This content is current only at the time of printing. This document was printed on 29 November 2020. A current copy is located at https://apvma.gov.au/node/945
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Veterinary vaccines and antisera
In addition to the standard labelling requirements, labels for veterinary vaccines and antisera should carry the following information, where applicable.
1. Signal heading
The Schedule 4 signal heading is required for all live-virus veterinary vaccines (except poultry vaccines, pigeon pox vaccine and scabby mouth vaccine) and specific antisera products, including canine tick antiserum, monoclonal antibodies for therapeutic use, and tetanus antitoxin.
2. Name of product
As well as the distinguishing word(s) (for example, ‘Canvac 4’, ‘Vibravac’, etc.), the name should identify whether the product is living or inactivated and be concluded with the word ‘vaccine’.
3. Active constituent(s) and scheduled non-active constituents
Labels for vaccines and antisera must state the measure of potency. This measure should be in the form of the end-of-shelf-life titre or potency. Measures should be expressed as international units or potency units where applicable; for example, TCID50/mL, µg/mL, etc.
The live antigen(s) should appear first in the ‘Active constituent’ statement, followed by the inactivated antigen(s). If the vaccine also contains non-biological chemical active constituents, they should be listed after any biological components.
Vaccine types (for example, ‘whole cells’, ‘cell fractions’, ‘subunits’, ‘toxoid’, etc.) are to 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.
Labels for vaccine products should state the end-of-shelf-life potency or titre of all active constituents, as well as the scheduled non-active constituents and the preservative used. Labels should also refer to relevant pharmacopoeial monographs, where applicable.
4. Label efficacy claims
The label efficacy claims for veterinary vaccines should follow APVMA guidance.
5. Directions for use
For multiple-dose containers and for freeze-dried products that must be reconstituted before use, the in-use shelf-life stability (viz. the time interval from broaching to the time when the product reaches end-of-shelf-life specifications) must be supported by data. The following statement must be placed under the ‘Directions for use’ heading:
USE ALL PRODUCT WITHIN [X] HOURS OF OPENING/RECONSTITUTION/MIXING.
5.1. General directions
Instructions to sterilise reusable syringes and needles should appear on labels for live vaccines for farm animals and should 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. Such statements should appear on labels under the ‘General directions’ heading.
6. Withholding periods
A withholding period of zero (0) days is generally acceptable for vaccines and antisera, unless otherwise indicated by data. If we require you to include a different withholding period we will advise you about this need.
7. User safety information
Additional user safety instructions apply to vaccines. These should be placed under the heading ‘User safety information’. The following statements relate to adjuvants, and the relevant statement based on the adjuvant used in the vaccine should be applied. For vaccines with no adjuvant, the ‘Mild-aluminium-like’ statement should be used. Note: some phrases are underlined for emphasis.
7.1. Standard mandatory warning statement for all vaccines
Take care to avoid self-injection.
In the event of self-administration, seek medical attention if you are concerned. Show the package leaflet or label to the Medical Practitioner.
7.3. Moderate—emulsion or vegetable oil-like
Accidental self-administration may result in local bruising, pain and swelling. In the event of self-administration, seek medical attention and show the package leaflet or label to the Medical Practitioner.
7.4. Severe—mineral oil-like
This product contains mineral oil. In the event of self-administration, seek prompt medical attention and take this package leaflet/carton with you. Accidental self-administration may result in local bruising, severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If pain persists for more than 12 hours after medical examination, seek medical advice again.
This product contains mineral oil and is an irritant. In the event of accidental 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, especially if the site of injection involves a finger joint or tendon sheath. Contact a doctor as soon as possible, 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 to avoid spread of the vaccine.
Ancillary advice to the medical practitioner
This product contains mineral oil. Even if small amounts of this product have been accidentally self-administered, it 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. 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 accidental 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.
8. Removable labels for small single-dose vaccines
We may approve removable, or part removable, labels (as used for vaccination recording purposes) provided the following criteria are met:
- the products are only for use by veterinarians
- the labels are for vials of single-dose vaccines
- label information clearly states that the removable label can only be removed after all contents have been used on the target animal (or otherwise disposed of)
- label information clearly states that the used vial must be disposed of via an authorised clinical waste repository
- the labels must, as a minimum, state the vaccine name, APVMA approval number, batch number and expiry date to enable traceback if there are complaints about the product.
We assess applications for removable labels on a case-by-case basis.