Florvetol Swine Injectable

Main information

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

Documents

Localization

  • Available in:
  • Florvetol Swine Injectable
    Hungary
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0157/001
  • Authorization date:
  • 20-01-2012
  • EU code:
  • FR/V/0157/001
  • 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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Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

“Vita-X Revitalizing Capsules” for men may pose serious health risks

“Vita-X Revitalizing Capsules” for men may pose serious health risks

Health Canada is advising Canadians that two versions of “Vita-X Revitalizing Capsules” by Lanlay Healthmetic Inc., promoted for “long lasting vital energy for men,” may pose serious health risks. One version contains seven capsules and has “NPN 80053009,” a Natural Product Number (NPN) indicating Health Canada authorization, on the label. The second version contains one capsule, has no NPN on the label and is not authorized by Health Canada.

Health Canada

9-11-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs

FDA is taking steps to modernize the agency’s inspections program

FDA - U.S. Food and Drug Administration

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Saratoga Springs, NY - Stewart’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 units of affected product were distributed in upstate New York and Southern Vermont.

FDA - U.S. Food and Drug Administration

12-9-2018

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

24-7-2018

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

19-7-2018

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Openfoodtox: over 300 substances added to EFSA chemical hazards database

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

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

17-5-2018

JAGUAR 30000 capsules

JAGUAR 30000 capsules

Safety advisory

Therapeutic Goods Administration - Australia

27-4-2018

EpiPen 300 mcg adrenaline auto-injector

EpiPen 300 mcg adrenaline auto-injector

Medicine shortages

Therapeutic Goods Administration - Australia

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

13-6-2017

Annual report 2016 - Clinical trials of medicines

Annual report 2016 - Clinical trials of medicines

LLast year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.

Danish Medicines Agency

6-4-2017

More batches of EpiPen® are withdrawn

More batches of EpiPen® are withdrawn

MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.

Danish Medicines Agency

17-3-2017

Withdrawal of a batch of EpiPen® 300 micrograms

Withdrawal of a batch of EpiPen® 300 micrograms

MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

Danish Medicines Agency

21-2-2017

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.

Danish Medicines Agency

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

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

27-6-2018

Yondelis (Pharma Mar S.A.)

Yondelis (Pharma Mar S.A.)

Yondelis (Active substance: Trabectedin) - PSUSA - Modification - Commission Decision (2018)4096 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/3001/201709

Europe -DG Health and Food Safety

29-5-2018

Osurnia (Elanco Europe Ltd)

Osurnia (Elanco Europe Ltd)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Yearly update - Commission Decision (2018)3406 of Tue, 29 May 2018

Europe -DG Health and Food Safety

16-5-2018

Busulfan Fresenius Kabi (Fresenius Kabi Deutschland GmbH)

Busulfan Fresenius Kabi (Fresenius Kabi Deutschland GmbH)

Busulfan Fresenius Kabi (Active substance: busulfan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3005 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2806/T/8

Europe -DG Health and Food Safety

15-5-2018

Lonquex (UAB Sicor Biotech)

Lonquex (UAB Sicor Biotech)

Lonquex (Active substance: lipegfilgrastim) - Centralised - Renewal - Commission Decision (2018)3009 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2556/R/39

Europe -DG Health and Food Safety

15-5-2018

Izba (Novartis Europharm Limited)

Izba (Novartis Europharm Limited)

Izba (Active substance: travoprost) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3002 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2738/T/10

Europe -DG Health and Food Safety

15-5-2018

KEYTRUDA (Merck Sharp and Dohme B.V.)

KEYTRUDA (Merck Sharp and Dohme B.V.)

KEYTRUDA (Active substance: pembrolizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3003 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3820/T/45

Europe -DG Health and Food Safety

15-5-2018

LIFMIOR (Pfizer Limited)

LIFMIOR (Pfizer Limited)

LIFMIOR (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018)3004 of Tue, 15 May 2018

Europe -DG Health and Food Safety

15-5-2018

Travatan (Novartis Europharm Limited)

Travatan (Novartis Europharm Limited)

Travatan (Active substance: Travoprost) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3001 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/390/T/59

Europe -DG Health and Food Safety

15-5-2018

Imatinib Teva B.V. (Teva B.V.)

Imatinib Teva B.V. (Teva B.V.)

Imatinib Teva B.V. (Active substance: imatinib) - Centralised - Withdrawal - Commission Decision (2018)3008 of Tue, 15 May 2018

Europe -DG Health and Food Safety

15-5-2018

Instanyl (Takeda Pharma A/S)

Instanyl (Takeda Pharma A/S)

Instanyl (Active substance: Fentanyl ) - PSUSA - Modification - Commission Decision (2018)3006 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/959/PSUSA/1369/201704

Europe -DG Health and Food Safety

15-5-2018

PecFent (Kyowa Kirin Services Ltd)

PecFent (Kyowa Kirin Services Ltd)

PecFent (Active substance: Fentanyl ) - PSUSA - Modification - Commission Decision (2018)3007 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1164/PSUSA/1369-201704

Europe -DG Health and Food Safety