natgillin/translations-raw huggingface dataset:
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BzmbTDx and TDx groups, respectively.
Jednu autolognu transplantaciju matičnih stanica primilo je 105 (81 %) bolesnika odnosno 78 (61 %) bolesnika u BzmbTDx i TDx skupini.
Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Drugi lijekovi i Bortezomib SUN Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
In vitro ispitivanja pokazuju da je bortezomib slabi inhibitor izoenzima citokroma P450 (CYP) 1A2, 2C9, 2C19, 2D6 i 3A4.
When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Kada se primjenjuje talidomid, potrebna je posebna pažnja vezana uz mjere prevencije i testiranje na trudnoću (vidjeti dio 4.6).
The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Prosječno poluvrijeme eliminacije (t1/2) bortezomiba nakon višekratnog doziranja kretao se u rasponu od 40 - 193 sata.
In patients with MCL, transient neutropenia that was reversible between cycles was observed, with no evidence of cumulative neutropenia.
U bolesnika s limfomom plaštenih stanica, zabilježena je prolazna reverzibilna neutropenija između ciklusa, bez dokaza kumulativne neutropenije.
In the Phase II study, patients who did not obtain an optimal response to therapy with bortezomib alone were able to receive high-dose dexamethasone in conjunction with bortezomib.
U ispitivanju faze II, bolesnici koji nisu postigli optimalni terapijski odgovor kod liječenja samo bortezomibom mogli su primiti visoku dozu deksametazona zajedno s bortezomibom.
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of Bortezomib SUN therapy.
Također se preporučuje da bolesnici u kojih postoji terapijski odgovor, ali nije postignuta kompletna remisija, prime ukupno 8 ciklusa terapije Bortezomib SUN-om.
It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m2).
Nije poznato je li farmakokinetika bortezomiba promijenjena u bolesnika s teškim oštećenjem bubrega koji nisu na dijalizi (CrCL < 20 ml/min/1,73 m2).
The concentration of the resulting solution will be 1 mg/ml.
Koncentracija dobivene otopine bit će 1 mg/ml.
HRb (95% CI)=0.63 p-valued < 0.001
HRb (95 % CI)=0,63 p-vrijednostd < 0,001
56.4 mo
56,4 mjeseci
Cochran Mantel-Haenszel test. b Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in BzmbDx group and 52/242 [21%] in VDDx group).
b Odnosi se na stope odgovora nakon druge transplantacije za ispitanike koji su prošli drugu transplantaciju (42/240 [18 % ] u BzmbDx skupini i 52/242 [21 %] u VDDx skupini).
The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m2.
Učinak oštećenja jetre na farmakokinetiku bortezomiba procijenio se u ispitivanju faze I tijekom prvog ciklusa liječenja, uključujući primarno 61 bolesnika s primarno solidnim tumorima i raznim stupnjevima oštećenja jetre u dozama bortezomiba u rasponu od 0,5 do 1,3 mg/m2.
Most patients required treatment for their orthostatic hypotension.
U većine je bolesnika bilo potrebno liječiti ortostatsku hipotenziju.
The solution should be injected subcutaneously, at a 45-90° angle.
Otopina se mora injicirati supkutano pod kutom od 45 - 90°.
a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p <
Intent to treat) b p-vrijednost iz stratificiranog log-rank testa; analiza po liniji liječenja isključuje stratifikaciju po prethodnim liječenjima;
Caution is advised when treating patients with a history of syncope receiving medicinal products known to be associated with hypotension; or who are dehydrated due to recurrent diarrhoea or vomiting.
Savjetuje se oprez kad se liječe bolesnici koji imaju sinkopu u anamnezi i primaju lijekove za koje se zna da su povezani s hipotenzijom ili koji su dehidrirani zbog rekurentnog proljeva ili povraćanja.
With a median duration of follow-up of 40 months, median OS (56.3 months in the R-CHOP group, and not reached in the BzmbR-CAP group) favoured the BzmbR-CAP group, (estimated HR=0.80; p=0.173).
S medijanom trajanja praćenja od 40 mjeseci, medijan OS (56,3 mjeseci u R-CHOP skupini, i nije postignut u BzmbR-CAP skupini) bio je u korist BzmbR-CAP skupine, (procijenjeni HR=0,80; p=0,173).
Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Sekundarni ishodi su uključili, vrijeme do progresije (TTP), vrijeme do sljedećeg liječenja limfoma (od engl. time to next anti-lymphoma treatment, TNT), trajanje intervala bez liječenja (od engl. treatment free interval TFI), ukupnu stopu odgovora (od engl. overall response rate, ORR) i stopu kompletnog odgovora (od engl. complete response, CR/CRu), ukupno preživljenje (od engl. overall survival, OS) i trajanje odgovora.
