FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Recommended intravenous dose regimens for Zerbaxa in patients with creatinine clearance ≤ 50 mL/min
Maltese: Tabella 2: Skedi rakkomandati għad-doża ta' Zerbaxa ġol-vini f'pazjenti bi tneħħija talkreatinina ≤ 50 mL/min
English: Phlebitis
Maltese: Flebite
English: Environmental risk assessment studies have shown that one of the active ingredients, ceftolozane, may pose a risk to surface water organisms (see section 6.6).
Maltese: Studji dwar valutazzjoni tar-riskju ambjentali urew li wieħed mis-sustanzi attivi, ceftolozane, jista' jkun ta' riskju għall-organiżmi tal-ilma tal-wiċċ (ara sezzjoni 6.6).
English: Plasma levels of ceftolozane/tazobactam do not increase appreciably following multiple IV infusions of up to 2.0 g / 1.0 g administered every 8 hours for up to 10 days in healthy adults with normal renal function.
Maltese: Il-livelli ta' ceftolozane/tazobactam fil-plażma ma jiżdidux b'mod sinifikanti wara infużjonijiet IV multipli sa 2.0 g / 1.0 g mogħtija kull 8 sigħat sa 10 ijiem f'adulti f'saħħithom b'funzjoni normali tal-kliewi.
English: Adverse reactions are classified according to MedDRA system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont il-klassi tas-sistemi u tal-organi MedDRA u l-frekwenza.
English: - The other excipients are sodium chloride, arginine, and citric acid, anhydrous.
Maltese: - L-eċċipjent l-oħra huma sodium chloride, arginine, u citric acid, anidru.
English: The mean terminal elimination half-life of ceftolozane and tazobactam in healthy adults with normal renal function is approximately 3 hours and 1 hour, respectively.
Maltese: Il-medja tal-half-life tal-eliminazzjoni terminali ta' ceftolozane u tazobactam f'adulti f'saħħithom b'funzjoni normali tal-kliewi hi ta' madwar 3 sigħat u siegħa, rispettivament.
English: In a population pharmacokinetic analysis of ceftolozane/tazobactam, no clinically relevant differences in AUC were observed for ceftolozane and tazobactam.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' ceftolozane/tazobactam, ma ġew osservati l-ebda differenzi klinikament rilevanti fl-AUC għal ceftolozane u tazobactam.
English: See below.
Maltese: Ara taħt.
English: Complicated intra-abdominal infections, complicated urinary tract infections, and acute pyelonephritis**
Maltese: Infezzjonijiet intraddominali kkumplikati, infezzjonijiet ikkumplikati tal-passaġġ urinarju, u pajelonefrite akuta**
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions are possible (see sections 4.3 and 4.8).
Maltese: Reazzjonijiet serji u xi kultant fatali ta' sensittività eċċessiva (reazzjonijiet anafilattiċi) huma possibbli (ara sezzjonijiet 4.3 u 4.8).
English: Animal studies with tazobactam have shown reproductive toxicity (see section 5.3) without evidence of teratogenic effects.
Maltese: Studji f'annimali b'tazobactam urew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3) mingħajr evidenza ta' effetti teratoġeniċi.
English: The resultant concentration is approximately 132 mg/mL (88 mg/mL of ceftolozane and 44 mg/mL of tazobactam) per vial.
Maltese: Il-konċentrazzjoni li tinkiseb hi ta' madwar 132 mg/mL (88 mg/mL ta' ceftolozane u 44 mg/mL ta' tazobactam) f'kull kunjett.
English: Headache, stomach ache, constipation, diarrhoea, nausea, vomiting, increase in liver enzymes (from blood tests), rash, fever (high temperature), decrease in blood pressure, decrease in potassium (from blood tests), increase in the number of certain types of blood cells known as platelets, dizziness, anxiety, difficulty sleeping, infusion site reactions
Maltese: Uġigħ ta' ras, uġigħ fl-istonku, stitikezza, dijarea, dardir, rimettar, żieda fl-enzimi tal-fwied (minn testijiet tad-demm), raxx, deni (temperatura għolja), tnaqqis fil-pressjoni tad-demm, tnaqqis fil-potassium (minn testijiet tad-demm), żieda fin-numru ta' ċerti tipi ta' ċelluli taddemm magħrufa bħala plejtlits, sturdament, ansjetà, diffikultà biex torqod, reazzjonijiet fil-post tal-injezzjoni
English: Co-administration of ceftolozane/tazobactam with OAT1 and OAT3 substrate furosemide in a clinical study did not significantly increase furosemide plasma exposures (geometric mean ratios of 0.83 and 0.87 for Cmax and AUC, respectively).
