natgillin/translations-raw huggingface dataset:
Failure to respond to methylthioninium chloride suggests cytochrome b5 reductase deficiency, glucose6- phosphate dehydrogenase deficiency or sulfhaemoglobinemia. 
Nedostatak reakcije na metiltioninijev klorid ukazuje na pomanjkanje citokrom-b5-reduktaze, pomanjkanje glukoza-6-fosfat-dehidrogenaze ili sulfhemoglobinemiju.
Cumulative doses of Methylthioninium chloride may lead to dyspnoea and tachypnoea, presumably related to reduced oxygen availability caused by methaemoglobinaemia, chest pain, tremor, cyanosis and haemolytic anaemia. 
Kumulativne doze metiltioninijeva klorida mogu dovesti do dispneje i tahipneje, koje su vjerojatno povezane sa smanjenom dostupnosti kisika uzrokovanom methemoglobinemijom, do boli u prsištu, tremora, cijanoze i hemolitičke anemije.
It is recommended not to exceed a cumulative dose for the course of treatment of 4 mg/kg in patients with dapsone-induced methaemoglobinaemia. 
Tijekom liječenja ne preporučuje se prekoračenje kumulativne doze od 4 mg/kg u bolesnika s methemoglobinemijom izazvanom dapsonom.
Haemolytic anaemia 
Nepoznato hemolitička anemija
In vitro, methylthioninium chloride has been shown to reduce motility of human sperm in a dose dependant manner. 
In vitro, metiltioninijev klorid je pokazao da smanjuje pokretljivost ljudskih spermija ovisno o dozi.
The administration of methylthioninium chloride Proveblue has the potential to transiently increase the exposure of drugs primarily cleared by renal transport involving the OCT2/MATE pathway, including cimetidine, metformin and acyclovir. 
Primjena lijeka Methylthioninium chloride Proveblue može prolazno povećati izloženost lijekovima koji se prvenstveno eliminiraju putem bubrega, transportom koji uključuje OCT2/MATE put, uključujući cimetidin, metformin i aciklovir.
Methylthioninium chloride Proveblue should not be used during pregnancy unless clearly necessary, e.g. in life-threatening methaemoglobinaemia. 
Methylthioninium chloride Proveblue ne smije se primjenjivati tijekom trudnoće, osim ako je to neophodno, npr. u slučaju methemoglobinemije opasne po život.
It must especially not be mixed with sodium chloride 9 mg/ml (0.9%) solution for injection because it has been demonstrated that chloride reduces the solubility of methylthioninium chloride. 
Osobito se ne smije miješati s otopinom natrijevog klorida 9 mg/ml (0,9 %) za injekcije jer je dokazano da kloridi smanjuju topljivost metiltioninijeva klorida.
No evidence of carcinogenic activity was observed in female rats. 
Nije opažen dokaz kancerogene aktivnosti u ženki štakora.
Methylthioninium chloride is a substrate of P-glycoprotein (P-gp). 
Metiltioninijev klorid supstrat je P-glikoproteina (P-gp).
Methylthioninium chloride may cause a photosensitivity reaction in the skin (sunburn-like reaction) when exposed to strong light sources, such as light therapy, lights in operating rooms and pulse oximeters. 
Metiltioninijev klorid može izazvati reakciju fotosenzitivnosti na koži (reakciju sličnu opeklinama od sunca) prilikom izlaganja izvorima snažnog svjetla, kao što je terapija svjetlom, svjetla u operacijskim salama i svjetla pulsnih oksimetara.
If you are given more Methylthioninium chloride Proveblue than you should As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too much or too little, however, tell your doctor if you notice one of the following adverse reactions: - feeling sick, - stomach pain, - chest pain, - dizziness, - headache, - sweating, - confusion, - an increase in methaemoglobin (an abnormal form of haemoglobin in the blood), - high blood pressure, - shortness of breath, - abnormally fast beating of the heart, - tremor, - skin discolouration. 
