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Date: Saturday, May 18, 2024 22:33

Release 3.404
ALPHA JECT micro 6 emulsion for injection for Atlantic salmon
 
Species: Fish
Therapeutic indication: Immunological veterinary medical products: For fish
Active ingredient: Vaccine Antigens
Product:ALPHA JECT® micro 6 emulsion for injection for Atlantic salmon
Product index: ALPHA JECT micro 6
Fish - meat: Zero degree days
Incorporating:
Presentation
A liquid paraffin adjuvanted water in oil emulsion vaccine for injection, consisting of an inactivated cultures of:
Aeromonas salmonicida subsp. salmonicida
> 12.6 log2 ELISA units
Listonella anguillarum* serotype O1
RPS ≥ 75%
Listonella anguillarum* serotype O2a
RPS ≥ 75%
Vibrio salmonicida
RPS ≥ 90%
Moritella viscosa
> 10.7 log2 ELISA units
Infectious Pancreatic Necrosis Virus serotype Sp
0.12 - 0.28 AU
ELISA units: Serological response in Atlantic salmon,
RPS: Relative Percentage Survival is based on results from challenge studies on Atlantic salmon at 60% mortality in the control group.
AU: Antigenicity Units (quantity of virus antigen measured in the final product).
* Listonella anguilllarum is synonymous with Vibrio anguillarum.
Uses
For active immunisation of Atlantic salmon to reduce mortality caused by infections with Aeromonas salmonicida (furunculosis), Vibrio salmonicida (coldwater vibriosis), Listonella anguillarum serotype O1and O2a (classical vibriosis), Moritella viscosa (winter sore) and IPNV (infectious pancreatic necrosis).
Onset of immunity
520 degree days post vaccination for the bacterial antigens and 600 degree days post vaccination for IPNV.
Duration of immunity
12 months for the bacterial antigens and 5.5 months for IPNV.
Dosage and administration
Posology
Administer a single dose of 0.05 ml per fish. Fish should not be vaccinated more than once.
Administration route
The vaccine should be administered by intraperitoneal (i.p.) injection into the midline about one fin length anterior to the base of the pelvic fin. To reduce the risk of adverse reactions, it is important to deposit the entire dose in the abdominal cavity. The injection needle used should have appropriate length to penetrate the abdominal wall and 1-2 mm into the abdominal cavity.
It is recommended to starve the fish for a minimum of 48 hours before vaccination.
The fish should be anaesthetised prior to injection.
Let the vaccine slowly reach 15-20°C by keeping it at room temperature.
Ensure a homogenous emulsion prior to use by squeezing and shaking the vaccine bag for approx. 2 minutes.
Only administer the vaccine if it appears as a homogenous, white to cream coloured emulsion.
The vaccine should not be used if the vaccine shows signs of a brownish water phase in the bottom of the container. Contact the distributor for further advice.
The injection devices used for vaccination, i.e. automatic vaccination machines or manual syringes, must be designed and suitable for administration of the recommended dose volume in the target species. The devices must be operated by trained personnel and should be calibrated according to the manufacturers' recommendation prior to use. Special care should be taken to ensure air is removed from the injection equipment (chambers and tubes) prior to vaccination. Regular dose controls are recommended.
The vaccination equipment should be thoroughly cleaned / sterilized before use.
Contra-indications, warnings, etc
Vaccinate healthy fish only.
Vaccination should preferably be performed at water temperatures of 15°C or below.
Do not vaccinate at water temperatures below 3°C or above 18°C.
Avoid vaccination during smoltification.
The potential effect of vaccination on spawning function has not been investigated.
Vaccination of broodfish should only be done according to a benefit-risk assessment by the responsible veterinarian/fish health biologist.
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.
Do not mix with any other veterinary medicinal product.
Adverse reactions
The frequency of adverse reactions observed after vaccination in laboratory studies and field trials:
Very common
Melanisation in the abdominal cavity
Mild visceral adhesions (Speilberg score 1-2)
Common
Moderate visceral adhesions (Speilberg score 3)
Very rare
Serious visceral adhesions (Speilberg score ≥ 4)
The severity of adverse reactions may be influenced by different factors such as sanitation, vaccination technique, fish size at vaccination and water temperature during vaccination and in the first 6-12 weeks after vaccination. As a general precaution it is recommended to perform vaccination at water temperature of 15 °C or below.
Small fish and high water temperature may increase the severity of adverse reactions.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- 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)
Following administration of 0.1 ml of the vaccine (double dose) no other adverse reactions than those described above were seen.
Withdrawal period
Zero degree days.
Operator warnings
People with known hypersensitivity to fish vaccines should avoid contact with the veterinary medicinal product.
Protective equipment consisting of guarded needles should be used during manual vaccination.
Ensure that the method of fixation and handling of the fish minimises the risk of accidental self-injection. Repeated self-injections may aggravate the adverse effects or increase the risk of anaphylactic shock.
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 veterinary medicinal 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.
Pharmaceutical precautions
Store and transport refrigerated (2°C - 8°C). Do not freeze. Protect from light.
Shelf-life after first opening the immediate packaging: 10 hours.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Injection bags containing 500 ml.
Marketing Authorisation Holder (if different from distributor)
Pharmaq AS
Skogmo Industriområde
Industrivegen 50
7863 Overhalla
Norway
Further information
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 (GB): Vm 21714/4007
UK (NI): Vm 21714/4007
Significant changes
GTIN