FrancophonIA/ELRC3.0 huggingface dataset:
English: The capsules must be swallowed whole with a glass of water and must not be opened or chewed.
Slovenian: Kapsule je treba pogoltniti cele s kozarcem vode in se jih ne sme odpirati ali žvečiti.
English: The major route of 14C elimination is renal.
Slovenian: Glavna pot izločanja 14C je skozi ledvice.
English: Opportunistic infections, including PCP
Slovenian: oportunistične infekcije, vključno s PCP
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
English: The reduction of blood cells is usually temporary, but in some cases may be for longer and may lead to a very severe form of anaemia (aplastic anaemia).
Slovenian: Zmanjšanje števila krvnih celic je ponavadi začasno, vendar pa lahko v nekaterih primerih traja dlje in pripelje do hude oblike anemije (aplastična anemija).
English: Dose during Cycle 1
Slovenian: Odmerek med 1. ciklom
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Accord should be administered without food.
Slovenian: Ker ni mogoče izključiti možnosti, da je sprememba Cmax klinično pomembna, je treba zdravilo Temozolomid Accord jemati brez hrane.
English: • palpitations (abnormal heart beats)
Slovenian: • palpitacije (nenormalni srčni utripi)
English: Dose during Cycles 2-6 in absence of toxicity Table 3.
Slovenian: Odmerek med cikli 2-6 v odsotnosti toksičnosti Preglednica 3.
English: • discolouration of your tongue
Slovenian: • razbarvanost jezika
English: Administration of TMZ with food resulted in a 33 % decrease in Cmax and a 9 % decrease in area under the curve (AUC).
Slovenian: Jemanje TMZ s hrano je povzročilo 33 % zmanjšanje Cmax in 9 % zmanjšanje površine pod krivuljo (AUC).
English: TMZ demonstrates low protein binding (10% to 20%), and thus it is not expected to interact with highly protein-bound substances.
Slovenian: TMZ izkazuje majhno stopnjo vezave na beljakovine (10 % do 20 %), zato medsebojnega delovanja z učinkovinami, ki se v veliki meri vežejo na beljakovine, ni pričakovati.
English: Your doctor will decide whether any change in your treatment is needed.
Slovenian: Vaš zdravnik bo določil, ali je potrebna kakšna sprememba vašega zdravljenja.
English: Swallow the capsule(s) whole with a glass of water.
Slovenian: Kapsulo (kapsule) pogoltnite celo (cele) s kozarcem vode.
English: Symptoms of diabetes insipidus include passing a lot of urine and feeling thirsty.
Slovenian: Simptomi diabetesa insipidusa vključujejo izločanje večje količine urina in občutek žeje.
English: • changes in blood cells,
Slovenian: • spremembe krvnih celic,
English: Then there may be up to 6 treatment cycles, and each one lasts 28 days.
Slovenian: Nato lahko sledi še do 6 ciklov zdravljenja, vsak pa traja 28 dni.
English: The lowest recommended dose is 100 mg/m2.
Slovenian: Najmanjši priporočen odmerek je 100 mg/m2.
English: Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2.
Slovenian: Stopnje odmerkov vključujejo 100 mg/m2, 150 mg/m2, in 200 mg/m2.
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1-2 weeks.
Slovenian: Mielosupresija je bila predvidljiva (navadno v prvih nekaj ciklih in je bila najizrazitejša med 21. in 28. dnevom), okrevanje pa je bilo hitro, običajno v enem do dveh tednih.
English: If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Slovenian: Če se odmerek ne poveča v 2. ciklu, se ga ne sme povečati niti v naslednjih ciklih.
English: You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Slovenian: Ta odmerek boste jemali 42 dni (do 49 dni) vsak dan v kombinaciji z radioterapijo.
English: In some cases, it may be necessary to stop treatment with temozolomide.
Slovenian: Možno je, da bo v nekaterih primerih treba prekiniti zdravljenje s temozolomidom.
English: If lymphopenia occurs, they are to continue the prophylaxis until recovery of lymphopenia to grade ≤1.
Slovenian: Če nastopi limfopenija, morajo nadaljevati s profilakso, dokler se limfopenija ne povrne na stopnjo ≤ 1.
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population)
Slovenian: Slika 1 Kaplan-Meierjeve krivulje skupnega preživetja (populacija, ki naj bi jo zdravili)
English: Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m2 per cycle both in children and in adults.
