FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon Cardiac tamponade#, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
Slovenian: Občasni tamponada srca#, srčno-pljučni zastoj*, srčna fibrilacija (vključno z atrijsko), srčno popuščanje (vključno z levim in desnim prekatom)*, aritmija*, tahikardija*, palpitacije, angina pektoris, perikarditis (vključno s perikardialnim izlivom)*, kardiomiopatija*, disfunkcija prekata*, bradikardija
English: Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
Slovenian: V randomizirani, odprti študiji faze III, LYM-3002, so pri odraslih bolnikih s predhodno nezdravljenim MCL (stopnje II, III ali IV) primerjali učinkovitost in varnost bortezomiba v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (BzmbR-CAP; n=243) z zdravljenjem z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (R-CHOP; n=244).
English: N=240 (ITT population)
Slovenian: n=240 (ITT
English: You might receive up to 8 cycles (24 weeks).
Slovenian: Lahko boste prejeli do največ 8 krogov zdravljenja (24 tednov).
English: Bzmb=bortezomib; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Slovenian: CR=popolni odziv; nCR=skoraj popolni odziv PR=delni odziv; MR=minimalni odziv
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib SUN (both IV and SC use) required for different body surface areas.
Slovenian: • Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega zdravila Bortezomib SUN (za i.v.
English: Dosage adjustments for transplant eligible patients
Slovenian: Prilagoditev odmerjanja pri bolnikih, primernih za presaditev krvotvornih matičnih celic
English: Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise,
Slovenian: Nekatere vključujejo oteženo dihanje, zasoplost, zasoplost brez telesnega napora, dihanje, ki postane plitvo, oteženo ali preneha, sopenje
English: disease.
Slovenian: - smrt.
English: Therefore, caution should be used during handling and preparation.
Slovenian: Splošni previdnostni ukrepi Bortezomib je citotoksično zdravilo, zato je med pripravo in ravnanjem z njim potrebna previdnost.
English: You might receive up to 6 cycles (24 weeks).
Slovenian: Lahko boste prejeli do 6 krogov zdravljenja (24 tednov).
English: In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib.
Slovenian: V študiji faze III so imeli bolniki, ki so prejemali bortezomib subkutano, za 13 % manjšo celokupno incidenco neželenih učinkov zaradi uporabe zdravila s stopnjo toksičnosti 3 ali več in za 5 % manjšo pogostnost prekinitve zdravljenja v primerjavi z bolniki, ki so prejemali bortezomib intravensko.
English: Hair disorder*
Slovenian: Stopnja jetrne okvare*
English: Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Slovenian: Klinična učinkovitost subkutanega dajanja bortezomiba bolnikom pri relapsu/diseminiranem plazmocitomu, odpornem na zdravljenje
English: Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy.
Slovenian: Pri bolnikih, ki pred zdravljenjem niso imeli epileptičnih napadov ali epilepsije, so občasno poročali o epileptičnih napadih.
English: Bortezomib SUN is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Slovenian: Zdravilo Bortezomib SUN boste prejeli intravensko na 1., 4., 8. in 11. dan, temu pa bo sledil premor brez zdravljenja.
English: It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.
Slovenian: Izdelan je specifično za zaviranje kimotripsinske aktivnosti 26S
English: Table 6: Recommended starting dose modification for Bortezomib SUN in patients with hepatic impairment Grade of hepatic impairment*
Slovenian: Preglednica 6: Priporočena prilagoditev začetnega odmerka zdravila Bortezomib SUN pri bolnikih z boleznijo jeter
English: Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Slovenian: Zelo pogosti periferna senzorična nevropatija, disestezija*, nevralgija*
English: Also included are adverse drug reactions identified in the BzmbR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Slovenian: Vključeni so tudi neželeni učinki, ugotovljeni v skupini BzmbR-CAP, ki so na podlagi podatkov študij diseminiranega plazmocitoma in po mnenju raziskovalcev najmanj verjetno ali možno povezani z uporabo bortezomiba.
