FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Daptomycin Hospira Contents of the pack and other information
Croatian: Kako čuvati Daptomicin Hospira Sadržaj pakiranja i druge informacije
English: Peripheral nerve changes were characterised by minimal to slight axonal degeneration and were frequently accompanied by functional changes.
Croatian: Promjene perifernih živaca bile su obilježene minimalnom do blagom degeneracijom aksona i često su bile praćene funkcionalnim promjenama.
English: Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Daptomycin Hospira.
Croatian: Ovisno o vrsti infekcije (infekcija) koju imate, Vaš liječnik može propisati i druge antibakterijske lijekove dok se liječite lijekom Daptomicin Hospira.
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 bubrega (vidjeti iznad i dio 4.4).
English: Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness.
Croatian: Odmah obavijestite svog liječnika ako osjetite neobjašnjivu bol, osjetljivost ili slabost u mišićima.
English: Tell your doctor straight away if you develop any of the following symptoms: - Serious, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including Daptomycin Hospira.
Croatian: Odmah obavijestite svojeg liječnika ako dobijete bilo koji od sljedećih simptoma: - Ozbiljne, akutne alergijske reakcije zabilježene su u bolesnika koji su liječeni gotovo svim antibakterijskim lijekovima, uključujući i lijek Daptomicin Hospira.
English: The mechanism(s) of daptomycin resistance is (are) not fully understood.
Croatian: Mehanizam (mehanizmi) rezistencije na daptomicin još nije (nisu) u potpunosti razjašnjen(i).
English: If this happens tell your doctor.
Croatian: Ako se to dogodi, obavijestite svog liječnika.
English: There is limited information on the safety and efficacy of daptomycin in the very obese and so caution is recommended.
Croatian: Postoje ograničene informacije o sigurnosti i djelotvornosti daptomicina u vrlo pretilih osoba te se stoga preporučuje oprez.
English: Daptomycin Hospira should be discontinued in the presence of unexplained muscle symptoms if the CPK level reaches greater than 5 times upper limit of normal.
Croatian: Daptomicin Hospira treba ukinuti ako postoje neobjašnjivi mišićni simptomi, a razina CPK poraste više od 5 puta od gornje granice normale.
English: Your doctor may need to change the dose of Daptomycin Hospira (see section 3 of this leaflet).
Croatian: Vaš liječnik će možda morati promijeniti dozu lijeka Daptomicin Hospira (vidjeti dio 3 ove upute).
English: - Diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or persistent.
Croatian: - Proljev, posebno ako uočite krv ili sluz, ili ako proljev postane težak ili dugotrajan.
English: The most serious side effects are described below:
Croatian: Niže su navedene najozbiljnije nuspojave:
English: In the event of overdose, supportive care is advised.
Croatian: U slučaju predoziranja preporučuju se potporne mjere.
English: It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Croatian: Nije vjerojatno da će daptomicin inhibirati niti inducirati pretvorbu lijekova koji se metaboliziraju putem sustava P450.
English: It is particularly important that you mention the following: - Medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal product used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis).
Croatian: Osobito je važno da spomenete sljedeće: - Lijekove koji se zovu statini ili fibrati (za snižavanje kolesterola) ili ciklosporin (lijek koji se koristi u presađivanju radi sprječavanja odbacivanja organa ili za neka druga stanja, npr. reumatoidni artritis ili atopijski dermatitis).
English: If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.
Croatian: Ako primijetite uzdignute ili tekućinom ispunjene kožne promjene na velikom dijelu tijela, odmah obavijestite svog liječnika ili medicinsku sestru.
English: The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection.
Croatian: Uobičajena doza za odrasle osobe iznosi 4 mg po kilogramu (kg) tjelesne težine jedanput na dan za kožne infekcije, a 6 mg po kilogramu tjelesne težine jedanput na dan za infekciju srca ili infekciju krvi povezanu s infekcijom kože ili srca.
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 sections 4.8 and 5.2).
