FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Id-dilwenti li jistgħu jintużaw jinkludu: sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni, dextrose 50 mg/mL (5%) soluzzjoni għall-injezzjoni, sodium chloride 4.5 mg/mL u dextrose 25 mg/mL soluzzjoni għall-injezzjoni (0.45% sodium chloride u 25% dextrose) jew soluzzjoni Lactated Ringer.
English: It is available in packs containing 10 vials.
Maltese: Jiġi f'pakketti li jkun fihom 10 kunjetti.
English: Table 5 Frequency of adverse reactions by system organ class from clinical trials and post marketing experience
Maltese: Tabella 5 Frekwenza tar-reazzjonijiet avversi skont is-sistema tal-klassifika tal-organi millprovi kliniċi u l-esperjenza ta' wara t-tqegħid fis-suq
English: Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva Reazzjonijiet serji u kultant fatali ta' sensittività eċċessiva huma possibbli (ara sezzjoni 4.3 u 4.8).
English: 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).
Maltese: Wara li ngħatat doża waħda ta' 600 mg ceftaroline fosamil minn ġol-vina, il-farmakokinetika ta' ceftaroline kienet simili bejn anzjani b'saħħithom (età ≥ 65 sena), u individwi adulti żgħar b'saħħithom (etajiet ta' 18-45 sena).
English: Zinforo is administered by intravenous infusion over 5 to 60 minutes for standard dose or 120 minutes for high dose (for cSSTI caused by S. aureus with MIC of 2 or 4 mg/L to ceftaroline) in infusion volumes of 50 mL, 100 mL or 250 mL (see section 6.6).
Maltese: Zinforo għandu jingħata permezz ta' infużjoni fil-vini fuq 5 sa 60 minuta għal doża standard jew 120 minuta għal doża għolja (għal cSSTI kkawżati minn S. aureus b'MIC ta' 2 jew 4 mg/L għal ceftaroline) f'volumi tal-infużjoni ta' 50 mL, 100 mL jew 250 mL (ara sezzjoni 6.6).
English: • Complicated skin and soft tissue infections (cSSTI) • Community-acquired pneumonia (CAP)
Maltese: • Pnewmonja li tkun ittieħdet mill-komunità (Community- acquired pneumonia, CAP)
English: After reconstitution, 1 mL of the solution contains 30 mg of ceftaroline fosamil.
Maltese: Wara r-rikostituzzjoni, 1 mL tas-soluzzjoni jkun fiha 30 mg ceftaroline fosamil.
English: ACS Dobfar S.p.A. Nucleo Industriale S. Atto 64100 Teramo Italy
Maltese: Atto 64100 Teramo L-Italja
English: The interaction potential of ceftaroline or ceftaroline fosamil on medicinal products metabolised by CYP450 enzymes is expected to be low since they are not inhibitors nor inducers of CYP450 enzymes in vitro.
Maltese: Il-potenzjal ta' interazzjoni ta' ceftaroline jew ceftaroline fosamil fuq prodotti mediċinali metabolizzati permezz ta' enzimi CYP450 huwa mistenni li jkun baxx minħabba li la huma inibituri u lanqas indutturi tal-enzimi CYP450 in vitro.
English: The incidence of DAGT seroconversion in patients receiving ceftaroline fosamil was 11.2% in the five pooled pivotal studies with administration every 12 hours (600 mg administered over 60 minutes every 12 hours) and 32.3% in a study in patients receiving ceftaroline fosamil every 8 hours (600 mg administered over 120 minutes every 8 hours), (see section 4.8).
Maltese: L-inċidenza ta' serokonverżjoni DAGT f'pazjenti li jkunu qed jirċievu ceftaroline fosamil kienet ta' 11.2% fil-ħames studji pivitali miġbura b'għoti kull 12-il siegħa (600 mg mogħtija fuq perjodu ta' 60 minuta kull 12-il siegħa) u 32.3% fi studju f'pazjenti li kienu qegħdin jirċievu ceftaroline fosamil kull 8 sigħat (600 mg mogħtija fuq perjodu ta' 120 minuta kull 8 sigħat), (ara sezzjoni 4.8).
