EQUIHES

Main information

  • Trade name:
  • EQUIHES 100 Mg/Ml Solution for Infusion
  • Dosage:
  • 100 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 100 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:
  • PA0736/024/002
  • Authorization date:
  • 26-01-2007
  • Last update:
  • 14-03-2018

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

PACKAGELEAFLET: INFORMATIONFOR THEUSER

EquiHes100 mg/mlsolution forinfusionEcoflacplus ®

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.

Read allofthis leafletcarefully before youstartusing this medicine becauseitcontains

importantinformationfor you.

Keep thisleaflet. You mayneedto readitagain.

Ifyou have anyfurtherquestions,askyourdoctor, nurseorpharmacist.

This medicine hasbeen prescribedforyou only. Do notpass itonto others. Itmay harm

them, even iftheirsigns ofillness are the same as yours.

Ifyou getanyside effects, talkto yourdoctor, nurseorpharmacist.Thisincludes any

possible side effects notlisted inthis leaflet. See section 4.

Whatis inthisleaflet:

1. WhatEquiHes100 mg/mlis and what it is used for

2. Whatyou need to knowbeforeyou useEquiHes100 mg/ml

3. How to useEquiHes100mg/ml

4. Possible side effects

5. Howto storeEquiHes100 mg/ml

6. Contents of thepack andotherinformation

1. WhatEquiHes100mg/ml is andwhatit is usedfor

EquiHes100 mg/ml is aninfusion solution which is administered via acannula into a

vein.

EquiHes100mg/mlisaplasmavolumesubstitutethatisusedtorestoretheblood

volumewhenyouhavelostbloodwhenotherproductscalledcrystalloidsarenot

considered sufficient alone.

2. Whatyouneedto know beforeyouuseEquiHes100mg/ml

Do not useEquiHes100mg/mlifyou:

areallergicto anyof theactivesubstancesoranyofthe other ingredients ofthis

medicine (listed in section 6).

sufferfrom seriousgeneralised infection (sepsis)

sufferfrom burn injury

havekidneyimpairmentorreceive dialysis

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 consider carefullyif thismedicine is suitableforyou.

Yourdoctor will adjustthe doseof EquiHes100 mg/ml carefullyin orderto prevent fluid

overload. This will be doneespeciallyifyou haveproblems withyour lungs or withyour

heart orcirculation.

Thenursingstaffwillalso takemeasures toobserveyour body's fluid balance, blood salt

level, kidneyfunction.Ifnecessaryyou mayreceiveadditional salts.

Inaddition it will be ensured thatyou receiveenough fluids.

EquiHes 100 mg/ml iscontraindicated ifyou havekidneyimpairment or kidneyinjury

requiringdialysis.

Ifimpaired kidneyfunction occurs duringtherapy:

Ifthe doctor detects firstsigns of kidneyimpairment he/shewillstopgivingyou this

medicine.In additionyourdoctormayneed to monitoryour kidneyfunction for up to 90

days.

Ifyou aregiven EquiHes100 mg/ml repeatedlyyour doctor will monitorthe abilityof

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

abilityofyour bloodto clot,your doctorwillstopgivingyou 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 100 mg/ml

Tellyour doctor orpharmacistifyouaretaking,haverecentlytakenor might takeany

othermedicines.

Yourdoctor will takespecial careaboutyou ifyoureceive/take

special typeofantibiotics called aminoglycosides

medicines that makeyouretain potassiumor sodium

medicines forthetreatment of heart weakness(e.g.digitalis preparations,

digoxin).

EquiHes100 mg/mlmayincreasethe undesirableeffects of thesemedicines.

Pregnancy andbreast-feeding

Ifyouarepregnantorbreast-feeding,thinkyoumaybepregnantorareplanningtohave

ababy, askyour doctor or pharmacistforadvicebeforetakingthis medicine.

Pregnancy

HarmfuleffectsontheunbornchildcanoccurwithHydroxyethylstarchwhenyouhave

an allergicreaction to theproduct.

Youwillreceivethismedicineonlyifthedoctorhas consideredthepotentialbenefits

outweighingthepossibleriskstotheunbornchild,especiallywhenyouareinthefirst

trimester.

Breast-feeding

It is notknown whetherHydroxyethyl starchpasses into the breast milk.Thereforeyour

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

decision willbemadewhethertotemporarilydiscontinuebreast-feeding.

Driving andusing machines

EquiHes100 mg/mlhasnoinfluenceyourabilityto driveandusemachines.

3. Howto useEquiHes100 mg/ml

EquiHes100 mg/mlis administeredtoyoubyadrip into thevein (intravenous infusion).

Dosage

Yourdoctor will decideon the correct dose foryou to receive.

YourdoctorwillusethelowestpossibleeffectivedoseandwillnotinfuseEquiHes100

mg/mlformorethan 24hours.

Adults

Themaximum dailydoseis18ml(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.

IfyoureceivemoreEquiHes100 mg/ml thanyoushould

IfyouhavereceivedtoomuchEquiHes100mg/ml,youmaysuffer fromfluidoverload

that mayaffectyour heart and lungfunction.

