natgillin/translations-raw huggingface dataset:
The medicinal product is supplied in packs of 10 vials.
Zdravilo je opremljeno v pakiranjih z 10 vialami.
Excipient with known effect: each vial contains 6.44 mmol of sodium (approximately 148 mg).
Pomožna snov z znanim učinkom: ena viala vsebuje 6,44 mmol natrija (približno 148 mg).
Animal studies with ceftazidime do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Študije ceftazidima na živalih niso pokazale neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
CrCL estimated using the Cockcroft-Gault formula
Očistek kreatinina ocenjen s Cockcroft-Gaultovo formulo.
2 hours Guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress
Odvisno od tega, kako huda je okužba, od patogena/patogenov in od bolnikovega kliničnega in bakteriološkega napredka
How Zavicefta works Zavicefta works by killing certain types of bacteria, which can cause serious infections.
Kako deluje zdravilo Zavicefta Zdravilo Zavicefta deluje tako, da uniči določene vrste bakterij, ki lahko povzročijo hude okužbe.
The European Medicines Agency has deferred the obligation to submit the results of studies with Zavicefta in one or more subsets of the paediatric population in the treatment of intra-abdominal infections, urinary tract infections, pneumonia and Gram-negative bacterial infections (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Zavicefta za eno ali več podskupin pediatrične populacije za zdravljenje intraabdominalnih okužb, okužb sečil, pljučnice in okužb z gramnegativnimi bakterijami (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In the rat, no adverse effects were observed on embryofetal development or fertility.
Pri podganah niso opažali neželenih učinkov na embrio-fetalni razvoj ali plodnost.
The following adverse reactions have been reported with ceftazidime alone and/or identified during the Phase 2 and Phase 3 trials with Zavicefta.
Poročali so o naslednjih neželenih učinkih ceftazidima samega in/ali ugotovljenih v kliničnih preskušanjih 2. in 3. faze z zdravilom Zavicefta.
Prolonged use may result in the overgrowth of non-susceptible organisms (e.g. enterococci, fungi), which may require interruption of treatment or other appropriate measures.
Dolgotrajna uporaba lahko povzroči razrast neobčutljivih organizmov (npr. enterokokov, gliv); to lahko zahteva prekinitev zdravljenja ali druge ustrezne ukrepe.
If you have too much Zavicefta it could have an effect on the brain and cause fits or coma.
Če ste prejeli prevelik odmerek zdravila Zavicefta, bi lahko to imelo učinek na možgane in povzročilo napade, podobne epileptičnim ali komo.
• redness, pain or swelling where Zavicefta was given into a vein
• pordelost, bolečina ali oteklost na mestu, kjer ste zdravilo Zavicefta dobili v veno
Approximately 87% of patients had APACHE II scores of ≤ 10 and 4.0% had bacteraemia at baseline.
Približno 87 % bolnikov je imelo oceno APACHE II ≤ 10 in 4 % so imeli izhodiščno bakteriemijo.
The resulting solution should be administered over 120 minutes.
Nastalo raztopino je treba infundirati 120 minut.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Za pogoje shranjevanja pripravljenega in razredčenega zdravila glejte poglavje 6.3.
Zavicefta is administered by intravenous infusion over 120 minutes in an infusion volume of 100 mL.
Zdravilo Zavicefta se daje v 120-minutni intravenski infuziji v infuzijskem volumnu 100 ml.
The total inuse stability from reconstitution to administration should not exceed 36 hours (24 hours at 2-8°C plus 12 hours room temperature).
Celotni čas od priprave do dajanja zdravila zaradi stabilnosti ne sme preseči 36 ur (24 ur na temperaturi od 2 do 8 °C in 12 ur na sobni temperaturi).
Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Drugi neželeni učinki Zdravniku ali medicinski sestri morate povedati, če opazite katerega od naslednjih neželenih učinkov:
Pharmacokinetic/pharmacodynamic relationship
Farmakokinetično/farmakodinamično razmerje
Death occurred in 2.1% (18/857) of patients who received Zavicefta and metronidazole and in 1.4% (12/863) of patients who received meropenem.
