FrancophonIA/ELRC3.0 huggingface dataset:
English: - Trembling, - Changesinheart 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: - Raxx tal-ġilda bil-ħakk, - Uġigħ, bugħawwieġ jew dgħufija fil-muskoli, infjammazzjoni tal-muskoli (mijożite), uġigħ fil ġogi, - Problemi fil-kliewi, - Infjammazzjoni u irritazzjoni tal-vaġina, - Uġigħ jew dgħufija ġenerali, għeja, - Test tad-demm li juri żieda fil-livelli ta' zokkor fid-demm, kreatinina fis-serum, mijoglobina, jew lattatdeidroġenażi (LDH), titwil fil-ħin li d-demm idum biex jagħqad jew żbilanċ tal-imluħa.
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: Ibbażat fuq data u mmudellar farmakokinetiċi, l-AUC ta' daptomycin matul l-ewwel jum wara l-għoti ta' doża ta' 6 mg/kg lil pazjenti adulti fuq HD jew CAPD kienet darbtejn ogħla minn dik osservat f'pazjenti adulti b'funzjoni normali tal-kliewi li rċivew l-istess doża.
English: Peripheral nerve changes were characterised by minimal to slight axonal degeneration and were frequently accompanied by functional changes.
Maltese: Il-bidliet finnervituri periferali kienu kkaratterizzati minn deġenerazzjoni assjonali minn minima sa ħafifa, u frekwentament kienu akkumpanjati minn tibdil funzjonali.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Other antibacterials, ATC code: J01XX09
Maltese: Antibatteriċi għal użu sistemiku, Antibatteriċi oħrajn, Kodiċi ATC:
English: The pharmacokinetics of daptomycin in paediatric subjects was evaluated in 3 single-dose pharmacokinetic studies.
Maltese: Il-farmakokinetika ta' daptomycin f'individwi pedjatriċi kienet evalwata fi tliet studji farmakokinetiċi b'doża waħda.
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 kienu vvalutati f'pazjenti pedjatriċi li kellhom minn sena sa 17-il sena (Studju DAP-PEDBAC-11-03) b'cSSTI ikkawżata minn patoġeni Gram-pożittivi.
English: Common: 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: Komuni: jistgħu jaffettwaw sa persuna 1 minn kull 10 - Infezzjonijiet fungali bħal infezzjoni fungali fil-ħalq fejn jiffurmaw irqajja' bojod (thrush), - Infezzjoni fil-passaġġ tal-awrina, - Tnaqqis fin-numru ta' ċelluli ħomor tad-demm (anemija), - Sturdament, ansjetà, diffikultà biex torqod, - Uġigħ ta' ras, - Deni, dgħufija (astenija), - Pressjoni tad-demm għolja jew baxxa, - Stitikezza, uġigħ ta' żaqq, - Dijarea, tħossok imdardar jew tkun ma tiflaħx (tirremetti), - Gass, - Nefħa fiż-żaqq, jew tħoss żaqqek minfuħa bil-gass, - Raxx jew ħakk tal-ġilda, - Uġigħ, ħakk jew ħmura fis-sit tal-infużjoni, - Uġigħ fid-dirgħajn jew riġlejn, - Testijiet tad-demm li juru li għandek livelli ogħla ta' enzimi tal-fwied jew ta' creatine phosphokinase (CPK).
English: The microbiological outcome at TOC for the daptomycin and SOC treatment arms for infections caused by MRSA and MSSA are presented in the table below (mMITT population).
Maltese: Ir-riżultat mikrobijoloġiku f'TOC għall-fergħat ta' trattament ta' daptomycin u SOC għallinfezzjonijiet ikkawżati minn MRSA u MSSA huma ppreżentati fit-tabella taħt (popolazzjoni mMITT).
