FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: • The other ingredient is sodium carbonate (anhydrous).
Slovenian: • Druga sestavina zdravila je natrijev karbonat (brezvodni).
English: Carcinogenicity studies have not been conducted with ceftazidime.
Slovenian: Študij kancerogenosti s ceftazidimom niso izvedli.
English: These include thrush (fungal infections of the mouth or genital area).
Slovenian: To vključuje kandidozo (glivično okužbo v ustih ali predelu spolovil).
English: 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.
Slovenian: 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.
English: Marketing Authorisation Holder Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Ireland
Slovenian: Imetnik dovoljenja za promet z zdravilom Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Irska
English: The contents of Zavicefta vial should be reconstituted with 10 mL of sterile water for injections.
Slovenian: Vsebino viale zdravila Zavicefta je treba pripraviti z 10 ml sterilne vode za injekcije.
English: Very common (≥1/10)
Slovenian: Zelo pogosti ≥ 1/10)
English: Dry powder
Slovenian: Suhi prašek:
English: Justification for not including Braille accepted
Slovenian: Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: 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).
Slovenian: Po uporabi zdravila Zavicefta se lahko pojavijo neželeni učinki (npr. omotica), ki lahko vplivajo na sposobnost vožnje in upravljanja strojev (glejte poglavje 4.8).
English: Hypersensitivity reactions
Slovenian: Preobčutljivostne reakcije
English: If you miss a dose of Zavicefta If you think you have missed a dose, tell your doctor or nurse straight away.
Slovenian: Če ste izpustili odmerek zdravila Zavicefta Če menite, da ste izpustili odmerek, morate to takoj povedati zdravniku ali medicinski sestri.
English: • a medicine for gout called probenecid
Slovenian: • zdravilo proti protinu, imenovano probenecid.
English: Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to ceftazidime/avibactam in vitro.
Slovenian: Učinkovitost je bila v kliničnih študijah dokazana proti naslednjim patogenom, ki so bili in vitro občutljivi za ceftazidim/avibaktam.
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali medicinsko sestro.
English: Ceftazidime may interfere with copper reduction methods (Benedict's, Fehling's, Clinitest) for detection of glycosuria leading to false positive results.
Slovenian: 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.
English: 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).
Slovenian: Za avibaktam je farmakokinetično-farmakodinamični indeks odstotek časa, ko je koncentracija prostega zdravila v odmernem intervalu nad pražno koncentracijo (% fT > CT).
English: The inhibitory spectrum of avibactam includes many of the enzymes that inactivate ceftazidime, including Ambler class A β-lactamases and class C β-lactamases.
Slovenian: Inhibicijski spekter avibaktama vključuje več encimov, ki inaktivirajo ceftazidim; med takšnimi so betalaktamaze razreda A in betalaktamaze razreda C po Amblerju.
English: Unchanged avibactam was the major drug-related component in human plasma and urine following dosing with [
Slovenian: C]-avibaktama je bil glavna z zdravilom povezana snov v človeški plazmi in urinu nespremenjeni avibaktam.
English: The human protein binding of both ceftazidime and avibactam is approximately 10% and 8%, respectively.
Slovenian: Vezava ceftazidima in avibaktama na človeške proteine je približno 10 % za ceftazidim in približno 8 % za avibaktam.
English: If you have any further questions, ask your doctor or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali medicinsko sestro.
English: There is a small possibility that you may get a different infection caused by another bacteria during or after treatment with Zavicefta.
Slovenian: Obstaja majhna verjetnost, da se vam med zdravljenjem z zdravilom Zavicefta ali po zdravljenju z njim pojavi drugačna okužba, ki jo povzročajo druge bakterije.
English: The reconstituted solution is pale yellow solution and free of particles.
Slovenian: Pripravljena raztopina je bledo rumena in brez delcev.
English: If any of the above apply to you (or you are not sure), talk to your doctor or nurse before using Zavicefta.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se pred uporabo zdravila Zavicefta posvetujte z zdravnikom ali medicinsko sestro.
English: Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins.
Slovenian: Kloramfenikol je in vitro antagonist ceftazidima in drugih cefalosporinov.
English: Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many class D enzymes.
Slovenian: Avibaktam ne zavira encimov razreda B (metalo-betalaktamaz) in ne more zavreti veliko encimov razreda D.
English: A white to yellow powder.
Slovenian: Bel do rumen prašek.
English: • you are allergic to other cephalosporin antibiotics
Slovenian: • če ste alergični na druge cefalosporinske antibiotike.
