Flunixin Injection

Main information

  • Trade name:
  • Flunixin Injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Flunixin Injection
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • steroids
  • Therapeutic area:
  • Horses

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0128/001
  • Authorization date:
  • 18-11-2009
  • EU code:
  • UK/V/0128/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:16July2009

AN:00229/2009

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Flunixin50mg/mlSolutionforInjectionforCattle,HorsesandPigs

FlunixinN-VetforCattle,HorsesandPigs(Sweden)

ParaflunixinRPS50mg/ml,SolutionforInjectionforCattle,Horsesand

Pigs(Germany)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveSubstance

Flunixin(asflunixinmeglumine) 50mg/ml

Excipients

Phenol 5.0mg/ml

SodiumFormaldehydeSulphoxylateDihydrate 2.5mg/ml

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Solutionforinjection.

Aclearcolourlesssolution

4. CLINICALPARTICULARS

4.1 Targetspecies:

Cattle,HorsesandPigs

4.2 Indicationsforuse,specifyingthetargetspecies:

Inhorses,indicatedforthealleviationofinflammationandpain

associatedwithmusculo-skeletaldisordersandforthealleviationof

visceralpainassociatedwithcolic,alsoindicatedforthetreatmentof

endotoxaemiaorsepticshockassociatedwithgastrictorsionandfor

otherconditionsinwhichthecirculationofthebloodtothe

gastrointestinaltractiscompromised.

Incattle,indicatedforthecontrolofacuteinflammationassociatedwith

respiratorydisease.Itmayalsobeusedasadjunctivetherapyinthe

treatmentofacutemastitis.

Inpigs,theproductisindicatedforuseasanadjunctivetherapyinthe

treatmentofswinerespiratorydiseases.

Revised:16July2009

AN:00229/2009

4.3 Contraindications:

Donotexceedtherecommendeddoseorthedurationoftreatment.

Donotadministertopregnantmares.

Donotadministertopregnantsows,giltsatmatingandinbreeding

boars.

Useiscontraindicatedinanimalssufferingfromcardiac,hepaticor

renaldisease,wherethereisthepossibilityofgastro-intestinal

ulcerationorbleeding,wherethereisevidenceofablooddyscrasiaor

hypersensitivitytotheproduct.

Donotuseindehydratedanimalssufferingfromileus-associatedcolics

4.4 SpecialWarningsforEachTargetSpecies:

Thecauseoftheunderlyinginflammatoryconditionorcolicshouldbe

determinedandtreatedwithappropriateconcomitanttherapy.

Non-steroidalanti-inflammatorydrugsarenotpermittedunderthe

RulesofRacingandunderrulescoveringothercompetitiveevents.

Horsesintendedforracingandcompetitionshouldbepreventedfrom

racingorcompetingwheninneedoftreatmentandhorseswhichhave

beenrecentlytreatedshouldbedealtwithaccordingtolocal

requirements.Appropriateprecautionsmustbetakentoensure

compliancewithcompetitionregulations.

Duetotheexcipientpropyleneglycol,life-threateningshockreactions

mayoccurinrarecases.Thesolutionforinjectionshouldthereforebe

injectedslowlyandbeofapproximatebodytemperature.

4.5 SpecialPrecautionsforUse:

(i)Specialprecautionsforuseinanimals:

Avoidintra-arterialinjection.

Useinanyanimallessthan6weeksofageorinagedanimalsmay

involveadditionalrisk.Ifsuchusecannotbeavoidedanimalsmay

requireareduceddosageandcarefulclinicalmanagement.

Donotuseinpigletsweightinglessthan6kg.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimal

exceptinthecaseofendotoxaemiaorsepticshock.

ItispreferablethatNSAIDs,whichinhibitprostaglandinsynthesisare

notadministeredtoanimalsundergoinggeneralanaesthesiauntilfully

recovered.

Revised:16July2009

AN:00229/2009

(ii)Specialprecautionstobetakenbythepersonadministeringthe

producttotheanimals:

Avoideyecontactanddirectcontactwithskin.

Inthecaseofaccidentalcontactwitheyes,rinseimmediatelywith

plentyofwaterandseekmedicaladvice.

