FrancophonIA/ELRC3.0 huggingface dataset:
English: tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Croatian: nesvjesticu - kašalj i poteškoće s disanjem ili stezanje u prsnom košu.
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 nalaz krvi*, povišen C-reaktivni protein
English: You should not breast-feed while using bortezomib.
Croatian: Ne smijete dojiti dok primate bortezomib.
English: Note: An OR > 1 indicates an advantage for bortezomib-containing induction therapy.
Croatian: Napomena: OR > 1 ukazuje na prednost za uvodno liječenje koje sadrži bortezomib.
English: Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ]
Croatian: Odnosi se na stope odgovora nakon druge transplantacije za ispitanike koji su prošli drugu transplantaciju (42/240 [18% ] u BDx skupini i 52/242 [21%] u VDDx skupini).
English: Response Rate at 4 cycles n (%) ORR (CR+PR) p-value
Croatian: Stopa odgovora u 4 ciklusa n (%) ORR (CR+PR) p-vrijednost a
English: Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded.
Croatian: Bolesnici koji su na početku ispitivanja imali perifrenu neuropatiju stupnja ≥ 2 ili s brojem trombocita < 50 000/μl bili su isključeni.
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11
Croatian: 1., 2., 3., 4. dan 8., 9., 10., 11. dan
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 bortezomib (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/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma.
Croatian: Klinička djelotvornost u prethodno neliječenih bolesnika s multiplim mijelomom Prospektivno, međunarodno, randomizirano (1:1) kliničko ispitivanje faze III otvorenog tipa (MMY3002 VISTA) koje je uključilo 682 bolesnika, provedeno je da bi se utvrdilo hoće li bortezomib (1,3 mg/m primijenjen intravenskom injekcijom) u kombinaciji s melfalanom (9 mg/m 2) 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: • to report any adverse event, or medication error experienced with the administration of Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg.
Croatian: • važnost prijave štetnih događaja ili medikacijskih pogrešaka kod primjene Bortezomib Hospira 1 mg, 2,5 mg, 3 mg i 3,5 mg.
English: Pegylated liposomal doxorubicin is administered at 30 mg/m² on day 4 of the Bortezomib Hospira treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib Hospira injection.
Croatian: Pegilirani liposomalni doksorubicin se primjenjuje u dozi od 30 mg/m² na 4. dan ciklusa liječenja lijekom Bortezomib Hospira, putem intravenske infuzije u trajanju od 1 sata, nakon primjene injekcije lijeka Bortezomib Hospira.
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate;
Croatian: CI= interval pouzdanosti; CR=kompletni odgovor; nCR=blizu kompletnog odgovora; ITT=Populacija bolesnika s namjerom liječenja (ITT, od engl.
English: Bortezomib Hospira may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Croatian: Bortezomib Hospira može vrlo često biti povezan s umorom, često s omaglicom, manje često sa sinkopom i često s ortostatskom/posturalnom hipotenzijom ili zamagljenim vidom.
English: However, the reconstituted solution is stable for 8 hours at 5°C and 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, pripremljena otopina je stabilna 8 sati na temperaturi od 5°C 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: Then, Bortezomib Hospira may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to
Croatian: Nakon toga, Bortezomib Hospira se može ponovno uvesti u dozi smanjenoj za jednu razinu doze (s 1,3 mg/m2 na
English: Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Toxicity
Croatian: Tablica 5: Prilagodbe doza tijekom liječenja za bolesnike s prethodno neliječenim limfomom plaštenih stanica
English: In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Croatian: U ispitivanjima s bolesnicima s relapsom multiplog mijeloma liječenih bortezomibom i s bolesnicima s prethodno neliječnim limfomom plaštenih stanica liječenih bortezomibom u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BRCAP), jedna od najčešćih hematoloških toksičnosti bila je prolazna trombocitopenija.
English: HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP).
Croatian: Infekcija HBV-om sa smrtonosnim ishodima pojavila se u 0,8% (n=2) bolesnika u skupini koja nije liječena bortezomibom (rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon; R-CHOP ) i u 0,4% (n=1) bolesnika koji su primali bortezomib u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BR-CAP).
