FrancophonIA/ELRC3.0 huggingface dataset:
English: - Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
Maltese: - Pazjenti adulti u pedjatriċi (minn sena sa 17-il sena) b'infezzjonijiet ikkumplikati tal-ġilda u tattessut artab (cSSTI, complicated skin and soft-tissue infections).
English: Daptomycin Hospira is available in packs containing 1 vial or 5 vials.
Maltese: Daptomycin Hospira hu disponibbli f'pakketti li fihom kunjett 1 jew 5 kunjetti.
English: Daptomycin Hospira is administered intravenously in 0.9 % sodium chloride (see section 6.6).
Maltese: Daptomycin Hospira jingħata ġol-vini f'0.9 % sodium chloride (ara sezzjoni 6.6).
English: A total of 81 subjects were treated in the study, including 55 subjects who received daptomycin and 26 subjects who received standard-of-care.
Maltese: Total ta' 81 individwu ġew ittrattati fl-istudju, inklużi 55 individwu li rċivew daptomycin u 26 individwu li rċivew kura standard.
English: Paediatric patients with SAB
Maltese: Pazjenti pedjtariċi b'SAB
English: Microbiological Success rate in Paedatric SAB n/N (%)
Maltese: Rata ta' Suċċess Mikrobijoloġiku f'SAB Pedjatrika n/N (%)
English: Comparator n/N (%)
Maltese: Kumparatur n/N (%)
English: Daptomycin Hospira given as 2-minute intravenous injection (adult patients only)
Maltese: Daptomycin Hospira mogħti bħala injezzjoni ġol-vini fuq perjodu ta' 2 minuti (pazjenti adulti biss)
English: - Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.
Maltese: - Pazjenti adulti b'endokardite infettiva fuq in-naħa tal-lemin (RIE, right-sided infective endocarditis) minħabba Staphylococcus aureus.
English: Enterococcal infections
Maltese: Infezzjonijiet enterokokkali
English: Anaphylaxis/hypersensitivity reactions
Maltese: Reazzjonijiet anafilassi/ta' sensittività eċċessiva
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
Maltese: Meta mqabbla ma' individwi mhux obeżi, l-esponiment sistemiku ta' daptomycin imkejjel mill-AUC, kien ta' madwar 28 % f'individwi obeżi b'mod moderat (Indiċi tal-Piż tal-Ġisem ta' 25-40 kg/m2) u b'42 % ogħla f'individwi estremament obeżi (Indiċi tal-Massa tal-Ġisem ta' >40 kg/m 2).
English: Clinical data on the use of daptomycin to treat RIE due to Staphylococcus aureus are limited to 19 adult patients (see “Information from clinical trials” in section 5.1).
Maltese: Data klinika dwar l-użu ta' daptomycin għall-kura ta' RIE minħabba Staphylococcus aureus hi limitata għal 19-il pazjent (ara “Informazzjoni mill-provi kliniċi” f'sezzjoni 5.1).
English: Transfer the reconstituted solution into a sodium chloride 9 mg/ml (0.9%) infusion bag (typical volume 50 ml).
Maltese: Ittrasferixxi s-soluzzjoni rrikostitwita f'borża tal-infużjoni ta' sodium chloride 9 mg/ml (0.9 %) (volum tipiku ta' 50 ml).
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: Pereżempju, pazjenti bi kwalunkwe grad ta' indeboliment tal-kliewi (tneħħija tal-kreatinina ta' <80 ml/min; ara wkoll sezzjoni 4.2), inkluż dawk fuq l-emodijaliżi jew CAPD, u pazjenti li jkunu qed jieħdu prodotti mediċinali oħrajn magħrufa li huma assoċjati ma' mijopatija (eż. inibituri ta' reductase HMG-CoA, fibrates u ciclosporin).
English: Clinical Success in Paedatric cSSTI Daptomycin n/N (%)
Maltese: Suċċess Kliniku f'cSSTI Pedjatrika Daptomycin n/N (%)
English: Table 1 Adverse reactions from clinical studies and post-marketing reports
Maltese: Tabella 1 Reazzjonijiet avversi mill-istudji kliniċi u rapporti ta' wara t-tqegħid fis-suq
English: - Adult and paediatric (1 to 17 years of age) patients withStaphylococcus aureus bacteraemia (SAB).
