natgillin/translations-raw huggingface dataset:
In the BzTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
U BzTDx skupini 12% bolesnika bili su citogenetički svrstani u skupinu visokog rizika naspram 16% bolesnika u TDx skupini.
42.9% and 10.4% of patients in the BzR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
42,9% i 10,4% bolesnika u BzR-CAP skupini bilo je u dobi unutar raspona 65-74 godina odnosno ≥ 75 godina starosti.
Congenital, familial and genetic disorders
obiteljski i genetski poremećaji
Wessling Hungary Kft. Fòti ùt 56., Budapest, 1047, Hungary
Fòti ùt 56., Budapest, 1047, Mađarska
Medianc(95% CI) (months) Response rate n: response-evaluable patients 229
Medijanc(95% CI) (mjeseci) Stopa odgovora n: bolesnici procjenjivi na odgovor
• advice on how to reduce the risk of mix-up of intravenous and subcutaneous reconstituted syringes
• uputstva kako smanjiti rizik zamjene pripremljenih intravenskih i supkutanih štrcaljki
Also included are adverse drug reactions identified in the BzR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Također su uključene nuspojave identificirane u skupini BzRCAP za koje su ispitivači smatrali da imaju barem moguću ili vjerojatnu uzročnu povezanost s bortezomibom na temelju na povijesnih podataka u ispitivanjima multiplog mijeloma.
By multivariate analysis, the response rate was independent of myeloma type, performance status, chromosome 13 deletion status, or the number or type of previous therapies.
stopa odgovora nije ovisila o vrsti mijeloma, funkcionalnom stanju, deleciji kromosoma 13 ili broju i vrsti prethodnih liječenja.
No new safety concerns were observed when Bortezomib Accord was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Nisu zabilježena nova sigurnosna pitanja kada je Bortezomib Accord bio dodan standardnoj osnovnoj pedijatrijskoj kemoterapiji za pre-B-staničnu ALL.
Pruritus*, Dermatitis*, Rash*
Pruritus*, dermatitis*, osip*
This study met its primary objective of non-inferiority for response rate (CR+PR) after 4 cycles of single agent bortezomib for both the subcutaneous and intravenous routes, 42% in both groups.
Ovo ispitivanje doseglo je svoj primarni cilj, neinferiornost u stopi odgovora (CR+PR) nakon 4 ciklusa samostalno primijenjenog bortezomiba za oba puta primjene, i supkutano i intravenski, 42% u obje skupine.
The European Medicines Agency has waived the obligation to submit the results of studies with bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja bortezomiba u svim podskupinama pedijatrijske populacije u multiplom mijelomu i limfomu plaštenih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BzR-CAP arm and with at least a possible or probable causal relationship to the components of the BzR-CAP arm, are listed in Table 8 below.
Nuspojave identificirane poput onih s incidencijom ≥ 1%, slične ili veće incidencije u BzR-CAP skupini s barem mogućom ili vjerojatnom uzročnom povezanošću s komponentama skupine BzR
Subcutaneous or Intravenous use.
Samo za supkutanu ili intravensku primjenu.
How to store Bortezomib Accord Contents of the pack and other information
Kako čuvati Bortezomib Accord Sadržaj pakiranja i druge informacije
You should not use Bortezomib Accord if you are pregnant, unless clearly necessary.
Accord se ne smije primjenjivati ako ste trudni, osim ako to nije jasno neophodno.
Spain
Mađarska
Median survival for the Bz+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Medijan preživljenja za skupinu koja je primala Bz+M+P bio je 56,4 mjeseci u odnosu na 43,1 za skupinu koja je primala M+P.
b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
Procjena omjera hazarda (HR) temelji se na Coxovom modelu proporcionalnog rizika prilagođenom prema čimbenicima stratifikacije: β2-mikroglobulinu, albuminu i regiji.
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 vezano uz mjere prevencije i testiranje na trudnoću (vidjeti dio 4.6).
Instructions for reconstitution Bortezomib Accord must be reconstituted by a healthcare professional.
Upute za pripremu Bortezomib Accord mora rekonstituirati zdravstveni radnik.
