natgillin/translations-raw huggingface dataset:
BzR-CAP=Bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
BzR-CAP=bortezomib, rituksimab, ciklofosfamid, doksorubicin in prednizon; R-CHOP= rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon; PN=periferna nevropatija
The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to bortezomib alone.
V skladu s protokolom so bolniki lahko prejeli deksametazon, če ni bilo pričakovanega odziva na zdravljenje z bortezomibom v monoterapiji.
In addition, when Bortezomib Accord is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these products should be considered in the event of toxicities according to the recommendations in the Summary of Product Characteristics.
Kadar dajemo zdravilo Bortezomib Accord v kombinaciji z drugimi kemoterapevtiki je v primeru pojava toksičnosti potrebno razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi Povzetki glavnih značilnosti zdravil.
Therefore, caution should be used during handling and preparation of Bortezomib Accord.
Spošni previdnostni ukrepi Bortezomib je citotoksičen, zato je potrebna previdnost med njegovo pripravo in ravnanjem z zdravilom Bortezomib Accord.
Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal*
nenormalno mednarodno umerjeno razmerje*, znižan pH v želodcu, zvečana agregacija trombocitov, zvišana koncentracija troponina I, identifikacija in serologija virusov*, nenormalni izvidi analize urina*
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bz= bortezomib; BzDx= bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
CI=interval zaupanja; CR=popoln odgovor; nCR=skoraj popoln odgovor; ITT=populacija, ki so jo nameravali zdraviti; RR=stopnja odgovora; Bz=bortezomib; BzDx=bortezomib in deksametazon; VDDx=vinkristin, doksorubicin in deksametazon; VGPR=zelo dober delni odgovor; PR=delni odgovor; OR=razmerje verjetnosti.
As a result of a pre-planned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered bortezomib, regardless of disease status.
Kot rezultat predhodno načrtovane vmesne analize, so del preskušanja, v katerem so bolniki dobivali deksametazon zaključili v skladu s priporočilom komisije, ki je spremljala podatke.
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzDx groups respectively; the majority of patients underwent one single transplant procedure.
Avtologno presaditev krvotvornih matičnih celic so opravili pri 198 (82%) bolnikih v skupini BzDx in
Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4
Dx 40 mg dan 1, 2, 3, 4 dan 8, 9, 10, 11krogi 2 do 4b
At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11
Po najmanj 6 mesecih po predhodnem zdravljenju, so bortezomib uvedli v odmerku, ki ga je bolnik pri predhodnem zdravljenju še prenašal, 1,3 mg/m2 (n=93) ali ≤ 1,0 mg/m2 (n=37).
Bortezomib Accord therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Zdravljenje z zdravilom Bortezomib Accord je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 1. stopnjo ali stanje pred začetkom zdravljenja.
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BzTDx and TDx groups, respectively.
BzTDx in 78 (61%) bolnikih v skupini TDx.
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.
Študija medsebojnega delovanja zdravil za učinkovine melfalan, prednizolon na farmakokinetiko bortezomiba (intravensko) je pokazala 17% zvečanje srednje vrednosti AUC bortezomiba (na osnovi podatkov 21 bolnikov).
Table 1: Recommended* posology modifications for Bortezomib Accord -related neuropathy
Preglednica 1: Priporočena* prilagoditev odmerjanja v primeru nevropatije v povezavi z zdravilom Bortezomib Accord
Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Barr, genitalni herpes, tonzilitis, mastoiditis, post virusni sindrom utrujenosti
Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome#, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
Občasni tremor, periferna motorična nevropatija, diskinezija*, motnje koordinacije in ravnotežja v malih možganih*, izguba spomina (brez demence)*, encefalopatija posteriorni reverzibilni encefalopatični sindrom#, nevrotoksičnost, motnje s krči*, postherpetična nevralgija, motnje govora*, sindrom nemirnih nog,
Injection into a vein is rapid, taking 3 to 5 seconds.