Maltese: - Pazjenti adulti u pedjatriċi (b'età minn sena sa 17-il sena) b'batteremija minħabba Staphylococcus aureus (SAB, Staphylococcus aureus bacteraemia).
English: Indication cSSTI without SAB
Maltese: Indikazzjoni cSSTI mingħajr SAB
English: Summary of sponsor-defined clinical outcome at TOC:
Maltese: Sommarju ta'eżitu kliniku definit mill-isponser f'TOC:
English: 350 mg presentation:
Maltese: Preżentazzjoni ta' 350 mg:
English: Uncommon: Renal impairment, including renal failure and renal insufficiency, serum creatinine increased
Maltese: Mhux komuni: Indeboliment tal-kliewi, inkluż kollass tal-kliewi u insuffiċjenza tal-kliewi, żieda tal-kreatinina fis-serum
English: RIE due to Staphylococcus aureus
Maltese: RIE minħabba Staphylococcus aureus
English: The differences noted are most likely due to the normal reduction in renal function observed in the geriatric population.
Maltese: Id-differenzi nnutati huma probabbli l-aktar minħabba t-tnaqqis normali fil-funzjoni tal-kliewi osservata fil-popolazzjoni ġerjatrika.
English: QUALITATIVEAND QUANTITATIVE COMPOSITION
Maltese: GĦAMLA KWALITATTIVA
English: Of these 19 patients 11 were infected with methicillin-susceptible and 8 with methicillin-resistant Staphylococcus aureus.
Maltese: Minn dawn id-19-il pazjent, 11 kienu infettati bi Staphylococcus aureus suxxettibbli għal methicillin, u 8 bi Staphylococcus aureus reżistenti għall-metiċillina.
English: Methicillin-susceptible Staphylococcus aureus (MSSA) Methicillin-resistant Staphylococcus aureus (MRSA)
Maltese: Staphylococcus aureus reżistenti għall-methicillin (MRSA, Methicillin-resistant Staphylococcus aureus)
English: In paediatric patients aged 7 to 17 years, Daptomycin Hospira is given by intravenous infusion over a 30-minute period (see section 6.6).
Maltese: F'pazjenti pedjatriċi li għandhom bejn 7 snin sa 17-il sena, Daptomycin Hospira jingħata permezz ta' infużjoni fil-vina fuq perjodu ta' 30 minuta (ara sezzjoni 6.6).
English: The site of metabolism has not been identified.
Maltese: Is-sit tal-metaboliżmu ma ġiex identifikat.
English: Prothrombin time (PT) prolonged Not known*: Thrombocytopaenia
Maltese: Dewmien fil-ħin ta' prothrombin (PT, prothrombin time) Mhux magħruf* Tromboċitopenija
English: In two adult clinical trials in complicated skin and soft tissues infections, 36% of patients treated with daptomycin met the criteria for systemic inflammatory response syndrome (SIRS).
Maltese: F'żewġ provi kliniċi fuq pazjenti adulti dwar infezzjonijiet kkumplikati tal-ġilda u tat-tessut artab, 36 % tal-pazjenti kkurati b'daptomycin laħqu l-kriterji għal sindrome ta' rispons infjammatorju sistemiku (SIRS, systemic inflammatory response syndrome).
English: Daptomycin exhibits rapid, concentration dependent bactericidal activity against Gram positive organisms in vitro and in in vivo animal models.
Maltese: Daptomycin juri attività batteriċida mgħaġġla, li tiddependi fuq il-konċentrazzjoni, kontra organiżmi Gram pożittivi in vitro u in vivo f'mudelli tal-annimali.
English: Age Range
Maltese: Firxa tal-Età
English: No clinical data on fertility are available for daptomycin.
Maltese: M'hemm l-ebda data klinika disponibbli dwar il-fertilità għal daptomycin.
English: Daptomycin Hospira will usually be given to you by a doctor or a nurse.
Maltese: Daptomycin Hospira normalment se jingħatalek minn tabib jew infermier.
English: Frequency Adverse reactions
Maltese: Klassi tas-sistemi tal-organi Frekwenza Reazzjonijiet avversi
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 sections 4.8 and 5.2).
