Poulvac Procerta HVT-ND

Company: Zoetis

Marek’s Disease-Newcastle Disease Vaccine

Serotype 3, Live Marek’s Disease Vector

For Veterinary Use Only

Read in full, follow directions carefully.

This product has been shown to be effective for the vaccination of healthy one-day-old chickens and 18- to 19-day-old embryonated chicken eggs against Marek’s and Newcastle diseases. The duration of immunity against Newcastle disease is at least 63 days; duration of immunity against Marek’s disease has not been demonstrated. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

Warning

Do not vaccinate within 21 days before slaughter.

Use entire contents when first opened.

Inactivate unused contents before disposal.

Contains gentamicin as preservative.

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

In case of human exposure, contact a physician.

Directions for subcutaneous administration:

1. Vaccinate healthy one-day-old chicks only.

2. Avoid early exposure of chicks to Marek’s disease virus challenge.

3. Use Zoetis Inc. diluent only. Store diluent at not over 27°C (80°F).

4. Wear protective clothing when withdrawing vaccine from liquid-nitrogen tank; protect hands with gloves, wear long sleeves, and use a face mask or goggles.

5. Before opening liquid-nitrogen tank, prepare a clean, wide-mouthed container with a capacity of 1 to 5 gallons (3.8-19 liters). Half fill this container with water 27°C (80°F).

6. When withdrawing a cane of vials from the liquid-nitrogen tank, expose only the vial to be used immediately. When removing a vial from the cane, hold palm of gloved hand away from face and body. Dilute only 1 vial at a time. Immediately replace cane with remaining vials into the canister in the liquid-nitrogen tank.

7. Place the vial into prepared container half-filled with water 27°C (80°F). The frozen material thaws rapidly. When thawed, towel-dry vial.

8. The vials are pre-scored below the gold band. Before snapping off the top portion, wrap vial with a cloth, holding the top part away from face and body.

9. For subcutaneous route of vaccination, use 400 mL diluent per 2,000 doses of vaccine; use 800 mL diluent per 4,000 doses. Using a sterile mixing syringe with a 1 1/2-inch (3.8 cm) long, 18-gauge needle, draw up a small volume of diluent. Then draw the contents from the vaccine vial into the syringe and swirl gently. Insert needle into diluent container and slowly expel contents of syringe. Mix well by gently swirling the bottle. Withdraw a small amount of the reconstituted vaccine and use to rinse each vial injecting the rinses back into the reconstituted vaccine. The vaccine is ready for use.

10. While vaccinating, maintain the diluted vaccine at 21° to 27°C (70° to 80°F). If the temperature cannot be held as low as 27°C (80°F), place the diluent bottle containing the diluted vaccine in an ice bath.

11. For vaccination, an automatic syringe with 22- to 20-gauge needles, 3/8- to 1/2-inch (0.95 to 1.27 cm) long, is recommended. Make certain that all equipment is sterilized and change needles frequently.

12. Inject each chick subcutaneously with 0.2 mL of the vaccine.

13. After diluting, use the vaccine within 2 hours. Do not save any vaccine that has been diluted. Inactivate all unused contents before disposal. Dispose of all materials in a proper manner.

Directions for use with in-ovo vaccination equipment:

1. Vaccinate using the in ovo route of vaccination in 18- to 19-day-old healthy embryonated chicken eggs only.

2. Use Zoetis Inc. diluent only. Store diluent at not over 27°C (80°F).

3. Sanitize the in ovo vaccination equipment in accordance with the procedures described in the in ovo vaccination equipment operator’s manual.

4. Wear protective clothing when withdrawing vaccine from liquid-nitrogen tank; protect hands with gloves, wear long sleeves, and use a face mask or goggles.

5. Before opening liquid-nitrogen tank, prepare a clean, wide-mouthed container with a capacity of 1 to 5 gallons (3.8-19 liters). Half-fill this container with water at 27°C (80°F).

6. When withdrawing a cane of vials from the liquid-nitrogen tank, expose only the vials to be used immediately. When removing a vial from the cane, hold palm of gloved hand away from face and body. Dilute only 5 vials at a time.

7. Place the vials into a prepared container half-filled with water 27°C (80°F). The frozen material thaws rapidly. When thawed, towel-dry vial.

8. The vials are pre-scored below the gold band. Before snapping off the top portion, wrap the vial with a cloth, holding the top part away from face and body.

9. For in ovo route of vaccination, use 100 mL diluent per 2,000 doses of vaccine; use 200 mL diluent per 4,000 doses.

10. Using 5 sterile mixing syringes with a 1 1/2-inch (3.8 cm) 18-gauge needle, draw up a small amount of diluent into each syringe. Then draw the contents from one vaccine vial into the syringe and swirl gently. Insert needle into diluent container and slowly expel contents of syringe. Repeat the previous two steps with the other 4 syringes. Mix well by gently swirling the container. Withdraw a small amount of the reconstituted vaccine and use to rinse each vial injecting the rinses back into reconstituted vaccine. The vaccine is ready for use.

11. While vaccinating, maintain the diluted vaccine (in the diluent container) at 21° to 27°C (70° to 80°F). If the temperature cannot be held as low as 27°C (80°F), place the diluent container containing the diluted vaccine in an ice bath.

12. Carefully read and follow the in ovo vaccination equipment operator’s manual before initiating vaccination. Failure to follow instructions for in ovo vaccination equipment operation may result in personal injury and/or embryonic morbidity and mortality.

13. The in ovo vaccination equipment is equipped with an automatic injection system which utilizes a 20-gauge needle and deposits the vaccine about 1 inch deep into the egg.

14. Inject each egg in ovo with 0.05 mL of the vaccine solution.

15. After diluting, use the vaccine solution within 2 hours. Do not save any vaccine that has been diluted. Inactivate unused contents before disposal.

Warning

Take all precautionary measures, including the use of gloves and face shield or goggles, to avoid potential hazards of handling liquid nitrogen and the possibility of explosion of glass vials as they are taken from the liquid-nitrogen tank or canister or holding cane, or as they are placed in the thawing container. When removing the vial from the cane, hold palm of the gloved hand away from face and body.

Poulvac Procerta HVT-ND Caution

This product should be stored, transported, and administered in accordance with the instructions and directions.

The use of this vaccine is subject to state laws, wherever applicable.

Records:

Keep a record of vaccine serial number and expiration date; date of receipt and date of vaccination; where vaccination takes place; and any reactions observed.

Disclaimer

Having cautioned the user concerning the handling of liquid nitrogen and the possibility of explosion of glass vials as they are removed from the liquid nitrogen tank or holding cane, or when placed in the thawing container, and having no control over the safety measures taken other than cautioning against possible dangers, Zoetis Inc. shall not be responsible for personal injury and/or property damage resulting from said handling and/or the possibility of explosion.

Store in the vapor or liquid phase of liquid nitrogen. Dilute before using.

This product is nonreturnable.

Technical inquiries should be directed to Zoetis Inc. Technical Services, (888) 963-8471.

VLN 190/PCN 16N1.R0

Zoetis Inc., Kalamazoo, MI 49007, USA

5 x 2,000 doses

5 x 4,000 doses

40028309

CPN: 3690584.0