Pulmo-Clear 10-1 dose vials 2ml dose each, USDA Code: 9360.00, U.S. Vet. License No. 188

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Pulmo-Clear 10-1 dose vials 2ml dose each

Prescription Medication for Animals can only be ordered by a U.S. licensed Veterinarian Doctor with a valid VM number. Products ordered and paid for will be shipped directly from the manufacturer's warehouse to the Veterinarians practice. Once Product has left the warehouse it cannot be returned for a refund, as the chain of custody has been broken.

****Disclosure**** Pulmo-Clear, a Caprine Serum Fraction, an Immunomodulator, is fully Licensed by the USDA for the indication of Equine Lower Respiratory Disease (ELRD) in Horses. It is subject to regulatory aspects when used for off label use****Disclosure****

Pulmo-Clear has been established as an Immunomodulator (IM) / Biological Response Modifier (BRM). IM/BRM's are the most recent classification of Biologics approved for use in animal and human populations. Immunomodulators and most ImmunoTherapeutic agents have shown, in multiple clinical trials, to provide adjunct and ancillary benefits far exceeding their original approval indication. These benefits include , but are not limited to:

1) Anti Inflammatory inhibiting due to the up regulation of Interleukin 10.

2) Cancer prevention and effective treatment due to the up regulation of INFg ,TNFa, and NK cells.

3) Regulation to normal, of over reacting immune systems due to modulation of Interleukin 6.

4) Modulating the potentially fatal stress mechanisms due to injury, environmental, chemical, and behavioral insult, due to the up regulation and modulation of Reactive Oxygen Species, Oxidative stress, and several Colony Stimulating Factors.

5) Effective anti viral and anti bacterial properties/proven effectiveness and survival against lethal challenge ParvoVirus and Salmonella(see attachment)

These properties are what are contributing to the increasing use of IM/BRM's for "off label" use, as the need for the benefits that they provide are required to meet unmet conditions, long before new indication approvals can be tested and issued.

****Disclosure**** Pulmo-Clear, a Caprine Serum Fraction, an Immunomodulator, is fully Licensed by the USDA for the indication of Equine Lower Respiratory Disease (ELRD) in Horses. It is subject to regulatory aspects when used for off label use****Disclosure****

****Disclosure**** Pulmo-Clear, a Caprine Serum Fraction, an Immunomodulator, is fully Licensed by the USDA for the indication of Equine Lower Respiratory Disease (ELRD) in Horses. It is subject to regulatory aspects when used for off label use****Disclosure****

Pulmo-Clear has been established as an Immunomodulator (IM) / Biological Response Modifier (BRM). IM/BRM's are the most recent classification of Biologics approved for use in animal and human populations. Immunomodulators and most ImmunoTherapeutic agents have shown, in multiple clinical trials, to provide adjunct and ancillary benefits far exceeding their original approval indication. These benefits include , but are not limited to:

1) Anti Inflammatory inhibiting due to the up regulation of Interleukin 10.

2) Cancer prevention and effective treatment due to the up regulation of INFg ,TNFa, and NK cells.

3) Regulation to normal, of over reacting immune systems due to modulation of Interleukin 6.

4) Modulating the potentially fatal stress mechanisms due to injury, environmental, chemical, and behavioral insult, due to the up regulation and modulation of Reactive Oxygen Species, Oxidative stress, and several Colony Stimulating Factors.

5) Effective anti viral and anti bacterial properties/proven effectiveness and survival against lethal challenge ParvoVirus and Salmonella(see attachment)

These properties are what are contributing to the increasing use of IM/BRM's for "off label" use, as the need for the benefits that they provide are required to meet unmet conditions, long before new indication approvals can be tested and issued.

****Disclosure**** Pulmo-Clear, a Caprine Serum Fraction, an Immunomodulator, is fully Licensed by the USDA for the indication of Equine Lower Respiratory Disease (ELRD) in Horses. It is subject to regulatory aspects when used for off label use****Disclosure****

The following content helps in understanding our USDA approved immunomodulator for domestic animals under the Veterinarian Biological Product License dated April 29, 2002. The product is currently manufactured under the name Pulmo-Clear and prescribed by Veterinarians per label for use in treating Equine Lower Respiratory Disease. Pulmo-Clear has been used off-label to treat other previous non treatable conditions in both large and small animals.

The active ingredient in Pulmo-Clear is the only known biological response modifier that affects and modulates both the innate and adaptive immune systems without negative side effects. It does this by resetting the immune system so that the body can heal itself. It also works to make other treatments more effective.

Innate immunity: Comprised of hereditary components that provide an immediate “first-line” of defense, to an initial invasion to continuously ward off pathogens.

