FrancophonIA/ELRC3.0 huggingface dataset:
English: Daptomycin administered as a 2-minute intravenous injection also exhibited dose proportional pharmacokinetics in the approved therapeutic dose range of 4 to 6 mg/kg.
Slovenian: Tudi farmakokinetika daptomicina, danega z 2-minutno intravensko injekcijo, je v odobrenem terapevtskem obsegu odmerjanja od 4 do 6 mg/kg sorazmerna z odmerkom.
English: Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism.
Slovenian: Daptomicin je metabolizmu, ki je odvisen od citokroma P450 (CYP 450), le malo, če sploh, podvržen.
English: Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold, respectively, based on comparison of Cmax values at the No Observed Effect Level (NOEL) with the Cmax achieved on dosing with 30-minute intravenous infusion of 6 mg/kg once daily in patients with normal renal function.
Slovenian: Glede učinkov na periferne živce je določanje še varnih odmerkov temeljilo na primerjavi med 8-kratno (pri podganah) oziroma 6-kratno (pri psih) vrednostjo Cmax pri odmerku brez opaženih učinkov (NOEL - No Observed Effect Level) in med Cmax pri odmerjanju 6 mg/kg enkrat dnevno s 30-minutno intravensko infuzijo pri bolnikih z normalnim delovanjem ledvic.
English: Invert the vial in order to allow the solution to drain towards the stopper.
Slovenian: Obrnite vialo, tako da raztopina lahko steče proti zamašku.
English: A total of 81 subjects were treated in the study, including 55 subjects who received daptomycin and
Slovenian: V študiji je bilo zdravljenih skupno 81 bolnikov, od katerih jih je 55 prejemalo daptomicin in 26 standardno oskrbo.
English: Very rare serious side effects (may affect up to 1 in 10,000 people) A hypersensitivity reaction (serious allergic reaction including anaphylaxis, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS)) has been reported, in some cases during administration of Cubicin.
Slovenian: Zelo redki resni neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) Poročali so o preobčutljivostni reakciji (resni alergijski reakciji, ki med drugim vključuje anafilaksijo, angioedem, z zdravilom povezan izpuščaj z eozinofilijo in sistemske simptome (sindrom DRESS)), do katere je v nekaterih primerih prišlo v času odmerjanja zdravila Cubicin.
English: Following administration of a single 4 mg/kg intravenous dose of Cubicin over a 30-minute period, the mean total clearance of daptomycin was approximately 35% lower and the mean AUC0-∞ was approximately 58% higher in elderly subjects (≥ 75 years of age) compared with those in healthy young subjects (18 to 30 years of age).
Slovenian: Po enkratni 30-minutni intravenski aplikaciji 4 mg/kg zdravila Cubicin je bila pri starejših osebah (starih 75 let ali več) povprečna vrednost celotnega očistka daptomicina nižja za približno 35 %, povprečna AUC0-∞ pa je bila večja za približno 58 % v primerjavi z zdravimi mladimi osebami (starimi od 18 do 30 let).
English: Relative to non-obese subjects daptomycin systemic exposure measured by AUC was about 28% higher in moderately obese subjects (Body Mass Index of 25-40 kg/m2) and 42% higher in extremely obese subjects (Body Mass Index of > 40 kg/m 2).
Slovenian: V primerjavi z osebami, ki nimajo prekomerne telesne mase, je bila sistemska izpostavljenost daptomicinu, merjena v obliki AUC, večja za okrog 28 % pri osebah s srednje zvečano telesno maso (indeks telesne mase 25-40 kg/m2) in večja za 42 % pri bolnikih z izrazito zvečano telesno maso
English: In adults, Cubicin is given by intravenous infusion (see section 6.6) and administered over a 30minute period or by intravenous injection (see section 6.6) and administered over a 2-minute period.
Slovenian: Pri odraslih se zdravilo Cubicin daje v obliki intravenske infuzije (glejte poglavje 6.6) s časom infundiranja 30 minut ali v obliki intravenske injekcije (glejte poglavje 6.6) s časom injiciranja 2 minuti.
