FrancophonIA/ELRC3.0 huggingface dataset:
English: VELCADE 3.5 mg reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: VELCADE 3,5 mg rekonstituirano raztopino dajte naenkrat v obliki 3-5 sekund trajajoče bolusne intravenske injekcije preko perifernega ali osrednjega intravenskega katetra, čemur naj sledi izpiranje katetra z 9 mg/ml (0,9%) raztopino natrijevega klorida za injiciranje.
English: There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mantle cell lymphoma.
Slovenian: Dokazov, ki bi potrdili, da je pri bolnikih z diseminiranim plazmocitomom ali limfomom plaščnih celic, starejših od 65 let potrebna prilagoditev odmerka, ni.
English: bleeding of the eye
Slovenian: • krvavitve iz nosu
English: VcR-CAP=VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Slovenian: VcR-CAP = VELCADE, rituksimab, ciklofosfamid, doksorubicin in prednizon; R-CHOP = rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon; PN = periferna nevropatija Periferna nevropatija vključuje priporočene termine: periferna senzorična nevropatija, periferna nevropatija, periferna motorična nevropatija in periferna senzomotorična nevropatija.
English: • Joint or muscle stiffness, sense of heaviness, pain in your groin
Slovenian: • okorelost sklepov ali mišic, občutek teže, bolečine v dimljah
English: • Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu like illness
Slovenian: • okužbe, vključno s pljučnico, okužba dihal, bronhitis, glivične okužbe, produktiven kašelj, gripi podobna bolezen
English: • Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μL
Slovenian: • Število trombocitov mora biti ≥ 100.000 celic/μl in celokupno število nevtrofilcev
English: Once the symptoms of the toxicity have resolved, VELCADE treatment may be re-initiated at a 25% reduced dose (1.3 mg/m2 reduced to 1.0 mg/m2; 1.0 mg/m2 reduced to 0.7 mg/m2).
Slovenian: Ko znaki toksičnosti minejo, lahko zdravljenje z zdravilom VELCADE ponovno uvedete, vendar s 25% manjšim odmerkom (1,3 mg/m2 zmanjšano na 1,0 mg/m
English: CR+nCR+ PR+MR
Slovenian: CR+ nCR + PR
English: Time to next therapy Events n (%) Median (95% CI)
Slovenian: Čas do naslednjega zdravljenja dogodki n (%) mediana a (95% CI)
English: #, Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge
Slovenian: #, vnetje očesa*, diplopija, suhe oči*, draženje očesa*, bolečina v očesu, povečano solzenje, izcedek iz očesa
English: • Blood clots in your lungs
Slovenian: • krvni strdki v pljučih
English: Both in patients who were refractory to their last prior therapy and those who were not refractory, overall survival was significantly longer and response rate was significantly higher on the VELCADE arm.
Slovenian: Tako pri bolnikih s plazmocitomom, odpornim na zdravljenje, po prejšnji vrsti zdravljenja, kot pri tistih, ki so se odzvali na zdravljenje, je bilo celokupno preživetje v skupini, ki je prejemala VELCADE, statistično značilno daljše in odziv na zdravljenje je bil statistično značilno boljši.
English: The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Slovenian: Po kriterijih Evropske skupine za transplantacijo kostnega mozga (EBMT - European Group for Blood and Marrow Transplantation) je bil primarni opazovani dogodek glede učinkovitosti TTP, sekundarna opazovana dogodka glede učinkovitosti pa OS in ORR (CR+PR).
English: An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of VELCADE versus the intravenous administration.
Slovenian: V odprti, randomizirani, študiji faze III na dveh enakovrednih skupinah so primerjali učinkovitost in varnost subkutanega in intravenskega dajanja zdravila VELCADE.
English: #, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer Acne*, Blister*, Pigmentation disorder*
Slovenian: #, dermatitis*, bolezni las*, petehije, ehimoze, spremembe na koži, purpura, kožna masa*, luskavica, hiperhidroza, nočno znojenje, dekubitusna razjeda
English: 24.0 mo
Slovenian: 24,0 mesecev
English: Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Slovenian: Presnovka, ki nastaneta po odcepitvi bora ne delujeta kot zaviralca 26S proteasoma.
