natgillin/translations-raw huggingface dataset:
Creatinine clearance ≤ 30 ml/ min [n (%)]
očistek kreatinina ≤ 30 ml/ min [n (%)]
At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered Vc+M+P treatment.
Ob predhodno določenem času vmesne analize je bil dosežen primarni cilj (čas do napredovanja bolezni) in bolnikom v MP kraku študije so ponudili zdravljenje z VcMP.
Efficacy results are presented in Table 8:
Podatki o učinkovitosti so navedeni v Preglednici 7:
Summary of Efficacy Analyses in the VISTA study Efficacy endpoint Time to progression
Povzetek analize učinkovitosti v študiji VISTA Učinkovitost Čas do napredovanja bolezni
Events (deaths) n (%) Hazard ratiob (95% CI) p-value c
dogodki (smrti) n (%) stopnja tveganjab (95% CI) p- vrednostc Stopnja odziva populacijae n = 668
Response rate populatione n = 668
34 Učinkovitost
n=337
Vc+M+P n=344
PRf n (%) nCR n (%) CR + PRf n (%) p-valued
PRf n (%) nCR n (%) CR + PRf n (%) p- vrednostd Zmanjšanje serumskega M- proteina populacijag n=667
Median Mediana response duration
srednja vrednost Srednja vrednosta trajanja odziva
Events n (%) Mediana (95% CI)
dogodki n (%) srednja vrednosta (95% CI) stopnja tveganjab
(18.3, 28.5)
127 (38) 20, 8 mesecev (18, 3, 28, 5)
(95% CI) p-value c
(95% CI) p- vrednostc a Ocena po metodi Kaplan- Meier. b
Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: beta2-microglobulin, albumin, and region.
Ocena stopnje tveganja na osnovi Coxovega proporcionalnega modela, prilagojena na osnovi stratifikacijskih dejavnikov: β2- mikroglobulin, albumin in regija.
A hazard ratio less than 1 indicates an advantage for VMP c p-value based on the stratified log-rank test adjusted for stratification factors: β 2-microglobulin, albumin, and region d p-value for Response Rate (CR + PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors e Response population includes patients who had measurable disease at baseline f EBMT criteria g All randomized patients with secretory disease NE:
Stopnja tveganja manjša kot 1 kaže prednost zdravljenja z VcMP. c p- vrednost na osnovi stratificiranega log- rank testa, prilagojena na osnovi stratifikacijskih dejavnikov: β2- mikroglobulin, albumin in regija. d p- vrednost za stopnjo odziva (CR + PR) po Cochran- Mantel- Haenszel hi- kvadratnem testu, prilagojena na osnovi stratifikacijskih dejavnikov e Populacijo, pri kateri je prišlo do odziva, predstavljajo bolniki, pri katerih so lahko ovrednotili bolezen pred začetkom zdravljenja. f EBMT kriteriji g Vsi randomizirani bolniki s sekrecijsko boleznijo NE:
Dosing regimens in Phase II and Phase III studies Phase/ arm Treatment schedule
Shema odmerjanja v preskušanjih druge in tretje faze
Dose
faza
Regimen
načrt zdravljenja
II III III
shema odmerjanja
Day 1,4,8,11, (rest Day 12-21) 1.3 mg/ m2 (intravenous bolus) Vc* 1.3 mg/ m2 a) Days 1,4,8,11, (Rest Day 12-21) (intravenous bolus) b) Days 1,8,15,22 Dex 40 mg (oral) c) Days 1– 4, 9 – 12, 17– 20Days 1– 4
a) dan 1, 4, 8, 11 (premor 12. - 21. dan) b) dan 1, 8, 15, 22
Q3 weeks x 8 cycles (extension**) a) Q3weeks x 8, then b) Q5 weeks x 3 a) Q5 week x 4 b) Q4 week x 5
a) 3 tedne x 8, nato b) 5 tednov x 3
Add Dex*** 20 mg (oral) (Days 1,2,4,5,8,9, 11,12)
20 mg (peroralno) (dan 1, 2, 4, 5, 8, 9, 11, 35 12)
Myeloma IgG Myeloma IgA Myeloma light chain Median duration since diagnosis (yrs) Chromosome 13 abnormalities
hemoglobin < 100 g/ l mediana vrednost očistka kreatinina, ml/ min (območje) IgG plazmocitom IgA plazmocitom plazmocitom lahke verige mediana vrednost trajanja od diagnoze (leta) napake na kromosomu 13 mediana vrednost konc. β2 mikroglobulina (mg/ l)
