natgillin/translations-raw huggingface dataset:
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. 
Za sklepanje o morebitni klinični učinkovitosti zdravila Cubicin pri zdravljenju okužb z enterokoki, vključno z bakterijama Enterococcus faecalis in Enterococcus faecium, ni dovolj dokazov.
The results can suggest poor blood clotting when, in fact, there is no problem. 
Izvidi lahko kažejo slabo strjevanje krvi, kadar se kri v resnici normalno strjuje.
Cubicin given as 2 -minute intravenous injection (adult patients only) 
Zdravilo Cubicin za vnos z 2-minutno intravensko injekcijo (samo za odrasle bolnike)
Therefore, caution is advised when daptomycin is coadministered with any other medicinal product known to reduce renal filtration. 
Zaradi tega priporočamo previdnost pri sočasnem dajanju daptomicina in katerega koli drugega zdravila, za katerega je znano, da zmanjšuje ledvično funkcijo.
Daptomycin exhibits rapid, concentration dependent bactericidal activity against Gram positive organisms in vitro and in in vivo animal models. 
Daptomicin ima hiter, od koncentracije odvisen baktericiden učinek proti grampozitivnim organizmom na živalskih modelih in vitro in in vivo.
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. 
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.
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. 
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.
However, no dose adjustment is considered to be necessary based on obesity alone. 
Vendar pa velja, da samo na osnovi prekomerne telesne mase prilagajanje odmerka ni potrebno.
The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial. 
Dokončno pripravljena raztopina je videti bistra, ob robu viale pa lahko ostanejo majhni mehurčki ali pena.
In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be coadministered with appropriate antibacterial agent(s). 
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.
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. 
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.
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). 
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).
Daptomycin pharmacokinetics in patients in this study are summarized in Table 2. 
Farmakokinetika daptomicina pri bolnikih v tej študiji je povzeta v preglednici 2.
The reconstituted solution should then be injected intravenously slowly over 2 minutes as directed in section 4.2. 
Rekonstituirano raztopino je treba nato počasi v 2 minutah intravensko injicirati, kot je navedeno v poglavju 4.2.
The reconstituted solution should then be injected intravenously slowly over 2 minutes. 
Rekonstituirano raztopino je treba nato počasi intravensko injicirati 2 minuti.
In most reported cases associated with Cubicin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia. 
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.
The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes as directed in section 4.2. 
Rekonstituirano in razredčeno raztopino je treba nato intravensko infundirati 30 ali 60 minut, kot je navedeno v poglavju 4.2.
Reconstituted solutions of Cubicin range in colour from pale yellow to light brown. 
Rekonstituirane raztopine zdravila Cubicin so v barvnem razponu od bledo rumene do svetlo rjave barve.
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). 
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).
Available in packs containing 1 vial or 5 vials. 
Zdravilo je na voljo v pakiranju, ki vsebuje 1 vialo ali 5 vial.
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). 
Verjetnost nepravilnih rezultatov zmanjšamo tako, da vzorce za določitev PT ali INR vzamemo, ko pričakujemo padec koncentracije daptomicina v plazmi (glejte poglavje 4.4).
Your doctor will check the condition of your lungs and decide whether or not you should continue Cubicin treatment. 
Zdravnik vam bo pregledal pljuča in se odločil, ali je za vas nadaljevanje zdravljenja z zdravilom Cubicin primerno ali ne.
Limb pain, serum creatine phosphokinase (CPK) increased 
bolečine v okončinah, zvišana vrednost kreatin-fosfokinaze v serumu (CPK)
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. 
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.
Driving and using machines Cubicin has no known effects on the ability to drive or use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Pri zdravilu Cubicin ni znanih učinkov na sposobnost upravljanja vozil in strojev.
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. 
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.
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). 
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.
Cubicin 350 mg powder for solution for injection or infusion EU/1/05/328/001 
Cubicin 350 mg prašek za raztopino za injiciranje ali infundiranje EU/1/05/328/001
Cubicin 500 mg powder for solution for injection or infusion EU/1/05/328/002 
Cubicin 500 mg prašek za raztopino za injiciranje ali infundiranje EU/1/05/328/002
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 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.
Cubicin given as 2-minute intravenous injection (adult patients only) Water should not be used for reconstitution of Cubicin for intravenous injection. 
