natgillin/translations-raw huggingface dataset:
Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m2 basis are associated with increases in heart rate, decreases in contractility, hypotension and death. 
Farmakološka preskušanja kardiovaskularne varnosti zdravila na opicah in psih kažejo povezavo med intravenskimi odmerki, ki so bili dva- do trikrat večji od priporočenega kliničnega odmerka (v mg/m in povišanjem srčne frekvence, zmanjšanjem kontraktilnosti srca, hipotenzijo in smrtjo.
• If, after Bortezomib Hospira has been held, the toxicity does not resolve, as defined above, then Bortezomib Hospira must be discontinued. 
• Če po prekinitvi zdravljenja z zdravilom Bortezomib Hospira toksičnost ne mine kot je opisano zgoraj, je treba zdravljenje z zdravilom Bortezomib Hospira ukiniti.
Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with Bortezomib Hospira. 
Zaradi morebitnih resnih neželenih učinkov na dojene otroke je treba med zdravljenjem z zdravilom Bortezomib Hospira dojenje prekiniti.
• 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). 
• Navodila za predpisovanje in odmerjanje, vključno z dolžino in številom ciklov zdravljenja, z namenom zmanjšanja tveganja za napake pri zdravljenju in dajanju zdravila, do katerih lahko privede zaradi dveh različnih kombinacij režima uvajanja bortezomiba pred transplantacijo (zdravilo Bortezomib Hospira v kombinaciji z deksametazonon in zdravilo Bortezomib Hospira v kombinaciji z deksametazonom in talidomidom).
• Low blood pressure, sudden fall of blood pressure on standing which may lead to fainting 
• nizek krvni tlak, nenaden padec krvnega tlaka pri vstajanju, kar lahko vodi do omedlevice
Female patients of childbearing potential and male patients must use effective contraceptive measures during and for 3 months following treatment. 
Ženske v rodni dobi in moški morajo uporabljati ustrezno kontracepcijsko metodo med in še 3 mesece po zdravljenju.
No new safety concerns were observed during the study, and in particular bortezomib did not exacerbate target organ damage (heart, kidney and liver). 
Med preskušanjem se niso pokazali dodatni varnostni pomisleki o varnosti zdravljenja in uporaba bortezomiba ni povečala poškodb tarčnih organov (srce, ledvice, jetra).
• Infection or inflammation of the stomach and intestines 
• okužba ali vnetje trebuha in črevesja
You will receive 9 cycles (54 weeks). 
Prejeli boste 9 ciklov zdravljenja (54 tednov).
Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells, the complications of tumour lysis syndrome may occur. 
Bortezomib je citotoksična učinkovina in lahko hitro uniči maligne plazemske celice, zato lahko pride do zapletov sindroma tumorske lize.
1 mg/m 2, or from 1 mg/m 2 to 0.7 mg/m 2). 
1 mg/m 2 ali z 1 mg/m 2 na 0,7 mg/m
In patients with MCL, transient neutropenia that was reversible between cycles was observed, with no evidence of cumulative neutropenia. 
Pri bolnikih z MCL so opažali prehodno nevtropenijo, ki je bila med cikli zdravljenja reverzibilna.
The following medicinal products are given on day 1 of each bortezomib 21-day treatment cycle as intravenous infusions: 
Naslednja zdravila boste prejeli 1. dan vsakega 21-dnevnega cikla zdravljenja z zdravilom Bortezomib Hospira v obliki intravenske infuzije:
Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median haemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l. 
Bolniki so imeli plazmocitom IgG/IgA/lahke verige v 63 %/25 %/8 %, mediano koncentracijo hemoglobina 105 g/l in mediano število trombocitov 221,5 x 10
Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib. 
Bolniki, pri katerih se je pojavila ortostatska hipotenzija ob bortezomibu (intravensko), niso imeli pred zdravljenjem z bortezomibom nobenih znakov ortostatske hipotenzije.
Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group. 
Pojavnost smrti zaradi napredovanja bolezni je bila v subkutani skupini 18 % in v intravenski skupini
It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness. 
