natgillin/translations-raw huggingface dataset:
In a second field study involving 263 dairy cows the percentage of Velactis-treated cows with milk leakages during a 14-day period after drying-off was 3.9% compared with 17.6% for the cows treated with placebo.
V drugi terenski študiji, v katero je bilo vključenih 263 krav molznic, je mleko v 14-dnevnem obdobju po presušitvi uhajalo pri 3,9 % krav, zdravljenih z zdravilom Velactis, in pri 17,6 % krav, zdravljenih s placebom.
The withdrawal period for milk from dairy cows treated with Velactis is ‘zero' days, which means there is no mandatory waiting time after calving, if the dry period length is 32 days or more.
Karenca za mleko krav molznic, zdravljenih z zdravilom Velactis, je nič dni, kar pomeni, da po telitvi ni obvezne čakalne dobe, če obdobje presušitve traja vsaj 32 dni.
Velactis treated cows showed reduced discomfort on the first day of drying-off as indicated by increased daily lying time.
Pri kravah, zdravljenih z zdravilom Velactis, je prišlo do zmanjšanja nelagodja prvi dan presušitve, kar se je pokazalo kot podaljšan čas dnevnega ležanja.
Other information about Velactis?
Druge informacije o zdravilu Velactis
Velactis is given as a single injection into the muscle within four hours of the last milking on the day of drying off. Velactis is available as a solution for injection in multidose vials of 5 ml, 25 ml or 50 ml.
Zdravilo Velactis je na voljo kot raztopina za injiciranje v večodmernih vialah s 5 ml, 25 ml ali 50 ml.
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
V primeru nenamernega samo-injiciranja nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
Safety information has been included in the summary of product characteristics and the package leaflet for Velactis, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila Velactis in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
How does Velactis work?
Kako zdravilo Velactis deluje?
For more information about treatment with Velactis, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Velactis naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For practical information about using Velactis, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Velactis naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
In an initial field study with 917 cows, Velactis was given to cows free of subclinical mastitis (inflammation of the udder without visible clinical signs) and in the absence of antimicrobial treatment, showed a 5.5% reduction of new udder infections during the dry period compared to cows treated with placebo (the dummy treatment).
V začetni terenski študiji z 917 kravami so zdravilo Velactis dajali kravam brez subkliničnega mastitisa (vnetja vimen brez vidnih kliničnih znakov) in v odsotnosti protimikrobnega zdravljenja.
How is Velactis used?
Kako se zdravilo Velactis uporablja?
It is 4 days (8 milkings) after calving when the dry period length is less than 32 days.
Če obdobje presušitve traja manj kot 32 dni, je karenca 4 dni (8 molž).
• Diarrhoea: if this happens, it is important that you drink more water than usual.
• driska: če se to zgodi, morate piti več vode kot običajno.
Some of these events have been fatal.
Nekateri izmed teh dogodkov so bili smrtni.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ne smete mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
Unopened vial 3 years
Zaprta viala 3 leta
• Disorders that affect your lungs, preventing your body from getting enough oxygen.
• motnje, ki prizadenejo vaša pljuča in preprečujejo telesu, da dobi dovolj kisika.
• Partial or total loss of vision
• delna ali popolna izguba vida
• Hormone abnormality which may affect salt and water absorption
• hormonske motnje, ki lahko vplivajo na absorpcijo soli in vode
Information on autonomic neuropathy and its contribution to these undesirable effects is limited.
Podatki o avtonomni nevropatiji in tem, koliko le-ta prispeva k tem neželenim učinkom, so omejeni.
n: ITT patients
n: bolniki ITT
Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določenev seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Eighteen percent of patients achieved, or had an improved response [MR (11%) or PR (7%)] with combination treatment.
Pri 18% bolnikov so dosegli odziv ali izboljšan odziv [MR (11%) ali PR (7%)] pri kombiniranem zdravljenju.
Median a response duration
Mediana a trajanja odziva
• Breakdown of muscle fibers leading to other complications
• razkroj mišičnih vlaken, ki vodi do drugih zapletov
Median follow-up was 16.3 months.
