In addition to the standard labelling requirements, labels on anthelmintic products for horses must also carry the following information, as applicable.
4. Statement of claims for use
All approved label claims (E-label template) must contain, as a minimum, the following statements:
[Name of product] contains [name of active ingredient], a member of the [name of the anthelmintic group] family of chemicals.
It is effective against sensitive strains of the following internal parasites: [list of scientific and common names used in Australia] including stages [example: adults/ L3 or L4/ encysted/arterial stages].
Resistance may develop to any chemical.
- Labels may also show claims that a product is effective against resistant parasites, providing you present us with convincing data to satisfy registration requirements.
- Both the common and scientific name of parasites must appear in the ‘Claims for use’ statement on the label.
- Resistance statements can be modified to align with the claims, which will be assessed during product evaluation.
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- Claims, resistance warning statements and parasite names must be provided in full on the approved label (i.e. E-label template). These can be summarised on the main panel on the marketed label and provided in full on the ancillary panel or leaflet. Please note that abbreviate claims must be included on the E-label template and will be assessed during product evaluation.
- The scientific name must either be written in italics or underlined.
- For example:
This product is effective for the treatment and control of:
Tapeworm: Anoplocephala perfoliata.
Large strongyles: Strongylus vulgaris (adults, L3 and L4 arterial larval stages), Strongylus edentatus (adults and L4 visceral larval stages), Strongylus equinus (adults), Triodontophorus spp. (adults) including T. brevicauda, T. serratus and T. tenuicollis, Craterostomum acuticaudatum (adults).
Ascarids (roundworm): Parascaris equorum (adult and immature).
- Labels on products for horses should also contain the following statements:
Ask your local veterinarian or animal health adviser for recommended parasite management practices for your area to reduce development of resistance.
It is advisable that a resistance test be conducted before any parasite treatment is used.
6.2. Contraindications
For all anthelmintic products to be used in horses, the following contraindication statement should be included:
This product should not be used in dogs or any other pets.
6.5. Dosage and administration
- Dose rates should be based on the live weight of the horse, weighed by either scales or a weigh band. Do not overdose.
- For oral drenches and oral pastes, clear instructions about applicator (for example syringes and plungers) and application method are required under this section.
For example:
Adjust syringe to the weight of the horse and insert into the side of the horse’s mouth between the front and back teeth and deposit paste towards the back of the tongue by dressing plunger.