natgillin/translations-raw huggingface dataset:
A sustained haemoglobin level of greater than 12 g/dl (7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment if haemoglobin values exceeding 12 g/dl (7.45 mmol/l) are observed are described below.
Dolgotrajni ravni hemoglobina, višji od 12 g/dl (7,45 mmol/l), se je treba izogibati.
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Biopoin 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 2 leti
EU/1/09/565/009 6 pre-filled syringes
EU/1/09/565/009 6 napolnjenih injekcijskih brizg
Therapy should be reinitiated at approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/dl (7.45 mmol/l) or below.
Spodaj so opisane smernice za ustrezno prilagajanje odmerka, če vrednosti hemoglobina presegajo 12 g/dl (7,45 mmol/l).
Biopoin 4,000 IU/0.5 ml injection Epoetin theta
Biopoin 4000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 30.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
Biopoin 1,000 IU/0.5 ml
Biopoin 1000 i.e./0,5 ml
EU/1/09/565/001 6 pre-filled syringes
EU/1/09/565/001 6 napolnjenih injekcijskih brizg
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Biopoin 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 2 leti
Excipients
PRCA
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/009
Biopoin 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/565/009
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
Before you give yourself an Biopoin injection, you must do the following: Hold the syringe and gently remove the cover from the needle without twisting.
Primite brizgo in nežno odstranite pokrovček z igle, brez obračanja.
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Biopoin 20.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
Biopoin 3,000 IU/0.5 ml injection Epoetin theta
Biopoin 3000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/005
Biopoin 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/565/005
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Biopoin 10.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 30 mesecev
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
EU/1/09/565/010 6 pre-filled syringes with safety device EU/1/09/565/033 6 pre-filled syringes with safety needle
EU/1/09/565/040 1 napolnjena injekcijska brizga z varnostno iglo EU/1/09/565/041 4 napolnjene injekcijske brizge z varnostno iglo EU/1/09/565/042 6 napolnjenih injekcijskih brizg z varnostno iglo
EU/1/09/565/003 6 pre-filled syringes
EU/1/09/565/003 6 napolnjenih injekcijskih brizg
Biopoin 30,000 IU/1 ml injection Epoetin theta
Biopoin 30.000 i.e./1 ml injekcija epoetin theta s.c., i.v.
6 pre-filled syringes with safety needle containing 1 ml.
6 napolnjenih injekcijskih brizg, ki vsebujejo 1 ml. 6 napolnjenih injekcijskih brizg z varnostno iglo, ki vsebujejo 1 ml.
4 pre-filled syringes with safety needle containing 1 ml.
4 napolnjene injekcijske brizge, ki vsebujejo 1 ml. 4 napolnjene injekcijske brizge z varnostno iglo, ki vsebujejo 1 ml.
Biopoin 10,000 IU/1 ml injection Epoetin theta
Biopoin 10.000 i.e./1 ml injekcija epoetin theta s.c., i.v.
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Biopoin 30.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 30 mesecev
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/001
Biopoin 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/565/001
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Biopoin 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 2 leti
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Biopoin 30.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
1 pre-filled syringe with safety needle containing 1 ml.
1 napolnjena injekcijska brizga, ki vsebuje 1 ml. 1 napolnjena injekcijska brizga z varnostno iglo, ki vsebuje 1 ml
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Biopoin 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 2 leti
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Biopoin 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Biopoin 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
EU/1/09/565/005 6 pre-filled syringes
EU/1/09/565/005 6 napolnjenih injekcijskih brizg
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Biopoin 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
Biopoin 1,000 IU/0.5 ml injection Epoetin theta
Biopoin 1000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/003
Biopoin 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/565/003
EU/1/09/565/006 6 pre-filled syringes with safety device EU/1/09/565/031 6 pre-filled syringes with safety needle
EU/1/09/565/034 1 napolnjena injekcijska brizga z varnostno iglo EU/1/09/565/035 4 napolnjene injekcijske brizge z varnostno iglo EU/1/09/565/036 6 napolnjenih injekcijskih brizg z varnostno iglo
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Biopoin 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
Hydrochloric acid (6 M) (for pH adjustment) Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfatdihidrat natrijev klorid polisorbat 20 trometamol klorovodikova kislina (6 M) (za uravnavanje pH) voda za injekcije
Do not pass it on to others.
