natgillin/translations-raw huggingface dataset:
ORe (95% CI)=1.688 (1.148; 2.481) p-valueg=0.007
ORe (95% CI)=1,688 (1,148; 2,481) p-vrijednostg=0,007
Combination therapy with pegylated liposomal doxorubicin
Kombinirano liječenje s pegiliranim liposomalnim doksorubicinom
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 leukaemia (ALL) or acute myeloid leukaemia (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).
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
• a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate Bortezomib Accord dose.
• instrument za izračun doze koji omogućava propisivaču lijeka da na osnovu unosa podataka o visini i težni bolesnika izračuna tjelesnu površinu (engl. body surface area, BSA), te tako odredi potrebnu dozu lijeka Bortezomib Accord.
> 1.0 x −1.5 x ULN Any
> 1,0x−1,5x GGN bilo koja
Hazard ratiob (95% CI) p-valuec a Kaplan-Meier estimate.
Omjer hazardab (95% CI) p-vrijednost a Kaplan-Meierova analiza.
You will have to take regular blood tests before and during your treatment with Bortezomib Accord, to check your blood cell counts regularly.
Imati ćete redovne kontrole krvi prije i tijekom liječenja lijekom Bortezomib Accord, kako bi se redovito provjerio broj krvnih stanica.
For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib Accord as outlined in Table 1.
Kod neuropatske boli povezane s bortezomibom i/ili periferne neuropatije, pričekajte s primjenom i/ili prilagodite dozu lijeka Bortezomib Accord kako je prikazano u Tablici 1.
The MAH shall ensure thatall healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib Accord are provided with educational material.
Nositelj odobrenja će osigurati dostupnost edukacijskog materijala svim zdravstvenim radnicima koji su uključeni u postupak propisivanja, doziranje, pripremu i primjenu lijeka Bortezomib Accord.
• Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μL
• Broj trombocita mora biti ≥ 100 000 stanica/μL i apsolutni broj neutrofila mora biti ≥ 1500 stanica/μL
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
U bolesnika s limfomom plaštenih stanica (ispitivanje LYM-3002), incidencija infekcije virusom herpes zoster bila je 6,7% u BzR-CAP skupini i 1,2% u R-CHOP skupini (vidjeti dio 4.8).
The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible.
Kinetika inhibicije proteasoma ocjenjivala se in vitro i pokazalo se da se bortezomib razdvaja od proteasoma uz t½ od 20 minuta,
No clinical data are available for bortezomib with regard to exposure during pregnancy.
Trudnoća Nema dostupnih kliničkih podataka o izloženosti bortezomibu tijekom trudnoće.
Absorption 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.
Apsorpcija 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 overall incidence of hepatitis B infections was similar in patients treated with BzR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Ukupna incidencija infekcija hepatitisom B bila je slična u bolesnika liječenih s BzR-CAP i liječenih s R-CHOP (0,8% odnosno 12%).
• Feeling sick (nausea) or vomiting, loss of appetite
• vrućica • mučnina ili povraćanje, gubitak apetita
Patients in the BzTDx 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 BzTDx odnosno TDx skupini, bio je 57 naspram 56 godina, 99% naspram 98% bolesnika bili su bijele rase, a 58% naspram
• ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
neutropenija stupnja 4 koja traje duže od 7 dana, broj trombocita < 10 000 stanica/μL
Mantle cell lymphoma (MCL)
Limfom plaštenih stanica (MCL)
Male patients and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Muškarci i žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i do
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 MMY-3010), incidencija periferne neuropatije u kombiniranim režimima prikazana je u tablici dolje:
• Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
• Isperite periferni ili centralni venski kateter sterilnom 0,9%-tnom otopinom natrijevog klorida (9 mg/ml).
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).
Bortezomib Accord will be administered by a health care professional experienced in the use of cytotoxic medicines.
Bortezomib Accord će Vam primijeniti zdravstveni radnik koji ima iskustvo u primjeni citotoksičnih lijekova.
Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
Vrlo rijetko su bili zabilježeni slučajevi John Cunningham (JC) virusne infekcije nepoznate uzročnosti, koji su rezultirali progresivnom multifokalnom leukoencefalopatijom (PML) i smrću kod bolesnika liječenih bortezomibom.
• Bortezomib Accord 3.5 mg can be administered both intravenously and subcutaneously, while Bortezomib Accord 1 mg can be administered only intravenously
• Bortezomib Accord 3,5 mg može biti primijenjen intravenski i supkutano, dok Bortezomib Accord 1 mg može biti primijenjen samo intravenski
• Inject the solution subcutaneously, under a 45-90°angle.
• Primjenite injekciju supkutano, pod kutem od 45-90°.
Bz= Bortezomib Accord; 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
Bz=Bortezomib Accord; 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.
