natgillin/translations-raw huggingface dataset:
Patients in the BzmbTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Medijan dobi bolesnika u BzmbTDx odnosno TDx skupini, bio je 57 naspram 56 godina, 99 % naspram 98 % bolesnika bili su bijele rase, a 58 % naspram 54 % bili su muškarci.
Common Hypertension*, Hypotension*, Orthostatic hypotension
Hipertenzija*, hipotenzija*, ortostatska hipotenzija
Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with bortezomib at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2).
Izloženost bortezomibu povećana je u bolesnika s umjereno ili teško oštećenom jetrom; te bolesnike treba liječiti smanjenim dozama bortezomiba i pomno ih pratiti na znakove toksičnosti (vidjeti dijelove 4.2 i 5.2).
The incidence of herpes zoster among patients in the BzmbR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Incidencija herpes zostera među bolesnicima u BzmbR-CAP skupini bila je 10,7 % za bolesnike kojima nije bila primijenjena antivirusna profilaksa u uspredbi s 3,6 % za bolesnike kojima je primijenjena antivirusna profilaksa (vidjeti dio 4.4).
The following medicinal products are given on day 1 of each Bortezomib SUN 21-day treatment cycle as intravenous infusions:
Sljedeći lijekovi daju se 1. dana svakog ciklusa liječenja Bortezomib SUN-om u trajanju od 21 dan kao infuzije u venu:
Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Klinička djelotvornost uz supkutanu primjenu bortezomiba u bolesnika s relapsnim/refraktornim multiplim mijelomom
Bortezomib is highly selective for the proteasome.
Bortezomib je visoko selektivan za proteasome.
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded.
Bolesnici s osnovnom periferenom neuropatijom stupnja ≥ 2 ili s brojem trombocita < 50 000/µl bili su isključeni.
Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Rituksimab 375 mg/m2, ciklofosfamid 750 mg/m2 i doksorubicin 50 mg/m2.
Incidence of PN (%) All GradePN ≥ Grade 2 PN ≥ Grade 3 PN Discontinuation due to PN (%)
Svi stupnjevi PN ≥ Stupanj 2 PN ≥ Stupanj 3 PN
19.9 mo
19,9 mjeseci
Bortezomib SUN is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Bortezomib SUN primjenjuje se u venu ili potkožno 1., 4., 8. i 11. dan, nakon čega slijedi „period odmora” bez liječenja.
Patients with moderate or severe hepatic impairment should be started on Bortezomib SUN at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
U bolesnika s umjerenim ili teškim oštećenjem jetre liječenje bortezomibom treba započeti smanjenom dozom od 0,7 mg/m2 po injekciji tijekom prvog ciklusa liječenja, a naknadno povećanje doze na 1,0 mg/m2 ili daljnje smanjenje doze na 0,5 mg/m2 može se razmotriti na temelju podnošljivosti liječenja za bolesnika (vidjeti Tablicu 6 i dijelove 4.4 i 5.2).
• different reconstitution requirements for intravenous (IV) or subcutaneous (SC) use
• različite zahtjeve za rekonstituciju za intravensku (i.v.) ili supkutanu (s.c.) primjenu lijeka
g P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
g P-vrijednost Cochran Mantel-Haenszelovog hi-kvadrat testa, s IPI i stadijem bolesti kao stratifikacijskim faktorima.
Table 13: Efficacy results from study MMY-3010 Endpoints
Tablica 13: Rezultati djelotvornosti iz ispitivanja MMY-3010 Mjere ishoda
Overall response (CR+CRu+PR)h n(%)
Ukupni odgovor (CR+CRu+PR)h n(%)
In particular, tell your doctor if you are using medicines containing any of the following active substances: - ketoconazole, used to treat fungal infections - ritonavir, used to treat HIV infection - rifampicin, an antibiotic used to treat bacterial infections - carbamazepine, phenytoin or phenobarbital used to treat epilepsy - St. John's Wort (Hypericum perforatum), used for depression or other conditions - oral antidiabetics
Posebno naglasite svome liječniku ako koristite lijek koji u svom sastavu ima sljedeće tvari: - ketokonazol, za liječenje gljivičnih infekcija - ritonavir, uzima se za liječenje HIV infekcije - rifampicin, antibiotik za liječenje bakterijskih infekcija - karbamazepin, fenitoin ili fenobarbital za liječenje epilepsije - gospinu travu (Hypericum perforatum) koja se primjenjuje kod depresije ili drugih stanja
In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus.
Uz perifernu neuropatiju, nekim nuspojavama može pridonijeti i autonomna neuropatija, kao što je posturalna hipotenzija i teški zatvor s ileusom.
CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio;
CR=Kompletni odgovor; CRu=Nepotvrđeni kompletni odgovor; PR=Djelomični odgovor; CI=Interval pouzdanosti, HR=Omjer hazarda; OR=Omjer izgleda; ITT=Populacija namijenjena za liječenje
It is recommended that patients receive 2 cycles of Bortezomib SUN following a confirmation of a complete response.
Preporučuje se da bolesnici prime još 2 ciklusa liječenja Bortezomib SUN-om nakon potvrđenog kompletnog odgovora.
- swelling of body, to include eyes and other parts of the body - shivering - redness and pain at injection site - general ill feeling - weight loss - weight increase.
- oticanje tijela, uključujući oči i druge dijelove tijela - drhtanje - crvenilo i bol na mjestu primjene injekcije - opći osjećaj bolesti - gubitak težine - povećanje težine.
The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
Medijan dobi bolesnika u ispitivanju bio je 71 godina, 50 % bili su muškarci, 88 % bili su bijele rase a medijan rezultata funkcionalnog stanja po Karnofskom za bolesnike je bio 80.
Once weekly Bortezomib SUN (cycles 5-9)
Bortezomib SUN jednom tjedno (5. - 9. ciklus)
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***)
A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Provedeno je farmakokinetičko ispitivanje u bolesnika s različitim stupnjevima oštećenja bubrega koji su bili podijeljeni prema vrijednostima klirensa kreatinina (CrCL) u sljedeće skupine: Normalno (CrCL ≥ 60 ml/min/1,73 m2, n=12), blago (CrCL=40 - 59 ml/min/1,73 m2, n=10), umjereno (CrCL=20 - 39 ml/min/1,73 m2, n=9) i teško (CrCL < 20 ml/min/1,73 m2, n=3).
Bortezomib SUN contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Bortezomib SUN sadrži djelatnu tvar bortezomib, koja se naziva „inhibitor proteasoma”.
The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib SUN are provided with educational materials.
Nositelj odobrenja će osigurati dostupnost edukacijskog materijala svim zdravstvenim radnicima koji su uključeni u postupak propisivanja, doziranje, pripremu i primjenu Bortezomib SUN-a.
When Bortezomib SUN is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Kada se Bortezomib SUN daje zajedno s talidomidom, morate slijediti program namijenjen prevenciji trudnoće za talidomid (vidjeti uputu o lijeku za talidomid).
The benefit/risk ratio should be considered prior to continuing bortezomib therapy.
Potrebno je razmotriti omjer koristi i rizika prije nastavka liječenja bortezomibom.
OR; 95% CI; P valuea
OR; 95 % CI; P
Response Evaluable Population n=73
Populacija procjenjiva na odgovor n=73
- The other ingredient is mannitol (E421).
- Pomoćna tvar je manitol (E421).
Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose, schedule or route of administration to subcutaneous (see section 4.2).
Bolesnike kod kojih se pojavi nova ili im se pogorša postojeća periferna neuropatija mora se neurološki pregledati, a po potrebi im treba promijeniti dozu, vremenski raspored primjene ili promijeniti put primjene na supkutani (vidjeti dio 4.2).
ORe (95% CI)=1.688 p-valueg=0.007
ORe (95 % CI)=1,688 p-vrijednostg=0,007
Common Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Hiperbilirubinemija*, abnormalan nalaz analize proteina*, smanjena težina, povećana težina
Bzmb=bortezomib; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Bzmb=bortezomib; Dx=deksametazon CR=Kompletni odgovor; nCR=blizu kompletnog odgovora
Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 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/m2 odnosno 1,3 mg/m2 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.
The duration of overall response was 21.4 months longer in the BzmbR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Trajanje ukupnog odgovora bilo je 21,4 mjeseca duže u BzmbR-CAP skupini (medijan 36,5 mjeseci naspram 15,1 mjeseci u R-CHOP skupini).
h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
h Uključuje sve radiološke CR+CRu+PR prema IRC neovisno o potvrdi koštanom srži i LDH.
Dosage adjustments for transplant eligible patients
Prilagodbe doze za bolesnike za koje je prikladna transplantacija
> 1.0 x - 1.5 x ULN Any
> 1,0 x - 1,5 x GGN Bilo koja
- If platelet counts < 25,000 cells/μl.
Ako je broj trombocita < 25 000 stanica/μl.
Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
≥ 3 (24% naspram 19% u 1. bloku i 22% naspram 11% u 2. bloku), povišen ALT (17% naspram 8% u 2. bloku), hipokalemija (18% naspram 6% u 1. bloku i 21% naspram 12% u 2. bloku), te hiponatrijemija (12% naspram 5% u 1. bloku i 4% naspram 0 u 2. bloku).
