natgillin/translations-raw huggingface dataset:
Step 1: Initial dilution of the concentrate for solution for infusion with the supplied solvent. 
1. korak: Začetno redčenje koncentrata za raztopino za infundiranje s priloženim vehiklom.
1 vial of 1.5 ml concentrate and 1 vial of 4.5 ml solvent. 
1 viala z 1,5 ml koncentrata in 1 viala s 4,5 ml vehikla.
From 20 to 15 mg/m2: 58 (10.0%) From 15 to 12 mg/m2: 9 (1.6%) 
Z 20 na 15 mg/m2: 58 (10,0 %) S 15 na 12 mg/m2: 9 (1,6 %)
Due to potential exposure via seminal liquid, men treated with cabazitaxel should prevent contact with the ejaculate by another person throughout treatment. 
Zaradi možne izpostavljenosti preko semenske tekočine morajo moški, zdravljeni s kabazitakselom, med celotnim zdravljenjem poskrbeti, da ejakulat ne pride v stik z drugo osebo.
This medicine contains 15% v/v ethanol (alcohol), equivalent to 14 ml of beer or 6 ml of wine. 
Zdravilo vsebuje 15% v/v etanola; to ustreza 14 ml piva ali 6 ml vina.
Data in patients below the 20 mg/m2 dose are limited. 
Podatkov o bolnikih z odmerkom pod 20 mg/m2 je malo.
Exposures in animals were similar or lower than those seen in humans receiving clinically relevant doses of cabazitaxel. 
Izpostavljenosti pri živalih so bile podobne ali manjše kot pri ljudeh, ki prejemajo klinično pomembne odmerke kabazitaksela.
Based on in vitro studies, the potential risk of inhibition by cabazitaxel at clinically relevant concentrations is possible towards medicinal products that are mainly substrate of CYP3A. 
Na podlagi študij in vitro je mogoče, da pri klinično pomembnih koncentracijah kabazitaksela obstaja tveganje zavrtja zdravil, ki so predvsem substrati CYP3A.
In the population pharmacokinetic analysis in 70 patients of 65 years and older (57 from 65 to 75 and 13 patients above 75), no age effect on the pharmacokinetics of cabazitaxel was observed. 
V populacijski farmakokinetični analizi 70 bolnikov, starih 65 let in več (57 od 65 do 75 let in 13 starejših od 75 let), niso opazili vpliva starosti na farmakokinetiko kabazitaksela.
Patients presenting end stage renal disease (creatinine clearance (CLCR< 15 mL/min/1.73 m2), by their condition and the limited amount of data available should be treated with caution and monitored carefully during treatment (see sections 4.4 and 
Bolnike s končno fazo ledvične bolezni (očistek kreatinina je manjši od 15 ml/min/1.73 m2 ) je treba glede na njihovo stanje in zaradi maloštevilnih dostopnih podatkov zdraviti previdno in jih med zdravljenjem natančno kontrolirati (glejte poglavji 4.4 in 5.2).
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vials after EXP. 
Tega zdravila JEVTANA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini in na nalepki vial poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
The safety profile of cabazitaxel 25 mg/m2 observed in study EFC11785 was qualitatively and quantitatively similar to that observed in the study EFC6193. 
Varnostne značilnosti 25 mg/m2 kabazitaksela so bile v študiji EFC11785 kakovostno in količinsko podobne kot v študiji EFC6193.
Animal studies showed that cabazitaxel affected reproductive system in male rats and dogs without any functional effect on fertility (see section 5.3). 
Študije na živalih so pokazale, da kabazitaksel vpliva na reproduktivni sistem pri podganjih in pasjih samcih, ne da bi funkcijsko vplival na plodnost (glejte poglavje 5.3).
The phase 2 part did not demonstrate efficacy of cabazitaxel as single agent in paediatric population with recurrent or refractory diffuse intrinsic pontine glioma (DIPG) and high grade glioma (HGG) treated at 30 mg/m². 
Druga faza ni pokazala učinkovitosti kabazitaksela v monoterapiji pri pediatrični populaciji s ponovnim ali refraktarnim difuznim intrinzičnim pontinim gliomom (DIPG) ali visokostopenjskim gliomom (HGG - high grade glioma), zdravljeni s 30 mg/m2.
Therefore, no pharmacokinetic interaction of cabazitaxel on warfarin is expected in vivo. 