English: 20 mL glass vial (Type 1) closed with a rubber (halobutyl) stopper and aluminium seal with flip-off cap.
Slovenian: 20-ml steklena viala (iz stekla tipa 1), zaprta z gumijastim (halobutilnim) zamaškom, aluminijsko zaporo in snemljivim pokrovčkom.
English: Ceftazidime crosses the placenta readily, and is excreted in the breast milk.
Slovenian: Ceftazidim zlahka prehaja placento in se izloča v materino mleko.
English: This is because Zavicefta is removed from your body by the kidneys.
Slovenian: Zdravilo Zavicefta se namreč izloča iz telesa skozi ledvice.
English: 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.
Slovenian: 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.
English: Animal studies with avibactam have shown reproductive toxicity without evidence of teratogenic effects (see section 5.3).
Slovenian: Študije avibaktama na živalih so pokazale vpliv na sposobnost razmnoževanja brez znakov teratogenosti (glejte poglavje 5.3).
English: Withdraw the needle and shake the vial to give a clear solution.
Slovenian: Izvlecite iglo in pretresite vialo, da nastane bistra raztopina.
English: Other medicines and Zavicefta Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Overdose with ceftazidime/avibactam can lead to neurological sequelae including encephalopathy, convulsions and coma, due to the ceftazidime component.
Slovenian: Preveliko odmerjanje ceftazidima/avibaktama ima lahko zaradi ceftazidimske sestavine nevrološke posledice, vključno z encefalopatijo, konvulzijami in komo.
English: • Complicated intra-abdominal infection (cIAI)
Slovenian: • zapletenih intraabdominalnih okužb (cIAI - complicated intra-abdominal infection),
English: Each vial contains ceftazidime pentahydrate equivalent to 2 g ceftazidime and avibactam sodium equivalent to 0.5 g avibactam.
Slovenian: Ena viala vsebuje ceftazidim pentahidrat, ki ustreza 2 g ceftazidima, in natrijev avibaktamat, ki ustreza 0,5 g avibaktama.
English: No data are available on animal studies with ceftazidime.
Slovenian: Podatkov o študijah ceftazidima na živalih ni.
English: Zavicefta is used in adults to treat:
Slovenian: Za kaj uporabljamo zdravilo Zavicefta Zdravilo Zavicefta se uporablja pri odraslih za zdravljenje:
English: 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).
Slovenian: 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).
English: The pharmacokinetics of ceftazidime in patients with severe hepatic impairment has not been established.
Slovenian: Farmakokinetika ceftazidima pri bolnikih s hudo okvaro jeter ni ugotovljena.
English: 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.
Slovenian: Ker v jetrih ni pomembne presnove ceftazidima in avibaktama, ni pričakovati, da bi okvara jeter bistveno spremenila sistemski očistek enega ali drugega.
English: • 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,
Slovenian: • 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])
English: Very common: (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti: (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: Zavicefta should not be mixed with or physically added to solutions containing other medicinal products.
Slovenian: Zdravila Zavicefta se ne sme mešati z raztopinami, ki vsebujejo druga zdravila, in se ga ne sme fizično dodajati takšnim raztopinam.
English: • infections of the stomach and gut (abdomen)
Slovenian: • okužb želodca in črevesa (okužb v trebuhu),
English: 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.
Slovenian: 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.
English: Hypersensitivity to any cephalosporin antibacterial agent.
Slovenian: Preobčutljivost za kateri koli cefalosporinski antibiotik.
English: VIAL LABEL
Slovenian: NALEPKA NA VIALI
English: No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes).
Slovenian: V preparatih človeških jeter (mikrosomi in hepatociti) niso opazili presnove avibaktama.
English: Animal studies with avibactam do not indicate harmful effects with respect to fertility (see section 5.3).
Slovenian: Študije avibaktama na živalih ne kažejo škodljivih učinkov na plodnost (glejte poglavje
English: 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.
Slovenian: Po enkratni intravenski uporabi sta tako farmakokinetika ceftazidima kot avibaktama v raziskanem razponu (od 50 mg do 2000 mg) približno linearni.
English: Zavicefta is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1):
Slovenian: Zdravilo Zavicefta je indicirano pri odraslih za zdravljenje naslednjih okužb (glejte poglavji 4.4 in
English: 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).
Slovenian: 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).
English: • an increase in the level of some types of substances in your blood (called “creatinine” and
Slovenian: • zvišanje ravni določenih snovi v krvi (imenovanih "kreatinin" in "sečnina").
