FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib treatment must be withheld at the onset of any grade 3 non-haematological or any grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Croatian: Prilagodbe doze za vrijeme i kod ponovnog uvođenja monoterapije Liječenje bortezomibom mora se prekinuti po javljanju svake nehematološke toksičnosti 3. stupnja ili bilo kakve hematološke toksičnosti 4. stupnja, isključujući neuropatiju, kako je objašnjeno u daljnjem tekstu (vidjeti također dio 4.4).
English: h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Croatian: Uključuje sve radiološke CR+CRu+PR prema IRC neovisno o potvrdi koštanom srži i LDH.
English: In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine-doxorubicin-dexamethasone [VDDx, n=242].
Croatian: U ispitivanju IFM-2005-01 bortezomib u kombinaciji s deksametazonom [BDx, n = 240] bio je uspoređen s vinkristinom-doksorubicinom-deksametazonom [VDDx, n = 242].
English: In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Croatian: U ispitivanju faze III uspoređena je intravenska primjena bortezomiba u odnosu na supkutanu primjenu, incidencija periferne neuropatije stupnja ≥ 2 bila je 24% u skupini sa supkutanom primjenom injekcije i 41% u intravenskoj skupini (p = 0,0124).
English: d Based on Log rank test stratified with IPI risk and stage of disease.
Croatian: Temeljeno na Log rank testu stratificiranom s IPI rizikom i stadijem bolesti.
English: B=bortezomib; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
Croatian: B= bortezomib; Dx = deksametazon; T = talidomid a Doza talidomida se povisuje na 100 mg od 3. tjedna 1. ciklusa samo ako se podnosi doza od 50 mg, a na 200 mg od 2.
English: Note: An OR > 1 indicates an advantage for B-containing induction therapy.
Croatian: Napomena: OR > 1 ukazuje na prednost za uvodno liječenje koje sadrži B.
English: A lower starting dose is recommended in patients with moderate or severe hepatic impairment, and those patients should be closely monitored (see section 4.2, table 6).
Croatian: U bolesnika s umjerenim ili teškim oštećenjem jetre preporučuje se niža početna doza i te bolesnike treba pomno pratiti (vidjeti dio 4.2, tablica 6).
English: Response Rate at 8 cycles n (%) ORR (CR+PR) p-value a
Croatian: Stopa odgovora u 8 ciklusa n (%) ORR (CR+PR) p-vrijednost a
English: * Survival update based on a median duration of follow-up at 60.1 months mo: months
Croatian: * Ažurirano preživljenje na temelju medijana trajanja praćenja od 60,1 mjesec CI = Interval pouzdanosti
English: In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib.
Croatian: U ispitivanju faze III bolesnici koji su primili bortezomib supkutano u odnosu na intravensku primjenu, ukupno su imali 13% manju incidenciju nuspojava stupnja toksičnosti 3 ili više, koje su proizašle iz liječenja i 5% manju incidenciju prekida primjene bortezomiba.
English: • to report any adverse event, or medication error experienced with the administration of bortezomib 3.5 mg.
Croatian: • važnost prijave štetnih događaja ili medikacijskih pogrešaka kod primjene bortezomiba 3,5 mg.
English: You must not breast-feed while using bortezomib.
Croatian: Ne smijete dojiti dok primate bortezomib.
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with Bortezomib+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Croatian: U ispitivanju faze III kod bolesnika s prethodno neliječenim multiplim mijelomom, ukupna incidencija reaktivacije virusa herpes zoster bila je češća u bolesnika koji su primali bortezomib+melfalan+prednizon nego u onih koji su primali melfalan+prednizon (14% naspram 4%).
English: The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following singleor repeated-dose intravenous administration of 1.0 mg/m or 1.3 mg/m to patients with multiple myeloma.
Croatian: Prosječni volumen distribucije (Vd) bortezomiba kretao se u rasponu od 1659 l do 3294 l nakon jednokratne ili ponovljene intravenske primjene doze od 1,0 mg/m ili 1,3 mg/m bolesnicima s multiplim mijelomom.