English: 12 mg/kg to a maximum of 600 mg
Maltese: 12 mg/kg sa massimu ta' 600 mg
English: 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).
Maltese: Id-dożaġġi rrakkomandati ta' Zinforo murija f'Tabelli 1 sa 4 għat-trattament ta' cSSTI kkawżata minn S. aureus b'MIC ta' ceftaroline ta' 2 jew 4 mg/L huma bbażati fuq l-immudellar u s-simulazzjoni farmakokinetiċi-farmakodinamiċi (ara sezzjonijiet 4.2 u 5.1).
English: Clostridium difficile-associated diarrhoea
Maltese: Dijarea assoċjata ma' Clostridium difficile
English: The resulting solution should be shaken prior to being transferred to an infusion bag or bottle containing either 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.
Maltese: Is-soluzzjoni li tifforma trid titħawwad qabel ma tiġi trasferita fil-borża jew il-flixkun tal-infużjoni li jkun fih jew sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni, dextrose 50 mg/mL (5%) soluzzjoni għall-injezzjoni, sodium chloride 4.5 mg/mL u dextrose 25 mg/mL soluzzjoni għall-injezzjoni (0.45% sodium chloride u 2.5% dextrose) jew soluzzjoni Lactated Ringer.
English: Adolescents aged from 12 to < 18 years with bodyweight ≥ 33 kg
Maltese: Adolexxenti minn 12 sa < 18-il sena b'piż tal-ġisem ≥ 33 kg
English: High dose cSSTI confirmed or suspected to be caused by S. aureus with an MIC = 2 mg/L or 4 mg/L to ceftaroline
Maltese: Doża għolja cSSTI ikkonfermati jew suspettati li huma kkawżati minn S. aureus b'MIC = 2 mg/L jew 4 mg/L għal ceftaroline
English: Do not use Zinforo:
Maltese: Wara li jiġi dilwit:
English: Table 3 Dosage in adults with impaired renal function, creatinine clearance (CrCL)
Maltese: Tabella 3 Dożaġġ f'adulti b'funzjoni renali indebolita, tneħħija tal-kreatinina (CrCL)
English: The medicinal product is supplied in packs of 10 vials.
Maltese: Dan il-prodott mediċinali jiġi f'pakketti ta' 10 kunjetti.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti għas-sottomissjoni ta' rapporti perjodiċi aġġornati dwar is-sigurtà għal dan ilprodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Direct antiglobulin test (Coombs test) seroconversion and potential risk of haemolytic anaemia The development of a positive direct antiglobulin test (DAGT) may occur during treatment with cephalosporins.
Maltese: Test dirett antiglobulina (Test Coombs) serokonverżjoni u riskju potenzjali ta' anemija emolitika
English: Clostridium difficile colitis (see section 4.4)
Maltese: Test Dirett ta' Coombs Pożittiv (ara sezzjoni 4.4)
English: 8 mg/kg b/every 8 hours
Maltese: 8 mg/kg b/kull 8 sigħat
English: Adverse reactions are classified according to System Organ Class and frequency.
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont is-Sistema tal-Klassifika tal-Organi u l-frekwenza.
English: Hepatic impairment No dosage adjustment is considered necessary in patients with hepatic impairment (see section 5.2).
Maltese: Indeboliment epatiku Mhux meqjus li hemm bżonn ta' tibdil tad-doża f'pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: Overall, the safety profile in these 227 patients was similar to that observed in the adult population.
Maltese: B'mod ġenerali, il-profil tas-sigurtà f'dawn il-227 pazjent kien simili għal dak osservat fil-popolazzjoni adulta.
English: After dilution:
Maltese: Tużax Zinforo:
English: A greater incidence of rash in Asian patients (see below) and a greater incidence of DAGT seroconversion (see section 4.4) were observed in a study of adult patients with cSSTI conducted with Zinforo 600 mg administered over 120 minutes every 8 hours.
