APO-GO PFS 5 Mg/Ml Solution for Infusion

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
APOMORPHINE HYDROCHLORIDE
Available from:
Genus Pharmaceuticals Limited
INN (International Name):
APOMORPHINE HYDROCHLORIDE
Dosage:
5 Mg/Ml
Pharmaceutical form:
Solution for Infusion
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization number:
PA1496/002/003
Authorization date:
0000-00-00

APO-go ®PFS

5mg/ml Solution forInfusioninPre-filled Syringe

apomorphinehydrochloride50mg/10ml

Foruseinadults

PackageLeaflet: Information fortheUser

Readallofthis leafletcarefully beforeyoustart using this medicine.

Keep this leaflet.You mayneed to read itagain.

Ifyou haveanyfurther questions, askyour doctoror pharmacist.

This medicinehas been prescribedforyou. Do not pass iton to others. Itmay

harm them, even if theirsymptoms arethe same asyours.

Ifanyof thesideeffectsget serious, orifyou noticeanysideeffects notlisted

in this leaflet, pleasetellyourdoctor orpharmacist.

Inthis leaflet:

1. What APO-go PFSisand what it is used for

2. Beforeyou useAPO-go PFS

3. Howto useAPO-go PFS

4. Possible sideeffects

5. Howto storeAPO-goPFS

6. Furtherinformation

1.WhatAPO-goPFSis andwhatit is usedfor

Apomorphine hydrochloride belongs to agroup ofmedicines known as dopamine

agonists whichareused to treat Parkinson‟s disease. It helps to reducetheamountof

time spent in an “off”orimmobile state in people who havepreviouslybeen treated for

Parkinson‟s diseasewithlevodopaand/or other dopamineagonists. Yourdoctor ornurse

willhelpyou to recognise the signs of when to useyour medicine.

2.BeforeyouuseAPO-goPFS

Do not useAPO-goPFS

ifyou areunder 18yearsofage

ifyou havebreathingdifficulties or sufferfrom asthma

ifyou havedementia orAlzheimer‟s disease

ifyou sufferfrom confusion, hallucinations or anyothersimilar problems

ifyou haveliver problems

ifyou haveseveredyskinesia (involuntarymovements) orseveredystonia

(inabilityto move) on account of thetreatment with levodopa

ifyou areallergic to apomorphineoranyof theother ingredients ofAPO-go

PFS(forotheringredients seesection 6)

Ifyou orsomeoneinyour familyareknown to havean abnormalityof

electrocardiogram (ECG)called “longQT syndrome”. Tellyour doctor

Takespecialcarewith APO-goPFS

ifyou havekidneyproblems

ifyou havelungproblems

ifyou haveheart problems

ifyou havelow blood pressureorfeel faintand dizzywhenyou stand

ifyouaretakinganymedicines to treat high blood pressure

ifyou feel sick or suffer from beingsick

ifyou haveanymental disorders whenAPO-go PFSis started

ifyou areelderlyor frail

when drivingor operatingmachinerysinceapomorphine maycausesleepiness

includingsudden sleep onset episodes (you must notdriveor operate machinery

if APO-go PFSmakesyou sleepy)

yourdoctor should checkyour blood regularlywhen takingAPO-go PFSwith

levodopa(another treatment forParkinson‟s disease).

Tellyour doctor ifyou oryourfamily/carer notices thatyou aredeveloping urges or

cravings to behavein waysthat areunusual foryou andyoucannot resist theimpulse,

drive ortemptation to carryout certainactivities that could harmyourself orothers.

Thesearecalled impulse control disorders andcanincludebehaviours suchas addictive

gambling, excessiveeatingor spending,an abnormallyhigh sexdriveor an increasein

sexual thoughts or feelings.Yourdoctor mayneed to adjustor stopyour dose.

Ifany oftheabovesituations applies to you, please informyourdoctorornurse.

Checkwith yourdoctororpharmacist beforetaking yourmedicineif:

Youareusingmedicinesthatareknowntoaffectthewayyourheartbeats.Thisincludes

medicinesusedforheartrhythmproblems(suchasquinidineandamiodarone)for

depression(includingtricyclicantidepressantssuchasamitriptylineandimipramine)and

forbacterialinfections(„macrolide‟antibioticssuchaserythromycin,azithromycinand

clarithromycin) anddomperidone.

