Desloratadine Teva

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
09-06-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
09-06-2022
Public Assessment Report Public Assessment Report (PAR)
08-12-2011

Active ingredient:

desloratadin

Available from:

Teva B.V

ATC code:

R06AX27

INN (International Name):

desloratadine

Therapeutic group:

Antihistaminiki za sistemsko zdravljenje,

Therapeutic area:

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Therapeutic indications:

Desloratadine Teva je primerna za lajšanje simptomov, povezanih z:alergijski rinitis;urtikarija.

Product summary:

Revision: 18

Authorization status:

Pooblaščeni

Authorization date:

2011-11-24

Patient Information leaflet

                                15
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
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
Teva B.V.
Swensweg 5
2031 GA Haarlem
Nizozemska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/11/732/001 7 filmsko obloženih tablet
EU/1/11/732/002 10 filmsko obloženih tablet
EU/1/11/732/003 14 filmsko obloženih tablet
EU/1/11/732/004 20 filmsko obloženih tablet
EU/1/11/732/005 21 filmsko obloženih tablet
EU/1/11/732/006 28 filmsko obloženih tablet
EU/1/11/732/007 30 filmsko obloženih tablet
EU/1/11/732/008 40 filmsko obloženih tablet
EU/1/11/732/009 50 filmsko obloženih tablet
EU/1/11/732/010 60 filmsko obloženih tablet
EU/1/11/732/011 90 filmsko obloženih tablet
EU/1/11/732/012 100 filmsko obloženih tablet
EU/1/11/732/013 50 x 1 filmsko obložena tableta (za enkratni odmerek)
EU/1/11/732/014 105 filmsko obloženih tablet
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16
16.
PODATKI V BRAILLOVI PISAVI
Desloratadin Teva 5 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
PC:
SN:
NN:
17
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOT
1.
IME ZDRAVILA
Desloratadin Teva 5 mg filmsko obložene tablete
desloratadin
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Teva B.V.
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
DRUGI PODATKI
18
B. NAVODILO ZA UPORABO
19
NAVODILO ZA UPORABO
DESLORATADIN TEVA 5 MG FILMSKO OBLOŽENE TABLETE
desloratadin
PRED ZAČETKOM JEMANJA ZDRAVILA 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
farmacev
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Desloratadin Teva 5 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena tableta vsebuje 5 mg desloratadina.
Pomožne snovi z znanim učinkom:
Ena filmsko obložena tableta vsebuje 1,2 mg laktoze monohidrata
(glejte poglavje 4.4).
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta
Modra, okrogla, bikonveksna filmsko obložena tableta brez oznake na
obeh straneh.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Desloratadin Teva je indiciran pri odraslih in mladostnikih,
starih 12 let in več, za lajšanje
simptomov:
-
alergijskega rinitisa (glejte poglavje 5.1)
-
urtikarije (glejte poglavje 5.1)
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Odrasli in mladostniki (stari 12 let ali več)
Priporočeni odmerek zdravila Desloratadin Teva 5 mg filmsko obložene
tablete je ena tableta enkrat
na dan.
Intermitentni alergijski rinitis (kadar so simptomi prisotni manj kot
4 dni na teden ali manj kot
4 tedne) zdravite na podlagi ocene bolnikove pretekle anamneze v zvezi
s to boleznijo. Zdravljenje
lahko prekinete po umiritvi simptomov in ga ponovno uvedete, če se ti
spet pojavijo.
Pri perzistentnem alergijskem rinitisu (kadar so simptomi prisotni 4
dni ali več na teden in dlje kot
4 tedne), lahko bolnikom predlagate nadaljevanje zdravljenja tudi v
času izpostavljenosti alergenom.
_Pediatrična populacija _
Izkušenj iz kliničnih preskušanj glede učinkovitosti uporabe
desloratadina pri mladostnikih, starih od
12 do 17 let, je malo (glejte poglavji 4.8 in 5.1).
Varnost in učinkovitost zdravila Desloratadin Teva 5 mg filmsko
obložene tablete pri otrocih, mlajših
od 12 let, nista bili dokazani.
Način uporabe
peroralna uporaba
Odmerek se lahko vzame s hrano ali brez nje.
4.3
KONTRAINDIKACIJE
3
Preobčutljivost na učinkovino ali katero koli pomožno snov,
navedeno v poglavju 6.1, ali na loratadin.
4.4
POSEBNA OPOZORILA IN PREVIDNOSTNI UKREPI
V primeru hude ledvične insuficien
                                
                                Read the complete document

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Active ingredient desloratadin

desloratadin

ATC code R06AX27

R06AX27

Marketed by Teva B.V

Teva B.V

INN (International Name) desloratadine

desloratadine

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Patient Information leaflet Patient Information leaflet Bulgarian 09-06-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 09-06-2022
Public Assessment Report Public Assessment Report Bulgarian 08-12-2011
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Summary of Product characteristics Summary of Product characteristics Spanish 09-06-2022
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Public Assessment Report Public Assessment Report Czech 08-12-2011
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Public Assessment Report Public Assessment Report Danish 08-12-2011
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Public Assessment Report Public Assessment Report German 08-12-2011
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