GAMMANORM

Main information

  • Trade name:
  • GAMMANORM Solution for Injection 165 Mg/Ml
  • Dosage:
  • 165 Mg/Ml
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GAMMANORM Solution for Injection 165 Mg/Ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0521/014/001
  • Authorization date:
  • 10-09-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0521/014/001

CaseNo:2050397

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

OctapharmaLimited

TheZenithBuilding,26SpringGardens,Manchester,M21AB,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

GAMMANORM,165mg/mlsolutionforinjection.HumanNormalImmunoglobulin,ampoule.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom15/10/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

GAMMANORM,165mg/ml,solutionforinjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Humannormalimmunoglobulin(SC/IMIg)

Humannormalimmunoglobulin 165mg/ml*

*correspondingtohumanproteincontentofwhichatleast95%isIgG.

Oneampouleof10mlcontains:1650mg*ofhumannormalimmunoglobulin.

DistributionofIgGsubclasses:

4.9%

0.5%

max.82.5microgram/ml

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection.

Clearorslightlyopalescentandpaleyellowtolight-brownsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Replacementtherapyinadultsandchildreninprimaryimmunodeficiencysyndromessuchas:

congenitalagammaglobulinaemiaandhypogammaglobulinaemia

commonvariableimmunodeficiency(CVID)

severecombinedimmunodeficiency

IgGsubclassdeficiencieswithrecurrentinfections

Replacementtherapyinmyelomaorchroniclymphaticleukaemiawithseveresecondaryhypogammaglobulinaemia

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4.2Posologyandmethodofadministration

Posology

Replacementtherapy

Thetreatmentshouldbeinitiatedandmonitoredunderthesupervisionofaphysicianexperiencedinthetreatmentof

immunodeficiency.

Thedosagemayneedtobeindividualisedforeachpatientdependentonthepharmacokineticandclinicalresponse.The

followingdosageregimensaregivenasaguidance.

ThedosageregimenusingthesubcutaneousrouteshouldachieveasustainedlevelofIgG.Aloadingdoseofatleast

0.2-0.5g/kgmayberequired.AftersteadystateIgGlevelshavebeenattained,maintenancedosesareadministeredat

repeatedintervalstoreachacumulativemonthlydoseoftheorderof0.4-0.8g/kg.

Troughlevelsshouldbemeasuredinordertoadjustthedoseanddosageinterval.

Forintramuscularadministrationseebelow.

Methodofadministration

Gammanormshouldbeadministeredviathesubcutaneousorintramuscularroute.Inexceptionalcases,where

subcutaneousadministrationmaynotbeapplicable,lowdosesofGammanormcanbeadministeredviathe

intramuscularroute.

Subcutaneousinfusionforhometreatmentshouldbeinitiatedbyaphysicianexperiencedintheguidanceofpatients

forhometreatment.Thepatientwillbeinstructedintheuseofasyringedriver,infusiontechniques,thekeepingofa

treatmentdiaryandmeasurestobetakenincaseofsevereadverseevents.

Subcutaneousinfusionwithpump

Acommondoseis0.6ml(100mg)Gammanormperkgbodyweightonceaweek,whichmaybeadministeredat

severalinfusionsites.Initialinfusionrate:10ml/hour/pump.Theinfusionratemaybegraduallyincreasedby1

ml/hour/pumpeverythreetofourweeks.Themaximumdoseadministeredhasbeen40ml/hourusingtwopumps

simultaneously.

Whenlargedosesaregiven,itisadvisabletoadministerthemindivideddosesatdifferentsites.

Intramuscularinjectionmustbegivenbyaphysicianornurse.

PaediatricPatients

DataonchildrensufferingfromPIDareavailable.Aswithadults,troughlevelsshouldbemeasuredinordertoadjust

thedoseanddosageinterval.AftersteadystateIgGlevelshavebeenattained,maintenancedosesofabout80to100

mg/kg/weekareusuallyadministeredtoreachacumulativemonthlydoseoftheorderof0.4-0.8g/kg.Ifhome

treatmentisconsidered,advicefromaphysicianexperiencedintheguidanceofpatientsforhometreatmentshouldbe

sought.Thepatient'sparentsshouldbeinstructedintheuseoftheapplicationdevice,infusiontechniques,thekeeping

ofatreatmentdiaryandmeasurestobetakenincaseofsevereadverseevents.

