Parareg

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
14-05-2009
Summary of Product characteristics Summary of Product characteristics (SPC)
14-05-2009
Public Assessment Report Public Assessment Report (PAR)
13-05-2009

Active ingredient:

cinakalcet

Available from:

Dompé Biotec S.p.A.

ATC code:

H05BX01

INN (International Name):

cinacalcet

Therapeutic group:

Kalcij homeostaza

Therapeutic area:

Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism

Therapeutic indications:

Zdravljenje sekundarnega hiperparatiroidizma (HPT) pri bolnikih s končno ledvično boleznijo (ESRD) pri vzdrževalnem dializnem zdravljenju. Mimpara se lahko uporablja kot del terapevtski režim, vključno z fosfat veziv in/ali Vitamina D sterolov, kot je primerno (glej poglavje 5. Zmanjšanje hypercalcaemia pri bolnikih z:-parathyroid karcinom. - primarni HPT, za katere parathyroidectomy bi se kazalo na osnovi seruma calciumlevels (kot je opredeljeno z ustreznimi smernicami za zdravljenje), ampak v katero parathyroidectomy ni klinično primerno ali je kontraindicirana.

Product summary:

Revision: 6

Authorization status:

Umaknjeno

Authorization date:

2004-10-22

Patient Information leaflet

                                European Medicines Agency
7 Westferry Circus, Canary Wharf, London E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68
E-mail: mail@emea.europa.eu http://www.emea.europa.eu
©
European Medicines Agency, 2008. Reproduction is authorised provided
the source is acknowledged.
EMEA/H/C/575
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
_ _
PARAREG
POVZETEK EPAR ZA JAVNOST
_Ta dokument je povzetek evropskega javnega poročila 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 informacij o svojem 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 PARAREG?_ _
Parareg je zdravilo, ki vsebuje zdravilno učinkovino cinakalcet. Na
voljo je v obliki svetlozelenih
ovalnih tablet (30, 60 ali 90 mg).
ZA KAJ SE ZDRAVILO PARAREG UPORABLJA ?
Zdravilo Parareg se uporablja pri odraslih in starostnikih:
•
za zdravljenje sekundarnega hiperparatiroidizma. To je stanje, pri
katerem obščitnice v vratu
tvorijo preveč paratiroidnega hormona (PTH). „Sekundarni“ pomeni,
da hiperparatiroidizem
nastane kot posledica drugega bolezenskega stanja. Posledica so lahko
bolečine v kosteh in
sklepih
ter
deformacije
rok
in
nog.
Zdravilo
Parareg
se
uporablja
pri
bolnikih
s
hudim
obolenjem ledvic, ki za očiščenje odpadnih snovi iz krvi
potrebujejo dializo. Uporablja se lahko
kot del zdravljenja, ki vključuje vezalce fosfatov ali sterole
vitamina D.
•
za
zmanjšanje
hiperkalciemije
(visokih
ravni
kalcija
v
krvi)
pri
bolnikih
s
paratiroidnim
karcinomom (rakom obščitnic) ali pri bolnikih s primarnim
hiperparatiroidizmom, pri katerih
odstranitev obščitnic ni možna, ali za katere zdravnik meni, da
odstranitev obšč
                                
                                Read the complete document

Summary of Product characteristics

                                European Medicines Agency
7 Westferry Circus, Canary Wharf, London E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68
E-mail: mail@emea.europa.eu http://www.emea.europa.eu
©
European Medicines Agency, 2008. Reproduction is authorised provided
the source is acknowledged.
EMEA/H/C/575
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
_ _
PARAREG
POVZETEK EPAR ZA JAVNOST
_Ta dokument je povzetek evropskega javnega poročila 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 informacij o svojem 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 PARAREG?_ _
Parareg je zdravilo, ki vsebuje zdravilno učinkovino cinakalcet. Na
voljo je v obliki svetlozelenih
ovalnih tablet (30, 60 ali 90 mg).
ZA KAJ SE ZDRAVILO PARAREG UPORABLJA ?
Zdravilo Parareg se uporablja pri odraslih in starostnikih:
•
za zdravljenje sekundarnega hiperparatiroidizma. To je stanje, pri
katerem obščitnice v vratu
tvorijo preveč paratiroidnega hormona (PTH). „Sekundarni“ pomeni,
da hiperparatiroidizem
nastane kot posledica drugega bolezenskega stanja. Posledica so lahko
bolečine v kosteh in
sklepih
ter
deformacije
rok
in
nog.
Zdravilo
Parareg
se
uporablja
pri
bolnikih
s
hudim
obolenjem ledvic, ki za očiščenje odpadnih snovi iz krvi
potrebujejo dializo. Uporablja se lahko
kot del zdravljenja, ki vključuje vezalce fosfatov ali sterole
vitamina D.
•
za
zmanjšanje
hiperkalciemije
(visokih
ravni
kalcija
v
krvi)
pri
bolnikih
s
paratiroidnim
karcinomom (rakom obščitnic) ali pri bolnikih s primarnim
hiperparatiroidizmom, pri katerih
odstranitev obščitnic ni možna, ali za katere zdravnik meni, da
odstranitev obšč
                                
                                Read the complete document

Similar products

Active ingredient cinakalcet

cinakalcet

ATC code H05BX01

H05BX01

Marketed by Dompé Biotec S.p.A.

Dompé Biotec S.p.A.

INN (International Name) cinacalcet

cinacalcet

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Patient Information leaflet Patient Information leaflet Bulgarian 14-05-2009
Summary of Product characteristics Summary of Product characteristics Bulgarian 14-05-2009
Public Assessment Report Public Assessment Report Bulgarian 13-05-2009
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Summary of Product characteristics Summary of Product characteristics Spanish 14-05-2009
Public Assessment Report Public Assessment Report Spanish 13-05-2009
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Parareg