Nastalo raztopino se nato hitro, v 3 do5 sekundah, injicira v veno.
N=240 (ITT population) N=242 (ITT population)
n=242 (ITT populacija)
No new safety concerns were observed during the study, and in particular bortezomib did not exacerbate target organ damage (heart, kidney and liver).
Uporaba bortezomiba ni povečala poškodb tarčnih organov (srce,
When Bortezomib Accord is given together with dexamethasone, you will receive Bortezomib Accord intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib Accord 21-day treatment cycle.
Če jemljete zdravilo Bortezomib Accord skupaj z deksametazonom boste prejeli zdravilo Bortezomib Accord v veno ali v podkožje v 21-dnevnem krogu zdravljenja in 40 mg deksametazona peroralno na 1., 2., 3., 4., 8., 9., 10. in 11. dan kroga zdravljenja z zdravilom Bortezomib Accord.
The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukaemia (ALL) or acute myeloid leukaemia (AML).
dvakrat na teden 104 pediatričnim bolnikom (starim 2-16 let) z akutno limfoblastno levkemijo (ALL
• a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate Bortezomib Accord dose.
Navodila za odmerjanje zdravila morajo vsebovati naslednje ključne elemente: • Model izračuna s katerim bo lahko predpisovalec izračunal odmerek zdravila in telesno površino, na podlagi bolnikove višine in telesne mase, in tako določil pravi odmerek zdravila Bortezomib Accord.
Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy#, Different degrees of visual impairment (up to blindness)*
očesne bolezni (vključno z vekami) NOS, pridobljen dakrioadenitis, fotofobija, fotopsija, optična nevropatija#, različne stopnje okvare vida (vse do slepote)*
Table 2: Recommended posology for Bortezomib Accord in combination with melphalan and prednisone
Preglednica 2: Priporočeno odmerjanje zdravila Bortezomib Accord v kombinaciji z melfalanom in prednizolonom
Refer to the Summary of Product Characteristics of thalidomide for additional information.
s sklicem na SmPC za talidomid za pridobitev dodatnih informacij.
T 100 mg a
T 100 mga na dan na dan
Setting (Bortezomib Accord plus dexamethasone, and Bortezomib Accord plus dexamethasone and thalidomide).
Bortezomib Accord v kombinaciji z deksametazonon in zdravilo Bortezomib Accord v kombinaciji z deksametazonom in talidomidom).
Bortezomib Accord is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years: - alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (progressive) after receiving at least one prior treatment and for whom blood stem cell transplantation was not successful or is unsuitable.
Zdravilo Bortezomib Accord se uporablja za zdravljenje diseminiranega plazmocitoma (rak kostnega mozga) pri bolnikih, starejših od 18 let: - samostojno ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali deksametazonom pri bolnikih, pri katerih je bolezen napredovala po tem, ko so prejeli vsaj eno predhodno vrsto zdravljenja in so jim že presadili krvotvorne matične celice ali presaditev krvotvornih matičnih celic pri njih ni mogoča
Patients with moderate or severe hepatic impairment should be started on Bortezomib Accord at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Na osnovi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja a odmerka na 1,0 mg/m2 ali zmanjšanja odmerka na 0,5 mg/m2 (glejte preglednico 6 ter poglavji 4.4 in 5.2).
Incidence Adverse reaction
Motnje imunskega odziva
At least 72 hours should elapse between consecutive doses of bortezomib.
Med zaporednimi odmerki bortezomiba mora preteči najmanj 72 ur.
# Post-marketing adverse reaction regardless of indication
* združevanje več priporočenih terminov po klasifikaciji MedDRA # neželeni učinki v obdobju trženja, neodvisno od indikacije
Vertigo*
nevralgija*
• Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
• vnetje srčne ovojnice ali nabiranje tekočine okoli srca • okužbe, vključno z okužbo sečil, gripa, okužba s herpes virusom, ušesne okužbe in celulitis
An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of bortezomib versus the intravenous administration.
