natgillin/translations-raw huggingface dataset:
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. 
kB je transkripcijski faktor, katerega aktivacija je potrebna za mnoge stopnje nastanka tumorja, npr.
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy. 
Analiza je dokazala izboljšan ORR (CR+PR) (razmerje obetov 3,769; 95 % CI 2,045-6,947; p < 0,001), PFS (razmerje tveganja 0,511;
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive Bortezomib SUN together with two other medicines; melphalan and prednisone. 
Če vam diseminiranega plazmocitoma še niso zdravili in presaditev krvotvornih matičnih celic za vas ni primerna, vam bodo zdravilo Bortezomib SUN injicirali v veno skupaj z zdraviloma melfalan in prednizon.
The final survival update was performed with a median duration of follow-up of 60.1 months. 
Po 60,1 meseca (mediana trajanja spremljanja) so posodobili podatke o končnem preživetju.
Special handling instructions 
Posebna navodila za ravnanje z zdravilom.
After reconstitution, each ml solution contains 1 mg bortezomib. 
Po rekonstituciji vsak ml raztopine vsebuje 1 mg bortezomiba.
(95% CI) Hazard ratio (95% CI)c p-valued 
razmerje tveganja (95 % CI)c p-vrednostd
After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib. 
Po rekonstituciji 1 ml raztopine za intravensko injiciranje vsebuje 1 mg bortezomiba.
Table 7: Adverse reactions in patients with Multiple Myeloma treated with bortezomib in clinical trials, and all post-marketing adverse reactions regardless of indication# 
Preglednica 7: Neželeni učinki pri bolnikih z diseminiranim plazmocitomom, zdravljenih z bortezomibom v kliničnih preskušanjih in v obdobju trženja, neodvisno od indikacije Organski sistem Pogostnost Neželeni učinek
It is recommended that patients receive 2 cycles of Bortezomib SUN following a confirmation of a complete response. 
Priporočamo, da bolniki po potrjenem popolnem odzivu prejmejo še dva kroga zdravljenja z zdravilom Bortezomib SUN. Priporočamo tudi,
CRf 
NF
Common Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough* 
Pogosti dispneja*, epistaksa, okužba zgornjih/spodnjih dihal*,
Transfusion reaction, Fractures*, Rigors*, Face injury, Joint injury*, Burns, Laceration, Procedural pain, Radiation injuries* 
Redki reakcije na transfuzijo, zlomi*, okorelost*, poškodbe obraza, poškodbe sklepov*, opekline, raztrganine, bolečina pri posegu, poškodbe pri obsevanju*
Combination therapy with dexamethasone 
Kombinirano zdravljenje z deksametazonom
CR+nCR+PR% (95% CI) 
CR+nCR CR+nCR+PR% (95 %
Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration. 
Če se zakasnitve krogov zdravljenja ponavljajo, je treba razmisliti o profilaktični uporabi granulocitne kolonije spodbujajočih faktorjev.
Patients in the BzmbTDx group received six 4-week cycles, each consisting of bortezmib (1.3 mg/m2 administered twice weekly days 1, 4, 8, and 11, followed by a 17-day rest period from day 12 to day 28), dexamethasone (40 mg administered orally on days 1 to 4 and days 8 to 11), and thalidomide (administered orally at 50 mg daily on days 1-14, increased to 100 mg on days 15-28 and thereafter to 200 mg daily). 
V vsakem krogu so prejeli bortezomib (1.3 mg/m2 dvakrat na teden na 1., 4., 8., in 11. dan, ki mu sledi 17-dnevni premor od 12. do 28. dne), deksametazon (40 mg peroralno na 1. do 4. dan in 8. do 11. dan) in talidomid (50 mg na dan peroralno na 1. do 14. dan, povečan odmerek 100 mg na 15. do 28. dan in potem povečan odmerek 200 mg na dan).
The incidence of herpes zoster among patients in the Bzmb+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis. 
