Possia

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
01-02-2013
Download Summary of Product characteristics (SPC)
01-02-2013
Download Public Assessment Report (PAR)
07-01-2011

Active ingredient:

Ticagrelor

Available from:

AstraZeneca AB

ATC code:

B01AC24

INN (International Name):

ticagrelor

Therapeutic group:

Antitrombotična sredstva

Therapeutic area:

Peripheral Vascular Diseases; Acute Coronary Syndrome

Therapeutic indications:

Possia, co-upravlja z acetilsalicilna kislina (ASA), je indiciran za preprečevanje atherothrombotic dogodkov pri odraslih bolnikih z akutni koronarni sindrom (Nestabilna angina pektoris, non-ST-infarkta miokarda [NSTEMI] ali ST-nadmorske višine miokardni infarkt [STEMI]); vključno z bolniki, ki upravlja z zdravili, in tistih, ki so z perkutano koronarno intervencijo (PCI) ali koronarne arterije cepljenje obvod (CABG).

Product summary:

Revision: 2

Authorization status:

Umaknjeno

Authorization date:

2010-12-03

Patient Information leaflet

                                24
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
_ _
AstraZeneca AB
S-151 85
Södertälje
Švedska
12.
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
EU/1/10/656/001 60 filmsko obloženih tablet
EU/1/10/656/002 180 filmsko obloženih tablet
EU/1/10/656/003 14 filmsko obloženih tablet
EU/1/10/656/004 56 filmsko obloženih tablet
EU/1/10/656/005 168 filmsko obloženih tablet
EU/1/10/656/006 100x1 filmsko obložena tableta
13.
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV
Serija
14.
NAČIN IZDAJANJA ZDRAVILA
Izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
_ _
16.
PODATKI V BRAILLOVI PISAVI_ _
possia 90 mg
Zdravilo nima veā dovoljenja za promet
25
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PERFORIRANI PRETISNI OMOTI ZA ENKRATNI ODMEREK (100 X 1 TABLETA)
1.
IME ZDRAVILA
_ _
Possia 90 mg tablete
tikagrelor
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
AstraZeneca AB
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV
Lot
5.
DRUGI PODATKI
_ _
Zdravilo nima veā dovoljenja za promet
26
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOT (10 TABLET)
1.
IME ZDRAVILA
_ _
Possia 90 mg tablete
tikagrelor
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
AstraZeneca AB
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV
Lot
5.
DRUGI PODATKI
_ _
_ _
simbol sonce/mesec
Zdravilo nima veā dovoljenja za promet
27
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
KOLEDARSKI PRETISNI OMOT (14 TABLET)
1.
IME ZDRAVILA
_ _
Possia 90 mg tablete
tikagrelor
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
AstraZeneca AB
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV
Lot
5.
DRUGI PODATKI
Pon Tor Sre Čet Pet Sob Ned
simbol sonce/mesec
Zdravilo nima veā dovoljenja za promet
28
B. NAVODILO ZA UPORABO
Zdravilo nima veā dovoljenja za promet
29
NAVODILO 
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
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Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
Possia 90 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena tableta vsebuje 90 mg tikagrelorja.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Filmsko obložena tableta (tableta).
Okrogla, bikonveksna rumena tableta z oznako "90" nad "T" na eni
strani in brez oznak na drugi
strani.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Possia je sočasno z acetilsalicilno kislino (ASA) indicirano
za preprečevanje
aterotrombotičnih dogodkov pri odraslih bolnikih z akutnimi
koronarnimi sindromi (nestabilno angino
pektoris, miokardnim infarktom brez dviga ST [NSTEMI] ali z dvigom ST
[STEMI]), vključno s
konzervativno zdravljenimi bolniki in bolniki, zdravljenimi s
perkutano koronarno intervencijo ali
obvodno koronarno operacijo.
Za dodatne informacije glejte poglavje 5.1.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Zdravljenje z zdravilom Possia je treba začeti z enim 180-mg
polnilnim odmerkom (dve tableti po
90 mg) in ga nadaljevati z 90 mg dvakrat na dan.
Bolniki, ki jemljejo zdravilo Possia, morajo jemati tudi ASA, če ni
posebej kontraindicirana. Po
uvodnem odmerku ASA je treba zdravilo Possia uporabljati z
vzdrževalnim odmerkom ASA od 75 do
150 mg (glejte poglavje 5.1).
Zdravljenje je priporočljivo nadaljevati do 12 mesecev, razen če je
prenehanje uporabe zdravila Possia
klinično indicirano (glejte poglavje 5.1). Izkušenj z uporabo več
kot 12 mesecev je malo.
Bolnikom z akutnimi koronarnimi sindromi (ACS – Acute Coronary
Syndrome) lahko prezgodnje
prenehanje uporabe kateregakoli antiagregacijskega zdravila, tudi
zdravila Possia, poveča tveganje
kardiovaskularne smrti ali miokardnega infarkta zaradi njihove osnovne
bolezni. Zato se je treba
izogniti prezgodnjemu prenehanju zdravljenja.
Izogibati se je treba tudi izpuščan
                                
                                Read the complete document

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ATC code B01AC24

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Summary of Product characteristics Summary of Product characteristics Bulgarian 01-02-2013
Public Assessment Report Public Assessment Report Bulgarian 07-01-2011
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Public Assessment Report Public Assessment Report Spanish 07-01-2011
Patient Information leaflet Patient Information leaflet Czech 01-02-2013
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Public Assessment Report Public Assessment Report Greek 07-01-2011
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