FrancophonIA/ELRC3.0 huggingface dataset:
English: This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Slovenian: Vmesna analiza je pokazala zmanjšanje tveganja za TTP za 45 % (95 % CI; od 29 do 57 %, p < 0,0001) pri bolnikih, ki so prejemali kombinirano terapijo z bortezomibom in pegiliranim liposomskim doksorubicinom.
English: - When Bortezomib SUN is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Slovenian: - Če uporabljate zdravilo Bortezomib SUN skupaj s talidomidom in deksametazonom, traja en krog zdravljenja 28 dni (4 tedne).
English: Phase II
Slovenian: Faza II
English: If a diagnosis of PML is suspected, patients should be referred to a specialist in PML and appropriate diagnostic measures for PML should be initiated.
Slovenian: V primeru suma na PML je treba bolnika napotiti k specialistu in opraviti ustrezne diagnostične teste.
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for bortezomib the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing bortezomib is unchanged subject to the proposed changes to the product information.
Slovenian: Podlaga za priporočilo spremembe pogojev dovoljenj(-a) za promet z zdravilom Na podlagi znanstvenih zaključkov za bortezomib odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo bortezomib ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: 56.4 mo
Slovenian: 56,4 meseca
English: Thalidomide causes birth defects and foetal death.
Slovenian: Talidomid povzroča prirojene poškodbe in smrt ploda.
English: h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Slovenian: h Vključuje vse radiološke diagnostične metode CR+CRu+PR po IRC, ne glede na preverjanje kostnega mozga in LDL.
English: - Inject the solution subcutaneously, under a 45-90°angle.
Slovenian: - Raztopino injicirajte subkutano, pod kotom 45-90°.
English: Median survival for the Bzmb+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Slovenian: Mediana preživetja v skupini Bzmb+M+P je bila 56,4 meseca, v skupini M+P pa 43,1 meseca.
English: Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median hemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l.
Slovenian: Bolniki so imeli plazmocitom IgG/IgA/lahke verige v 63 %/25 %/8 % primerov, mediano koncentracijo hemoglobina 105 g/l in mediano število trombocitov 221,5 x 109/l.
English: A minority of patients with orthostatic hypotension experienced syncopal events.
Slovenian: Manjši del bolnikov z ortostatsko hipotenzijo je imelo sinkope.
English: Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Slovenian: Odmerjanje pri zdravljenju diseminiranega plazmocitoma (bolniki, ki so pred tem že prejeli vsaj eno vrsto terapije)
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and
Slovenian: V primeru prevelikega odmerka bortezomiba je treba spremljati bolnikove vitalne znake in uvesti ustrezne podporne ukrepe za vzdrževanje krvnega tlaka (npr.: tekočine, učinkovine, ki zvišujejo krvni tlak, in/ali inotropne učinkovine) in telesne temperature
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 rekonstituirana raztopina ne porabi takoj, je za čas in pogoje shranjevanja zdravila po rekonstituciji odgovoren uporabnik.
English: Patients with renal impairment should be monitored closely (see sections 4.2 and 5.2).
Slovenian: Bolnike z motenim delovanjem ledvic je treba skrbno spremljati (glejte poglavji 4.2 in 5.2).
English: 10 ml Type 1 tubular colourless glass vial with a grey bromobutyl rubber stopper, sealed with a light green flip off aluminium seal containing 3.5 mg bortezomib.
Slovenian: 10 ml cevasta viala iz brezbarvnega stekla tipa 1 s sivim bromobutilnim gumijastim zamaškom, zaprta s svetlo zeleno dvižno aluminijasto zaporko, ki vsebuje 3,5 mg bortezomiba.
English: Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Slovenian: Sekundarna ocena učinkovitosti je zajemala stopnje odziva po presaditvi (CR+nCR, CR+nCR+VGPR+PR), čas preživetja brez napredovanja bolezni in celokupni čas preživetja.
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
English: Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Slovenian: Na podlagi majhnega deleža (7 %) encima CYP2D6 pri presnovi bortezomiba ni pričakovati, da bi fenotip slabe presnove s CYP2D6 vplival na skupno izločanje bortezomiba.
