natgillin/translations-raw huggingface dataset:
The PRAC concluded that the risk-benefit balance of flupirtine containing medicinal product(s) in the treatment of acute pain remains favourable subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and additional risk minimisation measures agreed.
PRAC je zaključil, da je razmerje med tveganji in koristmi zdravil(a) z vsebnostjo flupirtina pri zdravljenju akutnih bolečin še vedno pozitivno, če se upoštevajo dogovorjene omejitve, opozorila, druge spremembe informacij o zdravilu, dodatne dejavnosti farmakovigilance in dodatni ukrepi za zmanjšanje tveganja.
In addition, treatment with flupirtine is not recommended in patients with pre-existing liver disease or taken concomitantly other medication known to cause drug liver injury.
Poleg tega zdravljenje s flupirtinom ni priporočljivo pri bolnikih z že obstoječo boleznijo jeter ali bolnikih, ki sočasno uporabljajo druga zdravila, ki povzročajo okvare jeter.
In view of this and of the very limited efficacy of flupirtine in the management of chronic pain, PRAC concluded that the benefit-risk balance of flupirtine containing medicinal products in the management of chronic pain was no longer favourable.
Zaradi tega dejstva in zelo omejene učinkovitosti flupirtina pri obvladovanju kroničnih bolečin je PRAC zaključil, da razmerje med tveganji in koristmi za zdravila, ki vsebujejo flupirtin, pri obvladovanju kroničnih bolečin ni več pozitivno.
• The PRAC considered that flupirtine containing medicinal products only show very limited efficacy in the management of chronic pain.
• PRAC je menil, da je učinkovitost zdravil, ki vsebujejo flupirtin, pri obvladovanju kroničnih bolečin zelo omejena.
The protocol of drug utilisation study in order to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription should be also be submitted as part of the RMP.
V okviru RMP je treba predložiti tudi protokol študije uporabe zdravila, s katero bi razjasnili prakse pri predpisovanju teh zdravil med običajno klinično uporabo pri reprezentativni skupini zdravstvenih delavcev, ki predpisujejo ta zdravila, in opredelili glavne razloge za predpisovanje.
In addition, treatment with flupirtine is contraindicated in patients with pre-existing liver disease or taken concomitantly other medication known to cause drug liver injury.
Poleg tega je zdravljenje s flupirtinom kontraindicirano pri bolnikih z že obstoječo boleznijo jeter in bolnikih, ki sočasno uporabljajo druga zdravila, ki povzročajo okvare jeter.
The PRAC reviewed the data submitted by the marketing authorisation holders and other stakeholders from clinical and non-clinical studies, epidemiological studies, spontaneous reports and published literature.
Odbor PRAC je pregledal podatke iz kliničnih in predkliničnih študij, epidemioloških študij, spontanih poročil in objavljene literature, ki so jih predložili imetniki dovoljenj za promet z zdravili in druge zainteresirane strani.
Overall, the duration of treatment is recommended to be established individually by the prescriber.
Največji dnevni odmerek ne sme preseči 600 mg. Na splošno je priporočljivo, da trajanje zdravljenja določi zdravnik, ki bo predpisal zdravilo, za vsakega bolnika posebej.
With regards to the management of chronic pain PRAC concluded that the benefit-risk in this indication is no longer favourable.
Glede razmerja med tveganji in koristmi pri obvladovanju kroničnih bolečin je PRAC zaključil, da razmerje pri tej indikaciji ni več pozitivno.
A total of 570 serious (421) and non-serious (149) flupirtine hepatic case reports have been reported up to 28 March 2013, accordingly to the market leader MAH's safety database.
Glede na bazo podatkov o varnosti imetnika dovoljenja za promet z zdravilom, ki je vodilni na trgu, so do 28. marca 2013 poročali o skupno 570 primerih bolezni jeter, povezanih s flupirtinom, med katerimi je bilo 421 resnih in 149 takih, ki niso bili resni.
Therefore, the PRAC considered that flupirtine containing medicinal products only show very limited efficacy in the management of chronic pain.
Zato je odbor menil, da je učinkovitost zdravil, ki vsebujejo flupirtin, pri obvladovanju kroničnih bolečin zelo omejena.
