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Immunocal powder sachet

The following is the actual word for word writeup in the PDR for Immunocal

DESCRIPTION and CLINICAL PHARMACOLOGY

IMMUNOCAL is a U.S. patented natural food protein concentrate in the FDA category of GRAS (generally recognized as safe) which assists the body in maintaining optimal concentrations of glutathione (GSH) by supplying the precursors required for intracellular glutathione synthesis. It is clinically proven to raise glutathione values (Lands et al, 1999).

Glutathione is a tripeptide made intracellularly from its constituent amino acids L-glutamate, L-cysteine and glycine. The sulfhydryl (thiol) group (SH) of cysteine serves as a proton donor and is responsible for the biological activity of glutathione. Provision of this amino acid is the rate-limiting factor in glutathione synthesis by the cells since cysteine is relatively rare in foodstuffs and furthermore, if released as the free amino acid, is toxic and spontaneously catabolized in the gastrointestinal tract and blood plasma.

Immunocal is a bovine whey protein isolate specially prepared so as to provide a rich source of bioavailable cysteine. Following digestion, the cysteine remains as the stable form cystine (2 molecules of cysteine linked by disulfide bond) and glutamylcystine. After absorption, these dipeptides travel safely in the blood stream and readily enter the cells to release free cysteine for intracellular glutathione synthesis. Immunocal can thus be viewed as a cysteine delivery system.

The disulphide bond in cystine is pepsin and trypsin resistant but may be split by heat, low pH or mechanical stress releasing free cysteine. When subject to heat or shearing forces (inherent in most extraction processes), the fragile disulfide bonds within the peptides are broken and the bioavailablility of cysteine is greatly diminished.

Glutathione is a tightly regulated intracellular constituent and is limited in its production by negative feedback inhibition of its own synthesis through the enzyme gamma-glutamylcysteine synthetase, thus greatly minimizing any possibility of overdosage.

Glutathione has multiple functions:

  1. It is the major endogenous antioxidant produced by the cells, participating directly in the neutralization of free radicals and reactive oxygen compounds, as well as maintaining exogenous antioxidants such as vitamins C and E in their reduced (active) forms.
  2. Through direct conjugation, it detoxifies many xenobiotics (foreign compounds) and carcinogens, both organic and inorganic.
  3. It is essential for the immune system to exert its full potential, e.g. (1) modulating antigen presentation to lymphocytes, thereby influencing cytokine production and type of response (cellular or humoral) that develops, (2) enhancing proliferation of lymphocytes thereby increasing magnitude of response, (3) enhancing killing activity of cytotoxic T cells and NK cells, and (4) regulating apoptosis, thereby maintaining control of the immune response.
  4. It plays a fundamental role in numerous metabolic and biochemical reactions such as DNA synthesis and repair, protein synthesis, prostaglandin synthesis, amino acid transport and enzyme activation. Thus, every system in the body can be affected by the state of the glutathione system, especially the immune system, the nervous system, the gastrointestinal system and the lungs.

 

Indications and Usage

IMMUNOCAL is a natural food supplement and as such is limited from stating medical claims per se. Statements have not been evaluated by the FDA. As such, this product is thus not intended to diagnose, cure, prevent or treat any disease.

Glutathione augmentation is a strategy developed to address states of glutathione deficiency, high oxidative stress, immune deficiency, and xenobiotic overload in which glutathione plays a part in the detoxification of the xenobiotic in question. Glutathione deficiency states include, but are not limited to: HIV/AIDS, chemical and infectious hepatitis, prostate and other cancers, cataracts, Alzheimer’s, Parkinsons, chronic obstructive pulmonary disease, asthma, radiation poisoning, malnutritive states, arduous physical stress, aging, and has been associated with sub-optimal immune response. Many clinical pathologies are associated with oxidative stress and are elaborated upon in numerous medical references.

Low glutathione is also strongly implicated in wasting and negative nitrogen balance (Droge and Holm, 1997), notably as seen in cancer, AIDS, sepsis, trauma, burns and even athletic overtraining. Glutathione supplementation can oppose this process and in AIDS, for example, result in improved survival rates (Herzenberg et al, 1997).

 

Contraindications

IMMUNOCAL is contraindicated in individuals who develop or have known hypersensitivity to specific milk proteins.

 

Precautions

Each sachet of IMMUNOCAL contains nine grams of protein. Patients on a protein-restricted diet need to take this into account when calculating their daily protein load. Although a bovine milk derivative, IMMUNOCAL contains less than 1% lactose and therefore is generally well tolerated by lactose-intolerant individuals.

 

WARNINGS

Patients undergoing immunosuppressive therapy should discuss the use of this product with their health professional.