Bzmb+M+P, je prišlo do reaktivacije virusa herpes zoster pri 17 % bolnikov, ki niso prejemali protivirusnih zdravil, pri bolnikih, ki so prejemali protivirusna zdravila, pa je prišlo do reaktivacije virusa pri 3 % bolnikov.
* Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate, severe). 
*Na podlagi klasifikacije jetrnih okvar (blaga, zmerna, huda) Delovne skupine za disfunkcije organov nacionalnega onkološkega inštituta ZDA (National Cancer Institute Organ Dysfunction Working Group).
Pegylated liposomal doxorubicin is administered at 30 mg/m2 on day 4 of the Bortezomib SUN treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib SUN injection. 
Pegilirani liposomski doksorubicin se daje v obliki 1-urne intravenske infuzije v odmerku 30 mg/m2 na 4. dan kroga zdravljenja, po injiciranju zdravila Bortezomib SUN.
Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy#, Different degrees of visual impairment (up to blindness)* 
Redki poškodba roženice*, ekzoftalmus, vnetje mrežnice, skotom, očesne bolezni (vključno z vekami) n.d.n., pridobljen dakrioadenitis, fotofobija, fotopsija, optična nevropatija#, različne stopnje okvare vida (vse do slepote)*
In addition, when Bortezomib SUN is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these medicinal products should be considered in the event of toxicities, according to the recommendations in the respective Summary of Product Characteristics. 
Kadar dajemo zdravilo Bortezomib SUN v kombinaciji z drugimi kemoterapevtiki, je v primeru pojava toksičnosti treba razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi Povzetki glavnih značilnosti zdravil.
After reconstitution, each ml solution contains 2.5 mg bortezomib. 
Po rekonstituciji vsak ml raztopine vsebuje 2,5 mg bortezomiba.
However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe. 
Zdravilo je kemično in fizikalno stabilno 8 ur pri temperaturi do 25 °C, če ga pred uporabo shranjujemo v originalni viali in/ali injekcijski brizgi.
After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib. 
Po rekonstituciji 1 ml raztopine za subkutano injiciranje vsebuje 2,5 mg bortezomiba.
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.
Congenital, familial and genetic disorders 
Prirojene in dedne genetske okvare
TDx (N=126) 
(n=126)
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega
(feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching - arthritis, including inflammation of the joints in the fingers, toes, and the jaw - disorders that affect your lungs, preventing your body from getting enough oxygen. 
- vnetje sklepa (artritis), vključno z vnetjem sklepov prstov na roki in nogi ter čeljusti - motnje, ki prizadenejo pljuča in preprečujejo telesu, da bi dobilo dovolj kisika.
Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264). 
Periferna nevropatija ≥ 3. stopnje se je pojavila pri 6 % bolnikov v skupini s subkutanim dajanjem v primerjavi s 16 %
Marketing Authorisation Holder and Manufacturer Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 
Imetnik dovoljenja za promet z zdravilom in izdelovalec Sun Pharmaceutical Industries Europe B.V.
If you are given Bortezomib SUN for the treatment of multiple myeloma the side effects you may get are listed below: 
Če prejemate zdravilo Bortezomib SUN za zdravljenje diseminiranega plazmocitoma, se lahko pri vas pojavijo naslednji neželeni učinki:
Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively. 
Po ponovljenih odmerkih je bil razpon od 15 do 32 l/h za odmerek 1,0 mg/m2 in od 18 do 32 l/h za odmerek 1,3 mg/m2.
An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of bortezomib versus the intravenous administration. 
V odprti, randomizirani študiji faze III na dveh enakovrednih skupinah so primerjali učinkovitost in varnost subkutanega in intravenskega dajanja bortezomiba.
PRf n (%) nCR n (%) 
CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-vrednostd
1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib SUN powder by using a syringe of the appropriate size without removing the vial stopper. 
1.1 Priprava 3,5 mg viale: previdno dodajte 3,5 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib SUN. Za rekonstitucijo uporabite primerno brizgo, pri tem ne odstranite zamaška z viale.
