FrancophonIA/ELRC3.0 huggingface dataset:
English: Daptomycin administered as a 2-minute intravenous injection also exhibited dose proportional pharmacokinetics in the approved therapeutic dose range of 4 to 6 mg/kg.
Maltese: Daptomycin mogħti bħala injezzjoni ta' 2 minuti fil-vina ukoll wera farmakokinetika fi proporzjon mad-doża fuq il-medda tad-doża terapewtika approvata ta' 4 sa 6 mg/kg.
English: In paediatric patients aged 7 to 17 years, Cubicin is given by intravenous infusion over a 30-minute period (see section 6.6).
Maltese: F'pazjenti pedjatriċi li għandhom bejn 7 snin u 17-il sena, Cubicin jingħata permezz ta' infużjoni filvina fuq perjodu ta' 30 minuta (ara sezzjoni 6.6).
English: - Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB).
Maltese: - Pazjenti adulti u pedjatriċi (b'età minn sena sa 17-il sena) b'batterimja minn Staphylococcus aureus (SAB).
English: Cubicin 500 mg powder for solution for injection or infusion EU/1/05/328/002
Maltese: Cubicin 500 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni EU/1/05/328/002
English: Cubicin 350 mg powder for solution for injection or infusion EU/1/05/328/001
Maltese: Cubicin 350 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni EU/1/05/328/001
English: 12 mg/kg once every 24 hours infused over 60 minutes cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; (1) Minimum duration of Cubicin for paediatric SAB should be in accordance with the perceived risk of complications in the individual patient.
Maltese: 24 siegħa infuża fuq perjodu ta' 60 minuta cSSTI (complicated skin and soft-tissue infections) = infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob; SAB = batterimja bi S. aureus; (1) It-tul minimu ta' żmien ta' Cubicin għal SAB pedjatrika għandu jkun skont ir-riskju perċettibbli ta' kumplikazzjonijiet fil-pazjent individwali.
English: No data are available in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: M'hemmx dejta dwar pazjenti b'indeboliment tal-fwied sever (Klassi C ta' Child-Pugh).
English: 1 vial 5 vials
Maltese: 5 kunjetti
English: Eosinophilic pneumonia has been reported in patients receiving Cubicin (see section 4.8).
Maltese: Pulmonite eosinofilika kienet irrappurtata f'pazjenti mogħtija Cubicin (ara sezzjoni 4.8).
English: No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed.
Maltese: Ma ġewx osservati differenzi klinikament sinifikanti fil-farmakokinetika ta' daptomycin relatati massess tal-persuna.
English: Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
English: Relative to non-obese subjects daptomycin systemic exposure measured by AUC was about 28% higher in moderately obese subjects (Body Mass Index of 25-40 kg/m2) and 42% higher in extremely obese subjects (Body Mass Index of > 40 kg/m 2).
Maltese: Imqabbla ma' individwi li m'għandomx piż żejjed, l-esponiment sistemiku ta' daptomycin imkejjel mill-AUC kien madwar 28% ogħla f'individwi b'piż żejjed b'mod moderat (Indiċi tal-Piż tal-Ġisem ta' 25-45 kg/m2) u 42% ogħla f'individwi b'piż żejjed b'mod esaġerat (Indiċi tal-Piż tal-Ġisem ta' >40 kg/m2).
English: - Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting.
Maltese: - Antikoagulanti orali (eż. warfarin), li huma mediċini li ma jħallux id-demm jagħqad.
English: Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients and 156 were healthy volunteers.
Maltese: F'dawn il-provi, 1,221 individwu rċevew doża ta' 4 mg/kg kuljum li minnhom 1,108 kienu pazjenti u 113 kienu voluntiera b'saħħithom; 460 individwu irċevew doża ta' 6 mg/kg li minnhom 304 kienu pazjenti u 156 kienu voluntiera f'saħħithom.
