Hypermune RE

Main information

  • Trade name:
  • Hypermune RE
  • Pharmaceutical form:
  • Solution for infusion
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Hypermune RE
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BEE
  • Therapeutic area:
  • Horses Young

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0298/001
  • Authorization date:
  • 28-05-2008
  • EU code:
  • UK/V/0298/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

RevisedMay2012

AN:01006/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

HYPERMUNE-REEquinePlasma

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

QualitativeCompositionFrozenEquinePlasma

QuantitativeComposition

Activesubstances:

EquineIg G≥24g/l

EquineTotalProtein≥50g/l

AntibodiestoRhodococcusequi≥40%VILstandard

Excipient:

AcidCitrateDextrose-Atoensurecitratecontent10-20mmols/l

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Plasmaforintravenousinfusion,afterthawing.

4. CLINICALPARTICULARS

4.1 Targetspecies

Foalsfrom24hourstosixdaysofage.

4.2 Indicationsforuse,specifyingthetargetspecies

ForfoalswithFailureofPassiveTransfer

ToraisethelevelofcirculatingIgGinneonatalfoalswhichhavebeenshowntohavelow

levels(lessthan4g/l).Theraisedlevelhasbeendemonstratedapproximately24hours

afteradministrationbutthedurationoftheeffectisnotknown.

ForfoalswithNormalpassiveTransfer

ToraisethelevelofRhodococcusequiantibodies.Theraisedlevelhasbeen

demonstratedapproximately24hoursafteradministrationandraisedlevelsthough

declininggenerallylastforupto21days.

4.3 Contraindications

None

RevisedMay2012

AN:01006/2011

Page2of6

4.4 Specialwarnings<foreachtargetspecies>

ItisrecommendedthatappropriateRhodococcuscontrolmeasuresshouldbe

implementedtocontroldisease.Suchmeasuresincludeavoidanceofovercrowding,

controllingpaddockdustlevels,provisionofshadefortheanimals,removaloffaecesfrom

pasturesandclosemonitoringoffoalhealth.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Donotadministermorethan2dosestoananimal.

Ifaseconddoseisrequireddonotadministerthisbefore24hours.

Toreduceriskofadversereactions:

TransfusionReactions.Carefulmonitoring,especiallyatthestartandthroughoutthe

transfusionisessential.Distinctionmustbemadebetweenreactiontorestraintand

catheterisation and signs attributable to transfusion reaction. If tachycardia,

hyperventilatingortremblingoccurs,thetransfusionshouldbesloweddownorstopped

altogether.Ifsignsabatewithinfiveminutes,astheyshould,thenthetransfusionshould

becontinued.Iftheyrecuragain,thetransfusionshouldbestoppedentirely.

Anaphylaxis.Carefulmonitoring,especiallyatthestartandthroughoutthetransfusion,is

essential.Iftachycardia,hyperventilatingortremblingoccurs,thetransfusionshouldbe

sloweddownorstoppedaltogether.Ifsignsabatewithinfiveminutes,astheyshould,then

thetransfusionshouldbecontinued.Iftheyrecuragain,thetransfusionshouldbestopped

entirely.Ifsevere,orothersignsoccursuchascolic,pyrexia,cardiacarrhythmias,urticaria

andcollapse,thetransfusionshouldbestoppedandifnecessaryepinephrine(0.01mg/kg),

corticosteroidsandintravenoussalineadministered.Theseemergencydrugsshould

alwaysbeonhand.Flunixinmeglumineat0.25mg/kgmaybeusedprophylacticallyto

reducetheincidenceofsideeffects.

VolumeOverload.Volumeoverloadisapossiblehazardofplasmatransfusionespeciallyif

theadministrationiscarriedoutinfoalscompromisedinanywayortooquickly.Everyfoal

shouldbefullyclinicallyexaminedpriortotransfusionandinthecaseofcompromised

foalsthetransfusionshouldbemaintainedataslowrate,1litrefora50kgfoalorprorata

in1hour.Carefulmonitoringthroughoutthetransfusionisessential.Ifhyperventilating,

respiratorydistressortremblingoccurs,thetransfusionshouldbesloweddownorstopped

altogether.Diureticsmaybeusedinseverecases.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Administeronlyusingabloodgivingsettominimiseriskofself-injection.Incaseof

accidentalcontactwithskin,washaffectedareasthoroughlywithwarmsoapywater.

