EQUIHES

Main information

  • Trade name:
  • EQUIHES 60 Mg/ Ml Solution for Infusion
  • Dosage:
  • 60 Mg/ Ml
  • Pharmaceutical form:
  • Solution for Infusion
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EQUIHES 60 Mg/Ml Solution for Infusion
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Blood substitutes and plasma protein fractions

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PA0736/024/001
  • Authorization date:
  • 26-01-2007
  • Last update:
  • 20-10-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PACKAGELEAFLET: INFORMATIONFOR THEUSER

EquiHes60 mg/ml solutionforinfusionEcoflacplus ®

This medicineis subject to additional monitoring. This will allow quick identification

ofnew safetyinformation. You can help byreportinganysideeffectsyoumayget. See

the end ofsection 4 forhow to report side effects.

Readallofthis leafletcarefully beforeyoustart using this medicinebecauseit

containsimportant informationforyou.

Keep this leaflet. You mayneed to read itagain.

Ifyou haveanyfurther questions, askyour doctor, nurseor pharmacist.

This medicinehas been prescribedforyou only. Do not pass iton to others.It

mayharm them, even if their signs of illness arethesameasyours.

Ifyouget anysideeffects, talk toyour doctor, nurseor pharmacist. This includes

anypossible sideeffectsnot listed in this leaflet. Seesection 4.

Whatis inthisleaflet:

1. WhatEquiHes60 mg/ml is andwhat it is used for

2. Whatyou need to knowbeforeyou useEquiHes60 mg/ml

3. Howto useEquiHes60mg/ml

4. Possible side effects

5. Howto storeEquiHes60mg/ml

6. Contents of thepack andotherinformation

1. WhatEquiHes60mg/ml is andwhatit is usedfor

EquiHes60 mg/ml is an infusionsolution which isadministered via acannula into avein.

EquiHes60mg/mlisaplasmavolumesubstitutethatisusedtorestorethebloodvolume

whenyouhavelostbloodwhenotherproductscalledcrystalloidsarenotconsidered

sufficient alone.

2. Whatyouneedto know beforeyouuseEquiHes60 mg/ml

DonotuseEquiHes60mg/mlifyou:

areallergicto anyof theactivesubstancesoranyofthe other ingredients ofthis

medicine (listed in section 6).

sufferfrom seriousgeneralised infection (sepsis)

sufferfrom burn injury

havekidneyimpairmentorreceivedialysis

havesevereliver disease

sufferfrom bleedingin thebrain (intracranialorcerebralbleeding)

arecriticallyill (e.g.youneed to stayin an intensivecareunit)

havetoo much fluid inyour bodyandyou havebeen told thatyou haveacondition

known as hyperhydration.

havefluid in thelungs(pulmonaryoedema)

aredehydrated

havebeen told thatyou haveasevereincreasepotassium, sodiumor chloridein

yourblood

haveseverelyimpairedliver function

havesevereheart failurehavesevereproblems withyour blood clotting

havereceivedan organ transplant

Warnings andprecautions

It is important to tellyour doctor ifyou have:

impairment ofyourliverfunction

problems withyourheartorcirculation

bloodclotting(coagulation)disorders

problems withyour kidneys

Because of theriskof allergic(anaphylactic/anaphylactoid)reactions,youwillbe

monitored closely to detect earlysigns ofan allergic reaction whenyou receive this

medicine.

Surgeryand trauma:

Yourdoctor will considercarefullyif thismedicine is suitableforyou.

Yourdoctor will adjustthe doseof EquiHes 60 mg/ml carefullyin order to prevent fluid

overload. This will be doneespeciallyifyou haveproblems withyour lungs or withyour

heart orcirculation.

Thenursingstaffwillalso takemeasures toobserveyour body's fluidbalance, blood salt

level, kidneyfunction.Ifnecessaryyou mayreceiveadditional salts.

Inaddition it will be ensured thatyou receiveenough fluids.

EquiHes60 mg/ml is contraindicated ifyou havekidneyimpairment or kidneyinjury

requiringdialysis.

Ifimpaired kidneyfunction occurs duringtherapy:

Ifthe doctor detects firstsigns of kidneyimpairment he/shewillstopgivingyou this

medicine.In additionyourdoctor mayneed tomonitoryour kidneyfunction for up to 90

days.

Ifyou aregivenEquiHes60 mg/ml repeatedlyyourdoctor will monitorthe abilityof

yourblood to clot, bleedingtime and other functions.Incaseof an impairment of the

abilityofyour blood to clot,yourdoctorwillstopgivingyou this medicine.

Ifyou areundergoingopen heart surgeryandyouareon aheart/lungmachine to assist in

pumpingyour blood duringthe surgery, theadministration ofthis solution is not

recommended.

Elderlypatients

Yourdoctor will closelymonitoryour condition duringtreatment and mayadjustyour

dose,as elderlypatients aremorelikelyto sufferfrom problems with kidneysand heart.

Othermedicines andEquiHes 60 mg/ml

Tellyour doctor orpharmacistifyouaretaking,haverecentlytakenor might takeany

othermedicines,

Yourdoctor will takespecial careaboutyou ifyoureceive/take

aspecial typeof antibiotics called aminoglycosides

medicinesthat makeyouretain potassiumor sodium

medicines forthe treatment of heart weakness(e.g.digitalis preparations,

digoxin).

EquiHes 60 mg/ml mayincreasethe undesirable effects of thesemedicines.

Pregnancy andbreast-feeding

Ifyouarepregnantorbreast-feeding,thinkyoumaybepregnantorareplanningtohavea

baby,askyour doctor orpharmacistforadvicebeforetakingthis medicine.

Pregnancy

HarmfuleffectsontheunbornchildcanoccurwithHydroxyethylstarchwhenyouhave

an allergicreaction to theproduct.

Youwillreceivethismedicineonlyifthedoctorhasconsideredthepotentialbenefits

outweighingthepossibleriskstotheunbornchild,especiallywhenyouareinthefirst

trimester.

Breast-feeding

It is notknown whetherHydroxyethyl starchpasses into the breast milk.Thereforeyour

doctor will administer this solution toyou onlyifhe/she thinks it is necessaryand a

decision willbemadewhethertotemporarilydiscontinuebreast-feeding.

Driving andusing machines

EquiHes 60 mg/ml doesnot influenceyourabilityto driveandusemachines.

3. Howto use EquiHes 60mg/ml

EquiHes60 mg/ml is administeredtoyoubyadrip into thevein (intravenous infusion).

Dosage

Yourdoctor will decideon the correct dose foryou to receive.

YourdoctorwillusethelowestpossibleeffectivedoseandwillnotinfuseEquiHes60

mg/ml formorethan24hours.

Adults

Themaximum dailydoseis 30ml(1.8 gHydroxyethyl starch)per kgbodyweight.

Usein children

Thereisonlylimitedexperienceoftheuseofthismedicineinchildren.Thereforeitis

not recommended to usethis medicinein children.

Elderlypatientsand patients with a specialcondition

Ifyouareanelderlypatientorhaveproblemswiththelungs,heartorcirculationthe

dosagewillbeadjusted toyour individual situation.

IfyoureceivemoreEquiHes60 mg/ml thanyoushould

IfyouhavereceivedtoomuchEquiHes60mg/ml,youmaysufferfromfluidoverload

that mayaffectyour heart and lungfunction.

Ifthishappens,yourdoctorwillstoptheinfusionofEquiHes60mg/mlimmediatelyand

giveyouanynecessarytreatment.

Ifyouhaveanyfurtherquestionsontheuseofthismedicine,askyourdoctoror

pharmacist.

4. Possible sideeffects

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygets

them.

Themostcommonsideeffectsobservedaredirectlyrelatedtothetherapeuticeffectof

starch solutions and the doses administered, whichmeans dilution ofyourblood and parts

ofyourbloodwhichareresponsibleforbloodclotting.Furthermoreseriousallergic

reactions havebeen observed.