English: Therefore, you will have to take regular blood tests before and during your treatment with bortezomib, to check your blood cell counts regularly.
Croatian: Stoga ćete prije i za vrijeme liječenja bortezomibom morati ići na redovite kontrole krvi, kako bi se redovito provjerio broj krvnih stanica.
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, anaemia, 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: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and 1.3 mg/m respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, 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/m 2, a nakon sljedećih doza kretao se u rasponu od 15 to 32 l/h kod doze od 1,0 mg/m i
English: Fertility Fertility studies were not conducted with Bortezomib Hospira (see section 5.3).
Croatian: Plodnost Nisu provedena ispitivanja utjecaja lijeka Bortezomib Hospira na plodnost (vidjeti dio 5.3).
English: Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Croatian: Periferna neuropatija uključila je preporučene izraze: periferna senzorna neuropatija, periferna neuropatija, periferna motorna neuropatija i periferna senzomotorna neuropatija
English: If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive bortezomib intravenously or subcutaneously together with two other medicines; melphalan and prednisone.
Croatian: Ukoliko se prethodno niste liječili od multiplog mijeloma i niste pogodni za transplantaciju krvotvornih matičnih stanica, primat ćete bortezomib u venu ili potkožno u kombinaciji s druga dva lijeka; melfalanom i prednizonom.
English: During clinical trials, hypoglycaemia and hyperglycaemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycaemics.
Croatian: Tijekom kliničkih ispitivanja, hipoglikemija je bila manje često, a hiperglikemija često zabilježena u bolesnika s dijabetesom koji su primali oralne hipoglikemike.
English: A Phase II, single-arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
Croatian: Ispitivanje faze II u kojem su se ispitivali aktivnost, sigurnost i farmakokinetika u jednoj skupini bolesnika, provedeno od strane Skupine za dječju onkologiju (od engl.Childrens Oncology Group), procijenilo je aktivnost dodavanja bortezomiba u ponovno uvedenu kemoterapiju s više lijekova u pedijatrijskih i mladih odraslih bolesnika s limfoidnim malignim bolestima (pre-B-stanična akutna limfoblastična leukemija [ALL], T-stanična ALL i T-stanični limfoblastični limfom [LL]).
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 “Rok valjanosti“.
English: Mantle cell lymphoma (MCL) The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-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 bortezomiba u 240 bolesnika s MCLom liječenih s 1,3 mg/m bortezomiba u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BR-CAP), naspram 242 bolesnika liječena 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: • If toxicity resolves i.e. patient has an ANC ≥ 750cells/μL and a platelet count ≥ 25,000 cells/μL, Bortezomib Hospira may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m
Croatian: • Ako se toksičnost povuče, tj. bolesnik ima apsolutni broj neutrofila ≥ 750 stanica/μl i broj trombocita ≥ 25 000 stanica/μl, Bortezomib Hospira se može ponovno uvesti u dozi smanjenoj za jednu razinu doze (s 1,3 mg/m na 1 mg/m2, ili s 1 mg/m2 na 0,7 mg/m
English: Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each Bortezomib Hospira treatment cycle.
Croatian: I melfalan i prednizon trebaju se primijeniti peroralno na 1., 2., 3. i 4. dan prvog tjedna svakog ciklusa liječenja lijekom Bortezomib Hospira.
English: Survival update based on a median duration of follow-up at 60.1 months mo: months
Croatian: * Ažurirano preživljenje na temelju medijana trajanja praćenja od 60,1 mjesec CI=Interval pouzdanosti
English: In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Croatian: U bolesnika s limfomom plaštenih stanica (ispitivanje LYM-3002), postojala je viša incidencija (56,7% naspram 5,8%) trombocitopenije stupnja ≥ 3 u skupini liječenoj bortezomibom (BR-CAP), u usporedbi sa skupinom koja nije liječena bortezomibom (rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon [R-CHOP]).
English: Aseptic technique must be strictly observed throughout the handling of Bortezomib Hospira, since it contains no preservative.
