FrancophonIA/ELRC3.0 huggingface dataset:
English: The volume of distribution at steady state of daptomycin in healthy adult subjects was approximately 0.1 l/kg and was independent of dose.
Slovenian: Volumen porazdelitve daptomicina v stanju dinamičnega ravnovesja je pri zdravih odraslih osebah znašal približno 0,1 l/kg, pri čemer ni bil odvisen od višine odmerka.
English: Most patients who failed due to persisting or relapsing Staphylococcus aureus infection had deep-seated infection and did not receive necessary surgical intervention.
Slovenian: Večina bolnikov z neuspehom zdravljenja zaradi persistentne ali ponovne okužbe z bakterijo Staphylococcus aureus je imela globoko okužbo, potrebnega kirurškega posega pa pri njih niso opravili.
English: If this applies to you, tell your doctor or nurse.
Slovenian: Če se to nanaša na vas, povejte zdravniku ali medicinski sestri.
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.
Slovenian: Pri odraslih se zdravilo Cubicin uporablja tudi za zdravljenje okužb tkiv notranje plasti srca (vključno s srčnimi zaklopkami), kadar take okužbe povzroča vrsta bakterije z imenom Staphylococcus aureus.
English: Inactive metabolites were detected in urine, as determined by the difference in total radioactive concentrations and microbiologically active concentrations.
Slovenian: V urinu so ugotovili prisotnost neaktivnih presnovkov, in sicer so jih določili kot razliko med skupno koncentracijo radioaktivno označene učinkovine in koncentracijo mikrobiološko aktivne učinkovine.
English: The most frequently reported side effects are described below:
Slovenian: Spodaj so navedeni neželeni učinki, o katerih so najbolj pogosto poročali:
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.
Slovenian: Pri nobeni ravni odmerjanja niso opažali temu ustreznih histopatoloških sprememb niti v tkivih perifernega in centralnega živčevja niti v skeletnih mišicah in tako mehanizem in klinični pomen teh neželenih kliničnih znakov nista znana.
English: In paediatric studies, 372 patients received Cubicin, of whom 61 received a single dose and 311 received a therapeutic regimen for cSSTI or SAB (daily doses ranged from 4 mg/kg to 12 mg/kg).
Slovenian: V pediatričnih študijah je zdravilo Cubicin prejemalo 372 bolnikov; 61 od teh jih je prejelo en sam odmerek, 311 pa jih je prejemalo terapevtsko shemo za zapletene okužbe kože in mehkih tkiv ali bakteriemijo z bakterijo Staphylococcus aureus (dnevni odmerki so segali od 4 mg/kg do 12 mg/kg).
English: A study in dogs demonstrated that skeletal myopathy was reduced upon once daily administration as compared to fractionated dosing at same total daily dose, suggesting that myopathic effects in animals were primarily related to time between doses.
Slovenian: V študiji na psih se je pokazalo, da je obseg skeletne miopatije zmanjšan pri odmerjanju enkrat dnevno v primerjavi z deljenim odmerjanjem istega dnevnega odmerka, kar nakazuje, da so bile miopatske spremembe pri živalih odvisne predvsem od intervalov med odmerjanji.
English: Cubicin given as an intravenous infusion over 30 or 60 minutes
Slovenian: Zdravilo Cubicin za vnos z intravensko infuzijo, ki traja 30 ali 60 minut
English: The pharmacokinetics of daptomycin in patients with severe hepatic impairment (Child-Pugh C classification) have not been evaluated.
Slovenian: Farmakokinetika daptomicina pri bolnikih s hudo okvaro jeter (klasifikacija Child Pugh C) še ni bila ocenjena.
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.
Slovenian: Pri dajanju zdravila Cubicin bolnikom, ki so že imeli določeno stopnjo okvare ledvic (očistek kreatinina < 80 ml/min) pred začetkom terapije z zdravilom Cubicin, je potrebna previdnost.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Slovenian: Kadar je lokalna prevalenca rezistence takšna, da je, vsaj pri nekaterih tipih okužb, koristnost sredstva vprašljiva, je potrebno poiskati strokovno pomoč.
English: Adults - cSSTI without concurrent SAB: Cubicin 4 mg/kg is administered once every 24 hours for 7-14 days or until the infection is resolved (see section 5.1).
Slovenian: Odrasli - Zapletene okužbe kože in mehkih tkiv brez sočasne SAB: Zdravilo Cubicin je treba dajati v odmerku 4 mg/kg vsakih 24 ur, od 7 do 14 dni oziroma dokler okužba ni odpravljena (glejte poglavje 5.1).
