Nuflor Swine Injectable

Main information

  • Trade name:
  • Nuflor Swine Injectable
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Nuflor Swine Injectable
    Liechtenstein
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Amphenicols
  • Therapeutic area:

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0118/001
  • Authorization date:
  • 20-01-2012
  • EU code:
  • FR/V/0118/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

RESFLOR300/16.5mg/mLSolutionforInjectionforCattle(UK, IE)

RESFLOR300/16.5mg/mLΕνέσιμο Διάλυμαγιαβοοειδή(CY, EL)

Resflorvet.injection,solutionforInjectionforCattle(DK, FI, EE,LT,LV,NO)

RESFLOR300/16,5mg/mLSoluçãoInjectávelparaBovinos(PT)

RESFLORSOLUTIONINJECTABLE(FR)

RESFLOR300/16.5mg/mLLösungzurInjektionfürRinder(AT,DE)

Resflorinjekčníroztokpro skot(CZ)

RESFLOR300/16,5 mg/mLSOLUZIONEINIETTABILEperbovini(IT)

Resflorinjekčnýroztokprehovädzídobytok(SK)

RESFLORSOLUCIÓNINYECTABLE(ES)

Resflor300, 16,5 mg/mLoplossingvoorinjectievoorrunderen(NL)

Resflor300, 16,5 mg/mLsolutioninjectablepourbovines(BE,LU)

Resflor300, 16,5 mg/mLInjektionslösungfürRinder(BE)

RESFLOR300/16.5mg/mLsolutieinjectabilapentrubovine(RO)

РЕСФЛОР300/16,5мг/млРазтвор заинжективноприложениеприЕдри

преживниживотни(BG)

Resflor300/16,5mg/mLraztopinazainjiciranjezagovedo(SI)

Resflor300/16,5mg/mLroztwórdowstrzykiwańdlabydła (PL)

RESFLORINJEKCIÓSOLDAT(HU)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

EachmLcontains

Activesubstance:

Florfenicol 300.0mg

Flunixin 16.5 mg

(asflunixinmeglumine)

Excipients:

Propyleneglycol(AntimicrobialPreservative)

E1520 150.0mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Solutionforinjection

Clear,lightyellowto strawcolouredliquid

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle

4.2 Indicationsforuse,specifyingthetargetspecies

Forcattle:

-CurativetreatmentofrespiratoryinfectionscausedbyMannheimiahaemolytica,

PasteurellamultocidaandHistophilussomniassociatedwithpyrexia.

4.3 Contra-indications

Donotuseinadultbullsintendedforbreedingpurposes.

Donotuseinanimalssufferingfromhepaticandrenaldiseases.

Donotuseifthereisariskofgastrointestinalbleedingorincaseswherethereis

evidenceofalteredhemostasis.

Donotuseinanimalssufferingfromcardiacdiseases.

Donotuseinthecaseofknownhypersensitivitytoactivesubstancesorto anyofthe

excipients

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.

Avoiduseindehydrated,hypovolaemicorhypotensiveanimalsasthereisapotential

riskofincreasedrenaltoxicity.Concurrentadministrationofpotentiallynephrotoxic

drugsshouldbeavoided.

Repeateddailydosinghasbeenassociatedwithabomasalerosionsinthepre-ruminant

calf.Theproductshouldbeusedwithcautioninthisagegroup.

Thesafetyoftheproducthasnotbeentestedincalvesof3 weeksofageorless.

Specialprecautionsto betakenby thepersonadministeringthemedicinal

producttoanimals

Careshouldbetakento avoidaccidentalself-injection.

Washhandsafteruse.

Donotusetheproductinknowncasesofsensitivityto propyleneglycoland

polyethyleneglycols.

4.6 Adversereactions(frequencyandseriousness)

Subcutaneousadministrationoftheproductmayresultininjectionsiteswellingsthat

becomepalpable2-3daysafterinjection.Thedurationoftheinjectionsiteswellings

rangedfrom15-36dayspost-injection.Grossly,thisisassociatedwithminimalto

mildirritationofthesubcutis.Extensionintotheunderlyingmusclewasnotedin

onlyafewinstances.By56 dayspost-dosing,nogrosslesionswereobservedthat

wouldrequireanytrim-outatslaughter.

