Procox 0.9 mg/ml + 18 mg/ml Oral Suspension for Dogs

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Emodepside, Toltrazuril

Dostępny od:

Vetoquinol SA

Kod ATC:

QP52AX60

INN (International Nazwa):

Emodepside, Toltrazuril

Forma farmaceutyczna:

Oral suspension

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Dogs

Dziedzina terapeutyczna:

Anthelmintic

Status autoryzacji:

Authorized

Data autoryzacji:

2011-04-20

Charakterystyka produktu

Revised: November 2023
AN: 01821/2023
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
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_
Revised: November 2023
AN: 01821/2023
Page 2 of 7
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.
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 f