FrancophonIA/ELRC3.0 huggingface dataset:
English: No synergy or antagonism was demonstrated in in vitro drug combination studies with ceftazidime/avibactam and metronidazole, tobramycin, levofloxacin, vancomycin, linezolid, colistin and tigecycline.
Maltese: La ntweriet sinerġija u lanqas intwera antagoniżmu fi studji ta' kombinament tal-mediċini in vitro b'ceftazidime/avibactam u metronidazole, tobramycin, levofloxacin, vancomycin, linezolid, colistin u tigecycline.
English: Immune system disorders
Maltese: Disturbi fissistema immuni
English: GlaxoSmithKline Manufacturing S.p.A VIA A. FLEMING, 2
Maltese: GlaxoSmithKline Manufacturing S.p.A VIA A.
English: After reconstitution, 1 mL of solution contains 167.3 mg of ceftazidime and 41.8 mg of avibactam (see section 6.6).
Maltese: Wara r-rikostituzzjoni, 1 mL ta' soluzzjoni fih 167.3 mg ta' ceftazidime u 41.8 mg ta' avibactam (ara sezzjoni 6.6).
English: Gammaglutamyltransferase increased
Maltese: Żieda fil-gammaglutamyltransferase
English: ANNEX I
Maltese: NUMRU(I)
English: 7-14 days
Maltese: 7-14-il jum
English: Rash maculopapular
Maltese: Raxx makulopapulari
English: Dosage strength ceftazidime/avibactam (mg)
Maltese: Qawwa tad-dożaġġ ceftazidime/avibactam (mg)
English: Haemolytic anaemia
Maltese: Anemija emolitika
English: Complicated UTI, including pyelonephritis
Maltese: UTI kkumplikata, inkluż il-pjelonefrite
English: • Complicated urinary tract infection (cUTI), including pyelonephritis
Maltese: • Infezzjoni Kkumplikata fl-Apparat tal-Awrina (cUTI), inkluż il-pjelonefrite
English: Deutschland Pfizer Pharma PFE GmbH Tel: +49 (0)800 8535555
Maltese: PFE GmbH Tel: +49 (0)800 8535555
English: Eosinophilia
Maltese: Eosinofilja
English: Zavicefta is an antibiotic medicine that contains two active substances ceftazidime and avibactam.
Maltese: Zavicefta huwa mediċina antibijotika li fiha żewġ sustanzi attivi ceftazidime u avibactam.
English: • a medicine for gout called probenecid
Maltese: • mediċina għall-gotta msejħa probenecid
English: 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.
Maltese: Dan jinibixxi kemm β-lactamases talklassi A Ambler u β-lactamases tal-klassi C u xi enzimi tal-klassi D, inkluż β-lactamases b'firxa estiża (extended-spectrum β-lactamases) (ESBLs), KPC u OXA-48 carbapenemases, u enzimi AmpC.
English: Uncommon Very rare
Maltese: Mhux komuni Rari ħafna
English: Adverse reactions are classified according to frequency and System Organ Class.
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont il-frekwenza u s-Sistema tal-Klassifika tal-Organi.
English: (CYPRUS BRANCH) Τηλ: +357 22 817690
Maltese: Τηλ: +357 22 817690
English: 0.75 g/0.1875 g Every 48 hours
Maltese: 0.75 g/0.1875 g
English: Coombs direct test positive
Maltese: Test dirett pożittiv ta' Coombs
English: • a type of antibiotic called an aminoglycoside - such as gentamicin, tobramycin
Maltese: • tip ta' antibijotiku msejjaħ aminoglycoside - bħal gentamicin, tobramycin
English: • abnormal result with a test called “DAGT” or “Coombs”.
Maltese: • riżultat anormali b'test imsejjaħ "DAGT" jew "Coombs".
English: Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of β-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems).
Maltese: Sensittività eċċessiva severa (eż. reazzjoni anafilattika, reazzjoni severa tal-ġilda) għal kwalunkwe tip ieħor ta' aġent antibatterjali β-lactam (eż. peniċillini, monobattami jew karbapenemi).
