natgillin/translations-raw huggingface dataset:
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%).
V shemi zdravljenja z bortezomibom so se naslednji neželeni učinki (stopnje ≥ 3) pojavili pogosteje kot v predhodnem kontrolnem preskušanju, kjer so bolniki prejemali samo osnovno shemo zdravljenja: v 1. sklopu periferna senzorična nevropatija (3 % proti 0 %), ileus (2,1 % proti 0 %), hipoksija (8 % proti 2 %).
When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).
Če jemljete talidomid, morate biti še posebej pozorni na zahteve po preverjanju in preprečevanju nosečnosti (glejte poglavje Nosečnost in dojenje).
If you have mantle cell lymphoma and are given the medicine rituximab with bortezomib you should tell your doctor:
Če imate limfom plaščnih celic in prejemate rituksimab skupaj z bortezomibom, zdravniku povejte, če:
Response rate population e n=668
vrednost p Stopnja odziva populacija e n = 668
Table 11: Efficacy results following the final survival update to VISTA study Efficacy endpoint
Preglednica 11:Rezultati učinkovitosti zdravila po končni posodobitvi podatkov o preživetju v preskušanju VISTA
A. MANUFACTURERSRESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
- Keep this leaflet.
Odlepite tukaj.
If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Če opazite kakršnokoli obarvanje ali prisotnost delcev, morate rekonstituirano raztopino zavreči.
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Preglednica 15: Povzetek analize učinkovitosti subkutanega in intravenskega dajanja bortezomiba bortezomib intravensko bortezomib subkutano
Special handling instructions.
- Navodilo shranite.
Therefore, you will have to take regular blood tests before and during your treatment with bortezomib, to check your blood cell counts regularly.
Zato vam bodo pred in med zdravljenjem z bortezomibom s preiskavami krvi redno preverjali število krvnih celic.
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Pri bolnikih z MCL (preskušanje LYM-3002) je bila pojavnost okužbe z virusom herpes zoster v skupini BR-CAP 6,7 % in v skupini R-CHOP 1,2 % (glejte poglavje 4.8).
Fertility Fertility studies were not conducted with Bortezomib Hospira (see section 5.3).
Plodnost Študije plodnosti pri uporabi zdravila Bortezomib Hospira niso bile izvedene (glejte poglavje 5.3).
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.
Absorpcija Po intravenski aplikaciji bolusnega odmerka 1,0 mg/m2 in 1,3 mg/m2 11 bolnikom z diseminiranim plazmocitomom in očistkom kreatinina večjim kot 50 ml/min, sta bili povprečni vrednosti največjih plazemskih koncentracij bortezomiba po prvem odmerku 57 oziroma 112 ng/ml.
In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BR-CAP arm and 61% of patients in the R-CHOP arm.
V preskušanju LYM-3002 je podporno zdravljenje s kolonijami spodbujajočih faktorjev prejelo 78 % bolnikov v skupini BR-CAP in 61 % bolnikov v skupini R-CHOP.
Bortezomib Hospira therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Zdravljenje z zdravilom Bortezomib Hospira je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 2. stopnjo ali še izboljšajo.
Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
h Vključuje vse radiološke diagnostične metode CR+CRu+PR po IRC, ne glede na preverjanje kostnega mozga in LDL.
Caution should be exercised when Bortezomib Hospira is combined with CYP3A4or CYP2C19 substrates (see section 4.5).
Kadar se zdravilo Bortezomib Hospira daje v kombinaciji s substrati encima CYP3A4 ali CYP2C19, je potrebna previdnost (glejte poglavje 4.5).
Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BR-CAP arm and with at least a possible or probable causal relationship to the components of the BR-CAP arm, are listed in Table 8 below.
V preglednici 8 so navedeni ugotovljeni neželeni učinki s pogostnostjo ≥ 1 %, ki je bila podobna ali večja v skupini BR-CAP in z najmanj verjetno ali možno vzročno povezavo s komponentami v skupini BR-CAP.
Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy
Preglednica 9: Pojavnost periferne nevropatije med uvajalnim zdravljenjem glede na stopnjo toksičnosti in prekinitev zdravljenja zaradi periferne nevropatije
How to store Bortezomib Hospira Contents of the pack and other information
Shranjevanje zdravila Bortezomib Hospira Vsebina pakiranja in dodatne informacije
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.
Bolniki v preskušanju faze II, ki niso dosegli optimalnega odziva na zdravljenje z bortezomibom samim, so poleg bortezomiba lahko prejemali tudi deksametazon v velikih odmerkih.