4.7 Useduringpregnancy,lactationorlay

Theeffectofflorfenicolonbovinereproductiveperformance,pregnancyandlactation

hasnotbeenassessed.Useonlyaccordinglytothebenefit/riskassessmentbythe

responsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofotheractivesubstancesthathaveahighdegreeofproteinbinding

maycompetewithflunixinforbindingandthusleadto toxiceffects.Pre-treatment

withotheranti-inflammatorysubstancesmayresultinadditionalorincreasedadverse

effectsandaccordinglyatreatment-freeperiodwithsuchdrugsshouldbeobserved

foratleast24hoursbeforethecommencementoftreatment.Thetreatment-free

period,however,shouldtakeintoaccountthepharmacokineticpropertiesofthe

productsusedpreviously.

TheproductmustnotbeadministeredinconjunctionwithotherNSAIDsor

glucocorticosteroids.Gastrointestinaltractulcerationmaybeexacerbatedby

corticosteroidsinanimalsgivenNSAIDs.

4.9 Amount(s)to beadministeredandadministrationroute

40 mg/kgflorfenicoland2.2 mg/kgflunixin(2mL/15kgbodyweight)tobe

administeredbyasinglesubcutaneousinjection.

Thedosevolumegivenatanyoneinjectionsiteshouldnotexceed10mL.

Itisrecommendedtotreatanimalsintheearlystagesofthediseaseandtoevaluate

theresponseto treatment48 hoursafterinjection.Theanti-inflammatorycomponent

ofResflor,flunixin,maymaskapoorbacteriologicalresponsetoflorfenicolinthe

first24 hoursafterinjection.Ifclinicalsignsofrespiratorydiseasepersistorincrease,

orifrelapseoccurs,treatmentshouldbechanged,usinganotherantibiotic,and

continueduntilclinicalsignshaveresolved.

Theinjectionshouldonlybegivenintheneck.

Swabseptumbeforeremovingeachdose.Useadrysterileneedleandsyringe.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuracyaspossible

to avoidunderdosing.

4.10 Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Overdosestudiesinthetargetspeciesfor3 timesthedurationoftreatmentshowed

decreasedfoodconsumptioninthegroupsgiven3 and5 timestherecommended

dose. Decreasedbodyweightswereobservedinthe5 timesoverdosegroup

(secondarytodecreasedfoodconsumption).Decreasedwaterconsumptionwas

observedinthe5 timesoverdosegroup.Tissueirritationincreaseswithinjection

volume.

Treatmentat3 timestherecommendedtreatmentdurationwasassociatedwithdose-

relatederosiveandulcerativeabomasumlesions.

4.11 Withdrawalperiods

Meatandoffal: 46 days.

Milk:Notauthorizedforuseinlactatinganimalsproducingmilkforhuman

consumption.Do notuseduringlactationordryingoffperiods.Do notusein

pregnantanimalswhichareintendedto producemilkforhumanconsumptionwithin

2 monthsofexpectedparturition

5. PHARMACOLOGICALPROPERTIES

PharmacotherapeuticGroup:antibacterialsforsystemicuse,amphenicols,

combinationsATCvetCode:QJ01BA99

5.1 Pharmacodynamicproperties

Florfenicolisasyntheticbroad spectrumantibioticeffectiveagainstmostGram-

positiveandGram-negativebacteriaisolatedfromdomesticanimals.Florfenicolacts

byinhibitingbacterialproteinsynthesisattheribosomallevelandisbacteriostatic.

Laboratorytestshaveshownthatflorfenicolisactiveagainstthemostcommonly

isolatedbacterialpathogensinvolvedinbovinerespiratorydiseasewhichinclude

Mannheimiahaemolytica, PasteurellamultocidaandHistophilussomni.

Florfenicolisconsideredtobeabacteriostaticagent,butinvitrostudiesofflorfenicol

demonstratebactericidalactivityagainst Mannheimiahaemolytica,Pasteurella

multocidaandHistophilussomni .