Taking othermedicines

Ifyou takeapomorphinein combination with othermedicines (especiallyneuroleptica

suchas clozapine ormedicines to reduceyour blood pressureor other medicines for

Parkinson‟s disease) theeffect ofyour medicinesmaybealtered. Yourdoctor will advise

you ifyou need to adjustthe doseofyourapomorphine oranyofyour other medicines.

Pleasetellyour doctor orpharmacistifyou aretakingor haverecentlytaken anyother

medicines, includingmedicines obtained withoutaprescription.

Using APO-goPFSwith foodanddrink

Food and drink do notaffect APO-go PFS.

Pregnancy andbreast-feeding

APO-go PFSshould not be used duringpregnancyunless clearlynecessary. Checkwith

yourdoctor ornursebeforeusingAPO-go PFSifyou arepregnant, thinkyou maybe

pregnant oryouareplanningto becomepregnant.

It is notknown whetherAPO-go PFSis transferred to breast milk. Talk toyour doctor if

you arebreast-feedingorintend to breast-feed. Yourdoctor will explain to you, whether

you should continue/discontinuebreast-feedingorcontinue/discontinuetakingthis

medicine.

Askyour doctor orpharmacistforadvicebeforetakinganymedicine.

Driving andusing machines

Do not drive ifAPO-goPFSmakesyou sleepy. Do not useanytools ormachines if

APO-go PFSmakesyousleepy.

Important informationabout someoftheingredients ofAPO-go PFS

Rarelysodium metabisulphitemaycauseasevereallergic reaction and difficulty

breathing.

This medicinal product contains less than 1 mmol(23mg) of sodium per10ml, i.e.

essentiallysodium free.

3.Howto useAPO-goPFS

Theinfusion is given subcutaneously(i.e. into theareaunder theskin).

Do not useasyringeif thesolution has turned green.

Always use APO-go PFSexactlyasyour doctor has toldyou. You should check with

yourdoctor orpharmacist ifyou arenot sure.

APO-go PFShas been designed for continuous infusionwith a syringedriver.It is notto

beusedforintermittent injection. Yourdoctor will decidewhich minipump and/or

syringe-driverand whichdosagesettingsyou should use.

Both theamountof APO-go PFSthatyou shoulduse and the total amountoftimeyou

should receiveyour medicine each day, willdepend uponyour personal needs. Your

doctor willdiscuss this withyou and tellyou howmuch ofyour medicineyou should

administer. Theamountthat willwork best willhavebeen determined onyourvisit to

the specialistclinic. Theaverageinfusion dose per hour is between 1mgand 4mg

apomorphinehydrochloride. Continuous infusionis usuallygiven whenyou areawake

and generallystopped beforesleeping. Theamount of apomorphinehydrochloridethat

you receiveeach dayshould notexceed 100mg. Your doctor ornursewilldecide which

doseis best foryou.

A different site foryour infusionshould beusedevery12 hours.

This medicineshould not be administered into avein.

Thereis noneed to diluteAPO-go PFSbeforeuse.Inaddition, it should not be mixed

with other medicines.

IfyouusemoreAPO-go PFSthanyoushould

tellyour doctor orcontactyour nearest hospital emergencydepartment

immediately.

itis important to administerthe correct doseof APO-go PFSand not to use

morethan theamountrecommended byyour doctor. Higher doses maycausea

slow heart rate, excessivesickness, excessivesleepiness and/or difficulty

breathing. You mayalsofeel faintor dizzyparticularlywhenyou stand up,due

to low blood pressure.Lyingdown andraisingyourfeet will help to treat low

blood pressure.

Ifyouforget to useAPO-go PFS

takeitwhenyou next requireit.

do not takeadouble doseto makeup for aforgotten dose.

Ifyoustopusing APO-go PFS

contactyour doctorbeforestoppingtreatment and discuss whetherthis is

appropriate or not.

Ifyou haveanyfurther questions on theuse of this product, askyour doctor or

pharmacist.

4.Possible sideeffects

Likeallmedicines, APO-go PFScan causeside effects, although not everybodygets

them. Tellyour doctor ifyou thinkyour medicineis makingyou feel unwell or ifyouget

anyof thefollowing:

Verycommon sideeffects(morethan 1 user in 10):

lumps under theskin at thesiteof injection whicharesore, troublesomeand may

bered and itchy.In orderto avoid gettingtheselumps,itis advisable to change

the siteof injection everytimeyou insert theneedle.

