Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

A freeze-dried pellet, each dose containing live attenuated Bovine Respiratory Syncytial Virus, strain RB94, minimum 105.5 CCID50 supplied with a vial of sterile diluent (water for injection and sodium chloride) for reconstitution.

Uses

For the active immunisation of calves to reduce infections and clinical signs associated with BRSV.

Onset of immunity occurs by 7 days after vaccination, as demonstrated serologically.

Studies have shown a duration of immunity of at least 4 months.

Dosage and administration

Reconstitute each 5 dose vial with 10 ml sterile diluent. Immediately give 2 ml reconstituted vaccine intramuscularly.

As far as possible take reasonable aseptic precautions in reconstituting and withdrawing vaccine. Reconstituted vaccine should be used immediately. Do not use chemically-sterilised syringes or needles, as these will affect the effectiveness of the vaccine.

Vaccination programme:

Animals older than 4 months of age:

Give 2 doses three to four weeks apart.

Animals from 7 days to 4 months of age:

Give two doses with a three to four week interval, with a third dose at 4 months of age. The third dose is required due to the possible interference from high titres of maternally derived antibodies during the first few months of life. An interval of at least 14 days should be observed between the second and third injection.

Ideally animals should be vaccinated during the autumn or at housing prior to the period of greatest risk. Maximum protection occurs when the whole herd is vaccinated.

Contra-indications, warnings, etc

Do not vaccinate unhealthy animals.

Anaphylactic reactions may occasionally occur. Where necessary, appropriate antihistaminic treatment should be instituted.

No reactions other than those listed above have been observed following administration of a ten times overdose with Rispoval RS.

Withdrawal period:

Zero days.

Operator warning:

In case of accidental self-injection, wash the area immediately with water. If symptoms develop, seek medical attention showing a copy of the package insert.

Pharmaceutical precautions

Store between +2°C and +8°C. Do not freeze.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except Rispoval™ Pasteurella (inactivated Mannheimia (Pasteurella) haemolytica vaccine), Tracherine™ (live infectious bovine rhinotracheitis vaccine) and Imuresp™ RP (live infectious bovine rhinotracheitis and Parainfluenza type 3 vaccine). It is therefore recommended that no other vaccines other than these should be administered within 14 days before or after vaccination with this product.

Do not mix with any other immunological product except the diluent provided.

Empty or part-used vials should be burned or immersed in an approved disinfectant before disposal.