natgillin/translations-raw huggingface dataset:
p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm. 222 subjects were enrolled into the study; 221 subjects were treated with VELCADE Hazards ratio estimate is based on a Cox model adjusted for stratification factors: ISS staging and number of prior lines.
V študijo je bilo vključenih 222 preiskovancev; 221 preiskovancev se je zdravilo z zdravilom VELCADE Ocena stopnje tveganja temelji na modelu po Cox-u, prilagojen na osnovi stratifikacijaskih faktorjev: ISS razvrstitvi in številu predhodnih zdravljenj.
• Loss of conciousness
• izguba zavesti
The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to VELCADE alone.
V skladu s protokolom so bolniki lahko prejeli deksametazon, če ni bilo pričakovanega odziva na zdravljenje z zdravilom VELCADE v monoterapiji.
It is recommended that patients receive 2 cycles of VELCADE following a confirmation of a complete response.
Priporočamo, da bolniki po potrjenem popolnem odgovoru prejmejo še 2 kroga zdravljenja z zdravilom VELCADE.
The resulting solution is then injected into a vein rapidly, over 3 to 5 seconds.
Nastalo raztopino se nato hitro, v 3 do 5 sekundah, injicira v veno.
Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Redki periferni embolizem, limfedem, bledica, eritromelalgija, vazodilatacija, sprememba barve ven, venska insufucienca
1.4 mo
1,4 mesecev
Then, VELCADE may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to
Nato lahko ponovno uvedete zdravilo VELCADE v odmerku, ki je eno stopnjo manjši od prejšnjega (z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na
• Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
• mišični krči, oslabelost mišic, bolečine v udih
A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the VcR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
14% preiskovancev iz skupine VcR-CAP in 17% bolnikov iz skupine R-CHOP je prejelo 2 dodatna kroga zdravljenja.
Uncommon 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*
You should not breast-feed while using VELCADE.
Med uporabo zdravila VELCADE ne smete dojiti.
Patients with moderate or severe hepatic impairment should be started on VELCADE 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/m or further dose reduction to 0.5 mg/m 2 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/m 2 (glejte preglednico 6 ter poglavji 4.4 in 5.2).
The following medicinal products are administered on day 1 of each VELCADE 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m 2, cyclophosphamide at 750 mg/m 2 and doxorubicin at 50 mg/m
Naslednja zdravila boste prejeli 1. dan vsakega 21-dnevnega kroga zdravljenja z zdravilom VELCADE v obliki intravenske infuzije: 375 mg/m 2 rituksimaba, 750 mg/m 2 ciklofosfamida in 50 mg/m 2 doksorubicina.
You may experience a reduction in the number of: - platelets, which may make you be more prone to bruising, or to bleeding without obvious injury
Lahko boste imeli zmanjšanje števila: - krvnih ploščic, zaradi česar ste lahko bolj dovzetni za podplutbe ali krvavitve brez očitnih poškodb (npr.: krvavitve v črevesju, želodcu, ustih in dlesnih ali krvavitve v možganih ali jetrih).
• Reduced functioning of your kidneys
• zmanjšano delovanje ledvic
However, the dose-normalised mean AUC values were increased by approximately 60% in patients with moderate or severe hepatic impairment.
Pri bolnikih z zmerno ali hudo jetrno okvaro so se vrednosti povprečnega, na odmerek normaliziranega AUC povečale za 60%.
Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose, schedule or route of administration to subcutaneous (see section 4.2).
Pri bolnikih, pri katerih se periferna nevropatija pojavi prvič ali se obstoječa periferna nevropatija poslabša, je treba napraviti nevrološko oceno in po potrebi prilagoditi odmerek ali shemo odmerjanja na subkutano (glejte poglavje 4.2).
Mantle Cell Lymphoma (MCL) The safety profile of VELCADE in 240 MCL patients treated with VELCADE at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Varnostni profil zdravila VELCADE pri 240 bolnikih, zdravljenih z zdravilom VELCADE v odmerku 1,3 mg/m2 telesne površine, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (VcR-CAP) v primerjavi z 242 bolniki, zdravljenimi z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom [R-CHOP], je bil relativno skladen s profilom, opaženim pri bolnikih z diseminiranim plazmocitomom.
Dosage adjustments for transplant eligible patients For VELCADE dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Prilagoditev odmerjanja pri bolnikih, primernih za presaditev Za prilagoditev odmerjanja zdravila VELCADE je treba upoštevati navodila za odmerjanje, opisana pri samostojnem zdravljenju.
