COVEXIN® 8 + BOTULISM

COMPOSITION

Contains bacterins and toxoids of Clostridium spp. to meet the following potency values:

C. septicum C. novyi type B C. botulinum type C C. botulinum type D C. perfringens type C C. perfringens type D C. tetani C. sordellii C. chauvoei

Potency value/dose > 2,5 IU > 3,5 IU > 5 IU > 2 IU > 10 IU β toxoid > 2 IU ξ toxoid > 2,5 IU > 1 IU Complies Ph. Eur. and CFR (USA)

Although Clostridium perfringens type B is not a component of the vaccine, immunity is provided against the beta- and epsilon toxins produced by Clostridium perfringens type B. This is due to the combination of C. perfringens type C (beta toxin) and type D (epsilon toxin) fractions.

STORAGE INSTRUCTIONS

• Store between 2 °C and 8 °C in a refrigerator.
• Protect from light. 
• Do not freeze.

WARNINGS

• Withdrawal period: DO NOT SLAUGHTER ANIMALS FOR HUMAN CONSUMPTION WITHIN 21 DAYS OF LAST ADMINISTRATION.
• Vaccinate only healthy cattle and sheep over 2 months of age.
• Concurrent use of other vaccines is not recommended.
• Covexin® 8 + Botulism is not a substitute for the supplementary feeding of phosphorus.
• Do not mix Covexin® 8 + Botulism with other veterinary medicinal products.
• As with any vaccine, occasional hypersensitivity reactions may occur. In such cases, appropriate treatment such as adrenaline and/or antihistamines should be administered without delay. Consult a veterinarian.
• As with any vaccine, absolute immunity cannot be guaranteed in all animals. It is, therefore, advisable to consult a veterinarian regarding additional control measures instead of relying on the vaccine alone.
• Usually, no marked reaction follows vaccination although a transient swelling may appear at the vaccination site, and some animals may show a moderate rise of temperature for 1 or 2 days.
• Partially used containers and vaccination equipment should be disposed of according to local waste disposal regulations at the end of each day’s operation, since under field conditions it may be difficult to avoid accidental contamination of the vaccine.
• 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.

PRECAUTIONS

• Only sterile needles and properly sterilised vaccinators should be used. In order to maintain proper hygiene, it is advisable to change to clean sterile needles as frequently as possible.
• In case of long fleece, it is necessary to make sure that the needle has penetrated the skin before injecting the product.
• Vaccination of stressed animals should be avoided.      
• Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
• Do not use disinfectants or antiseptics to sterilise any equipment.
• It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
• Do not eat, drink or smoke whilst handling the product.
• Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
• Do not contaminate rivers, dams or any water sources with containers or waste.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

SHAKE WELL BEFORE AND DURING USE.

Method of administration: Subcutaneous injection.

Dose

Cattle and calves over 2 months of age

Primary vaccination: Two subcutaneous injections of 5 mℓ each, with an interval of 4 weeks.

Revaccinate with a single dose.

Sheep and lambs over 2 months of age

Primary vaccination: Two subcutaneous injections of 3 mℓ each, with an interval of 4 weeks.

Revaccinate with a single dose.

Administration

• Subcutaneous injection in loose skin, preferably on the side of the neck.
• After primary vaccination course, animals must receive booster injections at intervals of not more than 12 months.
• In high-risk areas where animals are likely to be exposed to exceptionally severe infection or high concentrations of botulism toxins in food, water or environment, vaccination every 4 to 6 months is necessary, especially for young animals with little or no previous vaccination history.
• The vaccine course should be completed at least 2 weeks before maximum immunity is required i.e., a period of risk or pregnancy.
• Previously sensitised cows/ewes should be injected at least 2 weeks prior to calving/lambing as this will provide passive protection for several weeks via the colostrum.
• When animals under 3 months of age have been vaccinated, it may be advisable to revaccinate at 4 to 6 months of age, especially in high-risk conditions/areas. Vaccinate annually thereafter. Consult a veterinarian.

PRESENTATION

100 mℓ

REGISTRATION HOLDER                                                                     

Cooper Veterinary Products (Pty) Ltd.                                          

20 Spartan Road                                                                         

Spartan, 1619, RSA                                                                                    

Tel: +27 (0) 11 923 9300                                                                          

E-mail: msdahza@msd.com

www.msd-animal-health.co.za                          

MARKETED BY

MSD Animal Health

20 Spartan Road

Spartan, 1619

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

11 March 2021