Maltese: Inċidenza ikbar ta' raxx f'pazjenti Asjatiċi (ara taħt) u inċidenza ikbar ta' serokonverżjoni ta' DAGT (ara sezzjoni 4.4) ġew osservati fi studju ta' pazjenti adulti b'cSSTI mwettqa b'Zinforo 600 mg mogħtija fuq 120 minuta kull 8 sigħat.
English: 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.
Maltese: Is-soluzzjoni li tifforma trid tingħata skont id-doża magħżula fuq perjodu ta' 5 sa 60 minuta għal doża standard jew 120 minuta għal doża għolja fil-volumi tal-infużjoni ta' 50 mL, 100 mL jew 250 mL.
English: Zinforo 600 mg powder for concentrate ceftaroline fosamil
Maltese: Zinforo 600 mg trab għal konċentrat ceftaroline fosamil IV
English: Dose is based on CrCL.
Maltese: Id-doża hija bbażata fuq CrCL.
English: Ceftaroline is primarily eliminated by the kidneys.
Maltese: Ceftaroline huwa eliminat prinċipalment mill-kliewi.
English: Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems, ATC code: J01DI02
Maltese: Antibatteriċi għall-użu sistemiku, cephalosporins oħrajn u penems, Kodiċi ATC:
English: Creatinine clearance (mL/min)
Maltese: Tneħħija talkreatinina (mL/min)
English: 12 mg/kg to a maximum of 400 mg b/every 8 hours
Maltese: 12 mg/kg sa massimu ta' 400 mg b/kull 8 sigħat
English: Immediate and severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or carbapenems).
Maltese: Sensittività eċċessiva immedjata u severa (eż. reazzjoni anafilattika) għal kwalunkwe tip ieħor ta' sustanza antibatterika beta-lactam (eż. penicillins jew carbapenems).
English: • Morganella morganii
Maltese: • Klebsiella oxytoca • Morganella morganii
English: 10 mg/kg to a maximum of 400 mg
Maltese: 10 mg/kg sa massimu ta' 400 mg
English: Gram-positive micro-organisms
Maltese: Mikro-organiżmi Gram-pożittivi
English: 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).
Maltese: Studji bijokimiċi wrew li ceftaroline għandu affinità kbira għal PBP2a ta' Staphylococcus aureus reżistenti għall-methicillin (MRSA) u PBP2x ta' Streptococcus pneumoniae mhux suxxettibli għall-penicillin (PNSP) minħabba l-affinità kbira li għandu għall-proteini alterati li jeħlu mal-penicillin (PBPs).
English: Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ring metabolite, ceftaroline M-1.
Maltese: Isseħħ idroliżi taċ-ċirku beta-lactam ta' ceftaroline biex jiġi ffurmat il-metabolit mikrobijoloġikament inattiv, b'ċirku miftuħ, ceftaroline M-1.
English: There are limited clinical trial data on the use of ceftaroline to treat cSSTI caused by S. aureus with an MIC of > 1 mg/L.
Maltese: Hemm data limitata tal-provi kliniċi dwar l-użu ta' ceftaroline għat-trattament ta' cSSTI kkawżata minn S. aureus b'MIC ta' > 1 mg/L.
English: 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.
Maltese: Ceftaroline fosamil u ceftaroline kienu klastoġeniċi f'assaġġ b'abberazzjoni kromosali in vitro, madankollu ma kienx hemm evidenza ta' attività mutaġenika f'assaġġ Ames, limfoma tal-ġurdien u sinteżi tad-DNA mhux skedati.
English: Pyrexia, infusion site reactions (erythema, phlebitis, pain)
Maltese: Deni, reazzjonijiet fissit tal-injezzjoni (eritema, flebite, uġigħ)
English: Infusion times of less than 60 minutes are based on pharmacokinetic and pharmacodynamic analyses only.
Maltese: Ħinijiet tal-infużjoni ta' inqas minn 60 minuta huma bbażati fuq l-analiżijiet farmakokinetiċi u farmakodinamiċi biss.
English: 120/every 8 hours
Maltese: 120/kull 8 sigħat
English: Children and adolescents aged from ≥ 2 years to < 18 years
Maltese: Adolexxenti u tfal minn ≥sentejn sa < 18 -il sena
English: Ceftaroline or ceftaroline fosamil are not metabolised by CYP450 enzymes in vitro, therefore co-administered CYP450 inducers or inhibitors are unlikely to influence the pharmacokinetics of ceftaroline.
