Baycox Sheep, 50 mg/ml oral suspension.

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Toltrazuril

Tillgänglig från:

Elanco GmbH

ATC-kod:

QP51AJ01

INN (International namn):

Toltrazuril

Dos:

50 milligram(s)/millilitre

Läkemedelsform:

Oral suspension

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapiområde:

toltrazuril

Bemyndigande status:

Authorised

Tillstånd datum:

2009-01-30

Produktens egenskaper

Health Products Regulatory Authority
16 October 2020
CRN009PNN
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baycox Sheep, 50 mg/ml oral suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
1 ml contains:
Toltrazuril
50.0 mg
EXCIPIENTS:
Sodium benzoate (E211)
2.1 mg
Sodium propionate (E281)
2.1 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
White or yellowish oral suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
For Sheep (lambs).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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
None.
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 lambs in a pen.
Hygienic measures may reduce the risk of ovine 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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION FOR USE IN ANIMAL
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Wash any splashes from skin or eyes immediately with water.
For environmental reasons:
Health Products Regulatory Authority
16 October 2020
CRN009PNN
Page 2 of 4
Lambs kept throughout the whole life span indoors under an intensive
rearing system must not be treated beyond the age of 6
weeks or body weight of more than 20 kg at treatment. Manure from
these animals should only be applied to the same piece
of land every third year.
The major metabolite of toltrazuril, toltrazuril sulfone (pona