English: In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m2 weekly and 1.3 mg/m2 twice-weekly.
Slovenian: Pri analizi učinkovitosti, merjene s hematološkim odzivom (M-protein), pri 49 bolnikih, pri katerih je bila mogoča ocena in so prejemali največje dovoljene odmerke 1,6 mg/m2 na teden in 1,3 mg/m2 dvakrat na teden, je bila stopnja odziva 67,3% (vključno z deležem CR 28,6%).
English: Week Vc (1.3 mg/m
Slovenian: Teden Vc (1,3 mg/m dan 1, 4
English: • Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood,
Slovenian: • težave s spanjem, znojenje, tesnoba, nihanje razpoloženja, depresivno razpoloženje, nemir ali vznemirjenost, spremembe v vašem duševnem stanju, dezorientiranost
English: VELCADE might cause tiredness, dizziness, fainting, or blurred vision.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo VELCADE lahko povzroči utrujenost, omotičnost, omedlevico ali zamegljen vid.
English: VELCADE contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Slovenian: Zdravilo VELCADE vsebuje učinkovino bortezomib, ki je zaviralec proteasomov.
English: The reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Rekonstituirano raztopino dajte naenkrat v obliki 3-5 sekund trajajoče bolusne intravenske injekcije preko perifernega ali osrednjega intravenskega katetra, čemur naj sledi izpiranje katetra z 9 mg/ml (0,9%) raztopino natrijevega klorida za injiciranje.
English: In B-ALL patients with relapse within 18 months of diagnosis (n = 27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62).
Slovenian: Pri bolnikih z Bcelično ALL in relapsom v manj kot 18 mesecih po diagnozi (n = 27) je bil delež popolnih odgovorov 67% (95% CI: 46, 84) in delež 4-mesečnega preživetja bolnikov brez dogodkov 44% (95% CI: 26, 62).
English: • Problems with blood clotting
Slovenian: • motnje v strjevanju krvi
English: Neutrophils were lowest at Day 11 of each cycle of VELCADE treatment and typically recovered to baseline by the next cycle.
Slovenian: Število nevtrofilcev je bilo najmanjše 11. dan vsakega cikla zdravljenja z zdravilom VELCADE in se je do naslednjega kroga zdravljenja običajno povrnilo na začetno vrednost.
English: Each carton of VELCADE 3.5 mg powder for solution for injection contains a glass 10 ml vial with a royal blue cap, in a transparent blister pack.
Slovenian: Ena škatla zdravila VELCADE 3,5 mg prašek za raztopino za injiciranje vsebuje stekleno 10 ml vialo s pokrovčkom modre barve v prozorni zavarjeni vrečki.
English: • Respiratory infections, bronchitis, coughing with phlegm, flu like illness
Slovenian: • okužbe dihal, bronhitis, produktiven kašelj, gripi podobna bolezen
English: tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Slovenian: omedlevica - težave s kašljem in dihanjem ali tiščanje v prsih
English: The resulting solution is then either injected into a vein or under the skin.
Slovenian: Nastalo raztopino se nato injicira v veno ali v podkožje.
English: In a drug-drug interaction study assessing the effect of omeprazole, a potent CYP2C19 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 17 patients.
Slovenian: V študiji medsebojnega delovanja zdravil, ki je ocenjevala učinek omeprazola, močnega inhibitorja encima CYP2C19, na farmakokinetiko bortezomiba (danega intravensko), na osnovi podatkov 17 bolnikov, ni bilo pomembnega vpliva na farmakokinetiko bortezomiba.
English: In patients developing PRES, VELCADE should be discontinued.
Slovenian: Če se pri bolniku razvije PML, je treba zdravljenje z zdravilom VELCADE prekiniti.
English: Table 7: Adverse reactions in patients with Multiple Myeloma treated with VELCADE in clinical trials, and all post-marketing adverse reactions regardless of indication System Organ Class
Slovenian: Preglednica 7: Neželeni učinki pri bolnikih z diseminiranim plazmocitomom, zdravljenih z zdravilom VELCADE v kliničnih preskušanjih in v obdobju trženja, neodvisno od indikacije
English: 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 VELCADE, regardless of disease status.
