Lutetium (177Lu) chloride Billev (previously Illuzyce)

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
08-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
08-12-2022
Public Assessment Report Public Assessment Report (PAR)
08-12-2022

Active ingredient:

lutetium (177Lu) chloride

Available from:

Billev Pharma Aps

ATC code:

V10X

INN (International Name):

lutetium (177Lu) chloride

Therapeutic group:

Radjofarmaċewtiċi terapewtiċi

Therapeutic area:

Radjonuklidi Imaging

Therapeutic indications:

Lutetium (177Lu) chloride Billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride.

Product summary:

Revision: 2

Authorization status:

Awtorizzat

Authorization date:

2022-09-15

Patient Information leaflet

                                25
B. FULJETT TA’ TAGĦRIF
26
FULJETT TA' TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
LUTETIUM (
177
LU) CHLORIDE BILLEV 51.8 GBQ/ML PREKURSUR RADJUFARMAĊEWTIKU,
SOLUZZJONI
lutetium (
177
Lu) chloride
AQRA SEW DAN IL-FULJETT TA’ TAGĦRIF QABEL TINGĦATA L-MEDIĊINA
KKUMBINATA MA’
LUTETIUM (
177
LU) CHLORIDE BILLEV PERESS LI FIH INFORMAZZJONI IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa' taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib tal-mediċina
nukleari tiegħek li jkun qed
jissorvelja l-proċedura.
-
Jekk ikollok xi effetti sekondarji, kellem lit-tabib tal-mediċina
nukleari tiegħek. Dan jinkludi xi
effett sekondarju possibbli li mhuwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F'DAN IL-FULJETT
1.
X’inhu Lutetium (
177
Lu) chloride Billev u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża Lutetium (
177
Lu) chloride Billev
3.
Kif għandek tuża l-mediċina radjutikkettata b’Lutetium (
177
Lu) chloride Billev
4.
Effetti sekondarji possibbli
5.
Kif taħżen Lutetium (
177
Lu) chloride Billev
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU LUTETIUM (
177
LU) CHLORIDE BILLEV U GĦALXIEX JINTUŻA
Lutetium (
177
Lu) chloride Billev huwa tip ta’ prodott imsejjaħ prekursur
radjufarmaċewtiku. Fih
is-sustanza attiva lutetium (
177
Lu) chloride li jarmi radjazzjoni beta-minus.
Lutetium (
177
Lu) chloride Billev mhux maħsub li jintuża waħdu. Qabel l-użu jrid
jiġi kkombinat ma’
mediċini oħra (l-hekk imsejħa mediċini trasportaturi) li ġew
żviluppati b'mod speċjali għall-użu ma’
lutetium(
177
Lu) chloride. Dan il-proċess jissejjaħ radjutikkettar.
Dawn il-mediċini trasportaturi jistgħu jkunu sustanzi li ġew
imfassla sabiex jagħrfu tip partikolari ta'
ċellola fil-ġisem. Il-mediċina trasportatur tingħata lill-pazjent
skont l-istruzzjonijiet fl-informazzjoni
tal-prodott ta’dik il-mediċna. Imbagħad iġġorr ir-radjazzjoni
fejn hi meħtieġa fil-ġisem, biex jiġi
ttrattat il-mard jew biex jinkisbu xbihat fuq skrin li jintu
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Lutetium (
177
Lu) chloride Billev 51.8 GBq/mL prekursur radjufarmaċewtiku,
soluzzjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
1 mL soluzzjoni fiha 51.8 GBq lutetium (
177
Lu) chloride fil-ħin ta' referenza tal-attività (
_activity _
_reference time, _
ART), li jikkorrispondi għal massimu ta’ 12.6 mikrogrammi ta'
llutetium (
177
Lu) (bħala
chloride).
L-ART huwa mfisser bħala tmiem il-produzzjoni. L-attività minima
hija 3,000 GBq/mg lutetium
(
177
Lu) f’ART.
Kull kunjett ta' 5 mL fih volum li jvarja minn 0.1 mL sa 4 mL li
jikkorispondi għal attività li tvarja
5.2 sa 207.2 GBq f’ART.
Kull kunjett ta' 10 mL fih volum li jvarja minn 0.1 mL sa 8 mL li
jikkorrispondi għal attività li
tvarjaminn 5.2 sa 414.4 GBq f’ART.
L-attività fid-data u l-ħin ordnat mill-klijent, indikat bħala CAL
(kalibrazzjoni), hi stabbilita bil-ħin li
jkun għadda mill-ART u l-half-life ta’ lutetium (
177
Lu).
Lutetium (
177
Lu) għandu half-life ta’ 6.7 ijiem. Lutetium (
177
Lu) li mhux trasportatur miżjud hu prodott
b’irradjazzjoni ta’ newtroni ta’ itterbju arrikkit (
176
Yb). Lutetium (
177
Lu) jiddiżentegra permezz
tal-emmissjoni ta' β-minus għal Hafnium stabbli (
177
Hf), bl-aktar β-minus abundanti (79.3%) ikollu
enerġija massima ta’ 497 keV. Anke, enerġija baxxa ta’ gamma
hija emmessa pereżempju f’113 keV
(6.2%) u 208 keV (11%).
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Prekursur radjufarmaċewtiku, soluzzjoni.
Soluzzjoni ċara, mingħajr kulur.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Lutetium (
177
Lu) chloride Billev huwa prekursur radjofarmaċewtiku, u mhuwiex
maħsub għall-użu
dirett fil-pazjenti. Dan għandu jintuża biss għar-radjutikkettar
ta’ molekuli trasportaturi li jkunu ġew
żviluppati b'mod speċifiku u awtorizzati għar-radjutikkettar
b’lutetium (
177
Lu) chloride.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Lutetium (
177
Lu) 
                                
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Active ingredient lutetium (177Lu) chloride

lutetium (177Lu) chloride

ATC code V10X

V10X

Marketed by Billev Pharma Aps

Billev Pharma Aps

INN (International Name) lutetium (177Lu) chloride

lutetium (177Lu) chloride

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Lutetium (177Lu) chloride Billev (previously Illuzyce)