English: The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Slovenian: Po ponavljajočih se odmerkih je bil razpon razpolovnih časov (t1/2) bortezomiba 40-193 ur.
English: Antiviral prophylaxis should be considered.
Slovenian: Razmisliti je treba o protivirusnem zdravljenju.
English: Uncommon side effects (may affect up to 1 in 100 people) - hepatitis - severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing,
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - vnetje jeter (hepatitis) - znaki hude alergijske reakcije (anafilaktična reakcija), ki lahko vključujejo oteženo dihanje,
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Slovenian: Pri sočasni uporabi s talidomidom je potrebna posebna pozornost pri preverjanju nosečnosti in ukrepih za preprečevanje nosečnosti (glejte poglavje 4.6).
English: The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Slovenian: Primarna ocena učinkovitosti je bila stopnja odziva po uvedbi (Cr+nCR).
English: TTP, days [95% CI]
Slovenian: TTP, meseci (95 % CI)
English: Patients with mild hepatic impairment do not require a dose adjustment and should be treated per the recommended dose.
Slovenian: Pri bolnikih z blago jetrno okvaro ni treba prilagajati odmerka, treba jih je zdraviti s priporočenim odmerkom.
English: Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Slovenian: Za neželene učinke, navedene v preglednici 7, so raziskovalci menili, da imajo vsaj možno do verjetno vzročno povezavo z bortezomibom.
English: - Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
Slovenian: - Raztopino injicirajte v obliki 3-5 sekund trajajoče bolusne intravenske injekcije skozi periferno ali centralno intravensko cevko v veno.
English: The following medicinal products are given on day 1 of each Bortezomib SUN 21-day treatment cycle as intravenous infusions:
Slovenian: Naslednja zdravila boste prejeli 1. dan vsakega 21-dnevnega kroga zdravljenja z zdravilom Bortezomib SUN v obliki intravenske infuzije:
English: Other reported hepatic reactions include increases in liver enzymes, hyperbilirubinaemia, and hepatitis.
Slovenian: Poročali so tudi o povišanju vrednosti jetrnih encimov, hiperbilirubinemiji in hepatitisu.
English: • Induction Transplant Regimens Graph The Reconstitution, dosing and administration booklet shall contain the following key elements:
Slovenian: • Diagram režima uvajanja pred transplantacijo Izobraževalna knjižica z navodili za rekonstitucijo, odmerjanje in načinom uporabe mora vsebovati naslednje ključne elemente:
English: - Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
Slovenian: - Izperite periferni ali intravenski kateter s sterilno raztopino 9 mg/ml (0,9 %) natrijevega klorida.
English: Male and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Slovenian: Moški in ženske v rodni dobi morajo uporabljati ustrezno kontracepcijsko metodo med zdravljenjem in še 3 mesece po njem.
English: All these target organs have shown partial to full recovery following discontinuation of treatment.
Slovenian: Po ukinitvi zdravljenja so ugotavljali delno do popolno okrevanje vseh navedenih tarčnih organov.
English: 19.9 mo
Slovenian: 19,9 meseca
English: What Bortezomib SUN is and what it is used for What you need to know before you are given Bortezomib SUN How to use Bortezomib SUN
Slovenian: Kaj je zdravilo Bortezomib SUN in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Bortezomib SUN Kako uporabljati zdravilo Bortezomib SUN
English: The European Medicines Agency has waived the obligation to submit the results of studies with bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov z bortezomibom za vse skupine pediatrične populacije za indikacijo diseminiranega plazmocitoma in limfoma plaščnih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The concentration of the resulting solution will be 1 mg/ml.
Slovenian: Koncentracija dobljene raztopine je 1 mg/ml.
English: Median PFS by investigator assessment was 30.7 months in the BzmbR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Slovenian: Mediana PFS po oceni raziskovalca je bila 30,7 meseca v skupini BzmbR-CAP in 16,1 meseca v skupini R-CHOP (razmerje tveganja [HR]=0,51; p < 0,001).
