FrancophonIA/ELRC3.0 huggingface dataset:
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 Grampositive 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: Each vial contains 500 mg daptomycin.
Maltese: Kull kunjett fih 500 mg daptomycin.
English: Rash, pruritus
Maltese: Sturdament, uġigħ ta' ras
English: Excipient: Sodium hydroxide
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Sodium hydroxide
English: 6 mg/kg every 48 hours cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia (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 studies and modelling results (see sections 4.4 and 5.2).
Maltese: cSSTI (complicated skin and soft-tissue infections) = infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob; SAB = batterimja bi S. aureus (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: After a single 4 mg/kg dose of Cubicin, total clearance normalized 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' Cubicin, it-tneħħija totali normalizzata skont il-piż u l-half-life ta' eliminazzjoni ta' daptomycin fl-adolexxenti (età ta' 12-17-il sena) b'infezzjoni Grampożittiva kienet tixbah dik fl-adulti.
English: Methicillin-resistant Staphylococcus aureus (MRSA)
Maltese: Staphylococcus aureus reżistenti għall-metiċillina (MRSA)
English: No dose adjustment is necessary when administering Cubicin 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 jingħata Cubicin lill-pazjenti b'indeboliment talfwied ħafif jew moderat (Klassi B ta' Child-Pugh) (ara sezzjoni 5.2).
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: L-aktar livell baxx fejn deher effett (LOEL) għal mijopatija fil-firien u klieb seħħet b'livelli ta' esponiment ta' 0.8 sa 2.3 darbiet tal-livelli terapewtiċi fil-bniedem b'6 mg/kg (infużjoni ta' 30 minuta fil-vina) għall-pazjenti b'funzjoni renali normali.
English: Therefore, it is recommended that:
Maltese: TA' EĊĊIPJENTI Eċċipjent:
English: Rare: Not known*:
Maltese: Mhux komuni: Mhux magħruf*:
English: In the paediatric SAB study, the mean duration of IV Cubicin was 12 days, with a range of 1 to 44 days.
Maltese: Fl-istudju ta' SAB pedjatrika, il-medja tat-tul ta' żmien ta' Cubicin IV kienet 12-il jum b'firxa minn jum 1 sa 44 jum.
English: No fibrosis or rhabdomyolysis was observed.
Maltese: Ma dehru l-ebda fibrożi jew rabdomijolisi.
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°C8°C).
Maltese: Għall-infużjoni ta' 30 minuta fil-vina, il-ħin tal-ħażna kombinat (soluzzjoni mħallta fil-kunjett u soluzzjoni dilwita fil-borża tal-infużjoni, ara sezzjoni 6.6) f'temperatura ta' 25°C ma jridx jaqbeż it12-il siegħa (jew l-24 siegħa f'temperatura ta' 2°C - 8°C).
English: - Known or suspected RIE due to Staphylococcus aureus: Cubicin 6 mg/kg is administered once every 24 hours.
Maltese: - Meta jkun magħruf jew suspettat li jkun hemm RIE minħabba Staphylococcus aureus: jingħataw 6 mg/kg Cubicin darba kull 24 siegħa.
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: Effetti fuq nervituri periferali dehru b'dożi ogħla minn dawk assoċjati ma' effetti fil-muskoli skeletriċi fil-firien u klieb adulti, u kienu l-aktar relatati mas-Cmax fil-plażma.
English: The differences noted are most likely due to the normal reduction in renal function observed in the geriatric population.
Maltese: Id-differenzi nnutati x'aktarx li seħħu minħabba tnaqqis normali fil-funzjoni tal-kliewi kif osservat fil-popolazzjoni ġerjatrika.
English: • Cubicin should not be administered to patients who are taking other medicinal products associated with myopathy unless it is considered that the benefit to the patient outweighs the risk.
Maltese: • Cubicin m'għandux jingħata lill-pazjenti li jkunu qed jieħdu prodotti mediċinali oħra li huma assoċjati ma' mijopatija sakemm ma jitqiesx li l-benefiċċju għal pazjent jegħleb ir-riskju.
English: Cubicin is not physically or chemically compatible with glucose-containing solutions.
Maltese: Cubicin mhuwiex kompatibbli fiżikament jew kimikament ma' soluzzjonijiet li fihom glucose.
