FrancophonIA/ELRC3.0 huggingface dataset:
English: Bortezomib might cause tiredness, dizziness, fainting, or blurred vision.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Bortezomib lahko povzroči utrujenost, omotičnost, omedlevico ali zamegljen vid.
English: Uncommon Pancytopenia*
Slovenian: Občasni pancitopenija*
English: Leukopenia*, Lymphopenia* Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia
Slovenian: Občasni pancitopenija*, febrilna nevtropenija, koagulopatija*, levkocitoza*, limfadenopatija, hemolitična anemija
English: How to store Bortezomib Fresenius Kabi
Slovenian: Shranjevanje zdravila Bortezomib Fresenius Kabi
English: Bortezomib is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years: - alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (progressive) after receiving at least one prior treatment and for whom blood stem cell transplantation was not successful or is unsuitable.
Slovenian: Bortezomib se uporablja za zdravljenje diseminiranega plazmocitoma (rak kostnega mozga) pri bolnikih, starejših od 18 let: - samostojno ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali deksametazonom pri bolnikih, pri katerih je bolezen napredovala po tem, ko so prejeli vsaj eno predhodno vrsto zdravljenja in so jim že presadili krvotvorne matične celice ali presaditev krvotvornih matičnih celic pri njih ni primerna.
English: What Bortezomib Fresenius Kabi looks like and contents of the pack Bortezomib powder for solution for injection is a white to off-white lyophilized powder or cake.
Slovenian: Izgled zdravila Bortezomib Fresenius Kabi in vsebina pakiranja Bortezomib prašek za raztopino za injiciranje je bel do belkast liofiliziran prašek ali pogača .
English: If you are given bortezomib for the treatment of multiple myeloma the side effects you may get are listed below:
Slovenian: Če prejemate bortezomib za zdravljenje diseminiranega plazmocitoma, se lahko pri vas pojavijo naslednji neželeni učinki:
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 jemljete 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: Adverse reaction left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
Slovenian: #, 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: Dose adjustments for combination therapy for patients with progressive multiple myeloma For bortezomib dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Slovenian: Prilagoditev odmerjanja pri kombiniranem zdravljenju bolnikov z diseminiranim plazmocitomom Za prilagoditev odmerjanja bortezomiba pri kombiniranem zdravljenju upoštevajte navodila, za samostojno zdravljenje, opisana zgoraj.
English: Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
Slovenian: #, nevrotoksičnost, motnje s krči*, post-herpetična nevralgija, motnje govora*, sindrom nemirnih nog, migrena, išias, motnje pozornosti, nenormalni refleksi*, parozmija
English: Very common Thrombocytopenia*, Neutropenia*, Anaemia* Common
Slovenian: Zelo pogosti trombocitopenija*, nevtropenija*, anemija*
English: A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of bortezomib plus pegylated liposomal doxorubicin versus bortezomib monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy.
Slovenian: Bortezomib v kombinaciji s pegiliranim liposomskim doksorubicinom (študija DOXIL-MMY-3001) Pri 646 bolnikih je bila opravljena randomizirana, odprta, multicentrična študija faze III pri vzporednih skupinah, v kateri so primerjali varnost in učinkovitost kombinirane terapije z bortezomibom in pegiliranim liposomskim doksorubicinom z monoterapijo z bortezomibom pri bolnikih z diseminiranim plazmocitomom, ki so že prejeli najmanj eno vrsto terapije in pri katerih bolezen ni napredovala med prejemanjem antraciklinske terapije.
English: • advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
Slovenian: • Navodilo kako zmanjšati možnost zamenjave injekcijskih brizg za i.v.
English: - If platelet counts < 25,000 cells/μL.
Slovenian: ≥ 75.000 celic/μl.
English: Prednisone is given orally at 100 mg/m on days 1, 2, 3, 4 and 5 of the bortezomib treatment cycle.
Slovenian: Prednizon boste jemali peroralno v odmerku 100 mg/m na 1., 2., 3., 4. in 5. dan cikla zdravljenja z bortezomibom.