Croatian: ASEPTIČNA TEHNIKA RADA MORA SE STROGO POŠTOVATI TIJEKOM CIJELOG POSTUPKA RUKOVANJA LIJEKOM BORTEZOMIB HOSPIRA, BUDUĆI DA LIJEK NE SADRŽI KONZERVANSE.
English: Bortezomib Hospira therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Croatian: Liječenje lijekom Bortezomib Hospira se mora prekinuti dok se simptomi toksičnosti ne povuku do stupnja 2 ili manjeg.
English: Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Croatian: Rijetko periferna embolija, limfedem, bljedoća, eritromelalgija, vazodilatacija, diskoloracija vena, venska insuficijencija
English: If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Croatian: Ako se primijeti promjena boje ili prisutnost čestica, rekonstituirana otopina mora se baciti.
English: Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Croatian: b Procjena omjera hazarda temelji se na Coxovom modelu stratificiranom prema IPI riziku i stadiju bolesti.
English: Bortezomib Hospira 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 Bortezomib Hospira mora se prekinuti do 2 tjedna, dok bolesnik ne dostigne apsolutni broj neutrofila ≥ 750 stanica/μl i broj trombocita ≥ 25 000 stanica/μl.
English: Type I glass 10 ml vial with a rubber stopper and an aluminium seal containing 2.5 mg, 3 mg or 3.5 mg bortezomib.
Croatian: Staklena bočica (staklo tip 1) od 10 ml sa gumenim čepom i aluminijskim zatvaračem koja sadrži 2,5 mg, 3 mg ili 3,5 mg bortezomiba.
English: Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Croatian: Rijetko meningitis (uključujući bakterijski), infekcija Epstein-Barrovim virusom, genitalni herpes, tonzilitis, mastoiditis, sindrom umora nakon virusa
English: Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing
Croatian: Neki od slučajeva uključuju otežano disanje, nedostatak zraka, nedostatak zraka u stanju bez napora, disanje koje postaje plitko, teško ili prestaje, piskanje - krvni ugrušci u plućima - žućkasta boja očiju i kože (žutica)
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: Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Croatian: Trombociti su bili najniži na 11. dan svakog ciklusa liječenja bortezomibom i obično su se do sljedećeg ciklusa vratili na početno stanje.
English: Bortezomib Hospira contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Croatian: Hospira sadrži djelatnu tvar bortezomib, koja se naziva ‘inhibitor proteasoma'.
English: Note: An OR > 1 indicates an advantage for bortezomib-containing induction therapy
Croatian: Napomena: OR > 1 ukazuje na prednost za uvodno liječenje koje sadrži bortezomib
English: b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Croatian: ciklusa nadalje ako se podnosi doza od 100 mg. b Bolesnicima koji nakon 4 ciklusa postignu bar parcijalni odgovor, može se dati do 6 ciklusa
English: Common Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
Croatian: Često herpes zoster (uključujući diseminirani i oftalmički), pneumonija*, herpes simpleks*, gljivična infekcija*
English: May be fatal if given by other routes
Croatian: Primjena drugim putovima primjene može biti smrtonosna.
English: Bortezomib Hospira should not be administered intrathecally.
Croatian: Bortezomib Hospira se ne smije primjeniti intratekalno.
English: M (9 mg/m P (60 mg/m
Croatian: M (9 mg/m P (60 mg/m dan dan dan dan period odmora period odmora
English: The most commonly reported adverse reactions during treatment with bortezomib 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 bortezomibom jesu mučnina, proljev, konstipacija, povraćanje, umor, pireksija, trombocitopenija, anemija, neutropenija, periferna neuropatija (uključujući senzornu), glavobolja, parestezija, smanjeni apetit, dispneja, osip, herpes zoster i mijalgija.
English: This study included 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 of bortezomib 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 bortezomib 1,3 mg/m bilo supkutano ili intravenski u 8 ciklusa.
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: Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4
Croatian: 1., 2., 3., 4. dan 8., 9., 10., 11. dan2. do 4. ciklus
English: Once the symptoms of the toxicity have resolved, Bortezomib Hospira 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).