Florfenicolbactericidalactivitywascharacterisedasessentiallytimedependant

againstthethreetargetpathogenswiththepossibleexceptionofH.somniwherea

concentrationdependencywasobserved.

Duringtheflorfenicolsusceptibilitymonitoringprogram(2000-2003)atotalof487

M. haemolytica,522P.multocidaand25H. somniisolateswerecollected.MIC

valuesrangedbetween<0.12 and2 µg/mlforM.haemolytica(MIC

= 1 µg/ml),

between<0.12 and2 µg/mlforP. multocida(MIC

= 0.50 µg/ml)andbetween0.12

and0.5 µg/mlforH.somni. BreakpointshavebeenestablishedbytheCLSI(Clinical

andLaboratoryStandardInstitute)forbovinerespiratorypathogensasfollows:

Pathogen FlorfenicolDisk

Concentration

(µg) Diameter(mm) MIC(µg/ml)

S I R S I R

M.haemolytica

P.multocida

H.somni 30

19 15-18

14

2 4

8

Theonlymechanismsofchloramphenicolresistancethatareknownto have

significantclinicalrelevanceareCAT-mediatedinactivationandefflux-pump

resistance.Ofthese,onlysomeoftheeffluxmediatedresistancewouldalsoconfer

resistancetoflorfenicolandthushavethepotentialto beaffectedbyflorfenicolusein

animals. Resistancetoflorfenicolinthetargetpathogenshasonlybeenreportedon

rareoccasionsandwasassociatedwitheffluxpumpandthepresenceofthefloRgene.

Flunixinmeglumineisanon-steroidalanti-inflammatorydrugwithanalgesicand

antipyreticactivity.

Flunixinmeglumineactsasareversiblenon-selectiveinhibitorofcyclo-oxygenase

(bothCOX1 andCOX2 forms),animportantenzymeinthearachidonicacidcascade

pathwaywhichisresponsibleforconvertingarachidonicacidtocyclicendoperoxides.

Consequently,synthesisofeicosanoids,importantmediatorsoftheinflammatory

processinvolvedincentralpyresis,painperceptionandtissueinflammation,is

inhibited.Throughitseffectsonthearachidonicacidcascade, flunixinalsoinhibits

theproductionofthromboxane,apotentplateletpro-aggregatorandvasoconstrictor

whichisreleasedduringbloodclotting.Flunixinexertsitsantipyreticeffectby

inhibitingprostaglandinE2synthesisinthehypothalamus.Althoughflunixinhasno

directeffectonendotoxinsaftertheyhavebeenproduced,itreducesprostaglandin

productionandhencereducesthemanyeffectsoftheprostaglandincascade.

Prostaglandinsarepartofthecomplexprocessesinvolvedinthedevelopmentof

endotoxicshock.

5.2 Pharmacokineticparticulars

Theadministrationoftheproductbythesubcutaneousrouteattherecommended

dosageof40 mg/kgflorfenicolmaintainedefficaciousplasmalevelsincattle(i.e.

abovetheMIC

oftheleastsensitiverespiratorypathogen,Mannheimiahaemolytica)

forlongerthan39 hours.Maximumplasmaconcentration(Cmax)ofapproximately

4.3 µg/mLoccurredapproximately5.5 hours(Tmax)afterdosing.

Afteradministrationoftheproductbythesubcutaneousrouteattherecommended

dosageof2.2 mg/kgflunixinpeakplasmaconcentrationsof2.9 µg/mLwereachieved

after1.3 hours.Thevolumeofdistributionwasapproximately2 litresperkg.

Thebindingofflorfenicolonproteinsisapproximately20%andforflunixin> 99%.

Thedegreeofeliminationofflorfenicolresiduesinurineisapproximately68%andin

faecesapproximately8%.Thedegreeofeliminationofflunixinresiduesinurineis

approximately34%andforfaecesapproximately57%.

6 PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Propyleneglycol(E1520)

N-methyl-2-pyrrolidone

Anhydrouscitricacid

(Macrogol300)

6.2 Incompatibilities

Donotmixtheproductwithothermedicinalproducts.

