FrancophonIA/ELRC3.0 huggingface dataset:
English: 60 minutes cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; (1) Minimum duration of Daptomycin Hospira for paediatric SAB should be in accordance with the perceived risk of complications in the individual patient.
Maltese: 12 mg/kg darba kull 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' Daptomycin Hospira għal SAB pedjatrika għandu jkun skont ir-riskju perċettibbli ta' kumplikazzjonijiet fil-pazjent individwali.
English: After a single 6 mg/kg dose of daptomycin, 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' daptomycin, ittneħħija 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: Due to limited clinical experience (see table and footnotes below) daptomycin should only be used in adult patients with any degree of renal impairment (CrCl <80 ml/min) when it is considered that the expected clinical benefit outweighs the potential risk.
Maltese: Minħabba esperjenza klinika limitata (ara t-tabella u n-noti taħt it-tabella ta' hawn taħt), daptomycin għandu jintuża biss f'pazjenti adulti bi kwalunkwe grad ta' indeboliment tal-kliewi (CrCl ta' < 80 ml/min) meta jiġi kkunsidrat li l-benefiċċju kliniku mistenni jkun akbar mir-riskju potenzjali.
English: If a focus of infection other than cSSTI or RIE is identified after initiation of daptomycin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Maltese: Jekk jiġi identifikat fokus ta' infezzjoni li ma jkunx cSSTI jew RIE wara li tinbeda terapija b'Daptomycin Hospira, għandu jiġi kkunsidrat li tingħata terapija antibatterika alternattiva li tkun intweriet li hi effikaċi fil-kura tat-tip ta' infezzjoni(jiet) speċifika(ċi) preżenti.
English: Tissue distribution studies in rats showed that daptomycin appears to only minimally penetrate the blood-brain barrier and the placental barrier following single and multiple doses.
Maltese: Studji dwar id-distribuzzjoni fit-tessut fil-firien urew li daptomycin jidher li jippenetra biss minimament il-barriera ematoenċefalika u l-barriera plaċentali wara dożi waħidhom u multipli.
English: Each vial contains 500 mg daptomycin.
Maltese: Kull kunjett fih 500 mg ta' daptomycin.
English: 1 to <2 years (N=30)
Maltese: Sena sa < sentejn (N=30)b
English: Mechanism of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
Maltese: Daptomycin hu prodott naturali lipopeptidu ċikliku li hu attiv kontra batterji li huma Gram pożittivi biss.
English: 9 mg/kg 60 minutes
Maltese: 9 mg/kg 60 minuta
English: CARTON FOR 1 VIAL CARTON FOR 5 VIALS
Maltese: KARTUNA GĦAL KUNJETT 1 KARTUNA GĦAL 5
English: A Phase 4 study (DAP-PEDS-07-03) was conducted to assess safety, efficacy, and pharmacokinetics of daptomycin in paediatric patients (1 to 17 years old, inclusive) with cSSTI caused by Gram-positive pathogens.
Maltese: Sar studju ta' Fażi 4 (DAP-PEDS-07-03) biex jistma s-sigurtà, l-effikaċja, u l-farmakokinetika ta' daptomycin f'pazjenti pedjatriċi (li għandhom minn sena sa 17-il sena, inklużi) b'cSSTI kkawżata minn patoġeni Gram-pożittivi.
English: Overall Success a rate in Paedatric cSSTI n/N (%)
Maltese: Rata globali ta' suċċessa f'cSSTI Pedjatrika n/N (%)
English: Whenever possible, Daptomycin Hospira should be administered following the completion of dialysis on dialysis days (see section 5.2).
Maltese: Kull meta jkun possibbli, fil-ġranet taddijalisi Daptomycin Hospira għandu jiġi amministrat wara li titlesta d-dijalisi (ara sezzjoni 5.2).