4.3Contraindications

Hypersensitivitytoanyofthecomponents.

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Gammanormmustnotbeadministeredintramuscularlyincasesofseverethrombocytopeniaandinotherdisordersof

haemostasis.

4.4Specialwarningsandprecautionsforuse

IfGammanormisaccidentallyadministeredintoabloodvessel,patientscoulddevelopshock.

Therecommendedinfusionratestatedunder“4.2Methodofadministration”shouldbeadheredto.

Patientsshouldbecloselymonitoredandcarefullyobservedforanyadverseeventsthroughouttheinfusionperiodand

foratleast20minutesaftertheinfusion.

Certainadversereactionsmayoccurmorefrequentlyinpatientswhoreceivehumannormalimmunoglobulinforthe

firsttimeor,inrarecases,whenthehumannormalimmunoglobulinproductisswitchedorwhentreatmenthasbeen

stoppedformorethaneightweeks.

Truehypersensitivityreactionsarerare.TheycanparticularlyoccurintheveryrarecasesofIgAdeficiencywithanti-

IgAantibodiesandthesepatientsshouldbetreatedwithcaution.

Rarely,humannormalimmunoglobulincaninduceafallinbloodpressurewithanaphylacticreaction,eveninpatients

whohadtoleratedprevioustreatmentwithhumannormalimmunoglobulin.

Potentialcomplicationscanoftenbeavoidedbyensuringthat:

patientsarenotsensitivetohumannormalimmunoglobulin,byfirstinjectingtheproductslowly(seesection4.2,

Posologyandmethodofadministration);

patientsarecarefullymonitoredforanysymptomsthroughouttheinfusionperiod.Inparticular,patientsnaïveto

humannormalimmunoglobulin,patientsswitchedfromanalternativeproductorwhentherehasbeenalong

intervalsincethepreviousinfusionshouldbemonitoredduringthefirstinfusionandforthefirsthourafterthe

firstinfusion,inordertodetectpotentialadversesigns.Allotherpatientsshouldbeobservedforatleast20

minutesafteradministration.

Suspicionofallergicoranaphylactictypereactionsrequiresimmediatediscontinuationoftheinjection.Incaseof

shock,standardmedicaltreatmentshouldbeimplemented.

Standardmeasurestopreventinfectionsresultingfromtheuseofmedicinalproductspreparedfromhumanbloodor

plasmaincludeselectionofdonors,screeningofindividualdonationsandplasmapoolsforspecificmarkersof

infectionandtheinclusionofeffectivemanufacturingstepsforinactivation/removalofviruses.Despitethis,when

medicinalproductspreparedfromhumanbloodorplasmaareadministered,thepossibilityoftransmittinginfective

agentscannotbetotallyexcluded.Thisalsoappliestounknownoremergingvirusesandotherpathogens.

ThemeasurestakenareconsideredeffectiveforenvelopedvirusessuchasHIV,HBVandHCV.

Themeasurestakenmaybeoflimitedvalueagainstnon-envelopedvirusessuchasHAVandparvovirusB19.

ThereisareassuringclinicalexperienceregardingthelackofhepatitisAorparvovirusB19transmissionwith

immunoglobulinsanditisalsoassumedthattheantibodycontentmakesanimportantcontributiontotheviralsafety.

ItisstronglyrecommendedthateverytimethatGammanormisadministeredtoapatient,thenameandbatchnumber

oftheproductarerecordedinordertomaintainalinkbetweenthepatientandthebatchoftheproduct.

GammanormdoesnotprotectagainsthepatitisA.

Thismedicinalproductcontains4.35mmol(or100mg)sodiumperdose(40ml).Tobetakenintoconsiderationby

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Liveattenuatedvirusvaccines

Immunoglobulinadministrationmayimpairforaperiodofatleast6weeksandupto3monthstheefficacyoflive

attenuatedvirusvaccinessuchasmeasles,rubella,mumpsandvaricella.Afteradministrationofthisproduct,an

intervalof3monthsshouldelapsebeforevaccinationwithliveattenuatedvirusvaccines.Inthecaseofmeasles,this

impairmentmaypersistforupto1year.Thereforepatientsreceivingmeaslesvaccineshouldhavetheirantibodystatus

checked.

