Aquavac Erm Concentrate For Dip Suspension For Rainbow Trout
Revised: October 2010
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Concentrate for dip suspension for Rainbow trout
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance :
cells of Yersinia
(Hagerman type I strain) RPS(*) ≥ 75% after vaccination
Formaldehyde: ≤ 0.5 mg/ml
*RPS : relative percentage of survival in Rainbow Trout
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for dip suspension
4. CLINICAL PARTICULARS
4.1 Target species
Rainbow trout (Oncorhynchus mykiss)
4.2 Indications for use, specifying the target species
In Rainbow Trout of 2 grams weight or over: Active immunization 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.
4.4 Special warnings
Only vaccinate healthy fish.
4.5 Special precautions for use
Special precautions for use in animals
During vaccination, the temperature of the diluted vaccine should not differ from the water temperature in the holding area by more than ± 5oC.
Fish should be subject to the minimum of manipulations such as sorting and transportation during the periods shortly before and after vaccination
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Personal protective equipment consisting of rubber gloves should be worn during all vaccination operations.
4.6 Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy, lactation or lay
Do not administer to fish intended as broodstock or to broodstock.
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
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 100kg 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects have been noted following a double dose of vaccine.
4.11 Withdrawal period
5. IMMUNOLOGICAL PROPERTIES
To stimulate active immunity in Rainbow Trout against Enteric Redmouth disease caused by Yersinia ruckeri.
ATC Vet Code: QI10BB03
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Formaldehyde, Sodium chloride solution
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after dilution according to directions: 5 hours.
6.4. Special precautions for storage
Store in a refrigerator (+2C - +8C).
Protect from light.
Do not freeze.
6.5 Nature and composition of immediate packaging
High density polyethylene bottles, closed with a rubber stopper and sealed with an aluminium cap containing 1 litre of vaccine.
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 products should be disposed of in accordance with the local requirements.
7. MARKETING AUTHORISATION HOLDER
Intervet UK Ltd
8. MARKETING AUTHORISATION NUMBER
9. DATE OF RENEWAL OF THE AUTHORISATION
3 August 2009
10. DATE OF REVISION OF THE TEXT
PROHIBITION OF SALE, SUPPLY AND/OR USE
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