In order to ensure a favourable benefit/risk in this indication, PRAC concluded that treatment should be restricted to a maximum of 2 weeks.
PRAC je zaključil, da je treba za zagotovitev pozitivnega razmerja med tveganji in koristmi pri tej indikaciji zdravljenje omejiti na največ 2 tedna.
c. the marketing authorisations should be varied.
b. naj imetniki dovoljenj za promet z zdravili izvajajo ukrepe za zmanjšanje tveganja;
Do not use <Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Ne uporabljajte zdravila <ime zdravila>, če: - imate že obstoječo bolezen jeter;
The PRAC in accordance with Article 107j(3) of Directive 2001/83/EC, recommended by a majority that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study, as well as a drug utilisation study (see Annex IV - Conditions of marketing Authorisations); b. the marketing authorisation holders should implement risk minimisation measures; c. the marketing authorisations of flupirtine containing medicinal products (see Annex I) should be varied (in accordance with changes to the product information as set out in Annex III).
a. naj imetniki dovoljenj za promet z zdravili sponzorirajo študijo varnosti zdravila v obdobju trženja in nadaljnje vrednotenje rezultatov študije ter tudi študijo uporabe zdravila (glejte Prilogo IV - Pogoji dovoljenj za promet z zdravili);
Supportive measures should be provided as necessary.
Po potrebi se uvedejo podporni ukrepi.
You may also need other treatments.
Morda boste potrebovali tudi druga zdravila.
However, no unacceptable risks appear to be present in this patient group.
Vendar ne kaže, da bi bilo v tej skupini bolnikov prisotno kakršnokoli nesprejemljivo tveganje.
Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Kapsule vzemite na prazen želodec, na primer vsaj eno uro, preden nameravate zajtrkovati.
• which days are your dosing days.
• kateri dnevi so dnevi odmerjanja.
In 43 patients stable disease was reported.
Pri 43 bolnikih so poročali o stabilni bolezni.
• how many capsules you need to take every dosing day.
• koliko kapsul morate vzeti vsak dan odmerjanja.
Elderly patients (> 70 years of age)
Starejši bolniki (nad 70 let)
Each one lasts 28 days.
Vsako bo trajalo 28 dni.
After Day 28, the next cycle will begin.
Po 28. dnevu se bo začel nov cikel.
This latency period is very short even for an alkylating agent.
Ta latentna doba je zelo kratka celo za alkilirajočo učinkovino.
Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to do so.
Ne vzemite dvojnega odmerka, da bi nadomestili pozabljenega, razen če vam tako naroči zdravnik.
Achieving a radiological objective response or maintaining progression-free status was strongly associated with maintained or improved quality of life.
Dosega radiološko objektivnega odziva ali vzdrževanje stanja brez napredovanja bolezni sta bila močno povezana z ohranjeno ali izboljšano kakovostjo življenja.
In the event of an overdose, haematological evaluation is needed.
V primeru prevelikega odmerka je potrebna hematološka preiskava.
Ask your doctor or pharmacist to write it down (including the colour).
Prosite zdravnika ali farmacevta, da vam to napiše (vključno z barvo kapsul);
For the eligible histology population, the efficacy results were similar.
V populaciji, primerni za histološko preiskavo, so bili rezultati učinkovitosti podobni.
Median overall survival was 14.6 months.
Srednje skupno preživetje je bilo 14,6 meseca.
Your doctor will work out your exact dose.
Zdravnik vam bo izračunal natančni odmerek.
Keep the bottle tightly closed in order to protect from moisture.
Steklenička mora biti dobro zaprta za zagotovitev zaščite pred vlago.
During treatment a complete blood count should be obtained weekly.
Med zdravljenjem je treba vsak teden narediti celotno krvno sliko.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake “EXP”.
Tolerance to TMZ is similar to adults.
Toleranca za TMZ je bila podobna kot pri odraslih.
TMZ demonstrates low protein binding (10% to 20%), and thus it is not expected to interact with highly protein-bound substances.
TMZ se veže na beljakovine v majhni meri (10 do 20 %), zato ni pričakovati medsebojnega delovanja s snovmi, ki se obsežno vežejo na beljakovine.