S obzirom na to da ćete ovaj lijek primati dok ste u bolnici, malo je vjerojatno da ćete primiti previše ili premalo lijeka, ali ipak, recite liječniku ako primijetite jednu od sljedećih nuspojava: - mučnina, - bol u trbuhu, - bol u prsištu, - omaglicu, - glavobolju, - znojenje, - smetenost, - povišenje methemoglobina (nenormalan oblik hemoglobina u krvi), - povišen krvni tlak, - nedostatak zraka, - nenormalno brzo kucanje srca, - tremor, - promjena boje kože.
Individuals with methaemoglobinaemia 
Osobe s methemoglobinemijom
What you need to know before you are given Methylthioninium chloride Proveblue 
Što morate znati prije nego primite Methylthioninium chloride Proveblue
Methylthioninium chloride Proveblue is not an in vitro inducer of CYP2B6 and CYP3A4. 
Methylthioninium chloride Proveblue nije in vitro induktor CYP2B6 i CYP3A4.
Patients treated with methylthioninium chloride in combination with serotonergic drugs should be monitored for the emergence of serotonin syndrome. 
Bolesnike koji se liječe metiltioninijevim kloridom u kombinaciji sa serotonergičkim lijekovima treba pratiti zbog moguće pojave serotoninskog sindroma.
Methylthioninium chloride has moderate influence on the ability to drive and use machines. 
Metiltioninijev klorid umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range (see section 4.4 for important safety information). 
Ponovljenu dozu (0,3 do 0,5 mg/kg tjelesne težine, tj. 0,06 do 0,1 ml/kg tjelesne težine) moguće je primijeniti jedan sat nakon prve doze u slučajevima perzistentnih ili rekurentnih simptoma ili ako su razine methemoglobina ostanu znatno više od normalnog kliničkog raspona (za važne informacije o sigurnosti vidjeti dio 4.4).
It must not be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection because it has been demonstrated that chloride reduces the solubility of methylthioninium chloride. 
Ne smije se razrjeđivati s otopinom natrijevog klorida 9 mg/ml (0,9%) za injekcije jer je dokazano da kloridi smanjuju topljivost metiltioninijeva klorida.
A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg) may be given after one hour in case of persistence or recurrence of symptoms. 
Ponovljenu dozu (0,3 do 0,5 mg/kg tjelesne težine, tj. 0,06-0,1 ml/kg) moguće je dati nakon jedan sat u slučaju neprestajanja ili ponovne pojave simptoma.
Electrocardiogram (ECG) and blood pressure should be monitored during and after treatment with Methylthioninium chloride Proveblue as hypotension and cardiac arrhythmia are potential adverse reactions (see section 4.8). 
Tijekom i nakon liječenja lijekom Methylthioninium chloride Proveblue potrebno je praćenje elektrokardiograma (EKG-a) i krvnog tlaka jer su hipotenzija i srčana aritmija potencijalne nuspojave (vidjeti dio 4.8).
Do not use Methylthioninium chloride Proveblue if the solution is discoloured, cloudy, turbid, or a precipitate or particles are present. 
Nemojte koristiti Methylthioninium chloride Proveblue ako je otopina promijenila boju, ako je zamućena, zamagljena, ili ako su prisutni talog ili čestice.
Methylthioninium chloride Proveblue is an in vitro inhibitor of P-gp. 
Methylthioninium chloride Proveblue je in vitro inhibitor P-gp-a.
• Very common side effects (may affect more than 1 in 10 people) pain in extremity dizziness sweating skin discolouration. 
• Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): - bol u udu - omaglica - znojenje - promjena boje kože.
A repeat dose (1 to 2 mg/kg body weight, i.e. 0.2-0.4 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range. 
Ponovljenu dozu (1 do 2 mg/kg tjelesne težine, tj. 0,2-0,4 ml/kg tjelesne težine) moguće je primijeniti jedan sat nakon prve doze u slučajevima perzistentnih ili rekurentnih simptoma ili ako razine methemoglobina ostanu znatno više od normalnog kliničkog raspona.
Monitoring tests You will undergo monitoring tests during and after treatment with Methylthioninium chloride Proveblue. 
Proći ćete testove tijekom i nakon liječenja lijekom Methylthioninium chloride Proveblue.
Methylthioninium chloride may cause a cutaneous photosensitivity reaction when exposed to strong light sources, such as phototherapy, those found in operating theatres or locally from illuminating devices such as pulse oximeters. 
