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Injectable Emulsion
Inactive Bivalent Bacterial Fish Vaccine
COMPOSITION
PRIMEVAC IP AH/AV is an inactive bacterial vaccine prepared against Aeromonas Septicemia disease caused by A. hydrophila and A. veronii in rainbow trout (Oncorhynchus mykiss), inactivated with formaldehyde, containing Tween 80 and Sorbitan oleate as adjuvants and phenol as preservative.
In 1 ml vaccine;
Active ingredients:
Aeromonas Veronii *RPS ≥ 65
Aeromonas hydrophila *RPS ≥ 65
* Relative Percentage Survival (RPS)
Excipient:
Phenol : < 0.5 mg/ml
Immunological Properties:
Provides stimulation of active immunity against Aeromonas hydrophila and Aeromonas Veronii bacteria. The product is manufactured to be used for first and second vaccination.
AREA OF USE / INDICATIONS
PRIMEVAC IP AH/AV is used to prevent Aeromonas Septicemia disease caused by A. hydrophila and A. veronii in rainbow trout (Oncorhynchus mykiss).
METHOD OF ADMINISTRATION AND DOSAGE
The vaccine is administered as 0.1 ml by intraperitoneal injection (I.P).
SPECIFIC 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. recent 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 a 1/10 diluted vaccine suspension, the diluted vaccine suspension should be destroyed according to the relevant legislation.
Use During Pregnancy and Lactation:
There is no information regarding the use of this product during pregnancy, lactation and spawning.
UNDESIRABLE EFFECTS
Following vaccination, fish may experience a temporary loss of appetite due to the stress that the 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 efficacy of this product when used with other medical products (on the same day or at different times) are unknown. It should not be used together or mixed with other medical products.
SYMPTOMS, PRECAUTIONS AND ANTIDOTE IN OVERDOSE
No abnormal local and systemic reactions were observed in high-dose studies conducted on target animals with a dose twice the application dose.
WARNINGS FOR RESIDUE IN ANIMALS WITH FOOD VALUE
Zero (0) days.
CONTRAINDICATIONS
There is no known contraindication.
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, gloves) is used during application.
According to good medical practice, contact of the skin, eyes and clothing with the vaccine material should be avoided during vaccination.
STORAGE CONDITIONS AND SHELF LIFE
The vaccine should be stored in a dark place at +2/+8 C and protected from sunlight. It should not be frozen.
Shelf life is 24 months.
END OF USE DESTRUCTION 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 1L in Styrofoam. The bottles are closed with a stopper made of butyl plastic and an aluminum cap. Not all package sizes may be marketed.