FOR ANIMAL TREATMENT ONLY
EQUIMUNE®
MYCOBACTERIAL CELL WALL FRACTION
IMMUNOSTIMULANT
1 mg/mL Mycobacterial Cell Wall Fraction
Contains 30 mcg/mL Gentamicin as a preservative
An immunotherapeutic agent for use as an aid in the treatment
of Equine Respiratory Tract Infections of viral origin.
Description:
Research has shown that mycobacterial cell wall compounds have
immunomodulating activity. Equimune® is a sterile emulsion of
purified mycobacterial cell walls which have been extracted by a
process which reduces their toxic and allergic effects, 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.1 This
amplification includes both cell mediated immunity (CMI) and humoral
antibody (HA) responses.1-3,6 IL-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 IL-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 IL-1 and thus IL-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 virus4,15 and herpesvirus
infections3,11 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 Mycobacterial cell
wall preparations have been shown to increase the number of alveolar
macrophages in animals8, 9 and to stimulate the release of IL-1 from
these cells.10, 14 In-vitro trials demonstrate IL-1 production from equine
alveolar macrophages as well as equine peripheral blood monocytes.18
Mycobacterial Cell Wall Fraction Immunostimulant has been shown
to cause the transformation of Lymphocytes previously sensitized by
viruses.17
DIRECTIONS FOR USE:
FOR USE ONLY BY, OR UNDER THE DIRECTION OF, A REGISTERED
VETERINARY SURGEON. FOR INTRAVENOUS USE ONLY
Horses with a history of hyper-immune disease (vaccine bumps,
allergies, etc.) should be closely monitored, by a veterinarian. In
the event of urticaria, edema, pneumonitis or persistent fever, treat
appropriately. Do not repeat treatment with Equimune® in horses
which 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.
Dosage and Administration:
1. It is important to ensure that the emulsion remains thoroughly
mixed during injections. Shake vial gently, roll between hands, or
heat under 65°C water to assist emulsification. Air space has been
provided in the vial to facilitate mixing. Inject using a disposable
syringe and a 21G x 1.5" disposable needle.
2. Use entire contents when first opened. Discard remaining portions.
3. Observe aseptic techniques when injecting animals.
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. For best results, Equimune® should be administered at the first
clinical signs of equine respiratory tract infections of viral origin.
Precautions:
1. In the event of an anaphylactic reaction, administer adrenaline.
2. KEEP OUT OF REACH OF CHILDREN.
3. 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.
4. Contains 30 mcg/mL Gentamicin as a preservative.
Safety:
In field use, there have been no reported adverse effects with pregnant
mares. Other than the contraindications listed below, Equimune®
is compatible with standard treatment and vaccination regimens.16
Contraindications:
Cortisone reduces the production of IL-1.1 Concurrent use
of corticosteroids, ACTH and other products known to be
immunosuppressive is not recommended.
Side Effects:
Mild fever, drowsiness, and an increased metabolic rate leading
to decreased appetite may occur for one to two days following an
Equimune® injection. These are normal responses to the release of
IL-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.
MEAT WITHHOLDING PERIOD (HORSES):
DO NOT USE less than 28 days before slaughter for human
consumption.
Disposal:
Dispose of empty container by wrapping with paper and putting in
garbage. Discarded needles should immediately be placed in a designated
and appropriately labelled “sharps” container. The container should be
of a type to reduce the possibility of injury to handlers during collection
and disposal. Incineration is the preferred method of disposal, otherwise
“sharps” should be buried at a suitable site, such as an on‑farm chemical
disposal pit located away from watercourses.
Storage:
Store between 2°C and 8°C (Refrigerate. Do not freeze.)
APVMA Approval No. 51105/106194
Presentation:
Equimune® is packaged in 1.5 mL single dose vials.
References:
1. Dinarello, C.A. Biology of interleukin 1. FASEB J. 2: 108–115; 1988.
2. Tizard, I. Basic immunology-3: The importance of macrophages. Vet. Med.
pp 250–257; 1986.
3. Allison, A.C. Effects of adjuvants on different cell types and their interaction in
immune responses. Ciba Foundation Symposium on Immunopotentiation. Elsevier, N.Y.
pp 73–94, 1973.
4. Winters, W.D. and S.C. Harris. Interferon induction in healthy and tumor-bearing dogs
by cell walls of Mycobacterium bovis strain bacille Calmette-Guerin. Amer. J. Vet. Res.
43:1232-1237; 1982.
5. Winters, W.D. and S.C. Harris. Increased survival and interferon induction in pet dogs with
mammary tumors. Proc. 73rd An. Mtg. Amer. Assoc. Cancer Res. 23:244 (964); 1982.
6. Tizard, I. Basic immunology-4: The indispensable lymphocyte. Vet. Med. pp 332-346, 1986.
7. Bourne, J. and T. Newby. Mucosal immunity. In Prac. 3(5):5-11; 1981.
8. Bhagwat, A.G. and P.E. Conen. Characterization of ”free alveolar cells” in experimental
adjuvant induced pneumonia. Arc. Path. 88:21–29; 1969.
9. Charley, B., C. Leclerc, E. Petit and L. Chedid. In-vitro effects of lipopolysaccharides
and mycobacterial cell wall components on swine alveolar macrophages. Res. Vet.
Sci. 34. 212-217; 1983.
10.Gauldie, J. Personal communication. 1987.
11.Morgenson, S.C. Role of macrophages in natural resistance to virus infection.
Microbiol. Rev. 43:1–26; 1979.
12.Dutta, S.K., A. Myrup and M.K. Bumgardner. Lymphocyte responses to virus and
mitogen in ponies during experimental infection with equine herpesvirus 1. Amer. J.
Vet. Res. 41:2066-2068; 1980.
13.Gerber, J.D., A.E. Marron, E.P. Bass and W.H. Beckenhauer. Effects of age and
pregnancy on the antibody and cell mediated immune responses of horses to equine
herpesvirus 1. Can. J. Comp. Med. 41:471–487; 1977.
14.Wilks, C.R. and L. Coggins. Immunity to equine herpesvirus type 1 (rhinopneumonitis):
in vitro lymphocyte response. Amer. J. Vet. Res. 37:487–492; 1976.
15.Leneau, H., P. Steinmeyer and W.L. Ragland. Immunotherapy of equine infectious
rhinopneumonitis. Proc. 32nd. An. Conv. Amer. Assoc. Equine Prac. pp. 615– 622, 1986.
16.Vetrepharm Research Inc. (Canada). Data on file. 1985 – 90.
17.Archambault, D., G. Morin and M.A.S.Y. Elazhary. Effect of sodium diethyldithiocarbamate,
Corynebacterium parvum and mycobacterium cell wall extract on in-vitro blastogenic
responses of bovine blood lymphocytes. Cornell Vet. 79:11-24; 1989.
18.Data on file with Agriculture Canada and United States Department of Agriculture.
Manufactured by: NovaVive USA, Inc.,
Athens G.A. 30601 U.S.A.
U.S. Veterinary Licence No. 289
APVMA Approval No. 51105/0903
Distributed by:
NovaVive (A/Asia) Pty Ltd ACN 607 502 19854
54 Beecroft Rd, Epping NSW 2121 Australia
Telephone: 0428 214 543