Maltese: Madankollu, meta mqabbla mal-istess dożi mogħtija bħala infużjonijiet ġol-vini fuq perjodu ta' 30 minuta, ma kien hemm l-ebda differenza klinikament importanti fil-farmakokinetika u l-profil tas-sigurtà ta' daptomycin (ara sezzjonijiet 4.8 u 5.2).
English: 7-11 years (N=19)
Maltese: 7 snin-11-il sena (N=19)
English: Eosinophilic pneumonia has been reported in patients receiving daptomycin (see section 4.8).
Maltese: Ġiet irrappurtata pnewmonja eosinofilika f'pazjenti li kienu qed jirċievu daptomycin (ara sezzjoni 4.8).
English: The interaction between daptomycin and tobramycin with an approved dose of daptomycin is unknown.
Maltese: L-interazzjoni bejn daptomycin u tobramycin ma' doża approvata ta' daptomycin mhijiex magħrufa.
English: Regular monitoring of renal function is advised (see section 5.2).
Maltese: Hu rrakkomandat monitoraġġ regolari tal-funzjoni tal-kliewi (ara sezzjoni 5.2).
English: In paediatric patients aged 1 to 6 years, Daptomycin Hospira 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, Daptomycin Hospira jingħata permezz ta' infużjoni fil-vina fuq perjodu ta' 60 minuta (ara s-sezzjoni 6.6).
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 ġol-vini, it-tneħħija ta' daptomycin mill-plażma hi ta' madwar 7 sa 9 ml/h/kg, u ttneħħija tiegħu mill-kliewi hi ta' 4 sa 7 ml/h/kg.
English: This dose is given directly into the blood stream (into a vein), as an infusion lasting about 30-60 minutes.
Maltese: Din id-doża tingħata direttament fid-demm (ġo vina), bħala infużjoni li ddum 30-60 minuta.
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 ġeneralment hi lineari u tiddependi miż-żmien f'dożi ta' 4 sa 12 mg/kg mogħtija bħala doża waħda kuljum permezz ta' infużjoni ġol-vini ta' 30 minuta għal sa 14il jum f'voluntiera adulti b'saħħithom.
English: The highest measured concentration of daptomycin in the breast milk was 0.045 mcg/ml, which is a low concentration.
Maltese: L-ogħla konċentrazzjoni mkejla ta' daptomycin fil-ħalib tas-sider kienet ta' 0.045 mcg/ml, li hi konċentrazzjoni baxxa.
English: Daptomycin Hospira should only be reconstituted with sodium chloride 9 mg/ml (0.9%).
Maltese: Daptomycin Hospira għandu jiġi rrikostitwit biss b'sodium chloride 9 mg/ml (0.9 %).
English: Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Maltese: Daptomycin Hospira huwa indikat għall-kura tal-infezzjonijiet li ġejjin (ara sezzjonijiet 4.4 u 5.1).
English: 500 mg presentation:
Maltese: Preżentazzjoni ta' 500 mg:
English: No fibrosis or rhabdomyolysis was observed.
Maltese: Ma ġew osservati l-ebda fibrożi jew rabdomjoliżi.
English: An adjustment of daptomycin dose interval is needed for adult patients whose creatinine clearance is <30 ml/min (see sections 4.2 and 5.2).
Maltese: Hu meħtieġ aġġustament tal-intervall tad-doża ta' Daptomycin Hospira għal pazjenti adulti li ttneħħija tal-kreatinina tagħhom tkun ta' <30 ml/min (ara sezzjonijiet 4.2 u 5.2).
English: • Age group 2 (n=28): 7 to 11 years treated with daptomycin dosed at 9 mg/kg or SOC;
Maltese: • Grupp ta' età 2 (n=28): 7 snin sa 11-il sena ttrattati b'daptomycin b'doża ta' 9 mg/kg jew SOC;
English: The safety and efficacy of daptomycin was evaluated in paediatric patients aged 1 to 17 years (Study DAP-PEDBAC-11-02) with bacteraemia caused by Staphylococcus aureus.
Maltese: Is-sigurtà u l-effikaċja ta' daptomycin kienet ivvalutata f'pazjenti pedjatriċi li kellhom minn sena sa 17-il sena (Studju DAP-PEDBAC-11-02) b'batterimja kkawżata minn Staphylococcus aureus.