The incidence of all grade peripheral neuropathy with bortezomib administered intravenously was lower in the historical studies with bortezomib administered intravenously than in study MMY-3021.
Incidencija periferene neuropatije svih stupnjeva uz intravensku primjenu bortezomiba bila je niža u prethodnim ispitivanjima s bortezomibom primijenjenim intravenski, nego u ispitivanju MMY-3021.
c Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
p < 0,0001 c Populacija s terapijskim odgovorom uključuje bolesnike koji su imali mjerljivu bolesti na početku liječenja i primili su najmanje 1 dozu ispitivanog lijeka.
In patients developing PRES, bortezomib should be discontinued.
U bolesnika u kojih se razvije PRES mora se prekinuti primjena bortezomiba.
When compared to patients with normal hepatic function, mild hepatic impairment did not alter dosenormalised bortezomib AUC.
U usporedbi s bolesnicima s normalnom funkcijom jetre, blago oštećenje funkcije jetre nije promijenilo prema dozi normalizirani AUC bortezomiba.
Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Deboronirani metaboliti bortezomiba ne djeluju kao inhibitori 26S proteasoma.
Bortezomib intravenous arm
Bortezomib intravenska skupina
d Based on Log rank test stratified with IPI risk and stage of disease.
d Temeljeno na Log rank testu stratificiranom s IPI rizikom i stadijem bolesti.
Bortezomib SUN should not be given by other routes.
Bortezomib SUN ne smije se primijeniti drugim putevima primjene.
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 %).
Withhold Bortezomib SUN treatment until symptoms of toxicity have resolved.
Prekinuti liječenje Bortezomib SUN-om dok se simptomi toksičnosti ne povuku.
LIST OF EXCIPIENTS Excipient: mannitol (E421)
POPIS POMOĆNIH TVARI Pomoćna tvar: manitol (E421)
Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
Reaktivacija virusa hepatitisa B (HBV) i infekcija
Six percent of patients had an adverse local reaction to subcutaneous administration, mostly redness.
Šest posto bolesnika imalo je nuspojave na mjestu supkutane primjene, uglavnom crvenilo.
Melphalan (9 mg/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Melfalan (9 mg/m2) i prednizon (60 mg/m2) primjenjuju kroz usta i daju se 1., 2., 3. i 4. dana prvog tjedna primjene tijekom svih ciklusa.
TTP, days [95% CI]
TTP, mjeseci (95 % CI)
Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells and MCL cells, the complications of tumour lysis syndrome may occur.
Budući da je bortezomib citotoksično sredstvo i može brzo uništiti zloćudne plazma stanice i stanice limfoma plaštenih stanica, mogu se pojaviti komplikacije zbog sindroma lize tumora.
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/μl, 90% of 21 patients had a count ≤ 25,000/μl 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 ≤ 25,000/μl during the study.
U bolesnika s uznapredovalim mijelomom, težina trombocitopenije bila je povezana s brojem trombocita prije liječenja: kod početnog broja trombocita < 75 000/μl, 90 % od 21 bolesnika imalo je ≤ 25 000/μl trombocita za vrijeme ispitivanja, uključujući njih 14 % s < 10 000/μl; nasuprot tome, kod početnog broja trombocita > 75 000/μl, samo 14 % od 309 bolesnika imalo je ≤ 25 000/μl trombocita za vrijeme ispitivanja.
e Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
e Koristi se Mantel-Haenszelova procjena zajedničkog omjera izgleda za stratificirane tablice, s IPI rizikom i stadijem bolesti kao stratifikacijskim faktorima.
In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
U ispitivanju kod bolesnika s prethodno neliječenim limfomom plaštenih stanica, 42,9 % i 10,4 % bolesnika izloženih bortezomibu bilo je dobi unutar raspona 65 - 74 godine odnosno ≥ 75 godina starosti.
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).
1.3 The reconstituted solution is preservative free and should be used immediately after preparation.
1.3 Rekonstituirana otopina ne sadrži konzervanse i treba ju primijeniti odmah nakon pripreme.
Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Tablica 1: Preporučene* prilagodbe doziranja kod neuropatije povezane s bortezomibom Težina neuropatije
- 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.
Week Bzmb (1.3 mg/m2) Day 1, 4
Tjedan Bzmb (1,3 mg/m2) Dan 1, 4
Elderly MCL patients 42.9% and 10.4% of patients in the BzmbR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
42,9 % i 10,4 % bolesnika u sklupini BzmbR-CAP bilo je dobi unutar raspona 65-74 godine odnosno ≥ 75 godina starosti.
A biological plausibility supports the association between bortezomib and chalazion/blepharitis; theoretically, bortezomib-related myelosuppression may facilitate viral infections such as herpes zoster thereby promoting chalazia.
