FrancophonIA/ELRC3.0 huggingface dataset:
English: Prevymis contains the active substance letermovir.
Maltese: Prevymis fih is-sustanza attiva letermovir.
English: The full EPAR for Prevymis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Prevymis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Prevymis.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Prevymis.
English: Of the patients receiving Prevymis, about 38% (122 out of 325) had signs of CMV becoming active 24 weeks after the stem cell transplant compared with 61% of the patients (103 out of 170) receiving placebo.
Maltese: Millpazjenti li ngħataw Prevymis, f'madwar 38 % (122 minn 325) ġew innutati sinjali li s-CMV kien qed isir attiv 24 ġimgħa wara li sar it-trapjant taċ-ċelloli staminali meta mqabbel ma' 61 % tal-pazjenti (103 minn 170) li ngħataw plaċebo.
English: Because the number of patients with CMV disease is low, the disease is considered ‘rare', and Prevymis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 April 2011.
Maltese: Peress li n-numru ta' pazjenti li jbatu mill-marda CMV huwa wieħed baxx, il-marda titqies bħala waħda ‘rari', u Prevymis ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża għal mard rari) fil15 ta' April 2011.
English: Why is Prevymis approved?
Maltese: Għaliex ġie approvat Prevymis?
English: The combination of Prevymis and ciclosporin must not be used with dabigatran, atorvastatin, pitavastatin, rosuvastatin and simvastatin.
Maltese: Il-kumbinazzjoni ta' Prevymis u ċ-ċiklosporina ma għandhiex tintuża ma' dabigatran, atorvastatin, pitavastatin, rosuvastatin u simvastatin.
English: Other information about Prevymis
Maltese: Informazzjoni oħra dwar Prevymis
English: Terminase is involved in packaging the DNA in the protein shells of the virus.
Maltese: It-terminase tkun involuta fl-ippakkjar tad-DNA fil-qxur tal-proteini tal-vajrus.
English: A main study involving 570 adults found Prevymis was more effective than placebo (a dummy treatment) in preventing CMV infection after allogeneic haematopoietic stem cell transplantation.
Maltese: Studju prinċipali li involva 570 adult wera li Prevymis kien aktar effettiv minn plaċebo (kura finta) filprevenzjoni ta' infezzjoni mis-CMV wara trapjant alloġeniku emopojetiku taċ-ċelloli staminali.
English: Prevymis letermovir
Maltese: Sommarju tal-EPAR għall-pubbliku letermovir
English: The usual recommended dose by mouth or as an infusion is 480 mg once daily.
Maltese: Id-doża rakkomandata normali li tittieħed mill-ħalq jew bħala infużjoni hija ta' 480 mg darba kuljum.
English: Prevymis must not be used together with the medicine pimozide, or ergot medicines such as ergotamine and dihydroergotamine.
Maltese: Prevymis ma jistax tintuża flimkien mal-mediċina pimozide jew mediċini ergot bħal pereżempju ergotamina jew diidroergotamina.
English: For the full list of side effects reported with Prevymis, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati b'Prevymis, ara l-fuljett ta' tagħrif.
English: Prevymis is an antiviral medicine used to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant to replace their bone marrow.
Maltese: Prevymis hija mediċina antivirali li tintuża sabiex tipprevjeni mard ikkawżat miċ-ċitomegalovajrus (cytomegalovirus (CMV)) f'adulti li jkun sarilhom trapjant alloġeniku emopojetiku taċ-ċelloli staminali sabiex jinbidlilhom il-mudullun.
English: Treatment with Prevymis is started on the day of the transplant or on any day up to 28 days afterwards and it is continued for 100 days after the transplantation; longer treatment may be considered in some patients.
Maltese: Il-kura b'Prevymis tinbeda fil-ġurnata tat-trapjant jew sa 28 jum wara li dan isir u titkompla għal 100 jum wara t-trapjant; kura aktar twila tista' tiġi kkunsidrata fil-każ ta' ċerti pazjenti.
English: If ciclosporin (a medicine that prevents rejection of the transplant) is used at the same time, the Prevymis dose is reduced to 240 mg once daily.
