FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 389 subjects were treated in the study, including 256 subjects who received daptomycin and 133 subjects who received standard-of-care.
Croatian: U ispitivanju je liječeno ukupno 389 ispitanika, uključujući 256 ispitanika koji su primali daptomicin i 133 bolesnika koji su primali SOC.
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).
Croatian: Temeljem navedenog preporučuje se da se odraslim bolesnicima na hemodijalizi ili kontinuiranoj ambulantnoj peritonejskoj dijalizi daptomicin primjenjuje jedanput svakih 48 sati u preporučenoj dozi za određenu vrstu infekcije koja se liječi (vidjeti dio 4.2).
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.
Croatian: Volumen distribucije daptomicina u ravnotežnom stanju bio je u zdravih odraslih dobrovoljaca otprilike 0,1 l/kg te je bio neovisan o dozi.
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.
Croatian: Osobito su zabilježeni izvještaji neuspješnog liječenja u bolesnika inficiranih sa Staphylococcus aureus, Enterococcus faecalis ili Enterococcus faecium, uključujući bolesnike s bakterijemijom, a koji su povezani s naknadnom pojavom mikroorganizama sa smanjenom osjetljivošću ili evidentnom rezistencijom na daptomicin tijekom terapije.
English: Cubicin given as an intravenous infusion over 30 or 60 minutes
Croatian: Cubicin za primjenu kao intravenska infuzija tijekom 30 ili 60 minuta
English: - Occasionally, patients receiving Cubicin may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information).
Croatian: - Ponekada se u bolesnika koji primaju Cubicin može javiti osjetljivost ili bol u mišićima ili mišićna slabost (za više podataka vidjeti dio 4 ove upute).
English: Uncommon: Supraventricular tachycardia, extrasystole
Croatian: Manje često: Supraventrikularna tahikardija, ekstrasistole
English: Failure of treatment due to persisting or relapsing Staphylococcus aureus infections was observed in 19/120 (15.8%) patients treated with Cubicin, 9/53 (16.7%) patients treated with vancomycin and 2/62 (3.2%) patients treated with an anti-staphylococcal semi-synthetic penicillin.
Croatian: Neuspjeh u liječenju zbog ustrajnih i/ili rekurentnih infekcija izazvanih Staphylococcus aureus uočen je u 19/120 (15,8%) bolesnika liječenih lijekom Cubicin, u 9/53 (16,7%) bolesnika liječenih vankomicinom i u 2/62 (3,2%) bolesnika liječena polusintetskim anti-stafilokoknim penicilinom.
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).
Croatian: Bolesnike koji tijekom terapije lijekom Cubicin razviju znakove ili simptome koji bi mogli predstavljati perifernu neuropatiju treba pregledati te razmotriti ukidanje daptomicina (vidjeti dijelove 4.8 i 5.3).
English: The symptoms can include difficulty breathing, new or worsening cough, or new or worsening fever.
Croatian: Simptomi mogu uključivati otežano disanje, pojavu ili pogoršanje kašlja te pojavu ili pogoršanje vrućice.
English: Anticoagulant activity in patients receiving Cubicin and warfarin should be monitored for the first several days after therapy with Cubicin is initiated.
Croatian: U bolesnika koji primaju Cubicin i varfarin potrebno je pratiti antikoagulantnu aktivnost tijekom prvih nekoliko dana nakon uvođenja terapije lijekom Cubicin.
English: In addition, there is a potential for a pharmacodynamic interaction to occur during coadministration due to additive renal effects.
Croatian: Osim toga, pri istodobnoj primjeni postoji i mogućnost farmakodinamičke interakcije zbog dodatnih učinaka na bubrege.
English: The most frequently reported side effects are described below:
Croatian: Niže su navedene najčešće prijavljene nuspojave:
English: Eosinophilic pneumonia has been reported in patients receiving Cubicin (see section 4.8).
Croatian: Eozinofilna pneumonija je prijavljena u bolesnika koji su dobivali Cubicin (vidjeti dio 4.8).
English: In healthy adult volunteers and adult patients treated with daptomycin, protein binding averaged about 90% including subjects with renal impairment.
Croatian: U zdravih odraslih dobrovoljaca i u odraslih bolesnika liječenih daptomicinom, uključujući ispitanike s oštećenjem funkcije bubrega, vezanje na proteine iznosilo je u prosjeku oko 90%.
English: In neonatal dogs, daptomycin caused marked clinical signs of twitching, muscle rigidity in the limbs, and impaired use of limbs, which resulted in decreases in body weight and overall body condition at doses ≥50 mg/kg/day and necessitated early discontinuation of treatment in these dose groups.
Croatian: U novorođenih pasa daptomicin je uzrokovao naglašene kliničke znakove trzanja mišića, ukočenosti mišića u udovima i ograničene mogućnosti korištenja udova, što je rezultiralo smanjenjima tjelesne težine i cjelokupnog tjelesnog stanja pri dozama od ≥50 mg/kg/dan te je zahtijevalo prijevremeni prekid liječenja u tim doznim skupinama.
English: In a randomised controlled open-label study in 235 adult patients with Staphylococcus aureus bacteraemia (i.e. at least one positive blood culture of Staphylococcus aureus prior to receiving the first dose) 19 of 120 patients treated with Cubicin met the criteria for RIE.
Croatian: U randomiziranom, kontroliranom, otvorenom ispitivanju na 235 odraslih bolesnika s bakterijemijom izazvanom Staphylococcus aureus (odnosno s najmanje jednom pozitivnom kulturom krvi na Staphylococcus aureus prije primjene prve doze), 19 od 120 bolesnika liječenih lijekom Cubicin zadovoljilo je mjerila za desnostrani infektivni endokarditis.
English: Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during coadministration with medicinal products that reduce renal filtration (e.g. NSAIDs and COX-2 inhibitors).
Croatian: Daptomicin se primarno uklanja bubrežnom filtracijom tako da njegove razine u plazmi mogu porasti pri istodobnoj primjeni s lijekovima koji smanjuju bubrežnu filtraciju (npr. nesteroidni protuupalni lijekovi i COX-2 inhibitori).
English: Expel air, large bubbles, and any excess solution in order to obtain the required dose.
Croatian: Zrak, velike mjehure i sav višak otopine treba izbaciti kako bi se dobila potrebna doza.
English: It has been demonstrated in clinical studies that Cubicin is not effective in the treatment of pneumonia.
Croatian: U kliničkim ispitivanjima je dokazano da Cubicin nije učinkovit u liječenju pneumonije, stoga Cubicin nije indiciran za liječenje pneumonije.
English: Uncommon: Decreased appetite, hyperglycaemia, electrolyte imbalance
Croatian: Manje često: Smanjen apetit, hiperglikemija, elektrolitni disbalans
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.
Croatian: • U bolesnika s početnom vrijednošću CPK 5 puta višom od gornje granice normale ne može se isključiti povećan rizik od daljnjih porasta tijekom terapije daptomicinom.
English: Most patients who failed due to persisting or relapsing Staphylococcus aureus infection had deep-seated infection and did not receive necessary surgical intervention.
Croatian: Većina bolesnika u kojih je uspjeh izostao zbog ustrajnih ili rekurentnih infekcija izazvanih Staphylococcus aureus imala je duboko smještene infekcije te nije bila podvrgnuta potrebnim kirurškim zahvatima.
English: Therefore, caution is advised when daptomycin is coadministered with any other medicinal product known to reduce renal filtration.
Croatian: Stoga se savjetuje oprez pri istodobnoj primjeni daptomicina s bilo kojim lijekom za koji je poznato da smanjuje bubrežnu filtraciju.