natgillin/translations-raw huggingface dataset:
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Opazili so statistično značilno razliko v prid kombinaciji bortezomiba z deksametazonom in talidomidom.
Patients in the BzTDx group received six 4-week cycles, each consisting of bortezomib (1.3 mg/m2
Bolniki v skupini BzTDx so prejeli šest 4-tedenskih krogov zdravljenja.
IV only
Samo i.v.
Bortezomib Accord 3.5 mg powder for solution for injection Each carton of Bortezomib Accord 3.5 mg powder for solution for injection contains a glass 10 ml vial with a grey chlorobutyl rubber stopper and aluminium seal, with a red cap.
Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje Ena škatla zdravila Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje vsebuje stekleno 10 ml vialo s sivim zamaškom iz klorobutilne gume in aluminijasto zaporko, z rdečim pokrovčkom.
Bortezomib Accord 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.
Intravensko injiciranje Zdravilo Bortezomib Accord dajte naenkrat v obliki 3-5 sekund trajajoče bolusne intravenske injekcije preko perifernega ali osrednjega intravenskega katetra, čemur naj sledi izpiranje katetra z 9 mg/ml
CR+nCR+ PR+MR 146 (46) 108 (35)
CR + nCR+ PR+MR 146 (46) Mediana trajanja odziva dnevi (meseci)
Bortezomib Accord 3.5 mg powder for solution for injection Type 1 glass 10 ml-vial with a grey chlorobutyl rubber stopper and an aluminium seal, with a red cap containing 3.5 mg bortezomib.
Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje 10 ml, steklena viala, steklo tipa I, s sivim zamaškom iz klorobutilne gume in aluminijasto zaporko zaporko z rdečim pokrovčkom, ki vsebuje 3,5mg bortezomiba.
You should not breast-feed while using Bortezomib Accord.
Med uporabo zdravila Bortezomib Accord ne smete dojiti.
chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse
• znaki hude alergijske reakcije (anafilaktični šok), ki lahko vključujejo oteženo dihanje, bolečino ali tiščanje v prsih in/ali omotico/omedlevico, hudo srbenje kože ali dvignjene bulice na koži, otekanje obraza, ustnic, jezika in/ali grla, kar lahko povzroči oteženo požiranje in kolaps
Bortezomib Accord 1 mg powder for solution for injection Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Bortezomib Accord 1 mg prašek za raztopino za injiciranje Ena viala vsebuje 1 mg bortezomiba (v obliki estra manitola in borove kisline).
Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia
koma, neravnovesje v delovanju avtonomnega živčevja, avtonomna nevropatija, kranialna paraliza*, paraliza*, pareza*, presinkopa, sindrom možganskega debla, možgansko-žilne bolezni, lezija živčnih korenov, psihomotorna hiperaktivnost, kompresija hrbtenjače, kognitivna motnja NOS, motorične motnje, bolezni živčevja NOS, radikulitis, slinjenje, hipotonija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 3.5 mg
PODATKI NA ZUNANJI OVOJNINI ŠKATLA, 3,5 mg
Bortezomib Accord 1 mg powder for solution for injection Bortezomib Accord 3.5 mg powder for solution for injection
Bortezomib Accord 1 mg prašek za raztopino za injiciranje Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje
The chemical and physical in-use stability of the reconstituted solution of 2.5 mg/ml has been demonstrated for 8 hours at 20°C-25°C stored in the original vial and/or a syringe.
Rekonstituirana raztopina s koncentracijo 2,5 mg/ml je kemično in fizikalno stabilna 8 ur pri temperaturi 20−25 °C, če jo pred uporabo shranjujemo v originalni viali in/ali injekcijski brizgi.
Eye swelling*, Vision abnormal*, Conjunctivitis*
Pogosti zatekanje očesa*, nenormalen vid*, konjuktivitis*
Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).
Uporaba bortezomiba je lahko povezana z utrujenostjo (zelo pogosto), omotico (pogosto), sinkopami (občasno) in ortostatsko oz. posturalno hipotenzijo ali zamegljenim vidom (pogosto), zato morajo biti bolniki pri vožnji ali upravljanju s stroji previdni Bolnike je treba opozoriti naj v primeru pojava teh simptomov ne vozijo ali upravljajo s stroji (glejte poglavje 4.8).
