Pyroflam Injection for Pigs

Main information

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

Documents

Localization

  • Available in:
  • Pyroflam Injection for Pigs
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • flunixin
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0231/002
  • Authorization date:
  • 28-02-2009
  • EU code:
  • UK/V/0231/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised03/12/2009–AN00582/2008

SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinary MedicinalProduct

Pyroflam50 mg/mlSolutionforInjectionforCattle, Horsesand Pigs

FlunixinInjectableSolution50 mg/mlNorbrook (France)

2. QualitativeandQuantitativeComposition

ActiveSubstance

Flunixin(asflunixinmeglumine) 50 mg/ml

Excipients

Phenol 5 mg/ml

SodiumFormaldehydeSulphoxylateDihydrate 2.5 mg/ml

Excipients to 1 ml

Forafulllistofexcipients, seesection6.1

3. PharmaceuticalForm

Solutionforinjection.

Aclearcolourlesssolution

4. ClinicalParticulars

4.1 Targetspecies:

Cattle

Horses

Pigs

4.2 Indicationsforuse, specifying thetargetspecies:

Inhorses:

-alleviationofinflammationand painassociated withmusculo-skeletaldisorders.

-alleviationofvisceralpainassociated withcolic.

-adjunctivetherapyinthetreatmentofendotoxaemiaand septicshock..

Incattle:

-reductionofacuteinflammationassociated withrespiratorydisease.

-adjunctivetherapyinthetreatmentofacutemastitis.

Inpigs:

Adjunctivetherapyinthetreatmentofswinerespiratorydiseases.

Revised03/12/2009–AN00582/2008

4.3 Contraindications:

Do notexceed thestated doseordurationoftreatment.

Useiscontraindicatedinanimalssufferingfromcardiac,hepaticorrenaldisease,

wherethereisthepossibilityofgastrointestinalulcerationorbleeding, wherethereis

evidenceofablood dyscrasia.

Donotuseincaseofhypersensitvitytotheactivesubstanceortoanyofthe

excipients.

Do notadministerto pregnantsows,giltsatmatingand inbreedingboars.

Forpregnantmares,useonlyaccordingtothebenefit/riskassessmentbythe

ResponsibleVeterinarian.

4.4 SpecialWarningsforEachTargetSpecies:

Thecauseoftheunderlyinginflammatoryconditionshouldbedeterminedand

treated withappropriateconcomitanttherapy.

4.5 SpecialPrecautionsforUse:

(i) Specialprecautionsforuseinanimals:

Avoid intra-arterialinjection.

Useinanyanimallessthan6 weeksofageorinaged animalsmayinvolveadditional

risk.Ifsuchusecannotbeavoidedanimalsmayrequireareduceddosageand

carefulclinicalmanagement.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimalexceptinthe

caseofendotoxaemiaorsepticshock.

ItispreferablethatNSAIDs,whichinhibitprostaglandinsynthesisarenot

administered to animalsundergoinggeneralanaesthesiauntilfullyrecovered.

Do notuseinpigletsweightinglessthan6 kg.

(ii) Specialprecautionstobetakenbythepersonadministeringthe

productto theanimals:

Avoid eyecontactand directcontactwithskin

Washhandsafteruse. Inthecaseofaccidentalcontactwitheyes, rinseimmediately

withplentyofwaterand seek medicaladvice.

Avoid accidentalself-injection.

Toavoidpossiblesensitisationreactions,avoidcontactwiththeskin.

Glovesshouldbewornduring application.

Theproductmaycausereactionsinsensitiveindividuals.Ifyouhaveknown

hypersensitivityfornon-steroidalanti-inflammatoryproductsdonothandlethe

product. Reactionsmaybeserious.

Revised03/12/2009–AN00582/2008

(iii) Otherprecautions:

None.

Revised03/12/2009–AN00582/2008

4.6 Adversereactions(frequencyand seriousness):

Flunixinmeglumineisanonsteroidalanti-inflammatorydrug(NSAID).Untoward

effectsincludegastrointestinalirritation,ulcerationand,especiallyindehydratedor

hypovolaemicanimals, potentialforrenaldamage.

Inpigs,transientirritationmayoccurattheinjectionsite, thisresolvesspontaneously

within14 days.

4.7 Useduring pregnancy, lactationorlay:

Maybeused inpregnantand lactatingcattle.

Forpregnantmares,useonlyaccordingtothebenefit/riskassessmentbythe

ResponsibleVeterinarian.

Do notadministerto pregnantsows, giltsatmatingand inbreedingboars.

4.8 Interactionswithothermedicinalproductsand otherformsofinteraction:

Monitordrugcompatibilitycloselywhereadjunctivetherapyisrequired.

Donotadministerothernon-steroidalanti-inflammatorydrugs(NSAIDs)

concurrentlyorwithin24 hoursofeachother. SomeNSAIDsmaybehighlybound

toplasmaproteinsandcompetewithotherhighlybounddrugswhichcanleadto

toxiceffects.

Concurrentadministrationofpotentiallynephrotoxicdrugsshould beavoided.

4.9 Amountto beadministered and administrationroute:

Forintravenousadministrationto cattleand horses.

HORSES: Foruseinequinecolic,therecommendeddoserateis1.1mg

flunixin/kgbodyweightequivalentto1mlper45kgbodyweight.

Treatmentmayberepeated onceortwiceifcolicrecurs.

Foruseinmusculo-skeletaldisorders,therecommendeddoserate

is1.1mgflunixin/kgbodyweightequivalentto1mlper45kg

bodyweight,oncedailyforupto5daysaccordingtoclinical

response.