Instructions for reconstitution Bortezomib SUN must be reconstituted by a healthcare professional.
Upute za rekonstituciju Bortezomib SUN mora rekonstituirati zdravstveni radnik.
Bortezomib SUN treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however Bortezomib SUN may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Liječenje Bortezomib SUN-om se mora započeti pod nadzorom liječnika koji je iskusan u liječenju bolesnika s rakom, međutim Bortezomib SUN može primijeniti zdravstveni radnik koji je iskusan u primjeni kemoterapije.
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Analiza je pokazala poboljšani ORR (CR+PR) (omjer izgleda 3,769; 95 % CI 2,045 - 6,947; p < 0,001), PFS (omjer hazarda 0,511; 95 % CI 0,309 - 0,845; p=0,008), TTP (omjer hazarda 0,385; 95 % CI 0,212 - 0,698; p=0,001) za bortezomib u kombinaciji s deksametazonom nad monoterapijom bortezomibom.
You will receive 4 cycles (12 weeks).
Primit ćete 4 ciklusa (12 tjedna).
Table 12: Efficacy results from study IFM-2005-01 Endpoints
Tablica 12: Rezultati djelotvornosti iz ispitivanja IFM-2005-01 Mjere ishoda
Nine treatment cycles of this combination therapy are administered.
Primjenjuje se devet ciklusa ovog kombiniranog liječenja.
It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
Preporučuje se pažljivo praćenje bolesnika zbog simptoma neuropatije kao što su osjećaj žarenja, hiperestezija, hipoestezija, parestezija, nelagoda, neuropatska bol ili slabost.
No clinical data are available for bortezomib with regard to exposure during pregnancy.
Nema dostupnih kliničkih podataka o izloženosti bortezomibu tijekom trudnoće.
In the unlikely event of an overdose, your doctor will monitor you for side effects.
U slučaju predoziranja, koje nije vjerojatno, liječnik će Vas pratiti radi nuspojava.
The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects.
Analiza odgovarajućih parova je statistička metoda u kojoj se bolesnici u liječenoj skupini (npr. bortezomib u kombinaciji s deksametazonom) i bolesnici u usporednoj skupini (npr. bortezomib) učine usporedivima s obzirom na zbunjujuće čimbenike tako da se individualno uparuju ispitanici u ispitivanju.
Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Na temelju populacijske farmakokinetičke analize klirens bortezomiba povećava se s porastom površine tijela
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+) NA=not applicable, NE=not estimated TTP-Time to Progression
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
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, sljepoćom i drugim poremećajima vida i neurološkim poremećajima.
Phase II
Faza II
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy:
Prilagodbe doza tijekom liječenja za bolesnike s prethodno neliječenim limfomom plaštenih stanica Prije početka novog ciklusa liječenja:
Antiviral prophylaxis was administered to 26% of the patients in the Bzmb+M+P arm.
Antivirusna profilaksa se primijenila u 26 % bolesnika u skupini koja je primala Bzmb+M+P.
Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with BzmbR-CAP in a clinical trial
Tablica 8: Nuspojave u bolesnika s limfomom plaštenih stanica liječenih s BzmbR-CAP u kliničkom ispitivanju
Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Za nuspojave u Tablici 7 ispitivači su smatrali da postoji barem mogućnost ili vjerojatnost uzročnoposljedične povezanosti s bortezomibom.
Hazard ratiob (95% CI) p-valuec a Kaplan-Meier estimate.
Omjer hazardab (95 % CI) p-vrijednostc a Kaplan-Meierova analiza.
A pre-treatment chest radiograph is recommended to serve as a baseline for potential post-treatment pulmonary changes.
Preporučuje se napraviti rendgenogram pluća prije liječenja, da posluži kao početni nalaz u slučaju mogućih plućnih promjena nakon liječenja.
There have been isolated cases of QT-interval prolongation in clinical studies, causality has not been established.
U kliničkim ispitivanjima prijavljeni su izolirani slučajevi produljenja QT intervala, ali uzročno posljedična povezanost nije ustanovljena.
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.
Progresivna multifokalna leukoencefalopatija (PML) 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.
Patients on oral antidiabetic agents receiving bortezomib treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
U bolesnika na terapiji oralnim antidijabeticima koji se liječe bortezomibom može biti potrebno pomno praćenje razine glukoze u krvi i prilagodba doze antidijabetika.
Uncommon Fall, Contusion Rare
Manje često Pad, kontuzija Rijetko
The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BzmbR-CAP group and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BzmbR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
Dvije liječene skupine imale su sličnu ukupnu incidenciju događaja krvarenja svih stupnjeva (6,3 % u BzmbR-CAP skupini i 5,0 % u R-CHOP skupini), kao i stupnja 3 i višeg za događaje krvarenja (BzmbR-CAP: 4 bolesnika [1,7 %]; R-CHOP: 3 bolesnika [1,2 %]).