V odprti, randomizirani, študiji faze III na dveh enakovrednih skupinah so primerjali učinkovitost in varnost subkutanega in intravenskega dajanja bortezomiba.
Then, Bortezomib Accord 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/m2).
Nato lahko ponovno uvedete zdravilo Bortezomib Accord v odmerku, ki je eno stopnjo nižji od prejšnjega (z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na 0,7 mg/m2).
Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Pogosti hiperbilirubinemija*, nenormalni izvidi analiz proteinov, zmanjšana telesna masa, zvečana telesna masa
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.
Zdravilo Bortezomib Accord 1 mg prašek za raztopino za injiciranje JE SAMO ZA INTRAVENSKO UPORABO, medtem ko je zdravilo Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje ZA SUBKUTANO ALI INTRAVENSKO UPORABO.
In Cycles 1-4, Bortezomib Accord is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
V krogih 1-4 se zdravilo Bortezomib Accord daje dvakrat na teden, na 1., 4., 8., 11., 22., 25., 29. in 32. dan, v krogih 5-9 pa enkrat na teden, na 1., 8., 22. in 29. dan.
When Bortezomib Accord is given together with dexamethasone, you will receive Bortezomib Accord intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the Bortezomib Accord, 21-day treatment cycle.
Če boste prejeli zdravilo Bortezomib Accord skupaj z deksametazonom, boste prejeli zdravilo v veno ali v podkožje v 21-dnevnem krogu zdravljenja in 20 mg deksametazona peroralno na 1., 2., 4., 5., 8., 9., 11. in 12. dan kroga zdravljenja z zdravilom Bortezomib Accord.
Day
Teden
Concomitant medicinal products
UPORABO ZDRAVILA
Injection sites should be rotated for successive injections.
Za uspešno injiciranje je treba mesta injiciranja menjati.
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.
Bortezomib Accord 1 mg prašek za raztopino za injiciranje Ena škatla zdravila Bortezomib Accord 1 mg prašek za raztopino za injiciranje vsebuje stekleno 6 ml vialo s sivim zamaškom iz klorobutilne gume in aluminijasto zaporko, z modrim pokrovčkom, vsebuje 1 mg bortezomiba.
a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p <
b p-vrednost iz stratificiranega testa log-ranga; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi, p < 0,0001
There are no studies on the use of bortezomib in elderly patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Študij o uporabi bortezomiba pri starejših bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v visokih odmerkih, niso izvedli.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benigne, maligne in neopredeljene neoplazme
Dysacusis (inc tinnitus)*,Hearing impaired (up to and inc deafness), Ear discomfort*
Občasni disakuza (vključno s tinitusom) *, okvara sluha (vse do in vključno z gluhostjo), neprejeten občutek v ušesu*
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bz= bortezomib; BzTDx= bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response; OR=odds ratio * Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
CI= interval zaupanja; CR= popoln odgovor; nCR= skoraj popoln odgovor; ITT=populacija, ki so jo nameravali zdraviti; RR=stopnja odgovora; Bz=bortezomib; BzTDx=bortezomib, talidomid, deksametazon; TDx=talidomid, deksametazon; PR= delni odgovor; OR= razmerje verjetnosti;
Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
sindrom razpada tumorja, pljučna hipertenzija, sindrom reverzne posteriorne encefalopatije, akutna difuzna infiltracijska pljučna stanja in redko o avtonomni nevropatiji.
Bortezomib Accord 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Zdravilo Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje je namenjeno za intravensko ali subkutano uporabo.
