FrancophonIA/ELRC3.0 huggingface dataset:
English: In very rare cases (reported in less than 1 in every 10,000 patients), muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.
Croatian: U vrlo rijetkim slučajevima (zabilježenima u manje od jednog na svakih 10 000 bolesnika), problemi s mišićima mogu biti ozbiljni, uključujući raspadanje mišića (rabdomioliza), što može dovesti do oštećenja bubrega.
English: Cubicin should be discontinued immediately and treatment with systemic steroids should be initiated when appropriate.
Croatian: Potrebno je odmah prekinuti liječenje lijekom Cubicin i započeti liječenje sustavnim steroidima kada je prikladno.
English: Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry.
Croatian: Obrišite vrh gumenog čepa alkoholnim tupferom ili drugom antiseptičkom otopinom i pustite da se osuši.
English: What Cubicin is and what it is used for What you need to know before you are given Cubicin How Cubicin is given
Croatian: Što je Cubicin i za što se koristi Što morate znati prije nego primite Cubicin Kako primjenjivati Cubicin Moguće nuspojave
English: There is insufficient evidence to be able to draw any conclusions regarding the possible clinical efficacy of Cubicin against infections due to enterococci, including Enterococcus faecalis and Enterococcus faecium.
Croatian: Nema dovoljno podataka koji bi omogućili donošenje bilo kakvih zaključaka o mogućoj kliničkoj djelotvornosti lijeka Cubicin protiv infekcija izazvanih enterokokima, uključujući Enterococcus faecalis i Enterococcus faecium.
English: However, when compared with the same doses given as intravenous infusions over 30 minutes there were no clinically important differences in the pharmacokinetics and safety profile of daptomycin (see also sections 4.8 and 5.2).
Croatian: Međutim, kada se usporedio s istim dozama danim putem intravenske infuzije tijekom 30 minuta, nije bilo klinički značajnih razlika u farmakokinetici i sigurnosnom profilu daptomicina (vidjeti također dijelove 4.8 i 5.2).
English: • Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.
Croatian: • U svakog bolesnika koji razvije neobjašnjivu bol, osjetljivost, slabost ili grčeve mišića, potrebno je kontrolirati razine CPK svaka 2 dana.
English: The use of antibacterials may promote the overgrowth of non-susceptible micro-organisms.
Croatian: Primjena antimikrobika može pospješiti prekomjerni rast neosjetljivih mikroorganizama.
English: No fibrosis or rhabdomyolysis was observed.
Croatian: Fibroza ni rabdomioliza nisu uočeni.
English: Cubicin is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a type of bacteria called Staphylococcus aureus.
Croatian: Cubicin se također koristi u odraslih osoba za liječenje infekcija u tkivima koja oblažu unutrašnjost srca (uključujući srčane zaliske) koje su izazvane vrstom bakterije pod nazivom Staphylococcus aureus.
English: Cubicin is available in packs containing 1 vial or 5 vials.
Croatian: Cubicin je dostupan u pakiranjima koja sadrže 1 bočicu ili 5 bočica.
English: Daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog.
Croatian: Primjena daptomicina bila je povezana s minimalnim do blagim degenerativnim/regenerativnim promjenama u skeletnim mišićima u štakora i psa.
English: Please inform your doctor that you are on treatment with Cubicin.
Croatian: Molimo da obavijestite svog liječnika da se liječite lijekom Cubicin.
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.
Croatian: Sigurnost i djelotvornost prilagođavanja intervala doziranja nisu procjenjivani u kontroliranim kliničkim ispitivanjima te se preporuke uglavnom temelje na podacima dobivenim farmakokinetičkim modelom.
English: However, renal function should be assessed and the dose should be reduced if there is evidence of severe renal impairment.
Croatian: Međutim, potrebno je procijeniti funkciju bubrega, i dozu smanjiti ako postoji dokaz o teškom oštećenju funkcije bubrega.
English: Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution.
Croatian: Na kraju bočicu treba nježno vrtjeti/okretati nekoliko minuta, koliko je potrebno da se dobije bistra rekonstituirana otopina.
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.
Croatian: Ako se istodobna primjena ne može izbjeći, CPK razine treba određivati češće od jedanput tjedno i bolesnike treba pozorno pratiti radi pojave bilo kojeg znaka ili simptoma koji može ukazivati na miopatiju.
English: There was no relevant difference in local tolerability or in the nature and frequency of adverse reactions.
Croatian: Nije bilo značajne razlike u lokalnoj podnošljivosti niti u prirodi i učestalosti nuspojava.