English: In healthy adult volunteers and adult patients treated with daptomycin, protein binding averaged about 90% including subjects with renal impairment.
Maltese: F'voluntiera adulti f'saħħithom u f'pazjenti adulti kkurati b'daptomycin, l-irbit mal-proteini laħaq medja ta' 90% inklużi individwi b'indeboliment renali.
English: There is insufficient evidence to be able to draw any conclusions regarding the possible clinical efficacy of Cubicin against infections due to enterococci, including Enterococcus faecalis and Enterococcus faecium.
Maltese: M'hemmx biżżejjed evidenza sabiex wieħed jasal għal xi konklużjonijiet fir-rigward tal-effikaċja klinika possibbli ta' Cubicin għall-infezzjonijiet ġejjin minn enterokokki, inklużi Enterococcus faecalis u Enterococcus faecium.
English: Uncommon: Thrombocythaemia, eosinophilia, international normalised ratio (INR) increased, leukocytosis
Maltese: Tromboċitemija, eosinofilja, żieda fil-proporzjon internazzjonali normalizzat (INR), lewkoċitożi
English: Dizziness, headache
Maltese: Dispepsja, glossite
English: Table 1 Adverse reactions from clinical studies and post-marketing reports
Maltese: Tabella 1 Reazzjonijiet avversi skont studji kliniċi u rapporti ta' wara t-tqegħid fis-suq
English: Following intravenous administration, plasma clearance of daptomycin is approximately 7 to 9 ml/h/kg and its renal clearance is 4 to 7 ml/h/kg.
Maltese: Wara li jingħata minn ġol-vina, it-tneħħija ta' daptomycin mill-plażma hija madwar 7 sa 9 ml/siegħa/kg u t-tneħħija mill-kliewi hija 4 sa 7 ml/siegħa/kg.
English: The response to treatment, renal function and creatine phosphokinase (CPK) levels should be closely monitored in all patients with any degree of renal impairment (see also sections 4.4 and 5.2).
Maltese: Irrispons għat-trattament, il-funzjoni renali u l-livelli ta' creatine phosphokinase (CPK) għandhom ikunu segwiti mill-qrib fil-pazjenti kollha li għandhom kwalunkwe grad ta' indeboliment renali (ara wkoll sezzjonijiet 4.4 u 5.2).
English: For example, patients with any degree of renal impairment (creatinine clearance < 80 ml/min; see also section 4.2), including those on haemodialysis or CAPD, and patients taking other medicinal products known to be associated with myopathy (e.g. HMG-CoA reductase inhibitors, fibrates and ciclosporin).
Maltese: Per eżempju, pazjenti bi kwalunkwe grad ta' indeboliment tal-kliewi (tneħħija tal-krejatinina < 80 ml/min; ara wkoll sezzjoni 4.2), inkluż dawk li qegħdin fuq l-emodijalisi jew is-CAPD, u pazjenti li qed jieħdu prodotti mediċinali oħra magħrufa li huma assoċjati ma' mijopatija (eż. impedituri ta' HMG-CoA reductase, fibrates u ciclosporin).
English: In particular, there have been reports of treatment failures in patients infected with Staphylococcus aureus, Enterococcus faecalis or Enterococcus faecium, including bacteraemic patients, that have been associated with the selection of organisms with reduced susceptibility or frank resistance to daptomycin during therapy.
Maltese: B'mod partikolari, kien hemm rapporti ta' fallimenti ta' kura f'pazjenti infettati b'Staphylococcus aureus, Enterococcus faecalis jew Enterococcus faecium, inklużi pazjenti bil-batterimja, li kienet assoċjata mal-għażla tal-organiżmi b'suxxettibilità mnaqqsa jew reżistenza evidenti għal daptomycin waqt itterapija.
English: In two adult clinical trials in complicated skin and soft tissues infections, 36% of patients treated with Cubicin met the criteria for systemic inflammatory response syndrome (SIRS).
