FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 pediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Slovenian: Farmakokinetiko bortozomiba so ovrednotili po intravenski aplikaciji bolusnega odmerka 1,3 mg/m dvakrat na teden 104 pediatričnim bolnikom (starim 2-16 let) z akutno limfoblastno levkemijo (ALLAcute Lymphoblastic Leukemia) ali z akutno mieloično levkemijo (AML - Acute Myeloid Leukemia).
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the VcTDx and TDx groups, respectively.
Slovenian: Eno avtologno presaditev krvotvornih matičnih celic so opravili pri 105 (81%) bolnikih v skupini VcTDx in 78 (61%) bolnikih v skupini TDx.
English: CR+nCR+ PR+MR Median duration Days (months) Time to response CR+PR (days)
Slovenian: CR+nCR+ PR+MR Mediana trajanja odziva dnevi (meseci) Čas do odziva CR+PR (dnevi)
English: • bleeding problems and/or low number of platelets in your blood
Slovenian: • imate težave s strjevanjem krvi in/ali majhno število krvnih ploščic (trombocitov),
English: The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
Slovenian: Bolniki v obeh skupinah so na splošno imeli podobne demografske in bolezenske značilnosti: mediana starost bolnikov je bila 66 let, 74% je bilo moških, 66% je bilo belcev in 32% azijcev, 69% bolnikov je imelo pozitivno aspiracijo kostnega mozga in/ali pozitivno biopsijo kostnega mozga za MCL, 54% bolnikov je imelo vrednost mednarodnega prognostičnega indeksa (International Prognostic Index-IPI) ≥ 3 in 76% bolnikov je bilo v IV. stadiju bolezni.
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the VcR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Slovenian: Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost okužbe z virusom herpes zoster v skupini VcR-CAP 6,7% in v skupini R-CHOP 1,2% (glejte poglavje 4.8).
English: Median OS was 90.7 months for the VcR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
Slovenian: V skupini VcR-CAP je bilo mediano OS 90,7 mesecev v primerjavi s 55,7 meseci v skupini R-CHOP (HR=0,66; p=0,001).
English: The MAH shall ensure thatall healthcare professionals involved in the prescribing, dispensing, handling or administration of VELCADE are provided with educational material.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravstveni delavci, ki bodo predpisovali, izdajali ali uporabljali zdravilo, prejeli izobraževalno gradivo.
English: VELCADE treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Slovenian: Zdravljenje z zdravilom VELCADE je zelo pogosto povezano s toksičnimi učinki na hematološki sistem (trombocitopenija, nevtropenija in anemija).
English: • heart or blood pressure problems
Slovenian: • imate težave s srcem ali s krvnim tlakom,
English: 9/l and the absolute neutrophils count should be ≥ 1.0 x 10
Slovenian: Neutrophil Count) mora biti ≥ 1,0 x 10
English: • General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness
Slovenian: • splošno slabo počutje, bolečina, vrtoglavica, blagi glavoboli, občutek šibkosti ali izguba zavesti
English: In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to 120 ng/ml for the 1.3 mg/m2 dose.
Slovenian: Pri ponovljenih odmerkih so bile povprečne vrednosti najvišjih plazemskih koncentracij v razponu 67 do 106 ng/ml pri odmerku 1,0 mg/m2 in 89 do 120 ng/ml pri odmerku 1,3 mg/m
English: Patients in the VcTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Slovenian: V skupini VcTDx oziroma TDx je bila mediana starost bolnikov 57 let oziroma 56 let, 99% oziroma 98% je bilo belcev, moških je bilo 58% oziroma 54%.
English: Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each VELCADE treatment cycle.
Slovenian: Melfalan in prednizon je treba dati peroralno na 1., 2., 3. in 4. dan v prvem tednu vsakega kroga zdravljenja z zdravilom VELCADE.
English: Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Slovenian: Večja je bila tudi pojavnost okužb z nevtropenijo stopnje ≥ 3 (24% proti 19% v 1. sklopu in 22% proti 11% v 2. sklopu), povečane koncentracije ALT (17% proti 8% v 2. sklopu), hipokaliemije (18% proti 6% v 1. sklopu in 21% proti 12% v 2. sklopu) in hiponatriemije (12% proti 5% v 1. sklopu in 4% proti 0 v 2. sklopu).