Croatian: Kad se simptomi toksičnosti povuku, može se ponovno uvesti liječenje lijekom Bortezomib Hospira uz dozu smanjenu za 25% (1,3 mg/m2 smanjeno na 1,0 mg/m 2; 1,0 mg/m 2 smanjeno na 0,7 mg/m 2).
English: Uncommon Fall, Contusion Rare
Croatian: Manje često pad, kontuzija
English: ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF BORTEZOMIB HOSPIRA SINCE NO PRESERVATIVE IS PRESENT.
Croatian: Aseptična tehnika mora se strogo poštovati tijekom cijelog postupka rukovanja lijekom Bortezomib Hospira budući da lijek ne sadrži konzervanse.
English: The benefit/risk ratio should be considered prior to continuing Bortezomib Hospira therapy.
Croatian: Potrebno je razmotriti omjer koristi i rizika prije nastavka liječenja lijekom Bortezomib Hospira.
English: However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 5°C and 25°C stored in the original vial and/or a syringe.
Croatian: Međutim, dokazana kemijska i fizikalna stabilnost rekonstituirane otopine u primjeni je 8 sati na temperaturi od 5°C do 25°C kad se prije primjene čuva u originalnoj bočici i/ili štrcaljki.
English: Injection under the skin is in either the thighs or the abdomen.
Croatian: Potkožna injekcija primjenjuje se ili u bedro ili trbuh.
English: Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Croatian: Za potvrdu dijagnoze koristi se snimanje mozga, po mogućnosti magnetskom rezonancom (MRI, od engl.
English: Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic
Croatian: Manje često infekcija*, bakterijske infekcije*, virusne infekcije*, sepsa (uključujući septički šok)*, bronhopneumonija, infekcija virusom herpesa*, herpetični meningoencefalitis
English: Very Common
Croatian: Manje često
English: For additional information concerning pegylated liposomal doxorubicin, see the corresponding Summary of Product Characteristics.
Croatian: Za dodatne informacije vezane uz pegilirani liposomalni doksorubicin, vidjeti odgovarajući sažetak opisa svojstava lijeka.
English: #, Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge
Croatian: #, upala oka*, diplopija, suho oko*, iritacija oka*, bol u oku, pojačano suzenje, iscjedak iz oka
English: If you have not been treated before for mantle cell lymphoma, you will receive bortezomib intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Croatian: Ako Vam prethodno nije liječen limfom plaštenih stanica bortezomib ćete primiti u venu ili potkožno zajedno s lijekovima rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom.
English: If you are given bortezomib together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
Croatian: Ako bortezomib primate zajedno s drugim lijekovima za liječenje limfoma plaštenih stanica mogu
English: Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
Croatian: Progresivna multifokalna leukoencefalopatija (PML) Vrlo rijetko su bili zabilježeni slučajevi John Cunningham (JC) virusne infekcije nepoznate uzročnosti, koji su rezultirali progresivnom multifokalnom leukoencefalopatijom (PML) i smrću u bolesnika liječenih bortezomibom.
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib Hospira (both IV and SC use) required for different body surface areas.
Croatian: • upute za doziranje s primjerima: kako izračunati površinu tijela bolesnika i volumen rekonstituirane otopine lijeka Bortezomib Hospira (za oba puta primjene, i.v. i s.c.) s obzirom na različite tjelesne površine.
English: Each carton of 1 mg Bortezomib Hospira contains a glass 5 ml siliconised vial with a rubber stopper and an aluminium seal.
Croatian: Svaka kutija lijeka Bortezomib Hospira od 1 mg sadrži jednu silikoniziranu staklenu bočicu od 5 ml sa gumenim čepom i aluminijskim zatvaračem.
English: Bortezomib is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.
Croatian: Bortezomib se primjenjuje u liječenju limfoma plaštenih stanica (vrsta raka koji zahvaća limfne čvorove) u bolesnika starosti 18 godina ili starijih u kombinaciji s lijekovima rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom, u bolesnika čija bolest prethodno nije bila liječena i za koje nije prikladna transplantacija krvotvornih matičnih stanica.
English: For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
Croatian: Za dodatne informacije o melfalanu i prednizonu, vidjeti odgovarajuće sažetke opisa svojstava tih lijekova.