Ne uporabite,
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Biopoin 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
Biopoin 2,000 IU/0.5 ml injection Epoetin theta
Biopoin 2000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
EU/1/09/565/008 6 pre-filled syringes with safety device EU/1/09/565/032 6 pre-filled syringes with safety needle
EU/1/09/565/018 1 napolnjena injekcijska brizga z varnostnim pripomočkom EU/1/09/565/019 4 napolnjene injekcijske brizge
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Biopoin 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
Biopoin 2,000 IU/0.5 ml
Biopoin 2000 i.e./0,5 ml
This is expected and may last for a few months.
To je pričakovano in lahko traja nekaj mesecev.
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
ponedeljek torek sreda četrtek petek sobota nedelja peroralna uporaba
The incidence for the 5-year period was 11%.
Incidenca v 5-letnem obdobju je bila 11%.
48-month follow-up
48-mesečno spremljanje
This does not necessarily mean that your blood cancer is getting worse.
To ne pomeni nujno, da se vaš krvni rak slabša.
Recommended dose modifications are described below:
Priporočene prilagoditve odmerjanja so opisane spodaj:
This means you should tell your doctor if you take other medicines that increase your risk of bleeding.
To pomeni, da morate zdravniku povedati, če jemljete druga zdravila, ki povečujejo tveganje za krvavitev.
Push tablet through from other side.
Tableto pritisnite z druge strani in jo potisnite skozi folijo.
Final Analysis at 65-month follow-up
Končna analiza po 65-mesečnem spremljanju
Not known (frequency cannot be estimated from available data)
Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
Talk to your doctor about what your test results mean.
Z zdravnikom se pogovorite o tem, kaj pomenijo izvidi vaših preiskav.
Frequency (All grades)
Pogostnost (vse stopnje)
The mechanism for the bleeding-related events is not fully understood.
Mehanizem dogodkov v povezavi s krvavitvami, ni popolnoma jasen.
Your doctor may adjust your dose.
Zdravnik vam lahko spremeni odmerek.
A risk to breast-fed children cannot be excluded.
Tveganja za dojene otroke ne moremo izključiti.
Not reached (1.9+, 36.4+)
ni dosežena (1,9+; 36,4+)
The safety and efficacy of IMBRUVICA in children and adolescents aged 0 to 18 years have not been established.
Varnost in učinkovitost zdravila IMBRUVICA pri otrocih in mladostnikih, starih od 0 do 18 let, nista bili dokazani.
ORR (%) p-value p<0.0001
ORR (%) vrednost-p p < 0,0001
The study enrolled 269 patients with CLL.
V študijo je bilo vključenih 269 bolnikov s KLL.
Carcinogenicity/genotoxicity
Karcinogenost/genotoksičnost
CLL and WM
KLL in WM
Not reached
ni dosežena
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in v vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The following adverse effects were seen in studies of 13-weeks duration in rats and dogs.
Spodaj navedene neželene učinke so opažali v 13-tedenskih študijah na podganah in psih.
Total (N=63)
skupaj (N = 63)
The half-life of ibrutinib is 4 to 13 hours.
Razpolovni čas izločanja ibrutiniba je 4 do 13 ur.
Apparent clearance (CL/F) is approximately 1,000 L/h.
Navidezni očistek (CL/F) znaša približno 1.000 l/h.
Median time to response was 1.9 months.
Mediani čas, do odgovora je bil 1,9 meseca.
Table 10: ORR and DOR in patients with WM
Preglednica 10: ORR in DOR pri bolnikih z WM
No clinical data are available on this interaction.
