Quadramet

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
03-06-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
03-06-2015
Public Assessment Report Public Assessment Report (PAR)
31-03-2008

Active ingredient:

samarium (153Sm) lexidronam pentasodium

Available from:

CIS bio international

ATC code:

V10BX02

INN (International Name):

samarium [153Sm] lexidronam pentasodium

Therapeutic group:

Radjofarmaċewtiċi terapewtiċi

Therapeutic area:

Pain; Cancer

Therapeutic indications:

Quadramet huwa indikat għall-ħelsien ta ' l-għadam uġigħ fil-pazjenti ma multipli bl-uġigħ osteoblastic iskeletru metastaΩi li jibdew technetium [99mTc]-tikketta biphosphonates fuq scan għadam. Il-preżenza ta huma l-metastasi osteoblastiċi li jieħu sa ' technetium [99mTc]-tikketta biphosphonates għandha tiġi kkonfermata qabel it-terapija.

Product summary:

Revision: 15

Authorization status:

Awtorizzat

Authorization date:

1998-02-04

Patient Information leaflet

                                18
B. FULJETT TA’ TAGĦRIF
19
FULJETT TA’ TAGħRIF: INFORMAZZJONI GħALL-PAZJENT
QUADRAMET 1.3GBQ/ML SOLUZZJONI GħALL-INJEZZJONI
Samarium (
153
Sm) lexidronam pentasodium.
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEħU DIN IL-MEDIëINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GħALIK.
-
śomm dan il-fuljett. Jista’ jkollok bŜonn terāa` taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiŜjar
tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiŜjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li m’huwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu Quadramet u għalxiex jintuŜa
2.
X’għandek tkun taf qabel ma tieħu Quadramet
3.
Kif għandek tieħu Quadramet
4.
Effetti sekondarji possibbli
5.
Kif taħŜen Quadramet6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU QUADRAMET U GħALXIEX JINTUŜA
Quadramet huwa prodott mediëinali għal uŜu terapewtiku biss.
Dan ir-radjufarmaëewtiku jintuŜa għall-kura tal-uāigħ fl-għadam
minħabba l-marda tiegħek.
Quadramet għandu affinità għolja għat-tessut skeletali. Meta jiāi
injettat, ikun hemm konëentrazzjoni
tiegħu fil-leŜjonijiet tal-għadam. Minħabba li Quadramet fih
ammonti Ŝgħar tal-element radjuattiv,
samarium-153, ir-radjazzjonijiet jingħataw lokalment fuq
il-leŜjonijiet tal-għadam, biex jittaffa l-uāigħ
tal-għadam.
2.
X’GħANDEK TKUN TAF QABEL MA TIEħU QUADRAMET
TIEħUX QUADRAMET
•
Jekk inti allerāiku għal ethylene diamine tetramethylene phosphonic
acid (EDTMP) jew għal
prodotti simili ta’ komposti ta’ phosphonate jew għal xi sustanzi
oħra ta’ din il-mediëina
(elenkati fis-sezzjoni 6),
•
Jekk inti tqila,
•
Jekk irëevejt kimoterapija jew terapija ta’ radjazzjoni esterna fuq
nofs il-gisem matul perijodu
preëedenti ta’ 6 āimgħat.
TWISSIJIET U PREKAWZJONIJIET
KELLEM LIT-TABIB TIEGħEK ABEL TIEħU QUADRAMET
It-tabib tiegħek ser jeħodlok kampjuni tad-demm kull āimgħa għal
mill-inqas 8 āimgħat, sabiex
jiëëekkj
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIêI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIêINALI
Quadramet 1.3 GBq/ml soluzzjoni għall-injezzjoni.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
:Kull ml ta’ soluzzjoni fih 1.3 GBq Samarium (
153
Sm) lexidronam pentasodium fid-data ta’ referenza
(li tikkorrespondi għal 20 sa 80 µg/ml ta’ samarium għal kull
kunjett)
Attività speëifika għal samarium hi madwar 16 – 65 MBq/µg ta’
sammarium
Kull kunjett fih 2-4 GBq fid-data ta’ referenza
Samarium-153 jarmi kemm partikuli beta ta’ enerāija medja kif ukoll
foton gamma li jista’ jsir xbieha,
u għandu perijodu ta’ 46.3 sigħat (1.93 āranet). L-emissjonijiet
tar-radjazzjoni primarja ta’ samarium-
153 qed jiāu elenkati fit-Tabella 1.
TABELLA 1: SAMARIUM-153 DATA TA’ EMISSJONI TA’ RADJAZZJONI
PRINêIPALI
Radjazzjoni
Enerāija (keV)*
Abbundanza
Beta
640
30%
Beta
710
50%
Beta
810
20%
Gamma
103
29%
*
L-enerāiji massimi huma elenkati għall-emissjonijiet beta,
l-enerāija medja tal-partikula beta
hija ta’ 233 keV.
Eëëipjent b’effett magħruf: sodium 8.1 mg/ml
Għal-lista kompluta ta’ eëëipjenti, ara sezzjoni 6.1
3.
GĦAMLA FARMAêEWTIKA
Soluzzjoni għall-injezzjoni.
Soluzzjoni ëara, mingħajr kulur għal ambra ëar b’pH li jvarja
nejn 7.0 u 8.5.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIëI
Quadramet huwa indikat għas-serħan mill-uāigħ fl-għadam,
f’pazjenti b’metastasi skeletali
ostejoblastika multipla bl-uāigħ, li tieħu biphosphonates immarkati
b’sustanza radjuattiva ta’
technetium_ _(
99m
Tc) għal skan tal-għadam.
Il-preŜenza ta’ metastasi ostejoblastika li tieħu biphosphonates
immarkati b’sustanza radjuattiva ta’
technetium_ _(
99m
Tc)_ _għandha tiāi kkonfermata qabel it-terapija.
3
4.2
POŜOLOāIJA U METODU TA’ KIF GħANDU JINGħATA
Quadramet għandu jingħata biss minn tobba li għandhom esperjenza
fl-uŜu ta’ radjufarmaëewtiëi u
wara evalwazzjoni sħiħa onkoloāika fuq il-pazjent minn tobba
kkwalifikati.
PoŜoloāija
Id-doŜa rrakkomandata ta’ QUADRA
                                