English: ESRD including on haemodialysis
Maltese: ESRD inkluż fuq l-emodijalisi
English: Toxic epidermal necrolysis
Maltese: Nekroliżi epidermali tossika
English: In seven Phase 2 and Phase 3 clinical trials, 2024 adult patients were treated with Zavicefta.
Maltese: F'seba' provi kliniċi tal-Fażi 2 u Fażi 3, 2024 pazjent adult kienu kkurati b'Zavicefta.
English: 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.
Maltese: Probenecid (inibitur OAT qawwi) jinibixxi dan l-asorbiment b'56% sa 70% in vitro u, għaldaqstant, għandu l-potenzjal li jbiddel l-eliminazzjoni ta' avibactam.
English: 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.
Maltese: Wara l-għoti minn ġol-vina ta' doża waħda ta' 500 mg avibactam bħala infuzjoni IV ta' 30-minuta, lanzjani kellhom half-life terminali ta' avibactam aktar bil-mod, li jista' jkun attribwit għal tnaqqis relatat mal-età fit-tneħħija tal-kliewi.
English: How to store Zavicefta 6.
Maltese: Kif taħżen Zavicefta 6.
English: The resulting solution should be administered over 120 minutes.
Maltese: Is-soluzzjoni li tirriżulta għandha tingħata fuq 120 minuta.
English: Complicated intra-abdominal infections
Maltese: Infezzjonijiet intra-addominali kkumplikati
English: Pharmacotherapeutic group: Antibacterials for systemic use, ceftazidime, combinations, ATC code: J01DD52
Maltese: Antibatterjali għall-użu sistemiku, ceftazidime, kombinazzjonijiet,, kodiċi ATC:
English: Zavicefta is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1):
Maltese: Zavicefta huwa indikat għall-kura tal-infezzjonijiet li ġejjin fl-adulti (ara sezzjonijiet 4.4 u 5.1):
English: 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.
Maltese: Pulmonite li ttieħdet mill-isptar, inkluż il-pulmonite assoċjata mal-ventilatur Fi studju wieħed f'pazjenti b'pulmonite nosokomjali 280/808 (34.7 %) kellhom VAP u 40/808 (5.0 %) kienu batteremiċi fil-linja bażi.
English: 5-14 days
Maltese: 5-14-il jum
English: 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.
Maltese: Il-mewt seħħet fi 2.1% (18/857) tal-pazjenti li rċevew Zavicefta u metronidazole u 1.4% (12/863) tal-pazjenti li rċevew meropenem.
English: In pregnant rabbits administered avibactam at 300 and 1000 mg/kg/day, there was a dose-related lower mean foetal weight and delayed ossification, potentially related to maternal toxicity.
Maltese: Fi fniek tqal li ngħataw avibactam fi 300 u 1000 mg/kg/jum, kien hemm piż fetali medju aktar baxx u ossifikazzjoni ttardjata relatata mad-doża, potenzjalment relatata mat-tossiċità materna.
English: • yellowing of the whites of the eyes or skin sudden onset of a severe rash or blistering or peeling skin, possibly accompanied by a high fever or joint pain (these may be signs of more serious medical conditions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or a condition known as DRESS,
Maltese: • bidu f'daqqa ta' raxx sever jew infafet jew tqaxxir tal-ġilda, possibilment akkumpanjat minn deni għoli jew uġigħ fil-ġogi (dawn jistgħu jkunu sinjali ta' kundizzjonijiet mediċi aktar serji bħal nekroliżi epidermali tossika, sindrome ta' Stevens-Johnson, eritema multiformi, jew kundizzjoni magħrufa bħala DRESS, Reazzjoni tal-Mediċina b'Eosinofilja u Sintomi Sistemiċi)
English: Complicated intra-abdominal infections Gram-negative micro-organisms
Maltese: Infezzjonijiet intra-addominali kkumplikati Mikro-organiżmi Gram-negattivi
English: Agranulocytosis
Maltese: Agranuloċitożi
English: Total volume
Maltese: Volum totali
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: Dilwenti xierqa tal-infużjoni 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 2.5% dextrose) jew soluzzjoni tat-tip Lactated Ringer.
English: Angioedema
Maltese: Anġjoedema
English: The average increases in avibactam AUC are 3.8-fold and 7-fold in subjects with moderate and severe renal impairment, see section 4.2.
