natgillin/translations-raw huggingface dataset:
DATE OF FIRST RENEWAL OF THE AUTHORISATION 
DATUM PRVOG PRODULJENJA ODOBRENJA
All food producing species 
Sve vrste životinja koje se koriste za proizvodnju hrane
Pigs (sows and gilts). 
Svinje (nazimice i krmače).
Annex II of Council Regulation (EEC) No 2377/90 Pharmacologically active substance(s) 
Prilog II Uredbe Vijeća 2377/90
4.2 Indications for use specifying the target species 
4.2 Indikacije za primjenu, navesti ciljne vrste životinja
PACKAGE LEAFLET Neocolipor 
UPUTA O VMP Neocolipor
Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY 
Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein NJEMACKA
Store and transport at 2°C - 8°C, protected from light. 
Čuvati i prevoziti rashlađeno na 2 °C - 8 °C, zaštićeno od svjetla.
Adhesins: F4 (F4ab, F4ac, F4ad), F5, F6, F41 Aluminium adjuvant 
Adhezini: F4 (F4ab, F4ac, F4ad), F5, F6, F41 Aluminij adjuvans
Sodium hydroxide3 
natrijev hidroksid3
*: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig. 
* 1 SA.U: količina dostatna za poticanje stvaranja aglutinirajućih protutijela u visini titra od 1 log10 u zamorčadi.
*: SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig. 
*1 SA.U: količina dostatna za poticanje stvaranja aglutinirajućih protutijela u visini titra od 1 log10 u zamorčadi.
MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY 
NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
One 2 ml dose according to the following schedule: Primary vaccination: 
Jednu doza od 2 ml cjepiva u skladu sa sljedećim rasporedom cijepljenja:
Thiomersal Aluminium hydroxide Sodium chloride 
Aluminijev hidroksid Natrijev klorid
Store and transport between 2ºC and 8ºC, protected from light. 
Čuvati i prevoziti rashlađeno na 2 °C i 8 °C, zaštićeno od svjetla.
Intramuscular injection 
Intramuskularna injekcija.
Broached vial: 3 hours. 
Otvorena bočica: 3 sata.
Aluminium (as hydroxide) .................................................................................... 1.4 mg 
Aluminij (kao hidroksid) ............................................................................................................ 1,4 mg
First injection: 
Prvo cijepljenje: Prva injekcija:
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I NOSITELJ(I) ODOBRENJA
Aluminium hydroxide1 
Ostale odredbe aluminijev hidroksid1
EU/2/98/008/001 10 ml vial. 
EU/2/98/008/001 bočica od 10 ml.
Thiomersal2 
Tiomersal
The vaccine contains the inactivated strains of E. coli expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, which cause neonatal enterotoxicosis in piglets, in aluminium hydroxide adjuvant. 
Cjepivo sadrži formalinom inaktivirane sojeve bakterije E. coli, koji izlučuju adhezine F4ab, F4ac, F4ad, F5, F6 i F41 u adjuvansu aluminijevog hidroksida za smanjenu pojavu neonatalne enterotoksikoze prasadi.
E. coli adhesin F4 (F4ab, F4ac, F4ad), at least....................................................... 2.1 SA U* E. coli adhesin F5, at least ...................................................................................... 1.7 SA.U* E. coli adhesin F6, at least ...................................................................................... 1.4 SA.U* E. coli adhesin F41, at least .................................................................................... 1.7 SA.U* 
E. coli adhezin F4 (F4ab, F4ac, F4ad), najmanje .................................................................... ..2.1 SA.U* E. coli adhezin F5, najmanje ..................................................................................................... 1,7 SA.U* E. coli adhezin F6, najmanje ..................................................................................................... 1,4 SA.U* E. coli adhezin F41, najmanje ................................................................................................... 1,7 SA.U*
MANUFACTURER FOR THE BATCH RELEASE MERIAL 
NOSITELJ ODOBRENJA ZA PROIZVODNJU ODGOVORAN ZA PUŠTANJE SERIJE MERIAL
Aluminium (as hydroxide) ..................................................................................... 1.4 mg 
Aluminij (kao hidroksid) .......................................................................................................... 1,4 mg
Neocolipor suspension for injection 
Neocolipor suspenzija za injekcije.
