500 mg / 250 mg ceftolozane/tazobactam followed by a 100 mg / 50 mg maintenance dose of ceftolozane/tazobactam administered every 8 hours for the remainder of the treatment period.
Priporočeni odmerek pri bolnikih z zapletenimi okužbami v trebušni votlini, zapletenimi okužbami sečil ali akutnim pielonefritisom ter s končno odpovedjo ledvic na hemodializi je enkratni polnilni odmerek 500 mg/250 mg ceftolozana/tazobaktama, ki mu sledi vzdrževalni odmerek 100 mg/50 mg ceftolozana/tazobaktama na 8 ur med preostalim obdobjem zdravljenja.
The elimination half-life (t½) of ceftolozane is independent of dose.
Eliminacijski razpolovni čas (t1/2) ceftolozana ni odvisen od odmerka.
3, increased serum gamma-glutamyl transpeptidase (GGT)
2, zvišana gamaglutamiltransferaza pozitiven Coombsov test zvišana serumska gama-glutamiltranspeptidaza (GGT)
The mean terminal elimination half-life of ceftolozane and tazobactam in healthy adults with normal renal function is approximately 3 hours and 1 hour, respectively.
Pri zdravih odraslih z normalnim delovanjem ledvic je povprečni terminalni eliminacijski razpolovni čas ceftolozana 3 ure in tazobaktama 1 uro.
The recommended dose in hospital-acquired pneumonia, including ventilator-associated pneumonia subjects with end stage renal disease on haemodialysis is a single loading dose of 1.5 g / 0.75 g ceftolozane/tazobactam followed by a 300 mg / 150 mg maintenance dose of ceftolozane/tazobactam administered every 8 hours for the remainder of the treatment period.
Priporočeni odmerek pri bolnikih z bolnišnično pljučnico, vključno s pljučnico, povezano z umetnim predihavanjem, in končno odpovedjo ledvic na hemodializi je enkratni polnilni odmerek 1,5 g/0,75 mg ceftolozana/tazobaktama, ki mu sledi vzdrževalni odmerek 300 mg/150 mg ceftolozana/tazobaktama na 8 ur med preostalim obdobjem zdravljenja.
The reconstituted vial with 10 mL of 0.9% sodium chloride (normal saline) for injection contains 265 mg sodium in each vial.
Viala, pripravljena (rekonstituirana) z 10 ml 0,9 % natrijevega klorida (fiziološke raztopine) za injiciranje, vsebuje 265 mg natrija na vialo.
1, increased serum alkaline phosphatase Clostridioides test positive
1, zvišana serumska alkalna fosfataza
If you are breast-feeding, your doctor will advise you on whether you should stop breast-feeding or stop or avoid Zerbaxa therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Če dojite, vam bo zdravnik povedal, ali morate prenehati dojiti ali prenehati zdravljenje z zdravilom Zerbaxa oziroma ne smete začeti zdravljenja z zdravilom Zerbaxa.
The incidence of seroconversion to a positive direct Coombs test was 31.2% in patients receiving Zerbaxa and 3.6% in patients receiving meropenem in the hospital-acquired pneumonia, including ventilator-associated pneumonia clinical trial.
V kliničnem preskušanju pri bolnišnični pljučnici, vključno s pljučnico, povezano z umetnim predihavanjem, je bila pojavnost serokonverzije v pozitiven izvid direktnega Coombsovega testa 31,2 % pri bolnikih, ki so prejemali zdravilo Zerbaxa, in 3,6 % pri bolnikih, ki so prejemali meropenem.
In vitro data indicate that neither tazobactam nor the tazobactam metabolite M1 inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, or BSEP transporters at therapeutic plasma concentrations.
Podatki in vitro kažejo, da niti tazobaktam niti njegov presnovek M1 v terapevtskih plazemskih koncentracijah ne zavirata prenašalcev P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2 ali BSEP.
Plasma levels of ceftolozane/tazobactam do not increase appreciably following multiple IV infusions of up to 2.0 g / 1.0 g administered every 8 hours for up to 10 days in healthy adults with normal renal function.
Koncentracija ceftolozana/tazobaktama v plazmi se pri zdravih odraslih z normalnim delovanjem ledvic po intravenskih infuzijah odmerkov do 2,0 g/1,0 g na 8 ur v obdobju do 10 dni ne poveča opazno.
