Slentrol

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
24-02-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
24-02-2015
Public Assessment Report Public Assessment Report (PAR)
24-02-2015

Active ingredient:

dirlotapid

Available from:

Zoetis Belgium SA

ATC code:

QA08AB91

INN (International Name):

dirlotapide

Therapeutic group:

Psi

Therapeutic area:

Preparati za zaščito proti sončenju, prehrambeni izdelki

Therapeutic indications:

Kot pomoč pri obvladovanju prekomerne telesne teže in debelosti pri odraslih psih. Uporablja se kot del splošnega programa za upravljanje telesne teže, ki vključuje tudi ustrezne prehranske spremembe in prakso vadbe.

Product summary:

Revision: 7

Authorization status:

Umaknjeno

Authorization date:

2007-04-13

Patient Information leaflet

                                15
B. NAVODILO ZA UPORABO
Zdravilo nima veā dovoljenja za promet
16
NAVODILO ZA UPORABO
SLENTROL 5 MG/ML PERORALNA RAZTOPINA ZA PSE
1.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA
SPROŠČANJE SERIJ V EGP, ČE STA RAZLIČNA
Imetnik dovoljenja za promet z zdravilom
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgija
Izdelovalec, odgovoren za sproščanje serij:
Pfizer Service Company
Hoge Wei 10
1930 Zaventem
Belgija
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgija
2.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Slentrol 5 mg/ml peroralna raztopina za pse
Dirlotapid
3.
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
Dirlotapid 5 mg/ml je brezbarvna do bledo rumena raztopina.
4.
INDIKACIJA(E)
Kot pomoč pri nadziranju prekomerne telesne mase in debelosti pri
odraslih psih. Lečeči veterinar bo
določil ciljno maso in razložil, kako se Slentrol uporablja kot del
vodenja celotnega programa znižanja
telesne mase, ki bo vključeval tudi primerne spremembe prehrane in
gibalne aktivnosti.
5.
KONTRAINDIKACIJE
Ne uporabite zdravila pri psih v rasti.
Ne uporabite zdravila pri psicah v obdobju brejosti ali laktacije.
Ne uporabite zdravila pri psih z okvarjenim delovanjem jeter.
Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali
na katero koli pomožno snov.
Ne uporabite zdravila pri psih, pri katerih je prekomerna telesna masa
ali debelost posledica sočasne
sistemske bolezni kot so hipotireoidizem ali hiperadrenokorticizem.
Ne uporabite zdravila pri mačkah zaradi tveganosti razvoja jetrne
lipoidoze.
6.
NEŽELENI UČINKI
Pri nekaterih psih se lahko pojavi bruhanje, ki ga spremljajo znaki
utrujenosti, nezanimanja za hrano
ali diareja, ki se lahko tekom zdravljenja večkrat ponovijo. Ti znaki
se tipično začnejo v prvem
Zdravilo nima veā dovoljenja za promet
17
mesecu zdravljenja (okoli 30 % psov je bruhalo vsaj enkrat in do 12 %
psov je pokazalo enega od
ostalih stranskih učinkov), pojavnost 
                                
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Summary of Product characteristics

                                1
_ _
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Slentrol 5 mg/ml peroralna raztopina za pse
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
En ml vsebuje:
ZDRAVILNA UČINKOVINA:
Dirlotapid
5 mg
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Peroralna raztopina.
Brezbarvna do bledo rumena raztopina.
4.
KLINIČNI PODATKI
4.1
CILJNE ŽIVALSKE VRSTE
Psi
4.2
INDIKACIJE ZA UPORABO PRI CILJNIH ŽIVALSKIH VRSTAH
Kot dodatek pri nadziranju prekomerne telesne mase in debelosti pri
odraslih psih. Uporabiti kot del
celotnega programa nadziranja telesne mase, ki vključuje tudi
primerne spremembe v prehrani in
fizične aktivnosti.
4.3
KONTRAINDIKACIJE
Ne uporabite zdravila pri psih v rasti.
Ne uporabite zdravila pri psicah v obdobju brejosti ali laktacije.
Ne uporabite zdravila pri psih z okvarjenim delovanjem jeter.
Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali
na katero koli pomožno snov.
Ne uporabite zdravila pri psih, pri katerih je prekomerna telesna masa
ali debelost posledica sočasne
sistemske bolezni kot so hipotireoidizem ali hiperadrenokorticizem.
Ne uporabite zdravila pri mačkah zaradi tveganosti razvoja jetrne
lipidoze.
4.4.
POSEBNA OPOZORILA ZA VSAKO CILJNO ŽIVALSKO VRSTO
V kliničnih poskusih so zdravljeni psi po prenehanju zdravljenja
hitro spet pridobili izgubljeno maso,
če prehrana ni bila omejena. Da se izognete ponovnemu povečanju
telesne mase, je potrebno hraniti
živali tako, da prejemajo le vzdrževalno količino energije.
Pravilen način prehrane in gibanja se
Zdravilo nima veā dovoljenja za promet
3
vzpostavi že med zdravljenjem ali proti koncu zdravljenja, da se
zagotovi dolgoročno vzdrževanje
telesne mase.
4.5
POSEBNI PREVIDNOSTNI UKREPI
Posebni previdnostni ukrepi za uporabo pri živalih
Pred uporabo zdravila za uporabo v veterinarski medicini morate
oceniti delovanje jeter pri psih, za
katere se sumi, da so podvrženi kateremukoli jetrnemu obolen
                                
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Similar products

Active ingredient dirlotapid

dirlotapid

ATC code QA08AB91

QA08AB91

Marketed by Zoetis Belgium SA

Zoetis Belgium SA

INN (International Name) dirlotapide

dirlotapide

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Patient Information leaflet Patient Information leaflet Bulgarian 24-02-2015
Summary of Product characteristics Summary of Product characteristics Bulgarian 24-02-2015
Public Assessment Report Public Assessment Report Bulgarian 24-02-2015
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Public Assessment Report Public Assessment Report Spanish 24-02-2015
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