Active substance

Avian infectious bursal disease (IBDV / Gumboro) (serotype 1) (strain SYZA-26) (attenuated)

ATC code

QI01AD09 Avian infectious bursal disease (IBDV / Gumboro)

QI01AD Live viral vaccines

QI01A Immunologicals for domestic fowl

QI01 Immunologicals for aves

QI Immunologicals

Species

Chickens

Indications

For active immunisation of day-old future layer chickens in order to reduce clinical signs and acute lesions of bursa of Fabricius caused by very virulent avian Infectious Bursal Disease (IBD) virus infection.

Onset of immunity: expected from 30 days of age onwards depending on the initial MDA level.

The immunisation is influenced by the natural decline of maternally derived antibodies (MDA), and has been found to occur when MDA have reached appropriate release level. The onset of clinical protection depends on the initial MDA level.

In vaccinated day old future layer chicks the release of the vaccine virus (vaccine virus take) was observed between 21-42 days after vaccination.

Duration of immunity: up to 9 weeks of age.

The virulent challenge tests conducted to support the claim were carried out on day old future layer chicks having MDA ELISA titre of 3,000 to 5,700 (average Day 0 MDA levels).

Field trials carried out showed that vaccine virus replication in the bursa of Fabricius occurs in day old future layer chicks having average MDA titre levels of 6,000 ELISA units.

Dose to be administered and administration route

The vaccine must be administered by subcutaneoususe.

The vaccine is to be administered once at 1 day of age.

Automatic syringe may be used. The injection volume is 0.2 ml per dose. The vaccine is delivered under the skin of the neck.

Use sterile devices and equipment for reconstitution and for administration of the vaccine.

Proposed dilutions for subcutaneous administration:

Number of vaccine ampoules	Solvent	Volume of one dose
2 x 500 doses	200 ml	0.2 ml
4 x 500 doses	400 ml
8 x 500 doses	800 ml
1 x 1000 doses	200 ml
2 x 1000 doses	400 ml
4 x 1000 doses	800 ml
1 x 2000 doses	400 ml
2 x 2000 doses	800 ml
2 x 2000 + 1 x 1000 doses	1000 ml
3 x 2000 doses	1200ml
4 x 2000 doses	1600 ml

Preparation of vaccine:

1. After matching the dose size of the vaccine ampoule(s) with the solvent (Cevac Solvent Poultry) size, quickly remove from liquid nitrogen container the exact number of ampoules needed.

2. Draw up 2-5 ml of solvent into a 5-10 ml sterile syringe. Use at least 18 gauge needles.

3. Thaw rapidly the contents of the ampoules by gentle agitation in water at 27-39°C.

4. As soon as they are completely thawed, open ampoules holding them at arm’s length in order to prevent any risk of injury should the ampoule break.

5. Once the ampoule is open slowly draw up the content into the needle already containing 25 ml solvent.

6. Transfer the suspension into the solvent bag. The vaccine prepared as described is mixed by gentle agitation.

7. Withdraw a portion of the vaccine into the syringe to rinse ampoule. Remove the washing from the ampoule and inject it gently into the solvent bag. Repeat it one or two times.

8. The vaccine prepared as described is mixed by gentle agitation so as to be ready for use.

Repeat the operations in point 2-7 for the appropriate number of ampoules to be thawed.

The vaccine should not be used if there are visible signs of unacceptable decolourisation in the vials.

The reconstituted vaccine is orange to red, clear to opaque suspension. Insoluble particles may be present.

Adverse reactions

Chickens:

Very common (>1 animal / 10 animals treated):

Bursa of Fabricius lymphocyte depletion¹

¹Mild to moderate which is maximal at around 7 days after vaccine take. After further 7 days, this depletion decreases and is followed by lymphocyte repopulation and regeneration of the bursa of Fabricius.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

Dispensing

POM-V - Prescription Only Medicine – Veterinarian

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Novamune concentrate and solvent for suspension for injection for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (0.2 ml) contains:

Active substance:

Infectious bursal disease virus,

serotype 1, strain SYZA26 (intermediate plus), live attenuated) 2.65 – 4.2 log10 CID₅₀* *Chicken Infective Dose 50% Excipients:

Qualitative composition of excipients and other constituents	Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Vaccine concentrate:
BDA (Bursal Disease Antibody)	1.3 – 2.2 log10 AB unit**
Sucrose
Water for injections
Solvent:
Sucrose
Casein hydrolysate
Sorbitol
Dipotassium hydrogen phosphate
Potassium dihydrogen phosphate
Phenol red
Water for injections

** Antibody unit

Vaccine: reddish-brownish frozen suspension. Solvent: clear, orange to red liquid.

