DePuy CMW 1 Gentamicin bone cement 1.7%w/w

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Gentamicin
Available from:
Johnson & Johnson Medical New Zealand Ltd
Dosage:
1.7%w/w
Pharmaceutical form:
bone cement
Units in package:
Ampoule, 40g pack/monomer in blister, 18.37 g
Class:
Prescription
Manufactured by:
DePuy International Ltd T/A DePuy CMW
Authorization number:
8008
Authorization date:
1999-04-03

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Name ofMedicine

DEPUYCMW 1 GENTAMICIN BONE CEMENT

DEPUYCMW 2 GENTAMICIN BONE CEMENT

DEPUYCMW 3 GENTAMICIN BONE CEMENT

Antibiotic BoneCementcontainingGentamicinSulphate 2.9%w/w,equivalent

to 1.7%w/wGentamicinbasein the preparedbonecement.

Presentation

DePuy CMW1Gentamicin BoneCement, DePuy CMW2Gentamicin Bone

Cement and DePuy CMW3 Gentamicin BoneCement are supplied as two-

component presentations consistingofbone cementpowder,containing

GentamicinSulphate,andbonecementliquid.These two components are

mixedtogetherbeforeuse toformthe preparedbonecement.DePuyCMW1

GentamicinBoneCement,DePuyCMW2 GentamicinBone Cementand

DePuy CMW3Gentamicin BoneCementare available in20g or 40g unit

packs sizes.Eachunitpack consists of20gor40g bonecement powderina

sterilebagandbone cement liquid inasterile ampoule. (SeePACKAGE

QUANTITIES and FURTHERINFORMATION for full product descriptions.)

Uses

Actions

DePuy CMW1Gentamicin BoneCement, DePuy CMW2Gentamicin Bone

Cement and DePuy CMW3 Gentamicin BoneCement are self-curing,

radiopaque, polymethyl methacrylate based cements, containingantibiotic,

usedfor securingametal orpolymericprosthesis tolivingboneinarthroplasty

procedures.The bonecements havenointrinsicadhesiveproperties,but rely

instead onclosemechanicalinterlock betweentheirregular bone surfaceand

the prosthesis.

DePuy CMW1Gentamicin BoneCementisahigh viscosity cement intended

for either digitalor syringe application.

DePuy CMW2Gentamicin BoneCementisafast-settingcementdesigned

fordigital application to small jointssuch asthepatellaoftheknee andthe hip

acetabulum.

DePuy CMW3Gentamicin BoneCementisamedium viscosity cement that is

primarilyintended for syringeapplication.IfDePuyCMW3 Gentamicinis

applied digitally, the surgeon mustuse theirclinicaljudgementto decide when

the cementis of a suitable viscosity toallowthesurgical procedure to

continue.

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Thepowder component is a white, finely divided powder, composed of a

polymethylmethacrylatebased polymer.The powdercontains gentamicin

sulphatefor anancillary,local antibiotic effect.Benzoyl peroxideispresentin

the powdercomponenttoinitiatecement polymerisationwhenthe powder and

liquidcomponents aremixed. The powder componentalsocontains the

radiopaqueagentbariumsulphate.

Gentamicinis a well-establishedpotent aminoglycoside broad-spectrum

antibioticwhich is especially effectiveagainstinfectionscausedby gram-

negativebacteria. It is alsostableto the heat generatedduring thecement

setting process andtothegamma irradiationused tosterilise thebone

cementpowder. Gentamicin incorporated intothebone cement is eluted

rapidly fromthecured cement into thebody fluidsatthe operative site.

Gentamicinis an aminoglycoside antibiotic derived fromMicromonospora

purpurea.Itis commercially available asapharmacopoeial material (BP,

Ph.Eur), which iscomprisedofacomplexmixtureof the sulphatesof

Gentamicin C

, GentamicinC

, GentamicinC

and,toa lesserextent,

Gentamicin C

.TheGentamicins are characterised by 4,6-substitutionona

central 2-deoxystreptamineringwith cyclic amino-sugars attachedby

glycosidic linkages; they are broad-spectrum,basic,heatstable, watersoluble

antibioticswhich maybe sterilised by gammairradiation.

