FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Slovenian: Občasni sindrom tumorske lize, zastoj rasti*, hipomagneziemija*, hipofosfatemija*, hiperkaliemija*, hiperkalciemija*, hipernatriemija*, nenormalne koncentracije sečne kisline*, sladkorna bolezen*, zastajanje tekočine
English: 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 VELCADE powder by using a 1 ml syringe without removing the vial stopper.
Slovenian: 1.1 Priprava 1 mg viale: previdno dodajte 1,0 ml sterilne 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila VELCADE.
English: Change VELCADE treatment schedule to 1.3 mg/m2 once per week
Slovenian: zmanjšajte odmerek zdravila VELCADE na 1,0 mg/m ali spremenite shemo zdravljenja z zdravilom VELCADE na odmerek 1,3 mg/m 2 enkrat na teden
English: • Redness of skin
Slovenian: • srbenje kože
English: Each 5 ml vial of VELCADE must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a 1 ml syringe, without removing the vial stopper.
Slovenian: Vsako 5 ml vialo zdravila VELCADE morate previdno rekonstituirati z 1 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
English: • Cancer of the skin
Slovenian: • kožni rak
English: Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each VELCADE treatment cycle.
Slovenian: Bolnik jemlje 100 mg/m2 prednizona peroralno na 1., 2., 3., 4. in 5. dan vsakega kroga zdravljenja z zdravilom VELCADE.
English: Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Slovenian: Preglednica 1: Priporočena* prilagoditev odmerjanja v primeru nevropatije v povezavi z bortezomibom Stopnja nevropatije
English: Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).
Slovenian: Glede na vaš odziv na zdravljenje, pojavnost določenih neželenih učinkov in morebitne druge bolezni (npr. težave z jetri) lahko zdravnik spremeni odmerek in število krogov zdravljenja.
English: VELCADE 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.
Slovenian: Zdravilo VELCADE je v kombinaciji z melfalanom in prednizonom indicirano za zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih pred presaditvijo krvotvornih matičnih celic kemoterapija v velikih odmerkih ni primerna.
English: IV on day 1; and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day VELCADE treatment cycle.
Slovenian: na 1. dan in 100 mg/m prednizona peroralno na 1. do 5. dan 21-dnevnega cikla zdravljenja z zdravilom VELCADE.
English: The benefit/risk ratio should be considered prior to continuing VELCADE therapy.
Slovenian: Pred nadaljevanjem zdravljenja z zdravilom VELCADE je potrebno oceniti razmerje med koristjo in tveganjem.
English: Bortezomib is eliminated more rapidly following the first dose compared to subsequent doses.
Slovenian: V primerjavi s ponovljenimi odmerki, se bortezomib po prvem odmerku hitreje izloči iz telesa.
English: • shingles (localised including around the eyes or spread across the body)
Slovenian: • pasasti izpuščaj (herpes zoster (lokaliziran, vključno s področjem okoli oči, ali razširjen po telesu))
English: If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive VELCADE intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Slovenian: Če pri vas diseminiranega plazmocitoma še niso zdravili in je presaditev krvotvornih matičnih celic za vas primerna, boste kot uvajalno zdravljenje prejeli zdravilo VELCADE v veno ali v podkožje v kombinaciji z deksametazonom ali z deksametazonom in talidomidom.
English: Intrathecal administration
Slovenian: Intratekalna uporaba
English: Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of VELCADE in dual and triple combinations with other chemotherapeutic agents, as induction therapy prior to stem cell transplantation in patients with previously untreated multiple myeloma.
Slovenian: Bolniki, primerni za presaditev krvotvornih matičnih celic Za potrditev varnosti in učinkovitosti uvajalnega zdravljenja z zdravilom VELCADE v kombinacijah z dvema ali tremi kemoterapevtskimi učinkovinami, pred presaditvijo krvotvornih matičnih celic pri bolnikih s še nezdravljenim diseminiranim plazmocitomom so izvedli dve randomizirani, odprti, multicentrični preskušanji faze III (IFM-2005-01, MMY-3010).
English: 1.1 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 VELCADE powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: 1.1 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 VELCADE.
English: Day 1, 2, 3, 4
Slovenian: Dx 40 mg dan, 1, 2, 3, 4
English: You must read the package leaflets of all medicinal products to be taken in combination with VELCADE for information related to these medicines before starting treatment with VELCADE.