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 partikulari, kien hemm rapporti ta' kura li ma rnexxietx f'pazjenti infettati bi Staphylococcus aureus, Enterococcus faecalis jew Enterococcus faecium, inkluż pazjenti batteremiċi, li ġew assoċjati malgħażla ta' organiżmi b'suxxettibilità mnaqqsa jew b'reżistenza ċara għal daptomycin matul it-terapija.
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: 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 tal-annimali, l-AUC/MIC u sCmax/MIC jikkorrellaw mal-effikaċja u l-qtil batteriku in vivo f'dożi waħidhom ekwivalenti għal dożi fil-bnedmin adulti ta' 4 mg/kg u 6 mg/kg darba kuljum.
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: Sensittività eċċessiva**, li dehret minn rapporti spontanji iżolati li jinkludu, iżda li mhumiex limitati għal anġjoedema, raxx minħabba mediċina b'esinofilija u b'sintomi sistemiċi (DRESS, drug rash with eosinophilia and systemic symptoms), eosinofilija pulmonari, raxx vesikobulluż blinvolviment tal-membrana mukuża u sensazzjoni ta' nefħa orofarinġeali, anafilassi**, reazzjonijiet għall-infużjoni li jinkludu s-sintomi li ġejjin: takikardija, tħarħir, deni, tertir, fwawar sistemiċi, vertigo, sinkope u togħma ta' metall
English: After infusion of 14C-daptomycin in healthy adults, the plasma radioactivity was similar to the concentration determined by microbiological assay.
Maltese: Wara l-infużjoni ta' 14C-daptomycin f'adulti b'saħħithom, ir-radjuattività fil-plażma kienet simili għall-konċentrazzjoni determinata minn assaġġ mikrobijoloġiku.
English: Gender No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed.
Maltese: Ma ġew osservati l-ebda differenzi klinikament sinifikanti fil-farmakokinetika ta' daptomycin relatati mas-sess tal-persuna.
English: Following administration of a single 4 mg/kg intravenous dose of daptomycin 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 ġol-vini ta' 4 mg/kg doża ta' daptomycin fuq perjodu ta' 30 minuta, ittneħħija totali medja ta' daptomycin kienet ta' madwar 35 % aktar baxxa, u l-medja tal-AUC0-∞ kienet ta' madwar 58 % ogħla f'individwi anzjani (≥ 75 sena) meta mqabbla ma' dawk f'individwi żgħażagħ b'saħħithom (18 sa 30 sena).
English: Uncommon: Myositis, increased myoglobin, muscular weakness, muscle pain, arthralgia, serum lactate dehydrogenase (LDH) increased, muscle cramps
Maltese: Mhux komuni: Mijożite, żieda fil-mijoglobina, dgħufija muskolari, uġigħ fil-muskoli, artralġija, żieda tal-lactate dehydrogenase (LDH) fis-serum, bugħawwiġijiet fil-muskoli Rabdomjoliżi
English: For the 30-minute intravenous infusion, the combined storage time (reconstituted solution in vial and diluted solution in infusion bag; see section 6.6) at 25°C must not exceed 12 hours (or 24 at 2°C-8°C).
Maltese: Għall-infużjoni ġol-vini ta' 30 minuta, il-ħin kkombinat tal-ħażna (soluzzjoni rrikostitwita fil-kunjett u s-soluzzjoni dilwita fil-borża tal-infużjoni; ara sezzjoni 6.6) f'temperatura ta' 25°C, ma jridx jaqbeż 12-il siegħa (jew 24 siegħa f'temperatura ta' 2°C - 8°C).
English: Obesity In obese subjects with Body Mass Index (BMI) >40 kg/m2 but with creatinine clearance >70 ml/min, the
Maltese: Obeżità F'individwi obeżi b'Indiċi tal-Massa tal-Ġisem (BMI, Body Mass Index) ta' >40 kg/m2 iżda bi tneħħija tal-kreatinina ta' >70 ml/min, l-AUC0-∞ ta' daptomycin żdiedet b'mod sinifikanti (medja ta' 42 % ogħla), meta mqabbla ma' kontrolli mqabbla ta' individwi mhux obeżi.
