Equimune

Company: NovaVive USA

MYCOBACTERIUM CELL WALL FRACTION IMMUNOSTIMULANT

FOR INTRAVENOUS USE ONLY

For Veterinary use only.

An immunotherapeutic agent for the treatment of Equine Respiratory Disease Complex (ERDC). The common causes of ERDC are equine herpes virus (rhinopneumonitis), Influenza A equine-1 (H7N7) and Influenza A equine-2 (H3N8).

Description

Research has shown that mycobacterium cell wall compounds have immunomodulating activity. Equimune^® is an emulsion of purified mycobacterium cell walls which have been extracted by a process which reduces their toxic and allergic effect, but retains their immunostimulating activity.

Equimune^® activates antigen presenting cells thereby enhancing the production of the polypeptide cytokine interleukin 1 (IL-1). The IL-1 molecule is one of the body’s natural adjuvants, and therefore nonspecifically amplifies the immune response to antigens. This amplification included both cell meditated immunity (CMI) and humoral antibody (HA) responses. IL intensifies the CMI response by inducing the proliferation of cytotoxic lymphocytes (Tc), augmenting the phagocytic abilities of monocytes and macrophages, and by activating cytokine production. IL-1 also acts directly on the hypothalamus to induce a fever which then enhances the function of T lymphocytes. Proliferation of fibroblasts is induced by IL-1 and this IL-1 production aids in the wound healing processes. Wound healing processes are further augmented by the increased phagocytic action of macrophages and monocytes. This is important in overcoming alveolar cell damage caused by respiratory disease.

Cell mediated immunity plays a major role in resistance to, and recovery from, viral infection such as influenza virus and herpesvirus infections including equine herpesvirus. Immunotherapy trials conducted in Canada, the U.S.A. and elsewhere have indicated a positive response in horses with viral respiratory tract infections. Mycobacterium cell wall preparations have been shown to increase the number of alveolar macrophages in animals and to stimulate the release of IL-1 from these cells. In vitro trials demonstrate IL-1 production from equine alveolar macrophages as well as equine peripheral blood monocytes. Mycobacterium Cell Wall Fraction Immunostimulant has been shown to cause the transformation of lymphocytes previously sensitized by the viruses.

Equimune Indications

Equimune^® is indicated in those conditions where immunotherapy will enhance the immune response to respiratory tract infections. Efficacy of Equimune^® is not altered by concurrent use of antibiotics.

Side Effects

Mild fever, drowsiness, and increased catabolic rate leading to decreased appetite may occur for one or two days following an Equimune^® injection. These are normal responses to the release of IL-1. An elevated body temperature enhances the immune function by stimulating lymphocyte activity, and thus is not an adverse side effect.

Dosage and Administration

FOR INTRAVENOUS USE ONLY. The recommended dose for immunostimulation is 1.5 mL by intravenous injection into the jugular vein. Treatment may be repeated in one to three weeks.

Safety: Equimune^® is safe to use in pregnant mares. Other than the contraindications listed below.

Equimune^® is compatible with standard treatment and vaccination regimes.

Contraindications

Cortisone reduces the production of IL-1. Horses being treated with corticosteroids or ACTH may not respond to Equimune^® therapy.

Precaution:

1. It is important to ensure that the emulsion remains thoroughly mixed during injections. Shake vial gently and roll between hands to assist emulsification.

2. Store at 2°C - 7°C (35°F - 45°F). Do not freeze.

3. Use entire contents when first opened.

4. Observe aseptic techniques when injecting animals.

5. Horses with a history of hyper-immune disease (vaccine bumps, allergies etc.) should be closely monitored. In the event of urticaria, edema, pneumonitis, or persistent fever, treat appropriately. Do not repeat treatment with Equimune^® in horses which develop these symptoms.

6. In the event of an anaphylactic reaction, administer epinephrine.

7. KEEP OUT OF REACH OF CHILDREN.

8. Contains gentamicin as a preservative.

9. Do not administer within 21 days of slaughter.

Packaging: Equimune^® is packaged in a single-dose vial.

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

U.S. Vet. Lic. No. 289

1-844-663-3349

Protected by one or more of the following patents:

US: 4744984, 5632995, 5759554, 6139844, 6890541

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

CPN: 1843001.0