Slovenian: Kot rezultat predhodno načrtovane vmesne analize, so del preskušanja, v katerem so bolniki dobivali deksametazon zaključili v skladu s priporočilom komisije, ki je spremljala podatke.
English: The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Slovenian: Primarna ocena učinkivitosti je bila stopnja odgovora po uvedbi zdravljenja in po presaditvi (CR+nCR).
English: Patients in the VcDx group received four 21 day cycles, each consisting of VELCADE (1.3 mg/m2 administered intravenously twice weekly on days 1, 4, 8, and 11), and oral dexamethasone (40 mg/day on days 1 to 4 and days 9 to 12, in Cycles 1 and 2, and on days 1 to 4 in Cycles 3 and 4).
Slovenian: V vsakem krogu so prejeli zdravilo VELCADE (1,3 mg/m2 intravensko dvakrat na teden na 1., 4., 8. in 11. dan) in deksametazon (40 mg/dan, peroralno, 1. do 4. in 9. do 12. dan v 1. in 2. krogu in 1. do 4. dan v 3. in 4. krogu).
English: *RR (Post-induction) CR+nCR
Slovenian: *RR (po uvedbi) CR+nCR
English: Atrial flutter, Myocardial infarction*, Atrioventricular block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest
Slovenian: Redki atrijska undulacija, miokardni infarkt*, atrioventrikularni blok*, srčno-žilne bolezni (vključno s kardiogenim šokom), Torsade de pointes, nestabilna angina pektoris, bolezni srčnih zaklopk*, insuficienca koronarnih arterij, sinusni zastoj
English: After reconstitution, each ml solution contains 2.5 mg bortezomib.
Slovenian: Po rekonstituciji, vsak ml raztopine vsebuje 2,5 mg bortezomiba.
English: Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Slovenian: Ocena razmerja tveganja na osnovi Coxovega modela, stratificirani z IPI tveganjem in stopnjo bolezni.
English: Four treatment cycles of this combination therapy are administered.
Slovenian: Bolnik prejme štiri kroge kombiniranega zdravljenja.
English: 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 of VELCADE by either the subcutaneous or intravenous route for 8 cycles.
Slovenian: V študijo je bilo vključenih 222 bolnikov z relapsom/diseminiranim plazmocitomom, odpornim na zdravljenje, randomiziranih 2:1 na zdravilo VELCADE, z odmerkom1,3 mg/m2 telesne površine subkutano ali intravensko 8 krogov zdravljenja.
English: p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm. 222 subjects were enrolled into the study; 221 subjects were treated with VELCADE Hazards ratio estimate is based on a Cox model adjusted for stratification factors: ISS staging and number of prior lines.
Slovenian: V študijo je bilo vključenih 222 preiskovancev; 221 preiskovancev se je zdravilo z zdravilom VELCADE Ocena stopnje tveganja temelji na modelu po Cox-u, prilagojen na osnovi stratifikacijaskih faktorjev: ISS razvrstitvi in številu predhodnih zdravljenj.
English: • Loss of conciousness
Slovenian: • izguba zavesti
English: The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to VELCADE alone.
Slovenian: V skladu s protokolom so bolniki lahko prejeli deksametazon, če ni bilo pričakovanega odziva na zdravljenje z zdravilom VELCADE v monoterapiji.
English: It is recommended that patients receive 2 cycles of VELCADE following a confirmation of a complete response.
Slovenian: Priporočamo, da bolniki po potrjenem popolnem odgovoru prejmejo še 2 kroga zdravljenja z zdravilom VELCADE.
English: The resulting solution is then injected into a vein rapidly, over 3 to 5 seconds.
Slovenian: Nastalo raztopino se nato hitro, v 3 do 5 sekundah, injicira v veno.
English: Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Slovenian: Redki periferni embolizem, limfedem, bledica, eritromelalgija, vazodilatacija, sprememba barve ven, venska insufucienca
English: 1.4 mo
Slovenian: 1,4 mesecev
English: Then, VELCADE 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
Slovenian: Nato lahko ponovno uvedete zdravilo VELCADE v odmerku, ki je eno stopnjo manjši od prejšnjega (z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na
English: • Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
Slovenian: • mišični krči, oslabelost mišic, bolečine v udih
English: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the VcR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Slovenian: 14% preiskovancev iz skupine VcR-CAP in 17% bolnikov iz skupine R-CHOP je prejelo 2 dodatna kroga zdravljenja.
