Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle

Main information

  • Trade name:
  • Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Ceftiofur
  • Therapeutic area:
  • Cattle, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0148/001
  • Authorization date:
  • 23-02-2011
  • EU code:
  • NL/V/0148/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:.

Activesubstance:

Ceftiofur(ashydrochloride)50.0mg

Excipients:

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Suspensionforinjection.

Whitetooffwhitecolouredsuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigsweighingupto125kg.

Cattle.

4.2 Indicationsforuse,specifyingthetargetspecies

Infectionsassociatedwithbacteriasensitivetoceftiofur:

Inpigs:

-TreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocida,Actinobacillus

pleuropneumoniaeandStreptococcussuis.

Thisproductisnottobeusedinpigswithabodyweightmorethan125kg.

Incattle:

-TreatmentofbacterialrespiratorydiseaseassociatedwithMannheimiahaemolytica,Pasteurella

multocidaandHaemophilussomnus.

-Treatmentofacuteinterdigitalnecrobacillosis(panaritium,foulinthefoot),associatedwith

FusobacteriumnecrophorumandBacteroidesmelaninogenicus(Porphyromonasasaccharolytica).

-Treatmentofthebacterialcomponentofacutepost-partum(puerperal)metritiswithin10daysafter

calvingassociatedwithEscherichiacoli,ArcanobacteriumpyogenesandFusobacterium

necrophorum,sensitivetoceftiofur.Theindicationisrestrictedtocaseswheretreatmentwithanother

antimicrobialhasfailed

4.3 Contraindications

Donotinjectintravenously.

Donotadministertoananimalpreviouslyfoundtobehypersensitivetoceftiofurandotherb-lactam

antibioticsortoanyoftheexcipients.

Donotuseinpoultry(includingeggs)duetoriskofspreadofantimicrobialresistancetohumans.

4.4 Specialwarningsforeachtargetspecies

Donotuseincaseofknownresistancetotheactivesubstance.

Crossresistancetootherlactamantibioticscanbepresent.Donotuseincasessuchcross-resistanceis

known.

4.5 Specialprecautionsforuse

Shakethebottlewellbeforeusetobringtheproductbackintosuspension.

Specialprecautionsforuseinanimals

Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

Ceftiosanselectsforresistantstrainssuchasbacteriacarryingextendedspectrumbetalactamases

(ESBL)andmayconstitutearisktohumanhealthifthesestrainsdisseminatetohumanse.g.viafood.

Forthisreason,Ceftiosanshouldbereservedforthetreatmentofclinicalconditionswhichhaveresponded

poorly,orareexpectedtorespondpoorly(referstoveryacutecaseswhentreatmentmustbeinitiated

withoutbacteriologicaldiagnosis)tofirstlinetreatment.Official,nationalandregionalantimicrobialpolicies

shouldbetakenintoaccountwhentheproductisused.Increaseduse,includinguseoftheproduct

deviatingfromtheinstructionsgivenintheSPC,mayincreasetheprevalenceofsuchresistance.

Wheneverpossible,Ceftiosanshouldonlybeusedbasedonsusceptibilitytesting.

Ceftiosanisintendedfortreatmentofindividualanimals.Donotusefordiseasepreventionorasapartof

heardhealthprogrammes.Treatmentofgroupsofanimalsshouldbestrictlyrestrictedtoongoingdisease

outbreaksaccordingtotheapprovedconditionsofuse.

Donotuseasprophylaxisincaseofretainedplacenta.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,ingestion

orskincontact.Hypersensitivitytopenicillinsmayleadtocrossreactionstocephalosporinsandvice

versa.Allergicreactionstothesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottoworkwith

suchpreparations.Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathing,aremore

serioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

Hypersensitivityreactionsunrelatedtodosecanoccur.Allergicreactions(e.g.skinreactions,anaphylaxia)

mayoccasionallyoccur.Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

Inpigs,mildreactionsattheinjectionsite,suchasdiscolorationofthefasciaorfat,havebeenobservedin

someanimalsforupto20daysafterinjection.

Incattle,mildinflammatoryreactionsattheinjectionsite,suchastissueoedemaanddiscolorationofthe

subcutaneoustissueand/orfascialsurfaceofthemusclemaybeobserved.Clinicalresolutionisreachedin

mostanimalsby10daysafterinjectionalthoughslighttissuediscolorationmaypersistfor28daysormore.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudieshavenotproducedanyevidenceofateratogenic,foetotoxicormaternotoxiceffects.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinthetargetspeciesduring

pregnancyandlactation.

Useonlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidalpropertiesofcephalosporinsareantagonizedbysimultaneoususeofbacteriostatic

antibiotics(macrolides,sulfonamidesandtetracyclines).

4.9 Amountstobeadministeredandadministrationroute

Pigs:

Bacterialrespiratorydisease:3mgceftiofur/kgbw/dayfor3daysviaintramuscularroute,i.e.1ml/16kg

bwateachinjection.

Themaximuminjectionvolumemustnotexceed4mlperinjectionsite.Eachinjectionmustbegivenat

separatesites,withnooverlapofsubsequentinjections.Thisproductisnottobeusedinpigswitha

bodyweightmorethan125kg.

Cattle:

Bacterialrespiratorydisease:1mgceftiofur/kgbw/dayfor3to5daysbysubcutaneousinjection,i.e.1

ml/50kgbwateachinjection.

Acuteinterdigitalnecrobacillosis:1mg/kgbw/dayfor3daysbysubcutaneousinjection,i.e.1ml/50kgbw

ateachinjection.

Acutepost-partummetritiswithin10daysaftercalving:1mg/kgbw/dayfor5consecutivedaysby

subcutaneousinjection,i.e.1ml/50kgbwateachinjection.