Croatian: Međutim, kada se usporedio s istim dozama danim putem intravenskih infuzija tijekom 30 minuta, nije bilo klinički značajnih razlika u farmakokinetici i sigurnosnom profilu daptomicina (vidjeti dijelove 4.8 i 5.2).
English: There is insufficient evidence to be able to draw any conclusions regarding the possible clinical efficacy of daptomycin 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 daptomicina protiv infekcija izazvanih enterokokima, uključujući Enterococcus faecalis i Enterococcus faecium.
English: In some cases of myopathy involving raised CPK and muscle symptoms, the patients also presented with elevated transaminases.
Croatian: U nekim slučajevima miopatije koje su uključivale povišenje CPK i mišićne simptome bolesnici su također imali i povišene transaminaze.
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: 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 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 pasa.
English: Regular monitoring of renal function is advised (see section 5.2).
Croatian: Savjetuje se redovito praćenje bubrežne funkcije (vidjeti također dio 5.2).
English: The dose will depend on how much you weigh and the type of infection being treated.
Croatian: Doza ovisi o Vašoj tjelesnoj težini i vrsti infekcije koja se liječi.
English: Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK.
Croatian: Mikroskopske su promjene u skeletnim mišićima bile minimalne (otprilike 0,05% zahvaćenih miofibrila), a više doze su bile praćene porastima CPK-a.
English: The dose for children and adolescents (1 to 17 years of age) will depend on the age of patient and the type of infection being treated.
Croatian: Doza za djecu i adolescente (u dobi od 1 do 17 godina) ovisi o dobi bolesnika i vrsti infekcije zbog koje se liječi.
English: Patients who develop these signs and symptoms while receiving daptomycin 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 daptomicinom treba napraviti hitnu medicinsku obradu uključujući, ukoliko je potrebno, bronhoalveolarnu lavažu kako bi se isključili drugi uzroci (npr. bakterijska infekcija, gljivična infekcija, paraziti, drugi lijekovi).
English: 7 to 11 years
Croatian: 7 do 11 godina
English: The duration of therapy may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient.
Croatian: Trajanje terapije može biti i dulje od 14 dana, ovisno o procijenjenom riziku od komplikacija u pojedinog bolesnika.
English: Inactive metabolites were detected in urine, as determined by the difference in total radioactive concentrations and microbiologically active concentrations.
Croatian: Neaktivni metaboliti pronađeni su u mokraći, a određeni su razlikom ukupne radioaktivne koncentracije i mikrobiološki aktivne koncentracije.
English: No dose adjustment is necessary based on age alone.
Croatian: Prilagođavanje doze samo zbog dobi nije potrebno.
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 stoga mehanizam i klinički značaj tih štetnih kliničkih znakova nepoznati.
English: Daptomycin Hospira 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: Daptomycin Hospira 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: Daptomycin should be discontinued immediately and treatment with systemic steroids should be initiated when appropriate.
Croatian: Potrebno je odmah prekinuti liječenje daptomicinom i započeti liječenje sustavnim steroidima kada je prikladno.
English: Gram negative organisms * denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Croatian: Mikroorganizmi s prirođenom rezistencijom Gram-negativni mikroorganizmi * označava vrste za koje se smatra da je aktivnost na njih zadovoljavajuće dokazana kliničkim ispitivanjima.
English: Daptomycin is reversibly bound to human plasma proteins in a concentration independent manner.
Croatian: Daptomicin se reverzibilno veže na proteine plazme u ljudi, na način neovisan o koncentraciji.
English: No patients 1 to <2 years of age were enrolled in the study.
Croatian: U ispitivanje nisu bili uključeni bolesnici u dobi od 1 do <2 godine.
English: - Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib).
Croatian: - Lijekove protiv bolova koji se zovu nesteroidni protuupalni lijekovi (NSAIL) ili COX-2 inhibitori (npr. celekoksib).
English: Clinical efficacy in paediatric patients
Croatian: Klinička djelotvornost u pedijatrijskih bolesnika
English: The highest measured concentration of daptomycin in the breast milk was 0.045 mcg/ml, which is a low concentration.
