natgillin/translations-raw huggingface dataset:
What you need to know before you use Zinforo
Što morate znati prije nego počnete primjenjivati Zinforo
• Diarrhoea that becomes severe or does not go away or stool that contains blood or mucus during or after treatment with Zinforo.
• proljev koji se pogoršava ili ne prolazi, ili prisutnost krvi ili sluzi u stolici tijekom ili nakon liječenja lijekom Zinforo.
The infusion solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline fosamil.
Koncentracija otopine za infuziju tijekom pripremanja i primjene ne smije prelaziti 12 mg/ml ceftarolinfosamila.
Resistance may also be mediated by bacterial impermeability or drug efflux pump mechanisms.
Rezistencija može biti posredovana i mehanizmima bakterijske nepropusnosti ili efluks-pumpe za lijek.
• A decrease in the total number of white blood cells, ora certain type of white blood cells in your blood (leucopenia and neutropenia).
• smanjen ukupni broj bijelih krvnih zrnaca ili određenih vrsta bijelih krvnih stanica (leukopenija i neutropenija).
As a result, minimum inhibitory concentrations (MICs) of ceftaroline against a proportion of these organisms tested fall into the susceptible range (see Resistance section below).
Kao posljedica toga, minimalne inhibitorne koncentracije (MIK) ceftarolina protiv ispitanog dijela tih organizama padaju unutar granica osjetljivosti (vidjeti dio "Rezistencija" u nastavku).
Your doctor may increase your dose to 600 mg every 8 hours for some infections.
Kod nekih infekcija Vaš liječnik može povisiti dozu na 600 mg svakih 8 sati.
• Changes in tests which measure how well your blood clots.
• promjene rezultata testova koji mjere zgrušavanje krvi
Limited data in patients receiving higher than recommended Zinforo dosages show similar adverse reactions as observed in the patients receiving recommended dosages.
Ograničeni podaci u bolesnika koji su primili više doze lijeka Zinforo od preporučenih pokazuju da su nuspojave slične kao one opažene u bolesnika koji su primali preporučene doze.
This test looks for certain antibodies which may act against your red blood cells.
Tom se pretragom ispituje postojanje određenih protutijela koja mogu djelovati protiv Vaših crvenih krvnih stanica.
Rash, pruritus Anaphylaxis, hypersensitivity (e.g. urticaria, lip and face swelling) (see sections 4.3 and 4.4)
Osip, svrbež Anafilaksija , preosjetljivost (npr. urtikarija, oticanje usana i lica) (vidjeti dijelove 4.3 i 4.4)
Histopathologic findings included pigment deposition and inflammation of the tubular epithelium.
Patohistološki nalazi uključivali su taloženje pigmenta i upalu tubularnog epitela.
Therefore, interactions of ceftaroline with medicinal products that are substrates or inhibitors (e.g. probenecid) of these transporters would not be expected.
Stoga se ne očekuju interakcije ceftarolina s lijekovima koji su supstrati ili inhibitori tih prijenosnika (npr. probenecid).
Organisms that express these enzymes and which are therefore resistant to ceftaroline occur at very variable rates between countries and between healthcare facilities within countries.
Organizmi koji proizvode te enzime te su stoga rezistentni na ceftarolin pojavljuju se u vrlo različitim stopama od zemlje do zemlje kao i između zdravstvenih ustanova u istoj zemlji.
Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems, ATC code: J01DI02
Farmakoterapijska skupina: Lijekovi za liječenje bakterijskih infekcija za sustavnu primjenu, ostali cefalosporini i penemi, ATK oznaka: J01DI02
The recommended dosage of Zinforo shown in Table 2 for paediatric patients < 2 months of age are based on pharmacokinetic-pharmacodynamic modelling and simulation.
Preporučeno doziranje lijeka Zinforo, prikazano u Tablici 2 za pedijatrijske bolesnike u dobi od < 2 mjeseca, temeljeno je na farmakokinetičkom-farmakodinamičkom modeliranju i simulacijama.
The colour of Zinforo infusion solutions ranges from clear, light to dark yellow depending on the concentration and storage conditions.
Zinforo otopina za infuziju je bistra, svijetlo do tamnožute boje, ovisno o koncentraciji i uvjetima čuvanja.