Haupt Pharma Amareg GmbH Donaustaufer Straβe 378 93055 Regensburg Germany
Haupt Pharma Amareg GmbH Donaustaufer Straβe 378 93055 Regensburg Nemčija
The half-life (t1/2) in plasma is approximately 1.8 hours.
Izločanje Razpolovni čas (t1/2) v plazmi je približno 1,8 ure.
- if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na temozolomid ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
- if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
- če ste kdaj imeli alergijsko reakcijo na dakarbazin (zdravilo proti raku, ki ga včasih imenujemo
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.
TMZ je bolj toksičen za podgane in pse kot za ljudi; klinični odmerek približno ustreza najmanjšemu smrtnemu odmerku za podgane in pse.
Administration of TMZ with food resulted in a 33% decrease in Cmax and a 9% decrease in area under the curve (AUC).
Vnos TMZ s hrano je povzročil 33 odstotno zmanjšanje vrednosti Cmax in 9 odstotno zmanjšanje površine pod krivuljo (AUC).
Temozolomide Teva treatment can cause a reduction in certain kinds of blood cells.
Uporaba zdravila Temozolomide Teva lahko povzroči zmanjšanje števila nekaterih vrst krvnih celic.
TMZ dose levels are listed in Table 2.
Ravni odmerkov TMZ so navedene v razpredelnici 2.
If a full day has gone by, check with your doctor.
Če je pretekel ves dan, se posvetujte z zdravnikom.
There are no data in pregnant women.
O uporabi zdravila pri nosečnicah ni podatkov.
The incidence of severe nausea and vomiting was 4%.
Incidenca hude navzeje in bruhanja je bila 4-odstotna.
The following side effects may occur, and may require medical attention.
Lahko se pojavijo naslednji neželeni učinki, zaradi katerih boste morda potrebovali zdravniško pomoč.
Errors in how you take this medicine may have serious health consequences.
Če se pri jemanju zdravila zmotite, s tem tvegate hude zdravstvene posledice.
In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).
Če zdravilo tako vpliva na vas, ne smete voziti in uporabljati orodij ali strojev ali se voziti s kolesom, dokler ne ugotovite, kako to zdravilo vpliva na vas (glejte poglavje 4).
The presence of thrombocytopenia may increase the risk of bleeding, and the presence of neutropenia or leukopenia may increase the risk of infection.
Prisotnost trombocitopenije lahko poveča tveganje za krvavitve, medtem ko lahko prisotnost nevtropenije ali levkopenije poveča tveganje za okužbo.
Colour/marking
jakost barva/oznake
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.
Mielosupresija je bila predvidljiva (ponavadi v prvih nekaj ciklih zdravljenja, z najnižjimi vrednostmi med 21. in 28. dnem), okrevanje pa hitro, ponavadi v enem do dveh tednih.
Rats appear to be particularly sensitive to oncogenic effects of TMZ, with the occurrence of first tumours within 3 months of initiating dosing.
Kaže, da so podgane še posebej občutljive za onkogene učinke TMZ - prvi tumorji se pojavijo v treh mesecih po začetku odmerjanja.
This is bedcause you must not be treated with Temozolomide Teva during pregnancy unless clearly indicated by your doctor.
To morate storiti zato, ker se med nosečnostjo ne smete zdraviti z zdravilom Temozolomide Teva, razen če vam je to izrecno predpisal vaš zdravnik.
TMZ + concomitant RT n=288*
TMZ + sočasno obsevanje n = 288*
Therefore, special care should be taken when TMZ is administered in elderly patients.
Zato je potrebna posebna previdnost, kadar se TMZ daje starejšim bolnikom.
Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
Sočasno uporabo z valprojsko kislino so povezali z majhnim, vendar statistično pomembnim zmanjšanjem očistka TMZ.
You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Ta odmerek boste jemali 42 dni (do 49 dni) vsak dan, v kombinaciji z obsevanjem.
In very rare cases, patients taking Temozolomide Teva and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Pri zelo redkih bolnikih, ki uporabljajo Temozolomide Teva in podobna zdravila, obstaja majhno tveganje za razvoj sekundarnega raka, tudi levkemije.
The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Menijo, da je citotoksičnost MTIC predvsem posledica alkilacije DNA, v glavnem na položajih gvanina O6 in N7.
Recurrent anaplastic astrocytoma
Ponavljajoč se anaplastični astrocitom
TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see sections 4.8).