These enzymes make bacteria resistant to ceftolozane by breaking down the antibiotic before it can act. By blocking their action, tazobactam makes ceftolozane more effective at killing bacteria.
Ti encimi naredijo bakterije odporne proti ceftolozanu, ker ga razgradijo, preden lahko deluje.
As this product is given by a doctor or other healthcare professional, it is very unlikely that you will be given too much Zerbaxa.
Če ste prejeli večji odmerek zdravila Zerbaxa, kot bi smeli Zdravilo Zerbaxa vam bo dal zdravnik ali drug zdravstveni delavec, zato je zelo malo verjetno, da bi ga prejeli preveč.
The following adverse reactions have been identified during clinical trials with Zerbaxa.
V kliničnih preskušanjih zdravila Zerbaxa so ugotovili naslednje neželene učinke.
See section 4.2 for recommended dose regimens for Zerbaxa based on indication and renal function.
Za priporočene sheme odmerjanja zdravila Zerbaxa glede na indikacijo in delovanje ledvic glejte poglavje 4.2.
2 g ceftolozane / 1 g tazobactam
2 g ceftolozana/ 1 g tazobaktama na 8 ur
Infections caused by bacteria that are not sensitive to Zerbaxa or caused by a fungus can occur during or following treatment with Zerbaxa.
Med zdravljenjem ali po zdravljenju z zdravilom Zerbaxa se lahko pojavijo okužbe, ki jih povzročijo bakterije, ki niso občutljive na zdravilo Zerbaxa, ali okužbe, ki jih povzročijo glive.
Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion
Zerbaxa 1 g/0,5 g prašek za koncentrat za raztopino za infundiranje
The elimination half-life (t½) of ceftolozane or tazobactam is independent of dose.
Eliminacijski razpolovni čas (t1/2) ceftolozana ali tazobaktama ni odvisen od odmerka.
In a population pharmacokinetic analysis of ceftolozane/tazobactam, no clinically relevant differences in ceftolozane/tazobactam AUC were observed in Caucasians compared to other ethnicities.
Populacijska farmakokinetična analiza ceftolozana/tazobaktama ni pokazala klinično pomembnih razlik AUC ceftolozana/tazobaktama pri belcih v primerjavi z drugimi etničnimi skupinami.
The ceftolozane dose normalized geometric mean AUC increased up to 1.26-fold, 2.5-fold, and 5-fold in subjects with mild, moderate, and severe renal impairment, respectively, compared to healthy subjects with normal renal function.
V primerjavi z zdravimi osebami z normalnim delovanjem ledvic se je geometrična sredina AUC ceftolozana, normalizirana na odmerek, pri osebah z blago okvaro ledvic povečala za 1,26-krat, z zmerno okvaro ledvic za 2,5-krat in s hudo okvaro ledvic za 5-krat.
What Zerbaxa looks like and contents of the pack Zerbaxa is a white to slightly yellow powder for concentrate for solution for infusion (powder for concentrate) supplied in a vial.
Zdravilo Zerbaxa je bel do rumenkast prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) v viali.
See section 6.6 for instructions on reconstitution and dilution of the medicinal product before administration.
Za navodila glede priprave in redčenja zdravila pred dajanjem glejte poglavje 6.6.
These may be signs of a severe allergic reaction (anaphylaxis) and may be lifethreatening - Diarrhoea that becomes severe or does not go away or stool that contains blood or mucus during or after treatment with Zerbaxa.
- driska, ki postane huda ali ki ne mine, ali kri ali sluz v blatu med ali po zdravljenju z zdravilom Zerbaxa.