Maltese: Ceftaroline jew ceftaroline fosamil mhumiex metabolizzati b'enzimi CYP450 in vitro, għalhekk l-għoti flimkien ta' indutturi jew inibituri ta' CYP450 mhux probabbli li jinfluwenza l-farmakokinetika ta' ceftaroline.
English: 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.
Maltese: L-aktar reazzjonijiet avversi komuni li seħħew f'≥ 3% ta' madwar 3242 pazjent trattati b'Zinforo fi studji kliniċi kienu dijarrea, uġigħ ta' ras, dardir u prurite, u ġeneralment kienu ħfief għal moderati fisseverità.
English: Interaction with other antibacterial agents
Maltese: Interazzjoni ma' sustanzi antibatteriċi oħra
English: 6 mg/kg to a maximum of 200 mg
Maltese: 6 mg/kg sa massimu ta' 200 mg
English: 8 mg/kg to a maximum of 300 mg
Maltese: 8 mg/kg sa massimu ta' 300 mg
English: The mean terminal elimination half-life of ceftaroline in healthy adults is approximately 2.5 hours.
Maltese: Il-medja tal-half life tal-eliminazzjoni terminali ta' ceftaroline f'adulti b'saħħithom hija madwar 2.5 sigħat.
English: Clostridium difficile-associated disease (CDAD) and severe hypersensitivity reactions may also occur.
Maltese: Marda assoċjata ma' Clostridium difficile (Clostridium difficile-associated disease, CDAD) u reazzjonijiet ta' sensittività eċċessiva severa jistgħu jseħħu wkoll.
English: 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.
Maltese: Ceftaroline fosamil (promediċina) jiġi konvertit f'ceftaroline attiv fil-plażma permezz ta' enzimi fosfetejż u l-konċentrazzjonijiet tal-promediċina jistgħu jitkejlu fil-plażma prinċipalment waqt linfużjoni fil-vini.
English: 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.
Maltese: Il-volum ta' distribuzzjoni fiss medjan ta' ceftaroline f'irġiel adulti b'saħħithom wara doża waħda fil-vini ta' 600 mg ta' ceftaroline fosamil radjutikkettat kien ta' 20.3 l, simili għallvolum tal-fluwidu ekstraċellulari.
English: Resistant (R>)
Maltese: NUMRU(I)
English: 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.
Maltese: Il-valutazzjoni tas-sigurtà f'pazjenti pedjatriċi hija bbażata fuq id-data tas-sigurtà minn 2 provi li fihom 227 pazjent li kellhom minn xahrejn sa 17-il sena b'cSSTI jew CAP irċevew Zinforo.
English: Genetic toxicology
Maltese: GĦAMLA FARMAĊEWTIKA
English: There is no experience with ceftaroline in the treatment of CAP in the following patient groups: the immunocompromised, patients with severe sepsis/septic shock, severe underlying lung disease, those with PORT Risk Class V, and/or CAP requiring ventilation at presentation, CAP due to methicillinresistant S. aureus or patients requiring intensive care.
Maltese: M'hemmx esperjenza b'ceftaroline għat-trattament ta' CAP fil-gruppi ta' pazjenti li ġejjin: il-pazjenti immunokompromessi, pazjenti b'sepsi severa/xokk settiku, mard serju eżistenti fil-pulmun, dawk bi Klassi ta' Riskju PORT V, u/jew CAP li teħtieġ ventilazzjoni malli tippreżenta ruħha, CAP minħabba S. aureus reżistenti għal methicillin jew pazjenti li jkunu jeħtieġu trattament intensiv.
English: For treatment of S. aureus for which the ceftaroline MIC is ≤ 1 mg/L, the standard dose is recommended.
Maltese: Għat-trattament ta' S. aureus li l-MIC ta' ceftaroline tagħha hija ≤ 1 mg/L, hija rakkomandata d-doża standard.