The cysts involved a small portion of the kidney and ocurred in the absence of significant changes in either renal function or urinary parameters.
Ciste su zahvaćale mali dio bubrega i javljale se bez značajnih promjena bubrežne funkcije ili urinarnih parametara.
Biochemical studies have shown that ceftaroline has high affinity for PBP2a of methicillin-resistant Staphylococcus aureus (MRSA) and PBP2x of penicillin non-susceptible Streptococcus pneumoniae (PNSP).
Biokemijska ispitivanja su pokazala da ceftarolin ima visoki afinitet za PBP2a meticilin-rezistentnih sojeva bakterije Staphylococcus aureus (MRSA) te za PBP2x penicilin neosjetljivih sojeva bakterije Streptococcus pneumoniae (PNSP).
If you have kidney problems your doctor may lower your dose because Zinforo is removed from your body by the kidneys.
Ako imate tegoba s bubrezima, liječnik će Vam možda sniziti dozu jer se Zinforo uklanja iz tijela putem bubrega.
• an infection of the lungs called ‘pneumonia'
• infekciju pluća koja se zove upala pluća (pneumonija).
120/every 8 hours
120/svakih 8 sati
Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to ceftaroline in vitro.
U kliničkim je ispitivanjima dokazana djelotvornost protiv patogena popisanih pod svakom indikacijom koji su bili osjetljivi na ceftarolin in vitro.
Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to ceftaroline in the absence of acquired mechanisms of resistance:
Nije utvrđena klinička djelotvornost protiv sljedećih patogena, iako ispitivanja in vitro upućuju na to da bi oni bili osjetljivi na ceftarolin ako nema stečenih mehanizama rezistencije:
Ceftaroline is a cephalosporin antibacterial with in vitro activity against Gram-positive and -negative bacteria.
Ceftarolin je cefalosporinski antibiotik s in vitro aktivnošću protiv Gram-pozitivnih i Gram-negativnih bakterija.
In vitro studies have not demonstrated any antagonism between ceftaroline in combination with other commonly used antibacterial agents (e.g. amikacin, azithromycin, aztreonam, daptomycin, levofloxacin, linezolid, meropenem, tigecycline, and vancomycin).
Ispitivanja in vitro nisu pokazala antagonizam između ceftarolina i drugih često korištenih antibiotika (npr. amikacina, azitromicina, aztreonama, daptomicina, levofloksacina, linezolida, meropenema, tigeciklina i vankomicina).
Interaction with other antibacterial agents
Interakcija s drugim antibioticima
Dose adjustments are required for neonates, infants, children and adolescents with bodyweight < 33 kg (see section 4.2).
Potrebne su prilagodbe doze u novorođenčadi, dojenčadi, djece i adolescenata koji imaju tjelesnu težinu <33 kg (vidjeti dio 4.2).
Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ceftaroline fosamil.
Bolesnici koji su preosjetljivi na cefalosporine, peniciline ili druge beta-laktamske antibiotike mogu također biti preosjetljivi i na ceftarolinfosamil.
• If you are allergic to other cephalosporin antibiotics
• ako ste alergični na druge cefalosporinske antibiotike
Parenteral drug products should be inspected visually for particulate matter prior to administration.
Lijekovi za parenteralnu primjenu moraju se prije primjene vizualno provjeriti na prisutnost čestica.
MIC breakpoints (mg/L) Susceptible (≤ S)
Granične vrijednosti MIK-a (mg/l) Osjetljiv (≤ S)
Therefore, Zinforo should be used with caution in this patient population.
Stoga se Zinforo u ovoj populaciji bolesnika mora primjenjivati uz oprez.
Overall, no adverse effects on fertility or post-natal development were observed in the rat at up to 5 times the observed clinical exposure.
Sveukupno, nisu opaženi štetni učinci na plodnost ni postnatalni razvoj štakora pri izloženosti do 5 puta većoj od kliničke.
Dose recommendations for neonates, infants and children and adolescents are based on pharmacokinetic (PK) modelling.
Preporučene doze za novorođenčad, dojenčad i djecu i adolescente temelje se na farmakokinetičkom modeliranju.
Infusion time (minutes)/Frequency
Trajanje infuzije (minute)/učestalost
Ceftaroline is not active against strains of Enterobacterales producing extended-spectrum betalactamases (ESBLs) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class B metallo-beta-lactamases or class C (AmpC) cephalosporinases.
