natgillin/translations-raw huggingface dataset:
The reconstituted solution is stable for 8 hours at 20°C-25°C stored in the original vial and/or a syringe.
Pripremljena otopina stabilna je 8 sati na temperaturi od 20°C do 25°C kad se prije primjene čuva u originalnoj bočici i/ili štrcaljki.
Bortezomib Accord 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.
Accord 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.
• If, after Bortezomib Accord has been held, the toxicity does not resolve, as defined above, then Bortezomib Accord must be discontinued.
kako je definirano iznad, Bortezomib Accord se mora prestati primjenjivati.
Bortezomib Accord is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Bortezomib Accord se primjenjuje intravenski ili supkutano 1., 4., 8. i 11. dan, nakon čega slijedi
Intravenous use: Add 1 ml 0.9% sodium chloride to make 1 mg/ml final concentration.
Intravenska primjena: Dodati 1 ml 0,9%-tne otopine natrijeva klorida kako bi se pripremila konačna otopina koncentracije 1 mg/ml.
Gastrointestinal haemorrhage (inc mucosal)*, Abdominal distension, Dyspepsia, Oropharyngeal pain*, Gastritis*, Oral ulceration*, Abdominal discomfort, Dysphagia, Gastrointestinal inflammation*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*
Gastrointestinalno krvarenje (uključujući mukozno)*, distenzija abdomena, dispepsija, orofaringealna bol *, gastritis*, ulceracije u ustima*, nelagoda u abdomenu, disfagija, gastrointestinalna upala*, bol u abdomenu (uključujući gastrointestinalnu bol i bol slezene)*, poremećaj u ustima*
Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2
Razmotriti povećanje doze na 1,0 mg/m2 ili daljnje smanjenje doze na 0,5 mg/m2 u sljedećim ciklusima na temelju bolesnikova podnošenja liječenja.
Intravenous use: Add 3.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Intravenska primjena: Dodati 3,5 ml 0,9%-tne otopine natrijeva klorida kako bi se pripremila konačna otopina koncentracije 1 mg/ml.
When Bortezomib Accord is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Kada se Bortezomib Accord primjenjuje u kombinaciji s drugim lijekovima, za dodatne kontraindikacije pogledajte sažetke opisa svojstava lijeka tih lijekova.
When Bortezomib Accord is given together with pegylated liposomal doxorubicin, you will receive Bortezomib Accord intravenously or subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m2 is given on day 4 of the Bortezomib Accord 21-day treatment cycle as an intravenous infusion after the Bortezomib Accord injection.
Accord 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 Bortezomib Accord, na 4. dan ciklusa liječenja lijekom Bortezomib Accord koji traje 21 dan.
Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours is not recommended.
(2g/m2 na dan) kontinuiranom infuzijom u trajanju od 24 sata.
Bortezomib Accord 1 mg powder for solution for injection IS FOR INTRAVENOUS USE ONLY, while Bortezomib Accord 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Bortezomib Accord 1 mg prašak za otopinu za injekciju JE SAMO ZA INTRAVENSKU PRIMJENU, dok je Bortezomib Accord 3,5 mg prašak za otopinu za injekciju ZA SUPKUTANU ILI INTRAVENSKU PRIMJENU.
Bortezomib Accord in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Accord je indiciran u kombinaciji s deksametazonom ili s deksametazonom i talidomidom kao uvodno liječenje odraslih bolesnika s prethodno neliječenim multiplim mijelomom za koje je prikladna kemoterapija u visokim dozama s transplantacijom hematopoetskih matičnih stanica.
Bortezomib Accord 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Bortezomib Accord 3,5 mg prašak za otopinu za injekciju JE ZA SUPKUTANU ILI INTRAVENSKU PRIMJENU.
Bortezomib Accord 1 mg powder for solution for injection Bortezomib Accord 3.5 mg powder for solution for injection
Bortezomib Accord 1 mg prašak za otopinu za injekciju Bortezomib Accord 3,5 mg prašak za otopinu za injekciju
Respiratory failure, Acute respiratory distress syndrome, Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension, Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis, Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis, Bronchial disorder*, Hypocapnia*, Interstitial lung disease, Lung infiltration, Throat tightness, Dry throat, Increased upper airway secretion, Throat irritation, Upper-airway cough syndrome
tahipneja, plućna fibroza, bronhijalni poremećaj*, hipokapnija*, intersticijska bolest pluća, infiltracija pluća, stezanje u grlu, suhoća grla, povećana sekrecija gornjih dišnih puteva, iritacija grla, sindrom gornjih dišnih puteva koji je uzrok kašlja
Bortezomib Accord 1 mg powder for solution for injection is for intravenous use only, while Bortezomib Accord 3.5 mg powder for solution for injection is for intravenous or subcutaneous use.