Slovenian: Preden začnete zdravljenje z zdravilom VELCADE preberite tudi navodila za uporabo zdravil, ki jih jemljete skupaj z zdravilom VELCADE.
English: • Cerebrovascular disorders
Slovenian: • možganskožilne bolezni
English: • shortness of breath or cough
Slovenian: • slabost (navzea) ali bruhanje
English: #, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
Slovenian: #, vnetje prebavil*, disfagija, sindrom razdražljivega črevesja, bolezni prebavil NOS, obložen jezik, motnje črevesne motilitete*, motnje v delovanju žlez slinavk*
English: VELCADE powder has to be dissolved before administration.
Slovenian: Zdravilo VELCADE je v obliki praška, ki ga je potrebno raztopiti pred injiciranjem.
English: VELCADE 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.
Slovenian: Zdravilo VELCADE 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 velikih odmerkih.
English: For single use only Do not give by other routes.
Slovenian: Ne sme se dajati po nobeni drugi poti.
English: In addition, when VELCADE 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.
Slovenian: Kadar dajemo zdravilo VELCADE v kombinaciji z drugimi kemoterapevtiki, je v primeru pojava toksičnosti potrebno razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi povzetki glavnih značilnosti zdravil.
English: After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.
Slovenian: Po rekonstituciji, 1 ml raztopine za injiciranje vsebuje 1 mg bortezomiba.
English: 1 mg/m to 0.7 mg/m
Slovenian: 0,7 mg/m
English: VELCADE is given intravenously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Slovenian: Zdravilo VELCADE boste prejeli intravensko na 1., 4., 8. in 11. dan, temu pa bo sledil premor brez zdravljenja.
English: Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Slovenian: Zelo pogosti zmanjšan apetit Pogosti dehidracija, hipokaliemija*, hiponatriemija*, nenormalne koncentracije glukoze v krvi*, hipokalciemija*, encimske motnje*
English: Complete blood counts (CBC) with differential and including platelet counts should be frequently monitored throughout treatment with VELCADE.
Slovenian: Med zdravljenjem z zdravilom VELCADE je treba pogosto spremljati število krvnih celic z diferencialno krvno sliko, vključno s številom trombocitov.
English: 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 VELCADE powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: 1.1 Priprava 3,5 mg viale: previdno dodajte 1,4 ml sterilne 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila VELCADE.
English: • seizures
Slovenian: • slinjenje
English: * Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate,
Slovenian: Na osnovi klasifikacije jetrnih okvar (blaga, zmerna, huda) Delovne skupine za disfunkcije organov nacionalnega onkološkega inštituta ZDA (National Cancer Institute Organ Dysfunction Working Group).
English: • Muscle spasms
Slovenian: • rak ledvic
English: • If platelet counts < 25,000 cells/μL.
Slovenian: ≥ 75.000 celic/μl.
English: Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving VELCADE.
Slovenian: Sindrom reverzibilne posteriorne levkoencefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome)
English: In addition, when VELCADE is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these medicinal products should be considered in the event of toxicities, according to the recommendations in the respective Summary of Product Characteristics.
Slovenian: Kadar dajemo zdravilo VELCADE v kombinaciji z drugimi kemoterapevtiki je v primeru pojava toksičnosti potrebno razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi Povzetki glavnih značilnosti zdravil.
English: VELCADE is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Slovenian: Zdravilo VELCADE boste prejeli v veno ali v podkožje na 1., 4., 8. in 11. dan, temu pa bo sledil premor brez zdravljenja.
English: If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive VELCADE intravenously together with two other medicines; melphalan and prednisone.
Slovenian: Če vam diseminiranega plazmocitoma še niso zdravili in presaditev krvotvornih matičnih celic za vas ni primerna, vam bodo zdravilo VELCADE injicirali v veno skupaj z zdraviloma melfalan in prednizon.
English: If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive VELCADE intravenously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Slovenian: Če pri vas diseminiranega plazmocitoma še niso zdravili in je presaditev krvotvornih matičnih celic za vas primerna, boste kot uvajalno zdravljenje prejeli zdravilo VELCADE v veno v kombinaciji z deksametazonom ali z deksametazonom in talidomidom.
English: In study LYM-3002 in which VELCADE 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:
Slovenian: Pojavnost periferne nevropatije pri kombiniranem zdravljenju v študiji LYM-3002 z zdravilom VELCADE, skupaj z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (R-CAP), je navedena v spodnji preglednici:
English: The vial is contained in a transparent blister pack consisting of a tray with a lid. Each pack contains 1 single-use vial.