Smrt se je pojavila pri 2,1 % (18/857) bolnikih, ki so prejeli zdravilo Zavicefta in metronidazol in pri 1,4 % (12/863) bolnikih, ki so prejeli meropenem.
Probenecid (a potent OAT inhibitor) inhibits this uptake by 56% to 70% in vitro and, therefore, has the potential to alter the elimination of avibactam.
Probenecid (ki močno zavira OAT) in vitro zavre ta prevzem za 56 do 70 % in tako lahko spremeni izločanje avibaktama.
Reduced clearance of ceftazidime was observed in elderly patients, which was primarily due to agerelated decrease in renal clearance of ceftazidime.
Pri starejših bolnikih so opazili zmanjšan očistek ceftazidima, ki je bil predvsem posledica starostnega zmanjšanja njegovega ledvičnega očistka.
Each vial contains a total of 6.44 mmol of sodium (approximately 148 mg), equivalent to 7.4% of the WHO recommended maximum daily intake for sodium.
Ena viala vsebuje skupaj 6,44 mmol natrija (približno 148 mg), kar ustreza 7,4 % največjega dnevnega vnosa natrija, ki ga priporoča Svetovna zdravstvena organizacija (WHO - World Health Organisation).
Do not use Zavicefta if:
Ne uporabljajte zdravila Zavicefta:
Ceftazidime has little or no activity against the majority of Gram-positive organisms and anaerobes (see sections 4.2 and 5.1).
Ceftazidim deluje le malo ali sploh nič proti večini grampozitivnih organizmov in anaerobov (glejte poglavji 4.2 in 5.1).
Tell your doctor straight away if you notice any of the serious side effects above.
Zdravnika morate nemudoma obvestiti, če opazite katerega od zgoraj naštetih resnih neželenih učinkov.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
It inhibits both Ambler class A and class C β-lactamases and some class D enzymes, including extended-spectrum β-lactamases (ESBLs), KPC and OXA-48 carbapenemases, and AmpC enzymes.
Zavre betalaktamaze razreda A in razreda C po Amblerju ter nekatere encime razreda D, vključno z betalaktamazami razširjenega spektra (ESBL - extended-spectrum betalactamases), karbapenemazami KPC in OXA-48 ter encimi AmpC.
This medicinal product does not require any special storage conditions.
Posebna navodila za shranjevanje niso potrebna.
Note: to preserve product sterility, it is important that the gas relief needle is not inserted through the vial closure before the product is dissolved.
Opomba: za ohranitev sterilnosti zdravila je pomembno, da odzračevalne igle ne zabodete skozi pokrovček viale, dokler se zdravilo ne raztopi.
In vitro, avibactam is a substrate of OAT1 and OAT3 transporters which might contribute to the active uptake of avibactam from the blood compartment and therefore affect its excretion.
Avibaktam je in vitro substrat prenašalcev OAT1 in OAT3, ki lahko pripomoreta k njegovemu aktivnemu privzemu iz krvnega razdelka in s tem vplivata na njegovo izločanje.
Elimination of ceftazidime and avibactam is decreased in patients with moderate or severe renal impairment.
Odstranjevanje ceftazidima in avibaktama je zmanjšano pri bolnikih z zmerno ali hudo okvaro ledvic.
• you have ever had a severe allergic reaction to other antibiotics belonging to the penicillin or carbapenem groups
• če ste kdaj imeli hudo alergijsko reakcijo na druge antibiotike, ki spadajo v skupino penicilinov ali karbapenemov.
• Avibactam is a “beta-lactamase inhibitor” that helps ceftazidime kill some bacteria that it cannot kill on its own.
• Avibaktam je zaviralec beta-laktamaze in ceftazidimu pomaga, da uniči bakterije, ki jih sam ne more uničiti.
• a type of antibiotic called an aminoglycoside - such as gentamicin, tobramycin
• vrsto antibiotikov, imenovanih aminoglikozidi - na primer gentamicin, tobramicin,
Reduced doses may be achieved by transfer of an appropriate volume of the resultant solution to an infusion bag, based upon ceftazidime and avibactam content of 167.3 mg/mL and 41.8 mg/mL, respectively.
