Kelompok 3. Enzyme Inhibitor Pengertian ; Inhibitor Inhibitor
Anti-Inhibitor, Factor VIIa & IX critical-care products ...
Transcript of Anti-Inhibitor, Factor VIIa & IX critical-care products ...
IVIG, SCIG, IGIM
FACTOR VIIa, VIII, IX
ALBUMIN
HYPERIMMUNES
FLU VACCINE
OTHER VACCINES
ANTITHROMBIN III
C1 ESTERASE INHIBITOR
OTHER SPECIALTY BIOLOGICALS
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Anti-Inhibitor,Factor VIIa & IX The critical-care products
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FFF Enterprises is the nation’s most trusted supplier of biopharmaceuticals, plasma products, vaccines and clinical trial drugs. Our partners include all manufacturers of influenza vaccines, and we serve over 80% of U.S. hospitals and supply the nation’s leading non-acute care GPO members. FFF Enterprises is committed to improving and stabilizing the supply of specialty pharmaceuticals through our Guaranteed Channel Integrity™.
FFF Enterprises’ commitment to Guaranteed Channel Integrity includes our secure supply channel, a dedicated Customer Care Team and FFF’s Advisor Lines, which offer reimbursement and infusion support to healthcare providers in all sites of care.
Infusion Advisor Line Our infusion specialist will answer your questions about the principles of intravenous and subcutaneous infusion therapy, cost-effective care and improving patient outcomes at (800) 843-7477.
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©2014 FFF Enterprises, Inc. Products and trademarks are the property of their respective owners. Reflects prescribing information for products as of June 2014. FL175 Rev0614
Now in our 26th counterfeit-free year, Guaranteed Channel Integrity™
is the result of our long-term commitment to purchase only from
manufacturers and ship only to healthcare providers to protect
you and your patients from the risks of counterfeiting,
drug diversion and irresponsible pricing.
Our proprietary Verified Electronic Pedigree™ system and Lot-Track™
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SOURCES •Manufacturers'fullprescribinginformation •RegistryofClottingFactorConcentrates,9thEdition,April2012.
KEYAICC anti-inhibitorcoagulantcomplex
DIC disseminatedintravascularcoagulation
IU internationalunit
MI myocardialinfarction
NOTES 1 Referalsotofullprescribinginformation.
2 ClinicalexperiencesuggeststhatpatientswithfactorVIIIinhibitorslessthan5BethesdaUnits(BU)maybesuccessfullytreatedwithantihemophilicfactor.Patientswithtitersrangingbetween5and 10BUmayeitherbetreatedwithantihemophilicfactororFEIBANF.CaseswithfactorVIIIinhibitortitersgreaterthan10BUhavegenerallybeenrefractorytotreatmentwithantihemophilicfactor.
3 ActualnumberofunitsoffactorVIIIinhibitorbypassingactivityisstatedonthelabelofeachvial.
4 AlphaNineSDcontainslow,non-therapeuticlevelsoffactorsII,VIIandX,andthereforeisnotindicatedforthetreatmentoffactorII,VIIorXdeficiencies.Notindicatedforthereversalofcoumarin anticoagulant-inducedhemorrhage,northetreatmentofhemophiliaApatientswithinhibitorstofactorVIII.
5BebulinisnotindicatedforthetreatmentoffactorVIIdeficiency.NoclinicalstudieshavebeenconductedtoshowbenefitfromproductfortreatingdeficienciesotherthanfactorIXdeficiency.
6BeneFIXisnotindicatedforreversalofcoumarin-inducedanticoagulationortreatmentof(1)otherfactordeficiencies,(2)hemophiliaApatientswithinhibitorstofactorVIII,or(3)bleedingdue tolowlevelsofliver-dependentcoagulationfactors.
7 Mononineisnotindicated(1)inthetreatmentorprophylaxisofhemophiliaApatientswithinhibitorstofactorVIII,(2)asreplacementtherapyoffactorsII,VIIorX,or(3)inthetreatmentor reversalofcoumarin-inducedanticoagulationorinahemorrhagicstatecausedbyhepatitis-inducedlackofproductionofliver-dependentcoagulationfactors.