Ceftarolin nije aktivan protiv sojeva roda Enterobacterales koji proizvode beta-laktamaze proširenog spektra (engl. extended-spectrum beta-lactamases, ESBLs) iz obitelji TEM, SHV ili CTX-M, serinske karbapenemaze (kao što je KPC), metalo-beta-laktamaze klase B ili cefalosporinaze klase C (AmpC).
Ceftaroline is primarily eliminated by the kidneys.
Ceftarolin se prvenstveno eliminira putem bubrega.
Ceftaroline fosamil (prodrug) is converted into the active ceftaroline in plasma by phosphatase enzymes and concentrations of the prodrug are measurable in plasma primarily during intravenous infusion.
Ceftarolinfosamil (predlijek) se u plazmi pretvara u aktivni ceftarolin pomoću enzima fosfataze, a koncentracije predlijeka u plazmi mjerljive su prvenstveno tijekom intravenske infuzije.
As ceftaroline does not appear to undergo significant hepatic metabolism, the systemic clearance of ceftaroline is not expected to be significantly affected by hepatic impairment.
Budući da izgleda da ceftarolin ne podliježe značajnom jetrenom metabolizmu, ne očekuje se da će oštećenje jetre značajno utjecati na sustavni klirens ceftarolina.
What Zinforo is and what it is used for
Što je Zinforo i za što se koristi
Following administration throughout pregnancy and lactation in the rat, there was no effect on pup birth weight or growth, although minor changes in foetal weight and delayed ossification of the interparietal bone were observed when ceftaroline fosamil was administered during organogenesis (see section 5.3).
Nakon primjene tijekom trudnoće i laktacije u štakora nije bilo učinka na okotnu težinu ni rast mladunčadi, iako su opažene manje promjene u tjelesnoj težini ploda i usporeno okoštavanje interparijetalne kosti kada se ceftarolinfosamil primjenjivao tijekom organogeneze (vidjeti dio 5.3).
Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ring metabolite, ceftaroline M-1.
Dolazi do hidrolize beta-laktamskog prstena ceftarolina te nastaje mikrobiološki inaktivan metabolit otvorenog prstena, ceftarolin M-1.
The resulting solution should be administered according to the dose selected over 5 to 60 minutes for standard dose or 120 minutes for high dose in infusion volumes of 50 mL, 100 mL or 250 mL.
Dobivena otopina treba se primijeniti prema odabranoj dozi, tijekom 5 do 60 minuta za standardnu dozu ili 120 minuta za visoku dozu kod infuzijskih volumena od 50 ml, 100 ml ili 250 ml.
The European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints for susceptibility testing are presented below.
Europski odbor za testiranje osjetljivosti na antibiotike (EUCAST) utvrdio je sljedeće granične vrijednosti osjetljivosti:
In vitro data indicate that the following species are not susceptible to ceftaroline:
Podaci iz in vitro ispitivanja pokazuju da sljedeće vrste nisu osjetljive na ceftarolin:
Reproductive toxicology
Reproduktivna toksičnost
Ceftaroline fosamil and ceftaroline were clastogenic in an in vitro chromosomal aberration assay, however there was no evidence of mutagenic activity in an Ames test, mouse lymphoma and unscheduled DNA synthesis assay.
Ceftarolin fosamil i ceftarolin pokazali su se klastogenima u testu kromosomskih aberacija in vitro, međutim nije bilo dokaza mutagene aktivnosti u Amesovom testu, testu mišjeg limfoma ni testu nepredviđene sinteze DNK.
The plasma protein binding of ceftaroline is low (approximately 20%) and ceftaroline is not distributed into erythrocytes.
Ceftarolin se u maloj mjeri (približno 20%) vezuje za proteine plazme i ne distribuira se u eritrocite.
Table 5 Frequency of adverse reactions by system organ class from clinical trials and post marketing experience
Tablica 5 Učestalost nuspojava prema organskim sustavima na temelju kliničkih ispitivanja i iskustava nakon stavljanja lijeka u promet
The reconstituted solution must be further diluted to produce Zinforo solution for infusion.
