natgillin/translations-raw huggingface dataset:
Dose adjustments for combination therapy
Navodila za prilagajanje odmerkov pri kombiniranem zdravljenju
Dose modification and re-initiation of therapy when VELCADE is administered in combination with melphalan and prednisone
Prilagajanje odmerkov in ponovna uvedba zdravljenja pri dajanju zdravila VELCADE v kombinaciji z melfalanom in prednizolonom.
Prior to initiating a new cycle of therapy: • Platelet counts should be ≥ 70 x 109/ l and the absolute neutrophils count should be ≥ 1.0 x 109/ l • Non-haematological toxicities should have resolved to Grade 1 or baseline
Pred začetkom novega kroga zdravljenja: • Število trombocitov mora biti ≥ 70 x 109/ l in celokupno število nevtrofilcev (ANC - Absolute Neutrophil Count) mora biti ≥ 1, 0 x 109/ l. • Ne- hematološki neželeni učinki se morajo vrniti na 1. stopnjo ali vrednost pred začetkom zdravljenja.
Table 3: Posology modifications during subsequent cycles:
Preglednica 3:
Toxicity Haematological toxicity during a cycle
Prilagajanje odmerkov med kasnejšimi krogi zdravljenja Neželen učinek
• If platelet counts ≤ 30 × 109/ l or ANC ≤ 0.75 x 109/ l on a VELCADE dosing day (other than Day 1)
• Če je na dan odmerjanja zdravila VELCADE (razen dneva 1) število trombocitov ≤ 30 × 109/ l ali ANC ≤ 0, 75 x 109/ l
VELCADE therapy should be withheld
ne aplicirajte zdravila VELCADE.
VELCADE dose should be reduced by 1 dose level (from 1.3 mg/ m2 to 1 mg/ m2, or from 1 mg/ m2 to 0.7 mg/ m2) VELCADE therapy should be withheld until
Odmerek zdravila VELCADE je treba zmanjšati za 1 stopnjo (z 1, 3 mg/ m2 na 1 mg/ m2 ali z 1 mg/ m2 na 0, 7 mg/ m2) Zdravljenje z zdravilom VELCADE je treba prekiniti
Grade ≥ 3 non-haematological toxicities
Ne- hematološki neželeni učinki stopnje ≥ 3
symptoms of the toxicity have resolved to Grade 1 or baseline.
dokler se simptomi toksičnosti ne povrnejo na 1. stopnjo ali stanje pred začetkom zdravljenja.
Then, VELCADE may be reinitiated with one dose level reduction (from 1.3 mg/ m2 to 1 mg/ m2, or from 1 mg/ m2 to 0.7 mg/ m2).
Nato lahko ponovno uvedete zdravilo VELCADE v odmerku, ki je eno stopnjo nižji od prejšnjega (z 1, 3 mg/ m2 na 1 mg/ m2 ali z 1 mg/ m2 na 0, 7 mg/ m2).
For VELCADE-related neuropathic pain and/ or peripheral neuropathy, hold and/ or modify VELCADE as outlined in Table 1.
V primeru nevropatske bolečine in/ ali periferne nevropatije povezane z zdravilom VELCADE zakasnite in/ ali prilagodite odmerek zdravila VELCADE, kot je opisano v Preglednici 1.
4 4.3 Contraindications
4 Dajanje zdravila
Hypersensitivity to bortezomib, boron or to any of the excipients.
Preobčutljivost za bortezomib, bor ali katerokoli od pomožnih snovi.
Severe hepatic impairment (see section 4.4).
Hude okvare delovanja jeter (glejte poglavje 4. 4).
Gastrointestinal toxicity Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with VELCADE treatment.
Toksični učinki na prebavila Med zdravljenjem z zdravilom VELCADE se zelo pogosto pojavijo neželeni učinki na prebavila, kot so slabost, driska, bruhanje in zaprtje.
Cases of ileus have been uncommonly reported (see section 4.8); therefore patients who experience constipation should be closely monitored.