English: • Age group 3 (n=32): 1 to 6 years treated with daptomycin dosed at 12 mg/kg or SOC;
Maltese: • Grupp ta' età 3 (n=32): sena sa 6 snin ittrattati b'daptomycin b'doża ta' 12-il mg/kg jew SOC;
English: During post-marketing surveillance, cases of interference between daptomycin and particular reagents used in some assays of prothrombin time/international normalised ratio (PT/INR) have been reported.
Maltese: Matul is-sorveljanza ta' wara t-tqegħid fis-suq, ġew irrappurtati każijiet ta' interferenza bejn daptomycin u reaġenti partikulari li jintużaw f'xi assaġġi tal-ħin ta' prothrombin/proporzjon normalizzat internazzjonali (PT/INR, prothrombin time/international normalised ratio).
English: Pathogen
Maltese: Zaventem
English: Gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension
Maltese: Uġigħ addominali u gastro-intestinali, dardir, remettar, stitikezza, dijarea, gass, nefħa u distensjoni
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 jikkawżaw li tiżviluppa mijopatija (eż. inibituri ta' HMG-CoA reductase).
English: In adults, daptomycin is given by intravenous infusion (see section 6.6) and administered over a 30-minute period or by intravenous injection (see section 6.6) and administered over a 2-minute period.
Maltese: Fl-adulti, daptomycin jingħata permezz ta' infużjoni ġol-vini (ara sezzjoni 6.6) u jingħata fuq perjodu ta' 30 minuta jew permezz ta' injezzjoni ġol-vini (ara sezzjoni 6.6) u jingħata fuq perjodu ta' 2 minuti.
English: • Age group 1 (n=21): 12 to 17 years treated with daptomycin dosed at 7 mg/kg or SOC comparator;
Maltese: • Grupp ta' età 1 (n=21): 12 sa 17-il sena ttrattati b'daptomycin b'doża ta' 7 mg/kg jew b'kumparatur SOC;
English: 9 mg/kg 30 minutes
Maltese: 9 mg/kg 30 minuta
English: - Known or suspected RIE due to Staphylococcus aureus: daptomycin 6mg/kg is administered once every 24 hours.
Maltese: - Meta jkun magħruf jew suspettat li jkun hemm RIE minħabba Staphylococcus aureus: daptomycin 6 mg/kg jingħata darba kull 24 siegħa.
English: Caution is advised when administering daptomycin to patients who already have some degree of renal impairment (creatinine clearance <80 ml/min) before commencing therapy with Daptomycin Hospira.
Maltese: Hi rrakkomandata kawtela meta daptomycin jingħata lil pazjenti li diġà jkollhom xi grad ta' indeboliment tal-kliewi (tneħħija tal-kreatinina ta' <80 ml/min) qabel ma tibda t-terapija b'Daptomycin Hospira.
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
English: Paediatric patients 7 to 17 years old should receive daptomycin infused over 30 minutes.
Maltese: Pazjenti pedjatriċi li għandhom minn 7 snin sa 17-il sena għandhom jirċievu daptomycin infuż fuq 30 minuta.
English: The dosage card should contain the following key messages: - That there is a risk of severe skeletal muscle toxicity and so measuring the CPK at treatment initiation and at regular intervals is important.
Maltese: - Li hemm riskju ta' tossiċità severa fil-muskoli skeletriċi, u għalhekk, hu importanti li jitkejjel isCPK fil-bidu tal-kura u f'intervalli regolari.
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 lanqas dawn il-prodotti mediċinali ma bidlu l-farmakokinetika ta' daptomycin.
English: Effects on peripheral nerves were observed at higher doses than those associated with skeletal muscle effects in adult rats and dogs, and were primarily related to plasma Cmax.
Maltese: Ġew osservati effetti fuq n-nervaturi periferali f'dożi ogħla minn dawk assoċjati mal-effetti fuq ilmuskoli skeletriċi f'firien u klieb adulti, u kienu relatati l-aktar mas-Cmax fil-plażma.
