FrancophonIA/ELRC3.0 huggingface dataset:
English: Mannitol (E 421) Nitrogen
Croatian: 6.1 Popis pomoćnih tvari manitol (E 421) dušik
English: Uncommon Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis Rare
Croatian: Manje često Hepatotoksičnost (uključujući poremećaj jetre), hepatitis*, kolestaza
English: • symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion,
Croatian: • simptome sindroma lize tumora poput grčenja mišića, slabosti mišića, smetenosti, gubitka vida ili smetnji, te nedostatka zraka
English: Day 4 Day 8 Day rest period
Croatian: 8. dan 11. dan period odmora dan dan dan dan period odmora
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
Croatian: Nakon toga, VELCADE se može ponovno uvesti u dozi smanjenoj za jednu razinu doze (s 1,3 mg/m2 na 1 mg/m2, ili s
English: When VELCADE is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with VELCADE.
Croatian: Kada se VELCADE primjenjuje u kombinaciji s drugim lijekovima, prije započinjanja liječenja lijekom VELCADE morate se konzultirati sa Sažetkom opisa svojstava lijeka tih lijekova.
English: • Cysts in the lining of joints (synovial cysts)
Croatian: • ciste na ovojnici zglobova (sinovijalne ciste)
English: 1.3 mg/m 2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m 2 and 1.3 mg/m 2, respectively.
Croatian: Srednji ukupni tjelesni klirens nakon prve doze iznosio je 102 l/h kod doze od 1,0 mg/m2 i 112 l/h kod doze od 1,3 mg/m2, a nakon sljedećih doza kretao se u rasponu od 15 to 32 l/h kod doze od 1,0 mg/m i 18 do 32 l/h kod doze od 1,3 mg/m
English: A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC reduction of 45% based on data from 6 patients.
Croatian: Ispitivanje interakcija lijekova kojim se procjenjivao učinak rifampicina, jakog CYP3A4 induktora, na farmakokinetiku bortezomiba (primijenjenog intravenski), pokazalo je prosječno smanjenje AUC bortezomiba za 45% na temelju podataka o 6 bolesnika.
English: • Redness of skin
Croatian: • svrbež kože
English: • that VELCADE 1 mg is only for IV use
Croatian: • VELCADE 1 mg primjenjuje se samo i.v. putem
English: Powder for solution for injection 1 vial
Croatian: Prašak za otopinu za injekciju 1 bočica
English: At least 72 hours should elapse between consecutive doses of VELCADE.
Croatian: Između dviju uzastopnih doza lijeka VELCADE mora proteći najmanje 72 sata.
English: Table 3: Posology modifications during subsequent cycles of VELCADE therapy in combination with melphalan and prednisone Toxicity
Croatian: Tablica 3: Prilagodbe doziranja tijekom sljedećih ciklusa liječenja lijekom VELCADE u kombinaciji s melfalanom i prednizonom
English: Leukopenia*, Anaemia*, Lymphopenia* Uncommon Pancytopenia*
Croatian: leukopenija*, anemija*, limfopenija* Manje često Pancitopenija*
English: • diarrhoea, constipation, nausea or vomiting
Croatian: • proljev, zatvor, mučninu ili povraćanje
English: Early and regular monitoring for symptoms of treatment-emergent neuropathy with neurological evaluation should be considered in patients receiving VELCADE in combination with medicinal products known to be associated with neuropathy (e.g. thalidomide) and appropriate dose reduction or treatment discontinuation should be considered.
Croatian: U bolesnika koji primaju VELCADE u kombinaciji s lijekovima za koje je poznato da su povezani s neuropatijom (npr. talidomidom), mora se razmotriti rano i redovito praćenje, neurološkom procjenom, simptoma neuropatije proizašlih tijekom liječenja, te se u obzir mora uzeti prikladno smanjenje doze ili prekid liječenja.