English: Uncommon Dysacusis (inc tinnitus)*,Hearing impaired (up to and inc deafness), Ear discomfort*
Slovenian: Občasni disakuza (vključno s tinitusom) *, okvara sluha (vse do in vključno z gluhostjo), neprejeten občutek v ušesu*
English: You should not breast-feed while using VELCADE.
Slovenian: Med uporabo zdravila VELCADE ne smete dojiti.
English: Patients with moderate or severe hepatic impairment should be started on VELCADE 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/m or further dose reduction to 0.5 mg/m 2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Slovenian: Na osnovi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja a odmerka na 1,0 mg/m2 ali zmanjšanja odmerka na 0,5 mg/m 2 (glejte preglednico 6 ter poglavji 4.4 in 5.2).
English: The following medicinal products are administered on day 1 of each VELCADE 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
Slovenian: Naslednja zdravila boste prejeli 1. dan vsakega 21-dnevnega kroga zdravljenja z zdravilom VELCADE v obliki intravenske infuzije: 375 mg/m 2 rituksimaba, 750 mg/m 2 ciklofosfamida in 50 mg/m 2 doksorubicina.
English: You may experience a reduction in the number of: - platelets, which may make you be more prone to bruising, or to bleeding without obvious injury
Slovenian: Lahko boste imeli zmanjšanje števila: - krvnih ploščic, zaradi česar ste lahko bolj dovzetni za podplutbe ali krvavitve brez očitnih poškodb (npr.: krvavitve v črevesju, želodcu, ustih in dlesnih ali krvavitve v možganih ali jetrih).
English: • Reduced functioning of your kidneys
Slovenian: • zmanjšano delovanje ledvic
English: However, the dose-normalised mean AUC values were increased by approximately 60% in patients with moderate or severe hepatic impairment.
Slovenian: Pri bolnikih z zmerno ali hudo jetrno okvaro so se vrednosti povprečnega, na odmerek normaliziranega AUC povečale za 60%.
English: Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose, schedule or route of administration to subcutaneous (see section 4.2).
Slovenian: Pri bolnikih, pri katerih se periferna nevropatija pojavi prvič ali se obstoječa periferna nevropatija poslabša, je treba napraviti nevrološko oceno in po potrebi prilagoditi odmerek ali shemo odmerjanja na subkutano (glejte poglavje 4.2).
English: Mantle Cell Lymphoma (MCL) The safety profile of VELCADE in 240 MCL patients treated with VELCADE at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Slovenian: Varnostni profil zdravila VELCADE pri 240 bolnikih, zdravljenih z zdravilom VELCADE v odmerku 1,3 mg/m2 telesne površine, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (VcR-CAP) v primerjavi z 242 bolniki, zdravljenimi z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom [R-CHOP], je bil relativno skladen s profilom, opaženim pri bolnikih z diseminiranim plazmocitomom.
English: Dosage adjustments for transplant eligible patients For VELCADE dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Slovenian: Prilagoditev odmerjanja pri bolnikih, primernih za presaditev Za prilagoditev odmerjanja zdravila VELCADE je treba upoštevati navodila za odmerjanje, opisana pri samostojnem zdravljenju.
English: VELCADE therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Slovenian: Zdravljenje z zdravilom VELCADE je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 1. stopnjo ali stanje pred začetkom zdravljenja.
English: - in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).
Slovenian: - v kombinaciji z deksametazonom ali z deksametazonom in talidomidom, pri bolnikih, pri katerih bolezni še nismo zdravili in pred kemoterapijo v velikih odmerkih in presaditvijo krvotvornih matičnih celic (uvajalno zdravljenje).
English: Combination therapy with melphalan and prednisone VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Slovenian: Kombinirano zdravljenje z melfalanom in prednizonom Zdravilo VELCADE 3,5 mg se daje intravensko ali subkutano v kombinaciji s peroralnim melfalanom in prednizonom, kot je prikazano v preglednici 2.
