SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Poulvac Marek CVI + HVT concentrate and solvent for suspension for injection for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 0.2 ml dose contains:

Active substances:

Marek’s disease virus, serotype 1, strain CVI-988 (Rispens, cell-associated), live ≥

102.9 CCID50*

Turkey herpesvirus, strain FC-126 (cell-associated), live ≥ 1,000 PFU**

*CCID₅₀ = 50% cell culture infective dose. **PFU = plaque forming units.

Excipients:

Qualitative composition of excipients and other constituents

Concentrate

Dimethyl sulfoxide

Bovine calf serum

L-glutamine

Dulbecco’s Modified Eagle Medium

Solvent:

Sucrose

Potassium dihydrogen phosphate

Dipotassium phosphate

Peptone (NZ Amine)

Phenolsulfonphthalein (phenol red)

Water for injections

Concentrate: yellow to light orange frozen suspension. When thawed, light orange to light pink suspension. Solvent: clear and red liquid.

3. CLINICAL INFORMATION

3.1 Target species

Chickens (one day-old chicks).

3.2 Indications for use for each target species

Active immunisation of one-day old chickens against Marek’s disease virus to reduce mortality, clinical signs and lesions of Marek’s disease.

Onset of immunity: 9 days after vaccination.

3.3 Contraindications None.

3.4 Special warnings

Vaccinate healthy animals only.

3.5 Special precautions for use

Special precautions for safe use in the target species:

The vaccine viruses have the potential to spread. After 10 passages, the vaccine showed an increase in virulence in highly susceptible pure-bred Rhode Island Red chickens.

All chickens in the flock should be vaccinated at the same time.

Maternally derived antibodies may have some negative influence on vaccination. Avoid contact of the vaccinated chicks with feather dust of other chickens to allow development of protection.

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

Liquid nitrogen can cause serious freeze burns and thawing ampoules may occasionally explode as result of sudden temperature changes. Therefore, liquid nitrogen containers and vaccine ampoules should be handled by properly trained personnel only.

Personal protective equipment consisting of gloves, facial protection or safety goggles and skin-covering clothing should be worn when handling the veterinary medicinal product starting when withdrawing from liquid nitrogen.

General hygiene principles including cleaning and disinfecting of hands should be followed.

Store and use liquid nitrogen only in a dry and well-ventilated place.

In case of accidental self-injection seek medical advice immediately and show the package leaflet to the physician.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events

Chickens (one day-old chicks):

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 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:

The safety of the veterinary medicinal product has not been established during lay.

3.8 Interaction with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be administered concurrently with Poulvac IB Primer and Poulvac NDW. 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.

3.9 Administration routes and dosage

Intramuscular or subcutaneous use.

Administer a single dose (0.2 ml) to day-old-chicks by intramuscular injection in one of the leg muscles or by subcutaneous injection in the neck.

Preparation of the vaccine:

Preparation of the vaccine shall be planned before the ampoules are taken from the liquid nitrogen and the exact amount of vaccine ampoules and amount of solvent needed shall be calculated first. There is no information available on the number of doses on the ampoules once they are removed from the cane. Special care has to be taken to ensure that mix-ups of ampoules with different number of doses are avoided and the correct volume of solvent (Poulvac Solvent) is used.

Dilute each 1,000 doses with 200 ml of Poulvac Solvent (2,000 doses presentation with 400 ml of Poulvac Solvent and the 1,000 ml Poulvac Solvent presentation could be used for a total of 5,000 doses).

Take the ampoule(s) of vaccine concentrate out of the liquid nitrogen container and thaw the vaccine concentrate by carefully immersing in water at 25 °C – 30 °C, while gently swirling the ampoule(s) to disperse the content. Then remove the ampoule from the water and dry it. The thawed vaccine concentrate must be used immediately.

Break the ampoule and withdraw the total contents carefully into a 10 ml sterile disposable syringe, using an 18 G x 1.5” (1.2 mm x 40 mm) or larger gauge needle. Slowly draw about 8 ml of Poulvac Solvent into the syringe. Turn the syringe 510 times to mix the content well. Slowly transfer a small volume of the mixture into the empty ampoule in order to remove the last remnants of the vaccine concentrate and withdraw this small amount back into the syringe.

Carefully transfer the entire contents of the syringe into the Poulvac Solvent container. Rotate the container about 10 times to mix the contents well. The vaccine is now ready for use.

The ready to use vaccine is a red, transparent to slightly opalescent liquid. NB During vaccination procedure, rotate the bottle of reconstituted vaccine solution every 5 minutes to prevent the cells from sedimenting. Use within 2 hours of reconstitution.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

The vaccine has shown to be safe in ten-fold times the recommended dose. No emergency procedure has been described.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Zero days.

4. IMMUNOLOGICAL INFORMATION

4.1 ATCvet code: QI01AD03

The vaccine contains Marek’s disease virus, serotype 1, strain CVI-988, an attenuated homologous strain, and turkey herpesvirus strain FC-126, a heterologous strain non-pathogenic for poultry. The vaccination induces an active immunity against Marek’s disease in one-day-old chickens, which is demonstrated by challenge at 9 days after vaccination.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

Do not mix with any other veterinary medicinal product except solvent supplied for use with the veterinary medicinal product.

5.2 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 30 months.

Shelf life of the solvent (Poulvac Solvent) as packaged for sale: glass bottles: 3 years, plastic bags: 2 years. Shelf life after dilution according to directions: 2 hours.

5.3 Special precautions for storage

Concentrate:

Store and transport frozen at -196 ºC in liquid nitrogen. Once thawed, the vaccine concentrate cannot be refrozen.

Poulvac Solvent:

Store at or below 25 °C. Protect from light.

5.4 Nature and composition of immediate packaging

Concentrate:

Type I glass ampoule containing 1,000 or 2,000 doses of the vaccine.

The ampoules are stored in cryopreservation containers in a cane. (5 ampoules per cane). The dose presentation is presented on the extremity of each cane.

Poulvac Solvent:

Type II glass bottle containing 200 ml or 400 ml.

Polyvinylchloride (PVC) or polypropylene plastic bag containing 200 ml, 400 ml, 800 ml or 1 000 ml.

1 plastic bag or cardboard box of 10 glass bottles.

The solvent is packed separately from the ampoules.

Not all pack sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

7. MARKETING AUTHORISATION NUMBER

Vm 42058/5223

8. DATE OF FIRST AUTHORISATION

24 May 1999

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

October 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 21 October 2026