Zato in vivo ni pričakovati farmakokinetičnega medsebojnega delovanja kabazitaksela na varfarin.
The other ingredients are polysorbate 80 and citric acid in the concentrate, and ethanol 96% and water for injections in the solvent (see section 2 “JEVTANA contains alcohol”). 
Pomožne snovi so polisorbat 80 in citronska kislina v koncentratu ter 96 % etanol in voda za injekcije v vehiklu (glejte poglavje 2 »Zdravilo JEVTANA vsebuje alkohol«).
This can occur if you have severe or long-lasting diarrhoea, or fever, or if you are being sick 
Pojavi se lahko, če imate hudo ali dolgotrajno drisko, zvišano telesno temperaturo ali če bruhate.
• you are allergic (hypersensitive) to cabazitaxel, to other taxanes, or polysorbate 80 or any of the other excipients of this medicine (listed in section 6), 
• če ste alergični na kabazitaksel, druge taksane, ali polisorbat 80 ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
• antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent), 
• antihistaminik (5 mg deksklorfeniramina ali 25 mg difenhidramina ali enakovredni zdravili),
Cabazitaxel inhibited the transport of P-glycoprotein (PgP) (digoxin, vinblastin), Breast-Cancer-Resistant-Proteins (BCRP) (methotrexate) and Organic Anion Transporting Polypeptide OATP1B3 (CCK8) at concentrations at least 15 fold what is observed in clinical setting while it inhibited the transport of OATP1B1 (estradiol-17β-glucuronide) at concentrations only 5 fold what is observed in clinical setting. 
Kabazitaksel je zavrl transport s P-glikoproteinom (PgP) (digoksin, vinblastin), z rezistenčnimi beljakovinami raka dojke (BCRP; Breast Cancer Resistance Proteins) (metotreksat) in z organskim anionskim prenašalnim polipepetidom 1B3 OATP1B3 (CCK8) v koncentracijah, ki so bile vsaj 15-krat tolikšne, kot so jih zabeležili v kliničnih okoliščinah; hkrati pa je kabazitaksel zavrl transport OATP1B1 (estradiol-17β-glukuronid) v koncentracijah, ki so bile le 5-krat tolikšne, kot so jih zabeležili v kliničnih okoliščinah.
Your doctor may reduce the dose of JEVTANA or stop the treatment. 
Zdravnik vam lahko zmanjša odmerek zdravila JEVTANA ali konča zdravljenje.
The number of patients who completed the study treatment (10 cycles) was respectively 29.4% and 13.5% in the JEVTANA group and in the comparator group. 
Delež bolnikov, ki so dokončali raziskovano zdravljenje (10 ciklusov), je bil v skupini z zdravilom JEVTANA 29,4 % in v primerjalni skupini 13,5 %.
These medicines include the following: - ketoconazole, rifampicin (for infections); - carbamazepine, phenobarbital or phenytoin (for seizures); - St John's Wort (Hypericum perforatum) (herbal remedy for depression and other conditions); - statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (for reducing the cholesterol in your blood); - valsartan (for hypertension); - repaglinide (for diabetes). 
Med takšnimi zdravili so: - ketokonazol, rifampicin (za okužbe), - karbamazepin, fenobarbital ali fenitoin (za napade krčev), - šentjanževka (Hypericum perforatum) (zeliščno zdravilo proti depresiji in drugim stanjem), - statini (kot so simvastatin, lovastatin, atorvastatin, rosuvastatin ali pravastatin) (za zniževanje ravni holesterola v vaši krvi), - valsartan (za povišan krvni tlak), - repaglinid (za sladkorno bolezen).
The concentrate is a clear yellow to brownish-yellow oily solution. 
Koncentrat je bistra, rumena do rjavkastorumena oljnata raztopina.
This was confirmed by a dedicated comparative pharmacokinetic study in solid cancer patients with normal renal function (8 patients), moderate (8 patients) and severe (9 patients) renal impairment, who received several cycles of cabazitaxel in single IV infusion up to 25 mg/m2. 
To je bilo potrjeno z namensko primerjalno farmakokinetično študijo bolnikov s parenhimskimi tumorji in normalnim delovanjem ledvic (8 bolnikov) ali z zmerno (8 bolnikov) ali hudo (9 bolnikov) okvaro ledvic, ki so prejeli več ciklusov kabazitaksela v enkratni intravenski infuziji do 25 mg/m2.