4.6Adversereactions(frequencyandseriousness)

ItshouldbenotedthatACD-Aisanexcipientandthatexcesscitratemaycauseareaction

intherecipientfoal.Thismaybeseenasmusclefasciculations,weaknessandcardiac

abnormalities.

RevisedMay2012

AN:01006/2011

Page3of6

TransfusionReactionsareveryrare;signsincludetachycardia,hyperventilatingand

trembling.

Anaphylaxisisveryrare,butcanoccurwithproductsofthisnature.Signsinclude

tachycardia,hyperventilatingandtrembling,orothersignssuchascolic,pyrexia,cardiac

arrhythmias,urticariaandcollapse.

VolumeOverloadisararehazardofplasmatransfusionespeciallyiftheadministrationis

carriedoutinfoalscompromisedinanywayortooquickly.Signsincluderespiratory

distress,hyperventilation,staggeringandcollapsewheninstandingrestraint.Additionally,

ifthefoalisinlateralrecumbencyfrothmaybeseenatthenostril.

Measurestoavoidtheseadversereactionsaredetailedinsection4.5

4.7Useduringpregnancy,lactationorlay

Donotuseinpregnantorlactatinghorses.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

SafetyandefficacydataareavailablewhichdemonstratethatHypermune-REcanbe

administeredonthesamedaybutnotmixedwithtetanusantitoxin.

NoinformationisavailableonthesafetyandefficacyofHypermune-REwhenusedwith

anyotherveterinarymedicinalproductexcepttheproductmentionedabove.Adecisionto

usethisproductbeforeorafteranyotherveterinarymedicinalproductthereforeneedsto

bemadeonacasebycasebasis.

Aswithcolostrumderivedpassiveimmunity,thepassiveimmunitytransferredby

Hypermune-REmayinterferewithresponsetovaccine.Itisrecommendedthatthisis

consideredwhenstartingavaccineprogrammewithdueadherencetothevaccine

manufacturer’sinstructions.

4.9 Amountstobeadministeredandadministrationroute

ForfoalswithFailureofPassiveTransfer

Hypermune-REmaybeadministeredtofoalsfrom24hoursto6daysofagewhereithas

beenshownaftertestingthattheyhavelowlevelsofserumIgG(lessthan4g/l).The

doserequiredisonelitrefora50kgfoal(andprorata,i.e.20mlperkg).

Abloodsampleshouldbecollectedfromthefoalapproximately24hourslaterandre-

testedforthelevelofserumIgG.Ifthisisstilllow,afurtherdosemaybeadministered.

Thisshouldbegivenwithin24 –48hoursofthefirstadministrationandbegiveninthe

samemannerasthefirst(intravenously,viaabloodgivingset,over15-20minutes).

ForfoalswithNormalPassiveTransfer

Thedoserequiredisonelitrefora50kgfoal(andprorata,i.e.20mlperkg).Tosustain

raisedlevelsofcirculatingRhodococcusequiantibodiesaseconddosemaybegivenat

approximately21dayslater.Thisshouldbegiveninthesamemannerasthefirst

(intravenously,viaabloodgivingset,over15-20minutes).

Methodofadministration

RevisedMay2012

AN:01006/2011

Page4of6

Therequireddoseisadministeredviaacatheterplacedinthejugularveinusingablood

givingsetequippedwithameshfilter.Theproductshouldbeadministeredslowly,

particularlyatthestart,andadministrationshouldtake15 –20minutes.Throughoutthe

administration,thefoalshouldbemonitoredforsignsofadversereactions.

Thawingshouldnottakeplaceinamicrowaveoven.Thelitrebagofplasmashouldbe

immersedonlyinwarmwateratnotmorethan40ºC.Awaterbathsuchasasinkfullof

domesticwarmwaterisideal.Astheplasmathawsandthewatercools,morewarmwater

maybeaddedasrequiredbuthotwater(notgreaterthanhandhot)mustbeavoidedasit

willdamagetheproteins.Theentirelitreofplasmashouldbebroughtslowlytobody

temperaturebeforeusetoensureallthecryoprecipitateisdissolved.Underoptimum

conditionsthiswholeprocessmaytake2-2½hours.Occasionallysmallamountsoffibrin

maystillbeseenfloatingintheplasma.Itisnotsignificantbutmustbefilteredoutbythe

filterinthebloodadministrationset.