Maltese: F'żewġ provi kliniċi ta' infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob fl-adulti, 36% talpazjenti kkurati b'Cubicin laħqu l-kriterju għal sindromu ta' rispons infjammatorju sistemiku (SIRS).
English: Uncommon: Myositis, increased myoglobin, muscular weakness, muscle pain, arthralgia, serum lactate dehydrogenase (LDH) increased, muscle cramps
Maltese: Mijosite, żieda fil-mijoglobina, dgħufija tal-muskoli, uġigħ fil-muskoli, artralġja, żieda tal-lactate dehydrogenase fis-serum (LDH), bugħawwiġijiet filmuskoli
English: The interaction between daptomycin and tobramycin with an approved dose of Cubicin is unknown.
Maltese: L-interazzjoni bejn daptomycin u tobramycin b'doża approvata ta' Cubicin m'hijiex magħrufa.
English: - Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.
Maltese: - Pazjenti adulti b'endokardite infettiva fin-naħa tal-lemin (RIE) minħabba Staphylococcus aureus.
English: - That Cubicin can interfere with coagulation tests (PT/INR) and this might lead to false results.
Maltese: - Li Cubicin jista' jinterferixxi mat-testijiet ta' koagulazzjoni (PT/INR) u dan jista' jwassal għal riżultati foloz.
English: Daptomycin is active against Gram positive bacteria only (see section 5.1).
Maltese: Daptomycin huwa attiv kontra batterji tat-tip Gram pożittivi biss (ara sezzjoni 5.1).
English: Not known*: Hypersensitivity**, manifested by isolated spontaneous reports including, but not limited to angioedema, drug rash with eosinophilia and systemic symptoms (DRESS), pulmonary eosinophilia, vesicobullous rash with mucous membrane involvement and sensation of oropharyngeal swelling, anaphylaxis**, infusion reactions including the following symptoms: tachycardia, wheezing, pyrexia, rigors, systemic flushing, vertigo, syncope and metallic taste
Maltese: Ipersensittività**, murija permezz ta' rapporti spontanji iżolati li jinkludu, imma mhux limitati għal anġjoedima, raxx minħabba l-mediċina b'eosinofilja u sintomi sistemiċi (DRESS), eosinofilja tal-pulmuni, raxx vesikobulluż b'involviment ta' membrana mukuża u sensazzjoni ta' nefħa fil-ħalq u l-farinġi, anafilassi**, reazzjonijiet għall-infużjoni li jinkludu s-sintomi li ġejjin: takikardija, tħarħir, deni, tertir, fwawar sistemiċi, vertigo, sinkope u togħma ta' metall
English: Studies of Cubicin with anticoagulants other than warfarin have not been conducted.
Maltese: Ma sarux studji dwar Cubicin ma' antikoagulanti apparti mal-warfarin.
English: Cubicin will usually be given to you by a doctor or a nurse.
Maltese: Cubicin normalment jingħatalek minn tabib jew infermier.
English: Clinical data on the use of Cubicin to treat RIE due to Staphylococcus aureus are limited to 19 adult patients (see “Information from clinical trials” in section 5.1).
Maltese: Dejta klinika dwar l-użu ta' Cubicin għall-kura ta' RIE minħabba Staphylococcus aureus hija limitata għall-19-il pazjent (ara “Tagħrif minn provi kliniċi” f'sezzjoni 5.1).
English: However, when compared with the same doses given as intravenous infusions over 30 minutes there were no clinically important differences in the pharmacokinetics and safety profile of daptomycin (see also sections 4.8 and 5.2).
Maltese: Madankollu, meta mqabbel mal-istess dożi mogħtija bħala infużjoni ġol-vini fuq perjodu ta' 30 minuta ma kien hemm l-ebda differenzi klinikament importanti fil-farmakokinetika u l-profil ta' sigurtà ta' daptomycin (ara wkoll sezzjonijiet 4.8 u 5.2).