Priporočljivo je skrbno spremljanje bolnikov glede simptomov nevropatije, kot so pekoč občutek, hiperestezija, hipestezija, parestezija, neprijeten občutek, nevropata bolečina ali oslabelost.
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. 
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, bolnikom, ki so bili randomizirani na deksametazon pa so ponudili bortezomib, ne glede na status njihove bolezni.
The duration of overall response was 21.4 months longer in the BR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group). 
Trajanje celokupnega odziva je bilo 21,4 mesecev daljše v skupini BR-CAP (mediana 36,5 mesecev proti 15,1 meseca v skupini R-CHOP).
Bortezomib Hospira therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL. 
Zdravljenje z Bortezomib Hospira je treba prekiniti za največ 2 tedna, dokler nima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl.
With a median duration of follow-up of 40 months, median OS (56.3 months in the R-CHOP group, and not reached in the BR-CAP group) favoured the BR-CAP group, (estimated HR=0.80; p=0.173). 
Z medianim nadaljnjim spremljanjem 40 mesecev, je bila glede medianega OS (56,3 mesecev v skupini R-CHOP, v skupini BR-CAP ni bilo doseženo) v prednosti skupina BR-CAP (ocenjeno HR = 0,80; p = 0,173).
• Inject the solution subcutaneously, under a 45-90°angle. 
• Raztopino injicirajte subkutano, pod kotom 45-90°.
For dose adjustments, see Table 5 below. 
Za prilagajanje odmerkov glejte spodnjo preglednico
Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib. 
Na osnovi majhnega deleža (7 %) encima CYP2D6 pri presnovi bortezomiba ni pričakovati, da bi fenotip slabe presnove s CYP2D6 vplival na skupno izločanje bortezomiba.
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. 
Kinetiko zaviranja proteasoma so ovrednotili in vitro in pri tem pokazali, da disociacija bortezomiba s proteasoma poteka z razpolovnim časom t½ = 20 minut, kar pomeni, da je zaviranje proteasoma, ki ga doseže bortezomib, povratno.
Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy 
Stopnja 4 (posledice, ki ogrožajo življenje; potrebno je nujno ukrepanje) in/ali močna avtonomna nevropatija ukinitev zdravila Bortezomib Hospira
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. 
Pri bolnikih v skupini B+M+P so opazili statistično pomembno izboljšanje preživetja (HR (Hazard Ratio - razmerje ogroženosti) = 0,695; p = 0,00043), ne glede na kasnejša zdravljenja, vključno z zdravljenjem z bortezomibom.
Uncommon Cardiovascular disorder (inc cardiogenic shock) 
Občasni srčnožilne bolezni (vključno s kardiogenim šokom)
The reconstituted solution is clear and colourless, with a final pH of 4 to 7.The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration. 
Rekonstituirana raztopina je bistra in brezbarvna, njen končni pH pa je od 4 do 7.Rekonstituirano raztopino je treba pred uporabo pregledati glede prisotnosti trdnih delcev in obarvanosti.
• heart or blood pressure problems 
• imate težave s srcem ali krvnim tlakom,
The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours. 
Po ponavljajočih odmerkih je bil razpon srednjih razpolovnih časov (t1/2) bortezomiba 40-193 ur.
Response parameters as well as TTP remained significantly better for bortezomib independently of age. 
Parametri odziva na zdravljenje, kot tudi čas do napredovanja bolezni (TTP) so bili, neodvisno od starosti, pri zdravljenju z bortezomibom statistično pomembno boljši.
• Confirm the dose and concentration in the syringe prior to use (check that the syringe is markedas intravenous administration). 
• Pred dajanjem zdravila preverite odmerek in koncentracijo v brizgi (prepričajte se, da je na brizgi oznaka za intravensko dajanje).
≤ 1.0 x ULN 
≤ 1,0 x ULN > ULN ni potrebna
May be fatal if given by other routes 
Dajanje po drugi poti je lahko smrtno nevarno.
Table 13: Efficacy results from study MMY-3010 Endpoints 
Preglednica 13: Rezultati učinkovitosti v preskušanju MMY-3010 Opazovani dogodki učinkovitosti
The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib Hospira is provided with educational material. 
