FERROLOGIC 20 MG/ ML SOLUTION FOR INJECTION/ CONCENT

Main information

  • Trade name:
  • FERROLOGIC 20 MG/ ML SOLUTION FOR INJECTION/ CONCENT
  • Dosage:
  • 20
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FERROLOGIC 20 MG/ML SOLUTION FOR INJECTION/CONCENT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1350/001/001
  • Authorization date:
  • 18-04-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FerroLogic20mg/mlsolutionforinjection/concentrateforsolutionforinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmillilitreofsolutioncontains20mgironasironsucrose[iron(III)-hydroxidesucrosecomplex].

Each5mlampoulecontains100mgironasironsucrose[iron(III)-hydroxidesucrosecomplex].

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection/concentrateforsolutionforinfusion.

Ferrologicisadarkbrown,nontransparent,aqueoussolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Ferrologicisindicatedfortheparenteraltreatmentofirondeficiencyinthosecaseswhereoralironpreparationsare

inadequate.

Thiscanapplyto:

Patientswhodemonstratedintolerancetooralironpreparations,

Patientswhodemonstratednon-compliancewithoralirontherapy,

Conditionswherethereisaclinicalneedtodeliverironrapidlytoironstores,

Patientswhoinsufficientlyabsorboralironpreparations(e.g.duetoactiveinflammatoryboweldisease).

Thediagnosisofirondeficiencymustbebasedonappropriatelaboratorytests(e.g.serumferritin,serumiron,

transferrinsaturation,haemoglobin,haematocrit,erythrocyticcountandhypochromicredcellsorredbloodcells

indices:MCV,MCH,MCHC).

4.2Posologyandmethodofadministration

Calculationoftherequireddosage

AdultsandElderly:

ThetotalcumulativedoseofFerrologic,equivalenttothetotalirondeficit(mg),isdeterminedbythehaemoglobin

levelandbodyweight.ThedoseanddosagescheduleforFerrologicmustbeindividuallyestimatedforeachpatient

basedonacalculationofthetotalirondeficit:

Totalirondeficit[mg]=bodyweight[kg]x(targetHb-actualHb)[g/l]x0.24*+depotiron[mg]

Upto35kgbodyweight:targetHb=130g/lrespectivelydepotiron=15mg/kgbodyweight

Above35kgbodyweight:targetHb=150g/lrespectivelydepotiron=500mg

*Factor=0.0034x0.07x1000(Ironcontentofhaemoglobin0.34%;Bloodvolume7%ofbodyweight;Factor1000=

conversionfromgtomg)

ThetotalamountofFerrologicrequiredisdeterminedfromeithertheabovecalculationorthefollowingdosagetable

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ToconvertHb(mM)toHb(g/l),multiplytheformerby16.1145.

Whenthetotalnecessarydoseexceedsthemaximumdailydose,theadministrationshouldbesplit.

When,after1-2weeks,thehaematologicalparametersshownoreaction,theinitialdiagnosisdeservesreconsideration.

Calculationofthedosageforreplacingbloodlossesandcompensatingautologousbloodtransfusions

Iftheamountofbloodlostisknown:

Theadministrationof200mgofiron(=2ampoulesofFerrologic)causesanincreaseinhaemoglobinsthatis

equivalenttoonebloodunit(=400mlwith150g/lofHb).

Ironbeingreplaced[mg] =totalnumbersofbloodunitslostx200or

NumberofFerrologicampoulesrequired =numbersofbloodunitslostx2

Ifthehaemoglobinvalueisreduced:

Usetheafore-mentionedformula,consideringthattheirondepositsdonotneedtoberestored.

Ironbeingreplaced[mg] =bodyweight[kg]x0.24x(idealHb–realHb)[g/l]

e.g.:bodyweight=60kg,Hbdeficit=10g/l amountofirontobereplaced=150mg=1.5ampoules(=7.5ml)of

Ferrologicarerequired.

Dosage:

AdultsandElderly:

ThecumulativedoseofFerrologicistobeadministeredinsingledosesof100mgofiron(oneampouleofFerrologic)

givennotmorethanthreetimesperweekdependinguponthehaemoglobinvalues.However,ifclinicalcircumstances

requirerapiddeliveryofirontothebodyironstores,thedosageschedulemaybeincreasedto200mgofironnotmore

thanthreetimesperweek.

