FrancophonIA/ELRC3.0 huggingface dataset:
English: • to report any adverse event, or medication error experienced with the administration of
Slovenian: • Pomembnost sporočanja kakršnihkoli neželenih učinkov ali napak pri uporabi zdravila
English: Cycles 1 to 4
Slovenian: Vc+ Dx krog 1 do 4
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: ≥ 2 prior lines
Slovenian: ≥ stopnja 2 PN
English: 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.
Slovenian: 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.
English: • Fungal infections
Slovenian: • glivične okužbe
English: 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).
Slovenian: 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).
English: How to store VELCADE
Slovenian: Kako boste prejeli zdravilo VELCADE
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Slovenian: Ena viala vsebuje 3,5 mg bortezomiba (v obliki estra manitola in borove kisline).
English: • Hair loss and abnormal hair texture
Slovenian: • izpadanje las in nenormalna tekstura las
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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*
English: Platelets were lowest at Day 11 of each cycle of VELCADE treatment and typically recovered to baseline by the next cycle.
Slovenian: 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.
English: T 100 mg
Slovenian: T 100 mg na dan na dan
English: 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*
Slovenian: 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*
English: VIAL VELCADE 3.5 mg FLAG LABEL
Slovenian: VIALA VELCADE 3,5 mg NALEPKA
English: Hepatic enzyme abnormality*
Slovenian: Pogosti nenormalne koncentracije jetrnih encimov*
English: e (95% CI)=1.688 (1.148; 2.481) p-value g=0.007
Slovenian: OR e (95% CI) = 1,688 (1,148;
English: Vc (1.3 mg/m
Slovenian: Vc (1,3 mg/m dan 1, 4
English: Intravenous use: Add 3.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Slovenian: Intravenska uporaba: dodajte 3,5 ml sterilne 0,9% raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
English: • Fluid retention
Slovenian: • zadrževanje tekočine
English: In Cycles 1-4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Slovenian: 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.
English: 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
Slovenian: 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
English: 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.
Slovenian: 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.
English: Prednisone is given orally at 100 mg/m 2 on days 1, 2, 3, 4 and 5 of the VELCADE treatment cycle.
Slovenian: Prednizon boste jemali peroralno v odmerku 100 mg/m 2 na 1., 2., 3., 4. in 5. dan kroga zdravljenja z zdravilom VELCADE.
English: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and
Slovenian: 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.
English: When VELCADE is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Slovenian: Pri sočasni uporabi zdravila VELCADE z drugimi zdravili, glejte Povzetke glavnih značilnosti teh zdravil za dodatne kontraindikacije.
English: Antiviral prophylaxis is recommended in patients being treated with VELCADE.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom VELCADE, priporočamo, da razmislite o uporabi protivirusnih zdravil.
English: Limited information on VELCADE retreatment in relapsed multiple myeloma is available.
Slovenian: Na voljo so le omejeni podatki o ponovnem zdravljenju z zdravilom VELCADE pri bolnikih s ponovitvijo diseminiranega plazmocitoma.
English: VELCADE 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Slovenian: Zdravilo VELCADE 3,5 mg prašek za raztopino za injiciranje je ZA SUBKUTANO ALI INTRAVENSKO UPORABO.
English: • Abnormal vision, blurred vision
Slovenian: • nenormalen, zamegljen vid
English: CR CR+nCR 41 (13) CR+nCR+PR 121 (38)
Slovenian: b 2 (< 1) CR+nCR 41 (13) CR+nCR+PR
English: 8 cycles of VELCADE therapy.
Slovenian: Bolnik prejme šest krogov zdravljenja z zdravilom VELCADE.
English: Progression Free Survival, months (95% CI)
Slovenian: Preživetje brez napredovanja bolezni, meseci (95% CI) razmerje tveganja (95% CI) p-vrednost
English: Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Slovenian: Ena viala vsebuje 1 mg bortezomiba (v obliki estra manitola in borove kisline).
English: Therefore, caution should be used during handling and preparation of VELCADE.
Slovenian: Bortezomib je citotoksičen, zato je potrebna previdnost med pripravo in ravnanjem z zdravilom VELCADE.
English: Intravenous use: Add 1 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Slovenian: Intravenska uporaba: dodajte 1 ml sterilne 0,9% raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
English: A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone and thalidomide group.
Slovenian: Opazili so statistično značilno razliko v prid kombinaciji zdravila VELCADE z deksametazonom in talidomidom.
English: • fainting, dizziness or light-headedness in the past
Slovenian: • ste v preteklosti kdaj izgubljali zavest, bili omotični ali vrtoglavi,
English: Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the VELCADE treatment cycle.
Slovenian: 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.
English: A 6-week period is considered a treatment cycle.