Croatian: Najviša izmjerena koncentracija daptomicina u majčinom mlijeku iznosila je 0,045 µg/ml, što predstavlja nisku koncentraciju.
English: Table 1 Adverse reactions from clinical studies and post-marketing reports
Croatian: Tablica 1 Nuspojave iz kliničkih ispitivanja i sigurnosnih izvješća nakon stavljanja lijeka u promet
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.
Croatian: Pri nižim dozama (25 mg/kg/dan), blagi i reverzibilni klinički znakovi trzanja mišića i jedan slučaj ukočenosti mišića bili su uočeni bez ikakvih učinaka na tjelesnu težinu.
English: - Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting.
Croatian: - Oralne antikoagulanse (npr. varfarin), koji su lijekovi za sprječavanje zgrušavanja krvi.
English: No fibrosis or rhabdomyolysis was observed.
Croatian: Fibroza i rabdomioliza nisu uočene.
English: It is also used to treat infections in the blood when associated with skin infection.
Croatian: Također se primjenjuje za liječenje infekcija u krvi kad su udružene s infekcijom kože.
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.
Croatian: Većina slučajeva se pojavila nakon više od 2 tjedna liječenja daptomicinom, a do poboljšanja je došlo nakon prekida liječenja daptomicinom i uvođenja terapije steroidima.
English: The primary objective of Study DAP-PEDBAC-11-02 was to assess the safety of intravenous daptomycin versus SOC antibiotics.
Croatian: Primarni cilj ispitivanja DAP-PEDBAC-11-02 bio je procijeniti sigurnost intravenske primjene daptomicina naspram SOC antibiotika.
English: Your doctor may decide not to give you Daptomycin Hospira or to stop the other medicine for a while.
Croatian: Vaš liječnik može odlučiti da neko vrijeme ne primate lijek Daptomicin Hospira ili na neko vrijeme prekinuti liječenje drugim lijekom.
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 1 na svakih 10 000 bolesnika), problemi s mišićima mogu biti ozbiljni, uključujući raspadanje mišića (rabdomioliza), što može dovesti do oštećenja bubrega.
English: Daptomycin Hospira is available in packs containing 1 vial or 5 vials.
Croatian: Daptomicin Hospira dostupan je u pakiranjima s 1 bočicom ili 5 bočica.
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: - 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 u mišićima, osjetljivost, slabost ili grčeve mišića, potrebno je kontrolirati razine CPK svaka 2 dana.
English: Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Croatian: Daptomicin Hospira indiciran je za liječenje sljedećih infekcija (vidjeti dijelove 4.4 i 5.1).
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: It is possible that the risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with Daptomycin Hospira.
Croatian: Moguće je da rizik od nastanka nuspojava koje pogađaju mišiće bude veći ako se bilo koji od tih lijekova (i neki drugi koji mogu utjecati na mišiće) uzima tijekom liječenja lijekom Daptomicin Hospira.
English: Steady-state concentrations are achieved by the third daily dose.
Croatian: Koncentracije u stanju dinamičke ravnoteže postignute su s trećom dnevnom dozom.
English: The most frequently reported side effects are described below:
Croatian: Niže su navedene najčešće zabilježene nuspojave:
English: Daptomycin is slowly cleared from the body by haemodialysis (approximately 15% of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours).
Croatian: Daptomicin se iz tijela sporo uklanja hemodijalizom (otprilike 15% primijenjene doze ukloni se tijekom 4 sata) ili peritonejskom dijalizom (otprilike 11% primijenjene doze ukloni se tijekom 48 sati).
English: If not used immediately, in-use storage times are the responsibility of the user and would not normally be longer than 24 hours at 2°C-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja odgovornost je korisnika i normalno ne smije biti dulje od 24 sata pri 2°C - 8°C, osim ako se rekonstitucija/razrjeđivanje ne obavlja u kontroliranim i validiranim aseptičkim uvjetima.
English: A total of 81 subjects were treated in the study, including 55 subjects who received daptomycin and 26 subjects who received standard-of-care.