Inspectforleakageandifapparentonthawingtheentirecontentsmustbediscarded.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noinformationisavailableontheeffectsofadministeringanoverdose

Volumeoverloadinfoals

Volumeoverloadisararehazardofplasmatransfusionespeciallyiftheadministrationis

carriedoutinfoalscompromisedinanywayortooquickly.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Tomodulatetheimmunesystembyprovidingequineimmunoglobulins,andspecific

antibodiestoRhodococcusequi.Fromlimitedfieldstudiesthereisatrendofreduced

severityofR.equidiseaseandareducedrequirementforintensiveantibiotictreatment

withtheuseofHypermuneREbytherecommendedschedule

ATCvetcode:QI05AM.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

AcidCitrateDextrose-A

6.2Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

RevisedMay2012

AN:01006/2011

Page5of6

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeoncethawed:24hours

6.4.Specialprecautionsforstorage

Storeinafreezer(-30°Cto-20°C)

HYPERMUNE-REshouldbehandledcarefullywhenbeingunpackedandstoredinthe

freezer.Thebubble-wrapshouldnotberemovedasitprotectsthebrittlefrozenplasticwhich

issusceptibletodamagefromcarelesshandlingsuchasbeingdroppedorknockedinthe

freezer.Whenthaweditshouldbestoredinarefrigerator.

6.5Natureandcompositionofimmediatepackaging

ThecontainerisaPVCwithDEHPone-litrehumanplasmasteriletransferbagwithtwo

protectivesterileports.Thewholebagisoverwrappedwithprotectivebubblewrapfor

storageandtransport.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VeterinaryImmunogenicsLtd

CarletonHill

Penrith

Cumbria

CA118TZ

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBERS

Vm18513/4001 VPA10662/001/001

9. DATEOFFIRSTAUTHORISATION

03/04/2007(UK) 22/08/2008(IE)

10 DATEOFREVISIONOFTHETEXT

May2012

RevisedMay2012

AN:01006/2011

Page6of6

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable

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In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we’re looking at ways to promote the use of more recent predicates

These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we’re looking at ways to promote the use of more recent predicates

These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we’re looking at ways to promote the use of more recent predicates

FDA - U.S. Food and Drug Administration

20-11-2018

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients.  https://go.usa.gov/xPAf7 pic.twitter.com/IATHeEUgHe

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients. https://go.usa.gov/xPAf7 pic.twitter.com/IATHeEUgHe

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients. https://go.usa.gov/xPAf7  pic.twitter.com/IATHeEUgHe

FDA - U.S. Food and Drug Administration

21-10-2018

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting  ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting https://go.usa.gov/xPnyd .

FDA - U.S. Food and Drug Administration

21-10-2018

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding  ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding https://go.usa.gov/xPnda . pic.twitter.com/nktV9BDAC3

FDA - U.S. Food and Drug Administration

5-9-2018

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical devices

FDA - U.S. Food and Drug Administration

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

6-8-2018

A reminder about the safe and correct use of condoms

A reminder about the safe and correct use of condoms

A reminder on the safe use of condoms, including making sure you’re aware of the expiry date

Therapeutic Goods Administration - Australia

22-7-2018

Medical device safety is a key #FDA priority. We’re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and addre

Medical device safety is a key #FDA priority. We’re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and addre

Medical device safety is a key #FDA priority. We’re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and address unmet medical need. pic.twitter.com/Dm73SQ213p

FDA - U.S. Food and Drug Administration

22-7-2018

Some devices come to market after #FDA determines that they're substantially equivalent to another legally marketed device called the predicate – this is the 510(k) pathway typically used for moderate risk devices.

Some devices come to market after #FDA determines that they're substantially equivalent to another legally marketed device called the predicate – this is the 510(k) pathway typically used for moderate risk devices.

Some devices come to market after #FDA determines that they're substantially equivalent to another legally marketed device called the predicate – this is the 510(k) pathway typically used for moderate risk devices.

FDA - U.S. Food and Drug Administration

22-7-2018

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path  https://bit.ly/2O43EqH  and providing streamlined paths for

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path https://bit.ly/2O43EqH  and providing streamlined paths for

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path https://bit.ly/2O43EqH  and providing streamlined paths for comparative safety claims pic.twitter.com/30wLydOAec

FDA - U.S. Food and Drug Administration

18-7-2018

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity:  https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://healthsectorcouncil.org/health-sector-mobilizes-against-cyber-threats/ …

FDA - U.S. Food and Drug Administration

11-6-2018

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Active substance: idelalisib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3765 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3843/T/40

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2021 (Chemo Research S.L.)

EU/3/18/2021 (Chemo Research S.L.)

EU/3/18/2021 (Active substance: Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin) - Orphan designation - Commission Decision (2018)3388 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/17

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety