FrancophonIA/ELRC3.0 huggingface dataset:
English: • Heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach
Croatian: • žgaravica, nadutost, podrigivanje, vjetrovi, bol u želucu, krvarenje iz crijeva ili iz želuca
English: • 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,
Croatian: • nadražene ili upaljene oči, pretjerano vlaženje očiju, bol u oku, suhe oči, infekcije oka, kvržica na kapku (halacion), crveni i otečeni kapci, iscjedak iz očiju, poremećaj vida, krvarenje oka
English: Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased
Croatian: Manje često Hiperbilirubinemija*, abnormalan nalaz proteina*, povećana težina, abnormalan krvni nalaz*, povišen C-reaktivni protein
English: OUTER CARTON, VELCADE 3.5 mg
Croatian: VANJSKO PAKIRANJE, VELCADE 3,5 mg
English: • Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
Croatian: • Isperite periferni ili centralni venski kateter sterilnom 0,9% otopinom natrijevog klorida (9 mg/ml).
English: (95% CI)=1.428 (0.749; 2.722) p-value g=0.275
Croatian: (95% CI)=1,428 (0,749; 2,722) p-vrijednost g = 0,275
English: • Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage
Croatian: • osjetljivost, utrnulost, trnci ili osjećaj žarenja kože ili bol u šakama ili stopalima zbog oštećenja živaca
English: ≤ 1.0 x ULN
Croatian: ≤ 1,0x GGN
English: An odds ratio (OR) > 1 indicates an advantage for VcR-CAP.
Croatian: Omjera izgleda (OR) > 1 ukazuje na prednost za VcR-CAP.
English: e (95% CI)=1.688 (1.148; 2.481) p-value g=0.007
Croatian: e (95% CI)=1,688 (1,148; 2,481) p-vrijednost g = 0,007
English: Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to VELCADE.
Croatian: Za nuspojave u Tablici 7 ispitivači su smatrali da postoji barem mogućnost ili vjerojatnost uzročno-posljedične povezanosti s lijekom VELCADE.
English: Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough*
Croatian: Dispneja*, epistaksa, infekcija gornjih/donjih dišnih puteva*, kašalj*
English: The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to VELCADE alone.
Croatian: Prema planu ispitivanja, bolesnici su mogli primiti deksametazon ako je njihov odgovor na liječenje samo lijekom VELCADE bio slabiji od optimalnog.
English: Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Croatian: Bolesnicima koji nakon 4 ciklusa postignu najmanje parcijalni odgovor, može se dati do 6 ciklusa
English: Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see Table 4).
Croatian: Talidomid se primjenjuje oralno, 50 mg dnevno, od 1. do 14. dana i, u slučaju da se podnosi, doza se povisuje na 100 mg tijekom 15.-28. dana, a potom se može dalje povisiti na 200 mg dnevno od 2. ciklusa (vidjeti Tablicu 4).
English: The benefit/risk ratio should be considered prior to continuing VELCADE therapy.
Croatian: Potrebno je razmotriti omjer koristi i rizika prije nastavka liječenja lijekom VELCADE.
English: Fertility Fertility studies were not conducted with VELCADE (see section 5.3).
Croatian: Plodnost Nisu provedena ispitivanja utjecaja lijeka VELCADE na plodnost (vidjeti dio 5.3).
English: VELCADE may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Croatian: VELCADE može vrlo često biti povezan s umorom, često s omaglicom, manje često sa sinkopom i često s ortostatskom/posturalnom hipotenzijom ili zamagljenim vidom.
English: Vc=VELCADE; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Croatian: CR = Kompletni odgovor; nCR = blizu kompletnog odgovora PR = Parcijalni odgovor; MR = Minimalni odgovor
English: Note: An OR > 1 indicates an advantage for Vc-containing induction therapy.
Croatian: Napomena: OR > 1 ukazuje na prednost za uvodno liječenje koje sadrži Vc.
