Levodopa/Carbidopa/Entacapone Orion

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Active ingredient:

levodopa, carbidopa, entacapone

Available from:

Orion Corporation

ATC code:

N04BA03

INN (International Name):

levodopa, carbidopa, entacapone

Therapeutic group:

Živčni sistem

Therapeutic area:

Parkinsonova bolezen

Therapeutic indications:

Levodopo/Carbidopa/Entacapone Orion je indiciran za zdravljenje odraslih bolnikov s Parkinsonovo boleznijo in konec odmerek motor nihanja ne ustalile na levodopo / Dope-decarboxylase (DDC)-zaviralec zdravljenje.

Product summary:

Revision: 13

Authorization status:

Pooblaščeni

Authorization date:

2011-08-23

Patient Information leaflet

                                21
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do:
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
_Škatla_
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finska
_Nalepka_
Orion Corporation
12.
ŠTEVILK(E) DOVOLJENJ(A) ZA PROMET
EU/1/11/706/001 10 filmsko obloženih tablet
EU/1/11/706/002 30 filmsko obloženih tablet
EU/1/11/706/003 100 filmsko obloženih tablet
EU/1/11/706/004 130 filmsko obloženih tablet
EU/1/11/706/005 175 filmsko obloženih tablet
EU/1/11/706/006 250 filmsko obloženih tablet
13.
ŠTEVILKA SERIJE
Številka serije:
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
levodopa/carbidopa/entacapone orion 50/12,5/200 mg_ [samo škatla]_
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako._ [samo
škatla]_
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
_[samo škatla]:_
22
PC {številka}
SN {številka}
< NN {številka}>
23
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
NALEPKA NA STEKLENIČKI IN BESEDILO NA ZUNANJI OVOJNINI
1.
IME ZDRAVILA
Levodopa/Carbidopa/Entacapone Orion 75 mg/18,75 mg/200 mg filmsko
obložene tablete
levodopa/karbidopa/entakapon
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ena filmsko obložena tableta vsebuje 75 mg levodope, 18,75 mg
karbidope in 200 mg entakapona.
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje saharozo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
_Škatla_
10 filmsko obloženih tablet
30 filmsko obloženih tablet
100 filmsko obloženih tablet
130 filmsko obloženih tablet
175 filmsko obloženih tablet
_Nalepka_
10 tablet
30 tablet
100 tablet
130 tablet
175 tablet
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
peroralna uporaba
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
8.
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg filmsko
obložene tablete
Levodopa/Carbidopa/Entacapone Orion 75 mg/18,75 mg/200 mg filmsko
obložene tablete
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg filmsko
obložene tablete
Levodopa/Carbidopa/Entacapone Orion 125 mg/31,25 mg/200 mg filmsko
obložene tablete
Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg filmsko
obložene tablete
Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg filmsko
obložene tablete
Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg filmsko
obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
50 mg/12,5 mg/200 mg
Ena tableta vsebuje 50 mg levodope, 12,5 mg karbidope in 200 mg
entakapona.
Pomožna snov z znanim učinkom:
Ena tableta vsebuje 1,2 mg saharoze.
75 mg/18,75 mg/200 mg
Ena tableta vsebuje 75 mg levodope, 18,75 mg karbidope in 200 mg
entakapona.
Pomožna snov z znanim učinkom:
Ena tableta vsebuje 1,4 mg saharoze.
100 mg/25 mg/200 mg
Ena tableta vsebuje 100 mg levodope, 25 mg karbidope in 200 mg
entakapona.
Pomožna snov z znanim učinkom:
Ena tableta vsebuje 1,6 mg saharoze.
125 mg/31,25 mg/200 mg
Ena tableta vsebuje 125 mg levodope, 31,25 mg karbidope in 200 mg
entakapona.
Pomožna snov z znanim učinkom:
Ena tableta vsebuje 1,6 mg saharoze.
150 mg/37,5 mg/200 mg
Ena tableta vsebuje 150 mg levodope, 37,5 mg karbidope in 200 mg
entakapona.
Pomožne snovi z znanim učinkom:
Ena tableta vsebuje 1,9 mg saharoze in 2,6 mg natrija, kot sestavina
pomožne snovi.
175 mg/43,75 mg/200 mg
Ena tableta vsebuje 175 mg levodope, 43,75 mg karbidope in 200 mg
entakapona.
Pomožna snov z znanim učinkom:
Ena tableta vsebuje 1,89 mg saharoze.
200 mg/50 mg/200 mg
Ena tableta vsebuje 200 mg levodope, 50 mg karbidope in 200 mg
entakapona.
Pomožna snov z znanim učinkom:
Ena tableta vsebuje 2,3 mg saharoze.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta (tableta)
50 mg/12,5 mg/
                                
