Dasselta

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)
15-12-2011

Active ingredient:

desloratadin

Available from:

Krka, d.d., Novo mesto

ATC code:

R06AX27

INN (International Name):

desloratadine

Therapeutic group:

Antihistaminiki za sistemsko zdravljenje,

Therapeutic area:

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Urticaria

Therapeutic indications:

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

Product summary:

Revision: 13

Authorization status:

Pooblaščeni

Authorization date:

2011-11-28

Patient Information leaflet

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Dasselta 5 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena filmsko obložena tableta vsebuje 5 mg desloratadina.
Pomožna snov z znanim učinkom
:
Ena filmsko obložena tableta vsebuje 16,15 mg laktoze (v obliki
monohidrata).
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta
Svetlo modre, okrogle, filmsko obložene tablete s prirezanimi robovi
(premer: 6,5 mm, debelina: 2,3–
3,5 mm).
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Dasselta je indicirano 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 Dasselta 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 neprekinjeno zdravljenje 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 Dasselta pri otrocih, mlajših od 12
let, nista bili dokazani.
Način uporabe
peroralna uporaba
Tableto se lahko vzame s hrano ali brez nje.
4.3
KONTRAINDIKACIJE
Preobčutljivost na učinkovino ali katero koli pomožno snov,
navedeno v poglavju 6.1 ali na loratadin.
4.4
POSEBNA OPOZORILA IN PREVIDNOSTNI UKREPI
3
V primeru hude ledvične insuficience morate zdravilo Dasselta
uporabljati previdno (glejte po
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Dasselta 5 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena filmsko obložena tableta vsebuje 5 mg desloratadina.
Pomožna snov z znanim učinkom
:
Ena filmsko obložena tableta vsebuje 16,15 mg laktoze (v obliki
monohidrata).
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta
Svetlo modre, okrogle, filmsko obložene tablete s prirezanimi robovi
(premer: 6,5 mm, debelina: 2,3–
3,5 mm).
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Dasselta je indicirano 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 Dasselta 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 neprekinjeno zdravljenje 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 Dasselta pri otrocih, mlajših od 12
let, nista bili dokazani.
Način uporabe
peroralna uporaba
Tableto se lahko vzame s hrano ali brez nje.
4.3
KONTRAINDIKACIJE
Preobčutljivost na učinkovino ali katero koli pomožno snov,
navedeno v poglavju 6.1 ali na loratadin.
4.4
POSEBNA OPOZORILA IN PREVIDNOSTNI UKREPI
3
V primeru hude ledvične insuficience morate zdravilo Dasselta
uporabljati previdno (glejte po
                                
                                Read the complete document

Similar products

Active ingredient desloratadin

desloratadin

ATC code R06AX27

R06AX27

Marketed by Krka, d.d., Novo mesto

Krka, d.d., Novo mesto

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 15-12-2011
Patient Information leaflet Patient Information leaflet Spanish 09-06-2022
Summary of Product characteristics Summary of Product characteristics Spanish 09-06-2022
Public Assessment Report Public Assessment Report Spanish 15-12-2011
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Summary of Product characteristics Summary of Product characteristics Czech 09-06-2022
Public Assessment Report Public Assessment Report Czech 15-12-2011
Patient Information leaflet Patient Information leaflet Danish 09-06-2022
Summary of Product characteristics Summary of Product characteristics Danish 09-06-2022
Public Assessment Report Public Assessment Report Danish 15-12-2011
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Summary of Product characteristics Summary of Product characteristics German 09-06-2022
Public Assessment Report Public Assessment Report German 15-12-2011
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Summary of Product characteristics Summary of Product characteristics Estonian 09-06-2022
Public Assessment Report Public Assessment Report Estonian 15-12-2011
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Summary of Product characteristics Summary of Product characteristics Greek 09-06-2022
Public Assessment Report Public Assessment Report Greek 15-12-2011
Patient Information leaflet Patient Information leaflet English 09-06-2022
Summary of Product characteristics Summary of Product characteristics English 09-06-2022
Public Assessment Report Public Assessment Report English 15-12-2011
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Summary of Product characteristics Summary of Product characteristics French 09-06-2022
Public Assessment Report Public Assessment Report French 15-12-2011
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Public Assessment Report Public Assessment Report Lithuanian 15-12-2011
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Summary of Product characteristics Summary of Product characteristics Hungarian 09-06-2022
Public Assessment Report Public Assessment Report Hungarian 15-12-2011
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Public Assessment Report Public Assessment Report Portuguese 15-12-2011
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Summary of Product characteristics Summary of Product characteristics Romanian 09-06-2022
Public Assessment Report Public Assessment Report Romanian 15-12-2011
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Summary of Product characteristics Summary of Product characteristics Slovak 09-06-2022
Public Assessment Report Public Assessment Report Slovak 15-12-2011
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Summary of Product characteristics Summary of Product characteristics Finnish 09-06-2022
Public Assessment Report Public Assessment Report Finnish 15-12-2011
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Dasselta