Patients with a history of congestive heart failure, or myocardial infarction within last 6 months, or patients with uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension were not included in the study. 
V študijo niso bili vključeni bolniki s kongestivnim srčnim popuščanjem, bolniki z miokardnim infarktom v zadnjih 6 mesecih in bolniki z neobvladanimi motnjami srčnega ritma, angino pektoris in/ali hipertenzijo.
Cabazitaxel is mainly excreted in the faeces as numerous metabolites (76% of the dose); while renal excretion of cabazitaxel and metabolites account for less than 4% of the dose (2.3% as unchanged medicinal product in urine). 
Kabazitaksel se v glavnem izloči v blatu v obliki številnih presnovkov (76 % odmerka), na račun ledvičnega izločanja kabazitaksela in presnovkov pa gre manj kot 4 % odmerka (2,3 % kot nespremenjeno zdravilo v urinu).
The study met its primary objective of demonstrating the non-inferiority of cabazitaxel 20 mg/m2 in comparison with 25 mg/m2 (see table 4). 
Študija je dosegla svoj primarni cilj in je dokazala neinferiornost 20 mg/m2 kabazitaksela v primerjavi s 25 mg/m2 (glejte preglednico 4).
PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA 60 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION 
PRAKTIČNE INFORMACIJE ZA ZDRAVSTVENO OSEBJE O PRIPRAVI, UPORABI IN RAVNANJU Z ZDRAVILOM JEVTANA 60 MG KONCENTRAT IN VEHIKEL ZA RAZTOPINO ZA INFUNDIRANJE
Patients under treatment with cabazitaxel should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop. 
Bolnikom, ki prejemajo kabazitaksel, je treba naročiti, naj pred nadaljevanjem zdravljenja obvestijo svojega zdravnika, če se jim pojavijo simptomi nevropatije, npr. bolečine, pekoč občutek, mravljinčenje, omrtvičenost ali šibkost.
• liver problems occur during the treatment. 
• če se vam med zdravljenjem pojavijo težave z jetri.
Study EFC11785 demonstrated a better safety profile for the cabazitaxel 20 mg/m2 dose. 
Študija EFC11785 je dokazala boljše varnostne značilnosti odmerka 20 mg/m2 kabazitaksela.
This is because JEVTANA may increase the risk of bleeding or developing holes in the gut wall. 
Zdravilo JEVTANA namreč lahko poveča tveganje za krvavitve ali za nastanek predrtja (luknje) v steni črevesa.
The concentrate and solvent vials must be used immediately. 
Viali koncentrata in vehikla je treba uporabiti nemudoma.
There is no known antidote to cabazitaxel. 
Za kabazitaksel ni znanega antidota.
• inflammation of the bladder, which can occur when your bladder has been previously exposed to radiation therapy (cystitis due to radiation recall phenomenon). 
• vnetje sečnega mehurja, ki se lahko pojavi, če je bil mehur kdaj izpostavljen obsevalnemu zdravljenju (cistitis zaradi pojava pomnjenja obsevanja).
• pain in mouth or throat 
• bolečine v ustih ali žrelu
Concentrate vial: polysorbate 80 and citric acid; Solvent vial: ethanol 96% and water for injections. 
Viala s koncentratom: polisorbat 80 in citronska kislina; Viala z vehiklom: 96 % etanola in voda za injekcije.
Overall survival was significant longer with JEVTANA compared to mitoxantrone (15.1 months versus 12.7 respectively), with a 30% reduction in the risk of death compared to mitoxantrone (see table 3 and figure 1). 
Celokupno preživetje je bilo značilno daljše z zdravilom JEVTANA kot z mitoksantronom (15,1 mesece v primerjavi z 12,7 meseca), s 30 % zmanjšanjem tveganja smrti v primerjavi z mitoksantronom (glejte preglednico 3 in sliko 1).
In 3 patients with severe hepatic impairment (total bilirubin >3 ULN), a 39% decrease in clearance was observed when compared to patients with mild hepatic impairment, indicating some effect of severe hepatic impairment on cabazitaxel pharmacokinetics. 