Interferencewithserologicaltesting

Afterinjectionofimmunoglobulinthetransitoryriseofthevariouspassivelytransferredantibodiesinthepatients

bloodmayresultinmisleadingpositiveresultsinserologicaltesting.

Passivetransmissionofantibodiestoerythrocyteantigens,e.g.A,B,Dmayinterferewithsomeserologicaltests

(reticulocytecount,haptoglobinandCoombstest).

4.6Pregnancyandlactation

Thesafetyofthismedicinalproductforuseinhumanpregnancyhasnotbeenestablishedincontrolledclinicaltrials

andGammanormshouldthereforeonlybegivenwithcautiontopregnantwomenandbreast-feedingmothers.Clinical

experiencewithimmunoglobulinssuggeststhatnoharmfuleffectsonthecourseofpregnancy,oronthefoetusandthe

neonatearetobeexpected.

4.7Effectsonabilitytodriveandusemachines

Noeffectsonabilitytodriveandusemachineshavebeenobserved.

4.8Undesirableeffects

AdversereactionsforGammanormarerare.Incaseofseverereactions,theinfusionshouldbestoppedandan

appropriatetreatmentshouldbeinitiated.

ThefollowingadversereactionshavebeenobservedforGammanorm:

Verycommon(>1/10);common(>1/100,<1/10);uncommon(>1/1,000,<1/100);rare(>1/10,000,<1/1,000);veryrare

(<1/10,000),includingisolatedreports.

Forinformationonviralsafetyseesection4.4.,Specialwarningsandprecautionsforuse.

4.9Overdose

SystemOrganClass Common Rare Veryrare

Immunesystemdisorders hypersensitivity anaphylacticshock

Nervoussystemdisorders headache,dizziness

Vasculardisorders hypotension

Gastrointestinaldisorders nausea,vomiting

Musculoskeletaland

connectivetissuedisorders lowbackpain,

arthralgia

Generaldisordersand

administrationsiteconditions injectionsite

reaction fever

rigors

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:immuneseraandimmunoglobulins:immunoglobulins,normalhuman,forextravascular

administration,ATCcode:J06BA01

HumannormalimmunoglobulincontainsmainlyimmunoglobulinG(IgG)withabroadspectrumofantibodiesagainst

infectiousagents.

HumannormalimmunoglobulincontainstheIgGantibodiespresentinthenormalpopulation.Itisusuallyprepared

frompooledplasmafromnotfewerthan1000donations.IthasadistributionofimmunoglobulinGsubclassesclosely

proportionaltothatinnativehumanplasma.AdequatedosesofGammanormmayrestoreabnormallylow

immunoglobulinGlevelstothenormalrange.

5.2Pharmacokineticproperties

Withsubcutaneousadministrationofhumannormalimmunoglobulin,peaklevelsareachievedintherecipient`s

circulationafteradelayof4-6days.

DatafromclinicalstudiesshowthattroughlevelsofGammanormcanbemaintainedbydosingregimensof100mg/kg

perweek.

Withintramuscularadministration,humannormalimmunoglobulinisbioavailableintherecipient`scirculationaftera

delayof2-3days.

IgGandIgG-complexesarebrokendowninthecellsofthereticuloendothelialsystem.

5.3Preclinicalsafetydata

Therearenorelevantdata.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycine

Sodiumchloride

Sodiumacetate

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3ShelfLife

3years

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6.4Specialprecautionsforstorage

Storeinarefrigerator(2 o

C–8 o

C).Keeptheampouleintheoutercarton.

Withinitsshelf-life,theproductmaybestoredbelow25°Cforupto1month,withoutbeingrefrigeratedagainduring

thisperiodandmustbediscardedifnotusedafterthis.

6.5Natureandcontentsofcontainer

10mlofsolutioninanampoule(TypeIglass)–packsizeof1,10or20.

6.6Specialprecautionsfordisposalandotherhandling

Theproductshouldbebroughttoroomorbodytemperaturebeforeuse.

Thesolutionshouldbeclearorslightlyopalescent.Donotusesolutionsthatarecloudyorhavedeposits.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

OctapharmaLimited

TheZenithBuilding

26SpringGardens

ManchesterM21AB

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0521/014/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10September2004

Dateoflastrenewal:15October2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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