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.
Slovenian: Priporočamo, da med zdravljenjem z zdravilom Cubicin po možnosti začasno prekinete z dajanjem drugih zdravil, povezanih z nastankom miopatij, razen v primeru, če so koristi sočasne uporabe večje od tveganja.
English: Patients with deep-seated infections should receive any required surgical interventions (e.g. debridement, removal of prosthetic devices, valve replacement surgery) without delay.
Slovenian: Bolnike z globokimi okužbami je treba nemudoma ustrezno kirurško oskrbeti (npr. kirurško odstraniti nekrotično tkivo, odstraniti protetične pripomočke ali operativno zamenjati zaklopke).
English: In some instances treatment failure has been associated with the selection of organisms with reduced susceptibility or frank resistance to daptomycin (see section 5.1).
Slovenian: V nekaterih primerih je bil neuspeh zdravljenja povezan z določenimi mikroorganizmi, ki so postali manj občutljivi za daptomicin ali so bili rezistentni nanj (glejte poglavje 5.1).
English: Prothrombin time (PT) prolonged Thrombocytopaenia
Slovenian: podaljšanje protrombinskega časa (PT) trombocitopenija
English: Cubicin vials are for single-use only.
Slovenian: Viale z zdravilom Cubicin so samo za enkratno uporabo.
English: Uncommon: Renal impairment, including renal failure and renal insufficiency, serum creatinine increased
Slovenian: okvara ledvic, vključno z odpovedjo in insuficienco ledvic, zvišana vrednost kreatinina v serumu
English: Whenever possible, Cubicin should be administered following the completion of dialysis on dialysis days (see section 5.2).
Slovenian: Če je le mogoče, je treba zdravilo Cubicin dati na dializne dni po dokončani dializi (glejte poglavje 5.2).
English: Other side effects which may occur following Cubicin treatment are described below:
Slovenian: Spodaj so navedeni drugi neželeni učinki, do katerih lahko pride pri zdravljenju z zdravilom Cubicin:
English: What Cubicin contains - The active substance is daptomycin.
Slovenian: Kaj vsebuje zdravilo Cubicin - Učinkovina je daptomicin.
English: Cubicin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk.
Slovenian: Zdravilo Cubicin se lahko daje takim bolnikom le, če pričakujemo, da bo klinična korist večja od možnega tveganja.
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.
Slovenian: Za sklepanje o morebitni klinični učinkovitosti zdravila Cubicin pri zdravljenju okužb z enterokoki, vključno z bakterijama Enterococcus faecalis in Enterococcus faecium, ni dovolj dokazov.
English: The results can suggest poor blood clotting when, in fact, there is no problem.
Slovenian: Izvidi lahko kažejo slabo strjevanje krvi, kadar se kri v resnici normalno strjuje.
English: Cubicin given as 2 -minute intravenous injection (adult patients only)
Slovenian: Zdravilo Cubicin za vnos z 2-minutno intravensko injekcijo (samo za odrasle bolnike)
English: Therefore, caution is advised when daptomycin is coadministered with any other medicinal product known to reduce renal filtration.
Slovenian: Zaradi tega priporočamo previdnost pri sočasnem dajanju daptomicina in katerega koli drugega zdravila, za katerega je znano, da zmanjšuje ledvično funkcijo.
English: Daptomycin exhibits rapid, concentration dependent bactericidal activity against Gram positive organisms in vitro and in in vivo animal models.
Slovenian: Daptomicin ima hiter, od koncentracije odvisen baktericiden učinek proti grampozitivnim organizmom na živalskih modelih in vitro in in vivo.
English: Simulation using a population pharmacokinetic model demonstrated that the AUCss (area under the concentrationtime curve at steady state) of daptomycin in paediatric patients 1 to <2 years of age receiving 12 mg/kg once daily would be comparable to that in adult patients receiving 6 mg/kg once daily.
Slovenian: Simulacija z uporabo populacijskega farmakokinetičnega modela je pokazala, da je AUCss (površina pod krivuljo koncentracije v odvisnosti od časa v stanju dinamičnega ravnovesja) za daptomicin pri pediatričnih bolnikih, starih od 1 do < 2 let, ki so prejemali 12 mg/kg enkrat dnevno, primerljiva s tistim pri odraslih bolnikih, ki so prejemali 6 mg/kg enkrat dnevno.
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.
