natgillin/translations-raw huggingface dataset:
Erfaringer efter markedsføringen
Post Marketing Experience
Klinisk signifikante utilsigtede reaktioner er nævnt i tabel 6, hvis de er indberettet efter godkendelsen af VELCADE og er eller er ikke indberettet fra kliniske forsøg:
Clinically significant adverse reactions are listed in Table 6, if they have been reported during post approval use of VELCADE and may or may not have been reported in clinical trials.
Hjertetamponade, perikardit, hjerte - og hjerte- lungestop, ventrikulær Ikke kendt:
Cardiac tamponade, pericarditis, cardiac and cardiopulmonary arrest, Not known:
arytmi, totalt atrioventrikulært blok, atrieflimren, takykardi, sinus - og ventrikulær takykardi.
ventricular arrhythmias, atrio-ventricular block complete, atrial fibrillation, tachycardia, sinus and ventricular tachycardia
Luftveje, thorax og mediastinum (se pkt.
Gastrointestinal disorders
5. 3).
For preclinical cardiovascular safety pharmacology studies, see section 5.3.
31 Der findes ingen specifik antidot mod overdosering af bortezomib.
There is no known specific antidote for bortezomib overdose.
Andre antineoplastiske midler, ATC- kode:
Other antineoplastic agent, ATC code:
NF - κB er en transkriptionsfaktor, hvis aktivering kræves til mange aspekter af tumorgenese, inklusive cellevækst og – overlevelse, angiogenese, celle- celle- interaktioner og metastase.
NF-kB is a transcription factor whose activation is required for many aspects of tumourigenesis, including cell growth and survival, angiogenesis, cell-cell interactions, and metastasis.
Forsøg har påvist, at bortezomib er cytotoksisk over for en række cancercelletyper, og at cancerceller er mere følsomme over for proapoptotiske virkninger af proteasom- hæmning end normale celler.
Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types and that cancer cells are more sensitive to the proapoptotic effects of proteasome inhibition than normal cells.
Et prospektivt, internationalt, randomiseret (1: 1), åbent klinisk fase III- forsøg (VISTA) med 682 patienter blev gennemført for at bestemme, om VELCADE (1, 3 mg/ m2) i kombination med melphalan (9 mg/ m2) og prednison (60 mg/ m2) medførte en forbedring i tid til progression (TTP) ved sammenligning med melphalan (9 mg/ m2) og prednison (60 mg/ m2) til patienter med tidligere ubehandlet myelomatose.
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomized (1:1), open-label clinical study (VISTA) of 682 patients was conducted to determine whether VELCADE (1.3 mg/ m2) in combination with melphalan (9 mg/ m2) and prednisone (60 mg/ m2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/ m2) and prednisone (60 mg/ m2) in patients with previously untreated multiple myeloma.
32 Tabel 7:
Table 7:
Patientkarakteristika
Patient Characteristics
Race: kaukasisk/ asiatisk/ sort/ andet Karnofsky performance statusscore ≤ 70 Hæmoglobin < 100 g/ l 9
Caucasian/ asian/ black/ other Karnofsky performance status score ≤ 70 Hemoglobin < 100 g/ l Platelet count < 75 x 109/ l
88%
88%
/ 10% / 1% / 1% 35% 37%
/ 10% / 1% / 1% 35% 37% < 1%
/ 11% / 2% / 0% 33% 36%
/ 11% / 2% / 0% 33% 36% 1%
Myelomatype (%):
33 Disease Characteristics Type of myeloma (%):
IgG/ IgA/ Let kæde Median β2- mikroglobulin (mg/ l)
IgG/ IgA/ Light chain Median β 2-microglobulin (mg/ l)
64% /
64% /
24% / 8% 4, 2
24% / 8% 4.2
62% / 26% / 8% 4, 3
26% / 8% 4.3
Median albumin (g/ l)
Median albumin (g/ l)
Kreatininclearance ≤ 30 ml/ min [n (%)]
Creatinine clearance ≤ 30 ml/ min [n (%)]
20 (6%)
20 (6%)
16 (5%)
16 (5%)
Effektresultaterne fremgår af tabel 8:
Efficacy results are presented in Table 8:
Oversigt over effektanalyserne i VISTA- forsøget Effektmål Tid til progression –
Summary of Efficacy Analyses in the VISTA study Efficacy endpoint Time to progression
Hændelser (dødsfald) n (%) Hazard ratiob (95% CI) p- værdi c
Events (deaths) n (%) Hazard ratiob (95% CI) p-value c
PRf n (%) nCR n (%) CR + PRf n (%) p- værdid
PRf n (%) nCR n (%) CR + PRf n (%) p-valued
Median Mediana responsvarighed
Median Mediana response duration
33
Hazard ratiob
Effektmål
(26.1, NE)
Vc+M+P n=344
0.52
M+P n=338
(18.3, 28.5)
Mediana (95% CI) Hazard ratiob
(95% CI) p-value c
20, 8 md (18, 3, 28, 5)
(0.39, 0.70) 0.000009
(95% CI) p- værdi c a Kaplan- Meier- estimat b
a Kaplan-Meier estimate. b
(0, 39, 0, 70) 0, 000009
34
Estimatet af Hazard ratio er baseret på Cox 'proportionelle risikomodel justeret for opdelingsfaktorer: β2- mikroglobulin, albumin og region.
Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: beta2-microglobulin, albumin, and region.
Et risikoforhold på mindre end 1 indikerer en fordel for VMP c p- værdi baseret på den stratificerede log- rank- test justeret for opdelingsfaktorer: beta2 - microglobulin, albumin og region d p- værdi for responsrate (CR + PR) fra Cochran- Mantel- Haenszel chi- square- test justeret for opdelingsfaktorer e Responspopulation omfatter patienter, som havde målbar sygdom ved baseline f EBMT- kriterier g Alle randomiserede patienter med sekretorisk sygdom NE:
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:
Ikke- estimerbar
Not estimable
Dosering i fase II - og fase III- forsøg Fase II
Dosing regimens in Phase II and Phase III studies Phase/ arm Treatment schedule
Plan Vc:
Dose
Dosis 1, 3 mg/ m2 (intravenøs bolus)
Regimen
Dex c) dag 1- 4, 9- 12, 17- 20 d) dag 1- 4
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) hver 5. uge x 4 b) hver 4. uge x 5
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
Medianalder i Kaukasisk
Myeloma IgG Myeloma IgA Myeloma light chain Median duration since diagnosis (yrs) Chromosome 13 abnormalities
59 (34- 84) 81%
60% 24% 14% 4.0 15%
61 (33- 84) 90%
60% 23% 12% 3.5 25.7%
61 (27- 86) 88%
59% 24% 13% 3.1 25.0%
Trombocytter < 75. 000/ μl Hæmoglobin < 100g/ l
35 Median β 2 microglobulin (mg/ l) Median number prior treatment lines* (range)
21% 44%
3.5 6 (2-15)
6% 32%
3.7 2 (1-7)
4% 28%
3.6 2 (1-8)
Median kreatinin- clearance, ml/ min (interval) Myelom- IgG Myelom- IgA Letkædet myelom Median varighed siden diagnosen (år) Kromosom 13- abnormiteter Median β2 mikroglobulin (mg/ l) Median antal tidligere behandlinger (interval) * 1 tidligere behandling > 1 tidligere behandling
1 prior line > 1 prior line
73, 3 (15, 6- 170, 7) 60% 23% 12% 3, 5 25, 7% 3, 7 2 (1- 7) n=132( 40%) n= 186 (60%)
n =132 (40%) n = 186 (60%) n =
73, 3 (15, 3- 261, 1) 59% 24% 13% 3, 1 25, 0% 3, 6 2 (1- 8) n= 119 (35%) n= 194 (65%)
n = 119 (35%) 194 (65%)
Fase III Vc
Patient exposure to treatment with VELCADE during Phase II Vc
Fase III Dex
Phase II and III studies Phase III Phase III Vc Dex
27% (8 cyklusser) ikke relevant
27% (8 cycles) NA n = 63 pts (median 7 cycles) or total median 14 cycles (range 7-32)
Som et resultat af den forud planlagte interimanalyse blev dexametason- gruppen standset på anbefaling fra datamonitoreringskomiteen og fik derefter tilbudt VELCADE uanset sygdommens status.
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.
