Active substance

(vHVT013-69) (recombinant)

ATC code

QI01AD15 Avian infectious bursal disease (IBDV / Gumboro) and avian herpesvirus (Mareks disease / MD)

QI01AD Live viral vaccines

QI01A Immunologicals for domestic fowl

QI01 Immunologicals for aves

QI Immunologicals

Species

Day-old chickens and 18 days embryonated eggs.

Indications

For active immunisation of chickens:

• To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.

Onset of immunity: 2 weeks

Duration of immunity:9 weeks

• To reduce mortality, clinical signs and lesions of Marek’s disease.

Onset of immunity: 4 days

Duration of immunity:a single vaccination is sufficient to provide protection during the risk period.

Dose to be administered and administration route

Reconstitution of the vaccine

• Wear protective gloves and spectacles during the ampoule thawing and opening operations.

• Remove from the liquid nitrogen container only those ampoules which are to be used immediately. When this product is mixed with Marek’s disease vaccine containing either Rispens (CVI988) strain or RN1250 strain, both should be diluted in the same solvent bag.

• Thaw the contents of the ampoules rapidly by agitation in water at 25°C - 30°C. Proceed immediately to next step.

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

• Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.

• Transfer the concentrate into the solvent (do not use if cloudy).

• Draw up 2 ml of the contents of the solvent into the syringe.

• Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the solvent. Repeat the rinsing operation once or twice.

• Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be reconstituted in the solvent; either 1 ampoule of 1,000 doses of vaccine per 200 ml of solvent (or 1 ampoule of 2,000 doses of vaccine per 400 ml of solvent) for subcutaneous administration, or 4 ampoules of 1,000 doses of vaccine per 200 ml of solvent (or 4 ampoules of 2,000 doses of vaccines per 400 ml of solvent) for in ovo administration.

• The reconstituted vaccine prepared as described is mixed by gentle agitation so as to be ready for use. It should be used immediately after the preparation (all

of the reconstituted vaccine should be used up within two hours). This is why the vaccine suspension should only be prepared as and when required.

Posology

One single injection of 0.2 ml per chicken at the age of one day, by subcutaneous route.

One single injection of 0.05 ml per chicken egg at 18 days of embryonation, by in ovo route.

Method of administration

The vaccine must be administered by subcutaneous route or by in ovo route.

For in ovo administration, an automated egg injection machine can be used. The device should be proven to safely and effectively deliver the appropriate dose. The instructions for use of this device should be strictly followed.

Adverse reactions

Chickens:

None known.

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 its local representative 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

Vaxxitek HVT+IBD concentrate and solvent for suspension for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of vaccine contains:

Active substance:

Live vHVT013-69 recombinant virus, at least 3.6 to 4.4 log10 PFU*

Excipient:

Excipient qs 1 dose

Solvent:

Solvent qs 1 dose

* Plaque forming unit

3. PHARMACEUTICAL FORM

Concentrate: homogeneous suspension. Solvent: red-orange limpid solution.

4. CLINICAL PARTICULARS

4.1 Target species

Day-old chickens and 18 days embryonated eggs.

4.2 Indications for use, specifying the target species

For active immunisation of chickens:

• To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.

Onset of immunity: 2 weeks

Duration of immunity:9 weeks

• To reduce mortality, clinical signs and lesions of Marek’s disease.

Onset of immunity: 4 days

Duration of immunity:a single vaccination is sufficient to provide protection during the risk period.

4.3 Contraindications

None.

4.4 Special warnings for each target species

Vaccinate healthy animals only.

4.5 Special precautions for use

Special precautions for use in animals

Apply the usual aseptic precautions to all administration procedures.

As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys. Safety and reversion to virulence trials have shown that the strain is safe for turkeys. However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.

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

Wear protective gloves and spectacles during the ampoule thawing and opening operations.

Open ampoules holding them at arm’s length in order to prevent any risk of injury should an ampoule break.

Special precautions for the protection of the environment: Not applicable.

4.6 Adverse reactions (frequency and seriousness)

Chickens:

None known.

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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

4.7 Use during pregnancy, lactation or lay

Do not use in breeding birds and birds in lay.

4.8 Interaction with other medicinal products and other forms of interaction

For subcutaneous route:

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim attenuated vaccines against Marek’s disease containing either Rispens (CVI988) strain or RN1250 strain. Chickens with maternally derived antibodies against MD, when vaccinated with the mixed products, may have a delayed onset of immunity against infectious bursal disease.

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Boehringer Ingelheim attenuated vaccines against Newcastle disease and Infectious bronchitis. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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.

For in ovo route:

In the absence of specific studies, no other veterinary medicinal product should be administered concurrently with the product.

4.9 Amount(s) to be administered and administration route