Manjše odmerke je mogoče dobiti s prenosom ustrezne količine nastale raztopine v infuzijsko vrečko upoštevaje vsebnost 167,3 mg/ml ceftazidima in 41,8 mg/ml avibaktama.
• fungal infections, including those of the mouth and vagina
• glivične okužbe, vključno z okužbami v ustih in nožnici
Intravenous use
intravenska uporaba
Clinical efficacy has not been established against the following pathogens that are relevant to the approved indications although in vitro studies suggest that they would be susceptible to ceftazidime/avibactam in the absence of acquired mechanisms of resistance.
Klinična učinkovitost ni ugotovljena proti naslednjim patogenom, ki so relevantni za odobrene indikacije, čeprav študije in vitro kažejo, da so občutljivi za ceftazidim/avibaktam, če ni pridobljenih mehanizmov odpornosti.
After reconstitution, 1 mL of solution contains 167.3 mg of ceftazidime and 41.8 mg of avibactam (see section 6.6).
Po pripravi vsebuje 1 ml raztopine 167,3 mg ceftazidima in 41,8 mg avibaktama (glejte poglavje 6.6).
Nausea and diarrhoea were usually mild or moderate in intensity.
Navzea in driska sta bili običajno blagi ali zmerni.
Carcinogenicity studies have not been conducted with avibactam.
Študij kancerogenosti z avibaktamom niso izvedli.
After reconstitution
Po rekonstituciji:
• diarrhoea that keeps getting worse or does not go away, or stools that contains blood or mucus this may happen during or after treatment is stopped with Zavicefta.
• Drisko, ki se slabša ali ne mine, ali blato, ki vsebuje kri ali sluz - driska se lahko pojavi med zdravljenjem z zdravilom Zavicefta ali po koncu zdravljenja z njim.
• Ceftazidime belongs to the group of antibiotics called “cephalosporins”.
• Ceftazidim spada v skupino antibiotikov, imenovanih "cefalosporini".
Ceftazidime and avibactam are eliminated via the kidneys, therefore, the dose should be reduced according to the degree of renal impairment (see section 4.2).
Ceftazidim in avibaktam se izločita skozi ledvice, zato je treba odmerek zmanjšati glede na stopnjo okvare ledvic (glejte poglavje 4.2).
The effects of ceftazidime/avibactam on fertility in humans have not been studied.
Vplivi ceftazidima/avibaktama na plodnost pri človeku niso raziskani.
The maximum daily dose of this product is equivalent to 22.2% of the WHO recommended maximum daily intake for sodium.
Največji dnevni odmerek tega zdravila ustreza 22,2 % največjega dnevnega vnosa natrija, ki ga priporoča WHO.
Complicated intra-abdominal infections
Zapletene intraabdominalne okužbe
Patients experiencing anaemia during or after treatment with Zavicefta should be investigated for this possibility.
Pri bolnikih, ki se jim med zdravljenjem z zdravilom Zavicefta ali po njem pojavi anemija, je treba raziskati to možnost.
• Staphylococcus aureus (methicillin-susceptible and methicillin-reistant)
• Staphylococcus aureus (tako občutljiv kot odporen na meticilin)
While DAGT seroconversion in patients receiving Zavicefta was very common in clinical studies (the estimated range of seroconversion across Phase 3 studies was 3.2% to 20.8% in patients with a negative Coombs test at baseline and at least one followup test), there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
V kliničnih študijah je bila serokonverzija DAGT pri bolnikih, ki so prejemali zdravilo Zavicefta, zelo pogosta (ocenjeni razpon serokonverzij v študijah 3. faze je bil od 3,2 do 20,8 % pri bolnikih, ki so imeli izhodiščno negativen Coombsov test in vsaj še enega med spremljanjem), a pri bolnikih, ki se jim je med zdravljenjem pojavil pozitiven DAGT, ni bilo dokazov o hemolizi.
How much to use The recommended dose is one vial (2 g of ceftazidime and 0.5 g of avibactam), every 8 hours.