35 Tabel 12:
36 Table 12:
Resume over sygdomsresultater fra fase III - og II- forsøg
Summary of Disease Outcomes from the Phase III and Phase II studies
Fase III
Phase III Phase III
Fase
Phase III > 1 Prior line of
III
≥ 2
Fase III
Phase II prior
fase II
All patients
1 tidligere
1 Prior line of therapy
> 1 tidligere
therapy
≥2
lines
Alle patienter
Time related
behandling
Vc
behandling Dex
Dex Vc Dex Vc Dex
Vc n=119
Dex Vc Dex Vc Dex
hændelser TTP, dage
events TTP, days
n=333a 189b
=333a 189b
n=336a 106b
=336a 106b
n=132a 212d
=132a 212d
a n=200a 169d 148b
=119a 169d
N=217a 87b
n =217a 87b
n=202a 210
=202a 210
[105, [129,
[129, 192]
[84,
[84, 107]
[154,
[154, 281]
73 [62, 83
72d
[64, 82]]
[62,83]
[53, 71]
[64,82]
Bedste respons
[53,71]
Vc
Best
Dex
response (%) CR
Dex Vc
Vc n =315c 20 (6) b
Vc n=193
Vc n =128 8 (6)
n=315c
Dex n =110 2 (2)
n=312c
Vc n =187 12 (6)
n=128
Dex n =202 0 (0)
n=110 n=187
Vc n=193 (4)**
n=202
CR
CR CR + nCR
+ nCR
2 (2) 12 (6) 4 (4) 25 (13) 29
25 (13)
64 (34) b (26) d b
64 (34) b
Median varighed dage (måneder) Tiden indtil
Days (months)
respons CR + PR (dage) a
Time to response CR + PR (days) a
I bortezomibs
This suggests that bortezomib distributes widely to peripheral tissues.
36 koncentrationsinterval på 0, 01- 1, 0 µg/ ml var in vitro proteinbindingen gennemsnitligt 82, 9% i humant plasma.
Over a bortezomib concentration range of 0.01 to 1.0 μ g/ ml, the in vitro protein binding averaged 82.9% in human plasma.
Metabolisme In vitro- forsøg med humane levermikrosomer og cDNA- udtrykte cytokrom P450- isozymer indikerer, at bortezomib hovedsageligt metaboliseres ved oxydering via cytokrom P450- enzymer, 3A4, 2C19 og 1A2.
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,
Elimination Den gennemsnitlige eliminationshalveringstid (t 1/ 2) for bortezomib efter gentagne doser var mellem 40- 193 timer.
Elimination The mean elimination half-life of bortezomib upon multiple dosing ranged from 40-193 hours.
For efterfølgende doser lå den gennemsnitlige totale clearance på 15- 32 l/ t. og 18- 32 l/ t. for doser på henholdsvis 1, 0 mg/ m2 og 1, 3 mg/ m2.
Mean total body clearances were 102 and 112 l/ h following the first dose for doses of 1.0 mg/ m2 and 1.3 mg/ m2, respectively, and ranged from 15 to 32 l/ h and 18 to 32 l/ h following subsequent doses for doses of 1.0 mg/ m2 and 1.3 mg/ m2, respectively.
4. 3).
In the absence of data VELCADE is contraindicated in patients with severe liver impairment (see section 4.3).
Nedsat nyrefunktion Et farmakokinetisk forsøg er foretaget hos patienter med varierende grad af nedsat nyrefunktion, som blev klassificeret i følgende grupper i henhold til deres kreatinin- clearance (CrCL):
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:
Bortezomib var positivt for klastogen aktivitet (strukturelle kromosomafvigelser) i in vitro- analysen af kromosomafvigelser ved hjælp af ovarieceller fra kinesiske hamstre (CHO) i koncentrationer så lave som 3, 125 µg/ ml, som var den lavest vurderede koncentration.
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.
I generelle toksicitetsforsøg med flere cyklusser med rotter og aber omfattede de vigtigste målorganer mave- tarm- kanalen, hvilket resulterede i opkastning og/ eller diaré, hæmatopoietisk og lymfatisk væv, hvilket resulterede i perifere blodcytopenier, lymfoidt vævsatrofi og hæmatopoietisk knoglemarvs - hypocellularitet, perifer neuropati (set hos aber, mus og hunde) som involverer sensoriske nerveaxoner og mindre forandringer i nyrerne.
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.
6. 2 Uforligeligheder
6.3 Incompatibilities
6. 3 for opbevaringsforholdene for det rekonstituerede produkt.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Type 1, 10 ml hætteglas med en grå bromobutyl- prop og en aluminiumsforsegling med kongeblåt låg.
Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap.
38 Instruktioner for rekonstitution Hvert hætteglas rekonstitueres med 3, 5 ml natriumchlorid til injektion 9 mg/ ml (0, 9%).