English: Anaphylaxis/hypersensitivity reactions have been reported with Cubicin.
Maltese: Kienu rrappurtati reazzjonijiet anafilattiċi/ta' ipersensittività bi Cubicin.
English: Minimum inhibitory concentration (MIC) breakpoint established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for Staphylococci and Streptococci (except S. pneumoniae) are Susceptible ≤ 1 mg/l and Resistant > 1 mg/l.
Maltese: Pneumoniae) huma Suxxettibli ≤1 mg/l u Resistenti >1 mg/l.
English: Cubicin given as 30 or 60-minute intravenous infusion A 50 mg/ml concentration of Cubicin 350 mg powder for infusion is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Cubicin mogħti bħala infużjoni ta' 30 jew 60 minuta fil-vina Konċentrazzjoni ta' 50 mg/ml ta' Cubicin 350 mg trab għall-infużjoni tinkiseb meta tħallat il-prodott lajofilizzat ma' 7 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: Mechanism of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
Maltese: Mekkaniżmu ta' azzjoni Daptomycin huwa prodott naturali lipopeptidu ċikliku li jaħdem kontra il-batterji Gram pożittivi biss.
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°C8°C.
Maltese: L-istabbiltà kimika u fiżika tas-soluzzjoni dilwita fil-boroż tal-infużjoni hija stabbilita bħala 12-il siegħa f'temperatura ta' 25°C jew 24 siegħa f'temperatura ta' 2°C - 8°C.
English: Cubicin 350 mg powder for solution for injection or infusion Each vial contains 350 mg daptomycin.
Maltese: Cubicin 350 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Kull kunjett fih 350 mg daptomycin.
English: Caution is advised when administering Cubicin to patients who already have some degree of renal impairment (creatinine clearance < 80 ml/min) before commencing therapy with Cubicin.
Maltese: Il-kawtela hi rrikmandata meta jingħata Cubicin lill-pazjenti li diġà għandhom xi grad ta' indeboliment renali (tneħħija tal-krejatinina <80 ml/min) qabel ma tibda t-terapija bi Cubicin.
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 f'saħħithom, ir-radjuattività fil-plażma kien jixbah lillkonċentrazzjoni ddeterminata permezz ta' analiżi mikrobijoloġika.
English: Pathogen
Maltese: Fwawar
English: • Age group 1 (n=21): 12 to 17 years treated with daptomycin dosed at 7 mg/kg or SOC
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: The primary objective of Study DAP-PEDS-07-03 was to assess the safety of treatment.
Maltese: L-għan primarju tal-Istudju DAP-PEDS-07-03 kien li jevalwa s-sigurtà tat-trattament.
English: Cubicin 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: Cubicin jintuża fl-adulti u fi tfal u adoloxxenti (minn sena sa 17-il sena) biex jikkura infezzjonijiet tal-ġilda, u t-tessuti taħt il-ġilda.
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: Waqt sorveljanza ta' wara t-tqegħid fis-suq, każijiet ta' interferenza bejn daptomycin u kimiċi partikulari li jintużaw f'xi analiżi tal-ħin ta' prothrombin/proporzjon internazzjonali normalizzat (PT/INR) kienu rappurtati.
English: The majority of transaminase elevations were of Grade 1-3 toxicity and resolved upon discontinuation of treatment.
Maltese: Il-maġġoranza taż-żidiet ta' transaminases kienu ta' Grad ta' tossiċità 1-3 u marru lura għan-normal meta twaqqfet il-kura.
English: 10 mg/kg 60 minutes
Maltese: 10 mg/kg
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 ta' sigurtà għall-effetti periferali fuq in-nervituri fil-firien u klieb huma 8- u 6-darbiet aktar rispettivament ibbażati fuq tqabbil tal-figuri ta' Cmax fil-Livell fejn Ma jkunx Jidher Effett (NOEL) bis-Cmax jinkiseb b'doża ta' infużjoni ta' 30 minuta fil-vina ta' 6 mg/kg darba kuljum f'pazjenti b'funzjoni renali normali.
English: Simulation using a population pharmacokinetic model demonstrated that the AUCss (area under the concentrationtime curve at steady state) of daptomycin in paediatric patients 1 to <2 years of age receiving 12 mg/kg once daily would be comparable to that in adult patients receiving 6 mg/kg once daily.