Maltese: L-għoti flimkien ta' ceftolozane/tazobactam ma' substrat ta' OAT1 u OAT3 furosemide fi studju kliniku ma żiedx b'mod sinifikanti l-esponimenti ta' furosemide fil-plażma (proporzjonijiet medji ġeometriċi ta' 0.83 u 0.87 għas-Cmax u l-AUC, rispettivament).
English: Zerbaxa was evaluated in Phase 3 comparator-controlled clinical trials of complicated intra-abdominal infections and complicated urinary tract infections (including pyelonephritis), which included a total of 1,015 patients, treated with Zerbaxa (1 g / 0.5 g intravenously every 8 hours, adjusted to match renal function where appropriate) for up to 14 days.
Maltese: Zerbaxa ġie evalwat fi provi kliniċi, ta' Fażi 3 ikkontrollati b'komparatur, dwar infezzjonijiet intraddominali kkumplikati u infezzjonijiet ikkumplikati tal-passaġġ urinarju (li jinkludu pajelonefrite), li kienu jinkludu total ta' 1,015-il pazjent, ittrattati b'Zerbaxa (1 g/ 0.5 g fil-vini kull 8 sigħat, aġġustat biex ikun jaqbel mal-funzjoni tal-kliewi fejn ikun xieraq) sa 14-il jum.
English: The ceftolozane/tazobactam dose should be adjusted based on renal function (see section 4.2, Table 2).
Maltese: Id-doża ta' ceftolozane/tazobactam għandha tiġi aġġustata abbażi tal-funzjoni tal-kliewi (ara sezzjoni 4.2, Tabella 2).
English: Infections and infestations Clostridioides difficile colitis
Maltese: 1, infezzjoni kkawżata minn Clostridioides difficile
English: Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems, ATC code: J01DI54.
Maltese: Antibatteriċi għal użu sistemiku, cephalosporins u penems oħra, Kodiċi ATC:
English: Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterial agents may also be hypersensitive to ceftolozane/tazobactam.
Maltese: Pazjenti li għandhom storja medika ta' sensittività eċċessiva għal cephalosporins, penicillins jew sustanzi antibatteriċi beta-lactam oħrajn, jista' wkoll ikollhom sensittività eċċessiva għal ceftolozane/tazobactam.
English: Hyperglycaemia hypomagnesaemia hypophosphataemia
Maltese: 1, ipomagnesimja ipofosfatemija
English: Ceftolozane/tazobactam is also contraindicated in patients with severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems) (see section 4.3).
Maltese: Ceftolozane/tazobactam huwa kontraindikat ukoll f'pazjenti b'sensittività eċċessiva severa (eż., reazzjoni anafilattika, reazzjoni severa fil-ġilda) għal kwalunkwe tip ieħor ta' sustanza antibatterika beta-lactam (eż., penicillins jew carbapenems) (ara sezzjoni 4.3).
English: 2, liver function test abnormal
Maltese: 2, riżultat mhux normali ta' test tal-funzjoni tal-fwied
English: After reconstitution with 10 mL diluent, the total volume of the solution in the vial is 11.4 mL, which contains 88 mg/mL of ceftolozane and 44 mg/mL of tazobactam.
Maltese: Wara r-rikostituzzjoni b'10 mL ta' dilwent, il-volum totali tas-soluzzjoni fil-kunjett huwa 11.4 mL, li fih 88 mg/mL ta' ceftolozane u 44 mg/mL ta' tazobactam.
English: Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftolozane/tazobactam (see section 4.8).
Maltese: Kolite assoċjata ma' mediċini antibatterjali u kolite psewdomembranuża ġew irrappurtati b'ceftolozane/tazobactam (ara sezzjoni 4.8).
English: The incidence of seroconversion to a positive direct Coombs test was 31.2% in patients receiving Zerbaxa and 3.6% in patients receiving meropenem in the hospital-acquired pneumonia, including ventilator-associated pneumonia clinical trial.
Maltese: L-inċidenza ta' serokonverżjoni għal riżultat pożittiv għat-test dirett ta' Coombs kienet ta' 31.2% f'pazjenti li kienu qed jirċievu Zerbaxa u 3.6% f'pazjenti li kienu qed jirċievu meropenem filprova klinika ta' pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur.