Maltese: Jekk fl-istess waqt tkun qed tintuża ċ-ċiklosporina (mediċina li tipprevjeni r-rifjut tat-trapjant), id-doża ta' Prevymis titnaqqas għal 240 mg darba kuljum.
English: The most common side effects with Prevymis (which may affect up to 1 in 10 people) are nausea (feeling sick), diarrhoea and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni ta' Prevymis (li jistgħu jaffettwaw sa persuna minn kull 10) huma dardir (tħossok ma tiflaħx), dijarea u ramettar.
English: How is Prevymis used?
Maltese: Kif jintuża Prevymis?
English: What are the risks associated with Prevymis?
Maltese: X'inhuma r-riskji assoċjati mal-Prevymis?
English: How does Prevymis work?
Maltese: Kif jaħdem Prevymis?
English: Prevymis is effective in preventing CMV from becoming active and causing disease in adult recipients of a stem cell transplantation to replace the bone marrow.
Maltese: Prevymis huwa effettiv biex jipprevjeni lis-CMV milli jsir attiv u jikkawża l-mard f'riċevituri adulti ta' trapjanti ta' ċelloli staminali sabiex jiġi sostitwit il-mudullun.
English: Many people have CMV in their body but it is usually inactive and it does not cause harm.
Maltese: Is-CMV huwa preżenti fil-ġisem ta' ħafna persuni, iżda ġeneralment ikun inattiv u ma jikkawżax ħsara.
English: 15 to 29
Maltese: 15 sa 29
English: CrCL (mL/min)*
Maltese: CrCL stmata (mL/min)*
English: 30 to 50
Maltese: 30 sa 50
English: 63963, Clermont Ferrand Cedex 9 France
Maltese: 63963, Clermont Ferrand Cedex 9 Franza
English: Minimum Inhibitory Concentrations (mg/L)
Maltese: Konċentrazzjonijiet Inibitorji Minimi (mg/L)
English: 2031 BN Haarlem The Netherlands
Maltese: 2031 BN Haarlem L-Olanda
English: Tazobactam is a substrate for OAT1 and OAT3.
Maltese: Tazobactam huwa sottostrat għal OAT1 u OAT3.
English: 7 days
Maltese: 7 ijiem
English: Tazobactam is a beta-lactam structurally related to penicillins.
Maltese: Tazobactam huwa beta-lactam strutturalment relatat mal-penicillins.
English: Date of first authorisation: 18 September 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Settembru 2015
English: Modification of PBPs
Maltese: Modifikazzjoni tal-PBPs
English: System organ class
Maltese: Klassi tas-sistemi u talorgani
English: Direct antiglobulin test (Coombs test) seroconversion and potential risk of haemolytic anaemia
Maltese: Serokonverżjoni bit-test dirett ta' antiglobulina (test ta' Coombs) u riskju possibbli ta' anemija emolitika
English: 8-14 days
Maltese: 8-14-il jum
English: Gram-positive bacteria Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius
Maltese: Batterji Gram pożittivi Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius
English: Pack size of 10 vials.
Maltese: Daqs tal-pakkett ta' 10 kunjetti.
English: 4-14 days
Maltese: 4-14-il jum
English: These include: - Probenecid (a medicine for gout).
Maltese: - Probenecid (mediċina għall-gotta).
English: Serine-based carbapenemases (e.g., Klebsiella pneumoniae carbapenemases [KPCs]) iii.
Maltese: Carbapenemases abbażi ta' serine (eż., Klebsiella pneumoniae carbapenemases [KPCs]) iii.
English: Zerbaxa is indicated for the treatment of the following infections in adults (see section 5.1):
Maltese: Zerbaxa hu indikat għat-trattament tal-infezzjonijiet li ġejjin fl-adulti (ara sezzjoni 5.1):
English: 1, dizziness
Maltese: 1, dijarea
English: Approximately 66% of ceftolozane, 56% of tazobactam, and 51% of the M1 metabolite of tazobactam were removed by dialysis.
Maltese: Madwar 66% ta' ceftolozane, 56% ta' tazobactam, u 51% tal-metabolit M1 ta' tazobactam, tneħħew permezz tad-dijalisi.