English: Since a clinical interaction study of avibactam and probenecid has not been conducted, co-administration of avibactam with probenecid is not recommended.
Slovenian: Kliničnih študij medsebojnega delovanja avibaktama in probenecida niso izvedli, zato sočasna uporaba avibaktama in probenecida ni priporočljiva.
English: Amount to be withdrawn
Slovenian: Količina za izvlek celotna količina
English: This diagnosis should be considered in patients who present with diarrhoea during or subsequent to the administration of Zavicefta (see section 4.8).
Slovenian: Na to diagnozo treba pomisliti pri vseh bolnikih, ki med uporabo zdravila Zavicefta ali po njej dobijo drisko (glejte poglavje 4.8).
English: • decrease in the number of red blood cells (haemolytic anaemia) - shown in blood tests
Slovenian: • zmanjšanje števila rdečih krvnih celic (hemolitična anemija) - pokaže se na preiskavi krvi
English: 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.
Slovenian: Sočasno zdravljenje z velikimi odmerki cefalosporinov in nefrotoksičnih zdravil, npr. aminoglikozidov ali močnih diuretikov (npr. furosemida), lahko neugodno vpliva na delovanje ledvic.
English: Standard aseptic techniques should be used for solution preparation and administration.
Slovenian: Za pripravo in dajanje raztopine je treba upoštevati standardne aseptične postopke.
English: Complicated intra-abdominal infections Gram-negative micro-organisms
Slovenian: Zapletene intraabdominalne okužbe Gramnegativni mikroorganizmi
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Ceftazidime does not interfere with enzymebased tests for glycosuria.
Slovenian: Ceftazidim ne vpliva na encimske teste glikozurije.
English: Resistant
Slovenian: Rezistentni
English: Resistance
Slovenian: Odpornost
English: Ceftazidime is not metabolised.
Slovenian: Ceftazidim se ne presnavlja.
English: • The active substances are ceftazidime and avibactam.
Slovenian: • Učinkovini sta ceftazidim in avibaktam.
English: Clostridium difficile colitis
Slovenian: Driska, povezana s Clostridium difficile
English: Driving and using machines Zavicefta may make you feel dizzy.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Zavicefta vam lahko povzroči omotico.
English: Penetration of ceftazidime into the intact blood-brain barrier is poor.
Slovenian: Ceftazidim slabo prodira skozi intaktno krvno-možgansko pregrado.
English: Avibactam and ceftazidime showed no in vitro cytochrome P450 induction at clinically relevant concentrations.
Slovenian: Avibaktam in ceftazidim v klinično pomembnih koncentracijah in vitro nista inducirala citokroma P450.
English: Table 1 shows the recommended intravenous dose for patients with estimated creatinine clearance (CrCL) ≥ 51 mL/min (see sections 4.4 and 5.1).
Slovenian: Preglednica 1 prikazuje priporočene intravenske odmerke za bolnike z ocenjenim očistkom kreatinina (CrCL) ≥ 51 ml/min ( glejte poglavji 4.4 in 5.1).
English: • infections of the bladder or kidneys called “urinary tract infections”
Slovenian: • okužb mehurja ali ledvic, ki jih imenujemo "okužbe sečil",
English: • increase in the amount of some enzymes produced by your liver - shown in blood tests
Slovenian: • zvišanje ravni nekaterih encimov, ki jih proizvajajo jetra - pokaže se na preiskavah krvi
English: Aseptic technique must be followed in preparing the infusion solution.
Slovenian: Pri pripravi raztopine za infundiranje je treba upoštevati aseptični postopek.
English: How to use Zavicefta
Slovenian: Kako uporabljati zdravilo Zavicefta
English: Zavicefta will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose.
Slovenian: 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.
English: • a water tablet called furosemide
Slovenian: • tablete za odvajanje vode, imenovane furosemid,
English: • an antibiotic called chloramphenicol
Slovenian: • antibiotik, imenovan kloramfenikol,
English: 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.
Slovenian: Avibaktam se nespremenjen izloča v urin z ledvičnim očistkom približno 158 ml/min; to kaže, da poleg glomerulne filtracije poteka aktivna tubulna sekrecija.
English: Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many of the class D enzymes (see section
Slovenian: Avibaktam ne zavira encimov razreda B (metalo-betalaktamaz) in ne more zavreti veliko encimov razreda D (glejte poglavje 5.1).
English: Avibactam showed no significant inhibition of cytochrome P450 enzymes in vitro.
