Bovilis® Vista Once SQ

FOR ANIMAL USE ONLY                            

Bovilis ^® Vista Once SQ

Reg. No. G4061 (Act 36/1947)

Modified live cultures of bovine rhinotracheitis (IBR) virus, bovine virus diarrhoea (BVD) virus (type 1 and 2), parainfluenza virus 3 (PI₃) virus, bovine respiratory syncytial virus (BRSV) and avirulent live cultures of Mannheimia haemolytica type A1 and Pasteurella multocida type A.

INDICATIONS

For the vaccination of healthy cattle, 3 months of age and older, as an aid in the prevention of respiratory disease caused by infectious bovine rhinotracheitis (IBR) virus, bovine virus diarrhoea (BVD) virus type 1 and 2 and bovine respiratory syncytial virus (BRSV); and as an aid in the control of respiratory disease caused by bovine virus diarrhoea (BVD) virus, parainfluenza (PI₃) virus 3, Mannheimia haemolytica type A1 and Pasteurella multocida type A.

Additionally, Bovilis^® Vista Once SQ is for the vaccination of healthy cows and heifers prior to breeding as an aid in the prevention of foetal infection, including persistently infected calves, caused by BVD virus (types 1 and 2) and as an aid in the reduction of abortion due to IBR. 

IMMUNITY

Reproductive duration of immunity (DOI) has been demonstrated to be at least 217 days for IBR and at least 206 days for BVD (types 1 and 2).                   

Duration of immunity:       At least 365 days for IBR

                                                     At least 365 days for BVD (type 1)

                                                     At least 365 days for BVD (type 2)

COMPOSITION

Active ingredients	Quantity per 2 mℓ dose
Infectious bovine rhinotracheitis virus (IBR)	≥10 3,6 TCID50
Bovine virus diarrhoea virus type 1 (BVD1)	≥10 3,6 TCID50
Bovine virus diarrhoea virus type 2 (BVD2)	≥10 3,4 TCID50
Parainfluenza virus 3 (PI3)	≥10 5,1 TCID50
Bovine respiratory syncytial virus (BRSV)	≥10 3,8 TCID50
Mannheimia (Pasteurella) haemolytica type A1	≥ 6 x 105 CFU
Pasteurella multocida type A	≥ 6 x 105 CFU

Bovilis ^® Vista Once SQ may contain residual streptomycin from the bacterial culture media (necessary growth factor) and residual penicillin/streptomycin from the cell culture media (preservative during virus propagation).

STORAGE INSTRUCTIONS

• Store between 2 °C and 7 °C.
• Do not freeze.

WARNINGS

• Withdrawal period: Do not slaughter animals for human consumption within 21 days after vaccination.
• Use immediately after reconstitution, do not save unused contents.
• 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 mix Bovilis ^® Vista Once SQ with other veterinary medicinal products.
• 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

Special precautions for use in animals

• Vaccinate healthy cattle only.
• Foetal health risks associated with vaccination of pregnant animals with modified, live vaccines cannot unequivocally be determined by clinical trials conducted for licensure.  Management strategies based on vaccination of pregnant animals with modified live vaccines should be discussed with a veterinarian.

Special precautions to be taken by the person administering the vaccine to

animals

• The transfer needle is sharp and may cause injury to self or animals if not handled properly or disposed of properly.
• In case of accidental self-injection, seek medical advice immediately and show this package insert to the physician.

USE DURING PREGNANCY AND LACTATION

Safe for use in pregnant heifers and cows, or calves nursing pregnant cows, provided the cows and heifers in the herd are vaccinated prior to breeding, within the previous 12 months, with any of the modified live IBR and BVD containing vaccine(s) in this product line.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Dosage

• Inject 2 mℓ of vaccine subcutaneously to healthy cattle 3 months of age or older.
• Annual revaccination is recommended.
• A revaccination dose can be administered at more frequent intervals based upon individual farm disease risk assessment or anytime epidemic conditions exist or are reported. Consult your veterinarian.
• Calves nursing immune dams should be vaccinated from the age of 3 months when maternal antibody levels will allow active immunisation.

Mixing directions
5 and 10 dose presentation:

• Rehydrate the freeze dried vaccine vial of Bovilis^® Vista Once SQ with the enclosed diluent.
• Mix reconstituted vial well.

50 and 100 dose presentation:

• Rehydrate the  freeze dried vaccine vial of Bovilis^® Vista Once SQ with part of the enclosed diluent using the transfer needle provided (see insert for pictorial directions).
• Mix reconstituted vial well and transfer rehydrated vaccine into diluent vial and mix reconstituted vial well.
• Peel label from the vaccine vial of Bovilis^® Vista Once SQ and place on the diluent vial, that now contains all the vaccine.

ADVERSE REACTIONS

• If anaphylactic reaction occurs, treat with epinephrine.
• Slight transient reactions at the site of injection may occur.
• Consult your veterinarian.

PRESENTATION

The vaccine is presented in glass vials with rubber stoppers that contains 5, 10, 50 or 100 doses.

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

Not all pack sizes may 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 THIS INSERT

25 April 2016