FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
Slovenian: Progresivna multifokalna levkoencefalopatija (PML) Pri bolnikih, zdravljenih z bortezomibom, so poročali o zelo redkih primerih okužbe z JC virusom (John Cunningham virus), z neznano vzročno povezavo, ki je vodila v PML in smrt.
English: Based on Log rank test stratified with IPI risk and stage of disease.
Slovenian: d Na osnovi Log-rank testa, stratificiranega z IPI tveganjem in stopnjo bolezni.
English: Each carton of 1 mg Bortezomib Hospira contains a glass 5 ml siliconised vial with a rubber stopper and an aluminium seal.
Slovenian: Ena škatla zdravila Bortezomib Hospira 1 mg vsebuje stekleno 5 ml silikonizirano vialo z gumijastim zamaškom in aluminijasto zaporko.
English: Bortezomib is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Slovenian: Bortezomib boste prejeli v veno ali v podkožje na 1., 4., 8. in 11. dan, temu pa bo sledil premor brez zdravljenja.
English: Common Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache*
Slovenian: Pogosti motorična nevropatija*, izguba zavesti (vključno s sinkopo), omotica*, disgevzija*, letargija, glavobol*
English: Pegylated liposomal doxorubicin is administered at 30 mg/m² on day 4 of the Bortezomib Hospira treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib Hospira injection.
Slovenian: Pegilirani liposomski doksorubicin se daje v obliki 1-urne intravenske infuzije v odmerku 30 mg/m² na 4. dan cikla zdravljenja, po injiciranju zdravila Bortezomib Hospira.
English: Bortezomib Hospira may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Slovenian: Uporaba zdravila Bortezomib Hospira je lahko povezana z utrujenostjo (zelo pogosto), omotico (pogosto), sinkopami (občasno) in ortostatsko oz. posturalno hipotenzijo ali zamegljenim vidom (pogosto).
English: Therefore, caution should be used during handling and preparation of Bortezomib Hospira.
Slovenian: Bortezomib je citotoksičen, zato je potrebna previdnost med njegovo pripravo in ravnanjem z zdravilom Bortezomib Hospira.
English: In B-ALL patients with relapse within 18 months of diagnosis (n = 27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62).
Slovenian: Pri bolnikih z B-celično ALL in ponovitvijo v manj kot 18 mesecih po diagnozi (n = 27) je bil delež popolnih odzivov 67 % (95 % IZ: 46, 84) in delež 4-mesečnega preživetja bolnikov brez dogodkov 44 % (95 % IZ: 26, 62).
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema, vezivnega tkiva in kosti
English: Bortezomib Hospira therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Slovenian: Zdravljenje z zdravilom Bortezomib Hospira je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 1. stopnjo ali stanje pred začetkom zdravljenja.
English: Patients were administered intravenous doses of 0.7 to 1.3 mg/m 2 of bortezomib twice weekly.
Slovenian: Bolniki so dvakrat na teden prejemali intravenske odmerke bortezomiba v odmerku od 0,7 do 1,3 mg/m2.
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, psihomotorična hiperaktivnost, kompresija hrbtenjače, kognitivna motnja NOS, motorične motnje, bolezni živčevja NOS, radikulitis, slinjenje, hipotonija
English: This 4-week period is considered a treatment cycle.
Slovenian: To 4-tedensko obdobje predstavlja en cikel zdravljenja.
English: #, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Slovenian: #, bronhospazem, kronična obstruktivna pljučna bolezen*, hipoksemija*, kongestija dihal*, hipoksija, plevritis*, kolcanje, izcedek iz nosu, disfonija, piskanje v pljučih
English: The reconstituted solution should be used immediately after preparation.
Slovenian: Rekonstituirano raztopino je treba uporabiti takoj po pripravi.
English: 1.2 Before administration, visually inspect the solution for particulate matter and discolouration.
Slovenian: Pred dajanjem raztopino preverite glede prisotnosti trdnih delcev in obarvanosti.
English: • Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots (usually on the legs) to large bruise-like patches under the skin or tissue
Slovenian: • vnetje ali krvavitev krvnih žil, ki se lahko kaže kot majhne rdeče ali vijolične pike
English: Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Slovenian: Klinična učinkovitost subkutanega dajanja bortezomiba bolnikom pri ponovitvi/diseminiranem plazmocitomu, odpornem na zdravljenje
English: Oedema (inc peripheral), Chills, Injection site reaction*, Malaise*
Slovenian: Pogosti edem (vključno s perifernim), mrazenje, reakcija na mestu injiciranja*, splošno slabo počutje*
English: In a drug-drug interaction study assessing the effect of omeprazole, a potent CYP2C19 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 17 patients.