Ifthishappens,yourdoctorwillstoptheinfusionofEquiHes100mg/mlimmediately

and giveyou anynecessarytreatment.

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,the

medicationmustbe stoppedanda doctorshould beconsultedimmediately.

Verycommon(mayaffectmorethan 1 in 10people):

Decreasedred blood cells andreduced blood protein concentration duetodilution.

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

Dilutionofyourbloodclottingfactors(partsofyourbloodwhichareresponsiblefor

blood clotting). This maycause bleedingcomplications.

Rare(mayaffect up to 1 in 1000 people):

Allergicreactionsmayoccurindependentofdose.Theycanbeseriousandevenprogress

toshock.Ifanallergicreaction,especiallyananaphylactic/anaphylactoidreaction

(includingswellingoftheface,tongueorthroat,difficultiestoswallow,hivesand

breathingdifficulties)occurs,yourdoctorwillstoptheinfusionofEquiHes100mg/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(mayaffectupto 1in 100people):

Itchingmayoccuraftertreatment,evensomeweeksafterthetreatmentisstopped.The

itchingcanpersistforseveral months.

Reportingof sideeffects

Ifyougetanysideeffects, talk toyour doctor,pharmacistornurse. Thisincludes any

possible side 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 100 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

WhatEquiHes100 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 1.0mmol/l

Chloride 118 mmol/l

Acetate 24 mmol/l

L-Malate 5.0 mmol/l

pH: 5.6

6.4

Theoretical osmolarity: 297mOsmol/l

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

WhatEquiHes100 mg/ml looks likeandcontents ofthepack

Clear, colourless, aqueous solution.

EquiHes100 mg/ml is available in the followingpacks and pack sizes.

Polyethylenebottle (Ecoflacplus) availablein a pack 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 566171 0

Telefax: +49 566171 4567

This medicinal product is authorisedintheMemberStates ofthe EEA underthe

followingnames:

Austria Tetraspan10%Infusionslösung

Belgium Tetraspan10%,100 mg/mloplossingvoorinfusie

Czech Republic Tetraspan10%

Denmark Tetraspan100 mg/ml infusionsvæske

Estonia Tetraspan100 mg/ml infusioonilahus

Finland Tetraspan100 mg/ml infuusioneste, liuos

Germany Tetraspan10%Infusionslösung

Greece Tetraspan,διάλυμαγιαέγχυση10%

Hungary Tetraspan10%oldatos infúzió

Ireland EquiHes 100 mg/ml Solution forInfusion

Italy Tetraspan100 mg/mlsoluzione per infusione

Latvia Tetraspan100 mg/mlšķīdumsinfūzijām

Lithuania Tetraspan100 mg/ml infuzinis tirpalas

Luxembourg Tetraspan10%Infusionslösung

Poland Tetraspan100 mg/ml HESroztwórdoinfuzji

Portugal Tetraspan100 mg/mlsolução paraperfusão

Slovak Republic Tetraspan10%

Slovenia Tetraspan100 mg/ml raztopinazainfundiranje

Spain Isohes 10% Solución paraperfusion

Sweden Tetraspan100 mg/ml infusionsvätska, lösning

TheNetherlands Tetraspan10%g/v,oplossingvoorinfusie100g/l

United Kingdom Tetraspan10%Solution forInfusion

This leafletwas lastrevisedin 28February 2014

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Thefollowinginformation is intended for healthcareprofessionals only:

UseofHydroxyethylstarch (HES)should berestricted to theinitialphaseofvolume

resuscitationwith amaximumtimeintervalof24 h.

Thefirst10-20 mlshould be infused slowlyand undercarefulmonitoringofthe patientsothat

anyanaphylactic/anaphylactoidreactioncan be detected asearlyaspossible.

Thelowestpossible effective dose should be applied.Treatmentshould beguided bycontinuous

haemodynamic monitoringso thattheinfusion is stopped assoon as appropriatehaemodynamic

goals have been achieved.Themaximumrecommended dailydosemustnotbe exceeded.

Useassoon as the primarypackagingis opened. Anyunusedcontents shouldbe discarded.

Administration shouldbegin immediatelyafterconnectingthecontainertotheadministration set.

For single use only. Do notre-connectpartiallyused containers.Useonlyifthe solution isclear,

colourlessandthe containerisundamaged.

Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithother

medicinalproducts.

EquiHes100mg/mlis hyperoncotic:

EquiHes100 mg/mlis ahyperoncoticsolution, i.e.theincrease in the intravascularplasma

volume exceedstheinfusedvolume (bymobilisation ofextravascularfluid).Therefore, the risk

ofhypervolaemia should beparticularlyconsidered.

InstructionsforuseforinfusionunderpressureofEquiHes in:

Ecoflacpluscontainer:

Ifitiswishedtohaveaveryrapidinfusionunderpressure,allairmustberemovedfrom

boththeplasticpackagingandtheinfusionsetbeforetheinfusionisinstitutedtoprevent

theriskofanairembolismduringtheinfusion.Aninfusionunderpressureshouldbe

given with apressurecuff.

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