English: It contains two active substances: - ceftolozane, an antibiotic that belongs to the group of “cephalosporins” and which can kill certain bacteria that can cause infection; - tazobactam, which blocks the action of certain enzymes called beta-lactamases.
Maltese: Huwa fih żewġ sustanzi attivi: - ceftolozane, antibijotiku li jagħmel parti mill-grupp tas-“cephalosporins” u li jista' joqtol ċerti batterji li kapaċi jikkawżaw infezzjoni; - tazobactam, li jimblokka l-azzjoni ta' ċerti enzimi msejħa beta lactamases.
English: More than 80% of tazobactam was excreted as the parent compound with the remaining amount excreted as the tazobactam M1 metabolite.
Maltese: Iktar minn 80% ta' tazobactam tneħħa bħala l-kompost oriġinali bil-bqija tal-ammont li tneħħa bħala l-metabolit M1 ta' tazobactam.
English: Zerbaxa is available in packs containing 20 mL Type I clear glass vial with stopper (bromobutyl rubber) and flip-off seal.
Maltese: Zerbaxa hu disponibbli f'pakketti li jkun fihom kunjett ta' ħġieġ ċar ta' Tip I ta' 20 mL b'tapp (lastku tal-bromobutyl) u siġill tat-tip flip-off.
English: Tel.: +48 22 549 51 00 msdpolska@merck.com
Maltese: MSD Polska Sp.z o.o. Tel.: +48 22 549 51 00 msdpolska@merck.com
English: The development of a positive direct antiglobulin test (DAGT) may occur during treatment with ceftolozane/tazobactam (see section 4.8).
Maltese: L-iżvilupp ta' riżultat pożittiv għat-test dirett ta' antiglobulina (DAGT - direct antiglobulin test) jista' jseħħ waqt trattament b'ceftolozane/tazobactam (ara sezzjoni 4.8).
English: Other medicines and Zerbaxa
Maltese: Mediċini oħra u Zerbaxa
English: - Each vial contains ceftolozane sulfate equivalent to 1 g ceftolozane and tazobactam sodium equivalent to 0.5 g tazobactam.
Maltese: - Kull kunjett fih ceftolozane sulfate ekwivalenti għal 1 g ta' ceftolozane u tazobactam sodium ekwivalenti għal 0.5 g ta' tazobactam.
English: Dizziness may occur following administration of Zerbaxa (see section 4.8).
Maltese: Jista' jseħħ sturdament wara lgħoti ta' Zerbaxa (ara sezzjoni 4.8).
English: Ceftolozane and tazobactam were not substrates for P-gp or BCRP, and tazobactam was not a substrate for OCT2, in vitro at therapeutic plasma concentrations.
Maltese: Ceftolozane u tazobactam ma kinux substrati għal P-gp jew BCRP, u tazobactam ma kienx substrat għal OCT2, in vitro f'konċentrazzjonijiet terapewtiċi fil-plażma.
English: Tabulated list of adverse reactions for complicated intra-abdominal infections, complicated urinary tract infections, including pyelonephritis, and hospital-acquired pneumonia, including ventilator-associated pneumonia
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella għal infezzjonijiet intraddominali kkumplikati, infezzjonijiet ikkumplikati fl-apparat tal-awrina, inkluża pajelonefrite, u pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur.
English: Table 1: Intravenous dose of Zerbaxa by type of infection in patients with creatinine clearance > 50 mL/min
Maltese: Tabella 1: Doża fil-vini ta' Zerbaxa skont it-tip ta' infezzjoni f'pazjenti bi tneħħija talkreatinina ta' > 50 mL/min
English: Specific for the hospital-acquired pneumonia, including ventilator-associated pneumonia indication treated with Zerbaxa (2 g / 1 g intravenously every 8 hours) for up to 14 days.
Maltese: Speċifiku/a/ċi għall-indikazzjoni ta' pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata malventilatur ittrattata b'Zerbaxa (2 g / 1 g ġol-vini kull 8 sigħat) sa 14-il jum.
English: The Cmax and AUC of ceftolozane/tazobactam increase approximately in proportion to dose within ceftolozane single-dose range of 250 mg to 3 g and tazobactam single-dose range of 500 mg to 1.5 g. No appreciable accumulation of ceftolozane/tazobactam is observed following multiple 1-hour IV infusions of 1 g / 0.5 g ceftolozane/tazobactam or 2 g / 1 g ceftolozane/tazobactam administered every 8 hours for up to 10 days in healthy adults with normal renal function.
