Quadramet

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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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:

Terapeutiske radioaktive lægemidler

Therapeutic area:

Pain; Cancer

Therapeutic indications:

Quadramet er indiceret til lindring af knoglesmerter hos patienter med flere smertefulde osteoblastic knogle metastaser, der fylder technetium [99mTc]-mærket biphosphonates på knoglescanning. Tilstedeværelsen af osteoblastic metastaser, som kan tage op technetium [99mTc]-mærket biphosphonates skal være bekræftet forud for terapi.

Product summary:

Revision: 15

Authorization status:

autoriseret

Authorization date:

1998-02-04

Patient Information leaflet

                                18
B. INDLÆGSSEDDEL
19
INDLÆGSSEDDEL: INFORMATION TIL PATIENTEN
QUADRAMET 1,3 GBQ/ML INJEKTIONSVÆSKE, OPLØSNING.
Samarium (
153
Sm) lexidronam pentanatrium.
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT INDEN DE BEGYNDER AT TAGE DETTE
LÆGEMIDDEL, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER.
-
Gem indlægssedlen. De kan få brug for at læse den igen.
-
Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
-
Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver
værre, eller De får
bivirkninger, som ikke er nævnt her. Se punkt 4.
OVERSIGT OVER INDLÆGSSEDLEN:
1.
Virkning og anvendelse
2.
Det skal De vide, før De begynder at bruge Quadramet
3.
Sådan skal De bruge Quadramet
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Lægemidlet Quadramet er kun til terapeutisk brug.
Dette radioaktive lægemiddel anvendes til behandling af
knoglesmerter, som er forårsaget af Deres
sygdom.
Quadramet har en høj affinitet for knoglevæv. Når det er injiceret,
koncentrerer det sig i
knoglelæsionerne. Da Quadramet indeholder små mængder af et
radioaktivt grundstof, samarium 153,
afgives der bestråling lokalt til knoglelæsionerne, hvorved der sker
lindring af knoglesmerter.
2.
DET SKAL DE VIDE, FØR DE BEGYNDER AT BRUGE QUADRAMET
BRUG IKKE QUADRAMET,
•
hvis De er allergisk over for ethylendiamintetramethylenfosfonsyre
(EDTMP) eller lignende
fosfonatforbindelser eller et af de øvrige indholdsstoffer i
Quadramet (angivet i punkt 6),
•
hvis De er gravid,
•
hvis De har modtaget kemoterapi eller ekstern
halvkropsbestrålingsbehandling inden for 6 uger
før.
20
ADVARSLER OG FORSIGTIGHEDSREGLER
Kontakt lægen, før De bruger Quadramet.
Deres læge vil tage blodprøver en gang om ugen i mindst 8 uger for
at kontrollere antallet af Deres
blodplader samt hvide og røde blodlegemer, som kan falde lidt på
grund af behandlingen.
Deres læge vil anbefale Dem at indtage drikkevarer og tømme deres
blære så ofte som muligt i de
første 6 timer efter Quadram
                                
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Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Quadramet 1,3 GBq/ml injektionsvæske, opløsning.
2.
KVALITATIVOG KVANTITATIV SAMMENSÆTNING
Hver ml opløsning indeholder 1,3 GBq samarium (
153
Sm) lexidronam pentanatrium på referencedato.
(svarende til 20 til 80 µg/ml samarium pr. hætteglas)
Samariums specifikke aktivitet er ca. 16 - 65 MBq/µg samarium.
Hvert hætteglas indeholder 2 - 4 GBq på referencedato.
Samarium-153 emitterer både middelenergi betapartikler og en
billeddannende gammafoton og har en
halveringstid på 46,3 timer (1,93 dage). De primære
strålingsemissioner for samarium-153 er anført i
Tabel 1.
TABEL 1 : DE VÆSENTLIGSTE STRÅLINGSEMISSIONSDATA FOR SAMARIUM-153
Stråling
Energi (keV)*
Forekomst
Beta
640
30%
Beta
710
50%
Beta
810
20%
Gamma
103
29%
*
De maksimale energier er opført for betaemissioner; den
gennemsnitlige betapartikelenergi er
233 keV.
Hjælpestof, som behandleren skal være opmærksom på: natrium 8,1
mg/ml.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Injektionsvæske, opløsning.
Klar, farveløs til lysegul opløsning med pH mellem 7,0 og 8.5.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Quadramet er indiceret til lindring af knoglesmerter hos patienter med
multiple smertefulde
osteoblastiske knoglemetastaser, som optager teknetium (
99m
Tc)-mærkede bisfosfonater på
knoglescanning.
Tilstedeværelsen af osteoblastiske metastaser, der optager teknetium
(
99m
Tc)-mærkede bisfosfonater,
bør bekræftes inden behandlingen.
3
4.2
DOSERING OG ADMINISTRATION
Quadramet bør kun indgives efter fyldestgørende onkologisk
evaluering af patienten af en kvalificeret
læge, der har erfaring i brugen af radioaktive lægemidler.
Dosering
Den anbefalede dosis af QUADRAMET er 37 MBq per kg legemsvægt
_ _
_Pædiatrisk population _
Quadramet bør ikke anvendes til børn under 18 år p.g.a. manglende
dokumentation for sikkerhed og
virkning.
Administration
Quadramet skal injiceres langsomt (ca. 1 min.) intravenøst gennem et
intravenøst kateder. Quadramet