Biološka plauzibilnost podupire povezanost između primjene bortezomiba i nastanka halaciona/blefaritisa; teoretski, mijelosupresija povezana s primjenom bortezomiba može olakšati pojavu virusne infekcije kao što je herpes zoster što pospješuje nastanak halaciona.
The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for
Demografski podaci i karakteristike bolesti na početku ispitivanja općenito su bile dobro izbalansirane unutar dvije liječene skupine: medijan dobi bolesnika bio je 66 godina, 74 % su bili muškarci, 66 % su bili bijele rase, a 32 % azijskog porijekla, 69 % bolesnika imalo je pozitivan aspirat koštane srži i/ili pozitivnu biopsiju koštane srži na limfom plaštenih stanica, 54 % bolesnika imalo je skor Internacionalnog indeksa prognoze (od engl.
Patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Bolesnici koji primaju bortezomib u kombinaciji s talidomidom moraju se pridržavati programa za sprječavanje trudnoće.
# Post-marketing adverse reaction regardless of indication
# Nuspojave nakon stavljanja lijeka u promet neovisno o indikaciji
Bortezomib SUN treatment must be withheld at the onset of any ≥ Grade 3 bortezomib-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section .4).
Liječenje Bortezomib SUN-om mora se prekinuti u slučaju nastupa bilo koje nehematološke toksičnosti ≥ stupnja 3 povezane s bortezomibom (isključujući neuropatiju) ili hematološke toksičnosti ≥ stupnja 3 (također vidjeti dio 4.4).
If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Ako se primijeti promjena boje ili prisutnost čestica, rekonstituirana otopina mora se odbaciti.
An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of bortezomib versus the intravenous administration.
U otvorenom, randomiziranom ispitivanju neinferiornosti, faze III uspoređena je djelotvornost i sigurnost supkutane primjene bortezomiba u odnosu na intravensku primjenu.
1 year survival, [95% CI]
1-godišnje preživljenje, (95 % CI)
Reduce Bortezomib SUN to 1.0 mg/m2
Smanjiti dozu Bortezomib SUN-a na 1,0 mg/m2
France tel. +33 1 41 44 44 50
+33 1 41 44 44 50 Italia
Change Bortezomib SUN treatment schedule to 1.3 mg/m2 once per week
Promijeniti raspored primjene Bortezomib SUN-a na 1,3 mg/m2 jedanput tjedno
Age The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric 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/m2 u 104 pedijatrijska bolesnika (u dobi od 2-16 godina) s akutnom limfoblastičnom leukemijom (ALL) ili akutnom mijeloidnom leukemijom (AML).
A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzmbR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Medijan od 6 ciklusa primili su bolesnici u obje liječene skupine, a 14 % ispitanika u BzmbR-CAP skupini i 17 % bolesnika u R-CHOP skupini primilo je 2 dodatna ciklusa.
b Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
b Procjena omjera hazarda temelji se na Coxovom modelu stratificiranom prema IPI riziku i stadiju bolesti.
In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
U ispitivanjima u kojima je bortezomib bio primijenjen kao uvodno liječenje u kombinaciji s deksametazonom (ispitivanje IFM-2005-01), i deksametazonom-talidomidom (ispitivanje MMY3010), incidencija periferne neuropatije u kombiniranim režimima prikazana je u tablici dolje:
b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin,
Procjena omjera hazarda (HR) temelji se na Coxovom modelu proporcionalnog rizika prilagođenom prema čimbenicima stratifikacije: β2-mikroglobulinu, albuminu i regiji.
Thalidomide causes birth defects and foetal death.
Talidomid uzrokuje prirođene poremećaje i dovodi do smrti fetusa.
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).
Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Manje često Cushingov sindrom*, hipertireoza*, neadekvatno lučenje antidiuretskog hormona
Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with bortezomib.
Otvoreno ispitivanje faze II s jednom skupinom, MMY-2036 (RETRIEVE), bilo je provedeno kako bi se utvrdile djelotvornost i sigurnost ponovljenog liječenja bortezomibom.
Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4b
Dan 1, 2, 3, 4 Dan 8, 9, 10, 112. do 4.b ciklus
You will have to take regular blood tests before and during your treatment with Bortezomib SUN, to check your blood cell counts regularly.
Imati ćete redovne kontrole krvi prije i tijekom liječenja Bortezomib SUN-om kako bi se redovito provjerio broj krvnih stanica.
> 1.5 x - 3 x ULN Any
> 1,5 x - 3 x GGN Bilo koja
Post-marketing adverse reactions not seen in clinical trials are also included.
Također su uključene nuspojave zabilježene nakon stavljanja lijeka u promet, a koje nisu bile primijećene u kliničkim ispitivanjima.