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravstveni delavci, ki bodo predpisovali ali uporabljali zdravilo Bortezomib Hospira, prejeli izobraževalno gradivo.
The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BR-CAP group and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]). 
V obeh skupinah pa je bila podobna celokupna pojavnost krvavitev vseh stopenj (6,3 % v BR-CAP in 5,0 % v R-CHOP) in krvavitev stopnje 3 ali več (BR-CAP: 4 bolniki [1,7 %]; R-CHOP: 3 bolniki [1.2 %]).
• Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution. 
• Sperite periferni ali intravenski kateter s sterilno 9 mg/ml (0,9 %) raztopino natrijevega klorida.
In this case, the duration of a treatment cycle is 42 days (6 weeks). 
V tem primeru traja en cikel 42 dni (6 tednov).
All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively. 
Periferno nevropatijo vseh stopenj so opazili pri 40 %, periferno nevropatijo stopnje ≥ 3 pa pri 8,5 % bolnikov.
The primary efficacy endpoint of the study was post-induction response rate (CR+nCR). 
Primarni opazovani dogodek učinkovitosti je bila stopnja odziva po uvedbi (Cr+nCR).
39 ml/min/1.73 m 2, n=9), and Severe (CrCL < 20 ml/min/1.73 m 2, n=3). 
ml/min/1,73 m 2, n = 10), zmerna okvara ledvic (CrCL = 20-39 ml/min/1,73 m 2, n = 9), huda okvara ledvic (CrCL < 20 ml/min/1,73 m2, n = 3).
In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolised via cytochrome P450 enzymes, 3A4, 2C19, and 1A2. 
In vitro študije na humanih jetrnih mikrosomih in izocimih citokroma P450 z izraženo človeško cDNA kažejo, da se bortezomib v prvi vrsti oksidativno presnovi preko encimov citokroma P450, 3A4, 2C19 in 1A2.
Do not use Bortezomib Hospira - 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. 
Ne uporabljajte zdravila Bortezomib Hospira - če ste alergični na bortezomib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
• to remind that patients receiving Bortezomib Hospira in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information. 
• Bolnike, ki prejemajo zdravilo Bortezomib Hospira v kombinaciji s talidomidom, je treba opozoriti, da morajo upoštevati program preprečevanja nosečnosti, kot je predpisan za talidomid, s sklicem na SmPC za talidomid za dodatne informacije.
What Bortezomib Hospira looks like and contents of the pack Bortezomib Hospira powder for solution for injection is a white to off-white cake or powder. 
Izgled zdravila Bortezomib Hospira in vsebina pakiranja Bortezomib Hospira prašek za raztopino za injiciranje je bela do belkasta pogača ali prašek.
Patients with mild hepatic impairment do not require a dose adjustment and should be treated per the recommended dose. 
Pri bolnikih z blago okvaro jeter odmerka ni treba prilagajati, treba jih je zdraviti s priporočenim odmerkom.
Orthostatic/postural hypotension was not acutely related to bolus infusion of bortezomib. 
Ortostatska/posturalna hipotenzija ni bila akutno povezana z infuzijo bortezomiba.
Although in patients aged ≥ 75 years, both BR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BR-CAP groups was 68%, compared to 42% in the R-CHOP group. 
Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, BR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini BR-CAP 68 % v primerjavi z 42 % v skupini R-CHOP.
Inhibition of the proteasome results in cell cycle arrest and apoptosis. 
Zaviranje proteasoma povzroči ustavitev celičnega ciklusa in apoptozo.
The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients. 
Mediana vrednost TTP je znašala 6,5 mesecev pri bolnikih, ki so prejemali samo bortezomib, v primerjavi z 9,3 meseci pri tistih, ki so prejemali kombinirano zdravljenje z bortezomibom in pegiliranim liposomskim doksorubicinom.
The median duration of complete response was 42.1 months in the BR-CAP group compared with 18 months in the RCHOP group. 
Mediano trajanje popolnega odziva je bilo 42,1 meseca v skupini BR-CAP in 18 mesecev v skupini R-CHOP.