English: Instructions for reconstitution Bortezomib SUN must be reconstituted by a healthcare professional.
Slovenian: Navodila za rekonstitucijo Zdravilo Bortezomib SUN mora rekonstituirati zdravstveno osebje.
English: Patients achieving a response or a stable disease after 4 cycles of this combination therapy can continue to receive the same combination for a maximum of 4 additional cycles.
Slovenian: Bolniki, ki prejemajo kombinirano zdravljenje in po 4 krogih zdravljenja dosežejo odziv ali so stabilni, lahko prejmejo enako zdravljenje še največ 4 dodatne kroge.
English: It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
Slovenian: Priporočamo, da bolnike skrbno spremljate in ugotavljate simptome nevropatije, npr. pekoč občutek, hiperestezijo, hipestezijo, parestezijo, neprijeten občutek, nevropatično bolečino ali oslabelost.
English: d Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
Slovenian: d Log-rank test, prilagojen na podlagi stratifikacijskih faktorjev: ISS-razvrstitvi in številu predhodnih zdravljenj.
English: In patients aged ≥ 75 years, both regimens, BzmbR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Slovenian: Bolniki, stari ≥ 75 let, so slabše prenašali oba režima zdravljenja, BzmbR-CAP in R-CHOP (glejte poglavje 4.8).
English: Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with bortezomib alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after bortezomib administration.
Slovenian: Bolniki, ki niso dosegli optimalnega odziva (manj kot popolni odziv [CR]) na zdravljenje z bortezomibom v monoterapiji po 4 krogih zdravljenja, so prejeli 20 mg deksametazona na dan brez zdravila in po dajanju bortezomiba.
English: Secondary efficacy endpoints included Progression Free Survival and Overall Survival.
Slovenian: Sekundarna ocena učinkovitosti je vključevala rezultate časa preživetja brez napredovanja bolezni in celokupni čas preživetja.
English: Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells and MCL cells, the complications of tumour lysis syndrome may occur.
Slovenian: Bortezomib je citotoksična učinkovina in lahko hitro uniči maligne plazemske in MCL-celice, zato lahko povzroči zaplete sindroma razpada tumorja.
English: A statistically significant survival benefit in favour of the Bzmb+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Slovenian: Pri bolnikih v skupini Bzmb+M+P so opazili statistično značilno izboljšanje preživetja (HR (Hazard Ratio - razmerje tveganja)=0,695; p=0,00043), kljub poznejšim terapijam, vključno s terapijo z bortezomibom.
English: By interfering with their function, bortezomib can kill cancer cells.
Slovenian: Z zaviranjem njihovega delovanja lahko bortezomib uniči rakave celice.
English: The overall best response rate (CR + PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1, 47.4).
Slovenian: Pri 130 bolnikih je bila celokupna stopnja odgovora (CR+PR) 38,5% (95% CI: 30,1; 47,4).
English: Table 13: Efficacy results from study MMY-3010 Endpoints
Slovenian: Preglednica 13: rezultati učinkovitosti študije MMY-3010 Ocena učinkovitosti
English: Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Slovenian: Preverite in zagotovite pravilni odmerek za intravensko dajanje zdravila (1 mg/ml).
English: Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Slovenian: Razvrstitev po 2. različici enotnih meril toksičnosti za vrednotenje neželenih učinkov nacionalnega onkološkega inštituta (NCI Common Toxicity Criteria CTCAE v 4.0).
English: Haematological toxicity - ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μl
Slovenian: Toksični učinki na hematološki sistem - nevtropenija z zvečano telesno temperaturo stopnje ≥ 3, nevtropenija 4. stopnje, ki traja več kot 7 dni, število trombocitov < 10.000 celic/μl
English: Median
Slovenian: mediana
English: The concentration of the resulting solution will be 2.5 mg/ml.
Slovenian: Koncentracija dobljene raztopine je 2,5 mg/ml.
English: Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group.