60% 24% 14% 4.0 15%
44% 74 (14- 221) 60% 24% 14% 4, 0 15% 3, 5
35 Median β 2 microglobulin (mg/ l) Median number prior treatment lines* (range)
mediana vrednost št. predhodnjih vrst terapije * 6 (območje)
3.5 6 (2-15)
(2- 15)
Table 11:
Preglednica 11:
Patient exposure to treatment with VELCADE during Phase II Vc
Izpostavljenost bolnikov zdravljenju z zdravilom VELCADE v preskušanjih II. in III. faze
Phase II and III studies Phase III Phase III Vc Dex
Vc III. faza
a) all initial cycles (number) b) full course (number) c) extension *
d) vsi začetni krogi (število) e) celotno zdravljenje
27% (8 cycles) NA n = 63 pts (median 7 cycles) or total median 14 cycles (range 7-32)
NA
As a result of a preplanned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered VELCADE, regardless of disease status.
Bolnikom, ki so
Due to this early crossover, the median duration of follow-up for surviving patients is 8.3 months.
36 bili randomizirani na deksametazon so ponudili zdravilo VELCADE, ne glede na status njihove bolezni.
36 Table 12:
37 Preglednica 12:
Summary of Disease Outcomes from the Phase III and Phase II studies
Povzetek izidov bolezni v preskušanjih III. in II. faze
Phase III Phase III
III. faza III. faza
Phase III > 1 Prior line of
III. faza > 1 predhodna vrsta
Phase II prior
II. faza ≥2
1 Prior line of therapy
1 predhodna vrsta zdravljenja
therapy
zdravljenja
lines
predhodni vrsti zdravljenja
Time related
Časovno
Dex Vc Dex Vc Dex
Vc
Dex Vc Dex Vc Dex
Vc Dex n=119
Dex Vc Dex Vc Dex
dogodki
Vc
n=336a
events TTP, days
n=132a
=333a 189b
n=200a
n
n=217a
=336a 106b
n=202a
n
TTP
=132a 212d
106b
=119a 169d
169d
[95% CI]
(dnevi [95% IZ])
[105, 191]
191] d
1 year survival,%
1- letno
[62,83]
]
Best
Vc n=315c
response (%) CR
Dex n=312c
Vc n =315c 20 (6) b
Vc
Dex n =312c 2 (< 1) b
Dex Vc
Dex n =110 2 (2)
2 (< 1)
Vc n =187 12 (6)
n=110 n=187
Dex n =202 0 (0)
n=202
Vc n=193 (4)**
n=193
41 (13) b
41 (13)
4 (4)
4 (4) 25 (13) 29
25 (13)
b
1 (< 1)
1 (< 1) 27 (13)
121 (38) b
121 (38)
57 (45) d
57 (45)
29 (26) d
(26) d
64 (34) b
b
27 (13) b
CR + nCR+
(27)**
108
45 (41)
(41)
Days (months)
Mediana
242 (8.0)
vrednost
189 (6.2)
238 (7, 8)
238 (7.8)
(5, 6)
126 (4.1)
(6, 2)
Time to response CR + PR (days) a
CR + PR (dnevi) 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 < 0.0001 c Response population includes patients who had measurable disease at baseline and received at least 1 dose of study drug. d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history *CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA = not applicable, NE = not estimated
Populacija oz. skupina bolnikov, ki naj bi jo zdravili (intent to treat, ITT) b p- vrednost iz stratificiranega testa log- ranga; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi, p < 0. 0001 c Populacija oz. skupina bolnikov, pri kateri so ovrednotili odziv na zdravljenje, vključuje bolnike, ki so imeli merljivo bolezen na začetku in so prejeli najmanj en odmerek raziskovalnega zdravila d p- vrednost iz Cochran- Mantel- Haenszelovega hi- kvadrat testa, korigiranega s faktorji stratifikacije; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi * CR+PR+MR; ** CR=CR, (IF -); nCR=CR (IF+) NA = ne velja za ta primer, NE = odziva ni bilo mogoče oceniti
Distribution The mean distribution volume (Vd) of bortezomib ranged from 1659 l to 3294 l following single- or repeated-dose administration of 1.0 mg/ m2 or 1.3 mg/ m2 to patients with multiple myeloma.