Complicated intra-abdominal infections, complicated urinary tract infections, and acute pyelonephritis**
Zapletene okužbe v trebušni votlini, zapletene okužbe sečil in akutni pielonefritis**
A single loading dose of 500 mg ceftolozane / 250 mg tazobactam followed after 8 hours by a 100 mg ceftolozane / 50 mg tazobactam maintenance dose administered every 8 hours for the remainder of the treatment period (on haemodialysis days, the dose should be administered at the earliest possible time following completion of haemodialysis)
500 mg ceftolozana/250 mg tazobaktama intravensko na 8 ur končna odpoved ledvic na hemodializi enkratni polnilni odmerek 500 mg ceftolozana/250 mg tazobaktama, ki mu po 8 urah sledi vzdrževalni odmerek 100 mg ceftolozana/50 mg tazobaktama vsakih 8 ur do zaključka zdravljenja (ob dneh hemodialize je treba odmerek uporabiti čim prej po koncu hemodialize)
Infections and infestations Clostridioides difficile colitis
1, okužbe s Clostridioides difficile
2, blood alkaline phosphatase increased 2, gammaglutamyltransferase increased
2, zvišana alkalna fosfataza v krvi
Tabulated list of adverse reactions for complicated intra-abdominal infections, complicated urinary tract infections, including pyelonephritis, and hospital-acquired pneumonia, including ventilator-associated pneumonia
Seznam neželenih učinkov pri zapletenih okužbah v trebušni votlini, zapletenih okužbah sečil, vključno s pielonefritisom, in bolnišnični pljučnici, vključno s pljučnico, povezano z umetnim predihavanjem
1, dizziness
1, anksioznost
- Each vial contains ceftolozane sulfate equivalent to 1 g ceftolozane and tazobactam sodium equivalent to 0.5 g tazobactam.
- Ena viala vsebuje ceftolozan sulfat, kolikor ga ustreza 1 g ceftolozana, in natrijev tazobaktamat,
The incidence of seroconversion to a positive direct Coombs test was 0.2% in patients receiving Zerbaxa and 0% in patients receiving the comparator in the complicated intra-abdominal infections and complicated urinary tract infections clinical trials.
V kliničnih preskušanjih pri zapletenih okužbah v trebušni votlini in zapletenih okužbah sečil je bila pojavnost serokonverzije v pozitiven izvid direktnega Coombsovega testa 0,2 % pri bolnikih, ki so prejemali zdravilo Zerbaxa, in 0 % pri bolnikih, ki so prejemali primerjalno zdravilo.
Talk to your doctor or pharmacist before taking Zerbaxa if you know you are, or have previously been allergic to cephalosporins, penicillins or other antibiotics.
Če veste, da ste alergični, ali ste v preteklosti bili alergični na cefalosporine, peniciline ali druge antibiotike, se pred začetkom uporabe zdravila Zerbaxa posvetujte z zdravnikom ali farmacevtom.
1 g ceftolozane / 0.5 g tazobactam intravenously every 8 hours
1 g ceftolozana/0,5 g tazobaktama intravensko na 8 ur
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj urtikarija
Zerbaxa 1 g / 0.5 g powder for concentrate ceftolozane / tazobactam
Zerbaxa 1 g / 0,5 g prašek za koncentrat ceftolozan / tazobaktam
Complicated intra-abdominal infection*
Zapletene okužbe v trebušni votlini*
1 g ceftolozane / 0.5 g tazobactam
1 g ceftolozana/ 0,5 g tazobaktama na 8 ur
Specific for the complicated intra-abdominal infections, acute pyelonephritis, and complicated urinary tract infections indications treated with Zerbaxa (1 g / 0.5 g intravenously every 8 hours) for up to 14 days.
1, pozitiven test za Clostridioides Značilno za indikacije zapletene okužbe v trebušni votlini, akutni pielonefritis in zapletene okužbe sečil, zdravljene z zdravilom Zerbaxa (1 g/0,5 g intravensko na 8 ur) do 14 dni.
Hospital-acquired pneumonia, including ventilator-associated pneumonia**
Bolnišnična pljučnica, vključno s pljučnico, povezano z umetnim predihavanjem**
Hospital-acquired pneumonia, including ventilator-associated pneumonia
Bolnišnična pljučnica, vključno s pljučnico, povezano z umetnim predihavanjem
In clinical studies, there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
Pri bolnikih, pri katerih je v kliničnih študijah med zdravljenjem prišlo do pozitivnega DAGT, ni bilo dokazov o hemolizi.
How to store Zerbaxa
Shranjevanje zdravila Zerbaxa
Hepatic impairment
Psihiatrične motnje nespečnost
1, anxiety Nervous system disorders Headache
Bolezni živčevja glavobol
Gram-negative bacteria Escherichia coli Klebsiella pneumoniae Proteus mirabilis
Gramnegativne bakterije Escherichia coli Klebsiella pneumoniae
Zerbaxa 1 g / 0.5 g powder for concentrate for solution for infusion ceftolozane / tazobactam
Zerbaxa 1 g / 0,5 g prašek za koncentrat za raztopino za infundiranje ceftolozan / tazobaktam
A decline in renal function has been seen in patients receiving ceftolozane/tazobactam.