If you are given Bortezomib Accord for the treatment of multiple myeloma the side effects you may get are listed below:
Če prejemate zdravilo Bortezomib Accord za zdravljenje diseminiranega plazmocitoma, se lahko pri vas pojavijo naslednji neželeni učinki:
An odds ratio (OR) > 1 indicates an advantage for BzR-CAP. f Include all CR+CRu, by IRC, bone marrow and LDH.
f Vključuje vse CR+CRu, IRC, kostni mozeg in LDH.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1 mg
PODATKI NA ZUNANJI OVOJNINI ŠKATLA, 1 mg
Very Common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Bolezni živčevja Zelo pogosti periferna senzorična nevropatija, disestezija *, nevralgija*
Any
dan
Bortezomib Accord 1 mg powder for solution for injection is available for intravenous administration only.
Zdravilo Bortezomib Accord 1 mg prašek za raztopino za injiciranje je namenjeno samo za intravensko uporabo.
administered twice weekly days 1, 4, 8, and 11, followed by a 17-day rest period from day 12 to day 28), dexamethasone (40 mg administered orally on days 1 to 4 and days 8 to 11), and thalidomide (administered orally at 50 mg daily on days 1-14, increased to 100 mg on days 15-28 and thereafter to 200 mg daily).
deksametazon (40 mg peroralno na 1. do 4. dan in 8. do 11. dan) in talidomid (50 mg na dan peroralno na 1. do 14. dan, povečan odmerek 100 mg na 15. do 28. dan in potem povečan odmerek 200 mg na dan).
• to report any adverse event, or medication error experienced with the administration of
• Pomembnost sporočanja kakršnihkoli neželenih učinkov ali napak pri dajanju zdravila
Posology for patients with previously untreated mantle cell lymphoma (MCL)
Priporočeno odmerjanje pri bolnikih, pri katerih limfom plaščnih celic (MCL) še ni bil zdravljen
• If platelet counts ≤ 30 x 109/l or ANC ≤ 0.75 x 109/l on a Bortezomib Accord dosing day (other than day 1)
Bortezomib Accord (razen dneva 1) število trombocitov ≤ 30 × 109/l ali ANC ≤ 0,75 x 109/l
Wessling Hungary Kft. Anonymus u. 6., Budapest, 1045, Hungary
Anonymus u. 6., Budapest, 1045, Madžarska
Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and
Po odmerku 1,0 mg/m2 je povprečni celotni očistek telesa po prvem odmerku znašal 102 l/h in 112 l/h po odmerku
* Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate,
* Na osnovi klasifikacije jetrnih okvar (blaga, zmerna, huda) Delovne skupine za disfunkcije organov nacionalnega onkološkega inštituta ZDA (National Cancer Institute Organ Dysfunction Working Group).
For Bortezomib Accord dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Prilagoditev odmerjanja pri kombiniranem zdravljenju bolnikov z diseminiranim plazmocitomom Za prilagoditev odmerjanja zdravila Bortezomib Accord pri kombiniranem zdravljenju upoštevajte navodila, za samostojno zdravljenje, opisana zgoraj.
Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the Bortezomib Accord treatment cycle.
Deksametazon se jemlje peroralno v odmerku 20 mg na 1., 2., 4., 5., 8., 9., 11. in 12. dan v krogu zdravljenja z zdravilom Bortezomib Accord.
Prednisone is given orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of the Bortezomib Accord treatment cycle.
Prednizon boste jemali peroralno v odmerku 100 mg/m2 na 1., 2., 3., 4. in 5. dan kroga zdravljenja z zdravilom Bortezomib Accord.
The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Rekonstituirano raztopino morate pred uporabo vizualno pregledati, da ugotovite če vsebuje morebitne delce in če se je razbarvala.
4.63 (2.61, 8.22); < 0.001a a
3,46 (1,90; 6,27); < 0,001a
In B-ALL patients with relapse within 18 months of diagnosis (n = 27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62).