English: In a mass balance study using radiolabelled material, 78% of the administered dose was recovered from the urine based on total radioactivity, whilst urinary recovery of unchanged daptomycin was approximately 50% of the dose.
Maltese: Fi studju ta' mass balance b'materjal radjutikkettat, 78% tad-doża mogħtija kienet irkuprata millawrina bbażata fuq ir-radjuattività totali, filwaqt li l-ammont ta' daptomycin mhux mibdul irkuprat mill-awrina kien madwar 50% tad-doża.
English: The volume of distribution at steady state of daptomycin in healthy adult subjects was approximately 0.1 l/kg and was independent of dose.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss ta' daptomycin f'individwi adulti b'saħħithom kien madwar 0.1 l/kg u kien indipendenti mid-doża.
English: The pharmacokinetics of daptomycin is not altered in subjects with moderate hepatic impairment (Child-Pugh B classification of hepatic impairment) compared with healthy volunteers matched for gender, age and weight following a single 4 mg/kg dose.
Maltese: Il-farmakokinetika ta' daptomycin ma tinbidilx f'individwi b'indeboliment tal-fwied moderat (Klassi B ta' indeboliment tal-fwied ta' Child-Pugh) meta mqabbla ma' voluntiera b'saħħithom ippariġġati skont is-sess, l-età u l-piż tal-ġisem wara doża waħda ta' 4 mg/kg.
English: Daptomycin is an antibacterial that can stop the growth of certain bacteria.
Maltese: Daptomycin huwa antibatteriku li jista' jwaqqaf it-tkattir ta' ċerti batterji.
English: It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Maltese: M'huwiex mistenni li daptomycin jinibixxi jew jinduċi l-metaboliżmu ta' prodotti mediċinali mmetabolizzati bis-sistema P450.
English: Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy adult volunteers.
Maltese: Il-farmakokinetika ta' daptomycin normalment issegwi linja dritta u ma tiddependix mill-ħin f'dożi ta' 4 sa 12-il mg/kg mogħtija bħala doża waħda kuljum permezz ta' infużjoni ta' 30 minuta fil-vina għal mhux aktar minn 14-il jum f'voluntiera adulti f'saħħithom.
English: In paediatric patients aged 1 to 6 years, Cubicin is given by intravenous infusion over a 60-minute period (see section 6.6).
Maltese: F'pazjenti pedjatriċi li għandhom bejn sena u 6 snin, Cubicin jingħata permezz ta' infużjoni fil-vina fuq perjodu ta' 60 minuta (ara s-sezzjoni 6.6).
English: Transfer the required reconstituted dose into 50 ml sodium chloride 9 mg/ml (0.9%).
Maltese: Ittrasferixxi d-doża rrikostitwita meħtieġa ġo 50 ml sodium chloride 9 mg/ml (0.9%).
English: In adults, Cubicin is given by intravenous infusion (see section 6.6) and administered over a 30minute period or by intravenous injection (see section 6.6) and administered over a 2-minute period.
Maltese: Fl-adulti, Cubicin jingħata permezz ta' infużjoni fil-vina (ara sezzjoni 6.6) u jingħata fuq perijodu ta' 30 minuta jew permezz ta' injezzjoni fil-vina (ara sezzjoni 6.6) u jingħata fuq perijodu ta' 2 minuti.
English: Cubicin given as an intravenous infusion over 30 or 60 minutes
Maltese: Cubicin mogħti bħala infużjoni fil-vina fuq perjodu ta' 30 jew 60 minuta
English: An adjustment of Cubicin dose interval is needed for adult patients whose creatinine clearance is < 30 ml/min (see sections 4.2 and 5.2).
Maltese: Aġġustament tal-intervall tad-doża ta' Cubicin huwa meħtieġ għal pazjenti adulti li t-tneħħija talkrejatinina tagħhom hija <30 ml/min (ara sezzjonijiet 4.2 u 5.2).