Koliko zdravila uporabiti Priporočeni odmerek je ena viala (2 g ceftazidima in 0,5 g avibaktama) na 8 ur.
Following administration of avibactam throughout pregnancy and lactation in the rat, there was no effect on pup survival, growth or development, however there was an increase in incidence of dilation of the renal pelvis and ureters in less than 10% of the rat pups at maternal exposures greater than or equal to approximately 1.5 times human therapeutic exposures.
Uporaba avibaktama med celotno brejostjo in obdobjem dojenja pri podganah ni vplivala na preživetje mladičev, njihovo rast ali razvoj, ugotovili pa so večjo pojavnost razširjenih ledvičnih mehov in sečevodov, a pri manj kot 10 % mladičev podgan, pri katerih je bila izpostavljenost ≥ 1,5-kratniku terapevtske izpostavljenosti pri človeku.
The following side effects may happen with this medicine:
Med uporabo tega zdravila se lahko pojavijo naslednji neželeni učinki:
• you have ever had any allergic reaction (even if only a skin rash) to other antibiotics belonging to the penicillin or carbapenem groups
• če ste kdaj imeli kakršno koli alergijsko reakcijo (tudi če je bil to le izpuščaj na koži) na druge antibiotike, ki spadajo v skupino penicilinov ali karbapenemov.
Serum levels of ceftazidime can be reduced by haemodialysis or peritoneal dialysis.
Koncentracijo ceftazidima v serumu je mogoče zmanjšati s hemodializo ali peritonealno dializo.
What you need to know before you use Zavicefta
Kaj morate vedeti, preden boste uporabili zdravilo Zavicefta
Lab tests
Laboratorijske preiskave
Following a single intravenous administration of 500 mg avibactam as a 30-minute IV infusion, the elderly had a slower terminal half-life of avibactam, which may be attributed to age related decrease in renal clearance.
Po enkratnem intravensko uporabljenem odmerku 500 mg avibaktama v 30-minutni intravenski infuziji so imeli starejši bolniki daljši terminalni razpolovni čas avibaktama, kar je morda mogoče pripisati starostnemu zmanjšanju ledvičnega očistka.
People with kidney problems
Osebe, ki imajo težave z ledvicami
Minimum Inhibitory Concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for ceftazidime/avibactam are as follows: Organisms
Mejni vrednosti minimalne inhibitorne koncentracije (MIC - Minimum Inhibitory Concentration), ki ju je za ceftazidim/avibaktam postavil Evropski odbor za testiranje protimikrobne občutljivosti (EUCAST - European Committee on Antimicrobial Susceptibility Testing), sta:
5-14 days
5-14 dni
Gram-negative micro-organisms
Gramnegativni mikroorganizmi
Non-susceptible organisms
Neobčutljivi organizmi
Introduce the syringe needle through the vial closure and inject 10 mL of sterile water for injections.
Vstavite iglo brizge skozi zaporko viale in injicirajte 10 ml sterilne vode za injekcije.
• Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
• bolnišnične pljučnice (HAP - hospital-acquired pneumonia), vključno s pljučnico zaradi uporabe respiratorja (VAP - ventilator associated pneumonia).
Vials of ceftazidime/avibactam powder should be reconstituted with 10 mL of sterile water for injections, followed by shaking until the content dissolves.
Viale s praškom ceftazidima/avibaktama je treba pripraviti z 10 ml sterilne vode za injekcije in jih nato stresati, dokler se vsebina ne raztopi.
Do not use Zavicefta if any of the above apply to you.
Ne uporabljajte zdravila Zavicefta, če kaj od naštetega velja za vas.
Do not insert a gas relief needle until the product has dissolved.
Ne vstavite odzračevalne igle, dokler se zdravilo ne raztopi.
The concentration time profiles are similar for ELF and plasma.
Časovni potek koncentracij v epitelijski tekočini in plazmi je podoben.
Avibactam and ceftazidime do not inhibit the major renal or hepatic transporters in the clinically relevant exposure range, therefore the interaction potential via these mechanisms is considered to be low.
Avibaktam in ceftazidim v klinično pomembnem razponu ne zavirata glavnih ledvičnih in jetrnih prenašalcev, zato velja, da je možnost za medsebojno delovanje preko teh mehanizmov majhna.
