PRIMEVAC IP SI/LG/YR

COMPOSITION

PRIMEVAC IP 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≥65

Lactococcus garvieae *RPS≥65

Yersinia ruckeri *RPS≥65

* 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.

 

AREA 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

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.

 

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 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 your 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 the 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 the dark at +2/+8 and protected from sunlight. It should not be frozen.

 

END OF USE DESTRUCTION AND WARNINGS FOR NON-TARGET SPECIES

Unused or remaining product should be disposed of in accordance with 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 marketed.