For animal use only.

Bru-Tect Rev1 is a lyophilised vaccine containing live attenuated Brucella melitensis Rev 1 for the prevention of ovine and caprine brucellosis. Prophylactic immunisation against Brucella ovis infection (epididymitis, orchi-epididymitis and infertility) is indicated for ovine ram lambs only. Prophylactic immunication against Brucella melitensis infection is indicated for ovine lambs and caprine kids of both sexes.

Brucellosis is a controlled disease in terms of the Animal Diseases Act (Act no. 35 of 1984) and any suspicion or confirmation of the disease must be reported to the responsible state veterinarian immediately.

COMPOSITION PER DOSE (2 ml)

Bru-Tect Rev 1 is a lyophilised vaccine containing live attenuated B. melitensis Rev 1. Each 2 ml (1 dose) of reconstituted vaccine contains 5 x 10⁸ cfu/dose - 2 x 10⁹ cfu/dose.

STORAGE

Store and transport refrigerated between 2°C and 8°C. Do not freeze. Protect from high temperatures and sunlight during vaccination. Do not use after the expiry date printed on the container. Do not store any vials into which a needle or another device has been inserted, for future use. Use entire contents of the vial within 2 hours of reconstitution.

DIRECTIONS FOR USE - USE ONLY AS DIRECTED

Please consult with your veterinarian before use.

Draw up 2 ml to 3 ml of the diluent component from the HDPE vial and inject into the 7 ml glass vial containing the live attenuated B. melitensis Rev 1 lyophilised cake. Owing to the nature of the product, it is normal for the cake to take few minutes to dissolve. Very gently aspirate at least 5 times with a 15-18G needle and syringe to assist with dissolving the cake. Mix gently to dissolve the powder, aspirate contents gently and TRANSFER BACK into the HDPE diluent vial. Mix gently to distribute the bacterial suspension evenly throughout the liquid. Use the entire contents of the vial within 2 hours of reconstituion.

DOSAGE

B. ovis: Single 2 ml subcutaneous injection on the side of the neck only, in ovine ram lambs only, between 2 and 4 months of age. Goats do not develop B. ovis infections and should not be vaccinated for this purpose.
B. melitensis: Single 2 ml subcutaneous injection on the side of the neck only, in ovine lambs and caprine kids of both sexes, between 2 and 4 months of age. Vaccination against B. melitensis is not common practice as the disease is not widespread wihtin the country.
Inject ovine lambs or caprine kids subcutaneously, on the side of the nect. DO NOT deviate from the recommended route and injection site location.

PACKING SIZE AND ORDERING CODE

20 ml/10 ds (LVS06309)

Reg. no. G4497 (36/1947)

Reg. holder: Vetvax (Pty) Ltd, Reg. no. 2004/035302/07, 442 Rigel Avenue South, Erasmusrand, Pretoria | Tel. 012 349 2772

BRU-TECT REV1 | Ovine and Caprine Vaccine

Withdrawal period: Do not slaughter animals for human consumption within 21 days of vaccination.

Vaccinate healthy animals only.

Do not mix with any other vaccine or immunological product.

Potentially harmful to humans. Care should be taken to avoid direct contact with the product, to prevent self-injections, or contamination of the eyes or skin. If contact occurs, rinse affected area repeatedly with clean water. Medical advice should be sought in the event of accidental exposure.

Do not over- or under-dose the vaccine.

Usually no marked reactions follow vaccination, although a transient swelling may appear at the site of inoculation, and some animals may show a moderate rise of temperature for one or two days.

Ensure that marketed animals do not have local reactions (swellings) at the site of vaccination, or elevated temperature reactions (fever) as this may result in the condemnation of the carcasses.

Simultaneous administration of antibiotics to vaccinated animals is contraindicated as the antibiotic will interfere with the vaccine.

Antibiotics should not be given for several days before and after vaccination.

Use the entire contents of the vial once opened.

Do not use in animal species other than those indicated.

DO NOT USE IN PREGNANT ANIMALS.

DO NOT USE IN MALE ANIMALS OLDER THAN 4 MONTHS.

Do not administer to animals in poor or extremely poor body condition.

Do not inject intravenously.

KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.

Although this product 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; notify the registration holder and the registrar.
Observe aseptic precautions. Ensure that all vaccination equipment (needles, syringes, etc.) is clean and sterile prior to use.

Do not use the contents of damaged vials.

Wash and disinfect hands with a disinfectant after vaccination.

Wear protective clothing, masks, gloves, etc. according the hazard standards.

Avoid contact with skin, eyes and mouth.

Do not eat, drink or smoke whilst handling the product.

Used disposable vaccine equipment, unsued vaccine, etc. must be disposed of according to the National Environmental Waste Act, 2008 (Act 59 of 2008).

Do not contaminate rivers, dams or any water sources with containers or waste.

Syringes and needles that are used for BRU-TECT REV 1 administration, cannot be used for any other purpose. If syringes and needles are re-used for BRU-TECT REV 1 administration, they must be dedicated for this purpose only. Where chemical sterilisation of needles and syringes are practised, needles and syringes must be rinsed in cooled down boiled water before re-use to ensure that the attenuated live bacterial component of the next dose is not destroyed by the disinfectant.

A single inoculation of this vaccine will not produce absolute immunity in all animals. Therefore, complete reliance should not be placed on the vaccine alone to prevent an control brucellosis. It is important that a veterinarian be consulted regarding additonal control measures.

Local reactions may occur in some animals at the injection site. They will disappear after a few days. If you notice any serious effects, please inform your veterinarian.

BRU-TECT REV1 | Ovine and Caprine Vaccine

Warnings

Precautions