Adjuvanted inactivated vaccine for the reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41. 
Inaktivirano cjepivo s adjuvansom protiv neonatalne enterotoksikoze prasadi, uzrokovane sojevima bakterije Escerichia coli, koji izlučuju adhezine F4ab, F4ac, F4ad, F5, F6 i F41.
2 ml = 1 dose 5d 
2 ml = 1 doza 5d bočica od 10 ml
Shake the vial vigorously before use. 
Prije primjene snažno protresite
E. coli adhesin F4 (F4ab, F4ac, F4ad), at least..................................................... 2.1 SA.U* E. coli adhesin F5, at least .................................................................................... 1.7 SA.U* E. coli adhesin F6, at least .................................................................................... 1.4 SA.U* E. coli adhesin F41, at least .................................................................................. 1.7 SA.U* *: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig. 
E. coli adhezin F4 (F4ab, F4ac, F4ad), najmanje ...................................................................... 2.1 SA.U* E. coli adhezin F5, najmanje ..................................................................................................... 1,7 SA.U* E. coli adhezin F6, najmanje ..................................................................................................... 1,4 SA.U* E. coli adhezin F41, najmanje ................................................................................................... 1,7 SA.U*
2 ml = 1 dose 25 d 
2 ml = 1 doza 25 d bočica od 50 ml
2 ml = 1 dose 10 d 
2 ml = 1 doza 10 d bočica od 20 ml
Adhesins: 
adhezini:
Shelf life of broached vial: 3 hours. 
Rok valjanosti nakon otvaranja bočice: 3 sata.
F6, at least ................................................................................................................................... 1.4 SA.U* 
Tiomersal ................................................................................................................................... 0,2 mg
All food producing species For use as excipient 
Sve vrste životinja koje se koriste za proizvodnju hrane tiomersal2
250 doses =100 ml vial. 
50 doza bočica 100 ml.
Reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, during the first days of life. 
Smanjenje neonatalne enterotoksikoze prasadi tijekom prvih nekoliko dana po rođenju, uzrokovane sojevima bakterije E. coli, koji izlučuju adhezine F4ab, F4ac, F4ad, F5, F6 i F41.
Box of 50-dose 100 ml vial (glass type I vial with butyl rubber stopper). 
Kutija od 50 doza - bočica od 100 ml (bočica iz stakla tip I s čepom iz butilne gume).
EU/2/98/008/003 50 ml vial. 
EU/2/98/008/002 bočica od 20 ml. EU/2/98/008/003 bočica od 50 ml. EU/2/98/008/004 bočica od 100 ml.
Box of 25-dose 50 ml vial (glass type I vial with butyl rubber stopper). 
Kutija od 25 doza - bočica od 50 ml (bočica iz stakla tip I s čepom iz butilne gume).
Manufacturer responsible for batch release 
Nositelj odobrenja za proizvodnju za puštanje proizvodne serije
Box of 10-dose 20 ml vial (glass type I vial with butyl rubber stopper). 
Kutija od 10 doza - bočica od 20 ml (bočica iz stakla tip I s čepom iz butilne gume).
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 
Farmakološki djelatna(e) tvar(i) Životinjska vrsta
Box of 5-dose 10 ml vial (glass type I vial with butyl rubber stopper). 
Kutija od 5 doza - bočica od 10 ml (bočica iz stakla tip I s čepom iz butilne gume).
Primary vaccination: 
Prvo cijepljenje:
Pack size 
bočica HDPE
This medicine must not be used in children and adolescents because it is not known how it will affect them. 
Ovaj lijek se ne smije primjenjivati kod djece i adolescenata, jer nije poznato kako će utjecati na njih.
For dose adjustments, see table 5 below. 
Za prilagodbe doza, vidjeti Tablicu 5 ispod.
a Based on Independent Review Committee (IRC) assessment (radiological data only). 
Temeljeno na ocjeni Nezavisnog odbora za procjenu (IRC) (samo radiološki podaci).
