Poulvac MD-Vac Lyophilisate and diluent for suspension for injection

Introduction

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.pfizerah.co.uk

Presentation

Lyophilisate and diluent for suspension for injection.

Marek HVT strain F#126 2,250-17,500 PFU per 0.2ml dose.

Uses

To prevent mortality and clinical signs due to infection with Marek's disease virus. Onset of immunity has been demonstrated from 5 days after vaccination. No information is available on the duration of the protection elicited by vaccination. However, experience in the field suggests that Marek's disease vaccine virus strains and antibody titres persist for up to 2 years after vaccination.

Dosage and administration

One dose of 0.2ml per chicken.

The vaccine is to be administered either by intramuscular injection in the thigh or by subcutaneous injection in the neck to one-day-old chickens.

Reconstitute each 1,000 doses of Poulvac MD Vac with 200 ml of diluent at room temperature. Remove the centre tabs of aluminium seals on both vaccine vial and diluent bottle, leaving intact the outer ring on both vial and bottle. Cleanse rubber stoppers with alcohol and allow to dry. All equipment used for vaccination should be sterile and contain no traces of detergents or disinfectants. Using a sterile needle and syringe, insert through diluent bottle stopper and withdraw 3 ml of diluent. Transfer by inserting through vaccine vial stopper. After slight agitation of the vial to ensure that the vaccine has dissolved, insert needle and withdraw entire contents into the syringe. Remove the syringe containing all the reconstituted vaccine from vial and re-insert into diluent bottle. Expel syringe contents into diluent. The reconstituted vaccine is now ready for use. For administration of the vaccine an automatic syringe with a 23 gauge x 1 inch (0.60 x 25 mm) needle is recommended. Inject each chick intramuscularly with 0.2 ml of vaccine, the usual site being the upper thigh, or subcutaneously in the neck. Use within 2 hours of reconstitution.

Advice on correct administration:

Avoid exposure to heat or direct sunlight. Avoid contact with disinfectants as this renders the vaccine inactive. Use clean materials for vaccination. Avoid stress in chickens before and after vaccination. Avoid injection into or near joints and tendons.

Contra-indications, warnings, etc

For Animal Treatment Only.

Do not use in sick chickens. Do not vaccinate in an infected environment. Do not use in birds in lay. Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Poulvac IBMM, Poulvac Hitchner B1 and Poulvac Bursine 2. The products should be given at different sites. 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. Do not mix with any other vaccine/immunological product except the diluent provided.

Maternally-derived antibody (MDA) can interfere with the development of active immunity. Where it is likely that recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high level of MDA, the timing of the vaccination programme should be planned accordingly.

Adverse Reactions:

No local or systemic reactions have been observed following the administration of the vaccine during safety studies. However, and in common with other immunological products, it is expected that local or systemic reactions may occur in a very small proportion of vaccinated birds.

Pharmaceutical precautions

Keep out of the reach and sight of children.

Poulvac MD Vac

Store and transport at +2°C to +8°C. Do not freeze. Protect from light.

Poulvac Marek Diluent

Store and transport at room temperature or at +2°C to +8°C in the dark. Avoid exposure to heat and/or direct sunlight. Do not freeze.

Following dilution the dissolved vaccine should be kept at room temperature and used within 2 hours.

Legal category

POM-VPS

Packaging Quantities

Poulvac MD Vac

10 x 500, 1000 and 2000 dose.

Poulvac Marek Diluent

Glass bottles of 200 ml, 400 ml or 500 ml.

Collapsible plastic bag of 200ml, 400ml, 500ml or 1 litre.

Not all pack sizes may be marketed.

Further information

No local or systemic reactions have been observed after the administration of a tenfold overdose.

Disposal:

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Marketing authorisation number

Vm 00057/4374