Aquavac Relera vet.
Active substance
ATC code
Species
Rainbow trout (Oncorhynchus mykiss).
Indications
Active immunisation against Enteric Redmouth disease (ERM) to reduce mortality caused by Hagerman type 1 and EX5 biotype strains of Yersinia ruckeri.
Immersion route:
Onset of immunity: 336 degree days (28 days at 12 °C) for Hagerman type 1 and for EX5 biotype.
Duration of immunity:
6 months (205 days at 12 °C) for the Hagerman type 1. 4 months (133 days at 12 °C) for the EX5 biotype.
Please note that the level of protection against the EX5 biotype wanes during the indicated period.
Intraperitoneal route (only for booster vaccination):
Duration of immunity: immunity has not been studied beyond 28 days (336 degree days).
Dose to be administered and administration route
Primary vaccination should be by the immersion route only. In the event that a booster vaccination is required to extend the duration of immunity for a further 28 days then the intraperitoneal route should be used.
When administering by immersion, dilute the contents immediately after opening the container, and use diluted vaccine immediately.
The development of protective immunity is dependent on the water temperature. Shake the bottle before use.
Primary vaccination by immersion (Fish of at least 5 g)
Dilute the contents of the bottle (1 litre) in 9 litres of hatchery water, clean and suitably oxygenated.
Place the fish into batches and immerse for 30 seconds in the diluted vaccine.
A litre of vaccine (making 10 litres of diluted vaccine) allows the vaccination of a maximum of 100 kg of fish.
Booster vaccination by intraperitoneal injection (Fish of at least 12 g) The vaccine must be administered using a multi-dose injection applicator incorporating a mechanism to prevent flush-back. This applies equally to handheld and automatic systems.
The product is administered by intraperitoneal injection in the ventral area, just anterior to the pelvic fins. The dose is 0.1 ml per fish. The fish should be anaesthetised prior to vaccination.
Adverse reactions
Rainbow trout (Oncorhynchus mykiss):
|
Very common (>1 animal / 10 animals treated): |
Adhesion in fish1. |
1 Very slight (Speilberg score 1) induced by injection administration at the site of injection, which may persist for 7 weeks but are normally no longer observed 3 months after injection.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
AquaVac Relera Concentrate for dip suspension or suspension for injection for
Rainbow Trout
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
|
Inactivated cells of Yersinia ruckeri (Hagerman type 1 strain) |
≥ 75% RPS* |
|
Inactivated cells of Yersinia ruckeri (EX5 biotype strain) Excipient |
≥ 75% RPS* |
|
Residual Formaldehyde |
≤ 0.05% w/v |
*RPS : relative percentage of survival in Rainbow Trout For the full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Concentrate for dip suspension or suspension for injection
Suspension in brown aqueous liquid
4. CLINICAL PARTICULARS
4.1 Target species
Rainbow trout (Oncorhynchus mykiss)
4.2 Indications for use, specifying the target species
Active immunization against Enteric Redmouth disease (ERM) to reduce mortality caused by Hagerman type 1 and EX5 biotype strains of Yersinia ruckeri.
Immersion route:
Onset of immunity:
336 degree days (28 days at 12°C) for Hagerman type 1 and for EX5 biotype.
Duration of immunity:
6 months (205 days at 12°C) for the Hagerman type 1.
4 months (133 days at 12°C) for the EX5 biotype.
Please note that the level of protection against the EX5 biotype wanes during the indicated period.
Injection route (only for booster vaccination):
Duration of immunity:
Immunity has not been studied beyond 28 days (336 degree days).
4.3 Contraindications
None
4.4 Special warnings for each target species
The minimum weights for fish before vaccination must be respected (see section 4.9 of the SPC).
4.5 Special precautions for use
Special precautions for use in animals Only vaccinate healthy fish.
Do not vaccinate if the water temperature is below 12°C.
Avoid stress at the time of the handling of fish, as well as temperature variations, in particular between the vaccine suspension and the water of the holding area.
Special precautions to be taken by the persons administering the veterinary medicinal product to animals
Protective equipment should be used to avoid self injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Injection administration can induce very slight adhesions (Speilberg score 1) at the site of injection, which may persist for 7 weeks but are normally no longer observed 3 months after injection.
4.7 Use during pregnancy, lactation or lay
Do not administer to broodstock or fish intended as 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
Primary vaccination should be by the immersion route only. In the event that a booster vaccination is required to extend the duration of immunity for a further 28 days then the injection route should be used.
When administering by immersion, dilute the contents immediately after opening the container, and use diluted vaccine immediately.
The development of protective immunity is dependant on the water temperature. Shake the bottle before use.
Primary vaccination by immersion (Fish of at least 5 g)
Dilute the contents of the bottle (1 litre) in 9 litres of hatchery water, clean and suitably oxygenated.
Place the fish into batches and immerse for 30 seconds in the diluted vaccine. A litre of vaccine (making 10 litres of diluted vaccine) allows the vaccination of a maximum of 100 kg of fish.
Booster vaccination by injection (Fish of at least 12 g)
The vaccine must be administered using a multi-dose injection applicator incorporating a mechanism to prevent flush-back. This applies equally to handheld and automatic systems.
The product is administered by intra-peritoneal injection in the ventral area, just anterior to the pelvic fins. The dose is 0.1 ml per fish. The fish should be anaesthetised prior to vaccination.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects have been noted following a double dose of vaccine by immersion or injection.
4.11 Withdrawal period(s)
Zero degree days
5. IMMUNOLOGICAL PROPERTIES
The vaccine induces active immunity against enteric redmouth disease caused by Yersinia ruckeri, Hagerman type 1 strain and the EX5 biotype. ATC Vet Code QI10BB03
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Residual Formaldehyde Sodium chloride
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: 2 years. Shelf life after first opening the immediate packaging: use within 5 hours.
6.4 Special precautions for storage
Store and transport refrigerated (2°C – 8°C). Do not freeze. Protect from light.
6.5 Nature and composition of immediate packaging
Nature of primary packaging
high-density polyethylene bottles, red bromobutyl stoppers, aluminium cap
Packages intended for sales
The product is supplied in 1000 ml crimp-sealed bottles.
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 material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
MSD Animal Health UK Limited
Walton Manor
Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8. MARKETING AUTHORISATION NUMBER
Vm 01708/4615
9. DATE OF FIRST AUTHORISATION
15 May 2009
10. DATE OF REVISION OF TEXT
June 2020
Approved: 10 June 2020