Forthetreatmentofendotoxaemiaorsepticshockassociatedwith

gastrictorsionandwithotherconditionsinwhichthecirculationof

blood to thegastrointestinaltractiscompromised: 0.25 mg/kg(1 ml

per200 kg)every6-8 hours.

Revised03/12/2009–AN00582/2008

CATTLE Therecommendeddoserateis2.2mgflunixin/kgbodyweight

equivalentto2mlper45kgbodyweight.Repeatasnecessaryat

24 hourintervalsforup to 5 consecutivedays.

Forintramuscularinjectionto pigs.

PIGS Therecommendeddoserateis2mlper45kgbodyweight

(equivalentto2.2mgflunixin/kg)oncebyintramuscularinjection, in

theneck, inconjunctionwithappropriateantimicrobialtherapy. The

injectionvolumeshouldbelimitedtoamaximumof5mlper

injectionsite.

Anappropriategraduatedsyringemustbeusedtoallowaccurateadministrationof

therequireddosevolume.Thisisparticularlyimportantwheninjectingsmall

volumes.

Thestoppershouldnotbepuncturedmorethan50times.Adraw-offneedle

should beused to avoid excessivepuncturingofthestopper.

4.10 Overdose(symptoms, emergencyprocedures, antidotes)(ifnecessary):

Overdosestudiesinthetargetspecieshaveshowntheproductto bewelltolerated.

Overdosageisassociated withgastrointestinaltoxicity.

4.11 Withdrawalperiods:

Cattle: Meatand offal:10 Days

Milk: 24 Hours

Horses: Meatand offal:10 Days

Milk: Theproductisnotauthorisedforuseinlactating

animalsproducingmilk forhumanconsumption.

Pigs: Meatand offal:22 Days

5. PharmacologicalProperties

Pharmacotherapeuticgroup:Non-steroidalanti-inflammatory

ATCvetCode:QM01 AG90

Revised03/12/2009–AN00582/2008

5.1 Pharmacodynamicproperties:

Flunixinmeglumineisarelativelypotentnon-narcotic,non-steroidalanalgesicwith

anti-inflammatory, anti-endotoxicand anti-pyreticproperties.

Flunixinmeglumineactsasareversibleinhibitorofcyclo-oxygenase,animportant

enzymeinthearachidonicacid cascadepathwaywhichisresponsibleforconverting

arachidonicacidtocyclicendoperoxides.Consequently,synthesisofeicosanoids,

importantmediatorsoftheinflammatoryprocessinvolvedincentralpyresis,pain

perceptionandtissueinflammation,isinhibited.Throughitseffectsonthe

arachidonicacidcascade,flunixinalsoinhibitstheproductionofthromboxane,a

potentplateletpro-aggregatorandvasoconstrictorwhichisreleasedduringblood

clotting.FlunixinexertsitsantipyreticeffectbyinhibitingprostaglandinE2synthesis

inthehypothalamus.Byinhibitingthearachidonicacidcascadepathway,flunixin

alsoproducesananti-endotoxiceffectbysuppressingeicosanoidformationand

thereforepreventingtheirinvolvementinendotoxinassociated diseasestates.

5.2 Pharmacokineticparticulars:

Flunixinwasadministeredintravenouslytohorsesasasingledoseof1.1 mg/kg. At

thefirsttimepointmeasured(10minutesafteradministration)theplasma

concentrationwas11.45 µg/ml, AUCwas21.45 µg.h/mland theeliminationhalf-life

wasapproximately2 hours.

Flunixinwasadministeredintravenouslytocattleasasingledoseof2.2mg/kg. At

thefirsttimepointmeasured(10minutesafteradministration)theplasma

concentrationwas12.32 µg/ml, AUCwas14.87 µg.h/mland theeliminationhalf-life

wasapproximately4 hours.

Inanexperimentalstudy,flunixinwasadministeredintravenouslytopigsasasingle

doseof2.0mg/kg.Flunixinwas>98%proteinbound atallphysiologicallyrelevant

concentrations,butalsohadalargevolumeofdistributionatsteady-state.All

plasmaconcentrationswerebelowthelimitofquantitation(0.02 µg/ml)by48 hours

and theeliminationhalf-lifewas7.76 hours.

Environmentalproperties:

Noneknown.

Revised03/12/2009–AN00582/2008

6. PharmaceuticalParticulars

6.1 Listofexcipients:

SodiumFormaldehydeSulphoxylateDihydrate

DisodiumEdetate

Phenol

PropyleneGlycol

Diethanolamine

HydrochloricAcid

WaterforInjections

6.2 Incompatibilities:

Intheabsenceofincompatibilitystudies,thismedicinalproductmustnotbemixed

withothermedicinalproducts.

6.3 Shelf-life:

2 years.

Followingwithdrawalofthefirstdoseusetheproductwithin28days.Discard

unused product.

6.4 Specialprecautionsforstorage:

Donotstoreabove25°C.Keepcontainerintheoutercartonto protectfromlight.

Avoid introductionofcontamination.

6.5 Natureand compositionofimmediatepackaging:

Thisproductissuppliedin50ml,100mland250mlTypeIclearcolourlessglass

vials, completewithbromobutylbungsand aluminiumcaps.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productsorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate:

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. Marketing AuthorisationHolder

Norbrook LaboratoriesLimited

StationWorks

CamloughRoad

Revised03/12/2009–AN00582/2008

NEWRY

Co. Down, BT35 6JP

NorthernIreland

Revised03/12/2009–AN00582/2008

8. Marketing AuthorisationNumber

Vm02000/4253

9. DateofFirstAuthorisation

23February2006

10. DateofRevisionoftheText

3 December2009