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection bortezomib
Slovenian: Bortezomib Fresenius Kabi 3,5 mg prašek za raztopino za injiciranje bortezomib
English: Each 10 ml vial of bortezomib must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Vsako 10 ml vialo bortezomiba morate previdno rekonstituirati z 1,4 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: * Primary endpoint a
Slovenian: * Primarna ocena učinkovitosti a
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 (intravensko) je pokazala 17 % zvečanje srednje vrednosti AUC bortezomiba (na osnovi podatkov 21 bolnikov).
English: 9/l or ANC
Slovenian: 9/l ali
English: (n=93) or ≤ 1.0 mg/m (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Slovenian: Zdavilo so prejemali na 1., 4., 8., in 11. dan vsake tri tedne, največ 8 ciklov zdravljenja kot samostojno zdravljenje ali v kombinaciji z deksametazonom, skladno s klinično prakso.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij Fresenius Kabi Deutschland GmbH
English: 1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, sodium chloride 9 mg/ml (0.9%) solution for injection to the vial containing the bortezomib 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, ki vsebuje prašek bortezomib.
English: Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the bortezomib treatment cycle.
Slovenian: Deksametazon se jemlje peroralno v odmerku 20 mg na 1., 2., 4., 5., 8., 9., 11. in 12. dan cikla zdravljenja z bortezomibom.
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: 1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, sodium chloride 9 mg/ml (0.9%) solution for injection to the vial containing the bortezomib 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, ki vsebuje prašek bortezomib.
English: Hypertension*, Hypotension*, Orthostatic
Slovenian: Pogosti hipertenzija*, hipotenzija*, ortostatska hipotenzija
English: When bortezomib is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Slovenian: Pri sočasni uporabi bortezomiba z drugimi zdravili, glejte Povzetke glavnih značilnosti teh zdravil za dodatne kontraindikacije.
English: Pegylated liposomal doxorubicin is administered at 30 mg/m on day 4 of the bortezomib treatment cycle as a 1 hour intravenous infusion administered after the bortezomib 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 bortezomiba.
English: In addition, when bortezomib 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 bortezomib v kombinaciji z drugimi kemoterapevtiki je v primeru pojava toksičnosti potrebno razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi povzetki glavnih značilnosti zdravil.
English: This medicine contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Slovenian: Zdravilo Bortezomib Fresenius Kabi vsebuje učinkovino bortezomib, ki je zaviralec proteasomov.
English: Bortezomib treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however bortezomib may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Slovenian: Bortezomib pa lahko aplicira tudi zdravstveno osebje, ki ima izkušnje z zdravljenjem s kemoterapevstkimi učinkovinami.
English: Each 10 ml vial of bortezomib must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Vsako 10 ml vialo bortezomiba morate previdno rekonstituirati s 3,5 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: In addition, when bortezomib is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these products should be considered in the event of toxicities according to the recommendations in the Summary of Product Characteristics.
Slovenian: Kadar dajemo bortezomib v kombinaciji z drugimi kemoterapevtiki je v primeru pojava toksičnosti potrebno razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi Povzetki glavnih značilnosti zdravil.
English: CLINICAL PARTICULARS
Slovenian: Samostojno zdravljenje
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection
Slovenian: Bortezomib Fresenius Kabi 3,5 mg prašek za raztopino za injiciranje
English: Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Slovenian: Pogosti dehidracija, hipokaliemija*, hiponatriemija*, nenormalne koncentracije glukoze v krvi*, hipokalciemija*, encimske motnje*
English: Patients with moderate or severe hepatic impairment should be started on bortezomib at a reduced dose of 0.7 mg/m per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m may be considered based on patient tolerability (see table 6 and sections 4.4 and 5.2).
Slovenian: Zmanjšati odmerek bortezomiba v prvem ciklu zdravljenja na 0,7 mg/m Na osnovi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja odmerka na 1,0 mg/m ali zmanjšanja odmerka na 0,5 mg/m huda
English: Immune system disorders Uncommon Angioedema
Slovenian: Organski sistem Pogostnost Neželeni učinek Žilne bolezni
English: #, Stevens-Johnson syndrome Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer
Slovenian: #, dermatitis*, bolezni las*, petehije, ehimoze, spremembe na koži, purpura, kožna masa*, luskavica, hiperhidroza, nočno znojenje, dekubitusna razjeda akne*, mehurček*, motnje pigmentacije*
English: Bortezomib therapy should be withheld until symptoms of the toxicity have resolved to grade 1 or baseline.
