FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice (see sections 4.4 and 5.1).
Croatian: Pri donošenju odluke o korištenju daptomicina preporučuje se uzeti u obzir antibakterijsku osjetljivost mikroorganizma, a odluka se mora temeljiti na savjetu stručnjaka (vidjeti dijelove 4.4 i
English: Patients were enrolled in a stepwise approach into well-defined age groups and given age-dependent doses once daily for up to 14 days, as follows:
Croatian: Bolesnici su bili postupno uključeni u dobro definirane dobne skupine i dobivali o dobi ovisne doze jedanput na dan do 14 dana, kako slijedi:
English: Long-term carcinogenicity studies in rodents were not conducted.
Croatian: Nisu provedena dugotrajna ispitivanja kancerogenosti u glodavaca.
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.
Croatian: U zasebnom ispitivanju nisu nađeni metaboliti u plazmi, a u mokraći je nađena manja količina triju oksidativnih metabolita i jedan neutvrđeni spoj.
English: Uncommon: Fatigue, pain * Based on post-marketing reports.
Croatian: Umor, bolovi * Temeljeno na izvješćima nakon stavljanja lijeka u promet.
English: The mechanism of action involves binding (in the presence of calcium ions) to bacterial membranes of both growing and stationary phase cells causing depolarisation and leading to a rapid inhibition of protein, DNA, and RNA synthesis.
Croatian: Mehanizam djelovanja obuhvaća vezanje (u prisutnosti kalcijevih iona) na bakterijsku membranu stanica i u fazi rasta i u fazi mirovanja, čime uzrokuje depolarizaciju koja vodi k brzoj inhibiciji sinteze proteina, DNK i RNK.
English: 1 to < 2 years
Croatian: 1 do < 2 godine
English: Patients were randomised in a 2:1 ratio into the following age groups and given age-dependent doses once daily for up to 42 days, as follows:
Croatian: Bolesnici su bili randomizirani u omjeru 2:1 u sljedeće dobne skupine i dobivali doze ovisno o dobi jedanput na dan do 42 dana kako slijedi:
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 i pojavu ili pogoršanje vrućice.
English: Daptomycin is active against Gram positive bacteria only (see section 5.1).
Croatian: Daptomicin djeluje samo na gram-pozitivne bakterije (vidjeti dio 5.1).
English: The following have been shown to be compatible when added to Daptomycin Hospira containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.
Croatian: Sljedeći lijekovi su se pokazali kompatibilnima kada se dodaju infuzijskim otopinama koje sadrže lijek Daptomicin Hospira: aztreonam, ceftazidim, ceftriakson, gentamicin, flukonazol, levofloksacin, dopamin, heparin i lidokain.
English: From a microbiological point of view, the product should be used immediately after reconstitution (see section 6.3).
Croatian: S mikrobiološkog stajališta, lijek treba primijeniti odmah nakon rekonstitucije (vidjeti dio 6.3).
English: In addition, dose regimens of daptomycin that might be appropriate for the treatment of enterococcal infections, with or without bacteraemia, have not been identified.
Croatian: Uz to, nije ustanovljeno doziranje daptomicina koje bi moglo biti odgovarajuće za liječenje enterokoknih infekcija, sa ili bez bakterijemije.
English: Daptomycin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk.
Croatian: Daptomicin se u tih bolesnika smije primjenjivati samo kada se smatra da očekivana klinička korist nadmašuje mogući rizik.
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.
Croatian: Nalazi in vitro i nekih in vivo ispitivanja kojima se istraživao mehanizam miotoksičnosti daptomicina pokazuju da je cilj toksičnog djelovanja plazmatska membrana diferenciranih mišićnih stanica koje se spontano kontrahiraju.
English: The same dose is recommended in people aged over 65 years provided their kidneys are working well.
Croatian: Jednaka se doza preporučuje i osobama starijima od 65 godina, pod uvjetom da im bubrezi dobro rade.
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).
Croatian: Potrebno je prilagoditi interval doziranja daptomicina u odraslih bolesnika čiji je klirens kreatinina < 30 ml/min (vidjeti dijelove 4.2 i 5.2).
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.
Croatian: Daptomicin Hospira se u odraslih osoba te u djece i adolescenata (u dobi od 1 do 17 godina) koristi za liječenje infekcija kože i tkiva ispod kože.
English: The laboratory susceptibility testing leaflet should contain the following key messages: - That susceptibility testing minimises the risk of treatment failure by identifying strains with potential resistance to daptomycin.
Croatian: Letak za laboratorije vezano uz testiranje osjetljivosti treba sadržavati sljedeće ključne obavijesti: - da testiranje osjetljivosti smanjuje rizik od neuspješnog liječenja, budući da se njime mogu odrediti sojevi kod kojih je moguća rezistencija na daptomicin.