1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib SUN powder by using a syringe of the appropriate size without removing the vial stopper. 
1.1 Priprava 3,5 mg viale: previdno dodajte 1,4 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib SUN. Za rekonstitucijo uporabite primerno brizgo, pri tem ne odstranite zamaška z viale.
You should not breast-feed while using Bortezomib SUN. 
Med uporabo zdravila Bortezomib SUN ne smete dojiti.
You should tell your doctor if you have any of the following: - low numbers of red or white blood cells - bleeding problems and/or low number of platelets in your blood - diarrhoea, constipation, nausea or vomiting - fainting, dizziness or light-headedness in the past - kidney problems - moderate to severe liver problems - numbness, tingling, or pain in the hands or feet (neuropathy) in the past - heart or blood pressure problems - shortness of breath or cough - seizures - shingles (localised including around the eyes or spread across the body) - symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion, 
Zdravniku povejte, če za vas velja kar koli od naslednjega: - če imate majhno število rdečih (eritrocitov) ali belih (levkocitov) krvnih celic, - če imate težave s strjevanjem krvi in/ali majhno število krvnih ploščic (trombocitov), - če imate drisko, ste zaprti, vam je slabo ali bruhate, - če ste v preteklosti kdaj izgubljali zavest, bili omotični ali vrtoglavi, - če imate težave z ledvicami, - če imate zmerne do hude težave z jetri, - če ste imeli v preteklosti kakršne koli težave z odrevenelostjo, mravljinci ali bolečino v dlaneh ali stopalih (nevropatija), - če imate težave s srcem ali krvnim tlakom, - če imate težave z dihanjem ali kašljate, - če imate epileptične napade, - če opazite pasasti izpuščaj (lokaliziran, vključno s predelom okoli oči ali razširjen po telesu), - če imate simptome sindroma razpada tumorja, kot so mišični krči, šibkost mišic, zmedenost,
A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzmbR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles. 
14 % preiskovancev iz skupine BzmbR-CAP in 17 % bolnikov iz skupine R-CHOP je prejelo 2 dodatna kroga zdravljenja.
Progression free survival (IRC)a Events n (%) 
n: bolniki (ITT) Preživetje brez napredovanja bolezni (IRC)a dogodki n (%)
Patients were administered intravenous doses of 0.7 to 1.3 mg/m2 of bortezomib twice weekly. 
Bolniki so dvakrat na teden prejemali intravenske odmerke bortezomiba v odmerku od 0,7 do 1,3 mg/m2.
Incidence of PN (%) All GradePN ≥ Grade 2 PN ≥ Grade 3 PN Discontinuation due to PN (%) 
≥ stopnja 2 PN ≥ stopnja 3 PN
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. 
Študija medsebojnega delovanja zdravil o učinku melfalana in prednizona na farmakokinetiko bortezomiba (danega intravensko) je pokazala 17 % zvečanje srednje vrednosti AUC bortezomiba (na podlagi podatkov 21 bolnikov).
However, the dose-normalised mean AUC values were increased by approximately 60% in patients with moderate or severe hepatic impairment. 
Pri bolnikih z zmerno ali hudo jetrno okvaro so se vrednosti povprečnega, na odmerek normaliziranega AUC povečale za 60 %.
a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 
b P-vrednost iz stratificiranega testa log-rank; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi, p < 0,0001
Hazard ratiob (95% CI) p-valuec a Kaplan-Meier estimate. 
p-vrednostc a Ocena po metodi Kaplan-Meier.
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). 
< 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000),
Common Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased 
Pogosti hiperbilirubinemija*, nenormalni izvidi analiz proteinov, zmanjšana telesna masa, zvečana telesna masa
Aplasia, Gastrointestinal malformation, Ichthyosis 
Redki aplazija, gastrointestinalne malformacije, ihtioza
A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3). 
