natgillin/translations-raw huggingface dataset:
In mixed infections where Gram negative and/ or certain types of anaerobic bacteria are suspected, Cubicin should be co- administered with appropriate antibacterial agent(s).
Pri mešanih okužbah, kjer obstaja sum na prisotnost po Gramu negativnih in/ ali določenih tipov anaerobnih bakterij, je treba Cubicin dajati skupaj z enim ali več ustreznimi protimikrobnimi zdravili.
The recommended dose is
- Zapletene okužbe kože in mehkih tkiv brez sočasne bakteriemije s Staphylococcus aureus:
4 mg/ kg administered once every 24 hours for 7-14 days or until the infection is resolved (see section 5.1).
Priporočeni odmerek je 4 mg/ kg vsakih 24 ur, od 7 do 14 dni oziroma dokler okužba ni odpravljena (glejte poglavje 5. 1).
The recommended dose is 6 mg/ kg
- Zapletene okužbe kože in mehkih tkiv s sočasno bakteriemijo s Staphylococcus aureus:
administered once every 24 hours.
Priporočeni odmerek je 6 mg/ kg vsakih 24 ur.
See below for dose adjustments in patients with renal insufficiency.
Za prilagajanje odmerjanja pri bolnikih z ledvično insuficienco glejte spodaj.
The
- Dokazan infektivni endokarditis desne strani zaradi bakterije Staphylococcus aureus ali sum
recommended dose is 6 mg/ kg administered once every 24 hours.
Priporočeni odmerek je 6 mg/ kg vsakih 24 ur.
Renal insufficiency Daptomycin is eliminated primarily by the kidney.
Ledvična insuficienca Daptomicin se izloča primarno preko ledvic.
2 Due to limited clinical experience (see table and footnotes below) Cubicin should only be used in patients with any degree of renal insufficiency (Cr Cl < 80 ml/ min) when it is considered that the expected clinical benefit outweighs the potential risk.
2 Zaradi omejenega obsega kliničnih izkušenj se sme uporabljati zdravilo Cubicin pri bolnikih z ledvično insuficienco katerekoli stopnje (z očistkom kreatinina < 80 ml/ min) samo v primeru, da pričakovane klinične koristi pretehtajo tveganja (glejte spodnjo tabelo in opombe).
The response to treatment and renal function should be closely monitored in all patients with some degree of renal insufficiency (see also sections 4.4 and 5.2).
Pri vseh bolnikih z ledvično insuficienco katerekoli stopnje je treba natančno spremljati odziv na zdravljenje in delovanje ledvic (glejte tudi poglavji 4. 4 in 5. 2).
Dose adjustments in patients with renal insufficiency by indication and creatinine clearance
Prilagajanje odmerkov pri bolnikih z ledvično insuficienco glede na indikacijo in očistek kreatinina
Indication for use (1) cSSTI without S.
indikacija za uporabo (1) zapletene okužbe kože
Creatinine clearance (1)
očistek kreatinina (1) ≥ 30 ml/ min
Dose recommendation (1)
priporočeno odmerjanje (1)
aureus bacteraemia
in mehkih tkiv brez bakteriemije s S. aureus
4 mg/ kg once daily
4 mg/ kg enkrat dnevno
See section 5.1
poglavje 5. 1
4
4 mg/ kg vsakih 48 ur
associated with S. aureus bacteraemia
infektivni endokarditis
6 mg/ kg once daily
6 mg/ kg enkrat dnevno
(1) The safety and efficacy of the dose interval adjustment has not been clinically evaluated and the recommendation is based on pharmacokinetic modelling data (see sections 4.4 and 5.2).
(1) Varnost in učinkovitost prilagajanja intervalov odmerjanja nista bili klinično ovrednoteni, smernice temeljijo na podatkih farmakokinetskih modelov (glejte poglavji 4. 4 in 5. 2).