English: Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK.
Maltese: It-tibdil mikroskopiku fil-muskoli skeletriċi kien minimu (madwar 0.05 % tal-mijofibri affettwati), u fid-dożi ogħla kienu akkumpanjati minn żidiet fis-CPK.
English: On the second day after administration of a 6 mg/kg dose to HD and CAPD adult patients the daptomycin AUC was approximately 1.3-fold higher than that observed after a second 6 mg/kg dose in adult patients with normal renal function.
Maltese: Fit-tieni jum wara l-għoti ta' doża ta' 6 mg/kg lil pazjenti adulti b'HD u CAPD, l-AUC ta' daptomycin kienet ta' madwar 1.3 darbiet ogħla minn dik osservata wara t-tieni doża ta' 6 mg/kg f'pazjenti adulti b'funzjoni normali tal-kliewi.
English: Daptomycin Hospira given as 30 or 60-minute intravenous infusion
Maltese: Daptomycin Hospira mogħti bħala infużjoni ġol-vini fuq perjodu ta' 30 jew 60 minuta
English: There is insufficient evidence to be able to draw any conclusions regarding the possible clinical efficacy of daptomycin against infections due to enterococci, including Enterococcus faecalis and Enterococcus faecium.
Maltese: Enterococcus faecalis u Enterococcus faecium.
English: Anaphylaxis/hypersensitivity reactions have been reported with daptomycin.
Maltese: Ġew irrappurtati reazzjonijiet anafilassi/ta' sensittività eċċessiva b'daptomycin.
English: RIE or cSSTI associated withSAB ≥30ml/min
Maltese: CL/wt (ml/siegħa/kg)
English: The Marketing Authorisation Holder shall ensure that all laboratories expected to perform Daptomycin Hospira susceptibility testing are provided with: - Summary of Product Characteristics - Laboratory susceptibility testing leaflet
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li l-laboratorji kollha li jkunu mistennija li jwettqu ttestjar tas-suxxettibilità ta' Daptomycin Hospira, jiġu pprovduti bi: - Sommarju tal-Karatteristiċi tal-Prodott - Fuljett dwar l-ittestjar tas-suxxettibilità tal-laboratorju
English: a 2-6 years (N=7)
Maltese: Sentejn sa 6 snin (N=7)
English: Use in elderly
Maltese: Ż-ŻGĦAR EWLENIN
English: No dose adjustment is necessary when administering daptomycin to patients with mild or moderate hepatic impairment (Child-Pugh Class B) (see section 5.2).
Maltese: M'hemmx bżonn ta' aġġustament tad-doża meta daptomycin jingħata lill-pazjenti b'indeboliment ħafif jew moderat tal-fwied (Child-Pugh Klassi B) (ara sezzjoni 5.2).
English: ITT (intention to treat) Population RIE
Maltese: Popolazzjoni ITT (intenzjoni li tikkura)
English: How Daptomycin Hospira is given
Maltese: Tużax Daptomycin Hospira:
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: Avvenimenti avversi rrappurtati b'mod inqas frekwenti, iżda aktar serji, jinkludu reazzjonijiet ta' sensittività eċċessiva, pnewmonja eosinofilika (li kultant tidher bħala pulmonite sistematizzata), raxx minħabba l-mediċina b'esinofilija u bżsintomi sistemiċi (DRESS, drug rash with eosinophilia and systemic symptoms), anġjoedema u rabdomjoliżi.
English: The pharmacokinetics of daptomycin were not significantly altered by aztreonam.
Maltese: Il-farmakokinetika ta' daptomycin ma nbidlitx b'mod sinifikanti minn aztreonam.
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 sezzjonijiet 4.2 u 5.2).
English: Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold, respectively, based on comparison of Cmax values at the No Observed Effect Level (NOEL) with the Cmax achieved on dosing with 30-minute intravenous infusion of 6 mg/kg once daily in patients with normal renal function.