English: The lowest observable effect level (LOEL) for myopathy in rats and dogs occurred at exposure levels of 0.8 to 2.3-fold the human therapeutic levels at 6 mg/kg (30-minute intravenous infusion) for patients with normal renal function.
Maltese: Il-livell bl-inqas effett osservat (LOEL) għal mijopatija fil-firien u l-klieb, seħħ f'livelli ta' esponiment ta' minn 0.8 sa 2.3 darbiet tal-livelli terapewtiċi fil-bniedem f'doża ta' 6 mg/kg għal pazjenti b'funzjoni normali tal-kliewi.
English: Daptomycin Hospira is used in adults and in children and adolescents (age from 1 to 17 years) to treat infections of the skin and the tissues below the skin.
Maltese: Daptomycin Hospira jintuża fl-adulti u fi tfal u adolexxenti (eta minn sena sa 17-il sena) biex jikkura infezzjonijiet tal-ġilda u tattessuti taħt il-ġilda.
English: Eosinophilic pneumonia
Maltese: Pnewmonja eosinofilika
English: Daptomycin is active against Gram positive bacteria only (see section 5.1).
Maltese: Daptomycin hu attiv biss kontra batterji tat-tip Gram pożittivi (ara sezzjoni 5.1).
English: 5 mg/kg 30 minutes
Maltese: 5 mg/kg 30 minuta
English: ** See section 4.4.
Maltese: (ara sezzjonijiet 4.4 u 5.1).
English: Intent-to-treat
Maltese: TAL-PRODOTT
English: Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours at 2°C - 8°C.
Maltese: Listabbiltà kimika u fiżika tas-soluzzjoni dilwita fil-boroż tal-infużjoni hi stabbilita bħala 12-il siegħa f'temperatura ta' 25°C jew 24 siegħa f'temperatura ta' 2°C - 8°C.
English: 12 mg/kg 60 minutes
Maltese: 12 mg/kg 60 minuta
English: How to store Daptomycin Hospira
Maltese: Mediċini oħra u Daptomycin Hospira
English: Uncommon: Fatigue, pain * Based on post-marketing reports.
Maltese: Mhux komuni: Għeja, uġigħ * Ibbażat fuq rapporti wara t-tqegħid fis-suq.
English: This interference led to a false prolongation of PT and elevation of INR.
Maltese: Din linterferenza wasslet għal titwil falz tal-PT u żieda fl-INR.
English: Following administration of a single 4 mg/kg or 6 mg/kg intravenous dose of daptomycin over a 30-minute period to adult subjects with various degrees of renal impairment, total daptomycin clearance (CL) decreased and systemic exposure (AUC) increased as renal function (creatinine clearance) decreased.
Maltese: Wara l-għoti ta' doża waħda ta' daptomycin ta' 4 mg/kg jew 6 mg/kg ġol-vini fuq perjodu ta' 30 minuta lil individwi adulti bi gradi differenti ta' indeboliment tal-kliewi, it-tneħħija (CL) totali ta' daptomycin naqset, u l-esponiment sistemiku (AUC) żdied hekk kif il-funzjoni tal-kliewi (tneħħija talkreatinina) naqset.
English: The overall therapeutic response rate also was similar for the daptomycin and SOC treatment arms for infections caused by MRSA, MSSA and Streptococcus pyogenes (see table below; ME population); response rates were > 94% for both treatment arms across these common pathogens.
Maltese: Ir-rata ta' rispons terapewtiku globali wkoll kienet simili għall-fergħat ta' trattament b'daptomycin u SOC għal infezzjonijiet ikkawżati minn MRSA, MSSA u Streptococcus pyogenes (ara t-tabella ta' hawn taħt; popolazzjoni tal-ME); ir-rati ta' rispons kienu > 94% għaż-żewġ fergħat ta' trattament fost dawn il-patoġeni komuni.
