natgillin/translations-raw huggingface dataset:
Avibactam is a non β-lactam, βlactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis.
Avibaktam je nebetalaktamski zaviralec betalaktamaze; deluje s tvorbo kovalentnega addukta z encimom, ki je stabilen pri hidrolizi.
Elderly No dosage adjustment is required in elderly patients (see section 5.2).
Starejši Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
Important: Please refer to the Summary of Product Characteristics before prescribing.
Pomembno: Preden predpišete to zdravilo, glejte povzetek glavnih značilnosti zdravila.
Ceftazidime inhibits bacterial peptidoglycan cell wall synthesis following binding to penicillin binding proteins (PBPs), which leads to bacterial cell lysis and death.
Ceftazidim z vezavo na penicilin vezavne proteine (PBP - penicillin binding proteins) zavre sintezo peptidoglikana bakterijske celične stene in tako povzroči lizo in odmrtje bakterijske celice.
Among a subgroup with baseline CrCL 30 to 50 mL/min death occurred in 16.7% (9/54) of patients who received Zavicefta and metronidazole and 6.8% (4/59) of patients who received meropenem.
V podskupini z izhodiščnim očistkom kreatinina (CrCL) 30 do 50 ml/min se je smrt pojavila pri 16,7 % (9/54) bolnikih, ki so prejeli zdravilo Zavicefta in metronidazol in pri 6,8 % (4/59) bolnikih, ki so prejeli meropenem.
Powder for concentrate for solution for infusion (powder for concentrate).
prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat)
• abnormal result with a test called “DAGT” or “Coombs”.
• nenormalen izvid preiskave, imenovane "DAGT" oz. "Coombsov test".
Avibactam penetration of the blood brain barrier has not been studied clinically; however, in rabbits with inflamed meninges, CSF exposures of ceftazidime and avibactam were 43% and 38% of plasma AUC, respectively.
Prodiranje avibaktama skozi krvno-možgansko pregrado ni klinično raziskano, a je bila pri kuncih z vnetjem mening izpostavljenost ceftazidimu v cerebrospinalni tekočini 43 % AUC v plazmi, avibaktamu pa 38 % AUC v plazmi.
• an infection of the lungs called “pneumonia”
• okužbe pljuč, ki jo imenujemo "pljučnica",
Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options (see sections 4.2, 4.4 and 5.1).
Zdravilo Zavicefta je indicirano tudi za zdravljenje okužb z aerobnimi gramnegativnimi bakterijami pri odraslih bolnikih, pri katerih so možnosti zdravljenja omejene (glejte poglavja 4.2, 4.4 in 5.1).
• The other ingredient is sodium carbonate (anhydrous).
• Druga sestavina zdravila je natrijev karbonat (brezvodni).
Carcinogenicity studies have not been conducted with ceftazidime.
Študij kancerogenosti s ceftazidimom niso izvedli.
These include thrush (fungal infections of the mouth or genital area).
To vključuje kandidozo (glivično okužbo v ustih ali predelu spolovil).
Mild to moderate hepatic impairment had no effect on the pharmacokinetics of ceftazidime in individuals administered 2 g intravenously every 8 hours for 5 days, provided renal function was not impaired.
Blaga do zmerna okvara jeter ni vplivala na farmakokinetiko ceftazidima pri osebah, ki so 5 dni prejemale 2 g ceftazidima na 8 ur intravensko in niso imele okvarjenega delovanja ledvic.
Marketing Authorisation Holder Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Ireland
Imetnik dovoljenja za promet z zdravilom Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Irska
The contents of Zavicefta vial should be reconstituted with 10 mL of sterile water for injections.
Vsebino viale zdravila Zavicefta je treba pripraviti z 10 ml sterilne vode za injekcije.
Very common (≥1/10)
Zelo pogosti ≥ 1/10)
Dry powder
Suhi prašek:
Justification for not including Braille accepted
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
Undesirable effects may occur (e.g. dizziness), which may influence the ability to drive and use machines following administration of Zavicefta (see section 4.8).
