natgillin/translations-raw huggingface dataset:
In the VcR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
V skupini VcR-CAP je prejelo infuzijo trombocitov 22,5% bolnikov, v skupini R-CHOP pa 2,9% bolnikov.
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 inhibitorji encima CYP3A4 (npr. ketokonazolom, ritonavirjem) skrbno spremljati.
Progression free survival (IRC) Events n (%)
Preživetje brez napredovanja bolezni (IRC) dogodki n (%)
• to report any adverse event, or medication error experienced with the administration of VELCADE 3.5 mg.
• Pomembnost sporočanja kakršnihkoli neželenih učinkov ali napak pri uporabi zdravila VELCADE 3,5 mg.
In patients aged ≥ 75 years, both regimens, VcR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Bolniki, stari ≥ 75 let, so oba režima zdravljenja, VcR-CAP in R-CHOP, slabše prenašali (glejte poglavje 4.8).
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 VELCADE+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
V študiji faze III, pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, je bila splošna pojavnost reaktivacije virusa herpes zoster pri bolnikih zdravljenih z zdravili VELCADE+melfalan+prednizon pogostejša, kot pri bolnikih zdravljenih z melfalanom+prednizonom (14% v primerjavi s 4%).
Grade ≥ 3 non-haematological toxicities
Ne-hematološka toksičnost stopnje ≥ 3
For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
Za dodatne informacije o melfalanu in prednizonu, glejte ustrezna Povzetka glavnih značilnosti zdravila.
The incidence of herpes zoster among patients in the VcR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Pogostnost virusa herpes zoster v skupini VcR-CAP je bila 10,7% pri bolnikih, ki niso prejemali protivirusnih zdravil, pri bolnikih, ki so prejemali protivirusna zdravila pa 3,6% (glejte poglavje 4.4).
If you are given VELCADE together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
Če prejemate zdravilo VELCADE skupaj z drugimi zdravili za zdravljenje limfoma plaščnih celic, se lahko pri vas pojavijo naslednji neželeni učinki:
If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če se rekonstituirane raztopine ne uporabi takoj, je za rok uporabe in pogoje shranjevanja po pripravi odgovoren uporabnik.
• Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
• okužbe, vključno z okužbo sečil, gripa, okužba s herpes virusom, ušesne okužbe in celulitis
• Yellow discolouration of eyes and skin (jaundice)
• rumeno obarvanje beločnic ali kože (zlatenica)
Injection sites should be rotated for successive injections.
Mesta injiciranja je treba med zaporednimi injiciranji menjavati..
Vc=VELCADE; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Vc = VELCADE; Dex = deksametazon CR = popolni odgovor; nCR = skoraj popolni odgovor PR = delni odgovor; MR = minimalni odgovor
Dexamethasone was administered in combination with VELCADE to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of VELCADE retreatment cycles.
V 1. krogu zdravljenja je skupaj z zdravilom VELCADE prejemalo deksametazon 83 bolnikov, v nadaljnjih krogih zdravljenja z zdravilom VELCADE pa še dodatnih 11 bolnikov.
Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Redki meningitis (vključno z bakterijskim), okužba z virusom EpsteinBarr, genitalni herpes, tonzilitis, mastoiditis, post virusni sindrom utrujenosti
What VELCADE contains - The active substance is bortezomib.
Kaj vsebuje zdravilo VELCADE - Učinkovina je bortezomib.
12.8 mo
12,8 mesecev
• Swelling of body, to include around eyes and other parts of the body
• otekanje telesa, vključno z otekanjem okoli oči in ostalih delov telesa
• memory loss, trouble thinking, difficulty with walking or loss of vision.
• doživite izgubo spomina, imate težave z mišljenjem, s hojo ali se vam poslabša vid.
N=240 (ITT population) N=242 (ITT population)
n = 240 (ITT populacija) n = 242 (ITT populacija)
• Inflammation of the lining around your heart or fluid around your heart
• vnetje srčne ovojnice ali nabiranje tekočine okoli srca
An effective re-induction multi-agent chemotherapy regimen was administered in 3 blocks.
Bolnikom so ponovno uvedli učinkovito indukcijsko kemoterapijo z več zdravili v 3 sklopih.
VELCADE must be reconstituted by a healthcare professional.
Zdravilo VELCADE mora rekonstituirati zdravstveno osebje.
