Vectormune HVT IBD & SB-1

Company: Ceva Animal Health

BURSAL DISEASE-MAREK’S DISEASE VACCINE, Serotypes 2 & 3, Live Virus, Live Marek’s Disease Vector

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

Directions For Use

Description

VECTORMUNE^® HVT IBD & SB-1 contains a genetically engineered Marek’s disease vaccine of serotype 3 (turkey herpesvirus or HVT) expressing infectious bursal disease key protective antigens and a serotype 2 (SB-1) Marek’s disease virus. This bivalent Marek’s disease vaccine containing serotypes 2 and 3 is presented in a frozen cell associated form in 2 ampoules. One ampoule contains the HVT IBD fraction and one ampoule contains the SB-1 fraction. The cells and virus particles are very fragile and require careful handling to prevent damage or loss of titer in order to achieve optimum efficacy. The vaccine is stored and shipped in frozen form in liquid nitrogen.

STORAGE CONDITIONS

● Vaccine ampoules: Store in liquid nitrogen

● Diluent: Store at room temperature between 68-77°F (20-25°C)

Vectormune HVT IBD & SB-1 Indications

This product has been shown to be effective for the vaccination of healthy 18 to 19-day-old embryonated eggs and healthy one day old chicks against bursal disease, due to Standard and Variant E viruses, and Marek’s Disease caused by very virulent Marek’s Disease. The duration of immunity is unknown. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Good management practices are recommended to reduce exposure to bursal disease virus and Marek’s disease virus for at least two weeks following vaccination.

Preparation And Administration Of Vaccine

Carefully read the directions before use. The instructions must be completely followed. Prior to use, the vaccine must be thawed and diluted appropriately. One ampule of HVT IBD is mixed with one ampule of SB-1 at a 1:1 ratio in the diluent.

1. For subcutaneous injection of one-day-old chicks: Mix 200 mL of diluent for each 1,000 doses of vaccine. One-day-old chicks are subcutaneously vaccinated with 0.2 mL of vaccine in the back of the neck.

2. For in ovo vaccination of 18 to 19 day-old chicken embryos: Mix 100 mL of diluent for each 1,000 doses of vaccine to administer 0.1 mL per chicken embryo or mix 50 mL for each 1,000 doses of vaccine to administer 0.05 mL per chicken embryo.

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 ampoules 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 matching the dose size of the vaccine with the diluent size, quickly remove the exact number of ampoules needed.

5. A maximum of 3 ampoules should be thawed at one time. After inspecting the diluent and completing all preparations, the vaccine should be quickly removed from the dewar and placed into a clean 80ºF (26.5ºC) 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, mix the vaccine with the diluent at room temperature (68-77°F or 20-25°C). 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.

7. Immediately use the vaccine, and mix occasionally to ensure uniform suspension of cells.

SUBCUTANEOUS VACCINATION

1. For subcutaneous injection, sterilize the automatic syringe, needles, and other accessory equipment by autoclaving or boiling prior to vaccination.

2. Use a short (3/8 inch or 1/2 inch) 20-gauge needle for vaccination. Subcutaneously inject 0.2 mL into the back of the neck of each chick.

IN OVO VACCINATION

1. The vaccine is administered in ovo to 18 to 19 day-old embryonated eggs. Read the egg injection system operator’s manual before initiating vaccination. Failure to follow instructions may result in personal injury, excessive embryonic mortality, and low hatchability. Inoculate each embryo with one full dose (0.05 mL or 0.1 mL).

2. Sanitize the egg injection system before and after use following the procedures described in the operator’s manual.

Notice

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

Vectormune HVT IBD & SB-1 Caution

1. Read the above directions carefully.

2. Do not vaccinate within 21 days before slaughter.

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

4. Inactivate unused contents before disposal.

5. Do not remove vaccine from liquid nitrogen until ready for use.

6. Do not refreeze the vaccine.

7. Do not use vaccine that has thawed in the liquid nitrogen container.

8. Do not overdose or over dilute the vaccine

9. The effect of combining this vaccine with other products is not known and could impact vaccine efficacy.

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

11. Use entire contents when first opened.

12. For use in animals only.

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

Ceva Animal Health, LLC, Lenexa, KS 66215, U.S.A.

Phone: (913) 894-0230

VLN 368/PCN 1A88.R2

PX5100XXUS-101

Presentation: 2,000 dose and 4,000 dose ampoules delivered in liquid nitrogen dewars.

CPN: 1129057.3