Prime Pac PRRS+

Company: Intervet/Merck Animal Health

PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME VACCINE

Reproductive and Respiratory Form, Modified Live Virus

Directions For Use

PLEASE READ CAREFULLY

Description

Prime Pac™ PRRS+ is a live vaccine containing a modified porcine reproductive and respiratory syndrome (PRRS) virus which has been grown to high titer in an approved cell line, blended with stabilizing agents and lyophilized. At the time of use the lyophilized vaccine is rehydrated with the accompanying diluent.

The vaccine virus is derived from a field virus. The virus was attenuated by serial passage in cell culture but shown to remain immunogenic in vaccination and challenge studies. No evidence of reversion to virulence was detected in backpassage studies conducted in susceptible animals.

Prime Pac PRRS+ Indications

For the vaccination of healthy swine as an aid in the reduction of clinical signs of reproductive disease in female breeding age swine and respiratory disease in pigs 3-4 weeks of age and older due to PRRS virus.

Administration/dosage

Sows and Gilts: Inject a single 2 mL dose intramuscularly (IM) 3 to 6 weeks prior to each breeding. Piglets: Inject a single 1 mL dose (IM) at 3-4 weeks of age or older. The duration of immunity is at least four months.

PREPARATION OF THE VACCINE

1. Do not rehydrate the vaccine until ready for use.

2. Mix only one set of vials at a time and use entire contents promptly after rehydration.

3. Using a sterile transfer needle, transfer the entire contents of sterile diluent into the bottle of freeze dried vaccine and shake the combined vaccine and diluent to suspend evenly. The vaccine is now ready for use.

Prime Pac PRRS+ Caution

1. This vaccine is not intended for use in pregnant swine or for use in boars.

2. Vaccine virus can shed and spread to nonvaccinated contact animals and may result in seroconversion of the entire herd.

3. For animal use only. Do not vaccinate within 21 days before slaughter.

4. Store at 2°-7°C (35°-45°F). Protect the vaccine from excessive light and heat.

5. Use aseptic technique and only sterile needles and syringes to inject the vaccine. Syringes and needles may be sterilized by boiling for 15 to 20 minutes. Do NOT disinfect with chemicals since they destroy the PRRS vaccine virus. Do not transfer the vaccine to other containers.

6. Use entire contents when first opened. Burn containers and all unused contents.

7. Do not dilute the vaccine or otherwise attempt to stretch the dosage.

8. If allergic response occurs, administer epinephrine.

PRESERVATIVE: Gentamicin

WARNING: This product has caused immediate anaphylactic reactions in a significant number of animals in some herds.

Intervet Inc., Merck Animal Health, division of Intervet Inc., Omaha, Nebraska 68103 USA

U.S. Vet Lic. No. 165A

1 800 521-5767

For patent information:

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

142386-01

CPN: 1047513.1