Slovenian: Pediatrični bolniki so imeli večji AUC kot odrasli bolniki, vendar je bil največji odmerek, ki so ga bolniki še prenašali (MTD - »maximum tolerated dose«) 1.000 mg/m2 na cikel pri otrocih in odraslih.
English: TMZ is more toxic to the rat and dog than to humans, and the clinical dose approximates the minimum lethal dose in rats and dogs.
Slovenian: TMZ je bolj toksičen za podgane in pse kot ljudi, klinični odmerek pa je približno enak minimalnemu letalnemu odmerku za podgane in pse.
English: • change in your sense of smell
Slovenian: • spremembe občutka za vonj
English: Your doctor will decide the correct dose of temozolomide for you to take, based on your size (height and weight) and whether you have had chemotherapy treatment.
Slovenian: Vaš zdravnik bo določil ustrezen odmerek temozolomida, ki ga boste jemali glede na vašo velikost (višino in telesno maso) in na osnovi tega, ali ste že imeli kemoterapijo.
English: Opportunistic infections and reactivation of infections
Slovenian: Oportunistične okužbe in reaktivacija okužb
English: The carton contains one bottle.
Slovenian: Škatla vsebuje eno stekleničko.
English: Each time you start a new treatment cycle, be sure you understand exactly how many capsules of each strength you need to take each day and how many days you will receive this dose.
Slovenian: Vsakič, ko začnete nov cikel zdravljenja, se prepričajte, da res veste, koliko kapsul kakšne jakosti morate vzeti vsak dan in koliko časa morate jemati ta odmerek.
English: If Temozolomide Accord comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Slovenian: Če pride zdravilo Temozolomid Accord v stik s kožo ali sluznico, je treba takoj in temeljito izprati z milom in vodo.
English: However, because the doses implicated in retinal degeneration were in the lethal dose range, and no comparable effect has been observed in clinical studies, this finding was not considered to have clinical relevance.
Slovenian: Ker pa so bili odmerki, pri katerih je prišlo do degeneracije mrežnice v območju letalnih odmerkov in ker v kliničnih študijah ni bilo primerljivih učinkov, se ta podatek ne smatra kot klinično pomemben.
English: • pain with urination
Slovenian: • bolečine pri uriniranju
English: - you may have a small risk of other changes in blood cells, including leukaemia.
Slovenian: - Obstaja tudi majhno tveganje za druge spremembe krvnih celic, vključno z levkemijo.
English: Ask your doctor or pharmacist to write down the number of each strength (including colour) that you need to take each dosing day.
Slovenian: Prosite svojega zdravnika ali farmacevta, da vam napiše število kapsul vsake jakosti (in pripiše tudi njihovo barvo), ki jih morate vzeti vsak dan jemanja zdravila.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Slovenian: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND OF CHILDREN
English: CTC Grade 4b a : TMZ dose levels are listed in Table 2. b : TMZ is to be discontinued if:
Slovenian: SMT stopnje 4b a : Stopnje odmerka TMZ so navedene v preglednici 2. b : Jemanje TMZ je treba prenehati, če:
English: Post-marketing experience
Slovenian: Postmarketinške izkušnje:
English: If you vomit frequently before or during treatment, ask your doctor about medicines to help prevent vomiting or control the vomiting and the best time to take temozolomide until the vomiting is under control.
Slovenian: Če pogosto bruhate pred ali po zdravljenju, svojega zdravnika povprašajte o zdravilih, ki pomagajo preprečiti ali omejiti bruhanje, in o najboljšem času za jemanje temozolomida, dokler bruhanje ni pod nadzorom.
English: During treatment a complete blood count should be obtained weekly.
Slovenian: Med zdravljenjem je treba vsak teden preveriti celotno krvno sliko.
English: There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Slovenian: Možno je, da je pojavnost PCP večja takrat, ko se TMZ uporablja v daljšem režimu odmerjanja.
English: In the tables, undesirable effects are classified according to System Organ Class and frequency.
Slovenian: V preglednicah so neželeni učinki razvrščeni po organskih sistemih in pogostnosti.
English: See footnote b
Slovenian: Glejte opombo b
English: The presence of thrombocytopenia may increase the risk of bleeding, and the presence of neutropenia or leukopenia may increase the risk of infection.