(CrCL=40-59 ml/min/1,73 m2, n=10), zmerna okvara ledvic (CrCL=20-39 ml/min/1,73 m2, n=9) in huda okvara ledvic (CrCL < 20 ml/min/1,73 m2, n=3).
Bortezomib SUN might cause tiredness, dizziness, fainting, or blurred vision. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Bortezomib SUN lahko povzroči utrujenost, omotičnost, omedlevico ali zamegljen vid.
Four treatment cycles of this combination therapy are administered. 
Bolnik prejme štiri kroge zdravljenja s to kombinacijo.
An odds ratio (OR) > 1 indicates an advantage for BzmbR-CAP. f Include all CR+CRu, by IRC, bone marrow and LDH. 
f Vključuje vse CR+CRu, IRC, kostni mozeg in LDH.
Hypotension Bortezomib treatment is commonly associated with orthostatic/postural hypotension. 
Zdravljenje z bortezomibom je pogosto povezano z ortostatsko hipotenzijo oz. posturalno hipotenzijo.
Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir). 
Zato je treba bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 (npr.
• need to handling the medicinal product in sterile setting 
• Med ravnanjem z zdravilom je potrebno ves čas strogo upoštevati aseptično pripravo.
Peripheral neuropathy in combination regimens Multiple myeloma 
Periferna nevropatija pri kombiniranem zdravljenju
There are no studies on the use of bortezomib in elderly patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. 
Študij o uporabi bortezomiba pri starejših bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v velikih odmerkih, niso izvedli.
Bortezomib SUN reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml 
Intravensko injiciranje Rekonstituirano raztopino zdravila Bortezomib SUN dajte naenkrat v obliki 3-5 sekund trajajoče bolusne intravenske injekcije prek perifernega ali osrednjega intravenskega katetra, čemur naj sledi izpiranje katetra z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
Batch 
CHOP.
Uncommon Dysacusis (inc tinnitus)*,Hearing impaired (up to and inc deafness), Ear discomfort* 
Občasni disakuza (vključno s tinitusom)*, okvara sluha (vse do in vključno z gluhostjo), neprejeten občutek v ušesu*
25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients. 
Za bolnike, zdravljene samo z bortezomibom, je bilo mediano OS 30,8 meseca (95 % CI; 25,2-36,5 meseca), za bolnike, zdravljene z bortezomibom v kombinaciji s pegiliranim liposomskim doksorubicinom, pa 33,0 meseca (95 % CI; 28,9-37,1 meseca).
• a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate 
• Model izračuna s katerim bo lahko predpisovalec izračunal odmerek zdravila in Telesio površino, na podlagi bolnikove višine in telesne mase, in tako določil pravi odmerek zdravila Bortezomib SUN.
Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation 
Zelo pogosti simptomi navzee in bruhanja*, driska*, stomatitis*,
Bortezomib SUN treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however Bortezomib SUN may be administered by a healthcare professional experienced in use of chemotherapeutic agents. 
Zdravilo Bortezomib SUN pa lahko aplicira tudi zdravstveno osebje, ki ima izkušnje z zdravljenjem s kemoterapevstkimi učinkovinami Zdravilo Bortezomib SUN
Six Bortezomib SUN cycles are recommended, although for patients with a response first documented at cycle 6, two additional Bortezomib SUN cycles may be given. 
Bolnik prejme šest krogov zdravljenja z zdravilom Bortezomib SUN. Priporočamo, da bolniki, ki dosežejo odziv šele v 6. krogu, prejmejo dva dodatna kroga zdravljenja.
Common Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex* Uncommon Hepatitis B, Infection*, Bronchopneumonia 
Zelo pogosti pljučnica* Pogosti sepsa (vključno s septičnim šokom)*, herpes zoster (vključno z diseminiranim in očesnim), okužba s herpes virusom*, bakterijske okužbe*, okužba zgornjih/spodnjih dihal*, glivična okužba*, herpes simplex*
Bortezomib SUN therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline. 