Rekonstituirana otopina mora se dalje razrijediti kako bi se dobila Zinforo otopina za infuziju.
Clinical study experience with ceftaroline fosamil in patients with pre-existing seizure disorders is very limited.
Iskustvo u kliničkim ispitivanjima s ceftarolinfosamilom u bolesnika s postojećim poremećajima s napadajima je vrlo ograničeno.
• Staphylococcus aureus (including methicillin-resistant strains)
• Staphylococcus aureus (uključujući sojeve rezistentne na meticilin)
There is limited experience in treating patients with diabetic foot infections.
Iskustvo u liječenju bolesnika s infekcijama dijabetičkog stopala je ograničeno.
Intravenous bolus dosing of ceftaroline fosamil to suckling rats from post-natal day 7 to 20 was well tolerated at plasma exposures approximately 2-fold higher than those for paediatric patients.
Intravenska bolus doza ceftarolinfosamila primijenjena u dojene mladunčadi štakora od 7. do 20. dana nakon rođenja bila je dobro podnošena pri izloženostima u plazmi približno 2 puta većima nego u pedijatrijskih bolesnika.
• If you have had previous severe allergic reactions to other antibiotics like penicillin or carbapenem.
• ako ste ranije imali ozbiljne alergijske reakcije na druge antibiotike poput penicilina ili karbapenema.
It is free of any particles.
Otopina ne sadrži čestice.
If you use more Zinforo than you should If you think you have been given too much Zinforo, tell your doctor or nurse straight away.
Ako primite više lijeka Zinforo nego što ste trebali Ako mislite da ste možda primili preveliku dozu lijeka Zinforo, odmah o tome obavijestite liječnika ili medicinsku sestru.
After reconstitution, 1 mL of the solution contains 30 mg of ceftaroline fosamil.
Nakon rekonstitucije, 1 ml otopine sadrži 30 mg ceftarolinfosamila.
Convulsions have been observed at relatively high exposures during single and multi-dose studies in both the rat and monkey (≥ 7 times to the estimated ceftaroline Cmax level of a 600 mg twice a day).
Konvulzije su zabilježene i u štakora i u majmuna tijekom istraživanja s primjenom jedne i više doza pri relativno visokim izloženostima (≥ 7 puta većima od procijenjene razine Cmax ceftarolina od 600 mg dvaput na dan).
Therefore, no dosage adjustment is recommended for patients with hepatic impairment.
Stoga se ne preporučuje prilagodba doziranja u bolesnika s oštećenjem jetre.
• Redness, pain or swelling where the injection was given.
• crvenilo, bol ili oticanje na mjestu injekcije.
If you are not sure, talk to your doctor or nurse before using Zinforo.
Ako niste sigurni, porazgovarajte s liječnikom ili medicinskom sestrom prije nego uzmete Zinforo.
Hepatic impairment No dosage adjustment is considered necessary in patients with hepatic impairment (see section 5.2).
Ne smatra se potrebnim prilagođavati dozu u bolesnika s oštećenjem jetre (vidjeti dio 5.2).
Zinforo powder should be reconstituted with 20 mL of sterile water for injections.
Zinforo prašak se mora rekonstituirati s 20 ml sterilne vode za injekcije.
Amount to be withdrawn
Količina koju treba uvući
Talk to your doctor or nurse before using Zinforo:
Obratite se svom liječniku ili medicinskoj sestri prije nego primite Zinforo:
600 mg b/every 12 hours
600 mg b/svakih 12 sati
Anaerobic micro-organisms Gram-positive micro-organisms
Anaerobni mikroorganizmi Gram-pozitivni mikroorganizmi
Agranulocytosis, eosinophilia
Agranulocitoza, eozinofilija
≥ 15 to ≤ 30 300 mg ESRD, including haemodialysis
≥ 15 do ≤ 30 300 mg završna faza bubrežne bolesti, uključujući hemodijalizu
Gram-positive micro-organisms
Gram-pozitivni mikroorganizmi
What Zinforo is used for
Za što se koristi Zinforo
Do not use this medicine after the expiry date which is stated on the container.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na spremniku iza oznake „EXP“.
Zinforo dose adjustment is not required in elderly patients with creatinine clearance above 50 mL/min.
Nije potrebna prilagodba doze lijeka Zinforo u starijih bolesnika s klirensom kreatinina iznad 50 ml/min.