English: You may also be given VELCADE together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Croatian: VELCADE Vam se također može dati zajedno s lijekovima koji se zovu pegilirani liposomalni doksorubicin ili deksametazon.
English: 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.
Croatian: Značajne razlike u populaciji bolesnika s limfomom plaštenih stanica kada se usporede s ispitivanjima s bolesnicima s multiplim mijelomom bile su ≥ 5% viša incidencija hematoloških nuspojava (neutropenija, trombocitopenija, leukopenija, anemija, limfopenija), periferna senzorna neuropatija, hipertenzija, pireksija, pneumonija, stomatitis i poremećaji dlakavosti.
English: VELCADE therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL.
Croatian: Liječenje lijekom VELCADE mora se prekinuti do 2 tjedna, dok bolesnik ne dostigne apsolutni broj neutrofila ≥ 750 stanica/μL i broj trombocita ≥ 25 000 stanica/μL.
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.
Croatian: U ispitivanje su uključena 222 bolesnika s relapsnim/refraktornim multiplim mijelomom, koji su bili randomizirani u omjeru 2:1, kako bi primili VELCADE 1,3 mg/m2 bilo supkutano ili intravenski u 8 ciklusa.
English: Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake “Rok valjanosti“.
English: Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy
Croatian: Kornelane lezije*, egzoftalmus, retinitis, skotom, nespecificirani poremećaj oka (uključujući kapak), stečeni dakrioadenitis, fotofobija, fotopsija, optička neuropatija
English: 1 mg/m 2 to 0.7 mg/m
Croatian: 1 mg/m 2 na 0,7 mg/m
English: • Inflammation of a vein, blood clots in your veins and lungs
Croatian: • upala vena, krvni ugrušci u venama i plućima
English: VDDx=vincristine, doxorubicin, dexamethasone; VcDx=VELCADE, dexamethasone; TDx=thalidomide, dexamethasone; VcTDx=VELCADE, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
Croatian: VDDx = vinkristin, doksorubicin, deksametazon; VcDx = VELCADE, deksametazon; TDx = talidomid, deksametazon; VcTDx = VELCADE, talidomid, deksametazon; PN = periferna neuropatija Napomena: Periferna neuropatija je uključila preferirane termine: periferna neuropatija, periferna motorna neuropatija, periferna senzorna neuropatija i polineuropatija.
English: You must read the package leaflets of all medicinal products to be taken in combination with VELCADE for information related to these medicines before starting treatment with VELCADE.
Croatian: Za informacije o svim lijekovima koji se uzimaju zajedno s lijekom VELCADE, morate pročitati pripadajuću uputu o lijeku, prije započinjanja liječenja lijekom VELCADE.
English: Gastrointestinal and intracerebral haemorrhage, have been reported in association with VELCADE treatment.
Croatian: Gastrointestinalno i intracerebralno krvarenje bilo je prijavljeno u vezi s liječenjem lijekom VELCADE.
English: • Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
Croatian: • grčevi u mišićima, mišićni spazam, mišićna slabost, bol u udovima
English: Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose or schedule of VELCADE (see section 4.2).
Croatian: Bolesnike kod kojih se pojavi nova ili im se pogorša postojeća periferna neuropatija mora se neurološki pregledati, a po potrebi im treba promijeniti dozu ili vremenski raspored primjene lijeka VELCADE (vidjeti dio 4.2).
English: • Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μL
Croatian: • Broj trombocita mora biti ≥ 100 000 stanica/μL i apsolutni broj neutrofila mora biti
English: Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise,
Croatian: Neki od slučajeva uključuju otežano disanje, nedostatak zraka, nedostatak zraka u stanju bez napora, disanje koje postaje plitko, teško ili prestaje, piskanje
English: Table 15: Efficacy results from study LYM-3002
Croatian: Tablica 15: Rezultati djelotvornosti iz ispitivanja LYM-3002
English: #, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection*
Croatian: #, bakterijemija (uključujući stafilokoknu), hordeolum (ječmenac), influenca, celulitis, infekcija povezana s proizvodom, kožna infekcija*, infekcija uha*, infekcija stafilokokom, infekcija zuba*
English: Type 1 glass 5 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a green cap containing 1 mg bortezomib.
