Pdr en 2013 (1)

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  1. 1. AslistedinthePhysiciansDeskReference(PDR) IMMUNOCAL PDR 2013 NUTRACEUTICAL Glutathioneprecursor(Bondedcysteinesupplement) PowderSachets DESCRIPTIONandCLINICALPHARMACOLOGY IMMUNOCALisaU.S.patentednaturalfoodproteinisolateintheFDA categoryofGRAS(generallyrecognizedassafe)whichassiststhebodyin maintainingoptimalconcentrationsofglutathione(GSH)bysupplyingthe precursorsrequiredforintracellularglutathionesynthesis.Itisclinically proventoraiseglutathionevalues. Glutathioneisatripeptidemadeintracellularlyfromitsconstituent aminoacidsLglutamate,Lcysteineandglycine.Thesulfhydryl(thiol) group(SH)ofcysteineisresponsibleforthebiologicalactivityofglutathione.Provisionofthisaminoacidistherate limitingfactoringlutathionesynthesisbythecellssincebioavailablecysteineisrelativelyrareinfoodstuffs. Immunocalisabovinewheyproteinisolatespeciallypreparedsoastoprovidearichsourceofbioavailablecysteine. Immunocalcanthusbeviewedasacysteinedeliverysystem. Thedisulphidebondincystineispepsinandtrypsinresistantbutmaybesplitbyheat,lowpHormechanicalstress releasing free cysteine. When subject to heat or shearing forces (inherent in most extraction processes), the fragile disulfidebondswithinthepeptidesarebrokenandthebioavailabilityofcysteineisgreatlydiminished. Glutathioneisatightlyregulatedintracellularconstituentandislimitedinitsproductionbynegativefeedbackinhibition ofitsownsynthesisthroughtheenzymegammaglutamylcysteinesynthetase,thusgreatlyminimizinganypossibilityof overdosage. Glutathionehasmultiplefunctions: 1. Itisthemajorendogenousantioxidantproducedbythecells,participatingdirectlyintheneutralizationoffree radicalsandreactiveoxygencompounds,aswellasmaintainingexogenousantioxidantssuchasvitaminsCandE intheirreduced(active)forms. 2. Throughdirectconjugation,itdetoxifiesmanyxenobiotics(foreigncompounds)andcarcinogens,bothorganic andinorganic. 3. It is essential for the immune system to exert its full potential, e.g. (1) modulating antigen presentation to lymphocytes,therebyinfluencingcytokineproductionandtypeofresponse(cellularorhumoral)thatdevelops, (2) enhancing proliferation of lymphocytes thereby increasing magnitude of response, (3) enhancing killing activityofcytotoxicTcellsandNKcells,and(4)regulatingapoptosis,therebymaintainingcontroloftheimmune response. 4. ItplaysafundamentalroleinnumerousmetabolicandbiochemicalreactionssuchasDNAsynthesisandrepair, proteinsynthesis,prostaglandinsynthesis,aminoacidtransportandenzymeactivation.Thus,mostsystemsin thebodycanbeaffectedbythestateoftheglutathionesystem,especiallytheimmunesystem,thenervous system,thegastrointestinalsystemandthelungs.
  2. 2. INDICATIONSANDUSAGE IMMUNOCALisanaturalfoodsupplementandassuchislimitedfromstatingmedicalclaimsperse.Statementshave 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, immunedeficiency,andxenobioticoverloadinwhichglutathioneplaysapartinthedetoxificationofthexenobioticin question.Glutathionedeficiencystatesinclude,butarenotlimitedto:HIV/AIDS,infectioushepatitis,certaintypesof cancers,cataracts,AlzheimersDisease,Parkinsons,chronicobstructivepulmonarydisease,asthma,radiation,poisoning byacetominophenandrelatedagents,malnutritivestates,arduousphysicalstress,aging,andhasbeenassociatedwith suboptimalimmuneresponse.Manyclinicalpathologiesareassociatedwithoxidativestressandareelaboratedupon innumerousmedicalreferences. Lowglutathioneisalsostronglyimplicatedinwastingandnegativenitrogenbalance,notablyasseenincancer,AIDS, sepsis,trauma,burnsandevenathleticovertraining.CysteinesupplementationcanopposethisprocessandinAIDS,for example,resultinimprovedsurvivalrates. CONTRAINDICATIONS IMMUNOCALiscontraindicatedinindividualswhodeveloporhaveknownhypersensitivitytospecificmilkproteins. PRECAUTIONS EachsachetofIMMUNOCALcontainsninegramsofprotein.Patientsonaproteinrestricteddietneedtotakethisinto accountwhencalculatingtheirdailyproteinload.Althoughabovinemilkderivative,IMMUNOCALcontainslessthan 1%lactoseandthereforeisgenerallywelltoleratedbylactoseintolerantindividuals. WARNINGS Patientsundergoingimmunosuppressivetherapyshoulddiscusstheuseofthisproductwiththeirhealthprofessional. Individuals with the autosomalrecessive metabolic disorder cystinuria, are at higher risk of developing cysteine nephrolithiasis(12%ofrenalcalculi). ADVERSEREACTIONS Gastrointestinal bloating and cramps if not sufficiently rehydrated. Transient urticariallike rash in rare individuals undergoingseveredetoxificationreaction.Rashabateswhenproductintakestoppedorreduced. OVERDOSAGE OverdosingonIMMUNOCALhasnotbeenreported. DOSAGEANDADMINISTRATION Formildtomoderatehealthchallenges,20gramsperdayisrecommended.ClinicaltrialsinpatientswithAIDS,COPD, cancer and chronic fatigue syndrome have used 3040 grams per day without ill effect. IMMUNOCAL is best administeredonanemptystomachorwithalightmeal.Concomitantintakeofanotherhighproteinloadmayadversely affectabsorption. RECONSTITUTION IMMUNOCAL is a dehydrated powdered protein isolate. It must be appropriately rehydrated before use. Ideally consumedaftermixing.Ifitispremixedforlaterconsumption,itshouldberefrigeratedandconsumedshortlyafter mixing.DONOTheatoruseahotliquidtorehydratetheproduct.DONOTuseahighspeedblenderforreconstitution. Thesemethodswilldecreasetheactivityoftheproduct. Propermixingisimperative.Consultinstructionsincludedinpackaging.