Občasno so poročali o primerih zapore črevesja, zato je treba bolnike z zaprtjem skrbno spremljati.
Haematological toxicity VELCADE treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Toksični učinki na hematološki sistem Zdravljenje z zdravilom VELCADE je zelo pogosto povezano z zmanjšanjem števila krvnih celic (trombocitopenija, nevtropenija in anemija).
The most common haematologic toxicity is transient thrombocytopenia.
Najpogostejša je prehodna trombocitopenija.
Platelets were lowest at Day 11 of each cycle of VELCADE treatment.
Število trombocitov je bilo najmanjše 11. dan vsakega kroga zdravljenja z zdravilom VELCADE.
There was no evidence of cumulative thrombocytopenia, including in the Phase II extension study.
O kumulativni trombocitopeniji ni bilo podatkov, kar velja tudi za podaljšanje preskušanja II. faze.
The mean platelet count nadir measured was approximately 40% of baseline.
Mediana vrednost najnižjega izmerjenega števila trombocitov je znašala približno 40% začetne vrednosti.
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/μ l, 90% of 21 patients had a count ≤ 25,000/ μ l during the study, including 14 %< 10,000/μl; in contrast, with a baseline platelet count > 75,000/μl, only 14% of 309 patients had a count ≤25×109/l during the study.
Pri bolnikih, z napredovalim plazmocitomom, je bila resnost trombocitopenije povezana s številom trombocitov pred zdravljenjem (90% od 21 bolnikov, ki so imeli začetno število trombocitov < 75. 000/ μl, je med preskušanjem imelo število trombocitov ≤ 25. 000/ μl (vključno s 14% bolnikov, ki so imeli število trombocitov < 10. 000/ μl).
Platelet counts should be monitored prior to each dose of VELCADE.
Pred dajanjem vsakega odmerka zdravila VELCADE je treba določiti število trombocitov.
Therapy should be held when the platelet count is < 25,000/μ l and re-initiated at a reduced dose after resolution (see section 4.2).
Če je število trombocitov < 25. 000/ μl, zdravljenje prekinite in ga ponovno uvedite z zmanjšanim odmerkom po normalizaciji števila trombocitov (glejte poglavje 4. 2).
Therefore, complete blood counts (CBC) including platelet counts should be frequently monitored throughout treatment with VELCADE.
Med zdravljenjem z zdravilom Velcade je treba pogosto spremljati število krvnih celic, vključno s številom trombocitov.
Peripheral neuropathy Treatment with VELCADE is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Periferna nevropatija Zdravljenje z zdravilom VELCADE je zelo pogosto povezano s periferno nevropatijo, ki je pretežno senzorična.
It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
Priporočamo, da bolnike skrbno spremljate in ugotavljate simptome nevropatije, npr. občutek pečenja, hiperestezijo, hipoestezijo, parestezije, neprijeten občutek, nevropatično bolečino ali oslabelost.
Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require the dose and schedule of VELCADE to be modified (see section 4.2).
Pri bolnikih, pri katerih se periferna nevropatija pojavi prvič ali se obstoječa periferna nevropatija poslabša, je je treba napraviti nevrološko oceno in po potrebi prilagoditi odmerek in shemo odmerjanja zdravila VELCADE (glejte poglavje 4. 2).
Neuropathy has been managed with supportive care and other therapies.
Nevropatijo so doslej zdravili s podpornim zdravljenjem in z drugimi načini.
Improvement in, or resolution of, peripheral neuropathy was reported in 51% of patients with ≥ Grade 2 peripheral neuropathy in the single-agent Phase III multiple myeloma study and 71% of patients with grade 3 or 4 peripheral neuropathy or peripheral neuropathy leading to discontinuation of treatment in Phase II studies, respectively.
5 uporabljali samo eno učinkovino, tretje faze in pri 71% bolnikov v preskušanjih druge faze s periferno nevropatijo 3. ali 4. stopnje ali periferno nevropatijo, ki je vodila do ukinitve zdravljenja.
