natgillin/translations-raw huggingface dataset:
Ceftaroline can be removed by haemodialysis; over a 4 hour dialysis period, approximately 74% of a given dose was recovered in the dialysate.
Ceftarolin je mogoče odstraniti s hemodializo; med 4-urno dializo se je v dializatu pojavilo približno 74 % danega odmerka.
Furthermore, in vivo micronucleus assays in rat and mouse were negative.
Poleg tega so bili mikrojedrni preizkusi pri podganah in miših in vivo negativni.
Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Preobčutljivostne reakcije Možne so resne preobčutljivostne reakcije, občasno s smrtnim izidom (glejte poglavji 4.3 in 4.8).
In clinical studies there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
V kliničnih študijah ni bilo znakov hemolize pri bolnikih, pri katerih se je med zdravljenjem razvil pozitiven DAGT.
In addition, the safety assessment in neonates is based on the safety data from 2 trials in which 34 patients (age range from birth to less than 60 days) received Zinforo; 23 of these patients received only a single dose of Zinforo.
Dodatno ocena varnosti pri novorojenčkih temelji na podatkih o varnosti iz 2 preskušanj, v katerih je zdravilo Zinforo prejemalo 34 bolnikov (starostni razpon od rojstva do manj kot 60 dni); 23 od teh bolnikov je prejelo samo en odmerek zdravila Zinforo.
The colour of Zinforo infusion solutions ranges from clear, light to dark yellow depending on the concentration and storage conditions.
Barva raztopine za infundiranje Zinforo sega od bistre, svetle do temno rumene, odvisno od koncentracije in pogojev shranjevanja.
The compatibility of Zinforo with other medicines has not been established.
Kompatibilnost zdravila Zinforo z drugimi zdravili ni ugotovljena.
As a precautionary measure, it is preferable to avoid the use of Zinforo during pregnancy unless the clinical condition of the woman requires treatment with an antibiotic with Zinforo's antibacterial profile.
Zaradi previdnosti se je zdravilu Zinforo med nosečnostjo bolje izogniti, razen če klinično stanje ženske zahteva zdravljenje z antibiotikom, ki ima takšen protibakterijski profil kot zdravilo Zinforo.
Zinforo will be given to you by a doctor or nurse.
Zdravilo Zinforo vam bo dal zdravnik ali medicinska sestra.
The infusion solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline fosamil.
Koncentracija raztopine za infundiranje med pripravo in dajanjem ne sme presegati 12 mg/ml fosamilceftarolina.
The medicinal product is supplied in packs of 10 vials.
Zdravilo je pakirano v pakiranje z 10 vialami.
A 250 mL, 100 mL or 50 mL infusion bag can be used to prepare the infusion, based on the patient's volume requirements.
Za pripravo infuzije se lahko uporabi 250 ml, 100 ml ali 50 ml infuzijsko vrečko, odvisno od bolnikovih zahtev glede infundiranega volumna.
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).
Biokemijske študije so pokazale, da ima ceftarolin visoko afiniteto za PBP2a proti meticilin odpornemu Staphylococcus aureus (MRSA - methicillin-resistant Staphylococcus aureus) in PBP2x za penicilin neobčutljivega Streptococcus pneumoniae (PNSPpenicillin non-susceptible Streptococcus pneumoniae).
Calculated using the Schwartz formula for paediatric patients (in mL/min/1.73 m
Izračunano z uporabo Schwartzove formule za pediatrične bolnike (v ml/min/1,73 m2).
Therefore, these findings were not considered to be adverse.
Zato teh izsledkov niso uvrstili med neželene.
Histopathologic findings included pigment deposition and inflammation of the tubular epithelium.
Med histopatološkimi izsledki so bili odlaganje pigmenta in vnetje tubulnega epitelija.
For patients with supranormal renal clearance receiving the standard dose, an infusion time of 60 minutes may be preferable.
Pri bolnikih z ledvičnim očistkom nad normalno vrednostjo, ki prejemajo običajni odmerek, je bolj primeren 60 minutni čas infundiranja.
Table 5 Frequency of adverse reactions by system organ class from clinical trials and post marketing experience
Preglednica 5 Pogostnost neželenih učinkov iz kliničnih preskušanj in izkušenj v obdobju trženja po organskih sistemih
In vitro data indicate that the following species are not susceptible to ceftaroline:
Podatki in vitro kažejo, da naslednje vrste niso občutljive za ceftarolin:
However, the possibility that haemolytic anaemia may occur in association with cephalosporins including Zinforo treatment cannot be ruled out.