VELCADE therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Zdravljenje z zdravilom VELCADE je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 1. stopnjo ali stanje pred začetkom zdravljenja.
- in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).
- v kombinaciji z deksametazonom ali z deksametazonom in talidomidom, pri bolnikih, pri katerih bolezni še nismo zdravili in pred kemoterapijo v velikih odmerkih in presaditvijo krvotvornih matičnih celic (uvajalno zdravljenje).
Combination therapy with melphalan and prednisone VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Kombinirano zdravljenje z melfalanom in prednizonom Zdravilo VELCADE 3,5 mg se daje intravensko ali subkutano v kombinaciji s peroralnim melfalanom in prednizonom, kot je prikazano v preglednici 2.
• Reconstitution poster
• Plakat z navodili za rekonstitucijo
VELCADE will be administered by a health care professional experienced in the use of cytotoxic medicines.
Zdravilo VELCADE pa lahko aplicira tudi zdravstveno osebje, ki ima izkušnje z zdravljenjem s kemoterapevtskimi učinkovinami.
13.1 mo
13,1 mesecev
Subcutaneous reconstitution: After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Subkutana rekonstitucija: Po rekonstituciji, 1 ml raztopine za subkutano injiciranje vsebuje 2,5 mg bortezomiba.
Time to progression Events n (%) Median a (95% CI)
Čas do napredovanja bolezni dogodki n (%) mediana a (95% CI)
The final survival update was performed with a median duration of follow-up of 60.1 months.
Po 60,1 mesecih (mediana trajanja spremljanja) so posodobili podatke o končnem preživetju.
• Swelling of the liver, bleeding from the liver
• otekanje jeter, krvavitev v jetrih
Clinical efficacy with subcutaneous administration of VELCADE in patients with relapsed/refractory multiple myeloma
Klinična učinkovitost subkutanega dajanja zdravila VELCADE bolnikom pri relapsu/diseminiranem plazmocitomu, odpornem na zdravljenje
The incidence of herpes zoster among patients in the Vc+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
V skupini, zdravljeni z Vc+M+P, je pri 17% bolnikov, ki niso prejemali protivirusnih zdravil, prišlo do reaktivacije virusa herpes zoster, pri bolnikih, ki so prejemali protivirusna zdravila, pa je prišlo do reaktivacije virusa pri 3% bolnikov.
When VELCADE is given together with pegylated liposomal doxorubicin, you will receive VELCADE intravenously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m is given on day 4 of the VELCADE 21-day treatment cycle as an intravenous infusion after the VELCADE injection.
Če boste prejeli zdravilo VELCADE skupaj s pegiliranim liposomskim doksorubicinom, boste prejeli zdravilo VELCADE v veno v 21-dnevnem krogu zdravljenja in pegilirani liposomski doksorubicin v odmerku 30 mg/m2 v obliki enourne intravenske infuzije na 4. dan 21-dnevnega kroga zdravljenja, po injekciji zdravila VELCADE.
- 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 prednizonom, pri bolnikih, pri katerih bolezni še niso zdravili in pri njih kemoterapija v velikih odmerkih, pred presaditvijo krvotvornih matičnih celic ni primerna.
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.
VELCADE 1 mg powder for solution for injection is for intravenous use only, while VELCADE 3.5 mg powder for solution for injection is for intravenous or subcutaneous use.
Zdravilo VELCADE 1 mg prašek za raztopino za injiciranje se daje samo intravensko, zdravilo VELCADE 3,5 mg prašek za raztopino za injiciranje pa intravensko ali subkutano.
VELCADE 1 mg powder for solution for injection
VELCADE 1 mg prašek za raztopino za injiciranje
Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakiuria
Občasni akutna odpoved ledvic, kronična odpoved ledvic*, okužba sečil*, znaki in simptomi bolezni sečil*, hematurija*, retenca urina, težave pri uriniranju*, proteinurija, azotemija, oligurija*, polakiurija
VELCADE 3.5 mg powder for solution for injection
VELCADE 3,5 mg prašek za raztopino za injiciranje
In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the VELCADE treatment group (VcR-CAP) as compared to the non-VELCADE treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost trombocitopenije stopnje 3 ali več v skupini, ki je prejemala zdravilo VELCADE (VcR-CAP), večja (56,7% proti 5,8%) v primerjavi s skupino, ki zdravila VELCADE ni prejemala (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon [R-CHOP]).