Rash*, Pruritus*, Erythema, Dry skin
Pogosti izpuščaj*, srbenje*, eritem, suha koža
Patients receiving VELCADE in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Bolniki, ki prejemajo zdravilo VELCADE v kombinaciji s talidomidom morajo upoštevati program preprečevanja nosečnosti, kot je predpisan pri talidomidu.
All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively.
Periferno nevropatijo (vseh stopenj) so opazili pri 40%, periferno nevropatijo stopnje ≥ 3 pa pri 8,5% bolnikov.
Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the VcR-CAP arm.
V VcR-CAP kraku študije je protivirusna zdravila prejelo 137 od 240 bolnikov (57%).
Post-marketing adverse reactions not seen in clinical trials are also included.
Vključuje neželene učinke v obdobju trženja, ki se v kliničnih študijah niso pojavili.
Note: An OR > 1 indicates an advantage for Vc-containing induction therapy.
Opomba: OR > 1 kaže na prednost uvajalnega zdravljenja z Vc.
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, anemia, 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, zvečana telesna temperatura, pljučnica, stomatitis in bolezni las.
• Inflammation of the spinal nerve
• vnetje hrbtenjačnega živca
In study IFM-2005-01 VELCADE combined with dexamethasone [VcDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
V študiji IFM-2005-01 so primerjali kombinacijo zdravila VELCADE in deksametazona [VcDx, n = 240] s kombinacijo vinkristin-doksorubicin-deksametazon VDDx, n = 242].
Withhold VELCADE treatment until symptoms of toxicity have resolved.
prekinite zdravljenje z zdravilom VELCADE, dokler ne minejo znaki toksičnosti.
Based on Log rank test stratified with IPI risk and stage of disease.
Na osnovi Log rank testa, stratificiranega z IPI tveganjem in stopnjo bolezni.
• A severe reversible brain condition which includes seizures, high blood pressure, headaches,
• hudo reverzibilno stanje možganov s krči, visokim krvnim tlakom, glavoboli, utrujenostjo,
• Injection sites should be rotated for successive injections.
• Mesta injiciranja je treba med zaporednimi injiciranji menjavati..
• Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion), red and swollen eyelids, discharge from the eyes, abnormal vision,
• draženje ali vnetje oči, prekomerno solzne oči, boleče oči, suhe oči, okužbe oči, zatrdlina na veki (halazij), rdeče in otekle veke, izcedek iz oči, motnje vida, krvavitve v očesu
VELCADE dose should be reduced by 1 dose level (from 1.3 mg/m 2 to 1 mg/m 2, or from
Odmerek zdravila VELCADE je treba zmanjšati za 1 stopnjo (z 1,3 mg/m 2 na 1 mg/m 2 ali z
Table 16: Efficacy results from study LYM-3002
Preglednica 16: Rezultati učinkovitosti zdravila v študiji LYM-3002
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 VELCADE (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo VELCADE 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).
• Increased heartbeat, high blood pressure, sweating,
• zvišan srčni utrip, visok krvni tlak, potenje
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and VcDx 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 VcDx.
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 ponovljenem odmerku (AUCzadnji) ekvivalentna pri subkutanem in intravenskem dajanju.
Aseptic technique must be strictly observed throughout the handling of VELCADE, since it contains no preservative.
MED RAVNANJEM Z ZDRAVILOM VELCADE MORATE VES ČAS STROGO UPOŠTEVATI ASEPTIČNO PRIPRAVO, SAJ ZDRAVILO NE VSEBUJE KONZERVANSA.
If any discolouration or particulate matter is observed, the solution should be discarded.
Če opazite kakršnokoli spremembo barve ali delce v raztopini, jo morate zavreči.
• Induction Transplant Regimens Graph.
• Diagram režima uvajanja pred transplantacijo
Common Sleep disorders and disturbances*
Pogosti motnje spanja*
• 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 VELCADE dose.
• Model izračuna s katerim bo lahko predpisovalec izračunal odmerek zdravila in telesno površino, na podlagi bolnikove višine in telesne mase, in tako določil pravi odmerek zdravila VELCADE.
Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Bolnike, ki imajo nevropatično bolečino in/ali periferno nevropatijo, povezano z jemanjem bortezomiba, zdravite v skladu s preglednico 1 (glejte poglavje 4.4).
The median number of cycles received for both groups was 4 cycles.
so Mediano število krogov zdravljenja je bilo 4 v obeh skupinah.
VELCADE should not be given by other routes.
Zdravilo VELCADE se ne sme dajati po nobeni drugi poti.
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
Bolniki, ki so imeli na začetku študije stopnjo periferne nevropatije ≥ 2 ali število trombocitov < 50,000/µl, so bili izključeni.