English: Response Rate at 4 cycles n (%) ORR (CR+PR) p-value a
Croatian: Stopa odgovora u 4 ciklusa n (%) ORR (CR+PR) p-vrijednost a
English: The overall incidence of hepatitis B infections was similar in patients treated with BR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Croatian: Ukupna incidencija infekcija hepatitisom B bila je slična u bolesnika liječenih s BR-CAP i liječenih s R-CHOP (0,8% odnosno
English: • Bortezomib 3.5 mg can be administered both intravenously and subcutaneously
Croatian: • bortezomib 3,5 mg može biti primijenjen intravenski i supkutano
English: • storage precautions for reconstituted solution • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Croatian: • prikaz potencijalnih rizika kod primjene uključujući predoziranje, poddoziranje te da je nehotična intratekalna primjena rezultirala smrtnim ishodom
English: Bortezomib is for single use only.
Croatian: Bortezomib je samo za jednokratnu primjenu.
English: 10 ml clear Type I glass vial with grey chlorobutyl rubber stopper and blue aluminium flip-off over seal, containing 3.5 mg bortezomib.
Croatian: Staklena (staklo tip I) prozirna bočica od 10 ml sa sivim klorbutilnim gumenim čepom i plavim aluminijskim flip-off zatvaračem, koja sadrži 3,5 mg bortezomiba.
English: What Bortezomib Fresenius Kabi is and what it is used for
Croatian: Što je Bortezomib Fresenius Kabi i za što se koristi
English: - If, after bortezomib has been held, the toxicity does not resolve, as defined above, then bortezomib must be discontinued.
Croatian: , toksičnost ne povuče, kako je definirano iznad, bortezomib se mora prestati primjenjivati.
English: Aseptic technique must be strictly observed throughout the handling of bortezomib, since it contains no preservative.
Croatian: Aseptična tehnika mora se strogo poštovati tijekom cijelog postupka rukovanja bortezomibom, budući da lijek ne sadrži konzervanse.
English: Median PFS by investigator assessment was 30.7 months in the BR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Croatian: Medijan preživljenja bez progresije prema procjeni ispitivača bio je 30,7 mjeseci u BR-CAP skupini i 16,1 mjeseci u R-CHOP skupini (omjer hazarda [HR] = 0,51; p < 0,001).
English: In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Croatian: U ispitivanjima s bolesnicima s relapsom multiplog mijeloma liječenih s bortezomibom i s bolesnicima s prethodno neliječenim limfomom plaštenih stanica liječenih s bortezomibom u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BRCAP), jedna od najčešćih hematoloških toksičnosti bila je prolazna trombocitopenija.
English: • Inject the solution subcutaneously, under a 45-90°angle.
Croatian: • Primijenite injekciju supkutano, pod kutem od 45°-90°.
English: Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
Croatian: Herpes zoster (uključujući diseminirani i oftalmički), pneumonija*, herpes simpleks*, gljivična infekcija*
English: Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Croatian: Tablica 5: Prilagodbe doza tijekom liječenja za bolesnike s prethodno neliječenim limfomom plaštenih stanica Toksičnost
English: • Severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse
Croatian: • teška alergijska reakcija (anafilaktička reakcija) znakovi koji mogu uključiti otežano disanje, bol ili stezanje u prsnom košu i/ili osjećaj omaglice/nesvjestice, teški oblik svrbeža kože ili izbočine na koži, oticanje lica, usnica, jezika i /ili grla, što može izazvati otežano gutanje, kolaps
English: 1 mg/m to 0.7 mg/m
Croatian: mg/m na 0,7 mg/m
English: • Cancer of the skin
Croatian: • rak kože
English: Subcutaneous use: Add 1.4 ml sodium chloride 0.9% to make 2.5 mg/ml final concentration.
Croatian: Supkutana primjena: Dodati 1,4 ml 0,9%-tne otopine natrijeva klorida kako bi se pripremila konačna otopina koncentracije 2,5 mg/ml.