Maltese: Iż-żidiet medji fl-AUC ta' avibactam huma 3.8 u 7 darbiet aktar rispettivament f'individwi b'indeboliment moderat u sever tal-kliewi, ara sezzjoni 4.2.
English: No appreciable accumulation of ceftazidime or avibactam was observed following multiple intravenous infusions of 2000 mg/500 mg of ceftazidime/avibactam administered every 8 hours for up to 11 days in healthy adults with normal renal function.
Maltese: Ma ġietx osservata akkumulazzjoni apprezzabli ta' ceftazidime jew avibactam wara infużjonijiet multipli minn ġol-vina ta' 2000 mg/500 mg ta' ceftazidime/avibactam mogħtija kull 8 sigħat sa 11-il jum f'adulti f'saħħithom b'funzjoni normali tal-kliewi.
English: The steady-state volumes of distribution of ceftazidime and avibactam were about 22 L and 18 L, respectively in healthy adults following multiple doses of 2000 mg/500 mg ceftazidime/avibactam infused over 2 hours every 8 hours.
Maltese: Il-volumi ta' distribuzzjoni fi stadju fiss ta' ceftazidime u avibactam kienu bejn wieħed u ieħor 22 L u 18 L, rispettivament f'adulti b'saħħithom wara dożi multipli ta' 2000 mg/500 mg ceftazidime/avibactam infużi fuq sagħtejn kull 8 sigħat.
English: Do not use Zavicefta if:
Maltese: Tużax Zavicefta jekk:
English: Drug Reaction with Eosinophilia and Systemic Symptoms)
Maltese: Reazzjonijiet talMediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS)
English: During a 4-hour haemodialysis period, 55% of the avibactam dose was removed.
Maltese: Waqt perjodu ta' 4 sigħat ta' emodijalisi, tneħħew 55% mid-doża ta' avibactam.
English: This is equivalent to 22.2% of the adult recommended maximum daily dietary intake for sodium.
Maltese: Dan huwa ekwivalenti għal 22.2 % tat-teħid massimu rakkomandat dijetiku ta' kuljum għall-adulti (adult recommended maximum daily dietary intake) għas-sodium.
English: 20 mL glass vial (Type 1) closed with a rubber (halobutyl) stopper and aluminium seal with flip-off cap.
Maltese: 20 mL kunjett tal-ħġieġ (Tip 1) magħluq b'tapp tal-gomma (halobutyl) u siġill tal-aluminju b'għatu flip-off.
English: Interference with laboratory tests
Maltese: Interferenza ma' testijiet tal-laboratorju
English: • Anaerobes
Maltese: • Anerobi
English: Avibactam showed no significant inhibition of cytochrome P450 enzymes in vitro.
Maltese: Avibactam ma weriex inibizzjoni sinifikanti tal-enzimi taċ-ċitokromu P450 in vitro.
English: 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).
Maltese: L-attività antimikrobjali ta' ceftazidime kontra patoġeni speċifiċi ntweriet li tikkorrelata l-aħjar malħin perċentwali tal-konċentrazzjoni tal-mediċina ħielsa fuq il-konċentrazzjoni inibitorja minima ta' ceftazidime/avibactam fuq l-intervall tad-doża (%fT >MIC ta' ceftazidime/avibactam).
English: 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.
Maltese: Doża ta' 1000 mg/250 mg jew 750 mg/187.5
English: Among a subgroup with baseline CrCL 30 to 50 mL/min death occurred in 16.7% (9/54) of patients who received Zavicefta and metronidazole and 6.8% (4/59) of patients who received meropenem.
Maltese: Fost sottogrupp b'CrCL tal-linja bażi minn 30 sa 50 mL/min, il-mewt seħħet f'16.7% (9/54) talpazjenti li rċevew Zavicefta u metronidazole u 6.8% (4/59) tal-pazjenti li rċevew meropenem.
English: Avibactam and ceftazidime showed no in vitro cytochrome P450 induction at clinically relevant concentrations.
Maltese: Avibactam u ceftazidime ma wrewx induzzjoni in vitro taċ-ċitokromu P450 f'konċentrazzjonijiet klinikament relevanti.