Mediana je bila 16,3 mesecev.
Do not give by other routes.
Ne dajajte po drugi poti.
Kaplan-Meier estimate.
Ocena po metodi Kaplan-Meier.
Most cases of PML were diagnosed within 12 months of their first dose of VELCADE.
Večina primerov PML je bila diagnosticirana v 12 mesecih po prvem odmerku zdravila VELCADE.
Peri- and postnatal development studies were not conducted.
Raziskave peri- in postnatalnega obdobja niso opravili.
Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Pogostnost neželenih učinkov je opredeljena, kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Elderly MCL patients
Starejši bolniki z MCL
• if you think you have hepatitis infection now or have had it in the past.
• menite, da imate ali ste kdaj že imeli okužbo s hepatitisom.
Time related events
Časovno pogojeni dogodki
• Abnormal reaction to blood transfusions
• nenormalna reakcija na transfuzijo krvi
Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies
Preglednica 14: Povzetek izidov bolezni v študijah faze III (APEX) in II
The safety and efficacy of VELCADE in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Varnost in učinkovitost zdravila VELCADE pri otrocih, mlajših od 18 let, nista bili dokazani (glejte poglavji 5.1 in 5.2).
Date of first authorisation: 26 April 2004 Date of latest renewal: 10 January 2014
Datum prve odobritve: 26. april 2004 Datum zadnjega podaljšanja: 10. januar 2014
Reduction in serum M-protein population g n=667
Zmanjšanje serumskega M-proteina populacija g n = 667
Use of gloves and other protective clothing to prevent skin contact is recommended.
Priporočamo uporabo rokavic in drugih zaščitnih oblačil, da preprečimo stik zdravila s kožo.
• Inability to produce enough insulin or resistance to normal levels of insulin
• nezmožnost tvorbe insulina ali odpornost na normalne koncentracije insulina
VELCADE should not be used in children and adolescents because it is not known how the medicine will affect them.
Zdravilo VELCADE se pri otrocih in mladostnikih ne sme uporabljati, ker njegovega vpliva nanje ne poznamo.
Due to this early crossover, the median duration of follow-up for surviving patients is 8.3 months.
Zaradi te zgodnje zamenjave zdravila, znaša mediana trajanja spremljanja preživelih bolnikov 8,3 mesece.
Injection into a vein is rapid, taking 3 to 5 seconds.
Injiciranje v veno je hitro in traja 3 do5 sekund.
• Budd-Chiari syndrome (the clinical symptoms caused by blockage of the hepatic veins)
• Budd-Chiari sindrom (klinični simptomi, ki jih povzroča blokada ven v jetrih)
Based on Independent Review Committee (IRC) assessment (radiological data only).
Na osnovi ocene neodvisnega odbora (Independent Review Committee-IRC) (samo podatki slikovnih diagnostičnih metod).
The final analysis for OS performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Končna analiza OS po medianem spremljanju bolnikov 8,6 let ni pokazala pomembne razlike v OS med obema skupinama zdravljenja.
Treatment with VELCADE can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Zdravljenje z zdravilom VELCADE lahko zelo pogosto povzroči zmanjšanje števila rdečih in belih krvnih celic ter krvnih ploščic.
• Altered level of consciousness, confusion
• spremenjena stopnja zavesti, zmedenost
The final analysis for OS was performed after a median follow-up of 82 months.
Končno analizo OS so izvedli po medianem spremljanju bolnikov 82 mesecev.
• Bruises, falls and injuries
• modrice, padci in poškodbe
OR; 95% CI; P value
OR; 95% CI; p vrednost
Consider reduction of the melphalan dose by 25% in the next cycle.
V naslednjem krogu zdravljenja razmislite o zmanjšanju odmerka melfalana za 25%.
• Sensitivity to light
• občutljivost na svetlobo
Exposure of VELCADE (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
VELCADE (AUC in Cmax normalizirana glede na odmerek) je bila primerljiva med vsemi skupinami (glejte poglavje 4.2).
