RB-51

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

FOR ANIMAL USE ONLY

RB51
Reg. No. G3056 (Act 36/1947)
Namibia Reg. No. V03/24.4/756 NS0

Brucella abortus Vaccine
This vaccine may only be used by or under the supervision of persons registered in terms of or authorised in terms of section 23 (1) (c) of the Veterinary and Para- veterinary Professions Act, 1982 (Act 19 of 1982).

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

COMPOSITION

This lyophilised vaccine contains the RB51 strain of Brucella abortus

STORAGE

  • Protect from light.
  • Store between 2 °C and 8 °C.

WARNINGS

  • Do not vaccinate pregnant animals.
  • Withdrawal period:

Meat – do not slaughter for human consumption within 3 weeks of administration. Milk – if adult cows are vaccinated, milk should be pasteurized before human consumption.

  • If anaphylactic 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.
  • Dispose of any unused vaccine as well as all vaccine containers and vaccination equipment according to local waste disposal regulations.

PREGNANCY AND LACTATION
Do not vaccinate pregnant cattle due to the risk of abortion and potential shedding of the RB51 strain in calving fluids and milk.
For further information, please consult your veterinarian or MSD Animal Health.
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 this diluent only, to assure viability of the vaccine.
Use immediately after rehydrating.

Proposed Dosing Schedule

Proposed Dosing Schedule

  1. Brucella abortus negative herds:
    i) Herds which have not been vaccinated against Brucella abortus:
    Vaccinate heifers between 4 and 10 months of age with 2 mℓ, administered subcutaneously.
    Revaccinate with full dose between 12 and 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 between 4 and 10 months of age with 2 mℓ, administered subcutaneously.
Revaccinate with a full dose between 12 and 16 months of age.

  1. Brucella abortus positive herds:
    Vaccinate heifers between 4 and 10 months of age with 2 mℓ, administered subcutaneously.
    Revaccinate with full dose between 12 and 16 months of age. Adult cows, non-pregnant – administer 2 mℓ 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 RB51.

PRESENTATION

5 dose (rehydrate to 10mℓ); 25 dose (rehydrate to 50 mℓ).

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

MANUFACTURER
Colorado Serum Company
4950 York Street,
Denver, Colorado, USA

DATE OF PUBLICATION OF THIS PACKAGE INSERT

TBA