English: For the 2-minute intravenous injection, the storage time of the reconstituted solution in the vial (see section 6.6) at 25°C must not exceed 12 hours (or 48 at 2°C - 8°C).
Slovenian: Pri vnosu z 2-minutno intravensko injekcijo čas shranjevanja rekonstituirane raztopine v viali (glejte poglavje 6.6) pri 25 °C ne sme presegati 12 ur (ali 48 ur pri 2 °C - 8 °C).
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.
Slovenian: Glede na rezultate teh dveh študij so bile varnostne lastnosti in prenosljivost obeh načinov vnosa daptomicina: 2-minutne intravenske injekcije in 30-minutne intravenske infuzije, podobne.
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.
Slovenian: Glede na oceno zapletov pri posameznem bolniku je trajanje zdravljenja lahko daljše kot 14 dni.
English: • CPK should be measured more frequently (e.g. every 2-3 days at least during the first two weeks of treatment) in patients who are at higher risk of developing myopathy.
Slovenian: • Pri bolnikih z večjim tveganjem za nastanek miopatij je treba CPK meriti pogosteje (na primer vsake 2 do 3 dni, vsaj v prvih dveh tednih zdravljenja).
English: Recurrence of eosinophilic pneumonia upon reexposure has been reported.
Slovenian: Poročali so o ponovitvi eozinofilne pljučnice po ponovni uvedbi zdravila Cubicin.
English: On the second day after administration of a 6 mg/kg dose to HD and CAPD adult patients the daptomycin AUC was approximately 1.3-fold higher than that observed after a second 6 mg/kg dose in adult patients with normal renal function.
Slovenian: V drugem dnevu po aplikaciji odmerka 6 mg/kg odraslim bolnikom na hemodializi ali kontinuirani ambulantni peritonealni dializi (CAPD) je bila njihova AUC daptomicina približno 1,3-krat večja kot pri odraslih bolnikih z normalno ledvično funkcijo po drugem odmerku 6 mg/kg.
English: Less frequently reported, but more serious, adverse reactions include hypersensitivity reactions, eosinophilic pneumonia (occasionally presenting as organising pneumonia), drug rash with eosinophilia and systemic symptoms (DRESS), angioedema and rhabdomyolysis.
Slovenian: Med tistimi neželenimi učinki, o katerih so poročali manj pogosto, a so bolj resni, pa so preobčutljivostne reakcije, eozinofilna pljučnica (ki se občasno kaže kot organizirajoča pljučnica), z zdravilom povezan izpuščaj z eozinofilijo in sistemskimi simptomi (sindrom DRESS), angioedem in rabdomioliza.
English: EU/1/05/328/002 1 vial EU/1/05/328/004 5 vials
Slovenian: EU/1/05/328/002 1 viala EU/1/05/328/004 5 vial
English: Renal impairment has been reported during treatment with Cubicin.
Slovenian: Poročali so o pojavu okvare ledvic med zdravljenjem z zdravilom Cubicin.
English: Frequency not known (frequency cannot be estimated from the available data) Antibacterial-associated colitis, including pseudomembranous colitis (severe or persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever), easy bruising, bleeding gums, or nosebleeds.
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Vnetje debelega črevesa zaradi protibakterijskih zdravil, vključno s psevdomembranskim kolitisom (s hudo in trdovratno drisko, s katero se izločata kri in/ali sluz, spremljajo pa jo bolečine v trebuhu ali zvišana telesna temperatura), hiter pojav modric, krvaveče dlesni ali krvavitve iz nosu.
English: Obesity In obese subjects with Body Mass Index (BMI) > 40 kg/m2 but with creatinine clearance > 70 ml/min, the AUC0-∞ daptomycin was significantly increased (mean 42% higher) compared with non-obese matched controls.