English: Regular monitoring of renal function is advised (see also section 5.2).
Maltese: Monitoraġġ regolari tal-funzjoni renali huwa rrikmandat (ara wkoll sezzjoni 5.2).
English: Daptomycin had no effect on the pharmacokinetics of warfarin or probenecid, nor did these medicinal products alter the pharmacokinetics of daptomycin.
Maltese: Daptomycin ma kellu l-ebda effett fuq il-farmakokinetika ta' warfarin jew probenecid, u dawn ilprodotti mediċinali lanqas ma bidlu l-farmakokinetika ta' daptomycin.
English: • Age group 1 (n=113): 12 to 17 years treated with daptomycin dosed at 5 mg/kg or standard-of care comparator (SOC);
Maltese: • Grupp ta' età 1 (n=113): Minn 12 sa 17-il sena kkurati b'daptomycin f'doża ta' 5 mg/kg jew kumparatur standard ta' kura (SOC);
English: EU/1/05/328/002 1 vial EU/1/05/328/004 5 vials
Maltese: EU/1/05/328/002 kunjett 1 EU/1/05/328/004 5 kunjetti
English: There is limited experience regarding concomitant administration of daptomycin with other medicinal products that may trigger myopathy (e.g. HMG-CoA reductase inhibitors).
Maltese: Hemm esperjenza limitata dwar l-għoti fl-istess ħin ta' daptomycin ma' prodotti mediċinali oħrajn li jistgħu jqanqlu mijopatija (eż. inibituri ta' HMG-CoA reductase).
English: Coagulase negative staphylococci
Maltese: Staphylococci negattivi għall-Coagulase
English: Inactive metabolites were detected in urine, as determined by the difference in total radioactive concentrations and microbiologically active concentrations.
Maltese: Metaboliti inattivi nstabu fl-awrina, kif iddeterminat mid-differenza fit-total tal-konċentrazzjonijiet radjuattivi u l-konċentrazzjonijiet attivi mikrobijoloġikament.
English: EU/1/05/328/001 1 vial EU/1/05/328/003 5 vials
Maltese: EU/1/05/328/001 kunjett 1 EU/1/05/328/003 5 kunjetti
English: 12 mg/kg 60 minutes
Maltese: 12 mg/kg
English: constipation, diarrhoea, flatulence, bloating and distension, liver function tests abnormal (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP)), rash, pruritus, limb pain, serum creatine phosphokinase (CPK) increased, infusion site reactions, pyrexia, asthenia.
Maltese: Infezzjonijiet bil-fungu, infezzjoni fil-passaġġ tal-awrina, infezzjoni b'kandida, anemija, ansjetà, nuqqas ta' rqad, sturdament, uġigħ ta' ras, pressjoni għolja, pressjoni baxxa, uġigħ gastrointestinali u addominali, dardir, rimettar, stitikezza, dijarrea, gass fl-istonku, nefħa u distensjoni, testijiet mhux normali tal-funzjoni tal-fwied (żieda f'alanine aminotransferase (ALT), f'aspartate aminotransferase(AST) jew alkaline phosphatase (ALP)), raxx, ħakk, uġigħ fl-idejn u r-riġlejn, żieda fil-creatine phosphokinase fis-serum (CPK), reazzjonijiet fis-sit tal-infużjoni, deni, astenja.
English: Daptomycin exhibits rapid, concentration dependent bactericidal activity against Gram positive organisms in vitro and in in vivo animal models.
Maltese: Daptomycin juri attività mgħaġġla ta' qtil ta' batterji, li tiddependi mill-konċentrazzjoni, kontra organiżmi Gram pożittivi li huma in vitro u f'mudelli ta' annimali in vivo.
English: After a single 6 mg/kg dose of Cubicin, the clearance and elimination half-life of daptomycin in children 13-24 months of age were similar to children 2-6 years of age who received a single 4-10 mg/kg dose.
