natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
Daptomycin should be discontinued immediately and treatment with systemic steroids should be initiated when appropriate.
Potrebno je odmah prekinuti liječenje daptomicinom i započeti liječenje sustavnim steroidima kada je prikladno.
Gram negative organisms * denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Mikroorganizmi s prirođenom rezistencijom Gram-negativni mikroorganizmi * označava vrste za koje se smatra da je aktivnost na njih zadovoljavajuće dokazana kliničkim ispitivanjima.
Daptomycin is reversibly bound to human plasma proteins in a concentration independent manner.
Daptomicin se reverzibilno veže na proteine plazme u ljudi, na način neovisan o koncentraciji.
No patients 1 to <2 years of age were enrolled in the study.
U ispitivanje nisu bili uključeni bolesnici u dobi od 1 do <2 godine.
- Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib).
- Lijekove protiv bolova koji se zovu nesteroidni protuupalni lijekovi (NSAIL) ili COX-2 inhibitori (npr. celekoksib).
Clinical efficacy in paediatric patients
Klinička djelotvornost u pedijatrijskih bolesnika
The highest measured concentration of daptomycin in the breast milk was 0.045 mcg/ml, which is a low concentration.
Najviša izmjerena koncentracija daptomicina u majčinom mlijeku iznosila je 0,045 µg/ml, što predstavlja nisku koncentraciju.
Table 1 Adverse reactions from clinical studies and post-marketing reports
Tablica 1 Nuspojave iz kliničkih ispitivanja i sigurnosnih izvješća nakon stavljanja lijeka u promet
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.
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.
- Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting.
- Oralne antikoagulanse (npr. varfarin), koji su lijekovi za sprječavanje zgrušavanja krvi.
No fibrosis or rhabdomyolysis was observed.
Fibroza i rabdomioliza nisu uočene.
It is also used to treat infections in the blood when associated with skin infection.
Također se primjenjuje za liječenje infekcija u krvi kad su udružene s infekcijom kože.
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.
Većina slučajeva se pojavila nakon više od 2 tjedna liječenja daptomicinom, a do poboljšanja je došlo nakon prekida liječenja daptomicinom i uvođenja terapije steroidima.
The primary objective of Study DAP-PEDBAC-11-02 was to assess the safety of intravenous daptomycin versus SOC antibiotics.
Primarni cilj ispitivanja DAP-PEDBAC-11-02 bio je procijeniti sigurnost intravenske primjene daptomicina naspram SOC antibiotika.
Your doctor may decide not to give you Daptomycin Hospira or to stop the other medicine for a while.
Vaš liječnik može odlučiti da neko vrijeme ne primate lijek Daptomicin Hospira ili na neko vrijeme prekinuti liječenje drugim lijekom.
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.
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.
Daptomycin Hospira is available in packs containing 1 vial or 5 vials.
Daptomicin Hospira dostupan je u pakiranjima s 1 bočicom ili 5 bočica.
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.
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.
- Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.
- U svakog bolesnika koji razvije neobjašnjivu bol u mišićima, osjetljivost, slabost ili grčeve mišića, potrebno je kontrolirati razine CPK svaka 2 dana.
Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Daptomicin Hospira indiciran je za liječenje sljedećih infekcija (vidjeti dijelove 4.4 i 5.1).
After infusion of 14C-daptomycin in healthy adults, the plasma radioactivity was similar to the concentration determined by microbiological assay.
Nakon infuzije 14C-daptomicina u zdravih odraslih dobrovoljaca radioaktivnost plazme bila je slična koncentraciji utvrđenoj mikrobiološkom analizom.
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.
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.
Steady-state concentrations are achieved by the third daily dose.
Koncentracije u stanju dinamičke ravnoteže postignute su s trećom dnevnom dozom.
The most frequently reported side effects are described below:
Niže su navedene najčešće zabilježene nuspojave:
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).
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).
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.
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.
A total of 81 subjects were treated in the study, including 55 subjects who received daptomycin and 26 subjects who received standard-of-care.