6.3 Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2 years

Shelflifeafterfirstopeningtheimmediatepackaging:28 days

6.4 Specialprecautionsforstorage

Donotstoreabove30°C.

Donotfreeze. Protectfromfrost.

6.5 Natureandcompositionofimmediatepackaging

100 mland250 mL

GlassvialTypeI

Bromobutylstopper

Aluminiumcap.

Notallpack sizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

cfapplicationform

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION

10. DATEOFREVISIONOFTEXT

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Cartonboxfor100mL-and250mLvials

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

RESFLOR300/16.5mg/mLSolutionforInjectionforCattle

Florfenicol

Flunixin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1mLsolutioncontains:

Florfenicol 300.0mg

Flunixin 16.5 mg

(asflunixinmeglumine)

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

100mL

250mL

5. TARGETSPECIES

Cattle

6. INDICATION(S)

Notapplicablefortheouterpackage.

7. METHODANDROUTEOFADMINISTRATION

Fortreatmentbysubcutaneousadministration

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal: 46 days

Milk:Notauthorizedforuseinlactatinganimalsproducingmilkforhuman

consumption.Do notuseduringlactationordryingoffperiods.Do notusein

pregnantanimalswhichareintendedto producemilkforhumanconsumptionwithin

2 monthsofexpectedparturition

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year}>

Oncebroached,/opened,usewithin28 days.

11.SPECIALSTORAGECONDITIONS

Donotstoreabove30

C.

Donotfreeze.

Protectfromfrost.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSED

PRODUCTSORWASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsshouldbedisposedofin

accordancewithlocalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY”AND

CONDITIONSORRESTRICTIONSREGARDINGSUPPLYANDUSE,

ifapplicable

Foranimaltreatmentonly.To besuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOF

CHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATION

HOLDER

[Tobecompletednationally.]

16.MARKETINGAUTHORISATIONNUMBER(S)

[Tobecompletednationally.]

17.MANUFACTURER’SBATCHNUMBER

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

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGING

Labelforthe100mLand250mL-vials

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

RESFLOR300/16.5mg/mLSolutionforInjectionforCattle

Florfenicol

Flunixin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1mLsolutioncontains:

Florfenicol 300.0mg

Flunixin 16.5 mg

(asflunixinmeglumine)

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

100 mL

250 mL

5. TARGETSPECIES

Cattle

6. INDICATION(S)

Notapplicablefortheimmediatepackage.

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal: 46 days

Milk:Notauthorizedforuseinlactatinganimalsproducingmilkforhuman

consumption.Do notuseduringlactationordryingoffperiods.Do notusein

pregnantanimalswhichareintendedto producemilkforhumanconsumptionwhiting

2 monthsofexpectedparturition

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

Careshouldbetakento avoidaccidentalself-injection.

Swabseptumbeforeremovingeachdose.Useadrysterileneedleandsyringe.

10.EXPIRYDATE

<EXP{month/year}>

<Oncebroached,/opened,usewithin28 days.

11.SPECIALSTORAGECONDITIONS

Donotstoreabove30

C.

Donotfreeze.

Protectfromfrost.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSED

PRODUCTSORWASTEMATERIALS,IFANY

[Notrequested on theimmediatelabel ]

13.THEWORDS“FORANIMALTREATMENTONLY”AND

CONDITIONSORRESTRICTIONSREGARDINGSUPPLYANDUSE,

ifapplicable

Foranimaltreatmentonly.To besuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOF

CHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATION

HOLDER

[Tobecompletednationally.]

16.MARKETINGAUTHORISATIONNUMBER(S)

[Tobecompletednationally.]

17.MANUFACTURER’SBATCHNUMBER

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

B. PACKAGELEAFLET

PACKAGELEAFLET

RESFLOR300/16.5mg/mLSolutionforInjectionforCattle

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATION

HOLDERANDOFTHEMANUFACTURINGAUTHORISATION

HOLDERRESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

Manufacturerforthebatchrelease:

VetPharmaFriesoythe

SedelsbergerStrasse2

26169 Friesoythe

Germany

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

RESFLOR300/16.5mg/mLSolutionforInjectionforCattle

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHER

INGREDIENT(S)

Resflorisaclear,lightyellowto strawcolouredliquidsolutionforinjection,

containing300.0 mg/mlflorfenicoland16.5 mg/mlflunixin(asflunixinmeglumine).

