WELLIXINE

Main information

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

Documents

Localization

  • Available in:
  • WELLIXINE
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • flunixin
  • Therapeutic area:
  • Cattle, Horses, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0241/001
  • Authorization date:
  • 23-01-2013
  • EU code:
  • FR/V/0241/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Wellicox50mg/mlsolutionforinjectionforcattle,pigsandhorses

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Flunixin........................................................ 50 mg

(asmeglumine)

Excipients:

Phenol......................................................... 5 mg

Sodiumformaldehydesulfoxylate..................2.5 mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Colourlesstopaleyellowsolution,clearandexemptofparticles,withaslightodourofphenol.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle,pigsandhorses.

4.2 Indicationsforuse,specifyingthetargetspecies

Cattle:

- Alleviationofclinicalsignswhenrespiratorydiseaseconcurrentlywithappropriateanti-

infectivetherapy.

Pigs:

-TosupportappropriateantibiotictherapyinthetreatmentofMastitis-Metritis-Agalactia

syndrome.

-Alleviationoffeverassociatedwithrespiratorydiseasesasanadjunctivetherapytospecific

antibiotictherapy.

Horses:

- Alleviationofinflammationandpainassociatedwithmusculo-skeletaldisorders.

- Alleviationofvisceralpainassociatedwithcolic.

4.3 Contraindications

Donotuseinanimalssufferingfromchronicmusculo-skeletaldisorders.

Donotuseinanimalssufferingfromcardiac,hepaticorrenaldisease.

Donotuseinanimalswithgastro-intestinallesions(gastro-intestinalulcerationorbleeding).

Donotuseincaseofhemorrhagicdisorders.

Donotuseincaseofhypersensitivitytoflunixinemeglumine,otherNSAIDsoranyoftheexcipients.

Donotuseinanimalssufferingfromcoliccausedbyileusandassociatedwithdehydration.

Donotusetheproductwithin48hoursbeforeexpectedparturitionincows.Inthiscase,anincreasein

thenumberofstillbirthswasobserved.

Seealsosection4.7oftheSPC.

4.4 Specialwarningsforeachtargetspecies

Theunderlyingcauseoftheinflammationconditionorcolicmustbedeterminedandtreatedwith

appropriateconcomitanttherapy.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useinanyanimallessthan6weeksofage(cattleandhorse)orinagedanimalsmayinvolveadditional

risk.Ifsuchusecannotbeavoided,animalsmayrequireareduceddosageandcarefulclinical

management.

ItispreferablethatNSAIDswhichinhibitprostaglandinsynthesisarenotadministeredtoanimals

undergoinggeneralanaesthesiauntilfullyrecovered.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimalexceptinthecaseofendotoxaemia

orsepticshock.

Inrarecases,shockpotentiallylethalmayappearafterintravenousinjection,duetohighquantityof

propyleneglycolinthemedicinalproduct.Theproductmustbeinjectedslowlyandatbody

temperature.Stopinjectionatthefirstsignsofintoleranceandtreatshockifnecessary.

Duetotheanti-inflammatoryproperties,flunixinmayhideclinicalsignsandthereforeapossible

resistancetoantibiotictreatment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Theproductmaycausereactioninsensitivepersons.

Peoplewithknownhypersensitivitytosubstancesbelongingtonon-steroidalanti-inflammatorygroup,

shouldavoidcontactwiththeveterinarymedicinalproduct.Intolerancereactionsmaybeserious.

Avoidcontactwithskinoreyes.

Incaseofskincontact,washexposedareawithplentyofwaterandsoap.Ifsymptomspersistseek

medicaladvice.

Incaseofeyecontact,washeyesthoroughlywithcleanwaterandseekmedicaladvice.

Avoidriskofingestion,donoteatordrinkwhenusingtheproductand washhandsafteruse.Incaseof

ingestionoftheproductseekmedicaladvice.

Incaseofaccidentalselfinjection,seekmedicaladviceimmediatelyandshowthepackageleafletor

thelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Untowardeffectsincludebleedings,gastro-intestinallesions(irritation,gastriculceration),vomiting,

renaldamagemainlyindehydratedorhypovolaemicanimals.

Aswithothernon-steroidalanti-inflammatorydrugs,renalorhepaticidiosyncrasicuntowardeffects

maybeobserved.