 

Adverse Reactions

Gastrointestinal bloating and cramps if not sufficiently rehydrated. Transient urticarial-like rash in rare individuals undergoing severe detoxification reaction. Rash abates when product intake stopped or reduced.

 

Overdosage

Overdosing on IMMUNOCAL has not been reported.

 

Dosage and Administration

For mild to moderate health challenges, 20 grams per day is recommended. Clinical trials in patients with AIDS, COPD, cancer and chronic fatigue syndrome have used 30-40 grams per day without ill effect. IMMUNOCAL is best administered on an empty stomach or with a light meal. Concomitant intake of another high protein load may adversely affect absorption.

RECONSTITUTION

IMMUNOCAL is a dehydrated powdered protein isolate. It must be appropriately rehydrated before use. Remains bioactive up to 12 hours after mixing. DO NOT heat or use a hot liquid to rehydrate the product. DO NOT use a high-speed blender for reconstitution. These methods will decrease the activity of the product.

Proper mixing is imperative. Consult instructions included in packaging.

 

How Supplied

10 grams of bovine milk protein isolate powder per sachet.

30 sachets per box.

STORAGE

Store in a cool dry environment. Refrigeration is not necessary.

Patent no.’s: 5,230,902 – 5,290,571 – 5,456,924 – 5,451,412 – 5,888,552

 

References

  1. Baruchel S, Viau G, Olivier R. et al. Nutraceutical modulation of glutathione with a humanized native milk serum protein isolate, Immunocal: application in AIDS and cancer. In : Oxidative Stress in Cancer, AIDS and Neurodegenerative Diseases. Ed.; Montagnier L, Olivier R, Pasquier C. Marcel Dekker Inc. New York, 447-461, 1998
  2. Bounous G, Kongshavn P. Influence of protein type in nutritionally adequate diets on the development of immunity. In Absorption and Utilization of Amino Acids Vol.II. Ed. M. Friedman. CRC Press, Inc., Fla. 2:219-32, 1989
  3. Bounous G, Gold P. The biological activity of undenatured whey proteins: role of glutathione. Clin Invest Med 14:296-309, 1991
  4. Bounous G, Baruchel S, Falutz J. Gold P. Whey proteins as a food supplement in HIV-seropositive individuals. Clin Invest Med. 16:3; 204-209, 1992
  5. Bounous G. Whey protein concentrate (WPC) and glutathione modulation in cancer treatment. Anticancer Res. 20:4785-4792,2000
  6. Bounous G. Immunoenhancing properties of undenatured milk serum protein isolate in HIV patients. Int. Diary Fed: Whey: 293-305, 1998
  7. Droge W, Holm E. Role of cysteine and glutathione in HIV infection and other diseases associated with muscle wasting and immunological dysfunction. FASEB J: 11(13):1077-1089, 1997
  8. Herzenberg LA, De Rosa SC, Dubs JG et al. Glutathione deficiency is associated with impaired survival in HIV disease. Proc Natl Acad Sci 94:1967-72,1997
  9. Kennedy R, Konok G, Bounous G et al.. The use of a whey protein concentrate in the treatment of patients with metastatic carcinoma: A phase 1-II clinical study. Anticancer Res. 15:2643-50,1995
  10. Lands LC, Grey VL, Smountas AA. Effect of supplementation with a cysteine donor on muscular performance. J. Appl. Physiol. 87:1381-1385, 1999
  11. Locigno R, Castronovo V. Reduced glutathione System: Role in cancer development, prevention and treatment. International Journal of Oncology 19:221-236, 2001
  12. Lomaestro B, Malone M. Glutathione in health and disease: pharmacotherapeutic issues. Ann Pharmacother 29: 1263-73,1995
  13. Lothian B, Grey V, Kimoff RJ, Lands. Treatment of obstructive airway disease with a cysteine donor protein supplement: a case report. Chest 117:914-916, 2000
  14. Meister A. Glutathione. Ann Rev Biochem 52:711-60,1983
  15. Peterson JD, Herzenberg LA, Vasquez KK, Waltenbaugh C. Glutathione levels in antigen-presenting cells modulate Th1 versus Th2 response patterns. Proc.Natl. Acad. Sci. 95:3071-3076, 1998
  16. Watanabe A, Higachi K, Yasumura S. et al. Nutritional modulation of glutathione level and cellular immunity in chronic hepatitis B and C. Hepatology. 24:597A, 1996

 

Manufactured by Immunotec Research, Ltd. and Immunotec Medical Corp.

Distributed by AmmunoMed, LLC and NuMedTec

Tel: 877-687-2277

www.immunocal.com

 

 

So, what is the PDR?