Pri bolnikih, ki so prejemali ceftolozan/tazobaktam, so opazili zmanjšano delovanje ledvic.
1, renal failure
1, odpoved ledvic
Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftolozane/tazobactam (see section 4.8).
Pri uporabi ceftolozana/tazobaktama so poročali o kolitisu in psevdomembranskem kolitisu, povezanima z antibiotikom (glejte poglavje 4.8).
Complicated intra-abdominal infections* Complicated urinary tract infections* Acute pyelonephritis*
Enterobacterales zapletene okužbe v trebušni votlini* zapletene okužbe sečil* akutni pielonefritis*
Complicated intra-abdominal infections* Complicated urinary tract infections* Acute pyelonephritis* Hospital-acquired pneumonia, including ventilator-associated pneumonia**
P. aeruginosa zapletene okužbe v trebušni votlini* zapletene okužbe sečil* akutni pielonefritis* bolnišnična pljučnica, vključno s pljučnico, povezano z umetnim predihavanjem**
Hyperglycaemia hypomagnesaemia hypophosphataemia
Presnovne in prehranske motnje hipokaliemija hiperglikemija hipomagneziemija hipofosfatemija
For preparation of the 1.5 g ceftolozane / 0.75 g tazobactam dose: Withdraw the entire contents from one reconstituted vial (approximately 11.4 mL per vial) and 5.7 mL from a second reconstituted vial using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Za pripravo odmerka 1,5 mg ceftolozana/0,75 g tazobaktama: Z brizgo izvlecite celotno vsebino ene rekonstituirane viale (približno 11,4 ml na vialo) in 5,7 ml iz druge rekonstituirane viale in jo dodajte v infuzijsko vrečko, ki vsebuje 100 ml 0,9 % natrijevega klorida za injiciranje (fiziološke raztopine) ali 5 % glukoze za injiciranje.
Tazobactam is a beta-lactam structurally related to penicillins.
Tazobaktam je betalaktam, po zgradbi soroden penicilinom.
Candidiasis including oropharyngeal and vulvovaginal Clostridioides difficile colitis fungal urinary tract infection Clostridioides difficile infection
Infekcijske in parazitske bolezni kolitis zaradi Clostridioides difficile kandidoza, vključno z orofaringealno in vulvovaginalno
No dose adjustment is recommended for ceftolozane/tazobactam in subjects with hepatic impairment (see section 4.2).
Pri bolnikih z okvaro jeter prilagoditev odmerka ceftolozana/tazobaktama ni potrebna (glejte poglavje 4.2).
Dyspnoea
Odmerek
For preparation of the 2 g ceftolozane / 1 g tazobactam dose: Withdraw the entire contents from two reconstituted vials (approximately 11.4 mL per vial) using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Za pripravo odmerka 2 g ceftolozana/1 g tazobaktama: Z brizgo izvlecite celotno vsebino iz dveh rekonstituiranih vial (približno 11,4 ml na vialo) in jo dodajte v infuzijsko vrečko, ki vsebuje 100 ml 0,9 % natrijevega klorida za injiciranje (fiziološke raztopine) ali 5 % glukoze za injiciranje.
Zerbaxa was evaluated in Phase 3 comparator-controlled clinical trials of complicated intra-abdominal infections and complicated urinary tract infections (including pyelonephritis), which included a total of 1,015 patients, treated with Zerbaxa (1 g / 0.5 g intravenously every 8 hours, adjusted to match renal function where appropriate) for up to 14 days.
V preskušanja je bilo vključenih skupaj 1.015 bolnikov, ki so se do 14 dni zdravili z zdravilom Zerbaxa (1 g/0,5 g intravensko na 8 ur, prilagojeno delovanju ledvic, če je bilo potrebno).
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - Hypersensitivity to any cephalosporin antibacterial agent; - Severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems).
- Huda preobčutljivost (npr. anafilaktična reakcija, huda kožna reakcija) na katero koli drugo vrsto betalaktamskih antibiotikov (npr. na peniciline ali karbapeneme).
In addition tazobactam does not inhibit the following types of beta-lactamase:
Tazobaktam ne zavira vseh encimov skupine A. Prav tako tazobaktam ne zavira naslednjih tipov betalaktamaz: