natgillin/translations-raw huggingface dataset:
• Pregnancy Prevention Programme information o Definition of women of childbearing potential and actions the prescriber should take if unsure o Information on what is effective contraception o Safety advice for women of childbearing potential
• Podatke programa za preprečevanje nosečnosti o opredelitev žensk v rodni dobi in ukrepov za zdravnika, ki zdravilo predpiše, v primeru dvoma o informacije o zanesljivi kontracepciji o varnostne nasvete za ženske v rodni dobi
• A brain condition with symptoms including vision changes, headache, seizures, and confusion, with or without high blood pressure (Posterior Reversible Encephalopathy Syndrome or PRES).
• bolezen možganov s simptomi, ki vključujejo spremembe vida, glavobol, epileptične napade in zmedenost, ki jih lahko spremlja visok krvni tlak (sindrom posteriorne reverzibilne encefalopatije oz. PRES).
Peripheral neuropathy is a very common, potentially severe, adverse reaction of treatment with thalidomide that may result in irreversible damage (see section 4.4).
Periferna nevropatija je zelo pogost, potencialno resen neželen učinek pri zdravljenju s talidomidom, ki lahko privede do nepopravljivih okvar (glejte poglavje 4.4).
• Indigestion, feeling sick (nausea), being sick (vomiting), dry mouth.
• prebavne težave, slabo počutje (navzea), občutek slabosti (bruhanje), suha usta,
Therefore, these agents should be used with caution in multiple myeloma patients receiving thalidomide with prednisone and melphalan.
Zato je treba ta zdravila pri bolnikih z diseminiranim plazmocitomom, ki prejemajo talidomid s prednizonom in melfalanom uporabljati previdno.
The most clinically important adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone or dexamethasone include: deep vein thrombosis and pulmonary embolism, peripheral neuropathy, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, syncope, bradycardia, and dizziness (see sections 4.2, 4.4 and 4.5).
Klinično najpomembnejši neželeni učinki, povezani z uporabo talidomida v kombinaciji z melfalanom in prednizonom ali deksametazonom, vključujejo: globoko vensko trombozo in pljučno embolijo, periferno nevropatijo, resne kožne reakcije, vključno s Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo, bradikardijo, sinkopo in vrtoglavico (glejte poglavja 4.2, 4.4 in 4.5).
What Thalidomide Celgene is and what it is used for
Kaj je zdravilo Thalidomide Celgene in za kaj ga uporabljamo
• Underactive thyroid (hypothyroidism).
• premalo aktivna ščitnica (hipotiroidizem),
• That if she needs to change or stop using her method of contraception she should inform: ▪ The physician prescribing her contraception that she is on thalidomide ▪ The physician prescribing thalidomide that she has stopped or changed her method of contraception
• opozorilo, da mora v primeru spremembe ali prenehanja uporabe kontracepcijske metode obvestiti: zdravnika, ki je predpisal kontracepcijo, da jemlje talidomid zdravnika, ki je predpisal talidomid, da je prenehala uporabljati ali spremenila kontracepcijsko metodo
The MAH should also agree with each Member State prior to the launch of the product:
Imetnik dovoljenja za promet z zdravilom se mora prav tako v vsaki državi članici pred prihodom zdravila na trg dogovoriti o:
Patients with renal or hepatic impairment
Bolniki z ledvično ali jetrno okvaro
WARNING: Thalidomide causes birth defects and foetal death.
OPOZORILO: Talidomid povzroča prirojene okvare in smrt zarodka.
If powder from thalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Če pride prašek s talidomidom v stik s kožo, morate kožo takoj in temeljito sprati z milom in vodo.
Physicians should carefully evaluate patients before and during treatment using standard cancer screening and institute treatment as indicated.
Zdravniki naj pred zdravljenjem in med njim s standardnimi pregledi bolnike skrbno ocenjujejo in uvedejo zdravljenje, kot je indicirano.
