LysaKare

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Active ingredient:

L-arginine hydrochloride, L-lysine hydrochloride

Available from:

Advanced Accelerator Applications

ATC code:

V03AF11

INN (International Name):

arginine, lysine

Therapeutic group:

Detoxifying agents for antineoplastic treatment

Therapeutic area:

Ir-Radjazzjoni Korrimenti

Therapeutic indications:

LysaKare huwa indikat għat-tnaqqis tal-kliewi espożizzjoni għar-radjazzjoni matul il-Peptide-Riċettur Radjunuklidi-Terapija (PRRT) ma lutetium (177Lu) oxodotreotide fl-adulti.

Product summary:

Revision: 4

Authorization status:

Awtorizzat

Authorization date:

2019-07-25

Patient Information leaflet

                                17
B. FULJETT TA’ TAGĦRIF
18
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
LYSAKARE 25 G/25 G SOLUZZJONI GĦALL-INFUŻJONI
L-arginine hydrochloride/ L-lysine hydrochloride
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TUŻA DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib tiegħek. Dan
jinkludi xi effett sekondarju
possibbli li mhuwiex elenkat f’dan il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu LysaKare u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu LysaKare
3.
Kif għandek tieħu LysaKare
4.
Effetti sekondarji possibbli
5.
Kif taħżen LysaKare
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU LYSAKARE U GĦALXIEX JINTUŻA
X’INHU LYSAKARE
LysaKare fih is-sustanzi attivi arginine u lysine, żewġ aċidi
amminiċi differenti. Dan jappartjeni għal
grupp ta’ mediċini li jintużaw biex inaqqsu l-effetti sekondarji
ta’ mediċina kontra l-kanċer.
GĦALXIEX JINTUŻA LYSAKARE
LysaKare jintuża f’pazjenti adulti biex jipproteġi l-kliewi minn
radjazzjoni mhux meħtieġa matul it-
trattament b’Lutathera (lutetium (
177
Lu) oxodotreotide), mediċina radjuattivà użata għat-trattament
ta’
ċerti tumuri.
2.
X’GĦANDEK TKUN TAF QABEL MA TIEĦU LYSAKARE
Segwi l-istruzzjonijiet tat-tabib tiegħek b’attenzjoni. Billi se
tirċievi trattament ieħor, Lutathera,
flimkien ma’ LysaKare, AQRA SEW IL-FULJETT TA’ LUTATHERA KIF UKOLL DAN IL-FULJETT.
Jekk għandek xi mistoqsijiet dwar l-użu ta’ din il-mediċina,
staqsi lit-tabib, lill-infermier jew lill-
ispiżjar tiegħek.
MA GĦANDEKX TINGĦATA LYSAKARE
-
jekk inti allerġiku għal arginine u lysine jew għal xi sustanza
oħra ta’ din il-mediċina (imniżżla
fis-sezzjoni 6).
-
Jekk għandek livelli ta’ potassju fid-demm għoljin (iperkalimja).
TWISSIJIET U PREKAWZJONIJIET
Kellem lit-tabib tiegħek qabel tieħu LysaKare
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
LysaKare 25 g/25 g soluzzjoni għall-infużjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Borża waħda ta’ 1,000 mL fiha 25 g ta’ L-arginine hydrochloride
u 25 g ta’ L-lysine hydrochloride.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għall-infużjoni (infużjoni).
Soluzzjoni ċara, mingħajr kulur, ħielsa minn frak viżibbli
pH: 5.1 – 6.1
Osmolalità: 420 – 480 mOsm/L
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
LysaKare huwa indikat għat-tnaqqis tal-esponiment tal-kliewi
għar-radjazzjoni matul terapija
b’radjonuklidi tar-riċettur ta’ peptide (PRRT, peptide-receptor
radionuclide therapy) b’lutetium (
177
Lu)
oxodotreotide fl-adulti.
_ _
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
LysaKare huwa indikat għall-għoti ma’ PRRT b’lutetium (
177
Lu) oxodotreotide, għalhekk, dan għandu
jingħata biss minn fornitur tal-kura tas-saħħa li għandu
esperjenza fl-użu ta’ PRRT.
Pożoloġija
_Adulti _
Ir-reġim ta’ trattament rakkomandat fl-adulti jikkonsisti minn
infużjoni ta’ borża sħiħa ta’ LysaKare
mogħtija flimkien ma’ infużjoni ta’ lutetium (
177
Lu) oxodotreotide, anke meta l-pazjenti jeħtieġu
tnaqqis fid-doża ta’ PRRT.
It-trattament minn qabel b’mediċina kontra t-tqalligħ qabel ma
tinbeda l-infużjoni ta’ LysaKare huwa
rakkomandat biex inaqqas l-inċidenza ta’ nawsja u rimettar.
_Popolazzjonijiet speċjali _
_Indeboliment tal-kliewi _
Minħabba l-potenzjal għal komplikazzjonijiet kliniċi relatati ma’
volum eċċessiv u żieda fil-potassju
fid-demm assoċjati mal-użu ta’ LysaKare, dan il-prodott
m’għandux jingħata lil pazjenti bi tneħħija
tal-kreatinina <30 mL/min.
Għandha tingħata attenzjoni bl-użu ta’ LysaKare f’pazjenti bi
tneħħija tal-kreatinina bejn 30 u
50 mL/min. It-trattament b’lutetium (177Lu) oxodotreotide mhux
rakkomandat għal pazjenti
b’funzjoni tal-kliewi bejn 30 u 50 mL
                                