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing 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).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov z referenčnim zdravilom, ki vsebuje bortezomib, za vse skupine pediatrične populacije za indikacijo diseminirani plazmocitom in limfom plaščnih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje
Overall survival* Events (deaths) n (%) Median a (95% CI)
Celokupno preživetje* dogodki (smrti) n (%) mediana a (95 % IZ)
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BDx groups respectively; the majority of patients underwent one single transplant procedure.
Avtologno presaditev krvotvornih matičnih celic so opravili pri 198 (82 %) bolnikih v skupini VDDx in 208 (87 %) bolnikih v skupini BDx.
Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
Bortezomib povzroči zmanjšanje rasti tumorja in vivo v mnogih predkliničnih tumorskih modelih, vključno z diseminiranim plazmocitomom.
In the BR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
V skupini BR-CAP je prejelo infuzijo trombocitov 22,5 % bolnikov, v skupini RCHOP pa 2,9 % bolnikov.
SC or IV use only.
ali s.c. uporabi.
When compared to patients with normal hepatic function, mild hepatic impairment did not alter dose-normalised bortezomib AUC.
V primerjavi z bolniki z normalnim delovanjem jeter, pri bolnikih z blago okvaro jeter ni bilo sprememb v na odmerek normalizirani AUC bortezomiba.
• ketoconazole, used to treat fungal infections
• ketokonazol, ki se uporablja za zdravljenje glivičnih okužb
Bortezomib Hospira should not be given by other routes.
Zdravilo Bortezomib Hospira se ne sme dajati po nobeni drugi poti.
Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice.
Bortezomib se ni izkazal za genotoksičnega v in vitro preskusu mutagenosti (Amesov preskus) in v in vivo mikrojedrnemu testu pri miših.
Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Zato je potrebno bolnike, ki prejemajo bortezomib v kombinaciji z močnimi zaviralci encima CYP3A4 (npr. ketokonazolom, ritonavirjem) skrbno spremljati.
Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BR-CAP arm.
V BR-CAP kraku preskušanja je protivirusna zdravila prejelo 137 od 240 bolnikov (57 %).
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Če ste prejeli večji odmerek zdravila Bortezomib Hospira, kot bi smeli To zdravilo vam bo injiciral zdravnik ali medicinska sestra zato ni verjetno, da bi ga lahko prejeli preveč.
BR-CAP= bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy
BR-CAP = bortezomib, rituksimab, ciklofosfamid, doksorubicin in prednizon; R-CHOP = rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon; PN = periferna nevropatija
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.
V 1. ciklu zdravljenja je skupaj z bortezomibom prejemalo deksametazon 83 bolnikov, v nadaljnjih ciklih zdravljenja z bortezomibom pa še dodatnih 11 bolnikov.
For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Bolniki, ki so dosegli odziv šele v 6. ciklu, so prejeli dva dodatna cikla zdravljenja.
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.
Mediana starost bolnikov v preskušanju je bila 71 let, 50 % sodelujočih je bilo moških, 88 % belcev in mediana ocena stanja zmogljivosti po Karnofskem je bila 80.
Combination therapy with melphalan and prednisone Bortezomib Hospira is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Kombinirano zdravljenje z melfalanom in prednizonom Zdravilo Bortezomib Hospira se daje intravensko ali subkutano v kombinaciji s peroralnim melfalanom in prednizonom, kot je prikazano v preglednici 2.
There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving bortezomib (see section 4.8).
Pri bolnikih, ki so prejemali bortezomib, so redko poročali o akutni difuzni infiltracijski pljučni bolezni neznane etiologije, kot je pnevmonitis, intersticijska pljučnica, infiltracija pljuč in sindrom akutne respiratorne stiske (SARS) (glejte poglavje 4.8).
Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anaemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
Opazne razlike v populaciji bolnikov z MCL v primerjavi z bolniki v študijah diseminiranega plazmocitoma so bile ≥ 5 % večja pojavnost hematoloških neželenih učinkov (nevtropenija, trombocitopenija, levkopenija, anemija, limfopenija), periferna senzorična nevropatija, hipertenzija, pireksija, pljučnica, stomatitis in bolezni las.
0.7 mg/m
na 0,7 mg/m
If you are given bortezomib together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
Če prejemate bortezomib skupaj z drugimi zdravili za zdravljenje limfoma plaščnih celic, se lahko pri vas pojavijo naslednji neželeni učinki:
Be sure that the correct dose is being given for the subcutaneous route of administration (2.5 mg/ml).