Pri 3 bolnikih s hudo okvaro jeter (celokupni bilirubin > 3-kratna ZNM) so v primerjavi z bolniki z blago okvaro jeter opažali 39 % zmanjšanje očistka; to kaže na določen vpliv hude okvare jeter na farmakokinetiko kabazitaksela.
• skin feeling hot or flushed 
• občutek vroče kože ali zardevanje
Repeated administration of rifampin (600 mg once daily), a strong CYP3A inducer, resulted in an increase in cabazitaxel clearance of 21% corresponding to a decrease in AUC of 17%. 
Ponavljajoče se uporaba rifampina (600 mg enkrat na dan), ki je močan induktor CYP3A, je povečala očistek kabazitaksela za 21 %; to ustreza zmanjšanju AUC za 17 %.
Cabazitaxel is extensively metabolised in the liver (>95%), mainly by the CYP3A isoenzyme (80% to 90%). 
Kabazitaksel se izdatno presnovi v jetrih (> 95 %), predvsem z izoencimi CYP3A (80 % do 90 %).
Renal disorders, have been reported in association with sepsis, severe dehydration due to diarrhoea, vomiting and obstructive uropathy. 
Ledvične motnje so bile opisane v povezavi s sepso, hudo dehidracijo zaradi driske, bruhanjem in obstruktivno uropatijo.
From a microbiological point of view, the concentrate-solvent mixture should be used immediately. 
Z mikrobiološkega stališča je treba mešanico koncentrata z vehiklom uporabiti nemudoma.
Table 2: Reported adverse reactions and haematological abnormalities with cabazitaxel in combination with prednisone or prednisolone in the TROPIC study (n=371) 
Preglednica 2: Opisani neželeni učinki in hematološke nepravilnosti med zdravljenjem z kabazitakselom skupaj s prednizonom ali prednizolonom v študiji TROPIC (n=371)
There was no statistically difference with regards to the other secondary endpoints (PFS, tumour and pain response, tumour and pain progression, and four subcategories of FACT-P). 
Glede drugih sekundarnih opazovanih dogodkov (PFS, odziv tumorja in bolečin, napredovanje tumorja in bolečin in štirih podkategorij FACT-P) ni bilo statistično značilnih razlik.
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the supplied solvent by partially inverting the vial. 
Uporabite brizgo z nameščeno iglo in aseptično izvlecite celotno količino priloženega vehikla iz viale tako, da vialo delno obrnete.
Overall survival (OS) was the primary efficacy end-point. 
Primarni opazovani dogodek učinkovitosti je bilo celokupno preživetje (OS).
Hazard Ratioa versus CBZ25+PRED 1-sided 98.89% UCI 1-sided 95% LCI CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednisone/Prednisolone CI=confidence interval, LCI=lower bound of the confidence interval, UCI=upper bound of the confidence interval a Hazard ratio is estimated using a Cox Proportional Hazards regression model. 
s CBZ25 + PRED 1-stranski 98,89 % ZIZ 1-stranski 98,89 % SIZ CBZ20 = kabazitaksel 20 mg/m2, CBZ25 = kabazitaksel 25 mg/m2, PRED = prednizon/prednizolon IZ = interval zaupanja, SIZ = spodnja meja intervala zaupanja, ZIZ = zgornja meja intervala zaupanja a Razmerje ogroženosti je ocenjeno s Coxovim regresijskim modelom sorazmernih ogroženosti.
However, in repeated-dose toxicity studies, degeneration of seminal vesicle and seminiferous tubule atrophy in the testis were observed in rats, and testicular degeneration (minimal epithelial single cell necrosis in epididymis), was observed in dogs. 
Toda v študijah toksičnosti ponavljajočih se odmerkov so pri podganah opazili degeneracijo seminalnih vezikul in atrofijo semenskih tubulov v modih, pri psih pa degeneracijo testisov (minimalno nekrozo posameznih epitelijskih celic v epididimisu).
Cabazitaxel is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Kabazitaksela ni priporočljivo uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
After initial dilution of JEVTANA 60 mg concentrate with the entire contents of the solvent vial chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature. 
Po začetnem redčenju koncentrata JEVTANA 60 mg z celotno vsebino viale z vehiklom: Kemična in fizikalna stabilnost med uporabo sta dokazani za 1 uro na okoljski temperaturi.