What VELCADE is and what it is used for
Kaj je zdravilo VELCADE in za kaj ga uporabljamo
SGOT (AST) levels
Koncentracija SGOT (AST)
You should tell your doctor if you have any of the following:
Zdravniku povejte, če:
• Inability to tolerate alcohol consumption
• nezmožnost prenašanja alkohola
The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the VcDx group.
Mediani čas trajanja zdravljenja je bil 13 tednov v skupini VDDx in 11 tednov v skupini VcDx.
Treatment duration (median=17 weeks) and duration of follow-up (median=40 months) were comparable in both treatment arms.
Trajanje zdravljenja (mediana = 17 tednov) in trajanje nadaljnjega spremljanja bolnikov (mediana = 40 mesecev) sta bila primerljiva v obeh zdravljenih skupinah.
Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli za oznako EXP.
VELCADE must be reconstituted by a healthcare professional (see section 6.6).
Zdravilo VELCADE mora rekonstituirati zdravstveno osebje (glejte poglavje 6.6).
Both men and women receiving VELCADE must use effective contraception during and for up to 3 months after treatment.
Moški in ženske, ki prejemajo zdravilo VELCADE, morajo uporabljati učinkovito kontracepcijo med in do 3 mesece po zdravljenju.
• Skin reactions and disorders (which may be severe and life threatening), skin ulcers
• kožne reakcije in bolezni (ki so lahko resne in življenjsko nevarne), kožne razjede
• Reduction in the number of red blood cells and or white blood cells (see above)
• zmanjšanje števila rdečih krvnih celic ali belih krvnih celic (glejte zgoraj)
The primary endpoint was best confirmed response to retreatment as assessed by EBMT criteria.
Primarna ocena učinkovitosti je bil najboljši potrjeni odgovor na ponovno zdravljenje, skladno z EBMT kriteriji.
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.
NF-kB je transkripcijski faktor, katerega aktivacija je potrebna za mnoge stopnje nastanka tumorja, npr. za rast in preživetje celic, angiogenezo, interakcije med celicami in metastaziranje.
• Heart problems to include heart attack, angina
• težave s srcem, ki vključujejo srčni infarkt, angino pektoris
VELCADE may have a moderate influence on the ability to drive and use machines.
Zdravilo VELCADE ima lahko zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
• Abnormal protein deposits in your vital organs
• nenormalno kopičenje beljakovin v vitalnih organih
The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Mediana preživetja vseh bolnikov, vključenih v raziskavo je bila 17 mesecev (območje < 1 do 36 mesecev).
Median duration of follow up is 11.8 months
Mediano trajanje nadaljevanja zdravljenja je 11,8 mesecev.
• Hypersensitivity (allergic reaction)
• preobčutljivostne (alergijske reakcije)
• Insufficient circulation
• nezadostna cirkulacija
Rare side effects (may affect up to 1 in 1,000 people) • Blood clot in small blood vessels (thrombotic microangiopathy)
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • krvni strdek v malih krvnih žilah (trombotična mikroangiopatija)
• Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine, fluid retention
• povečano ali zmanjšano nastajanje urina (zaradi poškodbe ledvic), boleče odvajanje urina ali kri/proteini v urinu, zadrževanje tekočine
• High or low blood pressure
• visok ali nizek krvni tlak
Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in VcDx group and 52/242 [21%] in VDDx group).
Nanaša se na stopnjo odgovora po drugi presaditvi pri posameznikih, pri katerih je bila le-ta izvedena (42/240 [18%] v skupini VcDx in 52/242 [21%] v skupini VDDx).
VELCADE should not be used during pregnancy unless the clinical condition of the woman requires treatment with VELCADE.
Zdravila VELCADE ne smete uporabljati med nosečnostjo, razen če klinično stanje ženske zahteva zdravljenje z zdravilom VELCADE.
Moreover, in dog studies, a slight increase in the corrected QT interval was observed.
Pri psih so zaznali tudi majhno povečanje v korigiranem QT intervalu.
The reported efficacy data are considered inconclusive (see section 4.2).