English: • Reconstitution poster
Slovenian: • Plakat z navodili za rekonstitucijo
English: VELCADE will be administered by a health care professional experienced in the use of cytotoxic medicines.
Slovenian: Zdravilo VELCADE pa lahko aplicira tudi zdravstveno osebje, ki ima izkušnje z zdravljenjem s kemoterapevtskimi učinkovinami.
English: 13.1 mo
Slovenian: 13,1 mesecev
English: Subcutaneous reconstitution: After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Slovenian: Subkutana rekonstitucija: Po rekonstituciji, 1 ml raztopine za subkutano injiciranje vsebuje 2,5 mg bortezomiba.
English: Time to progression Events n (%) Median a (95% CI)
Slovenian: Čas do napredovanja bolezni dogodki n (%) mediana a (95% CI)
English: The final survival update was performed with a median duration of follow-up of 60.1 months.
Slovenian: Po 60,1 mesecih (mediana trajanja spremljanja) so posodobili podatke o končnem preživetju.
English: • Swelling of the liver, bleeding from the liver
Slovenian: • otekanje jeter, krvavitev v jetrih
English: Clinical efficacy with subcutaneous administration of VELCADE in patients with relapsed/refractory multiple myeloma
Slovenian: Klinična učinkovitost subkutanega dajanja zdravila VELCADE bolnikom pri relapsu/diseminiranem plazmocitomu, odpornem na zdravljenje
English: The incidence of herpes zoster among patients in the Vc+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Slovenian: V skupini, zdravljeni z Vc+M+P, je pri 17% bolnikov, ki niso prejemali protivirusnih zdravil, prišlo do reaktivacije virusa herpes zoster, pri bolnikih, ki so prejemali protivirusna zdravila, pa je prišlo do reaktivacije virusa pri 3% bolnikov.
English: When VELCADE is given together with pegylated liposomal doxorubicin, you will receive VELCADE intravenously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m is given on day 4 of the VELCADE 21-day treatment cycle as an intravenous infusion after the VELCADE injection.
Slovenian: Če boste prejeli zdravilo VELCADE skupaj s pegiliranim liposomskim doksorubicinom, boste prejeli zdravilo VELCADE v veno v 21-dnevnem krogu zdravljenja in pegilirani liposomski doksorubicin v odmerku 30 mg/m2 v obliki enourne intravenske infuzije na 4. dan 21-dnevnega kroga zdravljenja, po injekciji zdravila VELCADE.
English: - in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation.
Slovenian: - v kombinaciji z melfalanom in prednizonom, pri bolnikih, pri katerih bolezni še niso zdravili in pri njih kemoterapija v velikih odmerkih, pred presaditvijo krvotvornih matičnih celic ni primerna.
English: Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Slovenian: Subkutana uporaba: dodajte 1,4 ml sterilne 0,9% raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
English: VELCADE 1 mg powder for solution for injection is for intravenous use only, while VELCADE 3.5 mg powder for solution for injection is for intravenous or subcutaneous use.
Slovenian: Zdravilo VELCADE 1 mg prašek za raztopino za injiciranje se daje samo intravensko, zdravilo VELCADE 3,5 mg prašek za raztopino za injiciranje pa intravensko ali subkutano.
English: VELCADE 1 mg powder for solution for injection
Slovenian: VELCADE 1 mg prašek za raztopino za injiciranje
English: Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakiuria
Slovenian: Občasni akutna odpoved ledvic, kronična odpoved ledvic*, okužba sečil*, znaki in simptomi bolezni sečil*, hematurija*, retenca urina, težave pri uriniranju*, proteinurija, azotemija, oligurija*, polakiurija
English: VELCADE 3.5 mg powder for solution for injection
Slovenian: VELCADE 3,5 mg prašek za raztopino za injiciranje
English: In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the VELCADE treatment group (VcR-CAP) as compared to the non-VELCADE treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Slovenian: Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost trombocitopenije stopnje 3 ali več v skupini, ki je prejemala zdravilo VELCADE (VcR-CAP), večja (56,7% proti 5,8%) v primerjavi s skupino, ki zdravila VELCADE ni prejemala (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon [R-CHOP]).