38 Porazdelitev Po enkratnem ali večkratnem dajanju odmerkov 1, 0 mg/ m2 ali 1, 3 mg/ m2 bolnikom z diseminiranim plazmocitomom je bil povprečni volumen porazdelitve (Vd) 1659 l do 3294 l.
Metabolism In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolized via cytochrome P450 enzymes, 3A4,
Presnova In vitro študije na človeških jetrnih mikrosomih in izocimih citokroma P450 s izraženo človeško cDNA kažejo, da se bortezomib v prvi vrsti oksidativno presnovi z encimi citokroma P450, 3A4, 2C19 in 1A2.
Elimination The mean elimination half-life of bortezomib upon multiple dosing ranged from 40-193 hours.
Izločanje Po ponavljajočih odmerkih je bil razpon razpolovnih časov bortezomiba 40- 193 ur.
Renal impairment 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:
Ledvična okvara Pri bolnikih z različnimi stopnjami okvare delovanja ledvic so izvedli študijo farmakokinetike.
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).
Bolnike so glede na vrednost očistka kreatinina (CrCL) razdelili v naslednje skupine: normalno delovanje ledvic (CrCL ≥ 60 ml/ min/ 1, 73 m2, n=12), blaga okvara ledvic (CrCL=40- 59 ml/ min/ 1, 73 m2, n=10), zmerna okvara ledvic (CrCL=20- 39 ml/ min/ 1, 73 m2, n=9), resna okvara ledvic (CrCL < 20 ml/ min/ 1, 73 m2, n=3).
Bortezomib was positive for clastogenic activity (structural chromosomal aberrations) in the in vitro chromosomal aberration assay using Chinese hamster ovary cells (CHO) at concentrations as low as 3.125 μ g/ ml, which was the lowest concentration evaluated.
V in vitro preskusu kromosomskih aberacij z uporabo ovarijskih celic kitajskega hrčka (CHO celic) je bil bortezomib v koncentraciji le 3, 125 μg/ ml, ki je bila najnižja ovrednotena koncentracija, pozitiven na klastogeno aktivnost (strukturne kromosomske aberacije).
In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/ or diarrhoea, haematopoietic and lymphatic tissues resulting in peripheral blood cytopenias, lymphoid tissue atrophy and hematopoietic bone marrow hypocellularity: peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
V raziskavah splošne toksičnosti z več krogi zdravljenja na podganah in opicah so bili poglavitni tarčni organi prebavila s posledičnim bruhanjem in/ ali drisko, ter krvotvorni organi s posledičnim zmanjšanjem števila krvnih celic v periferni krvi, zmanjšanjem limfatičnega tkiva ter hipocelularnostjo kostnega mozga, periferno nevropatijo (ki so jo opažali pri opicah, miših in psih) s prizadetostjo
6.3 Incompatibilities
6. 2 Inkompatibilnosti
The reconstituted solution should be used immediately after preparation.
Pripravljeno zdravilo je treba porabiti takoj po raztapljanju.
If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če se rekonstituirane raztopine ne porabi takoj, je za čas in pogoje shranjevanja zdravila po pripravi odgovoren uporabnik.