3. CLINICAL INFORMATION

3.1 Target species

Chickens

3.2 Indications for use for each target species

For active immunisation of day-old future layer chickens in order to reduce clinical signs and acute lesions of bursa of Fabricius caused by very virulent avian Infectious Bursal Disease (IBD) virus infection.

Onset of immunity: expected from 30 days of age onwards depending on the initial MDA level.

The immunisation is influenced by the natural decline of maternally derived antibodies (MDA), and has been found to occur when MDA have reached appropriate release level. The onset of clinical protection depends on the initial MDA level.

In vaccinated day old future layer chicks the release of the vaccine virus (vaccine virus take) was observed between 21-42 days after vaccination.

Duration of immunity: up to 9 weeks of age.

The virulent challenge tests conducted to support the claim were carried out on day old future layer chicks having MDA ELISA titre of 3,000 to 5,700 (average Day 0 MDA levels).

Field trials carried out showed that vaccine virus replication in the bursa of Fabricius occurs in day old future layer chicks having average MDA titre levels of 6,000 ELISA units.

3.3 Contraindications

Do not use in chickens from non-vaccinated parent flocks or having no MDA against IBDV as vaccination of such birds may cause immunosuppression.

3.4 Special warnings

Vaccinate healthy animals only.

Vaccinate only MDA positive birds which have at least an average day-old MDA level of 2500 ELISA units (this MDA level was determined from studies which used a commercially available ELISA kit from BioCheck).

3.5 Special precautions for use

Special precautions for safe use in the target species:

Vaccinated chickens may excrete the vaccine strain up to 14 days following the vaccine virus take. During this time, the contact of immunosuppressed and unvaccinated chickens with vaccinated chickens should be avoided.

Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible birds. Vaccinate all the birds in a flock at the same time.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Liquid nitrogen containers and vaccine should be handled by properly trained personnel only.

Personal protective equipment consisting of protective gloves, spectacles and boots should be worn when handling the veterinary medicinal product, before withdrawing from liquid nitrogen, during the ampoule thawing and opening operations.

Frozen glass ampoules can explode during sudden temperature changes. Store and use liquid nitrogen only in a dry and well-ventilated place. Inhalation of the liquid nitrogen is dangerous.

Personnel involved in the treatment of vaccinated birds should use hygiene principles and take particular care in handling litter from vaccinated chickens.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events Chickens:

Very common (>1 animal / 10 animals treated):

Bursa of Fabricius lymphocyte depletion¹

¹Mild to moderate which is maximal at around 7 days after vaccine take. After further 7 days, this depletion decreases and is followed by lymphocyte repopulation and regeneration of the bursa of Fabricius.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Laying birds:

Do not use in birds in lay and within 4 weeks before the start of the laying period.

3.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.

3.9 Administration routes and dosage

The vaccine must be administered by subcutaneoususe.

The vaccine is to be administered once at 1 day of age.

Automatic syringe may be used. The injection volume is 0.2 ml per dose. The vaccine is delivered under the skin of the neck.

Use sterile devices and equipment for reconstitution and for administration of the vaccine.

Proposed dilutions for subcutaneous administration:

Number of vaccine ampoules	Solvent	Volume of one dose
2 x 500 doses	200 ml	0.2 ml
4 x 500 doses	400 ml
8 x 500 doses	800 ml
1 x 1000 doses	200 ml
2 x 1000 doses	400 ml
4 x 1000 doses	800 ml
1 x 2000 doses	400 ml
2 x 2000 doses	800 ml
2 x 2000 + 1 x 1000 doses	1000 ml
3 x 2000 doses	1200ml
4 x 2000 doses	1600 ml