FERRLECIT

InformatIon for HealtHcare ProfessIonals

ferrlecit

®

1.nameoftHemeDIcInalProDUct

Ferrlecit ® 62.5 mg

Active substance: sodium ferric gluconate sucrose complex

2.QUalItatIVeanD QUantItatIVecomPosItIon

One ampoule of5 ml contains:

Sodium ferric gluconate sucrose complex

equivalent to: 62.5 mg iron(III) ion

Prepared from:

Ferric chloride hexahydrate

Sodium carbonate, anhydrous

Sodium gluconate

Sucrose

Contains45mgbenzylalcoholperampoule(5ml)(seesections4.4

and 4.8).

Fora full list ofexcipients, see section 6.1.

3. PHarmaceUtIcalform

Solution for injection or concentrate for solution for infusion.

4.clInIcalPartIcUlars

4.1therapeutic indications

Severeirondeficiencystatesonlywhenoraladministrationhasbeenfound

impossible;incasesofgastrointestinalmalabsorptionwhichrulesout

oral iron therapy; patientstreated by dialysis getting erythropoietin.

4.2 Posology and method ofadministration

Unlessotherwiseordered,dependingonthelevelofirondeficiency,

adultsaregivenoneampouledailyof5mlbyslowintravenousinjection

or by infusion after dilution with0.9% sodium chloride.

Notmorethanoneampouleshouldbegiven,eveninexceptionalcases

such as marked iron deficiencyafter repeated autologous donation.

I.V.injectionsmustalwaysbegivenveryslowlywiththepatient

supine.

Forpreference,theproductcanalsobegivenasanintravenousinfusion

over20to30minutesdilutedwith100to250mlof0.9%sodium

chloride.

Fromsixyearsofageandupwardsuntilachievementofabodyweightof

40kg,childrenwithirondeficiencyanderythropoietintherapyunder

haemodialysisreceiveadoseof0.12mlFerrlecit/kgbodyweight,

equivalent to 1.5 mgiron (III) ion/kg body weight at each dialysis.

Childrenandadolescentswithabodyweightofmorethan40kgreceive

asingledoseof5mlFerrlecit,equivalentto62.5mgiron(III)ionat

each dialysis.

Thedurationoftreatmentdependsonthedegreeofirondeficiency,that

can be approximately calculated according to the following equation:

Required

amount of

iron [mg] = body weight 1) [kg] xHb deficit [g/dl] 2) x factor 3.5

1) tobe based on the normal weight in the case ofoverweight patients.

target Hb corresponding to normal forage and gender.

Reliablevaluesforserumferritinandtransferrinsaturationwillnotbe

obtainedforatleastoneweekafterthelastFerrlecitdose.Totaland

reticulocytehaemoglobinbegintoincreasewithinonetotwoweeks

ofstarting treatment.

4.3contraindications

Ferrlecit should not be used in

-hypersensitivity tothe active substance or one ofthe excipients,

-ironoverload(haemochromatosis,chronichaemolysis)orironutilisation

disorders (sideroblastic anaemia, leadanaemia, thalassaemia),

-severe inflammatory diseases ofthe liver or kidneys,

-infants and small children under 3 years ofage.

Duetothecontentofbenzylalcohol,Ferrlecitmustnotbegivento

Ferrlecitisnotrecommendedforuseinchildrenbetweenthreeandsix

years ofage dueto inadequate safety data.

Becauseofitssucrosecontent,thismedicinalproductmustnotbeusedin

patientssufferingfromhereditaryfructoseintolerance,glucose-galactose

malabsorption or saccharase-isomaltasedeficiency.

4.4special warnings and precautions for use

Ferrlecit should onlybe used with special caution in:

-patients with known allergicdiathesis e.g. in asthmatics

-chronicinflammatorydiseases(Crohn’sdisease,progressiverheumatoid

arthritis)

Inordertoavoidhaemosiderosis,itisessentialtocalculatetheamount

ofiron required beforethe i.v. administration ofiron.