Incaseofuntowardeffectsstoptreatmentandseekmedicaladvice.

Inrarecases,lethalanaphylacticreactions(collapsus)havebeenobservedincattleandhorse,mainly

duringrapidintravenousinjection.

Inthehorse,afterintravenousinjection,bloodinthefaeceshasbeenreportedaswellasliquid

diarrhoea.

Incattle,reactionatinjectionsitemaybeobservedafterintramuscularinjection.

Theproductmaydelayparturitionandincreasestillbirthsthroughatocolyticeffectbyinhibiting

prostaglandinsthatareimportantinsignallingtheinitiationofparturition.Theuseoftheproductinthe

immediatepost-partumperiodmayresultinretainedplacentae.

Seealsosection4.7oftheSPC.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshaveproducedevidenceoffoetotoxicityofflunixinafteroral

administration(rabbitandrat)andintramuscularadministration(rat)atmaternotoxicdosesaswellas

anincreaseofthepregnancyperiod(rat).

Thesafetyofflunixinhasnotbeenassessedinpregnantmares,breedingstallionsandbulls.Donotuse

intheseanimals.

Thesafetyofflunixinwasdemonstratedinpregnantcowsandsows,aswellasboars.Theproduct

maybeusedintheseanimalsexceptwithin48hoursbeforeparturition(seesections4.3and4.6).

Theproductshouldonlybeadministeredwithinthefirst36hourspost-partumfollowingabenefit/risk

assessmentperformedbytheresponsibleveterinarian,andtreatedanimalsshouldbemonitoredfor

retainedplacentae.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

DonotadministerotherNSAIDsconcurrentlyorwithin24hoursofeachother,asitmayincreasethe

toxicity,mainlygastro-intestinal,evenwithlowdosesofacetylsalicylicacid.

Theconcurrentadministrationofcorticoidsmayincreasetoxicityofthetwoproductsandincreasethe

riskofgastro-intestinalulceration.Itshouldthereforebeavoided.

Flunixinmayreducetheeffectofsomeanti-hypertensivemedicinalproductbyinhibitionofthe

prostaglandinssynthesis,suchasdiuretics(ACEinhibitors),IACE(inhibitorsofangiotensinconversion

enzyme)andbetablockers.

Concurrentadministrationofpotentiallynephrotoxicdrugs,particularlyaminoglycosides,shouldbe

avoided.

Flunixinmayreducerenaleliminationofsomedrugsandincreasetheirtoxicity,suchas

aminoglycosidesforexample.

4.9 Amountstobeadministeredandadministrationroute

Intramuscularuseforcattleandpigs.

Intravenoususeforcattleandhorses.

Cattle:

2mgofflunixinperkgbodyweightandperday,equivalentto2mlofsolutionper50kg

bodyweight,byintravenousorintramuscularinjectionfor1to5consecutivedays.

Maximumdosagevolumeperinjectionsiteshouldnotexceed16ml.Anadministrationvolumeof

morethan16mlshouldbedividedandadministeredatdifferentinjectionsites.

Pigs:

-TosupportappropriateantibiotictherapyinthetreatmentofMastitis-Metritis-Agalactia

syndrome:

2mgofflunixinperkgbodyweightandperday,equivalentto2mlofsolutionper50kg

bodyweight,byintramuscularinjectionfor1to3consecutivedays.

-Alleviationoffeverassociatedwithrespiratorydiseases:

2mgofflunixinperkgbodyweightandperday,equivalentto2mlofsolutionper50kg

bodyweight,oncebyintramuscularinjection.

Maximumdosagevolumeperinjectionsiteshouldnotexceed5ml.Anadministrationvolumeof

morethan5mlshouldbedividedandadministeredatdifferentinjectionsites.

Horses:

-Alleviationofinflammationandpainassociatedwithmusculo-skeletaldisorders:

1mgofflunixinperkgbodyweightandperday,equivalentto1mlofsolutionper50kg

bodyweight,byintravenousinjectionfor1to5consecutivedays.

-Alleviationofvisceralpainassociatedwithcolic:

1mgofflunixinperkgbodyweightandperday,equivalentto1mlofsolutionper50kg

bodyweight,byintravenousinjection.Treatmentmayberepeatedonceortwiceifcolicrecurs.