Vendar možnosti pojava hemolitične anemije v povezavi s cefalosporini, vključno z zdravilom Zinforo, ni mogoče izključiti.
Ceftaroline is neither a substrate, nor an inhibitor of renal uptake transporters (OCT2, OAT1, and OAT3) in vitro.
Ceftarolin in vitro ni ne substrat ne zaviralec ledvičnih privzemnih prenašalcev (OCT2, OAT1 in OAT3).
Volume of diluent to be added (mL)
Količina vehikla, ki ga je treba dodati (ml)
• Changes in tests which measure how well your blood clots.
• spremembe izvidov preiskav, ki merijo sposobnost strjevanja krvi
Animal studies with ceftaroline fosamil do not indicate harmful effects with respect to fertility (see section 5.3).
Študije s fosamilceftarolinom na živalih ne kažejo škodljivih učinkov na plodnost (glejte poglavje 5.3).
Do not use Zinforo:
Ne uporabljajte zdravila Zinforo:
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:
Klinična učinkovitost ni ugotovljena proti naslednjim patogenom, čeprav so študije in vitro nakazovale, da so občutljivi za ceftarolin, če ni pridobljenih mehanizmov odpornosti:
Dose recommendations for neonates, infants and children and adolescents are based on pharmacokinetic (PK) modelling.
Priporočila za odmerjanje pri novorojenčkih, dojenčkih, otrocih in mladostnikih temeljijo na farmakokinetičnem modeliranju.
Renal cortical cysts were oberved in all groups, including controls, on PND50.
Na PND50 so opažali ledvične kortikalne ciste v vseh skupinah, vključno s kontrolnimi živalmi.
The most common adverse reactions occurring in ≥ 3% of approximately 3242 patients treated with Zinforo in clinical studies were diarrhoea, headache, nausea, and pruritus, and were generally mild or moderate in severity.
Najpogostejši neželeni učinki, ki so se pojavili pri ≥ 3 % od približno 3242 bolnikov, ki so bili v kliničnih študijah zdravljeni z zdravilom Zinforo, so bili driska, glavobol, navzea in srbenje.
S. aureus with ceftaroline MICs ≥ 4 mg/L are rare.
S. aureus z MIK ceftarolina ≥ 4 mg/l so redki.
Posology (mg/infusion)
Odmerjanje (mg/infuzijo)
It is given as a drip into a vein lasting 5 to 60 minutes if you receive the usual dose or 120 minutes if you receive an increased dose.
Zdravilo se daje s kapljično infuzijo v veno v obdobju od 5 do 60 minut, če prejmete običajni odmerek, ali 120 minut, če prejmete večji odmerek.
If you have kidney problems your doctor may lower your dose because Zinforo is removed from your body by the kidneys.
Če imate težave z ledvicami, vam bo zdravnik morda zmanjšal odmerek, ker se zdravilo Zinforo izloči iz telesa preko ledvic.
• If you are allergic to other cephalosporin antibiotics
• če ste alergični na druge cefalosporinske antibiotike,
What Zinforo is and what it is used for
Kaj je zdravilo Zinforo in za kaj ga uporabljamo
A course of treatment usually lasts for 5 to 14 days for skin infections and 5 to 7 days for pneumonia.
Zdravljenje po navadi traja od 5 do 14 dni pri okužbah kože in od 5 do 7 dni pri pljučnici.
Limited data in patients receiving higher than recommended Zinforo dosages show similar adverse reactions as observed in the patients receiving recommended dosages.
Maloštevilni podatki pri bolnikih, ki so prejeli večje odmerke zdravila Zinforo kot so priporočeni, kažejo podobne neželene učinke kot so bili opaženi pri bolnikih, zdravljenih s priporočenimi odmerki.
However, when ceftaroline was administered throughout pregnancy and lactation, there was no effect on pup weight or growth.
Če pa je bil ceftarolin uporabljan med celotno nosečnostjo in dojenjem, niso opazili vpliva na telesno maso ali rast mladičev.
It is unknown whether ceftaroline fosamil or ceftaroline is excreted in human milk.
Ni znano, ali se fosamilceftarolin ali ceftarolin pri človeku izloča v materino mleko.
Infer susceptibility from susceptibility to benzylpenicillin.
Na občutljivost je treba sklepati na podlagi občutljivosti za benzilpenicilin.
Creatinine clearance (mL/min)
Očistek kreatinina (ml/min)
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).
