Amplimune (Canada)

MYCOBACTERIUM CELL WALL IMMUNOSTIMULANT

FOR VETERINARY USE ONLY

Description and Action: The Mycobacteriaceae have been known for many years to have immune amplifying activity. Amplimune™ is an emulsion of mycobacterium cell wall fractions (MCWF) that have been modified to reduce their toxic and allergic effects, but retain their immunotherapeutic activity. Amplimune™ stimulates monocytes, macrophages and neutrophils, thereby initiating an innate immune response against invading pathogens.^1,2

Indications: Amplimune™ is recommended for use in neonatal calves (1 to 5 days of age) as a one-time immunotherapeutic treatment for the reduction of mortality and clinical signs associated with calf scours caused by K99^+ve Escherichia coli.

Amplimune Caution

A mild fever, drowsiness, and decreased appetite may occur for one to two days following an Amplimune™ injection. These reactions are a normal response to the release of cytokines.^3,4 An elevated body temperature enhances the immune function by stimulating lymphocyte activity,⁵ and therefore should not be considered an adverse reaction. Although rare in neonates, allergic reactions, including anaphylaxis, could occur. Treat anaphylaxis with epinephrine. Treat other cases of allergic reaction appropriately.

Contraindication: Immunotherapy may not be as effective in animals with higher than normal circulating cortisol (cortisolemia). Avoid the use of corticosteroids or ACTH whenever possible.

Precaution: This product contains gentamicin as a preservative. Do not administer to animals within 21 days of slaughter for human consumption. Use entire contents when first opened.

Administration and Dosage: Aseptically administer Amplimune™ as a 1 mL intravenous, intramuscular or subcutaneous injection to calves that are at least 1 day old and younger than 6 days of age.

Storage and Handling: Store at 2 to 7°C in a refrigerator; do not freeze. If the emulsion separates on standing, resuspend Amplimune™ by shaking or rotating the vial between the hands until the emulsion has a homogeneous appearance.

Volumes: 5 mL, 20 mL and 100 mL vials

References

1. Tizard, I., 2013. Veterinary Immunology, 9th Ed. Chap. 2, Innate Immunity: The Recognition of Invaders. Saunders, ISBN: 978-1-4557-0362-3

2. Tizard, I., 2013. Veterinary Immunology, 9th Ed. Chap.4, Innate Immunity: Neutrophils and Phagocytosis. Saunders, ISBN: 978-1-4557-0362-3

3. Dinarello, C.A., 1988. Biology of interleukin-1. FASEB J. 2:108-115

4. Tizard, I., 2013. Veterinary Immunology, 9th Ed. Chap. 8, Cell Signaling: Cytokines and Their Receptors. Saunders, ISBN: 978-1-4557-0362-3

5. Tizard, I., 2013. Veterinary Immunology, 9th Ed. Chap. 13, Lymphocytes. Saunders, ISBN: 978-1-4557-0362-3

Manufactured for:

NovaVive Inc., Belleville, Ontario, Canada

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

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: 1842001.0