Metiltioninijev klorid može izazvati reakciju fotosenzitivnosti na koži prilikom izlaganja izvorima jakog svjetla, kao što su fototerapija, izvori svjetla u operacijskim dvoranama ili lokalno iz svjetlećih uređaja kao što su pulsni oksimetri.
Methylthioninium chloride should be used with caution in patients with moderate to severe renal disease since there is limited data available and methylthioninium chloride is predominantly renally eliminated. 
Metiltioninijev klorid treba oprezno primjenjivati u bolesnika s umjerenom do teškom bolesti bubrega zbog ograničenih podataka i jer se metiltioninijev klorid uglavnom eliminira putem bubrega.
What Methylthioninium chloride Proveblue contains - The active substance is methylthioninium chloride. 
Što Methylthioninium chloride Proveblue sadrži - Djelatna tvar je metiltioninijev klorid.
Warnings and precautions Talk to your doctor or nurse before you are given Methylthioninium chloride Proveblue - if you have moderate or severe renal disease; lower doses (< 1 mg/kg) may be needed - if your blood disorder has been caused by a chemical called aniline, which is contained in dyes; lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3 of this package leaflet) - if your blood disorder has been caused by a medicine called dapsone (used to treat leprosy and other skin conditions); lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3) 
Obratite se svom liječniku ili medicinskoj sestri prije nego primite Methylthioninium chloride Proveblue: - ako imate umjerenu ili tešku bolest bubrega, niže doze (< 1 mg/kg) možda budu potrebne - ako je Vaš poremećaj krvi uzrokovan kemikalijom koja se zove anilin, koja je sadržana u bojama; možda budu potrebne niže doze i ukupna kumulativna doza ne smije prijeći 4 mg/kg
Not known (frequency cannot be estimated from the available data): - serotonin syndrome when Methylthioninium chloride Proveblue has been taken with certain medicines to treat depression or anxiety, see section 2 - decreased haemoglobin (protein in red blood cells that carry oxygen in the blood) levels may be reported during blood tests - reduction in red blood cells which may turn your skin pale and make you breathless and weak - local tissue damage at the injection site - jaundice (yellowing of the skin and eyes) - this has only been reported in infants - problems with speech - high or low blood pressure - agitation - lack of oxygen - irregular heartbeat, including an abnormally slow or fast beating of the heart - severe allergic reactions (so called anaphylactic reaction which may cause your throat or face to swell, difficulty breathing or a severe rash) - an increase in methaemoglobin (an abnormal form of haemoglobin in the blood) - shortness of breath - confusion - shaking - hives - fever - rapid breathing - dilated pupils - discoloured stools. 
mogu biti zabilježene tijekom obavljanja pretraga krvi - smanjenje broja crvenih krvnih stanica zbog čega možete imati blijedu kožu, nedostatak zraka i slabost - lokalno oštećenje tkiva na mjestu injekcije - žutica (žutilo kože i očiju) - prijavljena je samo kod dojenčadi - problemi s govorom - povišen ili snižen krvni tlak - uznemirenost - nedostatak kisika - nepravilni otkucaji srca, uključujući i nenormalno spore ili brze otkucaje srca - teške alergijske reakcije (takozvana anafilaktička reakcija koja može uzrokovati oticanje grla ili lica, otežano disanje ili jaki osip) - povećanje methemoglobina (nenormalan oblik hemoglobina u krvi) - nedostatak zraka - smetenost - tresenje - koprivnjača - vrućica - ubrzano disanje - proširene zjenice - promjena boje stolice.
Additional information on how Methylthioninium chloride Proveblue can be given is provided in section 3 of the Package Leaflet. 
Dodatne informacije o tome kako se Methylthioninium chloride Proveblue primjenjuje su dane u dijelu 3 ove upute o lijeku.
• venlafaxine 
• venlafaksin
Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava methemoglobinemija
It is unknown whether methylthioninium chloride is excreted in human breast milk. 
Nije poznato izlučuje li se metiltioninijev klorid u majčino mlijeko u ljudi.
Hyperbilirubinaemia has been observed in infants after administration of 20 mg/kg methylthioninium chloride. 