Thestoppershouldnotbepuncturedmorethan15times.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosageisassociatedwithgastrointestinaltoxicity.Ataxiaandincoordinationsymptomsmayalso

appear.

Inhorses,from3foldtherecommendeddose(3mg/kgbodyweight)administeredbyintravenousroute,

atransientincreaseofthebloodpressuremaybeobserved.

Incattle,administrationof3foldtherecommendeddose(6mg/kgbodyweight)byintravenousroutedid

notinduceuntowardeffects.

Inpigs,from2mgflunixin/kg,administeredtwiceaday,painfulreactionsattheinjectionsiteandan

increaseofleucocytesnumberwerereported.

4.11Withdrawalperiod(s)

Cattle:

Meatandoffal:10days.

Milk:24hours.

Pigs:

Meatandoffal:20days.

Horses:

Meatandoffal:10days.

Milk:theproductisnotauthorisedforuseinlactatinganimalsproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinflammatoryandanthirheumaticproducts,nonsteroids-Fenamates

ATCvetcode:QM01AG90

5.1 Pharmacodynamicproperties

Flunixin(asmeglumine)demonstratespotentinhibitionofthecyclo-oxygenasesystem(COX),the

enzymeconvertsarachidonicacidtoinstablecyclicendoperoxides,whichareconvertedto

prostaglandins,prostacyclinandtromboxane.Someoftheseprostanoids,suchasprostaglandinsare

involvedintheanti-inflammatory,alleviationofpainandfeverphysiopathologicmechanisms.The

inhibitionofthesynthesisofsuchcomponentswouldberesponsibleforthetherapeuticeffectsof

flunixinmeglumine.

Prostaglandinsbeingalsopartofotherphysiologicprocesses,COXinhibitorsshouldberesponsiblefor

someuntowardeffectssuchasgastrointestinalandrenaldamages.

Prostaglandinsareinvolvedinthecomplexprocessofendotoxemicshock.

5.2 Pharmacokineticparticulars

Incattle,afterintramuscularinjectionatadoseof2mg/kg,amaximumconcentrationof2.5μg/mlis

observedabout30minutesafterinjection.

Afterintravenousinjection,flunixin,distributesrapidly.Theeliminationisslow(about4hours).

Flunixinishighlyboundtoplasmaproteins(>99%).

Inpigs,afterintramuscularinjectionatadoseof2mg/kg,amaximumconcentrationof4μg/mlis

observedabout30minutesafterinjection.

Afterintravenousinjection,flunixin,distributesrapidly.Theeliminationisslow(about8hours).

Flunixinishighlyboundtoplasmaproteins(>98%).

Inthehorse,afterintravenousinjectionatadoseof1mg/kg,flunixin,distributesrapidly.The

eliminationhalf-lifeis1.6hours.

Flunixiniseliminatedmainlyviathekidneysasconjuguatedform.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Phenol

Sodiumformaldehydesulfoxylate

Disodiumedetate

Diethanolamine

Propyleneglycol

Dilutehydrochloricacid

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsaleinaglassbottle:3years

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsaleinapolyethyleneterephatalatebottle:2

years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Donotstoreabove25

Cafterfirstopeningtheimmediatepackaging.

6.5 Natureandcompositionofimmediatepackaging

ColourlessTypeIIglassbottleORcolourlesspolyethyleneterephtalatebottle,sealedwithchlorobutyl

rubberstoppersandaluminiumoverseals.

Boxof1glassbottleof50ml

Boxof1glassbottleof100ml

Boxof1glassbottleof250ml

Boxof1polyethyleneterephtalatebottleof50ml

Boxof1polyethyleneterephtalatebottleof100ml

Boxof1polyethyleneterephtalatebottleof250ml

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

COOPHAVET

23,RueduPrieuré

SaintHerblon

44150Ancenis

FRANCE

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION

<{DD/MM/YYYY}><{DDmonthYYYY}>…

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

CARTONBOX

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Wellicox50mg/mlsolutionforinjectionforcattle,pigsandhorses

Flunixin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:

Activesubstance:

Flunixin........................................................ 50 mg

(asmeglumine)

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

50ml

100ml

250ml

5. TARGETSPECIES

Cattle,pigsandhorses

6. INDICATION(S)

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Cattle/pigs:IM.