1-year Overall Survival (%) 
1-godišnje opće preživljenje (%)
The following information is intended for healthcare professionals only: Only the 3.5 mg vial can be administered subcutaneously, as described below. 
Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Samo bočica od 3,5 mg se smije primijeniti supkutano, kako je opisano ispod.
Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8). 
Stoga bolesnici moraju biti oprezni kada upravljaju vozilima ili rade sa strojevima te im je potrebno savjetovati da ne voze i ne upravljaju strojevima ako dožive te simptome (vidjeti dio 4.8).
b b d d b b 
TTP, dani b b d d b b
From a microbiological point of view, the reconstituted solution should be used immediately after preparation. 
S mikrobiološkog stajališta, rekonstituirana otopina mora se primijeniti odmah nakon pripreme.
Therefore, caution must be used during handling and preparation. 
Stoga je potreban oprez tijekom rukovanja i pripreme.
Do not drive or operate tools or machines if you experience such side effects; even if you do not, you must still be cautious. 
Nemojte voziti niti rukovati alatima ili strojevima ako imate takve nuspojave, a čak i ako ih ne osjećate, i dalje morate biti na oprezu.
B=bortezomib; M=melphalan, P=prednisone 
B = Bortezomib; M = melfalan, P = prednizon
RR (Post-transplant) 
RR (Posttransplantacijska)
e Median duration of follow up is 11.8 months 
Medijan trajanja praćenja je 11,8 mjeseci
Very common Decreased appetite Common 
Vrlo često Smanjeni apetit Često
A hazard ratio less than 1 indicates an advantage for VMP 
Omjer hazarda manji od 1 pokazuje da VMP ima prednost.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. 
Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja do primjene odgovornost su korisnika.
Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies Phase III 
Tablica 14: Sažetak ishoda bolesti u ispitivanjima faze III (APEX) i faze II
Bortezomib must be reconstituted by a healthcare professional (see section 6.6). 
Bortezomib mora rekonstituirati zdravstveni radnik (vidjeti dio 6.6).
• The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left). 
• Rekonstituirana otopina primjenjuje se supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (table 15). 
Dodatno, ishodi djelotvornosti povezani sa sekundarnim odgovorom i vremenom do događaja pokazali su dosljedne rezultate za supkutanu i intravensku primjenu (tablica 15).
EBMT criteria g All randomised patients with secretory disease 
EBMT kriteriji g Svi randomizirani bolesnici sa sekrecijskom bolešću.
Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom 
Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, Ujedinjeno Kraljevstvo
Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BR-CAP arm and with at least a possible or probable causal relationship to the components of the BR-CAP arm, are listed in table 8 below. 
Nuspojave identificirane poput onih s incidencijom ≥ 1%, slične ili veće incidencije u BR-CAP skupini s barem mogućom ili vjerojatnom uzročnom povezanošću s komponentama skupine BRCAP, navedene su u Tablici 8 ispod.
• that bortezomib is to be given only by IV or SC injections; no other route of administration is allowed 
• bortezomib se primjenjuje samo putem i.v. ili s.c. injekcije; bilo koji drugi put primjene nije dozvoljen
In the refractory population of the Phase II study, responses were determined by an independent review committee and the response criteria were those of the European Bone Marrow Transplant 
U populaciji s refraktornom bolešću u ispitivanju faze II, odgovore na liječenje je utvrdilo neovisno ocjenjivačko povjerenstvo, a odgovor se procjenjivao prema kriterijima Europske skupine za presađivanje koštane srži.
Your doctor will work out your dose of bortezomib according to your height and weight (body surface area). 
Vaš će liječnik izračunati dozu bortezomiba prema vašoj visini i težini (površini tijela).
Hazard ratio b 
Omjer hazarda b
Median a 
Medijan a
Peripheral neuropathy in combination regimens Multiple myeloma 
Periferna neuropatija u kombiniranim režimima Multipli mijelom
BSA-normalized clearance of bortezomib in pediatric patients was similar to that observed in adults. 
BSA-normalizirani klirens bortezomiba u pedijatrijskih bolesnika bio je sličan onom zabilježenom u odraslih.
Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m basis are associated with increases in heart rate, decreases in contractility, hypotension and death. 
Ispitivanja kardiovaskularne sigurnosne farmakologije u majmuna i pasa pokazala su da su intravenske doze koje su približno dva do tri puta veće od preporučene kliničke doze izražene na temelju mg/m2 povezane s povećanjem broja otkucaja srca, smanjenjem kontraktilnosti, hipotenzijom i smrću.
Do not use bortezomib - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems. 
Nemojte primjenjivati Bortezomib Fresenius Kabi ako ste alergični na bortezomib, bor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ako imate određene teške plućne ili srčane tegobe.
In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately. 
U slučaju pojave novih ili pogoršanja postojećih plućnih simptoma (npr. Kašalj, dispneja), bolesnicima se mora napraviti brza dijagnostička obrada, te ih je potrebno liječiti na odgovarajući način.
Once weekly bortezomib (cycles 5-9) 
Bortezomib jednom tjedno (5.-9. ciklus)
Overall complete response (CR+CRu) 
Ukupni kompletni odgovor (CR+CRu)
(CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3). 
ml/min/1,73 m2, n = 9) i teško (CrCL < 20 ml/min/1,73 m2, n = 3).
Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region. 
b Procjena omjera hazarda (HR) temelji se na Coxovom modelu proporcionalnog rizika prilagođenom prema čimbenicima stratifikacije: β2-mikroglobulinu, albuminu i regiji.
- Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration). 
• Potvrdite dozu i koncentraciju lijeka u štrcaljki prije primjene (provjerite da je štrcaljka označena za intravensku primjenu).
This medicine is for intravenous or subcutaneous use. 
Ovaj lijek je namijenjen za intravensku ili supkutanu primjenu.
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. 
Dodatno, incidencija perifernih neuropatija stupnja 3 ili više bila je 10% niža, a stopa prekida primjene zbog perifernih neuropatija bila je 8% niža za supkutanu skupinu u usporedbi s intravenskom skupinom.
In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and 4.4). 
U slučaju predoziranja potrebno je pratiti vitalne znakove bolesnika te im pružiti odgovarajuće potporne mjere za održavanje krvnog tlaka (kao što je tekućina, presorni lijekovi . i/ili inotropni lijekovi) i tjelesne temperature (vidjeti dijelove 4.2 i 4.4).
** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; *** Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden. 
**Instrumentalni ADL: odnosi se na pripremu obroka, kupnju namirnica ili odjeće, korištenje telefona, rukovanje novcem, itd; ***ADL samozbrinjavanja: odnosi se na kupanje, oblačenje i svlačenje, hranjenje, odlazak na toalet, uzimanje lijekova i ne odnosi se na bolesnike koji leže nepokretni u krevetu.
Pregnancy and breast-feeding You must not use this medicine if you are pregnant, unless clearly necessary. 
Ovaj lijek se ne smije primjenjivati ako ste trudni, osim ako to nije jasno neophodno.
Other medicines and bortezomib Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
At 10 μM 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. 
U koncentraciji od 10 µM, bortezomib ne inhibira niti jedan od probranih raznih receptora i proteaza i pokazuje više nego 1500 puta veću selektivnost prema proteasomima nego sljedećem enzimu prema kojem ima afinitet.
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BDx groups respectively; the majority of patients underwent one single transplant procedure. 
Autologne transplantate matičnih stanica primilo je 198 (82%) bolesnika odnosno 208 (87%) bolesnika u VDDx i BDx skupinama; većina bolesnika prošla je jednu transplantaciju.
The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible. 
Kinetika inhibicije proteasoma ocjenjivala se in vitro i pokazalo se da se bortezomib razdvaja od proteasoma uz t1/2 od 20 minuta, pokazujući tako da je inhibicija proteasoma bortezomibom reverzibilna.
Therefore, caution should be used during handling and preparation of bortezomib. 
Stoga je potreban oprez tijekom rukovanja i pripreme bortezomiba.
The following medicinal products are given on day 1 of each bortezomib 21-day treatment cycle as intravenous infusions: 
Sljedeći lijekovi daju se 1. dana svakog ciklusa liječenja bortezomibom u trajanju od 21-dan kao intravenske infuzije:
* Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate, severe). 