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Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 22-09-2023
Public Assessment Report Public Assessment Report Bulgarian 30-07-2019
Patient Information leaflet Patient Information leaflet Spanish 22-09-2023
Public Assessment Report Public Assessment Report Spanish 30-07-2019
Patient Information leaflet Patient Information leaflet Czech 22-09-2023
Public Assessment Report Public Assessment Report Czech 30-07-2019
Patient Information leaflet Patient Information leaflet Danish 22-09-2023
Public Assessment Report Public Assessment Report Danish 30-07-2019
Patient Information leaflet Patient Information leaflet German 22-09-2023
Public Assessment Report Public Assessment Report German 30-07-2019
Patient Information leaflet Patient Information leaflet Estonian 22-09-2023
Public Assessment Report Public Assessment Report Estonian 30-07-2019
Patient Information leaflet Patient Information leaflet Greek 22-09-2023
Public Assessment Report Public Assessment Report Greek 30-07-2019
Patient Information leaflet Patient Information leaflet English 22-09-2023
Public Assessment Report Public Assessment Report English 30-07-2019
Patient Information leaflet Patient Information leaflet French 22-09-2023
Public Assessment Report Public Assessment Report French 30-07-2019
Patient Information leaflet Patient Information leaflet Italian 22-09-2023
Public Assessment Report Public Assessment Report Italian 30-07-2019
Patient Information leaflet Patient Information leaflet Latvian 22-09-2023
Public Assessment Report Public Assessment Report Latvian 30-07-2019
Patient Information leaflet Patient Information leaflet Lithuanian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 22-09-2023
Public Assessment Report Public Assessment Report Lithuanian 30-07-2019
Patient Information leaflet Patient Information leaflet Hungarian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 22-09-2023
Public Assessment Report Public Assessment Report Hungarian 30-07-2019
Patient Information leaflet Patient Information leaflet Dutch 22-09-2023
Public Assessment Report Public Assessment Report Dutch 30-07-2019
Patient Information leaflet Patient Information leaflet Polish 22-09-2023
Public Assessment Report Public Assessment Report Polish 30-07-2019
Patient Information leaflet Patient Information leaflet Portuguese 22-09-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 22-09-2023
Public Assessment Report Public Assessment Report Portuguese 30-07-2019
Patient Information leaflet Patient Information leaflet Romanian 22-09-2023
Public Assessment Report Public Assessment Report Romanian 30-07-2019
Patient Information leaflet Patient Information leaflet Slovak 22-09-2023
Public Assessment Report Public Assessment Report Slovak 30-07-2019
Patient Information leaflet Patient Information leaflet Slovenian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 22-09-2023
Public Assessment Report Public Assessment Report Slovenian 30-07-2019
Patient Information leaflet Patient Information leaflet Finnish 22-09-2023
Public Assessment Report Public Assessment Report Finnish 30-07-2019
Patient Information leaflet Patient Information leaflet Swedish 22-09-2023
Public Assessment Report Public Assessment Report Swedish 30-07-2019
Patient Information leaflet Patient Information leaflet Norwegian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 22-09-2023
Patient Information leaflet Patient Information leaflet Icelandic 22-09-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 22-09-2023
Patient Information leaflet Patient Information leaflet Croatian 22-09-2023
Public Assessment Report Public Assessment Report Croatian 30-07-2019

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