The MAH should agree the final text of the Dear Healthcare Professional letter and the contents of the Educational Healthcare Professional's Kit with the National Competent Authority in each Member State prior to launch of the medicinal product and ensure that the materials contain the key elements as described below.
Imetnik dovoljenja za promet z zdravilom se mora pred prihodom zdravila na trg s pristojnim nacionalnim organom v vsaki državi članici dogovoriti o končnem besedilu Neposrednega obvestila za zdravstvene delavce in vsebini paketa izobraževalnih gradiv za zdravstvene delavce in zagotoviti, da gradiva vsebujejo ključne elemente, kot je opisano spodaj.
• Pregnancy reporting requirements o Instruction to stop thalidomide immediately upon suspicion of pregnancy, if female patient o Need to refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation o Complete pregnancy reporting form as provided in the “Educational Healthcare Professional's Kit” o Local contact details for reporting of any suspected pregnancy
• Zahteve poročanja nosečnosti o navodilo za bolnice, da je v primeru suma na nosečnost treba takoj ustaviti zdravljenje s talidomidom o potreba po napotitvi k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji zaradi svetovanja in ocenitve o izpolnitev obrazca za poročanje o nosečnosti, ki se nahaja v „Paketu izobraževalnih gradiv za zdravstvene delavce“ o lokalne kontaktne podatke glede poročanja kakršnegakoli suma na nosečnost
Decreased platelet counts were noted in the mouse and rat studies.
V študijah miši in podgan so opazili zmanjšano število trombocitov.
• by stopping blood vessels growing in the cancer
• ustavlja rast krvnih žil v rakavem delu
Common (may affect up to 1 in 10 people)
Pogosti (pojavijo se lahko pri do 1 od 10 bolnikov)
• Levonorgestrel-releasing intrauterine system (IUS)
• intrauterini sistem (IUS), ki sprošča levonorgestrel
• A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leukocytoclastic vasculitis).
• bolezen, ki vpliva na kožo in jo povzroča vnetje krvnih žilic, skupaj z bolečino v sklepih in povišano telesno temperaturo (levkocitoklastični vaskulitis).
In addition to the adverse reactions outlined above, thalidomide in combination with dexamethasone in other clinical studies led to the very common adverse reaction of fatigue; common adverse reactions of transient ischaemic event, syncope, vertigo, hypotension, mood altered, anxiety, blurred vision, nausea and dyspepsia; and uncommon adverse reactions of cerebrovascular accident, diverticular perforation, peritonitis, orthostatic hypotension and bronchitis.
Poleg zgoraj opisanih neželenih učinkov je talidomid v kombinaciji z deksametazonom v drugih kliničnih študijah povzročil zelo pogost neželeni učinek: utrujenost; pogoste neželene učinke: prehodni ishemični dogodek, sinkopo, vrtoglavico, hipotenzijo, spremembo razpoloženja, anksioznost, nejasen vid, slabost in dispepsijo; in občasne neželene učinke: cerebrovaskularni insult, divertikularno perforacijo, peritonitis, ortostatsko hipotenzijo in bronhitis.
* see section 4.8 description of selected adverse reactions identified from post marketing data ^ Acute myeloid leukaemia and Myelodysplastic syndrome were reported in one clinical study in patients with previously untreated MM receiving the combination of melphalan, prednisone and thalidomide (MPT)
* glejte poglavje 4.8 Opis izbranih neželenih učinkov † na osnovi podatkov po začetku trženja ^ o akutni mieloični levkemiji in mielodisplastičnem sindromu so poročali v klinični študiji pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, ki so prejemali kombinacijo melfalana, prednizona in talidomida (MPT)
Peripheral neuropathy is a very common, potentially severe, adverse reaction to treatment with thalidomide that may result in irreversible damage (see section 4.8).
Periferna nevropatija je razširjen, potencialno resen neželen učinek pri zdravljenju s talidomidom, ki lahko privede do nepopravljivih okvar (glejte poglavje 4.8).