• An increase in the number of certain white blood cells in your blood (eosinophilia).
• povišen broj određenih bijelih krvnih stanica u Vašoj krvi (eozinofilija).
Renal clearance of ceftaroline is approximately equal, or slightly lower than the glomerular filtration rate in the kidney, and in vitro transporter studies indicate that active secretion does not contribute to the renal elimination of ceftaroline.
Bubrežni klirens ceftarolina je približno jednak, ili nešto manji od brzine glomerularne filtracije u bubrezima, a ispitivanja prijenosnika in vitro pokazuju da aktivna sekrecija ne pridonosi eliminaciji ceftarolina bubrezima.
The reconstituted solution is a pale yellow solution that is free of any particles.
Rekonstituirana otopina je blijedožuta otopina koja ne sadrži čestice.
Seizures have occurred in toxicology studies at 7-25 times human ceftaroline Cmax levels (see section 5.3).
Napadaji su zabilježeni u toksikološkim ispitivanjima pri razinama Cmax ceftarolina koje su bile 7-25 puta više od razina u ljudi (vidjeti dio 5.3).
S. aureus with ceftaroline MICs ≥ 4 mg/L are rare.
S. aureus kod kojeg je MIK ≥ 4 mg/l je rijedak.
• Diarrhoea, stomach pain
• proljev, bolovi u trbuhu
20 mL glass vial (Type 1) closed with a rubber (halobutyl) stopper and aluminium seal with flip-off cap.
Staklena bočica od 20 ml (tipa 1), zatvorena gumenim (halobutilnim) čepom i aluminijskim zaštitnim prstenom s "flip-off"zatvaračem.
It is unknown whether ceftaroline fosamil or ceftaroline is excreted in human milk.
Nije poznato izlučuju li se ceftarolinfosamil ili ceftarolin u majčino mlijeko.
Important: Please refer to the Summary of Product Characteristics before prescribing.
Važno: Prije propisivanja pročitajte sažetak opisa svojstava lijeka.
The contents of Zinforo vial should be reconstituted with 20 mL of sterile water for injections.
Sadržaj bočice lijeka Zinforo mora se rekonstituirati s 20 ml sterilne vode za injekcije.
Ceftaroline should be used with caution in patients with a history of non-severe hypersensitivity reactions to any other beta-lactam antibiotics (e.g. penicillins or carbapenems).
Ceftarolin je potrebno koristiti s oprezom u bolesnika koji su imali reakcije preosjetljivosti, koje nisu bile teške, na bilo koje druge beta-laktamske antibiotioke (npr. peniciline ili karbapeneme).
Pharmacokinetic/pharmacodynamic relationship
Farmakokinetički/farmakodinamički odnos(i)
Following the administration of a single 600 mg intravenous dose of radiolabelled ceftaroline fosamil to healthy male adults, approximately 88% of radioactivity was recovered in urine and 6% in faeces.
Nakon primjene jedne intravenske doze od 600 mg radioaktivno označenog ceftarolin fosamila u zdravih odraslih muškaraca, približno 88% radioaktivnosti nađeno je u mokraći, a 6% u fecesu.
Clostridium difficile colitis (see section 4.4)
Kolitis uzrokovan bakterijom Clostridium difficile (vidjeti dio 4.4)
The bactericidal action of ceftaroline is mediated through binding to essential penicillinbinding proteins (PBPs).
Baktericidno djelovanje ceftarolina posredovano je vezanjem na ključne proteine koji vežu penicilin (engl. penicillin-binding proteins, PBP).
The recommended dosages of Zinforo shown in Tables 1 to 4 for the treatment of cSSTI caused by S. aureus with ceftaroline MIC of 2 or 4 mg/L are based on pharmacokineticpharmacodynamic modelling and simulation (see sections 4.2 and 5.1).
Preporučeno doziranje lijeka Zinforo, prikazano u Tablicama 1 do 4 za liječenje komplicirane infekcije kože i mekog tkiva čiji je uzročnik S. aureus, kod kojeg je MIK ceftarolina 2 ili 4 mg/l je temeljeno na farmakokinetičkomfarmakodinamičkom modeliranju i simulacijama (vidjeti dijelove 4.2 i 5.1).