Bortezomib Accord 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.
Zdravilo Bortezomib Accord je v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom indicirano za zdravljenje odraslih bolnikov z limfomom plaščnih celic, ki še niso prejemali zdravljenja in pri katerih presaditev krvotvornih matičnih celic ni mogoča.
Bortezomib combination treatment with dexamethasone
Bortezomib v kombinaciji z deksametazonom
Bortezomib Accord 3.5 mg powder for solution for injection Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje Ena viala vsebuje 3,5 mg bortezomiba (v obliki estra manitola in borove kisline).
Bortezomib Accord treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however Bortezomib Accord may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Zdravilo Bortezomib Accord pa lahko aplicira tudi zdravstveno osebje, ki ima izkušnje z zdravljenjem s kemoterapevstkimi učinkovinami.
Vaginal haemorrhage, Genital pain*, Erectile dysfunction,
Občasni krvavitev iz nožnice, bolečina v spolovilih*, erektilna disfunkcija
Multiple myeloma
Večina primerov PML
After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Intravenska rekonstitucija: Po rekonstituciji, 1 ml raztopine za intravensko injiciranje vsebuje 1 mg bortezomiba.
> 1.0 x −1.5 x ULN Any
> 1,0x−1,5x ULN katera koli ni potrebna zmerna
• Bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina
• krvavo blato, krvavitve iz sluznic, npr. v ustih, nožnici • možganskožilne bolezni
The reconstituted solution is stable for 8 hours at 20°C-25°C stored in the original vial and/or a syringe.
Rekonstituirana raztopina je stabilna 8 ur pri temperaturi 20−25°C, če jo pred uporabo shranjujemo v originalni viali in/ali injekcijski brizgi.
In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolised via cytochrome P450 enzymes, 3A4, 2C19, and 1A2.
kažejo, da se bortezomib v prvi vrsti oksidativno presnovi z encimi citokroma P450, 3A4, 2C19 in
Bortezomib Accord 3.5 mg powder for solution for injection bortezomib
Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje bortezomib
Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage#, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Občasni pljučni embolizem, plevralni izliv, pljučni edem (vključno z akutnim), pljučna alveolarna krvavitev#, bronhospazem, kronična obstruktivna pljučna bolezen*, hipoksemija*, kongestija dihal*,
For Bortezomib Accord dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Prilagoditev odmerjanja pri bolnikih, primernih za presaditev krvotvornih matičnih celic Za prilagoditev odmerjanja zdravila Bortezomib Accord je treba upoštevati navodila za odmerjanje, opisana pri samostojnem zdravljenju.
Cerebrovascular accident#, Deep vein thrombosis*, Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)*
krvavitev*, tromboflebitis (vključno s površinskim), cirkulatorni kolaps (vključno s hipovolemičnim šokom), flebitis, pordelost, hematom (vkjlučno s perirenalnim)*, slaba periferna prekrvavitev*, vaskulitis, hiperemija (vključno z očesno)*
When Bortezomib Accord is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Pri sočasni uporabi zdravila Bortezomib Accord z drugimi zdravili, glejtePovzetke glavnih značilnosti teh zdravil za dodatne kontraindikacije.
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/m2) and prednisone (60 mg/m2) 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.
To Progression-TTP) v primerjavi z zdravljenjem samo z melfalanom (9 mg/m2) in prednizolonom (60 mg/m2), pri bolnikih s predhodno ne-zdravljenim diseminiranim plazmocitomom, so izvedli prospektivno, mednarodno, randomizirano (1:1) odprto klinično študijo faze III (MMY-3002 VISTA)
In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to 120 ng/ml for the 1.3 mg/m2 dose.
1,0 mg/m2 in 89 do 120 ng/ml pri odmerku 1,3 mg/m2.
Intravenous use: Add 1 ml 0.9% sodium chloride to make 1 mg/ml final concentration.
Intravenska uporaba: dodajte 1 ml sterilne 0,9% raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
Overall response (CR+CRu+PR)
Celokupni odgovor (CR+CRu+PR)h n(%)
At least 72 hours should elapse between consecutive doses of Bortezomib Accord.