Slovenian: Prisotnost trombocitopenije lahko poveča tveganje za krvavitev, prisotnost nevtropenije ali levkopenije pa lahko poveča tveganje za okužbo.
English: In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43%) and vomiting (36%).
Slovenian: V kliničnih preskušanjih so bili najpogostejši z zdravljenjem povezani neželeni učinki prebavne motnje, še posebej navzea (43 %) in bruhanje (36 %).
English: The capsules contain lactose (a kind of sugar).
Slovenian: Kapsule vsebujejo majhno količino laktoze (vrsta sladkorja).
English: - if you have liver or kidney problems as your dose of temozolomide may need to be adjusted.
Slovenian: - Če imate težave z jetri ali ledvicami, ker bo morda treba prilagoditi vaš odmerek temozolomida.
English: • partial loss of vision, dry or painful eyes
Slovenian: • delna izguba vida, suhe ali boleče oči
English: If you are taking Temozolomide Accord capsules alone (without radiotherapy):
Slovenian: Če jemljete kapsule zdravila Temozolomid Accord same (brez radioterapije):
English: PHARMACEUTICAL FORM Hard capsule.
Slovenian: FARMACEVTSKA OBLIKA trde kapsule
English: In preclinical studies in rats and rabbits receiving 150 mg/m2, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Slovenian: V predkliničnih študijah pri podganah in kuncih, ki so prejemali 150 mg/m2, sta bili ugotovljeni teratogenost in/ali toksičnost za plod (glejte poglavje 5.3).
English: Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Slovenian: Rezultati testa po Ames/Salmonella in testa kromosomskih aberacij v človeških limfocitih iz periferne krvi (HPBL - »Human Peripheral Blood Lymphocyte«) so pokazali pozitiven mutageni odziv.
English: However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
Slovenian: Vseeno pa je treba vse bolnike, ki prejemajo TMZ, še posebej tiste, ki prejemajo tudi steroide, skrbno spremljati zaradi možnosti pojava PCP ne glede na režim zdravljenja.
English: These reactions were usually Grade 1 or 2 (0 - 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Slovenian: Ti učinki so bili navadno stopnje 1 ali 2 (0-5 epizod bruhanja v 24 urah) in so izzveneli sami od sebe ali pa jih je bilo mogoče zlahka nadzorovati s standardnim antiemetičnim zdravljenjem.
English: Before each new treatment cycle, your blood will be tested to see if the temozolomide dose needs to be adjusted.
Slovenian: Pred začetkom vsakega cikla zdravljenja boste opravili preiskave krvi, da bi ugotovili ali je treba prilagoditi vaš odmerek temozolomida.
English: Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed.
Slovenian: Vaš zdravnik bo redno preverjal vašo kri in zaradi morebitnih sprememb ter odločil, ali je potrebno kakšno posebno zdravljenje.
English: A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
Slovenian: Skupno 573 bolnikov je bilo randomiziranih v skupini, ki sta prejemali TMZ + RT (n=287) ali samo RT (n=286).
English: Male patients should use effective contraception and not father a child for up to 6 months after stopping treatment.
Slovenian: Moški bolniki morajo uporabljati učinkovito kontracepcijsko metodo in ne smejo spočeti otroka vsaj 6 mesecev po končanem zdravljenju.
English: - Be sure you know exactly which days are your dosing days.
Slovenian: - Prepričajte se, da res veste, katere dneve morate jemati odmerek.
English: nausea and vomiting).
Slovenian: slabosti in bruhanja).
English: However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (see section 5.2).
Slovenian: Ker se TMZ ne presnavlja v jetrih in izkazuje majhen obseg vezave na beljakovine, je malo verjetno, da bi vplival na farmakokinetiko drugih zdravil (glejte poglavje 5.2).
English: • Abnormal liver function tests,
Slovenian: • nenormalni rezultati testov jetrne funkcije
English: If you take more Temozolomide Accord than you should If you accidentally take more capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Temozolomid Accord, kot bi smeli Če po nesreči vzamete več kapsul, kot vam je bilo predpisano, se takoj posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: Sometimes the dose or the mix of capsules you need to take will be different from the last cycle.
Slovenian: Včasih se bo odmerek oziroma kombinacija kapsul razlikovala od tiste, ki ste jo jemali v prejšnjem ciklu zdravljenja.
English: A treatment cycle comprises 28 days.
Slovenian: Cikel zdravljenja traja 28 dni.
