Indications for use, specifying the target species
For the active immunisation of Atlantic salmon to reduce impaired daily weight gain, and reduce mortality, and cardiac, pancreatic and skeletal muscle lesions caused by pancreas disease following infection with salmonid alphavirus subtype 3 (SAV3).

Onset of immunity occurs within 399 degree days (mean water temperature in °C multiplied by number of holding days) following vaccination.

Duration of immunity: 1 year for reduction in impaired daily weight gain, and cardiac, pancreatic and skeletal muscle lesions and 9.5 months for reduction of mortality (demonstrated in a laboratory efficacy study in saltwater conditions using a cohabitation challenge model).

Contraindications
None.

Special warnings for each target species
Vaccinate healthy animals only.

Special precautions for use
Special precautions for use in animals
A minimum body weight of 25 g is recommended at vaccination.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Personal protective equipment, for example, consisting of appropriate protective gloves, should be worn when handling the veterinary product.

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

Adverse reactions (frequency and seriousness)
Transient changes in swimming behaviour, pigmentation and inappetence are very common and can be observed for up to 2, 7 and 9 days, respectively.

Needle injuries at the site of injection are common following administration of the vaccine which can persist in up to 5% of fish for at least 90 days, and can be seen both macroscopically and microscopically.

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).

Use during pregnancy, lactation or lay
The effect of vaccine on reproductive performance has not been investigated. Do not use in broodstock.

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.

Amounts to be administered and administration route
Intramuscular use.

Shake product gently before use.

Transfer tubing kit instructions: using the spiked end, screw the transfer tubing set onto the fill port of the ethyl vinyl acetate (EVA) bag with a ¼ turn in order to secure the line in place. Connect the other end of the transfer tubing set to the vaccine injection equipment (gun).

Anaesthetise the fish to immobilise them, and administer 0.05 ml of the vaccine by intramuscular injection in the area immediately anterior and lateral to the dorsal fin in the epaxial muscle.

Position the needle at 90° in the epaxial muscle, central to the dorsal fin and above the mid-line.

Based on a 25 g fish weight a standard 0.5 mm diameter 3mm depth needle is recommended to be used routinely. Consideration should be made for the weight of the fish before the final selection is made. Injection equipment should be calibrated and inspected regularly to ensure appropriate dosing of the fish.

Overdose (symptoms, emergency procedures, antidotes), if necessary
No effects other than those described in section 'Adverse reactions' have been observed following the administration of a ten-fold overdose.

Withdrawal period(s)
Zero degree days.