natgillin/translations-raw huggingface dataset:
The total storage time for the reconstituted medicinal product should not exceed 96 hours (if stored at 25°C) and 8 days (if stored at 2-8 °C) prior to administration.
Ukupno vrijeme čuvanja rekonstituiranog lijeka prije primjene ne smije prijeći 96 sati (ako se čuva na temperaturi od 25°C) i 8 dana (ako se čuva na temperaturi 2°C -8°C).
Grade 2 with pain or grade 3 (severe symptoms; limiting self care ADL***)
2. stupanj s bolovima ili 3. stupanj (teški simptomi; ograničavaju aktivnosti samozbrinjavanja u svakodnevnom životu***)
For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify bortezomib as outlined in table 1.
Kod neuropatske boli povezane s bortezomibom i/ili periferne neuropatije, pričekajte s primjenom i/ili prilagodite dozu bortezomiba kako je prikazano u Tablici 1.
Retreatment of patients with relapsed multiple myeloma In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
U ispitivanju u kojem se liječenje bortezomibom primijenilo ponovno kod 130 bolesnika s relapsom multiplog mijeloma, koji su prethodno imali barem parcijalni odgovor na režim liječenja koji je uključivao bortezomib, najčešći štetni događaji svih stupnjeva, koji su se pojavili u barem 25% bolesnika bili su trombocitopenija (55%), neuropatija (40%), anemija (37%), proljev (35%) i konstipacija (28%).
• Infection or inflammation of the stomach and intestine
• infekcija ili upala želuca i crijeva
d p-value from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+)
d p-vrijednost iz Cochran Mantel-Haenszelovog hi-kvadrat testa prilagođena za čimbenike stratifikacije; analiza po liniji terapije isključuje stratifikaciju po prethodnim liječenjima *CR+PR+MR **CR = CR, (IF-); nCR = CR (IF+) NA=nije primjenjivo, NE=nije procijenjeno TTP-Vrijeme do progresije bolesti CI = Interval pouzdanosti
Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in table 1 (see section 4.4).
Bolesnici kod kojih se razvije neuropatska bol povezana s bortezomibom i/ili periferna neuropatija liječit će se prema uputama u tablici 1 (vidjeti dio 4.4).
Bortezomib therapy should be withheld when the platelet count is < 25,000/μl or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/μl (see section 4.2).
Liječenje bortezomibom mora se prekinuti kad je broj trombocita < 25 000/µl, a u slučaju kombinacije s melfalanom i prednizonom kad je broj trombocita ≤ 30 000/µl (vidjeti dio 4.2).
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each bortezomib treatment cycle.
Melfalan i prednizon trebaju se primijeniti oralno 1., 2., 3. i 4. dan prvog tjedna svakog ciklusa liječenja bortezomibom.
Time to progression Events n (%) Median a
Vrijeme do progresije događaji n (%) Medijan a
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
U ispitivanju LYM-3002 u kojem je bortezomib primijenjen s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BR-CAP), incidencija periferne neuropatije u kombiniranim režimima prikazana je u tablici ispod:
In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m dose and 89 to 120 ng/ml for the 1.3 mg/m dose.
Nakon sljedećih doza, primijećene srednje vrijednosti maksimalne koncentracije u plazmi bile su u rasponu od 67 do 106 ng/ml kod doze od 1,0 mg/m i 89 do 120 ng/ml kod doze od 1,3 mg/m
- Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
• Ubrizgajte otopinu lijeka intravenskom bolus injekcijom kroz 3-5 sekundi kroz periferni ili centralni venski kateter u venu.
Absorption Following intravenous bolus administration of a 1.0 mg/m and 1.3 mg/m dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Nakon intravenske primjene bolus doze od 1,0 mg/m odnosno 1,3 mg/m u 11 bolesnika s multiplim mijelomom čije su vrijednosti klirensa kreatinina bile više od 50 ml/min, srednje vrijednosti maksimalne koncentracije bortezomiba u plazmi nakon prve doze iznosile su 57 odnosno 112 ng/ml.
An odds ratio (OR) > 1 indicates an advantage for BR-CAP.
Omjera izgleda (OR) > 1 ukazuje na prednost za BR-CAP.
Median OS was 90.7 months for the BR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
Medijan ukupnog preživljenja bio je 90,7 mjeseci za BR-CAP skupinu u usporedbi s 55,7 mjeseci za R-CHOP skupinu (HR=0,66; p=0,001).
Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Stoga je potrebno pomno pratiti bolesnike kad im se daje bortezomib u kombinaciji s jakim inhibitorima enzima CYP3A4 (npr. Ketokonazol, ritonavir).
The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m doses to 104 pediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Farmakokinetika bortezomiba bila je okarakterizirana nakon primjene intravenske bolusne injekcije dva puta tjedno u dozi od 1,3 mg/m u 104 pedijatrijska bolesnika (u dobi od 2-16 godina) s akutnom limfoblastičnom leukemijom (ALL) ili akutnom mijeloidnom leukemijom (AML).
You may experience a reduction in the number of: - platelets, which may make you be more prone to bruising, or to bleeding without obvious injury (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver) - red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness - white blood cells may make you more prone to infections or flu-like symptoms.
krvnih pločica, zbog čega možete biti skloniji pojavljivanju modrica ili krvarenju bez vidljivih ozljeda (npr. krvarenje iz crijeva, želuca, usta i desni ili krvarenje u mozgu ili jetri) - crvenih krvnih stanica, što može prouzročiti anemiju sa simptomima kao što su umor i bljedoća - bijelih krvnih stanica, zbog čega možete biti skloniji infekcijama ili simptomima sličnima gripi.
Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see table 4).
Talidomid se primjenjuje oralno, 50 mg dnevno, od 1. do 14. dana i, u slučaju da se podnosi, doza se povisuje na 100 mg tijekom 15.-28. dana, a potom se može dalje povisiti na 200 mg dnevno od 2. ciklusa (vidjeti Tablicu 4).
Very common Hair disorder* Common
Vrlo često Poremećaj dlakavosti* Često
Table 6: Recommended starting dose modification for bortezomib in patients with hepatic impairment
Tablica 6: Preporučena prilagodba početne doze bortezomiba u bolesnika s oštećenjem jetre
Bortezomib combination treatment with dexamethasone In the absence of any direct comparison between bortezomib and bortezomib in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of bortezomib in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the bortezomib monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Radi nepostojanja bilo kakve izravne usporedbe između bortezomiba i bortezomiba u kombinaciji s deksametazonom u bolesnika s progresivnim multiplim mijelomom, provedena je statistička analiza odgovarajućih parova, radi usporedbe rezultata nerandomizirane skupine bortezomiba u kombinaciji s deksametazonom (otvoreno ispitivanje faze II, MMY-2045), s rezultatima koji su dobiveni u skupini na monoterapiji bortezomibom iz različitih ispitivanja faze III (M34101-039 [APEX] i DOXIL MMY-3001), u istoj indikaciji.
- Flush the peripheral or intravenous catheter with sterile, sodium chloride 9 mg/ml (0.9%) solution.
• Isperite periferni ili centralni venski kateter sterilnom 0,9%-tnom otopinom natrijevog klorida (9 mg/ml).
Hepatitis B virus (HBV) reactivation and infection Mantle cell lymphoma
Reaktivacija virusa hepatitisa B (HBV) i infekcija Limfom plaštenih stanica
You will have to take regular blood tests before and during your treatment with bortezomib, to check your blood cell counts regularly.
Imat ćete redovne kontrole krvi prije i tijekom liječenja bortezomibom, kako bi se redovito provjerio broj krvnih stanica.
Time related events
Odnos događaja
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive bortezomib together with two other medicines; melphalan and prednisone.
Ukoliko se prethodno niste liječili od multiplog mijeloma i niste predviđeni za transplantaciju krvotvornih matičnih stanica, bortezomib ćete primiti u kombinaciji s druga dva lijeka; melfalan i prednizon.
What Bortezomib Fresenius Kabi looks like and contents of the pack Bortezomib powder for solution for injection is a white to off-white lyophilized powder or cake.
Kako Bortezomib Fresenius Kabi izgleda i sadržaj pakiranja Bortezomib Fresenius Kabi prašak za otopinu za injekciju je bijeli do gotovo bijeli liofilizirani prašak ili kolačić.
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).
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).
h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Uključuje sve radiološke CR+CRu+PR prema IRC neovisno o potvrdi koštanom srži i LDH.
In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine-doxorubicin-dexamethasone [VDDx, n=242].
U ispitivanju IFM-2005-01 bortezomib u kombinaciji s deksametazonom [BDx, n = 240] bio je uspoređen s vinkristinom-doksorubicinom-deksametazonom [VDDx, n = 242].
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).
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).
d Based on Log rank test stratified with IPI risk and stage of disease.