TheGentamicincomplex is bactericidalandis thoughttointerferewith

bacterialprotein synthesisbybindingirreversibly tothe 30Ssubunit ofthe

bacterialribosome.It is effective againstmany strains of Gram-negative

bacteria including speciesofEscherichia,Enterobacter,Klebsiella,

Salmonella,Serratia,Shigella,ProteusandPseudomonas aeruginosa.

Althoughlessactiveagainst Gram-positivebacteria,Staphylococcusaureusis

highly sensitive;Bacillus,ClostridiumandCorynebacteriumspeciesand

Listeria monocytogenesmayalsobe susceptible.Gentamicin is alsoactive

against some strains ofMycobacteria,andMycoplasmas havebeenreported

tobesensitive;fungiareresistant.

Pharmacokinetics

Theantibiotic is elutedfromthe cured cements intothebody fluids.The

mechanismby whichGentamicinisreleasedfrombone cements is uncertain.

Theantibiotics may diffuse throughthe matrixorthrough pores in the cement,

but essentially isonlyreleased fromthe surface layers.In-vivoandin-vitro

studies show that the bulk of theGentamicinrelease occurs withinthefirst72

hours.

Gentamicinis excretedby glomerularfiltration, almost entirely asunchanged

drug. The only metabolicreaction inhumans is conjugationandgentamicin

has nopharmacologically activemetabolites. A small amountisexcretedin

the bile and there isnoevidence of enterohepatic circulation. Gentamicin

persistsin tissues for longperiodsand undergoes reabsorptionfrom the

lumenof the proximaltubules.Concentrations inthe renalcorticaltissue

sometimesreach levels 100timeshigher thanin the serum. Serumprotein

bindingisestimatedat25% orless.

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Indications

DePuy CMW1Gentamicin BoneCement, DePuy CMW2Gentamicin Bone

Cement and DePuy CMW3 Gentamicin BoneCement are indicatedfor the

fixationof prosthesesto livingbonein arthroplasty procedures ofjointsin

which infectionby Gentamicinsensitiveorganismsis a potential risk.

The cements areindicated for use in children only inthe caseoflimb

preservation wherenoother procedureislikely togive a good chance of

successfultreatment.

Thecementsshouldbeusedwithanappropriateprosthesis.

Dosage andAdministration

DePuy CMW1Gentamicin BoneCement, DePuy CMW2Gentamicin Bone

Cement and DePuy CMW3 Gentamicin BoneCement are packed in two

sizes (see PRESENTATION).Astandard doseof bone cement is preparedby

mixing the entireliquidcontentsof theampoule withtheentirecontents of the

powderbag. The amountofmixedcementrequiredforclinical use is

determined bythesurgeonineachindividualcase. Thesurgeonapplies the

cementdigitallyorviasyringe(exceptDePuyCMW2 Gentamicinwhich

should onlybeapplieddigitally)andinsertsthe prosthesiswhen the cementis

in the doughy state. The cement doughpolymerises in situ and secures the

prosthesis in place. The cementisfor single useandonceimplanted remains

in-situpermanently,unlessrevisionsurgery is deemed necessary.Themajor

phaseof Gentamicinreleaseoccursduringthefirst72hours after

implantation.

Information forUse

(see also WARNINGSANDPRECAUTIONS)

Preparation

The following sectionapplies onlyto the useof bonecements intotal

jointreplacement techniques.

The followingstatementsshouldbe read carefullypriorto theuse of DePuy

CMW1 GentamicinBoneCement, DePuy CMW2 Gentamicin BoneCement

orDePuyCMW3GentamicinBoneCement.

1.Bonecementsareheatsensitive. Any increaseordecreasein

temperature(either ambient,and/or ofthecementcomponents andmixing

equipment)from therecommendedtemperatureof73°F (23°C) will affect

the handling characteristics and setting timeofthecement.Note: Manual

handling and bodytemperaturewillreduce the finalsettingtime.