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (including thrombocytopenic purpura)
Croatian: Diseminirana intravaskularna koagulacija, trombocitoza*, sindrom hiperviskoznosti, nespecificirani poremećaj trombocita, trombotička mikroangiopatija (uključujući trombocitopenijsku purpuru)
English: Week B (1.3 mg/m
Croatian: Tjedan B (1,3 mg/m2)
English: Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy
Croatian: Neuropatije*, motorna neuropatija*, gubitak svijesti (uključujući sinkopu), encefalopatija*, periferna senzorno-motorna neuropatija, omaglica*, disgeuzija*, autonomna neuropatija
English: - If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m to 1 mg/m 2, or from
Croatian: • Ako se toksičnost povuče, tj. bolesnik ima apsolutni broj neutrofila ≥ 750 stanica/μL i broj trombocita ≥ 25 000 stanica/μL, bortezomib se može ponovno uvesti u dozi smanjenoj za jednu razinu doze (s 1,3 mg/m na 1 mg/m 2, ili s 1 mg/m na 0,7
English: Once the symptoms of the toxicity have resolved, bortezomib treatment may be re-initiated at a 25% reduced dose (1.3 mg/m reduced to 1.0 mg/m 2; 1.0 mg/m reduced to 0.7 mg/m 2).
Croatian: Kad se simptomi toksičnosti povuku, može se ponovno uvesti liječenje bortezomibom uz dozu smanjenu za 25% (1,3 mg/m smanjeno na 1,0 mg/m 2; 1,0 mg/m smanjeno na
English: Uncommon Autonomic nervous system imbalance
Croatian: Manje često Neravnoteža autonomnog živčanog sustava Poremećaji oka Često
English: This study included 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m of bortezomib by either the subcutaneous or intravenous route for 8 cycles.
Croatian: U ispitivanje su uključena 222 bolesnika s relapsnim/refraktornim multiplim mijelomom, koji su bili randomizirani u omjeru 2:1, kako bi primili bortezomib 1,3 mg/m bilo supkutano ili intravenski u 8 ciklusa.
English: In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Croatian: U bolesnika s limfomom plaštenih stanica (ispitivanje LYM-3002), postojala je viša incidencija (56,7% naspram 5,8%) trombocitopenije stupnja ≥ 3 u skupini liječenoj bortezomibom (BR-CAP) u usporedbi sa skupinom koja nije liječena bortezomibom (rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon [R-CHOP]).
English: HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP).
Croatian: Infekcija HBV-om sa smrtonosnim ishodima pojavila se kod 0,8% (n = 2) bolesnika u skupini koja nije liječena bortezomibom (rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon; R-CHOP ) i u 0,4% (n = 1) bolesnika koji su primali bortezomib u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BR-CAP).
English: Time to next therapy Events n (%) Median a
Croatian: Vrijeme do sljedeće terapije događaji n (%)
English: VDDx=vincristine, doxorubicin, dexamethasone; BDx=bortezomib, dexamethasone; TDx=thalidomide, dexamethasone; BTDx=bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
Croatian: VDDx = vinkristin, doksorubicin, deksametazon; BDx = bortezomib, deksametazon; TDx = talidomid, deksametazon; BTDx = bortezomib, talidomid, deksametazon; PN = periferna neuropatija Napomena: Periferna neuropatija je uključila preferirane termine: periferna neuropatija, periferna motorna neuropatija, periferna senzorna neuropatija i polineuropatija.
English: Very common Musculoskeletal pain* Common
Croatian: Vrlo često Mišićno-koštana bol* Često
English: Bortezomib therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL.
Croatian: Liječenje bortezomibom mora se prekinuti do 2 tjedna, dok bolesnik ne dostigne apsolutni broj neutrofila ≥ 750 stanica/μL i broj trombocita ≥ 25 000 stanica/μL.