Poročani podatki ne dovoljujejo dokončnih zaključkov o učinkovitosti (glejte poglavje 4.2).
What you need to know before you use VELCADE
Kaj morate vedeti, preden boste uporabili zdravilo VELCADE
Two (1%) of the patients had severe reactions; 1 case of pruritus and 1 case of redness.
Pri dveh bolnikih (1%) so se pojavile hude reakcije; pruritus in rdečica.
Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.
Če imate navedene neželene učinke ne vozite in ne upravljajte orodij ali strojev, pa tudi če jih nimate morate vseeno biti previdni.
• Difficulty or problems in sleeping
• težave s spanjem
56.4 mo
56,4 mesecev
Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types and that cancer cells are more sensitive to the pro-apoptotic effects of proteasome inhibition than normal cells.
Raziskave so potrdile, da je bortezomib citotoksičen za številne različne vrste rakavih celic in da so rakave celice bolj občutljive za proapoptotične učinke zavore proteasoma od normalnih.
Other medicines and VELCADE
Druga zdravila in zdravilo VELCADE
• Blood clot in small blood vessels (thrombotic microangiopathy)
• krvni strdek v malih krvnih žilah (trombotična mikroangiopatija)
Your doctor may give you another medicine to control diarrhoea
Vaš zdravnik vam bo lahko dal tudi zdravilo za obvladovanje driske.
Time to first response in CR + PR Median
Čas do prvega odziva pri CR + PR mediana
• Problems with your ear, bleeding from your ear
• težave z ušesi, krvavitev iz ušesa
• Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.
• Po raztapljanju odvzemite ustrezno količino rekonstituirane raztopine po izračunu odmerka na osnovi bolnikove telesne površine.
Potential benefit of the treatment should be carefully weighed against the risks, particularly in case of moderate to severe thrombocytopenia and risk factors for bleeding.
Skrbno pretehtajte potencialne koristi zdravljenja glede na tveganja, še posebno v primeru srednje do hude trombocitopenije in ob obstoječih dejavnikih tveganja za krvavitev.
Response Evaluable Population n=73
Odgovor preiskovane populacije n = 73
Treatment with VELCADE is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Zdravljenje z zdravilom VELCADE je zelo pogosto povezano s periferno nevropatijo, ki je pretežno senzorična.
BSA-normalized clearance of bortezomib in pediatric patients was similar to that observed in adults.
Očistek bortezomiba normaliziran na BSA je bil pri pediatričnih bolnikih podoben očistku, ki so ga opazili pri odraslih.
(usually on the legs) to large bruise-like patches under the skin or tissue
(najpogosteje na nogah) do velikimi, modricam podobnimi podkožnimi ali tkivnimi lisami
At 10 M concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1,500-fold more selective for the proteasome than for its next preferable enzyme.
Pri koncentraciji 10 M bortezomib ne zavira nobenega od številnih različnih pregledanih receptorjev in proteaz in je več kot 1500-krat bolj selektiven za proteasom kot za njegov drugouvrščeni prednostni encim.
A vial is for single use only and the remaining solution must be discarded.
Viala je namenjena izključno enkratni uporabi, preostalo raztopino morate zavreči.
tiredness, confusion, blindness or other vision problems.
zmedenestjo, slepoto in drugimi težavami z vidom.
Phase III
faza III
• Injuries
• poškodbe
Patients with pre-existing severe neuropathy may be treated with VELCADE only after careful risk/benefit assessment.
Bolnike z obstoječo hudo nevropatijo lahko zdravite z zdravilom VELCADE šele po skrbnem pretehtanju razmerja med koristjo in tveganjem.
Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.
Zavora 26S proteasoma preprečuje to ciljano proteolizo in vpliva na več signalnih kaskad v celici ter končno vodi do smrti rakave celice.
In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Imetnik dovoljenja za promet z zdravilom se bo v vsaki državi članici s pristojnim nacionalnim organom države dogovoril za obliko in vsebino izobraževalnih gradiv za zdravstvene delavce.
However, cases of severe motor neuropathy with or without sensory peripheral neuropathy have been reported.
