Settle (Canada)

Company: NovaVive

MYCOBACTERIUM CELL WALL FRACTION IMMUNOSTIMULANT

FOR VETERINARY USE ONLY

FOR INTRAUTERINE ADMINISTRATION ONLY

Settle Indications

An immunotherapeutic agent for use as an aid in the treatment of equine endometritis caused by Streptococcus zooepidemicus.

KEEP OUT OF REACH OF CHILOREN

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

Mix thoroughly before administering. Use entire contents when first opened.

In the event of an anaphylactic reaction, administer epinephrine.

Contains gentamicin as a preservative.

Do not administer to horses within 21 days of slaughter.

Product Description: Settle is an emulsion of purified mycobacterium cell walls that enhances the innate humoral immune responses by activating macrophages and stimulating the cloning of polymorphonuclear (PMN) leukocytes. These activated phagocytic cells stimulate a cytokine cascade that results in the destruction of bacteria, such as Streptococcus zooepidemicus.

Dosage & Administration: Administer the complete vial of Settle (1.5 mL) into the uterus during the early estrus period. Dilute Settle in sterile lactated ringers, normal saline, water for injection or semen extender to provide an approximate final volume of 25 - 50 mL. Using strict aseptic technique, instill the diluted solution into the uterus using a sterile catheter.

Contraindications

Cortisone reduces the production of interleukin-1 (IL-1). Mares being treated with corticosteroids or ACTH may not respond to Settle therapy.

Side Effects

Mild fever, drowsiness, and decreased appetite may occur for one to two days following the administration of Settle. These are normal responses to the release of IL-1. An elevated body temperature enhances the immune function by stimulating leukocyte activity and thus is not an adverse side effect.

Precaution:

1. The Settle emulsion may separate on standing. Resuspend by shaking or rotating the vial between the hands until the emulsion has a homogenous ‘milky’ appearance.

2. Observe aseptic techniques when treating horses with Settle.

3. Horses with a history of immune disorders or hypersensitivity reactions (vaccine injection-site reactions, allergies, etc.) should be monitored. In the event of urticaria, edema, pneumonitis, or persistent fever, treat appropriately. Do not repeat treatment with Settle in horses that develop these symptoms. Many factors influence the efficacy of immunotherapy in animals. Concurrent disease, stresses due to shipping or weaning, nutritional status, parasitism, environmental conditions, and concurrent therapeutic regimens are important considerations.

4. Immune stimulation regimens have the potential to stimulate hypersensitivity reactions. These may be manifested as a persistent fever with or without pulmonary involvement. Veterinary attention should be sought if these symptoms occur.

5. Efficacy has been demonstrated for intrauterine (IU) route of administration. A large-scale field study to demonstrate safety following single or repeated IU administrations of this formulation was not performed, as this route was added after the approval of the original intravenous (IV) route in multiple jurisdictions. Settle was first licensed in 2004 in the country of origin and is currently marketed in several countries.

6. The intravenous (IV) use of this product has the potential to cause pulmonary inflammation.

Packaging: Settle^® is available in 1.5 mL single-dose vials.

Manufactured for:

NovaVive Inc., Napanee, Ontario, Canada

by NovaVive USA Inc., Athens, Georgia, 30601 U.S.A.

USDA Establishment License Number 289

TOLL-FREE: 1-844-663-3349

info@novavive.ca

Protected by one or more of the following patents:

US: 4744984, 5632995, 5759554, 6139844, 6890541

CA: 1293190, 2154689, 2170142, 2284932, 2284937, 2378888

CPN: 1842003.0