In addition to the standard labelling requirements, labels on immunobiological products (veterinary vaccines, antisera, biologicals) must also carry the following information, as applicable.

1. Signal heading

The Schedule 4 signal heading: PRESCRIPTION ANIMAL REMEDY is required for:

  • all live-virus veterinary vaccines (unless listed as exempt from Schedule 4 for live veterinary vaccines in the Poisons Standard)
  • canine tick antiserum
  • monoclonal antibodies
  • Plasmid DNA vaccines for animal use except when separately specified in the Poisons Standard.

2. Product name

The name must identify whether the product is live or inactivated where applicable.

The name of the product may also include the word ‘vaccine’ or ‘antisera’ or other suffix to indicate its class of action.

3. Constituent statements

3.1. Active constituent(s) and scheduled non-active constituents

Labels for vaccines and antisera should include the qualitative and quantitative details of the active ingredient(s). This will normally be expressed as the end of shelf life titre of the product or as the antigen.

Vaccine types (for example, ‘whole cells’, ‘cell fractions’, ‘subunits’, ‘toxoid’, etc.) must be described in the ‘Active constituent’ statement unless already in the product name. If a vaccine contains both live and inactivated components, then this should be clearly stated in the ‘Active constituents’ statement.

The qualitative and quantitative composition of the adjuvant(s) must be stated. For 'tradenames' and confidential formulas the APVMA can address them on a case-by-case basis.

The qualitative and quantitative details of any preservative must be listed on the label.

Scheduled excipients, adjuvants and preservatives must be referred to by their recommended Pharmacopoeia or CAS name.

Labels for monoclonal antibody products must include minimum and maximum dose.

The actives should appear first, followed by adjuvants and preservatives and scheduled excipients.

The concentration and name of any adjuvant(s) or preservative must be proceeded by the following subheading:

Also contains:

And have immediately following or beside the ingredient statement the word:

Adjuvant(s) / Preservative(s) / Excipient(s)

4. Statement of claims for use

The label efficacy claims for veterinary vaccines should follow APVMA guidance.

6.5. Dosage and administration

For multiple-dose containers and for freeze-dried products that must be reconstituted before use, the in-use shelf-life stability statement must be placed under the ‘Dosage and administration’ sub heading. In the absence of data the statement 'use immediately on broaching or reconstitution' must be included on the label.

Use within [X] hours/days of opening/reconstitution/mixing.
Use immediately on broaching/reconstitution.

6.6. General directions

Instructions to sterilise reusable syringes and needles should appear on labels for vaccines for livestock and must include specific advice on the number of washings required when devices have been chemically sterilised or the period required for cooling down when heat sterilised.

7. Withholding period statements

A withholding period of zero (0) days must be included on labels for food producing animals unless the data indicates an alternative specified withholding period.

8. Trade advice

Export slaughter interval – If determined to be zero (0) days, the default statement as described in the general labelling requirements content is not required for immunobiological products. Statement to include:

EXPORT SLAUGHTER INTERVAL (ESI): Zero (0) days

11. Additional user safety information

Additional user safety instructions may apply to vaccines. These should be placed under the heading ‘Additional user safety information’.

For all injectable vaccines a standard warning statement must be included:

Take care to avoid self-injection

The following statements relate to adjuvants, and the relevant statement based on the type of adjuvant used in the vaccine must be applied. Statements for other adjuvants not included in the list below will be treated on a case-by-case basis during assessment.

11.1. Aluminum

In the event of self-administration, seek medical attention if you are concerned. Show the package leaflet or label to the medical practitioner.

11.2. Emulsion, vegetable oil, mineral oil or Freund’s

This product contains [adjuvant type] and is an irritant. In the event of self-administration, it can cause significant pain and swelling at the injection site, perhaps also involving the draining lymph nodes. Medical or surgical intervention may be required. Contact a doctor immediately, even if only a very small amount is injected, and take this package leaflet/carton with you. Allow the wound to bleed freely and DO NOT squeeze or interfere with the injection site.

Ancillary advice to the medical practitioner

This product contains [adjuvant type]. Even small amounts of self-administered [adjuvant type] can cause intense swelling and a persistent granulomatous inflammatory reaction. If injected into a finger joint or tendon sheath, the product may track along the tendon, perhaps also involving the draining lymph nodes. The swelling and inflammation may compromise blood supply and result in necrosis that, in rare cases, may lead to the loss of a digit.

Following appropriate immediate local cleansing, corticosteroids may be considered to decrease the severity of any local reaction. Ascertain the patient’s tetanus immunisation status, and provide booster or primary series, as appropriate.

In some cases of self-injection, PROMPT surgical attention may be required. The wound should be incised and irrigated to remove the vaccine, especially where there is involvement of finger pulp or tendon. Complete curettage or total excision of the lesion may be required for chronic granulomatous reactions. Meticulous technique is required to stop inadvertent spread of the product.