Avoidaccidentalself-injection.

Toavoidpossiblesensitisationreactions,avoidcontactwiththeskin.

Glovesshouldbewornduringapplication.

Theproductmaycausereactionsinsensitiveindividuals.Ifyouhave

knownhypersensitivityfornon-steroidalanti-inflammatoryproductsdo

nothandletheproduct.Reactionsmaybeserious.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness):

Flunixinmeglumineisanonsteroidalanti-inflammatorydrug(NSAID).

Untowardeffectsincludegastrointestinalirritation,ulcerationand,in

dehydratedorhypovolaemicanimals,potentialforrenaldamage.

Inpigs,transientirritationmayoccurattheinjectionsite,thisresolves

spontaneouslywithin14days.

Rarecasesofanaphylacticreactionhavebeenreported

4.7 Useduringpregnancy,lactationorlay:

Maybeusedinpregnantandlactatingcattle.

Donotadministertopregnantmares.Donotadministertopregnant

sows,giltsatmatingandinbreedingboars.Safetystudiesinpregnant

maresorsowshavenotbeenconducted.

Theproductshouldnotbeusedinlactatingsows.

4.8 Interactionswithothermedicinalproductsandotherformsof

interaction:

Monitordrugcompatibilitycloselywhereadjunctivetherapyisrequired.

Donotadministerothernon-steroidalanti-inflammatorydrugs

(NSAIDs)concurrentlyorwithin24hoursofeachother.SomeNSAIDs

maybehighlyboundtoplasmaproteinsandcompetewithotherhighly

bounddrugswhichcanleadtotoxiceffects.

Revised:16July2009

AN:00229/2009

Concurrentadministrationofpotentiallynephrotoxicdrugsshouldbe

avoided.

4.9 Amounttobeadministeredandadministrationroute:

Forintravenousadministrationtocattleandhorsesandintramuscular

injectiontopigs.

HORSES: Foruseinequinecolic,therecommendeddoserateis

1.1mgflunixin/kgbodyweightequivalentto1mlper45

kgbodyweight.Treatmentmayberepeatedonceor

twiceifcolicrecurs.

Foruseinmusculo-skeletaldisorders,therecommended

doserateis1.1mgflunixin/kgbodyweightequivalentto1

mlper45kgbodyweight,oncedailyforupto5days

accordingtoclinicalresponse.

Forthetreatmentofendotoxaemiaorsepticshock

associatedwithgastrictorsionandwithotherconditions

inwhichthecirculationofbloodtothegastrointestinal

tractiscompromised:0.25mg/kg(1mlper200kg)every

6-8hours.

CATTLE Therecommendeddoserateis2.2mgflunixin/kg

bodyweightequivalentto2mlper45kgbodyweight.

Repeatasnecessaryat24hourintervalsforupto5

consecutivedays.

PIGS Foruseinpigs,therecommendeddoserateis2mlper

45kgbodyweight(equivalentto2.2mgflunixin/kg)once

byintramuscularinjection,intheneck,inconjunctionwith

appropriateantimicrobialtherapy.Theinjectionvolume

shouldbelimitedtoamaximumof5mlperinjectionsite.

Thestoppershouldnotbepuncturedmorethan50times.Adrawoff

needleshouldbeusedtoavoidexcessivepuncturingofthestopper.

Donotexceedtherecommendeddoseordurationoftreatment.

Anappropriatelygraduatedsyringemustbeusedtoallowaccurate

administrationoftherequireddosevolume.Thisisparticularly

importantwheninjectingsmallvolumes.

Cattleshouldbetreatedwithflunixininconjunctionwithdisease-

specifictherapyandanimprovementinhousingconditions.

Theuseofflunixininconjunctionwithdisease-specificantibiotic

therapymaymaskantibioticresistanceofthebacteria,dueto

alleviationofinflammationsymptoms.

Revised:16July2009

AN:00229/2009

4.10Overdose(symptoms,emergencyprocedures,antidotes)(if

necessary):

Overdosestudiesinthetargetspecieshaveshowntheproducttobe

welltolerated.Overdosageisassociatedwithgastrointestinaltoxicity.