English: Severe renal impairment may in itself also pre-dispose to elevations in daptomycin levels which may increase the risk of development of myopathy (see above).
Croatian: Teško oštećenje bubrega može samo po sebi stvoriti sklonost porastima razina daptomicina, čime se može povećati rizik od razvoja miopatije (vidjeti iznad).
English: It has been demonstrated in clinical studies that daptomycin is not effective in the treatment of pneumonia.
Croatian: U kliničkim ispitivanjima je dokazano da daptomicin nije učinkovit u liječenju pneumonije.
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.
Croatian: U štakora su ispitivanja distribucije u tkiva pokazala da daptomicin samo minimalno prolazi krvno-moždanu barijeru i posteljicu nakon jednokratne i višekratnih doza.
English: Daptomycin Hospira should not be used during pregnancy unless clearly necessary i.e., only if the expected benefit outweighs the possible risk.
Croatian: Daptomicin Hospira ne smije se primjenjivati tijekom trudnoće, osim ako to nije doista nužno, odnosno smije se primjenjivati samo ako očekivana korist nadmašuje mogući rizik.
English: Available in packs containing 1 vial or 5 vials.
Croatian: Dostupno u pakiranjima s 1 bočicom ili 5 bočica.
English: Duration of Therapy
Croatian: Trajanje terapije
English: There is limited experience regarding concomitant administration of daptomycin with other medicinal products that may trigger myopathy (e.g. HMG-CoA reductase inhibitors).
Croatian: Postoji ograničeno iskustvo istodobne primjene daptomicina s drugim lijekovima koji mogu izazvati miopatiju (npr. inhibitori HMG-CoA reduktaze).
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: Na temelju 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: Anaphylaxis/hypersensitivity reactions
Croatian: Anafilaksija/reakcije preosjetljivosti
English: - Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake Rok valjanosti/EXP.
English: - Daptomycin Hospira 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.
Croatian: - Daptomicin Hospira ne smije se primjenjivati u bolesnika koji uzimaju druge lijekove povezane s miopatijom, osim ako se ne smatra da korist za bolesnika nadmašuje rizik.
English: Driving and using machines Daptomycin Hospira has no known effects on the ability to drive or use machines.
Croatian: Upravljanje vozilima i strojevima Daptomicin Hospira nema poznatih učinaka na sposobnost upravljanja vozilima ili strojevima.
English: The symptoms generally go away within a few days of stopping Daptomycin Hospira.
Croatian: Simptomi obično prolaze unutar nekoliko dana nakon prekida primjene lijeka Daptomicin Hospira.
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.
Croatian: European Committee on Antimicrobial Susceptibility Testing, EUCAST) za stafilokoke i streptokoke (osim za S. pneumoniae) iznosi ≤ 1 mg/l za osjetljive i > 1 mg/l za rezistentne.
English: There is a possibility that your blood levels of Daptomycin Hospira could be higher than those found in persons of average weight and you may need careful monitoring in case of side effects.
Croatian: Postoji mogućnost da razine lijeka Daptomicin Hospira u Vašoj krvi budu više od onih u osoba s prosječnom tjelesnom težinom te će Vas možda trebati pozorno pratiti u slučaju nuspojava.
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 standard skrbi.
English: Secondary objectives included an assessment of efficacy of age-dependent doses of intravenous daptomycin in comparison with standard-of-care therapy.
Croatian: Sekundarni ciljevi bili su procjena djelotvornosti doza intravenskog daptomicina koje su ovisile o dobi u usporedbi s liječenjem standardom skrbi.
English: Any unused portion remaining in the vial should be discarded.
Croatian: Sav neiskorišteni lijek zaostao u bočici treba ukloniti.
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.
Croatian: Stopa ukupnog terapijskog odgovora bila je slična i za skupine liječene daptomicinom i standardnom skrbi za infekcije uzrokovane MRSA-om, MSSA-om i bakterijom Streptococcus pyogenes (vidjeti tablicu u nastavku; mikrobiološki ocjenjiva populacija); stope odgovora bile su > 94% za obje liječene skupine za sve ove česte patogene.
English: If an allergic reaction to daptomycin occurs, discontinue use and institute appropriate therapy.
Croatian: Ako se pojavi alergijska reakcija na daptomicin, potrebno je prekinuti njegovu primjenu i uvesti odgovarajuću terapiju.
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.
Croatian: Savjetuje se oprez pri primjeni daptomicina u bolesnika s već prisutnim oštećenjem bubrega određenoga stupnja (klirens kreatinina < 80 ml/min) prije početka terapije lijekom Daptomicin Hospira.
English: However, daptomycin can cross the placenta in pregnant rats (see section 5.2).
