For animal use only.

A lyophilised vaccine containing live attenuated Brucella abortus S19 for the prevention of bovine brucellosis (contagious abortion).

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.

As per Table 2 of the Animal Diseases Regulations (R. 2026 of 1986), all heifers between the ages of 4 and 8 months must be vaccinated against brucellosis, and no bovine above the age of 8 months may be vaccinated against brucellosis without the written consent of the responsible state veterinarian.

COMPOSITION PER DOSE (2 ml)

BRU-TECT S19 is a lyophilised vaccine containing live attenuated B. abortus S19. Each 2 ml (1 dose) of reconstituted vaccine contains 5 x 10¹⁰ cfu/dose - 1 x 10¹¹ 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. For 20 ml and 100 ml pack sizes: 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. abortus S19 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

Inject a single 2 ml subcutaneous injection on the side of the neck only, in heifers between the ages of 4 and 8 months. DO NOT deviate from the recommended route and injection site location. Do not repeat vaccination.

PACKING SIZE AND ORDERING CODE

10 ds (LVS06308)

50 ds (LVS06307)

Reg. no. G4496 (36/1947)

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

BRU-TECT S19 | Bovine 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 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 remedy 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 S19 administration, cannot be used for any other purpose. If syringes and needles are re-used for BRU-TECT S19 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 S19 | Bovine Vaccine

Warnings

Precautions