Plenadren

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
06-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
06-12-2022
Public Assessment Report Public Assessment Report (PAR)
05-01-2017

Active ingredient:

hidrokortizon

Available from:

Takeda Pharmaceuticals International AG Ireland Branch

ATC code:

H02AB09

INN (International Name):

hydrocortisone

Therapeutic group:

Kortikosteroidi za sistemsko uporabo

Therapeutic area:

Nadledvična insuficienca

Therapeutic indications:

Zdravljenje nadledvične insuficience pri odraslih.

Product summary:

Revision: 14

Authorization status:

Pooblaščeni

Authorization date:

2011-11-03

Patient Information leaflet

                                17
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
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Irska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/11/715/001 50 tablet s prirejenim sproščanjem
EU/1/11/715/003 100 (2x50) tablet s prirejenim sproščanjem
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Plenadren 5 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC
SN
NN
18
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
PLASTENKA
1.
IME ZDRAVILA IN POT(I) UPORABE
Plenadren 5 mg tablete s prirejenim sproščanjem
hidrokortizon
peroralna uporaba
2.
POSTOPEK UPORABE
Pred uporabo preberite priloženo navodilo!
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
50 tablet s prirejenim sproščanjem
6.
DRUGI PODATKI
Takeda
19
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Plenadren 20 mg tablete s prirejenim sproščanjem
hidrokortizon
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ena tableta s prirejenim sproščanjem vsebuje 20 mg hidrokortizona.
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
tableta s prirejenim sproščanjem
50 tablet s prirejenim sproščanjem
100 tablet s prirejenim sproščanjem (2x50)
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Tablete pogoltnite cele. Tablet ne smete prelomiti, zdrobiti ali
prežvečiti.
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.
DATUM IZTEKA ROKA UPORABNO
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Plenadren 5 mg tablete s prirejenim sproščanjem
Plenadren 20 mg tablete s prirejenim sproščanjem
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Plenadren 5 mg tablete s prirejenim sproščanjem
Ena tableta s prirejenim sproščanjem vsebuje 5 mg hidrokortizona.
Plenadren 20 mg tablete s prirejenim sproščanjem
Ena tableta s prirejenim sproščanjem vsebuje 20 mg hidrokortizona.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
tableta s prirejenim sproščanjem
Plenadren 5 mg tablete s prirejenim sproščanjem
Tablete so okrogle (s premerom 8 mm), izbočene in rožnate.
Plenadren 20 mg tablete s prirejenim sproščanjem
Tablete so okrogle (s premerom 8 mm), izbočene in bele.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravljenje adrenalne insuficience pri odraslih.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Zdravilo Plenadren se daje kot vzdrževalna terapija. Peroralni
nadomestni odmerki se določijo za
vsakega bolnika posebej na podlagi kliničnega odziva. Običajni
vzdrževalni odmerek je 20–30 mg na
dan, ki se daje enkrat na dan, in sicer zjutraj. Pri bolnikih, pri
katerih se še tvori endogeni kortizol, bo
morda zadostoval manjši odmerek. Največji preučeni vzdrževalni
odmerek je 40 mg. Uporablja naj se
najmanjši možni vzdrževalni odmerek. Kadar je telo izpostavljeno
čezmernemu telesnemu in/ali
psihičnemu naporu, bodo bolniki morda potrebovali dodatne nadomestne
tablete hidrokortizona s
takojšnjim sproščanjem, zlasti popoldne/zvečer; glejte tudi
poglavje „Uporaba pri sočasni bolezni“,
kjer so opisani drugi načini začasnega povečanja odmerka
hidrokortizona
_Prehod s konvencionalnega zdravljenja s peroralnimi glukokortikoidi
na zdravljenje z zdravilom _
_Plenadren_
Pri prehodu bolnikov s konvencionalnega peroralnega nadomestnega
zdravljenja s hidrokortizonom, ki
so ga bolniki jemali trikrat na dan, na zdravljenje z zdravilom
Plenadren se lahko daje enak skupni
dnevni odmerek. Zaradi nižje b
                                