Temeljeno na Log rank testu stratificiranom s IPI rizikom i stadijem bolesti.
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.
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.
Note: An OR > 1 indicates an advantage for B-containing induction therapy.
Napomena: OR > 1 ukazuje na prednost za uvodno liječenje koje sadrži B.
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).
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).
Response Rate at 8 cycles n (%) ORR (CR+PR) p-value a
Stopa odgovora u 8 ciklusa n (%) ORR (CR+PR) p-vrijednost a
* Survival update based on a median duration of follow-up at 60.1 months mo: months
* Ažurirano preživljenje na temelju medijana trajanja praćenja od 60,1 mjesec CI = Interval pouzdanosti
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.
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.
• to report any adverse event, or medication error experienced with the administration of bortezomib 3.5 mg.
• važnost prijave štetnih događaja ili medikacijskih pogrešaka kod primjene bortezomiba 3,5 mg.
You must not breast-feed while using bortezomib.
Ne smijete dojiti dok primate bortezomib.
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).
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%).
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.
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.
Response Rate at 4 cycles n (%) ORR (CR+PR) p-value a
Stopa odgovora u 4 ciklusa n (%) ORR (CR+PR) p-vrijednost a
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).
Ukupna incidencija infekcija hepatitisom B bila je slična u bolesnika liječenih s BR-CAP i liječenih s R-CHOP (0,8% odnosno
• Bortezomib 3.5 mg can be administered both intravenously and subcutaneously
• bortezomib 3,5 mg može biti primijenjen intravenski i supkutano
• storage precautions for reconstituted solution • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
• prikaz potencijalnih rizika kod primjene uključujući predoziranje, poddoziranje te da je nehotična intratekalna primjena rezultirala smrtnim ishodom
Bortezomib is for single use only.
Bortezomib je samo za jednokratnu primjenu.
10 ml clear Type I glass vial with grey chlorobutyl rubber stopper and blue aluminium flip-off over seal, containing 3.5 mg bortezomib.
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.
What Bortezomib Fresenius Kabi is and what it is used for
Što je Bortezomib Fresenius Kabi i za što se koristi
- If, after bortezomib has been held, the toxicity does not resolve, as defined above, then bortezomib must be discontinued.
, toksičnost ne povuče, kako je definirano iznad, bortezomib se mora prestati primjenjivati.
Aseptic technique must be strictly observed throughout the handling of bortezomib, since it contains no preservative.
Aseptična tehnika mora se strogo poštovati tijekom cijelog postupka rukovanja bortezomibom, budući da lijek ne sadrži konzervanse.
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).
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).
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.
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.
• Inject the solution subcutaneously, under a 45-90°angle.
• Primijenite injekciju supkutano, pod kutem od 45°-90°.
Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
Herpes zoster (uključujući diseminirani i oftalmički), pneumonija*, herpes simpleks*, gljivična infekcija*
Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Tablica 5: Prilagodbe doza tijekom liječenja za bolesnike s prethodno neliječenim limfomom plaštenih stanica Toksičnost
• 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
• 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
1 mg/m to 0.7 mg/m
mg/m na 0,7 mg/m
• Cancer of the skin
• rak kože
Subcutaneous use: Add 1.4 ml sodium chloride 0.9% to make 2.5 mg/ml final concentration.
Supkutana primjena: Dodati 1,4 ml 0,9%-tne otopine natrijeva klorida kako bi se pripremila konačna otopina koncentracije 2,5 mg/ml.
Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (including thrombocytopenic purpura)
Diseminirana intravaskularna koagulacija, trombocitoza*, sindrom hiperviskoznosti, nespecificirani poremećaj trombocita, trombotička mikroangiopatija (uključujući trombocitopenijsku purpuru)
Week B (1.3 mg/m
Tjedan B (1,3 mg/m2)
Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy
Neuropatije*, motorna neuropatija*, gubitak svijesti (uključujući sinkopu), encefalopatija*, periferna senzorno-motorna neuropatija, omaglica*, disgeuzija*, autonomna neuropatija
- 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
• 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
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).
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
Uncommon Autonomic nervous system imbalance
Manje često Neravnoteža autonomnog živčanog sustava Poremećaji oka Često
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.
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.
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]).
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]).
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).
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).
Time to next therapy Events n (%) Median a
Vrijeme do sljedeće terapije događaji n (%)
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.
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.
Very common Musculoskeletal pain* Common
Vrlo često Mišićno-koštana bol* Često
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.
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.
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.
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.