Maltese: Il-marġini tas-sigurtà għall-effetti periferali fuq in-nervaturi fil-firien u klieb huma ta' 8 u 6 darbiet aktar, rispettivament, abbażi tattqabbil tal-valuri tas-Cmax fil-Livell bla effett osservat (NOEL), bis-Cmax li jinkiseb b'dożaġġ permezz ta' infużjoni ġol-vini ta' 30 minuta ta' 6 mg/kg darba kuljum, f'pazjenti b'funzjoni normali tal-kliewi.
English: - The other ingredientsaresodium hydroxideand citric acid.
Maltese: - Is-sustanzi mhux attivi l-oħra huma sodium hydroxide u citric acid.
English: Duration of Therapy
Maltese: Tul ta' Żmien tat-Terapija
English: In paediatric studies, 372 patients received daptomycin, of whom 61 received a single dose and 311 received a therapeutic regimen for cSSTI or SAB (daily doses ranged from 4 mg/kg to 12 mg/kg).
Maltese: Fi studji pedjatriċi, 372 pazjent irċivew daptomycin, li minnhom 61 irċivew doża waħda u 311 irċivew skeda terapewtika għal cSSTI jew SAB (id-dożi ta' kuljum kienu jvarjaw minn 4 mg/kg sa 12-il mg/kg).
English: A Phase 4 study (DAP-PEDBAC-11-02) was conducted to assess safety, efficacy, and pharmacokinetics of daptomycin in paediatric patients (1 to 17 years old, inclusive) with SAB. Daptomycin pharmacokinetics inpatients in this study are summarized in Table 3.
Maltese: Sar studju ta' Fażi 4 (DAP-PEDBAC-11-02) biex jistma s-sigurtà, l-effikaċja u l-farmakokientika ta' daptomycin f'pazjenti pedjatriċi (li għandhom minn sena sa 17-il sena, inklużi) b'SAB.
English: 6 mg/kg every 48 hours cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; RIE = right-sided infective endocarditis (1) The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is based on pharmacokinetic (PK) studies and modelling results (see sections 4.4 and 5.2).
Maltese: RIE = (right-sided infective endocarditis) endokardite infettiva tan-naħa tal-lemin (1) Is-sigurtà u l-effikaċja tal-aġġustament tal-intervall tad-doża ma ġewx stmati fi provi kliniċi kkontrollati u r-rakkomandazzjoni hija bbażata fuq l-istudji farmakokinetiċi u riżultati minn immudellar (ara sezzjonijiet 4.4 u 5.2).
English: Daptomycin Hospira is not usually given to pregnant women.
Maltese: Daptomycin Hospira normalment ma jingħatax lil nisa tqal.
English: In adults, daptomycin Hospira may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes.
Maltese: Fl-adulti, daptomycin Hospira jista' jingħata ġol-vini bħala infużjoni fuq perjodu ta' 30 minuta, jew bħala injezzjoni mogħtija fuq perjodu ta' 2 minuti.
English: Summary of overall therapeutic response by type of baseline pathogen (ME population):
Maltese: Sommarju tar-rispons terapewtiku globali skont it-tip ta' patoġenu fil-linja bażi (popolazzjoni tal-ME):
English: The safety data for the administration of daptomycin via 2-minute intravenous injection are derived from two pharmacokinetic studies in healthy adult volunteers.
Maltese: Id-data tas-sigurtà għall-għoti ta' daptomycin permezz ta' injezzjoni ġol-vini ta' 2 minuti nkisbet minn żewġ studji farmakokinetiċi f'voluntiera adulti f'saħħithom.
English: After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C - 8°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu tas-soluzzjoni rrikostitwita fil-kunjett intweriet għal 12-il siegħa f'temperatura ta' 25°C, u sa 48 siegħa f'temperatura ta' 2°C - 8°C.
