PLASMA - LYTE A INJECTION pH 7.4

" עעבקנהזןולעטמרופ " רשואוקדבנונכותותואירבהדרשמי ." רשואמןולע : יאמ 2008 .

“This leafletformat has beendetermined bythe MinistryofHealthand thecontentthereofhasbeen

checkedandapproved.”Date ofapproval:May 2008.

PLASMA-LYTE A Injection pH 7.4 (Multiple

Electrolytes Injection, Type 1, USP)

in VIAFLEXPlastic Container

Description

PLASMA-LYTE A Injection pH7.4(Multiple Electrolytes Injection,Type1, USP)isa

sterile,nonpyrogenic isotonic solutioninasingledosecontainer for intravenous

administration.Each100mLcontains526mg ofSodiumChloride,USP(NaCI); 502

mgofSodiumGluconate (C

);368mgof SodiumAcetate Trihydrate, USP

3H

0);37mgofPotassiumChloride,USP(KCI);and30mgofMagnesium

Chloride, USP (MgCI

6H

0). It contains no antimicrobial agents. The pH is adjusted

withsodiumhydroxide.The pH is 7.4(6.5 to 8.0).

PLASMA-LYTE A InjectionpH7.4(MultipleElectrolytes Injection,Type 1,USP)

administered intravenouslyhasvalue asasource ofwater,electrolytes,andcalories.

Oneliterhasanionicconcentrationof140 mEqsodium, 5mEqpotassium,3 mEq

magnesium,98 mEqchloride,27mEq acetate,and 23 mEqgluconate.The osmolarity

is294 mOsmol/L (calc.). Normalphysiologic osmolarityrange is 280 to 310

mOsmol/L. Administration of substantially hypertonic solutions maycausevein

damage. The calorie content is21kcal/L.

The VIAFLEXplastic container isfabricatedfroma specially formulated polyvinyl

chloride (PL146 Plastic). The amount ofwater that canpermeate frominsidethe

container intothe overwrap is insufficient to affectthesolutionsignificantly.Solutions

incontactwiththeplasticcontainercanleachoutcertainofitschemicalcomponentsin

verysmallamountswithin the expiration period, e.g., di-2-ethylhexyl phthalate

(DEHP), upto5 parts per million.However, thesafetyof theplastic has beenconfirmed

in tests inanimalsaccording toUSPbiologicaltests for plasticcontainersaswellasby

tissue culture toxicity studies.

ClinicalPharmacology

PLASMA-LYTE A Injection pH 7.4 (Multiple ElectrolytesInjection,Type1, USP)has

value as asource ofwater andelectrolytes. It is capable of inducingdiuresis

depending onthe clinical condition ofthe patient.

PLASMA-LYTE AInjectionpH7.4(MultipleElectrolytes Injection,Type1, USP)

producesametabolic alkalinizingeffect.Acetateandgluconate ionsaremetabolized

ultimatelytocarbondioxideandwater,whichrequirestheconsumptionofhydrogen

cations.

Indications andUsage

PLASMA-LYTE A Injection pH 7.4 (Multiple ElectrolytesInjection, Type1, USP)is

indicatedasasourceofwaterandelectrolytesorasanalkalinizingagent.

PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type1, USP)is

compatiblewith bloodor bloodcomponents. Itmay beadministeredpriortoor

following theinfusion ofblood throughthe sameadministrationset (i.e.,asa priming

solution),added toor infused concurrentlywithblood components,or usedas adiluent

inthetransfusion of packed erythrocytes. PLASMA-LYTEA Injectionand0.9% Sodium

ChlorideInjection,USP are equallycompatiblewithblood orblood components.

Contraindications

None known.

Warnings

PLASMA-LYTEA Injection pH7.4 (Multiple Electrolytes Injection, Type 1,USP) should

beusedwithgreatcare,ifatall,inpatientswithcongestiveheartfailure,severerenal

insufficiency,andinclinicalstatesinwhichthereexistsedemawithsodiumretention.