• abnormal feeling or loss of sensation or pain in hands and feet 
• nenormalni občutki ali izguba zaznavanja ali bolečine v dlaneh in stopalih
Concomitant administration of aprepitant, a moderate CYP3A inhibitor, had no effect on cabazitaxel clearance. 
Sočasna uporaba zmernega zaviralca CYP3A aprepitanta ni vplivala na očistek kabazitaksela.
Required amount of concentrate-solvent mixture 
Zahtevana količina mešanice koncentata in vehikla
From 25 to 20 mg/m2: 128 (21.5%) From 20 to 15 mg/m2: 19 (3.2%) From 15 to 12 mg/m2: 1 (0.2%) 
S 25 na 20 mg/m2: 128 (21,5 %) Z 20 na 15 mg/m2: 19 (3,2 %) S 15 na 12 mg/m2: 1 (0,2 %)
The solvent contains 573.3 mg ethanol 96% (15% v/v), equivalent to 14 ml of beer or 6 ml of wine. 
Viala z vehiklom vsebuje 573,3 mg 96 % (15% v/v) etanola; to ustreza 14 ml piva ali 6 ml vina.
This medicine must not be mixed with other medicines except those used for the dilutions. 
Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki se uporabljajo za redčenje.
Confounding causes such as disease progression, instrumentation, infection or anticoagulation/NSAID/aspirin therapy were identified in nearly two thirds of the cases. 
V skoraj dveh tretjinah primerov so bili ugotovljeni moteči vzroki, npr. napredovanje bolezni, instrumentacija, okužba ali zdravljenje z antikoagulansi/NSAID/acetilsalicilno kislino.
In addition, cabazitaxel demonstrated activity in tumour models insensitive to chemotherapy including docetaxel. 
Poleg tega se je izkazal za aktivnega v tumorskih modelih, neobčutljivih za kemoterapijo, vključno z docetakselom.
A population pharmacokinetic analysis carried out in 170 patients that included 14 patients with moderate renal impairment (creatinine clearance in the range of 30 to 50 ml/min) and 59 patients with mild renal impairment (creatinine clearance in the range of 50 to 80 ml/min) showed that mild to moderate renal impairment did not have meaningful effects on the pharmacokinetics of cabazitaxel. 
Populacijska farmakokinetična analiza 170 bolnikov, med katerimi je bilo 14 bolnikov z zmerno okvaro ledvic (očistek kreatinina od 30 do 50 ml/min) in 59 bolnikov z blago okvaro ledvic (očistek kreatinina od 50 do 80 ml/min), je pokazala, da blaga do zmerna okvara ledvic nima pomembnega vpliva na farmakokinetiko kabazitaksela.
Transaminases increased a based on laboratory values 
Preiskave zmanjšanje telesne mase zvišanje aspartataminotransferaze zvišanje transaminaz a na podlagi laboratorijskih vrednosti
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4.5 ml (ethanol 96% and water for injections). 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 4,5 ml (96 % etanol in voda za injekcije)
Neutropenia is the most common adverse reaction of cabazitaxel (see section 4.8). 
Nevtropenija je najpogostejši neželeni učinek kabazitaksela (glejte poglavje 4.8).
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Tega zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6.6.
From a microbiological point of view, the infusion solution should be used immediately. 
Z mikrobiološkega stališča je treba raztopino za infundiranje uporabiti takoj.
Administration of cabazitaxel to patients with mild hepatic impairment should be undertaken with caution and close monitoring of safety. 
Pri bolnikih z blago okvaro jeter je treba kabazitaksel uporabljati previdno in ob skrbnem spremljanju varnosti.
Adequate hydration should be ensured throughout treatment with cabazitaxel. 
Med celotnim zdravljenjem s kabazitakselom je treba zagotoviti zadostno hidracijo.
JEVTANA is administered as a 1 hour infusion. 
Zdravilo JEVTANA se daje v 1-urni infuziji.
A sub-group of 59 patients received prior cumulative dose of docetaxel <225 mg/m² (29 patients in JEVTANA arm, 30 patients in mitoxantrone arm). 
Podskupina z 59 bolniki, ki so predhodno prejeli kumulativni odmerek docetaksela <225 mg/m² (29 bolnikov v kraku z zdravilom JEVTANA, 30 bolnikov v kraku z mitoksantronom).
This fill volume has been established during the development of JEVTANA to compensate for liquid loss during preparation of the premix. 
