Cevac IBron FZN

Company: Ceva Biomune

BRONCHITIS VACCINE, Georgia Type, Live Virus

See productdata.aphis.gov for a summary of the studies approved by USDA for licensing this product. The package insert may also contain additional information developed by the licensee.

STORAGE CONDITIONS

● Vaccine containers: Store in liquid nitrogen

Cevac IBron FZN Indications

This product has been shown to be effective for the vaccination of healthy chickens at one day of age or older against bronchitis caused by IBV GA08 and IBV GA13 via the coarse spray route and IV GA08 and IBV DMV/1639/11 via gel droplet by oral administration. For more information regarding efficacy and safety data see productdata.aphis.usda.gov.

PRECAUTIONS

1. Do not over dose or under dose.

2. Vaccinate only healthy birds.

3. Be sure vaccination equipment is clean and ready for vaccination. Avoid residual chemical disinfectants (bleach, quaternary ammonia, etc) to come in contact with vaccine by thoroughly rinsing the equipment.

4. Do not open and mix vaccine until ready to vaccinate.

5. Be sure the machine is calibrated to deliver the require volume of vaccine per chicken by spraying into a volumetric cylinder.

VACCINE PREPARATION

1. Be familiar with all safety and precautionary measures for handling liquid nitrogen to prevent personal injury.

2. Wear gloves, a plastic face shield and protective goggles before removing vaccine ampules from the liquid nitrogen.

3. Check the container to confirm a sufficient amount of liquid nitrogen is present to keep the vaccine frozen. If thawed, do not use the vaccine. The containers (Dewars) must be checked regularly for liquid nitrogen level and must be refilled as needed.

4. After inspecting the diluent and completing all preparations, match the dose size of the vaccine with the diluent amount.

5. The vaccine should be quickly removed from the Dewar and placed into a clean 80°F (26.5°C) thaw bath. This step can be repeated until the appropriate dosage has been reached. Gentle agitation during the thawing process promotes rapid, uniform thawing and evenly distributes the vaccine in the ampoule.

6. Immediately after thawing, confirm the vaccine is removed from the ampoule neck and carefully open the ampoule.

7. Gently draw the vaccine from the ampoule with an 18-gauge, 1.5 inch needle and slowly mix with the diluent. Rinse the ampoule one time with the diluted vaccine.

Directions For Use

Carefully read the directions before use. The instructions must be completely followed.

Match the vaccine dose size to the proper distilled water dilution for administration.

For 10,000 doses of Cevac^® IBron by coarse spray

1. Transfer contents of the Cevac^® IBron ampoule into 1000mL distilled water at room temperature (68-77°F or 20-25°C).

2. Vaccinate at one day of age or older at a ratio of 10mL for every 100 birds, through a coarse spray machine or device.

3. Use vaccine within 90 minutes of preparation.

For 10,000 doses of Cevac^® IBron by gel droplet

1. For 10,000 doses add 70g of Cevagel^® to 2.5L of distilled water. Mix well with a blender. No further agitation is required for use on the same day.

2. Mix the vaccine vial well prior to opening.

3. Pour half of the gel Into a clean container, add the vaccine, then add the remaining gel to a final volume of 2.5L for 10,000 doses. Mix with a blender.

4. Vaccinate at one day of age or older with a ratio of 25mL for every 100 birds using a gel administration machine.

5. Use vaccine within 90 minutes of preparation.

Notice

This vaccine has been thoroughly tested for safety, purity and potency and is in compliance with all applicable USDA and Biomune Company standards.

WARNING

1. Do not vaccinate within 21 days before slaughter.

2. The vaccine contains gentamicin and amphotericin B as preservatives.

3. Inactivate unused contents before disposal.

4. Keep vaccine in liquid nitrogen until ready for use

5. Do not open and mix vaccine until ready vaccinate. Use entire contents when first opened.

6. Do not overdose or over dilute the vaccine.

7. Do not mix with other products, except as specified on the label.

8. In case of human exposure, contact a physician.

9. For use in animals only.

Cevac IBron FZN Caution

Federal regulations prohibit repackaging or sale of the contents of this package in fractional units. Do not accept if seal is broken. This vaccine is not returnable to the manufacturer.

Active Ingredients

Cevac^® IBron: Infectious Bronchitis Virus, Georgia Type

Patent Number US 8,679,504

BIOMUNE CO., Lenexa, Kansas 66215, U.S.A.

Phone: (913) 894-0230

VLN: 368

PCN: 1231.1J

PX580XXUS-02

Presentation: 1,000 doses, 5,000 doses, and 10,000 doses.

CPN: 1129082.1