English: • peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating
Slovenian: • luščenje kože, povečana občutljivost kože za sončno svetlobo, spremembe barve kože, povečano znojenje
English: If you are taking Temozolomide Accord in combination with radiotherapy (newly diagnosed patients):
Slovenian: Če jemljete zdravilo Temozolomid Accord v kombinaciji z radioterapijo (na novo diagnosticirani bolniki):
English: Special populations Paediatric population
Slovenian: Posebne populacije Pediatrična populacija
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: PRILOGA 1 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: What you need to know before you take Temozolomide Accord
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid Accord
English: • frequent urination, difficulty with holding your urine or urine leakage
Slovenian: • pogosto uriniranje, težave z zadrževanjem urina ali uhajanje urina
English: The following side effects may occur if you are taking only temozolomide (patients treated for brain tumours that have come back or that have spread)
Slovenian: Naslednji neželeni učinki se lahko pojavijo, če jemljete samo temozolomid (bolniki, ki se zdravijo zaradi možganskih tumorjev, ki so se ponovno pojavili ali pa so se razširili).
English: Each carton contains 5 or 20 sachets.
Slovenian: Škatla vsebuje 5 ali 20 vrečk.
English: What Temozolomide Accord is and what it is used for What you need to know before you take Temozolomide Accord How to take Temozolomide Accord Possible side effects
Slovenian: Kaj je zdravilo Temozolomid Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid Accord Kako jemati zdravilo Temozolomid Accord Možni neželeni učinki
English: Patients usually present with shortness of breath and cough.
Slovenian: Bolniki ponavadi razvijejo kratko sapo in kašelj.
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01A X03
Slovenian: Farmakoterapevtska skupina: Antineoplastična zdravila - Drugi alkilirajoči citostatiki, oznaka ATC: L01A X03
English: What Temozolomide Accord is and what it is used for
Slovenian: Kaj je zdravilo Temozolomid Accord in za kaj ga uporabljamo
English: Rats appear to be particularly sensitive to oncogenic effects of TMZ, with the occurrence of first tumours within 3 months of initiating dosing.
Slovenian: Zdi se, da so podgane posebej občutljive na onkogene učinke TMZ, prvi tumorji pa se pojavijo v 3 mesecih po začetku odmerjanja.
English: In some cases, your temozolomide dose will be reduced or discontinued.
Slovenian: V nekaterih primerih je treba zmanjšati ali ukiniti odmerek temozolomida.
English: Older patients are more prone to infections, increased bruising or bleeding.
Slovenian: Starejši bolniki so bolj dovzetni za okužbe, tvorbo modric ali pojav krvavitev.
English: Temozolomide Accord may cause permanent infertility.
Slovenian: Zdravilo Temozolomid Accord lahko povzroči trajno neplodnost.
English: This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and/or a reduced resistance to infections.
Slovenian: To lahko poveča nagnjenost k nastanku modric, anemije (pomanjkanja rdečih krvnih celic), vročine in/ali manjše odpornosti na okužbe.
English: Store in the original bottle.
Slovenian: Shranjujte v originalni steklenici.
English: For all patients, liver function tests should be checked after each treatment cycle.
Slovenian: Pri vseh bolnikih je treba funkcijske preiskave delovanja jeter opraviti po vsakem ciklu zdravljenja.
English: Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
Slovenian: Sočasno jemanje z valproično kislino je bilo povezano z majhnim, a statistično pomembnim zmanjšanjem očistka TMZ.
English: In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
Slovenian: V nekaterih primerih izpostavljenost sočasno jemanim zdravilom, ki jih povezujejo z aplastično anemijo, vključno s karbamezapinom, fenitoinom in sulfametoksazolom/trimetoprimom, otežuje oceno.
English: Dose-limiting toxicity was haematological and was reported with any dose but is expected to be more severe at higher doses.
Slovenian: Toksični učinki za omejitev odmerka so bili hematološki in so jih poročali pri vseh odmerkih, vendar je pričakovati, da bo toksičnost izrazitejša pri večjih odmerkih.
English: Very rarely, patients taking temozolomide and medicines like it may have a small risk of other changes in blood cells, including leukaemia.