2.Variations inhumidity will affectthe cementhandlingcharacteristics and

settingtime.

3.Thehandling characteristics andsetting timemay varyifthe cement

components or mixingequipmenthavenotbeenfullyequilibrated to 73°F

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(23°C) beforeuse. It is recommended that the unopened productisstored

at 73°F(23°C)foraminimum of24 hours beforeuse.

4.As with all bonecements,variations in the expected settingtime overthe

cement’s shelf lifecanoccur.This variationin setting time can bereduced

toa minimumproviding thecementisstoredunder therecommended

conditions throughoutits shelf life.

5.Vacuummixingofcementcannoticeably acceleratethesettingtimeofthe

product.The surgeon shouldreadthe manufacturer’s instructions andbe

familiarwiththe mixing system together with the cementprior to use.

CementPreparation

Theprotectiveouter foilpouch, the outerpeelablepouchofthe powder

component andthe blister pack enclosingthe ampoule of liquid component,

should be opened by acirculating nurse. The inner bag (or pouch)containing

the powdercomponentandthe sterile ampoulecontainingtheliquid

component areaseptically transferredinto the sterile operative area.

The sterilebag (orpouch)containingthe powdercomponent is opened with

sterilescissors andthe entirecontents areemptied intoa suitableclean, dry,

sterilemixingvesselmadefromaninert material(such asglass,ceramic,

stainless steel, or non-reactiveplastics).Thesterile ampoule containing the

liquidcomponent is opened and theentirecontentsareemptiedevenly onto

the powderin themixing vessel.

Astandard doseof bone cementisprepared by mixingtheentire liquid

contentsoftheampoule withthe entirecontents of thepowder bag. The

amount of mixed cement required for clinical useis determinedbythe

surgeonin each individual case.

Mixing and DigitalApplication

DePuy CMW1Gentamicin BoneCement, DePuy CMW2Gentamicin Bone

Cement and DePuy CMW3 Gentamicin BoneCementcan beapplied

digitally.If DePuy CMW3Gentamicin BoneCementisapplied digitally, the

surgeonmustuse their clinical judgementto decide whenthe cement is of a

suitableviscosityto allow the surgicalproceduretocontinue.

Prior to cement application, it is recommended that a cement restrictoris

always used duringcementation of the femur andthat this is introducedatthe

required depth.

The cementis mixed thoroughlybut carefullyto minimise theentrapmentof

air. Once a dough isformed the surgeon should waituntilthe cement no

longer adheres to theglove.Thecementcan then betaken intoglovedhands

andkneaded thoroughly. Itisvital that prematureinsertionofcementis

avoidedas this maylead to a drop inthepatient’s bloodpressure.Toavoid

this,the appearanceofthe cement shouldbeobservedto ensure the surface

has become dull as opposedtoshiny. Alsocementshouldnot adhere

excessivelytothe surgeon’s gloves. Note,thisstagewilloccuratdifferent

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times for different cement types. The timeofcement application and

prosthesis insertion isatthediscretionofthe surgeonandwill dependupon

the surgical procedureused.

Implantinsertionshouldbecarried out atatime appropriatefor the bone/joint

andprosthesis designconcerned.Ingeneral,implant insertionshouldbe

delayeduntil the cement hasdevelopeda sufficient degreeofviscosityto

resist excessivedisplacement by the implant.However, implantinsertion

should not bedelayedsuch that there is a riskthattheprocedurecannotbe

completed due tocementhardening.

Followingintroduction the implant must be firmlyheld inpositionto avoid

movement andpressurisationmustbemaintaineduntilthecement finally

hardens. Excessbonecement must be removedbeforethe cementhas

completelyhardened.

Syringe Application

DePuy CMW1Gentamicin BoneCementand DePuy CMW3Gentamicin

BoneCement may beappliedusing a suitable cement gunandsyringe.

