Ultifend IBD ND + SB1

Company: Ceva Biomune

BURSAL DISEASE-MAREK’S DISEASE-NEWCASTLE 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

ULTIFEND™ IBD ND + SB1 contains a genetically engineered Marek’s disease vaccine of serotype 3 (turkey herpesvirus or HVT) expressing infectious bursal disease and Newcastle disease key protective antigens and a serotype 2 (SB-1) Marek’s disease vaccine. The bivalent Marek’s disease vaccine containing serotypes 2 and 3 is presented in a frozen cell associated form. 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 ampules: Store in liquid nitrogen

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

Ultifend IBD ND + SB1 Indications

This product has been shown to be effective for the vaccination of healthy embryonated chicken eggs 18 to 19 days of age and healthy chickens 1 day of age or older against standard bursal disease, Newcastle disease and very virulent Marek’s disease. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Chickens may be vaccinated at 18 to 19 days embryonation via the in ovo route or 1 day of age or older via the subcutaneous route.

Good management practices are recommended to reduce exposure to bursal disease virus, Newcastle 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. Match the vaccine dose size to the proper diluent size and route of administration as follows:

1. For subcutaneous injection of day-old chicks

Mix 200 ml of diluent for each 1000 doses of vaccine

2. For in ovo vaccination of 18 to 19 day-old chicken embryos

Mix 100 ml of diluent for each 1000 doses of vaccine to administer 0.1 ml per chicken embryo or mix 50 ml for each 1000 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 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 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 size.

5. Quickly remove the vaccine ampules from liquid nitrogen and place into a clean 80°F (26.5°C) thaw bath. A maximum of 3 ampules should be thawed at one time. This step can be repeated until the appropriate dosage has been reached. Gentle agitation during the thawing process promotes rapid, even thawing and evenly distributes the vaccine in the ampule.

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 ampule with an 18-gauge, 1.5 inch needle and slowly mix with the diluent. Rinse the ampule 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 embryonating 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. The recommended dose is 0.05 ml or 0.1 ml per embryo for in ovo vaccination.

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 Biomune Co. standards.

Ultifend IBD ND + SB1 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. Use entire contents when first opened.

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

9. Do not overdose or over dilute the vaccine.

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

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

12. For use in animals only.

Ultifend™ trademark is the property of Ceva Santé Animale S.A.

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

Phone: (913) 894-0230

VLN 368

PCN 1A91.R0

PX377XXUS

Presentation: 1,000 doses, 2,000 doses, and 4,000 doses.

CPN: 1129087.0