(2) The same dose adjustments, which are also based solely on modelling are recommended for patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
(2) Za bolnike, ki so zdravljeni s hemodializo ali kontinuirano ambulantno peritonealno dializo (CAPD), je priporočeno enako prilagajanje odmerjanja, ki prav tako temelji samo na podatkih farmakokinetskih modelov.
Whenever possible, Cubicin should be administered following the completion of dialysis on dialysis days (see section 5.2).
Kadarkoli je to mogoče, je treba Cubicin dajati na dializne dni po končanem postopku dialize (glejte poglavje 5. 2).
(3) There are insufficient data to support a dose recommendation for patients with RIE or cSSTI associated with Staphylococcus aureus bacteraemia who have a creatinine clearance < 50 ml/ min.
(3) Pri bolnikih z infektivnim endokarditisom desne strani ali zapleteno okužbo kože in mehkih tkiv s sočasno bakteriemijo s S. aureus in z očistkom kreatinina < 50 ml/ min ni dovolj podakov za priporočila glede prilagajanja odmerjanja.
There are no data available to support the efficacy of 4 mg/ kg daily in patients with RIE or cSSTI associated with Staphylococcus aureus bacteraemia whose creatinine clearance is between 30-49 ml/ min or to support the use of 4 mg/ kg every 48 hours in such patients whose creatinine clearance is < 30 ml/ min.
Pri bolnikih z infektivnim endokarditisom desne strani ali zapleteno okužbo kože in mehkih tkiv s sočasno bakteriemijo s S. aureus in z očistkom kreatinina med 30- 49 ml/ min ni podatkov o učinkovitosti odmerka 4 mg/ kg dnevno oziroma o uporabi odmerka 4 mg/ kg vsakih 48 ur pri takih bolnikih, ki imajo očistek kreatinina < 30 ml/ min.
Hepatic insufficiency No dose adjustment is necessary when administering Cubicin to patients with mild or moderate hepatic insufficiency (Child-Pugh Class B) (see section 5.2).
Jetrna insuficienca Pri bolnikih z blago ali zmerno jetrno insuficienco (Child Pugh B) prilagajanje odmerka zdravila Cubicin ni potrebno (glejte poglavje 5. 2).
No data are available in patients with severe hepatic insufficiency (Child-Pugh Class C).
Za bolnike s hudo jetrno insuficienco (Child Pugh C) podatkov ni na voljo.
Elderly patients The recommended doses should be used in elderly patients except those with severe renal insufficiency (see above and section 4.4).
Starejši bolniki Pri starejših bolnikih, razen pri tistih s hudo ledvično insuficienco, je treba uporabljati priporočene odmerke.
However, there are limited data on the safety and efficacy of daptomycin in patients aged > 65 years and caution should be exercised if Cubicin is given to such patients.
Vendar pa je zaradi omejenih podatkov o varnosti in učinkovitosti daptomicina pri bolnikih, starejših od 65 let, potrebna previdnost, če prejemajo Cubicin.
See also section 5.2.
Otroci in mladostniki (< 18 let) Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Cubicin pri otrocih in mladostnikih (< 18 let) ni priporočljiva (glejte tudi poglavje 5. 2).
Method of administration Cubicin is given by intravenous infusion (see section 6.6) and administered over a 30 minute period.
Način uporabe Zdravilo Cubicin se daje v obliki intravenske infuzije (glejte poglavje 6. 6) s časom infundiranja 30 minut.
Hypersensitivity to the active substance or excipient.
Preobčutljivost za zdravilno učinkovino ali pomožno snov.
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.
Če se po začetku zdravljenja z zdravilom Cubicin odkrije drugo žarišče okužbe, ki ni zapletena okužba kože in mehkih tkiv ali infektivni endokarditis desne strani, je treba razmisliti o uvedbi drugega antibakterijskega zdravljenja, ki je dokazano učinkovito pri tej specifični prisotni okužbi oziroma več prisotnih okužbah.
