Tracleer

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-02-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-02-2023
Public Assessment Report Public Assessment Report (PAR)
03-12-2019

Active ingredient:

bosentan (as monohydrate)

Available from:

Janssen-Cilag International N.V.  

ATC code:

C02KX01

INN (International Name):

bosentan

Therapeutic group:

Antihipertenzivi,

Therapeutic area:

Scleroderma, Systemic; Hypertension, Pulmonary

Therapeutic indications:

Zdravljenje pljučne arterijske hipertenzije (PAH) za izboljšanje telesne zmogljivosti in simptomov pri bolnikih s funkcionalnim razredom III SZO. Efficacy has been shown in: , Primary (idiopathic and familial) PAH;, PAH secondary to scleroderma without significant interstitial pulmonary disease;, PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology. Nekatere izboljšave so tudi pokazale, pri bolnikih s PAH, KI funkcijski razred II. Tracleer je bilo tudi navedeno, da se zmanjša število novih digitalnih razjede pri bolnikih s sistemsko sklerozo in tekoče digitalni razjede bolezni.

Product summary:

Revision: 42

Authorization status:

Pooblaščeni

Authorization date:

2002-05-14

Patient Information leaflet

                                49
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
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/02/220/001
EU/1/02/220/002
EU/1/02/220/003
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Tracleer 62,5 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC
SN
NN
50
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA S 56 IN 112 TABLETAMI
ZUNANJA ŠKATLA/PRETISNI OMOT
1.
IME ZDRAVILA
Tracleer 125 mg filmsko obložene tablete
bosentan
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ena filmsko obložena tableta vsebuje 125 mg bosentana (v obliki
monohidrata).
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
56 filmsko obloženih tablet
112 filmsko obloženih tablet
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Peroralna uporaba
Pred uporabo preberite priloženo navodilo!
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 UPORABNOSTI ZDRAVILA
EXP {MM/LLLL}
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 25

C
51
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
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/02/220/004
EU/1/02/220/005
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Tracleer 125 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Tracleer 62,5 mg filmsko obložene tablete
Tracleer 125 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Tracleer 62,5 mg filmsko obložene tablete
Ena filmsko obložena tableta vsebuje 62,5 mg bosentana (v obliki
monohidrata).
Tracleer 125 mg filmsko obložene tablete
Ena filmsko obložena tableta vsebuje 125 mg bosentana (v obliki
monohidrata).
Pomožna snov z znanim učinkom
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v
bistvu pomeni ‘brez natrija’.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Filmsko obložena tableta (filmsko obložene tablete):
Tracleer 62,5 mg filmsko obložene tablete
Oranžnobele, okrogle, na obeh straneh izbočene filmsko obložene
tablete, ki imajo na eni strani
vtisnjeno „62,5“.
Tracleer 125 mg filmsko obložene tablete
Oranžnobele, ovalne, na obeh straneh izbočene filmsko obložene
tablete, ki imajo na eni strani
vtisnjeno „125“.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravljenje pljučne arterijske hipertenzije (PAH –_ Pulmonary
Arterial Hypertension_), za izboljšanje
fizične zmogljivosti in simptomov pri bolnikih s III. funkcijskim
razredom po SZO. Učinkovitost je
bila ugotovljena pri:

primarni (idiopatski in dedni) pljučni arterijski hipertenziji,

pljučni arterijski hipertenziji, ki je posledica skleroderme brez
resne intersticijske pljučne
bolezni,

pljučni arterijski hipertenziji, povezani s kongenitalnimi
sistemsko-pulmonalnimi šanti in
Eisenmengerjevo fiziologijo.
Določena izboljšanja so se pokazala tudi pri bolnikih s pljučno
arterijsko hipertenzijo II. funkcijskega
razreda SZO (glejte poglavje 5.1).
Zdravilo Tracleer se uporablja tudi za zmanjševanje števila novih
razjed prstov pri bolnikih s
sistemsko sklerozo in prisotno boleznijo razjed prstov (glejte
poglavje 5.1).
4.2
ODMERJANJE IN NAČIN UPORABE
Način uporabe
Tablete je treba zaužiti zjutraj in zvečer, s hrano ali brez nje.
Fil
                                
                                Read the complete document

Similar products

Active ingredient bosentan (as monohydrate)

bosentan (as monohydrate)

ATC code C02KX01

C02KX01

Marketed by Janssen-Cilag International N.V.  

Janssen-Cilag International N.V.  

INN (International Name) bosentan

bosentan

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Patient Information leaflet Patient Information leaflet Bulgarian 13-02-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-02-2023
Public Assessment Report Public Assessment Report Bulgarian 03-12-2019
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Public Assessment Report Public Assessment Report Spanish 03-12-2019
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