Information on autonomic neuropathy and its contribution to these undesirable effects is limited.
Podatki o avtonomni nevropatiji in tem, koliko le- ta prispeva k tem neželenim učinkom, so omejeni.
5 Seizures Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy.
Epileptični napadi Pri bolnikih, ki pred zdravljenjem niso imeli epileptičnih napadov ali epilepsije, so občasno poročali o epileptičnih napadih.
Hypotension VELCADE treatment is commonly associated with orthostatic/ postural hypotension.
Arterijska hipotenzija Zdravljenje z zdravilom VELCADE je pogosto povezano z ortostatsko hipotenzijo oz. posturalno hipotenzijo.
Most undesirable effects are mild to moderate in nature and are observed throughout treatment.
Ti neželeni učinki so po jakosti večinoma blagi do zmerni in jih opažamo ves čas zdravljenja.
Patients developing orthostatic hypotension on VELCADE did not have evidence of orthostatic hypotension prior to treatment with VELCADE.
Bolniki, pri katerih se pojavi ortostatska hipotenzija ob zdravilu VELCADE, niso imeli nobenih znakov ortostatske hipotenzije pred zdravljenjem z zdravilom VELCADE.
Orthostatic/ postural hypotension was not acutely related to bolus infusion of VELCADE.
Ortostatska oz. posturalna hipotenzija ni bila akutno povezana z infuzijo zdravila VELCADE.
Management of orthostatic/ postural hypotension may include adjustment of antihypertensive medicinal products, rehydration or administration of mineralocorticosteroids and/ or sympathomimetics.
Zdravljenje ortostatske oz. posturalne hipotenzije lahko vključuje tudi prilagoditev odmerjanja antihipertenzivov, rehidracijo bolnika ali dajanje mineralokortikosteroidov in/ ali simpatikomimetikov.
Heart failure Acute development or exacerbation of congestive heart failure, and/ or new onset of decreased left ventricular ejection fraction has been reported during bortezomib treatment.
Srčno popuščanje Med zdravljenjem z bortezomibom so poročali o akutnem razvoju ali poslabšanju kongestivnega srčnega odpovedovanja in/ ali novim pojavom zmanjšanja iztisne frakcije levega prekata.
In a single agent Phase III randomised, comparative study the incidence of heart failure in the VELCADE group was similar to that in the dexamethasone group.
V randomizirani primerjalni študiji tretje faze, v kateri so v vsakem kraku uporabljali samo eno učinkovino, je bila incidenca srčnega popuščanja v skupini, ki je prejemala zdravilo VELCADE, podobna kot v skupini, ki je prejemala deksametazon.
ECG investigations There have been isolated cases of QT-interval prolongation in clinical studies, causality has not been established.
Vzroka za podaljšanje QT intervala niso ugotovili.
Pulmonary disorders There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving VELCADE (see section 4.8).
Bolezni pljuč Pri bolnikih, ki so prejemali Velcade so redko poročali o akutni difuzni infiltracijski pljučni bolezni neznane etiologije, kot je pneumonitis, intersticijska pljučnica, infiltracija pljuč in sindrom akutne respiratorne stiske (SARS) (glejte poglavje 4. 8).
A pre-treatment chest radiograph is recommended to determine if any additional diagnostic measures are necessary and to serve as a baseline for potential post-treatment pulmonary changes.
Pred zdravljenjem je priporočljivo opraviti rentgenski posnetek prsnega koša za odločitev ali so potrebne dodatne diagnostične meritve in za oceno potencialnih pljučnih sprememb po zdravljenju.
The benefit/ risk ratio should be considered prior to continuing VELCADE therapy.
V primeru pojava novih ali poslabšanja obstoječih pljučnih simptomov (npr.: kašelj, dispneja) je potrebna takojšnja diagnostična ocena in uvedba ustreznega zdravljenja bolnika. Pred nadaljevanjem zdravljenja z zdravilom Velcade je potrebno oceniti razmerje med koristjo in tveganjem.
