Chanox Multi 50 mg/ml oral suspension for Piglets, Calves and Lambs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Toltrazuril

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP51AJ01

INN (International Name):

Toltrazuril

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs, Sheep

Therapeutic area:

toltrazuril

Therapeutic indications:

Coccidiostats

Authorization status:

Authorised

Authorization date:

2017-11-24

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Chanox Multi 50 mg/ml oral suspension for Piglets, Calves and Lambs
Chanox vet 50 mg/ml Oral Suspension for Piglets, Calves and Lambs
(Finland, Norway, Sweden)
Cenzuril 50 mg/ml Oral Suspension for Piglets, Calves and Lambs
(Spain)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Toltrazuril 50 mg
EXCIPIENTS:
Sodium benzoate (E211) 2.1 mg
Sodium propionate (E281) 2.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
White or yellowish suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (piglets), Cattle (calves on dairy farms – see section 4.3) and
Sheep (lambs)
’
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Piglets: For the prevention of clinical signs of coccidiosis in
neonatal piglets on farms with a
confirmed history of coccidiosis caused by
_Cystoisospora suis_
.
Calves: For the prevention of clinical signs of coccidiosis and
reduction of coccidia shedding in housed
calves replacing cows producing milk for human consumption (dairy
cows) on farms with a confirmed
history of coccidiosis caused by
_Eimeria bovis_
or
_Eimeria zuernii_
.
Lambs: For the prevention of clinical signs of coccidiosis and
reduction of coccidia shedding in lambs
on farms with a confirmed history of coccidiosis caused by
_Eimeria crandallis_
and
_Eimeria _
_ovinoidalis_
.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
For environmental reasons:
Do not use in calves weighing more than 80 kg bodyweight.
Do not use in fattening units such as veal or beef calves.
For more details see sections 4.5, other precautions and section 5.3,
environmental properties.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As with any antiparasiticide frequent and repeated use of
antiprotozoals from the same class may lead
to the development of resistance.
It is recommended to treat all animals in a pen.
Hygienic measures may