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Date: Thursday, May 30, 2024 5:57

Release 2.46
AquaVac® PD3 emulsion for injection for Atlantic Salmon
 
Species: Fish
Therapeutic indication: Immunological veterinary medical products: For fish
Active ingredient: Vaccine Antigens
Product:AquaVac® PD3 emulsion for injection for Atlantic Salmon
Product index: AquaVac® PD3
Fish - meat: Zero degree days
Incorporating:
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 salmonicida subsp. Salmonicida: ≥ 80% RPS603
1 RPP: relative percentage protection in a laboratory test in Atlantic salmon
2 Antigenic mass measured in the final product
3 RPS60: relative percentage survival at 60% control mortality in a laboratory test in Atlantic salmon.
Adjuvant:
Light liquid paraffin: 43 mg
For the full list of excipients, see section "Pharmaceutical particulars".
Pharmaceutical form
Emulsion for injection.
White to nearly white emulsion.
Clinical particulars
Target species
Atlantic salmon (Salmo salar L).
Indications for use
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 salmonicida subsp. salmonicida (furunculosis).
Onset of immunity: 500 degree days after vaccination for SPDV and Aeromonas salmonicida and 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.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy fish only.
Special precautions for use
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.
Operator warnings
Personal protective equipment consisting of e.g. needle protector should be used when handling the veterinary medicinal 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.
Adverse reactions
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 treated displaying adverse reactions
∙ common (more than 1 but less than 10 animals in 100 animals treated)
∙ uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
∙ rare (more than 1 but less than 10 animals in 10,000 animals treated)
∙ very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Fertility:
Do not use in broodstock. The possible effects of vaccination on spawning have not been investigated.
Interactions
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
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.
Overdose
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.
Withdrawal period
Zero degree days.
Pharmacological particulars
ATC vet code: QI10AL
The product stimulates active immunity against pancreas disease, infectious pancreatic necrosis, and furunculosis.
Pharmacotherapeutic group
Immunologicals for Pisces, inactivated viral and inactivated bacterial vaccines for Atlantic salmon.
Pharmaceutical particulars
Excipients
Light liquid paraffin
Polysorbate 80
Sorbitan monooleate
Phosphate buffered saline
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 19 months
Shelf-life after first opening the immediate packaging: use within 1 working day
Special precautions for storage
Store in a refrigerator (2 - 8°C). Do not freeze.
Immediate packaging
Bottles of polyethylene terephthalate (PET) closed with a rubber stopper and aluminium cap. Package size: 500 ml (5,000 doses).
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
UK: Vm 01708/4610
Significant changes
Date of the first authorisation or date of renewal
26 February 2015.
Date of revision of the text
August 2020.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:AquaVac PD3 1 x 500 ml:
GTIN:8713184142290