These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m2 and included in Table 7.
Ove nuspojave temelje se na integriranom setu podataka od 5476 bolesnika od kojih je 3996 bilo liječeno bortezomibom u dozi 1,3 mg/m2 te je uvršteno u Tablicu
In myeloma, bortezomib affects the ability of myeloma cells to interact with the bone marrow microenvironment.
Kod mijeloma, bortezomib utječe na sposobnost interakcije stanica mijeloma s mikrookolišem koštane srži.
Therefore, the concomitant use of bortezomib with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital and St. John's Wort) is not recommended, as efficacy may be reduced.
Stoga se ne preporučuje istodobna primjena bortezomiba i jakih induktora enzima CYP3A4 (npr. rifampicina, karbamazepina, fenitoina, fenobarbitala i Gospine trave), jer djelotvornost može biti smanjena.
Bortezomib is metabolised by liver enzymes.
Bortezomib metaboliziraju enzimi jetre.
Dexamethasone was administered in combination with bortezomib to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Deksametazon je bio primijenjen u kombinaciji s bortezomibom u 83 bolesnika u 1. ciklusu te u dodatnih 11 bolesnika koji su deksametazon primili tijekom ponovnog liječenja bortezomibom.
ORe (95% CI)=1.428 p-valueg=0.275
ORe (95 % CI)=1,428 p-vrijednostg=0,275
Autonomic neuropathy may be related to bortezomib or bortezomib may aggravate an underlying condition such as diabetic or amyloidotic neuropathy.
Autonomna neuropatija može biti povezana s bortezomibom ili bortezomib može pogoršati postojeće stanje kao što su dijabetička neuropatija ili neuropatija kod amiloidoze.
In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
U ispitivanju faze III, liječenje bortezomibom značajno je produljilo vrijeme do progresije bolesti i dovelo do značajno produljenog preživljenja te značajno veće stope odgovora u usporedbi s liječenjem deksametazonom (vidjeti Tablicu 14) u svih bolesnika, kao i u bolesnika koji su prethodno primili 1 liniju terapije.
Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
Bolesnici koji su razvili ortostatsku hipotenziju za vrijeme liječenja bortezomibom (injiciran intravenski) nisu imali znakove ortostatske hipotenzije prije liječenja bortezomibom.
Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Medijan dobi bolesnika u ispitivanju bio je 57 godina, 55 % bili su muškarci i 48 % bolesnika imalo je citogenetiku visokog rizika.
In patients aged ≥ 75 years, both regimens, BzmbR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
≥ 75 godina oba su režima, BzmbR-CAP i R-CHOP, podnosili lošije (vidjeti dio 4.8).
Patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors.
Bolesnike treba pomno pratiti kada primaju bortezomib u kombinaciji s jakim inhibitorima enzima CYP3A4.
The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Medijan TTP-a bio je 6,5 mjeseci za bolesnike na monoterapiji bortezomibom u usporedbi s 9,3 mjeseci za bolesnike na kombiniranoj terapiji bortezomibom plus pegilirani liposomalni doksorubicin.
Based on the data presented, the PRAC was of the view that the product information should be varied to update Section 4.8 the SmPC and relevant section of the package leaflet to add the following: chalazion, blepharitis and Thrombotic Microangiopathy.
Temljem predstavljenih podataka, stajalište je PRAC-a da je informacije o lijeku potrebno izmijeniti kako bi se ažurirali dio 4.8 sažetka opisa svojstava lijeka i relevantni dijelovi upute o lijeku kako bi se uvrstilo sljedeće: halacion, blefaritis i trombotička mikroangiopatija.
Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section 4.2).
Profilaktička primjena faktora stimulacije kolonija granulocita mora se uzeti u obzir kod ponovljenih zakašnjelih primjena ciklusa (vidjeti dio 4.2).
Animal studies to determine the effects of bortezomib on parturition and post-natal development were not conducted (see section 5.3).
Nisu provedena ispitivanja na životinjama koja bi utvrdila učinak bortezomiba na porod i postnatalni razvoj (vidjeti dio 5.3).
The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the bortezomib containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%).
(stupnja ≥ 3) zabilježene su u većoj incidenciji kod režima liječenja koji sadrži bortezomib u usporedbi s ispitivanjem s povijesnom kontrolom u kojem je osnovni režim davan samostalno: u 1. bloku periferna senzorna neuropatija (3% naspram 0%); ileus (2,1% naspram 0%); hipoksija (8% naspram 2%).