TMZ ima blag vpliv na sposobnost vožnje in upravljanja s stroji zaradi utrujenosti in zaspanosti (glejte poglavje 4.8).
If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Če se odmerek ni povečal v drugem ciklu, se ne sme niti v naslednjih.
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).
Vendar, ker se TMZ ne presnavlja v jetrih in ker se v majhni meri veže na beljakovine, ni verjetno, da bi vplival na farmakokinetiko drugih zdravil (glejte poglavje 5.2).
A treatment cycle with Temozolomide Teva lasts 28 days.
Cikel zdravljenja z zdravilom Temozolomide Teva obsega 28 dni.
There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
PCP je lahko pogostejša, če se TMZ uporablja v daljšem režimu odmerjanja.
Dose levels include 100 mg/m², 150 mg/m², and 200 mg/m².
Ravni odmerkov vključujejo 100 mg/m², 150 mg/m² in 200 mg/m².
Most of the toxicity showed evidence of reversibility, except for adverse events on the male reproductive system and retinal degeneration.
Za večino toksičnih učinkov so našli dokaze o reverzibilnosti, razen za neželene učinke na moške razmnoževalne organe in za degeneracijo mrežnice.
If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Če je treba pretehtati možnost uporabe med nosečnostjo, mora biti bolnica seznanjena z morebitnim tveganjem za plod.
Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5); the frequency of grade 3-4 laboratory findings is presented after each table.
O večini hematoloških neželenih učinkov so poročali pogosto ali zelo pogosto pri obeh indikacijah (razpredelnici 4 in 5); pogostost rezultatov laboratorijskih preiskav stopnje 3 do 4 je predstavljena pod vsako razpredelnico.
Plasma concentrations increase in a dose-related manner.
Koncentracije v plazmi se višajo sorazmerno z odmerkom.
Doserelated reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
Kaže, da so z odmerkom povezana zmanjšanja levkocitov in trombocitov občutljivi pokazatelji toksičnosti.
Warnings and precations
Opozorila in previdnostni ukrepi
Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg).
Odvisno od predpisanega odmerka boste morda morali vzeti več kapsul naenkrat, lahko v različnih jakostih (vsebnost zdravilne učinkovine v miligramih).
If you vomit after taking your dose, do not take a second dose on the same day.
Če bruhate po zaužitju odmerka, ne vzemite drugi odmerek istega dne;
As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Teva should be administered without food.
Ker ni mogoče izključiti, da je sprememba vrednosti Cmax klinično pomembna, je treba zdravilo
In preclinical studies in rats and rabbits receiving 150 mg/m² TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
V predkliničnih študijah na podganah in kuncih, ki so dobivali TMZ v odmerkih 150 mg/m², so ugotovili teratogenost in/ali fetalno toksičnost (glejte poglavje 5.3).
Plasma clearance, volume of distribution and half-life are independent of dose.
Plazemski očistek, volumen porazdelitve in razpolovni čas niso odvisni od odmerka.
Swallow the capsule(s) whole with a glass of water.
Pogoltnite cele kapsule in popijte kozarec vode.
Before each new treatment cycle, your blood will be tested to see if the Temozolomide Teva dose needs to be adjusted.
Pred vsakim novim ciklom zdravljenja bo zdravnik preveril vašo krvno sliko, da bi ugotovil, ali je treba odmerek zdravila Temozolomide Teva prilagoditi.
Temozolomide Teva is used in these tumours if they return or get worse after standard treatment.
Zdravilo Temozolomide Teva se uporablja za zdravljenje teh tumorjev, če se po standardnem zdravljenju ponovijo ali poslabšajo.
TMZ monotherapy n=224
Samostojno zdravljenje s TMZ n = 224
The hard capsules are dispensed in amber glass bottles containing 5 or 20 capsules.
Trde kapsule so na voljo v rjavih stekleničkah, ki vsebujejo po 5 ali 20 kapsul.
You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide Teva to prevent or control nausea and vomiting.
Morda boste dobili druga zdravila (antiemetike), ki jih boste vzeli pred zdravilom Temozolomide Teva oziroma po njem, za preprečevanje ali nadzor slabosti in bruhanja.
drug reaction with eosinophilia and systemic symptons (DRESS)
Neznani reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)
In the tables undesirable effects are classified according to System Organ Class and frequency.