AsDePuyCMW2 GentamicinBoneCement is a fast-settingcement, it is not

advisableto mixDePuyCMW2 GentamicinBoneCementinvacuum mixing

systems,ortoapply thiscementusinga cement gunandsyringe.

Thebone cementis preparedand mixed as describedpreviouslybyaddingall

oftheliquid componenttoallthe powdercomponent.Thecementisthen

transferred intoa suitablecementguncartridge. The surgeon should usetheir

experienceto judge whenthecementhas reached anappropriate viscosityto

be extruded.This will notoccuruntilafter thecementhas formed a dough.A

smallamount of cementshouldbe extrudedfromthe syringeandvisually

assessedto ensurethatthe surfaceofthe cement appears dull and excessive

flowundergravity hasceased. Note, thisstagewilloccur atdifferenttimesfor

differentcementtypes.

Prior to extrusion,itisrecommendedthatacementrestrictor be inserted,at

the required depth, intothe prepared bonecavity.Introductionofbone

cementinto the preparedcavity should becarried outin a retrograde fashion.

Once the cavity is filledit is stronglyadvisedthatadequatepressurisation is

applied and maintained upto thepointofhardening.Implant insertion should

be carriedout at a time appropriate for the bone/jointandprosthesisdesign

concerned. In general,implant insertionshouldbe delayed until thecement

has developedasufficientdegreeofviscosity to resistexcessive

displacementbythe implant. However, implantinsertion should notbe

delayedsuchthatthere isarisk that the procedurecannot be completed due

tocementhardening.

Followingintroduction the implant must be firmlyheld inpositionto avoid

movement andpressurisationmustbemaintaineduntilthecement finally

hardens. Excessbonecement must be removedbeforethecementhas

completelyhardened.

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For bothdigitalandsyringeapplication thehandlingcharacteristics and

settingtimes are affectedbyambient temperature.Pleaserefer to the

endof theinstructionleaflet for guidancecharts(Note: the usagecharts

weregeneratedunder controlled laboratoryconditions). The charts

provideinformation that is importantto thesuccessfuloutcomeofthe

surgical procedureifthe bonecement istobe usedatatemperature

other thanthatrecommended73°F (23°C)).

Limits of Usefulness

Store below 77°F (25°C)andprotect from light.

Store at the recommended mixing temperature of 73°F(23°C)fora

minimumof24hours beforeuse.

The setting time ofthecementcan bereducedifavacuummixing system

is used.

Sterility is onlyguaranteedifthepackagingisunopenedor undamaged.

DePuy CMW1Gentamicin BoneCementis forsingleuse only, donot

reuse. Resterilisation ofanyofthecomponents must not beattempted.

Contraindications

TheuseofDePuyCMW1GentamicinBoneCement, DePuy CMW2

GentamicinBoneCement and DePuy CMW3 Gentamicin Bone Cementis

contraindicated inthepresenceofthe conditionMyastheniaGravis.

TheuseofDePuyCMW1GentamicinBoneCement, DePuy CMW2

GentamicinBoneCement and DePuy CMW3 Gentamicin Bone Cementis

contraindicated inpatients withhypersensitivityto gentamicinor toany other

ofthecementcomponents.

Warnings and Precautions

Warnings

Follow carefully the suppliedinstructionsforhandling and mixingDePuy CMW

1GentamicinBoneCement,DePuy CMW2 GentamicinBoneCementand

DePuy CMW3Gentamicin BoneCement.

Patientsshouldbe carefullymonitoredforany change inblood pressure

during and immediately followingthe application of bonecement. Adverse

patientreactionsaffectingthecardiovascularsystemhavebeenassociated

with theuse of bone cements,these include: hypotension,hypoxemia,cardiac

arrhythmia,bronchospasm, cardiacarrest,myocardial infarction, pulmonary

embolism,cerebrovascular accidentandpossible death.Hypotensive

reactions have occurred between 10and165secondsfollowingapplication of

bone cement;they have lasted from 30seconds to 5 ormoreminutes.Some

haveprogressed to cardiacarrest.Inaddition,the over-pressurisation of the

Page7of13

bone cement shouldbeavoidedduring theinsertionofthebone cement and

the implantin order to minimise the occurrence ofpulmonaryembolism.

