Baycox 25 mg/ml, solution for use in drinking water for chickens and turkeys

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:

25 milligram(s)/millilitre

Pharmaceutical form:

Solution for use in drinking water

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens, Turkeys

Therapeutic area:

toltrazuril

Therapeutic indications:

Coccidiostats

Authorization status:

Authorised

Authorization date:

2014-08-15

Summary of Product characteristics

Health Products Regulatory Authority
09 July 2019
CRN008SPL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baycox 25 mg/ml, solution for use in drinking water for chickens and
turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains:
ACTIVE SUBSTANCE:
Toltrazuril 25 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for use in drinking water.
Colourless to brown solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers, pullets and breeders) and turkeys.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of coccidiosis in chickens and turkeys, caused by
infections with various species of _Eimeria_:
Chickens: _E. acervulina_, _E. brunetti_, _E. maxima_, _E. mitis_, _E.
necatrix_, _E. tenella_.
Turkeys: _E. adenoides_ and _E. meleagrimitis_.
4.3 CONTRAINDICATIONS
Do not use in animals with hypersensitivity to the active substance or
to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Good hygiene can reduce the risk of coccidiosis. It is therefore
recommended any deficiencies in husbandry should be
addressed in addition to treatment. Poultry houses should be kept
clean and dry.
It is recommended to treat all animals in a pen. For best results,
treatment should be initiated before the clinical signs of
disease have spread throughout the whole group.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
As with any anticoccidials, frequent and prolonged use of an
antiprotozoal of the same class may result in the development of
resistances. It is important to keep to the recommended dose in order
to minimise the risk of resistance.
If resistance is present it should be considered to use another
antiprotozoal from another class/mechanism of action.
This VMP should not be used together with feed additives/or other
veterinary medicinal products that might interfere with the
efficacy of the product, like "coccidiostats" and "histomonostats".
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