Resflor Injectable Solution

Main information

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

Documents

Localization

  • Available in:
  • Resflor Injectable Solution
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Amphenicols
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0167/001
  • Authorization date:
  • 20-01-2012
  • EU code:
  • FR/V/0167/001
  • 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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