English: • Age group 2 (n=113): 7 to 11 years treated with daptomycin dosed at 7 mg/kg or SOC;
Maltese: • Grupp ta' età 2 (n=113): Minn 7 snin sa 11-il sena kkurati b'daptomycin f'doża ta' 7 mg/kg jew
English: 10 mg/kg once every 24 hours infused over 60 minutes
Maltese: 10 mg/kg darba kull 24 siegħa infuża fuq perjodu ta' 60 minuta
English: Adults - cSSTI without concurrent SAB: daptomycin 4mg/kg is administered once every 24hours for 7-14 days or until the infection is resolved (see section 5.1).
Maltese: Adulti - cSSTI mingħajr SAB fl-istess ħin: daptomycin 4 mg/kg jingħata darba kull 24 siegħa għal 7-14il jum jew sakemm l-infezzjoni tfieq (ara sezzjoni 5.1). - cSSTI b'SAB fl-istess ħin: daptomycin 6 mg/kg jingħata darba kull 24 siegħa.
English: 12 mg/kg once every 24 hours infused over 60 minutes
Maltese: 12 mg/kg darba kull 24 siegħa infuża fuq perjodu ta' 60 minuta
English: Uncommon: Decreased appetite, hyperglycaemia, electrolyte imbalance
Maltese: Mhux komuni: Tnaqqis fl-aptit, ipergliċemija, żbilanċ fl-elettroliti
English: Liver function tests abnormal
Maltese: Testijiet tal-funzjoni tal-fwied b'riżultati anormali
English: However, daptomycin can cross the placenta in pregnant rats (see section 5.2).
Maltese: Madankollu, daptomycin jista' jaqsam il-plaċenta f'firien tqal (ara sezzjoni 5.2).
English: No clinical data on pregnancies are available for daptomycin.
Maltese: M'hemm l-ebda data klinika disponibbli dwar it-tqala għal daptomycin.
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 li hi kkunsidrata li kontra tagħha, l-attività ntweriet b'mod sodisfaċenti fl-istudji kliniċi.
English: To prepare Daptomycin Hospira for intravenous injection, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Daptomycin Hospira.
Maltese: - Ġew osservati reazzjonijiet allerġiċi serji u akuti f'pazjenti kkurati bi kważi l-mediċini antibatteriċi kollha, inkluż Daptomycin Hospira.
English: Experience with the concomitant administration of daptomycin and warfarin is limited.
Maltese: L-esperjenza bl-għoti fl-istess ħin ta' daptomycin u warfarin hi limitata.
English: Daptomycin Hospira 350 mg powder for solution for injection/infusion Each vial contains 350 mg daptomycin.
Maltese: Daptomycin Hospira 350 mg trab għal soluzzjoni għall-injezzjoni/infużjoni Kull kunjett fih 350 mg ta' daptomycin.
English: Daptomycin Hospira 350 mg powder for solution for injection/infusion daptomycin
Maltese: Daptomycin Hospira 350 mg trab għal soluzzjoni għall-injezzjoni/infużjoni daptomycin
English: Rash, pruritus
Maltese: Raxx, ħakk
English: The findings of in vitro and some in vivo studies designed to investigate the mechanism of daptomycin myotoxicity indicate that the plasma membrane of differentiated spontaneously contracting muscle cells is the target of toxicity.
Maltese: Is-sejbiet tal-istudji in vitro u xi studji in vivo maħsuba biex jinvestigaw il-mekkaniżmu talmijotossiċità ta' daptomycin, jindikaw li l-membrana tal-plażma ta' ċelluli tal-muskoli differenzjati li jagħmlu kontrazzjoni spontanjament, hi l-mira tat-tossiċità.
English: Reproductive system and breast disorders
Maltese: Disturbi fis-sistema riproduttiva fis-sider
English: (2) The same dose adjustments, which are based on PK 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: If you are receiving dialysis, and your next dose of Daptomycin Hospira is due on a dialysis day, you will be usually given Daptomycin Hospira after the dialysis session.
Maltese: Daptomycin Hospira għandu jitwaqqaf immedjatament u, meta jkun xieraq, għandha tinbeda kura bi sterojdi sistemiċi.
English: Coagulase negative staphylococci
Maltese: Staphylococcus haemolyticus stafilokokki negattivi għal koagulażi
English: After a single 4 mg/kg dose of daptomycin, total clearance of daptomycin in children 7-11 years of age with Gram-positive infection was higher than in adolescents, whereas elimination half-life was shorter.