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 tad-distribuzzjoni ta' daptomycin fl-istat fiss f'individwi adulti b'saħħithom kien ta' madwar 0.1 l/kg u kien indipendenti mid-doża.
English: After a single 4 mg/kg dose of daptomycin, total clearance normalised by weight and elimination half-life of daptomycin in adolescents (12-17 years of age) with Gram-positive infection were similar to adults.
Maltese: Wara doża waħda ta' 4 mg/kg ta' daptomycin, it-tneħħija totali normalizzata skont ilpiż u l-half-life ta' eliminazzjoni ta' daptomycin fl-adolexxenti (età ta' 12-17-il sena) b'infezzjoni Gram-pożittiva kienet tixbah dik fl-adulti.
English: Dizziness, headache
Maltese: Sena sa < sentejn
English: Not known*: Acute generalised exanthematous pustulosis
Maltese: Pustulożi exanthematous ġeneralizzata akuta
English: Daptomycin Hospira given as 30 or 60-minute intravenous infusion A 50 mg/ml concentration of Daptomycin Hospira for infusion is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Daptomycin Hospira mogħti bħala infużjoni ġol-vini fuq perjodu ta' 30 jew 60 minuta Konċentrazzjoni ta' 50 mg/ml ta' Daptomycin Hospira għall-infużjoni tinkiseb bir-rikostituzzjoni talprodott lajofilizzat b'7 ml ta' sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjoni.
English: After a single 4, 8, or 10 mg/kg dose of daptomycin, 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: 10 mg/kg ta' daptomycinit-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: Each vial contains 350 mg daptomycin.
Maltese: Kull kunjett fih 350 mg ta' daptomycin.
English: Daptomycin Hospira 500 mg powder for solution for injection/infusion daptomycin
Maltese: Daptomycin Hospira 500 mg trab għal soluzzjoni għall-injezzjoni/infużjoni daptomycin
English: • Age group 3 (n=125): 2 to 6 years treated with daptomycin dosed at 9 mg/kg or SOC;
Maltese: • Grupp ta' età 3 (n=125): Minn sentejn sa 6 snin ikkurati b'daptomycin f'doża ta' 9 mg/kg jew
English: 5 mg/kg once every 24 hours infused over 30 minutes
Maltese: 5 mg/kg darba kull 24 siegħa infuża fuq perjodu ta' 30 minuta
English: Daptomycin Hospira given as 30 or 60-minute intravenous infusion A 50 mg/ml concentration of Daptomycin Hospira for infusion is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Daptomycin Hospira mogħti bħala infużjoni ġol-vini fuq perjodu ta' 30 jew 60 minuta Konċentrazzjoni ta' 50 mg/ml ta' Daptomycin Hospira għall-infużjoni tinkiseb bir-rikostituzzjoni talprodott lajofilizzat b'10 ml ta' sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjoni.
English: One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution.
Maltese: Millilitru wieħed jipprovdi 50 mg ta' daptomycin wara r-rikostituzzjoni b'10 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %).
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 dwar bilanċ tal-massa bl-użu ta' materjal radjutikkettat, 78 % tad-doża mogħtija ġiet irkuprata mill-awrina, abbażi tar-radjuattività totali, filwaqt li l-irkuprar mill-awrina ta' daptomycin mhux mibdul kien ta' madwar 50 % tad-doża.
English: One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.
Maltese: Millilitru wieħed jipprovdi 50 mg ta' daptomycin wara r-rikostituzzjoni b'7 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %).
English: As the pharmacokinetics (see section 5.2) is comparable, the safety margins for both methods of administration are very similar.
Maltese: Billi l-farmakokinetika (ara sezzjoni 5.2) hi komparabbli, il-marġini tassigurtà għaż-żewġ metodi ta' għoti huma simili ħafna.
English: - It cannot be ruled out that those patients with CPK greater than 5 times upper limit of normal at baseline may be at increased risk of further increases during daptomycin therapy.