Med zaporednimi odmerki zdravila Bortezomib Accord mora preteči najmanj 72 ur.
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.
Zdravilo Bortezomib Accord je v kombinaciji z melfalanom in prednizolonom indicirano za zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih pred presaditvijo krvotvornih matičnih celic kemoterapija v visokih odmerkih ni primerna.
Hypermagnesaemia*, Acidosis, Electrolyte imbalance*, Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia*, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
hiperkloremija*, hiperfosfatemija*, presnovne motnje, pomanjkanje vitaminov B kompleksa, pomanjkanje vitamina B12,
Ear haemorrhage, Vestibular neuronitis, Ear disorder NOS
Redki ušesna krvavitev, vestibularni nevronitis, ušesne bolezni NOS
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Pojavnost periferne nevropatije pri kombiniranem zdravljenju v študiji LYM-3002 z bortezomibom, skupaj z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (R-CAP), je navedena v spodnji preglednici:
The mechanism of this event is unknown although a component may be due to autonomic neuropathy.
čeprav je deloma lahko posledica avtonomne nevropatije.
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.
Bortezomib Accord 1 mg prašek za raztopino za injiciranje 6 ml, steklena viala, steklo tipa I, s sivim zamaškom iz klorobutilne gume in aluminijasto zaporko, z modrim pokrovčkom, ki vsebuje 1 mg bortezomiba.
It is recommended that patients receive 2 cycles of bortezomib following a confirmation of a complete response.
Priporočamo, da bolniki po potrjenem popolnem odgovoru prejmejo še dva kroga zdravljenja z bortezomibom.
Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each bortezomib treatment cycle.
Bolnik jemlje 100 mg/m2 prednizona peroralno na 1., 2., 3., 4. in 5. dan kroga zdravljenja z bortezomibom.
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.
Priprava 3,5 mg viale: previdno dodajte 3,5 ml sterilne 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Accord.
Haematological toxicity
Toksični učinki na hematološki sistem
Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Občasni sindrom tumorske lize, zastoj rasti*, hipomagneziemija*, hipofosfatemija*, hiperkaliemija*, hiperkalciemija*,
and 32.
2 minutah.
Bz n=333a
Bz n=315
Muscle spasms*, Pain in extremity, Muscular weakness
Pogosti mišični krči*, bolečine v udih, mišična šibkost
After correcting for the BSA effect, other demographics such as age, body weight and sex did not have clinically significant effects on bortezomib clearance.
Po prilagoditvi glede na BSA drugi demografski dejavniki kot so starost,
Package leaflet: Information for the user Bortezomib Accord 1 mg powder for solution for injection Bortezomib Accord 3.5 mg powder for solution for injection bortezomib
Navodilo za uporabo Bortezomib Accord 1 mg prašek za raztopino za injiciranje Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje bortezomib
Discontinue Bortezomib Accord
Shranjevanje zdravila Bortezomib Accord
• that Bortezomib Accord 1 mg is only for intravenous use
• Zdravilo Bortezomib Accord 1 mg se lahko injicira samo intravensko.
When Bortezomib Accord 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 Bortezomib Accord.
Povzetke glavnih značilnosti teh zdravil pred začetkom zdravljenja z zdravilom Bortezomib Accord.
Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
Pogosti nevropatije*, motorična nevropatija*, izguba zavesti (vključno s sinkopo), encefalopatija*, periferna senzorična nevropatija,
TTP, months
TTP,
The benefit/risk ratio should be considered prior to continuing bortezomib therapy.
Pred nadaljevanjem zdravljenja z bortezomibom je potrebno oceniti razmerje med koristjo in tveganjem.
Bortezomib Accord 1 mg powder for solution for injection Each 6 ml vial of Bortezomib Accord must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Accord 1 mg prašek za raztopino za injiciranje Vsako 6 ml vialo zdravila Bortezomib Accord morate previdno rekonstituirati z 1 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
A hazard ratio less than 1 indicates an advantage for VMP c Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors e Response population includes patients who had measurable disease at baseline f CR=Complete Response; PR=Partial Response.
c Populacija oz. skupina bolnikov, pri kateri so ovrednotili odziv na zdravljenje, vključuje bolnike, ki so imeli merljivo bolezen na začetku in so prejeli najmanj en odmerek raziskovalnega zdravila d p-vrednost iz Cochran-Mantel-Haenszelovega hi-kvadrat testa, korigiranega s faktorji stratifikacije; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi
CR=Complete Response; nCR=near Complete response
Bz=bortezomib; Dex=deksametazon CR=popolni odgovor; nCR=skoraj popolni odgovor PR=delni odgovor; MR=minimalni odgovor
disease.