Slovenian: Zdravljenje z bortezomibom je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 1. stopnjo ali stanje pred začetkom zdravljenja.
English: Uncommon Muscle twitching, Joint swelling, Arthritis*, Joint stiffness, Myopathies*,Sensation of heaviness
Slovenian: Občasni trzanje mišic, otekanje sklepov, artritis*, okorelost sklepov, miopatije*, občutek teže
English: The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
Slovenian: Mediana starost bolnikov v študiji je bila 71 let, 50 % sodelujočih je bilo moških, 88 % belcev.
English: • 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, collapse
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, kolaps
English: • Platelet counts should be ≥ 70 x 10 9/l and the absolute neutrophils count should be
Slovenian: • Število trombocitov mora biti ≥ 100.000 celic/μl in celokupno število nevtrofilcev (ANC
English: HR
Slovenian: g
English: Change bortezomib treatment schedule to 1.3 mg/m once per week.
Slovenian: zmanjšajte odmerek bortezomiba na 1,0 mg/m ali spremenite shemo zdravljenja z bortezomibom na odmerek 1,3 mg/m enkrat na teden.
English: Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis
Slovenian: Občasni pankreatitis (vključno s kroničnim)*, hematemeza, otekanje ustnic*, obstrukcija prebavil (vključno z obstrukcijo tankega črevesa, ileusom)*, neprijeten občutek v trebuhu, razjede v ustih*, enteritis*, gastritis*, krvavitev iz dlesni, gastroezofagealna refluksna bolezen*, kolitis (vključno s kolitisom, povzročenim s clostridium difficile)*, ishemični kolitis
English: Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy
Slovenian: Redki poškodba roženice*, ekzoftalmus, vnetje mrežnice, skotom, očesne bolezni (vključno z vekami) NOS, pridobljen dakrioadenitis, fotofobija, fotopsija, optična nevropatija
English: • storage precautions for reconstituted solution • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Slovenian: • Možna tveganja napak pri uporabi zdravila, vključno z informacijami o prevelikem odmerjanju,
English: Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Slovenian: Redki hipermagneziemija*, acidoza, motnje ravnovesja elektrolitov*, čezmerno nabiranje tekočine, hipokloremija*, hipovolemija, hiperkloremija*, hiperfosfatemija*, presnovne motnje, pomanjkanje vitaminov B kompleksa, pomanjkanje vitamina B12, protin, zvečan apetit, neprenašanje alkohola
English: • advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
Slovenian: in s.c. uporabi in, da je treba pri s.c. uporabi menjavati mesta injiciranja.
English: Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Slovenian: Bortezomib je v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom indiciran za zdravljenje odraslih bolnikov z limfomom plaščnih celic, ki še niso prejemali zdravljenja in pri katerih presaditev krvotvornih matičnih celic ni mogoča.
English: Immune system disorders Common
Slovenian: Bolezni imunskega sistema
English: b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Slovenian: Bolniki, ki dosežejo vsaj delni odgovor po 4 ciklih, lahko prejmejo do 6 ciklov zdravljenja.
English: 9/l • Non-haematological toxicities should have resolved to grade 1 or baseline
Slovenian: • Ne-hematološke toksičnosti se morajo povrniti na 1. stopnjo ali na stanje pred začetkom zdravljenja.
English: Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction* Uncommon Cardiovascular disorder (inc cardiogenic shock)
Slovenian: Pogosti fibrilacija srca (vključno z atrijsko), aritmija*, srčno popuščanje (vključno s popuščanjem levega in desnega prekata)*, ishemija miokarda, moteno delovanje prekatov*
English: Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
Slovenian: 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: Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Slovenian: b Ocena razmerja tveganja na osnovi Coxovega modela, stratificiranega IPI tveganjem in stopnjo bolezni.
English: Therefore, caution must be used during handling and preparation.