Confusional state, Depression
Psihiatrične motnje pogosti zmedenost, depresija
As thalidomide is found in semen, as a precaution all male patients must use condoms during treatment, during dose interruption and for at least 7 days following discontinuation of treatment if their partner is pregnant or is of childbearing potential not using effective contraception.
Ker je talidomid prisoten v spermi, morajo vsi moški bolniki iz previdnosti uporabljati kondome med zdravljenjem, med prekinitvijo odmerjanja in še vsaj 7 dni po ukinitvi zdravljenja, če je partnerica noseča ali v rodni dobi in ne uporablja zanesljive kontracepcije.
Neutropenia
Nevtropenija
• Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection.
• Zvišana telesna temperatura, mrzlica, boleče grlo, kašelj, razjede v ustih ali katerikoli drugi simptomi okužbe.
Each capsule contains 50 mg of thalidomide.
Ena kapsula vsebuje 50 mg talidomida.
• Brochure for women of childbearing potential Brochure for women patients who are not of childbearing potential
• brošure za ženske, ki niso v rodni dobi
Marketing Authorisation Holder Celgene Europe B.V.
Imetnik dovoljenja za promet z zdravilom Celgene Europe B.V.
Do not take Thalidomide Celgene
Ne jemljite zdravila Thalidomide Celgene
• Your doctor will make sure that you have pregnancy tests o before treatment o every 4 weeks during treatment o 4 weeks after stopping treatment
• Bo vaš zdravnik poskrbel, da boste opravili teste nosečnosti o pred zdravljenjem o na vsake 4 tedne med zdravljenjem o 4 tedne po koncu zdravljenja
Capsules should not be opened or crushed.
• Kapsule ne zdrobite ali žvečite.
• Injury to the liver (hepatic disorder) including abnormal liver test results.
• poškodbe jeter (bolezni jeter), vključno z nenormalnimi rezultati jetrnih testov,
This may mean that you are more likely to develop infections.
• nizka koncentracija krvničk, to lahko pomeni, da pri vas obstaja večja verjetnost razvoja okužb.
Proportion thalidomide, the total mean recovery was 93.6 % of the administered dose by day 8.
Po enkratnem peroralnem odmerku 400 mg radioaktivno označenega talidomida so do 8. dne ponovno pridobili celokupno povprečno vrednost 93,6 % danega odmerka.
The recommended dose is 200 mg (4 x 50 mg capsules) a day for adults aged 75 years and under or 100 mg (2 x 50 mg capsules) a day for adults aged over 75 years.
Priporočeni odmerek za odrasle, stare 75 let ali manj, je 200 mg (4 x 50 mg kapsule) na dan, za odrasle, starejše od 75 let, pa 100 mg (2 x 50 mg kapsule) na dan, vendar lahko vaš zdravnik določi odmerek za vas, nadzira napredek in prilagodi odmerek.
• slow the heart rate (induce bradycardia, such as anticholinesterases and beta blockers).
• upočasnijo srčni utrip (povzročijo bradikardijo, kot so zaviralci holinesteraze in antagonisti adrenergičnih receptorjev beta);
Melphalan dosed once daily on Days 1 to 4 of each 42-day cycle.
c Melfalan se daje enkrat dnevno od 1. do 4. dne vsakega 42-dnevnega cikla.
Due to the sedative effect associated with thalidomide, administration at bedtime is known to generally improve tolerability.
b Znano je, da zaradi sedativnega učinka, povezanega s talidomidom, dajanje pred spanjem na splošno izboljša prenašanje.
,†, Leukocytoclastic vasculitis
levkocitoklastični vaskulitis†
You must not donate blood during Thalidomide Celgene treatment and for at least 7 days after stopping treatment.
Med zdravljenjem z zdravilom Thalidomide Celgene in še vsaj 7 dni po koncu zdravljenja ne smete darovati krvi.