Hiperbilirubinemija je primijećena kod dojenčadi nakon primjene metiltioninijeva klorida od 20 mg/kg.
22 rue Marc Donadille, 13013 Marseille, France 
22 rue Marc Donadille, 13013 Marseille, Francuska
If diluted in glucose 50 mg/ml (5%) solution for injection, methylthioninium chloride must be used with caution in patients with hyperglycaemia or diabetes mellitus, as these conditions may be exacerbated by the glucose solution. 
Ako se metiltioninijev klorid koristi razrijeđen u otopini glukoze za injekcije 50 mg/ml (5%), potreban je oprez kod primjene u bolesnika s hiperglikemijom ili šećernom bolesti jer otopina glukoze može pogoršati ta stanja.
Local tissue necrosis at the injection site Not known Injection site pain 
Često mjestu primjene lokalna nekroza tkiva na mjestu injiciranja
Eye disorders 
Poremećaji oka midrijaza
Methylthioninium chloride Proveblue has been observed to stain tissues selectively. 
Opaženo je da Methylthioninium chloride Proveblue selektivno boji tkivo.
How to store Methylthioninium chloride Proveblue 
Kako čuvati Methylthioninium chloride Proveblue
Its use in parathyroid surgery (not indicated) has induced adverse CNS effects when administered concomitantly with serotonergic medicinal products (see section 4.5). 
Njegova primjena uz istodobnu primjenu serotoninergičkih lijekova kod operacija paratireoidnih žlijezda (nije indiciran) izazvala je negativne nuspojave na SŽS-u (vidjeti dio 4.5).
Hyperbilirubinaemia 
Nepoznato hiperbilirubinemija
This medicine may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in children. 
Ovaj lijek može se razrijediti u 50 ml otopine glukoze za injekcije 50 mg/ml (5%) da bi se izbjegla lokalna bol, osobito kod djece.
For single use only Any solution remaining in the opened ampoules must be discarded. 
Neupotrebljenu otopinu iz otvorenih ampula potrebno je zbrinuti.
An equivocal evidence of carcinogenic activity was observed in female mice. 
Nisu opaženi pouzdani dokazi o kancerogenoj aktivnosti u ženki miševa.
Each 10 ml ampoule contains 50 mg methylthioninium chloride Each 2 ml ampoule contains 10 mg methylthioninium chloride 
Jedna ampula od 10 ml sadrži 50 mg metiltioninijeva klorida Jedna ampula od 2 ml sadrži 10 mg metiltioninijeva klorida
Methylthioninium chloride is an in vitro inducer of CYP1A2. 
Metiltioninijev klorid je in vitro induktor CYP1A2.
PROVEPHARM SAS 22 rue Marc Donadille, 13013 Marseille, France 
Provepharm SAS 22 rue Marc Donadille, 13013 Marseille, Francuska
Provepharm SAS 22 rue Marc Donadille, 13013 Marseille, France 
PROVEPHARM SAS 22 rue Marc Donadille, 13013 Marseille, Francuska
Death occurred in 2 infants after administration of 20 mg/kg methylthioninium chloride. 
Kod 2 dojenčeta je došlo do smrti nakon primjene metiltioninijeva klorida od 20 mg/kg.
Each carton contains a tray with 5 or 20 ampoules of 2 ml in blister. 
Jedna kutija sadrži podložak s 5 ili 20 ampula od 2 ml u blisteru.
Methylthioninium chloride Proveblue is for administration by a healthcare professional. 
Methylthioninium chloride Proveblue smije primjenjivati samo zdravstveni radnik.
The recommended dose is 0.3 to 0.5 mg/kg body weight, i.e. 0.06 to 0.1 ml/kg, over a period of 5 minutes. 
Preporučena doza je 0,3 do 0,5 mg/kg tjelesne težine, tj. 0,06 do 0,1 ml/kg, u trajanju od 5 minuta.
Haemodialysis may be used in patients with severe haemolysis. 
U bolesnika s teškom hemolizom može se primijeniti hemodijaliza.
Each box contains a tray with 20 ampoules of 2 ml. 
Jedna kutija sadrži podložak s 20 ampula od 2 ml.