English: The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. VELCADE in combination with dexamethasone) and patients in the comparison group (e.g. VELCADE) are made comparable with respect to confounding factors by individually pairing study subjects.
Slovenian: Analiza izenačenih parov je statistični postopek v katerem primerjamo bolnike v skupini, ki se zdravi (npr. zdravilo VELCADE v kombinaciji z deksametazonom) in bolnike v primerjalni skupini (npr. samo zdravilo VELCADE) po parih tako, da na osnovi nerandomiziranih podatkov izločimo moteče dejavnike, ki lahko vplivajo na oceno učinkov zdravljenja.
English: Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with VcR-CAP in a clinical trial System Organ Class
Slovenian: Preglednica 8: Neželeni učinki pri bolnikih z limfomom plaščnih celic, zdravljenih z VcR-CAP v kliničnih preskušanjih
English: (feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching
Slovenian: okus, vonj), motnje pozornosti, tresenje, trzanje
English: In study LYM-3002, colony stimulating factor support was given to 78% of patients in the VcR-CAP arm and 61% of patients in the R-CHOP arm.
Slovenian: V študiji LYM-3002 je podporno zdravljenje s kolonijami spodbujajočih faktorjev prejelo 78% bolnikov v skupini VcR-CAP in 61% bolnikov v skupini R-CHOP.
English: TTP, months (95% CI)
Slovenian: TTP, dnevi ([95% CI])
English: In the VcR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Slovenian: V skupini VcR-CAP je prejelo infuzijo trombocitov 22,5% bolnikov, v skupini R-CHOP pa 2,9% bolnikov.
English: Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Slovenian: Zato je potrebno bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 (npr. ketokonazolom, ritonavirjem) skrbno spremljati.
English: Progression free survival (IRC) Events n (%)
Slovenian: Preživetje brez napredovanja bolezni (IRC) dogodki n (%)
English: • to report any adverse event, or medication error experienced with the administration of VELCADE 3.5 mg.
Slovenian: • Pomembnost sporočanja kakršnihkoli neželenih učinkov ali napak pri uporabi zdravila VELCADE 3,5 mg.
English: In patients aged ≥ 75 years, both regimens, VcR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Slovenian: Bolniki, stari ≥ 75 let, so oba režima zdravljenja, VcR-CAP in R-CHOP, slabše prenašali (glejte poglavje 4.8).
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with VELCADE+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Slovenian: V študiji faze III, pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, je bila splošna pojavnost reaktivacije virusa herpes zoster pri bolnikih zdravljenih z zdravili VELCADE+melfalan+prednizon pogostejša, kot pri bolnikih zdravljenih z melfalanom+prednizonom (14% v primerjavi s 4%).
English: Grade ≥ 3 non-haematological toxicities
Slovenian: Ne-hematološka toksičnost stopnje ≥ 3
English: For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
Slovenian: Za dodatne informacije o melfalanu in prednizonu, glejte ustrezna Povzetka glavnih značilnosti zdravila.
English: The incidence of herpes zoster among patients in the VcR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Slovenian: Pogostnost virusa herpes zoster v skupini VcR-CAP je bila 10,7% pri bolnikih, ki niso prejemali protivirusnih zdravil, pri bolnikih, ki so prejemali protivirusna zdravila pa 3,6% (glejte poglavje 4.4).
English: If you are given VELCADE together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
Slovenian: Če prejemate zdravilo VELCADE skupaj z drugimi zdravili za zdravljenje limfoma plaščnih celic, se lahko pri vas pojavijo naslednji neželeni učinki:
English: If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se rekonstituirane raztopine ne uporabi takoj, je za rok uporabe in pogoje shranjevanja po pripravi odgovoren uporabnik.
English: • Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
Slovenian: • okužbe, vključno z okužbo sečil, gripa, okužba s herpes virusom, ušesne okužbe in celulitis
English: • Yellow discolouration of eyes and skin (jaundice)
Slovenian: • rumeno obarvanje beločnic ali kože (zlatenica)
English: Injection sites should be rotated for successive injections.
