Product Details - UNIVAX-BD

Reg. No. G 3674  Act/Wet 36/1947

Indication:
For use as an aid in the prevention of infectious bursal disease (Gumboro) in fowls.

Storage:
STORE BETWEEN 2°C AND 7°C IN REFRIGERATOR.

DO NOT FREEZE.
PROTECT FROM LIGHT.

Composition:

Contains a mild strain (ST-12) of live infectious bursal disease (Gumboro) virus with gentamicin as preservative.

Warnings:

Do not slaughter fowls for human consumption within 21 days after vaccination.

Vaccinate healthy fowls only.

Use only healthy embryonated eggs for the in ovo route.

Keep out of reach of children, uninformed persons and animals.

Do not spill or spatter the vaccine.

Burn empty bottles, caps and all unused vaccine and accessories.

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:

Use entire contents of vial when first opened.

Wash hands thoroughly after using the vaccine.

Do not dilute the vaccine or otherwise stretch the dosage.

It is good vaccination practice to avoid contact with the eyes, hands and clothes when handling/administering the vaccine.

DIRECTIONS FOR USE  - USE ONLY AS DIRECTED

When to vaccinate

Vaccinate 18 - 19 day old embryonated fowl eggs by the in ovo route using Embrex Inovoject® Egg Injection System or subcutaneously at 1 day of age and/or by drinking water at  1 week or older. Good management practices should be followed to reduce exposure of fowls to virulent infectious bursal disease virus during the first few weeks of life.

Preparation of the vaccine

In ovo and subcutaneous routes of administration.

Do not open and mix the vaccine until ready for use.

Open only one vial at a time and use entire contents within 2 hours.

Lift up top of seal on vaccine vial to expose rubber stopper. Using sterile needle and 5 mℓ  or 10 mℓ syringe, remove a small amount (5 mℓ) of diluent from the diluent bottle and transfer this to the vaccine vial. Vacuum in the vaccine vial will rapidly pull in the diluent. Release the vacuum remaining in the vial.

Vigorously shake vaccine vial with transferred diluent to rehydrate the vaccine.

Using the same sterile needle and syringe, completely transfer the rehydrated vaccine to remaining diluent in diluent bottle. Rinse syringe and vaccine vial by withdrawing additional diluent and repeating the process.

Vigorously shake final rehydrated vaccine for 20 – 30 seconds to mix thoroughly.

The vaccine is now ready for use.

Drinking water method.

Assemble the vaccine and equipment needed to vaccinate the entire flock at one time.

Do not open and mix the vaccine until ready for use.

Remove the tear-off aluminium seal from the vaccine vial without disturbing the rubber stopper.

Use cool, clean, non-chlorinated water to which 0,2 % (2 g/ℓ) skim milk powder has been added as directed under “How to vaccinate”.

Holding vial submerged in a bucket of water or under a running stream of water, lift the lip of the rubber stopper so that the water (skim milk powder added) is sucked into the vial.

Reseat the stopper and shake the vial to thoroughly dissolve the vaccine.

How to vaccinate

1. By in ovo route of administration:

Follow the Inovoject® operator’s manual before attempting any in ovo vaccination.

Sanitize the Inovoject® Egg Injection System according to the Embrex operator’s manual.

The Inovoject® Egg Injection System should be calibrated accurately to deliver 0,05 mℓ into each embryonated egg.

2. By subcutaneous route of administration:

Insert a filling tube (large, sharpened transfer tube) into the bottle of vaccine.

Connect the filling tube by means of rubber or plastic tubing to an automatic vaccinator fitted with a 22 gauge ½ inch needle.

The automatic vaccinator should be calibrated accurately ahead of time to deliver 0,2 mℓ.

3. By drinking water method:

Do not mix the vaccine into the drinking water until ready for use.

Drinking water for vaccination should be mixed with 0,2% (2 g/ℓ) skim milk powder to stabilize the vaccine virus.

Withhold water for 1 to 2 hours depending on the ambient temperature before vaccinating so fowls are thirsty.

Thoroughly clean and rinse all watering containers so that no residual disinfectants remain.

Dilute the vaccine immediately before use with cool, clean, non-chlorinated water (skim milk powder added).

Pour the dissolved vaccine material into the following amounts of water and mix thoroughly.

   Each 1 000 fowls:

Distribute diluted vaccine so that all fowls are able to drink within a 1 hour period and do not add any more water until the vaccine is consumed.

Avoid placing water in direct sunlight.

Use only as indicated.

Presentation:

Cartons containing 10 X 1 000, 10 X 5 000 and 10 X 20 000 dose vials.

Registration holder:

Schering-Plough Animal Health
Co. Reg. No. 1934/005207/07