Skin discoloration (blue) 
Poremećaji kože i potkožnog tkiva promjena boje kože (plava)
Faeces discoloration (blue-green) 
Poremećaji bubrega i mokraćnog sustava kromaturija (plavo-zelena)
Musculoskeletal and connective tissue disorder 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u ekstremitetu
The recommended dose is 0.3-0.5 mg/kg body weight, i.e. 0.06 to 0.1 ml/kg body weight, given over a period of 5 minutes. 
Preporučena doza je 0,3-0,5 mg/kg tjelesne težine, tj. 0,06 do 0,1 ml/kg tjelesne težine, primijenjena u periodu od 5 minuta.
The usual dose is 1 to 2 mg per kg body weight, i.e. 0.2-0.4 ml per kg body weight, given over a period of 5 minutes. 
Uobičajena doza je 1 do 2 mg na kg tjelesne težine, tj. 0,2-0,4 ml na kg tjelesne težine i primjenjuje se tijekom perioda od 5 minuta.
Methylthioninium chloride Proveblue is hypotonic and may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population. 
Methylthioninium chloride Proveblue je hipotoničan i može se razrijediti u 50 ml otopine glukoze za injekcije 50 mg/ml (5%) da bi se izbjegla lokalna bol, posebice u pedijatrijskoj populaciji.
Medac Pharma S.r.l. 
Magyarország Mediwings Pharma Kft.
Laboratoires ETHYPHARM Tel: + 33 1 41 12 65 63 
Tel: + 33 1 41 12 65 63
After intravenous administration Methylthioninium chloride Proveblue is rapidly taken up by the tissues. 
Nakon intravenske primjene tkiva brzo apsorbiraju Methylthioninium chloride Proveblue.
How Methylthioninium chloride Proveblue is given 
Kako primjenjivati Methylthioninium chloride Proveblue
Methylthioninium chloride Proveblue may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population. 
Methylthioninium chloride Proveblue može se razrijediti u 50 ml otopine glukoze za injekcije 50 mg/ml (5%) da bi se izbjegla lokalna bol, osobito u pedijatrijskoj populaciji.
Methylthioninium chloride Proveblue 5 mg/ml solution for injection 
Methylthioninium chloride Proveblue 5 mg/ml otopina za injekciju
Each 10 ml ampoule contains 50 mg methylthioninium chloride. 
Jedna ampula od 10 ml sadrži 50 mg metiltioninijeva klorida.
Lamepro B.V Tel: + 31 (0) 76-5600030 
Tel: + 31 (0) 76-5600030
Each ml of solution contains 5 mg methylthioninium chloride. 
Jedan ml otopine sadrži 5 mg metiltioninijeva klorida.
Intravenous use only For slow intravenous injection 
Za sporu injekciju u venu
Each 2 ml ampoule contains 10 mg methylthioninium chloride. 
Jedna ampula od 2 ml sadrži 10 mg metiltioninijeva klorida.
Each box contains a tray with 5 ampoules of 2 ml. 
Jedna kutija sadrži podložak s 5 ampula od 2 ml.
Each box contains a tray with 5 ampoules of 10 ml. 
Jedna kutija sadrži podložak s 5 ampula od 10 ml.
Dysgeusia 
Vrlo često disgeuzija
Tel.: + 48 694 775 205 
AB Pharm Sp. z o.o. Tel: + 48 694 775 205
Each carton contains a tray with 5 ampoules of 10 ml in blister. 
Jedna kutija sadrži podložak s 5 ampula od 10 ml u blisteru.
Lietuva Provepharm SAS 
Laboratoires ETHYPHARM
Methylthioninium chloride Proveblue 5 mg/ml injection methylthioninium chloride 
Methylthioninium chloride Proveblue 5 mg/ml injekcija metiltioninijev klorid
Tel: +33 (0)4 91 08 69 30 
Provepharm SAS Teл.: + 33 (0)4 91 08 69 30
Methylthioninium chloride Proveblue 5 mg/ml solution for injection Methylthioninium chloride 
Methylthioninium chloride Proveblue 5 mg/ml otopina za injekciju metiltioninijev klorid
Anaphylactic reactions 
Nepoznato afazija
Psychiatric disorders 
Psihijatrijski poremećaji stanje konfuzije
Abdominal pain 
Često bol u abdomenu
Dyspnoea 
AMPULA
Hepatic impairment 
Nepoznato agitacija
Intravenous use only 
Samo za primjenu u venu
Immune system disorders 
Poremećaji imunološkog sustava anafilaktičke reakcije
Tremor 
Često tremor
Tachypnoea 
Nepoznato tahipneja
The usual dose is 1 to 2 mg per kilogram of your body weight, i.e. 0.2 to 0.4 ml per kilogram given over a period of 5 minutes. 