Zdravilo Cubicin za vnos z 2-minutno intravensko injekcijo (samo odrasli bolniki) Za rekonstitucijo zdravila Cubicin za intravensko injiciranje se ne sme uporabiti vode.
The dosage regimen for Cubicin in paediatric patients with renal impairment has not been established. 
Režim odmerjanja zdravila Cubicin pri pediatričnih bolnikih z okvaro ledvic ni bil določen.
If you experience these symptoms, tell your doctor or nurse straight away. 
Če opazite navedene simptome, takoj povejte zdravniku ali medicinski sestri.
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. 
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).
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). 
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).
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 
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
No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed. 
V farmakokinetiki daptomicina niso opazili nikakršnih klinično pomembnih razlik, povezanih s spolom.
It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system. 
Le malo verjetno je, da bi daptomicin zaviral ali induciral metabolizem tistih zdravil, ki se presnavljajo s pomočjo sistema P450.
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). 
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).
No dose adjustment is necessary based on age alone. 
Samo na osnovi starosti prilagajanje odmerka ni potrebno.
The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes. 
Rekonstituirano in razredčeno raztopino je treba nato intravensko infundirati 30 ali 60 minut.
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). 
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).
No data are available in patients with severe hepatic impairment (Child-Pugh Class C). 
Za bolnike s hudo okvaro jeter (Child Pugh C) podatkov ni na voljo.
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 
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.
It is mixed with a solvent to form a liquid before it is administered. 
Pred uporabo ga je treba zmešati s tekočino, da nastane raztopina.
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. 
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.
Rare: Not known*: 
fungemija neznana pogostnost*:
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. 
Varnost in učinkovitost zdravila Cubicin pri otrocih in mladostnikih do 18. leta starosti z desnostranskim infekcijskim endokarditisom zaradi bakterije Staphylococcus aureus nista bili dokazani.
Renal impairment Daptomycin is eliminated primarily by the kidney. 
Okvara ledvic Daptomicin se izloča primarno skozi ledvice.
Cubicin is therefore not indicated for the treatment of pneumonia. 
Zato zdravilo Cubicin za zdravljenje pljučnice ni indicirano.
In some cases of myopathy involving raised CPK and muscle symptoms, the patients also presented with elevated transaminases. 
Pri nekaterih bolnikih z miopatijo z zvišano vrednostjo kreatin-fosfokinaze in mišičnimi simptomi so zabeležili tudi zvišane vrednosti aminotransferaz.
Eosinophilic pneumonia 
eozinofilna pljučnica
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. 
Tudi farmakokinetika daptomicina, danega z 2-minutno intravensko injekcijo, je v odobrenem terapevtskem obsegu odmerjanja od 4 do 6 mg/kg sorazmerna z odmerkom.
Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism. 
Daptomicin je metabolizmu, ki je odvisen od citokroma P450 (CYP 450), le malo, če sploh, podvržen.
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. 
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.
Invert the vial in order to allow the solution to drain towards the stopper. 
Obrnite vialo, tako da raztopina lahko steče proti zamašku.
A total of 81 subjects were treated in the study, including 55 subjects who received daptomycin and 
V študiji je bilo zdravljenih skupno 81 bolnikov, od katerih jih je 55 prejemalo daptomicin in 26 standardno oskrbo.
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. 
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.
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). 
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).
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). 
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
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. 
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.
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). 
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).
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. 
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.
The duration of therapy may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient. 
Glede na oceno zapletov pri posameznem bolniku je trajanje zdravljenja lahko daljše kot 14 dni.
• 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. 
• 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).
Recurrence of eosinophilic pneumonia upon reexposure has been reported. 
Poročali so o ponovitvi eozinofilne pljučnice po ponovni uvedbi zdravila Cubicin.
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. 
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.
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. 
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.
EU/1/05/328/002 1 vial EU/1/05/328/004 5 vials 
EU/1/05/328/002 1 viala EU/1/05/328/004 5 vial
Renal impairment has been reported during treatment with Cubicin. 
Poročali so o pojavu okvare ledvic med zdravljenjem z zdravilom Cubicin.
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. 
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.
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. 
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).
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. 
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.
EU/1/05/328/001 1 vial EU/1/05/328/003 5 vials 
EU/1/05/328/001 1 viala EU/1/05/328/003 5 vial