Slovenian: O neuspehu zdravljenja so poročali predvsem pri bolnikih, ki so bili okuženi s Staphylococcus aureus, z Enterococcus faecalis ali z Enterococcus faecium, med drugim pri bolnikih, ki so imeli med zdravljenjem bakteriemijo v povezavi z določenimi mikroorganizmi, ki so postali manj občutljivi za daptomicin ali so bili rezistentni nanj.
English: However, no dose adjustment is considered to be necessary based on obesity alone.
Slovenian: Vendar pa velja, da samo na osnovi prekomerne telesne mase prilagajanje odmerka ni potrebno.
English: The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.
Slovenian: Dokončno pripravljena raztopina je videti bistra, ob robu viale pa lahko ostanejo majhni mehurčki ali pena.
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).
Slovenian: Pri mešanih okužbah, kjer obstaja sum na prisotnost gramnegativnih in/ali določenih tipov anaerobnih bakterij, je treba zdravilo Cubicin dajati skupaj z enim ali več ustreznimi protimikrobnimi zdravili.
English: The lowest observable effect level (LOEL) for myopathy in rats and dogs occurred at exposure levels of 0.8 to 2.3-fold the human therapeutic levels at 6 mg/kg (30-minute intravenous infusion) for patients with normal renal function.
Slovenian: Do najnižje koncentracije z opaznim učinkom (LOEL - Lowest Observable Effect Level) za miopatijo je pri podganah in psih prišlo pri izpostavljenostih, ki so bile 0,8 do 2,3-kratniki terapevtskih koncentracij pri človeku pri odmerjanju 6 mg/kg (s 30-minutno intravensko infuzijo) za bolnike z normalnim delovanjem ledvic.
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).
Slovenian: Ta način vnosa zdravila so proučevali samo pri zdravih osebah, vendar v primerjavi z enakimi odmerki, danimi v obliki 30-minutne intravenske infuzije, ni bilo klinično pomembnih razlik v farmakokinetičnih in varnostnih lastnostih daptomicina (glejte tudi poglavji 4.8 in 5.2).
English: Daptomycin pharmacokinetics in patients in this study are summarized in Table 2.
Slovenian: Farmakokinetika daptomicina pri bolnikih v tej študiji je povzeta v preglednici 2.
English: The reconstituted solution should then be injected intravenously slowly over 2 minutes as directed in section 4.2.
Slovenian: Rekonstituirano raztopino je treba nato počasi v 2 minutah intravensko injicirati, kot je navedeno v poglavju 4.2.
English: The reconstituted solution should then be injected intravenously slowly over 2 minutes.
Slovenian: Rekonstituirano raztopino je treba nato počasi intravensko injicirati 2 minuti.
English: In most reported cases associated with Cubicin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
Slovenian: V večini primerov, o katerih so poročali in so bili povezani z zdravilom Cubicin, je pri bolnikih prišlo do zvišane telesne temperature, dispneje s hipoksično respiratorno insuficienco in do difuznih pljučnih infiltratov ali organizirajoče pljučnice.
English: The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes as directed in section 4.2.
Slovenian: Rekonstituirano in razredčeno raztopino je treba nato intravensko infundirati 30 ali 60 minut, kot je navedeno v poglavju 4.2.
English: Reconstituted solutions of Cubicin range in colour from pale yellow to light brown.
Slovenian: Rekonstituirane raztopine zdravila Cubicin so v barvnem razponu od bledo rumene do svetlo rjave barve.
English: Clinical data on the use of Cubicin to treat RIE due to Staphylococcus aureus are limited to 19 adult patients (see “Information from clinical trials” in section 5.1).
Slovenian: Desnostranski infekcijski endokarditis zaradi bakterije Staphylococcus aureus Klinični podatki o uporabi zdravila Cubicin za zdravljenje desnostranskega infekcijskega endokarditisa zaradi bakterije Staphylococcus aureus so omejeni na 19 odraslih bolnikov (glejte odstavek pod naslovom “Informacije iz kliničnih preskušanj” v poglavju 5.1).
English: Available in packs containing 1 vial or 5 vials.
Slovenian: Zdravilo je na voljo v pakiranju, ki vsebuje 1 vialo ali 5 vial.
English: The possibility of erroneous results may be minimised by drawing samples for PT or INR testing near the time of trough plasma concentrations of daptomycin (see section 4.4).
Slovenian: Verjetnost nepravilnih rezultatov zmanjšamo tako, da vzorce za določitev PT ali INR vzamemo, ko pričakujemo padec koncentracije daptomicina v plazmi (glejte poglavje 4.4).