Instructions for reconstitution Each 10 ml vial must be reconstituted with 3.5 ml of sodium chloride 9 mg/ ml (0.9%) for injection.
Bortskaffelse Kun til engangsbrug.
39 Disposal For single use only.
EU/ 1/ 04/ 274/ 001.
EU/ 1/ 04/ 274/ 001
39 BILAG II
40 ANNEX II
40 A.
41 A.
Turnhoutseweg 30, 2340 Beerse Belgien
Turnhoutseweg 30 B-2340 Beerse Belgium
Lægemidlet må kun udleveres efter begrænset recept (BEGR), (jf. bilag I:
Medicinal product subject to restricted medical prescription (See Annex I:
Risikostyringsplan
• OTHER CONDITIONS
Indehaveren af markedsføringstilladelsen er forpligtet til at udføre de forsøg og yderligere aktiviteter inden for bivirkningsovervågning, der er beskrevet i bivirkningsovervågningsplanen som vedtaget i version 2. 0 (af risikostyringsplanen) af ” Risk management plan ” (RMP), vedlagt i modul 1. 8. 2. i ansøgningen om markedsføringstilladelse og i alle senere opdateringer af RMP (risikostyringsplanen), som er aftalt med af CHMP.
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.
I henhold til CHMP' s retningslinjer for risikostyringssystemer i forbindelse med humanmedicinske lægemidler skal der indsendes en opdateret (risikostyringsplan) RMP samtidig med den næste periodiske sikkerhedsopdateringsrapport (PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Endvidere skal der indsendes en opdateret risikostyringsplan (RPM) i følgende tilfælde: • Når der modtages nye oplysninger, der kan have indflydelse på den aktuelle sikkerhedsspecifikation, bivirkningsovervågningsplan eller risikominimeringsaktiviteter • Senest 60 dage efter opnåelse af en vigtig milepæl (for bivirkningsovervågning eller risikominimering) • Efter anmodning fra EMEA
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
PSUR’ er Indehaveren af markedsføringstilladelsen skal indsende 6- måneders PSUR’ er, med mindre andet besluttes af CHMP.
PSURs The MAH will submit 6-monthly PSURs, unless otherwise specified by the CHMP.
Resultaterne af disse undersøgelser vil danne grundlaget for den årlige vurdering af risk/ benefit- forholdet.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
41 Område Kliniske aspekter
42 Area Clinical
Bortezomib- PK efter behandling med enkeltdosis
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.
PK/ PD- modellering.
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;
Forsøg ved leversvækkelse Endelig studierapport forventes klar senest den 31. december 2010
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
Ansøgeren præsenterer resultaterne fra det planlagte fase I/ II kliniske forsøg (protokollen til gennemgang hos NCI), der har til formål at udelukke muligheden for, at bortezomib- behandling kan øge risikoen for amyloidose og/ eller kan have en uheldig virkning på dets udvikling og manifestation i organerne som en konsekvens af proteasom- hæmning.
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.
Hvis dette forsøg ikke kommer i gang eller på anden vis ikke dækker de relevante emner, forpligter ansøgeren sig til at diskutere sagen med CHMP igen og indvillige i muligheden for at gennemføre et randomiseret, kontrolleret forsøg (eller aftalt, alternativt design) til patienter med amyloidose.
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.
Gennemgås hvert år Endelig studierapport forventes klar senest Q4 2008
To be reviewed annually Final study report expected by 4Q 2008
43 A.
43 ANNEX III
44 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
LABELLING
YDRE KARTON, VELCADE 1 MG
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
1 mg bortezomib (som mannitolborester).
Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
1 ml opløsning til injektion indeholder 1 mg bortezomib.
After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.
Kun til engangsbrug.
Special handling instructions For single use only.
45 Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
Keep the vial in the outer carton in order to protect from light.
JANSSEN- CILAG INTERNATIONAL NV Turnhoutseweg 30 B- 2340 Beerse Belgien
JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg, 30 B-2340 Beerse Belgium
INFORMATION OM BLINDESKRIFT
INFORMATION IN BRAILLE
46 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
47 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
HÆTTEGLAS (5 ml) VELCADE 1 mg
GLASS VIAL (5 ml) VELCADE 1 mg
VELCADE 1 mg pulver til injektionsvæske
VELCADE 1 mg powder for injection bortezomib IV use.