Kliničnih podatkov o tem medsebojnem delovanju ni.
Most patients with fatal infections also had neutropenia.
Večina bolnikov z okužbami, ki so privedle do smrti, je imela tudi nevtropenijo.
Long-term safety
Varnost pri dolgotrajni uporabi
Median PFS
mediana PFS
Each pack contains one bottle.
Ena škatla vsebuje eno plastenko.
Date of latest renewal: 25 June 2019
Datum prve odobritve: 21. oktober 2014 Datum zadnjega podaljšanja: 25. junij 2019
Your doctor or another healthcare provider may do blood tests to check for TLS.
Zdravnik ali drug zdravstveni delavec vam bo opravil krvne preiskave na TLS.
It is not known whether ibrutinib or its metabolites are excreted in human milk.
Ni znano, ali se ibrutinib ali njegovi presnovki izločajo v mleko pri ljudeh.
Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioral signs or symptoms.
Zdravniki morajo PML upoštevati v diferencialni diagnozi pri bolnikih z novimi ali s poslabšanjem obstoječih nevroloških, kognitivnih ali vedenjskih znakov ali simptomov.
Juvenile toxicity studies have not been conducted.
Študij toksičnega delovanja pri mladičih niso izvajali.
Use as directed by your physician.
Uporabljajte po navodilu zdravnika.
Hydration should be maintained and serum creatinine levels monitored periodically.
Vzdrževati je treba ustrezno hidracijo in periodično spremljati serumske koncentracije kreatinina.
It is currently unknown whether ibrutinib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method.
Trenutno še ni znano ali lahko ibrutinib zmanjša učinkovitost hormonskih kontraceptivov, zato morajo uporabnice hormonskih kontracepcijskih sredstev dodatno uporabljati še pregradno metodo.
Patients who ingested more than the recommended dose should be closely monitored and given appropriate supportive treatment.
Bolnike, ki zaužijejo večji odmerek od priporočenega, je treba skrbno spremljati in uvesti ustrezno podporno zdravljenje.
All gastrointestinal, lymphoid and bone findings recovered following recovery periods of 6-13 weeks.
Vsi gastrointestinalni, limfatični in skeletni izvidi so se normalizirali v obdobju okrevanja 6-13 tednov.
Ibrutinib exposure increases with doses up to 840 mg.
Izpostavljenost ibrutinibu se povečuje z večanjem odmerka do 840 mg.
All PRs achieved; p<0.0001 for ORR.
Vsi doseženi odgovori so bili delni; p < 0,0001 za ORR.
The primary endpoint in this study was ORR per investigator assessment.
Primarni cilj študije je bil ORR po oceni raziskovalca.
All patients received BR for a maximum of six 28-day cycles.
Vsi bolniki so prejeli BR največ šest 28-dnevnih krogov zdravljenja.
It belongs to a class of medicines called protein kinase inhibitors.
Sodi v skupino zdravil, ki jih imenujemo zaviralci proteinske kinaze.
Overall Response Rate (CR, VGPR, PR, MR)
Celokupni delež odgovora (CR, VGPR, PR, MR)
When you take a tablet, fill in the day of the week or the date in the space provided.
Ko vzamete tableto, v okence vpišite dan v tednu ali datum.
The IRC estimated median DOR was 19.6 months.
IRC je ugotovila, da je bila mediana trajanja odgovora 19,6 meseca.
The apparent volume of distribution at steady state (Vd, ss/F) was approximately 10,000 L.
V stanju dinamičnega ravnovesja je bil navidezni volumen porazdelitve (Vd,ss/F) približno 10.000 l.
The median time to response was 1.0 month (range: 0.7-13.4 months).
Mediana časa do odgovora je bila 1,0 mesec (razpon: 0,7-13,4 mesece).
Treatment with this medicinal product should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Zdravljenje s tem zdravilom mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo onkoloških zdravil.
