Scintimun

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-12-2022
Public Assessment Report Public Assessment Report (PAR)
30-09-2014

Active ingredient:

besilesomab

Available from:

CIS bio international 

ATC code:

V09HA03

INN (International Name):

besilesomab

Therapeutic group:

Diagnostični radiofarmacevtiki

Therapeutic area:

Osteomyelitis; Radionuclide Imaging

Therapeutic indications:

To zdravilo je za samo diagnostična uporaba in odobrene indikacije scintigraphic slikanje, v povezavi z druge primerne načine slikanja, za določitev vnetje/okužbe v perifernih kosti pri odraslih z suma osteomielitisa. Zdravila Scintimun ne smete uporabljati za diagnozo okužbe z diabetičnim nogam.

Product summary:

Revision: 6

Authorization status:

Pooblaščeni

Authorization date:

2010-01-11

Patient Information leaflet

                                20
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Sprejeta je utemeljitev, da Braillova pisava ni potrebna
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Navedba smiselno ni potrebna.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
Navedba smiselno ni potrebna.
21
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
STEKLENA VIALA
Scintimun
Ne vključuje modrega okenca
1.
IME ZDRAVILA IN POT(I) UPORABE
Scintimun 1 mg komplet za pripravo radiofarmaka
besilesomab
intravenska uporaba
2.
POSTOPEK UPORABE
Pred uporabo preberite priloženo navodilo.
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
Uporabite v 3 urah po radioaktivnem označenju.
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
1 mg
6.
DRUGI PODATKI
CIS bio international
22
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
STEKLENA VIALA VEHIKEL ZA ZDRAVILO SCINTIMUN
Ne vključuje modrega okenca
1.
IME ZDRAVILA IN POT(I) UPORABE
Vehikel za zdravilo Scintimun
2.
POSTOPEK UPORABE
Ni namenjeno neposredni uporabi pri bolniku.
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
2,82 mg
6.
DRUGI PODATKI
CIS bio international
23
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
DODATNA NALEPKA PO REKONSTITUIRANJU IN RADIOAKTIVNEM OZNAČEVANJU Z
RAZTOPINO NATRIJEVEGA
PERTEHNETATA (
99M
TC).
1.
IME ZDRAVILA IN POT(I) UPORABE
(
99m
Tc)- Scintimun
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
4.
ŠTEVILKA SERIJE
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
99M
TC
MBq
ml
ura/datum
6.
DRUGI PODATKI
CIS bio international
24
B. NAVODILO ZA UPORABO
25
NAVODILO ZA UPORABO
SCINTIMUN 1 MG KOMPLET ZA PRIPRAVO RADIOFARMAKA
besilesomab
PREDEN BOSTE PREJELI ZDRAVILO, NATANČNO PREBERITE NAVODILO, KER
VSEBUJE ZA VAS POMEMBNE
PODATKE!
-
Navodilo shranite. Morda ga boste želeli ponovno prebrati.
-
Če imate dodatna vprašanja, se posvetujte z zdravnikom ali

                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Scintimun 1 mg komplet za pripravo radiofarmaka
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
_ _
Ena viala zdravila Scintimun vsebuje 1 mg besilesomaba.
Besilesomab je monoklonsko protitelo proti granulocitom (BW 250/183),
izdelano v mišjih celicah.
Radionuklid ni del kompleta.
Pomožne snovi z znanim učinkom:
Vsaka viala zdravila Scintimun vsebuje 2 mg sorbitola.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
komplet za pripravo radiofarmaka
Scintimun: bel prašek
Vehikel za zdravilo Scintimun: bel prašek
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo je samo za diagnostične namene.
Po radioaktivnem označevanju z raztopino natrijevega (
99m
Tc) pertehnetata je dobljena raztopina
tehnecijevega (
99m
Tc) besilesomaba indicirana pri odraslih bolnikih za scintigrafsko
slikanje skupaj z
drugimi primernimi načini slikanja za določanje mesta vnetja/okužbe
v perifernih kosteh pri odraslih s
sumom na osteomielitis.
Zdravilo Scintimun se ne sme uporabljati za diagnozo okužbe
diabetičnega stopala.
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravilo se lahko uporablja le v odobrenih ustanovah za nuklearno
medicino. Z njim lahko rokujejo le
pooblaščene osebe.
Odmerjanje
_Odrasli _
Priporočena aktivnost tehnecijevega (
99m
Tc) besilesomaba mora biti med 400 MBq in 800 MBq.
To ustreza uporabi 0,25 do 1 mg besilesomaba.
Glede ponavljajoče se uporabe glejte poglavje 4.4.
_Starostniki _
Prilagajanje odmerka ni potrebno.
3
_Okvarjeno delovanje ledvic/okvarjeno delovanje jeter _
Uradne študije pri bolnikih z okvarjenim delovanjem ledvic in jeter
niso bile opravljene. Vendar
zaradi narave molekule in kratke razpolovne dobe tehnecijevega (
99m
Tc) besilesomaba prilagajanje
odmerka pri teh bolnikih ni potrebno.
_Pediatrična populacija _
Varnost in učinkovitost zdravila Scintimun pri otrocih in
mladostnikih še nista bili dokazani.
Podatki niso na voljo.
Način uporabe
Radioaktivno označena raztopina se uporabi intravensko kot 
                                
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Active ingredient besilesomab

besilesomab

ATC code V09HA03

V09HA03

Marketed by CIS bio international 

CIS bio international 

INN (International Name) besilesomab

besilesomab

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Patient Information leaflet Patient Information leaflet Bulgarian 13-12-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-12-2022
Public Assessment Report Public Assessment Report Bulgarian 30-09-2014
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Summary of Product characteristics Summary of Product characteristics Spanish 13-12-2022
Public Assessment Report Public Assessment Report Spanish 30-09-2014
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Public Assessment Report Public Assessment Report Czech 30-09-2014
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