Slovenian: Bolniki, ki jemljejo temozolomid in podobna zdravila, zelo redko razvijejo manjše tveganje za druge spremembe krvnih celic, vključno z levkemijo.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V*
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
Slovenian: Jemanje odmerkov TMZ se lahko nadaljuje ves čas 42-dnevnega obdobja sočasnega zdravljenja (do 49 dni), če so izpolnjeni vsi od naslednjih pogojev:
English: Temozolomide Accord should not be administered to pregnant women.
Slovenian: Zdravila Temozolomid Accord se ne sme dajati nosečim ženskam.
English: Your doctor may need to reduce the dose of your medicine or interrupt your treatment, or you may need other treatment.
Slovenian: Vaš zdravnik bo moral morda zmanjšati odmerek vašega zdravila ali prekiniti zdravljenje oziroma ga spremeniti.
English: Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Slovenian: Bolniki, pri katerih je v prejšnjih ciklih zdravljenja prišlo do hudega bruhanja (stopnja 3 ali 4), je potrebno antiemetično zdravljenje.
English: It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
Slovenian: Ni znano ali se TMZ izloča v materino mleko, zato je treba med zdravljenjem s TMZ prenehati z dojenjem.
English: Each sachet contains 1 hard capsule.
Slovenian: Vsaka vrečka vsebuje 1 trdo kapsulo.
English: Tolerance to TMZ is similar to adults.
Slovenian: TMZ so bolniki prenašali podobno kot odrasli.
English: No evidence of cumulative myelosuppression was observed.
Slovenian: Dokazov kumulativne mielosupresije niso opazili.
English: Polyester/aluminium/polyethylene (PET/alu/PE) sachet.
Slovenian: Vrečka iz poliestra/aluminija/polietilena (PET/alu/PE).
English: Temozolomide is an anti-cancer medicine.
Slovenian: Temozolomid je zdravilo za zdravljenje raka..
English: Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Slovenian: Zdravnik bo na osnovi rezultatov krvnih preiskav morda prilagodil vaš odmerek za naslednji cikel.
English: Frequency groupings are defined according to the following convention: Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Slovenian: Pogostnostne skupine so opredeljene po naslednjem načelu: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 to <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
English: There is limited information in patients over 3 years of age who have taken Temozolomide Accord.
Slovenian: Število podatkov pri bolnikih, starejših od 3 let, ki so jemali zdravilo Temozolomid Accord, je omejeno.
English: For patients with significant liver function abnormalities, physicians should assess the benefit/risk of continuing treatment.
Slovenian: Pri bolnikih s signifikantno nenormalnimi rezultati funkcijski preiskav delovanja jeter morajo zdravniki oceniti razmerje med koristnostjo zdravljenja in tveganjem, povezanim z nadaljevanjem zdravljenja.
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4% and 23%, respectively.
Slovenian: za TMZ je izpostavljenost MTIC in AIC ~ 2,4 % oziroma 23 %.
English: Patients will be carefully checked by their doctor for signs of this infection before treatment.
Slovenian: Pred začetkom zdravljenja bo zdravnik bolnike skrbno pregledal glede znakov te okužbe.
English: Following oral administration, approximately 5% to 10% of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4carboxamide (AIC) or unidentified polar metabolites.
Slovenian: Po peroralni uporabi se v 24 urah v nespremenjeni obliki v urin izloči približno 5 % do 10 % odmerka, preostanek pa se izloči kot temozolomidna kislina, 5-aminoimidazol-4-karboksamid (AIC) ali nedoločeni polarni presnovki.
English: Plasma concentrations increase in a dose-related manner.
Slovenian: Plazemske koncentracije se povečajo v odvisnosti od povečanja odmerka.
English: Use of TMZ in combination with other myelosuppressive agents may increase the likelihood of myelosuppression.
Slovenian: Uporaba TMZ v kombinaciji z drugimi mielosupresivnimi učinkovinami lahko poveča verjetnost pojava mielosupresije.
English: In the non-comparative trial, the PFS at 6 months was 19%, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
Slovenian: V neprimerjalnem preskušanju je bil PFS po 6 mesecih 19 %, mediana vrednost PFS 2,1 meseca in mediana vrednost celotnega preživetja 5,4 mesecev.
English: Anti-emetic therapy may be administered (see section 4.4).
Slovenian: Lahko se predpiše tudi antiemetično zdravljenje (glejte poglavje 4.4).
English: Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
Slovenian: Zdi se, da je pri starejših bolnikih tveganje za pojav nevtropenije in trombocitopenije večje, kot pri mlajših bolnikih.