Cattle/horses:IV.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Cattle:

Meatandoffal:10days.

Milk:24hours.

Pigs:

Meatandoffal:20days.

Horses:

Meatandoffal:10days.

Milk:theproductisnotauthorisedforuseinlactatinganimalsproducingmilkforhumanconsumption.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year}

Oncebroached,useby….

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25Cafterfirstopeningtheimmediatepackaging.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposeofwastematerialinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

COOPHAVET

23,RueduPrieuré

SaintHerblon

44150Ancenis

FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

BOTTLELABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Wellicox50mg/ml

Flunixin

2. QUANTITYOFTHEACTIVESUBSTANCE

1mlofWellicoxcontains50mgofFlunixin(asmeglumine).

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

50ml

4. ROUTE(S)OFADMINISTRATION

Cattle/pigs:IM.

Cattle/horses:IV.

Readthepackageleafletbeforeuse.

5. WITHDRAWALPERIOD

Cattle:

Meatandoffal:10days.

Milk:24hours.

Pigs:

Meatandoffal:20days.

Horses:

Meatandoffal:10days.

Milk:theproductisnotauthorisedforuseinlactatinganimalsproducingmilkforhumanconsumption.

6. BATCHNUMBER

<Batch><Lot><BN>{number}

7. EXPIRYDATE

EXP{month/year}

Oncebroached,useby….

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

BOTTLELABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Wellicox50mg/mlsolutionforinjectionforcattle,pigsandhorses

Flunixin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1mlofWellicoxcontains50mgofFlunixin(asmeglumine).

3. PHARMACEUTICALFORM

4. PACKAGESIZE

100ml

250ml

5. TARGETSPECIES

Cattle,pigsandhorses.

6. INDICATION(S)

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Cattle/pigs:IM.

Cattle/horses:IV.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Cattle:

Meatandoffal:10days.

Milk:24hours.

Pigs:

Meatandoffal:20days.

Horses:

Meatandoffal:10days.

Milk:theproductisnotauthorisedforuseinlactatinganimalsproducingmilkforhumanconsumption.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year}

Oncebroached,useby….

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25

Cafterfirstopeningtheimmediatepackaging.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

COOPHAVET

23,RueduPrieuré

SaintHerblon

44150Ancenis

FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

B.PACKAGELEAFLET

PACKAGELEAFLET

Wellicox50mg/mlsolutionforinjectionforcattle,pigsandhorses

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturerforthebatchrelease:

COOPHAVET

23,RueduPrieuré

SaintHerblon

44150Ancenis

FRANCE

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Wellicox50mg/mlsolutionforinjectionforcattle,pigsandhorses

Flunixin

3. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENTS

Eachmlcontains:

Activesubstance:

Flunixin........................................................ 50 mg

(asmeglumine)

Excipients:

Phenol......................................................... 5 mg

Sodiumformaldehydesulfoxylate..................2.5 mg

4. INDICATIONS

Cattle:

- Alleviationofclinicalsignswhenrespiratorydiseaseconcurrentlywithappropriateanti-

infectivetherapy.

Pigs:

-TosupportappropriateantibiotictherapyinthetreatmentofMastitis-Metritis-Agalactia

syndrome.

-Alleviationoffeverassociatedwithrespiratorydiseasesasanadjunctivetherapytospecific

antibiotictherapy.

Horses:

- Alleviationofinflammationandpainassociatedwithmusculo-skeletaldisorders.

- Alleviationofvisceralpainassociatedwithcolic.

5. CONTRAINDICATIONS

Donotuseinanimalssufferingfromchronicmusculo-skeletaldisorders.

Donotuseinanimalssufferingfromcardiac,hepaticorrenaldisease.

Donotuseinanimalswithgastro-intestinallesions(gastro-intestinalulcerationorbleeding).

Donotuseincaseofhemorrhagicdisorders.

Donotuseincaseofhypersensitivitytoflunixinemeglumine,otherNSAIDsoranyoftheexcipients.

Donotuseinanimalssufferingfromcoliccausedbyileusandassociatedwithdehydration.