Slovenian: Prekomerna telesna masa Pri bolnikih z izrazito zvečano telesno maso z indeksom telesne mase (BMI) > 40 kg/m2 in z očistkom kreatinina > 70 ml/min je bila v primerjavi s kontrolnimi bolniki z normalno telesno maso AUC0-∞ daptomicina znatno večja (v povprečju za 42 % večja).
English: Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy adult volunteers.
Slovenian: Farmakokinetika daptomicina je pri odmerkih od 4 do 12 mg/kg, danih zdravim odraslim prostovoljcem v enkratnem dnevnem odmerku s 30-minutno intravensko infuzijo do 14 dni, običajno linearna in neodvisna od časa.
English: EU/1/05/328/001 1 vial EU/1/05/328/003 5 vials
Slovenian: EU/1/05/328/001 1 viala EU/1/05/328/003 5 vial
English: Based on pharmacokinetic data and modelling, the daptomycin AUC during the first day after administration of a 6 mg/kg dose to adult patients on HD or CAPD was 2-fold higher than that observed in adult patients with normal renal function who received the same dose.
Slovenian: Glede na farmakokinetične podatke in modele je bila pri odraslih bolnikih na hemodializi ali kontinuirani ambulantni peritonealni dializi (CAPD) AUC daptomicina prvega dne po aplikaciji odmerka 6 mg/kg 2-krat večja kot pri odraslih bolnikih z normalno ledvično funkcijo, ki so prejeli enak odmerek.
English: There is limited experience regarding concomitant administration of daptomycin with other medicinal products that may trigger myopathy (e.g. HMG-CoA reductase inhibitors).
Slovenian: O sočasni uporabi daptomicina z drugimi zdravili, ki lahko povzročijo miopatijo (na primer z zaviralci HMG-CoA reduktaze), je na voljo le malo izkušenj.
English: No clinical data on pregnancies are available for daptomycin.
Slovenian: Za daptomicin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
English: If a focus of infection other than cSSTI or RIE is identified after initiation of Cubicin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Slovenian: Če se po začetku zdravljenja z zdravilom Cubicin odkrije drugo žarišče okužbe, ki ni zapletena okužba kože in mehkih tkiv ali desnostranski infekcijski endokarditis, je treba razmisliti o uvedbi drugega antibakterijskega zdravljenja, ki je dokazano učinkovito pri tej specifični prisotni okužbi oziroma več prisotnih okužbah.
English: • Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.
Slovenian: • Pri vsakem bolniku, pri katerem se razvijejo nepojasnjene bolečine v mišicah, občutljivost, oslabelost ali krči mišic, je treba raven CPK kontrolirati vsak drugi dan. Z uporabo zdravila Cubicin je treba v prisotnosti nepojasnjenih simptomov v mišicah prenehati, če raven CPK preseže 5-kratnik zgornje meje normale.
English: Daptomycin is excreted primarily by the kidneys.
Slovenian: Daptomicin se večinoma izloča preko ledvic.
English: The response to treatment, renal function and creatine phosphokinase (CPK) levels should be closely monitored in all patients with any degree of renal impairment (see also sections 4.4 and 5.2).
Slovenian: Pri vseh bolnikih z okvaro ledvic katere koli stopnje je treba natančno spremljati odziv na zdravljenje, delovanje ledvic in koncentracijo kreatin-fosfokinaze (CPK - creatine phosphokinase) (glejte tudi poglavji 4.4 in 5.2).
English: In a single human case study, Cubicin was intravenously administered daily for 28 days to a nursing mother at a dose of 500 mg/day, and samples of the patient's breast milk were collected over a 24hour period on day 27.
Slovenian: V študiji enega samega primera pri ljudeh je doječa mati 28 dni enkrat na dan intravensko prejemala zdravilo Cubicin v odmerku 500 mg/dan.
English: Clostridium difficile-associated diarrhoea (CDAD) has been reported with Cubicin (see section 4.8).
