Non-prescription injectable products

In addition to the standard labelling requirements, labels on injectable products should carry the following information, as applicable. These requirements only apply to non-prescription, injectable products and not to Schedule 4, Schedule 8 or vaccine products intended for use by or under direction of a registered veterinarian.

All multi-use injectable products must include an in-use shelf life statement on the label. This statement should be located under the ‘Directions for use’ heading, immediately beneath the ‘Dosage and administration’ subheading. In-use shelf life statements are determined by the APVMA during evaluation and are based on chemistry data. Where an in-use shelf life has not been previously determined for a product, the default in-use shelf life for the product is 24 hours. If you propose an alternative shelf life you must submit supporting data. We will assess the data and if we agree we may approve an alternative shelf life.

Example of an in-use shelf life statement:

Use the contents within [x] [hours/days/months] of first broaching the vial.
Discard the unused portion.

1. Intravenous injections

For all non-prescription products (excluding remedies for metabolic diseases -see below) that are intended for intravenous administration, or for any other products as directed by the APVMA, the following statement should appear as part of the claim or indications on the main panel and immediately below the ‘Dosage and administration’ subheading on the ancillary panel of the label. The statement should appear in bold-face, sans-serif letters as shown.

For intravenous (IV) use by or under the direction of a registered veterinary surgeon.

2. Subcutaneous injections

For non-prescription products intended for subcutaneous administration to food-producing animals, the following directions should appear on a leaflet or on the label with the ‘Caution’ statement in bold-face, sans-serif letters in sentence case.

Caution: avoid carcass damage
1. Sterilise all injection apparatus by boiling (or equivalent) before use. Avoid use of strong disinfectants on apparatus.
2. Maintain cleanliness at all times.
3. Keep needles sharp and clean. Replace frequently.
4. Use shortest needle possible, certainly not exceeding 15 mm.
5. As far as possible, avoid injection of animals during wet weather or under dusty conditions.
6. This product should be injected only under the skin.
7. If possible, inject high on the neck behind the ear.

Points to note:

  • Items 4, 5 and 7 may not be appropriate for calcium borogluconate and other metabolic disease remedies, or for other injections of relatively large volume.
  • Item 7 may not be appropriate for products administered to poultry.

3. Intramuscular injections

For non-prescription products intended for intramuscular administration to food-producing animals, the following directions may just appear on a leaflet or on a securely attached tag. The ‘Caution’ statement should be in bold-face sanserif letters in sentence case.

Caution: avoid carcass damage

  1. Sterilise all injection apparatus by boiling before use. Avoid use of strong disinfectants on apparatus.
  2. Maintain cleanliness at all times.
  3. Keep needles sharp and clean. Replace frequently.
  4. Use needles of appropriate gauge and length.
  5. As far as possible, avoid injection of animals during wet weather or under dusty conditions.
  6. This product should be injected only into muscle tissue.
  7. If possible, inject into muscle tissue on side of neck.

Points to note:

  • We suggest you replace item 7 for injectable iron compounds for preventing piglet anaemia—because of insufficient bulk of cervical muscle in newborn piglets—with:
    • Injections may be made into the muscles of the hind leg. This product is not to be administered to piglets after the first 4 weeks of life.

  • Item 7 may not be appropriate for products administered to poultry.

4. Combined intramuscular or subcutaneous injections

For non-prescription products intended to be administered either intramuscularly or subcutaneously to food-producing animals, the following directions may only appear on a leaflet or on a securely attached tag. The ‘Caution’ statement should be in bold-face, sans-serif letters in sentence case.

Caution: avoid carcass damage
1. Sterilise all injection apparatus by boiling before use. Avoid use of strong disinfectants on apparatus.
2. Maintain cleanliness at all times.
3. Keep needles sharp and clean. Replace frequently.
4. Use needles of appropriate gauge and length. For subcutaneous administration, use shortest needle possible, certainly not exceeding 15 mm.
5. As far as possible, avoid injection of animals in wet weather or under dusty conditions.
6. Intramuscular injections should be made into muscle tissue on the side of the neck. Subcutaneous injections should be made under the skin, high on the neck behind the ear.

Point to note:

  • Item 6 may need to be modified to delete the reference to injection on the neck for products administered to poultry.

5. Calcium, magnesium, glucose and phosphorus solutions for the treatment of metabolic diseases in sheep and cattle

In addition to the standard labelling requirements and the labelling requirements for non-prescription, injectable products above, solutions of calcium, magnesium, glucose and phosphorus for the treatment of metabolic diseases in sheep and cattle must also carry the information outlined below.

For calcium borogluconate and other metabolic disease remedies, the following statement should appear as part of the claim or indications on the main panel and immediately below the ‘Dosage and administration’ subheading on the ancillary panel of the label. The statement should appear in bold-face, sans-serif letters as shown.

Use of this product intravenously may be hazardous to the animal and advice from a registered veterinary surgeon should be sought.

Use of the phrase ‘four in one’ or ‘4 in 1’ in the product name for products containing calcium, magnesium, glucose and phosphorus will still be accepted on the basis of historical use, provided that:

  • only the calcium, phosphorus and magnesium content are declared as active constituents, as per the example below:
    • Active constituents—per 500 mL
    • Calcium (as the gluconate)—12.50 g
    • Phosphorus (as the hypophosphite)—6.00 g
    • Magnesium (as the hypophosphite)—2.35 g
    • Also contains:
    • Glucose (as dextrose monohydrate)—[x] g
  • only the treatment of hypocalcaemia (parturient paresis or milk fever) and related metabolic diseases (transit paresis, transit tetany) in sheep and cattle are claimed in the indications for use. The claim may also include the treatment of hypomagnesaemia (grass tetany or lactation tetany), provided that directions are given for initial treatment with a magnesium salt solution, as well as with the product making the claim. The claim should not include any indication for hypoglycaemia (pregnancy toxaemia or ketosis or acetonaemia).

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