Slovenian: Šest tedensko obdobje predstavlja en krog zdravljenja.
English: 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.
Slovenian: 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).
English: > 1.5 x 3 x ULN
Slovenian: > 1,5 x 3 x ULN katera koli
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Če vam limfoma plaščnih celic še niso zdravili, boste zdravilo VELCADE prejeli v veno, skupaj z rituksimabom, ciklofosamidom, doksorubicinom in prednizonom.
English: 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.
Slovenian: Prilagoditev odmerjanja pri kombiniranem zdravljenju bolnikov z diseminiranim plazmocitomom Za prilagoditev odmerjanja zdravila VELCADE pri kombiniranem zdravljenju upoštevajte navodila, za samostojno zdravljenje, opisana zgoraj.
English: If you have not been treated before for mantle cell lymphoma you will receive VELCADE intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Slovenian: Če vam limfoma plaščnih celic še niso zdravili, boste zdravilo VELCADE prejeli v veno ali v podkožje, skupaj z rituksimabom, ciklofosamidom, doksorubicinom in prednizonom.
English: • Cysts in the lining of joints (synovial cysts)
Slovenian: • cista sklepne ovojnice (sinovialna cista)
English: Mantle cell lymphoma
Slovenian: Limfom plaščnih celic (MCL)
English: • Bleeding from your bowels or stomach
Slovenian: • krvavitev v črevesju ali želodcu
English: 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.
Slovenian: Mediana starost bolnikov v študiji je bila 71 let, 50% sodelujočih je bilo moških, 88% belcev.
English: Do not store above 30 oC. Keep the vial in the outer carton in order to protect from light.
Slovenian: Vialo shranjujte v zunanji škatli, da bo zaščitena pred svetlobo.
English: • Stomach pain, bloating
Slovenian: • bolečine v trebuhu, napenjanje
English: Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces
Slovenian: Redki akutni pankreatitis, peritonitis*, edem jezika*, ascites, ezofagitis, heilitis, inkontinenca blata, atonija analnega sfinktra, fekalom*, razjede in perforacije v prebavilih*, hipertrofija dlesni, megakolon, izcedek iz rektuma, orofaringealni mehurji*, bolečina v ustnicah, parodontitis, analna fisura, spremembe pri odvajanju blata, proktalgija, nenormalno blato
English: (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver) - red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness - white blood cells may make you more prone to infections or flu-like symptoms.
Slovenian: - rdečih krvnih celic, kar lahko vodi v anemijo, s simptomi kot sta utrujenost in bledica - belih krvnih celic in tako bolj dovzetni za okužbe ali gripi podobne simptome.
English: If you are given VELCADE for the treatment of multiple myeloma the side effects you may get are listed below:
Slovenian: Če prejemate zdravilo VELCADE za zdravljenje diseminiranega plazmocitoma, se lahko pri vas pojavijo naslednji neželeni učinki:
English: For additional information concerning dexamethasone, see the corresponding Summary of Product Characteristics.
Slovenian: Za dodatne informacije o deksametazonu glejte Povzetek glavnih značilnosti tega zdravila.
English: Intravenous reconstitution: After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Slovenian: Intravenska rekonstitucija: Po rekonstituciji, 1 ml raztopine za intravensko injiciranje vsebuje 1 mg bortezomiba.
English: > 1.0 x 1.5 x ULN Any
Slovenian: > 1,0 x 1,5 x ULN katera koli ni potrebna zmerna
English: Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Slovenian: Bolniki, ki dosežejo vsaj delni odgovor po 4 krogih, lahko prejmejo do 6 krogov zdravljenja.
English: ≤ 30 ml/min (3% in each arm).
Slovenian: Podobno razmerje bolnikov je imelo očistek kreatinina ≤ 30 ml/min (3% v vsakem kraku študije).
English: (95% CI)=1.428 (0.749; 2.722) p-value g=0.275
Slovenian: (95% CI) = 1,428 (0,749;
English: • Nose bleeds
Slovenian: #, blefaritis
English: VELCADE 3.5 mg powder for solution for injection Bortezomib
Slovenian: VELCADE 3,5 mg prašek za raztopino za injiciranje bortezomib
English: VELCADE 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.
Slovenian: Zdravilo VELCADE 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.
English: VELCADE 1 mg powder for solution for injection Bortezomib
Slovenian: VELCADE 1 mg prašek za raztopino za injiciranje bortezomib
English: • Hypersensitivity
Slovenian: • preobčutljivost
English: This medicine is for intravenous or subcutaneous use.
Slovenian: To zdravilo se daje v veno ali v podkožje.
English: • that VELCADE is to be given only by IV or SC injections; no other route of administration is allowed
Slovenian: ali s.c., nobena druga uporaba ni dovoljena.