Študije in vitro niso pokazale antagonizma med ceftarolinom v kombinaciji z drugimi pogosto uporabljanimi antibiotiki (npr. z amikacinom, azitromicinom, aztreonamom, daptomicinom, levofloksacinom, linezolidom, meropenemom, tigeciklinom in vankomicinom).
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.
Po uporabi enkratnega intravenskega odmerka 600 mg radioaktivno označenega fosamilceftarolina pri zdravih odraslih moških se je približno 88 % radioaktivnosti pojavilo v urinu in 6 % v blatu.
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).
Po uporabi enkratnega intravenskega odmerka 600 mg fosamilceftarolina je bila farmakokinetika ceftarolina pri zdravih starejših preiskovancih (≥ 65 let) podobna kot pri zdravih mladih odraslih (18 - 45 let).
You may develop an abnormal lab test (called Coombs test) that looks for certain antibodies which may act against your red blood cells.
Pojavi se vam lahko nenormalen izvid določene laboratorijske preiskave (imenujemo jo Coombsov test); ta preiskava odkriva posebna protitelesa, ki lahko delujejo proti rdečim krvnim celicam.
Resistance may also be mediated by bacterial impermeability or drug efflux pump mechanisms.
Odpornost je prav tako lahko posledica bakterijske neprepustnosti ali mehanizmov izlivnih črpalk za izplavljanje zdravila.
Ceftaroline is primarily eliminated by the kidneys.
Ceftarolin se izloči predvsem skozi ledvice.
How Zinforo works Zinforo works by killing certain bacteria, which can cause serious infections.
Kako deluje zdravilo Zinforo Zdravilo Zinforo deluje tako, da uničuje določene bakterije, ki lahko povzročijo hude okužbe.
Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults(see sections 4.4 and 5.1):
Zdravilo Zinforo je indicirano pri novorojenčkih, dojenčkih, otrocih, mladostnikih in odraslih za zdravljenje naslednjih okužb (glejte poglavji 4.4 in 5.1):
The available clinical data cannot substantiate efficacy against penicillin non-susceptible strains of S. pneumoniae.
Klinični podatki, ki so na voljo, ne dokazujejo učinkovitosti proti sevom S. pneumoniae, neobčutljivim za penicilin.
Patients experiencing anaemia during or after treatment with Zinforo should be investigated for this possibility.
Zato je treba bolnike, pri katerih se med zdravljenjem z zdravilom Zinforo ali po njem pojavi anemija, pregledati glede te možnosti.
Instructions for the reconstitution of Zinforo vial are summarized below:
Navodila za pripravo viale zdravila Zinforo so povzeta spodaj:
400 mg c/every 12 hours
400 mg c/vsakih 12 ur
Standard aseptic techniques should be used for solution preparation and administration.
Za pripravo in dajanje raztopine je treba uporabiti standardne aseptične postopke.
Once removed from refrigeration to room temperature, the diluted product must be used within 6 hours.
Ko je razredčeno zdravilo enkrat vzeto iz hladilnika in dano na sobno temperaturo, ga je treba uporabiti v 6 urah.
Your doctor may increase your dose to 600 mg every 8 hours for some infections.
Pri nekaterih okužbah lahko zdravnik odmerek poveča na 600 mg na 8 ur.
However, the frequency of rash in the subgroup of Asian patients receiving Zinforo every 8 hours was very common (18.5%).
V podskupini azijskih bolnikov, zdravljenih z zdravilom Zinforo na 8 ur, pa se je izpuščaj pojavil s pogostnostjo zelo pogosti (18,5 %).
The recommended dosage of Zinforo shown in Table 2 for paediatric patients < 2 months of age are based on pharmacokinetic-pharmacodynamic modelling and simulation.
Priporočeni odmerki zdravila Zinforo, prikazani v preglednici 2, za pediatrične bolnike stare < 2 meseca, temeljijo na farmakokinetično-farmakodinamičnem modeliranju in simulacijah.
Alternatively they are stable for up to 24 hours under refrigerated storage.
Če so shranjene v hladilniku, so stabilne do 24 ur.
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).
Zato je na to diagnozo treba pomisliti pri vseh bolnikih, ki se jim med uporabo fosamilceftarolina ali po njej pojavi driska (glejte poglavje 4.8).
Dose adjustments are required for neonates, infants, children and adolescents with bodyweight < 33 kg (see section 4.2).
Odmerek je treba prilagoditi pri novorojenčkih, dojenčkih, otrocih in mladostnikih s telesno maso < 33 kg (glejte poglavje 4.2).
