Teslascan

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
02-08-2012
Summary of Product characteristics Summary of Product characteristics (SPC)
02-08-2012
Public Assessment Report Public Assessment Report (PAR)
02-08-2012

Active ingredient:

mangafodipir trinatrij

Available from:

GE Healthcare AS

ATC code:

V08CA05

INN (International Name):

mangafodipir

Therapeutic group:

Kontrastni mediji

Therapeutic area:

Slikanje z magnetno resonanco

Therapeutic indications:

To zdravilo je samo za diagnostično uporabo. Kontrast medij za diagnostično slikanje z magnetno resonanco (MRI) za odkrivanje poškodb jeter sum, da je zaradi metastatskim bolezni ali hepatocellular carcinomas. Kot dodatek k MRI za pomoč pri preiskavi osrednja lezij trebušne slinavke.

Product summary:

Revision: 9

Authorization status:

Umaknjeno

Authorization date:

1997-05-22

Patient Information leaflet

                                Zdravilo nima veā dovoljenja za promet
European Medicines Agency
7 Westferry Circus, Canary Wharf, London E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16
E-mail: mail@emea.europa.eu http://www.emea.europa.eu
©
EMEA 2007 Reproduction and/or distribution of this document is
authorised for non commercial purposes only provided the EMEA is
acknowledged
EMEA/H/C/137
EVROPSKO JAVNO POROČI
L
O O OCENI ZDRAVILA (EPAR)
TESLASCAN
POVZETEK EPAR ZA JAVNOST
_Ta dokument je povzetek Evropskega javnega poročil_
_a o oceni zdravila (EPAR). Pojasnjuje, kako _
_je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil
opravljene študije, na podlagi _
_katerih je oblikoval priporočila glede uporabe zdravila._
_Če potrebujete več_
_ informa_
_cij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo
za _
_uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim
zdravnikom ali farmacevtom. Če _
_želite več informacij, ki temeljijo na priporočilih CHMP,
preberite znanstveno razpravo (ki je _
_prav tako del EPAR)._
KAJ JE ZDRAVILO TESLASCAN?_ _
Zdravilo TESLASCAN je raztopina za infuzijo (dajanj
e
v veno), ki vsebuje zdravilno učinkovino
trinatrijev mangafodipir.
ZA KAJ SE ZDRAVILO TESLASCAN UPORABLJA?
Zdravilo TESLASCAN je za diagnostične namene. Zdravilo TESLASCAN se
uporablja pri bolnikih
pred magnetno resonančnim slikanjem (MRI), s pomočjo katerega se
ugotavljajo lezije (poškodbe
tkiva) v jetrih, ki bi jih utegnil povzročiti jetrni rak ali rak, ki
se je razširil iz jeter v druge dele telesa.
Zdravilo TESLACAN je „kontrastno sredstvo“, ki se uporablja za
jasnejšo vidnost slik. Zdravilo
TESLASCAN se lahko uporablja skupaj z magnetno resonančnim slikanjem
tudi pri preiskovanju lezij
na trebušni slinavki.
Zdravilo se dobi samo na recept.
KAKO SE ZDRAVILO TESLASCAN UPORABLJA?
Zdravilo TESLASCAN uporabljamo kot enkratno intravensko infuzijo v
odmerku, ki znaša 0,5 ml na
kilogram telesne mase. Hitrost infundiranja znaša 2 do 3 ml/min pri
slikanju jeter in 4 do 6 ml/min pri
sli
                                
                                Read the complete document

Summary of Product characteristics

                                Zdravilo nima veā dovoljenja za promet
European Medicines Agency
7 Westferry Circus, Canary Wharf, London E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16
E-mail: mail@emea.europa.eu http://www.emea.europa.eu
©
EMEA 2007 Reproduction and/or distribution of this document is
authorised for non commercial purposes only provided the EMEA is
acknowledged
EMEA/H/C/137
EVROPSKO JAVNO POROČI
L
O O OCENI ZDRAVILA (EPAR)
TESLASCAN
POVZETEK EPAR ZA JAVNOST
_Ta dokument je povzetek Evropskega javnega poročil_
_a o oceni zdravila (EPAR). Pojasnjuje, kako _
_je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil
opravljene študije, na podlagi _
_katerih je oblikoval priporočila glede uporabe zdravila._
_Če potrebujete več_
_ informa_
_cij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo
za _
_uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim
zdravnikom ali farmacevtom. Če _
_želite več informacij, ki temeljijo na priporočilih CHMP,
preberite znanstveno razpravo (ki je _
_prav tako del EPAR)._
KAJ JE ZDRAVILO TESLASCAN?_ _
Zdravilo TESLASCAN je raztopina za infuzijo (dajanj
e
v veno), ki vsebuje zdravilno učinkovino
trinatrijev mangafodipir.
ZA KAJ SE ZDRAVILO TESLASCAN UPORABLJA?
Zdravilo TESLASCAN je za diagnostične namene. Zdravilo TESLASCAN se
uporablja pri bolnikih
pred magnetno resonančnim slikanjem (MRI), s pomočjo katerega se
ugotavljajo lezije (poškodbe
tkiva) v jetrih, ki bi jih utegnil povzročiti jetrni rak ali rak, ki
se je razširil iz jeter v druge dele telesa.
Zdravilo TESLACAN je „kontrastno sredstvo“, ki se uporablja za
jasnejšo vidnost slik. Zdravilo
TESLASCAN se lahko uporablja skupaj z magnetno resonančnim slikanjem
tudi pri preiskovanju lezij
na trebušni slinavki.
Zdravilo se dobi samo na recept.
KAKO SE ZDRAVILO TESLASCAN UPORABLJA?
Zdravilo TESLASCAN uporabljamo kot enkratno intravensko infuzijo v
odmerku, ki znaša 0,5 ml na
kilogram telesne mase. Hitrost infundiranja znaša 2 do 3 ml/min pri
slikanju jeter in 4 do 6 ml/min pri
sli
                                
                                Read the complete document

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Active ingredient mangafodipir trinatrij

mangafodipir trinatrij

ATC code V08CA05

V08CA05

Marketed by GE Healthcare AS

GE Healthcare AS

INN (International Name) mangafodipir

mangafodipir

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Patient Information leaflet Patient Information leaflet Bulgarian 02-08-2012
Summary of Product characteristics Summary of Product characteristics Bulgarian 02-08-2012
Public Assessment Report Public Assessment Report Bulgarian 02-08-2012
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