English: Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality* Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Croatian: Dehidracija, hipokalijemija*, hiponatrijemija*, abnormalna glukoza u krvi*, hipokalcijemija*, abnormalni enzimi*, Manje često Sindrom lize tumora, izostanak uspješnog rasta*, hipomagenzijemija*, hipofosfatemija*, hiperkalijemija*, hiperkalcijemija*, hipernatrijemija*, abnormalna mokraćna kiselina*, dijabetes melitus*,zadržavanje tekućine
English: Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia(inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body
Croatian: Smrt (uključujući iznenadnu), multiorgansko zatajenje, krvarenje na mjestu injiciranja*, hernija (uključujući hijatus)*, poremećaj cijeljenja*, upala, flebitis na mjestu injiciranja*, osjetljivost, ulkus, iritabilnost, bol u prsištu ne-srčanog porijekla, bol na mjestu katetera, osjećaj stranog tijela
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: • Joint or muscle stiffness, sense of heaviness, pain in your groin
Croatian: • ukočenost zglobova ili mišića, osjećaj težine, bol u preponama
English: VIAL VELCADE 1 mg
Croatian: BOČICA, VELCADE 1 mg
English: VELCADE is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Croatian: VELCADE se primjenjuje intravenski ili supkutano 1., 4., 8. i 11. dan, nakon čega slijedi ‘period odmora' bez liječenja.
English: Dose adjustments for combination therapy for patients with progressive multiple myeloma For VELCADE dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Croatian: Za prilagodbu doze lijeka VELCADE u kombiniranom liječenju slijedite smjernice za promjenu doze opisane u tekstu iznad, pod monoterapija.
English: However, the reconstituted solution is stable for 8 hours at 25°C stored in the original vial and/or a syringe, with a total storage time for the reconstituted medicine not exceeding 8 hours prior to administration.
Croatian: Međutim, dokazana kemijska i fizikalna stabilnost pripremljene otopine u primjeni je 8 sati na temperaturi do 25°C kad se prije primjene čuva u originalnoj bočici i/ili štrcaljki, a ukupno vrijeme čuvanja pripremljenog lijeka, prije primjene, ne smije prijeći 8 sati.
English: A drug-drug interaction study assessing the effect of melphalan-prednisone on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 17% based on data from 21 patients.
Croatian: Ispitivanje interakcija lijekova u kojem se procjenjivao učinak melfalana i prednizona na farmakokinetiku bortezomiba (primijenjenog intravenski), pokazalo je srednje povećanje AUC bortezomiba od 17% na temelju podataka o 21 bolesniku.
English: • Tiredness, feeling weak • Fever
Croatian: • umor, osjećaj slabosti • vrućica
English: 13.1 mo
Croatian: 13,1 mjesec
English: Progression-free survival Events n (%)
Croatian: Preživljenje bez progresije bolesti događaji n (%)
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.
Croatian: Pripremljena otopina se primjenjuje intravenskom bolus injekcijom u trajanju od 3-5 sekundi kroz periferni ili centralni venski kateter, koji se potom mora isprati 9 mg/ml (0,9%) otopinom za injekciju natrijevog klorida.
English: Intravenous use only.
Croatian: Samo za intravensku primjenu.
English: Grade of hepatic impairment*
Croatian: Stupanj oštećenja jetre*
English: VELCADE 1 mg powder for solution for injection
Croatian: VELCADE 1 mg prašak za otopinu za injekciju
English: In Cycles 5-9, VELCADE is administered once weekly on days 1, 8, 22 and 29.
Croatian: Od 5. do 9. ciklusa, VELCADE se primjenjuje jednom tjedno, na 1., 8., 22. i 29. dan.
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.
Croatian: Pripremljena otopina lijeka VELCADE od 3,5 mg se primjenjuje intravenskom bolus injekcijom u trajanju od 3-5 sekundi kroz periferni ili centralni venski kateter, koji se potom mora isprati 9 mg/ml (0,9%) otopinom za injekciju natrijevog klorida.
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.
Croatian: 222 ispitanika bilo je uključeno u ispitivanje; 221 ispitanik bio je liječen s lijekom VELCADE Procjena omjera hazarda temelji se na Coxovom modelu proporcionalnog rizika prilagođenom prema čimbenicima stratifikacije: ISS stupnjevanje i broj prethodnih linija.