4.11Withdrawalperiods:

Cattle:- Meat:7Days

Milk:36Hours

Horses:- Meat:7Days

Pigs:- Meat:22Days

Donotuseinmaresproducingmilkforhumanconsumption

5. PHARMACOLOGICALPROPERTIES

ATCvetCode:QM01AG90

Pharmacotherapeuticgroup:Non-steroidalanti-inflamammatory

5.1 Pharmacodynamicproperties:

Flunixinmeglumineisarelativelypotentnon-narcotic,non-steroidal

analgesicwithanti-inflammatory,anti-endotoxicandanti-pyretic

properties.

Flunixinmeglumineactsasareversibleinhibitorofcyclo-oxygenase,

animportantenzymeinthearachidonicacidcascadepathwaywhichis

responsibleforconvertingarachidonicacidtocyclicendoperoxides.

Consequently,synthesisofeicosanoids,importantmediatorsofthe

inflammatoryprocessinvolvedincentralpyresis,painperceptionand

tissueinflammation,isinhibited.Throughitseffectsonthearachidonic

acidcascade,flunixinalsoinhibitstheproductionofthromboxane,a

potentplateletpro-aggregatorandvasoconstrictorwhichisreleased

duringbloodclotting.Flunixinexertsitsantipyreticeffectbyinhibiting

prostaglandinE2synthesisinthehypothalamus.Byinhibitingthe

arachidonicacidcascadepathway,flunixinalsoproducesananti-

endotoxiceffectbysuppressingeicosanoidformationandtherefore

preventingtheirinvolvementinendotoxinassociateddiseasestates.

Theproducthasbeenshowntohavesomebenefitinthetreatmentof

experimentalacutepulmonaryemphysema(fogfever).

Revised:16July2009

AN:00229/2009

5.2 Pharmacokineticsproperties

Flunixinwasadministeredintravenouslytohorsesasasingledoseof

1.1mg/kg.Atthefirsttimepointmeasured(10minutesafter

administration)theplasmaconcentrationwas11.45µg/ml,C

was

12.59µg/mlandtheeliminationhalf-lifewasapproximately2hours.

Flunixinwasadministeredintravenouslytocattleasasingledoseof

2.2mg/kg.Atthefirsttimepointmeasured(10minutesafter

administration)theplasmaconcentrationwas12.32µg/ml,C

was

15.55µg/mlandtheeliminationhalf-lifewasapproximately4hours.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients:

SodiumFormaldehydeSulphoxylate

DisodiumEdetate

Phenol

PropyleneGlycol

Diethanolamine

HydrochloricAcid

WaterforInjections

6.2 Incompatabilities:

Intheabsenceofincompatibilitystudies,thismedicinalproductmust

notbemixedwithothermedicinalproducts.

6.3 Shelf-Life:

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2

years.

Followingwithdrawalofthefirstdoseusetheproductwithin28days.

Discardunusedproduct.

6.4 SpecialPrecautionsforStorage:

Storebelow25°C.Keepthevialintheoutercartontoprotectfromlight.

6.5 Natureandcompositionofimmediatepackaging:

Thisproductissuppliedin50ml,100mland250mlclearcolourless

glassvials,completewithbromobutylbungsandaluminiumcaps.

Theproductisalsopresentedinpacksof5,10and12vialsforthe50

mland100mlandpacksof5vialsforthe250ml,eachvialwillbe

providedinanindividualcartonwhichwillinturnbepackedintoaplain

brownoutercardboardcontainingthespecifiednumberofvials.

Revised:16July2009

AN:00229/2009

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinary

medicinalproductorwastematerialsderivedfromtheuseofsuch

products:

Anyunusedproductorwastematerialshouldbedisposedofin

accordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

NEWRY

Co.Down,BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm02000/4170

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

November2003

10. DATEOFREVISIONOFTHETEXT

July2009

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Europe -DG Health and Food Safety

4-6-2018

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Active substance: apixaban) - Centralised - 2-Monthly update - Commission Decision (2018)3616 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2148/II/50

Europe -DG Health and Food Safety