Thalidomide must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or drug reaction with eosinophilia and systemic symptoms (DRESS) is suspected and should not be resumed following discontinuation for these reactions.
Talidomid je treba ukiniti pri angioedemu, izpuščaju 4. stopnje, eksfoliativnem ali buloznem izpuščaju in pri sumu na Stevens-Johnsonov sindrom (SJS), toksično epidermalno nekrolizo (TEN) ali reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) in ga po ukinitvi zaradi teh reakcij ne smemo spet začeti dajati.
• The need for effective contraception
• opozorilo, da je potrebna zanesljiva kontracepcija
Multiple myeloma generally cannot be cured.
Načeloma diseminiranega plazmocitoma ni mogoče ozdraviti.
You must use one effective method of contraception if you are a woman who is able to become pregnant (see section 2, “What you need to know before you take Thalidomide Celgene”).
Če lahko zanosite, morate uporabljati zanesljivo kontracepcijsko metodo (glejte poglavje 2 „Kaj morate vedeti, preden boste vzeli zdravilo Thalidomide Celgene“).
• you have a fall in the number of white blood cells (neutropenia) accompanied by fever and infection.
• imate zmanjšano število belih krvničk (nevtropenijo), ki ga spremljata povišana telesna temperatura in okužba;
White opaque capsules marked “Thalidomide Celgene 50 mg”.
Kapsule, motno bele barve, z oznako „Thalidomide Celgene 50 mg“.
There is no relevant use of Thalidomide Celgene in the paediatric population in the indication of multiple myeloma.
Zdravilo Thalidomide Celgene ni primerno za uporabo pri pediatrični populaciji za indikacijo diseminirani plazmocitom.
• Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
• tablete, ki zavirajo ovulacijo in vsebujejo samo progesteron (tj. dezogestrel)
OR < 100,000 but
ALI < 100.000, vendar ≥ 50.000
Hard capsule.
FARMACEVTSKA OBLIKA trda kapsula
As thalidomide is found in semen, as a precaution all male patients must use condoms during treatment, during dose interruption and for at least 7 days following discontinuation of treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential who is not using effective contraception.
Ker je talidomid prisoten v spermi, morajo vsi moški bolniki iz previdnosti uporabljati kondome med zdravljenjem, med prekinitvijo odmerjanja in še vsaj 7 dni po ukinitvi zdravljenja ob spolnih odnosih z nosečnico ali z žensko v rodni dobi in ne uporablja zanesljive kontracepcije.
Table 3: Adverse drug reactions (ADRs) reported in pivotal clinical study with thalidomide in combination with melphalan and prednisone and from post marketing use
Preglednica 3: Neželeni učinki, o katerih so poročali v ključni klinični študiji za talidomid v kombinaciji z melfalanom in prednizonom ter med uporabo po začetku trženja
The most commonly observed adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone are: neutropenia, leukopenia, constipation, somnolence, paraesthesia, peripheral neuropathy, anaemia, lymphopenia, thrombocytopenia, dizziness, dysaesthesia, tremor and peripheral oedema.
Najbolj pogosto opaženi neželeni učinki, povezani z uporabo talidomida v kombinaciji z melfalanom in prednizonom, so: nevtropenija, levkopenija, zaprtje, somnolenca, parestezija, periferna nevropatija, anemija, limfopenija, trombocitopenija, vrtoglavica, disestezija, tremor in periferni edem.
• A spinning feeling in your head, making it difficult to stand up and move normally.
• vrtoglavica, težave pri stanju pokonci in normalnem premikanju,
In addition, you must not become pregnant while taking Thalidomide Celgene.
Poleg tega med jemanjem zdravila Thalidomide Celgene ne smete zanositi.
Allergic reactions (hypersensitivity, angioedema, urticaria)
Bolezni imunskega sistema neznana pogostnost alergijske reakcije (preobčutljivost, angioedem, urtikarija) †
• Adverse reaction reporting forms
• Obrazce za poročanje neželenih učinkov
Patients should be monitored and dose reduction may be required.
