Ultifend IBD ND + Rispens (Canada)

Company: Ceva Animal Health

BURSAL DISEASE - MAREK’S DISEASE - NEWCASTLE DISEASE VACCINE, Serotypes 1 & 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 + Rispens 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 1 (Rispens) Marek’s disease vaccine. The bivalent Marek’s disease vaccine containing serotypes 1 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 ampoules: Store in liquid nitrogen

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

Ultifend IBD ND + Rispens Indications

This product has been shown to be effective for the vaccination of healthy chickens 1 day of age or older against standard bursal disease, Newcastle disease and 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, 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 1,000 doses of vaccine

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 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 ampoules from liquid nitrogen and place into a clean 80°F (26.5°C) thaw bath. A maximum of 3 ampoules 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 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.

Notice

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

Ultifend IBD ND + Rispens 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.

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

14. Even though studies performed by the manufacturer indicate that the recombinant vaccine virus is non-pathogenic to turkeys, precautionary measures should be taken to reduce the potential for spread of the virus to turkey populations, and the product should not be administered to chickens with probable direct or indirect exposure to turkeys.

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

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

Tel: (913) 894-0230

VLN 368/PCN 1A91.R1

PX378XXUS-102

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

CPN: 1221163.0