English: Zinforo powder should be reconstituted with 20 mL of sterile water for injections.
Maltese: It-trab Zinforo jrid jiġi rikostitwit b'20 mL ilma għall-injezzjonijiet sterili.
English: • Each vial contains 600 mg of ceftaroline fosamil.
Maltese: • Kull kunjett fih 600 mg ta' ceftaroline fosamil.
English: There is limited experience in treating patients with diabetic foot infections.
Maltese: Hemm esperjenza limitata fit-trattament ta' pazjenti b'infezzjonijiet dijabetiċi fis-saqajn.
English: Animal studies with ceftaroline fosamil do not indicate harmful effects with respect to fertility (see section 5.3).
Maltese: Studji fl-annimali b'ceftaroline fosamil ma jindikawx effetti ta' ħsara fir-rigward tal-fertilità (ara sezzjoni 5.3).
English: Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ceftaroline fosamil.
Maltese: Pazjenti li fil-passat sofrew minn sensittività eċċessiva għal cephalosporins, penicillins jew antibatteriċi beta-lactam oħra jistgħu jkunu jsofru wkoll minn sensittività eċċessiva għal ceftaroline fosamil.
English: Histopathologic findings included pigment deposition and inflammation of the tubular epithelium.
Maltese: Is-sejbiet istopatoloġiċi kienu jinkludu depożitu tal-pigment u infjammazzjoni tal-epitilju tubulari.
English: Headache, dizziness
Maltese: Trabi ≥ xahrejn sa < sentejn
English: The plasma protein binding of ceftaroline is low (approximately 20%) and ceftaroline is not distributed into erythrocytes.
Maltese: L-irbit ta' ceftaroline mal-proteini tal-plażma huwa baxx (madwar 20%) u ceftaroline ma jiġix distribwit fl-eritroċiti.
English: Zinforo is used to treat children (from birth) and adults with:
Maltese: Zinforo jintuża biex jitratta tfal (mit-twelid) u adulti b':
English: Complicated skin and soft tissue infections
Maltese: • Infezzjonijiet ikkomplikati tal-ġilda u tat-tessuti rotob (Complicated skin and soft tissue infections,
English: Table 2 Dosage in paediatric patients with normal renal function, creatinine clearance (CrCL)
Maltese: Tabella 2 Dożaġġ f'pazjenti pedjatriċi b'funzjoni renali normali, tneħħijia tal-kreatinina
English: 8 mg/kg to a maximum of 300 mg c/every 8 hours
Maltese: 8 mg/kg sa massimu ta' 300 mg c/kull 8 sigħat
English: 60/every 8 hours
Maltese: 60/kull 8 sigħat
English: Paediatric population As with adults, the interaction potential is expected to be low in paediatrics.
Maltese: Bħal fl-adulti, il-potenzjal tal-interazzjoni huwa mistenni li jkun baxx fil-pedjatriċi.
English: Susceptibility testing breakpoints
Maltese: Breakpoints għall-ittestjar tas-suxxettibilità
English: Adolescents aged from 12 years to < 18 years bodyweight < 33 kg and children ≥ 2 years to < 12 years
Maltese: Adolexxenti minn 12-il sena sa < 18-il sena b'piż talġisem < 33 kg u tfal li jkollhom ≥ sentejn sa < 12il sena
English: Studies have shown that Zinforo solutions for infusion are stable for up to 6 hours at room temperature.
Maltese: Studji wrew li s-soluzzjonijiet għall-infużjoni ta' Zinforo huma stabbli sa 6 sigħat f'temperatura ambjentali.
English: • If you are allergic to other cephalosporin antibiotics
Maltese: • Jekk inti allerġiku għal antibijotiċi oħra ta' cephalosporin
English: It belongs to a group of medicines called ‘cephalosporin antibiotics.'
Maltese: Huwa jagħmel parti minn grupp ta' mediċini li jissejħu ‘antibijotiċi cephalosporin'.
English: How to use Zinforo
Maltese: X'inhu Zinforo
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Ceftaroline administration to pregnant rabbits resulted in an increased foetal incidence of angulated hyoid alae, a common skeletal variation in rabbit fetuses, at exposures similar to those observed clinically.