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
Bolniki v obeh skupinah so na splošno imeli podobne demografske in bolezenske značilnosti: mediana starost bolnikov je bila 66 let, 74% je bilo moških, 66% je bilo belcev in 32% azijcev, 69% bolnikov je imelo pozitivno aspiracijo kostnega mozga in/ali pozitivno biopsijo kostnega mozga za MCL, 54%
A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone group.
Opazili so statistično značilno razliko v Cr+nCR v prid skupine, ki je prejemala zdravilo VELCADE in deksametazon.
Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Uporabljena je Mantel-Haenszelova ocena razmerja verjetnosti za stratificirane preglednice, skupaj s stratifikacijskima dejavnikoma IPI tveganjem in stopnjo bolezni.
Reduce VELCADE to 0.7 mg/m2 in the first treatment cycle.
Zmanjšati odmerek zdravila VELCADE v prvem krogu zdravljenja na 0,7 mg/m2.
When toxicity resolves re-initiate VELCADE treatment and reduce dose to 0.7 mg/m2 once per week.
Nato ponovno uvedite zdravljenje z zdravilom VELCADE in zmanjšajte odmerek na 0,7 mg/m enkrat na teden.
Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal*
Redki nenormalne koncentracije plinov v krvi*, nenormalen elektrokardiogram (vključno z podaljšanjem QT intervala)*, nenormalno mednarodno umerjeno razmerje*, znižan pH v želodcu, zvečana agregacija trombocitov, zvišana koncentracija troponina I, identifikacija in serologija virusov*, nenormalni izvidi analize urina*
VELCADE treatment must be withheld at the onset of any ≥ Grade 3 VELCADE-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section 4.4).
Zdravljenje z zdravilom VELCADE je treba prekiniti ob pojavu katere koli z uporabo zdravila VELCADE povezane ne-hematološke toksičnosti stopnje ≥ 3 (razen nevropatije) ali hematološke toksičnosti stopnje ≥ 3 (glejte tudi poglavje 4.4).
Type 1 glass 5 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a green cap containing 1 mg bortezomib.
5 ml, steklena viala, steklo tipa I, s sivim zamaškom iz bromobutilne gume in aluminijasto zaporko z zelenim pokrovčkom, ki vsebuje 1 mg bortezomiba.
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/m
Vpliv jetrne okvare na farmakokinetiko bortezomiba v odmerkih od 0,5 do 1,3 mg/m2 so ocenjevali v študiji faze I med prvim ciklom zdravljenja, ki je vključevala 61 bolnikov s primarno solidnimi tumorji in različnimi stopnjami jetrne okvare.
Hypotension*, Orthostatic hypotension, Hypertension*
Pogosti hipotenzija*, ortostatska hipotenzija, hipertenzija*
For additional information concerning pegylated liposomal doxorubicin, see the corresponding Summary of Product Characteristics.
Za dodatne informacije o pegiliranem liposomskem doksorubicinu glejte Povzetek glavnih značilnosti tega zdravila.
EBMT criteria All randomised patients with secretory disease * Survival update based on a median duration of follow-up at 60.1 months mo: months
Vsi randomizirani bolniki s sekrecijsko boleznijo preživetje na osnovi podatkov po 60,1 mesecih spremljanja CI = interval zaupanja
Based on animal studies, the penetration of bortezomib through the blood-brain barrier appears to be limited, if any and the relevance to humans is unknown.
Na osnovi rezultatov raziskav na živalih je prehajanje bortezomiba preko hematoencefalne bariere omejeno oz. zanemarljivo.
Modification of starting dose
Prilagoditev odmerjanja
Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Diagnozo potrdimo s slikovnimi preiskavami možganov, najbolje z magnetnoresonančnim slikanjem (MRI - Magnetic Resonance Imaging).
In the Phase III study comparing VELCADE 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).
V študiji faze III z zdravilom VELCADE, ki je primerjala intravensko in subkutano dajanje zdravila, je bila pogostnost dogodkov periferne nevropatije ≥ 2. stopnje v skupini, ki je prejemala zdravilo subkutano 24%, v skupini, ki je prejemala zdravilo intravensko pa 41% (p = 0,0124).
VELCADE was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Bolniki so prejeli zdravilo VELCADE le v 1. in 2. sklopu zdravljenja, da so izognili prekrivanju toksičnih učinkov z drugimi, sočasno danimi zdravili v 3. sklopu zdravljenja.
