RB-51 Bovilis 25 Doses (rehydrate to 50 ml)

RB-51For use in healthy female cattle as an aid in the prevention of infection and abortion caused by Brucella abortus.FOR ANIMAL USE ONLYRB-51Reg. No. G3056 (Act 36/1947)Namibia Reg. No. V03/24.4/756 [NS0]Brucella abortus vaccineBrucellosis is a controlled disease in terms of the Animal Disease Act, (Act 35 /1984). Any occurrence or suspected occurrence of brucellosis must be reported immediately to the local state veterinarian.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 RB-51 strain of Brucella abortus.STORAGE:Store between 2 °C and 8 °C.Protect from light.WARNINGS:DO NOT VACCINATE PREGNANT ANIMALS.Withdrawal period:Meat – do not slaughter for human consumption within 21 days of administration.Milk – if adult cows are vaccinated, milk should be pasteurized or boiled before use for human consumption. Consult the state veterinarian if you are intending to vaccinate adult cattle.If an anaphylactic reaction occurs administer adrenaline or an equivalent.In the case of accidental human exposure contact your physician.KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.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 PractitionersThis organism is rifampicin resistant. Alternative antibiotic therapy will therefore be essential should a patient be infected.An immunologic response to the RB-51 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.PRECAUTIONSDo not eat, drink or smoke during administration of RB-51.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 LACTATIONDo not vaccinate pregnant cattle due to the risk of abortion and potential shedding of the RB-51 strain in calving fluids and milk.For further information, please consult your veterinarian or MSD Animal Health’s technical advisors.DIRECTIONS FOR USE – USE ONLY AS DIRECTEDFor vaccination of female cattle only.Rehydrate by adding the accompanying sterile diluent to the freeze-dried vaccine.Mix well before use.The diluent is a buffered solution specifically prepared for use with the RB-51 vaccine.Use this diluent only, to assure viability of this vaccine.Use vaccine immediately after rehydrating.Proposed Dosing ScheduleBrucella abortus negative herds: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 a full dose between 12 and 16 months of age.           Adult cows, non-pregnant – administer 2 mℓ subcutaneously.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.Brucella abortus positive herds:         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. Adult cows, non-pregnant – administer 2 mℓ subcutaneously.Annual 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.PRESENTATIONType I glass vials of 5 doses (rehydrate to 10 mℓ) and 25 doses (rehydrate to 50 mℓ) closed with a sterile rubber stopper. Each carton contains a single vial.