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Date: Saturday, May 25, 2024 2:10

Release 3.92
AquaVac® Relera Concentrate for dip suspension or suspension for injection for Rainbow trout
 
Species: Fish
Therapeutic indication: Immunological veterinary medical products: For fish
Active ingredient: Vaccine Antigens
Product:AquaVac® Relera Concentrate for dip suspension or suspension for injection for Rainbow trout
Product index: AquaVac® Relera
Fish - meat: Zero degree days
Incorporating:
Qualitative and quantitative composition
Active ingredients
Inactivated cells of Yersinia ruckeri Hagerman type 1 strain
≥ 75% RPS*
Inactivated cells of Yersinia ruckeri (EX5 biotype strain)
≥ 75% RPS*
Excipient:
Residual Formaldehyde
< 0.05% w/w
*RPS : relative percentage of survival in Rainbow Trout
For the full list of excipients see section "Pharmaceutical particulars".
Pharmaceutical form
Concentrate for dip suspension or suspension for injection. Suspension in brown aqueous liquid.
Clinical particulars
Target species
Rainbow trout (Oncorhynchus mykiss).
Indications for use
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).
Contraindications
None.
Special warnings for each target species
The minimum weights for fish before vaccination must be respected (see section "Amounts to be administered and administration route").
Special precautions for use
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.
Operator warnings
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.
Adverse reactions
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.
Use during pregnancy or lactation
Do not administer to broodstock or fish intended as 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
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 ≥ 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 ≥ 12 g)
The vaccine must be administered using a multi-dose injection applicator incorporating a mechanism to prevent flush-back. This applies equally to hand-held 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.
Overdose
No adverse effects have been noted following a double dose of vaccine by immersion or injection.
Withdrawal period
Zero degree days.
Pharmacological particulars
ATC Vet Code: QI10BB03
Pharmacotherapeutic group
The vaccine induces active immunity against enteric redmouth disease caused by Yersinia ruckeri, Hagerman type 1 strain and the EX5 biotype.
Pharmaceutical particulars
Excipients
Residual Formaldehyde
Sodium chloride.
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 first opening the immediate packaging: use within 5 hours.
Special precautions for storage
Store and transport refrigerated (2°C – 8°C). Do not freeze. Protect from light.
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.
Disposal
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
UK(NI): Intervet International B.V., The Netherlands
Marketing Authorisation Number
UK: Vm 01708/4615
Significant changes
Date of the first authorisation or date of renewal
15 May 2009.
Date of revision of the text
June 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 Relera 1x1L:
GTIN:5017363773422