English: Vulvovaginal candidiasis and Oral candidiasis)
Maltese: Kandidijażi (inkluż Kandidijażi vulvovaġinali u Kandidijażi orali)
English: Leukopenia
Maltese: Lewkopenija
English: Approximately 87% of patients had APACHE II scores of ≤ 10 and 4.0% had bacteraemia at baseline.
Maltese: Bejn wieħed u ieħor 87% tal-pazjenti cIAI kellhom punteġġi APACHE II ta' ≤ 10 u 4.0% kellhom il-batterimja fil-linja bażi.
English: Dose of ceftazidime/avibactam
Maltese: Doża ta' ceftazidime/avibactam
English: • The other ingredient is sodium carbonate (anhydrous).
Maltese: • L-ingredjent l-ieħor huwa sodium carbonate (anhydrous).
English: Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many class D enzymes.
Maltese: Avibactam ma jinibixxix l-enzimi tal-klassi B (metallo-β-lactamases) u mhuwiex kapaċi jinibixxi ħafna enzimi tal-klassi D.
English: Ceftazidime is not metabolised.
Maltese: Ceftazidime mhuwiex metabolizzat.
English: • The active substances are ceftazidime and avibactam.
Maltese: • Is-sustanzi attivi huma ceftazidime u avibactam.
English: 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.
Maltese: In vitro, avibactam huwa sottostrat ta' trasportaturi OAT1 u OAT3 li jista' jikkontribwixxi għallassorbiment attiv ta' avibactam mill-kompartiment tad-demm u, għalhekk jaffettwa l-eliminazzjoni tiegħu.
English: Urticaria
Maltese: Urtikarja
English: Zavicefta is administered by intravenous infusion over 120 minutes in an infusion volume of 100 mL.
Maltese: Zavicefta jingħata permezz ta' infużjoni minn ġol-vina fuq 120 minuta f'volum tal-infużjoni ta' 100 mL.
English: Frequency categories are derived from adverse reactions and/or potentially clinically significant laboratory abnormalities, and are defined according to the following conventions:
Maltese: Il-kategoriji ta' frekwenza huma meħuda minn reazzjonijiet avversi u/jew anormalitajiet tal-laboratorju potenzjalment sinifikanti klinikament, u huma definiti skont ilkonvenzjonijiet li ġejjin:
English: The inhibitory spectrum of avibactam includes many of the enzymes that inactivate ceftazidime, including Ambler class A β-lactamases and class C β-lactamases.
Maltese: Il-firxa inibitorja ta' avibactam tinkludi ħafna mill-enzimi li jinattivaw ceftazidime, inkluż βlactamases tal-klassi A Ambler u β-lactamases tal-klassi C.
English: 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).
Maltese: F'żewġ studji dwar pazjenti b'cUTI, 381/1091 (34.9%) tal-pazjenti iddaħħlu b'cUTI mingħajr pjelonefrite filwaqt li 710 (65.1%) iddaħħlu bi pjelonefrite akuta (popolazzjoni mMITT).
English: Table 2 shows the recommended dose adjustments for patients with estimated CrCL ≤ 50 mL/min (see sections 4.4 and 5.2).
Maltese: Tabella 2 turi l-aġġustamenti tad-doża rakkomandati għal pazjenti b'CrCL stmata ≥ 50 mL/min (ara sezzjonijiet 4.4 u 5.2).
English: • infections caused by bacteria that other antibiotics may not be able to kill
Maltese: • infezzjonijiet ikkawżati minn batterji li antibijotiċi oħra ma jkunux jistgħu joqtlu
English: Hospital-acquired pneumonia, including VAP
Maltese: Pulmonite li ttieħdet mill-isptar, inkluż VAP
English: Reconstitution time is less than 2 minutes.
Maltese: Il-ħin tar-rikostituzzjoni huwa anqas minn 2 minuti.
English: Each vial contains ceftazidime pentahydrate equivalent to 2 g ceftazidime and avibactam sodium equivalent to 0.5 g avibactam.
Maltese: Kull kunjett fih ceftazidime pentahydrate ekwivalenti għal 2 g ceftazidime u avibactam sodium ekwivalenti għal 0.5 g avibactam.
English: Excipient with known effect: each vial contains 6.44 mmol of sodium (approximately 148 mg).