  3. 3. HOWSUPPLIED 10gramsofbovinemilkproteinisolatepowderpersachet. 30sachetsperbox. STORAGE Storeinacooldryenvironment.Refrigerationisnotnecessary. Patentno.'s:5,230,9025,290,5715,456,9245,451,4125,888,552 REFERENCES 1. BaruchelS,ViauG,OlivierR.etal.Nutraceuticalmodulationofglutathionewithahumanizednativemilkserum proteinisolate,Immunocal :applicationinAIDSandcancer.In:OxidativeStressinCancer,AIDSand NeurodegenerativeDiseases.Ed.;MontagnierL,OlivierR,PasquierC.MarcelDekkerInc.NewYork,447461,1998 2. BounousG,KongshavnP.Influenceofproteintypeinnutritionallyadequatedietsonthedevelopmentofimmunity. InAbsorptionandUtilizationofAminoAcidsVol.II.Ed.M.Friedman.CRCPress,Inc.,Fla.2:21932,1989 3. BounousG,GoldP.Thebiologicalactivityofundenaturedwheyproteins:roleofglutathione.ClinInvestMed 14:296309,1991 4. BounousG,BaruchelS,FalutzJ.GoldP.WheyproteinsasafoodsupplementinHIVseropositiveindividuals.Clin InvestMed.16:3;204209,1992 5. BounousG.Wheyproteinconcentrate(WPC)andglutathionemodulationincancertreatment.AnticancerRes. 20:47854792,2000 6. BounousG.ImmunoenhancingpropertiesofundenaturedmilkserumproteinisolateinHIVpatients.Int.DiaryFed: Whey:293305,1998 7. BrayT,TaylorC.Enhancementoftissueglutathioneforantioxidantandimmunefunctionsinmalnutrition.Biochem. Pharmacol.47:21132123,1994. 8. DrogeW,HolmE.RoleofcysteineandglutathioneinHIVinfectionandotherdiseasesassociatedwithmuscle wastingandimmunologicaldysfunction.FASEBJ:11(13):10771089,1997 9. HerzenbergLA,DeRosaSC,DubsJGetal.GlutathionedeficiencyisassociatedwithimpairedsurvivalinHIVdisease. ProcNatlAcadSci94:196772,1997 10. KennedyR,KonokG,BounousGetal..Theuseofawheyproteinconcentrateinthetreatmentofpatientswith metastaticcarcinoma:Aphase1IIclinicalstudy.AnticancerRes.15:264350,1995 11. LandsLC,GreyVL,SmountasAA.Effectofsupplementationwithacysteinedonoronmuscularperformance.J.Appl. Physiol.87:13811385,1999 12. LocignoR,CastronovoV.ReducedglutathioneSystem:Roleincancerdevelopment,preventionandtreatment. InternationalJournalofOncology19:221236,2001 13. LomaestroB,MaloneM.Glutathioneinhealthanddisease:pharmacotherapeuticissues.AnnPharmacother29: 126373,1995 14. LothianB,GreyV,KimoffRJ,Lands.Treatmentofobstructiveairwaydiseasewithacysteinedonorprotein supplement:acasereport.Chest117:914916,2000 15. MeisterA.Glutathione.AnnRevBiochem52:71160,1983 16. PetersonJD,HerzenbergLA,VasquezKK,WaltenbaughC.Glutathionelevelsinantigenpresentingcellsmodulate Th1versusTh2responsepatterns.Proc.Natl.Acad.Sci.95:30713076,1998 17. TozerRG,TaiP,FalconerW,DucruetT,KarabadjianA,BounousG,MolsonJ,DrgeW.Cysteinerichproteinreverses weightlossinlungcancerpatientsreceivingchemotherapyorradiotherapy.Antioxidants&redoxsignaling.10:395 402,2008. 18. WatanabeA,HigachiK,YasumuraS.etal.Nutritionalmodulationofglutathionelevelandcellularimmunityin chronichepatitisBandC.Hepatology.24:597A,1996 19. WitschiA,ReddyS,StoferB,LauterbergB.Thesystemicavailabilityoforalglutathione.Eur.J.Clin.Pharmacol. 43:667669,1992.

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