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Contra-indications, warnings, etc
Vaccination of broodfish is not recommended and should be subject to a risk benefit evaluation of the prescribing veterinarian/fish health biologist.
Fish with clinical symptoms of disease should not be vaccinated. Vaccination should preferably be performed at water temperatures of 15°C or lower. Avoid vaccination during smoltification.
Safety and efficacy data are available which demonstrate that this vaccine can be administered simultaneously with PHARMAQ's oil adjuvanted multivalent vaccines containing the following antigens: Aeromonas salmonicida, Listonella anguillarum O1 and O2a, Vibrio salmonicida, Moritella viscosa and Infectious Pancreas Necrosis Virus (IPNV). The vaccines are administered intraperitoneally either simultaneously (one injection) or in immediate succession (two injections) while fish are anaesthetised.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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 products.
Adverse reactions
Melanisation and vaccine residues are very commonly observed in the abdominal cavity after vaccination. Mild visceral adhesions (corresponding to Speilberg scores 1 – 2) are very common, moderate adhesions (corresponding to Speilberg score 3) are common, while the occurrence of severe adhesions (corresponding to Speilberg scores ≥ 4) are very rare. The same frequencies for visceral adhesions are observed both in fresh water and in sea water.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports)
Administration of a double dose of vaccine (0.1 ml) shows no other adverse reactions than those described in above.
Withdrawal period
Zero degree days.
Operator warnings
The use of needle guards is recommended in order to reduce the risk of accidental self-injection.
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.