Poročali so tudi o primerih hude motorične nevropatije (z ali brez senzorične periferne nevropatije).
• Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots
• vnetje ali krvavitev krvnih žil, ki se lahko kaže z majhnimi rdečimi ali vijoličnimi pikami
The 26S proteasome is a large protein complex that degrades ubiquitinated proteins.
26S proteasom je velik beljakovinski kompleks, ki razgradi ubikvitinske beljakovine.
Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than 8 cycles.
Bolniki s popolnim odgovorom lahko z zdravljenjem nadaljujejo še najmanj dva kroga po prvi ugotovitvi popolnega odgovora, tudi če to zahteva zdravljenje, daljše od 8 krogov.
M (9 mg/m P (60 mg/m
M (9 mg/m P (60 mg/m dan
If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of VELCADE must be considered unless the benefit of treatment clearly outweighs the risk.
Če toksičnost ne mine ali če se ponovi tudi pri najmanjšem odmerku, morate razmisliti o ukinitvi zdravila VELCADE, razen če koristi zdravljenja odtehtajo s tem povezano tveganje.
In the VcTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
V skupini VcTDx je imelo 12% bolnikov citogenetiko velikega tveganja v primerjavi s 16% v skupini TDx.
The majority of the patients in both groups completed treatment, 80% in the VcR-CAP group and 82% in the R-CHOP group.
Večina bolnikov v obeh skupinah je zdravljenje zaključila, 80% v skupini VcR-CAP in 82% v skupini R-CHOP.
• Constipation with or without bloating (can be severe)
• zaprtje z napenjanjem ali brez (lahko hujša oblika)
The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
Celukupna incidenca driske, gastrointestinalne in abdominalne bolečine, asteničnih stanj, okužb zgornjih dihal in perifernih nevropatij je bila za 12%-15% manjša v subkutani kot v intravenski skupini.
If VELCADE is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.
Če se zdravilo VELCADE uporablja v času nosečnosti ali če bolnica zanosi med jemanjem tega zdravila, jo morate obvestiti o potencialnem tveganju za plod.
Overall response (CR+CRu+PR)
Celokupni odgovor (CR+CRu+PR)
Since dialysis may reduce bortezomib concentrations, VELCADE should be administered after the dialysis procedure (see section 5.2).
Ker dializa lahko zmanjša koncentracijo bortezomiba, je treba zdravilo VELCADE injicirati po zaključku dializnega postopka (glejte poglavje 5.2).
When VELCADE is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Če jemljete zdravilo VELCADE skupaj z talidomidom in deksametazonom, traja en krog zdravljenja 28 dni (4 tedne).
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po rekonstituciji glejte poglavje 6.3.
Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function.
In vitro, ex-vivo in podatki iz živalskih modelov kažejo, da bortezomib spodbuja diferenciacijo in aktivnost osteoblastov ter zavira osteoklaste.
Of the 669 patients enrolled, 245 (37%) were 65 years of age or older.
245 (37%) izmed 669 vključenih bolnikov je bilo starih 65 let ali več.
• Wasting, or loss of body mass
• hiranje ali izguba telesne mase
At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered Vc+M+P treatment.
Ob predhodno določenem času vmesne analize je bil dosežen primarni cilj (čas do napredovanja bolezni) in bolnikom v M+P kraku študije so ponudili zdravljenje z Vc+M+P.
By multivariate analysis, the response rate was independent of myeloma type, performance status, chromosome 13 deletion status, or the number or type of previous therapies.
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.
1-year Overall Survival (%) (95% CI)
1-letno celokupno preživetje (%) (95% CI)
• Itching of the skin, lumps on the skin or dry skin
• srbenje kože, otekline na koži ali suha koža
Table 12: Efficacy results from study IFM-2005-01
Preglednica 12: rezultati učinkovitosti študije IFM-2005-01
Pregnancy and breast-feeding You should not use VELCADE if you are pregnant, unless clearly necessary.
Nosečnost in dojenje Če ste noseči zdravila VELCADE ne smete prejeti, razen, če je nujno potrebno.