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 prior to administration, with a maximum of 8 hours in the 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. V injekcijski brizgi se lahko zdravilo shranjuje največ 8 ur.
Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap.
10 ml, steklena viala, steklo tipa I, s sivim zamaškom iz bromobutilne gume in aluminijasto zaporko zaporko z modrim pokrovčkom.
Therefore, caution should be used during handling and preparation of VELCADE.
Spošni previdnostni ukrepi Bortezomib je citotoksičen, zato je potrebna previdnost med njegovo pripravo in ravnanjem z zdravilom VELCADE.
Aseptic technique must be strictly observed throughout handling of VELCADE, since it contains no preservative.
40 Pri delu z zdravilom VELCADE morate ves čas strogo upoštevati aseptično pripravo, ker zdravilo ne vsebuje konzervansov.
Instructions for reconstitution Each 10 ml vial must be reconstituted with 3.5 ml of sodium chloride 9 mg/ ml (0.9%) for injection.
Navodila za pripravo raztopine Vsako 10 ml vialo morate rekonstituirati s 3, 5 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje.
39 Disposal For single use only.
Odlaganje Samo za enkratno uporabo.
JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg, 30 B-2340 Beerse Belgium
JANSSEN- CILAG INTERNATIONAL NV Turnhoutseweg, 30, B- 2340 Beerse Belgija
26/ 04/ 2004 Date of latest renewal:
03/ 01/ 2007
40 ANNEX II
41 DODATEK II
Not applicable
• DRUGI POGOJI
• OTHER CONDITIONS
Načrt za obvladovanje tveganja
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 2. 0 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega mora posodobljen načrt za obvladovanje tveganja predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja. • V obdobju 60 dni po pomembnem mejniku (farmakološkem ali povezanim z zmanjševanjem tveganja). • Na zahtevo EMEA.
PSURs The MAH will submit 6-monthly PSURs, unless otherwise specified by the CHMP.
PSUR Imetnik dovoljenj za promet bo predložil 6- mesečni PSUR, razen če CHMP določi drugače.
42 Area Clinical
43 Področje Klinični vidiki
Description As an adjunct to the population pharmacokinetics (PK) study nested in the ongoing Phase III trial, the applicant will conduct a clinical PK study in 24 patients with multiple myeloma receiving bortezomib at the doses of 1.0 and 1.3 mg/ m2, twice a week for two weeks followed by a rest period.
Bolniki bodo prejemali bortezomib v odmerku 1, 0 in 1, 3 mg/ m2, dvakrat na teden dva tedna, čemur sledi premor v jemanju zdravila.
The aim of this study is to investigate: bortezomib PK after single and multiple dose treatment; the mechanisms behind the observed changes in the PK parameters after repeated dosing; any clinically plausible intrinsic factors that may explain and reduce variability; the relationship between body weight/ body surface area/ lean body weight) and PK parameters since dosing regimen is based on BSA; the concentration-proteasome inhibition relationship using PK/ PD-modelling;
PK bortezomiba po enkratnem in večkratnem odmerjanju; mehanizme, ki so vzrok, opaženim spremembam v PK parametrih po večkratnem odmerjanju;
Date due To be reviewed annually Summary of final results of PK studies below by 31 December 2010 Liver impairment study Final study report expected by 31 December 2010
Preskušanje poškodb jeter Končno poročilo preskušanja je predvideno do 31.
Clinical
decembra 2010.
The applicant will present the results from the planned Phase I/ II clinical trial (protocol under review at NCI) aimed at ruling out the possibility that secondary to proteasome inhibition bortezomib treatment may increase the risk of amyloidosis and/ or may have an adverse impact on its progression and organ manifestations.
Vlagatelj bo predstavil rezultate načrtovanega kliničnega preskušanja faze I/ II (protokol je v pregledu pri NCI), katerega cilj je izločiti možnost, da lahko bortezomib poveča tveganje za amiliodozo in/ ali vpliva na njeno poslabšanje in izraženost.
