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:

Elanco GmbH

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 area:

toltrazuril

Authorization status:

Authorised

Authorization date:

2016-11-25

Summary of Product characteristics

Health Products Regulatory Authority
01 October 2021
CRN00C7NZ
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
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
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 hypersensitivity to the active substance or to
any of the excipients. For further information on use in
cattle please refer to the table in section 4.5 Special precautions
for use, Other precautions.
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.
Health Products Regulatory Authority
01 October 2021
CRN00C7NZ
Page 2 of 5
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