PR=Partial Response; MR=Minimal response
f CR=Kompletni odgovor; PR=Parcijalni odgovor.
Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Multipli mijelom Za nuspojave u Tablici 7 ispitivači su smatrali da postoji barem mogućnost ili vjerojatnost uzročno-posljedične povezanosti s bortezomibom.
Note: An OR > 1 indicates an advantage for Bz-containing induction therapy.
Napomena: OR > 1 ukazuje na prednost za uvodno liječenje koje sadrži Bz.
• Decreased sex drive
• smanjena spolna želja • slinjenje
Both men and women receiving Bortezomib Accord must use effective contraception during and for up to 3 months after treatment.
I muškarci i žene moraju koristiti djelotvorna kontracepcijska sredstva dok su na liječenju lijekom Bortezomib Accord, te do 3 mjeseca nakon liječenja.
The usual starting dose of Bortezomib Accord is 1.3 mg/m2 body surface area twice a week.
Uobičajena početna doza lijeka Bortezomib Accord je 1,3 mg/m2 površine tijela, dva puta tjedno.
Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake
Note: An OR > 1 indicates an advantage for Bz-containing induction therapy
Napomena: OR > 1 ukazuje na prednost za uvodno liječenje koje sadrži Bz
The following medicinal products are administered on day 1 of each bortezomib 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Sljedeći lijekovi primjenjuju se 1. dan svakog 3-tjednog ciklusa liječenja bortezomibom kao intravenske infuzije: rituksimab 375 mg/m2, ciklofosfamid 750 mg/m2 i doksorubicin 50 mg/m2.
Very Common Hair disorder* Common
Vrlo često Poremećaj dlakavosti* Često
1 prior line of therapy > 1 prior line of therapy
> 1 linije prethodnog liječenja prethodne linije
Events (deaths) n (%) Mediana
događaji (smrti) n (%)
Aseptic technique must be strictly observed throughout the handling of Bortezomib Accord, since it contains no preservative.
Aseptična tehnika mora se strogo poštovati tijekom cijelog postupka rukovanja lijekom Bortezomib Accord, budući da lijek ne sadrži konzervanse.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
rizika za 45 % (95 % CI; 29-57 %, p < 0,0001) za bolesnike koji su liječeni kombinacijskom terapijom bortezomiba i pegiliranog liposomalnog doksorubicina.
• Pneumonia • Loss of appetite
• gubitak apetita
• that Bortezomib Accord 1 mg is only for intravenous use
• Bortezomib Accord 1 mg namijenjen je samo za intravensku primjenu
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%).
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.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE 1 mg
Retreatment of patients with relapsed multiple myeloma
Ponavljanje liječenja u bolesnika s relapsom multiplog mijeloma
The incidence of herpes zoster among patients in the Bz+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Incidencija herpes zostera u skupini bolesnika koja je primala Bz+M+P bila je 17% u onih kojima se nije primijenila antivirusna profilaksa, u usporedbi s 3% bolesnika kojima se primijenila antivirusna profilaksa.
Intent to Treat Populationb n=74
Populacija uključena u ispitivanjeb n=74
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m2) and prednisone (60 mg/m2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma.
Klinička djelotvornost u prethodno neliječenih bolesnika s multiplim mijelomom Prospektivno, međunarodno, randomizirano (1:1) kliničko ispitivanje faze III otvorenog tipa (MMY-3002 VISTA) koje je uključilo 682 bolesnika, provedeno je da bi se utvrdilo hoće li bortezomib (1,3 mg/m2 primijenjen intravenskom injekcijom) u kombinaciji s melfalanom (9 mg/m2) i prednizonom (60 mg/m2) rezultirati boljim vremenom do progresije bolesti (TTP od engl. time to progression) u usporedbi s melfalanom (9 mg/m2) i prednizonom (60 mg/m2) u prethodno neliječenih bolesnika s multiplim mijelomom.
Injection sites should be rotated for successive injections.
Mjesto primjene injekcije treba mijenjati kod svake uzastopne injekcije.
PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances.
PRES je rijetko neurološko stanje koje je često reverzibilno, brzo se razvija, a može biti predstavljeno napadajima, hipertenzijom, glavoboljom, letargijom, smetenošću,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 3.5 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE 3,5 mg
Bz n=200a
Bz n=200
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each Bortezomib Accord treatment cycle.
Melfalan i prednizon trebaju se primijeniti peroralno 1., 2., 3. i 4. dan prvog tjedna svakog ciklusa liječenja lijekom lijekom Bortezomib Accord.