U ispitivanju je bio liječen ukupno 81 ispitanik, uključujući 55 ispitanika koji su primili daptomicin i 26 ispitanika koji su primili standarnu skrb.
4 mg/kg every 48 hours
4 mg/kg svakih 48 sati
However, renal function should be assessed and the dose should be reduced if there is evidence of severe renal impairment.
Međutim, potrebno je procijeniti funkciju bubrega i dozu smanjiti ako postoji dokaz o teškom oštećenju bubrega.
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.
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.
12 to 17 years
12 do 17 godina
For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
Uvjete čuvanja nakon rekonstitucije ili nakon rekonstitucije i razrjeđivanja lijeka vidjeti u dijelu 6.3.
If your kidneys do not work well, you may receive Daptomycin Hospira less often, e.g. once every other day.
Ako Vaši bubrezi ne rade dobro, možda ćete lijek Daptomicin Hospira primati rjeđe, npr. jedanput svaki drugi dan.
Water should not be used for reconstitution of Daptomycin Hospira for intravenous injection.
Voda se ne smije koristiti za rekonstituciju lijeka Daptomicin Hospira za intravensku injekciju.
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.
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.
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%).
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%).
Uncommon: Decreased appetite, hyperglycaemia, electrolyte imbalance
Smanjen apetit, hiperglikemija, neravnoteža elektrolita
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.
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.
No functional or pathological changes in smooth or cardiac muscle were observed.
U glatkim mišićima ili srčanom mišiću nisu uočene nikakve funkcionalne ni patološke promjene.
In most reported cases associated with daptomycin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
U većini prijavljenih slučajeva povezanih s daptomicinom, bolesnici su razvili vrućicu, dispneju s hipoksičnom respiratornom insuficijencijom i difuzne plućne infiltrate ili organiziranu pneumoniju.
Daptomycin exhibits rapid, concentration dependent bactericidal activity against Gram positive organisms in vitro and in in vivo animal models.
Daptomicin iskazuje brzu, o koncentraciji ovisnu baktericidnu aktivnost prema gram-pozitivnim mikroorganizmima in vitro i u životinjskim modelima in vivo.
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).
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).
Mechanism of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
Daptomicin je prirodni ciklički lipopeptid koji djeluje samo na gram-pozitivne bakterije.
Sodium hydroxide (for pH adjustment) Citric acid (solubiliser/stabiliser)
Natrijev hidroksid (za prilagođavanje pH) Citratna kiselina (pomoćna tvar za otapanje/stabilizator)
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.
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.
Daptomycin Hospira is not physically or chemically compatible with glucose-containing solutions.
Daptomicin Hospira nije fizikalno ni kemijski kompatibilan s otopinama koje sadrže glukozu.
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).
Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na trudnoću, embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj (vidjeti dio 5.3).
Modified intent-to-treat (MITT) Microbiologically modified intent-to-treat (mMITT)
Modificirana populacija planirana za liječenje (MITT) Mikrobiološki modificirana populacija planirana za liječenje (mMITT)
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.
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.
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).
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
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:
Bolesnici su bili postupno uključeni u dobro definirane dobne skupine i dobivali o dobi ovisne doze jedanput na dan do 14 dana, kako slijedi:
Long-term carcinogenicity studies in rodents were not conducted.
Nisu provedena dugotrajna ispitivanja kancerogenosti u glodavaca.
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.
U zasebnom ispitivanju nisu nađeni metaboliti u plazmi, a u mokraći je nađena manja količina triju oksidativnih metabolita i jedan neutvrđeni spoj.
Uncommon: Fatigue, pain * Based on post-marketing reports.
Umor, bolovi * Temeljeno na izvješćima nakon stavljanja lijeka u promet.
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.
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.
1 to < 2 years
1 do < 2 godine
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:
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:
The symptoms can include difficulty breathing, new or worsening cough, or new or worsening fever.