Clinical data on the use of Cubicin to treat RIE due to Staphylococcus aureus are limited to 19 patients (see “ Information from clinical trials” in section 5.1).
Klinični podatki o uporabi zdravila Cubicin za zdravljenje infektivnega endokarditisa desne strani zaradi bakterije Staphylococcus aureus so omejeni na 19 bolnikov (glejte odstavek pod naslovom “ Informacije iz kliničnih preskušanj ” v poglavju 5. 1).
The efficacy of Cubicin in patients with prosthetic valve infections or with left-sided infective endocarditis due to Staphylococcus aureus has not been demonstrated.
Pri bolnikih z okužbo umetne zaklopke ali z infektivnim endokarditisom leve strani zaradi bakterije Staphylococcus aureus učinkovitosti zdravila Cubicin niso dokazali.
Patients with deep-seated infections should receive any required surgical interventions (e. g. debridement, removal of prosthetic devices, valve replacement surgery) without delay.
Bolnike z globokimi okužbami je treba nemudoma ustrezno kirurško oskrbeti (npr. kirurško odstraniti nekrotično tkivo, odstraniti protetične pripomočke ali operativno zamenjati zaklopke).
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).
Pri okužbah z enterokoki, ki jih je večinoma spremljala bakteriemija, so poročali o neuspehu zdravljenja z daptomicinom 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).
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 povečanju plazemske ravni kreatin- fosfokinaze (CPK; MM izoencim), povezane z bolečinami v mišicah in/ ali slabotnostjo in o primerih miozitisa, mioglobinemije in rabdomiolize (glejte poglavja 4. 5, 4. 8 in 5. 3).
In clinical studies, marked increases in plasma CPK to > 5x Upper Limit of Normal (ULN) without muscle symptoms occurred more commonly in Cubicin-treated patients (1.9%) than in those that received comparators (0.5%).
V kliničnih študijah je pri bolnikih, zdravljenih z zdravilom Cubicin, prišlo do pojava izrazitega povečanja ravni plazemske CPK na > 5x zgornjo mejo normale (ZMN) brez simptomov v mišicah bolj pogosto (1, 9%) kot pri tistih bolnikih, ki so prejemali primerljiva zdravila (0, 5%).
Therefore, it is recommended that: • Plasma CPK should be measured at baseline and at regular intervals (at least once weekly) during therapy in all patients. • It cannot be ruled out that those patients with CPK greater than 5 times upper limit of normal at baseline may be at increased risk of further increases during daptomycin therapy.
Zaradi tega je priporočljivo sledeče: • Plazemsko CPK je treba pri vseh bolnikih izmeriti pred začetkom terapije kot izhodiščno vrednost in nato med terapijo izvajati meritve v rednih intervalih (vsaj enkrat tedensko). • Ne moremo izključiti možnosti, da pri tistih bolnikih, ki imajo izhodiščno vrednost CPK več kot 5- krat večjo od zgornje meje normale, obstaja večje tveganje za dodatno zvišanje med zdravljenjem z daptomicinom.
This should be taken into account when initiating daptomycin therapy and, if daptomycin is given, these patients should be monitored more frequently than once weekly. • CPK should be measured more frequently than once weekly in patients who are at higher risk of developing myopathy.
To je treba upoštevati ob uvedbi zdravljenja z daptomicinom in v primeru uporabe daptomicina te bolnike spremljati pogosteje kot enkrat tedensko. • Pri bolnikih z večjim tveganjem za nastanek miopatij je treba CPK meriti bolj pogosto kot enkrat tedensko.
These patients include those with severe renal insufficiency (creatinine clearance < 30 ml/ min; see also section 4.2) and patients taking other medications known to be associated with myopathy (e. g.