Themaximumalloweddoseeachadministrationis:200mgofiron(twoampoulesofFerrologic)injectedduringat

least10minutesor0.35mlofFerrologic/kgofbodyweight(=7mgofiron/kgofbodyweight),notexceeding5

ampoules/day(500mgofiron)dilutedin500mlofserumandadministeredbyintravenousinfusionduringatleast3.5

Bodyweight

[kg] TotalnumbersofFerrologicampoulestobeadministered:

Hb60g/l Hb75g/l Hb90g/l Hb105g/l

12.5 11.5 10 9

13.5 12 11 9.5

11.5 10

10.5

13.5 11.5

16.5 14.5 12

17.5 15 12.5

18.5 16 13

22.5 19.5 16.5 13.5

23.5 20.5 17 14

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Children:

TheuseofFerrologichasnotbeenadequatelystudiedinchildrenand,therefore,Ferrologicisnotrecommendedforuse

inchildren.

Specialpatientgroups:

Itisnotknowntowhichextentrenalorhepaticdysfunctioncaninfluencethepharmacologicalcharacteristicsofiron

(III)hydroxidesucrosecomplex.

Administration:

Ferrologicmustonlybeadministeredbytheintravenousroute.Thismaybebyaslowintravenousinjectionorbyan

intravenousdripinfusion.However,administrationbyintravenousdripinfusionisthepreferredrouteofadministration

asthismayhelptoreducetheriskofhypotensiveepisodesandparavenousleakage.Beforeadministeringthefirst

therapeuticaldoseofFerrologictoanewpatient,atestdoseofbetween1and2.5mlofFerrologic(20to50mgof

iron)shouldbeinjectedslowlyoveraperiodof1to2minutes.Ifnoadversereactionsoccurforaperiodof15minutes

afteradministration,therestoftheinitialdosemaybeadministered.Facilitiesforcardio-pulmonaryresuscitationmust

beavailablewhenadministeringFerrologicbecauseallergicoranaphylactoidreactionsandhypotensiveepisodesmay

occur.Ferrologicisastronglyalkalinesolution(pH10.5-11.0)andmustneverbeadministeredbythe

subcutaneousorintramuscularroute,norisitsuitableforTDI(totaldoseinfusion)duringwhichthetotalnecessary

irondoseequivalenttotheirondepletion,isadministeredonasingleoccasion.

Ampoulesshouldbevisuallyinspectedforsedimentanddamagebeforeuse.Onlythosewithsedimentfreeand

homogenoussolutionmustbeused.Thedilutedsolutionmustappearasbrownandclear.Seealso6.3shelf-life.

Intravenousdripinfusion:

Ferrologicmustbedilutedonlyin0.9%sodiumchloridesolution(normalsaline).Each5mlampoule(100mgiron)of

Ferrologicshouldbedilutedin100mlof0.9%salineimmediatelybeforeinfusion(i.e.2ampoulesin200ml,etc.to

max.5ampoulesin500mlofnormalsaline).Forstabilityreasons,dilutionsoflowerFerrologicconcentrationsarenot

permissible.Thesolutionmustbeadministeredatthefollowingrate:100mlinatleast15minutes;200mlinatleast

30minutes;300mlinatleast1.5hours;400mlinatleast2.5hours;500mlinatleast3.5hours.

Intravenousinjection:

Ferrologicmaybeadministeredbyslowintravenousinjectionatarateof1mlundilutedsolutionperminute(i.e.5

minutesperampoule)andnotexceeding2ampoulesFerrologic(200mgiron)perinjection.Afteranintravenous

injection,extendandelevatethepatient’sarmandapplypressuretotheinjectionsiteforatleast5minutestoreduce

theriskofparavenousleakage.

Injectionintodialyser:

Ferrologicmaybeadministeredduringhaemodialysisdirectlyintothevenouslineofthedialyserunderthesame

proceduresasthoseoutlinedforintravenousadministration.

4.3Contraindications

TheuseofFerrologiciscontra-indicatedincasesof:

knownhypersensitivitytoparenteralironpreparations,Ferrologicoranyofitsexcipients,

anaemiasnotattributabletoirondeficiency,

ironoverloadordisturbancesinutilisationofiron,

patientswithahistoryofasthma,eczemaorotheratopicallergy,becausetheyaremoresusceptibletoexperience

allergicreactions,

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4.4Specialwarningsandprecautionsforuse

Parenterallyadministeredironpreparationscancausesevereallergicoranaphylactoidreactions,whichmaybe

potentiallyfatal.Therefore,facilitiesfortreatmentofseriousallergicreactionsincludingcardio-pulmonary

resuscitationmustbeavailable.