Theinformationpresentedinthisguideisnotmeanttoserveasaguidelineforpatientmanagement.Anyprocedures,medicationsorothercoursesofdiagnosisortreatmentdiscussedorsuggestedinthisguideshouldnotbeusedbyclinicianswithoutfullevaluationoftheirpatients’conditionsandpossiblecontraindicationsondangersinuse,reviewofanyapplicablemanufacturer’sproductinformation,andcomparisonwithrecommendationsofotherauthorities.
Anti-Inhibitor, Factor VIIa & IX ReferenceChart (800) 843-7477Emergency Orders 24/7/365
Place an Order
FFFenterprises.comMyFluVaccine.com
Online Ordering FAX (800) 418-4333 EMAIL [email protected]
REGULAR ORDERING HOURS8am - 8pm ET | 7am - 7pm CT | 6am - 6pm MT | 5am - 5pm PT
SHIPPING
FOB Origin - Standard: Overnight or 2 day delivery
FOB Destination - Expedited: Same day
Wow! Customer Care Ordering
PreventionandcontrolofbleedinginpatientswithfactorIXdeficiencyduetohemophiliaB.4
Inspectvisuallyforparticulatematteranddiscolorationpriortoadministration.Administerwithin3hoursafterreconstitution.
Donotrefrigerateafterreconstitution.UseplasticluerlocksyringesbecauseproteinsuchasFEIBAtendstostick
tothesurfaceofall-glasssyringes.
FEIBA®
Baxter
(800) 423-2090 (877) 668-6777
InhemophiliaAandBpatientswithinhibitors:
1) Controlandpreventionofbleedingepisodes2) Perioperativemanagement3) Routineprophylaxistopreventorreducethe frequencyofbleedingepisodes.2
InadultsandchildrenwithhemophiliaB:
1) Controlandpreventionofbleedingepisodes2) Perioperativemanagement3) Routineprophylaxistopreventorreduce thefrequencyofbleedingepisodes
500,1000and2500units3
1) KnownanaphylacticorseverehypersensitivityreactionstoFEIBAor anyofitscomponents,includingfactorsofthekiningeneratingsystem.2) Disseminatedintravascularcoagulation(DIC).3) Acutethrombosisorembolism(includingMI).
35nmnanofiltrationandvaporheattreatment
Notstatedinprescribinginformation
Trisodiumcitrate
Mustnotexceed2unitsperkgofbodyweightperminute.
20mLor50mL(inaccordancewithproductpotency)
SterileWaterforInjection,USP,andaBAXJECTIIHi-FlowNeedlelessTransferDevice
Storeatroomtemperature,nottoexceed25˚C(77˚F).
Alprolix™AlphaNine® SD
Biogen IdecGrifols
(855) 692-5776(800) 520-2807
500IU,1000IU,2000IU,3000IU500IU,1000IU,1500IU
Individualswhohaveaknownhistoryofhypersensitivityreactions,includinganaphylaxis,totheproductoritsexcipients.Noneknown
Nanofiltration,columnchromatographypurificationSolvent/detergent,nanofiltration
66.40to86.52hours(variesbyagerange;seeprescribinginformation)~21hours
Mannitol,L-histidineandpolysorbate-20andsucroseDextroseandpolysorbate-80
Shouldbedeterminedbythepatient'scomfortlevel,andnofasterthan10mLperminute.Nottoexceed10mL/minute.
5mLforalldosagestrengths10mL
Prefilledsyringecontaining5mLdiluent(sealedwithplungerstopperandtip-cap)andasterilevialadapter(reconstitutiondevice).10mLSterileWaterforInjection,USPandMix2Vial™filtertransferset
Storeat2°Cto8°C(36°Fto46°F).Ifstoredatroomtemperature(RT),donotexceed30°C(86°F)forasingle6monthperiod.Donotplaceproduct
backintorefrigerationafterwarmingtoRT.ReconstitutedproductmaybestoredatRT,nottoexceed30°C(86°F)fornolongerthan3hours.
Donotfreezetopreventdamagetodiluentsyringe.
Storeattemperaturesbetween2–8°C(36–46°F).Donotfreezetopreventdamagetothediluentvial.Maybestored
atroomtemperaturenottoexceed30°C(86°F)for1month.