The preparationof thebonemarrow cavityresultsinmarrowcontents entering

the bloodstream. Prior to theapplicationofbonecementtothebone, the

cavity shouldbethoroughly cleaned by brushingandwashing (lavage)to

remove fat,marrowand otherdebris. The cavity shouldbekeptasdry as

possible toprevent bloodanddebris becomingmixedwiththecement.

Thoroughcleaningof the bonereduces therisk of marrow content being

forced intothe vascular system duringthe insertion ofbonecement and

subsequentpressurisation.Theexpulsionof bonemarrowhas been

associatedwith theoccurrence ofpulmonaryembolisms, and this risk has

been foundto beincreasedinpatients with highly osteoporotic bone and

patients diagnosed withfemoralneckfracture. Reamingof the marrowcavity

can havesimilar effectsonmeanarterial pressureasintroduction ofthe bone

cement.Marrowcavitiesshouldbe ventedwhenthe cement is introduced

digitally.

The prematureinsertionofbonecementmayleadtoadropinbloodpressure,

which hasbeen linked tothe availability ofmethyl methacrylateatthe surface

oftheproduct, although this has notbeenproven. Thisdrop inblood

pressure, ontopofhypotensioninduced either accidentally orintentionally,

can leadtocardiac arrhythmias orto anischemic myocardium. To reduce this

risk the surgeon should avoid early insertionofthecementand itis

recommendedthatthe mixingand preparation instructions arefollowed

closely. Asageneralguide,priorto insertion the cementsurface should

appear dull andshouldnot stick tothe surgeon’s gloves. Thehypotensive

effectsofmethylmethacrylatearepotentiated if the patient is sufferingfrom

hypovolemia.

The surgeon should,byspecific trainingandexperience,bethoroughly

familiarwiththe properties, handling characteristics andapplicationof the

antibioticbonecements. Because thehandlingandcuringcharacteristics of

bone cements vary with temperature and mixing technique,theyare best

determinedby thesurgeon’s actualexperience.

Strictadherence to goodsurgicalprinciples and techniques isessential.Deep

wound infection is a seriouspost-operativecomplicationandmayrequire total

removal of the embedded cement. Deep wound infectionmaybelatentand

not manifest itselfforseveralyearspost-operatively.

Consideration should begiven tothe useof antibioticbonecementinpatients

diagnosedwith femoralneck fracture,assomepublishedliteraturehas

indicated thereis a potential for increased mortality comparedwith

uncemented techniques.

As theliquid monomeris highlyvolatileand flammable,theoperating room

should be adequatelyventilatedtoeliminate as much monomer vapouras

possible.Ignition of monomer fumes causedbyuse ofelectrocauterydevices

atsurgicalsites near freshlyimplanted bonecements has been reported.

Store the sealed outerpackbelow 77°F (25°C) and protect itfromlight to

prevent prematurepolymerisationof the liquid monomercomponent. Always

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check theconditionof the liquid monomer beforeperforming theprocedure.

Donotuse the liquid monomer if it shows anysignofthickening or premature

polymerisation. Donotuse the product after the expirationdate.

Cautionshouldbe exercisedduringthe mixingofthetwo components to

preventexcessiveexposuretotheconcentratedvapours ofthemonomer,

which mayproduce irritation of the respiratory tract, eyes, andpossibly the

liver. Iftheliquidcomponent comesinto contact with theeyes, wash with

copiousamounts ofwater. Concentratedvapours of the liquid component

may haveanadversereactionwithcontact lenses. Personnel wearing

contact lensesshouldbe informedandlimittheir exposure. Guidancefrom

contact lensmanufacturers regarding exposure to irritatingandnoxious

vapours should alwaysbefollowed.

Methylmethacrylatehas beendemonstratedtocausehypersensitivity in

susceptible persons,whichmay result inananaphylactic response.