Maltese: Wara doża waħda ta' 6 mg/kg ta' Cubicin, it-tneħħija u l-half-life ta' eliminazzjoni ta' daptomycin fit-tfal li għandhom età minn 13-24 xahar kienu jixbhu dawk ta' tfal li kellhom minn sentejn sa 6 snin li ħadu doża waħda ta' 4-10 mg/kg.
English: Anaphylaxis/hypersensitivity reactions
Maltese: Reazzjonijiet anafilattiċi/ta' ipersensittività
English: Obesity In obese subjects with Body Mass Index (BMI) > 40 kg/m2 but with creatinine clearance > 70 ml/min, the AUC0-∞ daptomycin was significantly increased (mean 42% higher) compared with non-obese matched controls.
Maltese: F'individwi b'ħafna piż żejjed b'Indiċi tal-Piż tal-Ġisem (BMI) >40 kg/m2 iżda bi tneħħija talkrejatinina >70 ml/min, l-AUC0-∞ ta' daptomycin għoliet b'mod sinifikanti (medja ta' 42% ogħla) meta mqabbla ma' kontrolli mingħajr piż żejjed ppariġġati magħhom.
English: Clostridium difficile-associated diarrhoea
Maltese: Dijarea assoċjata ma' clostridium difficile
English: No clinical data on fertility are available for daptomycin.
Maltese: L-ebda tagħrif kliniku dwar il-fertilità ma huwa disponibbli għal daptomycin.
English: Summary of Blinded Evaluator defined clinical outcome at TOC: Clinical Success in Paediatric SAB Daptomycin n/N (%)
Maltese: Suċċess Kliniku f'SAB Pedjatrika Daptomycin n/N (%)
English: In a randomised controlled open-label study in 235 adult patients with Staphylococcus aureus bacteraemia (i.e. at least one positive blood culture of Staphylococcus aureus prior to receiving the first dose) 19 of 120 patients treated with Cubicin met the criteria for RIE.
Maltese: Fi studju randomised ikontrollat open-label ta' 235 pazjent adult b'batterimja bi Staphylococcus aureus (jiġifieri mill-inqas koltura waħda tad-demm pożittiva bi Staphylococcus aureus qabel ma' rċievew l-ewwel doża) 19 mill-120 pazjent ikkurati bi Cubicin issodisfaw il-kriterji għal RIE.
English: RIE or cSSTI associated with SAB
Maltese: RIE jew cSSTI assoċjata ma' SAB
English: Following administration of a single 4 mg/kg intravenous dose of Cubicin over a 30-minute period, the mean total clearance of daptomycin was approximately 35% lower and the mean AUC0-∞ was approximately 58% higher in elderly subjects (≥ 75 years of age) compared with those in healthy young subjects (18 to 30 years of age).
Maltese: Wara l-għoti ta' doża waħda ta' 4 mg/kg Cubicin fil-vina fuq medda ta' 30 minuta, il-medja tattneħħija totali ta' daptomycin kienet madwar 35% anqas u l-medja tal-AUC0-∞ kienet madwar 58% ogħla f'individwi anzjani (età ta' ≥75 sena) meta mqabbla ma' dawk f'individwi żgħażagħ b'saħħithom (età bejn 18 u 30 sena).
English: Less frequently reported, but more serious, adverse reactions include hypersensitivity reactions, eosinophilic pneumonia (occasionally presenting as organising pneumonia), drug rash with eosinophilia and systemic symptoms (DRESS), angioedema and rhabdomyolysis.
Maltese: Reazzjonijiet avversi rrappurtati b'anqas frekwenza, imma aktar serji, jinkludu reazzjonijiet ta' sensittiva eċċessiva, pnewmonja eosinofilika (li kultant tidher bħala pulmonite sistematizzata), raxx minħabba l-mediċina b'eosinofilja u sintomi sistemiċi (DRESS), anġjoedima u rabdomijolisi.