Croatian: Međutim, daptomicin može proći kroz posteljicu gravidnih ženki štakora (vidjeti dio 5.2).
English: Daptomycin administered as a 2-minute intravenous injection also exhibited dose proportional pharmacokinetics in the approved therapeutic dose range of 4 to 6 mg/kg.
Croatian: Daptomicin primijenjen kao 2-minutna intravenska injekcija također pokazuje farmakokinetiku proporcionalnu dozi u odobrenom terapijskom rasponu doza od 4 do 6 mg/kg.
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 je pasa daptomicin 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 i zahtijevalo je prijevremeni prekid liječenja u tim doznim skupinama.
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.
Croatian: Tijekom praćenja nakon stavljanja lijeka u promet zabilježeni su slučajevi interferencije između daptomicina i određenih reagensa koji se koriste pri nekim određivanjima protrombinskog vremena/internacionalnog normaliziranog omjera (PV/INR).
English: If co-administration cannot be avoided, CPK levels should be measured more frequently than once weekly and patients should be closely monitored for any signs or symptoms that might represent myopathy (see sections 4.4, 4.8 and
Croatian: Ako se istodobna primjena ne može izbjeći, razine CPK treba određivati češće od jedanput tjedno i bolesnike treba pozorno pratiti radi pojave bilo kojeg znaka ili simptoma koji može ukazivati na miopatiju (vidjeti dijelove 4.4, 4.8 i 5.3).
English: Adverse reactions (i.e. considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported at similar frequencies for daptomycin and comparator regimens.
Croatian: Učestalost zabilježenih nuspojava (za koje je ispitivač ocijenio da su moguće, vjerojatno ili sigurno povezane s lijekom) bila je slična za daptomicin i lijekove usporedbe.
English: In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).
Croatian: Kada se radi o miješanim infekcijama kod kojih se sumnja na gram-negativne i/ili na određene vrste anaerobnih bakterija, uz daptomicin treba primijeniti i drugi odgovarajući antibakterijski lijek (lijekove).
English: Gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension
Croatian: Gastrointestinalni i abdominalni bolovi, mučnina, povraćanje, konstipacija, proljev, flatulencija, nadutost i distenzija trbuha
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 zabilježena izvješća o neuspješnom liječenju 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: In addition, there is a potential for a pharmacodynamic interaction to occur during co-administration due to additive renal effects.
Croatian: Osim toga, pri istodobnoj primjeni postoji i mogućnost farmakodinamičke interakcije zbog dodatnih učinaka na bubrege.
English: What you need to know before you are given Daptomycin Hospira
Croatian: Što morate znati prije nego počnete primati Daptomicin Hospira
English: Eosinophilic pneumonia
Croatian: Eozinofilna pneumonija
English: About 5% of the administered radiolabel was excreted in the faeces.
Croatian: Oko 5% primijenjenog spoja označenog radioaktivnim sredstvom izlučilo se stolicom.
English: - Occasionally, patients receiving Daptomycin Hospira 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 lijek Daptomicin Hospira može javiti osjetljivost ili bol u mišićima ili mišićna slabost (za više podataka vidjeti dio 4 ove upute).
English: The safety data for the administration of daptomycin via 2-minute intravenous injection are derived from two pharmacokinetic studies in healthy adult volunteers.
Croatian: Sigurnosni podaci o primjeni daptomicina putem 2-minutne intravenske injekcije su dobiveni iz dva farmakokinetička ispitivanja u zdravih odraslih dobrovoljaca.
English: No data are available in patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: Nisu dostupni podaci za bolesnike s teškim oštećenjem jetre (Child-Pugh stadij C).
English: Comparator
Croatian: Komparator
English: Patients with deep-seated infections should receive any required surgical interventions (e.g. debridement, removal of prosthetic devices, valve replacement surgery) without delay.
Croatian: U bolesnika s duboko smještenim infekcijama nužno je bez odlaganja izvršiti potreban kirurški zahvat (npr. debridman, odstranjivanje prostetičkih uređaja, kirurška zamjena zaliska).
English: Do not breast-feed if you are receiving Daptomycin Hospira, because it may pass into your breast milk and could affect the baby.
Croatian: Ako primate lijek Daptomicin Hospira, ne smijete dojiti jer on može ući u majčino mlijeko i utjecati na dojenče.
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.
Croatian: Farmakokinetika daptomicina općenito je linearna i neovisna o vremenu pri dozama od 4 do 12 mg/kg koje su primijenjene kao jednokratne dnevne doze putem 30-minutne intravenske infuzije zdravim odraslim dobrovoljcima do 14 dana.
English: 2 to 6 years
Croatian: 2 do 6 godina
English: Dose adjustments in adult patients with renal impairment by indication and creatinine clearance
Croatian: Prilagođavanje doze u odraslih bolesnika s oštećenjem funkcije bubrega, prema indikaciji i klirensu kreatinina
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.
