As listed in the Physicians' Desk Reference (PDR) IMMUNOCAL PDR

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<ul><li><p>AslistedinthePhysiciansDeskReference(PDR)</p><p>IMMUNOCAL PDR2015NUTRACEUTICALGlutathioneprecursor(Bondedcysteinesupplement)PowderSachetsDESCRIPTIONandCLINICALPHARMACOLOGYIMMUNOCALisaU.S.patentednaturalfoodproteinisolateintheFDAcategoryofGRAS(generallyrecognizedassafe)whichassiststhebodyinmaintainingoptimalconcentrationsofglutathione(GSH)bysupplyingtheprecursorsrequiredforintracellularglutathionesynthesis.Itisclinicallyproventoraiseglutathionevalues.GlutathioneisatripeptidemadeintracellularlyfromitsconstituentaminoacidsLglutamate,Lcysteineandglycine.Thesulfhydryl(thiol)group(SH)ofcysteineisresponsibleforthebiologicalactivityofglutathione.</p><p>Provisionofthisaminoacidistheratelimitingfactoringlutathionesynthesisbythecellssincebioavailablecysteineisrelativelyrareinfoodstuffs.Immunocalisabovinewheyproteinisolatespeciallypreparedsoastoprovidearichsourceofbioavailablecysteine.Immunocalcanthusbeviewedasacysteinedeliverysystem.Thedisulphidebond in cystine ispepsinand trypsin resistantbutmaybe splitbyheat, lowpHormechanical stressreleasing free cysteine.When subject toheator shearing forces (inherent inmost extractionprocesses), the fragiledisulfidebondswithinthepeptidesarebrokenandthebioavailabilityofcysteineisgreatlydiminished.Glutathioneisatightlyregulatedintracellularconstituentandislimitedinitsproductionbynegativefeedbackinhibitionofitsownsynthesisthroughtheenzymegammaglutamylcysteinesynthetase,thusgreatlyminimizinganypossibilityofoverdosage.Glutathionehasmultiplefunctions:</p><p>1. Itisthemajorendogenousantioxidantproducedbythecells,participatingdirectlyintheneutralizationoffreeradicalsandreactiveoxygencompounds,aswellasmaintainingexogenousantioxidantssuchasvitaminsCandEintheirreduced(active)forms.</p><p>2. Throughdirectconjugation, itdetoxifiesmanyxenobiotics(foreigncompounds)andcarcinogens,bothorganicandinorganic.</p><p>3. It is essential for the immune system to exert its full potential, e.g. (1)modulating antigen presentation tolymphocytes,therebyinfluencingcytokineproductionandtypeofresponse(cellularorhumoral)thatdevelops,(2) enhancing proliferation of lymphocytes thereby increasingmagnitude of response, (3) enhancing killingactivityofcytotoxicTcellsandNKcells,and(4)regulatingapoptosis,therebymaintainingcontroloftheimmuneresponse.</p><p>4. ItplaysafundamentalroleinnumerousmetabolicandbiochemicalreactionssuchasDNAsynthesisandrepair,proteinsynthesis,prostaglandinsynthesis,aminoacidtransportandenzymeactivation.Thus,mostsystemsinthebodycanbeaffectedby the stateof theglutathione system,especially the immune system, thenervoussystem,thegastrointestinalsystemandthelungs.</p></li><li><p>INDICATIONSANDUSAGEIMMUNOCAL isanaturalfoodsupplementandassuch is limitedfromstatingmedicalclaimsperse.Statementshavenot been evaluated by the FDA.As such, this product is thus not intended to diagnose, cure, prevent or treat anydisease.Glutathione augmentation is a strategy developed to address states of glutathione deficiency, high oxidative stress,immunedeficiency,andxenobioticoverload inwhichglutathioneplaysapart inthedetoxificationofthexenobiotic inquestion.Glutathionedeficiencystates include,butarenot limited to:HIV/AIDS, infectioushepatitis,certain typesofcancers,cataracts,AlzheimersDisease,Parkinsons,chronicobstructivepulmonarydisease,asthma,radiation,poisoningbyacetominophenandrelatedagents,malnutritivestates,arduousphysicalstress,aging,andhasbeenassociatedwithsuboptimalimmuneresponse.Manyclinicalpathologiesareassociatedwithoxidativestressandareelaborateduponinnumerousmedicalreferences.Lowglutathione isalsostrongly implicated inwastingandnegativenitrogenbalance,notablyasseen incancer,AIDS,sepsis,trauma,burnsandevenathleticovertraining.CysteinesupplementationcanopposethisprocessandinAIDS,forexample,resultinimprovedsurvivalrates.CONTRAINDICATIONSIMMUNOCALiscontraindicatedinindividualswhodeveloporhaveknownhypersensitivitytospecificmilkproteins.PRECAUTIONSEachsachetofIMMUNOCALcontainsninegramsofprotein.Patientsonaproteinrestricteddietneedtotakethisintoaccountwhencalculatingtheirdailyprotein load.Althoughabovinemilkderivative, IMMUNOCALcontains lessthan1%lactoseandthereforeisgenerallywelltoleratedbylactoseintolerantindividuals.WARNINGSPatientsundergoing