Administerwithin3hoursofreconstitution.Donotrefrigerateafterreconstitution.Keepawayfromdirectsunlight.Inspectforparticulate
matteranddiscolorationpriortoadministration.Donotadministerinthesametubingorcontainerwithothermedicinalproducts.
Warmdiluentandconcentratevialtoatleastroomtemperaturebeforereconstitution(butnotabove37˚C).Inspectforparticulate
matteranddiscolorationpriortoadministration.Usereconstitutedproductwithin3hoursofreconstitution.
Profilnine®
Grifols
(800) 520-2807
PreventionandcontrolofbleedinginpatientswithfactorIXdeficiency(hemophiliaB).
500IU,1000IU,1500IU
Noneknown
Solventdetergent
Nottoexceed10mL/minute.
500IU=5mL;1000IU=10mL;1500IU=10mL
SterileWaterforInjection,USPandMix2Vial™filtertransferset
Stablefor3years,uptotheexpirationdateprintedonitslabel,providedthatthestoragetemperaturedoesnotexceed
25°C(77°F).Donotfreeze.
Inspectvisuallyforparticulatematteranddiscolorationpriortoadministration.Administeratroomtemperature.Ensurethat
concentrateanddiluentareatroomtemperature(butnotabove37°C)beforereconstitution.Whilestablefor3hoursafterreconstitution,
promptadministrationisrecommended.
BeneFIX®
Pfizer
(800) 438-1985
1) Controlandpreventionofbleedingepisodesinadultand pediatricpatientswithhemophiliaB(congenitalfactorIX deficiencyorChristmasdisease).2) Peri-operativemanagementofadultand pediatricpatientswithhemophiliaB.6
250IU,500IU,1000IU,2000IU,3000IU
Patientswhohavemanifestedlife-threatening,immediatehypersensitivityreactions,includinganaphylaxis,totheproduct
oritscomponents,includinghamsterprotein
Nanofiltration
~18.8hours±5.4hours;range11to36hours
L-histidine,glycine,sucroseandpolysorbate-80
Administeroveraperiodofseveralminutes;adaptratetothecomfortlevelofeachindividualpatient.
5mLforalldosagestrengths
Sterileprefilleddiluentsyringe,vialadapterreconstitutiondevice,sterileinfusionset,2alcoholswabs,1bandageand1gauzepad.
Productmaybelabeledforeitherroomtemperaturestorageorrefrigeration;forstorageandhandlinginformationrefer
tofullprescribinginformationaccompanyingproduct.Donotfreezetopreventdamagetothediluentsyringe.
Inspectforparticulatematteranddiscolorationpriortoadministration.Reconstitutedproductshouldappearclearandcolorless.Administeratroomtemperature.Useproductwithin3hoursofreconstitution.Ifredbloodcellagglutinationisobservedinthetubingorsyringe,discard
allmaterials(tubing,syringeandBeneFIXsolution)andresumeadministrationwithanewpackage.
Mononine®
CSL Behring
(800) 504-5434
PreventionandcontrolofbleedinginfactorIXdeficiency,alsoknownashemophiliaBorChristmasdisease.7
500IU,1000IU
Knownhypersensitivitytomouseprotein
Monoclonalantibodyimmunoaffinitychromatography,sodiumthiocyanateandultrafiltration
Histidine,mannitolandpolysorbate-80
Therateofadministrationshouldbedeterminedbytheresponseandcomfortofthepatient;intravenousdosageadministrationratesofupto
225IU/minutehavebeenregularlytoleratedwithoutincident.Whenreconstitutedasdirected,i.e.,toapproximately100IU/mL,Mononineshouldbeadministeredatarateofapproximately2.0mLperminute.
500IU=5mL;1000IU=10mL
SterileWaterforInjectionUSPdiluent,double-endedneedleforreconstitution,ventedfilterspikeforwithdrawal,wingedinfusionsetandalcoholswabs
Whenstoredatrefrigeratortemperatureof2–8°C(36–46°F),Mononineisstablefortheperiodindicatedbytheexpirationdateonitslabel.
Withinthisperiod,Mononinemaybestoredatroomtemperaturenottoexceed25°C(77°F),forupto1month.Avoidfreezing,which
maydamagecontainerforthediluent.