Croatian: U ispitivanju je bio liječen ukupno 81 ispitanik, uključujući 55 ispitanika koji su primili daptomicin i 26 ispitanika koji su primili standarnu skrb.
English: 4 mg/kg every 48 hours
Croatian: 4 mg/kg svakih 48 sati
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 bubrega.
English: It is recommended that other medicinal products associated with myopathy should if possible be temporarily discontinued during treatment with daptomycin 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 daptomicinom, osim ako koristi od istodobne primjene nadmašuju rizik.
English: 12 to 17 years
Croatian: 12 do 17 godina
English: For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije ili nakon rekonstitucije i razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: If your kidneys do not work well, you may receive Daptomycin Hospira less often, e.g. once every other day.
Croatian: Ako Vaši bubrezi ne rade dobro, možda ćete lijek Daptomicin Hospira primati rjeđe, npr. jedanput svaki drugi dan.
English: Water should not be used for reconstitution of Daptomycin Hospira for intravenous injection.
Croatian: Voda se ne smije koristiti za rekonstituciju lijeka Daptomicin Hospira za intravensku injekciju.
English: Due to limited clinical experience (see table and footnotes below) daptomycin 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), u odraslih bolesnika s oštećenjem bubrega bilo kojega stupnja (CrCl < 80 ml/min) daptomicin se smije primjenjivati samo kada se smatra da očekivana klinička korist nadmašuje mogući rizik.
English: In clinical studies, marked increases in plasma CPK to >5x Upper Limit of Normal (ULN) without muscle symptoms occurred more commonly in daptomycin -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 (GGN) bez mišićnih simptoma bili češći u bolesnika liječenih daptomicinom (1,9%) nego u onih koji su primali lijekove usporedbe (0,5%).
English: Uncommon: Decreased appetite, hyperglycaemia, electrolyte imbalance
Croatian: Smanjen apetit, hiperglikemija, neravnoteža elektrolita
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.
Croatian: Hospira se ne smije primjenjivati u djece mlađe od jedne godine jer su ispitivanja na životinjama pokazala da u ovoj dobnoj skupini može doći do teških nuspojava.
English: No functional or pathological changes in smooth or cardiac muscle were observed.
Croatian: U glatkim mišićima ili srčanom mišiću nisu uočene nikakve funkcionalne ni patološke promjene.
English: In most reported cases associated with daptomycin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
Croatian: U većini prijavljenih slučajeva povezanih s daptomicinom, bolesnici su razvili vrućicu, dispneju s hipoksičnom respiratornom insuficijencijom i difuzne plućne infiltrate ili organiziranu pneumoniju.
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 i u životinjskim modelima in vivo.
English: In two adult clinical trials in complicated skin and soft tissues infections, 36% of patients treated with daptomycin 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 daptomicinom zadovoljilo je mjerila za sindrom sustavnog upalnog odgovora (engl. systemic inflammatory response syndrome, SIRS).
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: Sodium hydroxide (for pH adjustment) Citric acid (solubiliser/stabiliser)
Croatian: Natrijev hidroksid (za prilagođavanje pH) Citratna kiselina (pomoćna tvar za otapanje/stabilizator)
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.
Croatian: Učinci na periferne živce uočeni su pri višim dozama od onih povezanih s učincima na skeletne mišiće u odraslih štakora i pasa te su prvenstveno bili povezani s Cmax u plazmi.
English: Daptomycin Hospira is not physically or chemically compatible with glucose-containing solutions.
Croatian: Daptomicin Hospira nije fizikalno ni kemijski kompatibilan s otopinama koje sadrže glukozu.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na trudnoću, embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj (vidjeti dio 5.3).
English: Modified intent-to-treat (MITT) Microbiologically modified intent-to-treat (mMITT)
Croatian: Modificirana populacija planirana za liječenje (MITT) Mikrobiološki modificirana populacija planirana za liječenje (mMITT)
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 daptomycin 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 daptomicin primijenjen u dozi od 2 mg/kg, te promjene nisu bile statistički značajne.