BOVILIS® VISTA ONCE PMH SQ

COMPOSITION

Active Ingredients	Quantity per 2 mℓ dose
Mannheimia haemolytica	≥ 6 x 105 CFU
Pasteurella multocida	≥ 6 x 105 CFU

Bovilis^® Vista Once PMH SQ is a freeze-dried live vaccine  which contains no adjuvant or preservatives. Residual Streptomycin remaining after growth and deterioration is included at ≤ 400 µg/dose as a necessary growth factor.

STORAGE INSTRUCTIONS

• Store between 2 °C – 8 °C in a refrigerator.
• Do not freeze.
• Use immediately after reconstitution.

WARNINGS

• Withdrawal period: Do not slaughter cattle for human consumption within 21 days after vaccination.
• Vaccinate healthy cattle only.
• In case of accidental self-injection seek medical advice immediately and show the package insert to the physician.
• Do not mix with any other vaccine or immunological product.  
• Slight transient reactions at the site of injection may occur.
• If an anaphylactic reaction occurs, treat with epinephrine.
• Do not over- or under-dose the vaccine.
• Do not inject intravenously.
• 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

• 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.
• 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 Bovilis^® Vista Once PMH SQ.
• Use entire contents when container is first opened and do not store partially used containers for future use.

• Destroy any unused vaccine and dispose of all the 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.

PREGNANCY

A single dose of Bovilis^® Vista Once PMH SQ may be used in the last trimester of pregnancy without any negative influence on progeny.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

• Shake well before use.
• For subcutaneous injection only.
• Aseptically reconstitute the freeze-dried vaccine with the enclosed diluent.

Dosage and Administration

Bovilis^® Vista Once PMH SQ is administered by subcutaneous injection of 2 mℓ into healthy cattle, 3 months of age or older.  Annual revaccination is recommended.

PRESENTATION

The vaccine is presented in a sterile Type I glass vial containing 5, 10, 50 or 100 doses.

The diluent is presented in glass or plastic vials or bags, containing 10, 20, 100 or 200 mℓ.

Not all pack sizes may necessarily be marketed.

REGISTRATION HOLDER                                            

Intervet South Africa (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

DATE OF PUBLICATION OF PACKAGE INSERT

24 January 2008