English: Your doctor will check the condition of your lungs and decide whether or not you should continue Cubicin treatment.
Slovenian: Zdravnik vam bo pregledal pljuča in se odločil, ali je za vas nadaljevanje zdravljenja z zdravilom Cubicin primerno ali ne.
English: Limb pain, serum creatine phosphokinase (CPK) increased
Slovenian: bolečine v okončinah, zvišana vrednost kreatin-fosfokinaze v serumu (CPK)
English: The pharmacokinetics of daptomycin is not altered in subjects with moderate hepatic impairment (Child-Pugh B classification of hepatic impairment) compared with healthy volunteers matched for gender, age and weight following a single 4 mg/kg dose.
Slovenian: Farmakokinetika daptomicina pri osebah z zmerno okvaro jeter (klasifikacija okvare jeter Child Pugh B) pri dajanju enkratnih odmerkov 4 mg/kg ni spremenjena v primerjavi z zdravimi prostovoljci, primerljivimi glede na spol, starost in težo.
English: Driving and using machines Cubicin has no known effects on the ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Pri zdravilu Cubicin ni znanih učinkov na sposobnost upravljanja vozil in strojev.
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
Slovenian: utrujenost, bolečine * Na podlagi poročil v obdobju trženja zdravila; ker te učinke sporočajo spontano iz populacije, kateri ni mogoče določiti velikosti, ni mogoče zanesljivo ugotoviti njihove pogostnosti, zato je njihova pogostnost opredeljena kot neznana.
English: Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during coadministration with medicinal products that reduce renal filtration (e.g. NSAIDs and COX-2 inhibitors).
Slovenian: Daptomicin se primarno izloča z ledvično filtracijo, tako da se lahko pri sočasni uporabi zdravil, ki zavirajo ledvično filtracijo (npr. NSAID in zaviralci COX-2), zviša njegova raven v plazmi.
English: Cubicin 350 mg powder for solution for injection or infusion EU/1/05/328/001
Slovenian: Cubicin 350 mg prašek za raztopino za injiciranje ali infundiranje EU/1/05/328/001
English: Cubicin 500 mg powder for solution for injection or infusion EU/1/05/328/002
Slovenian: Cubicin 500 mg prašek za raztopino za injiciranje ali infundiranje EU/1/05/328/002
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.
Slovenian: Letak za laboratorije s pojasnili glede testiranja občutljivosti mora vsebovati naslednja ključna sporočila: - izvajanje testa občutljivosti zmanjšuje tveganje za neuspešno zdravljenje, ker je mogoče z njimi ugotoviti, kateri sevi so potencialno rezistentni na daptomicin, - pri testiranju občutljivosti za daptomicin mora biti v testnem mediju prisoten kalcij.
English: Cubicin given as 2-minute intravenous injection (adult patients only) Water should not be used for reconstitution of Cubicin for intravenous injection.
Slovenian: Zdravilo Cubicin za vnos z 2-minutno intravensko injekcijo (samo odrasli bolniki) Za rekonstitucijo zdravila Cubicin za intravensko injiciranje se ne sme uporabiti vode.
English: The dosage regimen for Cubicin in paediatric patients with renal impairment has not been established.
Slovenian: Režim odmerjanja zdravila Cubicin pri pediatričnih bolnikih z okvaro ledvic ni bil določen.
English: If you experience these symptoms, tell your doctor or nurse straight away.
Slovenian: Če opazite navedene simptome, takoj povejte zdravniku ali medicinski sestri.
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.
Slovenian: Zaradi majhnega obsega kliničnih izkušenj se sme zdravilo Cubicin pri odraslih bolnikih z okvaro ledvic katere koli stopnje (z očistkom kreatinina < 80 ml/min) uporabljati samo v primeru, da pričakovane klinične koristi presegajo tveganja (glejte spodnjo preglednico in opombe).
English: The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) at 25°C must not exceed 12 hours (24 hours if refrigerated).
Slovenian: Kombinirani čas shranjevanja (rekonstituirana raztopina v viali in razredčena raztopina v infuzijski vrečki) pri 25 °C ne sme presegati 12 ur (ali 24 ur pri shranjevanju v hladilniku).
English: The Marketing Authorisation Holder shall ensure that all laboratories expected to perform Cubicin susceptibility testing are provided with: - Summary of Product Characteristics - Laboratory susceptibility testing leaflet
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi laboratoriji, v katerih bodo predvidoma izvajali teste občutljivosti, prejeli: - povzetek glavnih značilnosti zdravila - letak za laboratorije s pojasnili glede testiranja občutljivosti
English: No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed.