English: Daptomycin is an antibacterial that can stop the growth of certain bacteria.
Croatian: Daptomicin je antibakterijska tvar koja može zaustaviti rast određenih bakterija.
English: Patients who develop these signs and symptoms while receiving Cubicin should undergo prompt medical evaluation, including, if appropriate, bronchoalveolar lavage, to exclude other causes (e.g. bacterial infection, fungal infection, parasites, other medicinal products).
Croatian: Bolesnicima koji razviju ove znakove i simptome tijekom liječenja lijekom Cubicin treba napraviti hitnu medicinsku obradu uključujući, ukoliko je to potrebno, i bronhoalveolarnu lavažu, kako bi se isključili drugi uzroci (npr. bakterijska infekcija, gljivična infekcija, paraziti, drugi lijekovi).
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 „EXP“.
English: Based on these study results, both methods of daptomycin administration, the 2-minute intravenous injection and the 30-minute intravenous infusion, had a similar safety and tolerability profile.
Croatian: Temeljeno na rezultatima tih ispitivanja, oba načina primjene daptomicina, 2-minutna intravenska injekcija i 30-minutna intravenska infuzija, imali su sličan sigurnosni profil i profil podnošljivosti.
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.
Croatian: Ispitanici koji su postigli klinički uspjeh (Klinički odgovor „Izlječenje“ ili „Poboljšanje“) i mikrobiološki uspjeh (odgovor „Iskorijenjen“ ili „Pretpostavka iskorijenjivanja“ za patogen) klasificirani su kao ukupni terapijski uspjeh.
English: However, from a microbiological point of view the product should be used immediately.
Croatian: Međutim, s mikrobiološkog stajališta, lijek treba primijeniti odmah.
English: Paediatric patients (1 to 17 years of age)
Croatian: Pedijatrijski bolesnici (u dobi od 1 do 17 godina)
English: Therefore caution should be exercised if Cubicin is given to such patients.
Croatian: Stoga je nužan oprez pri davanju lijeka Cubicin tim bolesnicima.
English: The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper.
Croatian: Potrebno je odstraniti polipropilensku „flip-off“ kapicu da se otkrije središnji dio gumenog čepa.
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: • 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.
Croatian: • Cubicin se ne smije primjenjivati u bolesnika koji uzimaju druge lijekove povezane s miopatijom, osim ako se ne smatra da korist za bolesnika nadmašuje rizik.
English: Water should not be used for reconstitution of Cubicin for intravenous injection.
Croatian: Voda se ne smije koristiti za rekonstituciju lijeka Cubicin za intravensku injekciju.
English: There was no histopathological correlation in the peripheral and central nervous system tissue, or in the skeletal muscle, at any dose level, and the mechanism and clinical relevance for the adverse clinical signs are therefore unknown.
Croatian: Nije bilo histopatološke korelacije u tkivu perifernog i središnjeg živčanog sustava, ili u skeletnim mišićima, pri bilo kojoj dozi, pa su mehanizam i klinički značaj tih štetnih kliničkih znakova stoga nepoznati.
English: Dispose of in accordance with local requirements
Croatian: Zbrinuti sukladno lokalnim propisima.
English: Due to limited clinical experience (see table and footnotes below) Cubicin 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.
Croatian: Zbog ograničenog kliničkog iskustva (vidjeti tablicu i napomene niže), Cubicin se smije primjenjivati u odraslih bolesnika s oštećenjem funkcije bubrega bilo kojega stupnja (CrCl <80 ml/min) samo kada se smatra da očekivana klinička korist nadmašuje mogući rizik.
English: About 5% of the administered radiolabel was excreted in the faeces.
Croatian: Oko 5% primijenjene radioaktivnosti izlučilo se stolicom.
English: After infusion of 14C-daptomycin in healthy adults, the plasma radioactivity was similar to the concentration determined by microbiological assay.
Croatian: Nakon infuzije 14C-daptomicina u zdravih odraslih dobrovoljaca, radioaktivnost plazme bila je slična koncentraciji utvrđenoj mikrobiološkom analizom.
English: The recommended doses should be used in elderly patients except those with severe renal impairment (see above and section 4.4).
Croatian: Preporučene doze smiju se primjenjivati u starijih bolesnika, osim onih s teškim oštećenjem funkcije bubrega (vidjeti iznad i dio 4.4).
English: Not known*: Acute generalised exanthematous pustulosis
Croatian: Nepoznato*: Akutna generalizirana egzantematozna pustuloza
English: In two adult clinical trials in complicated skin and soft tissues infections, 36% of patients treated with Cubicin met the criteria for systemic inflammatory response syndrome (SIRS).