Maltese: Wara doża waħda ta' 4 mg/kg ta' daptomycin, it-tneħħija totali ta' daptomycin fit-tfal b'età ta' 7 snin-11-il sena b'infezzjoni Gram-pożittiva kienet ogħla milli fl-adolexxenti, filwaqt li l-half-life ta' eliminazzjoni kienet iqsar.
English: Studies of daptomycin with anticoagulants other than warfarin have not been conducted.
Maltese: Ma twettqux studji ta' daptomycin ma' antikoagulanti oħrajn ħlief għal warfarin.
English: At lower dose levels (25 mg/kg/day), mild and reversible clinical signs of twitching and one incidence of muscle rigidity were observed without any effects on body weight.
Maltese: F'livelli aktar baxxi tad-doża (25 mg/kg/jum), sinjali kliniċi ħfief u riversibbli ta' kontrazzjoni u inċidenza waħda ta' riġidità tal-muskoli, ġew osservati mingħajr l-ebda effetti fuq il-piż tal-ġisem.
English: Modified intent-to-treat Clinically evaluable Microbiologically evaluable (ME)
Maltese: Intenzjoni tal-kura modifikata Klinikament evalwabbli
English: Age Range 12-17 years (N=6) 7-11 years (N=2)
Maltese: 12-17 il-sena (N=6)
English: Available in packs containing 1 vial or 5 vials.
Maltese: Disponibbli f'pakketti li fihom 1 kunjett jew 5 kunjetti.
English: Very rare serious side effects (may affect up to 1 in 10,000 people) A hypersensitivity reaction (serious allergic reaction including anaphylaxis, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS)) has been reported, in some cases during administration of daptomycin.
Maltese: Effetti sekondarji serji rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000) Reazzjoni ta' sensittività eċċessiva (reazzjoni allerġika serja li tinkludi anafilassi, anġjoedema, raxx tal-mediċina b'eosinofilija u sintomi sistemiċi (DRESS, drug rash with eosinophilia and systemic symptoms) ġiet irrappurtata, f'xi każijiet waqt l-għoti ta' Daptomycin Hospira.
English: Daptomycin Hospira should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects.
Maltese: Daptomycin Hospira m'għandux jingħata lil tfal taħt l-età ta' sena, għax studji fl-annimali indikaw li dan il-grupp ta' età jista' jkollu effetti sekondarji severi.
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: Il-valur kritiku tal-konċentrazzjoni inibitorja minima (MIC, minimum inhibitory concentration) stabbilit mill-Kumitat Ewropew dwar it-Testijiet tas-Suxxettibbiltà (EUCAST) għal stafilokokki u streptokokki (ħlief S. pneumoniae) huma Suxxettibbli ≤1 mg/l u Reżistenti >1 mg/l.
English: 9 mg/kg once every 24 hours infused over 30 minutes
Maltese: 9 mg/kg darba kull 24 siegħa infuża fuq perjodu ta' 30 minuta
English: Juvenile dogs developed peripheral and spinal nerve lesions at doses lower than those associated with skeletal muscle toxicity.
Maltese: Klieb ġuvenili żviluppaw leżjonijiet fin-nervaturi periferali u fis-sinsla, f'dożi aktar baxxi minn dawk assoċjati ma' tossiċità fil-muskoli skeletriċi.
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 daptomycin met the criteria for RIE.
Maltese: Fi studju randomizzat, ikkontrollat, open-label, li sar fuq 235 pazjent adult b'batteremija minn Staphylococcus aureus (jiġifieri, mill-inqas koltura waħda ta' demm pożittiv għal Staphylococcus aureus qabel ma' rċivew l-ewwel doża), 19 minn 120 pazjent ikkurati b'daptomycin issodisfaw ilkriterji għal RIE.
English: The active substance in Daptomycin Hospira powder for solution for injection/infusion is daptomycin.