• to report any adverse event, or medication error experienced with the administration of
• Pomembnost sporočanja kakršnihkoli neželenih učinkov ali napak pri uporabi zdravila
Cycles 1 to 4
Vc+ Dx krog 1 do 4
A hazard ratio less than 1 indicates an advantage for VMP Nominal p-value based on the stratified log-rank test adjusted for stratification factors: 2-microglobulin, albumin, and region p-value for Response Rate (CR+PR) from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors
Razmerje tveganja manjše kot 1 kaže prednost zdravljenja z VMP. nominalna p-vrednost na osnovi stratificiranega log-rank testa, prilagojena na osnovi stratifikacijskih dejavnikov: 2-mikroglobulin, albumin in regija.
In the same drug-drug interaction study assessing the effect of dexamethasone, a weaker CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 7 patients.
V isti študiji medsebojnega delovanja zdravil, ki je na osnovi podatkov 7 bolnikov ocenjevala učinek deksametazona, šibkega induktorja CYP3A4, na farmakokinetiko bortezomiba (danega intravensko), ni bilo pomembnega vpliva na farmakokinetiko bortezomiba.
≥ 2 prior lines
≥ stopnja 2 PN
VELCADE 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 VELCADE 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 primerna.
• Fungal infections
• glivične okužbe
Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose or schedule of VELCADE (see section 4.2).
Pri bolnikih, pri katerih se periferna nevropatija pojavi prvič ali se obstoječa periferna nevropatija poslabša, je treba napraviti nevrološko oceno in po potrebi prilagoditi odmerek ali shemo odmerjanja (glejte poglavje 4.2).
How to store VELCADE
Kako boste prejeli zdravilo VELCADE
When VELCADE is given together with pegylated liposomal doxorubicin, you will receive VELCADE intravenously or subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m is given on day 4 of the VELCADE 21-day treatment cycle as an intravenous infusion after the VELCADE injection.
Če boste prejeli zdravilo VELCADE skupaj s pegiliranim liposomskim doksorubicinom, vam bodo zdravilo VELCADE injicirali v veno ali v podkožje v 21-dnevnem krogu zdravljenja in pegilirani liposomski doksorubicin v odmerku 30 mg/m2 v obliki enourne intravenske infuzije na 4. dan 21dnevnega kroga zdravljenja, po injekciji zdravila VELCADE.
Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2).
Zato je treba te bolnike zdraviti z manjšimi odmerki zdravila VELCADE in pri njih skrbno spremljati morebitni pojav toksičnosti (glejte poglavji 4.2 in 5.2).
Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Ena viala vsebuje 3,5 mg bortezomiba (v obliki estra manitola in borove kisline).
• Hair loss and abnormal hair texture
• izpadanje las in nenormalna tekstura las
VELCADE combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001) A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of VELCADE plus pegylated liposomal doxorubicin versus VELCADE monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy.
Pri 646 bolnikih je bila opravljena randomizirana, odprta, multicentrična študija faze III pri vzporednih skupinah, v kateri so primerjali varnost in učinkovitost kombinirane terapije z zdravilom VELCADE in pegiliranim liposomskim doksorubicinom z monoterapijo z zdravilom VELCADE pri bolnikih z diseminiranim plazmocitomom, ki so že prejeli najmanj eno vrsto terapije in pri katerih bolezen ni napredovala med prejemanjem antraciklinske terapije.
Very Common Pneumonia* Common Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex* Uncommon Hepatitis B, Infection*, Bronchopneumonia
Zelo pogosti pljučnica* Pogosti sepsa (vključno s septičnim šokom)*, herpes zoster (vključno z diseminiranim in očesnim), okužba s herpes virusom, bakterijske okužbe *, okužba zgornjih/spodnjih dihal*, glivična okužba *, herpes simplex*
Platelets were lowest at Day 11 of each cycle of VELCADE treatment and typically recovered to baseline by the next cycle.
Število trombocitov je bilo najmanjše 11. dan vsakega kroga zdravljenja z zdravilom VELCADE in se je do naslednjega kroga zdravljenja običajno povrnilo na začetno vrednost.