Maltese: L-ebda akkumulazzjoni sinifikanti ta' ceftolozane/tazobactam ma tiġi osservata wara infużjonijiet IV multipli ta' siegħa ta' 1 g / 0.5 g ta' ceftolozane/tazobactam jew 2 g / 1 g ceftolozane/tazobactam mogħtija kull 8 sigħat sa 10 ijiem f'adulti f'saħħithom b'funzjoni normali tal-kliewi.
English: Following administration of a single 1 g / 0.5 g IV dose of ceftolozane/tazobactam to healthy male adults greater than 95% of ceftolozane was excreted in the urine as unchanged parent substance.
Maltese: IV ta' 1 g / 0.5 g ta' ceftolozane/tazobactam lil irġiel adulti f'saħħithom, iktar minn 95% ta' ceftolozane ġie eliminat fl-awrina bħala s-sustanza oriġinali mhux mibdula.
English: The respective tazobactam dose normalized geometric mean AUC increased approximately up to 1.3-fold, 2-fold, and 4-fold.
Maltese: Il-medja ġeometrika normalizzata tal-AUC ta' doża rispettiva ta' tazobactam żdiedet sa madwar 1.3 darbiet, darbtejn, u 4 darbiet aktar.
English: The incidence of seroconversion to a positive direct Coombs test was 0.2% in patients receiving Zerbaxa and 0% in patients receiving the comparator in the complicated intra-abdominal infections and complicated urinary tract infections clinical trials.
Maltese: Linċidenza ta' serokonverżjoni għal riżultat pożittiv għat-test dirett ta' Coombs kienet ta' 0.2% f'pazjenti li kienu qed jirċievu Zerbaxa u 0% f'pazjenti li kienu qed jirċievu s-sustanza ta' paragun filprovi kliniċi ta' infezzjonijiet intraddominali kkumplikati u infezzjonijiet ikkumplikati tal-passaġġ urinarju.
English: Complicated intra-abdominal infections* Complicated urinary tract infections* Acute pyelonephritis* Hospital-acquired pneumonia, including ventilator-associated pneumonia**
Maltese: Pajelonefrite akuta* Pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur**
English: In a population pharmacokinetic analysis of ceftolozane/tazobactam, no clinically relevant differences in exposure were observed with regard to age.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' ceftolozane/tazobactam, ma ġew osservati l-ebda differenzi klinikament rilevanti fl-esponiment fir-rigward tal-età.
English: Manufacturer
Maltese: Manifatturi
English: Following a single 1-hour intravenous infusion of 2 g / 1 g ceftolozane/tazobactam to critically ill patients with CrCL greater than or equal to 180 mL/min (N=10), mean terminal half-life values of ceftolozane and tazobactam were 2.6 hours and 1.5 hours, respectively.
Maltese: Wara infużjoni waħda ta' siegħa ġol-vini ta' 2 g / 1 g ceftolozane/tazobactam lill-pazjenti morda serjament b'CrCL akbar minn jew ta' 180 mL/min (N=10), il-valuri medji tal-half-life terminali ta' ceftolozane u tazobactam kienu ta' 2.6 sigħat u 1.5 sigħat, rispettivament.
English: Powder for concentrate for solution for infusion 10 vials
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni 10 kunjetti
English: Free plasma ceftolozane concentrations were greater than 8 mcg/mL over 70% of an 8-hour period; free tazobactam concentrations were greater than 1 mcg/mL over 60% of an 8-hour period.
Maltese: Konċentrazzjonijiet ta' ceftolozane ħieles fil-plasma kienu aktar minn 8 mcg/mL fuq 70% ta' perjodu ta' 8 sigħat; konċentrazzjonijiet ta' tazobactam ħieles kienu aktar minn 1 mcg/mL fuq 60% ta' perjodu ta' 8 sigħat.
English: The final volume is approximately 11.4 mL per vial.
Maltese: Il-volum finali hu ta' madwar 11.4 mL f'kull kunjett.
English: Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to Zerbaxa in vitro:
Maltese: L-effikaċja ntweriet fi studji kliniċi kontra l-patoġeni elenkati taħt kull indikazzjoni li kienu suxxettibbli għal Zerbaxa in vitro:
English: Zerbaxa was evaluated in a Phase 3 comparator-controlled clinical trial of hospital-acquired pneumonia, including ventilator-associated pneumonia, which included a total of 361 patients, treated with Zerbaxa (2 g / 1 g intravenously every 8 hours, adjusted to match renal function where appropriate) for up to 14 days.
