MabCampath

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
15-08-2012
Summary of Product characteristics Summary of Product characteristics (SPC)
15-08-2012
Public Assessment Report Public Assessment Report (PAR)
15-08-2012

Active ingredient:

alemtuzumab

Available from:

Genzyme Europe B.V.

ATC code:

L01XC04

INN (International Name):

alemtuzumab

Therapeutic group:

Aġenti antineoplastiċi

Therapeutic area:

Lewkimja, Linfokitika, Kronika, B-Ċellula

Therapeutic indications:

MabCampath huwa indikat għall-kura ta 'pazjenti b'lewkimja limfoċitika kronika taċ-Ċellula B (BCLL) li għalihom il-kemjoterapija kombinata ta' fludarabine mhijiex xierqa.

Product summary:

Revision: 14

Authorization status:

Irtirat

Authorization date:

2001-07-06

Patient Information leaflet

                                48
B. FULJETT TA' TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
49
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU
MINNU
MABCAMPATH 10 MG/ML KONĊENTRAT GĦAL SOLUZZJONI GĦALL-INFUŻJONI
Alemtuzumab
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TUŻA DIN IL-MEDIĊINA.

Żomm dan il-fuljett. Jista' jkollok bżonn terġa’ taqrah.

Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.

Jekk xi wieħed mill-effetti sekondarji jiggrava jew jekk tinnota xi
effetti sekondarji li m’humiex
imsemmijin f’dan il-fuljett, jekk jogħġbok, għid lit-tabib jew
lill-ispiżjar tiegħek.
F'DAN IL-FULJETT:
1.
X’inhu MabCampath u għalxiex jintuża
2.
Qabel ma tuża MabCampath
3.
Kif tuża MabCampath
4.
Effetti sekondarji li jista’ jkollu
5.
Kif taħżen MabCampath
6.
Aktar tagħrif
1.
X’INHU MABCAMPATH U GĦALXIEX JINTUŻA
MabCampath jintuża għall-kura ta’ pazjenti b’lewkimja
limfoċitika kronika (CLL), kanċer tal-limfoċiti
(tip ta’ ċellula bajda tad-demm). Huwa jintuża f’pazjenti li
għalihom taħlitiet ta’ kura inkluż
fludarabine (mediċina oħra li tintuża fil-lewkimja) mhux xierqa.
Is-sustanza attiva f’MabCampath, alemtuzumab, hija antikorp
monoklonali. Antikorp monoklonali
huwa antikorp (tip ta’ proteina) li ġie ddisinjat biex jagħraf u
jeħel ma’ struttura speċifika (msejħa
antiġen) li tinstab f’ċertu ċelluli fil-ġisem. F’CLL, jiġu
prodotti limfoċiti żejda. Alemtuzumab ġie
ddisinjat beix jeħel ma’ glycoprotein (proteina li hija miksija
b’molekoli taz-zokkor) li tinstab fil-wiċċ
tal-limfoċiti. Bħala riżultat
ta’ dan it-tagħqid, il-limfoċiti jmutu, u dan jgħin jikkontrolla
s-CLL.
2.
QABEL MA TUŻA MABCAMPATH
TUŻAX MABCAMPATH JEKK INTI:

allerġiku/a (tbati minn sensittività eċċessiva) għal alemtużumab
jew għal proteini ta’ oriġini
simili jew sustanzi oħra ta’ MabCampath (ara sezzjoni 6 “Aktar
Tagħrif”). It-tabib tiegħek se
jinfurmak dwar dan.

għandek infezzjoni.

għandek HIV
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
MabCampath 10 mg/ml konċentrat għal soluzzjoni għall-infużjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
1ml fih 10 mg ta’ Alemtuzumab.
Kull ampulla fiha 30 mg ta’ alemtuzumab.
Alemtuzumab huwa antikorp monoklonali umanizzat tat-tip IgG1 kappa
magħmul permezz ta’
inġinerija ġenetika, speċifiku għal glycoprotein (CD52) tal-wiċċ
taċ-ċellula limfoċita tat-tip 21-28 kD.
L-antikorp huwa prodott f’koltura f’suspensjoni ta’ ċelluli
mammiferi (Ovarju tal-Ħamster Ċiniż)
f’sustanza nutrittiva.
Għal-lista kompleta sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Konċentrat għal soluzzjoni għall-infużjoni.
Konċentrat bla kulur sa kemmxejn isfar.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
MabCampath huwa indikat għall-kura ta’ pazjenti b’lewkimja
limfoċitika kronika taċ-ċellula B (B-
CLL) li għalihom kimoterapija kombinata ta’ fludarabine mhix
xierqa.
4.2
POŻOLOĠIJA U METODU TA' KIF GĦANDU JINGĦATA
MabCampath għandu jiġi mogħti taħt is-sorveljanza ta’ tabib
b’esperjenza fl-użu ta’ terapija għall-
kanċer.
Pożoloġija
Matul l-ewwel ġimgħa ta’ kura, MabCampath għandu jingħata
f’dożi dejjem aktar qawwija: 3 mg fl-
ewwel jum, 10 mg fit-tieni jum u 30 mg fit-tielet jum 3 dejjem jekk
kull doża hija ittollerata tajjeb.
Minn hemm `il quddiem, id-doża rrakkomandata hija ta’ 30 mg kuljum,
li tingħata tliet darbiet fil-
ġimgħa, ġurnata iva, ġurnata le għal massimu ta’ 12-il
ġimgħa.
Fil-biċċa l-kbira tal-pazjenti, iż-żjieda fid-doża għal 30 mg
tista' tintlaħaq fi żmien 3-7 ijiem.
Madankollu, jekk isseħħu reazzjonijiet avversi akuti ta’ natura
moderata sa severa bħal pressjoni
baxxa, tertir, deni, qtugħ ta’ nifs, sirdat, raxx u bronkospażmu
(li wħud minnhom jistgħu jkunu
minħabba reħa ta’ cytokine) fil-livell ta’ dożaġġ ta’ 3 mg
jew ta’ 10 mg, dawk id-dożi għandhom
                                
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Active ingredient alemtuzumab

alemtuzumab

ATC code L01XC04

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Marketed by Genzyme Europe B.V.

Genzyme Europe B.V.

INN (International Name) alemtuzumab

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Patient Information leaflet Patient Information leaflet Bulgarian 15-08-2012
Summary of Product characteristics Summary of Product characteristics Bulgarian 15-08-2012
Public Assessment Report Public Assessment Report Bulgarian 15-08-2012
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Public Assessment Report Public Assessment Report Spanish 15-08-2012
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