If this trial will not start or otherwise fail to address the relevant issues, the applicant commits to re-discuss and agree with CHMP the possibility to conduct a randomised controlled trial (or agreed alternative design) in patients with amyloidosis.
Če se to preskušanje ne bo začelo ali ne bo odgovorilo na postavljena vprašanja, se vlagatelj zavezuje, da se bo ponovno posvetoval in strinjal s CPMP o možnosti izvedbe randomiziranega nadzorovanega preskušanja (ali se strinja z drugačno zasnovo preskušanja) pri bolnikih z amiloidozo.
To be reviewed annually Final study report expected by 4Q 2008
Pregledano bo letno Končno poročilo preskušanja je predvideno do zadnjega četrtletja 2008
44 A.
44 DODATEK III
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OZNAČEVANJE
VELCADE 1 mg powder for solution for injection bortezomib
VELCADE 1 mg prašek za raztopino za injiciranje
After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.
Vsaka viala vsebuje 1 mg bortezomiba (v obliki estra manitola in borove kisline) Po rekonstituciji 1 ml raztopine za injiciranje vsebuje 1 mg bortezomiba.
Mannitol (E421), nitrogen
manitol (E 421) dušik
Special handling instructions For single use only.
Samo za enkratno uporabo.
47 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
48 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VELCADE 1 mg powder for injection bortezomib IV use.
VELCADE 1 mg prašek za injiciranje
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
49 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON, VELCADE 3.5 mg
ŠKATLA VELCADE 3, 5 mg
VELCADE 3.5 mg powder for solution for injection bortezomib
VELCADE 3, 5 mg prašek za raztopino za injiciranje bortezomib
After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.
Vsaka viala vsebuje 3, 5 mg bortezomiba (v obliki estra manitola in borove kisline) Po rekonstituciji 1 ml raztopine za injiciranje vsebuje 1 mg bortezomiba.
GLASS VIAL (10 ml) VELCADE 3.5 mg
1.
VELCADE 3.5 mg powder for solution for injection bortezomib Intravenous use.
VELCADE 3, 5 mg prašek za raztopino za injiciranje
VELCADE 1 mg powder for solution for injection VELCADE 3.5 mg powder for solution for injection Bortezomib
53 NAVODILO ZA UPORABO
Read all of this leaflet carefully before you start using this medicine.
VELCADE 1 mg prašek za raztopino za injiciranje
please tell your doctor or pharmacist.
1.
1.
Kaj je zdravilo VELCADE in za kaj ga uporabljamo 2.
What VELCADE is and what it is used for 2.
Kaj morate vedeti, preden boste uporabili zdravilo VELCADE 3.
How to use VELCADE 4.
Kako uporabljati zdravilo VELCADE 4.
How to store VELCADE 6.
Shranjevanje zdravila VELCADE 6.
Proteasomes play an important role in controlling cell function and growth.
KAJ JE ZDRAVILO VELCADE IN ZA KAJ GA UPORABLJAMO
By interfering with their function, bortezomib can kill cancer cells.
Zdravilo VELCADE vsebuje učinkovino bortezomib, ki je zaviralec proteasomov.
VELCADE is used for the treatment multiple myeloma (a cancer of the bone marrow) in adults:
Zdravilo VELCADE se uporablja za zdravljenje diseminiranega plazmocitoma (rak kostnega mozga) pri odraslih:
- in combination with other medicines containing melphalan and prednisone, for patients who
- v kombinaciji z zdraviloma, ki vsebujeta melfalan in prednizolon, pri bolnikih, pri katerih
have not been previously treated for multiple myeloma and are unsuitable for high-dose chemotherapy with bone marrow transplant.
diseminiranega plazmocitoma še nismo zdravili in pri njih kemoterapija v visokih odmerkih, pred presaditvijo kostnega mozga, ni mogoča, ali
- alone (monotherapy) for patients whose disease is worsening (progressive) after receiving at
- samostojno (v monoterapiji) pri bolnikih, pri katerih je bolezen napredovala po tem, ko so prejeli
least one prior treatment and for whom. bone marrow transplantation was not successful or is unsuitable.
vsaj eno predhodno vrsto zdravljenja in so jim že presadili kostni mozeg ali presaditev kostnega mozga pri njih ni mogoča.