> 1.5 x −3 x ULN
> 1,5x−3x GGN bilo koja
Table 6: Recommended starting dose modification for Bortezomib Accord in patients with hepatic impairment
Tablica 6: Preporučena prilagodba početne doze lijeka Bortezomib Accord u bolesnika s oštećenjem jetre
You may also be given Bortezomib Accord together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Bortezomib Accord Vam se također može dati zajedno s lijekovima koji se zovu pegilirani liposomalni doksorubicin ili deksametazon.
In study IFM-2005-01 bortezomib combined with dexamethasone [BzDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
U ispitivanju IFM-2005-01 bortezomib u kombinaciji s deksametazonom [BzDx, n=240] bio je uspoređen s vinkristinom-doksorubicinom-deksametazonom [VDDx, n=242].
Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Manje često Cushingov sindrom*, hipertireoza*, neadekvatno lučenje antidiuretskog hormona
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 (BzR-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 (BzR-CAP), jedna od najčešćih hematoloških toksičnosti bila je prolazna trombocitopenija.
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 (BzR-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 (BzR-CAP).
A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzR-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 BzR-CAP skupini i 17% bolesnika u R-CHOP skupini primilo je 2
Bortezomib Accord should not be given by other routes.
Accord se ne smije primijeniti drugim putevima primjene.
The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-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.
Sigurnosni profil bortezomiba u 240 bolesnika s MCLom liječenih s 1,3 mg/m2 bortezomiba u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BzR-CAP), naspram242 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.
• Serious allergic reaction (anaphylactic shock) 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
• ozbiljna alergijska reakcija (anafilaktički šok) 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
rest period
Period odmora
For Bortezomib Accord dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Za prilagodbu doze lijeka lijeka Bortezomib Accord u kombiniranom liječenju slijedite smjernice za prilagodbu doze opisane u tekstu iznad, pod monoterapija.
• to report any adverse event, or medication error experienced with the administration of Bortezomib Accord.
• važnost prijave štetnih događaja ili medikacijskih pogrešaka kod primjene Bortezomib Accord.
*RR (Post-transplant)
*RR (Posttransplantacijska)
Other medicines and Bortezomib Accord
Drugi lijekovi i Bortezomib Accord
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (Vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
• Increase of platelets or plasma cells (a type of white cell) in the blood
• povećanje krvnih pločica ili plazma stanica (vrsta bijelih krvnih stanica) u krvi • krvni ugrušak u malim krvnim žilama (trombotička mikroangiopatija)
Bortezomib Accord treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however Bortezomib Accord may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
4.2 Doziranje i način primjene Liječenje lijekom lijekom Bortezomib Accord se mora započeti pod nadzorom liječnika koji je iskusan u liječenju bolesnika s rakom, međutim Bortezomib Accord može primijeniti zdravstveni radnik koji je iskusan u primjeni kemoterapije.
Bortezomib Accord therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Liječenje lijekom Bortezomib Accord mora se prekinuti dok se simptomi toksičnosti ne povuku do stupnja 2 ili manjeg.
Reduce Bortezomib Accord to 1.0 mg/m2
Smanjiti dozu lijeka lijeka Bortezomib Accord na 1,0 mg/m2
• instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction
• upute za propisivanje i primjenu koje uključuju duljinu i broj ciklusa, radi smanjenja rizika medikacijskih pogrešaka i pogrešaka pri pripremi moguće uzrokovane zbog postojanja dva različita režima kombinacije s bortezomibom kod transplantiranih bolesnika (Bortezomib Accord plus deksametazon i Bortezomib Accord plus deksametazon i talidomid).
• different reconstitution requirements for Bortezomib Accord 3.5 mg intravenous or subcutaneous use
• različite zahtjeve kod pripreme lijeka Bortezomib Accord 3,5 mg za intravenski ili supkutani put primjene
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the reconstituted solution should be used immediately after preparation.
S mikrobiološkog gledišta, pripremljena otopina se mora primijeniti odmah nakon pripreme osim ako način otvaranja/rekonstitucije/razrjeđivanja ne isključuje opasnost od mikrobne kontaminacije.
• dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib Accord (both intravenous and subcutaneous use) required for different body surface areas.
• upute za doziranje s primjerima: kako izračunati površinu tijela bolesnika i volumen rekonstituirane otopine lijeka Bortezomib Accord (za oba puta primjene, intravenski i supkutani) s obzirom na različite tjelesne površine.
222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 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/m2 bilo supkutano ili intravenski u 8 ciklusa.
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 primijenjuje peroralno, 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).
Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy#, Different degrees of visual impairment (up to blindness)*
Kornelane lezije*, egzoftalmus, retinitis, skotom, nespecificirani poremećaj oka (uključujući kapak), stečeni dakrioadenitis, fotofobija, fotopsija, optička neuropatija#, različiti stupnjevi oštećenja vida (do sljepoće)*
8 cycles.
dodatna ciklusa.