4. INDICATION(S)

Forcattle:

-CurativetreatmentofrespiratoryinfectionscausedbyMannheimiahaemolytica,

PasteurellamultocidaandHistophilussomniassociatedwithpyrexia.

5. CONTRAINDICATIONS

Donotuseinadultbullsintendedforbreedingpurposes.

Donotuseinanimalssufferingfromhepaticandrenaldiseases.

Donotuseifthereisariskofgastrointestinalbleedingorincaseswherethereis

evidenceofalteredhemostasis.

Donotuseinanimalssufferingfromcardiacdiseases.

Donotuseinthecaseofknownhypersensitivitytoactivesubstancesorto anyofthe

excipients

6. ADVERSEREACTIONS

Subcutaneousadministrationoftheproductmayresultininjectionsiteswellingsthat

becomepalpable2-3daysafterinjection.Thedurationoftheinjectionsiteswellings

rangedfrom15–36 dayspost-injection.Grossly,thisisassociatedwithminimalto

mildirritationofthesubcutis.Extensionintotheunderlyingmusclewasnotedinonly

afewinstances.By56 dayspost-dosing,nogrosslesionswereobservedthatwould

requireanytrim-outatslaughter.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

7. TARGETSPECIES

Cattle

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

40 mg/kgflorfenicoland2.2 mg/kgflunixin(2ml/15kgbodyweight)to be

administeredbyasinglesubcutaneousinjection.

9. ADVICEONCORRECTADMINISTRATION

Swabseptumbeforeremovingeachdose.Useadrysterileneedleandsyringe.

Toensurecorrectdosageandavoidunderdosing,bodyweightshouldbedeterminedas

accuratelyaspossible.

Thedosevolumegivenatanyoneinjectionsiteshouldnotexceed10ml.

Theinjectionshouldonlybegivenintheneck.

Itisrecommendedtotreatanimalsintheearlystagesofthediseaseandtoevaluate

theresponseto treatment48 hoursafterinjection.Theanti-inflammatorycomponent

ofResflor,flunixin,maymaskapoorbacteriologicalresponsetoflorfenicolinthe

first24 hoursafterinjection.Ifclinicalsignsofrespiratorydiseasepersistorincrease,

orifrelapseoccurs,treatmentshouldbechanged,usinganotherantibiotic,and

continueduntilclinicalsignshaveresolved.

10.WITHDRAWALPERIOD

Meatandoffal: 46 days

Milk:Notauthorizedforuseinlactatinganimalsproducingmilkforhuman

consumption.Do notuseduringlactationordryingoffperiods.Do notusein

pregnantanimalswhichareintendedto producemilkforhumanconsumptionwithin

2 monthsofexpectedparturition

11.SPECIALSTORAGEPRECAUTIONS

Keep outofthereachandsightofchildren.

Donotstoreabove30

C.

Donotfreeze.

Protectfromfrost.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2 years

Shelflifeafterfirstbroachingtheimmediatepackaging:28 days

12.SPECIALWARNING(S)

Contra-indications

Donotuseinadultbullsintendedforbreedingpurposes.

Donotuseinanimalssufferingfromhepaticandrenaldiseases.

Donotuseifthereisariskofgastrointestinalbleedingorincaseswherethereis

evidenceofalteredhemostasis.

Donotuseinanimalssufferingfromcardiacdiseases.

Donotuseinthecaseofknownhypersensitivitytoactivesubstancesorto anyofthe

excipients

Specialwarnings

Specialprecautionsforusein animals:

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.

Avoiduseindehydrated,hypovolaemicorhypotensiveanimalsasthereisapotential

riskofincreasedrenaltoxicity.Concurrentadministrationofpotentiallynephrotoxic

drugsshouldbeavoided.

Repeateddailydosinghasbeenassociatedwithabomasalerosionsinthepre-ruminant

calf.Theproductshouldbeusedwithcautioninthisagegroup.

Thesafetyoftheproducthasnotbeentestedincalvesof3 weeksofageorless.