English: VELCADE 3.5 mg powder for solution for injection
Croatian: VELCADE 3,5 mg prašak za otopinu za injekciju
English: Discontinue VELCADE if PML is diagnosed.
Croatian: Ukoliko je dijagnosticiran PML, liječenje lijekom VELCADE treba prekinuti.
English: Complete blood counts (CBC) with differential and including platelet counts should be frequently monitored throughout treatment with VELCADE.
Croatian: Za vrijeme liječenja lijekom VELCADE potrebno je često određivati kompletnu i diferencijalnu krvnu sliku (KKS), uključujući broj trombocita.
English: VELCADE in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Croatian: VELCADE je indiciran u kombinaciji s melfalanom i prednizonom za liječenje odraslih bolesnika s prethodno neliječenim multiplim mijelomom za koje nije prikladna kemoterapija u visokim dozama s transplantacijom hematopoetskih matičnih stanica.
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.
Croatian: Kada se VELCADE daje zajedno s pegiliranim liposomalnim doksorubicinom, VELCADE ćete primiti intravenski u ciklusu liječenja koji traje 21 dan, a pegilirani liposomalni doksorubicin u dozi od 30 mg/m2 daje se kao intravenska infuzija nakon injekcije lijeka VELCADE, na 4. dan ciklusa liječenja lijekom VELCADE koji traje 21 dan.
English: If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive VELCADE together with two other medicines; melphalan and prednisone.
Croatian: Ukoliko se prethodno niste liječili od multiplog mijeloma i niste predviđeni za transplantaciju krvotvornih matičnih stanica, VELCADE ćete primiti u kombinaciji s druga dva lijeka; melfalan i prednizon.
English: Time to response CR+PR (days)
Croatian: Medijan trajanja dani (mjeseci) Vrijeme do odgovora CR+PR (dani)
English: • In cycles 5 to 9, VELCADE is administered once weekly on days 1, 8, 22 and 29.
Croatian: • Tijekom 5. do 9. ciklusa, VELCADE se primjenjuje jednom tjedno (na 1., 8., 22. i 29. dan).
English: • Reduced functioning of your kidneys
Croatian: • smanjena funkcija bubrega
English: For additional information concerning dexamethasone, see the corresponding Summary of Product Characteristics.
Croatian: Za dodatne informacije vezane uz deksametazon, vidjeti odgovarajući Sažetak opisa svojstava lijeka.
English: When VELCADE is given together with pegylated liposomal doxorubicin, you will receive VELCADE intravenously or subcutaneously 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.
Croatian: Kada se VELCADE daje zajedno s pegiliranim liposomalnim doksorubicinom, VELCADE ćete primiti intravenski ili supkutano u ciklusu liječenja koji traje 21 dan, a pegilirani liposomalni doksorubicin u dozi od 30 mg/m2 daje se kao intravenska infuzija nakon injekcije lijeka VELCADE, na 4. dan ciklusa liječenja lijekom VELCADE koji traje 21 dan.
English: Common Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
Croatian: Sepsa (uključujući septički šok)*, herpes zoster (uključujući diseminirani i oftalmički), infekcija virusom herpesa*, bakterijske infeckcije*, infekcija gornjih/donjih dišnih puteva*, gljivična infekcija*, herpes simpleks*
English: If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Croatian: Ako se primijeti promjena boje ili prisutnost čestica, pripremljenu otopinu treba odbaciti.
English: Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Croatian: Jedna bočica sadrži 3,5 mg bortezomiba (u obliku estera boronatne kiseline i manitola).
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.
Croatian: Limfom plaštenih stanica (MCL) Sigurnosni profil lijeka VELCADE u 240 bolesnika s MCLom liječenih s 1,3 mg/m2 lijeka VELCADE u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (VcR-CAP), naspram 242 bolesnika liječenih s rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom i prednizonom [R-CHOP] bio je relativno sukladan onom zapaženom u bolesnika s multiplim mijelomom s glavnim razlikama koje su opisane ispod.