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).
Zato bi morala biti minimalna inhibitorna koncentracija (MIK) ceftarolina za delež testiranih organizmov območju občutljivosti (glejte poglavje Odpornost, spodaj).
Anaemia, leucopenia, neutropenia, thrombocytopenia, prothrombin time (PT) prolonged, activated partial thromboplastin time (aPTT) prolonged, international normalized ratio (INR) increased
Bolezni krvi in limfatičnega sistema anemija, levkopenija, nevtropenija, trombocitopenija, podaljšan protrombinski čas (PČ), podaljšan aktiviran parcialni tromboplastinski čas (aPTČ), povečanje mednarodnega umerjenega razmerja (INR)
It belongs to a group of medicines called ‘cephalosporin antibiotics.'
Spada v skupino zdravil, imenovanih cefalosporinski antibiotiki.
Clinical study experience with ceftaroline fosamil in patients with pre-existing seizure disorders is very limited.
Izkušenj iz kliničnih študij s fosamilceftarolinom pri bolnikih z obstoječo konvulzivno motnjo je zelo malo.
Seizures have occurred in toxicology studies at 7-25 times human ceftaroline Cmax levels (see section 5.3).
V toksikoloških študijah so se pri koncentracijah ceftarolina, ki so bile od 7- do 25-kratnik Cmax pri človeku, pojavile konvulzije (glejte poglavje 5.3).
10 mg/kg 120/every 8 hours
10 mg/kg 120/vsakih 8 ur
Zinforo is used to treat children (from birth) and adults with:
Za kaj uporabljamo zdravilo Zinforo Zdravilo Zinforo se uporablja za zdravljenje otrok (od rojstva) in odraslih z:
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 ni aktiven proti sevom Enterobacterales, ki tvorijo betalaktamaze razširjenega spektra (ESBL - extended-spectrum beta-lactamases) iz družin TEM, SHV in CTX-M, serinske karbapenemaze (npr. KPC), metalo-betalaktamaze skupine B ali skupino C (AmpC) cefalosporinaz.
The contents of Zinforo vial should be reconstituted with 20 mL of sterile water for injections.
Vsebino viale zdravila Zinforo je treba pripraviti z 20 ml sterilne vode za injekcije.
Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ceftaroline fosamil.
Bolniki z anamnezo preobčutljivosti za cefalosporine, peniciline ali druga betalaktamska zdravila za zdravljenje bakterijskih okužb so lahko preobčutljivi tudi na fosamilceftarolin.
The bactericidal action of ceftaroline is mediated through binding to essential penicillinbinding proteins (PBPs).
Ceftarolin deluje baktericidno z vezavo na esencialne penicilin vežoče beljakovine (PBPpenicillin binding proteins).
A pale yellowish-white to light yellow powder.
bledo rumenkastobel do svetlo rumen prašek
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).
Priporočeni odmerki zdravila Zinforo, prikazani v preglednicah 1-4, za zdravljenje zapletenih okužb kože in mehkih tkiv s S. aureus, pri katerih je MIK za ceftarolin od 2 do 4 mg/l, temeljijo na farmakokinetično-farmakodinamičnem modeliranju in simulacijah (glejte poglavji 4.2 in 5.1).
Dose is based on CrCL.
Odmerek temelji na očistku kreatinina.
How to use Zinforo
Kako uporabljati zdravilo Zinforo
• Staphylococcus aureus (including methicillin-resistant strains)
• Staphylococcus aureus (vključno s sevi, odpornimi proti meticilinu)
Parenteral drug products should be inspected visually for particulate matter prior to administration.
Zdravila za parenteralno uporabo je treba pred uporabo pregledati glede prisotnosti delcev.
The effects of ceftaroline fosamil on fertility on humans have not been studied.
Vpliv fosamilceftarolina na plodnost pri človeku ni raziskan.
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.
Fosamilceftarolin (predzdravilo) se v plazmi spremeni v aktivni ceftarolin z delovanjem fosfataz; koncentracija predzdravila je v plazmi merljiva predvsem med intravenskim infundiranjem.
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.
Ocena varnosti pri pediatričnih bolnikih temelji na podatkih o varnosti iz 2 preskušanj, v katerih je zdravilo Zinforo prejemalo 227 bolnikov, starih od 2 mesecev do 17 let, ki so imeli zapletene okužbe kože in mehkih tkiv oziroma zunajbolnišnično pljučnico.