T 100 mg
T 100 mg na dan na dan
Oedema (inc peripheral), Chills, Pain*, Malaise* Uncommon 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*
Občasni poslabšanje splošnega zdravstvenega stanja*, edem obraza*, reakcija na mestu injiciranja*, bolezni sluznice*, bolečina v prsih, motnje hoje, občutek mrazenja, ekstravazacija*, s katetrom povezani zapleti*, spremembe občutka žeje*, občutek nelagodja v prsih, občutek spreminjanja telesne temperature*, bolečina na mestu injiciranja*
VIAL VELCADE 3.5 mg FLAG LABEL
VIALA VELCADE 3,5 mg NALEPKA
Hepatic enzyme abnormality*
Pogosti nenormalne koncentracije jetrnih encimov*
Vc (1.3 mg/m
Vc (1,3 mg/m dan 1, 4
Intravenous use: Add 3.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Intravenska uporaba: dodajte 3,5 ml sterilne 0,9% raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
• Fluid retention
• zadrževanje tekočine
In Cycles 1-4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
V krogih 1-4 se zdravilo VELCADE 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.
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
Redki možganska krvavitev*, znotrajlobanjska krvavitev (vključno z subarahnoidalno)*, možganski edem, tranzitorna ishemična ataka, 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
There are no studies on the use of VELCADE in elderly patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Študij o uporabi zdravila VELCADE pri starejših bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v velikih odmerkih, niso izvedli.
Prednisone is given orally at 100 mg/m 2 on days 1, 2, 3, 4 and 5 of the VELCADE treatment cycle.
Prednizon boste jemali peroralno v odmerku 100 mg/m 2 na 1., 2., 3., 4. in 5. dan kroga zdravljenja z zdravilom VELCADE.
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 1,3 mg/m2.
When VELCADE is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Pri sočasni uporabi zdravila VELCADE z drugimi zdravili, glejte Povzetke glavnih značilnosti teh zdravil za dodatne kontraindikacije.
Antiviral prophylaxis is recommended in patients being treated with VELCADE.
Pri bolnikih, ki se zdravijo z zdravilom VELCADE, priporočamo, da razmislite o uporabi protivirusnih zdravil.
Limited information on VELCADE retreatment in relapsed multiple myeloma is available.
Na voljo so le omejeni podatki o ponovnem zdravljenju z zdravilom VELCADE pri bolnikih s ponovitvijo diseminiranega plazmocitoma.
VELCADE 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Zdravilo VELCADE 3,5 mg prašek za raztopino za injiciranje je ZA SUBKUTANO ALI INTRAVENSKO UPORABO.
• Abnormal vision, blurred vision
• nenormalen, zamegljen vid
CR CR+nCR 41 (13) CR+nCR+PR 121 (38)
b 2 (< 1) CR+nCR 41 (13) CR+nCR+PR
8 cycles of VELCADE therapy.
Bolnik prejme šest krogov zdravljenja z zdravilom VELCADE.
Progression Free Survival, months (95% CI)
Preživetje brez napredovanja bolezni, meseci (95% CI) razmerje tveganja (95% CI) p-vrednost
Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Ena viala vsebuje 1 mg bortezomiba (v obliki estra manitola in borove kisline).
Therefore, caution should be used during handling and preparation of VELCADE.
Bortezomib je citotoksičen, zato je potrebna previdnost med pripravo in ravnanjem z zdravilom VELCADE.
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.
A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone and thalidomide group.
Opazili so statistično značilno razliko v prid kombinaciji zdravila VELCADE z deksametazonom in talidomidom.
• fainting, dizziness or light-headedness in the past
• ste v preteklosti kdaj izgubljali zavest, bili omotični ali vrtoglavi,
Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the VELCADE 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 VELCADE.
A 6-week period is considered a treatment cycle.
Šest tedensko obdobje predstavlja en krog zdravljenja.
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, prednizon na farmakokinetiko bortezomiba (danega intravensko) je pokazala 17% zvečanje srednje vrednosti AUC bortezomiba (na osnovi podatkov 21 bolnikov).
> 1.5 x 3 x ULN
> 1,5 x 3 x ULN katera koli
Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see Table 4).
Če odmerek dobro prenaša se ga lahko poveča na 100 mg od 15. do 28. dneva in nato od 2. kroga zdravljenja naprej na 200 mg na dan (glejte preglednico 4).
If you have not been treated before for mantle cell lymphoma you will receive VELCADE intravenously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Če vam limfoma plaščnih celic še niso zdravili, boste zdravilo VELCADE prejeli v veno, skupaj z rituksimabom, ciklofosamidom, doksorubicinom in prednizonom.
Dose adjustments for combination therapy for patients with progressive multiple myeloma For VELCADE dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Prilagoditev odmerjanja pri kombiniranem zdravljenju bolnikov z diseminiranim plazmocitomom Za prilagoditev odmerjanja zdravila VELCADE pri kombiniranem zdravljenju upoštevajte navodila, za samostojno zdravljenje, opisana zgoraj.