English: The mean platelet count nadir measured was approximately 40% of baseline in the single-agent multiple myeloma studies and 50% in the MCL study.
Croatian: U ispitivanjima multiplog mijeloma s jednim lijekom najniža izmjerena srednja vrijednost broja trombocita bila je približno 40% početne vrijednosti a 50% u ispitivanju limfoma plaštenih stanica.
English: 1.3 The reconstituted product is preservative free and should be used immediately after preparation.
Croatian: Pripremljena otopina ne sadrži konzervanse i treba ju primijeniti odmah nakon pripreme.
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.
Croatian: Limfom plaštenih stanica (MCL) Sigurnosni profil lijeka VELCADE u 240 bolesnika s MCLom liječenih s 1,3 mg/m2 lijek VELCADE u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (VcR-CAP), naspram 242 bolesnika liječenih s rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom i prednizonom [R-CHOP] bio je relativno sukladan onom zapaženom u bolesnika s multiplim mijelomom s glavnim razlikama koje su opisane ispod.
English: VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Croatian: VELCADE je indiciran u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom za liječenje odraslih bolesnika s prethodno neliječenim limfomom plaštenih stanica za koje nije prikladna transplantacija hematopoetskih matičnih stanica.
English: VELCADE 1 mg powder for solution for injection bortezomib
Croatian: VELCADE 1 mg prašak za otopinu za injekciju bortezomib
English: Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with VELCADE alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after VELCADE administration.
Croatian: Complete Response]) na liječenje samo lijekom VELCADE, nakon 4 ciklusa, bilo je dozvoljeno primanje 20 mg deksametazona dnevno, na dan primjene i dan poslije primjene lijeka VELCADE.
English: • VELCADE 3.5 mg can be administered both intravenously and subcutaneously while VELCADE 1 mg can be administered only intravenously
Croatian: • VELCADE 3,5 mg može biti primijenjen intravenski i supkutano, dok
English: • Non-haematological toxicities should have resolved to Grade 1 or baseline.
Croatian: • Nehematološke toksičnosti moraju se povući na 1. stupanj ili početnu težinu.
English: Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the VELCADE treatment cycle.
Croatian: Deksametazon od 20 mg se primjenjuje oralno 1., 2., 4., 5., 8., 9., 11. i 12. dan tijekom ciklusa liječenja lijekom VELCADE.
English: Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic
Croatian: Manje često Pankreatitis (uključujući kronični) *, hematemeza, oticanje usnica*, gastrointestinalna opstrukcija (uključujući opstrukciju tankog crijeva, ileus)*, nelagoda u abdomenu, ulceracije u ustima*, enteritis*, gastritis*, krvarenje desni, gastroezofagealna refluksna bolest*, kolitis (uključujući clostridium difficile)*, ishemijski kolitis
English: #, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
Croatian: #, gastrointestinalna upala*, disfagija, sindrom iritabilnog crijeva, nespecificirani gastrointestinalni poremećaj, obložen jezik, poremećaj gastrointestinalne pokretljivosti*, poremećaj žlijezda slinovnica*
English: • Shortness of breath with exercise
Croatian: • nedostatak zraka pri tjelesnom naporu
English: The resulting solution is then injected into a vein rapidly, over 3 to 5 seconds.
Croatian: Ta se otopina daje intravenski tijekom 3 do 5 sekundi.
English: VELCADE 3.5 mg powder for solution for injection Bortezomib
Croatian: VELCADE 3,5 mg prašak za otopinu za injekciju bortezomib
English: Subcutaneous reconstitution: After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Croatian: Priprema za supkutanu primjenu: Nakon rekonstitucije, 1 ml otopine za primjenu supkutanom injekcijom sadrži 2,5 mg bortezomiba.
English: If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive VELCADE intravenously together with two other medicines; melphalan and prednisone.
Croatian: Ukoliko se prethodno niste liječili od multiplog mijeloma i niste predviđeni za transplantaciju krvotvornih matičnih stanica, VELCADE ćete primiti intravenski, u kombinaciji s druga dva lijeka; melfalan i prednizon.