Neželeni učinki so v razpredelnicah razvrščeni po organskih sistemih in pogostosti.
Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Na podlagi populacijske farmakokinetične analize pri bolnikih, starih med 19 in 78 let, starost ne vpliva na očistek TMZ.
Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100) ); Rare (≥1/10,000 to <1/1,000);
občasni (≥ 1/1.000 do < 1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000).
The colour and marking of the capsule is different for each strength (see table below).
Kapsule različnih jakosti se razlikujejo v barvi in oznakah (glejte spodnjo tabelo).
CSF penetration was confirmed in one patient; CSF exposure based on AUC of TMZ was approximately 30% of that in plasma, which is consistent with animal data.
Prodiranje v cerebrospinalno tekočino so potrdili pri enem bolniku; izpostavljenost cerebrospinalne tekočine na podlagi vrednosti AUC TMZ je bila približno 30 % izpostavljenosti plazme, kar ustreza podatkom, pridobljenim pri živalih.
Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed.
Zdravnik bo redno preverjal vašo krvno sliko, da bi odkril morebitne spremembe, in se bo odločil, ali potrebujete zdravljenje.
Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
Kaže, da so starejši bolniki v večji nevarnosti za nevtropenijo in trombocitopenijo v primerjavi z mlajšimi.
Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Rezultati Amesovega testa z bakterijami salmonella in testa kromosomskih aberacij s človeškimi perifernimi krvnimi limfociti (HPBL) so pokazali pozitiven mutageni odziv.
- as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
- ker vas mora zdravnik natančno opazovati, ali imate znake hude oblike okužbe pljuč, ki se imenuje pljučnica Pneumocystis jirovecii (PCP).
The 6-month event-free survival for the ITT population was 44% with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Šestmesečno preživetje brez dogodkov je bilo za populacijo z namenom zdravljenja 44-odstotno, s srednjim preživetjem brez dogodkov 4,6 meseca, kar je podobno rezultatom za preživetje brez napredovanja bolezni.
Use of TMZ in combination with other myelosuppressive agents may increase the likelihood of myelosuppression.
Uporaba TMZ v kombinaciji z drugimi mielosupresivnimi učinkovinami lahko poveča verjetnost za mielosupresijo.
Anti-emetic therapy may be administered (see section 4.4).
Lahko se uporabi antiemetično zdravljenje (glejte poglavje 4.4).
If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide Teva until the vomiting is under control.
Če pred zdravljenjem ali med njim pogosto bruhate, vprašajte zdravnika, kdaj je najbolje jemati zdravilo Temozolomide Teva, dokler se bruhanje ne umiri.
Allergic reactions, including anaphylaxis, angioedema
alergijske reakcije, vključno z anafilaksijo in angioedemom
If lymphopenia occurs, they are to continue the prophylaxis until recovery of lymphopenia to grade ≤ 1.
Če nastopi limfopenija, bolniki nadaljujejo profilakso, dokler se limfopenija ne popravi na stopnjo ≤ 1.
28 August 2014
28. januar 2010 Datum zadnjega podaljšanja: 28. avgust 2014
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o tem zdravilu so objavljene na spletnistrani Evropske agencije za zdravila http://www.ema.europa.eu.
In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46%.
V večcentričnem prospektivnem preskušanju faze II, v katerem so ocenili varnost in učinkovitost peroralnih odmerkov TMZ v zdravljenju bolnikov s prvim relapsom anaplastičnega astrocitoma, je bilo preživetje brez napredovanja bolezni po šestih mesecih 46-odstotno.
Very rare cases of severe rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed.
Opazili so zelo redke primere hudih izpuščajev z otekanjem kože, vključno z dlanmi in podplati, ali boleče in pordele kože in/ali mehurčkov na telesu ali v ustih.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.
Citotoksične lezije, ki se posledično razvijejo, so verjetno povezane z aberantnim popravilom metilnega adukta.
However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Vendar kaže, da je pri starejših bolnikih (starejših od 70 let) večje tveganje za nevtropenijo in trombocitopenijo (glejte poglavje 4.4).
Hypersensitivity to dacarbazine (DTIC).
Preobčutljivost za dakarbazin.