In the BzR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
U BzR-CAP skupini, 22,5% bolesnika primilo je transfuzije trombocita u usporedbi s 2,9% bolesnika u R-CHOP skupini.
Response Rate at 4 cycles n (%)
Stopa odgovora u 4 ciklusa n (%)
TTP, days [95% CI]
TTP, dani [95% CI]
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of bortezomib therapy.
Također se preporučuje da bolesnici u kojih postoji terapijski odgovor, ali nije postignuta kompletna remisija, prime ukupno 8 ciklusa terapije s bortezomibom.
Justification for not including Braille accepted.
Prihvaćeno obrazloženje za nenavođenje Braillea.
Once weekly Bortezomib Accord (cycles 5-9)
Bortezomib Accord jednom tjedno (5.-9. ciklus)
Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Učestalost se definira kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i
Dose adjustments for combination therapy for patients with progressive multiple myeloma
Prilagodbe doza u kombiniranom liječenju za bolesnike s progresivnim multiplim mijelomom
Six bortezomib cycles are recommended, although for patients with a response first documented at cycle 6, two additional bortezomib cycles may be given.
Preporučuje se šest ciklusa liječenja bortezomibom, iako se bolesnicima za koje je odgovor prvi put zabilježen u 6. ciklusu, mogu dati dva dodatna ciklusa liječenja bortezomibom.
Posterior reversible encephalopathy syndrome (PRES) There have been reports of PRES in patients receiving bortezomib.
Posterior reversible encephalopathy syndrome) Bili su prijavljeni slučajevi sindroma posteriorne reverzibilne encefalopatije (PRES) kod bolesnika koji su primali bortezomib.
Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001)
Kombinirano liječenje bortezomibom s pegiliranim liposomalnim doksorubicinom (ispitivanje DOXIL-MMY-3001)
* Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
* Primarni ishod a OR za stope odgovora temeljeno na Mantel-Haenszel procjeni zajedničkog omjera izlgleda za stratificirane tablice;
In patients aged ≥ 75 years, both regimens, BzR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
≥ 75 godina, su oba režima, BzR-CAP kao i R-CHOP, podnosili lošije (vidjeti dio 4.8).
When toxicity resolves re-initiate Bortezomib Accord treatment and reduce dose to 0.7 mg/m2 once per week.
Kad se toksičnost povuče, ponovno uvesti liječenje lijekom lijekom Bortezomib Accord i smanjiti dozu na 0,7 mg/m2 jedanput tjedno.
• that Bortezomib Accord is to be given only by intravenous or subcutaneous injections; no other route of administration is allowed
• Bortezomib Accord se primjenjuje samo putem intravenske ili supkutane injekcije; bilo koji drugi put primjene nije dozvoljen
Additional adverse drug reactions identified associated with the use of the combination therapy (BzR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Dodatne identificirane nuspojave povezane s primjenom kombiniranog liječenja (BzR-CAP) bile su infekcija hepatitisom B (< 1%) i ishemija miokarda (1,3%).
Response Rate at 8 cycles n (%)
Stopa odgovora u 8 ciklusa n (%)
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).
(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).
Patients were administered intravenous doses of 0.7 to 1.3 mg/m2 of bortezomib twice weekly.
Bolesnicima su bile primijenjene intravenske doze od 0,7 do 1,3 mg/m2 bortezomiba dva puta na tjedan.
Response rate populatione n=668
Stopa odgovora populacijae n = 668
• If several Bortezomib Accord doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Ako se prekine primijena nekoliko doza lijeka Bortezomib Accord u jednom ciklusu (≥ 3 doze tijekom primjene dva puta tjedno ili ≥ 2 doze tijekom primjene jedanput na tjedan)
Bortezomib Accord might cause tiredness, dizziness, fainting, or blurred vision.
Bortezomib Accord može uzrokovati umor, omaglicu, nesvjesticu ili zamagljen vid.
What Bortezomib Accord looks like and contents of the pack
Kako Bortezomib Accord izgleda i sadržaj pakiranja
At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered Bz+M+P treatment.
