Bovilis® Vista 5 L5 SQ

FOR ANIMAL USE ONLY

BOVILIS® VISTA 5 L5 SQ

Reg. No. G4336 (Act 36/1947)

A modified live virus vaccine and inactivated bacterin 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 foetal infection, including persistently infected calves caused by BVD Types 1 and 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 and 2).

In addition, the vaccine can be used as an aid in the:

  • Prevention of disease caused by IBR, BVD (Type 2) and BRSV,
  • Control of disease caused by BVD (Type 1) and PI3,
  • Preventing leptospirosis caused by Leptospira canicola, L. grippotyphosa, L. hardjo (including the L. borgpetersenii serovar hardjo bovis), L. icterohaemorrhagiae, and L. pomona,
  • Prevention of urinary shedding of L. hardjo organisms.

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

COMPOSITION

Active IngredientQuantity per 2 mℓ dose
IBR (Infectious bovine rhinotracheitis)≥ 103,6 TCID50/dose
BVD Type 1 (Bovine virus diarrhoea)≥ 103,8 TCID50/dose
BVD Type 2 (Bovine virus diarrhoea)≥ 103,5 TCID50/dose
PI3 (Parainfluenza 3 virus)≥ 105,1 TCID50/dose
BRSV (Bovine respiratory syncytial virus)≥ 103,8 TCID50/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.

Bovilis® Vista 5 L5 SQ contains EMA/DDA as an adjuvant and thimerosal as preservative.

Bovilis® Vista 5 L5 SQ may contain traces of penicillin/streptomycin.

STORAGE INSTRUCTIONS

  • 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.

WARNINGS

  • Withdrawal period: 21 days.
  • For subcutaneous injection only.
  • Slight transient reactions at the injection site may occur.
  • If an anaphylactic reaction occurs, treat with epinephrine.
  • Do NOT mix Bovilis® Vista 5 L5 SQ with any other vaccine, immunological product or other medication.
  • No information is available on the compatibility of Bovilis® Vista 5 L5 SQ with any other vaccine. Therefore, the safety and efficacy of Bovilis® Vista 5 L5 SQ when used with any other product (either when used on the same day or at different times) has not been demonstrated.
  • Use immediately after reconstitution, do not save partially used contents.
  • 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 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 label to the physician.
  • 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

Shake well before use.

  • Aseptically reconstitute the freeze-dried vaccine with the diluent.
  • Once reconstituted, the vaccine contains modified live cultures.
    • Bovilis® Vista 5 L5 SQ must be administered subcutaneously.

Mixing Directions

5 and 10 dose presentation:

Rehydrate freeze-dried vial of Bovilis® Vista 5 L5 SQ with the enclosed diluent. Mix reconstituted vial well.

50 and 100 dose presentation:

Rehydrate freeze-dried vial of Bovilis® Vista 5 SQ with part of the accompanying vials of Bovilis® Vista L5 SQ, using the transfer needle provided. Mix reconstituted vial well and transfer rehydrated vaccine into Bovilis® Vista L5 SQ vial using transfer needle. Remove transfer needle from former Bovilis® Vista L5 SQ vial and mix reconstituted vial well. Peel label from bottle of Bovilis® 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 AND 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 lyophilised vaccine to remove vacuum.
  2. Turn the vial of lyophilised 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 lyophilised vaccine is at the bottom and squeeze enough bacterin diluent into the vial of lyophilised vaccine to rehydrate the vaccine. Mix well.
  4. Turn attached bottles so rehydrated vaccine is on top. 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 lyophilised 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 healthy cattle, 6 months of age or older, with 2 mℓ subcutaneously 14 to 60 days prior to breeding.
  • 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                                      

Intervet South Africa (Pty) Ltd.                           

20 Spartan Road                                                        

Spartan                                                                          

1619, RSA

Tel: +27 (0) 11 923 9300

E-mail: msdahza@merck.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF PACKAGE INSERT

23 August 2022