English: AmpC enzymes (produced by Enterobacterales)
Maltese: Enzimi AmpC (magħmula minn Enterobacterales)
English: Metallo-beta-lactamases (e.g., New Delhi metallo-beta-lactamase [NDM]) iv. Ambler Class D beta-lactamases (OXA-carbapenemases)
Maltese: Metallo-beta-lactamases (eż., New Delhi metallo-beta-lactamase [NDM]) iv.
English: 1, flatulence 1, ileus paralytic
Maltese: 1, ileus paralitiku
English: Environmental Risk Assessment (ERA)
Maltese: Valutazzjoni tar-Riskju Ambjentali (ERA)
English: It is an inhibitor of many molecular Class A beta-lactamases, including CTX-M, SHV, and TEM enzymes.
Maltese: Huwa inibitur ta' ħafna betalactamases molekulari tal-Klassi A inkluż l-enzimi CTX-M, SHV, u TEM.
English: Sodium chloride, arginine, citric acid, anhydrous
Maltese: Sodium chloride, arginine, citric acid, anidru
English: Pharmacokinetic/pharmacodynamic relationships
Maltese: Relazzjonijiet farmakokinetiċi/farmakodinamiċi
English: Ceftolozane belongs to the cephalosporin class of antimicrobials.
Maltese: Ceftolozane jappartjeni għall-klassi ta' antimikrobjali cephalosporin.
English: In vitro, tazobactam inhibited human OAT1 and OAT3 transporters with IC50 values of 118 and 147 mcg/mL, respectively.
Maltese: OAT1 u OAT3 b'valuri IC50 ta' 118 u 147 mkg/mL, rispettivament.
English: - Complicated intra-abdominal infections (see section 4.4); - Acute pyelonephritis; - Complicated urinary tract infections (see section 4.4); - Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).
Maltese: - Infezzjonijiet ikkumplikati tal-passaġġ urinarju (ara sezzjoni 4.4); - Pulmonite li tittieħed fi sptar (HAP - hospital-acquired pneumonia), inkluża pulmonite assoċjata mal-ventilatur (VAP - ventilator-associated pneumonia).
English: Frequency categories are derived according to the following conventions: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) (see Table 3).
Maltese: Il-kategoriji ta' frekwenza jinkisbu skont il-konvenzjonijiet li ġejjin: komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100) (ara Tabella 3).
English: In the clinically evaluable (CE) patients, the clinical cure rates for ceftolozane/tazobactam were 95.9% in 293 patients aged less than 65 years and 87.8% in 82 patients aged 65 years or more.
Maltese: Fil-pazjenti li setgħu jiġu vvalutati b'mod kliniku (CE - clinically evaluable), ir-rati ta' kura klinika għal ceftolozane/tazobactam kienu ta' 95.9% f'293 pazjent li kellhom età anqas minn 65 sena u 87.8% fi 82 pazjent li kellhom età ta' 65 sena jew aktar.
English: 2, blood alkaline phosphatase increased 2, gammaglutamyltransferase increased
Maltese: 2, żieda flalkaline phosphatase fid-demm 2, żieda fil-gamma-glutamyltransferase
English: Gram-negative bacteria Escherichia coli Klebsiella pneumoniae Proteus mirabilis
Maltese: Batterji Gram negattivi Escherichia coli Klebsiella pneumoniae Proteus mirabilis
English: Gram-negative bacteria Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens
Maltese: Batterji gram negattivi Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens
English: Alanine aminotransferase increased aspartate aminotransferase increased transaminases increased
Maltese: Żieda fl-alanine aminotransferase 3, żieda fl-aspartate aminotransferase 3, żieda fit transaminases
English: Limitations of the clinical data
Maltese: Limitazzjonijiet tad-dejta klinika
English: Complicated intra-abdominal infection*
Maltese: Infezzjonijiet intraddominali kkumplikati*
English: In a randomised active-controlled trial 18.2% (126/693) of microbiologically evaluable (ME) patients had complicated lower urinary tract infection, including 60/126 patients who were treated with ceftolozane/tazobactam.
Maltese: Fi prova arbitrarja kkontrollata b'mod attiv 18.2% (126/693) tal-pazjenti li setgħu jiġu vvalutati b'mod mikrobijoloġiku (ME - microbiologically evaluable) kellhom infezzjoni kkumplikata fil-parti t'isfel tal-apparat tal-awrina, inkluż 60/126 pazjent li kienu ttrattati b'ceftolozane/tazobactam.