U vrijeme unaprijed planirane privremene analize postigla se primarna mjera ishoda, vrijeme do progresije te je bolesnicima u M+P kraku studije bilo ponuđeno liječenje Bz+M+P.
Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Doziranje pri liječenju progresivnog multiplog mijeloma (bolesnici koji su prethodno primili barem jednu liniju liječenja) Monoterapija
Bortezomib Accord contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Bortezomib Accord sadrži djelatnu tvar bortezomib, koja se naziva ‘inhibitor proteasoma'.
The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Medijan preživljenja svih uključenih bolesnika bio je 17 mjeseci (raspon <1
The median duration of complete response was 42.1 months in the BzR-CAP group compared with 18 months in the R-CHOP group.
Medijan trajanja kompletnog odgovora bio je 42,1 mjesec u BzR-CAP skupini u usporedbi s 18 mjeseci u R-CHOP skupini.
* Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate,
* Prema klasifikaciji Radne skupine za poremećaj funkcije organa Nacionalnog instituta za rak za kategorizaciju oštećenja jetre (blago, umjereno, teško).
It is recommended that patients receive 2 cycles of bortezomib following a confirmation of a complete response.
Preporučuje se da bolesnici prime još 2 ciklusa liječenja bortezomibom nakon potvrđenog kompletnog odgovora.
Overall complete response (CR+CRu)f n(%)
Ukupni kompletni odgovor (CR+CRu)f n(%)
The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BzR-CAPgroup and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BzR-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 BzR-CAP skupini i 5,0% u R-CHOP skupini) kao i stupnja 3 i višeg za događaje krvarenja (BzR-CAP: 4 bolesnika [1.7%]; R-CHOP: 3 bolesnika [1,2%]).
Bortezomib Accord was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Accord je bio primijenjen samo u 1. i 2.bloku zbog izbjegavanja mogućeg preklapanja toksičnosti s istodobno primijenjenim lijekovima u bloku 3.
Although in patients aged ≥ 75 years, both BzR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzR-CAP groups was 68%, compared to 42% in the RCHOP group.
Iako su bolesnici u dobi od ≥ 75 godina, podnosili lošije i BzR-CAP i R-CHOP, stopa ozbiljnih nuspojava u BzR-CAP skupini bila je 68%, u usporedbi s 42% u R-CHOP skupini.
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib bortezomib intravenous arm bortezomib subcutaneous arm
Tablica 15: Sažetak analize djelotvornosti usporedbe supkutane i intravenske primjene bortezomiba bortezomib intravenska skupina bortezomib supkutana skupina
Antiviral prophylaxis was administered to 26% of the patients in the Bz+M+P arm.
Antivirusna profilaksa se primijenila u 26% bolesnika u skupini koja je primala Bz+M+P.
The duration of overall response was 21.4 months longer in the BzR-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 BzR-CAP skupini (medijan 36,5 mjeseci naspram 15,1 mjeseci u R-CHOP skupini).
Mannitol (E421).
manitol (E421).
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.
In patients developing PRES, bortezomib should be discontinued.
U bolesnika u kojih se razvije PRES, mora se prekinuti primjena bortezomiba.
Bortezomib Accord should not be administered intrathecally.
Bortezomib Accord se ne smije primijeniti intratekalno.
Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
pojavila se kod 6% bolesnika u skupini liječenoj supkutano, u usporedbi sa 16% u skupini liječenoj intravenski (p=0,0264).
Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib Accord
Nehematološke toksičnosti stupnja ≥ 3 za koje se smatra da su povezane s lijekom Bortezomib Accord
Vision abnormal*
Abnormalan vid*
● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
● prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
Very Common Pneumonia* Common
Vrlo često Pneumonija*
The incidence of herpes zoster among patients in the BzR-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 BzR-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).