                                Read the complete document

Similar products

Active ingredient hidrokortizon

hidrokortizon

ATC code H02AB09

H02AB09

Marketed by Takeda Pharmaceuticals International AG Ireland Branch

Takeda Pharmaceuticals International AG Ireland Branch

INN (International Name) hydrocortisone

hydrocortisone

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 06-12-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 06-12-2022
Public Assessment Report Public Assessment Report Bulgarian 05-01-2017
Patient Information leaflet Patient Information leaflet Spanish 06-12-2022
Summary of Product characteristics Summary of Product characteristics Spanish 06-12-2022
Public Assessment Report Public Assessment Report Spanish 05-01-2017
Patient Information leaflet Patient Information leaflet Czech 06-12-2022
Summary of Product characteristics Summary of Product characteristics Czech 06-12-2022
Public Assessment Report Public Assessment Report Czech 05-01-2017
Patient Information leaflet Patient Information leaflet Danish 06-12-2022
Summary of Product characteristics Summary of Product characteristics Danish 06-12-2022
Public Assessment Report Public Assessment Report Danish 05-01-2017
Patient Information leaflet Patient Information leaflet German 06-12-2022
Summary of Product characteristics Summary of Product characteristics German 06-12-2022
Public Assessment Report Public Assessment Report German 05-01-2017
Patient Information leaflet Patient Information leaflet Estonian 06-12-2022
Summary of Product characteristics Summary of Product characteristics Estonian 06-12-2022
Public Assessment Report Public Assessment Report Estonian 05-01-2017
Patient Information leaflet Patient Information leaflet Greek 06-12-2022
Summary of Product characteristics Summary of Product characteristics Greek 06-12-2022
Public Assessment Report Public Assessment Report Greek 05-01-2017
Patient Information leaflet Patient Information leaflet English 06-12-2022
Summary of Product characteristics Summary of Product characteristics English 06-12-2022
Public Assessment Report Public Assessment Report English 05-01-2017
Patient Information leaflet Patient Information leaflet French 06-12-2022
Summary of Product characteristics Summary of Product characteristics French 06-12-2022
Public Assessment Report Public Assessment Report French 05-01-2017
Patient Information leaflet Patient Information leaflet Italian 06-12-2022
Summary of Product characteristics Summary of Product characteristics Italian 06-12-2022
Public Assessment Report Public Assessment Report Italian 05-01-2017
Patient Information leaflet Patient Information leaflet Latvian 06-12-2022
Summary of Product characteristics Summary of Product characteristics Latvian 06-12-2022
Public Assessment Report Public Assessment Report Latvian 05-01-2017
Patient Information leaflet Patient Information leaflet Lithuanian 06-12-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 06-12-2022
Public Assessment Report Public Assessment Report Lithuanian 05-01-2017
Patient Information leaflet Patient Information leaflet Hungarian 06-12-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 06-12-2022
Public Assessment Report Public Assessment Report Hungarian 05-01-2017
Patient Information leaflet Patient Information leaflet Maltese 06-12-2022
Summary of Product characteristics Summary of Product characteristics Maltese 06-12-2022
Public Assessment Report Public Assessment Report Maltese 05-01-2017
Patient Information leaflet Patient Information leaflet Dutch 06-12-2022
Summary of Product characteristics Summary of Product characteristics Dutch 06-12-2022
Public Assessment Report Public Assessment Report Dutch 05-01-2017
Patient Information leaflet Patient Information leaflet Polish 06-12-2022
Summary of Product characteristics Summary of Product characteristics Polish 06-12-2022
Public Assessment Report Public Assessment Report Polish 05-01-2017
Patient Information leaflet Patient Information leaflet Portuguese 06-12-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 06-12-2022
Public Assessment Report Public Assessment Report Portuguese 05-01-2017
Patient Information leaflet Patient Information leaflet Romanian 06-12-2022
Summary of Product characteristics Summary of Product characteristics Romanian 06-12-2022
Public Assessment Report Public Assessment Report Romanian 05-01-2017
Patient Information leaflet Patient Information leaflet Slovak 06-12-2022
Summary of Product characteristics Summary of Product characteristics Slovak 06-12-2022
Public Assessment Report Public Assessment Report Slovak 05-01-2017
Patient Information leaflet Patient Information leaflet Finnish 06-12-2022
Summary of Product characteristics Summary of Product characteristics Finnish 06-12-2022
Public Assessment Report Public Assessment Report Finnish 05-01-2017
Patient Information leaflet Patient Information leaflet Swedish 06-12-2022
Summary of Product characteristics Summary of Product characteristics Swedish 06-12-2022
Public Assessment Report Public Assessment Report Swedish 05-01-2017
Patient Information leaflet Patient Information leaflet Norwegian 06-12-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 06-12-2022
Patient Information leaflet Patient Information leaflet Icelandic 06-12-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 06-12-2022
Patient Information leaflet Patient Information leaflet Croatian 06-12-2022
Summary of Product characteristics Summary of Product characteristics Croatian 06-12-2022
Public Assessment Report Public Assessment Report Croatian 05-01-2017

Search alerts related to this product

Alerts Plenadren hidrokortizon hydrocortisone

Plenadren hidrokortizon hydrocortisone

View documents history

Documents history Documents history

Plenadren