Slovenian: Mesta injiciranja je treba med zaporednimi injiciranji menjavati..
English: Vc=VELCADE; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Slovenian: Vc = VELCADE; Dex = deksametazon CR = popolni odgovor; nCR = skoraj popolni odgovor PR = delni odgovor; MR = minimalni odgovor
English: Dexamethasone was administered in combination with VELCADE to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of VELCADE retreatment cycles.
Slovenian: V 1. krogu zdravljenja je skupaj z zdravilom VELCADE prejemalo deksametazon 83 bolnikov, v nadaljnjih krogih zdravljenja z zdravilom VELCADE pa še dodatnih 11 bolnikov.
English: Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Slovenian: Redki meningitis (vključno z bakterijskim), okužba z virusom EpsteinBarr, genitalni herpes, tonzilitis, mastoiditis, post virusni sindrom utrujenosti
English: What VELCADE contains - The active substance is bortezomib.
Slovenian: Kaj vsebuje zdravilo VELCADE - Učinkovina je bortezomib.
English: 12.8 mo
Slovenian: 12,8 mesecev
English: • Swelling of body, to include around eyes and other parts of the body
Slovenian: • otekanje telesa, vključno z otekanjem okoli oči in ostalih delov telesa
English: • memory loss, trouble thinking, difficulty with walking or loss of vision.
Slovenian: • doživite izgubo spomina, imate težave z mišljenjem, s hojo ali se vam poslabša vid.
English: N=240 (ITT population) N=242 (ITT population)
Slovenian: n = 240 (ITT populacija) n = 242 (ITT populacija)
English: • Inflammation of the lining around your heart or fluid around your heart
Slovenian: • vnetje srčne ovojnice ali nabiranje tekočine okoli srca
English: An effective re-induction multi-agent chemotherapy regimen was administered in 3 blocks.
Slovenian: Bolnikom so ponovno uvedli učinkovito indukcijsko kemoterapijo z več zdravili v 3 sklopih.
English: VELCADE must be reconstituted by a healthcare professional.
Slovenian: Zdravilo VELCADE mora rekonstituirati zdravstveno osebje.
English: Rash*, Pruritus*, Erythema, Dry skin
Slovenian: Pogosti izpuščaj*, srbenje*, eritem, suha koža
English: Patients receiving VELCADE in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Slovenian: Bolniki, ki prejemajo zdravilo VELCADE v kombinaciji s talidomidom morajo upoštevati program preprečevanja nosečnosti, kot je predpisan pri talidomidu.
English: All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively.
Slovenian: Periferno nevropatijo (vseh stopenj) so opazili pri 40%, periferno nevropatijo stopnje ≥ 3 pa pri 8,5% bolnikov.
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the VcR-CAP arm.
Slovenian: V VcR-CAP kraku študije je protivirusna zdravila prejelo 137 od 240 bolnikov (57%).
English: Post-marketing adverse reactions not seen in clinical trials are also included.
Slovenian: Vključuje neželene učinke v obdobju trženja, ki se v kliničnih študijah niso pojavili.
English: Note: An OR > 1 indicates an advantage for Vc-containing induction therapy.
Slovenian: Opomba: OR > 1 kaže na prednost uvajalnega zdravljenja z Vc.
English: Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
Slovenian: Opazne razlike v populaciji bolnikov z MCL v primerjavi z bolniki v študijah diseminiranega plazmocitoma so bile ≥ 5% večja pojavnost hematoloških neželenih učinkov (nevtropenija, trombocitopenija, levkopenija, anemija, limfopenija), periferna senzorična nevropatija, hipertenzija, zvečana telesna temperatura, pljučnica, stomatitis in bolezni las.
English: • Inflammation of the spinal nerve
Slovenian: • vnetje hrbtenjačnega živca
English: In study IFM-2005-01 VELCADE combined with dexamethasone [VcDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Slovenian: V študiji IFM-2005-01 so primerjali kombinacijo zdravila VELCADE in deksametazona [VcDx, n = 240] s kombinacijo vinkristin-doksorubicin-deksametazon VDDx, n = 242].
