Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

An adjuvanted inactivated vaccine against Mannheimia haemolytica* type A1 respiratory infections of cattle.

*Mannheimia haemolytica was formerly called Pasteurella haemolytica.

Uses

For the active immunisation of cattle against Mannheimia haemolytica* type A1 respiratory infections.

Dosage and administration

Administer by the intramuscular or the subcutaneous route.

Inject one 2 ml dose according to the following schedule:

Primary vaccination

Preferably before the risk period: 1st injection at a minimum age of 4 weeks, and 2nd injection 21-28 days later.

Booster vaccination

Preferably before each risk period: one injection no later than one year after the first vaccination.

Contra-indications, warnings, etc

For animal treatment only.

Vaccinate only healthy animals.

No information is available on the safety and efficacy of concurrent use of this product with any other. It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with PASTOBOV.

Vaccination by the subcutaneous route is followed by a limited 2-5 cm local reaction (oedema developing as a nodule) that regresses within 3 weeks. Vaccination by the intramuscular route can cause a transient, diffuse oedema and slight local reaction up to 5 cm diameter that regresses within 1-2 weeks. After subcutaneous and intramuscular injection, granulomas up to 5 cm diameter may occur. Vaccination (by the subcutaneous or intramuscular route) may sometimes induce a slight rise in body temperature (1°C) which is transient (24-72 hours). Hypersensitivity may also occur.

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

Withdrawal period

Nil.

Pharmaceutical precautions

Shake well before use.

Apply usual aseptic procedures. Apply usual procedures for the handling of the animals.

Store and transport between +2°C and +8°C, protected from light. Do not freeze.

Any open bottles should be used within one working day.

Do not mix with other medical products.

Keep out of reach of children.

Any unused product or waste materials should be disposed of in accordance with national requirements.

Legal category

POM-V

Packaging Quantities

Bottles containing 20 ml.

Further information

PASTOBOV is an adjuvanted, inactivated vaccine against Mannheimia haemolytica A1 respiratory infections of cattle. The vaccine induces an immune response against Mannheimia haemolytica A1 demonstrated by challenge and by the presence of antibodies against the Mannheimia haemolytica capsular and leucotoxin antigens. Booster vaccination results in an anamnestic response in the antibodies against Mannheimia haemolytica capsular and leucotoxin antigens.

PASTOBOV can be used during pregancy.

Marketing authorisation number

Vm 08327/4173.