Common sideeffects(1 to 10 users in 100):

feelingsick orbeingsick, particularlywhen startingAPO-go PFS. Domperidone

should bestarted at least2 days beforeAPO-go PFSto stopyou feelingorbeing

sick.Ifyou aretakingdomperidone and still feel sick, orifyou arenot taking

domperidone and havesickness, tellyour doctor or nurseas soonas possible.

feelingtired orexcessivesleepy.

confusion orhallucinations.

yawning.

feelingdizzyor light-headed when standingup.

Uncommon sideeffects(1 to 10 users in 1,000):

increased involuntarymovements or increased shakiness during'on'periods.

haemolyticanaemia,an abnormal breakdown ofred blood cells in theblood

vessels orelsewherein thebody. This is an uncommon sideeffect that canoccur

in patients also takinglevodopa

Suddenlyfallingasleep

rashes

breathingdifficulties

injection site ulceration

reduction in red blood cells which can makethe skin paleyellow andcause

weakness or breathlessness

reduction in blood platelets, whichincreases the risk of bleedingor bruising

Rareside effects(1 to 10 users in 10,000)

an allergicreaction suchas:

-difficultybreathingor tightness ofthe chest

-puffiness oftheeyelids, faceor lips

-swellingorredness of thetongue

eosinophilia, an abnormallyhighamountof whiteblood cells in theblood or in

bodytissues.

Side effects with unknown frequency(frequencycannot be estimated from the

available data):

Swellingof thelegs, feetorfingers.

Inabilityto resist theimpulse, drive ortemptationto perform anaction thatcould

beharmful toyou orothers, which mayinclude:

oStrongimpulse to gambleexcessivelydespiteserious personal or family

consequences.

oAltered or increased sexual interest and behaviourofsignificant concern to

you or to others, forexample, an increased sexual drive.

oUncontrollable excessiveshoppingor spending.

oBinge eating(eatinglargeamounts of food in a short timeperiod)or

compulsiveeating(eatingmorefoodthan normaland morethan is needed

to satisfyyour hunger).

Tellyourdoctorifyouexperienceany ofthesebehaviors;sheorhewill discuss

ways ofmanaging orreducing thesymptoms.

Ifanyof thesideeffectsget serious, orifyou noticeanysideeffects notlisted in this

leaflet, pleasetellyour doctor orpharmacist.

5.Howto storeAPO-goPFS

Keep out of thereach and sight of children.

Do not useAPO-go PFSafter theexpirydatewhich is stated on the label/carton. The

expirydate refers to the last dayof that month.

Keep the pre-filled syringein theouter carton inorder to protect from light.

Do not storeabove25°C.

Onceopened APO-go PFSshould beusedimmediatelyand anyremainingsolution

discarded.

Single useonly.

Do not useAPO-go PFSif thesolution has turned green.It should onlybeused if the

solution is clear, colourless and freeof anyvisibleparticles.

Withdraw contents immediatelyafter opening. Takecarenot to splash anyofthe solution

ontoyourself, orthe carpet as it maystaingreen.At the end ofuse theglass pre-filled

syringeshould bediscarded in a Sharps bin as wellas anyusedplasticsyringesand the

adaptor.

Medicines should notbedisposed of via wastewater orhousehold waste. Askyour

pharmacisthow to disposeofmedicines no longerrequired. Thesemeasureswillhelp to

protect theenvironment.

6.Furtherinformation

WhatAPO-goPFScontains

Theactivesubstanceis apomorphinehydrochloride. 1mlsolutioncontains 5mg

apomorphinehydrochloride. Each 10mlprefilledsyringecontains 50mgapomorphine

hydrochloride.

Theotheringredients are:

–Sodiummetabisulphite(E223)

–Hydrochloricacid, concentrated

–WaterforInjections

WhatAPO-goPFSlooks likeandcontents ofthepack

APO-go PFSis a solution forinfusion, pre-filled syringe.Thesolution isclear and

colourless.

APO-go PFSis supplied in clearglass pre-filled syringes.Each pack contains 5syringes

containing10mlsolution,in an outer cardboardcarton.Bundle packs of25(5 x5) and

bundle packs of 50(10 x5) areavailable in someterritories.