Maltese: Zerbaxa ġie evalwat fi prova klinika ta' Fażi 3, ikkontrollata b'sustanza ta' paragun, ta' pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur, li kienet tinkludi total ta' 361 pazjent, ittrattati b'Zerbaxa (2 g / 1 g ġol-vini kull 8 sigħat, aġġustat skont il-funzjoni tal-kliewi fejn kien xieraq) sa 14-il jum.
English: Ceftolozane/tazobactam is not active against bacteria that produce beta-lactamase enzymes which are not inhibited by tazobactam.
Maltese: Ceftolozane/tazobactam mhuwiex attiv kontra batterji li jipproduċu enzimi beta-lactamase li mhumiex inibiti minn tazobactam.
English: See section 4.2 for recommended dose regimens for Zerbaxa based on indication and renal function.
Maltese: Ara sezzjoni 4.2 għall-iskedi tad-dożi rakkomandati għal Zerbaxa abbażi tal-indikazzjoni u l-funzjoni tal-kliewi.
English: The most common adverse reactions (≥ 3% in pooled Phase 3 trials of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis) occurring in patients receiving Zerbaxa were nausea, headache, constipation, diarrhoea, and pyrexia and were generally mild or moderate in severity.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni (≥ 3% f'ġabra ta' provi ta' Fażi 3 ta' infezzjonijiet intraddominali kkumplikati u infezzjonijiet ikkumplikati tal-passaġġ urinarju, inkluża pajelonefrite) li seħħew f'pazjenti li kienu qed jirċievu Zerbaxa kienu dardir, uġigħ ta' ras, stitikezza, dijarea, u deni kienu ġeneralment ħfief jew moderati fis-severità tagħhom.
English: Complicated urinary tract infection
Maltese: Infezzjoni kkumplikata tal-passaġġ urinarju
English: Hypokalemia
Maltese: Ipokalimja
English: Following 1 hour intravenous infusions of 2 g / 1 g ceftolozane/tazobactam or adjusted based on renal function every 8 hours in ventilated patients with confirmed or suspected pneumonia (N=22), ceftolozane and tazobactam concentrations in pulmonary epithelial lining fluid were greater than 8 mcg/mL and 1 mcg/mL, respectively, over 100% of the dosing interval.
Maltese: Wara infużjonijiet ta' siegħa ġol-vini ta' 2 g / 1 g ceftolozane/tazobactam jew aġġustati abbażi talfunzjoni tal-kliewi kull 8 sigħat f'pazjenti ventilati b'pulmonite kkonfermata jew issusspettata (N=22), il-konċentrazzjonijiet ta' ceftolozane u tazobactam fil-fluwidu tal-kisja tal-epitelju tal-pulmun kienu aktar minn 8 mcg/mL u 1 mcg/mL, rispettivament, fuq 100% tal-intervall tal-għoti tad-doża.
English: The recommended dose in hospital-acquired pneumonia, including ventilator-associated pneumonia subjects with end stage renal disease on haemodialysis is a single loading dose of 1.5 g / 0.75 g ceftolozane/tazobactam followed by a 300 mg / 150 mg maintenance dose of ceftolozane/tazobactam administered every 8 hours for the remainder of the treatment period.
Maltese: Id-doża rakkomandata f'individwi b'pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur li jkollhom mard tal-kliewi fl-aħħar stadju u jkunu fuq l-emodijalisi hija doża waħda għolja tal-bidu ta' 1.5 g / 0.75 g ceftolozane/tazobactam segwita minn doża ta' manteniment ta' 300 mg / 150 mg ta' ceftolozane/tazobactam mogħtija kull 8 sigħat għall-kumplament tal-perjodu ta' trattament.
English: Infection due to C. difficile bacteria, C. difficile test positive (from stool test), Coombs test positive (a blood test that looks for antibodies that may fight against your red blood cells)
Maltese: Infezzjoni minħabba batterji C. difficile, test pożittiv għal C. difficile (minn test tal-ippurgar), rizultat pożittiv għat-test ta' Coombs (test tad-demm li jfittex antikorpi li jistgħu jiġġieldu kontra ċ-ċelluli ħomor fid-demm tiegħek)
English: Zerbaxa is used in adults to treat complicated infections within the abdomen, kidney and urinary system infections, and an infection of the lungs called “pneumonia”.