Concurrentuseofotheractivesubstancesthathaveahighdegreeofproteinbinding

maycompetewithflunixinforbindingandthusleadto toxiceffects.Pre-treatment

withotheranti-inflammatorysubstancesmayresultinadditionalorincreasedadverse

effectsandaccordinglyatreatment-freeperiodwithsuchdrugsshouldbeobserved

foratleast24 hoursbeforethecommencementoftreatment.Thetreatment-free

period,however,shouldtakeintoaccountthepharmacokineticpropertiesofthe

productsusedpreviously.

TheproductmustnotbeadministeredinconjunctionwithotherNSAIDsor

glucocorticosteroids.Gastrointestinaltractulcerationmaybeexacerbatedby

corticosteroidsinanimalsgivenNSAIDs.

Userwarnings:

Careshouldbetakento avoidaccidentalself-injection.

Washhandsafteruse.

Donotusetheproductinknowncasesofsensitivityto propyleneglycoland

polyethyleneglycols.

Adversereactions:

Subcutaneousadministrationoftheproductmayresultininjectionsiteswellingsthat

becomepalpable2-3daysafterinjection.Thedurationoftheinjectionsiteswellings

rangedfrom15-36dayspost-injection.Grossly,thisisassociatedwithminimalto

mildirritationofthesubcutis.Extensionintotheunderlyingmusclewasnotedin

onlyafewinstances.By56 dayspost-dosing,nogrosslesionswereobservedthat

wouldrequireanytrim-outatslaughter.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

Useduringpregnancyand lactation:

Theeffectofflorfenicolonbovinereproductiveperformance,pregnancyandlactation

hasnotbeenassessed.Useonlyaccordinglytothebenefit/riskassessmentbythe

responsibleveterinarian.

Overdose:

Overdosestudiesinthetargetspeciesfor3 timesthedurationoftreatmentshowed

decreasedfoodconsumptioninthegroupsgiven3 and5 timestherecommended

dose. Decreasedbodyweightswereobservedinthe5 timesoverdosegroup

(secondarytodecreasedfoodconsumption).Decreasedwaterconsumptionwas

observedinthe5 timesoverdosegroup.Tissueirritationincreaseswithinjection

volume.

Treatmentat3 timestherecommendedtreatmentdurationwasassociatedwithdose-

relatederosiveandulcerativeabomasumlesions.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSED

PRODUCTORWASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

100mland250mlvials.

Notallpack sizesmaybemarketed.

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FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA is aware of a shortage of Percorten™-V (desoxycorticosterone pivalate injectable suspension), which is approved for use as replacement therapy for mineralocorticoid deficit in dogs with primary adrenocortical insufficiency, more commonly known as Addison’s Disease.

FDA - U.S. Food and Drug Administration

11-7-2018

African swine fever: EFSA assesses measures to prevent spread

African swine fever: EFSA assesses measures to prevent spread

African swine fever: EFSA assesses measures to prevent spread

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

29-5-2018

Résultats ILPT Classical Swine Fever SEROLOGY 2018

Résultats ILPT Classical Swine Fever SEROLOGY 2018

France - Agence Nationale du Médicament Vétérinaire

19-5-2018

Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health Risks

Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health Risks

Health Canada is advising Canadians that it has seized an unauthorized “Botox” product and other unauthorized health products from Arshia Hair Salon and Spa (6062A Yonge Street) in Toronto, ON, because they may pose serious health risks. These products may have been administered as injectable treatments for cosmetic purposes.

Health Canada

19-4-2018

Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe

Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe

Injectable skin lightening products are unapproved, untested drugs that could potentially cause harm, the FDA warns. The FDA has not approved any injectable drugs for skin whitening or lightening.

FDA - U.S. Food and Drug Administration

25-7-2018

Respiporc Flu3 (IDT Biologika GmbH)

Respiporc Flu3 (IDT Biologika GmbH)

Respiporc Flu3 (Active substance: Inactivated vaccine against swine influenza in pigs) - Centralised - Yearly update - Commission Decision (2018)4991 of Wed, 25 Jul 2018

Europe -DG Health and Food Safety