English: Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with BzmbR-CAP in a clinical trial
Slovenian: Preglednica 8: Neželeni učinki pri bolnikih z limfomom plaščnih celic, zdravljenih z BzmbR-CAP v kliničnih preskušanjih Organski sistem Pogostnost Neželeni učinek
English: Reduce Bortezomib SUN to 0.7 mg/m2 in the first treatment cycle.
Slovenian: Zmanjšati odmerek zdravila Bortezomib SUN v prvem krogu zdravljenja na 0,7 mg/m2.
English: At least 72 hours should elapse between consecutive doses of Bortezomib SUN.
Slovenian: Med zaporednimi odmerki zdravila Bortezomib SUN mora preteči vsaj 72 ur.
English: Bzmb (1.3 mg/m2) Day 1, 4
Slovenian: Bzmb (1,3 mg/m2) dan 1, 4
English: In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m2 weekly and 1.3 mg/m2 twice-weekly.
Slovenian: Pri analizi učinkovitosti, merjene s hematološkim odzivom (M-protein), pri 49 bolnikih, pri katerih je bila mogoča ocena in so prejemali največje dovoljene odmerke 1,6 mg/m2 na teden in 1,3 mg/m2 dvakrat na teden, je bila stopnja odziva 67,3 % (vključno z deležem CR 28,6 %).
English: Bortezomib SUN is for intravenous or subcutaneous use.
Slovenian: Zdravilo Bortezomib SUN je namenjeno za intravensko ali subkutano uporabo.
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bzmb=bortezomib; BzmbTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response;
Slovenian: CI= interval zaupanja; CR= popoln odziv; nCR= skoraj popoln odziv; ITT=populacija, ki so jo nameravali zdraviti; RR=stopnja odziva; Bzmb=bortezomib; BzmbTDx=bortezomib, talidomid in deksametazon; TDx=talidomid in deksametazon; PR=delni odziv; OR=razmerje obetov
English: Uncommon Angioedema#, Hypersensitivity* Rare
Slovenian: Občasni angioedem#, preobčutljivost*
English: • Bortezomib SUN 3.5 mg can be administered both intravenously and subcutaneously
Slovenian: • Zdravilo Bortezomib SUN 3,5 mg se lahko daje intravensko in subkutano.
English: BzmbR-CAP=bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Slovenian: BzmbR-CAP=bortezomib, rituksimab, ciklofosfamid, doksorubicin in prednizon; R-CHOP= rituksimab ciklofosfamid, doksorubicin, vinkristin in prednizon; PN=periferna nevropatija
English: 13.1 mo
Slovenian: 13,1 meseca
English: * Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
Slovenian: * Primarna ocena učinkovitosti a OR za stopnje odziva na osnovi Mantel-Haenszelove ocene razmerja verjetnosti za stratificirane preglednice; p-vrednosti Cochran Mantel-Haenszelovega testa.
English: Testicular disorder*, Prostatitis, Breast disorder female, Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration
Slovenian: Redki bolezni mod*, prostatitis, bolezni dojk pri ženskah, občutljivost epididimisa, epididimitis, bolečina v medenici, razjede vulve
English: Common Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Slovenian: Pogosti mišični krči*, mišično-skeletna bolečina*, bolečine v udih
English: Injection under the skin is in either the thighs or the abdomen.
Slovenian: Pri podkožnem dajanju se zdravilo injicira v stegna ali trebuh.
English: The CR rate in first-relapsed T-cell ALL patients (n = 22) was 68% (95% CI: 45, 86) and the 4-month event free survival rate was 67% (95% CI: 42, 83).