Accidentalparavenousorintramuscularinjectionispainfulduetothe

contentofbenzylalcoholandmustthereforebeavoided.Inaddition,

accidentalparavenousadministrationcanleadtoreddish-brown

discolouration ofthe skin.

Benzylalcoholcancausetoxicandanaphylacticreactionsininfantsand

children below 3 years ofage.

Theadministrationofmedicationscontainingbenzylalcoholto

newbornsorprematureneonateshasbeenassociatedwithafatal

“GaspingSyndrome”(symptomsincludeastrikingonsetofgasping

syndrome,hypotension,bradycardia,andcardio-vascularcollapse).As

benzylalcoholmaycrosstheplacenta,solutionforinjectionshouldbe

used with caution in pregnancy.

4.5Interactionswithothermedicinalproductsandother

forms ofinteraction

Theincidenceandseverityofpossibleanaphylactic/anaphylactoid

reactionswithFerrlecittherapycanbeincreasedifFerrlecitisusedin

patients undertreatment with ACE-inhibitors.

4.6 Pregnancy and lactation

Pregnancy

Therearenoadequatedataontheuseofthesodiumferricgluconate

sucrosecomplexinpregnancy.Animalstudieshaveshownreproductive

toxicity(seesection5.3).Thepotentialriskforhumanisunknown.

Useduringpregnancyshouldonlybecontemplatediftheexpected

benefitsforthemotheroutweighallpossiblerisksforthefoetus(see

section5.3).

Duetotherarelyoccurringcirculatoryreactionsthataninjectionof

ironcancause(seesection4.8),thereisthepotentialriskwithpregnant

womenthatnutritionaldisordersoccurinthefoetusduetoinadequate

bloodsupplytotheplacenta.Thereforeparticularattentionshouldbe

paid tocorrect use (see section 4.2).

Lactation

Itisnotknownwhetherexcretionofironintobreastmilkisincreased

afterparenteraladministrationofiron.Ferrlecitshouldthereforebeused

during lactation only after carefullyweighing the benefits and risks.

4.7effects onability to drive and use machines

TherearenostudiesoftheeffectsofFerrlecitontheabilitytodriveor

operate machines.

4.8 Undesirable effects

Theassessmentofundesirableeffectsisbasedonthefollowing

frequencies:

Very common(≥ 10%)

Common (≥ 1% - < 10%)

Uncommon(≥ 0.1% - < 1%)

Rare (≥ 0.01% - < 0.1%)

Very rare (< 0.01%)

Notknown (frequencycannotbeestimatedonthebasisoftheavailable

data)

Blood and lymphatic system disorders

Veryrare:haemolysis,haemoglobulinuria(onoverloadofthetransferrin

system)

Vascular disorders

Rare: hypotensive eventseven progressing to circulatory collapse

Respiratory, thoracic and mediastinaldisorders

Rare:pulmonaryoedema,swellingofthebronchialmucosawith

dyspnoea

Skin and subcutaneous tissue disorders

Rare: exanthematous skin changes

General disorders and administration site conditions

Rare:anaphylacticreactionswithoedemaatvarioussitesinthebody,

alsointheregionoftheface,oralcavityandpharynx(e.g.glottal

oedema)

Intravenous injection

Additionalundesirableeffectsthathavebeenreportedonintravenous

injectionarelistedbelow.Thereforethei.v.injectionshouldalwaysbe

given very slowly, with thepatient supine.

Thefrequencyoftheseundesirableeffectscannotbeestimatedfrom

the available data.

