Procox

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-02-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
10-02-2021
Public Assessment Report Public Assessment Report (PAR)
13-06-2013

Active ingredient:

emodepside, toltrazuril

Available from:

Vetoquinol S.A.

ATC code:

QP52AX60

INN (International Name):

emodepside, toltrazuril

Therapeutic group:

Psi

Therapeutic area:

Antiparazitni izdelki, insekticidi in repelenti

Therapeutic indications:

Za pse, ko mešani parazitske okužbe, ki jih povzročajo roundworms in coccidia od naslednjih vrst so domnevno ali dokazano:Roundworms (nematodes)Toxocara canis (zrelih odraslih, nezreli odraslih, L4);Uncinaria stenocephala (zrel za odrasle);Ancylostoma caninum (zrel za odrasle). CoccidiaIsospora ohioensis kompleksna;Isospora canis. Procox je učinkovit proti replikaciji zdravila Isospora in tudi proti odtekanju oocist. Čeprav zdravljenje zmanjša širjenje okužbe, ne bo učinkovito glede na klinične znake okužbe pri že okuženih živalih.

Product summary:

Revision: 15

Authorization status:

Pooblaščeni

Authorization date:

2011-04-20

Patient Information leaflet

                                15
B. NAVODILO ZA UPORABO
16
NAVODILO ZA UPORABO
PROCOX 0,9 MG/ML + 18 MG/ML PERORALNA SUSPENZIJA ZA PSE
1.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA
RAZLIČNA
Imetnik dovoljenja za promet z zdravilom:
Vetoquinol S.A.
Magny-Vernois
70200 Lure
Francija
Proizvajalec odgovoren za sproščanje serij:
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324
24106 Kiel
Nemčija
2.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Procox 0,9 mg/ml + 18 mg/ml peroralna suspenzija za pse
emodepsid / toltrazuril
3.
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN
1 ml vsebuje:
ZDRAVILNE UČINKOVINE:
emodepsid
0,9 mg
toltrazuril
18 mg
POMOŽNE SNOVI:
butilhidroksitoluen (E321; kot antioksidant)
0,9 mg
sorbinska kislina (E200; kot kozervans)
0,7 mg
4.
INDIKACIJA(E)
Za pse, pri katerih obstaja ali je dokazana mešana parazitarna
okužba, ki jo povzročajo
valjasti črvi in kokcidije naslednjih vrst:
Valjasti črvi (nematodi):
-
_Toxocara canis_ (zrele odrasle, nezrele odrasle oblike, ličinke L4)
-
_Uncinaria stenocephala _(zrele odrasle oblike)
-
_Ancylostoma caninum _(zrele odrasle oblike)
-
_Trichuris vulpis _(zrele odrasle oblike)
Kokcidije:
-
Kompleks_ Isospora ohioensis_
-
_Isospora canis_
17
Zdravljenje bo upočasnilo širjenje okužbe, ne bo pa učinkovito
zoper klinične znake okužbe pri že
okuženih živalih.
5.
KONTRAINDIKACIJE
Ne uporabite pri psih/pasjih mladičih, mlajših od 2 tednov ali
lažjih od 0,4 kg.
Ne uporabite v primerih preobčutljivosti na učinkovine ali na katero
koli pomožno snov.
6.
NEŽELENI UČINKI
V zelo redkih primerih lahko nastopijo blage in prehodne prebavne
motne (npr. bruhanje ali driska).
Pogostnost neželenih učinkov je določena po naslednjem dogovoru:
- zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10
zdravljenih živali)
- pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih
živali)
- občasni (pri več kot 1, toda manj kot 10 živali od 1.000
zdravljenih živali)
- r
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Procox 0,9 mg/ml + 18 mg/ml peroralna suspenzija za pse
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
1 ml vsebuje:
UČINKOVINE:
emodepsid
0,9 mg
toltrazuril
18 mg
POMOŽNE SNOVI:
butilhidroksitoluen (E321; kot antioksidant)
0,9 mg
sorbinska kislina (E200; kot kozervans)
0,7 mg
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Peroralna suspenzija.
Bela do rumenkasta suspenzija.
4.
KLINIČNI PODATKI
4.1
CILJNE ŽIVALSKE VRSTE
Psi
4.2
INDIKACIJE ZA UPORABO PRI CILJNIH ŽIVALSKIH VRSTAH
Za pse, pri katerih obstaja ali je dokazana mešana parazitarna
okužba, ki jo povzročajo
valjasti črvi in kokcidije naslednjih vrst:
Valjasti črvi (nematodi):
-
_Toxocara canis_ (zrele odrasle, nezrele odrasle oblike, ličinke L4)
-
_Uncinaria stenocephala _(zrele odrasle oblike)
-
_Ancylostoma caninum _(zrele odrasle oblike)
-
_Trichuris vulpis _(zrele odrasle oblike)
Kokcidije:
-
Kompleks_ Isospora ohioensis_
-
_Isospora canis_
Procox učinkovito zavira replikacijo kokcidij _Isospora_ in
izločanje oocist. Čeprav zdravljenje upočasni
širjenje okužbe, ne bo učinkovito zoper klinične znake okužbe pri
že okuženih živalih.
4.3
KONTRAINDIKACIJE
Ne uporabite pri psih/pasjih mladičih, mlajših od 2 tednov ali
lažjih od 0,4 kg.
Ne uporabite v primerih preobčutljivosti na učinkovine ali na katero
koli pomožno snov.
3
4.4
POSEBNA OPOZORILA ZA VSAKO CILJNO ŽIVALSKO VRSTO
Procox učinkovito zavira replikacijo kokcidij in izločanje oocist.
Razmnoževanje parazita poškoduje
sluznico prebavnega trakta psa, kar lahko povzroči enteritis. Zato
zdravljenje samo s Procoxom ne
odpravlja kliničnih znakov, ki nastanejo zardi poškodovane črevesne
sluznice (npr. driska), do katerih
je prišlo pred zdravljenjem. V teh primerih je potrebno dodatno
podporno zdravljenje.
Zdravljenje zoper _Isosporo_ je namenjeno zmanjšanju izločanja
oocist v okolje in s tem zmanjšanju
ponovne okužbe v skupinah/zavetiščih z
                                
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Active ingredient emodepside, toltrazuril

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INN (International Name) emodepside, toltrazuril

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