English: Withhold VELCADE treatment until symptoms of toxicity have resolved.
Slovenian: prekinite zdravljenje z zdravilom VELCADE, dokler ne minejo znaki toksičnosti.
English: Based on Log rank test stratified with IPI risk and stage of disease.
Slovenian: Na osnovi Log rank testa, stratificiranega z IPI tveganjem in stopnjo bolezni.
English: • A severe reversible brain condition which includes seizures, high blood pressure, headaches,
Slovenian: • hudo reverzibilno stanje možganov s krči, visokim krvnim tlakom, glavoboli, utrujenostjo,
English: • Injection sites should be rotated for successive injections.
Slovenian: • Mesta injiciranja je treba med zaporednimi injiciranji menjavati..
English: • Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion), red and swollen eyelids, discharge from the eyes, abnormal vision,
Slovenian: • draženje ali vnetje oči, prekomerno solzne oči, boleče oči, suhe oči, okužbe oči, zatrdlina na veki (halazij), rdeče in otekle veke, izcedek iz oči, motnje vida, krvavitve v očesu
English: VELCADE dose should be reduced by 1 dose level (from 1.3 mg/m 2 to 1 mg/m 2, or from
Slovenian: Odmerek zdravila VELCADE je treba zmanjšati za 1 stopnjo (z 1,3 mg/m 2 na 1 mg/m 2 ali z
English: Table 16: Efficacy results from study LYM-3002
Slovenian: Preglednica 16: Rezultati učinkovitosti zdravila v študiji LYM-3002
English: There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving VELCADE (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo VELCADE so redko poročali o akutni difuzni infiltracijski pljučni bolezni neznane etiologije, kot je pnevmonitis, intersticijska pljučnica, infiltracija pljuč in sindrom akutne respiratorne stiske (SARS) (glejte poglavje 4.8).
English: • Increased heartbeat, high blood pressure, sweating,
Slovenian: • zvišan srčni utrip, visok krvni tlak, potenje
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and VcDx groups respectively; the majority of patients underwent one single transplant procedure.
Slovenian: Avtologno presaditev krvotvornih matičnih celic so opravili pri 198 (82%) bolnikih v skupini VDDx in 208 (87%) bolnikih v skupini VcDx.
English: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Slovenian: Pri bolnikih z diseminiranim plazmocitomom se po intravenski bolusni ali subkutani injekciji pri odmerku 1,3 mg/m2 (n = 14 pri intravenski in n = 17 pri subkutani skupini) je bila skupna sistemska izpostavljenost po ponovljenem odmerku (AUCzadnji) ekvivalentna pri subkutanem in intravenskem dajanju.
English: Aseptic technique must be strictly observed throughout the handling of VELCADE, since it contains no preservative.
Slovenian: MED RAVNANJEM Z ZDRAVILOM VELCADE MORATE VES ČAS STROGO UPOŠTEVATI ASEPTIČNO PRIPRAVO, SAJ ZDRAVILO NE VSEBUJE KONZERVANSA.
English: If any discolouration or particulate matter is observed, the solution should be discarded.
Slovenian: Če opazite kakršnokoli spremembo barve ali delce v raztopini, jo morate zavreči.
English: • Induction Transplant Regimens Graph.
Slovenian: • Diagram režima uvajanja pred transplantacijo
English: Common Sleep disorders and disturbances*
Slovenian: Pogosti motnje spanja*
English: • 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 VELCADE dose.
Slovenian: • 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 VELCADE.
English: Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Slovenian: Bolnike, ki imajo nevropatično bolečino in/ali periferno nevropatijo, povezano z jemanjem bortezomiba, zdravite v skladu s preglednico 1 (glejte poglavje 4.4).
English: The median number of cycles received for both groups was 4 cycles.
Slovenian: so Mediano število krogov zdravljenja je bilo 4 v obeh skupinah.
English: VELCADE should not be given by other routes.
Slovenian: Zdravilo VELCADE se ne sme dajati po nobeni drugi poti.