Inpatientswithliverdysfunction,parenteralironshouldonlybeadministeredaftercarefulrisk/benefitassessment.

Parenteralironadministrationshouldbeavoidedinpatientswithhepaticdysfunctionwhereironoverloadisa

precipitatingfactor,inparticularPorphyriaCutaneaTarda(PCT).Carefulmonitoringofironstatusisrecommendedto

avoidironoverload.

Parenteralironmustbeusedwithcautionincaseofacuteorchronicinfection.Itisrecommendedthatthe

administrationofironsucroseisstoppedinpatientswithongoingbacteraemia.Inpatientswithchronicinfectiona

risk/benefitevaluationhastobeperformed,takingintoaccountthesuppressionoferythropoiesis.

Hypotensiveepisodesmayoccuriftheinjectionisadministeredtoorapidly.Allergicreactions,sometimesinvolving

arthralgia,havebeenmorecommonlyobservedwhentherecommendeddoseisexceeded.

ParavenousleakagemustbeavoidedbecauseleakageofFerrologicattheinjectionsitemayleadtopain,inflammation,

tissuenecrosis,sterileabscessandbrowndiscolorationoftheskin.

Thismedicinalproductcontainslessthan1mmolsodium(23mg)perdose,i.e.essentially‘sodium-free’.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Aswithallparenteralironpreparations,Ferrologicshouldnotbeadministeredconcomitantlywithoraliron

preparationssincetheabsorptionoforalironisreduced.Therefore,oralirontherapyshouldbestartedatleast5days

afterthelastinjectionofFerrologic.

4.6Fertility,pregnancyandlactation

Dataonalimitednumberofexposedpregnanciesindicatednoadverseeffectsofironsucroseonpregnancyoronthe

healthofthefoetus/newbornchild.Nowell-controlledstudiesinpregnantwomenareavailabletodate.Limiteddata

fromanimalstudiesdonotindicatedirectorindirect

harmfuleffectswithrespecttopregnancy,embryonal/foetaldevelopment,parturitionorpostnataldevelopment.Itis

notknownwhethertheiron(III)-hydroxidesucrosecomplexcrossestheplacenta,incontrast,irondextranisknownto

crosstheplacentainsmallamounts.TheuseofFerrologicduringthefirsttrimesterofpregnancyiscontraindicated(see

section4.3).

Followingarisk/benefitevaluationthetreatmentmustbelimitedtothesecondandthirdtrimester.Ferrologicshouldbe

usedonlywhenperoraliron-containingproductsareineffectiveornottoleratedandtheanaemiaisconsideredassevere

toconstitutearisktomotherandfoetus.

Non-metabolisedironsucroseisunlikelytopassintothemother’smilk.Therefore,noeffectsonthesucklingchildare

anticipated.Ferrologiccanbeusedduringbreast-feeding.

4.7Effectsonabilitytodriveandusemachines

Inthecaseofsymptomsofdizziness,confusionorlight-headednessfollowingtheadministrationofFerrologic,patients

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4.8Undesirableeffects

Themostfrequentlyreportedadversedrugreactions(ADRs)ofFerrologicinclinicaltrialsweretransienttaste

perversion,hypotension,feverandshivering,injectionsitereactionsandnausea,occurringin0.5to1.5%ofthe

patients.Non-seriousanaphylactoidreactionsoccurredrarely.Ingeneralanaphylactoidreactionsarepotentiallythe

mostseriousadversereactions(seesection4.4).Inclinicaltrials,thefollowingadversedrugreactionshavebeen

reportedintemporalrelationshipwiththeadministrationofIVironsucrose,withatleastapossiblecausalrelationship:

Withineachsystemorganclass,theadversedrugreactionsarerankedundertheheadingsofreportingfrequency,using

thefollowingconvention:

Verycommon (1/10)

Common (1/100and<1/10)

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

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

Veryrare (<1/10,000)

Notknown (cannotbeestimatedfromtheavailabledata)

Nervoussystemdisorders

Common:transienttasteperversions(inparticularmetallictaste).

Uncommon:headache;dizziness.

Rare:paraesthesia.

Veryrare:seizures(inthecontextofhypersensitivityreactions)

Cardio-vasculardisorders

Uncommon:hypotensionandcollapse;hypertension,tachycardiaandpalpitations.

Respiratory,thoracicandmediastinaldisorders

Uncommon:bronchospasm,dyspnoea.