Marketing AuthorisationHolder

UKandIreland

Genus Pharmaceuticals

Park ViewHouse

65London Road, Newbury,

BerkshireRG14 1JN, United Kingdom

Malta

BritanniaPharmaceuticalsLtd

Park ViewHouse,

65London Road, Newbury

BerkshireRG14 1JN, United Kingdom

Manufacturers

Genus Pharmaceuticals

Park ViewHouse

65London Road, Newbury

BerkshireRG14 1JN, United Kingdom

Catalent BelgiumS.A

Font SaintLandry10,B-1120 Brussels

(Neder Over Heembeek),Belgium

Rovi Contract Manufacturing, S.L.,

Julián Camarillo,35

Madrid 28037, Spain

This medicinal product is authorisedintheMemberstates oftheEEA underthe

followingnames:

Austria, Germany, SwitzerlandAPO-go 5mg/mlInfusionslösungin einerFertigspritze

Bulgaria APO-go PFS5mg/ml Разтвор заинфузия в предварително

напълненаспринцовка

Cyprus APO-go® PFS5mg/ml ΔιάλυμαγιαΈγχυση σεΠρογεμισμένη

Σύριγγα

Denmark APO-go Pumpfill 5 mg/mlinfusionsvæske, opløsningi fyldt

injektionssprøjte

France,LuxembourgAPOGO5mg/ml Solution pour Perfusionen SeringuePréremplie

Greece APO-go PFS5mg/ml

Hungary Britaject 5mg/ml oldatos infúzió előretöltött fecskendőben

Iceland Apo-go Pumpfill 5mg/ml innrennslislyf, lausn

Ireland, UK, Malta APO-go PFS5mg/ml Solution forInfusionin Pre-filled Syringe

Netherlands APO-go 5mg/ml oplossingvoorinfusiein een voorgevulde spuit

Norway Britaject 5mg/ml infusjonsvæske, oppløsningi ferdigfyltsprøyte

Poland APO-go PFS, 5 mg/ml, roztwórdo infuzji

Portugal Apo-go 5mg/ml Soluçãoparaperfusãoem seringapré-cheia

Romania APO-go 5mg/ml soluţieperfuzabilăîn seringăpreumplută unidoză

Slovak Republic APO-go® 5mg/ml infúznyroztok naplenývinjekčnejstriekačke

Slovenia APO-go 5 mg/ml raztopinazainfundiranje v napolnjeni injekcijski

brizgi

Spain APO-go PFS5 mg/ml Solución paraPerfusión enJeringa

Precargada

Sweden APO-go Pumpfill 5 mg/mlinfusionsvätska, lösningi förfylld

spruta

This leaflet was lastrevisedinNovember2012.

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

APO-goPFS5mg/mlSolutionforInfusioninPre-filledSyringe

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains5mgapomorphinehydrochloride.

Each10mlpre-filledsyringecontains50mgapomorphinehydrochloride.

Excipient:

Sodiummetabisulphite(E223)0.5mgperml

Forafulllistofexcipients,seeSection6.1

3PHARMACEUTICALFORM

SolutionforInfusion,pre-filledsyringe

Clearsolution,practicallycolourless,odourlessandpracticallyfreefromvisibleparticles

pH3.0-4.0

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofmotorfluctuations('on-off'phenomena)inpatientswithParkinson’sdiseasewhicharenotsufficiently

controlledbyoralanti-Parkinsonmedication

4.2Posologyandmethodofadministration

SelectionofPatientsSuitableforAPO-goinjections:

PatientsselectedfortreatmentwithAPO-goshouldbeabletorecognisetheonsetoftheir‘off’symptomsandbe

capableofinjectingthemselvesorelsehavearesponsiblecarerabletoinjectforthemwhenrequired.

Itisessentialthatthepatientisestablishedondomperidone,usually20mgthreetimesdailyforatleasttwodaysprior

toinitiationoftherapy.

Apomorphineshouldbeinitiatedinthecontrolledenvironmentofaspecialistclinic.Thepatientshouldbesupervised

byaphysicianexperiencedinthetreatmentofParkinson’sdisease(e.g.neurologist).Thepatient’streatmentwith

levodopa,withorwithoutdopamineagonists,shouldbeoptimisedbeforestartingAPO-gotreatment.

Adults

Administration

APO-goPFS5mg/mlSolutionforInfusioninPre-filledSyringeisapre-dilutedpre-filledsyringeintendedforuse

withoutdilutionasacontinuoussubcutaneousinfusionbyminipumpand/orsyringe-driver.Itisnotintendedtobe

usedforintermittentinjection.

Apomorphinemustnotbeusedviatheintravenousroute.