Cardiac disorders

Palpitations

Nervoussystem disorders

Paraesthesia, dizziness, taste disorders

Gastrointestinal disorders

Nausea, abdominalpains

Musculoskeletal and connective tissue disorders

Paininthechestandback,muscleandjointpain,especiallyinpatients

withrheumatic disorders

Vascular disorders

Hypertension, facial reddening

Use in children

Thefollowingeventswereobservedinaclinicalstudyindialysis-dependent

children:

Cardiac disorders

Very common: palpitations

Infections andinfestations

Common:infections, pharyngitis, sinusitis

Vascular disorders

Very common: hypertension, hypotension

Common: thrombosis

Gastrointestinal disorders

Very common: nausea, vomiting, abdominalpain

Musculoskeletal and connective tissue disorders

Common: muscle and jointpain, chest and back pain

General disorders and administration siteconditions

Very common: headache

Common: fever, facial oedema

Rarely, benzylalcohol can cause hypersensitivity reactions.

4.9overdose

SignsofanoverdosewithFerrlecitmaybecirculatorycollapse,shock,

pallor,dyspnoea,restlessnessaswellasconfusionandcoma.Feverand

convulsionshave also been reported.

Ifserumironlevelsexceed3mg/landtheironbindingcapacityof

transferrinisexceeded,i.v.infusionof1to2gdeferoxamine(maximum

16mg/kg/hour)isrecommended.Theinfusionshouldberepeatedon

the next day ifnecessary and serumiron levels should be checked.

5. PHarmacoloGIcalProPertIes

5.1 Pharmacodynamicproperties

Pharmacotherapeutic group: iron-containing preparations,

ATC code: B03AC07

Ifthebodysuffersironlossoritsironrequirementsareincreased,the

irondeficitisreplacedbytheironcontainedinFerrlecit.Thisprovides

theerythropoieticcentreswithadequateamountsofironforthe

formationofhaemoglobin.Likewiseitenablesphysiologicalironreserves

to be built up.

Theeffectivenessofironreplacementisreflectedfirstinanincrease

innumbersofreticulocytesaswellasariseinhaemoglobinlevel,

haemoglobinconcentrationpersingleerythrocyteandanincreasein

5.2 Pharmacokinetic properties

Sodiumferricgluconatecomplexreachestheliverviatheblood.In

theliver,thetrivalentironreleasedafterenzymaticcleavageisbound

totransferrin,thecarrierproteinforironinplasma,whichtakesover

thetransporttocentresoferythropoiesisandthedepots.Ifthereisno

pathologicallossofironthroughbleeding,theironstoresofthebody

–apartfromaminimalphysiologicaldailyeliminationofiron-remain

virtually intact.

5.3Preclinical safety data

Preclinicaldataconcerningsafetypharmacologyandtoxicityon

singleorrepeatedadministrationproducednoinformationthatisnot

alreadymentionedinothersectionsoftheInformationforHealthcare

Professionals/SPC.

Thereisnoevidenceofapotentialmutagenicityofironinmammaliancells

in vivo. No long-term studies on carcinogenic potential are available.

Animalstudiesinratsandmiceproducednoevidenceofteratogenic

effects,butindosesfarabovethehumantherapeuticdose,embryotoxic

andfoetotoxic effects occurred.

6. PHarmaceUtIcalPartIcUlars

6.1excipients

Benzylalcohol,sodiumcarbonateanhydrous,waterforinjections,

nitrogen (protective gas)

6.2 Incompatibilities

Not to be mixed in syringes with otherdrugs!

Reducingsubstances(e.g.vitaminC,rutin,glucose,cysteineandother

substancescontainingSH-groups)mustnotbeadministeredatthesame

time as Ferrlecit solution for injection i.v.

6.3special precautions for storage

Store at a temperature not exceeding25°C and protectfrom light.

Thepreparedinfusionsolutionisstablefor24hoursatroom

temperature.

lIcenseHolDer

sanofi-aventis Israel ltd., P.O.B. 8090 Netanya 42504

manUfactUrer

Aventis Pharma, UK

The format ofthis leaflet was determined by the Ministry ofHealth

and its content was checked and approved inOctober 2012

FERR INJ INF PHY SH 120612