Procox
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
10-02-2021
Summary of Product characteristics
(SPC)
10-02-2021
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:
Dogs
Therapeutic area:
Antiparasitic products, insecticides and repellents
Therapeutic indications:
For dogs, when mixed parasitic infections caused by roundworms and coccidia of the following species are suspected or demonstrated:Roundworms (nematodes)Toxocara canis (mature adult, immature adult, L4);Uncinaria stenocephala (mature adult);Ancylostoma caninum (mature adult).CoccidiaIsospora ohioensis complex;Isospora canis.Procox is effective against the replication of Isospora and also against the shedding of oocysts. Although treatment will reduce the spread of infection, it will not be effective against the clinical signs of infection in already infected animals.
Product summary:
Revision: 15
Authorization status:
Authorised
Authorization date:
2011-04-20
Patient Information leaflet
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
PROCOX 0.9 MG/ML + 18 MG/ML ORAL SUSPENSION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Vetoquinol S.A.
Magny-Vernois
70200 Lure
France
Manufacturer responsible for batch release:
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324
24106 Kiel
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Procox 0.9 mg/ml + 18 mg/ml oral suspension for dogs
emodepside / toltrazuril
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
1 ml contains:
ACTIVE SUBSTANCES:
emodepside
0.9 mg
toltrazuril
18 mg
EXCIPIENTS:
butylhydroxytoluene (E321; as antioxidant)
0.9 mg
sorbic acid (E200; as preservative)
0.7 mg
4.
INDICATIONS
For dogs, when mixed parasitic infections caused by roundworms and
coccidia of the following
species are suspected or demonstrated:
Roundworms (Nematodes):
-
_Toxocara canis_ (mature adult, immature adult, L4)
-
_Uncinaria stenocephala _(mature adult)
-
_Ancylostoma caninum _(mature adult)
_ _
-
_Trichuris vulpis_ (mature adult)
Coccidia:
-
_Isospora ohioensis _complex
18
-
_Isospora canis _
_ _
Treatment will reduce the spread of _Isospora_ infection but will not
be effective against symptoms in
already infected animals.
5.
CONTRAINDICATIONS
Do not use in dogs/puppies which are under 2 weeks of age or weigh
less than 0.4 kg.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
6.
ADVERSE REACTIONS
Slight and transient digestive tract disorders (e.g., vomiting or
loose stools) may occur in very rare
cases.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Procox 0.9 mg/ml + 18 mg/ml oral suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCES:
emodepside
0.9 mg
toltrazuril
18 mg
EXCIPIENTS:
butylhydroxytoluene (E321; as antioxidant)
0.9 mg
sorbic acid (E200; as preservative)
0.7 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
White to yellowish suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For dogs, when mixed parasitic infections caused by roundworms and
coccidia of the following
species are suspected or demonstrated:
Roundworms (Nematodes):
-
_Toxocara canis_ (mature adult, immature adult, L4)
-
_Uncinaria stenocephala _(mature adult)
-
_Ancylostoma caninum _(mature adult)
-
_Trichuris vulpis_ (mature adult)
Coccidia:
-
_Isospora ohioensis _complex
-
_Isospora canis _
Procox is effective against the replication of _Isospora_ and also
against the shedding of oocysts.
Although treatment will reduce the spread of infection, it will not be
effective against the clinical
signs of infection in already infected animals.
4.3
CONTRAINDICATIONS
Do not use in dogs/puppies which are under 2 weeks of age or weigh
less than 0.4 kg.
3
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
4.4
SPECIAL WARNINGS
Procox is effective against the replication of coccidia and against
the shedding of oocysts. Replication
of the parasite damages the dog’s intestinal mucosa, which may cause
enteritis. Therefore, treatment
with Procox does not resolve clinical symptoms arising from mucosal
damage (e.g. diarrhoea) that
have arisen before treatment. In such cases supportive treatment may
be necessary.
Treatment against _Isospora _should aim to minimize the shedding of
oocysts into the environment,
thereby reducing the risk for reinfection in groups/kennels with known
and recurring _Isospora_
infections.
A pr
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