300 Joseph Carrier, Vaudreuil-Dorion, Québec J7V 5V5 • Tel: 450.424.9992 • Fax: 450.424.9993 • www.immunotec.com
As listed in the Compendium of Pharmaceuticals and Specialties (CPS) Immunocal® Whey protein isolate Glutathione Precursor Immunotec NPN(s): 80004370 Pharmacology IMMUNOCAL    is    a    natural    source    of    the    glutathione    precursor cysteine   for   the   maintenance   of   a   strong   immune   system.   It   is   fat - free     and    contains     less     than    1%     lactose     and    has    a    high     protein biological value (>110 BV) providing all essential amino acids. The    systemic    availability    of    oral    glutathione    is    negligible;    the    vast    majority    of    it    must    be manufactured   intracellularly   from   precursors.   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   bioavailable   cysteine   is   relatively   rare   in   foodstuffs.   Furthermore,   cysteine   if ingested   as   the   free   amino   acid   L-cysteine,   has   toxic   potential   and   is   spontaneously   catabolized in   the   gastrointestinal   tract   and   blood   plasma.   Toxicity   is   avoided   when   cysteine   is   integrated into larger proteins such as serum albumin, alpha lactalbumin and lactoferrin. IMMUNOCAL   is   an   undenatured   bovine   whey   protein   isolate   specially   prepared   to   provide   a rich   source   of   bioavailable   cysteine.   Following   digestion,   the   cysteine   remains   as   the   stable form   cystine   (2   molecules   of   cysteine   linked   by   a   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   is   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 bioavailability of cysteine is greatly diminished.
300 Joseph Carrier, Vaudreuil-Dorion, Québec J7V 5V5 • Tel: 450.424.9992 • Fax: 450.424.9993 • www.immunotec.com
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 the maintenance of 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 such as heavy metals, aromatic hydrocarbons, nitrosamines, benzopirines and others including pharmacological agents such as acetaminophen. 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 the 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. Many systems in the body are adversely affected by low glutathione levels, including the immune system, the nervous system, the gastrointestinal system and the cardiovascular-pulmonary system. Health Claim 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.   Many   clinical   pathologies   are   associated with   glutathione   deficiency   and   oxidative   stress   and   are   elaborated   upon   in   numerous   medical references.    Low    glutathione    is    also    strongly    implicated    in    cachexia    and    negative    nitrogen balance    seen    in    muscle    wasting.    Immunocal    has    been    demonstrated    to    improve    muscle function and it is clinically proven to raise glutathione. Contraindications In individuals who develop or have known hypersensitivity to specific milk proteins (this does  not include lactose intolerance).
300 Joseph Carrier, Vaudreuil-Dorion, Québec J7V 5V5 • Tel: 450.424.9992 • Fax: 450.424.9993 • www.immunotec.com
Warnings Patients undergoing immunosuppressive therapy should discuss the use of this product with their health care practitioner. Heating or adding IMMUNOCAL to a hot liquid or use of a high-speed blender to reconstitute it will significantly decrease the effectiveness of the product. Precautions Each   pouch   of   IMMUNOCAL   provides   9   g   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    is    well    tolerated    by    lactose-intolerant    individuals.    IMMUNOCAL    is contraindicated   in   individuals   who   develop   or   have   known   hypersensitivity   to   specific   milk proteins (this does not include lactose intolerance). Individuals with the autosomal-recessive metabolic disorder cystinuria, are at higher risk of  developing cysteine nephrolithiasis (1-2% of renal calculi). Pregnancy - No adverse effects have been reported. A health care practitioner should be  consulted prior to use if the patient is pregnant or has reason to believe she is. Lactation  No adverse effects have been reported.  A health care practitioner should be  consulted prior to use if the patient breast feeds. Geriatrics - Glutathione levels drop with age. Dosage recommendations may rise with  increasing age. Adverse Effects IMMUNOCAL   is   a   natural   source   of   protein   classified   as   a   Natural   Health   Product   and   has   not been   statistically   assessed   for   adverse   effects.   Gastrointestinal   bloating   and   cramps   are   possible if   the   product   is   not   sufficiently   rehydrated.   Transient   urticarial-like   skin   rash   has   been   reported in   rare   individuals   undergoing   severe   detoxification   reaction.   Skin   rash   abates   when   the   intake is stopped or reduced.
300 Joseph Carrier, Vaudreuil-Dorion, Québec J7V 5V5 • Tel: 450.424.9992 • Fax: 450.424.9993 • www.immunotec.com
Overdose Symptoms    and    Treatment    -    There    have    been    no    reports    of    toxicity    from    overdosing    on IMMUNOCAL.   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. For   management   of   a   suspected   drug   overdose,   CPhA   recommends   that   you   contact   your regional   Poison   Control   Centre.   See   the   eCPS   Directory   section   for   a   list   of   Poison   Control Centres. Dosage As   a   natural   source   of   the   glutathione   precursor   cysteine   for   the   maintenance   of   a   strong immune   system,   20   g   per   day   is   recommended.   30-40   g   per   day   has   been   used   in   clinical   trials without ill effects. IMMUNOCAL is best administered on an empty stomach or with a light meal. Concomitant  intake of another high protein load may adversely affect absorption. Supplied Each   individually-sealed   foil   pouch   contains:   10   g   of   powder,   9   g   of   which   is   protein.   The   other   is represented   by   naturally   occurring   ingredients   including   ash,   trace   minerals   and   trace   amounts of vitamins. Boxes of 30 pouches. IMMUNOCAL    is    a    dehydrated    powdered    whey    protein    isolate.    It    must    be    appropriately rehydrated   before   use.   Remains   bioactive   up   to   12   hours   after   mixing.   Ideally,   it   should   be consumed   immediately   after   mixing.   Should   the   product   be   premixed   for   later   consumption,   it should   be   refrigerated   and   consumed   within   a   short   period   after   mixing.   Do   not   heat   or   use   a hot    liquid    to    rehydrate    the    product    or    use    a    high-speed    blender    for    reconstitution.    These methods   will   decrease   the   effectiveness   of   the   product.   Proper   mixing   is   imperative.   Consult instructions    included    in    packaging.    Store    in    a    cool    dry    environment.    Avoid    excessive    heat. Refrigeration is not necessary. Compendium of Pharmaceuticals and Specialties, online version (e-CPS). © Canadian Pharmacists Association, 2016. All rights reserved.
Copy courtesy of Dr. Vicky Dominguez, D.Sc. www.immunotec.com/drvicky