Simptomi mogu uključivati otežano disanje, pojavu ili pogoršanje kašlja i pojavu ili pogoršanje vrućice.
Daptomycin is active against Gram positive bacteria only (see section 5.1).
Daptomicin djeluje samo na gram-pozitivne bakterije (vidjeti dio 5.1).
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.
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.
From a microbiological point of view, the product should be used immediately after reconstitution (see section 6.3).
S mikrobiološkog stajališta, lijek treba primijeniti odmah nakon rekonstitucije (vidjeti dio 6.3).
In addition, dose regimens of daptomycin that might be appropriate for the treatment of enterococcal infections, with or without bacteraemia, have not been identified.
Uz to, nije ustanovljeno doziranje daptomicina koje bi moglo biti odgovarajuće za liječenje enterokoknih infekcija, sa ili bez bakterijemije.
Daptomycin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk.
Daptomicin se u tih bolesnika smije primjenjivati samo kada se smatra da očekivana klinička korist nadmašuje mogući rizik.
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.
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.
The same dose is recommended in people aged over 65 years provided their kidneys are working well.
Jednaka se doza preporučuje i osobama starijima od 65 godina, pod uvjetom da im bubrezi dobro rade.
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).
Potrebno je prilagoditi interval doziranja daptomicina u odraslih bolesnika čiji je klirens kreatinina < 30 ml/min (vidjeti dijelove 4.2 i 5.2).
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.
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.
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.
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.
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).
Teško oštećenje bubrega može samo po sebi stvoriti sklonost porastima razina daptomicina, čime se može povećati rizik od razvoja miopatije (vidjeti iznad).
It has been demonstrated in clinical studies that daptomycin is not effective in the treatment of pneumonia.
U kliničkim ispitivanjima je dokazano da daptomicin nije učinkovit u liječenju pneumonije.
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.
U štakora su ispitivanja distribucije u tkiva pokazala da daptomicin samo minimalno prolazi krvno-moždanu barijeru i posteljicu nakon jednokratne i višekratnih doza.
Daptomycin Hospira should not be used during pregnancy unless clearly necessary i.e., only if the expected benefit outweighs the possible risk.
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.
Available in packs containing 1 vial or 5 vials.
Dostupno u pakiranjima s 1 bočicom ili 5 bočica.
Duration of Therapy
Trajanje terapije
There is limited experience regarding concomitant administration of daptomycin with other medicinal products that may trigger myopathy (e.g. HMG-CoA reductase inhibitors).
Postoji ograničeno iskustvo istodobne primjene daptomicina s drugim lijekovima koji mogu izazvati miopatiju (npr. inhibitori HMG-CoA reduktaze).
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).
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).
Anaphylaxis/hypersensitivity reactions
Anafilaksija/reakcije preosjetljivosti
- Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake Rok valjanosti/EXP.
- 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.
- 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.
Driving and using machines Daptomycin Hospira has no known effects on the ability to drive or use machines.
Upravljanje vozilima i strojevima Daptomicin Hospira nema poznatih učinaka na sposobnost upravljanja vozilima ili strojevima.
The symptoms generally go away within a few days of stopping Daptomycin Hospira.
Simptomi obično prolaze unutar nekoliko dana nakon prekida primjene lijeka Daptomicin Hospira.
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.
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.
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.
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.
A total of 389 subjects were treated in the study, including 256 subjects who received daptomycin and 133 subjects who received standard-of-care.
U ispitivanju je liječeno ukupno 389 ispitanika, uključujući 256 ispitanika koji su primali daptomicin i 133 bolesnika koji su primali standard skrbi.
Secondary objectives included an assessment of efficacy of age-dependent doses of intravenous daptomycin in comparison with standard-of-care therapy.
Sekundarni ciljevi bili su procjena djelotvornosti doza intravenskog daptomicina koje su ovisile o dobi u usporedbi s liječenjem standardom skrbi.
Any unused portion remaining in the vial should be discarded.
Sav neiskorišteni lijek zaostao u bočici treba ukloniti.
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.
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.