Po uporabi zdravila Zavicefta se lahko pojavijo neželeni učinki (npr. omotica), ki lahko vplivajo na sposobnost vožnje in upravljanja strojev (glejte poglavje 4.8).
Hypersensitivity reactions
Preobčutljivostne reakcije
If you miss a dose of Zavicefta If you think you have missed a dose, tell your doctor or nurse straight away.
Če ste izpustili odmerek zdravila Zavicefta Če menite, da ste izpustili odmerek, morate to takoj povedati zdravniku ali medicinski sestri.
• a medicine for gout called probenecid
• zdravilo proti protinu, imenovano probenecid.
Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to ceftazidime/avibactam in vitro.
Učinkovitost je bila v kliničnih študijah dokazana proti naslednjim patogenom, ki so bili in vitro občutljivi za ceftazidim/avibaktam.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali medicinsko sestro.
Ceftazidime may interfere with copper reduction methods (Benedict's, Fehling's, Clinitest) for detection of glycosuria leading to false positive results.
Ceftazidim lahko vpliva na teste za odkrivanje glikozurije, ki temeljijo na metodah z redukcijo bakra (Benedictova reakcija, Fehlingova reakcija, Clinitest), kar lahko vodi do lažno pozitivnih rezultatov.
For avibactam the PK-PD index is the percent time of the free drug concentration above a threshold concentration over the dose interval (% fT >CT).
Za avibaktam je farmakokinetično-farmakodinamični indeks odstotek časa, ko je koncentracija prostega zdravila v odmernem intervalu nad pražno koncentracijo (% fT > CT).
The inhibitory spectrum of avibactam includes many of the enzymes that inactivate ceftazidime, including Ambler class A β-lactamases and class C β-lactamases.
Inhibicijski spekter avibaktama vključuje več encimov, ki inaktivirajo ceftazidim; med takšnimi so betalaktamaze razreda A in betalaktamaze razreda C po Amblerju.
Unchanged avibactam was the major drug-related component in human plasma and urine following dosing with [
C]-avibaktama je bil glavna z zdravilom povezana snov v človeški plazmi in urinu nespremenjeni avibaktam.
The human protein binding of both ceftazidime and avibactam is approximately 10% and 8%, respectively.
Vezava ceftazidima in avibaktama na človeške proteine je približno 10 % za ceftazidim in približno 8 % za avibaktam.
If you have any further questions, ask your doctor or nurse.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali medicinsko sestro.
There is a small possibility that you may get a different infection caused by another bacteria during or after treatment with Zavicefta.
Obstaja majhna verjetnost, da se vam med zdravljenjem z zdravilom Zavicefta ali po zdravljenju z njim pojavi drugačna okužba, ki jo povzročajo druge bakterije.
The reconstituted solution is pale yellow solution and free of particles.
Pripravljena raztopina je bledo rumena in brez delcev.
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before using Zavicefta.
Če kaj od naštetega velja za vas (ali če ste negotovi), se pred uporabo zdravila Zavicefta posvetujte z zdravnikom ali medicinsko sestro.
Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins.
Kloramfenikol je in vitro antagonist ceftazidima in drugih cefalosporinov.
Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many class D enzymes.
Avibaktam ne zavira encimov razreda B (metalo-betalaktamaz) in ne more zavreti veliko encimov razreda D.
A white to yellow powder.
Bel do rumen prašek.
• you are allergic to other cephalosporin antibiotics
• če ste alergični na druge cefalosporinske antibiotike.
20 mL glass vial (Type 1) closed with a rubber (halobutyl) stopper and aluminium seal with flip-off cap.
20-ml steklena viala (iz stekla tipa 1), zaprta z gumijastim (halobutilnim) zamaškom, aluminijsko zaporo in snemljivim pokrovčkom.
Ceftazidime crosses the placenta readily, and is excreted in the breast milk.
Ceftazidim zlahka prehaja placento in se izloča v materino mleko.
This is because Zavicefta is removed from your body by the kidneys.
Zdravilo Zavicefta se namreč izloča iz telesa skozi ledvice.