Croatian: Staklena bočica (staklo tip 1) od 5 ml sa sivim brombutilnim čepom i aluminijskim prstenom, sa zelenom kapicom koja sadrži 1 mg bortezomiba.
English: • Different types of rash
Croatian: • različite vrste osipa
English: • Injection sites should be rotated for successive injections.
Croatian: • Za uzastopne injekcije treba mijenjati mjesta primjene injekcije.
English: Testicular disorder*, Prostatitis, Breast disorder female, Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration
Croatian: Poremećaj testisa*, prostatitis, poremećaj dojki u žena, osjetljivost epididimisa, epididimitis, bol zdjelice, ulceracija na vulvi
English: Rare cases of hepatic failure have been reported in patients receiving VELCADE and concomitant medicinal products and with serious underlying medical conditions.
Croatian: U rijetkim je slučajevima zabilježeno zatajenje jetre u bolesnika s ozbiljnim podležećim zdravstvenim stanjem koji su istodobno primali VELCADE i konkomitantne lijekove.
English: Marketing Authorisation Holder JANSSEN-CILAG INTERNATIONAL NV
Croatian: Nositelj odobrenja za stavljanje lijeka u promet JANSSEN-CILAG INTERNATIONAL NV
English: Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether VELCADE (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m 2) and prednisone
Croatian: Klinička djelotvornost u prethodno neliječenih bolesnika s multiplim mijelomom Prospektivno, međunarodno, randomizirano (1:1) kliničko ispitivanje faze III otvorenog tipa (MMY-3002 VISTA) koje je uključilo 682 bolesnika, provedeno je da bi se utvrdilo hoće li VELCADE (1,3 mg/m2 primijenjen intravenskom injekcijom) u kombinaciji s melfalanom (9 mg/m2) i prednizonom (60 mg/m2) rezultirati boljim vremenom do progresije bolesti (TTP od engl. time to progression) u usporedbi s melfalanom (9 mg/m2) i prednizonom (60 mg/m2) u prethodno neliječenih bolesnika s multiplim mijelomom.
English: 1.3 The reconstituted solution is preservative free and should be used immediately after preparation.
Croatian: 1.3 Pripremljena otopina ne sadrži konzervanse i treba ju primijeniti odmah nakon pripreme.
English: Efficacy results are presented in Table 15:
Croatian: Rezultati djelotvornosti prikazani su u Tablici 15:
English: Subcutaneous or Intravenous use only.
Croatian: Samo za supkutanu ili intravensku primjenu.
English: #, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer Acne*, Blister*, Pigmentation disorder*
Croatian: #, dermatitis*, poremećaj dlake*, petehije, ekhimoza, lezije kože, purpura, kožna masa*, psorijaza, hiperhidroza, noćno znojenje, dekubitalni ulkus
English: Rest Period
Croatian: Period odmora
English: Injection sites should be rotated for successive injections.
Croatian: Mjesto primjene injekcije treba mijenjati tijekom svake uzastopne injekcije.
English: OUTER CARTON, VELCADE 1 mg
Croatian: VANJSKO PAKIRANJE, VELCADE 1 mg
English: * Primary endpoint
Croatian: * Primarni ishod
English: • Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood,
Croatian: • poremećaji ili problemi sa spavanjem, znojenje, tjeskoba, promjene raspoloženja, depresivno raspoloženje, nemir i uznemirenost, promjene duševnog stanja, dezorijentiranost
English: N=130 (ITT population)
Croatian: N = 130 (ITT populacija)
English: * Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
Croatian: Prema prilagodbama doziranja u ispitivanjima liječenja multiplog mijeloma faze II i III i iskustvima nakon stavljanja lijeka u promet.