Adaptive (acquired) immunity: Is a subsystem of the overall immune system that is composed of highly specialized, systemic cells that eliminate or prevent pathogen growth.

Adaptive immunity creates immunologic memory after an initial invasion that stands ready to eliminate any subsequent invasion of that pathogen. This immune response is highly specific, and long lasting.

Actions Addressed by Pulmo-Clear’s Immunotherapy:

I. Inflammation

Preserving Acute inflammation which is necessary for healing, restoration and defense against invading pathogens. Reducing Chronic inflammation which is the beginning of the reversal of degenerative disease.

II. Restores proper Cell Signaling

Through cytokines, cell messenger pathways, cellular communication and transduction.

Reverses aberrant, dysregulated, disrupted, error altered, confused and distracted communication.

III. Acts as an Adjuvants or Adjunct

Help regulate and restore the proper on/off switches of immune cascade proteins and cell activity, especially Apoptosis (programmed cell death). This will amplify proper cell activity, messaging and signal routing.

Conditions Treated by Pulmo-Clear

Based on the research work, trials and antidotal evidence in humans and some antidotal evidence in animals, we believe Pulmo-Clear can be used to therapeutically treat the following conditions (This is not a complete list).

  • Various Therapeutic Resistant Cancers
  • Parvo in dogs
  • Chronic AutoImmune Diseases
  • Primary immunodeficiencies
  • Chronic Pain
  • Irritable Bowel Syndrome (IBD) and Ulcerative Colitis
  • Tick-borne diseases
  • Enlarged Heart (Dilated Cardiomyopathy) in Dogs

Shipping fever in cattle
Bovine Mastitis in cows
Cushings Disease in horses


Why Immunotherapy?

Immunotherapy is the treatment of disease by inducing, enhancing or suppressing an Immune Response. Ten years ago Immunotherapy was almost in the category of snake oil. A few years ago it was stated that Immunotherapy can work. Now Immunotherapy has entered the main stream.

Specificity. T-cells recognize peptides, which are short chain biological molecules that are produced by every cell category including virus, bacteria, cancer/mutations. T-cells can recognize them and can destroy them, and most importantly they have the following two important elements.

First, Memory. As T-cells destroy pathogens, which are biological or environmental invaders which produce abnormal cells, they go through 3 phases: expansion, contraction and memory. Expansion is when the T-cells multiply to overwhelm the attacker.

Contraction is when they diminish due to program cell death after the attacker is neutralized. Memory is a multiplication of cells that remember the genetic code of the attacker. Memory cells proliferate and circulate through the body standing ready to attack.

Second, Adaptability. Cancerous tumors, viruses and bacteria, can mutate and alter themselves in order to evade various medical therapies. Cancer alone has 9 resistant mechanisms used to trick, hide and survive. So called present “Standard of Care Therapies” which use in large measure synthetically produced drugs frequently harmful to the body, but can’t adapt fast enough to counteract and destroy the mutation capabilities of cancer cells, bacteria and viruses. However, T-cell antigen receptors can. They adapt and respond as quickly as the pathogens, because they can combine and alter themselves as many 10 to the 15th power in different combinations.

The stimulation of the T-cells is a natural response of the body’s immune system to the injection of PulmoClear. This is the key to why and how of immunotherapy.

Why Biologics?

So, what is a Biologic or biologic response modifier? According to the United States Food & Drug Administration (FDA) Website in their Questions and Answers Section:

“Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic protein.

Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources – human, animal, or microorganism – and may be produced by biotechnology methods and other cutting- edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.”

How do biological products differ from conventional drugs?

In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination. Therefore, it is necessary to use aseptic principles from initial manufacturing steps, which is also in contrast to most conventional drugs.”

Again, according to the FDA, “Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available.”

Therefore, Biologic response modifiers (BRMs) can improve or modify the body’s natural response to infection and disease. BRMs, a drug class of their own, are the newest medications which are based on compounds made by living cells, not synthetic drugs which the body naturally attempts to reject which frequently leads to injury of major organs like the liver and kidneys.

Biological response modifiers (BRMs) are substances that modify immune responses. They can be both endogenous (produced naturally within the body) and exogenous (as pharmaceutical drugs), and they can either enhance an immune response or suppress it.

Some of these substances arouse the body’s response to an infection, and others can keep the response from becoming excessive. Thus they serve as immunomodulators in immunotherapy (therapy that makes use of immune responses), which can be helpful in treating many diseases, such as cancer (where targeted therapy often relies on the immune system being used to attack cancer cells) and in treating autoimmune diseases (in which the immune system attacks the self), such as some kinds of arthritis and dermatitis.