Donotuseifthesolutionhasturnedgreen.Thesolutionshouldbeinspectedvisuallypriortouse.Onlyclear,

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ContinuousInfusion

Patientswhohaveshownagood‘on’periodresponseduringtheinitiationstageofapomorphinetherapy,butwhose

overallcontrolremainsunsatisfactoryusingintermittentinjections,orwhorequiremanyandfrequentinjections(more

than10perday),maybecommencedonortransferredtocontinuoussubcutaneousinfusionbyminipumpand/or

syringedriverasfollows:-

Thechoice,ofwhichminipumpand/orsyringe-drivertouse,andthedosagesettingsrequired,willbedeterminedby

thephysicianinaccordancewiththeparticularneedsofthepatient.

DeterminationofThresholdDose

Thethresholddoseforcontinuousinfusionshouldbedeterminedasfollows:Continuousinfusionisstartedatarateof

1mgapomorphineHCl(0.2ml)perhourthenincreasedaccordingtotheindividualresponseeachday.Increasesin

theinfusionrateshouldnotexceed0.5mgatintervalsofnotlessthan4hours.Hourlyinfusionratesmayrange

between1mgand4mg(0.2mland0.8ml),equivalentto0.014–0.06mg/kg/hour.Infusionsshouldrunforwaking

hoursonly.Unlessthepatientisexperiencingseverenight-timeproblems,24hourinfusionsarenotadvised.

Tolerancetothetherapydoesnotseemtooccuraslongasthereisanovernightperiodwithouttreatmentofatleast4

hours.Inanyevent,theinfusionsiteshouldbechangedevery12hours.

Patientsmayneedtosupplementtheircontinuousinfusionwithintermittentbolusboosts,asnecessary,andasdirected

bytheirphysician.

Areductionindosageofotherdopamineagonistsmaybeconsideredduringcontinuousinfusion.

Establishmentoftreatment.

Alterationsindosagemaybemadeaccordingtothepatient’sresponse.

Theoptimaldosageofapomorphinehydrochloridevariesbetweenindividualsbut,onceestablished,remains

relativelyconstantforeachpatient.

Precautionsoncontinuingtreatment

ThedailydoseofAPO-govarieswidelybetweenpatients,typicallywithintherangeof3-30mg.

ItisrecommendedthatthetotaldailydoseofapomorphineHClshouldnotexceed100mg.

Inclinicalstudiesithasusuallybeenpossibletomakesomereductioninthedoseoflevodopa;thiseffectvaries

considerablybetweenpatientsandneedstobecarefullymanagedbyanexperiencedphysician.

Oncetreatmenthasbeenestablisheddomperidonetherapymaybegraduallyreducedinsomepatientsbutsuccessfully

eliminatedonlyinafew,withoutanyvomitingorhypotension.

Childrenandadolescents

APO-goPFS5mg/mlSolutionforInfusioninPre-filledSyringeiscontra-indicatedforchildrenandadolescentsunder

18yearsofage(seeSection4.3).

Elderly

TheelderlyarewellrepresentedinthepopulationofpatientswithParkinson’sdiseaseandconstituteahighproportion

ofthosestudiedinclinicaltrialsofAPO-go.ThemanagementofelderlypatientstreatedwithAPO-gohasnotdiffered

fromthatofyoungerpatients.However,extracautionisrecommendedduringinitiationoftherapyinelderlypatients

becauseoftheriskofposturalhypotension.

Renalimpairment

Adoseschedulesimilartothatrecommendedforadults,andtheelderly,canbefollowedforpatientswithrenal

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4.3Contraindications

Inpatientswithrespiratorydepression,dementia,psychoticdiseasesorhepaticinsufficiency.

ApomorphineHCltreatmentmustnotbeadministeredtopatientswhohavean‘on’responsetolevodopawhichis

marredbyseveredyskinesiaordystonia.

APO-goshouldnotbeadministeredtopatientswhohaveahypersensitivitytoapomorphineoranyexcipientsofthe

medicinalproduct.

APO-goiscontra-indicatedforchildrenandadolescentsunder18yearsofage.

4.4Specialwarningsandprecautionsforuse

ApomorphineHClshouldbegivenwithcautiontopatientswithrenal,pulmonaryorcardiovasculardiseaseand

personspronetonauseaandvomiting.

Extracautionisrecommendedduringinitiationoftherapyinelderlyand/ordebilitatedpatients.