Bortezomib Accord 1 mg prašak za otopinu za injekciju primjenjuje se samo intravenski, dok se Bortezomib Accord 3,5 mg prašak za otopinu za injekciju primjenjuje intravenski ili supkutano.
If you are given Bortezomib Accord for the treatment of multiple myeloma the side effects you may get are listed below:
Ako Bortezomib Accord primate za liječenje multiplog mijeloma mogu
Mannitol (E 421)
6.1 Popis pomoćnih tvari manitol (E 421)
Hazard ratio (95% CI)c p-valued
Omjer hazarda (95% CI)c p-vrijednost d
Bz= Bortezomib Accord; M=melphalan, P=prednisone
Bz = Bortezomib Accord; M = melfalan, P = prednizon Prilagodbe doze za vrijeme i kod ponovnog uvođenja kombiniranog liječenja melfalanom i prednizonom
Prednisone is given orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of the Bortezomib Accord treatment cycle.
Prednizone se daje kroz usta 100 mg/m2 1., 2., 3., 4. i 5. dana ciklusa liječenja lijekom Bortezomib
After reconstitution, each ml solution contains 2.5 mg bortezomib.
jedan ml otopine sadrži 2,5 mg bortezomiba.
How to store Bortezomib Accord
Kako primjenjivati Bortezomib Accord
Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
pneumonitis, plućna hipertenzija, plućni edem (uključujući akutni)
Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Periferna embolija, limfedem, bljedoća, eritromelalgija,
Then, Bortezomib Accord may be reinitiated with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to
Potom se ponovno može uvesti liječenje lijekom Bortezomib Accord u dozi smanjenoj za jednu razinu (s 1,3 mg/m2 na 1 mg/m2 ili s 1 mg/m2 na
Eye haemorrhage*, Eyelid infection*, Chalazion# , Blepharitis# , Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge
Oticanje oka*, abnormalan vid*, konjunktivitis* Manje često Krvarenje u oku*, infekcija kapka*, halacion# , blefaritis#, upala oka*, diplopija, suho oko*, iritacija oka*, bolno oko, pojačano suzenje, iscjedak iz oka
Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Accord powder by using a syringe of the appropriate size without removing the vial stopper.
Priprema bočice od 3,5 mg: pažljivo dodajte 3,5 ml sterilne 0,9%-tne otopine natrijevog klorida za injekciju (9 mg/ml) u bočicu koja sadrži Bortezomib Accord prašak, koristeći štrcaljku prikladne veličine bez uklanjanja čepa bočice.
TTP-Time to Progression
TTP-Vrijeme do progresije bolesti CI=Interval pouzdanosti
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.
U eksplorativnoj analizi djelotvornosti, stopa odgovora od 67,3% (uključujući CR stopu od 28,6%) prema mjerenju hematološkog odgovora
Discontinue bortezomib if PML is diagnosed.
Ukoliko je dijagnosticiran PML, liječenje bortezomibom treba prekinuti.
However, the chemical and physical in-use stability has been demonstrated for 8 hours at 20°C-25°C stored in the original vial and/or a syringe.
Međutim, dokazana kemijska i fizikalna stabilnost pripremljene otopine u primjeni je 8 sati na temperaturi od 20°C do 25°C kad se prije primjene čuva u originalnoj bočici i/ili štrcaljki.
• Induction Transplant Regimens Graph.
• Pomična mjerka za izračun doze lijeka • Grafikon koji prikazuje uvodne sheme liječenja za transplanirane bolesnike.
Best response
Najbolji odgovor (%)
How Bortezomib Accord is given
Kako se primjenjuje Bortezomib Accord
• If local injection site reactions occur following Bortezomib Accord injection subcutaneously, either a less concentrated Bortezomib Accord solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
supkutano se može primijeniti otopina lijeka Bortezomib Accord manje koncentracije (1 mg/ml umjesto 2,5 mg/ml) ili se preporučuje prijeći na intravensku injekciju.
• In cycles 1 to 4, Bortezomib Accord is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29
• Tijekom 1. do 4. ciklusa, Bortezomib Accord se primjenjuje dva puta tjedno (na 1., 4., 8., 11.,
d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+)
d p-vrijednost iz Cochran Mantel-Haenszelovog hi-kvadrat testa prilagođena za čimbenike stratifikacije; analiza po liniji terapije isključuje stratifikaciju po prethodnim liječenjima
EBMT criteria g All randomised patients with secretory disease * Survival update based on a median duration of follow-up at 60.1 months mo: months
* Ažurirano preživljenje na temelju medijana trajanja praćenja od 60,1 mjesec CI=Interval pouzdanosti
Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic#, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection*
(uključujući septički šok)*, bronhopneumonija, infekcija virusom herpesa*, herpetični meningoencefalitis#, bakterijemija (uključujući stafilokoknu), hordeolum (ječmenac), influenca,
However, the chemical and physical in-use stability has been demonstrated for 3 days at 20°C-25°C stored in the original vial and/or a syringe.