Slovenian: Avibaktam in vitro ni pomembno zavrl encimov citokroma P450.
English: If you are not sure, talk to your doctor or nurse before using Zavicefta.
Slovenian: Če ste negotovi, se pred uporabo zdravila Zavicefta posvetujte z zdravnikom ali medicinsko sestro.
English: Table 2 shows the recommended dose adjustments for patients with estimated CrCL ≤ 50 mL/min (see sections 4.4 and 5.2).
Slovenian: Preglednica 2 prikazuje priporočene prilagoditve odmerka za bolnike z ocenjenim očistkom kreatinina ≤ 50 ml/min (glejte poglavji 4.4 in 5.2):
English: No synergy or antagonism was demonstrated in in vitro drug combination studies with ceftazidime/avibactam and metronidazole, tobramycin, levofloxacin, vancomycin, linezolid, colistin and tigecycline.
Slovenian: In vitro študije kombinacij s ceftazidimom/avibaktamom in metronidazolom, tobramicinom, levofloksacinom, vankomicinom, linezolidom, kolistinom in tigeciklinom niso pokazale ne sinergije ne antagonizma.
English: • significant decrease in the type of white blood cells used to fight infection - shown in blood tests
Slovenian: • bistveno zmanjšanje vrste belih krvnih celic, ki premagujejo okužbe - pokaže se na preiskavi krvi
English: Avibactam
Slovenian: Avibaktam
English: Gender and race The pharmacokinetics of ceftazidime/avibactam is not significantly affected by gender or race.
Slovenian: Spol in rasa Spol in rasa nimata pomembnega vpliva na farmakokinetiko kombinacije ceftazidim/avibaktam.
English: 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.
Slovenian: Manj kot 1 % ceftazidima se izloči z žolčem in manj kot 0,25 % avibaktama se izloči v blato.
English: Via Alessandro Fleming 2 Verona 37135
Slovenian: Via Alessandro Fleming 2
English: Dose of ceftazidime/avibactam
Slovenian: Odmerek ceftazidima/avibaktama
English: Table 3 Frequency of adverse reactions by system organ class
Slovenian: Pogostnost neželenih učinkov po organskih sistemih Organski sistem
English: Spectrum of activity of ceftazidime/avibactam
Slovenian: Spekter delovanja ceftazidima/avibaktama
English: Parenteral medicinal products should be inspected visually for particulate matter prior to administration.
Slovenian: Parenteralna zdravila je treba pred uporabo pregledati in se prepričati, da ne vsebujejo delcev.
English: Vulvovaginal candidiasis and Oral candidiasis)
Slovenian: Infekcijske in parazitske bolezni kandidoza (vključno z vulvovaginalno kandidozo in oralno kandidozo)
English: Caution should be used if ceftazidime/avibactam is given to patients with a history of non-severe hypersensitivity to penicillins, monobactams or carbapenems.
Slovenian: V primeru uporabe ceftazidima/avibaktama pri bolnikih z anamnezo preobčutljivosti na peniciline, monobaktame ali karbapeneme, ki ni huda, je potrebna previdnost.
English: Drug Reaction with Eosinophilia and Systemic Symptoms)
Slovenian: StevensJohnsonov sindrom multiformni eritem angioedem reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic
English: Total volume
Slovenian: Odmerna shema
English: Pharmacotherapeutic group: Antibacterials for systemic use, ceftazidime, combinations, ATC code: J01DD52
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje infekcij, ceftazidim, kombinacije.
English: • decrease in the number of some types of blood cells (called “leucocytes”) - shown in blood tests
Slovenian: • zmanjšanje števila nekaterih vrst krvnih celic (imenovanih "levkociti") - pokaže se na preiskavah krvi
English: • feeling sick (nausea) or being sick (vomiting)
Slovenian: • slabost (navzea) ali bruhanje
English: However, the possibility that haemolytic anaemia could occur in association with Zavicefta treatment cannot be ruled out.
Slovenian: V povezavi z zdravljenjem z zdravilom Zavicefta ni mogoče izključiti možnosti za hemolitično anemijo.
English: Dose recommendations are based on pharmacokinetic modelling Ceftazidime and avibactam are removed by haemodialysis (see sections 4.9 and 5.2).
Slovenian: Ceftazidim in avibaktam se odstranjujeta s hemodializo (glejte poglavji 4.9 in 5.2).
English: Hepatic impairment No dosage adjustment is required in patients with hepatic impairment (see section 5.2).
Slovenian: Okvara jeter Bolnikom z okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).