Combovac-30 (Canada)

NEWCASTLE-BRONCHITIS VACCINE

B1 Type, LaSota Strain, Mass & Conn Types, Live Virus

DIRECTIONS FOR USE, READ CAREFULLY

Description

This live virus vaccine is prepared from the proven Clone 30 strain of Newcastle disease virus and the regular Massachusetts and Connecticut types of bronchitis virus. The viruses have been propagated using SPF embryonated eggs.

Merck Animal Health’s research team cloned several lentogenic ND virus strains from separate possible sub-populations within these strains. These clones were then extensively tested for immunogenicity and reactivity. One clone, designated ND Virus Clone 30, was selected and proven to be of the same order of reactivity as the classical Hitchner B1 but provided considerably better protection.

Combovac-30 Indications For Use

This product has been shown to be effective for the vaccination of healthy chickens 2 weeks of age or older against Newcastle disease and infectious bronchitis virus, Massachusetts and Connecticut types. Duration of immunity has not been established. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Vaccination Programs

Many factors must be considered in determining the proper vaccination program for a particular farm or poultry operation. To be fully effective, the vaccine must be administered to healthy receptive chickens held in a proper environment under good management. In addition, the response may be modified by the age of the chickens and their immune status. Seldom does one vaccination under field conditions produce complete protection for all individuals, in a given flock. The amount of protection required will vary with the type of operation and the degree of exposure that a flock is likely to encounter. For these reasons a program of periodic revaccination may be required.

Preparation Of Vaccine

FOR DRINKING WATER OR COARSE SPRAY USE

DO NOT OPEN AND MIX THE VACCINE UNTIL READY TO BEGIN VACCINATION. USE VACCINE IMMEDIATELY AFTER MIXING.

1. Remove the tear-off seal and stopper from the vial containing the lyophilized vaccine.

2. Carefully pour clean, cool, non-chlorinated water into the vaccine vial until the vial is approximately two-thirds full.

3. Insert the rubber stopper and shake vigorously until all material is dissolved.

4. The vaccine is now ready to be applied as per label in accordance with the directions below. For best results, be sure to follow directions carefully!

Drinking Water Administration

FOR CHICKENS TWO WEEKS OF AGE OR OLDER

1. Do not use any disinfectants in the drinking water for 48 hours before vaccinating and 24 hours after vaccination.

2. Withhold water from the chickens until they are thirsty.

3. Calculate the water volume needed so the vaccine will be consumed in approximately 2 hours.

4. Optional: as an aid in preserving the virus, add a vaccine stabilizer to the stock solution or to the tank containing clean, cool, non-chlorinated water. Agitate thoroughly. Follow the manufacturer’s rate of administrations and wait time.

5. Add rehydrated vaccine from vial to the water and mix thoroughly.

6. Turn on tank valve or automatic dosing system.

7. Provide as sole source of drinking water until all vaccine-water solution has been consumed.

Coarse Spray Vaccination

FOR CHICKENS TWO WEEKS OF AGE OR OLDER

Calculate the water volume needed. For example, a machine which dispenses 21 ml to a box of 100 chickens - total volume for 10,000 doses is 2,100 ml of non-chlorinated water. For coarse spray in chicken houses, follow manufacturer’s direction for the particular spray machine. Add rehydrated vaccine and mix thoroughly.

Combovac-30 Caution

1. VACCINATE ONLY HEALTHY CHICKENS.

2. All chickens should be vaccinated at the same time.

3. The revaccination of laying hens with live Newcastle/bronchitis vaccine may be detrimental to the flock.

4. Use entire contents when first opened.

5. Do not vaccinate within 21 days before slaughter.

6. Store at 2° to 8°C (35° to 46°F). Do not freeze.

7. Inactivate unused contents before disposal.

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

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

10. Contains gentamicin as a preservative.

11. WARNING: Newcastle virus occasionally causes conjunctivitis in humans. Avoid any contact of vaccine with eyes.

12. FOR ANIMAL USE ONLY.

Notice

This vaccine has undergone rigid potency, safety and purity tests, and meets Merck Animal Health, U.S. and local regulatory requirements. It is designed to stimulate effective immunity when used as directed, but the user must be advised that the response to the product depends upon many factors, including, but not limited to, conditions of storage and handling by the user, administration of the vaccine, health and responsiveness of the individual chickens and the degree of field exposure. Therefore, directions should be followed carefully.

Records

Keep a record of vaccine, quantity, serial number, expiration date, and place of purchase; the date and time of vaccination; the number, age, breed, and locations of chickens; names of operators performing the vaccination and any observed reactions.

FEDERAL REGULATIONS PROHIBIT THE REPACKAGING OR SALE OF THE CONTENTS OF THIS CARTON IN FRACTIONAL UNITS. DO NOT ACCEPT IF SEAL IS BROKEN.

Intervet Inc. d/b/a Merck Animal Health, Omaha, NE 68103 USA

VLN 165A/PCN 17B1.17

1 800 211-3573 (USA)

1 866 683-7838 (CAN)

For patent information:

http://www.merck.com/product/patent/home.html

381232-11

CPN: 1208260.3