Physicians’ Desk Reference

From Wikipedia, the free encyclopedia

The Physicians’ Desk Reference (PDR) is a commercially published compilation of manufacturers’ prescribing information (package insert) on prescription drugs, updated annually. While designed to provide physicians with the full legally mandated information relevant to writing prescriptions (just as its name suggests), it is widely available in libraries andbookstores, widely used by other medical specialists, and in significant part valuable to consumers. It is financially supported in part by pharmaceutical manufacturing corporations which create drugs listed within its pages.

Since the late 20th century, a consumer edition has been offered at a much reduced price. Electronic editions are available on CD-ROM and the World Wide Web to subscribers. In 1984, Paul C. Kranz and Michael Grondin travelled to Oradell, New Jersey, and presented to Medical Economics (then-publisher of the PDR) a prototype developed by Grondin on aTI 99/4A computer of how a digital copy of the PDR would work and benefit clinicians. The idea originally conceived by Kranz was well received by the president and vice-president of IT and an agreement was struck to investigate. The result was the PDR on CD-ROM.

The main edition is usable by determined consumers in conjunction with a medical dictionary. Many practicing physicians receive free copies of the PDR and are willing to give a patient a previous year’s edition when they receive their new one but a recent edition generally differs from the current one by the absence of the drugs introduced during the course of the intervening year.

 

 

What is Drugs.com?

PDR Consumer Drug Information

Drugs.com began licensing and displayed Physician’s Desk Reference (PDR) drug information in 2003 and continued to publish PDR content until 2010. In mid-2010 a change in policy by the distributors of PDR resulted in the non-renewal of the licence and the removal of Physician’s Desk Reference Consumer Drug Information from the Drugs.com website.

Drugs.com also licenses content from a number of leading and respected medical content publishers including American Society of Health-System Pharmacists’ (ASHP), Cerner Multum andWolters Kluwer. This content has now replaced the PDR consumer drug information on the Drugs.com website.

AHFS DI from the American Society of Health-System Pharmacists’ is a comprehensive source of unbiased and authoritative drug information licensed to respected publishers such as Drugs.com and The National Institute of Health (NIH).

The Centers for Medicare and Medicaid Services, The U.S. Congress and various health care insurance providers have also recognized the authority of AHFS content as a source of information on the medically accepted uses of drugs. Monographs include recommendations of numerous authorities, including the U.S. Centers for Disease Control and Prevention, the American Heart Association, the Institute of Medicine of the National Academies, the Women’s Health Initiative, and many others. The publication also features major cautionary information from FDA MedWatch notices, as well as new and updated scientific findings.

Cerner Multum and Wolters Kluwer drug information is written in lay terms and is based on the official FDA-approved drug information. It gives consumers plain-English explanations for the safe and effective use of prescription and non-prescription medication that is consistent with information referenced by healthcare professionals using FDA approved Product Labels and FDA approved Patient Information Leaflets.

This information may, in some instances, provide more coverage for some medications than the PDR consumer drug information. It is also part of the extensive Drugs.com taxonomy – enabling direct links with more specific related information such as drug interactionspregnancy & breastfeeding warnings and side effects.

 


SUMMARY & ABSTRACTS OF 23 COMPLETED STUDIES

Please Note: The following studies are on Immunocal bioactive whey protein. Bioactive Whey Protein is not a drug. As such, this product is not intended to treat, cure or prevent disease.
This information is provided as a public service for you to discuss with your physician or health care professional in determining the best course for your health care.

 

1.        

BOUNOUS G, MOLSON J.
Competition For Glutathione Precursors Between The Immune System And The Skeletal Muscle: Pathogenesis Of Chronic Fatigue Syndrome.
Med Hypotheses. 1999 Oct;53(4) :347-9.

 

2.        

KENNEDY RS, KONOK GP, BOUNOUS G, BARUCHEL S, LEE TD
The Use Of A Whey Protein Concentrate In The Treatment Of Patients With Metastatic Carcinoma : A Phase I-II Clinical Study.
Anticancer Res. 1995 Nov-Dec;15(6B) :2643-9.

 

3.        

BOUNOUS G, BARUCHEL S, FALUTZ J, GOLD P.
Whey Proteins As A Food Supplement In HIV-Seropositive Individuals.
Clin Invest Med. 1993 Jun;16(3) :204-9.

 

4.        

BOUNOUS G, GOLD P.
The Biological Activity Of Undenatured Dietary Whey Proteins : Role Of Glutathione.
Clin Invest Mod. 1991 Aug;14(4) :296-309.

 

5.        

BOUNOUS G, BATIST G, GOLD P.
Whey Proteins In Cancer Prevention.
Cancer Lett. 1991 May 1;57(2) :91-4.  Review.