Maltese: Simulazzjoni bl-użu 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: Paediatric patients below the age of one year should not be given Cubicin 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: Il-pazjenti pedjatriċi taħt l-età ta' sena ma għandhomx jingħataw Cubicin minħabba r-riskju tal-effetti potenzjali fuq is-sistema muskolari, newromuskolari u/jew nervuża (periferali u/jew ċentrali) li kienu osservati fi klieb neonatali (ara sezzjoni 5.3).
English: 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 aIrrappurtati 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 s-CL/wt setgħu jiġu determinati għal pazjenti wieħed biss miż-żewġ pazjenti bL-analiżi farmakokinetika saret fuq il-ġabra ta' profil farmakokinetiku b'konċentrazzjonijiet medji fl-individwi kollha f'kull punt ta' żmien
English: Although small changes in the pharmacokinetics of daptomycin and tobramycin were observed during coadministration by intravenous infusion over a 30-minute period using a Cubicin dose of 2 mg/kg, the changes were not statistically significant.
Maltese: Minkejja li kienu osservati tibdiliet żgħar fil-farmakokinetika ta' daptomycin u tobramycin matul ilkoamministrazzjoni permezz ta' infużjoni minn ġol-vina ta' madwar 30 minuta meta ntużat doża ta' 2 mg/kg Cubicin, it-tibdiliet ma kenux sinjifikanti statistikament.
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 lgħoti ta' doża ta' 6 mg/kg lil pazjenti adulti fuq HD jew CAPD l-AUC ta' daptomycin kienet madwar 1.3 drabi ogħla minn dik osservata wara t-tieni doża ta' 6 mg/kg f'pazjenti adulti b'funzjoni tal-kliewi normali.
English: Not known*: Rhabdomyolysis
Maltese: Rabdomijolisi3**
English: (2) The same dose adjustments, which are based on pharmacokinetic data in volunteers including PK modelling results, are recommended for adult patients on haemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD).
Maltese: (2) L-istess aġġustamenti fid-dożi, li huma bbażati fuq dejta farmakokinetika f'voluntiera li tinkludi riżultati minn immudellar PK, huma rakkomandati għall-pazjenti adulti fuq l-emodijalisi (HD) jew id-dijalisi peritonali ambulatorja kontinwa (CAPD).
English: Cubicin 500 mg powder for solution for injection or infusion Single use 10 ml type I clear glass vials with type I rubber stoppers and aluminium closures with blue plastic flip off caps.
Maltese: Cubicin 500 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Kunjetti li jintużaw darba ta' 10 ml tal-ħġieġ trasparenti tat-tip I b'tappijiet tal-gomma tat-tip I u siġilli tal-aluminium b'għotjien tal-plastik blu li tiftaħhom b'daqqa ta' saba'.
English: In paediatric studies, 372 patients received Cubicin, 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 Cubicin, 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: 5 mg/kg 30 minutes
Maltese: 5 mg/kg
English: Each vial contains 350 mg daptomycin.
Maltese: Kull kunjett fih 350 mg daptomycin.
English: 9 mg/kg 60 minutes
Maltese: 9 mg/kg
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 rikostitwit (50 mg daptomycin/ml) mill-kunjett bl-użu ta' labra sterili b'dijametru ta' 21 gejġ jew inqas.
English: 7 mg/kg 30 minutes
Maltese: 7 mg/kg
English: Uncommon side effects (may affect up to 1 in 100 people) - Blood disorders (e.g. increased number of small blood particles called platelets, which may increase the tendency for blood clotting, or higher levels of certain types of white blood cells), - Decreased appetite, - Tingling or numbness of the hands or feet, taste disturbance, - Trembling, - Changes in heart rhythm, flushes, - Indigestion (dyspepsia), inflammation of the tongue, - Itchy rash of skin, - Muscle pain, cramping, or weakness, inflammation of the muscles (myositis), joint pain, - Kidney problems, - Inflammation and irritation of the vagina, - General pain or weakness, tiredness (fatigue), - Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactate dehydrogenase (LDH), prolonged blood clotting time or imbalance of salts, - Itchy eyes.
