Poulvac Marek CVI+HVT

Marek’s Disease Vaccine

Serotypes 1 & 3, Live Virus

Rispens strain•HVT

Frozen

For veterinary use only

Read in full, follow directions carefully.

This product has been shown to be effective for the vaccination of healthy 1-day-old chicks or 18- to 19-day-old embryonated chicken eggs against very virulent Marek’s disease. Duration of immunity has not been established. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

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

Use entire contents when first opened.

Inactivate unused contents before disposal.

Do not vaccinate within 21 days before slaughter.

Contains gentamicin as preservative.

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

In case of human exposure, contact a physician.

Preparation of vaccine

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

● Always wear a face mask and insulated gloves when checking liquid nitrogen levels or handling vaccine from the liquid nitrogen container.

● Ampoules can explode due to a sudden change in temperature. Pull the cane out of the liquid nitrogen container only as far as needed to reach the first ampoule.

● Wash the thaw bath with soap and water, dry it and spray with alcohol daily.

● Fill the water bath with distilled water and keep the water temperature at 80°F (+/- 2°) or 27°C (+/- 1°).

● Add chlorine to the thaw bath water for a final concentration of 200 ppm (15 mL of 5% bleach or sodium hypochlorite per gallon of water; 4 mL per liter of water).

● Thaw the vaccine for 70-90 seconds. Thawing time begins when the ampoule is taken out of the liquid nitrogen.

● Thaw no more than 4 ampoules at a time. Total time from thawing to addition to the diluent should be no more than 150 seconds. Immediately after thawing and before opening ampoule, dry hands and ampoule with a clean paper towel. Use a new paper towel for each thawing sequence (4 or fewer ampoules).

● Point the top of the ampoule away from the face and body and carefully break the ampoule at the neck.

● Do not spill the contents of the ampoule. Wipe the diluent bag port with alcohol and allow the surface to dry for 5 seconds.

● For subcutaneous route of vaccination, use 400 mL diluent per 2,000 doses of vaccine; use 800 mL diluent per 4,000 doses.

● For in ovo route of vaccination, use 100 mL diluent per 1,000 doses of vaccine; use 200 mL diluent per 2,000 doses.

● Using a sterile 20 mL syringe with an 18G x 1.5-inch long needle, draw 5 mL of diluent.

● Slowly (3 seconds) draw the entire content of the ampoule into the syringe. Note: The vaccine is cell associated. Fast drawing or injecting the vaccine could cause cell damage and reduce the potency of the vaccine.

● Using an ampoule holder is recommended. The ampoule holder improves safety by decreasing the risk of self-injection, provides a more stable platform to draw the vaccine and prevents heat transfer from the hand to the ampoule.

● Slowly (3 seconds) add the contents of the syringe to the bag of diluent.

● Draw a small amount of diluent, rinse the ampoule once and add to the vaccine diluent mixture. Note: Do not touch the outside of the ampoule or other unclean surfaces with the needle. If this occurs, it is better to discard the rinse than to potentially contaminate the bag of ready to use vaccine.

● Write the time the vaccine was added on each bag with a dark-colored marker. Mix the contents of the bag thoroughly by gently massaging and inverting the bag about 10 times.

● Do not shake vigorously and avoid creating bubbles. After mixing, chill the vaccine using clean, plastic-covered ice packs.

● Transport the vaccine to the vaccination device in a small cooler.

● Dry the outside of the bag thoroughly with a new and clean paper towel before hanging.

● Use aseptic technique to attach the bag to the vaccination device.

● For Embrex^® Inovoject^®, place the vaccine bag in the Intertherm bag with icepacks to provide on-going chilling during use.

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. 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.

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

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

3. 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.

4. 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 (2.5 cm) deep into the egg.

5. Inject each egg in ovo with 0.1 mL of the vaccine solution.

6. 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 refrigerator 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.

Before using this vaccine, be certain to read directions.

Disclaimer

Having cautioned the user concerning the handling of liquid nitrogen and the possibility of explosion of glass ampules as they are removed from the nitrogen 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.

Poulvac Marek CVI+HVT 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.

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

This product is nonreturnable.

VLN 190/PCN 16G1.02

Zoetis Inc., Kalamazoo, MI 49007, USA

40039123

Presentation: 5 x 1,000 doses and 5 x 2,000 doses.

CPN: 3690311.3