PLASMA-LYTEA Injection pH7.4 (Multiple Electrolytes Injection,Type1,USP)should

be usedwithgreat care,ifatall, inpatientswithhyperkalemia,severerenalfailure,and

in conditionsin whichpotassium retentionispresent.

PLASMA-LYTEA Injection pH7.4 (Multiple Electrolytes Injection, Type 1,USP) should

be usedwith greatcare inpatients withmetabolic orrespiratoryalkalosis.The

administrationof acetateor gluconate ions shouldbedonewithgreatcareinthose

conditionsinwhichthereisanincreasedlevel or an impairedutilization ofthese ions,

suchasseverehepaticinsufficiency.

The intravenous administration ofPLASMA-LYTEA Injection pH7.4 (Multiple

ElectrolytesInjection, Type1,USP) cancausefluidand/orsoluteoverloadingresulting

indilutionofserumelectrolyteconcentrations,overhydration,congestedstates,or

pulmonaryedema.The risk of dilutional states is inversely proportional to the

electrolyteconcentrations of the injection. The risk of solute overload causing

congested stateswith peripheral and pulmonary edemais directlyproportionaltothe

electrolyte concentrations of the injection.

In patientswith diminished renal function, administration ofPLASMA-LYTEAInjection

pH 7.4 (MultipleElectrolytes Injection,Type 1,USP)mayresultinsodiumor

potassium retention.

Precautions

Clinical evaluationandperiodic laboratory determinationsare necessarytomonitor

changes influid balance, electrolyte concentrations,and acid basebalanceduring

prolongedparenteraltherapy or whenever thecondition ofthe patientwarrants such

evaluation.

PLASMA-LYTEA Injection pH7.4 (Multiple Electrolytes Injection,Type1,USP)should

be usedwithcaution.Excess administrationmay resultinmetabolicalkalosis.

Cautionmustbeexercised inthe administrationofPLASMA-LYTEAInjection pH7.4

(MultipleElectrolytes Injection,Type1, USP)topatients receivingcorticosteroidsor

corticotropin.

Pregnancy:TeratogenicEffects

PregnancyCategoryC.Animal reproductionstudieshavenotbeenconductedwith

PLASMA-LYTE AInjection pH7.4 (MultipleElectrolytes Injection,Type1, USP). Itis

also not knownwhetherPLASMA-LYTEA InjectionpH7.4(MultipleElectrolytes

Injection,Type1,USP)cancausefetal harm when administeredto a pregnant woman

or can affect reproduction capacity. PLASMA-LYTEA InjectionpH7.4(Multiple

ElectrolytesInjection, Type1, USP)should begiven to apregnant womanonlyifclearly

needed.

Pediatric Use

Safety andeffectiveness of PLASMA-LYTE A Injection pH7.4 (MultipleElectrolytes

Injection,Type 1,USP) inpediatricpatients have not beenestablished byadequate and

wellcontrolledtrials,however,theuseofelectrolytesolutionsinthepediatric

population is referencedin the medical literature. The warnings, precautions and

adversereactionsidentified inthe label copyshouldbeobservedinthe pediatric

population.

Geriatric Use

Clinicalstudies of PLASMA-LYTEA Injection pH7.4 (Multiple ElectrolytesInjection,

Type1,USP)didnot include sufficientnumbers ofsubjects aged65andoverto

determinewhethertheyresponddifferentlyfromyoungersubjects.Otherreported

clinicalexperiencehasnotidentifieddifferences inresponsesbetween the elderlyand

younger patients. In general, dose selection foran elderlypatient should be cautious,

usually starting at the low end of thedosing range, reflecting thegreaterfrequencyof

decreasedhepatic, renal, or cardiac function,and of concomitant disease or drug

therapy.

Do not administer unless solution is clear and sealis intact.

Drug/LaboratoryTest Interactions

There havebeen reports of positive test results using the Bio-RadLaboratories

PlateliaAspergillusEIA test in patients receiving Baxter gluconate containing

PlasmalyteSolutions.These patients weresubsequently foundto be freeof

Aspergillusinfection. Therefore, positive test results for this test in patients receiving

Baxter gluconate containing Plasmalyte solutions should beinterpreted cautiously

and confirmed by other diagnosticmethods.

