Toltramax 50 mg/ml Oral Suspension for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Toltrazuril

Available from:

Lavet Pharmaceuticals Ltd

ATC code:

QP51AJ01

INN (International Name):

Toltrazuril

Pharmaceutical form:

Oral suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antiprotozoal anticoccidial

Authorization status:

Authorized

Authorization date:

2012-04-04

Summary of Product characteristics

Revised: March 2021
AN: 01793/2020 & 01795/2020
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Toltramax 50 mg/ml oral suspension for pigs
Toltrazuril
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Toltrazuril
50 mg
EXCIPIENTS:
Sodium benzoate (E211)
2 mg
Sodium propionate (E281)
2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
White or almost white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pig (Piglets 3 to 5 days old).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention of clinical signs of coccidiosis in neonatal
piglets (3 to 5 days old) on
farms with a confirmed history of coccidiosis caused by _Isospora
suis_.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
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 animals in a pen.
Revised: March 2021
AN: 01793/2020 & 01795/2020
Page 2 of 4
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.
4.5
SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
To alter the course of an established clinical coccidial infection, in
individual animals
already showing signs of diarrhoea, additional supportive therapy may
be required.
II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
In case of accidental ingestion seek medical advice immediately and
show the package
leaflet or the label to the physician.
This product may cause allergic reactions in those that are sensitive.
People with known hypersensitivity to toltrazuril should avoid contact
with the product.
The product may cause irrita