Maltese: Eċċipjent b'effett magħruf: kull kunjett fih 6.44 mmol ta' sodju (bejn wieħed u ieħor 148 mg).
English: Tubulointerstitial nephritis
Maltese: Nefrite tubulointerstizjali
English: Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva serji u xi drabi fatali huma possibbli (ara sezzjonijiet 4.3 u 4.8).
English: Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options (see sections 4.2, 4.4 and 5.1).
Maltese: Zavicefta huwa indikat ukoll għall-kura tal-infezzjonijiet minħabba organiżmi aerobiċi Gram-negattivi f'pazjenti adulti b'għażliet ta' kura limitati (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: • severe allergic reaction (see Serious side effects, above)
Maltese: • reazzjoni allerġika severa (ara Effetti sekondarji serji, hawn fuq)
English: Zavicefta contains sodium
Maltese: Zavicefta fih is-sodium
English: Approximate ceftazidime/avibactam concentration (mg/mL)
Maltese: Il-konċentrazzjoni ta' ceftazidime/avibactam bejn wieħed u ieħor (mg/mL)
English: Table 1 shows the recommended intravenous dose for patients with estimated creatinine clearance (CrCL) ≥ 51 mL/min (see sections 4.4 and 5.1).
Maltese: Tabella 1 turi d-doża minn ġol-vina rrakkomandat għal pazjenti bi tneħħija tal-krejatinina stmata (CrCL) ≥ 51 mL/min (ara sezzjonijiet 4.4 u 5.1).
English: Blood lactate dehydrogenase Increased
Maltese: Lactate dehydrogenase fiddemm
English: Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins.
Maltese: Chloramphenicol huwa antagonista in vitro ma' ceftazidime u ċefalosporini oħra.
English: It is available in packs containing 10 vials.
Maltese: Huwa disponibbli f'pakketti li fihom 10 kunjetti.
English: Clinical efficacy and safety studies of Zavicefta have been conducted in cIAI, cUTI and HAP (including VAP).
Maltese: Saru studji tal-effikaċja klinika u s-sigurtà ta' Zavicefta f'cIAI, cUTI u HAP (inkluż VAP).
English: Elderly patients (≥65 years)
Maltese: Pazjenti anzjani (≤65 sena)
English: Neurological sequelae, including tremor, myoclonus, non-convulsive status epilepticus, convulsion, encephalopathy and coma, have occasionally been reported with ceftazidime when the dose has not been reduced in patients with renal impairment.
Maltese: Xi kultant ġew irrapportati konsegwenzi newroloġiċi, inkluż tregħid, mijoklonus, status epilepticus mhux konvulsiv, aċċessjoni, enċefalopatija u koma, b'ceftazidime meta d-doża ma tnaqqsitx f'pazjenti b'indeboliment tal-kliewi.
English: powder for concentrate for solution for infusion 10 vials
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni 10 kunjetti
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: • Complicated intra-abdominal infection (cIAI)
Maltese: • Infezzjoni Intra-Addominali
English: A total of 81 cUTI patients (7.4%) had bacteraemia at baseline.
Maltese: Total ta' 81 pazjent b'cUTI (7.4%) kellhom il-batterimja fil-linja bażi.
English: Hepatic impairment
Maltese: Infezzjonijiet oħra
English: Paraesthesia
Maltese: Paresteżija
English: Ceftazidime/avibactam use may cause development of a positive direct antiglobulin test (DAGT, or Coombs test), which may interfere with the cross-matching of blood and/or may cause drug induced immune haemolytic anaemia (see section 4.8).
Maltese: L-użu ta' cetazidime/avibactam jista' jikkawża l-iżvilupp ta' test dirett pożittiv tal-antiglobulina (DAGT, jew it-test ta' Coombs), li jista' jinterferixxi mat-tqabbil tad-demm u/jew jista' jikkawża anemija emolitika immuni kkaġunata mill-mediċina (ara sezzjoni 4.8).
English: Animal studies with avibactam have shown reproductive toxicity without evidence of teratogenic effects (see section 5.3).
Maltese: Studji f'annimali b'avibactam urew effett tossiku fuq is-sistema riproduttiva mingħajr evidenza ta' effetti teratoġeniċi (ara sezzjoni 5.3).