English: Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
Slovenian: Bolniki, ki so imeli na začetku študije stopnjo periferne nevropatije ≥ 2 ali število trombocitov < 50,000/µl, so bili izključeni.
English: The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for
Slovenian: Bolniki v obeh skupinah so na splošno imeli podobne demografske in bolezenske značilnosti: mediana starost bolnikov je bila 66 let, 74% je bilo moških, 66% je bilo belcev in 32% azijcev, 69% bolnikov je imelo pozitivno aspiracijo kostnega mozga in/ali pozitivno biopsijo kostnega mozga za MCL, 54%
English: A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone group.
Slovenian: Opazili so statistično značilno razliko v Cr+nCR v prid skupine, ki je prejemala zdravilo VELCADE in deksametazon.
English: Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Slovenian: Uporabljena je Mantel-Haenszelova ocena razmerja verjetnosti za stratificirane preglednice, skupaj s stratifikacijskima dejavnikoma IPI tveganjem in stopnjo bolezni.
English: Reduce VELCADE to 0.7 mg/m2 in the first treatment cycle.
Slovenian: Zmanjšati odmerek zdravila VELCADE v prvem krogu zdravljenja na 0,7 mg/m2.
English: When toxicity resolves re-initiate VELCADE treatment and reduce dose to 0.7 mg/m2 once per week.
Slovenian: Nato ponovno uvedite zdravljenje z zdravilom VELCADE in zmanjšajte odmerek na 0,7 mg/m enkrat na teden.
English: 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*
Slovenian: Redki nenormalne koncentracije plinov v krvi*, nenormalen elektrokardiogram (vključno z podaljšanjem QT intervala)*, nenormalno mednarodno umerjeno razmerje*, znižan pH v želodcu, zvečana agregacija trombocitov, zvišana koncentracija troponina I, identifikacija in serologija virusov*, nenormalni izvidi analize urina*
English: VELCADE treatment must be withheld at the onset of any ≥ Grade 3 VELCADE-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section 4.4).
Slovenian: Zdravljenje z zdravilom VELCADE je treba prekiniti ob pojavu katere koli z uporabo zdravila VELCADE povezane ne-hematološke toksičnosti stopnje ≥ 3 (razen nevropatije) ali hematološke toksičnosti stopnje ≥ 3 (glejte tudi poglavje 4.4).
English: Type 1 glass 5 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a green cap containing 1 mg bortezomib.
Slovenian: 5 ml, steklena viala, steklo tipa I, s sivim zamaškom iz bromobutilne gume in aluminijasto zaporko z zelenim pokrovčkom, ki vsebuje 1 mg bortezomiba.
English: The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m
Slovenian: Vpliv jetrne okvare na farmakokinetiko bortezomiba v odmerkih od 0,5 do 1,3 mg/m2 so ocenjevali v študiji faze I med prvim ciklom zdravljenja, ki je vključevala 61 bolnikov s primarno solidnimi tumorji in različnimi stopnjami jetrne okvare.
English: Hypotension*, Orthostatic hypotension, Hypertension*
Slovenian: Pogosti hipotenzija*, ortostatska hipotenzija, hipertenzija*
English: For additional information concerning pegylated liposomal doxorubicin, see the corresponding Summary of Product Characteristics.
Slovenian: Za dodatne informacije o pegiliranem liposomskem doksorubicinu glejte Povzetek glavnih značilnosti tega zdravila.
English: EBMT criteria All randomised patients with secretory disease * Survival update based on a median duration of follow-up at 60.1 months mo: months
Slovenian: Vsi randomizirani bolniki s sekrecijsko boleznijo preživetje na osnovi podatkov po 60,1 mesecih spremljanja CI = interval zaupanja
English: Based on animal studies, the penetration of bortezomib through the blood-brain barrier appears to be limited, if any and the relevance to humans is unknown.
Slovenian: Na osnovi rezultatov raziskav na živalih je prehajanje bortezomiba preko hematoencefalne bariere omejeno oz. zanemarljivo.
English: Modification of starting dose
Slovenian: Prilagoditev odmerjanja