Maltese: - Disturbi tad-demm (eż. żieda fin-numru ta' partiċelli żgħar tad-demm, imsejħa plejtlits, li jistgħu jżidu t-tendenza tad-demm biex jagħqad, jew livelli ogħla ta' ċerti tipi ta' ċelluli bojod tad demm), - Tnaqqis fl-aptit, - Tingiż jew tnemnim tal-idejn jew saqajn, disturbi fit-togħma, - Tregħid, - Tibdil fir-ritmu tal-qalb, fwawar, - Indiġestjoni (dispepsja), infjammazzjoni tal-ilsien, - Raxx tal-ġilda bil-ħakk, - Uġigħ, bugħawwieġ jew dgħufija fil-muskoli, infjammazzjoni tal-muskoli (mijositi), uġigħ fil ġogi, - Problemi fil-kliewi, - Infjammazzjoni u irritazzjoni fil-vaġina, - Uġigħ ġenerali jew dgħufija, għeja, - Test tad-demm juri żidiet fil-livelli ta' zokkor fid-demm, krejatinina fis-serum, mijoglobina, jew lactate dehydrogenase (LDH), id-demm idum aktar biex jagħqad, jew żbilanċ fl-elettroliti, - Ħakk fl-għajnejn.
English: This interference led to a false prolongation of PT and elevation of INR.
Maltese: Din l-interferenza wasslet għal titwil falz tal-PT u INR ogħla.
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 mħallta fil-kunjett intweriet għal 12-il siegħa f'25°C u sa 48 siegħa f'2°C - 8°C.
English: Patients who develop signs or symptoms that might represent a peripheral neuropathy during therapy with Cubicin should be investigated and consideration should be given to discontinuation of daptomycin (see sections 4.8 and 5.3).
Maltese: Pazjenti li jkollhom sinjali jew sintomi li jistgħu jindikaw newropatija periferali waqt it-terapija bi Cubicin għandhom jiġu eżaminati u għandu jiġi kkonsidrat li jitwaqqaf daptomycin (ara sezzjonijiet 4.8 u 5.3).
English: 500 mg presentation:
Maltese: Preparat tat-500 mg:
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-dejta ta' sigurtà għall-għoti ta' daptomycin permezz ta' injezzjoni ta' 2 minuti fil-vina hija miġbura minn żewġ studji ta' farmakokinetika f'voluntiera adulti f'saħħithom.
English: Gram negative organisms * denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Maltese: Organiżmi Gram negattivi * tindika speċi fejn hu meqjus li l-attività kontrihom ntweriet b'mod sodisfaċenti fi studji kliniċi.
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 ta' daptomycin imkejla fil-ħalib tas-sider kienet ta' 0.045 mcg/ml, li hija konċentrazzjoni baxxa.
English: Daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog.
Maltese: L-għoti ta' daptomycin kien assoċjat ma' tibdil diġenerattiv/riġenerattiv minimu fil-muskoli skeletriċi tal-far u tal-kelb.
English: Cubicin 500 mg powder for solution for injection or infusion Each vial contains 500 mg daptomycin.
Maltese: Cubicin 500 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Kull kunjett fih 500 mg daptomycin.
English: Common side effects (may affect up to 1 in 10 people) - Fungal infections such as thrush, - Urinary tract infection, - Decreased number of red blood cells (anaemia), - Dizziness, anxiety, difficulty in sleeping, - Headache, - Fever, weakness (asthenia), - High or low blood pressure, - Constipation, abdominal pain, - Diarrhoea, feeling sick (nausea) or being sick (vomiting), - Flatulence, - Abdominal swelling or bloating, - Skin rash or itching, - Pain, itchiness or redness at the site of infusion, - Pain in arms or legs, - Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda f'kull 10) - Infezzjonijiet tal-moffa bħal traxx, - Infezzjoni fl-apparat tal-awrina, - Tnaqqis fl-ammont ta' ċelloli ħomor fid-demm (anemija), - Sturdament, ansjetà, tbati biex torqod, - Uġigħ ta' ras, - Deni, dgħufija (astenja), - Pressjoni togħla jew titbaxxa, - Stitikezza, uġigħ fl-addome, - Dijarea, tħoss tqalligħ (dardir) jew taqla' (rimettar), - Gass fl-istonku, - Nefħa fl-addome jew tħossok minfuħ, - Raxx tal-ġilda jew ħakk, - Uġigħ, ħakk jew ħmura fis-sit mnejn tingħata l-infużjoni, - Uġigħ fid-dirgħajn u r-riġlejn, - Testijiet tad-demm li juru li għandek livelli ogħla ta' enzimi tal-fwied jew creatine phosphokinase (CPK).
