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BALGELA 4% W/V SOLUTION FOR INFUSION

Active substance(s): SUCCINYLATED GELATIN / SUCCINYLATED GELATIN / SUCCINYLATED GELATIN

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1.3 Product Information

Document: 1.3.

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Page 1 of 1

Patient Information Leaflet

Balgela
4% w/v Solution for Infusion
(succinylated gelatin)
Read all of this leaflet carefully
‡KeepWhiVleafleWYouma\needWoreadiWagain
‡,I\ouhaveIurWherqueVWionVpleaseaVN\ourdoFWoror
nurse
In this leaflet:
1. What is Balgela and what does it do?
2. Before being given Balgela
3. How much Balgela to use and for how long?
4. Possible side effects
5. Storing Balgela
6. Further Information
1. What is Balgela and what does it do?
% D O J H O D  is a Wemporary plasma suEVWiWuWeVoluWion
conWainingVuccinylaWedgelaWiQ4%w/v(PlasmaisWhefluid
componenWofblRRGLQZKLFKWKHUHGFHOOVDQGZKLWHFHOOVare
carrieG %DOJHODis adminiVWered direFWly inWo a vein via a
drip Wube(inWravenouVinfusion)
Youwillbegiven%DOJHODiI\ouhaveloVWbloodoUbody
fluidVbecause of bleeding, injury, surgery, burns or
infeFWioQ,WWakes Wime for your body Wo replace Whe bloodor
body fluidsWhaW\ou have loVW% D O J H O D  can help mainWain
Whe volume ofIluid in your blood vessels during WhaW Wime 
%DOJHODis noWinWended Woprovide nuWriWion nor replace
blood componenWVVuchasredcellswhichFarryoxygenoU
whiWecellswhiFKIighWinfeFWion%DOJHODFanonl\replaceloVW
fluidYolume
%DOJHODcan be used for Whe WreaWmenW of inLWial blood loss
duringpregnanF\
2. Before being given Balgela
DonoWalloZBalgelaWobegivenWoyouifyouknowWhaW
youareallergiF(hypersensiWive)WoVuccinylaWedgelaWiQ
,f you are suffering or have suffered from Whe following
condiWionVpleaseWell\ourdoFWorornursebeforebeing
given%DOJHOD
‡HearWIailurH
‡Kidne\(renal)Iailure
PleaseinformyourdoFWorornurseifyouareWaking,or
haverecenWlyWaken,anyoWhermedicine,includingWhose
medicinesobWainedwiWhouWaprescripWioQ


PleaseaskyoXUdoFWorornurseforadviceifyouare
pregnanWorbreaVWIeedinJ
3. How much Balgela to use and for how long?
Youwillbegiven%DOJHODviaadripWubeinserWedinWoavein
,Wis unlikely WhaW you will ever have Wo use % D O J H O D 
yourself;infusionfluidsaremainlyinWendedWobegiveQby
yourdoFWorornurse
YourdoFWorornursewillworkouWhowoIWenyoushould
haveBalgela,andhowmuch%DOJHODshouldbeusedThe
amounWgivenwilldependuponyourindividualneedsYou
mighWalsobegivenoWherinfusionfluidsorproduFWVmade
fromblood,orabloodWransfusion
ForinfusionWheusualdoVHraWeVare
ForAdulWV500±1500ml/houU
ForChildren150±1500ml/houU
ForElderl\AVAdulWV

EachconWainerof%DOJHODisdesignedWolaVWonlyafew
hoursaWaWime;moVWofWhesuccinylaWedgelaWinispassed
ouWofWhebod\inleVVWhan12hourVForWhiVreason\ou
ma\begivenmorH%DOJHODwKHQ\RXUGRFWRURUQXUVH
WhinkVWKLVisnecessar\,nWime,yourbodywillmakeupWhe
blooGorbodyIluidVWhaW\oXhaveloVW
4. Possible Side Effects
Like all medicineV%DOJHODcan cause side effeFWV,
alWhoughnoWeverybod\geWVWheP

Rarel\(beWween1in1,000and1in10,000people),
paWienWVmayexperienceanallergiclikereaFWioQTellyour
doFWorornurseimmediaWel\iI\ounoWicean\oIWhe
following
‡SwellingofyourIacemouWhorWhroaW
‡Changes in youUbreaWhing, eg faVW breaWhing, difficulWy
breaWhingouWwheezinJ
‡ChangeVinWhewa\\ourhearWbeaWVegIaVWbeaWinJ
‡Changes in your blood pressure, eg feeling dizzy or
IainWheadachH
‡Changes in your body WemperaWure, eg chills, fever
VweaWinJ
‡Abnormal feelings in your skin, including iWFhing, rash
Vwellingoran\oWherFhangeVWoyourVNin
‡ShakingoI\ourarmVand/orlegs.
If you get any side effects, talk to your doctor or pharmacist. T
his includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine.

5. Storing Balgela
%DOJHODVhouldnoWbeuseGiI
‡WheFonWainerVhowVan\VignofleakagH
‡WheVoluWioniVFloudy
‡WheVoluWioniVNOTaclearpaleyelloworVWrawFolour
‡parWicleVDreYisiblewiWhinWheFonWaineU
‡WhedaWeofuseisaIWerWhelaVWdayofWhemonWhofWhe
expir\GDWHZKLFKiVVWDWHGRQWKHLQIXVLRQEDJLQWKH
IormaWMM/YYYY
PleaseinformyourdoFWorornurseimmediaWelyiI\ou
believeWhaWan\oIWheaboveViWuaWionVhaveoccurred
6. Further Information
TheaFWLYesubVWancein%DOJHODissuccinylaWedgelaWiQ
(40%w/v)500mland1000mlbagsof%DOJHODconWain20g
and40gofsuccinylaWedgelaWiQrespeFWivel\TheoWher
ingredienWsareVodium chloride, sodium hydroxide or
hydrochloric acid, andwaWerIorinjeFWionV
% D O J H O D  is a clear pale yellow or VWraw coloured soluWion
forinfusionwhichissuppliedin500mland1000mlflexible
plaVWicFonWainerV(infusionbags)
The MarkeWing AuWKorisaWion Holder for %DOJHODLV
%ULGJLQJ3KDUPDFHXWLFDOV/WG)ORRU7KRPDV
0RUH6TXDUH(:<:8.
The manufaFWurer of %DOJHODis Serumwerk Bernburg
A*HallescheLandVWraVVH05b,Bernburg
German\

7KLVOHDIOHWZDVODVWUHYLVHGLQ

%$/*(/$LVD5HJLVWHUHG7UDGHPDUNRI%ULGJLQJ3KDUPD/WG
6:;3%1$

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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