Odrasli, djeca starija od 3 mjeseca i starije osobe Uobičajena doza je 1 do 2 mg po kilogramu tjelesne težine, tj. od 0,2 do 0,4 ml po kilogramu i daje se u trajanju od 5 minuta.
Aphasia 
OBLIK
● At the request of the European Medicines Agency; 
● na zahtjev Europske agencije za lijekove;
Date of first authorisation: 20 July 2015 
Datum prvog odobrenja: 20. srpnja 2015.
• if you think you have hepatitis infection now or have had it in the past. 
• ako mislite da trenutno imate hepatitis infekciju ili ste ju imali u prošlosti.
TTP, months 
TTP, mjeseci
NA=not applicable, NE=not estimated 
NA=nije primjenjivo, NE=nije procijenjeno
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much. 
Budući da Vam ovaj lijek daje liječnik ili medicinska sestra, nije vjerojatno da će Vam se primijeniti previše lijeka.
Progression Free Survival, months 
Preživljenje bez progresije, mjeseci
A total of 218 patients were evaluable for response. 
U ukupno 218 bolesnika bila je moguća procijena odgovora.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain 
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Španjolska
The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BzDx group. 
Medijan trajanja liječenja bio je 13 tjedana za skupinu VDDx i 11 tjedana za BzDx skupinu.
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 pripremljene otopine odgovornost su korisnika.
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. 
Konačna analiza za OS koja je provedena nakon medijana praćenja od 8,6 godina nije pokazala značajnu razliku u OS-u između dvije liječene skupine.
e Median duration of follow up is 11.8 months 
e Medijan trajanja praćenja je 11,8 mjeseci
1-year Overall Survival (%)e 
1-godišnje opće preživljenje (%)e
If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk. 
Ako se toksičnost ne povuče ili se ponovno pojavi pri najnižoj dozi, mora se razmotriti prestanak primjene bortezomiba, osim ako je korist od liječenja neupitno veća od rizika.
Very Common Decreased appetite Common 
Vrlo često Smanjeni apetit
Most cases of PML were diagnosed within 12 months of their first dose of bortezomib. 
Većina slučajeva PMLa bila je dijagnosticirana unutar 12 mjeseci od primjene prve doze bortezomiba.
• Loss of consciousness 
• gubitak svijesti
Bortezomib Accord must be reconstituted by a healthcare professional (see section 6.6). 
Bortezomib Accord mora rekonstituirati zdravstveni radnik (vidjeti dio 6.6).
Cochran Mantel-Haenszel test. 
p-vrijednosti Cochran Mantel-Haenszelovog testa.
Hepatitis B virus (HBV) reactivation and infection 
Reaktivacija virusa hepatitisa B (HBV) i infekcija
Peripheral neuropathy in combination regimens 
Periferna neuropatija u kombiniranim režimima
Reduction in serum M-protein populationg n=667 
Smanjenje serumskog M proteina populacijag n=667
Overall survival* 
Ukupno preživljenje*
BSA-normalized clearance of bortezomib in paediatric patients was similar to that observed in adults. 
BSA-normalizirani klirens bortezomiba u pedijatrijskih bolesnika bio je sličan onim zabilježenim u odraslih.
• Skin reactions and disorders (which may be severe and life threatening), skin ulcers 
• kožne reakcije i poremećaji (koji mogu biti teški i opasni poživot), čirevi na koži
If any of the side effects, gets serious, or if you notice , any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately. 
Ako se bilo koja nuspojava pogorša ili ako primijetite bilo koju nuspojavu koja nije navedena u ovoj uputi, potrebno je odmah obavijestiti liječnika ili ljekarnika.