In addition to the standard labelling requirements, labels on anthelmintic products for sheep, goats and cattle must also carry the following information, as applicable.

4. Statement of claims for use

All approved label (E-label template) claims 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].
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 abbreviated 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:

Aids in control of Barber’s Pole Worm (Hemonchus contortus), Tapeworm (Moniezia expansa).

 

Labels on products for sheep and goats must 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 sheep, goat and/or cattle, the following contraindication statement should be included:

This product should not be used in dogs, horses or any other pets

For anthelmintic products to be used in sheep and/ or cattle the following contraindication statement should be included, unless data are provided to support the use in goats:

This product is not recommended for use in goats as safety and efficacy have not been evaluated

6.2.1. Abamectin based products

Products containing abamectin for sheep, goats and/or cattle should include the following ‘Contraindications’ statements, unless data are assessed to support an alternative:

6.2.1.1. Sheep and goats

This product is contraindicated for use in lambs/kids under 6 weeks of age or less than 10 kg body weight

6.2.1.2. Cattle

This product is contraindicated for use in calves under 16 weeks of age or less than 50 kg body weight

6.3. Precautions

6.3.1. Oral products containing levamisole

Oral products containing levamisole must include the following ‘Precautions’ statements:

Exercise care in handling weak, pregnant and young animals to avoid unnecessary stress.
Avoid yarding animals off-feed overnight and ensure animals have access to water when yarded prior to drenching.
Recommended dose should not be exceeded.

6.5. Dosage and administration

The directions for use should be simple, clear and concise and provide adequate information on how to use the product appropriately. Where appropriate, the ‘Dosage and administration’ instructions may appear in tabular form.

The dose rate of anthelmintic for sheep, goats and cattle is to be expressed as:

[x] mL/ [y] kg body weight

6.5.1. Sheep and goats

Dose volume tables are to be shown for sheep and goats up to 75 kg. Tables for sheep and goat products should include dose or volume increments of no greater than 10 kg of body weight for animals up to 75 kg body weight.

The following statement should appear after the dose or volume tables for sheep and goat products:

Animals heavier than 75 kg to be dosed at [x] mL per [y] kg. A representative sample of animals should be weighed before treatment. Dose the mob to the heaviest animal by live weight in each group (ewes, wethers, rams, lambs); (bucks, does, kids). Where there is a large variation in size within the group, dose rate should be based on the label directions for each weight range. Do not underdose. Drafting into 2 or more lines may be appropriate, to avoid excessive overdosing.

6.5.2. Cattle

Dose volume tables are to be shown for cattle up to 650 kilograms (kg).Tables for cattle products should include dose or volume tables with increments of no greater than 50 kg of body weight up to 650 kg body weight.

The following statement should appear after the dose or volume table for cattle products:

Cattle heavier than 650 kg should be dosed at [x] mL per [y] kg. A representative sample of animals should be weighed before treatment either with scales or a weighband. Dose rate to be based on heaviest cattle in each group (bulls, cows, steers, calves, etc.). Do not underdose. Where there is a large variation in size within the group, draft into 2 or more lines based on body weight, to avoid excessive overdosing.