English: 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
Maltese: L-użu ta' ceftazidime/avibactam għall-kura tal-pazjenti b'infezzjonijiet dovuti għal patoġeni aerobiċi Gram-negattivi li għandhom għażliet limitati ta' kura huwa bbażat fuq esperjenza b'ceftazidime biss u fuq analiżi tar-relazzjoni farmakokinetika-farmakodinamika għal ceftazidime/avibactam (ara sezzjoni 5.1).
English: Complicated urinary-tract infections Gram-negative micro-organisms
Maltese: Infezzjonijiet ikkumplikati fl-apparat tal-awrina Mikro-organiżmi Gram-negattivi
English: The mean elimination half-life of ceftazidime ranged from 3.5 to 4 hours following intravenous bolus dosing with 2 g every 12 hours in elderly patients aged 80 years or older.
Maltese: Il-half-life tal-eliminazzjoni medja ta' ceftazidime varjat minn 3.5 sa 4 sigħat wara dożaġġ bolus mogħti minn ġol-vina b'2 g kull 12-il siegħa f'pazjenti anzjani ta' 80 sena jew akbar.
English: The most common adverse reactions occurring in ≥ 5% of patients treated with Zavicefta were Coombs direct test positive, nausea, and diarrhoea.
Maltese: L-aktar reazzjonijiet avversi komuni li jseħħu f'≤5% tal-pazjenti kkurati b'Zavicefta kienu t-test dirett pożittiv ta' Coombs, dardir, jew dijarea.
English: • an infection of the lungs called “pneumonia”
Maltese: • infezzjoni tal-pulmun li tissejjaħ "pulmonite"
English: Paediatric population Safety and efficacy in children and adolescents below 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja fit-tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Zavicefta will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose.
Maltese: Zavicefta ser jingħatalek minn tabib jew infermier, li jagħmilha improbabbli li tingħata d-doża lħażina.
English: 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.
Maltese: Il-mekkaniżmi ta' reżistenza batterjali li potenzjalment jistgħu jaffetwaw ceftazidime/avibactam jinkludu PBPs mutanti jew akkwiżiti, permeabilità tal-membrana ta' barra mnaqqsa għal kwalunkwe kompost, effluss attiv ta' kwalunkwe kompost u enzimi β-lactamase refrattarji għal inibizzjoni b'avibactam u kapaċi jidrolizzaw ceftazidime.
English: • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
Maltese: • Pulmonite li tittieħed mill-isptar (HAP), inkluż pulmonite assoċjata mal-apparat li jagħti r respirazzjoni artifiċjali (Ventilator Associated Pneumonia -VAP)
English: Hypersensitivity to any cephalosporin antibacterial agent.
Maltese: Sensittività eċċessiva għal kwalunkwe aġent antibatterjali ċefalosporin.
English: The following adverse reactions have been reported with ceftazidime alone and/or identified during the Phase 2 and Phase 3 trials with Zavicefta.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrapportati b'ceftazidime biss u/jew identifikati waqt il-provi talFażi 2 u l-Fażi 3 b'Zavicefta.
English: • change in the number of some types of blood cells (called “eosinophils” and “thrombocytes”)
Maltese: • bidla fin-numru ta' xi tipi ta' ċelluli tad-demm (imsejħa "eosinofili" u "tromboċiti") - murija fit testijiet tad-demm
English: Pharmacokinetic/pharmacodynamic relationship
Maltese: Relazzjoni farmakokinetika/farmakodinamika
English: The safety assessment in children is based on the safety data from 1 trial in which 61 paediatric patients aged from 3 years to less than 18 years with cIAI received Zavicefta.
Maltese: Il-valutazzjoni tas-sigurtà fit-tfal hija bbażata fuq id-data tas-sigurtà minn prova 1 li fiha 61 pazjent pedjatriku ta' bejn 3 snin sa inqas minn 18-il sena b'cIAI rċevew Zavicefta.
English: ZAVICEFTA 2 g/0.5 g powder for concentrate ceftazidime/avibactam
Maltese: 2 g/0.5g trab għal konċentrat ceftazidime/avibactam IV