This should be considered when administering Zavicefta to patients who are on a controlled sodium diet.
To je treba upoštevati v primeru uporabe zdravila Zavicefta pri bolnikih, ki so na dieti z omejeno količino natrija.
Ask your pharmacist how to throw away medicines you no longer require.
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
Direct antiglobulin test (DAGT or Coombs test) seroconversion and potential risk of haemolytic anaemia
Serokonverzija direktnega antiglobulinskega testa (DAGT - direct antiglobulin test ali Coombsov test) in možno tveganje za hemolitično anemijo
Infections due to aerobic Gram-negative organisms in patients with limited treatment options
Okužbe z aerobnimi gramnegativnimi bakterijami pri bolnikih z omejenimi možnostmi zdravljenja
Interference with laboratory tests
Moteči vplivi na laboratorijske preiskave
Talk to your doctor before using Zavicefta if you are taking any of the following medicines:
Pred uporabo zdravila Zavicefta se posvetujte z zdravnikom, če jemljete katero od naslednjih zdravil:
For instructions on reconstitution and dilution of the medicinal product before administration see section 6.6.
Za navodila o pripravi in redčenju zdravila pred uporabo glejte poglavje 6.6.
A dose of 1000 mg/250 mg or 750 mg/187.5 mg is achieved with 6.0 mL or 4.5 mL aliquots, respectively.
Odmerek 1000 mg/250 mg ali 750 mg/187,5 mg je mogoče dobiti z alikvotoma 6,0 ml ali 4,5 ml.
The antimicrobial activity of ceftazidime against specific pathogens has been shown to best correlate with the percent time of free-drug concentration above the ceftazidime/avibactam minimum inhibitory concentration over the dose interval (%fT >MIC of ceftazidime/avibactam).
Ugotovljeno je, da protimikrobno delovanje ceftazidima proti specifičnim patogenom najbolje korelira z odstotkom časa, ko je koncentracija prostega zdravila v odmernem intervalu nad minimalno inhibicijsko koncentracijo ceftazidima/avibaktama (% fT > MIC ceftazidima/avibaktama).
Bacterial resistance mechanisms that could potentially affect ceftazidime/avibactam include mutant or acquired PBPs, decreased outer membrane permeability to either compound, active efflux of either compound, and β-lactamase enzymes refractory to inhibition by avibactam and able to hydrolyse ceftazidime.
Med mehanizme bakterijske odpornosti, ki bi potencialno lahko vplivali na ceftazidim/avibaktam, spadajo mutirani ali pridobljeni PBP, zmanjšanje permeabilnosti zunanje membrane za eno ali drugo učinkovino, aktivno izločanje ene ali druge učinkovine in betalaktamaze, ki so odporne proti zavrtju z avibaktamom in lahko hidrolizirajo ceftazidim.
Clinical data have demonstrated that there is no interaction between ceftazidime and avibactam, and between ceftazidime/avibactam and metronidazole.
Klinični podatki so pokazali, da med ceftazidimom in avibaktamom ter med kombinacijo ceftazidim/avibaktam in metronidazol ni medsebojnih delovanj.
The terminal half-life (t½) of both ceftazidime and avibactam is about 2 h after intravenous administration.
Terminalni razpolovni čas (t1/2) ceftazidima in avibaktama je po intravenski uporabi približno 2 uri.
Hospital-acquired pneumonia, including ventilator-associated pneumonia In a single study in patients with nosocomial pneumonia 280/808 (34.7%) had VAP and 40/808 (5.0%) were bacteraemic at baseline.
Bolnišnična pljučnica, vključno s pljučnico zaradi uporabe respiratorja V študiji pri bolnikih z bolnišnično pljučnico je 280 od 808 bolnikov (34,7 %) imelo VAP in 40 od 808 bolnikov (5,0 %) bakteriemijo na začetku študije.
Infusion time
Čas infundiranja
Tell the person taking the sample that you have been given Zavicefta.