In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/ m2 per day) by continuous infusion over 24 hours with daunorubicin and VELCADE for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
V kliničnem preskušanju, sta dva bolnika (od dveh), pri katerih so akutno mielogeno levkemijo zdravili z visokim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/ m2 na dan) skupaj z daunorubicinom in zdravilom VELCADE umrla zaradi SARS na začetku zdravljenja in študijo so ustavili.
Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/ m2 per day) by continuous infusion over 24 hours is not recommended.
Zato ta režim dajanja s sočasnim visokim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/ m2 na dan) ni priporočljiv.
Renal impairment Renal complications are frequent in patients with multiple myeloma.
6 Moteno delovanje ledvic Pri bolnikih z diseminiranim plazmocitomom so pogosti ledvični zapleti.
Such patients should be monitored closely (see sections 4.2 and 5.2).
Zato jih morate skrbno spremljati (glejte poglavje 4. 2 in 5. 2).
Hepatic impairment Patients with hepatic impairment should be treated with extreme caution and a dose reduction should be considered (see sections 4.2, 4.3 and 5.2).
Moteno delovanje jeter Bolnike z jetrno okvaro morate med zdravljenjem zelo skrbno spremljati in razmisliti o zmanjšanju odmerka (glejte poglavje 4. 2, 4. 3 in 5. 2).
6 Hepatic reactions Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.
Bolezni jeter Pri bolnikih z obstoječimi resnimi boleznimi, ki so sočasno prejemali več zdravil so poročali o redkih primerih akutne odpovedi jeter.
Such changes may be reversible upon discontinuation of bortezomib (see section 4.8).
Po prekinitvi zdravljenja z bortezomibom so te spremembe lahko reverzibilne (glejte poglavje 4. 8).
Tumour lysis syndrome Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells, the complications of tumour lysis syndrome may occur.
Sindrom razpada tumorja Bortezomib je citotoksična učinkovina in lahko hitro uniči maligne plazemske celice, zato lahko povzroči zaplete sindroma razpada tumorja.
Amyloidosis The impact of proteasome inhibition by bortezomib on disorders associated with protein accumulation such as amyloidosis is unknown.
Amiloidoza Učinek inhibicije proteasoma z bortezomibom na bolezni, povezane s kopičenjem proteinov (npr. amiloidoza) ni znan.
Caution is advised in these patients.
Pri teh bolnikih je potrebna previdnost.
Concomitant medicinal products Patients should be closely monitored when given bortezomib in combination with potent CYP3A4-inhibitors.
Sočasno jemanje zdravil Bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 je treba skrbno spremljati.
Caution should be exercised when bortezomib is combined with CYP3A4- or CYP2C19 substrates (see section 4.5).
Še posebna previdnost je potrebna, kadar se daje bortezomib v kombinaciji s substrati encima CYP3A4 ali CYP2C19 (glejte poglavje 4. 5).
Normal liver function should be confirmed and caution should be exercised in patients receiving oral hypoglycemics (see section 4.5).
Pri teh bolnikih je potrebna previdnost (glejte poglavje 4. 5.).
Potentially immunocomplex-mediated reactions Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Motnje imunskega odziva Redko so poročali so o reakcijah povzročenih z imunokompleksi, kot so serumska bolezen, poliartritis z izpuščajem in proliferativni glomerulonefritis.
Bortezomib should be discontinued if serious reactions occur.
Če se pojavijo hudi neželeni učinki, je treba zdravljenje z bortezomibom prekiniti.
Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metabolizer phenotype is not expected to affect the overall disposition of bortezomib.
Na osnovi majhnega deleža (7%) encima CYP2D6 pri presnovi bortezomiba ni pričakovati, da bi fenotip slabe presnove s CYP2D6 vplival na skupno izločanje bortezomiba.
An interaction study based on data from 12 patients, assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, showed a bortezomib AUC mean increase of 35% (CI90% [1.032 to 1.772]).
