uflor Drinking Water Concentrate for Swine

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
    Slovenia
  • 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.

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 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 propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

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

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

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