- if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
- ako ste alergični na bortezomib, bor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
HRb (95% CI)=0.63 (0.50; 0.79) p-valued < 0.001
HRb (95% CI)=0,63 (0,50; 0,79) p-vrijednostd < 0,001
If you are given Bortezomib Accord for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure,
Ako Bortezomib Accord primate za multipli mijelom ili limfom plaštenih stanica, odmah obavijestite svog liječnika ako primijetite bilo koji od sljedećih simptoma: - grčenje mišića, slabost mišića - smetenost, gubitak vida ili smetnje vida, sljepoću, napadaje, glavobolje
• to remind that patients receiving Bortezomib Accord in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
• kako bi se podsjetilo bolesnike koji primaju Bortezomib Accord u kombinaciji s talidomidom da se moraju pridržavati talidomidskog programa prevencije trudnoće, s upućivanjem na SPC za talidomid za dodatne informacije.
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 MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV
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 with moderate or severe hepatic impairment should be started on Bortezomib Accord 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 lijekom Bortezomib Accord 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).
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).
Table 8 Adverse reactions in patients with Mantle cell lymphoma treated with BzR-CAP in a clinical trial
Tablica 8: Nuspojave u bolesnika s limfomom plaštenih stanica liječenih s BzR-CAP u kliničkom ispitivanju
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 primjenjenim intravenski, nego u ispitivanju MMY-3021.
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.
• Shingles (localised including around the eyes or spread across the body)
• herpes zoster (lokalizirano, uključujući područje oko očiju ili prošireno po cijelom tijelu)
The majority of the patients in both groups completed treatment, 80% in the BzR-CAP group and 82% in the R-CHOP group.
Većina bolesnika u obje skupine završilo je liječenje, 80% u BzR-CAP skupini i 82%
• Infection or inflammation of the stomach and intestines
• infekcija ili upala želuca i crijeva
Patients in the BzTDx group received six 4-week cycles, each consisting of bortezomib (1.3 mg/m2
Bolesnici u BzDx skupini primili su četiri 21 dnevna ciklusa, od kojih je svaki uključivao bortezomib (1,3 mg/m2
Contents of the pack and other information What Bortezomib Accord contains
Sadržaj pakiranja i druge informacije Što Bortezomib
When Bortezomib Accord is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Kada se Bortezomib Accord daje zajedno s talidomidom, morate slijediti program namijenjen prevenciji trudnoće za talidomid (vidjeti uputu o lijeku za talidomid).
• Platelet counts should be ≥ 70 x 109/l and the absolute neutrophils count should be ≥ 1.0 x 109/l
Broj trombocita mora biti ≥ 70 x 109/l, a apsolutni broj neutrofila mora biti ≥ 1,0 x 109/l.
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.
Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median haemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l.
IgG/IgA/lakih lanaca u 63%/25%/8% slučajeva, medijan hemoglobina od 105 g/l, i medijan broja trombocita od 221,5 x 109/l.
Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Hiperbilirubinemija*, abnormalan nalaz analize proteina*, smanjena težina, povećana težina
• If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
Ako se primijetilo produljeno trajanje neutropenije 4. stupnja ili trombocitopenije ili trombocitopenija s krvarenjem u prethodnom ciklusu
If you have mantle cell lymphoma and are given the medicine rituximab with Bortezomib Accord you should tell your doctor:
Ako imate limfom plaštenih stanica i uz Bortezomib Accord primate lijek rituksimab morate obavijestiti svog liječnika:
c Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Populacija s terapijskim odgovorom uključuje bolesnike koji su imali mjerljivu bolesti na početku liječenja i primili su najmanje 1 dozu ispitivanog lijeka.
ORe (95% CI)=1.428 (0.749; 2.722) p-value g=0.275
ORe (95% CI)=1,428 (0,749; 2,722) p-vrijednost g=0,275
Bortezomib Accord is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Accord se primjenjuje supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
OR; 95% CI; P valuea
OR; 95% CI; P vrijednosta
Change Bortezomib Accord treatment schedule to 1.3 mg/m2 once per week
Promijeniti raspored primjene lijeka lijeka Bortezomib Accord na 1,3 mg/m2 jedanput tjedno
Bortezomib Accord powder for solution for injection is a white to off-white cake or powder.
Bortezomib Accord prašak za otopinu za injekciju je bijeli do gotovo bijeli kolačić ili prašak.