Slovenian: V študiji medsebojnega delovanja zdravil, ki je ocenjevala učinek omeprazola, močnega zaviralca encima CYP2C19, na farmakokinetiko bortezomiba (danega intravensko), na osnovi podatkov 17 bolnikov, ni bilo pomembnega vpliva na farmakokinetiko bortezomiba.
English: Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy
Slovenian: Redki poškodba roženice*, eksoftalmus, retinitis, skotom, očesne bolezni (vključno z vekami) NOS, pridobljen dakrioadenitis, fotofobija, fotopsija, optična nevropatija
English: If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive bortezomib 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 bortezomib v veno ali v podkožje v kombinaciji z deksametazonom ali z deksametazonom in talidomidom.
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: If any discolouration or particulate matter is observed, the solution should be discarded.
Slovenian: Če opazite kakršnokoli obarvanost ali prisotnost trdnih delcev, raztopino zavrzite.
English: 1, 4, 8, and 11), and oral dexamethasone (40 mg/day on days 1 to 4 and days 9 to 12, in Cycles 1 and 2, and on days 1 to 4 in Cycles 3 and 4).
Slovenian: V vsakem ciklu so prejeli bortezomib (1,3 mg/m2 intravensko dvakrat na teden na 1., 4., 8. in 11. dan) in deksametazon (40 mg/dan, peroralno, 1. do 4. in 9. do 12. dan v 1. in 2. ciklu in 1. do 4. dan v 3. in 4. ciklu).
English: Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Slovenian: Presnovka, ki nastaneta po odcepitvi bora, ne delujeta kot zaviralca 26S proteasoma.
English: A 6-week period is considered a treatment cycle.
Slovenian: Šesttedensko obdobje predstavlja en cikel zdravljenja.
English: The incidence of herpes zoster among patients in the B+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Slovenian: V skupini, zdravljeni z B+M+P, je pri 17 % bolnikov, ki niso prejemali protivirusnih zdravil, prišlo do reaktivacije virusa herpes zoster, pri bolnikih, ki so prejemali protivirusna zdravila, pa je prišlo do reaktivacije virusa pri 3 % bolnikov.
English: Time to progression Events n (%) Median a (95% CI)
Slovenian: Čas do napredovanja bolezni dogodki n (%) mediana a (95 % IZ)
English: • Weight increase
Slovenian: • povečan tek
English: performance status, chromosome 13 deletion status, or the number or type of previous therapies.
Slovenian: Pri multivariantni analizi stopnja odziva ni bila odvisna od vrste plazmocitoma, stanja fizične zmogljivosti bolnika, napak na kromosomu 13 in števila ali vrste predhodnih zdravljenj.
English: • Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
Slovenian: • mišični krči, oslabelost mišic, bolečina v udih
English: Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
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 simpleks*
English: N=240 (ITT population)
Slovenian: n = 240 (ITT populacija) n = 242 (ITT populacija)
English: A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Slovenian: Opazili so statistično pomembno razliko v prid kombinaciji bortezomiba z deksametazonom in talidomidom.
English: When bortezomib is given together with dexamethasone, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib 21-day treatment cycle.
Slovenian: Če boste prejeli bortezomib skupaj z deksametazonom, boste prejeli bortezomib v veno ali v podkožje v 21-dnevnem ciklu zdravljenja in 40 mg deksametazona peroralno na 1., 2., 3., 4., 8., 9., 10. in 11. dan cikla zdravljenja z bortezomibom.
English: - in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation.
Slovenian: • v kombinaciji z melfalanom in prednizonom pri bolnikih, pri katerih bolezni še niso zdravili in pri njih kemoterapija v velikih odmerkih s presaditvijo krvotvornih matičnih celic ni primerna;
English: #, Deep vein thrombosis*, 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: Bortezomib Hospira 1 mg powder for solution for injection Bortezomib Hospira 2.5 mg powder for solution for injection Bortezomib Hospira 3 mg powder for solution for injection Bortezomib Hospira 3.5 mg powder for solution for injection bortezomib
Slovenian: Bortezomib Hospira 1 mg prašek za raztopino za injiciranje Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje Bortezomib Hospira 3 mg prašek za raztopino za injiciranje Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje bortezomib
English: If local injection site reactions occur following Bortezomib Hospira subcutaneous injection, either a less concentrated Bortezomib Hospira solution (Bortezomib Hospira to be reconstituted to 1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Slovenian: Če se po subkutanem injiciranju zdravila Bortezomib Hospira na mestu injiciranja pojavijo lokalne reakcije, se priporoča, da subkutano injicirate manj koncentrirano raztopino zdravila Bortezomib Hospira (1 mg/ml namesto 2,5 mg/ml) ali pa preidete na intravensko dajanje zdravila.