Sinceapomorphinemayproducehypotension,evenwhengivenwithdomperidonepretreatment,careshouldbe

exercisedinpatientswithpre-existingcardiacdiseaseorinpatientstakingvasoactivemedicinalproductssuchas

antihypertensives,andespeciallyinpatientswithpre-existingposturalhypotension.

Sinceapomorphine,especiallyathighdose,mayhavethepotentialforQTprolongation,cautionshouldbeexercised

whentreatingpatientsatriskfortorsadesdepointesarrhythmia.

Apomorphineisassociatedwithlocalsubcutaneouseffects.Thesecansometimesbereducedbytherotationof

injectionsitesorpossiblybytheuseofultrasound(ifavailable)inordertoavoidtoareasofnodularityandinduration.

Haemolyticanaemiaandthrombocytopeniahavebeenreportedinpatientstreatedwithapomorphine.Haematology

testsshouldbeundertakenatregularintervalsaswithlevodopa,whengivenconcomitantlywithapomorphine.

Cautionisadvisedwhencombiningapomorphinewithothermedicinalproducts,especiallythosewithanarrow

therapeuticrange(seesection4.5).

Neuropsychiatricproblemsco-existinmanypatientswithadvancedParkinson’sdisease.Thereisevidencethatfor

somepatientsneuropsychiatricdisturbancesmaybeexacerbatedbyapomorphine.Specialcareshouldbeexercised

whenapomorphineisusedinthesepatients.

Apomorphinehasbeenassociatedwithsomnolenceandepisodesofsuddensleeponset,particularlyinpatientswith

Parkinson’sdisease.Patientsmustbeinformedofthisandadvisedtoexercisecautionwhilstdrivingoroperating

machinesduringtreatmentwithapomorphine.Patientswhohaveexperiencedsomnolenceand/oranepisodeofsudden

sleeponsetmustrefrainfromdrivingoroperatingmachines.Furthermore,areductionofdosagemaybeconsidered.

Impulsecontroldisorders

Patientsshouldberegularlymonitoredforthedevelopmentofimpulsecontroldisorders.Patientsandcarersshouldbe

madeawarethatbehaviouralsymptomsofimpulsecontroldisordersincludingpathologicalgambling,increasedlibido,

hypersexuality,compulsivespendingorbuying,bingeeatingandcompulsiveeatingcanoccurinpatientstreatedwith

dopamineagonistsincludingapomorphine.Dosereduction/tapereddiscontinuationshouldbeconsideredifsuch

symptomsdevelop.

APO-goPen10mg/mlSolutionforInjectioncontainssodiumbisulphitewhichmayrarelycausesevereallergic

reactionsandbronchospasm.

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

PatientsselectedfortreatmentwithapomorphineHClarealmostcertaintobetakingconcomitantmedicinalproducts

fortheirParkinson’sdisease.IntheinitialstagesofapomorphineHCltherapythepatientshouldbemonitoredfor

unusualundesirableeffectsorsignsofpotentiationofeffect.

Neurolepticmedicinalproductsmayhaveanantagonisticeffectifusedwithapomorphine.Thereisapotential

interactionbetweenclozapineandapomorphine,howeverclozapinemayalsobeusedtoreducethesymptomsof

neuropsychiatriccomplications.

IfneurolepticmedicinalproductshavetobeusedinpatientswithParkinson’sdiseasetreatedbydopamineagonists,a

gradualreductioninapomorphinedosemaybeconsideredwhenadministrationisbyminipumpand/orsyringe-driver

(symptomssuggestiveofneurolepticmalignantsyndromehavebeenreportedrarelywithabruptwithdrawalof

dopaminergictherapy).

Thepossibleeffectsofapomorphineontheplasmaconcentrationsofothermedicinalproductshavenotbeenstudied.

Thereforecautionisadvisedwhencombiningapomorphinewithothermedicinalproducts,especiallythosewitha

narrowtherapeuticrange.

AntihypertensiveandCardiacActiveMedicinalProducts

Evenwhenco-administeredwithdomperidone,apomorphinemaypotentiatetheantihypertensiveeffectsofthese

medicinalproducts(seeSection4.4).

ItisrecommendedtoavoidtheadministrationofapomorphinewithotherdrugsknowntoprolongtheQTinterval.

4.6Fertility,pregnancyandlactation

Thereisnoexperienceofapomorphineusageinpregnantwomen.

Animalreproductionstudiesdonotindicateanyteratogeniceffects,butdosesgiventoratswhicharetoxictothe

mothercanleadtofailuretobreatheinthenewborn..Thepotentialrisktohumansisunknown.SeeSection5.3.