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Active ingredient samarium (153Sm) lexidronam pentasodium

samarium (153Sm) lexidronam pentasodium

ATC code V10BX02

V10BX02

Marketed by CIS bio international

CIS bio international

INN (International Name) samarium [153Sm] lexidronam pentasodium

samarium [153Sm] lexidronam pentasodium

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Patient Information leaflet Patient Information leaflet Bulgarian 03-06-2015
Summary of Product characteristics Summary of Product characteristics Bulgarian 03-06-2015
Public Assessment Report Public Assessment Report Bulgarian 31-03-2008
Patient Information leaflet Patient Information leaflet Spanish 03-06-2015
Summary of Product characteristics Summary of Product characteristics Spanish 03-06-2015
Public Assessment Report Public Assessment Report Spanish 31-03-2008
Patient Information leaflet Patient Information leaflet Czech 03-06-2015
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Public Assessment Report Public Assessment Report Czech 31-03-2008
Patient Information leaflet Patient Information leaflet Danish 03-06-2015
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Public Assessment Report Public Assessment Report Danish 31-03-2008
Patient Information leaflet Patient Information leaflet German 03-06-2015
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Public Assessment Report Public Assessment Report German 31-03-2008
Patient Information leaflet Patient Information leaflet Estonian 03-06-2015
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Public Assessment Report Public Assessment Report Estonian 31-03-2008
Patient Information leaflet Patient Information leaflet Greek 03-06-2015
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Public Assessment Report Public Assessment Report Greek 31-03-2008
Patient Information leaflet Patient Information leaflet English 03-06-2015
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Public Assessment Report Public Assessment Report English 31-03-2008
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Quadramet