                                
                                Read the complete document

Similar products

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

Documents in other languages

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
Summary of Product characteristics Summary of Product characteristics Czech 03-06-2015
Public Assessment Report Public Assessment Report Czech 31-03-2008
Patient Information leaflet Patient Information leaflet German 03-06-2015
Summary of Product characteristics Summary of Product characteristics German 03-06-2015
Public Assessment Report Public Assessment Report German 31-03-2008
Patient Information leaflet Patient Information leaflet Estonian 03-06-2015
Summary of Product characteristics Summary of Product characteristics Estonian 03-06-2015
Public Assessment Report Public Assessment Report Estonian 31-03-2008
Patient Information leaflet Patient Information leaflet Greek 03-06-2015
Summary of Product characteristics Summary of Product characteristics Greek 03-06-2015
Public Assessment Report Public Assessment Report Greek 31-03-2008
Patient Information leaflet Patient Information leaflet English 03-06-2015
Summary of Product characteristics Summary of Product characteristics English 03-06-2015
Public Assessment Report Public Assessment Report English 31-03-2008
Patient Information leaflet Patient Information leaflet French 03-06-2015
Summary of Product characteristics Summary of Product characteristics French 03-06-2015
Public Assessment Report Public Assessment Report French 31-03-2008
Patient Information leaflet Patient Information leaflet Italian 03-06-2015
Summary of Product characteristics Summary of Product characteristics Italian 03-06-2015
Public Assessment Report Public Assessment Report Italian 31-03-2008
Patient Information leaflet Patient Information leaflet Latvian 03-06-2015
Summary of Product characteristics Summary of Product characteristics Latvian 03-06-2015
Public Assessment Report Public Assessment Report Latvian 31-03-2008
Patient Information leaflet Patient Information leaflet Lithuanian 03-06-2015
Summary of Product characteristics Summary of Product characteristics Lithuanian 03-06-2015
Public Assessment Report Public Assessment Report Lithuanian 31-03-2008
Patient Information leaflet Patient Information leaflet Hungarian 03-06-2015
Summary of Product characteristics Summary of Product characteristics Hungarian 03-06-2015
Public Assessment Report Public Assessment Report Hungarian 31-03-2008
Patient Information leaflet Patient Information leaflet Maltese 03-06-2015
Summary of Product characteristics Summary of Product characteristics Maltese 03-06-2015
Public Assessment Report Public Assessment Report Maltese 31-03-2008
Patient Information leaflet Patient Information leaflet Dutch 03-06-2015
Summary of Product characteristics Summary of Product characteristics Dutch 03-06-2015
Public Assessment Report Public Assessment Report Dutch 31-03-2008
Patient Information leaflet Patient Information leaflet Polish 03-06-2015
Summary of Product characteristics Summary of Product characteristics Polish 03-06-2015
Public Assessment Report Public Assessment Report Polish 31-03-2008
Patient Information leaflet Patient Information leaflet Portuguese 03-06-2015
Summary of Product characteristics Summary of Product characteristics Portuguese 03-06-2015
Public Assessment Report Public Assessment Report Portuguese 31-03-2008
Patient Information leaflet Patient Information leaflet Romanian 03-06-2015
Summary of Product characteristics Summary of Product characteristics Romanian 03-06-2015
Public Assessment Report Public Assessment Report Romanian 31-03-2008
Patient Information leaflet Patient Information leaflet Slovak 03-06-2015
Summary of Product characteristics Summary of Product characteristics Slovak 03-06-2015
Public Assessment Report Public Assessment Report Slovak 31-03-2008
Patient Information leaflet Patient Information leaflet Slovenian 03-06-2015
Summary of Product characteristics Summary of Product characteristics Slovenian 03-06-2015
Public Assessment Report Public Assessment Report Slovenian 31-03-2008
Patient Information leaflet Patient Information leaflet Finnish 03-06-2015
Summary of Product characteristics Summary of Product characteristics Finnish 03-06-2015
Public Assessment Report Public Assessment Report Finnish 31-03-2008
Patient Information leaflet Patient Information leaflet Swedish 03-06-2015
Summary of Product characteristics Summary of Product characteristics Swedish 03-06-2015
Public Assessment Report Public Assessment Report Swedish 31-03-2008
Patient Information leaflet Patient Information leaflet Norwegian 03-06-2015
Summary of Product characteristics Summary of Product characteristics Norwegian 03-06-2015
Patient Information leaflet Patient Information leaflet Icelandic 03-06-2015
Summary of Product characteristics Summary of Product characteristics Icelandic 03-06-2015
Patient Information leaflet Patient Information leaflet Croatian 03-06-2015
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Quadramet