natgillin/translations-raw huggingface dataset:
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.
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzDx 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 BzDx skupinama; većina bolesnika prošla je jednu transplantaciju.
When Bortezomib Accord is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Kada se Bortezomib Accord primjenjuje zajedno s talidomidom i deksametazonom, trajanje ciklusa liječenja je 28 dana (4 tjedna).
rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
< 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Bortezomib Accord should not be used in children and adolescents because it is not known how the medicine will affect them.
Accord se ne smije primjenjivati kod djece i adolescenata, jer nije poznato kako će lijek utjecati na njih.
Your doctor will work out your dose of Bortezomib Accord according to your height and weight (body surface area).
Vaš će liječnik izračunati dozu lijeka Bortezomib Accord prema vašoj visini i težini (površini tijela).
2 years (for Bortezomib Accord 1 mg) 3 years (for Bortezomib Accord 3.5 mg)
2 godine (za Bortezomib Accord 1 mg) 3 godine (za Bortezomib Accord 3,5 mg)
Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzR-CAP arm.
Antivirusna profilaksa bila je primijenjena u 137 od 240 bolesnika (57%) u BzR-CAP skupini.
Treatment with Bortezomib Accord can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Liječenje lijekom Bortezomib Accord vrlo često može uzrokovati smanjenje broja crvenih i bijelih krvnih stanica i krvnih pločica (trombocita) u krvi.
1 year survival, [95% CI]
1 godina preživljenja, % [95% CI]
Since dialysis may reduce bortezomib concentrations, Bortezomib Accord should be administered after the dialysis procedure (see section 5.2).
Budući da dijaliza može smanjiti koncentracije bortezomiba, Bortezomib Accord treba primijeniti nakon postupka dijalize (vidjeti dio 5.2).
Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than
Bolesnici koji postignu potpuni odgovor mogu nastaviti liječenje tijekom najmanje 2 ciklusa nakon prvog dokaza potpunog odgovora, čak i ako to zahtjeva liječenje u više od 8 ciklusa.
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:
Provedeno je farmakokinetičko ispitivanje u bolesnika s različitim stupnjevima oštećenja bubrega koji su bili podijeljeni prema vrijednostima klirensa kreatinina (CrCL) u sljedeće skupine: normalno
d Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
d Log rank test prilagođen za čimbenike stratifikacije: ISS stupnjevanje i broj prethodnih linija.
This leaflet was last revised in
Ova uputa je zadnji puta revidirana u <datum>.
What Bortezomib Accord is and what it is used for
Što je Bortezomib Accord i za što se koristi
For these dose cohorts, the combined 1-year survival rate was 88.1%.
kombinirana stopa jednogodišnjeg preživljenja iznosila je 88,1%.
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
Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with bortezomib.
Nositelji hepatitisa B i bolesnici s hepatitisom B u anamnezi, moraju se strogo nadzirati na kliničke i laboratorijske znakove aktivne infekcije HBV-om tijekom i nakon kombiniranog liječenja rituksimabom i bortezomibom.
A vial is for single use only and the remaining solution must be discarded.
Bočica je samo za jednokratnu primjenu a preostalu otopinu treba baciti.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP) koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mental cell lymphona.
Nema dokaza koji ukazuju da je neophodna prilagodba doze u bolesnika starijih od 65 godina s multiplim mijelomom ili s limfomom plaštenih stanica.
N=240 (ITT population) N=242 (ITT population)
N=240 (ITT populacija) N=242 (ITT populacija)
Incidence of PN (%) All GradePN ≥ Grade 2 PN ≥ Grade 3 PN
Incidencija PN (%) Svi stupnjevi PN ≥ Stupanj 2 PN ≥ Stupanj 3 PN Prekid radi PN (%)
Sleep disorders and disturbances*
Poremećaji i smetnje spavanja*
Patients with pre-existing severe neuropathy may be treated with bortezomib only after careful risk/benefit assessment.
Bolesnici s već prisutnom teškom neuropatijom mogu se liječiti bortezomibom samo nakon pomne procjene omjera rizika i koristi.
A statistically significant benefit (p < 0.001) in favour of the BzR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Statistički značajna korist (p < 0,001) za BzR-CAP liječenu skupinu u odnosu na R-CHOP skupinu bila je zapažena za TTP (medijan 30,5 naspram 16,1 mjesec), TNT (medijan 44,5 naspram 24,8 mjeseci) i TFI (medijan 40,6 naspram 20,5 mjeseci).