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Suspension for Immersion
Inactivated Trivalent Bacterial Fish Vaccine
COMPOSITION
PRIMEVAC DIP SI/LG/YR Vaccine is a bacterial vaccine containing Streptococcus iniae, Lactococcus garvieae, Yersinia ruckeri as active ingredients and phenol for preservative purposes.
In 1 ml vaccine;
Active ingredients:
Streptococcus iniae *RPS≥60
Lactococcus garvieae *RPS≥60
Yersinia ruckeri *RPS≥60
* Relative Percentage Survival (RPS)
Excipient:
Phenol: < 0.5 mg/ml
Immunological Properties:
Provides stimulation of active immunity against Streptococcus iniae, Lactococcus garvieae and Yersinia ruckeri bacteria. The product is manufactured to be used for first and second vaccination.
FIELD OF USE / INDICATIONS
Indicated against Streptococcus, Lactococcus and Enteric Red Mouth (ERM) diseases caused by Streptococcus iniae, Lactococcus garvieae and Yersinia ruckeri in rainbow trout (Oncorhynchus mykiss).
USAGE AND DOSAGE
Before vaccination; one liter of vaccine is diluted with nine liters of clean rearing water at a ratio of 1/10. Vaccination is performed by immersing the fish in this prepared vaccine solution for 30 seconds.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
• Only healthy animals should be vaccinated, fish showing any signs of disease or previously vaccinated with this vaccine should not be vaccinated.
Fish exposed to stress factors (e.g. new cage change) should not be vaccinated.
Fish should not be fed for at least one day before vaccination.
Vaccines and special dilution fluid should be brought to room temperature and shaken well before use.
After vaccinating a total of 100 kg of fish with the 1/10 diluted vaccine suspension, the diluted vaccine suspension should be disposed of according to the relevant legislation.
Use During Pregnancy and Lactation:
There is no information on the use of this product during pregnancy, lactation and ovulation.
UNDESIRABLE EFFECTS
After vaccination, a temporary loss of appetite may occur in fish due to the stress that vaccination may cause.
The Frequency of Undesirable Effects is as follows:
Very frequent (if seen in 1 or more animals out of 10)
Frequent (if seen in 1-9 animals out of 100)
Infrequent (if seen in 1-9 animals out of 1,000)
Rare (if seen in 1-9 animals out of 10,000)
Very rare (if seen in less than 1 animal out of 10,000)
DRUG INTERACTIONS
There is no information on the compatibility of this vaccine with other medical products. The safety and effectiveness of this product when used with other medical products (on the same day or at different times) are unknown. It is not used together or mixed with other medical products.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
No abnormal local and systemic reactions were observed in high dose studies conducted on target animals with a dose twice the application dose.
RESIDUE WARNINGS IN ANIMALS WITH FOOD VALUE
Zero (0) day.
CONTRAINDICATIONS
No known contraindications.
GENERAL WARNINGS
Keep out of reach of children
Consult a Veterinarian if an unexpected effect is observed.
PRECAUTIONS TO BE TAKEN BY THE APPLICATOR AND RECOMMENDATIONS FOR PHYSICIANS
• Vaccination applications are only performed by Veterinarians or Technicians under the supervision of a Veterinarian.
Protective equipment (such as aprons and gloves) is used during application.
• According to good medical practice, contact of skin, eyes and clothing with the vaccine material should be avoided during vaccination.
STORAGE CONDITIONS AND SHELF LIFE
The vaccine; should be stored in the dark at +2/+8 and protected from sunlight. It should not be frozen.
END OF USE DISPOSAL AND WARNINGS FOR NON-TARGET SPECIES
Unused or remaining product should be disposed of according to the relevant legislation.
COMMERCIAL PRESENTATION FORM
The vaccine; is packaged in polypropylene plastic bottles as 250 ml, 500 ml and 1 L in Styrofoam. The bottles; are closed with a stopper made of butyl plastic and an aluminum cap. Not all package sizes may be put on the market.