Croatian: U dva klinička ispitivanja kompliciranih infekcija kože i mekih tkiva u odraslih, 36% bolesnika liječenih lijekom Cubicin zadovoljilo je mjerila za sindrom sustavnog upalnog odgovora (engl. systemic inflammatory response syndrome, SIRS).
English: Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients and 156 were healthy volunteers.
Croatian: U tim ispitivanjima, dnevnu dozu od 4 mg/kg primao je 1221 ispitanik, od toga 1108 bolesnika i 113 zdravih dobrovoljaca; dnevnu dozu od 6 mg/kg primalo je 460 ispitanika, od toga 304 bolesnika i 156 zdravih dobrovoljaca.
English: If you are receiving dialysis, and your next dose of Cubicin is due on a dialysis day, you will be usually given Cubicin after the dialysis session.
Croatian: Ako idete na dijalizu, a sljedeću dozu lijeka Cubicin trebate primiti na dan dijalize, Cubicin ćete obično primiti nakon završetka dijalize.
English: Cubicin vials are for single-use only.
Croatian: Bočice lijeka Cubicin su samo za jednokratnu uporabu.
English: In clinical studies, marked increases in plasma CPK to > 5x Upper Limit of Normal (ULN) without muscle symptoms occurred more commonly in Cubicin-treated patients (1.9%) than in those that received comparators (0.5%).
Croatian: U kliničkim su ispitivanjima, izraženi porasti CPK u plazmi do >5x gornje granice normale bez mišićnih simptoma, bili češći u bolesnika liječenih lijekom Cubicin (1,9%) nego u onih koji su primali lijekove usporedbe (0,5%).
English: Cubicin should not be used during pregnancy unless clearly necessary i.e., only if the expected benefit outweighs the possible risk.
Croatian: Cubicin se ne smije primjenjivati tijekom trudnoće, osim ako to nije doista nužno, odnosno smije se primjenjivati samo ako očekivana korist nadmašuje mogući rizik.
English: It is recommended that other medicinal products associated with myopathy should if possible be temporarily discontinued during treatment with Cubicin unless the benefits of concomitant administration outweigh the risk.
Croatian: Preporučuje se da se drugi lijekovi povezani s miopatijom, ako je moguće, privremeno ukinu tijekom liječenja lijekom Cubicin, osim ako koristi od istodobne primjene ne nadmašuju rizik.
English: The majority of cases occurred after more than 2 weeks of treatment with Cubicin and improved when Cubicin was discontinued and steroid therapy was initiated.
Croatian: Većina slučajeva se pojavila nakon više od 2 tjedna liječenja lijekom Cubicin, a do poboljšanja je došlo nakon prekida liječenja lijekom Cubicin i uvođenja terapije steroidima.
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: Granična minimalna inhibitorna koncentracija (MIK) koju je odredio Europski odbor za ispitivanje antimikrobne osjetljivosti (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: Driving and using machines Cubicin has no known effects on the ability to drive or use machines.
Croatian: Upravljanje vozilima i strojevima Cubicin nema poznatih učinaka na sposobnost upravljanja vozilima ili strojevima.
English: There is a possibility that your blood levels of Cubicin 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 Cubicin u Vašoj krvi budu više od onih u osoba s prosječnom tjelesnom težinom te će Vas možda trebati pozorno pratiti u slučaju nuspojava.
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, doziranje daptomicina koje bi moglo biti odgovarajuće za liječenje enterokoknih infekcija, sa ili bez bakterijemije, nije ustanovljeno.
English: The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.
Croatian: Bočicu treba nježno vrtjeti da se lijek potpuno navlaži i zatim ostaviti stajati 10 minuta.
English: Long-term carcinogenicity studies in rodents were not conducted.
Croatian: Nisu provedena dugotrajna ispitivanja karcinogenosti u glodavaca.
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 Cubicin and comparator regimens.
Croatian: Učestalost prijavljenih nuspojava (za koje je istraživač ocijenio da su možda, vjerojatno ili sigurno povezane s lijekom) bila je slična za Cubicin i lijekove usporedbe.
English: Uncommon: Fatigue, pain * Based on post-marketing reports.
Croatian: Manje često: Umor, bolovi * Temeljeno na sigurnosnim izvješćima nakon stavljanja lijeka u promet.
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.
Croatian: Iako su uočene male promjene u farmakokinetici daptomicina i tobramicina tijekom istodobne primjene intravenske infuzije tijekom 30 minuta, pri čemu je Cubicin primijenjen u dozi od 2 mg/kg, te promjene nisu bile statistički značajne.