English: Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of the Bortezomib Hospira treatment cycle.
Slovenian: Deksametazon se jemlje peroralno v odmerku 20 mg na 1., 2., 4., 5., 8., 9., 11. in 12. dan v ciklu zdravljenja z zdravilom Bortezomib Hospira.
English: Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction*
Slovenian: Pogosti fibrilacija srca (vključno z atrijsko), aritmija*, srčno popuščanje (vključno s popuščanjem levega in desnega prekata)*, ishemija miokarda, motnja delovanja prekatov*
English: Common Renal impairment* Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakisuria
Slovenian: Občasni akutna odpoved ledvic, kronična odpoved ledvic*, okužba sečil*, znaki in simptomi bolezni sečil*, hematurija*, retenca urina, težave pri uriniranju*, proteinurija, azotemija, oligurija*, polakiurija
English: Each carton of 2.5 mg, 3 mg or 3.5 mg Bortezomib Hospira contains a glass 10 ml vial with a rubber stopper and an aluminium seal.
Slovenian: Ena škatla zdravila Bortezomib Hospira 2,5 mg, 3 mg ali 3,5 mg vsebuje stekleno 10 ml vialo z gumijastim zamaškom in aluminijasto zaporko.
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. cikla zdravljenja naprej na 200 mg na dan (glejte preglednico 4).
English: When bortezomib is given together with dexamethasone, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the bortezomib, 21-day treatment cycle.
Slovenian: Če boste prejeli bortezomib skupaj z deksametazonom, boste prejeli bortezomib v veno ali v podkožje v 21-dnevnem ciklu zdravljenja in 20 mg deksametazona peroralno na 1., 2., 4., 5., 8., 9., 11. in 12. dan cikla zdravljenja z bortezomibom.
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: The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Rekonstituirano raztopino je treba pred uporabo pregledati glede prisotnost trdnih delcev in obarvanosti.
English: • Feeling sick (nausea) or vomiting, loss of appetite
Slovenian: • slabost (navzea) ali bruhanje, izguba teka
English: Very Common Pyrexia*, Fatigue, Asthenia Common
Slovenian: Zelo pogosti pireksija*, utrujenost, astenija
English: Bortezomib Hospira IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Slovenian: Zdravilo Bortezomib Hospira je ZA SUBKUTANO ALI INTRAVENSKO UPORABO.
English: Bortezomib Hospira 1 mg powder for solution for injection Bortezomib Hospira 2.5 mg powder for solution for injection Bortezomib Hospira 3 mg powder for solution for injection Bortezomib Hospira 3.5 mg powder for solution for injection
Slovenian: Bortezomib Hospira 1 mg prašek za raztopino za injiciranje Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje Bortezomib Hospira 3 mg prašek za raztopino za injiciranje Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje
English: Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Slovenian: b Ocena razmerja ogroženosti na osnovi Coxovega modela, stratificirani z IPI tveganjem in stopnjo bolezni.
English: Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section
Slovenian: Če se zakasnitve ciklov zdravljenja ponavljajo, je treba razmisliti o profilaktični uporabi granulocitne kolonije spodbujajočih faktorjev (glejte poglavje 4.2).
English: Median c (95% CI) (months)
Slovenian: mediana c (95 % IZ) (meseci) 24,7 (19,8; 31,8) 14,4 (12; 16,9)
English: • advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
Slovenian: • Navodilo za zmanjšanje možnost zamenjave pripravljenih injekcijskih brizg za i.v.
English: Progression Free Survival, months (95% CI)
Slovenian: Preživetje brez napredovanja bolezni, meseci (95 % IZ) razmerje ogroženosti (95 % IZ) vrednost p
English: • Injection sites should be rotated for successive injections.
Slovenian: • Za uspešno injiciranje je treba mesta injiciranja menjati.
English: Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration.
Slovenian: Če se zakasnitve ciklov zdravljenja ponavljajo, je treba razmisliti o profilaktični uporabi granulocitne kolonije spodbujajočih faktorjev.