Although in patients aged ≥ 75 years, both VcR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the VcR-CAP groups was 68%, compared to 42% in the RCHOP group.
Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, VcR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini VcR-CAP 68% v primerjavi z 42% v skupini R-CHOP.
The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the VELCADE 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 dodanim zdravilom VELCADE so se naslednji neželeni učinki (stopnje≥ 3) pojavili pogosteje kot v predhodni kontrolni študiji, 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%).
• Different types of rash
• različne oblike izpuščaja
VELCADE therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Zdravljenje z zdravilom VELCADE je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 2. stopnjo ali še izboljšajo.
18.3 mo
18,3 mesecev
Tumour lysis syndrome
Občasni sindrom tumorske lize
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 krogi zdravljenja na podganah in opicah so bili poglavitni tarčni organi prebavila s posledičnim bruhanjem in/ali drisko, ter krvotvorni organi s posledičnim zmanjšanjem števila krvnih celic v periferni krvi, zmanjšanjem limfatičnega tkiva ter hipocelularnostjo kostnega mozga, periferno nevropatijo (ki so jo opažali pri opicah, miših in psih) s prizadetostjo senzoričnih živčnih končičev in blagimi spremembami ledvic.
Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased
Občasni hiperbilirubinemija*, nenormalni izvidi analiz proteinov*, zvečana telesna masa, nenormalni izvidi krvnih preiskav*, zvišana koncentracija C-reaktivnega proteina
• VELCADE 3.5 mg can be administered both intravenously and subcutaneously while VELCADE 1 mg can be administered only intravenously
• Zdravilo VELCADE 3,5 mg se lahko daje intravensko in subkutano, zdravilo VELCADE 1 mg pa samo intravensko.
Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Preglednica 5: Prilagajanje odmerkov med zdravljenjem pri bolnikih s predhodno nezdravljenim limfomom plaščnih celic
HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-VELCADE treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP).
Do okužbe s HBV s smrtnim izidom je prišlo pri 0,8% (n = 2) bolnikov v skupini, ki ni prejemala zdravila VELCADE (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon; skupina R-CHOP) in pri 0,4% (n = 1) bolnikov v skupini, ki je prejemala zdravilo VELCADE v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (skupina VcR-CAP).
Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of VELCADE (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Klinična učinkovitost pri relapsu ali diseminiranem plazmocitomu, odpornem na zdravljenje Varnost in učinkovitost zdravila VELCADE (injicirano intravensko) v priporočenem odmerku 1,3 mg/m2 so ovrednotili v dveh študijah: v randomizirani, primerjalni (primerjava z deksametazonom (Dex)) študiji faze III (APEX) pri 669 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, ki so pred tem že prejeli 1 do 3 vrste terapije ter v enodelni študiji faze II pri 202 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, ki so pred tem že prejeli najmanj 2 vrsti terapije in je bolezen ob zadnji vrsti terapije napredovala.
Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
Redki maligne neoplazme, plazmocitna levkemija, karcinom ledvičnih celic, masa, fungoidna mikoza, benigne neoplazme
NOS=not otherwise specified * Grouping of more than one MedDRA preferred term.
NOS (not otherwise specified) = ni drugače določeno združevanje več priporočenih terminov po klasifikaciji MedDRA neželeni učinki v obdobju trženja, neodvisno od indikacije
• If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
• Če je bila v prejšnjem krogu zdravljenja opažena dolgotrajna nevtropenija 4. stopnje, trombocitopenija ali trombocitopenija in krvavitev
When VELCADE is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Če jemljete zdravilo VELCADE v kombinaciji s talidomidom, morate upoštevati program za preprečevanje nosečnosti, ki velja za talidomid (glejte navodilo za uporabo talidomida).
20.7 mo
20,7 mesecev
• Alteration of liver functioning
• spremembe v delovanju jeter
Table 15: Efficacy results from study LYM-3002
Preglednica 15: Rezultati učinkovitosti zdravila v študiji LYM-3002
Grounds for the variation to the terms of the marketing authorisation(s)
Podlaga za priporočilo spremembe pogojev dovoljenj(-a) za promet z zdravilom
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).
Vpliv hude okvare ledvic na farmakokinetiko bortezomiba pri bolnikih, ki se še ne zdravijo z dializo (CrCL < 20 ml/min/1,73 m2), ni znan.
Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the VcR-CAP arm and with at least a possible or probable causal relationship to the components of the VcR-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 VcR-CAP in z najmanj verjetno ali možno vzročno povezanostjo s komponentami v skupini VcR-CAP.