Inadequatefixationorunanticipated post-operativeeventsmay affectthe

cement-bone interfaceandlead tomicromotion of the cement againstbone

surfaces,whichthe cement is incontactwith.A fibroustissue layermay

developbetweenthe cement and the bone.Longtermfollow-up isadvised for

allpatients ona regular scheduled basis.

The completionofcement polymerisationoccurs in the patientand isan

exothermicreaction withconsiderableliberation of heat.Thelong term effects

ofthe heatproducedin situhavenot yet been established.

The safety andeffectivenessofDePuy CMW1 Gentamicin Bone Cement,

DePuy CMW2Gentamicin BoneCementand DePuy CMW3Gentamicin

BoneCement in pregnantwomen or inchildren hasnot yet been established.

DePuy CMW1Gentamicin BoneCement, DePuy CMW2Gentamicin Bone

Cement and DePuy CMW3 Gentamicin BoneCementshould notbeused

during thefirstthird of pregnancy, and duringthe rest of the pregnancyperiod

should onlybeused inlife-threatening illnesses. DePuyCMW1Gentamicin

BoneCement, DePuyCMW2 GentamicinBone Cementand DePuyCMW3

GentamicinBoneCement shouldonly beusedin children for limb

preservation wherenoother procedureislikely togivea good chance of

successfultreatment.

Precautions

Theuseofantibiotic bonecementrequirescollaboration and consultation

betweenthe surgeonandthe anaesthetist.Theanaesthetistshouldbe told

during theoperation whenthebone cementis implanted.

Contactofmonomerwiththe skinor mucousmembranesshouldbe avoided.

The liquid component of bone cements hascausedcontactdermatitisin those

handlingandmixing them. Strict adherenceto theinstructions formixing the

powder and liquidcomponentsmayreducetheincidence ofthiscomplication.

The liquid component of bone cementisapowerfullipid solvent.This liquid

component shouldnotbe allowedto comeinto contact with surgicalgloves.

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Wearingofa secondpair ofsurgicalgloves and strict adherenceto themixing

instructionsmay diminish the possibility of hypersensitivityreactions.

The setting time of the cementcan be reduced if a vacuummixing system is

used. The surgeon should read the manufacturer’s instructionsandbe

familiarwiththe mixingsystemtogether with the cement prior to use.

Upon applicationof the bonecementitisimportant to maintainthe positioning

oftheprosthetic componentuntilthecompletion of the polymerisation

process.Thismust bedoneinorder to maintain properfixation.

It is recognisedthatforsomeapplications,forexample femoral head

resurfacing, theearly useofcementis preferred insomecases. There is

currently littleorno consensus,or longtermclinical data,astothepotential

risks to the patientassociated with thismethod. Thisshould beborne inmind

when choosing to adoptsuch practices.

Implantation of a foreign body inthe tissues increases the normal risk of

infection associatedwith surgery followingoperation. Evidencefrom clinical

investigationsclearly indicates the necessityfor strictcompliance to good

aseptic surgicaltechnique. Following theoperation the patientshould be

advisedthatin the event of an intercurrentinfection theymustimmediately

seek medicaladviceinorderto reducethe risk ofinfection tothe implant.

Extrusionofthe bonecementbeyond theregionofits intendedapplication

may occur resultingin thefollowing complications: hematuria; dysuria; bladder

fistula; delayedsciaticnerve entrapment fromextrusion of bone cement

beyondthe regionofits intendedapplication;local neuropathy; local vascular

erosionandocclusion; andintestinal obstructionduetoadhesions and

stricture of the ileum fromthe heatreleased during theexothermic

polymerisation.

Ensurethat the powder and liquidcomponentsto bemixedtogetherhavethe

samelotnumber, since the monomerand polymercomponents are

individuallyformulatedfor eachbatch. Itis essential toaddall oftheliquid

andpowdercomponentstogether whenmixing the cement, since the

componentsare premeteredtogiveoptimumresults.

Topreventanypossiblecontaminationof thecement withglassfragments,do

not break the ampoulecontainingtheliquidcomponent overthemixing

device.