English: Bortezomib Hospira dose should be reduced by 1 dose level (from 1.3 mg/m to 1 mg/m 2, or from 1 mg/m 2 to
Slovenian: Odmerek zdravila Bortezomib Hospira je treba zmanjšati za 1 stopnjo (z 1,3 mg/m2 na
English: Pigmentation disorder*
Slovenian: Občasni pancitopenija*
English: Common 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 spremembe telesne temperature*, bolečina na mestu injiciranja*
English: This 3-week period is considered a treatment cycle.
Slovenian: To 3-tedensko obdobje predstavlja en cikel zdravljenja.
English: • shingles (localised including around the eyes or spread across the body)
Slovenian: • pasasti izpuščaj (lokaliziran, vključno s področjem okoli oči ali razširjen po telesu)
English: • Severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing,
Slovenian: bolečino ali tiščanje v prsih, in/ali omotico/omedlevico, hudo srbenje kože ali dvignjene bulice na koži, otekanje obraza, ustnic, jezika in/ali grla, kar lahko povzroči oteženo požiranje,
English: An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of bortezomib versus the intravenous administration.
Slovenian: V odprtem, randomiziranem preskušanju faze III pri dveh enakovrednih skupinah so primerjali učinkovitost in varnost subkutanega in intravenskega dajanja bortezomiba.
English: Patients with moderate or severe hepatic impairment should be started on Bortezomib Hospira at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m 2 or further dose reduction to 0.5 mg/m 2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Slovenian: Na osnovi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja odmerka na 1,0 mg/m 2 ali zmanjšanja odmerka na 0,5 mg/m 2 (glejte preglednico 6 ter poglavji 4.4 in 5.2).
English: 9/l or ANC ≤ 0.75 x Bortezomib Hospira therapy should be withheld • If platelet counts ≤ 30 x 10
Slovenian: 9/l ali ANC ≤ 0,75 x 10
English: CR+nCR+PR 121 (38)b 56 (18)
Slovenian: CR+ nCR + PR 121
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (including 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: Bortezomib will be administered by a health care professional experienced in the use of cytotoxic medicines.
Slovenian: Zdravilo Bortezomib Hospira pa lahko aplicira tudi zdravstveno osebje, ki ima izkušnje z zdravljenjem s kemoterapevtskimi učinkovinami.
English: • Lump in the eyelid (chalazion), red and swollen eyelids
Slovenian: • zatrdlina na veki (halazij), pordele in otekle veke
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate;
Slovenian: CR = popoln odziv; nCR = skoraj popoln odziv; PR = delni odziv; MR = minimalni odziv
English: Day 1, 2, 3, 4
Slovenian: Dan 1 Dan 2 Dan 3 Dan 4 -
English: OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p values by Cochran Mantel-Haenszel test.
Slovenian: * Primarni opazovani dogodek a OR za stopnje odziva na osnovi Mantel-Haenszelove ocene razmerja obetov za stratificirane preglednice;
English: In addition, the incidence of Grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
Slovenian: manjša, delež prekinitev zdravljenja zaradi perifernih nevropatij pa za 8 % manjši kot v skupini, ki je zdravilo prejemala intravensko.
English: Retreatment of patients with relapsed multiple myeloma In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%),
Slovenian: Ponovno zdravljenje bolnikov s ponovitvijo diseminiranega plazmocitoma V preskušanju, v katerem so z bortezomibom ponovno zdravili 130 bolnikov s ponovitvijo diseminiranega plazmocitoma, ki so imeli vsaj delni odziv na predhodno zdravljenje, ki je vključevalo bortezomib, so bili najpogostejši neželeni učinki vseh stopenj, ki so se pojavili pri najmanj 25 % bolnikov, trombocitopenija (55 %), nevropatija (40 %), anemija (37 %), diareja (35 %) in zaprtje (28 %).
English: If you are given Bortezomib for the treatment of multiple myeloma the side effects you may get are listed below:
Slovenian: Če prejemate zdravilo Bortezomib Hospira za zdravljenje diseminiranega plazmocitoma, se lahko pri vas pojavijo naslednji neželeni učinki:
English: • Non-haematological toxicities should have resolved to Grade 1 or baseline.
Slovenian: • se morajo nehematološke toksičnosti povrniti na 1. stopnjo ali na stanje pred začetkom zdravljenja.
English: Sleep disorders and disturbances*
Slovenian: Psihiatrične motnje Pogosti motnje spanja*