Croatian: Kako Daptomicin Hospira izgleda i sadržaj pakiranja Daptomicin Hospira prašak za otopinu za injekciju/infuziju dostupan je kao svijetlo žuti do svijetlo smeđi liofilizirani kolačić ili prašak u staklenoj bočici.
English: Dose Infusion Time
Croatian: Doza trajanje infuzije
English: Comparator n/N (%)
Croatian: Komparator n/N (%)
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 bubrega, vezanje na proteine iznosilo je u prosjeku oko 90%.
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.
Croatian: Kartica za doziranje treba sadržavati sljedeće ključne obavijesti: - da postoji rizik od teškog toksičnog djelovanja na skeletne mišiće, pa je stoga važno određivati vrijednosti CPK na početku liječenja, a zatim u redovitim vremenskim razmacima.
English: Following administration of multiple doses, daptomycin exposure was similar across different age groups after dose adjustment based on body weight and age.
Croatian: Nakon primjene višestrukih doza, izloženost daptomicinu bila je slična u svim dobnim skupinama nakon prilagodbe doze na temelju tjelesne težine i dobi.
English: Patients who develop signs or symptoms that might represent a peripheral neuropathy during therapy with daptomycin should be investigated and consideration should be given to discontinuation of daptomycin (see sections 4.8 and 5.3).
Croatian: Bolesnike koji tijekom terapije daptomicinom razviju znakove ili simptome koji bi mogli predstavljati perifernu neuropatiju treba pregledati te razmotriti ukidanje daptomicina (vidjeti dijelove 4.8 i 5.3).
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 ponavljajućih infekcija izazvanih bakterijom Staphylococcus aureus imala je duboko smještene infekcije i nije bila podvrgnuta potrebnim kirurškim zahvatima.
English: Whenever possible, Daptomycin Hospira should be administered following the completion of dialysis on dialysis days (see section 5.2).
Croatian: Kad je god to moguće, Daptomycin Hospira treba primjenjivati na sam dan dijalize, nakon završetka postupka dijalize (vidjeti dio 5.2).
English: The polypropylene flip off cap should be removed to expose the central portion of the rubber stopper.
Croatian: Potrebno je odstraniti polipropilensku "flip-off" kapicu da se otkrije središnji dio gumenog čepa.
English: If you think you may be allergic, ask your doctor or nurse for advice.
Croatian: Ako mislite da biste mogli biti alergični, obratite se za savjet liječniku ili medicinskoj sestri.
English: Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
Croatian: Prije izvlačenja igle iz bočice, klip štrcaljke treba povući sve do kraja tijela štrcaljke kako bi se izvukla sva otopina iz preokrenute bočice.
English: Daptomycin had no effect on the pharmacokinetics of warfarin or probenecid, nor did these medicinal products alter the pharmacokinetics of daptomycin.
Croatian: Daptomicin nije utjecao na farmakokinetiku varfarina i probenecida, niti su navedeni lijekovi utjecali na farmakokinetiku daptomicina.
English: <Date of first authorisation: 22-March-2017> <Date of latest renewal: {DD month YYYY}>
Croatian: Datum prvog odobrenja: 22. ožujka 2017.
English: What Daptomycin Hospira contains - The active substance is daptomycin.
Croatian: Što lijek Daptomicin Hospira sadrži - Djelatna tvar je daptomicin.
English: Liver function tests abnormal
Croatian: Abnormalne vrijednosti testova jetrene funkcije
English: Secondary objectives included: Clinical outcome based on the blinded Evaluator's assessment of clinical response (success [cure, improved], failure, or non-evaluable) at the TOC Visit; and Microbiological response (success, failure, or non-evaluable) based on evaluation of Baseline infecting pathogen at TOC.
Croatian: Sekundarni ciljevi uključivali su: klinički ishod na temelju kliničkog odgovora prema slijepoj procjeni ocjenjivača (uspjeh [izlječenje, poboljšanje], neuspjeh ili neocjenjivo) prilikom dolaska zbog utvrđivanja izlječenja; i mikrobiološkog odgovora (uspjeh, neuspjeh, neocjenjivo) na temelju procjene zaraznog patogena s početka ispitivanja prilikom utvrđivanja izlječenja.
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.
Croatian: U randomiziranom, kontroliranom, otvorenom ispitivanju na 235 odraslih bolesnika s bakterijemijom izazvanom bakterijom Staphylococcus aureus (odnosno s najmanje jednom pozitivnom kulturom krvi na Staphylococcus aureus prije primjene prve doze), 19 od 120 bolesnika liječenih daptomicinom zadovoljilo je mjerila za desnostrani infektivni endokarditis.