Procox

Country: European Union

Language: Bulgarian

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:

Кучета

Therapeutic area:

Антипаразитни продукти, инсектициди и репеленти

Therapeutic indications:

За кучета при смесени паразитни инфекции, причинени от кръгли червеи и кокцидии от следните видове са заподозрени или разкри:кръгли червеи (нематоди)Тохосага Canis (възрастни, незрели възрастни, Л4);Uncinaria stenocephala (възрастен);Ancylostoma сатпит (възрастен). CoccidiaIsospora комплекс ohioensis;Isospora канис. Procox е ефективен срещу репликацията на Isospora и срещу проливането на ооцисти. Въпреки че лечението ще намали разпространението на инфекцията, то няма да бъде ефективно срещу клиничните признаци на инфекция при вече заразени животни.

Product summary:

Revision: 15

Authorization status:

упълномощен

Authorization date:

2011-04-20

Patient Information leaflet

                                16
B. ЛИСТОВКА
17
ЛИСТОВКА:
ПРОКОКС 0,9 MG/ML + 18 MG/ML ПЕРОРАЛНА
СУСПЕНЗИЯ ЗА КУЧЕТА
1.
ИМЕ И ПОСТОЯНEН АДРЕС НА ПРИТЕЖАТЕЛЯ
НА ЛИЦЕНЗА ЗА УПОТРЕБА
И НА ПРОИЗВОДИТЕЛЯ, АКО ТЕ СА РАЗЛИЧНИ
Притежател на лиценза за употреба:
Vetoquinol S.A.
Magny-Vernois
70200 Lure
Франция
Производител, отговорен за
освобождаване на партидата:
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324
24106 Kiel
Германия
2.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Procox 0,9 mg/ml + 18 mg/ml oral suspension for dogs
Прококс 0,9 mg/ml + 18 mg/ml перорална
суспензия за кучета
emodepside / toltrazuril
3.
СЪДЪРЖАНИЕ НА АКТИВНИТЕ СУБСТАНЦИИ И
ЕКСЦИПИЕНТИТЕ
1 ml съдържа:
АКТИВНИ СУБСТАНЦИИ:
emodepside
0,9 mg
toltrazuril
18 mg
ЕКСЦИПИЕНТИ:
бутилхидрокситолуен (E321; като
антиоксидант)
0,9 mg
сорбинова киселина (E200; като
консервант)
0,7 mg
4.
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
За кучета, при съмнение или при
проявени смесени паразитни инвазии от
кръгли червеи и
кокцидии от следните видове:
Кръгли червеи (Нематоди):
-
_Toxocara canis_
(зрели възрастни, незрели възрастни, L4)
-
_Uncinaria stenocephala _
(зрели възрастни)
-
_Ancylostoma caninum _
(зрели възрастни)
-
_Trichuris vulpis_
(зрели възрастни)
Кокцидии:
-
_Isospora ohioensis _
комплекс,
-
_Isospora canis_
18
Лечението ограничава
разпространението на
_Isospora_
, но не е ефективно 
                                
                                Read the complete document

Summary of Product characteristics

                                1
_ _
_ _
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Procox 0,9 mg/ml + 18 mg/ml oral suspension for dogs
Прококс 0,9 mg/ml + 18 mg/ml перорална
суспензия за кучета
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
1 ml съдържа:
АКТИВНИ СУБСТАНЦИИ:
emodepside
0,9 mg
toltrazuril
18 mg
ЕКСЦИПИЕНТИ:
бутилхидрокситолуен (E321; като
антиоксидант)
0,9 mg
сорбинова киселина (E200; като
консервант)
0,7 mg
За пълния списък на ексципиентите, виж
т. 6.1.
3.
ФАРМАЦЕВТИЧНА ФОРМА
Перорална суспензия.
Бяла до жълтеникава суспензия.
4.
КЛИНИЧНИ ДАННИ
4.1
ВИДОВЕ ЖИВОТНИ, ЗА КОИТО Е
ПРЕДНАЗНАЧЕН ВМП
Кучета.
4.2
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ, ОПРЕДЕЛЕНИ ЗА
ОТДЕЛНИТЕ ВИДОВЕ ЖИВОТНИ
За кучета, при съмнение или при
проявени смесени паразитни инвазии от
кръгли червеи и
кокцидии от следните видове:
Кръгли червеи (Нематоди):
-
_Toxocara canis_
(зрели възрастни, незрели възрастни, L4)
-
_Uncinaria stenocephala _
(зрели възрастни)
-
_Ancylostoma caninum _
(зрели възрастни)
-
_Trichuris vulpis_
(зрели възрастни)
Кокцидии:
-
_Isospora ohioensis _
комплекс
-
_Isospora canis_
Procox е ефективен срещу репликацията на
_Isospora_
и срещу отделянето на ооцисти.
Независимо от това, че лечението
ограничава разпространението на
инфекцията, то не е
ефек
                                
                                Read the complete document

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Active ingredient emodepside, toltrazuril

emodepside, toltrazuril

ATC code QP52AX60

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Marketed by Vetoquinol S.A.

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INN (International Name) emodepside, toltrazuril

emodepside, toltrazuril

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Patient Information leaflet Patient Information leaflet Spanish 10-02-2021
Summary of Product characteristics Summary of Product characteristics Spanish 10-02-2021
Public Assessment Report Public Assessment Report Spanish 13-06-2013
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Summary of Product characteristics Summary of Product characteristics Czech 10-02-2021
Public Assessment Report Public Assessment Report Czech 13-06-2013
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Public Assessment Report Public Assessment Report Danish 13-06-2013
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Public Assessment Report Public Assessment Report German 13-06-2013
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Public Assessment Report Public Assessment Report Estonian 13-06-2013
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Public Assessment Report Public Assessment Report Greek 13-06-2013
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