Bolnike je treba spremljati in jim po potrebi prilagoditi odmerek.
• That he should return the capsules to the pharmacist at the end of treatment
• ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu
• You must not donate semen: o during treatment o for at least 7 days after stopping treatment
• Ne smete darovati sperme: o med zdravljenjem o še vsaj 7 dni po koncu zdravljenja
Grade 4 (neuropathy which is disabling)
4. stopnja (nevropatija, ki bolnika onesposobi) Ukinite zdravljenje.
• That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom
• če partnerica zanosi, mora o tem takoj obvestiti zdravnika, ki ga zdravi, in vedno uporabljati kondom
• A fall in the number of white blood cells (neutropenia) accompanied by fever and infection.
• padec števila belih krvničk (nevtropenija), ki ga spremljata povišana telesna temperatura in okužba,
• Tubal sterilisation
• sterilizacija jajcevodov
• That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a woman with childbearing potential not on effective contraception
• opozorilo, da je talidomid prisoten v spermi in o potrebi zaščite s kondomom, če je spolna partnerica noseča ali v rodni dobi in ne uporablja zanesljive kontracepcije
• Treatment initiation forms and/or equivalent tool for male patients should also include: o Confirmation that the physician has discussed the following:
• Obrazci za začetek zdravljenja in/ali ustrezno orodje za moške bolnike morajo vsebovati tudi naslednje elemente: o Potrdilo, da se je zdravnik pogovoril o naslednjem:
There is no specific antidote for a thalidomide overdose.
Za prevelik odmerek talidomida ni posebnega antidota.
Myocardial infarction
Miokardni infarkt
The patient should continue anticoagulation therapy during the course of thalidomide treatment.
Med zdravljenjem s talidomidom naj bolnik nadaljuje z antikoagulacijsko terapijo.
Use only as directed by your doctor.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Uporabljajte le po navodilih zdravnika.
* WHO Criteria
* Kriteriji Svetovne zdravstvene organizacije
• Need to tell treating doctor immediately upon suspicion of pregnancy o Safety advice for men
• opozorilo, da je treba v primeru suma na nosečnost, o tem nemudoma obvestiti zdravnika, ki vodi zdravljenje o varnostne nasvete za moške
SUMMARY OF PRODUCT CHARACTERISTICS
PRILOGA I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
• Inflammation and swelling of the tubes in your lungs (bronchitis).
• vnetje in zatekanje pljučnih žil (bronhitis),
• The need for pregnancy tests i.e. before treatment, at least every 4 weeks during treatment and at least 4 weeks after treatment
• potreba po testih nosečnosti, in sicer pred zdravljenjem, vsaj vsake 4 tedne med samim zdravljenjem in vsaj 4 tedne po zdravljenju
Acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) AML and MDS were reported in one clinical study in patients with previously untreated multiple myeloma receiving the combination of melphalan, prednisone, and thalidomide (see section 4.4).
Akutna mieloična levkemija (AML) in mielodisplastični sindromi (MDS) V klinični študiji so poročali o AML in MDS pri bolnikih s predhodno nezdravljenim disemininiranim plazmocitomom, ki so prejemali kombinacijo melfalana, prednizona in talidomida (glejte poglavje 4.4).
If pregnancy occurs in a woman treated with thalidomide, treatment must be stopped immediately and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Če ženska, ki se zdravi s talidomidom, zanosi, je treba zdravljenje nemudoma ustaviti in bolnico napotiti k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
Myocardial infarction (MI) has been reported in patients receiving thalidomide, particularly in those with known risk factors.
Pri bolnikih, zlasti pri tistih z znanimi dejavniki tveganja, ki so prejemali talidomid, so poročali o miokardnem infarktu (MI).