Slovenian: Delež popolnih odgovorov pri prvih bolnikih s T-celično ALL (n = 22) je bil 68% (95% CI: 45, 86), delež 4-mesečnega preživetja bolnikov brez dogodkov pa 67% (95%
English: Respiratory failure, Acute respiratory distress syndrome, Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension, Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis, Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis, Bronchial disorder*, Hypocapnia*, Interstitial lung disease, Lung infiltration, Throat tightness, Dry throat, Increased upper airway secretion, Throat irritation, Upper-airway cough syndrome
Slovenian: Redki respiratorna odpoved, sindrom akutne dihalne stiske, apneja, pnevmotoraks, atelektaza, pljučna hipertenzija, hemoptiza, hiperventilacija, ortopneja, pnevmonitis, respiratorna alkaloza, tahipneja, pljučna fibroza, bolezni bronhijev*, hipokapnija*, intersticijska bolezen pljuč, infiltracija pljuč, stiskanje v grlu, suho grlo, zvečana sekrecija iz zgornjih dihal, draženje žrela, sindrom kašlja zgornjih dihalnih poti (UACS - Upper-airway cough syndrome)
English: Early and regular monitoring for symptoms of treatment-emergent neuropathy with neurological evaluation should be considered in patients receiving bortezomib in combination with medicinal products known to be associated with neuropathy (e.g. thalidomide) and appropriate dose reduction or treatment discontinuation should be considered.
Slovenian: (npr. talidomid), je potrebno zgodnje in redno spremljanje pojava simptomov (z zdravljenjem povezane) nevropatije, opraviti nevrološko oceno ter ustrezno zmanjšati odmerek ali razmisliti o ukinitvi zdravljenja.
English: Rest period Rest period
Slovenian: premor premor
English: NF-kB is a transcription factor whose activation is required for many aspects of tumourigenesis, including cell growth and survival, angiogenesis, cell-cell interactions, and metastasis.
Slovenian: kB je transkripcijski faktor, katerega aktivacija je potrebna za mnoge stopnje nastanka tumorja, npr.
English: The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Slovenian: Analiza je dokazala izboljšan ORR (CR+PR) (razmerje obetov 3,769; 95 % CI 2,045-6,947; p < 0,001), PFS (razmerje tveganja 0,511;
English: If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive Bortezomib SUN together with two other medicines; melphalan and prednisone.
Slovenian: Če vam diseminiranega plazmocitoma še niso zdravili in presaditev krvotvornih matičnih celic za vas ni primerna, vam bodo zdravilo Bortezomib SUN injicirali v veno skupaj z zdraviloma melfalan in prednizon.
English: The final survival update was performed with a median duration of follow-up of 60.1 months.
Slovenian: Po 60,1 meseca (mediana trajanja spremljanja) so posodobili podatke o končnem preživetju.
English: Special handling instructions
Slovenian: Posebna navodila za ravnanje z zdravilom.
English: After reconstitution, each ml solution contains 1 mg bortezomib.
Slovenian: Po rekonstituciji vsak ml raztopine vsebuje 1 mg bortezomiba.
English: (95% CI) Hazard ratio (95% CI)c p-valued
Slovenian: razmerje tveganja (95 % CI)c p-vrednostd
English: After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Slovenian: Po rekonstituciji 1 ml raztopine za intravensko injiciranje vsebuje 1 mg bortezomiba.
English: Table 7: Adverse reactions in patients with Multiple Myeloma treated with bortezomib in clinical trials, and all post-marketing adverse reactions regardless of indication#
Slovenian: Preglednica 7: Neželeni učinki pri bolnikih z diseminiranim plazmocitomom, zdravljenih z bortezomibom v kliničnih preskušanjih in v obdobju trženja, neodvisno od indikacije Organski sistem Pogostnost Neželeni učinek
English: It is recommended that patients receive 2 cycles of Bortezomib SUN following a confirmation of a complete response.
Slovenian: Priporočamo, da bolniki po potrjenem popolnem odzivu prejmejo še dva kroga zdravljenja z zdravilom Bortezomib SUN. Priporočamo tudi,
English: CRf
Slovenian: NF
English: Common Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough*
Slovenian: Pogosti dispneja*, epistaksa, okužba zgornjih/spodnjih dihal*,
English: Transfusion reaction, Fractures*, Rigors*, Face injury, Joint injury*, Burns, Laceration, Procedural pain, Radiation injuries*
Slovenian: Redki reakcije na transfuzijo, zlomi*, okorelost*, poškodbe obraza, poškodbe sklepov*, opekline, raztrganine, bolečina pri posegu, poškodbe pri obsevanju*
English: Combination therapy with dexamethasone
Slovenian: Kombinirano zdravljenje z deksametazonom
English: CR+nCR+PR% (95% CI)
Slovenian: CR+nCR CR+nCR+PR% (95 %
English: Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration.