Slovenian: Bortezomib je citotoksičen, zato je potrebna previdnost med njegovo pripravo in ravnanjem.
English: > 1.0 x −1.5 x ULN
Slovenian: > 1,0 x - 1,5 x ULN katera koli ni potrebna zmerna
English: IV on day 1; cyclophosphamide 750 mg/m
Slovenian: 750 mg/m ciklofosfamida, 50 mg/m doksorubicina i.v.
English: Discontinue bortezomib
Slovenian: Druga zdravila in bortezomib
English: You must read the package leaflets of all medicinal products to be taken in combination with bortezomib for information related to these medicines before starting treatment with bortezomib.
Slovenian: Preden začnete zdravljenje z bortezomibom preberite tudi navodila za uporabo zdravil, ki jih jemljete skupaj z bortezomibom.
English: Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage
Slovenian: Občasni pljučni embolizem, plevralni izliv, pljučni edem (vključno z akutnim), pljučna alveolarna krvavitev
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; BTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response; OR=odds ratio * Primary endpoint a
Slovenian: CI = interval zaupanja; CR = popoln odgovor; nCR = skoraj popoln odgovor; ITT = populacija, ki so jo nameravali zdraviti; RR = stopnja odgovora; BTDx = bortezomib, talidomid, deksametazon; TDx = talidomid, deksametazon; PR = delni odgovor; OR = razmerje verjetnosti; * 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: Peripheral neuropathy in combination regimens Multiple myeloma
Slovenian: Periferna nevropatija pri kombiniranem zdravljenju Diseminirani plazmocitom
English: SN:
Slovenian: LDH.
English: Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Slovenian: Občasni duševne motnje*, halucinacije*, psihotične motnje*, zmedenost*, nemir
English: Then, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m to 1 mg/m 2, or from 1 mg/m to
Slovenian: Nato lahko ponovno uvedete bortezomib v odmerku, ki je eno stopnjo manjši od prejšnjega (z 1,3 mg/m na 1 mg/m ali z 1 mg/m na
English: • If platelet counts ≤ 30 x 10
Slovenian: • Število trombocitov mora biti ≥ 70 x 10
English: Cycles 1 to 4
Slovenian: B+Dx cikel 1 do 4
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the
Slovenian: • Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega bortezomiba (za i.v.
English: Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
Slovenian: Redki rabdiomioliza, sindrom temporomandibularnega sklepa, fistula, izliv v sklep, bolečina v čeljusti, bolezni kosti, okužbe in vnetja mišično-skeletnega sistema in vezivnega tkiva*, sinovialna cista
English: Any
Slovenian: Ali
English: • that bortezomib is to be given only by IV or SC injections; no other route of administration is allowed
Slovenian: ali s.c., nobena druga pot uporabe ni dovoljena.
English: No new safety concerns were observed when bortezomib was added to the standard pediatric pre B cell ALL chemotherapy backbone.
Slovenian: Pri dodatku bortezomiba standardni pediatrični pre B-celični ALL osnovni kemoterapevtski shemi niso opazili novih vplivov na varnost.
English: It is recommended that patients receive 2 cycles of bortezomib following a confirmation of a complete response.
Slovenian: Priporočamo, da bolniki po potrjenem popolnem odgovoru prejmejo še 2 cikla zdravljenja z bortezomibom.
English: Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 3,5 mg bortezomiba (v obliki estra manitola in borove kisline).
English: • Shingles (localised including around the eyes or spread across the body)
Slovenian: • pasasti izpuščaj (herpes zoster (lokaliziran, vključno s področjem okoli oči, ali razširjen po telesu))
English: When bortezomib is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration.
Slovenian: Pri sočasni uporabi bortezomiba z drugimi zdravili glejte Povzetke glavnih značilnosti teh zdravil za navodila za odmerjanje.
English: Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Slovenian: Bortezomib je v kombinaciji z melfalanom in prednizonom indiciran za zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih pred presaditvijo krvotvornih matičnih celic kemoterapija v velikih odmerkih ni primerna.
English: Adverse reaction hypotension
Slovenian: Občasni anafilaktična reakcija
English: Hazard ratio b
Slovenian: 14,0 mesecev razmerje tveganja b