Special care is required when treating patients with any risk factors for seizures.
Poseban nadzor je potreban u liječenju bolesnika s nekim od čimbenika rizika za nastanak epileptičkih napadaja.
A total of 74 evaluable patients were administered dexamethasone in combination with bortezomib.
Ukupno je 74 bolesnika koje se moglo procijeniti, primilo deksametazon u kombinaciji s bortezomibom.
Hepatitis B Virus (HBV) reactivation and infection When rituximab is used in combination with bortezomib, HBV screening must always be performed in patients at risk of infection with HBV before initiation of treatment.
Reaktivacija virusa hepatitisa B (HBV) i infekcija Kada se rituksimab koristi u kombinaciji s bortezomibom u bolesnika koji imaju rizik od infekcije s HBVom, prije početka liječenja uvijek se mora provoditi probir na HBV.
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Tablica 15: Sažetak analize djelotvornosti usporedbe supkutane i intravenske primjene bortezomiba
Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
Bortezomib smanjuje rast tumora in vivo u mnogim nekliničkim modelima tumora, uključujući multipli mijelom.
• Bortezomib SUN 3.5 mg can be administered both intravenously and subcutaneously
• Bortezomib SUN 3,5 mg može biti primijenjen intravenski i supkutano
* Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
* Prema prilagodbama doziranja u ispitivanjima liječenja multiplog mijeloma faze II i III i iskustvima nakon stavljanja lijeka u promet.
Cases resolved in a median of 6 days, dose modification was required in two patients.
Medijan od 6 dana bio je potreban za prolazak nuspojave, a kod dvoje bolesnika bila je potrebna promjena doze.
Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with bortezomib.
Zbog mogućnosti ozbiljnih nuspojava u dojene djece, za vrijeme liječenja bortezomibom potrebno je prekinuti dojenje.
The median duration of complete response was 42.1 months in the BzmbR-CAP group compared with 18 months in the R-CHOP group.
Medijan trajanja kompletnog odgovora bio je 42,1 mjesec u BzmbR-CAP skupini u usporedbi s 18 mjeseci u R-CHOP skupini.
Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration.
Profilaktička primjena faktora stimulacije kolonija granulocita mora se uzeti u obzir kod ponovljenih zakašnjelih primjena ciklusa.
Although in patients aged ≥ 75 years, both BzmbR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzmbR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Iako su bolesnici u dobi od ≥ 75 godina, podnosili lošije i BzmbR-CAP i RCHOP, stopa ozbiljnih nuspojava u BzmbR-CAP skupini bila je 68 %, u usporedbi s 42 % u R-CHOP skupini.
Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Tablica 16: Rezultati djelotvornosti iz ispitivanja LYM-3002 Ishod djelotvornosti
Therefore, platelet counts should be monitored prior to each dose of bortezomib.
Stoga, broj trombocita potrebno je odrediti prije svake doze bortezomiba.
MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV
International Prognostic Index, IPI) ≥ 3, i 76 % imalo je stadij IV bolesti.
You will receive 9 cycles (54 weeks).
Primit ćete 9 ciklusa (54
• advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
• uputstva kako smanjiti rizik zamjene i.v. i s.c. pripremljenih štrcaljki
Grade ≥ 3 non-haematological toxicities
≥ 3. stupanj nehematoloških toksičnosti
In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours with daunorubicin and bortezomib for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
Tijekom kliničkog ispitivanja, dvoje bolesnika (od 2) koji su primali visoku dozu citarabina (2 g/m2 na dan) kontinuiranom infuzijom u trajanju od 24 sata s daunorubicinom i bortezomibom zbog relapsa akutne mijeloične leukemije umrla su od ARDS-a na početku liječenja, a ispitivanje je bilo prekinuto.
Bortezomib is a proteasome inhibitor.
Bortezomib je inhibitor proteasoma.
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Statistički značajna razlika CR+nCR bila je uočena u korist skupine s bortezomibom u kombinaciji s deksametazonom i talidomidom.
> ULN
> GGN
Bortezomib may have a moderate influence on the ability to drive and use machines.
Bortezomib može umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Bortezomib SUN reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Rekonstituirana otopina Bortezomib SUN-a primjenjuje se supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
As a result of a pre-planned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered bortezomib, regardless of disease status.
Kao posljedica unaprijed planirane privremene analize, skupini koja je primala deksametazon liječenje je zaustavljeno na preporuku radne skupine koja je pratila ispitivanja i svim je bolesnicima nakon toga ponuđeno liječenje bortezomibom bez obzira na stanje bolesti.
- Inject the solution subcutaneously, under a 45-90°angle.
- Primijenite injekciju supkutano, pod kutem od 45 - 90°.