Baycox 50 mg/ml Oral Suspension

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Toltrazuril

Disponibil de la:

Bayer plc

Codul ATC:

QP51AJ01

INN (nume internaţional):

Toltrazuril

Statutul autorizaţiei:

Expired

Caracteristicilor produsului

Revised: June 2013
AN. 01208/2012
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baycox 50 mg/ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Toltrazuril
50 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
Oral suspension
White or yellowish suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pig (Piglet).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention of clinical signs of coccidiosis in neonatal
piglets on farms
with a confirmed history of coccidiosis caused by _Isospora suis_.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS
None
4.5
SPECIAL PRECAUTIONS FOR USE
I.
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Not applicable
Revised: June 2013
AN. 01208/2012
Page 2 of 4
II.
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.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not applicable
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Individual animal treatment.
Each pig to be treated on day 3-5 of life with a single oral dose of
20 mg
toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per
kg body
weight.
Due to the small volumes required to treat individual piglets, use of
dosing
equipment with a dose accuracy of 0.1 ml is recommended.
The oral suspension must be shaken before use.
Treatment during an outbreak will be of limited value for the
individual piglet
because of damage to the small intestine having already occurred.
4.10 OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF
NECESSARY
A threefold overdose is well tolerated by healthy piglets without
signs of
intolerance.
4.11 WITHDRAWAL PERIOD(S)
Meat and offal: 77 d