Ceftaroline is a cephalosporin antibacterial with in vitro activity against Gram-positive and -negative bacteria.
Ceftarolin je cefalosporinski antibiotik z in vitro aktivnostjo proti Grampozitivnim in Gramnegativnim bakterijam.
• If you have ever had fits (seizures or convulsions)
• če ste kdaj imeli napad krčev (epileptični napad ali epileptične krče),
• an infection of the lungs called ‘pneumonia'
• okužbo pljuč, ki jo imenujemo pljučnica.
Other medicines and Zinforo Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo.
• Changes in a blood test called a ‘Coombs test' commonly seen in patients receiving this type of antibiotic.
• pri bolnikih, ki prejemajo to vrsto antibiotikov, je pogosta sprememba izvida preiskave krvi, imenovane "Coombsov test".
For treatment of S. aureus for which the ceftaroline MIC is ≤ 1 mg/L, the standard dose is recommended.
Za zdravljenje okužb s S. aureus, pri katerih je MIK ceftarolina ≤ 1 mg/l, je priporočen običajni odmerek.
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.
Ker v jetrih ni pomembne presnove ceftarolina, ni pričakovati, da bi okvara jeter bistveno prizadela sistemski očistek ceftarolina.
Store below 30°C.
Shranjujte pri temperaturi do 30°C.
Rash, pruritus Anaphylaxis, hypersensitivity (e.g. urticaria, lip and face swelling) (see sections 4.3 and 4.4)
Bolezni imunskega sistema izpuščaj, pruritus anafilaksija, preobčutljivost (npr. urtikarija, oteklina ustnic in obraza) (glejte poglavji 4.3 in 4.4)
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 odstranljivim pokrovčkom.
Diarrhoea, nausea, vomiting, abdominal pain
Bolezni prebavil driska, navzea, bruhanje, bolečine v trebuhu
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.
Če ste uporabili večji odmerek zdravila Zinforo, kot bi smeli Če menite, da ste dobili preveč zdravila Zinforo, to nemudoma povejte zdravniku ali medicinski sestri.
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).
Po uporabi med celotnim obdobjem brejosti in laktacije pri podganah ni bilo učinkov na porodno maso ali rast mladičev, čeprav so pri uporabi fosamilceftarolina med organogenezo opazili manjše spremembe v masi ploda in zapoznelo osifikacijo interparietalne kosti (glejte poglavje 5.3).
Clostridium difficile-associated diarrhoea
Driska, povezana s Clostridium difficile
Zinforo powder should be reconstituted with 20 mL of sterile water for injections.
Prašek Zinforo je treba pripraviti z 20 ml sterilne vode za injekcije.
• If you have had previous severe allergic reactions to other antibiotics like penicillin or carbapenem.
• če ste že imeli hudo alergijsko reakcijo na druge antibiotike, npr. penicilin, karbapenem.
Adolescents aged from 12 to < 18 years with bodyweight ≥ 33 kg
mladostniki, stari od 12 do < 18 let, s telesno maso ≥ 33 kg
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before using Zinforo.
Če kaj od naštetega velja za vas (ali če ste negotovi), se pred uporabo zdravila Zinforo posvetujte z zdravnikom ali medicinsko sestro.
• A significant decrease in the number of certain white blood cells in your blood
• zmanjšanje celotnega števila belih krvnih celic ali določene vrste belih krvnih celic v krvi
If you miss a dose of Zinforo If you think you have missed a dose, tell your doctor or nurse straight away.
Če ste izpustili odmerek zdravila Zinforo Če menite, da ste izpustili odmerek, morate to takoj povedati zdravniku ali medicinski sestri.
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).
Pri podganah in opicah so ob uporabi enkratnega in večkratnih odmerkov v študijah pri razmeroma veliki izpostavljenosti (≥ 7-kratnik ocenjene Cmax ceftarolina med uporabo 600 mg dvakrat na dan) opažali konvulzije.
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.
O zdravljenju zapletenih okužb kože in mehkih tkiv s ceftarolinom ni nobenih izkušenj pri naslednjih skupinah bolnikov: pri imunsko oslabelih bolnikih, bolnikih s hudo sepso/septičnim šokom, nekrotizirajočim fasciitisom, perirektalnim abscesom in pri bolnikih z obsežnimi opeklinami ali opeklinami tretje stopnje.
Clostridium difficile colitis (see section 4.4)
Infekcijske in parazitske bolezni kolitis zaradi Clostridium difficile (glejte poglavje 4.4)