Sem spadajo tisti bolniki, ki imajo hudo ledvično insufucienco (očistek kreatinina < 30 ml/ min, glejte tudi poglavje 4. 2), in tisti, ki jemljejo druga zdravila, za katera je poznano, da so povezana z nastankom miopatij (npr. inhibitorji HMG- CoA reduktaze, fibrati in ciklosporin). • Zdravila Cubicin ne smemo dajati bolnikom, ki jemljejo druga zdravila, povezana z nastankom miopatij, razen če menimo, da je korist za bolnika večja od tveganja. • Bolnike je treba med zdravljenjem redno pregledovati, da opazimo kakršnekoli znake ali
HMG-CoA reductase inhibitors, fibrates and ciclosporin). • Cubicin should not be administered to patients who are taking other medications associated with myopathy unless it is considered that the benefit to the patient outweighs the risk. • Patients should be reviewed regularly while on therapy for any signs or symptoms that might represent myopathy. • Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.
4 simptome, ki bi lahko predstavljali miopatijo. • Pri vsakem bolniku, pri katerem se razvijejo nepojasnjene bolečine v mišicah, občutljivost, oslabelost ali krči mišic, je treba raven CPK kontrolirati vsak drugi dan.
Cubicin should be discontinued in the presence of unexplained muscle symptoms if the CPK level reaches greater than 5 times upper limit of normal.
Z uporabo zdravila Cubicin je treba v prisotnosti nepojasnjenih simptomov v mišicah prenehati, če raven CPK preseže 5- kratnik zgornje meje normale.
4 Peripheral Neuropathy Patients who develop signs or symptoms that might represent a peripheral neuropathy during therapy with Cubicin should be investigated and consideration should be given to discontinuation of daptomycin (see sections 4.8 and 5.3).
Periferna nevropatija Bolnike, pri katerih se med terapijo z zdravilom Cubicin pojavijo znaki ali simptomi, ki bi lahko predstavljali periferno nevropatijo, je potrebno pregledati in premisliti o prekinitvi uporabe daptomicina (glejte poglavji 4. 8 in 5. 3).
Renal Insufficiency Renal insufficiency has been reported during treatment with Cubicin.
Ledvična insuficienca Poročali so o pojavu ledvične insuficience med zdravljenjem z zdravilom Cubicin.
Severe renal insufficiency may in itself also pre-dispose to elevations in daptomycin levels which may increase the risk of development of myopathy (see above).
Huda ledvična insuficienca lahko sama po sebi povzroči povišanje ravni daptomicina, kar lahko poveča tveganje za nastanek miopatije (glejte zgoraj).
Dose adjustment is needed for patients with cSSTI without bacteraemia whose creatinine clearance is < 30 ml/ min (see sections 4.2 and 5.2).
Prilagajanje odmerkov je potrebno pri bolnikih z zapletenimi okužbami kože in mehkih tkiv brez bakteriemije in z očistkom kreatinina < 30 ml/ min (glejte poglavji 4. 2 in 5. 2).
The safety and efficacy of the dose interval adjustment guidelines provided in section 4.2 are based on pharmacokinetic modelling and have not been clinically evaluated.
Varnost in učinkovitost smernic za prilagajanje intervalov odmerkov, predstavljenih v poglavju 4. 2, temeljita na farmakokinetskih modelih in nista bili klinično ocenjeni.
In addition there are no data to support the use of 6 mg/ kg daptomycin once daily in patients with RIE or with cSSTI associated with bacteraemia whose creatinine clearance is < 50 ml/ min.
Poleg tega pri bolnikih z infektivnim endokarditisom desne strani ali z zapletenimi okužbami kože in mehkih tkiv s sočasno bakteriemijo in očistkom kreatinina < 50 ml/ min ni nobenih podatkov, ki bi govorili v prid uporabi odmerka daptomicina 6 mg/ kg enkrat dnevno.
Caution is advised when administering Cubicin to patients who already have some degree of renal insufficiency (creatinine clearance < 80 ml/ min) before commencing therapy with Cubicin.