Donotusetheproductwithin48hoursbeforeexpectedparturitionincows.Inthiscase,anincreasein

thenumberofstillbirthswasobserved.

6. ADVERSEREACTIONS

Untowardeffectsincludebleedings,gastro-intestinallesions(irritation,gastriculceration),vomiting,

renaldamagemainlyindehydratedorhypovolaemicanimals.

Aswithothernon-steroidalanti-inflammatorydrugs,renalorhepaticidiosyncrasicuntowardeffects

maybeobserved.

Incaseofuntowardeffectsstoptreatmentandseekmedicaladvice.

Inrarecases,lethalanaphylacticreactions(collapsus)havebeenobservedincattleandhorse,mainly

duringrapidintravenousinjection.

Inthehorse,afterintravenousinjection,bloodinthefaeceshasbeenreportedaswellasliquid

diarrhoea.

Incattle,reactionatinjectionsitemaybeobservedafterintramuscularinjection.

Theproductmaydelayparturitionandincreasestillbirthsthroughatocolyticeffectbyinhibiting

prostaglandinsthatareimportantinsignallingtheinitiationofparturition.Theuseoftheproductinthe

immediatepost-partumperiodmayresultinretainedplacentae.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cattle,pigsandhorses.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Cattle/pigs:IM.

Cattle/horses:IV.

Cattle:

2mgofflunixinperkgbodyweightandperday,equivalentto2mlofsolutionper50kg

bodyweight,byintravenousorintramuscularinjectionfor1to5consecutivedays.

Maximumdosagevolumeperinjectionsiteshouldnotexceed16ml.Anadministrationvolumeof

morethan16mlshouldbedividedandadministeredatdifferentinjectionsites.

Pigs:

-TosupportappropriateantibiotictherapyinthetreatmentofMastitis-Metritis-Agalactia

syndrome:

2mgofflunixinperkgbodyweightandperday,equivalentto2mlofsolutionper50kg

bodyweight,byintramuscularinjectionfor1to3consecutivedays.

-Alleviationoffeverassociatedwithrespiratorydiseases:

2mgofflunixinperkgbodyweightandperday,equivalentto2mlofsolutionper50kg

bodyweight,oncebyintramuscularinjection

Maximumdosagevolumeperinjectionsiteshouldnotexceed5ml.Anadministrationvolumeof

morethan5mlshouldbedividedandadministeredatdifferentinjectionsites.

Horses:

-Alleviationofinflammationandpainassociatedwithmusculo-skeletaldisorders:

1mgofflunixinperkgbodyweightandperday,equivalentto1mlofsolutionper50kg

bodyweight,byintravenousinjectionfor1to5consecutivedays.

-Alleviationofvisceralpainassociatedwithcolic:

1mgofflunixinperkgbodyweightandperday,equivalentto1mlofsolutionper50kg

bodyweight,byintravenousinjection.Treatmentmayberepeatedonceortwiceifcolicrecurs.

Thestoppershouldnotbepuncturedmorethan15times.

9. ADVICEONCORRECTADMINISTRATION

10. WITHDRAWALPERIOD

Cattle:

Meatandoffal:10days.

Milk:24hours.

Pigs:

Meatandoffal:20days.

Horses:

Meatandoffal:10days.

Milk:theproductisnotauthorisedforuseinlactatinganimalsproducingmilkforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25

Cafterfirstopeningtheimmediatepackaging.

Donotuseaftertheexpirydatestatedonthe<label><carton>.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsaleinaglassbottle:3years

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsaleinapolyethyleneterephatalatebottle:2

years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

12. SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Theunderlyingcauseoftheinflammationconditionorcolicmustbedeterminedandtreatedappropriate

concomitanttherapy.

Specialprecautionsforuseinanimals

Useinanyanimallessthan6weeksofage(cattleandhorse)orinagedanimalsmayinvolveadditional

risk.Ifsuchusecannotbeavoided,animalsmayrequireareduceddosageandcarefulclinical

management.

ItispreferablethatNSAIDswhichinhibitprostaglandinsynthesisarenotadministeredtoanimals

undergoinggeneralanaesthesiauntilfullyrecovered.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimalexceptinthecaseofendotoxaemia

orsepticshock.

