Bovilis® Vista 5 LS SQ

BOVILIS®Vista 5 LS SQ


Reg. No. GXXXX (Act 36/1947)

A modified live virus vaccine and inactivated bacteria for the active immunisation of
healthy cows and heifers from the age of 6 months.

INDICATIONS
The combined product is for the vaccination of healthy cows and heifers, 6 months of
age or older, prior to breeding as an aid in the reduction of abortion due to IBR; as an aid
in the prevention of fetal infection, including persistently infected calves caused by BVD
Types 1 & 2. 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 & 2).

In addition, the vaccine can be used as an aid in the prevention of disease caused by
IBR, BVD (Type 2) and BRSV; and as an aid in the control of disease caused by BVD
(Type 1) and P’3; and as an aid in preventing leptospirosis caused by Leptospira
canicola
, L. grippotyphosa, L. hardjo (including the L. borgpetersenii serovar hardjo
bovis
), L. icterohaemorrhagiae, and L. pomona, and as an aid in the prevention of
urinary shedding of L. hardjo organisms.


Respiratory duration of immunity (DOI) has been demonstrated to be at least 182 days
for IBR, and at least 206 days for BVD Type 1 and at least 200 days for BVD Type 2.


STORAGE
• Store in the dark between 2 °C and 7 °C. Do not freeze.
• Avoid prolonged or repetitive exposure to high ambient temperatures following
withdrawal from the refrigerator.
• Protect from direct sunlight.
• Use within 2 hours after reconstitution.


COMPOSITION

Active IngredientQuantity per 2mℓ dose
IBR (Infectious bovine rhinotracheitis)>103,6 TCID50/dose
BVD Type1 (Bovine virus diarrhoea)>103,8 TCID50/dose
BVD Type2 (Bovine virus diarrhoea)>103,5 TCID50/dose
PI3 (Parainfluenza 3 virus)>105,1 TCID50/dose
BRSV (Bovine respiratory syncytial virus)>103,8TCID50/dose
Leptospira canicola>Operative min. RP value#
Leptospira grippotyphosa>Operative min. RP value#
Leptospira hardjo>Operative min. RP value#
Leptospira icterohaemorrhagiae>Operative min. RP value#
Leptospira pomona>Operative min. RP value#
• Displaying at least the operative minimum RP value (Relative Potency (RP) = value of test serial compared to an established reference),
using current operative master reference,


The product contains EMA/DDA as adjuvant and Thimerosal as preservative.
The product may contain traces of penicillin/streptomycin.

WARNINGS
• Withdrawal period: 21 days
• For subcutaneous injection only.
• Use immediately after reconstitution, do not save partial contents.
• Slight transient reactions at the site of injection may occur.
• If an anaphylactic reaction occurs, treat with epinephrine.
• KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS.
• Do NOT mix with any other vaccine, immunological product or other medication.
No information is available on the compatibility of this vaccine with any other vaccine.
Therefore the safety and efficacy of this product when used with any other product
(either when used on the same day or at different times) has not been demonstrated.
• 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 healthy cattle should be vaccinated.
• Foetal health risks associated with vaccination of pregnant animals with modified live
vaccines cannot be unequivocally determined by clinical trials conducted for
registration.
Management strategies based on vaccination of pregnant animals with modified live
vaccines should be discussed with a veterinarian.
• Observe aseptic precautions. Ensure that the vaccination equipment (needles,
syringes, etc.) are clean and sterile prior to use.
• 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 the package leaflet or the label to the physician.
• Shake well before use.
• It is good vaccination practice when handling the vaccine to avoid contact with the
eyes, hands and clothing.
• Dispose of all unused vaccine, containers and disposable equipment in accordance
with national waste disposal regulations.


USE DURING PREGNANCY AND LACTATION
May be used 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.
Management strategies based on vaccination of pregnant animals with modified live
vaccines should be discussed with a veterinarian.


DIRECTIONS FOR USE
USE ONLY AS DIRECTED
• Aseptically reconstitute the freeze-dried vaccine with the diluent.
• Once reconstituted, the vaccine contains modified live cultures.
• Shake well before use.

• This vaccine is administered subcutaneously.
Mixing Directions:
Rehydrate freeze-dried vial of Bovilis Vista 5 SQ with part of the accompanying vial of
Bovilis Vista L5 SQ, using the transfer needle provided. Mix reconstituted vial well and
transfer rehydrated vaccine into L5 SQ vial using transfer needle. Remove transfer
needle from former L5 SQ vial and mix reconstituted vial well. Peel label from bottle of
Vista 5 SQ and place on L5 SQ vial containing all vaccine.
Use entire contents of vial with reconstituted vaccine. Do not store for future use.


CAUTION: THE TRANSFER NEEDLE, INCLUDED IN THE CARTON PACKAGING, IS
SHARP ANO MAY CAUSE INJURY TO SELF OR ANIMALS IF NOT HANDLED
PROPERLY OR DISPOSED OF PROPERLY.

  1. Insert needle beyond breather valve into the vial of lyophilized vaccine to remove
    vacuum.
  2. Turn the vial of lyophilized vaccine upside down and fully insert needle into the
    bacterin diluent bottle. Be sure to clear cap with breather valve.
  3. Turn attached vial and bottle so the vial of lyophized vaccine is underneath the
    bacterin diluent bottle and squeeze enough bacterin diluent into the vial of
    lyophized vaccine to rehydrate the vaccine. Mix well.
  4. Turn attached bottles so rehydrated vaccine is above bacterin diluent bottle.
    Squeeze air into rehydrated vaccine vial.
  5. Squeeze and release sterile diluent or bacterin diluent bottle until all the solution
    in the rehydrated vaccine vial drains into the bacterin diluent bottle.
  6. Separate the vial of lyophilized vaccine and needle from the bacterin diluent
    bottle. Using the tab, remove the back of the vaccine vial label. Place the
    separated label over the bacterin diluent bottle label to accurately identify the
    newly created solution.

Dosage and Administration
Inject 2 mℓ subcutaneously 14-60 days prior to breeding to healthy cattle 6 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 any time epidemic conditions exist or are
reported.
Consult your veterinarian.


PRESENTATION
The freeze-dried viral vaccine is presented in glass vials with rubber stoppers, containing
5, 10, 50 or 100 doses.

The liquid bacterin diluent is presented in glass or plastic vials with rubber stoppers,
containing 10, 20, 100 or 200 mℓ, corresponding to 5, 10, 50 or 100 doses.
One vial of each is packed together in a carton box.


REGISTRATION HOLDER
lntervet South Africa (Pty) Ltd.
20 Spartan Road
Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www. msd-animal-health. co.za


Date of publication of package insert: TBA