Maltese: Is-sustanza attiva f'Daptomycin Hospira trab għal soluzzjoni għall-injezzjoni/infużjoni hi daptomycin.
English: 7 mg/kg once every 24 hours infused over 30 minutes
Maltese: 7 mg/kg darba kull 24 siegħa infuża fuq perjodu ta' 30 minuta
English: Daptomycin Hospira 500 mg powder for solution for injection/infusion Each vial contains 500 mg daptomycin.
Maltese: Daptomycin Hospira 500 mg trab għal soluzzjoni għall-injezzjoni/infużjoni Kull kunjett fih 500 mg ta' daptomycin.
English: The use of antibacterials may promote the overgrowth of non-susceptible micro-organisms.
Maltese: L-użu ta' mediċini antibatteriċi jista' jippromwovi t-tkabbir eċċessiv ta' mikroorganiżmi mhux suxxettibbli.
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 daptomycin (see also sections 4.5, 4.8 and 5.3).
Maltese: Creatine phosphokinase u mijopatija Matul it-terapija b'daptomycin, ġiet irappurtata żieda fil-livelli ta' creatine phosphokinase (CPK, creatine phosphokinase; isoenzima MM) assoċjata ma' uġigħ muskolari u/jew dgħufija u ġew irappurtati każijiet ta' mijożite, mijoglobinemija u rabdomjoliżi (ara wkoll sezzjonijiet 4.5, 4.8 u 5.3). Fl-istudji kliniċi, żidiet notevoli fis-CPK fil-plażma għal >5x tal-Limitu ta' Fuq tan-Normal (ULN, Upper Limit of Normal) mingħajr sintomi muskolari seħħew b'mod aktar komuni f'pazjenti kkurati b'daptomycin (1.9 %) milli f'dawk li rċivew il-komparaturi (0.5 %).
English: Daptomycin Hospira given as 2-minute intravenous injection (adult patients only) Water should not be used for reconstitution of Daptomycin Hospira for intravenous injection.
Maltese: Daptomycin Hospira mogħti bħala infużjoni ġol-vini fuq perjodu ta' 2 minuti (pazjenti adulti biss) L-ilma m'għandux jintuża għar-rikostituzzjoni ta' Daptomycin Hospira għal injezzjoni ġol-vini.
English: In a separate study, no metabolites were observed in plasma, and minor amounts of three oxidative metabolites and one unidentified compound were detected in urine.
Maltese: Fi studju separat, l-ebda metabolit ma ġie osservat fil-plażma, u ammonti żgħar ta' tliet metaboliti ossidattivi u kompost wieħed mhux identifikati ġew osservati fl-awrina.
English: On this basis, it is recommended that adult patients on HD or CAPD receive daptomycin once every 48 hours at the dose recommended for the type of infection being treated (see section 4.2).
Maltese: Abbażi ta' dan, hu rakkomandat li pazjenti adulti fuq HD jew CAPD jirċievu daptomycin darba kull 48 siegħa fid-doża rrakkomandata għat-tip ta' infezzjoni li tkun qed tiġi kkurata (ara sezzjoni 4.2).
English: Chemical and physical in-use stability on the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if stored under refrigeration (2°C-8°C).
Maltese: L-istabbiltà kimika u fiżika waqt l-użu tas-soluzzjoni rrikostitwita fil-kunjett intweriet għal 12il siegħa f'temperatura ta' 25°C, u sa 48 siegħa jekk tinħażen fi friġġ (2°C-8°C).
English: Daptomycin Hospira 500 mg powder for solution for injection/infusion
Maltese: Daptomycin Hospira 500 mg trab għal soluzzjoni għall-injezzjoni/infużjoni
English: Uncommon: Dyspepsia, glossitis
Maltese: Mhux komuni: Dispepsja, glossite Disturbi fil-fwied u fil-marrara Komuni:
English: Warnings and precautions Talk to your doctor or nurse before you are given Daptomycin Hospira.
Maltese: Twissijiet u prekawzjonijiet Kellem lit-tabib jew lill-infermier tiegħek qabel ma tingħata Daptomycin Hospira.