Slovenian: Viala je v prozornem omotu, sestavljenem iz pladnja, zaprtega s folijo.
English: VELCADE 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.
Slovenian: Zdravilo VELCADE je indicirano za zdravljenje napredujočega 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 krvotvorne matične celice ali presaditev pri njih ni primerna.
English: Each 10 ml vial of VELCADE 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.
Slovenian: Vsako 10 ml vialo zdravila VELCADE morate previdno rekonstituirati s 3,5 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
English: After reconstitution, each ml solution contains 1 mg bortezomib.
Slovenian: Po rekonstituciji, 1 ml raztopine vsebuje 1 mg bortezomiba.
English: Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
Slovenian: Redki rabdiomioliza, sindrom temporomandibularnega sklepa, fistula, izliv v sklep, bolečina v čeljusti, bolezni kosti, okužbe in vnetja mišično-skeletnega sistema, vezivnega tkiva*, sinovialna cista
English: VELCADE 3.5 mg powder for solution for injection is available for intravenous or subcutaneous administration.
Slovenian: Zdravilo VELCADE 3,5 mg prašek za raztopino za injiciranje je namenjeno za intravensko ali subkutano uporabo.
English: Gastrointestinal and intracerebral haemorrhage, have been reported in association with VELCADE treatment.
Slovenian: V povezavi z zdravljenjem z zdravilom VELCADE so poročali o gastrointestinalni in intracerebralni krvavitvi.
English: Each 10 ml vial of VELCADE 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.
Slovenian: Vsako 10 ml vialo zdravila VELCADE morate previdno rekonstituirati z 1,4 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
English: If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive VELCADE together with two other medicines; melphalan and prednisone.
Slovenian: Če vam diseminiranega plazmocitoma še niso zdravili in presaditev krvotvornih matičnih celic za vas ni primerna, vam bodo zdravilo VELCADE injicirali skupaj z zdraviloma melfalan in prednizon.
English: VELCADE 1 mg powder for solution for injection IS FOR INTRAVENOUS USE ONLY.
Slovenian: Zdravilo VELCADE 1 mg prašek za raztopino za injiciranje je samo za intravensko uporabo.
English: Refer to the Summary of Product Characteristics of thalidomide for additional information.
Slovenian: Za dodatne podatke glejte Povzetek glavnih značilnosti zdravila s talidomidom.
English: Antiviral prophylaxis was administered to 26% of the patients in the Vc+M+P arm.
Slovenian: V Vc+M+P kraku študije je protivirusna zdravila prejelo 26% bolnikov.
English: NA=not applicable, NE=not estimated TTP-Time to Progression
Slovenian: CR+PR+MR; **CR = CR, (IF-); nCR = CR (IF+) NA = ne velja za ta primer, NE = odziva ni bilo mogoče oceniti TTP-čas do napredovanja bolezni CI = interval zaupanja
English: When VELCADE is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration.
Slovenian: Pri sočasni uporabi zdravila VELCADE z drugimi zdravili glejte Povzetke glavnih značilnosti teh zdravil za navodila za odmerjanje.
English: Name and address of the manufacturer responsible for batch release Janssen Pharmaceutica NV
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: Concomitant medicinal products
Slovenian: Sočasno jemanje zdravil
English: Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE treatment cycle.
Slovenian: Deksametazon boste jemali peroralno v odmerku 40 mg na 1., 2., 3., 4., 8., 9., 10. in 11. dan 28dnevnega kroga zdravljenja z zdravilom VELCADE.
English: The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma.
Slovenian: Biotransformacija Po enkratnem ali večkratnem intravenskem dajanju odmerkov 1,0 mg/m2 ali 1,3 mg/m2 bolnikom z diseminiranim plazmocitomom je bil povprečni volumen porazdelitve (Vd) 1,659 l do 3,294 l. To nakazuje, da se bortezomib v veliki meri porazdeljuje v periferna tkiva.