English: Gram-negative bacteria Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
Maltese: Batterji Gram negattivi Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
English: Acute pyelonephritis
Maltese: Pajelonefrite akuta
English: The binding of ceftolozane and tazobactam to human plasma proteins is low (approximately 16% to 21% and 30%, respectively).
Maltese: It-twaħħil ta' ceftolozane u tazobactam mal-proteini tal-plażma tal-bniedem hu baxx (madwar 16% sa 21% u 30%, rispettivament).
English: Ceftolozane/tazobactam is contraindicated in patients with a history of hypersensitivity to ceftolozane, tazobactam, or cephalosporins (see section 4.3).
Maltese: Ceftolozane/tazobactam huwa kontraindikat f'pazjenti bi storja ta' sensittività eċċessiva għal ceftolozane, tazobactam, jew cephalosporins (ara sezzjoni 4.3).
English: Zerbaxa contains sodium
Maltese: Zerbaxa fih is-sodium
English: Excipient with known effect Each vial contains 10 mmol (230 mg) of sodium.
Maltese: Eċċipjenti b'effett magħruf Kull kunjett fih 10 mmol (230 mg) ta' sodium.
English: No significant medicinal product interactions are anticipated between ceftolozane/tazobactam and substrates, inhibitors, and inducers of cytochrome P450 enzymes (CYPs) based on in vitro and in vivo studies.
Maltese: L-ebda interazzjonijiet sinifikanti tal-prodott mediċinali mhuma antiċipati bejn ceftolozane/tazobactam u substrati, inibituri, u indutturi ta' enzimi ta' ċitokrom P450 (CYPs) ibbażat fuq studji in vitro u in vivo.
English: The beta-lactam ring of tazobactam is hydrolyzed to form the pharmacologically inactive, tazobactam metabolite M1.
Maltese: Iċ-ċirku beta-lactam ta' tazobactam jiġi idrolizzat biex jifforma l-metabolit M1 farmakoloġikament inattiv ta' tazobactam.
English: Ceftolozane/tazobactam and the tazobactam metabolite M1 are eliminated by the kidneys.
Maltese: Ceftolozane/tazobactam u l-metabolit M1 ta' tazobactam jiġu eliminati mill-kliewi.
English: In vitro studies demonstrated that ceftolozane, tazobactam and the M1 metabolite of tazobactam did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 and did not induce CYP1A2, CYP2B6, or CYP3A4 at therapeutic plasma concentrations.
Maltese: Studji in vitro wrew li ceftolozane, tazobactam u l-metabolit M1 ta' tazobactam ma inibixxewx CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, jew CYP3A4, u ma induċewx CYP1A2, CYP2B6, jew CYP3A4 f'konċentrazzjonijiet terapewtiċi fil-plażma.
English: Ceftolozane, tazobactam and the tazobactam metabolite M1 are eliminated by the kidneys.
Maltese: Ceftolozane, tazobactam u l-metabolit M1 ta' tazobactam jiġu eliminati mill-kliewi.
English: In vitro data indicate that neither tazobactam nor the tazobactam metabolite M1 inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, or BSEP transporters at therapeutic plasma concentrations.
Maltese: Dejta in vitro tindika li la tazobactam u lanqas il-metabolit M1 ta' tazobactam ma jinibixxu P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, jew it-trasportaturi BSEP f'konċentrazzjonijiet terapewtiċi fil-plażma.
English: Table 3: Adverse reactions identified during clinical trials with ceftolozane/tazobactam System organ class
Maltese: Tabella 3: Reazzjonijiet avversi identifikati matul il-provi kliniċi b'ceftolozane/tazobactam
English: The elimination half-life (t½) of ceftolozane is independent of dose.
Maltese: Ilhalf-life tal-eliminazzjoni (t½) ta' ceftolozane hija indipendenti mid-doża.
English: Atrial fibrillation 1, tachycardia angina pectoris
Maltese: 1, anġina pectoris
English: In a trial in patients with complicated intra-abdominal infections, the most common diagnosis was appendiceal perforation or peri-appendiceal abscess (420/970 [43.3%] patients), of which 137/420 (32.6%) had diffuse peritonitis at baseline.