English: Mantle cell lymphoma (MCL) The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Croatian: Limfom plaštenih stanica (MCL) Sigurnosni profil bortezomiba u 240 bolesnika s MCLom liječenih s 1,3 mg/m bortezomiba u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BR-CAP), naspram 242 bolesnika liječenih s rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom i prednizonom [R-CHOP] bio je relativno sukladan onom zapaženom u bolesnika s multiplim mijelomom s glavnim razlikama koje su opisane ispod.
English: Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m per day)
Croatian: Stoga se ne preporučuje ovaj kombinirani režim s istodobnom primjenom visokih doza citarabina (2g/m na dan) kontinuiranom infuzijom u trajanju od 24 sata.
English: You must read the package leaflets of all medicinal products to be taken in combination with bortezomib for information related to these medicines before starting treatment with bortezomib.
Croatian: Za informacije o svim lijekovima koji se uzimaju zajedno s bortezomibom, morate pročitati pripadajuću uputu o lijeku, prije započinjanja liječenja bortezomibom.
English: • If local injection site reactions occur following bortezomib injection subcutaneously, either a less concentrated bortezomib solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Croatian: • Ako se nakon supkutane injekcije bortezomiba pojave reakcije na mjestu primjene, supkutano se može primijeniti otopina bortezomiba manje koncentracije (1 mg/ml umjesto 2,5 mg/ml) ili se preporučuje prijeći na intravensku injekciju.
English: #, Acne*, Blister*, Pigmentation disorder*
Croatian: mjehur*, poremećaj pigmentacije*
English: Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
Croatian: Klinička djelotvornost kod prethodno neliječenog limfoma plaštenih stanica (MCL) Ispitivanje LYM 3002 bilo je randomizirano, otvoreno ispitivanje faze III koje je uspoređivalo djelotvornost i sigurnost kombinacije bortezomiba, rituksimaba, ciklofosfamida, doksorubicina i prednizona (BR-CAP; n = 243) s onima kombinacije rituksimaba, ciklofosfamida, doksorubicina, vinkristina, i prednizona (R-CHOP; n = 244) u odraslih bolesnika s prethodno neliječenim limfomom plaštenih stanica (Stadij II, III ili IV).
English: • Injection sites must be rotated for successive injections.
Croatian: • Za uzastopne injekcije potrebno je mijenjati mjesta primjene injekcije.
English: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m and 1.3 mg/m2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m and 1.3 mg/m 2, respectively.
Croatian: Srednji ukupni tjelesni klirens nakon prve doze iznosio je 102 l/h kod doze od 1,0 mg/m i 112 l/h kod doze od 1,3 mg/m 2, a nakon sljedećih doza kretao se u rasponu od 15 to 32 l/h kod doze od 1,0
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; B=bortezomib; BDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Croatian: CI = interval pouzdanosti; CR = kompletni odgovor; nCR = blizu kompletnog odgovora; ITT = Populacija bolesnika s namjerom liječenja; RR = stopa odgovora; B = bortezomib; BDx = bortezomib, deksametazon; VDDx = vinkristin, doksorubicin, deksametazon; VGPR = vrlo dobar parcijalni odgovor; PR = parcijalni odgovor; OR = omjer izgleda.
English: Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Croatian: Klinička djelotvornost kod relapsa ili refraktornog multiplog mijeloma Sigurnost i djelotvornost primjene bortezomiba (primijenjenog intravenskom injekcijom) u preporučenoj dozi od 1,3 mg/m procjenjivale su se u 2 ispitivanja: randomiziranom, komparativnom ispitivanju faze III (APEX), u usporedbi s deksametazonom (Dex) u 669 bolesnika s relapsom ili refraktornim multiplim mijelomom koji su prethodno bili primili 1-3 linije terapije te ispitivanju faze II u jednoj skupini od 202 bolesnika s relapsom i refraktornim multiplim mijelomom, koji su prethodno primili najmanje 2 linije terapije i u kojih je bolest napredovala za vrijeme posljednje terapije.
English: Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Croatian: Dehidracija, hipokalijemija*, hiponatrijemija*, abnormalna glukoza u krvi*, hipokalcijemija*, abnormalni enzimi*
English: The resulting solution is then either injected into a vein or under the skin.