English: Hypermagnesaemia*, Acidosis, Electrolyte imbalance*, Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia*, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Croatian: Hipermagnezijemija*, acidoza, neravnoteža elektrolita*, preopterećenje tekućinom, hipokloremija*, hipovolemija, hiperkloremija*, hiperfosfatemija*, poremećaj metabolizma, nedostatak vitamina B kompleksa, nedostatak vitamina B12, giht, pojačani apetit, netolerancija na alkohol
English: Hypotension*, Orthostatic hypotension, Hypertension* Uncommon Cerebrovascular accident
Croatian: Hipotenzija*, ortostatska hipotenzija, hipertenzija * Manje često Cerebrovaskularni događaj
English: Neutrophils were lowest at Day 11 of each cycle of VELCADE treatment and typically recovered to baseline by the next cycle.
Croatian: Trombociti su bili najniži 11. dana svakog ciklusa liječenja lijekom VELCADE i obično su se povukli do početnog stanja do sljedećeg ciklusa.
English: Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia
Croatian: Manje često Pancitopenija*, febrilna neutropenija, koagulopatija*, leukocitoza*, limfadenopatija, hemolitička anemija
English: • Coma
Croatian: • koma
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Vc=VELCADE; VcDx=VELCADE, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Croatian: CI = interval pouzdanosti; CR = kompletni odgovor; nCR = blizu kompletnog odgovora; ITT = Populacija bolesnika s namjerom liječenja; RR = stopa odgovora; Vc = VELCADE; VcDx = VELCADE, deksametazon; VDDx = vinkristin, doksorubicin, deksametazon; VGPR = vrlo dobar parcijalni odgovor; PR = parcijalni odgovor; OR = omjer izgleda.
English: In studies in patients with relapsed multiple myeloma treated with VELCADE and in patients with previously untreated MCL treated with VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Croatian: U ispitivanjima s bolesnicima s relapsom multiplog mijeloma liječenih s lijekom VELCADE i s bolesnicima s prethodno neliječenim limfomom plaštenih stanica liječenih s lijekom VELCADE u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (VcR-CAP), jedna od najčešćih hematoloških toksičnosti bila je prolazna trombocitopenija.
English: • Increased appetite
Croatian: • pojačan apetit,
English: N=127 (ITT population)
Croatian: N = 127 (ITT populacija)
English: Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction, Rare
Croatian: Manje često Vaginalno krvarenje, genitalna bol*, erektilna disfunkcija Rijetko
English: In addition, when VELCADE is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these products should be considered in the event of toxicities according to the recommendations in the Summary of Product Characteristics.
Croatian: Dodatno, kad se VELCADE primjenjuje u kombinaciji s ostalim kemoterapeuticima, u slučaju toksičnosti u obzir se moraju uzeti prikladne redukcije doza tih lijekova, u skladu s preporukama iz Sažetka opisa svojstava lijeka.
English: • General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness
Croatian: • opći osjećaj bolesti, bol, vrtoglavica, ošamućenost, osjećaj slabosti ili gubitak svijesti
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
Croatian: Undulacija atrija, infarkt miokarda*, atrioventrikularni blok*, kardiovaskularni poremećaj (uključujući kardiogeni šok), Torsade de pointes, nestabilna angina, poremećaji srčanih zalistaka*, insuficijencija koronarnih arterija, sinusni arest
English: CR+nCR+PR % (95% CI) *RR (Post-transplant) CR+nCR
Croatian: CR+nCR+PR % (95% CI) *RR (Posttransplantacijska) CR+nCR
English: A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 35% (CI90% [1.032 to 1.772]) based on data from 12 patients.
Croatian: Ispitivanje interakcija lijekova kojim se procjenjivao učinak ketokonazola, jakog CYP3A4 inhibitora na farmakokinetiku bortezomiba (primijenjenog intravenski), pokazalo je prosječno povećanje AUC bortezomiba za 35% (CI90% [1,032 do 1,772]) na temelju podataka o 12 bolesnika.