DePuy CMW1Gentamicin BoneCement, DePuy CMW2Gentamicin Bone

Cement and DePuy CMW3 Gentamicin BoneCement are supplied sterile for

singleuseonly. Do notre-use.Sterility is onlyguaranteedifthe packagingis

unopenedorundamaged. Resterilisationof any components of the cements

must notbeattempted.

As themonomer isvolatileandflammable,any wasteliquidcomponent

should be evaporatedunder a well-ventilatedhoodor absorbedbyan inert

materialandtransferredtoasuitablecontainer(whichdoesnot reactwiththe

monomer)for disposal.Prior todisposal thesurplusbone cement should be

allowed to set. Thepolymer componentandwaste powder should be

disposedof as clinicalwaste.

Page10of13

Adverse Effects

Serious adverseevents, some with fatal outcome,associated withthe use of

bone cements include:

Myocardial

infarction.

Cardiac

arrest.

Cerebrovascular

accident.

Pulmonary

embolism.

Anaphylaxis.

The most frequentadverse reactionsreported withbonecements are:

Transitory fallin bloodpressure.

Elevatedserumgamma-glutamyl-transpeptidase (GGTP) upto10days

post-operation.

Thrombophlebitis.

Hemorrhageandhematoma.

Pain and/orlossoffunction.

Loosening or displacement of the prosthesis.

Superficial ordeepwoundinfection.

Trochanteric

bursitis.

Short-term

cardiac conduction irregularities.

Hetertopic new boneformation.

Trochanteric

separation.

Other potentialadverseevents reportedforbonecements include:

Hypoxemia.

Cardiac

arrhythmia.

Bronchospasm.

Adverse tissue reaction.

Pyrexia due to allergytothe bone cement.

Hematuria.

Dysuria.

Bladder

fistula.

Local

neuropathy.

Local vascularerosionandocclusion.

Transitory worseningofpain duetoheatreleasedduringpolymerisation.

Delayed sciaticnerveentrapment due toextrusion ofthebonecement

beyondtheregionofitsintendedapplication.

Intestinal obstruction because ofadhesionsandstricture of the ileumdue

tothe heatreleased duringcement polymerisation.

Interactions

DePuy CMW1Gentamicin BoneCement, DePuy CMW2Gentamicin Bone

Cement and DePuy CMW3 Gentamicin BoneCementshould not be

administeredconcurrentlywith other potentially ototoxic ornephrotoxicdrugs.

Page11of13

Overdosage

Nil.

Pharmaceutical Precautions

Shelflife:36 months.

Specialprecautions for storage: Store below 25°C and protect fromlight.

Store at the recommended mixingtemperatureof23°C for a minimumof24

hours before use.

Sterility isonlyguaranteedifthecontainers areundamaged.Resterilisationof

any of the componentsshouldnot be attempted.

Package Quantities

Unit

Size DePuyCMW1

Gentamicin DePuyCMW2

Gentamicin DePuyCMW 3

Gentamicin

Powder

(g) Liquid(g) Powder

(g) Liquid (g) Powder

(g) Liquid (g)

40g 4018.374018.374017.90

20g 209.19209.19208.95

See FURTHER INFORMATIONforfull productdescriptions.

Further Information

Product descriptions:

DePuy CMW1Gentamicin BoneCement, DePuy CMW2Gentamicin Bone

Cement and DePuy CMW3 Gentamicin BoneCementconsistofatwo-

component system, apolymeric powdercomponent and a monomeric liquid

component.Thebone cement powder is containedin asterile polyethylene

bag,withina peelablepouch withinaprotectivenon-sterilelaminated foil

pouch. Thebone cement liquid is containedina sterileampoule comprising

an ampoulesafetycap onits tip that is contained within a blister pack.The

interiors of the blisterpack andpeelable pouchare sterile.

Sterilisation of the bonecementliquidis achieved by filtration,whilstthe

blister packissterilisedbyethylene oxide. Thebone cementpowder inthe

powderbagandpeelablepouchissterilised by gammairradiation.