Pri dajanju zdravila Cubicin bolnikom, ki so že imeli določeno stopnjo ledvične insuficience (očistek kreatinina < 80 ml/ min) pred začetkom terapije z zdravilom Cubicin, je potrebna previdnost.
Regular monitoring of renal function is advised (see also section 5.2).
Priporočeno je redno kontroliranje ledvične funkcije (glejte tudi poglavje 5. 2).
In addition, regular monitoring of renal function is advised during concomitant administration of potentially nephrotoxic agents, regardless of the patient’ s pre-existing renal function (see also section 4.5).
Poleg tega se pri sočasnem dajanju potencialno nefrotoksičnih sredstev svetuje redno kontroliranje ledvične funkcije, ne glede na bolnikovo obstoječo ledvično funkcijo (glejte tudi poglavje 4. 5).
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.
Pri zelo debelih bolnikih z indeksom telesne mase (BMI) > 40 kg/ m2 in z očistkom kreatinina > 70 ml/ min je bila AUC0- ∞ daptomicina, v primerjavi z normalno težko kontrolno skupino, znatno višja (v povprečju za 42% višja).
However, there is currently no evidence that a dose reduction is required (see section 5.2).
Vendar pa trenutno ni nikakršnih dokazov, da je potrebno zmanjšati odmerke (glejte poglavje 5. 2).
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening.
O kolitisu in psevdomembranskem kolitisu, ki sta povezana z antibiotiki, so poročali pri skoraj vseh antimikrobnih zdravilih, po resnosti pa lahko segata od blage do življenjsko nevarne oblike.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or shortly following treatment.
Zaradi tega je pomembno, da pri bolnikih, ki imajo med zdravljenjem ali kmalu po končanem zdravljenju drisko, upoštevate možnost te diagnoze.
Daptomycin undergoes little to no Cytochrome P450 (CYP450) mediated metabolism.
Daptomicin je metabolizmu, ki je odvisen od citokroma P450 (CYP 450), če sploh, le malo podvržen.
In vitro studies have determined that daptomycin does not inhibit or induce the activities of clinically significant human CYP isoforms (1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4).
Z in vitro študijami so določili, da daptomicin niti ne zavira niti ne inducira aktivnosti klinično pomembnih izooblik humanega CYP (1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4).
Therefore, no CYP450-related drug interactions are to be expected.
Zaradi tega ni pričakovati interakcij zdravila v povezavi s CYP450.
There is limited experience regarding concomitant administration of daptomycin with other medicinal products that may trigger myopathy.
O sočasni uporabi daptomicina z drugimi zdravili, ki lahko povzročijo miopatijo, so na voljo le omejene izkušnje.
However, some cases of marked rises in CPK levels and cases of rhabdomyolysis occurred in patients taking one of these medications at the same time as Cubicin.
Vendar pa je pri bolnikih, ki so jemali ta zdravila sočasno z zdravilom Cubicin, v nekaj primerih prišlo do izrazitega porasta ravni CPK in do nekaj primerov rabdomiolize.
It is recommended that other medications associated with myopathy should if possible be temporarily discontinued during treatment with Cubicin unless the benefits of concomitant administration outweigh the risk.
5 drugih zdravil, povezanih z nastankom miopatij, razen v primeru, če so koristi sočasne uporabe večje od tveganja.
If co-administration cannot be avoided, CPK levels should be measured more frequently than once weekly and patients should be closely monitored for any signs or symptoms that might represent myopathy.
Če se sočasnemu dajanju zdravil ni moč izogniti, je treba bolj pogosto kot enkrat tedensko kontrolirati ravni CPK, bolnike pa je treba skrbno pregledovati, da opazimo kakršnekoli znake ali simptome, ki bi lahko predstavljali miopatijo.
See sections 4.4, 4.8 and 5.3.
Glejte poglavja 4. 4, 4. 8 in 5. 3.
5 Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during co- administration with medicinal products that reduce renal filtration (e. g.
