PORPHYROMONAS DENTICANIS-GULAE-SALIVOSA BACTERIN
Pfizer Animal Health
Notice: This product license is conditional. Efficacy and/or potency of this product has not been fully demonstrated consultation with a veterinarian is recommended.
For use in dogs only

PRODUCT DESCRIPTION:
Porphyromonas Denticanis-Gulae-Salivosa Bacterin is for vaccination of healthy dogs as an aid in preventing periodontitis as demonstrated by a reduction in bone changes (bone loss/sclerosis) associated with Porphyromonas denticanis P. gulae and P. salivosa. This vaccine is a liquid preparation of inactivated Porphyromonas bacterium.

DISEASE DESCRIPTION:
Periodontal disease is a progressive on-going destructive disease that affects 85% of dogs over 3 years of age. The majority of dogs and cats greater than 3 years of age require some form of intervention or treatment. Periodontal disease encompasses the inflammation infection and subsequent destruction of the periodontium or the supporting structures of the tooth. It has traditionally been divided into two general categories gingivitis and periodontitis based upon whether attachment loss has occurred. Gingivitis is the presence of gingival inflammation without loss of connective tissue attachment (no pathological periodontal pocket). Periodontitis can be defined as gingival inflammation at sites where there has also been loss of attached gingiva and destruction of the periodontal ligament. This damage to the periodontal ligament leads to an irreversible destruction of underlying alveolar bone. Periodontal disease is a continuum of stages beginning with inflammation of the free gingival margin (gingivitis) and resulting in advanced periodontitis and tooth loss.

SAFETY AND EFFICACY:
Safety of Porphyromonas Denticanis-Gulae-Salivosa Bacterin was established in trials involving animals from multiple geographic locations. Healthy dogs as young as 7 weeks of age were vaccinated according to label directions. No significant adverse events were observed in any animals during the study period. Efficacy studies and potency test validation are in progress. A reasonable expectation of efficacy has been demonstrated in dogs 8 months of age. Duration of immunity for this product has not been evaluated.

DIRECTIONS:
General Directions: Vaccination of healthy dogs is recommended. Shake well. Aseptically administer 1 mL subcutaneously.
Primary Vaccination: Healthy dogs should receive 2 doses administered 3 weeks apart.
Revaccination: Duration of immunity for this product has not been evaluated; consultation with a veterinarian is recommended.

PRECAUTIONS:
Store at 2°-7°C (35°-44°F). Prolonged exposure to higher temperatures may adversely affect potency. Do not freeze.
Use entire contents when first opened.
Sterilized syringes and needles should be used to administer this vaccine.
In case of anaphylaxis administer epinephrine or equivalent.