DePuyCMW1GentamicinBone Cement

Page12of13

40gunitpack size:-Onepacksterile bonecement powder(40g) containing

GentamicinSulphate4.22%w/w 1 andoneampoulecontainingsterilebone

cementliquid(18.37g).

20gunitpack size:-Onepacksterile bonecement powder(20g) containing

GentamicinSulphate4.22%w/w 1 andoneampoulecontainingsterilebone

cementliquid (9.19g).

Variabledependent uponpotency andequivalentto1.0g(1.0M.I.U.)

Gentamicinbasein 40g unit;0.5g(0.5 M.I.U.)in20g unit

DePuyCMW2GentamicinBone Cement

40gunitpack size:-Onepacksterile bonecement powder(40g) containing

GentamicinSulphate4.22%w/w 1 andoneampoulecontainingsterilebone

cementliquid(18.37g).

20gunitpack size:-Onepacksterile bonecement powder(20g) containing

GentamicinSulphate4.22%w/w 1 andoneampoulecontainingsterilebone

cementliquid (9.19g).

Variabledependent uponpotency andequivalentto1.0g(1.0M.I.U.)

Gentamicinbasein 40g unit;0.5g(0.5 M.I.U.)in20g unit

DePuyCMW3GentamicinBone Cement

40gunitpack size:-Onepacksterile bonecement powder(40g) containing

GentamicinSulphate4.22%w/w 1 andoneampoulecontainingsterilebone

cementliquid(17.90g).

20gunitpack size:-Onepacksterile bonecement powder(20g) containing

GentamicinSulphate4.22%w/w 1 andoneampoulecontainingsterilebone

cementliquid (8.95g).

Variabledependent uponpotency andequivalentto1.0g(1.0M.I.U.)

Gentamicinbasein 40g unit;0.5g(0.5 M.I.U.)in20g unit

Excipients:

Bonecementpowder:polymethylmethacrylate,benzoylperoxide,barium

sulphate.

Bonecementliquid:methylmethacrylate,N,N-dimethyl-p-toluidine,

hydroquinone.

Preclinical safetyinformation:

The two mostimportantorgans thataresusceptibleto gentamicintoxicity are

the earandkidney.Inlarge-scale retrospective surveys of systemicclinical

treatment,the frequency of ototoxicity inhumans has been about2-3%. The

frequency ofnephrotoxicity hasvariedwidely andvaluesofas much as 26%

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havebeen reported.The sensitivity of these organs isdue to selective

accumulationintheperilymphandvestibularandcochleartissuesandinthe

renal cortical cells of the proximaltubule.

The reasonsforthis toxicityhavebeenextensively researchedin animals and

man . Itisa function of the chemicalproperties of gentamicinandis

concentrationdependent.Therefore,the pharmacokineticsofgentamicinand

its releasefromthecement formulationare relevant to thisaspect of safety.

Neuromuscular blockade isalsoa reported side-effectofhuman systemic

treatmentand, as a result, gentamicin mayunmask oraggravatemyasthenia

gravisandcausepost-operativerespiratorydistress.

Gentamicin,at relativelyhighdosages, hasbeenreportedtoaccumulatein

thefoetal tissuesofratsandguineapigs,andmay consequently affect renal

development inneonates.

Thetoxicityofgentamicinis anextensionofitspharmacologyrelatingtoits

cationic bindingtophospholipids andits concentration in susceptible tissues,

ie. ear and kidney,arisingfromblood concentrations above10-20

micrograms/mL.

Gentamicinis readilysolubleandthe bonecementpreparation releases

significant concentrationsinitiallyallowingsome measurable systemic levels

(but below2 micrograms/mL). Localconcentrationsare higher and at

therapeuticlevels thusassuringcontrol ofany immediate infectionsfollowing

surgery.

Medicine Classification

PrescriptionMedicine.

Name andAddress

Johnson&JohnsonMedical NewZealand

13 a Gabador Place

MtWellingtonAuckland

Phone 649 5741783

TollFree0800433789

Date of Preparation

23April 2008

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