Očesne bolezni
Both in patients who were refractory to their last prior therapy and those who were not refractory, overall survival was significantly longer and response rate was significantly higher on the bortezomib arm.
Tako pri bolnikih s plazmocitomom, odpornim na zdravljenje, po prejšnji vrsti zdravljenja, kot pri tistih, ki so se odzvali na zdravljenje, je bilo celokupno preživetje v skupini, ki je prejemala bortezomib,
If any of the side effects, gets serious, or if you notice , any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
Posterior reversible encephalopathy syndrome (PRES) There have been reports of PRES in patients receiving bortezomib.
Sindrom reverzibilne posteriorne encefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome)
• moderate to severe liver problems
• zasoplost pri telesnem naporu
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.
Priprava 1 mg viale: previdno dodajte 1 ml sterilne 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Accord.
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.
Pri sočasni uporabi zdravila Bortezomib Accord z drugimi zdravili glejte Povzetke glavnih značilnosti teh zdravil za navodila za odmerjanje.
Very Common Thrombocytopenia*, Febrile neutropenia, Neutropenia*,
Občasni pancitopenija*, febrilna nevtropenija, koagulopatija*,
Bortezomib Accord 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Accord must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Accord morate previdno rekonstituirati s 3,5 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
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, pljučna fibroza, bolezni bronhijev*, hipokapnija*, intersticijska bolezen pljuč, infiltracija pljuč, stiskanje v grlu, suho grlo, zvečana sekrecija iz zgornjih dihal, draženje žrela,
Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura) #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
trombocitopenična purpura, bolezni krvi NOS, trombotična mikroangiopatija (vključno s hemoragično diatezo#, limfocitna infiltracija
Bortezomib Accord as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
Zdravilo Bortezomib Accord je indicirano za zdravljenje diseminiranega plazmocitoma v monoterapiji ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali z deksametazonom pri odraslih bolnikih, ki so prejeli najmanj eno predhodno vrsto zdravljenja in so jim že presadili kostni mozeg ali presaditev krvotvornih matičnih celic pri njih ni mogoča.
Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib Accord treatment cycle.
Deksametazon boste jemali peroralno v odmerku 40 mg na 1., 2., 3., 4., 8., 9., 10. in 11. dan 28dnevnega kroga zdravljenja z zdravilom Bortezomib Accord.
No new safety concerns were observed when Bortezomib Accord was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Pri dodatku bortezomiba standardni pediatrični pre B-celični ALL osnovni kemoterapevtski shemi niso opazili novih vplivov na varnost.
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.
Zdravilo Bortezomib Accord je v kombinaciji z deksametazonom ali deksametazonom in talidomidom indicirano za indukcijsko zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v visokih odmerkih.
Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased
Občasni hiperbilirubinemija*, nenormalni izvidi analiz proteinov*,
Bortezomib Accord 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Accord must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Accord morate previdno rekonstituirati s 1,4 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
How to store Bortezomib Accord
Kako boste prejeli zdravilo Bortezomib Accord
Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2
Na osnovi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja odmerka na 1,0 mg/m2 ali zmanjšanja odmerka na 0,5 mg/m2.
Hepatic impairment
Bolezni ledvic
Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakisuria
Občasni akutna odpoved ledvic, kronična odpoved ledvic*, okužba sečil*, znaki in simptomi bolezni sečil*, hematurija*, retenca urina,
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.
(npr. bortezomib v kombinaciji z deksametazonom) in bolnike v primerjalni skupini (npr. samo bortezomib) po parih tako, da na osnovi nerandomiziranih podatkov izločimo moteče dejavnike, ki lahko vplivajo na oceno učinkov zdravljenja.