Slovenian: Diareja, ki jo povzroča bakterija Clostridium difficile Pri uporabi zdravila Cubicin so poročali o diareji, ki jo povzroča bakterija Clostridium difficile (Clostridium difficile associated diarrhoea - CDAD) (glejte poglavje 4.8).
English: How to store Cubicin
Slovenian: Shranjevanje zdravila Cubicin
English: After a single 6 mg/kg dose of Cubicin, the clearance and elimination half-life of daptomycin in children 13-24 months of age were similar to children 2-6 years of age who received a single 4-10 mg/kg dose.
Slovenian: Po enkratnem odmerku 6 mg/kg zdravila Cubicin sta bila celotni očistek in eliminacijski razpolovni čas daptomicina pri otrocih, starih od 13 do 24 mesecev, podobna kot pri otrocih, starih od 2 do 6 let, ki so prejeli enkraten odmerek 4-10 mg/kg.
English: In paediatric patients aged 1 to 6 years, Cubicin is given by intravenous infusion over a 60-minute period (see section 6.6).
Slovenian: Pri pediatričnih bolnikih (starih od 1 do 6 let) se zdravilo Cubicin daje v obliki intravenske infuzije s časom infundiranja 60 minut (glejte poglavje 6.6).
English: In paediatric patients aged 7 to 17 years, Cubicin is given by intravenous infusion over a 30-minute period (see section 6.6).
Slovenian: Pri pediatričnih bolnikih (starih od 7 do 17 let) se zdravilo Cubicin daje v obliki intravenske infuzije s časom infundiranja 30 minut (glejte poglavje 6.6).
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).
Slovenian: Pri uporabi določenih rekombinantnih tromboplastinskih reagentov za določanje protrombinskega časa so opažali lažno podaljšanje protrombinskega časa (PT - prothrombin time ) in zvišanje vrednosti mednarodnega normaliziranega razmerja (INR - international normalized ratio) (glejte tudi poglavje 4.5).
English: Eosinophilic pneumonia has been reported in patients receiving Cubicin (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Cubicin, so poročali o eozinofilni pljučnici (glejte poglavje 4.8).
English: The reconstituted solution should then be diluted with sodium chloride 9 mg/ml (0.9%) (typical volume 50 ml).
Slovenian: Rekonstituirano raztopino je treba nato razredčiti z natrijevim kloridom 9 mg/ml (0,9 %) (običajni volumen 50 ml).
English: After a single 4, 8, or 10 mg/kg dose of Cubicin, total clearance and elimination half-life of daptomycin in children 2-6 years of age were similar at different doses; total clearance was higher and elimination half-life was shorter than in adolescents.
Slovenian: Po enkratnem odmerku 4, 8 ali 10 mg/kg zdravila Cubicin sta bila celotni očistek in eliminacijski razpolovni čas daptomicina pri otrocih v starosti od 2 do 6 let ob različnih odmerkih podobna; celotni očistek je bil večji, eliminacijski razpolovni čas pa krajši kot pri mladostnikih.
English: Water should not be used for reconstitution of Cubicin for intravenous injection.
Slovenian: Za rekonstitucijo zdravila Cubicin za intravensko injiciranje se ne sme uporabiti vode.
English: Transfer the required reconstituted dose into 50 ml sodium chloride 9 mg/ml (0.9%).
Slovenian: Prenesite potrebni rekonstituirani odmerek v 50 ml natrijevega klorida 9 mg/ml (0,9 %).
English: The active substance in Cubicin powder for solution for injection or infusion is daptomycin.
Slovenian: Učinkovina v zdravilu Cubicin prašek za raztopino za injiciranje ali infundiranje je daptomicin.
English: Differences in Success n/N (%)
Slovenian: Razlike v odzivih n/N (%)
English: Daptomycin is reversibly bound to human plasma proteins in a concentration independent manner.
Slovenian: Daptomicin je na način, ki ni odvisen od koncentracije, reverzibilno vezan na humane plazemske proteine.