English: 1.1 Preparation of the 1 mg vial: carefully add 1.0 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a 1 ml syringe without removing the vial stopper.
Croatian: 1.1 Priprema bočice od 1 mg: pažljivo dodajte 1,0 ml sterilne 0,9%tne otopine natrijevog klorida za injekciju (9 mg/ml) u bočicu koja sadrži VELCADE prašak, koristeći štrcaljku od 1 ml bez uklanjanja čepa bočice.
English: VELCADE combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001) A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of VELCADE plus pegylated liposomal doxorubicin versus VELCADE monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy.
Croatian: Randomizirano, otvoreno, multicentrično ispitivanje faze III, usporednih skupina, bilo je provedeno sa 646 bolesnika kod kojih se uspoređivala sigurnost i djelotvornost lijeka VELCADE plus pegilirani liposomalni doksorubicin naspram monoterapija lijekom VELCADE, u bolesnika s multiplim mijelomom koji su barem jednom prethodno liječeni, te kod kojih nije došlo do progresije dok su primali antraciklinsko liječenje.
English: Very Common Nausea and vomiting symptoms*, Diarrhoea*, Constipation Common
Croatian: Vrlo često Mučnina i simptomi povraćanja*, proljev*, konstipacija, Često
English: Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each VELCADE treatment cycle.
Croatian: Prednizon se primjenjuje peroralno, 100 mg/m 2 1., 2., 3., 4. i 5. dan svakog ciklusa liječenja lijekom
English: When VELCADE is given alone, you will receive 4 doses of VELCADE intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period' without treatment.
Croatian: Kada se VELCADE daje sam (kao monoterapija), primit ćete 4 doze lijeka VELCADE intravenski ili supkutano 1., 4., 8. i 11. dana, nakon čega slijedi 10-dnevni ‘period odmora' bez primjene lijeka.
English: or ANC < 750 cells/μL on a VELCADE dosing day (other than Day 1 of each cycle)
Croatian: • Ako je broj trombocita < 25 000 stanica/μL. ili apsolutni broj neutrofila < 750 stanica/μL na dan primjene doze lijeka VELCADE (različit od 1. dana svakog ciklusa)
English: Discontinue VELCADE
Croatian: VELCADE se mora prekinuti
English: • Sore mouth or lip, throat pain
Croatian: • rane na ustima ili na usnama, grlobolja
English: N=240 (ITT population) N=242 (ITT population)
Croatian: N = 242 (ITT populacija)
English: When VELCADE is given alone, you will receive 4 doses of VELCADE intravenously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period' without treatment.
Croatian: Kada se VELCADE daje sam (kao monoterapija), primit ćete 4 doze lijeka VELCADE intravenski 1., 4., 8. i 11. dana, nakon čega slijedi 10-dnevni ‘period odmora' bez primjene lijeka.
English: • Chest pains or shortness of breath with exercise
Croatian: • bolovi u prsnom košu, nedostatak zraka pri tjelesnom naporu
English: Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Croatian: Supkutana primjena: Dodati 1,4 ml 0,9% otopine natrijeva klorida kako bi se pripremila konačna otopina koncentracije 2,5 mg/ml.
English: • Hearing loss, deafness
Croatian: • nagluhost, gluhoća
English: Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Croatian: Jedna bočica sadrži 1 mg bortezomiba (u obliku estera boronatne kiseline i manitola).
English: Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE treatment cycle.
Croatian: Deksametazon od 40 mg se primjenjuje oralno 1., 2., 3., 4., 8., 9., 10. i 11. dan tijekom ciklusa liječenja lijekom VELCADE.
English: • In cycles 1 to 4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Croatian: • Tijekom 1. do 4. ciklusa, VELCADE se primjenjuje dva puta tjedno (na 1., 4., 8., 11., 22., 25.,
English: Combination therapy with dexamethasone
Croatian: Kombinirano liječenje lijekom VELCADE s deksametazonom