*Prema klasifikaciji Radne skupine za poremećaj funkcije organa Nacionalnog instituta za rak za kategorizaciju oštećenja jetre (blago, umjereno, teško).
c p-value d 
c p-vrijednost d
Also included are adverse drug reactions identified in the BR-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. 
Također su uključene nuspojave identificirane u skupini BRCAP za koje su ispitivači smatrali da imaju barem moguću ili vjerojatnu uzročnu povezanost s bortezomibom na temelju na povijesnih podataka u ispitivanjima multiplog mijeloma.
• instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (bortezomib plus dexamethasone, and bortezomib plus dexamethasone and thalidomide). 
• upute za propisivanje i primjenu koje uključuju duljinu i broj ciklusa, radi smanjenja rizika medikacijskih pogrešaka i pogrešaka pri pripremi moguće uzrokovane zbog postojanja dva različita režima kombinacije s bortezomibom kod transplantiranih bolesnika (bortezomib plus deksametazon i bortezomib plus deksametazon i talidomid).
Table 12: Efficacy results from study IFM-2005-01 Endpoints 
Tablica 12: Rezultati djelotvornosti iz ispitivanja IFM-2005-01
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/m weekly and 1.3 mg/m twice-weekly. 
U eksplorativnoj analizi djelotvornosti, stopa odgovora od 67,3% (uključujući CR stopu od 28,6%) prema mjerenju hematološkog odgovora (M-protein) bila je zabilježena u 49 procijenjenih bolesnika liječenih maksimalnim dopuštenim dozama od 1,6 mg/m na tjedan i 1,3 mg/m dvaput na tjedan.
9/l on a bortezomib dosing day (other than day 1) 
9/l na dan primjene doze bortezomiba (osim 1. dana)
The majority of the patients in both groups completed treatment, 80% in the BR-CAP group and 82% in the R-CHOP group. 
Većina bolesnika u obje skupine završilo je liječenje, 80% u BR-CAP skupini i 82% u RCHOP skupini.
No new safety concerns were observed when bortezomib was added to the standard pediatric pre B cell ALL chemotherapy backbone. 
Nisu zabilježena nova sigurnosna pitanja kada je bortezomib bio dodan standardnoj osnovnoj pedijatrijskoj kemoterapiji za pre-B-staničnu ALL.
This medicinal product does not require any special temperature storage condition. 
Lijek ne zahtijeva čuvanje na određenoj temperaturi.
Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations. 
Nakon intravenske bolusne ili supkutane injekcije u dozi od 1,3 mg/m primijenjene bolesnicima s multiplim mijelomom (n = 14 u intravenskoj skupini, n = 17 u supkutanoj skupini), ukupna sistemska izloženost nakon primjene ponovljenih doza (AUCtrajanja) bila je jednaka za supkutane i intravenske primjene.
Instructions for reconstitution Bortezomib must be reconstituted by a healthcare professional. 
Upute za pripremu Bortezomib mora rekonstituirati zdravstveni radnik.
Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours. 
Geometrijska sredina (%CV) klirensa bila je 7,79 (25%) l/h/m volumen distribucije u stanju dinamičke ravnoteže bio je 834 (39%) l/m2, i poluvijek eliminacije bio je 100 (44%) sati.
Consider dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m in subsequent cycles based on patient tolerability. 
Razmotriti povećanje doze na 1,0 mg/m ili daljnje smanjenje doze na 0,5 mg/m u sljedećim ciklusima na temelju bolesnikova podnošenja liječenja.
Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met. 
Talidomid je kontraindiciran tijekom trudnoće i u žena reproduktivne dobi osim ako nisu postignuti svi uvjeti talidomidskog programa prevencije trudnoće Celgene.
A statistically significant survival benefit in favour of the B+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens. 
Primijećeno je statistički značajno veće preživljenje u skupini liječenoj s B+M+P (HR = 0,695; p = 0,00043) usprkos naknadnim terapijama koje uključuju liječenje bortezomibom.