Međutim, dokazana kemijska i fizikalna stabilnost pripremljene otopine u primjeni je 3 dana na temperaturi od 20°C do 25°C kad se prije primjene čuva u originalnoj bočici i/ili štrcaljki.
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 Bortezomib Accord powder by using a syringe of the appropriate size without removing the vial stopper.
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 Bortezomib Accord prašak, koristeći štrcaljku prikladne veličine bez uklanjanja čepa bočice.
Patients in the BzDx group received four 21 day cycles, each consisting of bortezomib (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).
primijenjen intravenski dva puta na tjedan 1., 4., 8. i 11. dana), i oralni deksametazon (40 mg/dan od 1. do 4. i 9. do 12. dana, u 1. i 2. ciklusu, te 1. do 4. dan u 3. i 4. ciklusu).
In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
bolesnika izloženih bortezomibu bilo je dobi unutar raspona 65-74 godine odnosno ≥ 75 godina starosti.
The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects.
bortezomib u kombinaciji s deksametazonom) i bolesnici u usporednoj skupini (npr. bortezomib)
Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis
Manje često Hepatotoksičnost (uključujući poremećaj jetre), hepatitis*,
Renal complications are frequent in patients with multiple myeloma.
Oštećenje bubrega Bubrežne komplikacije česte su u bolesnika s multiplim mijelomom.
• Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots
• upala ili krvarenje krvnih žila koja se može javiti u obliku malih crvenih ili ljubičastih točkica (obično na nogama) odnosno mrlja u obliku modrica pod kožom ili tkivom
Bortezomib Accord 1 mg powder for solution for injection Type 1 glass 6 ml-vial with a grey chlorobutyl stopper and an aluminium seal, with a blue cap containing 1 mg bortezomib.
Staklena bočica (staklo tip 1) od 6 ml sa sivim čepom od klorobutilne gume s aluminijskim prstenom i plavom kapicom, koja sadrži 1 mg bortezomiba.
Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis#, Stevens-Johnson syndrome#, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer#, Acne*, Blister*, Pigmentation disorder*
Osip*, pruritus*, eritem, suha koža Manje često Multriformni eritem, urtikarija, akutna febrilna neutrofilna dermatoza, izbijanje kožnih promjena uzrokovano toksičnim učinkom lijeka, toksična epidermalna nekroliza#, Stevens-Johnsonov sindrom#, dermatitis*, poremećaj dlake*,
Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura) #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
sindrom hiperviskoznosti, nespecificirani poremećaj trombocita, trombotička mikroangiopatija (uključujući trombocitopenijsku purpuru)#, nespecificirani poremećaj krvi, hemoragijska dijateza,
Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and
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/m2
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.
Najčešće prijavljene nuspojave tijekom liječenja bortezomibom jesu mučnina, proljev, zatvor, povraćanje, umor, pireksija, trombocitopenija, anemija, neutropenija, periferna neuropatija
The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Primarne mjere ishoda ispitivanja bile su postindukcijske i posttransplantcijske stope odgovora
CR n (%) PR n (%) nCR n (%)
ORR (CR+PR) p-vrijednosta CR n (%) PR n (%) nCR n (%)
Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib Accord 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
Bortezomib Accord koji traje 28 dana, a talidomid se uzima kroz usta, 50 mg na dan do 14 dana prvog ciklusa, te ukoliko se podnosi doza talidomida se povisuje na 100 mg 15.-28. dan, te se dalje može povisiti na 200 mg na dan od drugog ciklusa pa nadalje.
CR=Complete Response; nCR=near Complete response
Bz=bortezomib; Dex=deksametazon CR=Kompletni odgovor; nCR=blizu kompletnog odgovora PR=Parcijalni odgovor; MR=Minimalni odgovor
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.
viša incidencija hematoloških nuspojava (neutropenija, trombocitopenija, leukopenija, anemija, limfopenija), periferna senzorna neuropatija, hipertenzija, pireksija, pneumonija, stomatitis i poremećaji dlakavosti.
Atrial flutter, Myocardial infarction*, Atrioventricular block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest
kardiovaskularni poremećaj (uključujući kardiogeni šok), Torsade de pointes, nestabilna angina, poremećaji srčanih zalistaka*,
At least 72 hours should elapse between consecutive doses of Bortezomib Accord.
Između dvije uzastopne doze lijeka Bortezomib Accord, mora proći najmanje 72 sata.
Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence
stomatitis*, distenzija abdomena, orofaringealna bol*, bolovi u abdomenu (uključujući gastrointestinalnu bol i bol slezene)*, poremećaj u ustima*, flatulencija
Dex n=217a Bz n=202a
Dex n=202
Bortezomib Accord 1 mg powder for solution for injection Each carton of Bortezomib Accord 1 mg powder for solution for injection contains a glass 6 ml vial with a grey chlorobutyl rubber stopper and aluminium seal, with a blue cap, containing 1 mg of bortezomib.
Jedna kartonska kutija Bortezomib Accord 1 mg praška za otopinu za injekciju sadrži staklenu bočicu od 6 ml sa sivim čepom od klorobutilne gume i aluminijskim prstenom, s plavom kapicom.
Wessling Hungary Kft. Anonymus u. 6., Budapest, 1045, Hungary
6., Budapest, 1045,
Hepatotoxicity (inc liver disorder) Uncommon Hepatic failure
Hepatotoksičnost (uključujući poremećaj jetre)
Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
gljivična infekcija*, herpes simpleks*
Dysacusis (inc tinnitus)*,Hearing impaired (up to and inc deafness), Ear discomfort*
Manje često Disakuzija (uključujući tinitus)*, oštećenje sluha (do i uključujući gluhoću), nelagoda uha*
• fainting, dizziness or light-headedness in the past
• proljev, zatvor, mučninu ili povraćanje • nesvjesticu, omaglicu ili ošamućenost u prošlosti
Renal impairment*
ventrikularna disfunkcija*
1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Accord powder by using a syringe of the appropriate size without removing the vial stopper.
Priprema bočice od 3,5 mg: pažljivo dodajte 1,4 ml sterilne 0,9%-tne otopine natrijevog klorida za injekciju (9 mg/ml) u bočicu koja sadrži Bortezomib Accord prašak, koristeći štrcaljku prikladne veličine bez uklanjanja čepa bočice.
Bortezomib Accord 3.5 mg powder for solution for injection is available for intravenous or subcutaneous administration.
Bortezomib Accord 3,5 mg prašak za otopinu za injekciju namijenjen je za intravensku ili supkutanu primjenu.
• Non-haematological toxicities should have resolved to Grade 1 or baseline.
Nehematološke toksičnosti moraju se povući na 1. stupanj ili početnu težinu.
CYTOTOXIC
Bortezomib
Day rest period
8. dan period odmora
Intravenous use.
Samo za intravensku primjenu.
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Prilagodbe doza tijekom liječenja za bolesnike s prethodno neliječenim limfomom plaštenih stanica Prije započinjanja novog ciklusa liječenja:
Bortezomib Accord is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21 day treatment cycle.
Bortezomib Accord primjenjuje se putem intravenske ili supkutane injekcije u preporučenoj dozi od 1,3 mg/m2 površine tijela, dva puta tjedno tijekom dva tjedna, 1., 4., 8. i 11. dana, u ciklusu liječenja od 21 dan.
Discontinue Bortezomib Accord
Nemojte primjenjivati Bortezomib Accord
Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Dehidracija, hipokalijemija*, hiponatrijemija*, abnormalna glukoza u krvi*, hipokalcijemija*, abnormalni enzimi*, Manje često Sindrom lize tumora, izostanak uspješnog rasta*, hipomagenzijemija*, hipofosfatemija*, hiperkalijemija*,
Subcutaneous reconstitution:
Supkutana primjena:
Table 3: Posology modifications during subsequent cycles of Bortezomib Accord therapy in combination with melphalan and prednisone
Tablica 3: Prilagodbe doziranja tijekom sljedećih ciklusa liječenja lijekom lijekom Bortezomib
• seizures
• drhtanje
It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
Preporučuje se pažljivo praćenje bolesnika zbog simptoma neuropatije kao što su osjećaj žarenja,
A statistically significant survival benefit in favour of the Bz+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
(HR=0,695; p=0,00043) usprkos naknadnim terapijama koje uključuju liječenje bortezomibom.
• Drooling
• štucanje
Very Common Pyrexia*, Fatigue, Asthenia Common
Vrlo često Pireksija*, umor, astenija
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#, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
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)*,
When Bortezomib Accord is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration.
Kada se Bortezomib Accord daje u kombinaciji s drugim lijekovima, za upute o primjeni tih lijekova pogledajte njihov sažetak opisa svojstava lijeka.
Angioedema#, Hypersensitivity*
*, neutropenija *, anemija*
Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache*
omaglica*, disgeuzija*, letargija, glavobolja*
• Death
• zatvor
Fall, Contusion
konfuzija*, nemir
Median OS was 90.7 months for the BzR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
Medijan ukupnog preživljenja bio je 90,7 mjeseci za BzR-CAP skupinu u usporedbi s 55,7 mjeseci za
• Multi-organ failure
• oticanje spolnih organa
Hazard ratiob (95% CI) p-valuec
Omjer hazardab (95% CI) p-vrijednostc