Daptomicin se primarno izloča z ledvično filtracijo, tako da lahko pri sočasni uporabi zdravil, ki zavirajo ledvično filtracijo (npr.
NSAIDs and COX-2 inhibitors).
NSAID in zaviralci COX- 2), plazemske ravni narastejo.
Therefore, caution is advised when daptomycin is co- administered with any other medicinal product known to reduce renal filtration.
Zaradi tega priporočamo previdnost pri sočasnem dajanju daptomicina in kateregakoli drugega zdravila, za katerega je znano, da zmanjšuje ledvično funkcijo.
During post– marketing surveillance, cases of interference between daptomycin and particular reagents used in some assays of Prothrombin Time/ International Normalised Ratio (PT/ INR) have been reported.
Med postmarketinškim nadzorovanjem so poročali o primerih interference med daptomicinom in določenimi reagenti, ki se uporabljajo v nekaterih testih za določanje protrombinskega časa/ internacioanalno izmerjenega razmerja (PČ/ INR).
This interference led to an apparent prolongation of PT and elevation of INR.
Ta interferenca je povzročila navidezno podaljšanje PČ in dvig INR.
If unexplained abnormalities of PT/ INR are observed in patients taking daptomycin, consideration should be given to a possible in vitro interaction with the laboratory test.
Če pri bolnikih, ki jih zdravimo z daptomicinom, opazimo nepojasnjene nepravilnosti PČ/ INR, moramo pomisliti na možnost in vitro interakcije z laboratorijskim testom.
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.
Verjetnost napačnih rezultatov zmanjšamo tako, da vzorce za določitev PČ ali INR vzamemo, ko pričakujemo padec koncentracije daptomicina v plazmi.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/ fetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na plodnost, nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
Cubicin should not be used during pregnancy unless clearly necessary i. e., only if the potential benefit outweighs the possible risk.
Zdravila Cubicin ne smete uporabljati med nosečnostjo, razen če je nujno potrebno, to pomeni, samo če je morebitna korist večja od možnega tveganja.
It is not known whether daptomycin is excreted in human milk.
Ni znano, če se daptomicin izloča v materino mleko.
Therefore, breastfeeding should be discontinued during treatment with Cubicin.
Zato je potrebno med zdravljenjem z zdravilom Cubicin prekiniti dojenje.
Clinical Studies In clinical studies, 2,011 subjects received Cubicin.
Klinične študije V kliničnih študijah je več kot 2. 011 oseb prejemalo Cubicin.
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.
V okviru teh študij je 1. 221 oseb prejemalo dnevni odmerek 4 mg/ kg, od teh je bilo 1. 108 bolnikov, 113 pa zdravih prostovoljcev; 460 oseb je prejemalo dnevni odmerek 6 mg/ kg, od teh so bili 304 bolniki, 156 pa je bilo zdravih prostovoljcev.
Adverse reactions (i. e. considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported at similar frequencies for Cubicin and comparator regimens.
O neželenih učinkih (to pomeni tiste učinke, za katere raziskovalec meni, da so mogoče, verjetno ali definitivno povezani z zdravilom) so poročali s podobno pogostnostjo za Cubicin in za primerjalne sheme zdravljenja.
For subjects who received Cubicin, the adverse reactions that were most frequently reported during therapy plus follow-up were: headache, nausea, vomiting, diarrhoea, fungal infections, rash, infusion site reaction, increased Creatine phosphokinase (CPK) and abnormal liver enzymes; Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase.
Pri osebah, ki so prejemale Cubicin, so bili neželeni učinki, o katerih so najbolj pogosto poročali med terapijo in na kontrolah sledeči: glavobol, slabost, bruhanje, driska, glivične okužbe, izpuščaji, reakcija na mestu infundiranja, povečana kreatin- fosfokinaza (CPK) in nenormalne vrednosti jetrnih encimov: alanin aminotransferaze (ALT), aspartat aminotransferaze (AST) in alkalne fosfataze.