English: After a single 4, 8, or 10 mg/kg dose of Cubicin, total clearance and elimination half-life of daptomycin in children 2-6 years of age were similar at different doses; total clearance was higher and elimination half-life was shorter than in adolescents.
Maltese: Wara doża waħda ta' 4, 8, jew 10 mg/kg ta' Cubicin, it-tneħħija totali u l-half-life ta' eliminazzjoni ta' daptomycin fit-tfal b'età minn sentejn sa 6 snin kienu jixxiebhu b'dożi differenti; it-tneħħija totali kienet ogħla u l-half life ta' eliminazzjoni kienet iqsar milli fl-adolexxenti.
English: Clinical studies in patients employed infusion of daptomycin over at least 30 minutes.
Maltese: Fi studji kliniċi fuq pazjenti ntużat infużjoni ta' daptomycin fuq perjodu ta' mill-inqas 30 minuta.
English: In animal models AUC/MIC and Cmax/MIC correlate with efficacy and predicted bacterial kill in vivo at single doses equivalent to human adult doses of 4 mg/kg and 6 mg/kg once daily.
Maltese: F'mudelli ta' annimali, lAUC/MIC u Cmax/MIC jikkorelataw mal-effikaċja u l-qtil ta' batterji li jkun imbassar in vivo b'dożi ta' darba ekwivalenti għal dożi ta' 4 mg/kg u 6 mg/kg darba kuljum fil-bnedmin adulti.
English: • Age group 4 (n=45): 1 to < 2 years treated with daptomycin dosed at 10 mg/kg or SOC.
Maltese: • Grupp ta' età 4 (n=45): Minn sena sa < sentejn ikkurati b'daptomycin f'doża ta' 10 mg/kg jew SOC.
English: Available in packs containing 1 vial or 5 vials.
Maltese: Disponibbli f'pakketti li fihom kunjett 1 jew 5 kunjetti.
English: - The other ingredient is sodium hydroxide.
Maltese: - Is-sustanza l-oħra hija sodium hydroxide.
English: 350 mg presentation:
Maltese: Preparat tat-350 mg:
English: These may be signs of a rare but serious lung disorder called eosinophilic pneumonia.
Maltese: Dawn jistgħu jkunu sinjali ta' disturb rari imma serju fil-pulmun imsejjaħ pulmonite eosinofilika.
English: In adults, daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes.
Maltese: Fl-adulti daptomycin jista' jingħata fil-vini bħala infużjoni fuq perjodu ta' 30 minuta jew bħala injezzjoni fuq 2 minuti.
English: The safety and efficacy of daptomycin was evaluated in paediatric patients aged 1 to 17 years (Study DAP-PEDS-07-03) with cSSTI caused by Gram positive pathogens.
Maltese: Is-sigurtà u l-effikaċja ta' daptomycin ġew evalwati f'pazjenti pedjatriċi fl-età ta' bejn sena u 17il sena (Studju DAP-PEDS-07-03) b'cSSTI ikkawżata minn patoġeni Gram-pożittivi.
English: In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes (see sections 4.2 and 5.2).
Maltese: F'pazjenti pedjatriċi ta' taħt is-7 snin li jkunu qed jirċievu doża ta' 9-12-il mg/kg, daptomycin għandu jingħata fuq 60 minuta (ara sezzjonjiet 4.2 u 5.2).
English: Based on these study results, both methods of daptomycin administration, the 2-minute intravenous injection and the 30-minute intravenous infusion, had a similar safety and tolerability profile.
Maltese: Fuq il-bażi tar-riżultati ta' dawn l-istudji, iż-żewġ metodi tal-għoti ta' daptomycin, l-injezzjoni ta' 2 minuti fil-vina u l-infużjoni ta' 30 minuta fil-vina, kellhom profil ta' sigurtà u tollerabiltà simili.