Adverse Reactions

Reactionswhichmay occurbecauseof the solution orthe technique ofadministration

include febrile response, infectionat thesiteof injection, venous thrombosisor

phlebitis extending fromthe site of injection, extravasation, and hypervolemia.

If an adverse reactiondoes occur, discontinue the infusion, evaluatethe patient,

instituteappropriate therapeutic countermeasures,and savetheremainderofthefluid

for examination ifdeemed necessary.

DosageandAdministration

As directedby a physician. Dosageis dependent upon theage, weightand clinical

condition ofthe patient as well as laboratorydeterminations. Parenteral drug products

should beinspectedvisually forparticulatematter anddiscoloration prior to

administration whenever solution and containerpermit.

All injectionsinVIAFLEX plastic containersare intendedforintravenous administration

using sterileequipment.

Additives may be incompatible. Complete information is notavailable. Those additives

known to beincompatibleshould notbe used. Consult withpharmacist,ifavailable.If,

in the informed judgment of thephysician,itisdeemedadvisabletointroduce

additives, use aseptictechnique.Mix thoroughly whenadditives havebeen

introduced.Do not store solutions containing additives.

HowSupplied

PLASMA-LYTEA Injection pH7.4(Multiple Electrolytes Injection,Type1, USP) in

VIAFLEXplasticcontainers is availableas shownbelow:

Code Size (mL) NDC

2B2544 1000 NDC 0338-0221-04

2B2543 500 NDC 0338-0221-03

Exposure ofpharmaceutical productsto heat should be minimized. Avoid excessive

heat. It is recommended the product be storedat room temperature (25°C); brief

exposure up to 40°C does not adversely affect the product.

DirectionsforUseofVIAFLEXPlasticContainer

Warning:Donot use plastic containers inseriesconnections.Suchusecouldresultin

air embolism due toresidual airbeing drawn fromtheprimary container before

administration of the fluid fromthe secondary containeriscompleted.

To Open

Tearoverwrapdownsideatslitandremovesolutioncontainer.Someopacityof the

plastic dueto moisture absorptionduringthesterilization processmaybe observed.

This is normal anddoes not affectthe solutionquality or safety. The opacitywill

diminish gradually. Check for minuteleaks by squeezing inner bag firmly. If leaks are

found,discardsolutionassterility may beimpaired.Ifsupplementalmedicationis

desired, follow directionsbelow.

Preparationfor Administration

1.Suspend container fromeyelet support.

2.Remove plastic protector fromoutletport at bottom of container.

3.Attachadministrationset.Refer tocompletedirectionsaccompanyingset.

To Add Medication

Warning:Additivesmay be incompatible.

To addmedication before solutionadministration

1.Preparemedicationsite.

2.Using syringewith19to22 gauge needle, puncture resealable medicationport

and inject.

3.Mix solution and medication thoroughly. For high density medicationsuchas

potassiumchloride,squeezeportswhileportsareuprightandmixthoroughly.

To addmedicationduring solutionadministration

1.Close clamp onthe set.

2.Preparemedicationsite.

3.Using syringe with19to22 gaugeneedle,punctureresealablemedicationportand

inject.

4.Remove container fromIVpole and/orturn to anupright position.

5.Evacuatebothportsbysqueezingthemwhilecontainer isinthe uprightposition.

6.Mix solutionand medication thoroughly.

7. Return container to inuse position and continueadministration.

Drug Registration N O .: 042 29 23222 00

Baxter Healthcare Corporation

Deerfield, IL60015 USA

Printed in USA

Importer

Teva Medical Marketing Ltd.,

Haorgim St.2, Ashdod 77100.

Copyright 1978,1981,1982,1983, 1984,1989,1993,1995, BaxterHealthcareCorporation.

Allrightsreserved.

07-19-55-071

Rev.December 2007

BAXTER, PLASMA-LYTE, VIAFLEX,AND PL 146 ARETRADEMARKSOF BAXTERINTERNATIONAL INC