                                Read the complete document
                                
                            

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 03-04-2024
Summary of Product characteristics Summary of Product characteristics Bulgarian 03-04-2024
Public Assessment Report Public Assessment Report Bulgarian 19-09-2013
Patient Information leaflet Patient Information leaflet Spanish 03-04-2024
Public Assessment Report Public Assessment Report Spanish 19-09-2013
Patient Information leaflet Patient Information leaflet Czech 03-04-2024
Public Assessment Report Public Assessment Report Czech 19-09-2013
Patient Information leaflet Patient Information leaflet Danish 03-04-2024
Public Assessment Report Public Assessment Report Danish 19-09-2013
Patient Information leaflet Patient Information leaflet German 03-04-2024
Public Assessment Report Public Assessment Report German 19-09-2013
Patient Information leaflet Patient Information leaflet Estonian 03-04-2024
Public Assessment Report Public Assessment Report Estonian 19-09-2013
Patient Information leaflet Patient Information leaflet Greek 03-04-2024
Public Assessment Report Public Assessment Report Greek 19-09-2013
Patient Information leaflet Patient Information leaflet English 03-04-2024
Public Assessment Report Public Assessment Report English 19-09-2013
Patient Information leaflet Patient Information leaflet French 03-04-2024
Public Assessment Report Public Assessment Report French 19-09-2013
Patient Information leaflet Patient Information leaflet Italian 03-04-2024
Public Assessment Report Public Assessment Report Italian 19-09-2013
Patient Information leaflet Patient Information leaflet Latvian 03-04-2024
Public Assessment Report Public Assessment Report Latvian 19-09-2013
Patient Information leaflet Patient Information leaflet Lithuanian 03-04-2024
Summary of Product characteristics Summary of Product characteristics Lithuanian 03-04-2024
Public Assessment Report Public Assessment Report Lithuanian 19-09-2013
Patient Information leaflet Patient Information leaflet Hungarian 03-04-2024
Summary of Product characteristics Summary of Product characteristics Hungarian 03-04-2024
Public Assessment Report Public Assessment Report Hungarian 19-09-2013
Patient Information leaflet Patient Information leaflet Maltese 03-04-2024
Public Assessment Report Public Assessment Report Maltese 19-09-2013
Patient Information leaflet Patient Information leaflet Dutch 03-04-2024
Public Assessment Report Public Assessment Report Dutch 19-09-2013
Patient Information leaflet Patient Information leaflet Polish 03-04-2024
Public Assessment Report Public Assessment Report Polish 19-09-2013
Patient Information leaflet Patient Information leaflet Portuguese 03-04-2024
Summary of Product characteristics Summary of Product characteristics Portuguese 03-04-2024
Public Assessment Report Public Assessment Report Portuguese 19-09-2013
Patient Information leaflet Patient Information leaflet Romanian 03-04-2024
Public Assessment Report Public Assessment Report Romanian 19-09-2013
Patient Information leaflet Patient Information leaflet Slovak 03-04-2024
Public Assessment Report Public Assessment Report Slovak 19-09-2013
Patient Information leaflet Patient Information leaflet Finnish 03-04-2024
Public Assessment Report Public Assessment Report Finnish 19-09-2013
Patient Information leaflet Patient Information leaflet Swedish 03-04-2024
Public Assessment Report Public Assessment Report Swedish 19-09-2013
Patient Information leaflet Patient Information leaflet Norwegian 03-04-2024
Summary of Product characteristics Summary of Product characteristics Norwegian 03-04-2024
Patient Information leaflet Patient Information leaflet Icelandic 03-04-2024
Summary of Product characteristics Summary of Product characteristics Icelandic 03-04-2024
Patient Information leaflet Patient Information leaflet Croatian 03-04-2024