Settle

Company: NovaVive USA

MYCOBACTERIUM CELL WALL FRACTION IMMUNOSTIMULANT

For Veterinary Use Only

For intravenous / intrauterine use only

Settle Indications

Recommended as an aid in the treatment of equine endometritis caused by Streptococcus zooepidemicus.

Dosage & Administration: Administer 1.5 mL by intrauterine instillation with a sterile catheter or by intravenous injection into the jugular vein during the early estrus period. Treatment may be repeated at subsequent natural or induced estrus periods.

Intravenous: Administer 1.5 mL of Settle^® by intravenous injection into the jugular vein. Use strict aseptic technique.

Intrauterine: Administer 1.5 mL by intrauterine instillation using strict aseptic technique. Dilute 1.5 mL of Settle^® in sterile lactated ringers, normal saline, water for injection or semen extender to provide an approximate final volume of 25 - 50 mL. Aseptically administer the diluted solution into the uterus using a sterile catheter.

Precaution: Store at 2° - 7°C. (35° - 45°F). Do not freeze. Mix thoroughly before injecting. Use entire contents when first opened. Contains gentamicin as a preservative. Do not administer within 21 days of slaughter. If anaphylaxis occurs, administer epinephrine. KEEP OUT OF THE REACH OF CHILDREN.

Contraindications

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

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

Side Effects

Mild fever, drowsiness, and decreased appetite may occur for 1 to 2 days following intravenous injection. 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.

Packaging: Settle^® is available in cartons containing 6 x 1.5 mL single-dose vials.

Manufactured by NovaVive USA Inc., 119 Rowe Rd., Athens, Georgia, U.S.A. 30601

U.S. Vet. Lic. No. 289

Toll-free: 1-844-663-3349

Email: 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: 1843003.0