Slovenian: V farmakokinetiki daptomicina niso opazili nikakršnih klinično pomembnih razlik, povezanih s spolom.
English: It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Slovenian: Le malo verjetno je, da bi daptomicin zaviral ali induciral metabolizem tistih zdravil, ki se presnavljajo s pomočjo sistema P450.
English: Paediatric patients below the age of one year should not be given Cubicin due to the risk of potential effects on muscular, neuromuscular and/or nervous systems (either peripheral and/or central) that were observed in neonatal dogs (see section 5.3).
Slovenian: Pediatričnim bolnikom, ki so stari manj kot eno leto, se ne sme dajati zdravila Cubicin zaradi nevarnosti, da pride do učinkov na mišični, živčnomišični in/ali živčni sistem (periferni in/ali centralni), ki so jih opažali pri novoskotenih pasjih mladičih (glejte poglavje 5.3).
English: No dose adjustment is necessary based on age alone.
Slovenian: Samo na osnovi starosti prilagajanje odmerka ni potrebno.
English: The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes.
Slovenian: Rekonstituirano in razredčeno raztopino je treba nato intravensko infundirati 30 ali 60 minut.
English: Creatine phosphokinase and myopathy Increases in plasma creatine phosphokinase (CPK; MM isoenzyme) levels associated with muscular pains and/or weakness and cases of myositis, myoglobinaemia and rhabdomyolysis have been reported during therapy with Cubicin (see also sections 4.5, 4.8 and 5.3).
Slovenian: Kreatin-fosfokinaza in miopatija Med zdravljenjem z zdravilom Cubicin so poročali o zvišanju vrednosti kreatin-fosfokinaze v plazmi (CPK; MM izoencim), povezane z bolečinami v mišicah in/ali s slabotnostjo in o primerih miozitisa, mioglobinemije in rabdomiolize (glejte poglavja 4.5, 4.8 in 5.3).
English: No data are available in patients with severe hepatic impairment (Child-Pugh Class C).
Slovenian: Za bolnike s hudo okvaro jeter (Child Pugh C) podatkov ni na voljo.
English: Pharmacokinetic parameter values estimated by noncompartmental analysis Individual values reported as only two patients in this age group provided pharmacokinetic samples to enable pharmacokinetic analysis; AUC, apparent t1/2 and CL/wt could be determined for only one of the two patients Pharmacokinetic analysis conducted on the pooled pharmacokinetic profile with mean concentrations across subjects at each time point
Slovenian: Navedeni sta posamezni vrednosti, ker so le od dveh bolnikov v tej starostni skupini pridobili farmakokinetične vzorce, ki so omogočali farmakokinetično analizo; AUC, navidezni t1/2 in očistek na telesno maso so lahko določili le pri enem od teh dveh bolnikov.
English: It is mixed with a solvent to form a liquid before it is administered.
Slovenian: Pred uporabo ga je treba zmešati s tekočino, da nastane raztopina.
English: In adult patients, this dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes.
Slovenian: Pri odraslih bolnikih se ta odmerek aplicira v krvni obtok (v veno) bodisi kot infuzijo, ki traja okrog 30 minut ali kot injekcijo, ki traja približno 2 minuti.
English: Rare: Not known*:
Slovenian: fungemija neznana pogostnost*:
English: The safety and efficacy of Cubicin in children and adolescents aged below 18 years with right-sided infective endocarditis (RIE) due to Staphylococcus aureus have not been established.
Slovenian: Varnost in učinkovitost zdravila Cubicin pri otrocih in mladostnikih do 18. leta starosti z desnostranskim infekcijskim endokarditisom zaradi bakterije Staphylococcus aureus nista bili dokazani.
English: Renal impairment Daptomycin is eliminated primarily by the kidney.
Slovenian: Okvara ledvic Daptomicin se izloča primarno skozi ledvice.
English: Cubicin is therefore not indicated for the treatment of pneumonia.
Slovenian: Zato zdravilo Cubicin za zdravljenje pljučnice ni indicirano.
English: In some cases of myopathy involving raised CPK and muscle symptoms, the patients also presented with elevated transaminases.
Slovenian: Pri nekaterih bolnikih z miopatijo z zvišano vrednostjo kreatin-fosfokinaze in mišičnimi simptomi so zabeležili tudi zvišane vrednosti aminotransferaz.
English: Eosinophilic pneumonia
Slovenian: eozinofilna pljučnica