Table 6: Recommended starting dose modification for Bortezomib Hospira in patients with hepatic impairment Grade of hepatic impairment* 
Preglednica 6: Priporočena prilagoditev začetnega odmerka zdravila Bortezomib Hospira pri bolnikih z boleznijo jeter Stopnja okvare jeter*
What Bortezomib Hospira is and what it is used for 
Kaj je zdravilo Bortezomib Hospira in za kaj ga uporabljamo
Table 16: Efficacy results from study LYM-3002 Efficacy endpoint 
Preglednica 16: Rezultati učinkovitosti zdravila v preskušanju LYM-3002 Opazovan dogodek učinkovitosti
Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis. 
Bolniki, s predhodno zdravljeno amiloidozo lahkih verig (AL amiloidoza) V odprtem, nerandomiziranem preskušanju faze I/II so ugotavljali varnost in učinkovitost bortezomiba pri bolnikih s predhodno zdravljeno AL amiloidozo.
Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia). 
Zdravljenje z bortezomibom je zelo pogosto povezano s toksičnimi učinki na hematološki sistem (trombocitopenija, nevtropenija in anemija).
A hazard ratio < 1 indicates an advantage for BR-CAP. 
Razmerje ogroženosti < 1 predstavlja prednost za skupino BR-CAP.
Once weekly Bortezomib Hospira (cycles 5-9) 
Odmerjanje zdravila Bortezomib Hospira enkrat na teden (cikli 5-9)
B+Dx+T 
B+Dx+T cikel 1 Teden
The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects. 
Analiza izenačenih parov je statistični postopek, pri katerem primerjamo bolnike v skupini, ki se zdravi (npr. bortezomib v kombinaciji z deksametazonom) in bolnike v primerjalni skupini (npr. samo bortezomib) in z upoštevanjem motečih dejavnikov preskušance individualno razporedimo po parih.
Median PFS by investigator assessment was 30.7 months in the BR-CAP group and 16.1 months in the RCHOP group (Hazard Ratio [HR]=0.51; p < 0.001). 
Mediana PFS po oceni raziskovalca je bila 30,7 mesecev v skupini BR-CAP in 16,1 meseca v skupini R-CHOP (razmerje ogroženosti [HR] = 0,51; p < 0,001).
The incidence of herpes zoster among patients in the BR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4). 
Pojavnost virusa herpes zoster v skupini BR-CAP je bila 10,7 % pri bolnikih, ki niso prejemali protivirusnih zdravil, pri bolnikih, ki so prejemali protivirusna zdravila pa 3,6 % (glejte poglavje 4.4).
Melphalan (9 mg/m 2) and prednisone (60 mg/m 2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle. 
Melfalan (9 mg/m 2) in prednizon (60 mg/m 2) boste jemali peroralno na 1., 2., 3., in 4. dan prvega tedna vsakega cikla zdravljenja.
You should not breast-feed while using bortezomib. 
Med uporabo bortezomiba ne smete dojiti.
Instructions for reconstitution Bortezomib Hospira must be reconstituted by a healthcare professional. 
Navodila za rekonstitucijo raztopine Zdravilo Bortezomib Hospira mora rekonstuirati zdravstveno osebje.
Patients achieving a response or a stable disease after 4 cycles of this combination therapy can continue to receive the same combination for a maximum of 4 additional cycles. 
Bolniki, ki prejemajo kombinirano zdravljenje in po 4 ciklih zdravljenja dosežejo odziv ali so stabilni, lahko prejmejo enako zdravljenje še največ 4 dodatne cikle.
• symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath 
• imate simptome sindroma tumorske lize, kot so mišični krči, šibkost mišic, zmedenost, izguba ali motnje vida ter zasoplost,
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BTDx and TDx groups, respectively. 
Eno avtologno presaditev krvotvornih matičnih celic so opravili pri 105 (81 %) bolnikih v skupini BTDx in 78 (61 %) bolnikih v skupini TDx.
Caution is advised when treating patients with a history of syncope receiving medicinal products known to be associated with hypotension; or who are dehydrated due to recurrent diarrhoea or vomiting. 