Študija medsebojnega delovanja, ki je na osnovi podatkov 12 bolnikov ocenjevala učinek ketokonazola, močnega inhibitorja CYP3A4, je pokazala povprečen dvig AUC bortezomiba za 35% (CI90% (1. 032 do 1. 772)).
Therefore patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e. g. ketoconazole, ritonavir).
Zato je potrebno bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 (npr. ketokonazol, ritonavir) skrbno spremljati.
In an interaction study based on data from 17 patients, assessing the effect of omeprazole, a potent CYP2C19 inhibitor, there was no significant effect on the pharmacokinetics of bortezomib.
V študiji medsebojnega delovanja, ki je na osnovi podatkov 17 bolnikov ocenjevala učinek omeprazola, močnega inhibitorja encima CYP2C19, ni bilo pomembnega vpliva na farmakokinetiko bortezomiba.
Patients should be closely monitored when given bortezomib in combination with CYP2C19 inhibitors (e. g. fluoxetine).
Bolnike, ki prejemajo bortezomib v kombinaciji z inhibitorji encima CYP2C19 (npr. fluoksetin) je treba skrbno spremljati.
In the absence of interaction studies investigating the effect of CYP3A4 inducers on the pharmacokinetics of bortezomib, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inducers (e. g. rifampicin).
7 Zaradi pomanjkanja študiji medsebojnega delovanja, ki bi ocenjevale vpliv induktorjev encima CYP3A4 na farmakokinetiko bortezomiba, je potrebno bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 (npr. rifampicin) skrbno spremljati.
An interaction study assessing the effect of melphalan-prednisone on bortezomib showed a 17% increase in mean bortezomib AUC based on data from 21 patients.
Študija medsebojnega delovanja učinkovin melfalan, prednizolon in bortezomib je pokazala 17% povečanje srednje vrednosti AUC bortezomiba (na osnovi podatkov 21 bolnikov).
Patients on oral antidiabetic agents receiving
Med kliničnimi preskušanji so pri bolnikih z diabetesom, ki prejemajo peroralne antidiabetike, občasno poročali hipoglikemiji in pogosto o hiperglikemiji.
7 VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
Pri bolnikih, ki so prejemali peroralne antidiabetike in zdravilo VELCADE, je potrebno skrbno spremljanje koncentracije glukoze v krvi in prilagoditi odmerek antidiabetika.
In non-clinical studies, bortezomib had no effects on embryonal/ foetal development in rats and rabbits at the highest maternally tolerated doses.
V nekliničnih raziskavah bortezomib ni imel nobenih učinkov na embrionalni/ fetalni razvoj pri podganah in kuncih pri največjih odmerkih, ki so jih samice še lahko prenašale.
Animal studies to determine the effects of bortezomib on parturition and post-natal development were not conducted (see section 5.3).
Študije na živalih za ugotavljanje učinkov bortezomiba na porod in postnatalni razvoj niso bile opravljene (glejte poglavje 5. 3).
VELCADE should not be used during pregnancy unless clearly necessary.
Zdravila VELCADE ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
For VELCADE no clinical data with regard to exposure during pregnancy are available.
Za zdravilo VELCADE ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
Because of the potential for serious undesirable effects in breast-fed infants, lactation should be discontinued during treatment with VELCADE.
Ni znano, ali se bortezomib izloča v materino mleko, med zdravljenjem z zdravilom VELCADE je treba dojenje prekiniti.
Therefore, patients must be cautious when operating machinery, or when driving (see section 4.8).
Uporaba tega zdravila je lahko povezana z utrujenostjo (zelo pogosto), omotico (pogosto), sinkopami (občasno), ortostatsko oz. posturalno hipotenzijo ali zamegljenim vidom (pogosto), zato morajo biti bolniki pri delu s stroji in pri vožnji previdni (glejte poglavje 4. 8).