Slovenian: Če se zakasnitve krogov zdravljenja ponavljajo, je treba razmisliti o profilaktični uporabi granulocitne kolonije spodbujajočih faktorjev.
English: Patients in the BzmbTDx group received six 4-week cycles, each consisting of bortezmib (1.3 mg/m2 administered twice weekly days 1, 4, 8, and 11, followed by a 17-day rest period from day 12 to day 28), dexamethasone (40 mg administered orally on days 1 to 4 and days 8 to 11), and thalidomide (administered orally at 50 mg daily on days 1-14, increased to 100 mg on days 15-28 and thereafter to 200 mg daily).
Slovenian: V vsakem krogu so prejeli bortezomib (1.3 mg/m2 dvakrat na teden na 1., 4., 8., in 11. dan, ki mu sledi 17-dnevni premor od 12. do 28. dne), deksametazon (40 mg peroralno na 1. do 4. dan in 8. do 11. dan) in talidomid (50 mg na dan peroralno na 1. do 14. dan, povečan odmerek 100 mg na 15. do 28. dan in potem povečan odmerek 200 mg na dan).
English: The incidence of herpes zoster among patients in the Bzmb+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Slovenian: Bzmb+M+P, je prišlo do reaktivacije virusa herpes zoster pri 17 % bolnikov, ki niso prejemali protivirusnih zdravil, pri bolnikih, ki so prejemali protivirusna zdravila, pa je prišlo do reaktivacije virusa pri 3 % bolnikov.
English: * Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate, severe).
Slovenian: *Na podlagi klasifikacije jetrnih okvar (blaga, zmerna, huda) Delovne skupine za disfunkcije organov nacionalnega onkološkega inštituta ZDA (National Cancer Institute Organ Dysfunction Working Group).
English: Pegylated liposomal doxorubicin is administered at 30 mg/m2 on day 4 of the Bortezomib SUN treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib SUN 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 Bortezomib SUN.
English: Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy#, Different degrees of visual impairment (up to blindness)*
Slovenian: Redki poškodba roženice*, ekzoftalmus, vnetje mrežnice, skotom, očesne bolezni (vključno z vekami) n.d.n., pridobljen dakrioadenitis, fotofobija, fotopsija, optična nevropatija#, različne stopnje okvare vida (vse do slepote)*
English: In addition, when Bortezomib SUN is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these medicinal products should be considered in the event of toxicities, according to the recommendations in the respective Summary of Product Characteristics.
Slovenian: Kadar dajemo zdravilo Bortezomib SUN v kombinaciji z drugimi kemoterapevtiki, je v primeru pojava toksičnosti treba razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi Povzetki glavnih značilnosti zdravil.
English: After reconstitution, each ml solution contains 2.5 mg bortezomib.
Slovenian: Po rekonstituciji vsak ml raztopine vsebuje 2,5 mg bortezomiba.
English: However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe.
Slovenian: Zdravilo je kemično in fizikalno stabilno 8 ur pri temperaturi do 25 °C, če ga pred uporabo shranjujemo v originalni viali in/ali injekcijski brizgi.
English: After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Slovenian: Po rekonstituciji 1 ml raztopine za subkutano injiciranje vsebuje 2,5 mg bortezomiba.
English: As a result of a pre-planned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered bortezomib, regardless of disease status.
Slovenian: Kot rezultat predhodno načrtovane vmesne analize so del preskušanja, v katerem so bolniki dobivali deksametazon, zaključili v skladu s priporočilom komisije, ki je spremljala podatke.
English: Congenital, familial and genetic disorders
Slovenian: Prirojene in dedne genetske okvare
English: TDx (N=126)
Slovenian: (n=126)
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega
English: (feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching - arthritis, including inflammation of the joints in the fingers, toes, and the jaw - disorders that affect your lungs, preventing your body from getting enough oxygen.