English: cSSTI associated with SAB
Maltese: cSSTI assoċjata ma' SAB
English: One vial of powder contains 350 mg daptomycin.
Maltese: Kunjett wieħed bit-trab fih 350 mg ta' daptomycin.
English: There were no differences in Cmax.
Maltese: Ma kien hemm l-ebda differenza fis-Cmax.
English: Deep-seated infections
Maltese: TAL-PRODOTT MEDIĊINALI
English: Paediatric patients with cSSTI
Maltese: Pazjenti pedjatriċi b'cSSTI
English: A 50 mg/ml concentration of Daptomycin Hospira for injection is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Konċentrazzjoni ta' 50 mg/ml ta' Daptomycin Hospira għall-injezzjoni tinkiseb bir-rikostituzzjoni talprodott lajofilizzat b'7 ml ta' sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjoni.
English: Daptomycin Hospira 350 mg powder for solution for injection/infusion Daptomycin Hospira 500 mg powder for solution for injection/infusion
Maltese: Daptomycin Hospira 350 mg trab għal soluzzjoni għall-injezzjoni/infużjoni
English: The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is mainly based on pharmacokinetic modelling data.
Maltese: Is-sigurtà u l-effikaċja tal-aġġustament tal-intervall tad-doża ma ġewx evalwati fil-provi kliniċi kkontrollati, u rrakkomandazzjoni hi bbażata l-aktar fuq data ta' mmudellar farmakokinetiku.
English: In most reported cases associated with daptomycin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
Maltese: Fil-biċċa l-kbira tal-każijiet irrappurtati assoċjati ma' daptomycin, il-pazjenti żviluppaw deni, dispnea b'insuffiċjenza respiratorja ipossika, u infiltrati pulmonari diffużi jew pulmonite sistematizzata.
English: Draw 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device, then SLOWLY inject through the centre of the rubber stopper directly over the product plug in the vial.
Maltese: Iġbed 7 ml ta' sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjoni ġo siringa billi tuża labra sterili għat-trasferiment, jiġifieri labra ta' kejl ta' 21 jew li tkun iżgħar fid-dijametru, jew tagħmir bla labra, u mbagħad injetta BIL-MOD minn ġoċ-ċentru tat-tapp tal-lastku direttament fuq il-plagg tal-prodott ġol-kunjett.
English: What Daptomycin Hospira looks like and contents of the pack Daptomycin Hospira powder for solution for injection/infusion is supplied as a light yellow to light brown lyophilised cake or powder in a glass vial.
Maltese: Kif jidher Daptomycin Hospira u l-kontenut tal-pakkett Daptomycin Hospira trab għal soluzzjoni għall-injezzjoni/infużjoni hu fornut bħala cake jew trab isfar ċar sa kannella ċar lajofilizzat f'kunjett tal-ħġieġ.
English: Renal impairment Daptomycin is eliminated primarily by the kidney.
Maltese: Matul il-kura b'daptomycin, ġie rrappurtat indeboliment tal-kliewi.
English: Methicillin-susceptible Staphylococcus aureus (MSSA) Methicillin-resistant Staphylococcus aureus (MRSA) Streptococcus pyogenes a
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Not known*: Rhabdomyolysis
Maltese: F'dan il-fuljett
English: Daptomycin Hospira vials are for single-use only.
Maltese: Daptomycin Hospira m'għandux jintuża aktar ta' spiss minn darba kuljum.
English: The mechanism(s) of daptomycin resistance is (are) not fully understood.
Maltese: Il-mekkaniżmu(i) ta' reżistenza għal daptomycin mhuwiex (mhumiex) mifhum(a) kompletament.
English: The majority of cases occurred after more than 2 weeks of treatment with daptomycin and improved when daptomycin was discontinued and steroid therapy was initiated.
Maltese: Il-maġġoranza tal-każijiet seħħew wara aktar minn ġimagħtejn ta' kura b'daptomycin u meta twaqqaf daptomycin u nbdiet terapija bi sterojdi, dawn tjiebu.