BEFORE YOU USE VELCADE
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO VELCADE
Do not use VELCADE
Ne uporabljajte zdravila VELCADE
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of
- če ste alergični (preobčutljivi) na zdravilno učinkovino ali za katero koli sestavino zdravila
VELCADE
VELCADE,
- if you have severe liver problems
- če imate hudo bolezen jeter,
- if you have certain severe pulmonary or heart problems.
- če imate ali določene hude probleme s pljuči in srcem.
Take special care with VELCADE 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 • liver problems. • numbness, tingling, or pain in the hands or feet (neuropathy) in the past.
Bodite posebno pozorni pri uporabi zdravila VELCADE Zdravniku povejte, če: • imate premajhno število eritrocitovali levkocitov, • imate težave s strjevanjem krvi in/ ali majhno število trombocitov • imate drisko, ste zaprti, vam je slabo ali bruhate,, • ste v preteklosti kdaj izgubljali zavest, bili omotični ali vrtoglavi, • imate težave z ledvicami, • imate težave z jetri, • ste imeli v preteklosti kakršnekoli težave z odrevenelostjo, mravljinci ali bolečino v dlaneh ali stopalih (nevropatija), • imate težave s srcem ali s krvnim tlakom, 54 • imate amiloidozo, • imate težave z dihanjem ali kašljem.
VELCADE should not be used in children and adolescents, due to limited experience.
Izkušenj pri otrocih in mladostnikih je malo, zato se pri njih zdraviloVELCADE ne sme.
Using other medicines Please tell your doctor, or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
In particular, tell you doctor if you are using medicines containing any of the following active substances:
Še posebno ga morate obvesti, če jemljete zdravila, ki vsebujejo katero izmed naslednjih učinkovin:
- ketoconazole, used to treat fungal infections
- ketoconazol, ki se uporablja za zdravljenje glivičnih okužb,
- fluoxetine, used to treat depression
- fluoxetin, ki se uporablja za zdravljenje depresije,
- rifampicin, and antibiotic used to treat bacterial infections
- rifampicin, in antibiotik, ki se uporablja za zdravljenje bakterijskih okužb,
- oral antidiabetics
- peroralne antidiabetike.
Discuss with your doctorwhen it is safe to restart breast-feeding after finishing your treatment.
Ko zaključite zdravljenje se z zdravnikom pogovorite o tem, kdaj je varno ponovno začeti z dojenjem.
Driving and using machines VELCADE might cause tiredness, dizziness, fainting, or blurred vision.
Vpliv na sposobnost upravljanja vozil in strojev
Do not drive or operate any dangerous tools or machines if you experience such side effects; even if you do not, you should still be cautious.
Če imate navedene neželene učinke ne vozite in ne upravljajte nevarnih orodij ali strojev, pa tudi če jih nimate morate vseeno biti previdni.
HOW TO USE VELCADE
KAKO UPORABLJATI ZDRAVILO VELCADE
The usual starting dose is 1.3 mg/ m2 body surface area.
Običajni začetni odmerek je 1, 3 mg/ m2 telesne površine.
Your doctor may change the dose and total number of cycles, depending on your response to the treatment and on the occurrence of certain side effects.
Glede na vaš odziv na zdravljenje in pojavnost določenih neželenih učinkov lahko zdravnik spremeni odmerek in število krogov zdravljenja.
Monotherapy When VELCADE is given alone, one cycle of treatment with VELCADE consists of a total of 4 doses.
Kadar se zdravilo VELCADE uporablja samostojno, en krog zdravljenja z zdravilom VELCADE sestoji iz skupaj 4 odmerkov.