In pregnant rabbits administered avibactam at 300 and 1000 mg/kg/day, there was a dose-related lower mean foetal weight and delayed ossification, potentially related to maternal toxicity.
Pri brejih samicah kuncev, ki so dobivale avibaktam v odmerkih 300 in 1000 mg/kg/dan, so ugotavljali z odmerkom povezano zmanjšanje povprečne telesne mase plodov in zapoznelo osifikacijo; morda je bilo to povezano s toksičnostjo za samice-matere.
Animal studies with avibactam have shown reproductive toxicity without evidence of teratogenic effects (see section 5.3).
Študije avibaktama na živalih so pokazale vpliv na sposobnost razmnoževanja brez znakov teratogenosti (glejte poglavje 5.3).
Withdraw the needle and shake the vial to give a clear solution.
Izvlecite iglo in pretresite vialo, da nastane bistra raztopina.
Other medicines and Zavicefta Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
Obvestite zdravnika ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Overdose with ceftazidime/avibactam can lead to neurological sequelae including encephalopathy, convulsions and coma, due to the ceftazidime component.
Preveliko odmerjanje ceftazidima/avibaktama ima lahko zaradi ceftazidimske sestavine nevrološke posledice, vključno z encefalopatijo, konvulzijami in komo.
• Complicated intra-abdominal infection (cIAI)
• zapletenih intraabdominalnih okužb (cIAI - complicated intra-abdominal infection),
Each vial contains ceftazidime pentahydrate equivalent to 2 g ceftazidime and avibactam sodium equivalent to 0.5 g avibactam.
Ena viala vsebuje ceftazidim pentahidrat, ki ustreza 2 g ceftazidima, in natrijev avibaktamat, ki ustreza 0,5 g avibaktama.
No data are available on animal studies with ceftazidime.
Podatkov o študijah ceftazidima na živalih ni.
Zavicefta is used in adults to treat:
Za kaj uporabljamo zdravilo Zavicefta Zdravilo Zavicefta se uporablja pri odraslih za zdravljenje:
It is recommended that Zavicefta should be used to treat infections due to aerobic Gram-negative organisms in adult patients with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases (see section 4.4).
Pri odraslih bolnikih z omejenimi možnostmi zdravljenja je zdravljenje okužb z aerobnimi gramnegativnimi bakterijami z zdravilom Zavicefta priporočljivo uporabiti le po posvetu z zdravnikom, ki ima ustrezne izkušnje z obvladovanjem infekcijskih bolezni (glejte poglavje 4.4).
The pharmacokinetics of ceftazidime in patients with severe hepatic impairment has not been established.
Farmakokinetika ceftazidima pri bolnikih s hudo okvaro jeter ni ugotovljena.
As ceftazidime and avibactam do not appear to undergo significant hepatic metabolism, the systemic clearance of either active substance is not expected to be significantly altered by hepatic impairment.
Ker v jetrih ni pomembne presnove ceftazidima in avibaktama, ni pričakovati, da bi okvara jeter bistveno spremenila sistemski očistek enega ali drugega.
• yellowing of the whites of the eyes or skin sudden onset of a severe rash or blistering or peeling skin, possibly accompanied by a high fever or joint pain (these may be signs of more serious medical conditions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or a condition known as DRESS,
• nenaden pojav hudega izpuščaja, mehurjev ali lupljenja kože, lahko skupaj z močno zvišano telesno temperaturo ali bolečinami v sklepih (to so lahko znaki resnejših motenj, na primer toksične epidermalne nekrolize, Stevens-Johnsonovega sindroma, multiformnega eritema ali stanja, ki ga imenujemo "reakcija na zdravilo z eozinofilijo in sistemskimi simptomi" [DRESSDrug Reaction with Eosinophilia and Systemic Symptoms])
Very common: (may affect more than 1 in 10 people)
Zelo pogosti: (pojavijo se lahko pri več kot 1 od 10 bolnikov)
Zavicefta should not be mixed with or physically added to solutions containing other medicinal products.