 

6.        

PAPENBURG R, BOUNOUS G, FLEISZER D, GOLD P.
Dietary Milk Proteins Inhibit The Development Of Dimethylhydrazine-Induced Malignancy.
Tumour Biol. 1990;11(3) :129-36.

 

7.        

BOUNOUS G, GERVAIS F, AMER V, BATIST G, GOLD P.
The Influence Of Dietary Whey Protein On Tissue Glutathione And The Diseases Of Aging.
Clin Invest Med. 1989 Dec;12(6) :343-9.

 

8.        

BOUNOUS G, BATIST G, GOLD P.
Immunoenhancing Property Of Dietary Whey Protein In Mice: Role Of Glutathione.
Clin Invest Med. 1989 Jun;12(3) :154-61.

 

9.        

BOUNOUS G, KONGSHAVN PA, GOLD P.
The Immunoenhancing Property Of Dietary Whey Protein Concentrate.
Clin Invest Med. 1988 Aug;11(4) :271-8
.

 

10.    

BOUNOUS G, PAPENBURG R, KONGSHAVN PA, GOLD P, FLEISZER D.
Dietary Whey Protein Inhibits The Development Of Dimethylhydrazine Induced Malignancy.
Clin Invest Med. 1988 Jun;11(3) :213-7.

 

11.    

BOUNOUS G, SHENOUDA N, KONGSHAVN PA, OSMOND DG.
Mechanism Of Altered B-Cell Response Induced By Changes In Dietary Protein Type In Mice.
J Nutr. 1985 Nov;115(11) :1409-17.

12.    

BOUNOUS G, KONGSHAVN PA.
Differential Effect Of Dietary Protein Type On The B-Cell And T-Cell Immune Responses In Mice.
J Nutr. 1985 Nov;115(11) :1403-8.

 

 

 

13.     BOUNOUS G, LETOURNEAU L, KONGSHAVN PA.
Influence Of Dietary Protein Type On The Immune System Of Mice.
J Nutr. 1983 Jul;113(7) :1415-21.
 
14.     COSTANTINO AM, BALZOLA F, BOUNOUS G
Changes in biliary secretory immunoglobulins A in mice fed whey proteins
Minerva Dietol Gastroenterol 1989 35(4): 241-5
 
15.     BARUCHEL S, BOUNOUS G, GOLD P.
Place For An Antioxidant Therapy In Human Immunodeficiency Virus (HIV) Infection.
Oxidative Stress, Cell Activation and Viral Infection

C. Pasquier et al. (eds) 1994; 311-321.
 
16.     BOUNOUS G, KONGSHAVN PA.
Influence Of Dietary Proteins On The Immune System Of Mice.
J Nutr. 1982 Sep; 112(9) :1747-55.
 
17.     BOUNOUS G, STEVENSON MM, KONGSHAVN PA.
Influence Of Dietary Lactalbumin Hydrolysate On The Immune System Of Mice And Resistance
To Salmonellosis.

J Infect Dis. 1981 Sep; 144(3) :281.  No abstract available.
 
18.     LANDS LC, GREY VL, SMOUNTAS AA.
Effect Of Supplementation With A Cysteine Donor On Muscular Performance.
J Appl Physiol. 1999 Oct;87(4) :1381-5.
 
19.     LOTHIAN B, GREY V, KIMOFF RJ, LANDS LC.
Treatment Of Obstructive Airway Disease With A Cysteine Donor Protein Supplement Report.
Chest. 2000 Mar;117(3) :914-6.
 
20.     WATANABE A, HIGUCHI K, OKADA K, SHIMIZU Y, KONDO Y, KOHRI H.
Treatment Of Chronic Hepatitis Using Whey Protein (Non-Heated)
16th International Congress of Nutrition (Montreal, Canada 1997).
 
21.     BOUNOUS G.
Whey Protein Concentrate (WPC) And Glutathione Modulation In Cancer Treatment.
Anticancer Research 20 :4785-4792 (2000)
 
22.     TSAI WY, CHANG WH, CHEN CH, LU FJ.
Enhancing Effect Of Patented Whey Protein Isolate ([Immunocal]) On The Cytotoxicity Of
Anti-Cancer Drug.

Nutrition and Cancer, Vol 38, Issue #2.
 
23.     BARUCHEL S, VIAU G, OLIVIER R, BOUNOUS G, WAINBERG MA.
Nutriceutical Modulation Of Glutathione With A Humanized Native Milk Serum Protein Isolate,[Immunocal] : Application In AIDS And Cancer.
Marcel Dekker Inc. – New York – Basel – Hong Kong


 

 


 

 

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