Thefollowingsideeffectsmaybeserious.Ifanyofthefollowingsideeffectsoccur,

themedicationmust bestoppedandadoctorshouldbeconsultedimmediately.

Verycommon(mayaffectmorethan 1 in 10people):

Decreasedred blood cellsand reduced blood protein concentration duetodilution.

Common, depending on theadministered dose(mayaffect up to 1 in 10 people):

Dilutionofyourbloodclottingfactors(partsofyourbloodwhichareresponsiblefor

blood clotting). This maycausebleedingcomplications.

Rare(mayaffect up to 1 in 1000 people):

Allergicreactionsmayoccurindependentofdose.Theycanbeseriousandevenprogress

toshock.Ifanallergicreaction,especiallyananaphylactic/anaphylactoidreaction

(includingswellingoftheface,tongueorthroat,difficultiestoswallow,hivesand

breathingdifficulties)occurs,yourdoctorwillstoptheinfusionofEquiHes60mg/ml

immediatelyand treatyou with basic medical measures.

Itisnotpossibletopredictbytestswhichpatientsmaybeexpectedtosufferfroman

allergic reaction norto predict the courseor theseverityof such anallergicreaction.

Frequencynot known(cannot be estimated from theavailable data)

Kidneyinjury

Liver injury

Othersideeffects

Verycommon(mayaffectmorethan 1 in10 people):

InfusionofHydroxyethylstarchresultsinincreasedlevelsofanenzymecalledalfa-

amylasein serum. This could be misinterpreted asevidenceof apancreaticdisorder.

Uncommon(mayaffect up to 1 in 100 people):

Itchingmayoccuraftertreatment,evensomeweeksafterthetreatmentisstopped.The

itchingcanpersistforseveral months.

Reportingof sideeffects

Ifyougetanysideeffects, talk toyour doctor,pharmacistornurse. This includes any

possibleside effectsnot listed in this leaflet.You can also report side effects directlyvia

IMBPharmacovigilance,Earlsfort Terrace,IRL-Dublin 2;Tel:+353 1 6764971; Fax:

+353 1 6762517. Website:www.imb.ie; e-mail:imbpharmacovigilance@imb.ie

Byreportingsideeffectsyou can help providemoreinformation on thesafetyof this

medicine.

5. Howto storeEquiHes 60 mg/ml

Keepthis medicineout of thesightandreachofchildren.

Do not usethis medicineafter theexpirydatewhich is stated on the label. Theexpiry

date refers to the last dateof that month.

Forsingle useonly. After use, throwawaythecontainer and anyunused content.

Do not freeze.

Do not usethis medicineifthesolutionisnot clear, colourless orthecontainer orits

closureshow visible signs of damage.

6. Contents ofthepackandotherinformation

WhatEquiHes60 mg/ml contains

Theactivesubstances in1000 mlsolutionare:

Hydroxyethylstarch(HES) 60.0 g

(Molar substitution: 0.42)

(Averagemolecular weight: 130,000 Da)

Sodiumchloride 6.25 g

Potassiumchloride 0.30 g

Calcium chloride dihydrate 0.37 g

Magnesiumchloridehexahydrate 0.20 g

Sodiumacetatetrihydrate 3.27 g

L-Malicacid 0.67 g

Theotheringredients are:

Sodiumhydroxide(forpH adjustment)

Waterforinjections

Electrolyte concentrations:

Sodium 140 mmol/l

Potassium 4.0 mmol/l

Calcium 2.5 mmol/l

Magnesium 1.0 mmol/l

Chloride 118 mmol/l

Acetate 24 mmol/l

L-Malate 5.0 mmol/l

pH: 5.6

6.4

Theoretical osmolarity: 296 mOsmol/l

Acidity(titration to pH 7.4): <2.0 mmol/l

WhatEquiHes60 mg/ml looks likeandcontents ofthepack

Clear, colourless, aqueous solution.

EquiHes60 mg/ml is available in the followingpacks and pack sizes.

Polyethylenebottle (EcoflacPlus)available in apack of:

10 x500 ml

Not allpack sizes maybemarketed.