APO-goshouldnotbeusedinpregnancyunlessclearlynecessary.

Itisnotknownwhetherapomorphineisexcretedinbreastmilk.Adecisiononwhethertocontinue/discontinue

breastfeedingortocontinue/discontinuetherapywithAPO-goshouldbemadetakingintoaccountthebenefitofbreast-

feedingtothechildandthebenefitofAPO-gotothewoman.

4.7Effectsonabilitytodriveandusemachines

ApomorphineHClhasminorormoderateinfluenceontheabilitytodriveandusemachines.

Patientsbeingtreatedwithapomorphineandpresentingwithsomnolenceand/orsuddensleepepisodesmustbe

informedtorefrainfromdrivingorengaginginactivities(e.g.operatingmachines)whereimpairedalertnessmayput

themselvesorothersatriskofseriousinjuryordeathuntilsuchrecurrentepisodesandsomnolencehaveresolved(see

alsoSection4.4).

4.8Undesirableeffects

Verycommon(1/10)

Common(1/100to<1/10)

Uncommon(1/1,000to<1/100)

Rare(1/10,000to<1/1,000)

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Bloodandlymphaticsystemdisorders

Uncommon:

Haemolyticanaemiaandthrombocytopeniahavebeenreportedinpatientstreatedwithapomorphine.

Rare:

EosinophiliahasrarelyoccurredduringtreatmentwithapomorphineHCl.

Immunesystemdisorders

Rare:

Duetothepresenceofsodiummetabisulphite,allergicreactions(includinganaphylaxisandbronchospasm)mayoccur.

Psychiatricdisorders

Common:

Neuropsychiatricdisturbancesarecommoninparkinsonianpatients.APO-goshouldbeusedwithspecialcautionin

thesepatients.Neuropsychiatricdisturbances(includingtransientmildconfusionandvisualhallucinations)have

occurredduringapomorphineHCltherapy.

Notknown:

Impulsecontroldisorders:Pathologicalgambling,increasedlibido,hypersexuality,compulsivespendingorbuying,

bingeeatingandcompulsiveeatingcanoccurinpatientstreatedwithdopamineagonistsincludingapomorphine(see

section4.4).

Nervoussystemdisorders

Common:

TransientsedationwitheachdoseofapomorphineHClatthestartoftherapymayoccur;thisusuallyresolvesoverthe

firstfewweeks.

Apomorphineisassociatedwithsomnolence.

Dizziness/light-headednesshavealsobeenreported.

Uncommon:

Apomorphinemayinducedyskinesiasduring‘on’periods,whichcanbesevereinsomecases,andinafewpatients

mayresultincessationoftherapy.

Apomorphinehasbeenassociatedwithsuddensleeponsetepisodes.Seealsosection4.4.

Vasculardisorders

Uncommon:

Posturalhypotensionisseeninfrequentlyandisusuallytransient(SeeSection4.4).

Respiratory,thoracicandmediastinaldisorders

Common:

Yawninghasbeenreportedduringapomorphinetherapy.

Uncommon:

Breathingdifficultieshavebeenreported.

Gastrointestinaldisorders

Common:

Nauseaandvomiting,particularlywhenapomorphinetreatmentisfirstinitiated,usuallyasaresultoftheomissionof

Notknown(cannotbeestimatedfromtheavailabledata) Irish Medicines Board

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Skinandsubcutaneoustissuedisorders

Uncommon:

Localandgeneralisedrasheshavebeenreported.

Generaldisordersandadministrationsiteconditions

Verycommon:

Mostpatientsexperienceinjectionsitereactions,particularlywithcontinuoususe.Thesemayincludesubcutaneous

nodules,induration,erythema,tendernessandpanniculitis.Variousotherlocalreactions(suchasirritation,itching,

bruisingandpain)mayalsooccur.

Uncommon:

Injectionsitenecrosisandulcerationhavebeenreported.

Notknown:

Peripheraloedemahasbeenreported.

Investigations

Uncommon:

PositiveCoombs'testshavebeenreportedforpatientsreceivingapomorphine.

4.9Overdose

Thereislittleclinicalexperienceofoverdosewithapomorphinebythisrouteofadministration.Symptomsofoverdose

maybetreatedempiricallyassuggestedbelow:-

Excessiveemesismaybetreatedwithdomperidone.

Respiratorydepressionmaybetreatedwithnaloxone.

