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K-9 Immunityâ„¢ Information for the Veterinarian

DESCRIPTION
K9 Immunity Plusâ„¢ is an orally administered Veterinary Medical Food intended for daily use in adult dogs to optimize immune system response and function while undergoing conventional therapy for cancer and other health challenges. It consists of a heterogeneous mixture of multiple immune activating hetero-polysaccharides, a complex blend of immunoproteins and a blend of omega 3 fatty acids derived from cold water fish oils, in a liver flavored soft chew treat-like wafer. Each wafer of K9 Immunity Plusâ„¢ contains 600 mg of a complex blend of immune activating polysaccharides, including soluble 1,3-1,6 Beta Glucans and high molecular weight (HMW) hetero-polysaccharides. The primary types of immune activating polysaccharides in K9 Immunity Plusâ„¢ are different structures of long chain, high molecular weight, right- handed triple helix structure hetero-polysaccharides, primarily with 1-3 beta-linked glucan main chain formation. The main chain compositions are primarily composed of d-glucose subunits, with greater and lesser degrees of alpha- and beta- linked side chain branching. The side branches contain a number of different five and six carbon sugars such as arabinose, xylose, fucose, fructose, mannose and glucose, with and without attached polypeptides and proteins. These hetero-polysaccharides and polysaccharide-protein complexes are hot water soluble and ethanol insoluble. Each wafer of K9 Immunity Plusâ„¢ also contains 160 mg of an immunoprotein blend containing Transfer Factors class proteins, Alpha- and Beta- immune proteins, Proline Rich Polypeptides (PRP), and immunoglobulin antibodies of the IgA, IgG, IgM and IgY classes, which function is to bind with and increase the absorption and bioavailability of the immune activating polysaccharides. Each wafer of K9 Immunity Plusâ„¢ also contains 600 mg of an Omega-3 fatty acid blend. The Omega-3 fatty acid portion consists of concentrated and purified cold water fish oil extracted from the body fat of Anchovies with an optimized 12:18 ratio of the long chain Omega 3 fatty acids EPA and DHA.

CLINICAL PHARMACOLOGY
K9 Immunity Plus™ is a comprehensive immune enhancement and optimization formulation with considerable pharmacological potential. The main action exhibited by the immune-active heteropolysaccharides and protein-bound polysaccharides is for activation and enhancement of various aspects of innate and specific immune responses. The number and activity of T lymphocytes (Tcells), B lymphocytes (B-cells), natural killer cells (NK cells), macrophages and antigen presenting cells (APC) are enhanced. This immune system activation is accomplished by binding of the beta glucans, the HMW hetero-polysaccharides and the glycoproteins to specific receptor on the surface of the immune cells, including Complement Receptor type 3 (CR3), Dectin-1, LacCer, TLR and Scavenger Receptors. The immune-activating polysaccharides bind to the immune receptors as part of a cascade effect, only after priming of the immune cell by exposure to and attachment of a non-self protein antigen molecule, at which point the polysaccharides bind and perform as cellular triggers, activating that immune cell to ‘turn on’ or go active. Upon activation of any immune cell, the body’s immuno-conservative mechanism then triggers a further production cascade of new generations of cells of the same class as the immune cells thus triggered, resulting in a greater immune responsiveness than would otherwise be accomplished without this exogenous triggering mechanism. The enhanced immune responsiveness may also be (at least partly) explained by a generalized microbial antigen response triggered in the small intestines, where the complex fungal cell-wall derived polysaccharides are interpreted by the body as a massive invasion by foreign organisms, thus triggering a heightened state of immune awareness throughout the body, which immune surveillance is then available for addressing other immune challenges which may exist throughout the system.

INDICATIONS AND USAGE
K9 Immunity Plusâ„¢ is used primarily as an adjunct to conventional chemo- and radiation therapy in canine patients undergoing treatment for cancer. It is indicated as a daily supplement for use in adult dogs to help offset the side effects of chemotherapy and radiation therapy, and for the avoidance of neutropenia and resultant opportunistic infections associated with conventional cancer treatments. K9 Immunity Plusâ„¢ can be used on a daily basis for long periods of time in otherwise healthy adult canine cancer patients, and can result in an overall lower incidence of treatment side effects and enhancement of the QOL parameters, through its immune modulating effect. K9 Immunity Plusâ„¢ is also indicated as an adjuvant in antibiotic therapy and most other treatment regimens, as it is believed that the heightened immune awareness results is a faster and more pronounced response to virtually all other classes of medications.

CONTRAINDICATIONS
K9 Immunity Plusâ„¢ has no known contraindications in canines. K9 Immunity Plusâ„¢ has not been shown to increase autoimmune disease.