English: Creatine phosphokinase and myopathy Increases in plasma creatine phosphokinase (CPK; MM isoenzyme) levels associated with muscular pains and/or weakness and cases of myositis, myoglobinaemia and rhabdomyolysis have been reported during therapy with Cubicin (see also sections 4.5, 4.8 and 5.3).
Maltese: Creatine phosphokinase u mijopatija Żieda fil-livelli ta' creatine phosphokinase (CPK; isoenzima MM) fil-plażma assoċjati ma' uġigħ muskolari u/jew dgħufija u każijiet ta' mijosite, mijoglobinimja u rabdomijolisi kienu rappurtati waqt terapija bi Cubicin (ara wkoll sezzjonijiet 4.5, 4.8 u 5.3). Fl-istudji kliniċi, żidiet konsiderevoli fisCPK fil-plażma sa >5x Il-Limitu ta' Fuq tan-Normali (ULN) mingħajr sintomi muskolari seħħew b'mod aktar komuni f'pazjenti kkurati bi Cubicin (1.9%) milli f'dawk li rċevew sustanzi għat-tqabbil (0.5%).
English: There was no relevant difference in local tolerability or in the nature and frequency of adverse reactions.
Maltese: Ma kien hemm l-ebda differenza rilevanti fit-tollerabiltà lokali jew fin-natura u l-frekwenza tar-reazzjonijiet avversi.
English: Gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension Uncommon: Dyspepsia, glossitis
Maltese: Uġigħ gastro-intestinali u addominali, dardir, rimettar, stitikezza, dijarea, gass fl-istonku, nefħa u distensjoni
English: Microbiological Success rate in Paediatric SAB n/N (%)
Maltese: Daptomycin Kumparatur Differenzi fis-Suċċess n/N (%)
English: However, there is currently no evidence that a dose reduction is required (see section 5.2).
Maltese: Madankollu, s'issa m'hemmx evidenza li tnaqqis fid-doża huwa meħtieġ (ara sezzjoni 5.2).
English: However, renal function should be assessed and the dose should be reduced if there is evidence of severe renal impairment.
Maltese: Madankollu għandha titqies il-funzjoni renali u d-doża titnaqqas jekk ikun hemm evidenza ta' indeboliment renali sever.
English: The pharmacokinetics of daptomycin in patients with severe hepatic impairment (Child-Pugh C classification) have not been evaluated.
Maltese: Il-farmakokinetika ta' daptomycin f'pazjenti b'indeboliment tal-fwied sever (klassifikazzjoni ta' Child-Pugh Klassi C) ma kinitx evalwata.
English: One vial of powder contains 350 mg daptomycin.
Maltese: Kunjett wieħed ta' trab fih 350 mg daptomycin.
English: Cubicin 350 mg powder for solution for injection or infusion Single use 10 ml type I clear glass vials with type I rubber stoppers and aluminium closures with yellow plastic flip off caps.
Maltese: Cubicin 350 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Kunjetti li jintużaw darba ta' 10 ml tal-ħġieġ trasparenti tat-tip I b'tappijiet tal-gomma tat-tip I u siġilli tal-aluminium b'għotjien tal-plastik sofor li tiftaħhom b'daqqa ta' saba'.
English: Based on pharmacokinetic data and modelling, the daptomycin AUC during the first day after administration of a 6 mg/kg dose to adult patients on HD or CAPD was 2-fold higher than that observed in adult patients with normal renal function who received the same dose.
Maltese: Fuq bażi ta' dejta u mmudellar farmakokinetiku, l-AUC ta' daptomycin waqt l-ewwel jum wara lgħoti ta' doża ta' 6 mg/kg lil pazjenti adulti fuq HD jew CAPD kienet darbtejn ogħla minn dik osservata f'pazjenti adulti b'funzjoni normali tal-kliewi li rċivew l-istess doża.
English: A total of 81 subjects were treated in the study, including 55 subjects who received daptomycin and
Maltese: Total ta' 81 individwu ġew ittrattati fl-istudju, inklużi 55 individwu li rċivew daptomycin u 26 individwu li rċivew kura standard.