Hypotension:appropriatemeasuresshouldbetaken,e.g.raisingthefootofthebed.

Bradycardiamaybetreatedwithatropine.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmatherapeuticgroup:Dopamineagonists

ATCCode:N04BC07

Apomorphineisadirectstimulantofdopaminereceptorsand,whilepossessingbothD1andD2receptoragonist

properties,doesnotsharetransportormetabolicpathwayswithlevodopa.

Althoughinintactexperimentalanimals,administrationofapomorphinesuppressestherateoffiringofnigro-striatal

cellsandinlowdosehasbeenfoundtoproduceareductioninlocomotoractivity(thoughttorepresentpre-synaptic

inhibitionofendogenousdopaminerelease)itsactionsonparkinsonianmotordisabilityarelikelytobemediatedat

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5.2Pharmacokineticproperties

Aftersubcutaneousinjectionofapomorphineitsfatecanbedescribedbyatwo-compartmentmodel,withadistribution

half-lifeof5(±1.1)minutesandaneliminationhalf-lifeof33(±3.9)minutes.Clinicalresponsecorrelateswellwith

levelsofapomorphineinthecerebrospinalfluid;theactivesubstancedistributionbeingbestdescribedbyatwo-

compartmentmodel.Apomorphineisrapidlyandcompletelyabsorbedfromsubcutaneoustissue,correlatingwiththe

rapidonsetofclinicaleffects(4-12minutes),andthebriefdurationofclinicalactionoftheactivesubstance(about1

hour)isexplainedbyitsrapidclearance.Themetabolismofapomorphineisbyglucuronidationandsulphonationtoat

leasttenpercentofthetotal;otherpathwayshavenotbeendescribed.

5.3Preclinicalsafetydata

Repeatdosesubcutaneoustoxicitystudiesrevealnospecialhazardforhumans,beyondtheinformationincludedin

othersectionsoftheSmPC.

Invitrogenotoxicitystudiesdemonstratedmutagenicandclastogeniceffects,mostlikelyduetoproductsformedby

oxidationofapomorphine.However,apomorphinewasnotgenotoxicintheinvivostudiesperformed.

Theeffectofapomorphineonreproductionhasbeeninvestigatedinrats.Apomorphinewasnotteratogenicinthis

species,butitwasnotedthatdoseswhicharetoxictothemothercancauselossofmaternalcareandfailuretobreathe

inthenewborn.

Nocarcinogenicitystudieshavebeenperformed.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiummetabisulphite(E223)

Hydrochloricacid,concentrated(forpHadjustment)

WaterforInjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3Shelflife

2years

Onceopenedthepre-filledsyringeshouldbeusedimmediately.

Singleuseonly.Anyunusedsolutionshouldbediscarded.

6.4Specialprecautionsforstorage

Keepthepre-filledsyringeintheoutercartoninordertoprotectfromlight.

ForstorageoftheproductafteropeningseeSection6.3.

Donotstoreabove25 o

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6.5Natureandcontentsofcontainer

Clearglass(TypeI)pre-filledsyringe,10mlwitharubberstopperandtipcap.

Packscontain5Pre-filledSyringesinacardboardtrayinanoutercardboardcarton.

Bundlepacksof25and50Pre-filledSyringesareavailableinsometerritories:

The25pre-filledsyringesbundlepacksconsistsof5packseachcontaining5pre-filledsyringes.

The50pre-filledsyringesbundlepacksconsistsof10packseachcontaining5pre-filledsyringes.

Notallpacksizesaremarketed.

6.6Specialprecautionsfordisposalandotherhandling

APO-goPFS5mg/mlSolutionforInfusioninPre-filledSyringeisforsingleuseonly.Anyunusedsolutionshouldbe

discarded.

Donotuseifthesolutionhasturnedgreen.Thesolutionshouldbeinspectedvisuallypriortouse.Onlyclear,

colourlessandparticlefreesolutionshouldbeused.

Aftersingleuse,adaptorsandsyringesshouldbediscardedanddisposedofina“Sharps”bin.

7MARKETINGAUTHORISATIONHOLDER

GenusPharmaceuticalsLimited

ParkViewHouse

65LondonRoad

Newbury

BerkshireRG141JN

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA1496/2/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:29February2008

Dateoflastrenewal:15September2009

10DATEOFREVISIONOFTHETEXT

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Date Printed 26/06/2013 CRN 2132845 page number: 8

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