English: Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap containing 3.5 mg bortezomib.
Croatian: Staklena bočica (staklo tip 1) od 10 ml sa sivim brombutilnim čepom i aluminijskim prstenom, sa plavom kapicom koja sadrži 3,5 mg bortezomiba.
English: • Tiredness, feeling weak
Croatian: • umor, osjećaj slabosti
English: 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).
Croatian: Infekcija HBV-om sa smrtonosnim ishodima pojavila se kod 0,8% (n = 2) bolesnika u skupini koja nije liječena lijekom VELCADE (rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon; R-CHOP ) i u 0,4% (n = 1) bolesnika koji su primali VELCADE u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (VcR-CAP).
English: Hypotension*, Orthostatic hypotension, Hypertension*
Croatian: Hipertenzija*, hipotenzija*, ortostatska hipotenzija
English: 24.0 mo
Croatian: 24,0 mjeseca
English: The most commonly reported adverse reactions during treatment with VELCADE are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Croatian: Najčešće prijavljene nuspojave tijekom liječenja lijekom VELCADE jesu mučnina, proljev, zatvor, povraćanje, umor, pireksija, trombocitopenija, anemija, neutropenija, periferna neuropatija (uključujući senzornu), glavobolja, parestezija, smanjeni apetit, dispneja, osip, herpes zoster i mialgija.
English: • A sore mouth or lip, dry mouth, mouth ulcers or throat pain
Croatian: • rane na ustima ili na usnama, suha usta, čirevi u ustima ili grlobolja
English: #, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
Croatian: #, kardiopulmonalni arest *, fibrilacija srca (uključujući atrijsku), srčano zatajenje (uključujući lijevo i desno ventrikularno)*, aritmija*, tahikardija*, palpitacije, angina pektoris, perikarditis (uključujući perikardijalni izljev)*, kardiomiopatija*, ventrikularna disfunkcija*, bradikardija
English: • Bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina
Croatian: • krvave stolice ili krvarenje iz sluznica, npr. iz usta, rodnice
English: In B-ALL patients with relapse 18-36 months from diagnosis (n = 33) the CR rate was 79% (95% CI: 61, 91) and the 4-month event free survival rate was 73% (95% CI: 54, 85).
Croatian: U bolesnika s B-staničnom ALL s relapsom unutar 18-36 mjeseci od dijagnoze (n = 33) stopa kompletnog odgovora bila je 79% (95% CI: 61, 91) i stopa četveromjesečnog preživljenja bez događaja bila je 73% (95% CI: 54, 85).
English: #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
Croatian: #, nespecificirani poremećaj krvi, hemoragijska dijateza, limfocitna infiltracija
English: CR+nCR+ PR+MR
Croatian: CR+nCR+PR+M
English: • Facial blushing or tiny broken capillaries
Croatian: • crvenjenje lica ili popucale sitne kapilare
English: Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
Croatian: Klinička djelotvornost kod prethodno neliječenog limfoma plaštenih stanica (MCL) Ispitivanje LYM 3002 bilo je randomizirano, otvoreno ispitivanje faze III koje je uspoređivalo djelotvornost i sigurnost kombinacije lijeka VELCADE, rituksimaba, ciklofosfamida, doksorubicina i prednizona (VcR-CAP; n = 243) s onima kombinacije rituksimaba, ciklofosfamida, doksorubicina, vinkristina, i prednizona (R-CHOP; n = 244) u odraslih bolesnika s prethodno neliječenim limfomom plaštenih stanica (Stadij II, III ili IV).
English: • If local injection site reactions occur following VELCADE injection subcutaneously, either a less concentrated VELCADE solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Croatian: • Ako se nakon supkutane injekcije lijeka VELCADE pojave reakcije na mjestu primjene, supkutano se može primijeniti otopina lijeka VELCADE manje koncentracije (1 mg/ml umjesto 2,5 mg/ml) ili se preporučuje prijeći na intravensku injekciju.