Maltese: Fi prova f'pazjenti b'infezzjonijiet intraddominali kkumplikati, l-iktar dijanjosi komuni kienet perforazzjoni tal-appendiċi jew axxess viċin l-appendiċi (420/970 [43.3%] pazjent), li minnhom 137/420 (32.6%) kellhom peritonite mifruxa fil-linja bażi.
English: In vitro data indicate that ceftolozane did not inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, MRP, BSEP, OAT1, OAT3, MATE1, or MATE2-K in vitro at therapeutic plasma concentrations.
Maltese: Dejta in vitro tindika li ceftolozane ma inibixxiex P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, MRP, BSEP, OAT1, OAT3, MATE1, jew MATE2-K in vitro f'konċentrazzjonijiet terapewtiċi fil-plażma.
English: After a single dose of ceftolozane/tazobactam, renal clearance of ceftolozane (3.41 - 6.69 L/h) was similar to plasma clearance (4.10 - 6.73 L/h) and similar to the glomerular filtration rate for the unbound fraction, suggesting that ceftolozane is eliminated by the kidney via glomerular filtration.
Maltese: Wara doża waħda ta' ceftolozane/tazobactam, it-tneħħija ta' ceftolozane mill-kliewi (3.41 - 6.69 L/siegħa) kienet simili għat-tneħħija mill-plażma (4.10 - 6.73 L/siegħa) u kienet simili għar-rata ta' filtrazzjoni glomerulari tal-porzjon mhux imwaħħal, li jissuġġerixxi li ceftolozane jiġi eliminat mill-kliewi permezz ta' filtrazzjoni glomerulari.
English: 250 mg ceftolozane / 125 mg tazobactam intravenously every 8 hours
Maltese: 250 mg ceftolozane / 125 mg tazobactam ġol-vini kull 8 sigħat
English: Complicated intra-abdominal infections
Maltese: Infezzjonijiet intraddominali kkumplikati
English: The ceftolozane dose normalized geometric mean AUC increased up to 1.26-fold, 2.5-fold, and 5-fold in subjects with mild, moderate, and severe renal impairment, respectively, compared to healthy subjects with normal renal function.
Maltese: Il-medja ġeometrika normalizzata tal-AUC ta' doża ta' ceftolozane żdiedet sa 1.26 darbiet, 2.5 darbiet, u 5 darbiet aktar f'individwi b'indeboliment ħafif, moderat, u sever tal-kliewi rispettivament, meta mqabbla ma' individwi f'saħħithom b'funzjoni normali tal-kliewi.
English: 1, anxiety Nervous system disorders Headache
Maltese: Disturbi fis-sistema nervuża
English: Preparation of solutions
Maltese: Preparazzjoni tas-soluzzjonijiet
English: 20 mL vial (Type I clear glass) with stopper (bromobutyl rubber) and flip-off seal.
Maltese: Kunjett ta' 20 mL (ħġieġ ċar ta' Tip I) b'tapp (lastku tal-bromobutyl) u siġill tat-tip flip-off.
English: 500 mg ceftolozane / 250 mg tazobactam intravenously every 8 hours
Maltese: 500 mg ceftolozane / 250 mg tazobactam ġol-vini kull 8 sigħat
English: The following adverse reactions have been identified during clinical trials with Zerbaxa.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew identifikati matul il-provi kliniċi b'Zerbaxa.
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - Hypersensitivity to any cephalosporin antibacterial agent; - Severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems).
Maltese: - Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1; - Sensittività eċċessiva għal kwalunkwe sustanza antibatterika cephalosporin; - Sensittività eċċessiva severa (eż., reazzjoni anafilattika, reazzjoni severa fil-ġilda) għal kwalunkwe tip ieħor ta' sustanza antibatterika beta-lactam (eż., penicillins jew carbapenems).
English: Zerbaxa 1 g / 0.5 g powder for concentrate ceftolozane / tazobactam
Maltese: Zerbaxa 1 g / 0.5 g trab għal konċentrat ceftolozane / tazobactam
English: When the powder is reconstituted with 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, the vial contains 11.5 mmol (265 mg) of sodium.
