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SPC 124433
SPC 124433
AN: 00178/2009
2.
mg per ml
% w/v
Toltrazuril
25
2.5
PHARMACEUTICAL FORM
Oral solution.
Clear colourless to brown solution.
4.
CLINICAL PARTICULARS
4.1
Target species
Broilers and Broiler Breeders
4.2
4.3
Contraindications
None.
4.4
4.5
ii.
iii.
Other precautions
Only make up sufficient drinking water for requirements.
Wash out empty container with water 3 times when medicating birds
and add washings to drinking water.
Store litter from treated houses as long as possible. However, it should
only be stored where there is no risk of polluting surface water or
groundwater.
Do not apply to agricultural land at a rate greater than 1.5
tonnes/hectare/year.
If spreading within an NVZ ensure that the NVZ action programme
rules are complied with.
The principle metabolite of toltrazuril is persistent and mobile in
groundwater.
4.6
4.7
4.8
4.9
4.11
Withdrawal period(s)
Meat: 18 days.
Do not use in birds producing eggs for human consumption.
5.
PHARMACOLOGICAL PROPERTIES
Toltrazuril
ATC Vet Code: QP51AJ01
5.1
Pharmacodynamic properties
Anticoccidial, active against all intracellular stages but the mode of action is
unknown.
5.2
Pharmacokinetic particulars
In poultry toltrazuril is absorbed at a rate of at least 50%. The highest
equivalent concentrations are found in liver. The active substance is rapidly
metabolised in poultry. The main metabolite is characterised as a sulfonederivative. About 1 week after the last dose this metabolite represents by far
the most relevant residue in the animal.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Triethanolamine
Macrogol 200
6.2
Incompatibilities
None known
6.3
6.4
Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale:
5 years.
24 hours.
6.5
6.6
7.
8.
Vm: 00010/4084
9.
10.