Immediate and severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or carbapenems).
Trenutna i teška preosjetljivost (npr. anafilaktička reakcija) na bilo koju drugu vrstu beta-laktamskih antibiotika (npr. peniciline ili karbapeneme).
There is no experience with ceftaroline in the treatment of cSSTI in the following patient groups: the immunocompromised, patients with severe sepsis/septic shock, necrotizing fasciitis, perirectal abscess and patients with third degree and extensive burns.
Nema iskustva s primjenom ceftarolina u liječenju infekcija kože i mekog tkiva u sljedećih skupina bolesnika: u imunokompromitiranih bolesnika, bolesnika s teškom sepsom/septičkim šokom, bolesnika s nekrotizirajućim fasciitisom, perirektalnim apscesom, bolesnika s opeklinama trećeg stupnja ili opsežnim opeklinama.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftaroline fosamil (see section 4.8).
Stoga je važno da se u bolesnika u kojih se tijekom ili nakon primjene ceftarolinfosamila pojavi proljev uzme u obzir i ova dijagnoza (vidjeti dio 4.8).
Following administration of a single 600 mg intravenous dose of ceftaroline fosamil, the pharmacokinetics of ceftaroline were similar between healthy elderly subjects (≥ 65 years of age), and healthy young adult subjects (18-45 years of age).
Nakon primjene jedne intravenske doze od 600 mg ceftarolinfosamila, farmakokinetika ceftarolina bila je podjednaka u zdravih starijih ispitanika (≥ 65 godina) i zdravih mladih odraslih ispitanika
The mean plasma ceftaroline M-1 to ceftaroline AUC ratio following a single 600 mg intravenous infusion of ceftaroline fosamil in healthy subjects is approximately 20-30%.
Srednja vrijednost omjera AUC-a ceftarolina M-1 i ceftarolina u plazmi nakon jedne intravenske infuzije ceftarolin fosamila od 600 mg u zdravih ispitanika iznosi približno 20-30%.
What Zinforo contains
Što Zinforo sadrži
Adolescents aged from 12 to < 18 years with bodyweight ≥ 33 kg
Adolescenti u dobi od 12 do < 18 godina, tjelesne težine ≥ 33 kg
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before using Zinforo.
Ako se nešto od navedenog odnosi na Vas (ili niste sigurni), porazgovarajte s liječnikom ili medicinskom sestrom prije nego uzmete Zinforo.
400 mg c/every 12 hours
400 mg c/svakih 12 sati
A pale yellowish-white to light yellow powder.
Blijedožućkasto-bijeli do svijetložuti prašak.
Each vial contains ceftaroline fosamil acetic acid solvate monohydrate equivalent to 600 mg ceftaroline fosamil.
Jedna bočica sadrži ceftarolinfosamil solvat acetatne kiseline hidrat što odgovara 600 mg ceftarolinfosamila.
This may be because the level of platelets in your blood has dropped.
Razlog tomu može biti sniženje razine trombocita u krvi.
Patients with pre-existing seizure disorder
Bolesnici s postojećim poremećajima s napadajima
The safety assessment in paediatric patients is based on the safety data from 2 trials in which 227 patients aged from 2 months to 17 years with cSSTI or CAP received Zinforo.
Ocjena sigurnosti primjene u pedijatrijskih bolesnika temelji se na podacima o sigurnosti primjene iz 2 ispitivanja u kojima je lijek Zinforo primijenjen u 227 bolesnika u dobi od navršena 2 mjeseca do 17 godina, koji su imali komplicirane infekcije kože i mekog tkiva ili izvanbolnički stečenu pneumoniju.
The median steady-state volume of distribution of ceftaroline in healthy adult males following a single 600 mg intravenous dose of radiolabelled ceftaroline fosamil was 20.3 l, similar to the volume of extracellular fluid.
Medijan volumena distribucije ceftarolina u stanju dinamičke ravnoteže u zdravih odraslih muškaraca nakon jedne intravenske doze od 600 mg radioaktivno označenog ceftarolinfosamila iznosio je 20,3 l, što je podjednako volumenu izvanstanične tekućine.
Children and adolescents aged from ≥ 2 years to < 18 years
Djeca i adolescenti u dobi od ≥ 2 godine do < 18 godina