Slovenian: Incidenca smrti zaradi napredovanja bolezni je bila v subkutani skupini 18 % in v intravenski skupini
English: Orthostatic/postural hypotension was not acutely related to bolus infusion of bortezomib.
Slovenian: Ortostatska oz. posturalna hipotenzija ni bila akutno povezana z bolusno infuzijo bortezomiba.
English: - If, after Bortezomib SUN has been held, the toxicity does not resolve, as defined above, then Bortezomib SUN must be discontinued.
Slovenian: - Če po prekinitvi zdravljenja z zdravilom Bortezomib SUN toksičnost ne mine, kot je opisano zgoraj, je treba zdravljenje z zdravilom Bortezomib SUN ukiniti.
English: In myeloma, bortezomib affects the ability of myeloma cells to interact with the bone marrow microenvironment.
Slovenian: Pri plazmocitomu bortezomib vpliva na sposobnost plazmocitomskih celic za interakcijo z mikrookoljem kostnega mozga.
English: • to remind that patients receiving Bortezomib SUN in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
Slovenian: • Bolnike, ki prejemajo zdravilo Bortezomib SUN v kombinaciji s talidomidom je treba opozoriti, da morajo upoštevati program preprečevanja nosečnosti kot je predpisan za talidomid, s sklicem na SmPC za talidomid za pridobitev dodatnih informacij.
English: Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Slovenian: Preglednica 16: Rezultati učinkovitosti zdravila v študiji LYM-3002 Učinkovitost
English: Bortezomib SUN should not be given by other routes.
Slovenian: Zdravilo Bortezomib SUN se ne sme dajati po nobeni drugi poti.
English: - a severe reversible brain condition which includes seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems.
Slovenian: - hudo reverzibilno stanje možganov s krči, visokim krvnim tlakom, glavoboli, utrujenostjo, zmedenestjo, slepoto in drugimi težavami z vidom.
English: Post-marketing adverse reactions not seen in clinical trials are also included.
Slovenian: Vključuje tudi neželene učinke v obdobju trženja, ki se v kliničnih študijah niso pojavili.
English: Melphalan (9 mg/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Slovenian: Melfalan (9 mg/m2) in prednizon 60 mg/m2) se dajeta peroralno na 1., 2., 3., in 4. dan prvega tedna vsakega kroga zdravljenja.
English: • storage precautions for reconstituted solution
Slovenian: • Pogoje shranjevanja rekonstituirane raztopine.
English: Surgical and medical procedures
Slovenian: Kirurški in drugi medicinski posegi
English: The duration of overall response was 21.4 months longer in the BzmbR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Slovenian: Trajanje celokupnega odziva je bilo za 21,4 meseca daljše v skupini BzmbR-CAP (mediana 36,5 meseca proti 15,1 meseca v skupini R-CHOP).
English: Patients in the BzmbTDx 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 BzmbTDx 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: Following a review of post-marketing cases and literature reports for the period covered by this PSUR, 158 cases of “Lid, lash and lacrimal infections, irritations and inflammations” were retrieved in patients who received bortezomib.
Slovenian: Po pregledu primerov v obdobju trženja zdravila in poročil iz literature v obdobju, ki ga pokriva zadevni PSUR, so pri bolnikih, ki so prejemali bortezomib odkrili 158 primerov okužbe vek, trepalnic in lakrimalnih okužb, draženj in vnetij.
English: The major metabolic pathway is deboronation to form two deboronated metabolites that subsequently undergo hydroxylation to several metabolites.
Slovenian: Najpomembnejša pot presnove je odcepitev bora, pri čemer nastaneta dva presnovka, ki se nato hidroksilirata do številnih presnovkov.
English: A statistically significant benefit (p < 0.001) in favour of the BzmbR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Slovenian: (p < 0,001) v skupini BzmbR-CAP v primerjavi s skupino R-CHOP za TTP (mediana 30,5 proti 16,1 meseca), TNT (mediana 44,5 proti 24,8 meseca) in TFI (mediana 40,6 proti 20,5 meseca).