Maltese: Zerbaxa jintuża fl-adulti biex jittratta infezzjonijiet ikkumplikati ġewwa l-addome, infezzjonijiet filkliewi u fis-sistema urinarja, u infezzjoni fil-pulmun imsejħa “pulmonite”.
English: A risk to newborns/infants cannot be excluded.
Maltese: Ir-riskju gћat-trabi tat-twelid/trabi mhux eskluż.
English: Mechanisms of bacterial resistance to ceftolozane/tazobactam include: i.
Maltese: Mekkaniżmi ta' reżistenza tal-batterji għal ceftolozane/tazobactam jinkludu: i.
English: A dose of 300 mg/kg/day to rats was associated with a ceftolozane plasma exposure (AUC) value lower than the ceftolozane plasma AUC value at the highest recommended human dose of 2 grams every 8 hours.
Maltese: Doża ta' 300 mg/kg/jum lil firien ġiet assoċjata ma' valur ta' esponiment għal ceftolozane fil-plażma (AUC) inqas mill-valur tal-AUC ta' ceftolozane fil-plażma bl-ogħla doża rakkomandata fil-bniedem ta' 2 grammi kull 8 sigħat.
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 4 days at 2 to 8°C.
Maltese: Wara r-rikostituzzjoni, l-istabbilità kimika u fiżika waqt l-użu intweriet għal 4 ijiem f'temperatura ta' 2 sa 8°C.
English: Complicated urinary tract infections, including pyelonephritis
Maltese: Infezzjonijiet ikkumplikati tal-passaġġ urinarju, li jinkludu pajelonefrite
English: Hospital-acquired pneumonia, including ventilator-associated pneumonia**
Maltese: Pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur**
English: Candidiasis including oropharyngeal and vulvovaginal Clostridioides difficile colitis fungal urinary tract infection Clostridioides difficile infection
Maltese: 1, kolite kkawżata minn Clostridioides difficile infezzjoni bil-fungu fl-apparat tal-awrina
English: In addition tazobactam does not inhibit the following types of beta-lactamase:
Maltese: Barra dan tazobactam ma jinibixxix it-tipi ta' beta-lactamase li ġejjin:
English: The most common adverse reactions (≥ 5% in a Phase 3 trial of hospital-acquired pneumonia, including ventilator-associated pneumonia) occurring in patients receiving Zerbaxa were diarrhoea, alanine aminotransferase increased, and aspartate aminotransferase increased and were generally mild or moderate in severity.
Maltese: Ir-reazzjonjiet avversi l-aktar komuni (≥ 5% fi prova ta' Fażi 3 ta' pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur) li seħħew f'pazjenti li kienu qed jirċievu Zerbaxa kienu dijarea, żieda fl-alanine aminotransferase, u żieda fl-aspartate aminotransferase u b'mod ġenerali kienu ħfief jew moderati fis-severità tagħhom.
English: Ceftolozane administered to rats during pregnancy and lactation was associated with a decrease in auditory startle response in postnatal day (PND) 60 male pups (see section 5.3).
Maltese: Ceftolozane mogħti lil firien matul ittqala u t-treddigħ ġie assoċjat ma' tnaqqis fir-rispons awditorju għal ħasda fi frieħ irġiel f'jum 60 wara t-twelid (PND - postnatal day) (ara sezzjoni 5.3).
English: Hospital-acquired pneumonia, including ventilator-associated pneumonia
Maltese: Pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur
English: This medicine contains 230 mg sodium (main component of cooking/table salt) in each vial.
Maltese: Din il-mediċina fiha 230 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir/tal-mejda) f'kull kunjett.
English: The reconstituted vial with 10 mL of 0.9% sodium chloride (normal saline) for injection contains 265 mg sodium per vial, equivalent to 13.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Il-kunjett rikostitwit b'10 mL ta' 0.9% sodium chloride (salina normali) għall-injezzjoni jkun fih 265 mg ta' sodium f'kull kunjett, ekwivalenti għal 13.3% tal-ammont massimu ta' 2 g ta' sodium li għandu jittieħed minn adult kuljum irrakkomandat mill-WHO.
English: Zerbaxa 1 g / 0.5 g powder for concentrate for solution for infusion ceftolozane / tazobactam
Maltese: Zerbaxa 1 g/0.5 g trab għal konċentrat għal soluzzjoni għall-infużjoni ceftolozane/tazobactam
English: Clostridioides difficile-associated diarrhoea
Maltese: Kolite kkawżata minn Clostridioides difficile