Slovenian: - vnetje sklepa (artritis), vključno z vnetjem sklepov prstov na roki in nogi ter čeljusti - motnje, ki prizadenejo pljuča in preprečujejo telesu, da bi dobilo dovolj kisika.
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Slovenian: Periferna nevropatija ≥ 3. stopnje se je pojavila pri 6 % bolnikov v skupini s subkutanim dajanjem v primerjavi s 16 %
English: Marketing Authorisation Holder and Manufacturer Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Sun Pharmaceutical Industries Europe B.V.
English: If you are given Bortezomib SUN for the treatment of multiple myeloma the side effects you may get are listed below:
Slovenian: Če prejemate zdravilo Bortezomib SUN za zdravljenje diseminiranega plazmocitoma, se lahko pri vas pojavijo naslednji neželeni učinki:
English: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively.
Slovenian: Po ponovljenih odmerkih je bil razpon od 15 do 32 l/h za odmerek 1,0 mg/m2 in od 18 do 32 l/h za odmerek 1,3 mg/m2.
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 odprti, randomizirani študiji faze III na dveh enakovrednih skupinah so primerjali učinkovitost in varnost subkutanega in intravenskega dajanja bortezomiba.
English: PRf n (%) nCR n (%)
Slovenian: CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-vrednostd
English: 1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib SUN powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: 1.1 Priprava 3,5 mg viale: previdno dodajte 3,5 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib SUN. Za rekonstitucijo uporabite primerno brizgo, pri tem ne odstranite zamaška z viale.
English: 1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib SUN powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: 1.1 Priprava 3,5 mg viale: previdno dodajte 1,4 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib SUN. Za rekonstitucijo uporabite primerno brizgo, pri tem ne odstranite zamaška z viale.
English: You should not breast-feed while using Bortezomib SUN.
Slovenian: Med uporabo zdravila Bortezomib SUN ne smete dojiti.
English: You should tell your doctor if you have any of the following: - low numbers of red or white blood cells - bleeding problems and/or low number of platelets in your blood - diarrhoea, constipation, nausea or vomiting - fainting, dizziness or light-headedness in the past - kidney problems - moderate to severe liver problems - numbness, tingling, or pain in the hands or feet (neuropathy) in the past - heart or blood pressure problems - shortness of breath or cough - seizures - shingles (localised including around the eyes or spread across the body) - symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion,
Slovenian: Zdravniku povejte, če za vas velja kar koli od naslednjega: - če imate majhno število rdečih (eritrocitov) ali belih (levkocitov) krvnih celic, - če imate težave s strjevanjem krvi in/ali majhno število krvnih ploščic (trombocitov), - če imate drisko, ste zaprti, vam je slabo ali bruhate, - če ste v preteklosti kdaj izgubljali zavest, bili omotični ali vrtoglavi, - če imate težave z ledvicami, - če imate zmerne do hude težave z jetri, - če ste imeli v preteklosti kakršne koli težave z odrevenelostjo, mravljinci ali bolečino v dlaneh ali stopalih (nevropatija), - če imate težave s srcem ali krvnim tlakom, - če imate težave z dihanjem ali kašljate, - če imate epileptične napade, - če opazite pasasti izpuščaj (lokaliziran, vključno s predelom okoli oči ali razširjen po telesu), - če imate simptome sindroma razpada tumorja, kot so mišični krči, šibkost mišic, zmedenost,
English: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzmbR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Slovenian: 14 % preiskovancev iz skupine BzmbR-CAP in 17 % bolnikov iz skupine R-CHOP je prejelo 2 dodatna kroga zdravljenja.
English: Progression free survival (IRC)a Events n (%)
Slovenian: n: bolniki (ITT) Preživetje brez napredovanja bolezni (IRC)a dogodki n (%)
English: Patients were administered intravenous doses of 0.7 to 1.3 mg/m2 of bortezomib twice weekly.
Slovenian: Bolniki so dvakrat na teden prejemali intravenske odmerke bortezomiba v odmerku od 0,7 do 1,3 mg/m2.