Bioniche Animal Health

Mycobacterium Cell Wall Fraction Immunostimulant

U.S. Vet. Lic. No.: 289

Active Ingredient(s): Mycobacterium cell wall fraction immunostimulant.

Indications: An immunotherapeutic agent for the treatment of Equine Respiratory Disease Complex, (ERDC). The common causes of ERDC are equine herpesvirus (rhinopneumonitis), influenza A equine 1 and influenza A equine 2.

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

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

EQUIMUNE^® I.V. activates antigen presenting cells thereby enhancing the production of the polypeptide cytokine interleukin 1 (lL-1). The lL-1 molecule is one of the body's natural adjuvants, and therefore nonspecifically amplifies the immune response to antigens.¹ This amplification includes both cell-mediated immunity (CMI) and humoral antibody (HA) responses.^1-3,6 lL-1 intensifies the CMI response by inducing the proliferation of cytotoxic lymphocytes (Tc), augmenting the phagocytic abilities of monocytes and macrophages, and by actuating cytokine production.¹ lL-1 also acts directly on the hypothalamus to induce a fever which then enhances the function of T lymphocytes.^1,18 Proliferation of fibroblasts is induced by lL-1 and thus lL-1 production aids in the wound healing processes.¹ 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.¹⁷

Cell mediated immunity plays a major role in resistance to, and recovery from, viral infection¹⁷ such as influenza virus^4,15 and herpesvirus infections^3,11 including equine herpesvirus.^12-15 Immunotherapy trials conducted in Canada and elsewhere have indicated a positive response in horses with viral respiratory tract infections.^15,16 Mycobacterium cell wall preparations have been shown to increase the number of alveolar macrophages in animals^8,9 and to stimulate the release of lL-1 from these cells.^10,14

In vitro trials demonstrate lL-1 production from equine alveolar macrophages as well as equine peripheral blood monocytes.¹⁶ Mycobacterium cell wall fraction immunostimulant has been shown to cause the transformation of lymphocytes previously sensitized by viruses.¹⁷

Dosage and Administration: For intravenous use only.

The recommended dose for immunostimulation is 1.5 mL (1 syringe) by intravenous injection into the jugular vein. Treatment may be repeated in one (1) to three (3) weeks.

Contraindication(s): Cortisone reduces the production of lL-1.¹ Horses being treated with corticosteroids or ACTH may not respond to EQUIMUNE^® I.V. therapy.

Precaution(s):

1. It is important to ensure that the emulsion remains thoroughly mixed during injections. Shake syringe gently, roll between hands, or heat under 150°F (65°C) water to assist emulsification.

2. Store at 36-45°F (2-7°C). Do not freeze.

3. Use the entire contents when first opened. Discard remaining portions.

Caution(s):

1. Observe aseptic techniques when injecting animals.

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

Warning(s): Keep out of the reach of children.

Toxicology: Safety: EQUIMUNE^® I.V. is safe to use in pregnant mares. Other than the contraindications listed above, EQUIMUNE^® I.V. is compatible with standard treatment and vaccination regimes.¹⁶

Side Effects: Mild fever, drowsiness, and an increased catabolic rate leading to decreased appetite may occur for one to two days following an EQUIMUNE^® I.V. injection. These are normal responses to the release of lL-1.^1,2,6 An elevated body temperature enhances the immune function by stimulating lymphocyte activity^2,17 and thus is not an adverse side effect.

References: Available upon request.

Presentation: 1.5 mL vial and 4.5 mL multidose vial.

NAC No.: 11070022