English: False prolongation of prothrombin time (PT) and elevation of international normalised ratio (INR) have been observed when certain recombinant thromboplastin reagents are utilised for the assay (see also section 4.5).
Croatian: Lažno produljenje protrombinskog vremena (PV) i povećanje internacionalnog normaliziranog omjera (INR) primijećeni su kada se određeni rekombinantni tromboplastinski reagensi koriste u testu (vidjeti također dio 4.5).
English: Vigorous shaking/agitation should be avoided to prevent foaming of the product.
Croatian: Potrebno je izbjegavati snažno miješanje/potresanje da se spriječi pjenjenje lijeka.
English: Cubicin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk.
Croatian: Cubicin se u tih bolesnika smije primjenjivati samo kada se smatra da očekivana klinička korist nadmašuje mogući rizik.
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 tijekom do 14 dana, kako slijedi:
English: Mechanism of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
Croatian: Daptomicin je prirodni ciklički lipopeptid koji djeluje samo na Gram-pozitivne bakterije.
English: Daptomycin exhibits rapid, concentration dependent bactericidal activity against Gram positive organisms in vitro and in in vivo animal models.
Croatian: Daptomicin iskazuje brzu, o koncentraciji ovisnu baktericidnu aktivnost prema Gram-pozitivnim mikroorganizmima in vitro te u životinjskim modelima in vivo.
English: An adjustment of Cubicin 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 lijeka Cubicin u odraslih bolesnika čiji je klirens kreatinina <30 ml/min (vidjeti dijelove 4.2 i 5.2).
English: For Dilution:
Croatian: Za razrjeđivanje:
English: Replace needle with a new needle for the intravenous injection.
Croatian: Iglu treba zamijeniti novom iglom za intravensku injekciju.
English: How to store Cubicin
Croatian: Kako čuvati Cubicin
English: Patients were randomized 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: 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 standardnom skrbi.
English: No functional or pathological changes in smooth or cardiac muscle were observed.
Croatian: U glatkim mišićima i srčanom mišiću nisu uočene nikakve funkcionalne ni patološke promjene.
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 raspodjele u tkiva pokazala da daptomicin samo minimalno prolazi krvno-moždanu barijeru i posteljičnu barijeru nakon jednokratne i višekratnih doza.
English: In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be coadministered with appropriate antibacterial agent(s).
Croatian: Pri miješanim infekcijama kod kojih se sumnja na Gram-negativne i/ili na određene vrste anaerobnih bakterija, uz Cubicin treba primijeniti i drugi odgovarajući antibakterijski lijek (lijekove).
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 funkcije bubrega može samo po sebi stvoriti sklonost k porastima razina daptomicina, čime se može povećati rizik od razvoja miopatije (vidjeti iznad).
English: The following have been shown to be compatible when added to Cubicin containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.
Croatian: Sljedeći lijekovi su se pokazali kompatibilnima kada se dodaju infuzijskoj otopini koja sadrži Cubicin: aztreonam, ceftazidim, ceftriakson, gentamicin, flukonazol, levofloksacin, dopamin, heparin i lidokain.
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, prijavljeni su slučajevi interferencije između daptomicina i određenih reagensa koji se koriste pri nekim određivanjima protrombinskog vremena/internacionalnog normaliziranog omjera (PV/INR).
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 intervalima.
English: If an allergic reaction to Cubicin occurs, discontinue use and institute appropriate therapy.
Croatian: Ako se pojavi alergijska reakcija na Cubicin, potrebno je prekinuti njegovu primjenu te uvesti odgovarajuću terapiju.
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).
Croatian: 6 mg/kg svakih 48 sati cSSTI = komplicirane infekcije kože i mekih tkiva; SAB = bakterijemija izazvana bakterijom S. aureus (1) Sigurnost i djelotvornost prilagođavanja intervala doziranja nisu procijenjene u kontroliranim kliničkim ispitivanjima, a preporuka se temelji na rezultatima farmakokinetičkih ispitivanja i modela (vidjeti dijelove 4.4 i 5.2).
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: 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 te jedan neutvrđeni spoj.
English: CARTON FOR 1 VIAL CARTON FOR 5 VIALS
Croatian: KUTIJA ZA 1 BOČICU KUTIJA ZA 5 BOČICA
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.
Croatian: Savjetuje se oprez pri primjeni lijeka Cubicin u bolesnika s već prisutnim oštećenjem funkcije bubrega određenoga stupnja (klirens kreatinina <80 ml/min) prije početka terapije lijekom Cubicin.