Zdravljenje z zdravilom Bortezomib SUN je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 1. stopnjo ali stanje pred začetkom zdravljenja.
* Grouping of more than one MedDRA preferred term. 
* združevanje več priporočenih terminov po klasifikaciji MedDRA.
The overall incidence of hepatitis B infections was similar in patients treated with BzmbR-CAP or with R-CHOP (0.8% vs 1.2% respectively). 
Celokupna pogostnost okužbe z virusom hepatitisa B je bila podobna pri bolnikih, zdravljenih z BzmbR-CAP ali R-CHOP
In B-ALL patients with relapse within 18 months of diagnosis (n = 27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62). 
Pri bolnikih z Bcelično ALL in relapsom v manj kot 18 mesecih po diagnozi (n = 27) je bil delež popolnih odgovorov 67% (95% CI: 46, 84) in delež 4-mesečnega preživetja bolnikov brez dogodkov 44% (95%
Bzmb=Bortezomib SUN; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated. 
Bzmb= Bortezomib SUN; Dx=deksametazon; T=talidomid a V 3. tednu 1. kroga se lahko odmerek talidomida poveča na 100 mg samo, če bolnik dobro prenaša odmerek 50 mg in na 200 mg v 2. krogu, če bolnik dobro prenaša odmerek 100 mg. b Bolniki, ki dosežejo vsaj delni odziv po 4 krogih, lahko prejmejo do 6 krogov zdravljenja.
Patients in the BzmbDx group received four 21 day cycles, each consisting of bortezomib (1.3 mg/m2 administered intravenously twice weekly on days 1, 4, 8, and 11), and oral dexamethasone (40 mg/day on days 1 to 4 and days 9 to 12, in Cycles 1 and 2, and on days 1 to 4 in Cycles 3 and 4). 
V vsakem krogu so prejeli bortezomib (1,3 mg/m2 intravensko dvakrat na teden na 1., 4., 8. in 11. dan) in deksametazon (40 mg/dan, peroralno, 1. do 4. in 9. do 12. dan v 1. in 2. krogu in 1. do 4. dan v 3. in 4. krogu).
However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe. 
Rekonstituirana raztopina je kemično in fizikalno stabilna 8 ur pri temperaturi do 25 °C, če jo pred uporabo shranjujemo v originalni viali in/ali injekcijski brizgi.
• advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes 
• Navodilo kako lahko zmanjšamo možnost zamenjave injekcijskih brizg za i.v.
White to off-white lyophilized powder or cake. 
Bel do belkast liofiliziran prašek ali pogača.
CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; 
CR=popolni odziv; CRu=nepotrjen popolni odziv; PR=delni odziv; CI=interval zaupanja, HR=razmerje tveganja; OR=razmerje obetov; ITT=populacija, ki so jo nameravali zdraviti
# Post-marketing adverse reaction regardless of indication 
* združevanje več priporočenih terminov po klasifikaciji MedDRA. # neželeni učinki v obdobju trženja, neodvisno od indikacije
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). 
Če odmerek dobro prenaša, se ga lahko poveča na 100 mg od 15. do 28. dneva in nato od 2. kroga zdravljenja naprej na 200 mg na dan (glejte preglednico 4).
Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy 
Preglednica 1: Priporočena* prilagoditev odmerjanja v primeru nevropatije v povezavi z bortezomibom
• dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib SUN (both IV and SC use) required for different body surface areas (cross reference to Dosing Slide Rule) 
• Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volume rekonstituiranega zdravila Bortezomib SUN (za i.v.
Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone 
Kombinirano zdravljenje z melfalanom in prednizonom
During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics. 
Med kliničnimi preskušanji so pri bolnikih z diabetesom, ki prejemajo peroralne antidiabetike, občasno poročali o hipoglikemiji in pogosto o hiperglikemiji.
The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration. 
Rekonstituirano raztopino morate pred uporabo vizualno pregledati, da ugotovite, ali vsebuje delce in ali je spremenila barvo.