English: Therefore, until more experience is gained, breastfeeding should be discontinued when Cubicin is administered to nursing women.
Slovenian: Zato velja, da je treba prenehati z dojenjem, če doječa mati prejema zdravilo Cubicin, dokler ne bo na voljo več izkušenj.
English: For the 30-minute intravenous infusion, the combined storage time (reconstituted solution in vial and diluted solution in infusion bag; see section 6.6) at 25°C must not exceed 12 hours (or 24 at 2°C8°C).
Slovenian: Pri vnosu s 30-minutno intravensko infuzijo kombinirani čas shranjevanja (rekonstituirana raztopina v viali in razredčena raztopina v infuzijski vrečki: glejte poglavje 6.6) pri 25 °C ne sme presegati 12 ur (ali 24 ur pri 2 °C - 8 °C).
English: After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C - 8°C.
Slovenian: Po rekonstituciji: Kemijska in fizikalna stabilnost pripravljene rekonstituirane raztopine v viali je bila dokazana za 12 ur pri 25 °C in do 48 ur pri 2 °C do 8 °C.
English: Liver function tests abnormal
Slovenian: patološke vrednosti testov jetrne funkcije
English: Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
Slovenian: Preden injekcijsko iglo izvlečete iz viale, potegnite bat povsem do konca cevi injekcijske brizge, tako da lahko iz obrnjene viale odstranite prav vso raztopino.
English: Stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours if stored under refrigeration at 2°C - 8°C.
Slovenian: Stabilnost razredčene raztopine v infuzijski vrečki je bila dokazana za 12 ur pri 25 °C oziroma za 24 ur, če je bila raztopina shranjena v hladilniku pri 2 °C - 8 °C.
English: Uncommon: Myositis, increased myoglobin, muscular weakness, muscle pain, arthralgia, serum lactate dehydrogenase (LDH) increased, muscle cramps
Slovenian: miozitis, zvišana vrednost mioglobina, mišična šibkost, bolečine v mišicah, artralgija, zvišana vrednost laktat-dehidrogenaze v serumu (LDH), mišični krči neznana pogostnost*:
English: Unlike in adults, daptomycin should not be administered by injection over a 2 minute period in paediatric patients.
Slovenian: V nasprotju z odraslimi bolniki se pediatričnim bolnikom daptomicina ne sme dati z 2-minutno injekcijo.
English: Daptomycin was not mutagenic or clastogenic in a battery of in vivo and in vitro genotoxicity tests.
Slovenian: Daptomicin v vrsti genotoksičnih in vivo in in vitro testov ni bil mutagen ali klastogen.
English: Failures with daptomycin in the treatment of enterococcal infections that were mostly accompanied by bacteraemia have been reported.
Slovenian: Pri okužbah z enterokoki, ki jih je večinoma spremljala bakteriemija, so poročali o neuspehu zdravljenja z daptomicinom.
English: If not used immediately, in-use storage times are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C unless reconstitution /dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Običajno naj ta čas ne bi bil daljši od 24 ur pri 2 °C - 8 °C, razen če je bila rekonstitucija/razredčitev izvedena v nadzorovanih in validiranih aseptičnih pogojih.
English: (2) The same dose adjustments, which are based on pharmacokinetic data in volunteers including PK modelling results, are recommended for adult patients on haemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD).
Slovenian: (2) Za odrasle bolnike na hemodializi (HD) ali kontinuirani ambulantni peritonealni dializi (CAPD) je priporočeno enako prilagajanje odmerka, ki temelji na farmakokinetičnih podatkih prostovoljcev, vključno z rezultati farmakokinetičnega modeliranja.
English: No clinical data on fertility are available for daptomycin.
Slovenian: Za daptomicin ni na voljo kliničnih podatkov o vplivu na plodnost.
English: Dizziness, headache
Slovenian: dispepsija, glositis
English: In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.