Maltese: Meta t-trab jiġi rikostitwit b'10 mL ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride, il-kunjett ikun fih 11.5 mmol (265 mg) ta' sodium.
English: Inflammation of the large intestine due to C. difficile bacteria, inflammation of the stomach, abdominal distension, indigestion, excessive gas in stomach or bowel, obstruction of the intestine, yeast infection in the mouth (thrush), yeast infection of female genitalia, fungal urinary tract infection, increase in sugar (glucose) levels (from blood tests), decrease in magnesium levels (from blood tests), decrease in phosphate levels (from blood tests), ischemic stroke (stroke caused by reduced blood flow in brain), irritation or inflammation of a vein at injection site, venous thrombosis (blood clot in a vein), low red blood cell counts, atrial fibrillation (rapid or irregular heartbeat), fast heart beat, angina pectoris (chest pain or feeling of tightness, pressure or heaviness in chest), itchy rash or swellings on the skin, hives, Coombs test positive (a blood test that looks for antibodies that may fight against your red blood cells), kidney problems, kidney disease, shortness of breath
Maltese: Difficile, infjammazzjoni talistonku, nefħa fl-addome, indiġestjoni, gass eċċessiv fl-istonku jew fil-musrana, sadda filmusrana, infezzjoni bil-ħmira fil-ħalq (ħrar), infezzjoni bil-ħmira fil-partijiet ta' barra talġenitali tal-mara, infezzjoni bil-fungu fl-apparat tal-awrina, żieda fil-livelli (minn testijiet taddemm) ta' zokkor (glucose) fid-demm, tnaqqis fil-livelli (minn testijiet tad-demm) ta' magnesium, tnaqqis fil-livelli (minn testijiet tad-demm) ta' phosphate, puplesija iskemika (puplesija kkawżata minn tnaqqis fil-provvista tad-demm lejn il-moħħ), irritazzjoni jew infjammazzjoni ta' vina fil-post tal-injezzjoni, trombożi fil-vini (tagħqid tad-demm ġo vina), għadd baxx ta' ċelluli ħomor tad-demm, fibrillazzjoni tal-atriju (taħbit tal-qalb mgħaġġel jew irregolari), qalb tħabbat tgħaġġel, anġina pectoris (uġigħ fis-sider jew sensazzjoni ta' tagħfis,
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 web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornamenti sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Approximately 82% of all patients in the trial had APACHE II (Acute Physiology and Chronic Health Evaluation II) scores of < 10 and 2.3% had bacteraemia at baseline.
Maltese: Madwar 82% tal-pazjenti kollha fil-prova kellhom punteġġi APACHE II (Valutazzjoni ta' Fiżjoloġija Akuta u Saħħa Kronika II) ta' < 10 u 2.3% kellhom batterimja fil-linja bażi.
English: The mean (coefficient of variation CV%) steady-state volume of distribution of ceftolozane/tazobactam in healthy adult males (n=51) following a single 1 g / 0.5 g IV dose was 13.5 L (21%) and 18.2 L (25%) for ceftolozane and tazobactam, respectively, similar to extracellular fluid volume.
Maltese: IV ta' 1 g / 0.5 g kienet ta' 13.5 L (21%) u 18.2 L (25%) għal ceftolozane u tazobactam, rispettivament, u dan hu simili għall-volum ta' fluwidu ekstraċellulari.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: ceftolozane administered to rats during pregnancy and lactation was associated with a decrease in auditory startle response in postnatal day (PND) 60 male pups at maternal doses of 300 and 1,000 mg/kg/day.
Maltese: Reazzjonijiet avversi mhux osservati fl-istudji kliniċi, iżda li dehru fl-annimali f'livelli ta' esponiment simili għal livelli ta' esponiment kliniku u b'rilevanza possibbli għall-użu kliniku, kienu kif ġej: ceftolozane mogħti lil firien waqt it-tqala u t-treddigħ ġie assoċjat ma' tnaqqis fir-rispons awditorju għal ħasda f'60 ferħ raġel f'jum 60 wara t-twelid (PND - postnatal day) f'dożi materni ta' 300 u 1,000 mg/kg/jum.