Maltese: • Ma jistax jiġi eskluż li dawk il-pazjenti li jkollhom CPK ta' aktar minn 5 darbiet tal-limitu ta' fuq tan-normal fil-linja bażi, jistgħu jkunu f'riskju miżjud ta' żidiet addizzjonali matul it-terapija b'daptomycin.
English: Simulation using a population pharmacokinetic model demonstrated that the AUCss (area under the concentration-time curve at steady state) of daptomycin in paediatric patients 1 to <2 years of age receiving12 mg/kg once daily would be comparable to that in adult patients receiving 6 mg/kg once daily.
Maltese: Simulazzjoni blużu ta' mudell farmakokinetiku ta' popolazzjoni uriet li l-AUCss (erja taħt il-kurva tal-konċentrazzjoni mal-ħin fl-istat fiss) ta' daptomycin f'pazjenti pedjatriċi li għandhom minn sena sa <sentejn li jirċievu 12-il mg/kg darba kuljum għandha tkun kumparabbli ma' dik ta' pazjenti adulti li jirċievu 6 mg/kg darba kuljum.
English: 9 mg/kg once every 24 hours infused over 60 minutes
Maltese: 9 mg/kg darba kull 24 siegħa infuża fuq perjodu ta' 60 minuta
English: Subjects achieving clinical success (Clinical Response of “Cure” or “Improved”) and microbiological success (pathogen-level response of “Eradicated” or “Presumed Eradicated”) are classified as overall therapeutic success.
Maltese: Individwi li jiksbu suċċess kliniku (Rispons kliniku ta' “Kura” jew “Imtejjeb”) u suċċess mikrobijoloġiku (rispons fil-livell tal-patoġenu ta' “Eradikat” jew “Preżunt Eradikat”) jiġu klassifikati bħala li jiksbu suċċess terapewtiku globali.
English: For the 2-minute intravenous injection, the storage time of the reconstituted solution in the vial (see section 6.6) at 25°C must not exceed 12 hours (or 48 hours at 2°C-8°C).
Maltese: Għall-injezzjoni ġol-vini ta' 2 minuti, il-ħin tal-ħażna tas-soluzzjoni rrikostitwita fil-kunjett (ara sezzjoni 6.6) f'temperatura ta' 25°C, ma jridx jaqbeż 12-il siegħa (jew 48 siegħa f'temperatura ta' 2°C - 8°C).
English: Daptomycin is an antibacterial that can stop the growth of certain bacteria.
Maltese: Daptomycin hu antibatteriku li jista' jwaqqaf it-tkabbir ta' ċerti batterji.
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 moderat tal-fwied (klassifika ta' indeboliment tal-fwied Child-Pugh B) meta mqabbla ma' voluntiera b'saħħithom mqabbla skont is-sess, l-età u l-piż tal-ġisem, wara doża waħda ta' 4 mg/kg.
English: PP (per protocol) Population RIE
Maltese: Popolazzjoni PP (skont il-protokoll)
English: Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or smaller in diameter.
Maltese: Neħħi bil-mod il-likwidu rrikostitwit (50 mg ta' daptomycin/ml) mill-kunjett billi tuża labra sterili ta' kejl ta' 21 jew li tkun iżgħar fid-dijametru.
English: Anticoagulant activity in patients receiving daptomycin and warfarin should be monitored for the first several days after therapy with Daptomycin Hospira is initiated.
Maltese: L-attività antikoagulanti f'pazjenti li jkunu qed jirċievu Daptomycin Hospira u warfarin għandha tiġi mmonitorjata għall-ewwel ftit diversi jiem wara li tinbeda t-terapija b'Daptomycin Hospira.
English: Daptomycin Hospira may interfere with laboratory tests that measure how well your blood is clotting.
Maltese: Daptomycin Hospira jista' jinterferixxi mat-testijiet tal-laboratorju li jkejlu kemm qed jagħqad tajjeb id-demm.