Preverite pravilnost odmerka za subkutano dajanje zdravila (2,5 mg/ml).
BSA-normalized clearance of bortezomib in paediatric patients was similar to that observed in adults.
Očistek bortezomiba, normaliziran na telesno maso, je bil pri pediatričnih bolnikih podoben očistku, opaženem pri odraslih.
If you get any side effects, talk to your doctor or pharmacist.
- Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
V preskušanju IFM-2005-01 so primerjali kombinacijo bortezomiba in deksametazona [BDx, n = 240] s kombinacijo vinkristin-doksorubicin-deksametazon [VDDx, n = 242].
• If toxicity resolves i.e. patient has an ANC ≥ 750cells/μL and a platelet count ≥ 25,000 cells/μL, Bortezomib Hospira may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m
• Če toksičnost mine oz. ima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl, lahko ponovno uvedete zdravilo Bortezomib Hospira v odmerku, ki je eno stopnjo nižji od prejšnjega (z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2
A lower starting dose is recommended in patients with moderate or severe hepatic impairment, and those patients should be closely monitored (see section 4.2, Table 6).
Pri bolnikih z zmerno ali hudo okvaro jeter so priporočeni manjši začetni odmerki in potrebno je skrbno spremljanje (glejte poglavje 4.2, preglednica 6).
Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Pri bolnikih z diseminiranim plazmocitomom se po intravenski bolusni ali subkutani injekciji pri odmerku 1,3 mg/m2 (n = 14 pri intravenski in n = 17 pri subkutani skupini) je bila skupna sistemska izpostavljenost po ponavljajočem odmerjanju (AUCzadnji) enakovredna pri subkutanem in intravenskem dajanju.
• 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 Hospira dose.
• Model izračuna s katerim lahko predpisovalec na podlagi bolnikove višine in telesne mase izračuna telesno površino in tako določi primeren odmerek zdravila Bortezomib Hospira.
* Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
* na osnovi prilagoditev odmerjanja v preskušanjih faze II in III pri bolnikih z diseminiranim plazmocitomom in izkušenj v obdobju trženja.
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.
V kliničnem preskušanju, sta dva bolnika (od dveh), pri katerih so akutno mieloično levkemijo zdravili z velikim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/m2 na dan) skupaj z daunorubicinom in bortezomibom, umrla zaradi SARS na začetku zdravljenja in preskušanje so zaključili.
• Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion) and red and swollen eyelids, discharge from the eyes, abnormal vision, bleeding of the eye
• draženje ali vnetje oči, prekomerno solzne oči, boleče oči, suhe oči, okužbe oči, zatrdlina na veki (halazij) ter pordele in otekle veke, izcedek iz oči, motnje vida, krvavitve v očesu
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.
Pojavnost vseh stopenj periferne nevropatije pri dajanju bortezomiba intravensko je bila v že prej opravljenih preskušanjih nižja kot v preskušanju MMY-3021.
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group.
Opazili so statistično pomembno razliko v Cr+nCR v prid skupine, ki je prejemala bortezomib in deksametazon.
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.
V preskušanju je bil dosežen primarni cilj neinferiornosti stopnje odziva (CR+PR) po 4 ciklih zdravljenja samo z bortezomibom pri subkutani in intravenski uporabi, stopnja odziva je bila pri obeh 42 %.
Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib Hospira treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Prilagoditev odmerjanja med zdravljenjem in pri ponovni uvedbi zdravljenja v obliki monoterapije Zdravljenje z zdravilom Bortezomib Hospira morate prekiniti ob pojavu katerekoli nehematološke toksičnosti 3. stopnje ali katerekoli hematološke toksičnosti 4. stopnje, z izjemo nevropatije, kot je opisano v nadaljevanju (glejte tudi poglavje 4.4).
Hypertension*, Hypotension*, Orthostatic hypotension
Pogosti hipertenzija*, hipotenzija*, ortostatska hipotenzija
Bortezomib treatment is commonly associated with orthostatic/postural hypotension.
Zdravljenje z bortezomibom je pogosto povezano z ortostatsko/ posturalno hipotenzijo.
Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing
Nekatere vključujejo oteženo dihanje, zasoplost, zasoplost brez telesnega napora, dihanje postane plitvo,
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each Bortezomib Hospira treatment cycle.
Melfalan in prednizon je treba dati peroralno na 1., 2., 3. in 4. dan v prvem tednu vsakega cikla zdravljenja z zdravilom Bortezomib Hospira.
NOS=not otherwise specified * Grouping of more than one MedDRA preferred term.