Slovenian: Pri odraslih mora biti uporaba pri bakteriemiji povezana z desnostranskim infekcijskim endokarditisom ali zapleteno okužbo kože in mehkih tkiv, pri pediatričnih bolnikih pa mora biti uporaba pri bakteriemiji povezana z zapleteno okužbo kože in mehkih tkiv.
English: There were no differences in Cmax.
Slovenian: Vrednosti Cmax.
English: Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours at 2°C8°C.
Slovenian: Kemijska in fizikalna stabilnost razredčene raztopine v infuzijskih vrečkah je dokazana za 12 ur pri 25 °C ali 24 ur pri 2 °C - 8 °C.
English: If CDAD is suspected or confirmed, Cubicin may need to be discontinued and appropriate treatment instituted as clinically indicated.
Slovenian: Če obstaja sum na tovrstno diarejo ali je njena diagnoza potrjena, je v skladu s klinično indikacijo morda treba prekiniti uporabo zdravila Cubicin in uvesti ustrezno zdravljenje.
English: Excipient: Sodium hydroxide
Slovenian: Pomožna snov: natrijev hidroksid
English: After a single 4 mg/kg dose of Cubicin, total clearance of daptomycin in children 7-11 years of age with Gram-positive infection was higher than in adolescents, whereas elimination half-life was shorter.
Slovenian: Po enkratnem odmerku 4 mg/kg zdravila Cubicin je bil celotni očistek daptomicina pri otrocih, v starosti od 7 do 11 let, z grampozitivnimi okužbami večji kot pri mladostnikih, eliminacijski razpolovni čas pa je bil krajši.
English: Juvenile dogs developed peripheral and spinal nerve lesions at doses lower than those associated with skeletal muscle toxicity.
Slovenian: Pri mladih psih so, pri nižjih odmerkih od tistih, ki so povezani s toksičnostjo za skeletne mišice, nastale lezije perifernih in spinalnih živcev.
English: Cubicin 350 mg powder for solution for injection or infusion Single use 10 ml type I clear glass vials with type I rubber stoppers and aluminium closures with yellow plastic flip off caps.
Slovenian: Cubicin 350 mg prašek za raztopino za injiciranje ali infundiranje Viale za enkratno uporabo, 10 ml, iz prozornega stekla tipa I, z 1 gumijastim zamaškom in aluminijastimi zapirali z rumenimi plastičnimi snemnimi zaporkami.
English: You should not be given Cubicin
Slovenian: Ne uporabljajte zdravila Cubicin
English: Not known*: Acute generalised exanthematous pustulosis
Slovenian: urtikarija akutna generalizirana eksantematozna pustuloza
English: Tell a doctor or a nurse straight away if you experience symptoms suggestive of allergic reaction, such as wheezing, difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever (see section 4 of this leaflet for more information).
Slovenian: Če se pri vas pojavijo simptomi, ki nakazujejo alergijsko reakcijo, npr. piskanje pri dihanju, oteženo dihanje, otekanje obraza, vratu in žrela, izpuščaji in urtikarija ali zvišana telesna temperatura, takoj povejte zdravniku ali medicinski sestri (za več informacij glejte poglavje 4 v tem Navodilu za uporabo).
English: Cubicin 350 mg powder for solution for injection or infusion Cubicin 500 mg powder for solution for injection or infusion
Slovenian: Cubicin 350 mg prašek za raztopino za injiciranje ali infundiranje Cubicin 500 mg prašek za raztopino za injiciranje ali infundiranje
English: See below for dose adjustments in patients with renal impairment.
Slovenian: Za prilagajanje odmerjanja pri bolnikih z okvaro ledvic glejte spodaj.
English: How Cubicin is given
Slovenian: Kako se uporablja zdravilo Cubicin
English: Cubicin is administered intravenously in 0.9% sodium chloride (see section 6.6).
Slovenian: Zdravilo Cubicin je treba aplicirati intravensko v 0,9-odstotni raztopini natrijevega klorida (glejte poglavje 6.6).