English: AUC0-24hr (g×hr/ml) Cmax (g/ml) Apparent t1/2 (hr) CL/wt (ml/hr/kg) Pharmacokinetic parameter values estimated by noncompartmental analysis Individual values reported as only two patients in this age group provided pharmacokinetic samples to enable pharmacokinetic analysis; AUC, apparent t1/2 and CL/wt could be determined for only one of the two patients Pharmacokinetic analysis conducted on the pooled pharmacokinetic profile with mean concentrations across subjects at each time point
Maltese: Il-valuri tal-parametri farmakokinetiċi ġew stmati permezz ta' analiżi mhux kumpartimentalizzata Irrappurtati valuri individwali minħabba li żewġ pazjenti biss f'dan il-grupp ta' età ipprovdew kampjuni farmakokientiċi biex tkun tista' ssir analiżi farmakokinetika; l-AUC, t- t1/2 apparenti u sCL/wt setgħu jiġu determinati għal pazjenti wieħed biss miż-żewġ pazjenti L-analiżi farmakokinetika saret fuq il-ġabra ta' profil farmakokinetiku b'konċentrazzjonijiet medji flindividwi kollha f'kull punt ta' żmien
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 sections 4.4 and 5.2).
Maltese: Irrispons għall-kura, il-funzjoni tal-kliewi u l-livelli ta' creatine phosphokinase (CPK) għandhom jiġu mmonitorjati mill-qrib fil-pazjenti kollha li jkollhom kwalunkwe grad ta' indeboliment tal-kliewi (ara sezzjonijiet 4.4 u 5.2).
English: These could interfere with the effects of Daptomycin Hospira in the kidney.
Maltese: Dawn jistgħu jinterferixxu mal-effetti ta' Daptomycin Hospira fil-kliewi.
English: Paediatric patients below the age of one year should not be given daptomycin due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) that were observed in neonatal dogs (see section 5.3).
Maltese: Pazjenti pedjatriċi taħt l-età ta' sena m'għandhomx jingħataw daptomycin minħabba r-riskju ta' effetti potenzjali fuq is-sistemi muskolari, newromuskolari u/jew fuq is-sistema nervuża (jew periferali u/jew ċentrali) li ġew osservati fi klieb tat-twelid (ara sezzjoni 5.3).
English: The pharmacokinetics of daptomycin in patients with severe hepatic impairment (Child-Pugh C classification) have not been evaluated.
Maltese: Ilfarmakokinetika ta' daptomycin f'pazjenti b'indeboliment sever tal-fwied (klassifikazzjoni Child-Pugh C) ma ġietx evalwata.
English: Daptomycin was not mutagenic or clastogenic in a battery of in vivo and in vitro genotoxicity tests.
Maltese: Daptomycin ma kienx mutaġeniku jew klastoġeniku f'sensiela ta' testijiet in vivo u in vitro dwar il-ġenotossicità.
English: 10 mg/kg 60 minutes
Maltese: 10 mg/kg 60 minuta
English: Comparable exposure (AUC and Cmax) was demonstrated in healthy adult subjects following administration of daptomycin as a 30-minute intravenous infusion or as a 2-minute intravenous injection.
Maltese: Intwera esponiment komparabbli (AUC u Cmax) f'individwi adulti b'saħħithom wara l-għoti ta' daptomycin bħala infużjoni ġol-vini ta' 30 minuta jew bħala injezzjoni ġol-vini ta' 2 minuti.
English: Drug/laboratory test interactions
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: 7 mg/kg 30 minutes
Maltese: 7 mg/kg 30 minuta
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 b'saħħithom u f'pazjenti adulti kkurati b'daptomycin, it-twaħħil mal-proteini kellu medja ta' madwar 90 %, inklużi individwi b'indeboliment tal-kliewi.
English: False prolongation of prothrombin time (PT) and elevation of international normalised ratio (INR) have been observed when certain recombinant thromboplastin reagents are utilised for the assay (see section
Maltese: Interazzjonijiet tal-mediċina/tat-testijiet tal-laboratorju Titwil falz tal-ħin ta' prothrombin (PT, prothrombin time) u ż-żieda tal-proporzjon normalizzat internazzjonali (INR, international normalised ratio) ġew osservati meta ċerti reaġenti rikombinanti ta' thromboplastin jiġu utilizzati għall-assaġġ (ara sezzjoni 4.5).
English: Clinical studies in patients employed infusion of daptomycin over at least 30 minutes.
Maltese: Studji kliniċi fil-pazjenti użaw infużjoni ta' daptomycin fuq perjodu ta' mill-inqas 30 minuta.