immunosuppressivetherapyshoulddiscusstheuseofthisproductwiththeirhealthprofessional.Individuals with the autosomalrecessive metabolic disorder cystinuria, are at higher risk of developing cysteinenephrolithiasis(12%ofrenalcalculi).ADVERSEREACTIONSGastrointestinal bloating and cramps if not sufficiently rehydrated. Transient urticariallike rash in rare individualsundergoingseveredetoxificationreaction.Rashabateswhenproductintakestoppedorreduced.OVERDOSAGEOverdosingonIMMUNOCALhasnotbeenreported.DOSAGEANDADMINISTRATIONFormildtomoderatehealthchallenges,20gramsperday isrecommended.Clinicaltrials inpatientswithAIDS,COPD,cancer and chronic fatigue syndrome have used 3040 grams per day without ill effect. IMMUNOCAL is bestadministeredonanemptystomachorwithalightmeal.Concomitantintakeofanotherhighproteinloadmayadverselyaffectabsorption.RECONSTITUTIONIMMUNOCAL is a dehydrated powdered protein isolate. It must be appropriately rehydrated before use. Ideallyconsumedaftermixing. If it ispremixed for later consumption, it shouldbe refrigeratedand consumed shortlyaftermixing.DONOTheatoruseahotliquidtorehydratetheproduct.DONOTuseahighspeedblenderforreconstitution.Thesemethodswilldecreasetheactivityoftheproduct.Propermixingisimperative.Consultinstructionsincludedinpackaging.</p></li><li><p>HOWSUPPLIED10gramsofbovinemilkproteinisolatepowderpersachet.30sachetsperbox.STORAGEStoreinacooldryenvironment.Refrigerationisnotnecessary.REFERENCES1. BaruchelS,ViauG,OlivierR.etal.Nutraceuticalmodulationofglutathionewithahumanizednativemilkserum</p><p>proteinisolate,Immunocal:applicationinAIDSandcancer.In:OxidativeStressinCancer,AIDSandNeurodegenerativeDiseases.Ed.;MontagnierL,OlivierR,PasquierC.MarcelDekkerInc.NewYork,447461,1998</p><p>2. BounousG,KongshavnP.Influenceofproteintypeinnutritionallyadequatedietsonthedevelopmentofimmunity.InAbsorptionandUtilizationofAminoAcidsVol.II.Ed.M.Friedman.CRCPress,Inc.,Fla.2:21932,1989</p><p>3. BounousG,GoldP.Thebiologicalactivityofundenaturedwheyproteins:roleofglutathione.ClinInvestMed14:296309,1991</p><p>4. BounousG,BaruchelS,FalutzJ.GoldP.WheyproteinsasafoodsupplementinHIVseropositiveindividuals.ClinInvestMed.16:3;204209,1992</p><p>5. BounousG.Wheyproteinconcentrate(WPC)andglutathionemodulationincancertreatment.AnticancerRes.20:47854792,2000</p><p>6. BounousG.ImmunoenhancingpropertiesofundenaturedmilkserumproteinisolateinHIVpatients.Int.DiaryFed:Whey:293305,1998</p><p>7. BrayT,TaylorC.Enhancementoftissueglutathioneforantioxidantandimmunefunctionsinmalnutrition.Biochem.Pharmacol.47:21132123,1994.</p><p>8. DrogeW,HolmE.RoleofcysteineandglutathioneinHIVinfectionandotherdiseasesassociatedwithmusclewastingandimmunologicaldysfunction.FASEBJ:11(13):10771089,1997</p><p>9. HerzenbergLA,DeRosaSC,DubsJGetal.GlutathionedeficiencyisassociatedwithimpairedsurvivalinHIVdisease.ProcNatlAcadSci94:196772,1997</p><p>10. KennedyR,KonokG,BounousGetal..Theuseofawheyproteinconcentrateinthetreatmentofpatientswithmetastaticcarcinoma:Aphase1IIclinicalstudy.AnticancerRes.15:264350,1995</p><p>11. LandsLC,GreyVL,SmountasAA.Effectofsupplementationwithacysteinedonoronmuscularperformance.J.Appl.Physiol.87:13811385,1999</p><p>12. LocignoR,CastronovoV.ReducedglutathioneSystem:Roleincancerdevelopment,preventionandtreatment.InternationalJournalofOncology19:221236,2001</p><p>13. LomaestroB,MaloneM.Glutathioneinhealthanddisease:pharmacotherapeuticissues.AnnPharmacother29:126373,1995</p><p>14. LothianB,GreyV,KimoffRJ,Lands.Treatmentofobstructiveairwaydiseasewithacysteinedonorproteinsupplement:acasereport.Chest117:914916,2000</p><p>15. MeisterA.Glutathione.AnnRevBiochem52:71160,198316. PetersonJD,HerzenbergLA,VasquezKK,WaltenbaughC.Glutathionelevelsinantigenpresentingcellsmodulate</p><p>Th1versusTh2responsepatterns.Proc.Natl.Acad.Sci.95:30713076,199817. TozerRG,TaiP,FalconerW,DucruetT,KarabadjianA,BounousG,MolsonJ,DrgeW.Cysteinerichproteinreverses</p><p>weightlossinlungcancerpatientsreceivingchemotherapyorradiotherapy.Antioxidants&amp;redoxsignaling.10:395402,2008.</p><p>18. WatanabeA,HigachiK,YasumuraS.etal.NutritionalmodulationofglutathionelevelandcellularimmunityinchronichepatitisBandC.Hepatology.24:597A,1996</p><p>19. WitschiA,ReddyS,StoferB,LauterbergB.Thesystemicavailabilityoforalglutathione.Eur.J.Clin.Pharmacol.43:667669,1992.</p></li></ul>

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