Croatian: Ta se otopina zatim daje injekcijom ili u venu ili potkožno.
English: Pegylated liposomal doxorubicin is administered at 30 mg/m on day 4 of the bortezomib treatment cycle as a 1 hour intravenous infusion administered after the bortezomib injection.
Croatian: Pegilirani liposomalni doksorubicin se primjenjuje u dozi od 30 mg/m na 4. dan ciklusa liječenja bortezomibom, putem intravenske infuzije u trajanju od 1 sata, nakon primjene injekcije bortezomiba.
English: If you have not been treated before for mantle cell lymphoma you will receive bortezomib intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Croatian: Ako Vam prethodno nije liječen limfom plaštenih stanica bortezomib ćete primiti intravenski ili supkutano zajedno s lijekovima rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom.
English: Discontinue bortezomib
Croatian: BORTEZOMIB
English: 1.3 The chemical and physical in-use stability of the reconstituted solution has been demonstrated at concentrations of 1 mg/ml and 2.5 mg/ml for 96 hours at 25°C and 8 days at 2-8°C, when stored in the original vial and/or a syringe.
Croatian: 1.3. Dokazana kemijska i fizikalna stabilnost rekonstituirane otopine u primjeni pri koncentraciji od 1 mg/ml i 2,5 mg/ml je 96 sati na temperaturi od 25°C i 8 dana na temperaturi od 2°C do 8°C kada se čuva u originalnoj bočici i/ili štrcaljki.
English: Intravenous use: Add 3.5 ml sodium chloride 0.9% to make 1 mg/ml final concentration.
Croatian: Intravenska primjena: Dodati 3,5 ml 0,9%-tne otopine natrijeva klorida kako bi se pripremila konačna otopina koncentracije 1 mg/ml.
English: Table 7: Adverse reactions in patients with multiple myeloma treated with bortezomib in clinical trials and all post-marketing adverse reactions regardless of indication
Croatian: Tablica 7: Nuspojave u bolesnika s multiplim mijelomom liječenih bortezomibom u kliničkim ispitivanjima i nuspojave nakon stavljanja lijeka u promet neovisno o indikaciji
English: Bortezomib Fresenius Kabi 3.5 mg reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Croatian: Rekonstituirana otopina lijeka Bortezomib Fresenius Kabi 3,5 mg se primjenjuje supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
English: Bortezomib therapy should be withheld until symptoms of the toxicity have resolved to grade 2 or better.
Croatian: Liječenje bortezomibom mora se prekinuti dok se simptomi toksičnosti ne povuku do stupnja 2 ili manjeg.
English: The chemical and physical in-use stability of the reconstituted solution has been demonstrated at concentrations of 1 mg/ml and 2.5 mg/ml for 96 hours at 25°C and 8 days at 2-8°C, when stored in the original vial and/or a syringe.
Croatian: Dokazana kemijska i fizikalna stabilnost rekonstituirane otopine u primjeni pri koncentraciji od 1 mg/ml i 2,5 mg/ml je 96 sati na temperaturi od 25°C i 8 dana na temperaturi od 2°C do 8°C kada se čuva u originalnoj bočici i/ili štrcaljki.
English: Rash*, Pruritus*, Erythema, Dry skin Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis
Croatian: Osip*, pruritus*, eritem, suha koža Manje često Multiformni eritem, urtikarija, akutna febrilna neutrofilna dermatoza, izbijanje kožnih promjena uzrokovano toksičnim učinkom lijeka, toksična epidermalna nekroliza
English: -- -- rest period
Croatian: -- -- period odmora
English: BR-CAP=bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP=rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Croatian: BR-CAP = bortezomib, rituksimab, ciklofosfamid, doksorubicin i prednizon; R-CHOP = rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon; PN = periferna neuropatija Periferna neuropatija uključila je preporučene izraze: periferna senzorna neuropatija, periferna neuropatija, periferna motorna neuropatija i periferna senzorno-motorna neuropatija