What IMBRUVICA is and what it is used for
Kaj je zdravilo IMBRUVICA in za kaj ga uporabljamo
A high number of circulating lymphocytes (>400,000/mcL) may confer increased risk.
Veliko število cirkulirajočih limfocitov (> 400.000/mikroliter) lahko pomeni povečano tveganje.
Best Overall Response (%) CR
Najboljši dosežen odgovor (%) CR
The efficacy was similar across all of the subgroups examined, including in patients with and without deletion 17p, a pre-specified stratification factor (Table 8).
Učinkovitost je bila podobna v vseh preiskovanih podskupinah, vključno z bolniki z delecijo 17p oziroma brez nje, kar je bil vnaprej določen dejavnik za stratifikacijo (Preglednica 8).
With a median follow-up time on study of 34 months (range, 8.6+ to 37.7 months), the median duration of response has not been reached.
Z medianim trajanjem spremljanja bolnikov v študiji 34 mesecev (od 8,6+ do 37,7 meseca), mediana vrednost trajanja odgovora ni bila dosežena.
All Grades
Vse stopnje
The ORR and DOR were assessed using criteria adopted from the Third International Workshop of WM.
ORR in čas trajanja odgovora (DOR- duration of response) so ocenili z uporabo kriterijev tretje mednarodne delavnice o WM.
Forty-five percent of patients were treatment-naïve, and 55% of patients were previously treated.
Petinštirideset odstotkov bolnikov je bilo predhodno nezdravljenih, 55% bolnikov pa je predhodno že prejemalo zdravljenje.
Of the 1200 patients treated with IMBRUVICA, 64% were 65 years of age or older.
Med 1.200 bolniki, zdravljenimi z zdravilom IMBRUVICA, jih je bilo 64% starih 65 let ali več.
• The active substance is ibrutinib.
• Učinkovina je ibrutinib.
Table 1: Adverse reactions reported in clinical studies or during post marketing surveillance in patients with B-cell malignancies
Preglednica 1: Neželeni učinki poročani v kliničnih študijah ali med spremljanjem v obdobju trženja pri bolnikih z malignomi celic B
The median DOR was not reached.
Mediano trajanje odgovora ni bilo doseženo.
IMBRUVICA should be held at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.
Zdravila IMBRUVICA se ne sme jemati najmanj 3 do 7 dni pred kirurškim posegom in po njem, pri čemer je dolžina tega obdobja odvisna od vrste kirurškega posega in tveganja za krvavitev.
ECOG per CRF
Ocena ECOG v CRF
Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater were excluded from the study.
Bolniki z oceno splošne zmogljivosti po lestvici ECOG (Eastern Cooperative Oncology Group) 3 ali več niso smeli biti vključeni v študijo.
• severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals
• hud izpuščaj z mehurji in luščenjem kože, predvsem okrog ust, nosu, oči in genitalij (Stevens
Frequencies are defined as follows: 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), not known (cannot be estimated from the available data).
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Bleeding-related events
Dogodki v povezavi s krvavitvami
90% of radioactivity was excreted within 168 hours, with the majority (80%) excreted in the faeces and <10% accounted for in urine.
C], približno 90% radioaktivnosti izločilo v 168 urah, pri čemer se je večina (80%) izločila z blatom, < 10% pa z urinom.
Take the capsules and this leaflet with you.
Kapsule in to navodilo vzemite s seboj.
Adverse reactions leading to dose reduction occurred in approximately 7% of patients.
Zaradi pojava neželenih učinkov so odmerek zmanjšali pri približno 7% bolnikov.
The prevalence for Grade 3 or greater hypertension was 4% (year 0-1), 6% (year 1-2), 8% (year 2-3), 9% (year 3-4), and 9% (year 4-5).
Prevalenca hipertenzije stopnje 3 ali več je bila 4% (leto 0-1), 6% (leto 1-2), 8% (leto 2-3), 9% (leto 3-4) in 9% (leto 4-5).