Gastrointestinaldisorders

Uncommon:nausea;vomiting;abdominalpain;diarrhoea.

Skinandsubcutaneoustissuedisorders

Uncommon:pruritus;urticaria;rash,exanthema,erythema.

Musculoskeletalandconnectivetissuedisorders

Uncommon:musclecramps,myalgia.

Generaldisordersandadministrationsiteconditions

Uncommon:fever,shivering,flushing;chestpainandtightness.Injectionsitedisorderssuchassuperficial

phlebitis,burning,swelling.

Rareanaphylactoidreactions(rarelyinvolvingarthralgia);peripheraloedema;fatigue,asthenia;malaise.

Moreover,inspontaneousreportsthefollowingadversereactionshavebeenreported:

Notknown:reducedlevelofconsciousness,light-headedfeeling,confusion;angio-oedema;andswellingofjoints,

hyperhidrosis,backpain.

4.9Overdose

Overdosagecancauseacuteironoverloadingwhichmaymanifestitselfashaemosiderosis.Overdosageshouldbe

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Ironpreparations;Irontrivalent,parenteralpreparations

ATC-code:B03AC02

Thepolynucleariron(III)-hydroxidecoresare,atthesurface,surroundedbyalargenumberofnon-covalentlybound

sucrosemolecules,whichresultsinacomplexwithamolecularmassofapproximately43kD.Thisissufficientlylarge

topreventrenalelimination.Thecomplexisstableanddoes,underphysiologicalconditions,notreleaseanyionised

iron.Theironinthepolynuclearcoresisboundinastructuresimilartothephysiologicalferritin.AdministrationofIV

ironsucroseleadtophysiologicalalterationswhichareaccompaniedbyironuptake.

5.2Pharmacokineticproperties

Distribution

FollowingintravenousinjectionofasingledoseofFerrologiccontaining100mgironinhealthyvolunteers,maximum

ironlevels,averaging538µmol/l,wereobtained10minutesafterinjection.Thevolumeofdistributionofthecentral

compartmentcorrespondedwelltothevolumeofplasma(approximately3litres).

Biotransformation

TheferrokineticsofIVironsucroselabelledwith 59

Feand 52

Fewereassessedin5patientswithanaemiaandchronic

renalfailure.Plasmaclearanceof 52

Fewasintherangeof60to100minutes. 52

Fewasdistributedtotheliver,spleen

andbonemarrow.Attwoweeksafteradministration,themaximumredbloodcellutilisationof 59

Ferangedfrom62%

to97%.

Elimination

Theironinjectedwasrapidlyclearedfromtheplasma,theterminalhalf-lifebeingapprox.6h.Thevolumeof

distributionatsteadystatewasabout8litres,indicatingalowirondistributioninthebodyfluid.Duetothelower

stabilityofironsucroseincomparisontotransferrin,acompetitiveexchangeofirontotransferrinwasobserved.This

resultedinirontransportofapprox.31mgiron/24h.

Renaleliminationofiron,occurringinthefirst4hoursafterinjection,correspondstolessthan5%ofthetotalbody

clearance.After24hourstheplasmalevelsofironwerereducedtothepre-doseironlevelandabout75%ofthedosage

ofsucrosewasexcreted.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberthatareadditionaltoinformationalreadyinothersectionsof

theSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections

Sodiumhydroxide

6.2Incompatibilities

Ferrologicmustonlybemixedwith0.9%ofsodiumchloridesolution.Nootherintravenousdilutionsolutions

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6.3ShelfLife

2years.

Shelflifeafterfirstopeningthecontainer:

Fromamicrobiologicalpointofview,theproductshouldbeusedimmediately.

Shelflifeafterdilutionwith0.9%sodiumchloridesolution:

Chemicalandphysicalin-usestabilityhasbeendemonstratedfor24hoursat22±2°C . Fromamicrobiologicalpointof

view,thedilutedproductshouldbeusedimmediately.

6.4Specialprecautionsforstorage

Storeinoriginalpackageinordertoprotectfromlight.Donotfreeze.

Forstorageconditionsofthedilutedmedicinalproductseesection6.3.

6.5Natureandcontentsofcontainer

5mlTypeIglassampoule.

Ferrologicissuppliedinpackscontaining5ampoulesorinmulti-packscomprising10packs,eachcontaining5

ampoules.Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

FreseniusMedicalCareNephrologicaDeutschlandGmbH

61346BadHomburgv.d.H.

Germany

8MARKETINGAUTHORISATIONNUMBER

PA1350/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18thApril2008

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