English: A 50 mg/ml concentration of Daptomycin Hospira for injection is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Konċentrazzjoni ta' 50 mg/ml ta' Daptomycin Hospira għall-injezzjoni tinkiseb bir-rikostituzzjoni talprodott lajofilizzat b'10 ml ta' sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjoni.
English: Reversal of both the microscopic and functional effects was complete within 6 months post-dose.
Maltese: It-treġġigħ lura tal-effetti mikroskopiċi kif ukoll dawk funzjonali kien komplet fi żmien 6 xhur wara d-doża.
English: AUC0-24hr (g×hr/ml) Cmax (g/ml) Apparent t1/2 (hr) CL/wt (ml/hr/kg) Pharmacokinetic parameter values estimated using a model-based approach with sparsely collected pharmacokinetic samples from individual patients in the study.
Maltese: Għandu jinkiseb parir mingħand esperti skont il-ħtieġa, meta l-prevalenza lokali tar-reżistenza tkun tali li jkun hemm dubju dwar l-utilità tal-mediċina f'mill-inqas xi tipi ta' infezzjonijiet.
English: - That daptomycin susceptibility testing needs Ca in the testing medium and testing methods with mediums providing consistent Ca concentrations are recommended.
Maltese: - L-ittestjar tas-suxxettibilità għal daptomycin jeħtieġ Ca fil-mezz tal-ittestjar u metodi ta' ttestjar b'mezzi li jipprovdu konċentrazzjonijiet ta' Ca konsistenti huma rakkomandati.
English: No data are available in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: M'hemm l-ebda data disponibbli dwar pazjenti b'indeboliment sever tal-fwied (Child-Pugh Klassi Ċ).
English: Among these failures six patients treated with daptomycin and one patient treated with vancomycin were infected with Staphylococcus aureus that developed increasing MICs of daptomycin on or following therapy (see “Mechanisms of resistance” above).
Maltese: Fost dawn il-każjiet ta' kura li ma rnexxietx, sitt pazjenti kkurati b'daptomycin u pazjent wieħed ikkurat b'vancomycin, kienu infettati bi Staphlococcus aureus li żviluppa żieda fl-MICs ta' daptomycin matul jew wara t-terapija (ara “Mekkaniżmi ta' reżistenza” hawn fuq).
English: The primary objective of Study DAP-PEDS-07-03 was to assess the safety of treatment.
Maltese: L-iskop primarju tal-Istudju DAP-PEDBAC-11-03 kien li jevalwa s-sigurtà tat-trattament.
English: Not known*: Eosinophilic pneumonia 1**, cough
Maltese: Setgħu jiġu vvalutati b'mod kliniku (CE, clinically evaluable)
English: Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during co-administration with medicinal products that reduce renal filtration (e.g. NSAIDs and COX-2 inhibitors).
Maltese: Daptomycin jitneħħa primarjament permezz ta' filtrazzjoni tal-kliewi, u għalhekk, il-livelli fil-plażma jistgħu jiżdiedu waqt l-għoti flimkien ma' prodotti mediċinali li jnaqqsu l-filtrazzjoni tal-kliewi (eż.
English: In all populations the clinical success rates were comparable between the daptomycin and SOC treatment arms, supporting the primary efficacy analysis in the ITT population.
Maltese: Fil-popolazzjonijiet kollha, ir-rati tas-suċċess kliniku kienu komparabbli bejn it-trattament b'daptomycin u SOC, b'sostenn għall-analiżi tal-effikaċja primarja fil-popolazzjoni ITT.
English: Draw 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller diameter, or a needleless device, then SLOWLY inject through the centre of the rubber stopper directly over the product plug in the vial.
Maltese: Iġbed 10 ml ta' sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjoni ġo siringa billi tuża labra sterili għat-trasferiment, jiġifieri labra ta' kejl ta' 21 jew li tkun iżgħar fid-dijametru, jew tagħmir bla labra, u mbagħad injetta BIL-MOD minn ġoċ-ċentru tat-tapp tal-lastku direttament ġol-plagg tal-prodott ġol-kunjett.