Maltese: L-għoti ta' ceftaroline lil fniek tqal irriżulta f'żieda fl-inċidenza ta' hyoid alae angulata fil-feti, varjazzjoni skeletali komuni fil-feti tal-fniek, b'esponimenti simili għal dawk osservati klinikament.
English: Juvenile toxicity
Maltese: Tossiċità fiż-żgħożija
English: Dosage adjustments are required in adults, adolescents and children with CrCL ≤ 50 mL/min (see section 4.2).
Maltese: Huwa meħtieġ tibdil fid-doża fl-adulti, l-adolexxenti u t-tfal b'CrCL ≥ ≤ 50 mL/min) (ara sezzjoni 4.2).
English: Overall, the adverse events reported in these studies were consistent with the known safety profile for Zinforo.
Maltese: B'mod ġenerali, l-episodji avversi rrapportati f'dawn l-istudji kienu konsistenti mal-profil tas-sigurtà magħruf għal Zinforo.
English: The recommended dosage of Zinforo shown in Table 2 for paediatric patients < 2 months of age are based on pharmacokinetic-pharmacodynamic modelling and simulation.
Maltese: Id-dożaġġ rakkomandat ta' Zinforo muri fit-Tabella 2 għal pazjenti pedjatriċi < xahrejn huwa bbażat fuq l-immudellar u s-simulazzjoni farmakokinetika-farmakodinamika.
English: Non-susceptible organisms Superinfections may occur during or following treatment with Zinforo.
Maltese: Organiżmi mhux suxxettibbli Jistgħu jseħħu superinfezzjonijiet waqt u wara t-trattament b'Zinforo.
English: The Cmax and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to 1000 mg. No appreciable accumulation of ceftaroline is observed following multiple intravenous infusions of 600 mg every 8 or 12 hours in healthy adults with CrCL > 50 mL/min.
Maltese: Ma deherx li kien hemm akkumulu sinifikanti ta' ceftaroline wara li ngħataw ħafna infużjonijiet fil-vina b'doża ta' 600 mg kull 8 sigħat jew 12-il siegħa f'adulti b'saħħithom b'CrCL > 50 mL/min.
English: In pooled human liver microsomes, metabolic turnover was low for ceftaroline, indicating that ceftaroline is not metabolised by hepatic CYP450 enzymes.
Maltese: F'mikrożomi miġbura mill-fwied tal-bniedem, it-tibdil metaboliku ta' ceftaroline kien baxx, li jindika li ceftaroline ma jiġix metabolizzat mill-enzimi CYP450 tal-fwied.
English: • Changes in a blood test called a ‘Coombs test' commonly seen in patients receiving this type of antibiotic.
Maltese: • Tibdil f'test tad-demm li jissejjaħ ‘Test ta' Coombs' li s-soltu jidher f'pazjenti li jkunu qed jirċievu dan it-tip ta' antibijotiku.
English: Infusion times of less than 60 minutes, neonatal and high dose recommendations are based on pharmacokinetic and pharmacodynamic analyses only.
Maltese: Ħinijiet tal-infużjoni ta' inqas minn 60 minuta, rakkomandazzjonijiet neonatali u ta' doża għolja huma bbażati fuq l-analiżijiet farmakokinetiċi u farmakodinamiċi biss.
English: You may experience fever, flu-like symptoms, sore throat, or any other infection which may be serious.
Maltese: Tista' tesperjenza deni, sintomi simili għal influwenza, uġigħ fil-gerżuma, jew kwalunkwe infezzjoni oħra li tista' tkun serja.
English: 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.
Maltese: Id-dożaġġ bolus mill-vina ta' ceftaroline fosamil lil firien tat-treddigħ minn jum 7 sa 20 ta' wara ttwelid kien tollerat sew f'esponimenti tal-plażma bejn wieħed u ieħor darbtejn aktar minn dawk għal pazjenti pedjatriċi.
English: Zinforo 600 mg powder for concentrate for solution for infusion ceftaroline fosamil
Maltese: Zinforo 600 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Ceftaroline fosamil