The following undesirable effects were considered by the investigators to have at least a possible or probable causal relationship to VELCADE during the conduct of 5 non-comparative Phase II studies and 1 comparative Phase III trial VELCADE vs. dexamethasone in 663 patients with relapsed or refractory multiple myeloma, of whom 331 received VELCADE as single agent.
Za spodaj navedene neželene učinke so raziskovalci med izvajanjem petih neprimerjalnih preskušanj druge faze in enega primerjalnega preskušanja tretje faze zdravila VELCADE v primerjavi z deksametazonom pri 663 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, od katerih je 331 prejemalo zdravilo VELCADE v monoterapiji, menili, da imajo vsaj možno ali verjetno vzročno povezavo z zdravilom VELCADE.
The safety database comprises data from patients with multiple myeloma or B-cell lymphocytic leukemia (CLL).
Podatkovna baza vključuje tudi podatke o bolnikih z diseminiranim plazmocitomom ali B limfocitno levkemijo.
Patients were treated with VELCADE as a single agent, or in combination with dexamethasone.
Bolniki so zdravilo Velcade prejemali samostojno ali v kombinaciji z deksametazonom.
Adverse reactions are listed below by system organ class and frequency grouping.
Neželeni učinki so navedeni spodaj po organskih sistemih in po pogostnosti.
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), not known (cannot be estimated from the available data).
Pogostnost neželenih učinkov je opredeljena, kot sledi: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥ 1/ 1. 000 do < 1/ 100); redki (≥ 1/ 10. 000 do < 1/ 1. 000); zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
8 Table 4:
8 Preglednica 4:
Adverse reactions in patients with relapsed/ refractory multiple myeloma Infections and infestations Very common: herpes zoster (including disseminated).
Neželeni učinki pri bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje Infekcijske in parazitske bolezni Zelo pogosti
Common: pneumonia, bronchitis, sinusitis, nasopharyngitis, herpes simplex.
pljučnica, bronhitis, sinusitis, nazofaringitis, herpes simpleks. sepsa, bakteriemija, pneumokokna pljučnica, bronhopnevmonija, okužba zgornjih in
Uncommon: sepsis, bacteraemia, pneumonia pneumococcal, bronchopneumonia, upper and lower respiratory tract infection, catheter related infection, pleural infection, haemophilus infection, cytomegalovirus infection, influenza, infectious mononucleosis, varicella, urinary tract infection, gastroenteritis, candidal infection, fungal infection, post herpetic neuralgia, oral candidiasis, blepharitis, infection.
spodnjih dihal, s katetrom povezana okužba, plevralna okužba, okužba s hemofilusom, okužba s citomegalovirusom, gripa, infekcijska mononukleoza, varicella, okužba sečil, gastroenteritis, glivična okužba, post- herpetična nevralgija, oralna kandidiaza, blefaritis, okužba.
Neoplasms benign and malignant (including cysts and polyps) Uncommon: tumour lysis syndrome (see section 4.4).
Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi) Občasni:
Blood and the lymphatic system disorders (see section 4.4) Very common:
sindrom razpada tumorja (glejte poglavje 4. 4).
thrombocytopenia, neutropenia, anaemia.
Občasni:
Uncommon: pancytopenia, febrile neutropenia, haemolytic anaemia, thrombocytopenic purpura, lymphadenopathy.
levkopenija, limfopenija. pancitopenija, febrilna nevtropenija, hemolitična anemija, trombocitopenična purpura,
Immune system disorders Uncommon: hypersensitivity, immunocomplex mediated hypersensitivity, potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis (see section 4.4).
Bolezni imunskega sistema Občasni:
Endocrine disorders Uncommon: inappropriate antidiuretic hormone (ADH) secretion.
preobčutljivost, z imunokompleksi povzročena preobčutljivost, reakcije, ki so lahko
Metabolism and nutrition disorders Very common:
Bolezni endokrinega sistema Občasni:
appetite decreased.
motnje izločanja antidiuretičnega hormona (ADH).
Common: dehydration, hypokalaemia, hyperglycaemia.
Občasni: hiponatriemija,