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Date: Thursday, May 30, 2024 9:00

Release 2.52
AquaVac® ERM Concentrate for dip suspension for Rainbow trout
 
Species: Fish
Therapeutic indication: Immunological veterinary medical products: For fish
Active ingredient: Vaccine Antigens
Product:AquaVac® ERM Concentrate for dip suspension for Rainbow trout
Product index: AquaVac® ERM Concentrate
Fish - meat: Zero degrees days
Incorporating:
Qualitative and quantitative composition
Active substance:
Inactivated cells of Yersinia ruckeri (Hagerman type I strain): RPS* ≥ 75% after vaccination.
(*RPS: relative percentage of survival in Rainbow trout)
Excipient:
Formaldehyde: ≤ 0.5 mg/ml
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Concentrate for dip suspension.
Clinical particulars
Target species
Rainbow trout (Oncorhynchus mykiss)
Indications for use
In Rainbow trout of 2 grams weight or over: Active immunisation against Enteric Redmouth disease (ERM) to reduce mortality caused by the Hagerman Type I strain of Yersinia ruckeri. 336 degree days are required for the development of full immunity (28 days at a water temperature of 12 °C). The time for development of protective immunity will depend on water temperature.
A duration of immunity of 78 days has been shown under laboratory conditions.
Under field conditions, protection may be expected for at least 6 months.
A booster vaccination administered 4 months after primary vaccination may induce a better level of protection.
Contraindications
None.
Special warnings for each target species
Only vaccinate healthy fish.
Special precautions for use
During vaccination, the temperature of the diluted vaccine should not differ from the water temperature in the holding area by more than ± 5 °C.
Fish should be subject to the minimum of manipulations such as sorting and transportation during the periods shortly before and after vaccination.
Operator warnings
Personal protective equipment consisting of rubber gloves should be worn during all vaccination operations.
Adverse Reactions
None.
Use during pregnancy or lactation
Do not administer to fish intended as broodstock or to broodstock.
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
The product is administered to Rainbow trout of not less than 2 grams in weight by immersion for 30 seconds in vaccine diluted 1 in 10 with hatchery water.
1 litre of vaccine, diluted to 10 litre in total, is sufficient to vaccinate 100 kg of fish.
Fish may be vaccinated in batches. The size of each batch should be appropriate to the volume of diluted vaccine available and to the size of the fish.
The diluted vaccine should be oxygenated, if necessary, between vaccinations of individual batches.
Overdose
No adverse effects have been noted following a double dose of vaccine.
Withdrawal periods
Zero days.
Pharmacological particulars
ATCvet code: QI10BB03
To stimulate active immunity in Rainbow trout against Enteric Redmouth disease caused by Yersinia ruckeri.
Pharmaceutical particulars
Excipients
Formaldehyde
Sodium chloride solution
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after dilution according to directions: 5 hours.
Special precautions for storage
Store in a refrigerator (2°C – 8°C). Do not freeze. Protect from light.
Immediate packaging
High-density polyethylene bottles closed with a rubber stopper and sealed with an aluminium cap containing 1 litre of vaccine.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4564
Significant changes
Date of the first authorisation or date of renewal
03 August 2004.
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-VPS
GTIN
GTIN description:AquaVac® ERM 1x1l:
GTIN:5017363939255