English: Patients who had received 2 to 3 prior therapeutic regimens had a response rate of 32% (10/32) and patients who received greater than 7 prior therapeutic regimens had a response rate of 31% (21/67).
Slovenian: Bolniki, ki so prejeli 2 do 3 predhodne vrste zdravljenj, so imeli stopnjo odziva 32 % (10/32).
English: Cases of ileus have been uncommonly reported (see section 4.8).
Slovenian: Občasno so poročali o primerih zapore črevesja (glejte poglavje 4.8).
English: In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BzmbR-CAP arm and 61% of patients in the R-CHOP arm.
Slovenian: V študiji LYM-3002 je podporno zdravljenje s kolonije spodbujajočimi faktorji prejelo 78 % bolnikov v skupini BzmbR-CAP in 61 % bolnikov v skupini R-CHOP.
English: This medicine is for intravenous or subcutaneous use.
Slovenian: To zdravilo se uporablja intravensko ali subkutano.
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
Slovenian: Preglednica 10: Pojavnost periferne nevropatije v študiji LYM-3002 glede na stopnjo toksičnosti in prekinitev zdravljenja zaradi periferne nevropatije
English: Fertility Fertility studies were not conducted with bortezomib (see section 5.3).
Slovenian: Študije plodnosti pri uporabi bortezomiba niso bile izvedene (glejte poglavje 5.3).
English: - The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Slovenian: - Rekonstituirano raztopino injiciramo subkutano v stegno (desno ali levo) ali trebuh (desno ali levo).
English: The solution should be injected subcutaneously, at a 45-90° angle.
Slovenian: Raztopino morate injicirati subkutano, pod kotom 45-90°.
English: The fraction of bortezomib bound to plasma proteins was not concentration-dependent.
Slovenian: Delež bortezomiba, vezanega na plazemske beljakovine, ni bil odvisen od koncentracije zdravila.
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).
Slovenian: Če jemljete talidomid, morate biti še posebej pozorni na zahteve po testiranju in preprečevanju nosečnosti (glejte poglavje Nosečnost in dojenje).
English: Animal studies to determine the effects of bortezomib on parturition and post-natal development were not conducted (see section 5.3).
Slovenian: Študije na živalih za ugotavljanje učinkov bortezomiba na porod in postnatalni razvoj niso bile opravljene (glejte poglavje 5.3).
English: Bortezomib SUN therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μl and a platelet count ≥ 25,000 cells/μl.
Slovenian: Zdravljenje z zdravilom Bortezomib SUN je treba prekiniti za največ 2 tedna, dokler nima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl.
English: Table 12: Efficacy results from study IFM-2005-01 Endpoints
Slovenian: Preglednica 12: rezultati učinkovitosti študije IFM-2005-01 Ocena učinkovitosti
English: In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Slovenian: Raziskave in vitro kažejo, da je bortezomib šibek zaviralec izoencimov citokroma P450 (CYP) 1A2, 2C9, 2C19, 2D6 in 3A4.
English: Therefore, patients who experience constipation should be closely monitored.
Slovenian: Zato je treba bolnike z zaprtostjo skrbno spremljati.
English: Most patients required treatment for their orthostatic hypotension.
Slovenian: Pri večini bolnikov so zdravili ortostatsko hipotenzijo.
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BzmbR-CAP group and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BzmbR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
Slovenian: V obeh skupinah pa je bila podobna celokupna pojavnost krvavitev vseh stopenj (6,3% v BzmbR-CAP in 5,0% v R-CHOP) in krvavitev stopnje 3 ali več (BzmbR-CAP: 4 bolniki [1,7%]; R-CHOP: 3 bolniki [1.2%]).
English: For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Slovenian: Bolniki, ki so dosegli odziv šele v 6. krogu, so prejeli dva dodatna kroga zdravljenja.
English: Be sure that the correct dose is being given for the subcutaneous route of administration (2.5 mg/ml).
Slovenian: Preverite in zagotovite pravilni odmerek za subkutano dajanje zdravila (2,5 mg/ml).