Pri bolnikih z B-celično ALL in relapsom v manj kot 18 mesecih po diagnozi (n = 27) je bil delež popolnih odgovorov 67 % (95% CI: 46, 84) in delež 4-mesečnega preživetja bolnikov brez dogodkov 44 %
Cardiac tamponade#, 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
Občasni tamponada srca#, srčno-pljučni zastoj*, srčna fibrilacija (vključno z atrijsko), srčno popuščanje (vključno z levim in desnim prekatom)*, aritmija*, tahikardija*, palpitacije, angina pektoris,
• numbness, tingling, or pain in the hands or feet (neuropathy) in the past
• ste imeli v preteklosti kakršne koli težave z odrevenelostjo, mravljinci ali bolečino v dlaneh ali stopalih (nevropatija),
- in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation.
- v kombinaciji z melfalanom in prednizolonom, pri bolnikih, pri katerih bolezni še nismo zdravili in pri njih kemoterapija v visokih odmerkih, pred presaditvijo krvotvornih matičnih celic ni mogoča
Efficacy results are presented in Table 16:
Rezultati učinkovitosti so podani v preglednici 15:
Withhold Bortezomib Accord treatment until symptoms of toxicity have resolved.
Accord, dokler ne minejo znaki toksičnosti.
The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
Mediana starost bolnikov v študiji je bila 71 let, 50 % sodelujočih je bilo moških, 88% belcev.
The chemical and physical in-use stability of the reconstituted solution at a concentration of 1 mg/ml has been demonstrated for 3 days at 20°C-25°C stored in the original vial and/or a syringe.
Intravensko dajanje Rekonstituirana raztopina s koncentracijo 1 mg/ml je kemično in fizikalno stabilna 3 dni pri temperaturi 20−25 °C, če jo pred uporabo shranjujemo v originalni viali in/ali injekcijski brizgi.
General physical health deterioration*, Face oedema*, Injection site reaction*, Mucosal disorder*, Chest pain, Gait disturbance, Feeling cold, Extravasation*, Catheter related complication*, Change in thirst*, Chest discomfort, Feeling of body temperature change*, Injection site pain*
motnje hoje, občutek mrazenja, ekstravazacija*, s katetrom povezani zapleti*, spremembe občutka žeje*, občutek nelagodja v prsih, občutek spreminjanja telesne temperature*, bolečina na mestu injiciranja*
Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia#
Zelo pogosti trombocitopenija*, febrilna nevtropenija, nevtropenija *, levkopenija*, anemija*, limfopenija*
The reconstituted solution is stable for 3 days at 20°C-25°C stored in the original vial and/or a syringe.
Rekonstituirana raztopina je stabilna 3 dni pri temperaturi 20−25°C, če jo pred uporabo shranjujemo v originalni viali in/ali injekcijski brizgi.
• Redness and pain at injection site
• pordelost in bolečina na mestu injiciranja • splošno slabo počutje
The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (Creatinine Clearance [CrCL] > 20 ml/min/1.73 m2); therefore, dose adjustments are not necessary for these patients.
Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina [CrCL] > 20 ml/min/1,73 m2)
of the 21 day bortezomib treatment cycle.
4. dan 21-dnevnega kroga zdravljenja, po injekciji zdravila Bortezomib Accord.
Bortezomib Accord 1 mg powder for solution for injection bortezomib
Bortezomib Accord 1 mg prašek za raztopino za injiciranje bortezomib
Eye haemorrhage*, Eyelid infection*, Chalazion# , Blepharitis# , Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge
Občasni krvavitve v očesu*, okužba veke*, halazij#, blefaritis#, vnetje očesa*, diplopija, suhe oči*, draženje očesa*, bolečina v očesu, povečano solzenje, izcedek iz očesa
You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib Accord for information related to these medicines before starting treatment with Bortezomib Accord.
Preden začnete zdravljenje z zdravilom Bortezomib Accord preberite tudi navodila za uporabo zdravil, ki jih jemljete skupaj z zdravilom Bortezomib Accord.
Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Subkutana uporaba: dodajte 1,4 ml sterilne 0,9 % raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
Hazard ratio (95% CI)c p-valued
(95% CI) razmerjetveganja (95% CI)c p-vrednostd