English: Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)*
Slovenian: #, globoka venska tromboza*, krvavitev*, tromboflebitis (vključno s površinskim), cirkulatorni kolaps (vključno s hipovolemičnim šokom), flebitis, pordelost, hematom (vključno s perirenalnim)*, slaba periferna prekrvavitev*, vaskulitis, hiperemija (vključno z očesno)*
English: Very Common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* Common Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
Slovenian: Bolezni živčevja Zelo pogosti periferna senzorična nevropatija, disestezija *, nevralgija* Pogosti nevropatije*, motorična nevropatija*, izguba zavesti (vključno s sinkopo), encefalopatija*, periferna senzorična in motorična nevropatija, omotica*, disgevzija*, avtonomna nevropatija
English: • In cycles 1 to 4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Slovenian: - V krogih 1 do 4 se zdravilo VELCADE daje dvakrat na teden,1., 4., 8., 11., 22., 25., 29. in 32. dan. - V krogih 5 do 9 pa enkrat na teden, 1., 8., 22. in 29. dan.
English: Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia(inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body
Slovenian: Redki smrt (vključno z nenadno), odpoved več organov, krvavitev na mestu injiciranja*, kila (vključno s hiatusno)*, slabše celjenje*, vnetje, flebitis na mestu injiciranja*, občutljivost, razjede, razdražljivost, bolečina v prsih, ki ni srčnega izvora, bolečina na mestu katetra, občutek tujka
English: breathing that becomes shallow, difficult or stops, wheezing
Slovenian: oteženo ali preneha, sopenje
English: - Keep this leaflet.
Slovenian: Odluščite tukaj.
English: Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic
Slovenian: Občasni pankreatitis (vključno s kroničnim)*, hematemeza, otekanje ustnic*, obstrukcija prebavil (vključno z obstrukcijo tankega črevesa, ileusom)*, neprijeten občutek v trebuhu, razjede v ustih*, enteritis*, gastritis*, krvavitev iz dlesni, gastroezofagealna refluksna bolezen*, kolitis (vključno s kolitisom, povzročenim s clostridium difficile)*, ishemični kolitis
English: Day 1 Day 2 Day 3 Day rest period rest period
Slovenian: 1 dan 2 dan 3 dan premor premor
English: Peripheral neuropathy in combination regimens Multiple Myeloma
Slovenian: Periferna nevropatija pri kombiniranem zdravljenju Diseminirani plazmocitom
English: Rest Period Rest Period
Slovenian: premor premor
English: No new safety concerns were observed when VELCADE was added to the standard pediatric pre-B cell ALL chemotherapy backbone.
Slovenian: Pri dodatku zdravila VELCADE standardni pediatrični pre B-celični ALL osnovni kemoterapevtski shemi niso opazili novih vplivov na varnost.
English: After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Slovenian: Po rekonstituciji praška 1 ml raztopine za subkutano injiciranje vsebuje 2,5 mg bortezomiba.
English: 1.2 Before administration, visually inspect the solution for particulate matter and discolouration.
Slovenian: Pred dajanjem vizualno preverite, da raztopina ne vsebuje delcev in da barva ni spremenjena.
English: • Shingles (localized including around the eyes or spread across the body)
Slovenian: • opazite pasasti izpuščaj (lokaliziran, vključno s področjem okoli oči ali razširjen po telesu),
English: Notable differences in the safety profile of VELCADE administered subcutaneously versus intravenously as single agent
Slovenian: Pomembne razlike v varnostnem profilu uporabe zdravila VELCADE v monoterapiji subkutano oz. intravensko
English: OUTER CARTON, VELCADE 3.5 mg
Slovenian: ŠKATLA VELCADE 3,5 mg
English: Pegylated liposomal doxorubicin is administered at 30 mg/m² on day 4 of the VELCADE treatment cycle as a 1 hour intravenous infusion administered after the VELCADE injection.
Slovenian: Pegilirani liposomski doksorubicin se daje v obliki 1-urne intravenske infuzije v odmerku 30 mg/m² na 4. dan kroga zdravljenja, po injiciranju zdravila VELCADE.
English: • numbness, tingling, or pain in the hands or feet (neuropathy) in the past
Slovenian: • ste imeli v preteklosti kakršnekoli težave z odrevenelostjo, mravljinci ali bolečino v dlaneh ali stopalih (nevropatija),
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura)
Slovenian: Redki diseminirana intravaskularna koagulacija, trombocitoza*, hiperviskozni sindrom, bolezni trombocitov NOS, trombotična mikroangiopatija (vključno s trombocitopenično purpuro) bolezni krvi NOS, hemoragična diateza, limfocitna infiltracija
English: Uncommon Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis Rare
Slovenian: Občasni hepatotoksičnost (vključno z boleznimi jeter), hepatitis*, holestaza