PRECAUTIONS
There are no known precautions inherent to K9 Immunity Plusâ„¢ besides those used in the normal standards of good veterinary clinical practice.

USE IN PREGNANCY AND LACTATION
Safety and efficacy of K9 Immunity Plusâ„¢ has not been evaluated in pregnancy or lactation or in puppies under 1 yr. of age. Caution and careful observation should be used in these cases.

FOOD AND DRUG INTERACTIONS
There are no known food or drug interactions with K9 Immunity Plusâ„¢ .

WARNINGS
K9 Immunity Plus™ is intended for use in dogs only. The safety and efficacy have not been studied in other species of animals. K9 Immunity Plus™ is primarily used as a daily adjunct to conventional therapy in seriously ill canine patients; care givers should be counseled that immune modulation therapy alone may not be the best choice for treating their dog’s condition. Likewise, the attending veterinarian should realize that K9 Immunity Plus™ is intended to augment and enhance other therapeutic strategies. K9 Immunity Plus™ is not intended as a stand alone therapy, except in those cases where no other appropriate treatment options are available.

ADVERSE REACTIONS
There have been no adverse reactions noted with K9 Immunity Plusâ„¢ . An allergic reaction is always possible with this and all other biologically active agents. If an allergic reaction is suspected, stop the use of K9 Immunity Plusâ„¢ immediately and contact the manufacturer at (775) 886-6300. The usual supportive measure should be employed as with any other allergic reaction.

OVERDOSAGE
The acute and chronic safety of K9 Immunity Plusâ„¢ has been tested at dosages up to 1000 times the daily recommended dosage and no incidence of toxicity has been noted. There have been no known incidences of overdosage. K9 Immunity Plusâ„¢ is well tolerated in canines.

DOSAGE AND ADMINISTRATION
K9 Immunity Plusâ„¢ is administered once daily based upon body weight per the following schedule. K9 Immunity Plusâ„¢ May be given with or without food with equal effectiveness.

DOSAGE FOR DOGS CURRENTLY UNDERGOING CONVENTIONAL THERAPY FOR CANCER, AND FOR DOGS IN AN ACTIVE DISEASE STATE:

For dogs with a body weight of less than 30 pounds (13.6 kgs): 2 wafer per day.
Dogs with a body weight between 31 and 70 pounds (13.6 – 31.8 kgs): 4 wafers per day
Dogs with a body weight over 70 pounds (31.8 kgs): 6 wafers per day

DOSAGE FOR DOGS IN REMISSION AFTER CANCER TREATMENT AND WHEN USED AS ADJUVANTS FOR ANTIBIOTIC THERAPY

For dogs with a body weight of less than 30 pounds (13.6 kgs): 1 wafer per day.
Dogs with a body weight between 31 and 70 pounds (13.6 – 31.8 kgs): 2 wafers per day
Dogs with a body weight over 70 pounds (31.8 kgs): 3 wafers per day

DOSAGE FOR HEALTHY DOGS
As a daily supplement to maintain optimal immune function and good health, a single wafer per day may be used in any size dog.

HOW SUPPLIED
K9 Immunity Plusâ„¢ comes in Mylar resealable bags based upon the body weight containing 30, 60 and 90 soft chew wafers, which are brown in color, and which weigh 4500 mg each total weight.

STORAGE
Store at room temperature out of direct sunlight. Normal shelf life is 2 years from date of manufacture.

INGREDIENTS PER 4500 mg WAFER - ACTIVE INGREDIENTS
Omega 3 Concentrate from cold water Anchovy Fish Oil - 600 mg – yielding EPA 66 mg and DHA 44 mg
K9 Immunityâ„¢ Immune-active Polysaccharide Blend concentrate - 600 mg
APS 40 Colostrum-derived Immunoprotein concentrate - 160 mg
 

INACTIVE INGREDIENTS FOR WAFERING:

Brewers yeast, Chicken Liver, Glycerin , Soy lecithin, Maltodextrin, Sodium alginate, and Calcium sulfate, Canola Oil, Propionic Acid and Natural Mixed Tocopherols

MANUFACTURED BY:
Aloha Medicinals Inc.
2300 Arrowhead Dr.
Carson City, NV 89706
FDA Registration # 19446231888
Tel: (775) 886-6300

K9 Immunity Plusâ„¢ is 100% Made in America using only American Ingredients. K9 Immunity Plusâ„¢ Contains no imported ingredients.


AS WITH ALL DRUGS AND SUPPLEMENTS, KEEP OUT OF THE REACH OF CHILDREN