YDRE KARTON, VELCADE 3, 5 mg
OUTER CARTON, VELCADE 3.5 mg
VELCADE 3, 5 mg pulver til injektionsvæske, opløsning bortezomib
VELCADE 3.5 mg powder for solution for injection bortezomib
3, 5 mg bortezomib (som mannitolborester).
Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
48 9.
49 9.
49 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
50 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
HÆTTEGLAS (10 ml) VELCADE 3, 5 mg
GLASS VIAL (10 ml) VELCADE 3.5 mg
VELCADE 3, 5 mg pulver til injektionsvæske, opløsning
VELCADE 3.5 mg powder for solution for injection bortezomib Intravenous use.
51 INDLÆGSSEDDEL:
PACKAGE LEAFLET
VELCADE 1 mg pulver til injektionsvæske, opløsning
VELCADE 1 mg powder for solution for injection VELCADE 3.5 mg powder for solution for injection Bortezomib
VELCADE 3, 5 mg pulver til injektionsvæske, opløsning
Read all of this leaflet carefully before you start using this medicine.
Bortezomib
- Keep this leaflet.
Læs denne indlægsseddel grundigt inden du begynder at bruge medicinen. • Gem indlægssedlen.
- If you have any further questions, ask your doctor or pharmacist.
Du får muligvis behov for at læse den igen. • Spørg lægen eller på apoteket, hvis der er mere, du vil vide. • Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Oversigt over indlægssedlen 1.
please tell your doctor or pharmacist.
Virkning og anvendelse 2.
What VELCADE is and what it is used for 2.
Det skal du vide, før du begynder at bruge VELCADE 3.
Before you use VELCADE 3.
Sådan skal du bruge VELCADE 4.
How to use VELCADE 4.
Opbevaring 6.
How to store VELCADE 6.
VIRKNING OG ANVENDELSE
WHAT VELCADE IS AND WHAT IT IS USED FOR
VELCADE indeholder det aktive stof bortezomib, som er en såkaldt proteasomhæmmer.
VELCADE contains the active substance bortezomib, a so-called ‘ proteasome inhibitor’.
Proteasomer spiller en vigtig rolle i regulering af cellers funktion og vækst.
Proteasomes play an important role in controlling cell function and growth.
VELCADE bruges til behandling af myelomatose (kræft i knoglemarven) hos voksne:
VELCADE is used for the treatment multiple myeloma (a cancer of the bone marrow) in adults:
Dette bruges i
- in combination with other medicines containing melphalan and prednisone, for patients who
behandlingen af patienter, der ikke tidligere er blevet behandlet for myelomatose, og som ikke er egnede til højdosiskemoterapi med knoglemarvstransplantation.
have not been previously treated for multiple myeloma and are unsuitable for high-dose chemotherapy with bone marrow transplant.
- alene (monoterapi) til patienter, hvis sygdom er forværret (progressiv) efter mindst én
- alone (monotherapy) for patients whose disease is worsening (progressive) after receiving at
forudgående behandling, og som ikke har haft gavn af eller haft mulighed for at få en knoglemarvstransplantation.
least one prior treatment and for whom. bone marrow transplantation was not successful or is unsuitable.
DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE VELCADE
- if you have severe liver problems
Brug ikke VELCADE: • hvis du er allergisk (overfølsom) over for det aktive stof eller over for et af de øvrige indholdsstoffer i VELCADE. • hvis du har alvorlige leverproblemer. • hvis du lider af visse alvorlige lunge eller hjerteproblemer.
- if you have certain severe pulmonary or heart problems.
Vær ekstra forsigtig med at bruge VELCADE Fortæl lægen, hvis du lider af noget af det følgende: • lavt antal røde eller hvide blodlegemer • blødningsproblemer og/ eller lavt antal blodplader i blodet • diaré, forstoppelse, kvalme eller kaster op • tidligere er besvimet, har været svimmel eller ør i hovedet. • problemer med nyrerne. • problemer med leveren. • tidligere har haft problemer med følelsesløshed, følelse af prikken eller smerte i hænder eller fødder (neuropati)
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.
52 • problemer med hjertet eller blodtrykket. • en sygdom som kaldes amyloidose. • stakåndethed eller hoste
• heart or blood pressure problems.
VELCADE bør ikke bruges til børn og unge pga. begrænset erfaring.
VELCADE should not be used in children and adolescents, due to limited experience.
Dette gælder også medicin, som ikke er på recept.
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.