Zdravila Zavicefta se ne sme mešati z raztopinami, ki vsebujejo druga zdravila, in se ga ne sme fizično dodajati takšnim raztopinam.
• infections of the stomach and gut (abdomen)
• okužb želodca in črevesa (okužb v trebuhu),
The average increases in avibactam AUC are 3.8-fold and 7-fold in subjects with moderate and severe renal impairment, see section 4.2.
Povprečno se AUC avibaktama pri bolnikih z zmerno okvaro ledvic zviša 3,8-krat in pri bolnikih s hudo okvaro ledvic 7-krat, glejte poglavje 4.2.
Hypersensitivity to any cephalosporin antibacterial agent.
Preobčutljivost za kateri koli cefalosporinski antibiotik.
VIAL LABEL
NALEPKA NA VIALI
No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes).
V preparatih človeških jeter (mikrosomi in hepatociti) niso opazili presnove avibaktama.
Animal studies with avibactam do not indicate harmful effects with respect to fertility (see section 5.3).
Študije avibaktama na živalih ne kažejo škodljivih učinkov na plodnost (glejte poglavje
The pharmacokinetics of both ceftazidime and avibactam are approximately linear across the dose range studied (50 mg to 2000 mg) for a single intravenous administration.
Po enkratni intravenski uporabi sta tako farmakokinetika ceftazidima kot avibaktama v raziskanem razponu (od 50 mg do 2000 mg) približno linearni.
Zavicefta is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1):
Zdravilo Zavicefta je indicirano pri odraslih za zdravljenje naslednjih okužb (glejte poglavji 4.4 in
Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function (see section 4.4).
Sočasno zdravljenje z velikimi odmerki cefalosporinov in nefrotoksičnih zdravil, npr. aminoglikozidov ali močnih diuretikov (npr. furosemida) lahko neugodno vpliva na delovanje ledvic (glejte poglavje 4.4).
• an increase in the level of some types of substances in your blood (called “creatinine” and
• zvišanje ravni določenih snovi v krvi (imenovanih "kreatinin" in "sečnina").
Since a clinical interaction study of avibactam and probenecid has not been conducted, co-administration of avibactam with probenecid is not recommended.
Kliničnih študij medsebojnega delovanja avibaktama in probenecida niso izvedli, zato sočasna uporaba avibaktama in probenecida ni priporočljiva.
Amount to be withdrawn
Količina za izvlek celotna količina
This diagnosis should be considered in patients who present with diarrhoea during or subsequent to the administration of Zavicefta (see section 4.8).
Na to diagnozo treba pomisliti pri vseh bolnikih, ki med uporabo zdravila Zavicefta ali po njej dobijo drisko (glejte poglavje 4.8).
• decrease in the number of red blood cells (haemolytic anaemia) - shown in blood tests
• zmanjšanje števila rdečih krvnih celic (hemolitična anemija) - pokaže se na preiskavi krvi
Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function.
Sočasno zdravljenje z velikimi odmerki cefalosporinov in nefrotoksičnih zdravil, npr. aminoglikozidov ali močnih diuretikov (npr. furosemida), lahko neugodno vpliva na delovanje ledvic.
Standard aseptic techniques should be used for solution preparation and administration.
Za pripravo in dajanje raztopine je treba upoštevati standardne aseptične postopke.
Complicated intra-abdominal infections Gram-negative micro-organisms
Zapletene intraabdominalne okužbe Gramnegativni mikroorganizmi
An infusion bag may contain any of the following: sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, sodium chloride 4.5 mg/mL and dextrose 25 mg/mL solution for injection (0.45% sodium chloride and 2.5% dextrose) or Lactated Ringer's solution.
Infuzijska vrečka lahko vsebuje kar koli od naslednjega: 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje, 5 % (50 mg/ml) raztopino glukoze za injiciranje, raztopino 4,5 mg/ml natrijevega klorida in 25 mg/ml glukoze za injiciranje (0,45 % natrijevega klorida in 2,5 % glukoze) ali raztopino Ringerjevega laktata.
