Baycox Multi 50 mg/ml oral suspension for Cattle, Pigs and Sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Toltrazuril

Available from:

Bayer 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:

2016-11-25

Summary of Product characteristics

Health Products Regulatory Authority
17 June 2019
CRN0094D5
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baycox Multi 50 mg/ml oral suspension for Cattle, Pigs and Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBTSANCE:
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
Cattle (calves: dairy calves, beef suckler, bull beef), Pigs (Piglets,
3-5 days old), Sheep (lambs).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle: For the prevention of clinical signs of coccidiosis and
reduction of coccidia shedding in calves on farms with a confirmed
history of coccidiosis caused by _Eimeria bovis_ or _Eimeria zuernii_.
Pigs: For the prevention of clinical signs of coccidiosis in neonatal
piglets (3-5 days old) on farms with a confirmed history of
coccidiosis caused by _Cystoisospora suis_.
Sheep: 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 known hypersensitivity to the active substance
or any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is recommended to treat all animals in a pen.
Hygienic measures may reduce the risk of coccidiosis. It is therefore,
recommended to improve concomitantly the hygienic
conditions in the concerned facility, particularly dryness and
cleanliness.
To obtain maximum benefit, animals should be treated before the
expected onset of clinical signs, i.e. in the prepatent period.
To alter the course of an established clinical coccidial infection, in
individual animals already showing signs of diarrhoea,
additional supportive therapy may be required.
Health Products Regulatory Authority
17 June 2019
C