Baycox 50 mg/ml oral suspension, pig

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Toltrazuril

זמין מ:

Elanco GmbH

קוד ATC:

QP51AJ01

INN (שם בינלאומי):

Toltrazuril

כמות:

50 milligram(s)/millilitre

טופס פרצבטיות:

Oral suspension

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

איזור תרפויטי:

toltrazuril

מצב אישור:

Authorised

תאריך אישור:

2002-11-11

מאפייני מוצר

Health Products Regulatory Authority
19 October 2020
CRN009PRZ
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baycox 50 mg/ml oral suspension, pig
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
1 ml contains:
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
Pigs (Piglet 3 - 5 days old).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 _Isospora suis_.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None known.
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.
Health Products Regulatory Authority
19 October 2020
CRN009PRZ
Page 2 of 3
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Not applicable
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known, e.g there is no interaction in combination with iron
supplementation.
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 occured.
4.10 OVERDOSE (SYMPTOMS, EME