Appropriate infusion diluents include: sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, sodium chloride 4.5 mg/mL and dextrose 25 mg/mL solution for injection (0.45% sodium chloride and 2.5% dextrose) or Lactated Ringer's solution.
Ustrezni vehikli za infuzijo so: 0,9 % (9 mg/ml) raztopina natrijevega klorida za injiciranje, 5 % (50 mg/ml) raztopina glukoze za injiciranje, raztopina 4,5 mg/ml natrijevega klorida in 25 mg/ml glukoze za injiciranje (0,45 % natrijevega klorida in 2,5 % glukoze) ali raztopina Ringerjevega laktata.
Ceftazidime does not interfere with enzymebased tests for glycosuria.
Ceftazidim ne vpliva na encimske teste glikozurije.
Ceftazidime is not metabolised.
Ceftazidim se ne presnavlja.
• The active substances are ceftazidime and avibactam.
• Učinkovini sta ceftazidim in avibaktam.
Clostridium difficile colitis
Driska, povezana s Clostridium difficile
Driving and using machines Zavicefta may make you feel dizzy.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Zavicefta vam lahko povzroči omotico.
Penetration of ceftazidime into the intact blood-brain barrier is poor.
Ceftazidim slabo prodira skozi intaktno krvno-možgansko pregrado.
Avibactam and ceftazidime showed no in vitro cytochrome P450 induction at clinically relevant concentrations.
Avibaktam in ceftazidim v klinično pomembnih koncentracijah in vitro nista inducirala citokroma P450.
Table 1 shows the recommended intravenous dose for patients with estimated creatinine clearance (CrCL) ≥ 51 mL/min (see sections 4.4 and 5.1).
Preglednica 1 prikazuje priporočene intravenske odmerke za bolnike z ocenjenim očistkom kreatinina (CrCL) ≥ 51 ml/min ( glejte poglavji 4.4 in 5.1).
• infections of the bladder or kidneys called “urinary tract infections”
• okužb mehurja ali ledvic, ki jih imenujemo "okužbe sečil",
• increase in the amount of some enzymes produced by your liver - shown in blood tests
• zvišanje ravni nekaterih encimov, ki jih proizvajajo jetra - pokaže se na preiskavah krvi
Aseptic technique must be followed in preparing the infusion solution.
Pri pripravi raztopine za infundiranje je treba upoštevati aseptični postopek.
How to use Zavicefta
Kako uporabljati zdravilo Zavicefta
Zavicefta will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose.
Če ste uporabili večji odmerek zdravila Zavicefta, kot bi smeli Zdravilo Zavicefta vam bo dal zdravnik ali medicinska sestra, zato ni verjetno, da bi dobili napačen odmerek.
• a water tablet called furosemide
• tablete za odvajanje vode, imenovane furosemid,
• an antibiotic called chloramphenicol
• antibiotik, imenovan kloramfenikol,
Ceftazidime is excreted unchanged into the urine by glomerular filtration; approximately 80-90% of the dose is recovered in the urine within 24 h. Avibactam is excreted unchanged into the urine with a renal clearance of approximately 158 mL/min, suggesting active tubular secretion in addition to glomerular filtration.
Avibaktam se nespremenjen izloča v urin z ledvičnim očistkom približno 158 ml/min; to kaže, da poleg glomerulne filtracije poteka aktivna tubulna sekrecija.
Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many of the class D enzymes (see section
Avibaktam ne zavira encimov razreda B (metalo-betalaktamaz) in ne more zavreti veliko encimov razreda D (glejte poglavje 5.1).
Avibactam showed no significant inhibition of cytochrome P450 enzymes in vitro.
Avibaktam in vitro ni pomembno zavrl encimov citokroma P450.
If you are not sure, talk to your doctor or nurse before using Zavicefta.
Če ste negotovi, se pred uporabo zdravila Zavicefta posvetujte z zdravnikom ali medicinsko sestro.
Table 2 shows the recommended dose adjustments for patients with estimated CrCL ≤ 50 mL/min (see sections 4.4 and 5.2).
