RB-51

Reg. No. G 3056 (Act 36/1947)

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Indications:
For use in healthy female cattle as an aid in the prevention of infection and abortion caused by Brucella abortus.

Storage Instructions:
Protect from light. Store between 2°C and 8°C.

Composition:
This lyophilised vaccine contains the RB51 strain of Brucella abortus.

Warnings

Vaccination of pregnant animals may cause abortion.

Withdrawal period – do not slaughter within 3 weeks of administration.

If anaphylactoid reaction occurs administer adrenaline or equivalent.

In the case of accidental human exposure contact your physician.

Keep out of reach of children, uninformed persons and pets.

Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

Warning to Medical Practitioners

This organism is Rifampicin resistant. Alternative antibiotic therapy will therefore be essential should a patient be infected.

An immunologic response to the RB51 strain is not detected on routinely available serological tests used for the diagnosis of Brucella abortus infections.

A reasonable interim course of post exposure prophylaxis for adults would be doxycycline 100 mg orally twice daily for 21 days, with the addition of other suitable antimicrobials if evidence of infection appears.

Precautions

Do not eat, drink or smoke during administration of the vaccine.

Wash and disinfect hands after vaccination.

Care should be taken to avoid direct contact and self-injection.

Use entire contents when first rehydrated.

Burn or sterilize the container and any remaining contents.

Directions For Use: Use only as directed.

For vaccination of female cattle only.

Rehydrate by adding the accompanying sterile diluent to the dried vaccine.

Mix well before use.

The diluent is a buffered solution specifically prepared for use with this vaccine.

Use only this diluent to assure viability of the vaccine.

Use immediately after rehydrating.

Proposed Dosing Schedule:

1. Brucella abortus negative herds:

i) Herds which have not been vaccinated against Brucella abortus:

Vaccinate heifers 4 – 10 months of age with 2 mℓ administered subcutaneously. Revaccinate with full dose between 12 – 16 months of age.

Adult cows, non-pregnant – administer 2 mℓ subcutaneously.

ii) Herds with established immunity by previous vaccination against Brucella abortus:

Vaccinate heifers 4 – 10 months of age with 2 mℓ administered subcutaneously. Revaccinate with full dose between 12 – 16 months of age.

2. Brucella abortus positive herds:

Vaccinate heifers 4 – 10 months of age with 2 mℓ administered subcutaneously.

Revaccinate with full dose between 12 – 16 months of age.

Adult cows, non-pregnant – administer 2mℓ subcutaneously.

Yearly boosters can be administered if desired but it is not a prerequisite.

There is a risk of abortion if pregnant animals are vaccinated with RB-51.

Presentation:
5 dose (rehydate to 10mℓ); 25 dose (rehydrate to 50 mℓ)

Registration holder:
Schering-Plough Animal Health
Co. Reg. No. 1934/005207/07