uflor

Main information

  • Trade name:
  • uflor Drinking Water Concentrate for Swine
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • uflor Drinking Water Concentrate for Swine
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • florfenicol
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0127/001
  • Authorization date:
  • 20-01-2012
  • EU code:
  • FR/V/0127/001
  • 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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Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 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 HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

October 23, 2018 For immediate release

Health Canada

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

24-7-2018

July 23, 2018: Springfield EMT/Paramedic Pleads Guilty to Stealing Fentanyl, Morphine

July 23, 2018: Springfield EMT/Paramedic Pleads Guilty to Stealing Fentanyl, Morphine

July 23, 2018: Springfield EMT/Paramedic Pleads Guilty to Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

12-7-2018

Minimum service during 23 July - 3 August

Minimum service during 23 July - 3 August

Due to summer holidays minimum service level will be at the Icelandic Medicines Agency from 23 July till 3 August, both days included. Please note that the agency is closed on Monday 6 August due to a bank holiday.

IMA - Icelandic Medicines Agency

15-6-2018

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk

Kellogg Company today announced it is voluntarily recalling 15.3 oz. and 23 oz. packages of Kellogg’s® Honey Smacks® cereal (with code dates listed below) because these products have the potential presence of Salmonella. No other Kellogg products are impacted by this recall.

FDA - U.S. Food and Drug Administration

14-6-2018

Blokhuis: maak postnatale depressie bespreekbaar

Blokhuis: maak postnatale depressie bespreekbaar

In Nederland ontwikkelen jaarlijks ruim 23.400 vrouwen een depressie na de bevalling. Dat is 1 op de 8 moeders. Velen van hen durven hun situatie niet aan te kaarten. Zij zijn bang om gezien te worden als een slechte moeder (47,4%) en willen anderen niet belasten (52,2%), blijkt uit een peiling onder vrouwen die (signalen van) een postnatale depressie hebben gehad. Hierdoor blijft postnatale depressie, ook wel postpartum depressie (PPD) genoemd, te vaak onbesproken. Daarom geeft staatssecretaris Paul Blo...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

23-11-2018

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Active substance: Nitisinone) - PSUSA - Modification - Commission Decision (2018)7890 of Fri, 23 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2169/201802

Europe -DG Health and Food Safety

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

19-9-2018

Fortacin (Recordati Ireland Ltd)

Fortacin (Recordati Ireland Ltd)

Fortacin (Active substance: lidocaine / prilocaine) - Centralised - Renewal - Commission Decision (2018)6103 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2693/R/23

Europe -DG Health and Food Safety

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the CAT meeting 23-25 May 2018

Minutes of the CAT meeting 23-25 May 2018

Europe - EMA - European Medicines Agency

23-8-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Corrigendum - Commission Decision (2018)1246 of Thu, 23 Aug 2018

Europe -DG Health and Food Safety

23-8-2018

Public submissions on scheduling matters referred to the ACMS #23, ACCS #22 and Joint ACMS-ACCS #18 meetings held in March 2018

Public submissions on scheduling matters referred to the ACMS #23, ACCS #22 and Joint ACMS-ACCS #18 meetings held in March 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in March 2018

Therapeutic Goods Administration - Australia

2-8-2018

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Active substance: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23) - Transfer of orphan designation - Commission Decision (2018)5289 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/133/14/T/02

Europe -DG Health and Food Safety

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

25-7-2018

Moventig (Kyowa Kirin Holdings B.V.)

Moventig (Kyowa Kirin Holdings B.V.)

Moventig (Active substance: naloxegol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4985 of Wed, 25 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2810/T/23

Europe -DG Health and Food Safety

23-7-2018

Agenda:  Agenda - HMPC agenda of the 23-24 July 2018 meeting

Agenda: Agenda - HMPC agenda of the 23-24 July 2018 meeting

Europe - EMA - European Medicines Agency

23-7-2018

Agenda:  Agenda - CHMP agenda of the 23-26 July 2018 meeting

Agenda: Agenda - CHMP agenda of the 23-26 July 2018 meeting

Europe - EMA - European Medicines Agency

23-7-2018

Lopinavir/Ritonavir Mylan (Mylan S.A.S.)

Lopinavir/Ritonavir Mylan (Mylan S.A.S.)

Lopinavir/Ritonavir Mylan (Active substance: lopinavir / ritonavir) - Centralised - Yearly update - Commission Decision (2018)4888 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Translarna (PTC Therapeutics International Limited)

Translarna (PTC Therapeutics International Limited)

Translarna (Active substance: ataluren) - Centralised - Annual renewal - Commission Decision (2018)4879 of Mon, 23 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2720/R/41

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Plegridy (Biogen Netherlands B.V.)

Plegridy (Biogen Netherlands B.V.)

Plegridy (Active substance: peginterferon beta-1a) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4881 of Mon, 23 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2827/T/49

Europe -DG Health and Food Safety

23-7-2018

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Active substance: fidaxomicin) - Centralised - Yearly update - Commission Decision (2018)4889 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

PecFent (Kyowa Kirin Holdings B.V.)

PecFent (Kyowa Kirin Holdings B.V.)

PecFent (Active substance: Fentanyl ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4890 of Mon, 23 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1164/T/46

Europe -DG Health and Food Safety

23-7-2018

Trobalt (Glaxo Group Ltd)

Trobalt (Glaxo Group Ltd)

Trobalt (Active substance: retigabine) - Centralised - Withdrawal - Commission Decision (2018)4887 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4892 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

SANCUSO (Kyowa Kirin Holdings B.V.)

SANCUSO (Kyowa Kirin Holdings B.V.)

SANCUSO (Active substance: granisetron) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4891 of Mon, 23 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2296/T/52

Europe -DG Health and Food Safety

23-7-2018

Rituzena (Celltrion Healthcare Hungary Kft.)

Rituzena (Celltrion Healthcare Hungary Kft.)

Rituzena (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)4884 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Carmustine Obvius (NovImmune B.V.)

Carmustine Obvius (NovImmune B.V.)

Carmustine Obvius (Active substance: carmustine) - New authorisation - Commission Decision (2018)4882 of Mon, 23 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4326

Europe -DG Health and Food Safety

27-6-2018

 Minutes of the CVMP meeting of 23-25 May 2018

Minutes of the CVMP meeting of 23-25 May 2018

Europe - EMA - European Medicines Agency

15-6-2018

 Minutes of the CHMP meeting 23-26 April 2018

Minutes of the CHMP meeting 23-26 April 2018

Committee for medicinal products for human use (CHMP) minutes of the meeting on 23-26 April 2018

Europe - EMA - European Medicines Agency