Inrarecases,shockpotentiallylethalmayappearafterintravenousinjection,duetohighquantityof

propyleneglycolinthemedicinalproduct.Theproductmustbeinjectedslowlyandatbody

temperature.Stopinjectionatthefirstsignsofintoleranceandtreatshockifnecessary.

Duetotheanti-inflammatoryproperties,flunixinmayhideclinicalsignsandthereforeapossible

resistancetoantibiotictreatment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Theproductmaycausereactioninsensitivepersons.

Peoplewithknownhypersensitivitytosubstancesbelongingtonon-steroidalanti-inflammatorygroup,

shouldavoidcontactwiththeveterinarymedicinalproduct.Intolerancereactionsmaybeserious.

Avoidcontactwithskinoreyes.

Incaseofskincontact,washexposedareawithplentyofwaterandsoap.Ifsymptomspersistseek

medicaladvice.

Incaseofeyecontact,washeyesthoroughlywithcleanwaterandseekmedicaladvice.

Avoidriskofingestion,donoteatordrinkwhenusingtheproductand washhandsafteruse.Incaseof

ingestionoftheproductseekmedicaladvice.

Incaseofaccidentalselfinjection,seekmedicaladviceimmediatelyandshowthepackageleafletor

thelabeltothephysician.

Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshaveproducedevidenceoffoetotoxicityofflunixinafteroral

administration(rabbitandrat)andintramuscularadministration(rat)atmaternotoxicdosesaswellas

anincreaseofthepregnancyperiod(rat).

Thesafetyofflunixinhasnotbeenassessedinpregnantmares,breedingstallionsandbulls.Donotuse

intheseanimals.

Thesafetyofflunixinwasdemonstratedinpregnantcowsandsows,aswellasboars.Theproduct

maybeusedintheseanimalsexceptwithin48hoursbeforeparturition(seesections4.3and4.6).

Theproductshouldonlybeadministeredwithinthefirst36hourspost-partumfollowingabenefit/risk

assessmentperformedbytheresponsibleveterinarian,andtreatedanimalsshouldbemonitoredfor

retainedplacentae.

Interactionwithothermedicinalproductsandotherformsofinteraction

DonotadministerotherNSAIDsconcurrentlyorwithin24hoursofeachother,asitmayincreasethe

toxicity,mainlygastro-intestinal,evenwithlowdosesofacetylsalicylicacid.

Theconcurrentadministrationofcorticoidsmayincreasetoxicityofthetwoproductsandincreasethe

riskofgastro-intestinalulceration.Itshouldthereforebeavoided.

Flunixinmayreducetheeffectofsomeanti-hypertensivemedicinalproductbyinhibitionofthe

prostaglandinssynthesis,suchasdiuretics(ACEinhibitors),IACE(inhibitorsofangiotensinconversion

enzyme)andbetablockers.

Concurrentadministrationofpotentiallynephrotoxicdrugs,particularlyaminoglycosides,shouldbe

avoided.

Flunixinmayreducerenaleliminationofsomedrugs(animoglycosides)andincreasetheirtoxicity,such

asaminoglycosidesforexample.

Overdose(symptoms,emergencyprocedures,antidotes)

Overdosageisassociatedwithgastrointestinaltoxicity.Ataxiaandincoordinationsymptomsmayalso

appear.

Inhorses,from3foldtherecommendeddose(3mg/kgbodyweight)administeredbyintravenous

injection,atransientincreaseofthebloodpressuremaybeobserved.

Incattle,administrationof3foldtherecommendeddose(6mg/kgbodyweight)byintravenousinjection

didnotinduceuntowardeffects.

Inpigs,from2mgflunixin/kg,administeredtwiceaday,painfulreactionsattheinjectionsiteandan

increaseofleucocytesnumberwerereported.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelp

toprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Boxof1glassbottleof50ml

Boxof1glassbottleof100ml

Boxof1glassbottleof250ml

Boxof1polyethyleneterephtalatebottleof50ml

Boxof1polyethyleneterephtalatebottleof100ml

Boxof1polyethyleneterephtalatebottleof250ml

Notallpacksizesmaybemarketed.

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

29-11-2018

ANSES Newsletter in English - N°50 - November 2018

ANSES Newsletter in English - N°50 - November 2018

France - Agence Nationale du Médicament Vétérinaire

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

19-11-2018

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

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