Povejte osebi, ki ji oddate vzorec urina, da prejemate zdravilo Zavicefta.
powder for concentrate for solution for infusion 10 vials
prašek za koncentrat za raztopino za infundiranje 10 vial
The pharmacokinetics of avibactam in patients with any degree of hepatic impairment has not been studied.
Farmakokinetika avibaktama pri bolnikih s katero koli stopnjo okvare jeter ni raziskana.
The colour of Zavicefta infusion solution is pale yellow and free of particles.
Raztopina za infundiranje zdravila Zavicefta je bledo rumena in brez delcev.
Insert a gas relief needle through the vial closure to relieve the internal pressure.
Skozi zaporko viale vstavite odzračevalno iglo, da se bo notranji tlak izravnal.
What Zavicefta is and what it is used for
Kaj je zdravilo Zavicefta in za kaj ga uporabljamo
Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of β-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems).
Huda preobčutljivost (npr. anafilaktična reakcija, huda kožna reakcija) za katero koli drugo vrsto betalaktamskih antibiotikov (npr. na peniciline, monobaktame ali karbapeneme).
Discontinuation of therapy with Zavicefta and the administration of specific treatment for Clostridium difficile should be considered.
V poštev pride prenehanje zdravljenja z zdravilom Zavicefta in uporaba specifičnih zdravil proti Clostridium difficile.
However, if you have side effects or think you have been given too much Zavicefta, tell your doctor or nurse straight away.
Toda če imate neželene učinke, ali če menite, da ste dobili preveč zdravila Zavicefta, to nemudoma povejte zdravniku ali medicinski sestri.
Both ceftazidime and avibactam penetrate into human bronchial epithelial lining fluid (ELF) to the same extent with concentrations around 30% of those in plasma.
Ceftazidim in avibaktam pri človeku prodirata v bronhialno epitelijsko tekočino v enaki meri in v njej dosežeta koncentracijo, ki znaša približno 30 % koncentracije v plazmi.
The use of ceftazidime/avibactam to treat patients with infections due to Gram-negative aerobic pathogens who have limited treatment options is based on experience with ceftazidime alone and on analyses of the pharmacokinetic-pharmacodynamic relationship for ceftazidime/avibactam (see section
Uporaba ceftazidima/avibaktama za okužbe z gramnegativnimi aerobnimi patogeni pri bolnikih, pri katerih so možnosti zdravljenja omejene, temelji le na izkušnjah s samim ceftazidimom in na analizah farmakokinetičnega/farmakodinamičnega razmerja za kombinacijo ceftazidim/avibaktam (glejte poglavje 5.1).
In two studies in patients with cUTI, 381/1091 (34.9%) patients were enrolled with cUTI without pyelonephritis while 710 (65.1%) were enrolled with acute pyelonephritis (mMITT population).
V dve študiji bolnikov z zapletenimi okužbami sečil je bilo vključenih 381/1091 (34,9 %) bolnikov z zapletenimi okužbami sečil brez pielonefritisa in 710 (65,1 %) z akutnim pielonefritisom (populacija mMITT - microbiological Modified Intention to Treat).
Zavicefta is an antibiotic medicine that contains two active substances ceftazidime and avibactam.
Zdravilo Zavicefta je antibiotično zdravilo, ki vsebuje dve učinkovini: ceftazidim in avibaktam.
Complicated IAI
Zapletene IAI
• Complicated urinary tract infection (cUTI), including pyelonephritis
• zapletenih okužb sečil (cUTI - complicated urinary tract infection), vključno s pielonefritisom,
This is because you may get an abnormal result with a test called “DAGT” or “Coombs”.
Lahko se namreč zgodi, da boste imeli zaradi tega zdravila nenormalen izvid preiskave, imenovane "DAGT" oz. "Coombsov test".
The reconstituted solution must be further diluted to produce Zavicefta solution for infusion.
Pripravljeno raztopino je treba dodatno razredčiti, da nastane raztopina zdravila Zavicefta za infundiranje.
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serij
• change in the number of some types of blood cells (called “eosinophils” and “thrombocytes”)
• sprememba števila nekaterih vrst krvnih celic (imenovanih "eozinofilci" in "trombociti")