Inspectforparticulatematteranddiscolorationpriortoadministration.Usereconstitutedproductwithin3hoursofreconstitution.
Useofplasticdisposablesyringesisrecommended.
Bebulin®
Baxter
(800) 423-2090
PreventionandcontrolofhemorrhagicepisodesinhemophiliaBpatients.5
FactorIXactivityinIUsisstatedonthelabelofeachvial
Knownhistoryofhypersensitivityreactionstotheproduct.Knownallergytoheparin.Knownhistoryofheparin-inducedthrombocytopenia.
19.97hours±8.24hours
Heparinadded
Nanofiltrationandvaporheattreatment
Administerataratecomfortabletopatient.Maximumrate2mL/minute.
20mLforalldosagestrengths
SterileWaterforInjection,USPdiluent,double-endedneedleandfilterneedleforreconstitutionandwithdrawal
Storeatrefrigeratortemperature,2–8˚C(36–46˚F).Donotfreeze.
Inspectforparticulatematteranddiscolorationpriortoadministration.Administeratroomtemperature.Donotrefrigerateafterreconstitution.
Usereconstitutedproductwithin3hoursofreconstitution.
Administrationshouldtakeplacewithin3hoursafterreconstitution.Inspectvisuallyforparticulatematteranddiscolorationpriortoadministration.
Donotmixwithinfusionsolutions.IflineneedstobeflushedbeforeorafterNovoSevenRTadministration,use0.9%SodiumChlorideInjection,USP.
Refertofullprescribinginformation;administerasaslowbolusinjectionover2to5minutes,dependingonthedoseadministered.
Novo Nordisk
1)TreatmentofbleedingepisodesinhemophiliaAorBpatientswithinhibitorstofactorVIIIorfactorIXandinpatientswithacquiredhemophilia,2)PreventionofbleedinginsurgicalinterventionsorinvasiveproceduresinhemophiliaAorBpatientswithinhibitorstofactorVIIIorfactorIXandinpatientswithacquiredhemophilia,3)Treatmentofbleedingepisodesinpatientswithcongenitalfactor
VII(FVII)deficiency,4)PreventionofbleedinginsurgicalinterventionsorinvasiveproceduresinpatientswithcongenitalFVIIdeficiency.
1mg(1000mcg),2mg(2000mcg),5mg(5000mcg)and8mg(8000mcg)
NovoSevenRTpurificationprocess
HemophiliaAorB:2.3hours(range1.7–2.7).CongenitalfactorVIIdeficiency:2.82to3.11hours.
Mannitol,L-histidine,sucrose,polysorbate-80andcalciumchloridedihydrate
NovoSevenRT:1vialofhistidinediluent
NovoSevenRTwithMixPro™:1prefilledhistidinediluentsyringewithsterilevialadapter
Priortoreconstitution,storeNovoSevenRTpowderandhistidinediluentbetween2–25°C(36–77°F).Donotfreeze.Storeprotectedfromlight.
Afterreconstitution,NovoSevenRTmaybestoredeitheratroomtemperatureorrefrigeratedforupto3hours.Donotfreeze
reconstitutedproductorstoreinsyringes.
NovoSeven® RTAICC VIIa IXIX IX IX IX IX
10mmolsolutionofL-histidineinwaterforinjection
Anti-InhibitorCoagulantComplex CoagulationFactorVIIa(Recombinant)RoomTemperature-Stable CoagulationFactorIX(Recombinant),FcFusionProteinCoagulationFactorIX(Human) FactorIXComplex,NanofilteredandVaporHeated CoagulationFactorIX(Recombinant) CoagulationFactorIX(Human),MonoclonalAntibodyPurified FactorIXComplex,Solvent/DetergentTreated/Nanofiltered
None
~22.6hours ~24.68hours±8.29hours
Polysorbate-80
Contraindications
ProductName
Manufacturer
ManufacturerContactNumber
ProductDescriptor
Indications
ViralRemoval/Inactivation
Stabilization
OtherAdministrationConsiderations1
DosageStrengths
SerumHalf-Life(Mean)
OtherPackageContents
DiluentVolume
Storage
RateofAdministration1