MarketingAuthorisationHolderandManufacturer:

Marketing Authorisation Holder

B. Braun Melsungen AG

Carl-Braun-Strasse1

34212 Melsungen

Germany

Postaladdress:

34209 Melsungen,Germany

Telephone: +49 5661 71 0

Telefax: +49 5661 71 4567

This medicinal product is authorisedintheMemberStates oftheEEA underthe

followingnames:

Austria Tetraspan6%Infusionslösung

Belgium Tetraspan6%, 60 mg/mloplossingvoorinfusie

Czech Republic Tetraspan6%

Denmark Tetraspan60 mg/ml infusionsvæske

Estonia Tetraspan60 mg/ml infusioonilahus

Finland Tetraspan60 mg/ml infuusioneste, liuos

Germany Tetraspan6%Infusionslösung

Greece Tetraspanδιάλυμαγιαέγχυση6%

Hungary Tetraspan60 mg/ml oldatos infúzió

Ireland EquiHes 60 mg/ml Solution forInfusion

Iceland Tetraspan60 mg/ml innrennslislyf, lausn

Italy Tetraspan60 mg/mlsoluzione per infusione

Latvia Tetraspan60 mg/mlšķīduminfūzijām

Lithuania Tetraspan60 mg/ml infuzinis tirpalas

Luxembourg Tetraspan6%Infusionslösung

Norway Tetraspan60 mg/ml infusjonsvæske, oppløsning

Poland Tetraspan60 mg/ml HESroztwórdoinfuzji

Portugal Tetraspan60 mg/mlsolução paraperfusão

Slovak Republic Tetraspan6%

Slovenia Tetraspan60 mg/ml raztopinazainfundiranje

Spain Isohes 6% Solución paraperfusión

Sweden Tetraspan60 mg/ml infusionsvätska, lösning

TheNetherlands Tetraspan6%g/v,oplossingvoor infusie60g/l

United Kingdom Tetraspan6%Solution forInfusion

This leafletwas lastrevisedin28 February 2014

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Thefollowinginformation is intended for healthcareprofessionals only:

UseofHydroxyethylstarch(HES) shouldberestrictedto theinitialphase ofvolume

resuscitationwith amaximumtimeinterval of24 h.

Thefirst 10-20 mlshould beinfused slowlyand under careful monitoringofthe patient

so that anyanaphylactic/anaphylactoid reaction can bedetected as earlyaspossible.

Thelowest possibleeffectivedoseshould beapplied. Treatment should be guided by

continuous haemodynamic monitoringso that theinfusion is stopped as soon as

appropriate haemodynamic goals havebeen achieved. Themaximum recommended daily

dosemustnot be exceeded.

Useas soon as the primarypackagingis opened.Anyunused contents should be

discarded.

Administration should begin immediatelyafter connectingthecontainer tothe

administration set.

Forsingle useonly. Do not re-connect partiallyused containers.Useonlyif thesolution

is clear, colourless and thecontainer is undamaged.

Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwith

othermedicinal products.

EquiHes60 mg/ml is iso-oncotic:

EquiHes60 mg/ml is an iso-oncoticsolution, i.e. theincreasein theintravascularplasma

volumeis equivalent to the infusedvolume.

InstructionsforuseforinfusionunderpressureofEquiHesin:

Ecoflacpluscontainer:

Ifitiswishedtohaveaveryrapidinfusionunderpressure,allairmustberemovedfrom

theplasticpackagingandtheinfusionsetbeforetheinfusionisinstitutedtopreventthe

riskofanairembolismduringtheinfusion.Aninfusionunderpressureshouldbegiven

with a pressurecuff.

Ecoflac plus:

1 2

-Connect theinfusion set.

-Placethe containerupright.

-Open the roller clamp, expel theair from

the containerand fillhalfthe drip

chamberwith liquid.

-Turn the container upsidedown and

primethe infusiontube freefromair

bubbles.

-Placethe Ecoflacplusbottle in a

pressurecalf.

-Build up pressure.

-Open the roller clamp and start the

infusion