Preglednica 2 prikazuje priporočene prilagoditve odmerka za bolnike z ocenjenim očistkom kreatinina ≤ 50 ml/min (glejte poglavji 4.4 in 5.2):
No synergy or antagonism was demonstrated in in vitro drug combination studies with ceftazidime/avibactam and metronidazole, tobramycin, levofloxacin, vancomycin, linezolid, colistin and tigecycline.
In vitro študije kombinacij s ceftazidimom/avibaktamom in metronidazolom, tobramicinom, levofloksacinom, vankomicinom, linezolidom, kolistinom in tigeciklinom niso pokazale ne sinergije ne antagonizma.
• significant decrease in the type of white blood cells used to fight infection - shown in blood tests
• bistveno zmanjšanje vrste belih krvnih celic, ki premagujejo okužbe - pokaže se na preiskavi krvi
Gender and race The pharmacokinetics of ceftazidime/avibactam is not significantly affected by gender or race.
Spol in rasa Spol in rasa nimata pomembnega vpliva na farmakokinetiko kombinacije ceftazidim/avibaktam.
Approximately 97% of the avibactam dose is recovered in the urine, 95% within 12 h. Less than 1% of ceftazidime is excreted via the bile and less than 0.25% of avibactam is excreted into faeces.
Manj kot 1 % ceftazidima se izloči z žolčem in manj kot 0,25 % avibaktama se izloči v blato.
Dose of ceftazidime/avibactam
Odmerek ceftazidima/avibaktama
Table 3 Frequency of adverse reactions by system organ class
Pogostnost neželenih učinkov po organskih sistemih Organski sistem
Spectrum of activity of ceftazidime/avibactam
Spekter delovanja ceftazidima/avibaktama
Parenteral medicinal products should be inspected visually for particulate matter prior to administration.
Parenteralna zdravila je treba pred uporabo pregledati in se prepričati, da ne vsebujejo delcev.
Vulvovaginal candidiasis and Oral candidiasis)
Infekcijske in parazitske bolezni kandidoza (vključno z vulvovaginalno kandidozo in oralno kandidozo)
Caution should be used if ceftazidime/avibactam is given to patients with a history of non-severe hypersensitivity to penicillins, monobactams or carbapenems.
V primeru uporabe ceftazidima/avibaktama pri bolnikih z anamnezo preobčutljivosti na peniciline, monobaktame ali karbapeneme, ki ni huda, je potrebna previdnost.
Drug Reaction with Eosinophilia and Systemic Symptoms)
StevensJohnsonov sindrom multiformni eritem angioedem reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic
Total volume
Odmerna shema
Pharmacotherapeutic group: Antibacterials for systemic use, ceftazidime, combinations, ATC code: J01DD52
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje infekcij, ceftazidim, kombinacije.
• decrease in the number of some types of blood cells (called “leucocytes”) - shown in blood tests
• zmanjšanje števila nekaterih vrst krvnih celic (imenovanih "levkociti") - pokaže se na preiskavah krvi
• feeling sick (nausea) or being sick (vomiting)
• slabost (navzea) ali bruhanje
However, the possibility that haemolytic anaemia could occur in association with Zavicefta treatment cannot be ruled out.
V povezavi z zdravljenjem z zdravilom Zavicefta ni mogoče izključiti možnosti za hemolitično anemijo.
Dose recommendations are based on pharmacokinetic modelling Ceftazidime and avibactam are removed by haemodialysis (see sections 4.9 and 5.2).
Ceftazidim in avibaktam se odstranjujeta s hemodializo (glejte poglavji 4.9 in 5.2).
Hepatic impairment No dosage adjustment is required in patients with hepatic impairment (see section 5.2).
Okvara jeter Bolnikom z okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
No dosage adjustment is required in patients with mild renal impairment (estimated CrCL ≥ 51≤ 80 mL/min) (see section 5.2).
Bolnikom z blago okvaro ledvic (ocenjeni očistek kreatinina od 51 do ≤ 80 ml/min) odmerka ni treba prilagoditi (glejte poglavje 5.2).