Racing Pigeon Laboratory Testing

PACKAGE LEAFLET

Diftovac POX VACCINE  

Lyophilisate and Solvent for Suspension for Pigeons

1. Name and Address of the Marketing Authorisation Holder and Manufacturer

2. Name of the Veterinary Medicinal Product

Diftovac®
Lyophilisate and solvent for suspension for pigeons

3. Composition

Each vaccine dose contains:

Active Substance

Live Pigeon Pox Virus, Strain NJ

Minimum: 10⁴ EID₅₀
Maximum: 10⁶ EID₅₀

EID₅₀ = Egg Infective Dose 50%.

Diluent D contains:

·       Sodium hydrogen phosphate dodecahydrate

·       Potassium chloride

·       Potassium dihydrogen phosphate

·       Sodium chloride

·       Water for injections

The original packaging contains Diluent D.

4. Indications

For the active immunisation of pigeons against pigeon pox to reduce the clinical signs and lesions associated with pigeon pox virus infection.

Onset of immunity: Within 21 days after vaccination.

Duration of immunity: At least 9 months.

5. Contraindications

Do not vaccinate birds that are sick or suspected of suffering from any disease.

6. Adverse Reactions

Adverse reactions following subcutaneous administration are very rare.

Following feather-follicle administration, swollen follicles greater than 5 mm in diameter without exudate may rarely occur. These local swellings normally resolve within 9 days.

The frequency of adverse reactions is defined as:

·       Very common: More than 1 in 10 animals treated.

·       Common: More than 1 but fewer than 10 animals in 100 treated.

·       Uncommon: More than 1 but fewer than 10 animals in 1,000 treated.

·       Rare: More than 1 but fewer than 10 animals in 10,000 treated.

·       Very rare: Fewer than 1 animal in 10,000 treated, including isolated reports.

If you notice any serious side effects or effects not mentioned in this leaflet, please contact your veterinary surgeon.

7. Target Species

Pigeons.

8. Dosage and Method of Administration

Reconstitute the freeze-dried vaccine aseptically immediately before use.

Only sterile syringes, needles and equipment should be used. Equipment must be free from residues of chemical disinfectants.

Feather-Follicle Administration

Reconstitute:

·       50-dose vial with 5 ml of Diluent D.

·       100-dose vial with 10 ml of Diluent D.

Remove 10–15 feathers from the inside (medial side) of the leg.

Apply the vaccine into the exposed feather follicles.

Dose: 0.1 ml per pigeon.

Avoid causing bleeding from exposed follicles, as this may produce a stronger local reaction.

Apply only to clean, dry skin.

Do not disinfect the skin before application.

Subcutaneous Administration (Recommended)

Reconstitute:

·       50-dose vial with 10 ml of Diluent D.

·       100-dose vial with 20 ml of Diluent D.

Administer 0.2 ml per pigeon by subcutaneous injection.

The recommended injection site is the loose skin of the neck.

Vaccinate using aseptic technique.

9. Vaccination Programme

Primary Vaccination

Vaccinate pigeons from 4 weeks of age.

Revaccination

·       In lofts where pigeon pox infection is a significant risk, revaccinate every 9 months.

·       In lofts with a low risk of infection, annual revaccination is considered sufficient.

Shake the vaccine well before use and periodically during vaccination.

10. Withdrawal Period

Zero days.

11. Storage Instructions

Keep out of the sight and reach of children.

Store and transport refrigerated between 2°C and 8°C.

Do not freeze.

Protect from light and direct sunlight.

Store in a dry place.

Avoid even short-term deviations from the recommended storage temperature.

Once reconstituted, use the vaccine within 1 hour.

12. Special Warnings

Special Warnings for Pigeons

Very limited spread of the vaccine virus from vaccinated birds to unvaccinated birds in close contact may occur. This does not result in clinical disease.

Studies have demonstrated that the vaccine virus remains stable after at least five laboratory passages without reverting to virulence.

Special Precautions for Use in Animals

Successful vaccination should produce a small local swelling at the vaccination site within 4–10 days.

The swelling may form a scab and normally resolves within 4–6 weeks.

Failure to observe a vaccination reaction may indicate incorrect administration or previous immunity.

Avoid bleeding from exposed feather follicles, as this may result in a pronounced local reaction.

Apply only to clean, dry skin.

Do not disinfect the skin before feather-follicle vaccination.

Residual disinfectants on equipment may reduce vaccine effectiveness.

Subcutaneous administration is the preferred method of vaccination.

Precautions for the Person Administering the Vaccine

In the event of accidental self-injection, seek medical advice immediately and show the package leaflet or product label to the physician.

Use During Lay

The safety of the vaccine has not been established during the laying period.

Use during lay should only follow a benefit-risk assessment by the responsible veterinarian.

Interaction with Other Veterinary Medicinal Products

No information is available regarding the safety or efficacy of this vaccine when administered with any veterinary medicinal product other than the supplied Diluent D.

A decision to administer this vaccine before or after another veterinary medicinal product should therefore be made on a case-by-case basis.

Overdose

An overdose may increase the incidence of local reactions described in Section 6.

Incompatibilities

Do not mix this vaccine with any other veterinary medicinal product except the supplied Diluent D.

13. Disposal

Dispose of unused vaccine and waste materials by boiling, incineration, or immersion in an appropriate disinfectant approved by the competent authorities.

14. Date of Last Revision

[To be completed.]

15. Pack Sizes

Available pack sizes:

·       One vial containing 50 doses of lyophilised vaccine with one 10 ml vial of Diluent D.

One vial containing 100 doses of lyophilised vaccine with one 20 ml vial of Diluent

Donal Barry