Most BRMs are biopharmaceuticals (biologics), including monoclonal antibodies, interleukin 2, interferons, and various types of colony-stimulating factors (e.g., CSF, GM-CSF, G-CSF). “Immunotherapy makes use of BRMs to enhance the activity of the immune system to increase the body’s natural defense mechanisms against cancer”, whereas BRMs for rheumatoid arthritis aim to reduce inflammation.

Immunomodulatory drugs and their application to the management of companion animal immune-mediated disease.

The current understanding of immune response and T cell subsets in the context of development of autoimmunity in animals there is published evidence that the mode of action and rational usage in immune-mediated disease in dogs for five important immune-mediated diseases: immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia, myasthenia gravis, glomerulonephritis and inflammatory bowel disease.

Current status of Pulmo-Clear

The patent and intellectual property for Pulmo-Clear were purchased in 2005. One of the original patent holders on the Vet product, Dr. Kenneth Willeford from Mississippi State University is also working on the serum for humans, which is finished and approved for human use in research for homeopathic treatment in Mexico. It has been proven effective in treating previously non-treatable chronic diseases.

 

Efficacy studies demonstrate that Pulmo-Clear, when used with adjunctive therapy, successfully clears Equine Lower Respiratory Desease (ELRD), leading to increased recovery rates and reduce recovery times in affected horses*. In fact, combined data from field studies show that Pulmo-Clear helps promote an overall ELRD recovery rate as high as 86 percent*.





To address the faulty or improper immune response to the agents that cause ELRD, Pulmo-Clear works to modulate the immune system - allowing the horse improved recovery from the clinical conditions associated with the disease.



Note: The addition of Pulmo-Clear to antimicrobial therapy increased the recovery rate from 37.5% to 77.5%.

In dose response studies, endoscopic scores were part of clinical evaluations for each presenting horse. A diagnosis of lower airway disease was based upon history, clinical examination and endoscopic findings of exudates in the trachea. An endoscopic score was used to describe the amount, physical characteristics, and location of the tracheal exudates. Higher endoscopic scores indicated more severe disease.

Mean Endoscopic Scores Across Time


* Data on file with USDA
** p<0.05 versus placebo group

Contraindication: Corticosteroids and other drugs which may cause immunosuppression are not recommended for use with this product.

Directions: Store at 2° to 7° C. Do not freeze. Use entire contents when first opened. Do not vaccinate within 21 days before slaughter.

Precautions: Anaphylactoid reaction may occur following administration of products of this nature. If noted, administer adrenalin or equivalent.

In the event of accidental human exposure, consult a physician.

Dosage and Administration:
Inject one 2ml. dose deep intramuscularly in the neck. Repeat this dose in 7-10 days in the opposite side of the neck. Moderate exercise aids in preventing or reducing local reaction. Discontinue use if a severe local reaction occurs.

Pulmo-Clear is restricted to use by or under the direction of a Veterinarian.

Pulmo-Clear is a biological product.

General Information:
This product is a patented sterile filtered fraction of serum from pre-tested goats. Fraction is purified and standardized to assure uniformity of product. Response in treated horses is of an immunomodulating nature.

Directions when to vaccinate:
Do not vaccinate within 21 days before slaughter.

Precautions:
A systemic anaphylactic reaction is always possible after administration of a product of this nature. Discontinue use of this product and administer adrenalin or equivalent if an anaphylactic reaction occurs.

Protein-containing serum origin products may cause local reactions. These can include local swelling with increased heat at the injection site. Studies have demonstrated that these reactions are transient and usually recede within 48-72 hours. Rarely they may last longer. Moderate exercise aids in preventing or reducing local reaction. Discontinue use if a severe local reaction occurs.

Indications and Information:
Proper diagnosis, selection of treatment modalities, and follow-up examinations for Lower Respiratory Disease in equines require veterinary expertise. Therefore, it is recommended that Pulmo-Clear be used by or under the supervision of a veterinarian.

Pulmo-Clear is recommended for use as an aid in combination with adjunctive therapy in treatment of horses with lower respiratory disease. This problem often occurs in athletic horses involved in racing, rodeo, jumping, endurance and other stressful exercise. When horses become ill, performance is reduced and they are usually removed from competition, often for an extended time period.

Efficacy testing included evaluation of recovery as measured by improvement in clinical signs and reduction and/or elimination of exudate of the trachea and lower respiratory tract by bronchoscope exam. These tests demonstrated a significant reduction in recovery time for horses receiving Pulmo-Clear and adjunctive therapy when compared with horses receiving only adjunctive therapy.

Field safety testing included groups of horses from 6 months to 15 years of age.

Contraindication:
Corticosteroids and other drugs which may cause immunosuppression are not recommended for use with this product.

USDA Code: 9360.00
U.S. Vet. License No. 188

Pulmo-Clear can be bought directly from our website and comes in a package consisting of 10 vials filled with 2 ml each.

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