SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

AquaVac PD3 Emulsion for injection, for Atlantic salmon

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Per dose of 0.1 ml vaccine:

Active substance:

Salmon pancreas disease virus (SPDV) strain F93-125, ≥ 75% RPP¹

Infectious pancreatic necrosis virus (IPNV), ≥ 1.5 ELISA units²

Aeromonas salmonicidasubsp. salmonicida, ≥ 80% RPS₆₀³

¹ RPP: relative percentage protection in a laboratory test in Atlantic salmon

² Antigenic mass measured in the final product

³ RPS: relative percentage survival at 60% control mortalityin a laboratory test in Atlantic salmon

Adjuvant:

Light liquid paraffin, 43 mg

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

White to nearly white emulsion for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Atlantic salmon (Salmo salarL)

4.2 Indications for use, specifying the target species

For active immunisation of Atlantic salmon to reduce clinical signs (heart lesions and pancreas lesions), viremia, viral shedding and mortality from infection with SPDV (Pancreas disease) and to reduce mortality from infections with IPNV (Infectious pancreatic necrosis) and Aeromonas salmonicidasubsp. salmonicida(furunculosis).

Onset of immunity: 500 degree days after vaccination for SPDV and Aeromonas salmonicidaand 540 degree days after vaccination for IPNV.

Duration of immunity: demonstrated at 15 months post vaccination for SPDV and at 16 months post vaccination for Aeromonas salmonicida. Protection against mortality due to IPNV infection has been demonstrated at 4 months post vaccination in the field.

4.3 Contraindications

None

4.4 Special warnings for each target species

None

4.5 Special precautions for use

Special precautions for use in animals

The vaccine should be used in healthy fish.

Do not use in fish during smoltification.

Incorrect vaccination, stress and poor hygiene may lead to increased side effects.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Personal protective equipment consisting of e.g. needle protector should be used when handling the product.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.

To the user:

This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in 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 you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician:

This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

4.6 Adverse reactions (frequency and seriousness)

After vaccination melanisation and vaccine residues are very commonly observed in the abdominal cavity. Visceral adhesion may be observed; during the fresh water phase up to sea transfer phase slight to moderate adhesions (corresponding to Speilberg scores 1 – 3) very commonly occur while the occurrence of major adhesions (corresponding to Speilberg score of 4) is uncommon.

During the sea water phase mild adhesions (corresponding to Speilberg scores 1 – 2) are very common and moderate adhesions (corresponding to Speilberg score 3) are common.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Fertility:

Do not use in broodstock. The possible effects of vaccination on spawning have not been investigated.

4.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

4.9 Amounts to be administered and administration route

Dose:a single dose of 0.1 ml.

Administration:intraperitoneally along the central line, approximately 1 pelvic fin length in front of the pelvic fin base in Atlantic salmon. Shake the bottle well before use.

Vaccination is recommended for fish above 30 grams.

Food should be withheld for sufficient time (at least 48 hours) to ensure emptying of the gut prior to vaccination. The fish should be anaesthetised before vaccination. The length and the diameter of the applied needle should be adapted to the actual fish size. Ensure that the recommended dose is deposited into the abdominal cavity before the needle is withdrawn.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

After administration of a double dose more vaccine residues can be observed, but no increase in local reactions is observed compared to single dose administration.

4.11 Withdrawal period(s)

Zero degree days.

5. IMMUNOLOGICAL PROPERTIES

The product stimulates active immunity against pancreas disease, infectious pancreatic necrosis, and furunculosis.

Pharmacotherapeutic group: immunologicals; Atlantic salmon; inactivated viral and inactivated bacterial vaccines.

ATC vet code: QI10AL

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Light liquid paraffin

Polysorbate 80

Sorbitan monooleate

Phosphate buffered saline

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 19 months

Shelf-life after first opening the container: use within 1 working day

6.4 Special precautions for storage

Store in a refrigerator (2 - 8°C). Do not freeze.

6.5 Nature and composition of immediate packaging

Bottles of polyethylene terephthalate (PET) closed with a rubber stopper and aluminium cap. Package size: 500 ml (5,000 doses).

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm 01708/4610

9. DATE OF FIRST AUTHORISATION

26 March 2015

10. DATE OF REVISION OF THE TEXT

November 2015

Approved: 12 November 2015