NOS (not otherwise specified) = ni drugače določeno združitev več priporočenih terminov po MedDRA neželeni učinki v obdobju trženja, neodvisno od indikacije
Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Preverite pravilnost odmerka za intravensko dajanje zdravila (1 mg/ml).
In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
V raziskavah splošne toksičnosti z več cikli zdravljenja na podganah in opicah so bili poglavitni tarčni organi prebavila s posledičnim bruhanjem in/ali diarejo; krvotvorni in limfatični organi s posledičnim zmanjšanjem števila krvnih celic v periferni krvi, zmanjšanjem limfatičnega tkiva ter hipocelularnostjo kostnega mozga, periferno nevropatijo (ki so jo opazili pri opicah, miših in psih) s prizadetostjo senzoričnih živčnih končičev; ter blage spremembe ledvic.
There was a trend towards prolonged overall survival favouring the BR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BR-CAP group.
Ocenjena stopnja 4-letnega preživetja je bila v skupini R-CHOP 53,9 % in v skupini BR-CAP 64,4 %.
42.9% and 10.4% of patients in the BR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
V skupini BR-CAP je bilo 42,9 % bolnikov starih 65-74 let in 10,4 % bolnikov, starih ≥ 75 let.
The following medicinal products are administered on day 1 of each Bortezomib Hospira 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m 2, cyclophosphamide at 750 mg/m 2 and doxorubicin at 50 mg/m
Zdravila, ki se dajejo v obliki intravenske infuzije na 1. dan vsakega 3-tedenskega cikla zdravljenja z zdravilom Bortezomib Hospira so: 375 mg/m 2 rituksimaba, 750 mg/m 2 ciklofosfamida in 50 mg/m doksorubicina.
The median number of cycles received for both groups was 4 cycles.
Mediano število ciklov zdravljenja je bilo 4 v obeh skupinah.
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.
Ker se lahko zmanjša učinkovitost, sočasna uporaba bortezomiba z močnimi induktorji encima CYP3A4 (npr. rifampicinom, karbamazepinom, fenitoinom, fenobarbitalom in šentjanževko) ni priporočljiva.
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
Bolnike so glede na vrednost očistka kreatinina (CrCL) razvrstili v naslednje skupine: normalno delovanje ledvic (CrCL ≥ 60 ml/min/1,73 m2, n = 12), blaga okvara ledvic (CrCL = 40-59
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded.
Bolniki, ki so imeli na začetku preskušanja stopnjo periferne nevropatije ≥ 2 ali število trombocitov < 50,000/µl, so bili izključeni.
Induction Transplant Regimens Graph shall contain the following key elements:
Diagram režima uvajanja zdravljenja pred transplantacijo mora vsebovati naslednje ključne elemente
• Haemoglobin ≥ 8 g/dL
• mora biti koncentracija hemoglobina ≥ 8 g/dl (80 g/l).
Main efficacy results are presented in Table 13.
Glavni rezultati učinkovitosti so zbrani v preglednici 13.
The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to bortezomib alone.
V skladu s protokolom so bolniki lahko prejeli deksametazon, če ni bilo pričakovanega odziva na zdravljenje z bortezomibom samim.
• General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness
• splošno slabo počutje, bolečina, vrtoglavica, omotica, občutek šibkosti ali izguba zavesti
Patients receiving Bortezomib Hospira in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Bolniki, ki prejemajo zdravilo Bortezomib Hospira v kombinaciji s talidomidom, morajo upoštevati program preprečevanja nosečnosti, kot je predpisan pri talidomidu.
HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP).
Do okužbe s HBV s smrtnim izidom je prišlo pri 0,8 % (n = 2) bolnikov v skupini, ki ni prejemala bortezomiba (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon; skupina R-CHOP) in pri 0,4 % (n = 1) bolnikov v skupini, ki je prejemala bortezomib v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (skupina BR-CAP).
Main efficacy results are presented in Table 12.
Glavni rezultati učinkovitosti so zbrani v preglednici 12.
If you are given bortezomib 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,
Če prejemate bortezomib za zdravljenje diseminiranega plazmocitoma ali limfoma plaščnih celic, takoj obvestite zdravnika, če se pri vas pojavi katerikoli od naslednjih simptomov: mišični krči, mišična šibkost zmedenost, izguba ali motnje vida, slepota, epileptični napadi, glavoboli zasoplost, otekanje nog ali spremembe srčnega utripa, visok krvni tlak, utrujenost, omedlevica težave s kašljem in dihanjem ali tiščanje v prsih