• She understands the need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment
• Bolnica razume potrebo po zanesljivi kontracepciji brez prekinitev, vsaj 4 tedne pred pričetkom zdravljenja, med celotnim trajanjem zdravljenja ter vsaj 4 tedne po koncu zdravljenja.
• The need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment
• potrebna je zanesljiva kontracepcija brez prekinitev, vsaj 4 tedne pred pričetkom zdravljenja, med celotnim trajanjem zdravljenja ter vsaj 4 tedne po koncu zdravljenja
There is minimal cytochrome P450 catalysed hepatic metabolism of thalidomide.
Obstaja minimalna jetrna presnova talidomida, katalizirana s citokromom P450.
The benefit achieved with thalidomide and the risk of AML and MDS must be taken into account before initiating treatment with thalidomide in combination with melphalan and prednisone.
Pred uvedbo zdravljenja s talidomidom v kombinaciji z melfalanom in prednizonom je treba upoštevati oboje, koristi talidomida in tveganje AML in MDS.
• Bleeding from the stomach or bowels (gastrointestinal haemorrhage).
• krvavitev iz želodca ali črevesa (krvavitev prebavil),
2 D bar code carrying the unique identifier
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Prednisone dosed once daily on Days 1 to 4 of each 42-day cycle.
f Prednizon se daje enkrat na dan od 1. do 4. dne vsakega 42-dnevnega cikla.
• Treatment initiation forms and/or equivalent tool for women with no childbearing potential should also include: o Confirmation that the physician has discussed the following:
• Obrazci za začetek zdravljenja in/ali ustrezno orodje za ženske, ki niso v rodni dobi, morajo vsebovati tudi: o Potrdilo, da se je zdravnik pogovoril o naslednjem:
Table 2: Recommended dose modifications for thalidomide -related neuropathy in first line treatment of multiple myeloma
Preglednica 2: Priporočene spremembe odmerkov za nevropatijo, povezano s talidomidom, za primarno zdravljenje diseminiranega plazmocitoma Resnost nevropatije
Acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) A statistically significant increase of AML and MDS was observed in one clinical study in patients with previously untreated MM receiving the combination of melphalan, prednisone, and thalidomide (MPT).
Akutna mieloična levkemija (AML) in mielodisplastični sindromi (MDS) V klinični študiji so pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, ki so prejemali kombinacijo melfalana, prednizona in talidomida (MPT), opazili statistično pomembno povečanje AML in MDS.
It is important to note that a small number of patients with multiple myeloma may develop additional types of cancer, especially haematological malignancies, and it is possible that this risk may be increased with Thalidomide Celgene treatment; therefore your doctor should carefully evaluate the benefit and risk when you are prescribed Thalidomide Celgene.
Pomembno je omeniti, da se lahko pri majhnem številu bolnikov z diseminiranim plazmocitomom razvijejo dodatne vrste raka, zlasti hematološke malignosti.
Particularly, a haemoglobin concentration above 12g/dl should lead to discontinuation of erythropoietic agents.
Posebej pomembno je ukiniti zdravljenje z eritropoetskimi zdravili, če se koncentracija hemoglobina dvigne nad 12 g/dl.
Thalidomide causes birth defects and foetal death.
Talidomid povzroča prirojene okvare in smrt zarodka.
Myelodysplastic syndrome*
občasni mielodisplastični sindrom*,^
If pregnancy occurs in a partner of a male patient taking thalidomide, the female partner should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Če partnerica moškega, ki jemlje talidomid, zanosi, jo je treba napotiti k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
Dose delay, reduction or discontinuation, dependent upon the NCI CTC (National Cancer Institute Common Toxicity Criteria) grade, may be necessary.
Glede na stopnjo toksičnosti po splošnih merilih Nacionalnega inštituta za raka (NCI CTC - National Cancer Institute Common Toxicity Criteria) bo morda potrebna odložitev, zmanjšanje odmerka ali ukinitev zdravljenja.