Ta polnilni volumen so ugotovili med razvojem zdravila JEVTANA in sicer za nadomestitev izgube tekočine med pripravo mešanice.
The efficacy and safety of JEVTANA in combination with prednisone or prednisolone were evaluated in a randomised, open-label, international, multi-center, phase III study (EFC6193 study), in patients with metastatic castration resistant prostate cancer previsouly treated with a docetaxel containing regimen. 
Učinkovitost in varnost zdravila JEVTANA v kombinaciji s prednizonom ali prednizolonom so ocenili v randomizirani, odprti mednarodni multicentrični študiji III. faze (študija EFC6193) pri bolnikih z metastatskim, na kastracijo odpornim rakom prostate, predhodno zdravljenih s shemo, ki je obsegala docetaksel.
Haematological abnormalitiesc (%) 
Hematološke nepravilnostic (%)
Exposures in animals were lower than those seen in humans receiving clinically relevant doses of cabazitaxel. 
Izpostavljenosti pri živalih so bile manjše kot pri ljudeh, ki prejemajo klinično pomembne odmerke kabazitaksela.
Do not use JEVTANA if: 
Ne uporabljajte zdravila JEVTANA:
The incidence of tachycardia on cabazitaxel was 1.6%, none of which were Grade ≥3. 
Incidenca tahikardije je bila med prejemniki kabazitaksela 1,6 %; noben primer ni bil ≥ 3. stopnje.
Clinical neutropenia 
Klinična nevtropenija
METHOD OF ADMINISTRATION Use the ENTIRE content for dilution (see package leaflet). 
POSTOPEK UPORABE Za redčenje uporabite CELOTNO vsebino (glejte navodilo za uporabo).
Nevertheless, considering the pharmacological activity of taxanes, their genotoxic potential and effect of several compounds of this class on fertility in animal studies, effect on male fertility could not be excluded in human. 
Pri človeku ni mogoče izključiti vpliva na plodnost moških glede na farmakološko delovanje taksanov, njihov genotoksični potencial in vpliv več spojin iz te skupine na plodnost v študijah na živalih.
Therefore, at therapeutic doses, co-administration of CYP3A substrates with cabazitaxel to patients is not expected to have any clinical impact. 
Zato ni pričakovati, da bi sočasna uporaba substratov CYP3A in kabazitaksela pri bolnikih imela kakšen kliničen vpliv.
Other medicines and JEVTANA 
Druga zdravila in zdravilo JEVTANA
Patients should be re-treated only when neutrophils recover to a level ≥1,500/mm3 (see section 4.3). 
Zdravljenje bolnikov znova začnite, šele ko se število nevtrofilcev poveča na ≥ 1500/mm3 (glejte poglavje 4.3).
Patients had to have neutrophils >1,500/mm3, platelets >100,000/mm3, haemoglobin >10 g/dl, creatinine <1.5 x ULN, total bilirubin <1 x ULN, AST and ALT <1.5 x ULN. 
Bolniki so morali imeti število nevtrofilcev > 1.500/mm3 in trombocitov > 100.000/mm3, hemoglobin > 10 g/dl, kreatinin < 1,5-kratno ZNM, celotni bilirubin < 1-kratno ZNM ter AST in ALT < 1,5-kratno ZNM.
As an example, a dose of 45 mg JEVTANA would require 4.5 ml of the concentrate-solvent mixture prepared following Step 1. 
Primer: odmerek 45 mg zdravila JEVTANA bi zahteval 4,5 ml mešanice koncentrata in vehikla, pripravljene v koraku 1.
Caution is advised with treatment of patients most at risk of developing gastrointestinal complications: those with neutropenia, the elderly, concomitant use of NSAIDs, anti-platelet therapy or anti-coagulants, and patients with a prior history of pelvic radiotherapy or gastrointestinal disease, such as ulceration and GI bleeding. 
Previdnost je potrebna pri zdravljenju bolnikov, ki jih najbolj ogrožajo zapleti na prebavilih: pri bolnikih z nevtropenijo, starejših, med sočasno uporabo NSAID, antiagregacijskih zdravil ali antikoagulantov ter pri bolnikih z anamnezo obsevanja v predelu medenice ali anamnezo bolezni prebavil, npr. razjed in krvavitev v prebavilih.