English: Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache* Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome
Slovenian: Občasni tremor, periferna senzorična in motorična nevropatija, diskinezija*, motnje koordinacije in ravnotežja v malih možganih*, izguba spomina (brez demence)*, encefalopatija*, posteriorni reverzibilni encefalopatični sindrom nevrotoksičnost, motnje s krči*, post-herpetična nevralgija, motnje govora*, sindrom nemirnih nog, migrena, išias, motnje pozornosti, nenormalni refleksi*, parozmija
English: Uncommon Angioedema
Slovenian: Redki hipotiroidizem
English: > 1 prior line of therapy
Slovenian: > 1 predhodna vrsta zdravljenja
English: • Hepatitis
Slovenian: • glavobol
English: • Weight increase
Slovenian: • oteženo požiranje
English: In the Phase III study, treatment with VELCADE led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
Slovenian: Pri vseh bolnikih, kot tudi pri bolnikih, ki so pred tem že prejeli eno vrsto terapije, je študija faze III zdravljenja z zdravilom VELCADE vodilo do statistično značilno daljšega časa do napredovanja bolezni, statistično značilno podaljšanega preživetja in statistično značilno boljšega odziva na zdravljenje v primerjavi z zdravljenjem z deksametazonom (glejte preglednico 14).
English: • Confirm the dose and concentration in the syringe prior to use.
Slovenian: • Pred dajanjem zdravila preverite odmerek in koncentracijo v brizgi (prepričajte se, da je na brizgi oznaka za subkutano dajanje).
English: Retreatment of patients with relapsed multiple myeloma In a study in which VELCADE retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a VELCADE-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
Slovenian: Najpogostejši neželeni učinki (vseh stopenj), ki so se pojavili pri najmanj 25% bolnikov, so bili trombocitopenija (55%), nevropatija (40%), anemija (37%), diareja (35%) in zaprtje (28%).
English: Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether VELCADE (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m 2) and prednisone
Slovenian: (9 mg/m 2) in prednizonom (60 mg/m 2) prispeva k podaljšanju časa do napredovanja bolezni (Time To Progression-TTP) v primerjavi z zdravljenjem samo z melfalanom (9 mg/m 2) in prednizonom
English: VELCADE treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however VELCADE may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Slovenian: Zdravilo VELCADE pa lahko aplicira tudi zdravstveno osebje, ki ima izkušnje z zdravljenjem s kemoterapevstkimi učinkovinami.
English: Table 4: Posology for VELCADE combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Slovenian: Preglednica 4: Odmerjanje zdravila VELCADE pri bolnikih, s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih je presaditev krvotvornih matičnih celic primerna.
English: Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction, Rare
Slovenian: Občasni krvavitev iz nožnice, bolečina v spolovilih*, erektilna disfunkcija
English: Hypotension*, Orthostatic hypotension, Hypertension* Uncommon Cerebrovascular accident
Slovenian: Pogosti hipertenzija*, hipotenzija*, ortostatska hipotenzija
English: After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Slovenian: Po rekonstituciji praška 1 ml raztopine za intravensko injiciranje vsebuje 1 mg bortezomiba.
English: Posology for previously untreated multiple myeloma patients eligible for haematopoietic stem cell transplantation (induction therapy)
Slovenian: Odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in so primerni za presaditev krvotvornih matičnih celic (uvajalno zdravljenje) Kombinirano zdravljenje z deksametazonom
English: Moderate
Slovenian: Presnova
English: The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Rekonstituirano raztopino morate pred uporabo vizualno pregledati, da ugotovite če vsebuje morebitne delce in če je spremenila barvo.
English: • Multi-organ failure
Slovenian: • odpoved več organov
English: sometimes associated with pain or bleeding, poor movement of the intestines (including blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting of blood
Slovenian: • okužbe ali vnetja v ustih, razjede v ustih, požiralniku, želodcu in črevesju, ki jih včasih spremlja bolečina ali krvavitev, počasno gibanje črevesja (vključno z zaporo), nelagodje v trebuhu ali požiralniku, oteženo požiranje, bruhanje krvi
English: VELCADE may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Slovenian: Uporaba tega zdravila 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.
English: VELCADE 1 mg powder for solution for injection is administered via intravenous 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.
Slovenian: Priporočeni odmerek je 1,3 mg/m2 telesne površine, dvakrat na teden dva tedna, na 1., 4., 8. in 11. dan v 21 dnevnem krogu zdravljenja.
English: Therefore, caution should be used during handling and preparation.
Slovenian: Opozorilo: VELCADE je citotoksično zdravilo, zato je med pripravo in ravnanjem z njim potrebna previdnost.
English: Nine treatment cycles of this combination therapy are administered.
Slovenian: Zdravljenje z zdravilom VELCADE traja devet krogov.
English: Grade of hepatic impairment*
Slovenian: Občasni pancitopenija*