Pri zdravljenju bolnikov s sinkopami v anamnezi, ki prejemajo zdravila, za katera je znano, da so povezana s pojavom hipotenzije, ali pri tistih, ki so dehidrirani zaradi ponavljajoče diareje ali bruhanja, je priporočljiva previdnost.
OR; 95% CI; P value 
OR; 95 % IZ; vrednost p
In the unlikely event of an overdose, your doctor will monitor you for side effects. 
V primeru prevelikega odmerjanja vas bo zdravnik spremljal glede pojava neželenih učinkov.
Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA). 
Analiza populacijske farmakokinetike je pokazala, da se očistek bortezomiba zveča z zvečanjem telesne površine.
The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). 
Farmakokinetiko bortezomiba so ovrednotili po intravenski aplikaciji bolusnega odmerka 1,3 mg/m dvakrat na teden 104 pediatričnim bolnikom (starim 2-16 let) z akutno limfoblastno levkemijo (ALL) ali akutno mieloično levkemijo (AML).
What you need to know before you use Bortezomib Hospira 
Kaj morate vedeti, preden boste uporabili zdravilo Bortezomib Hospira
Patients on oral antidiabetic agents receiving Bortezomib Hospira treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics. 
Pri bolnikih, ki so prejemali peroralne antidiabetike in zdravilo Bortezomib Hospira, je potrebno skrbno spremljanje koncentracije glukoze v krvi in prilagoditi odmerek antidiabetika.
Patients in the BTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males. 
V skupini BTDx oziroma TDx je bila mediana starost bolnikov 57 oziroma 56 let, 99 % oziroma 98 % je bilo belcev, moških je bilo 58 % oziroma 54 %.
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy: 
Prilagajanje odmerkov med zdravljenjem pri bolnikih z nezdravljenim limfomom plaščnih celic Pred začetkom novega cikla zdravljenja:
The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the bortezomib containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%). 
V shemi zdravljenja z bortezomibom so se naslednji neželeni učinki (stopnje ≥ 3) pojavili pogosteje kot v predhodnem kontrolnem preskušanju, kjer so bolniki prejemali samo osnovno shemo zdravljenja: v 1. sklopu periferna senzorična nevropatija (3 % proti 0 %), ileus (2,1 % proti 0 %), hipoksija (8 % proti 2 %).
When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section). 
Če jemljete talidomid, morate biti še posebej pozorni na zahteve po preverjanju in preprečevanju nosečnosti (glejte poglavje Nosečnost in dojenje).
If you have mantle cell lymphoma and are given the medicine rituximab with bortezomib you should tell your doctor: 
Če imate limfom plaščnih celic in prejemate rituksimab skupaj z bortezomibom, zdravniku povejte, če:
Response rate population e n=668 
vrednost p Stopnja odziva populacija e n = 668
Table 11: Efficacy results following the final survival update to VISTA study Efficacy endpoint 
Preglednica 11:Rezultati učinkovitosti zdravila po končni posodobitvi podatkov o preživetju v preskušanju VISTA
A. MANUFACTURERSRESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
- Keep this leaflet. 
Odlepite tukaj.
If any discolouration or particulate matter is observed, the reconstituted solution must be discarded. 
Če opazite kakršnokoli obarvanje ali prisotnost delcev, morate rekonstituirano raztopino zavreči.
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib 
Preglednica 15: Povzetek analize učinkovitosti subkutanega in intravenskega dajanja bortezomiba bortezomib intravensko bortezomib subkutano
Special handling instructions. 
- Navodilo shranite.
Therefore, you will have to take regular blood tests before and during your treatment with bortezomib, to check your blood cell counts regularly. 
Zato vam bodo pred in med zdravljenjem z bortezomibom s preiskavami krvi redno preverjali število krvnih celic.
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8). 
Pri bolnikih z MCL (preskušanje LYM-3002) je bila pojavnost okužbe z virusom herpes zoster v skupini BR-CAP 6,7 % in v skupini R-CHOP 1,2 % (glejte poglavje 4.8).
Fertility Fertility studies were not conducted with Bortezomib Hospira (see section 5.3). 
Plodnost Študije plodnosti pri uporabi zdravila Bortezomib Hospira niso bile izvedene (glejte poglavje 5.3).