Incaseofacutepost-partummetritis,additionalsupportivetherapymightberequiredinsomecases.

Eachinjectionmustbegivenatseparatesites,withnooverlapofsubsequentinjections.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.Beforeuseshakethebottlefor15secondsor

untiltheproductappearsadequatelyresuspended.

Asthevialcannotbebroachedmorethan40times,theusershouldchoosethemoreappropriatevialsize.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thelowtoxicityofceftiofurhasbeendemonstratedinpigsusingceftiofursodiumatdosesinexcessof8

timestherecommendeddailydoseofceftiofuradministeredintramuscularlyfor15consecutivedays.

Incattle,nosignsofsystemictoxicityhavebeenobservedfollowingsubstantialparenteraloverdosages.

4.11Withdrawalperiod(s)

Pigs:

Meatandoffal:8days.

Cattle:

Meatandoffal:8days.

Milk:zerohours.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse

ATCvetcode:QJ01DD90

5.1 Pharmacodynamicproperties

Ceftiofurisalategenerationcephalosporin,whichisactiveagainstmanyGram-positiveandGram-

negativebacteria.Ceftiofurinhibitsthebacterialcellwallsynthesis,therebyexertingbactericidal

properties.

Beta-lactamsactbyinterferingwithsynthesisofthebacterialcellwall.Cellwallsynthesisisdependenton

enzymesthatarecalledpenicillin-bindingproteins(PBP's).Bacteriadevelopresistancetocephalosporins

byfourbasicmechanisms:1)alteringoracquiringpenicillinbindingproteinsinsensitivetoanotherwise

effective 

-lactam;2)alteringthepermeabilityofthecellto 

-lactams;3)producingb-lactamasesthat

cleavethe 

-lactamringofthemolecule,or4)activeefflux.

Some 

-lactamases,documentedinGram-negativeentericorganisms,mayconferelevatedMICsto

varyingdegreestothirdandfourthgenerationcephalosporins,aswellaspenicillins,ampicillins, 

-lactam

inhibitorcombinations,andfirstandsecondgenerationcephalosporins.

Ceftiofurisactiveagainstthefollowingmicroorganismswhichareinvolvedinrespiratorydiseasesinpigs:

Pasteurellamultocida,ActinobacilluspleuropneumoniaeandStreptococcussuis.Bordetella

bronchisepticaisintrinsicallynon-susceptibletoceftiofur.

Itisalsoactiveagainstbacteriainvolvedinrespiratorydiseaseincattle:Pasteurellamultocida,

Mannheimiahaemolytica,Haemophilussomnus.;bacteriainvolvedinacutebovinefoulinthefoot

(interdigitalnecrobacillosis)incattle:Fusobacteriumnecrophorum,Bacteroidesmelaninogenicus

(Porphyromonasasaccharolytica);andbacteriaassociatedwithacutepost-partum(puerperal)metritisin

cattle:Escherichiacoli,ArcanobacteriumpyogenesandFusobacteriumnecrophorum.

ThefollowingMinimumInhibitoryConcentrations(MIC)havebeendeterminedforceftiofurinEuropean

isolatesoftargetbacteria,isolatedfromdiseasedanimals:

Pigs

Organism(numberofisolates) MICrange(µg/mL) MIC

90 (µg/mL)

A.pleuropneumoniae(28)

0.03 *

0.03

Pasteurellamultocida(37)

0.03-0.13

0.03

Streptococcussuis(495)

0.03-0.25

0.03

Cattle

Organism(numberofisolates) MICrange(µg/mL) MIC

(µg/mL

Mannheimiahaemolytica(87)

0.03 *

0.03

P.multocida(42)

0.03-0.12

0.03

H.somnus(24)

0.03 *

0.03

Arcanobacteriumpyogenes(123)

0.03-0.5 0.25

Escherichiacoli(188) 0.13->32.0 0.5

Fusobacteriumnecrophorum

(67)(isolatesfromcasesoffoot

rot)

0.06-0.13 ND

Fusobacteriumnecrophorum

(2)(isolatesfromcasesofacute

metritis)

0.03-0.06 ND

*Norange;allisolatesyieldedthesamevalue.ND:notdetermined.Thefollowingbreakpointsare

recommendedbyNCCLSforbovineandporcinerespiratorypathogens:

ZoneDiameter(mm) MIC(μg/mL)

Interpretation

≥21 ≤2.0 (S)Susceptible

18-20 4.0 (I)Intermediate

≤17 ≥8.0

(R)Resistant

Nobreakpointshavebeendeterminedtodateforthepathogensassociatedwithfoulinthefootoracute

post-partummetritisincows.

5.2 Pharmacokineticparticulars

Afteradministration,ceftiofurisquicklymetabolisedtodesfuroylceftiofur,theprincipalactivemetabolite.

Desfuroylceftiofurhasanequivalentanti-microbialactivitytoceftiofuragainstthebacteriainvolvedin

respiratorydiseaseinanimals.Theactivemetaboliteisreversiblyboundtoplasmaproteins.Dueto

transportationwiththeseproteins,themetaboliteconcentratesatasiteofinfection,isactiveandremains

activeinthepresenceofnecrotictissueanddebris.

Inpigsgivenasingleintramusculardoseof3mg/kgbodyweight(bw),maximumplasmaconcentrationsof

7.34µg/mLwerereachedafter1.33hours;theterminaleliminationhalf-life(t½)ofdesfuroylceftiofurwas

10,9hours.Noaccumulationofdesfuroylceftiofurhasbeenobservedafteradoseof3mgceftiofur/kg

bw/dayadministereddailyover3days.

Theeliminationoccursmainlyviatheurineandpartlyinthefaeces.Ceftiofuriscompletelybioavailable

followingintramuscularadministration.

Afterasingle1mg/kgdosegivensubcutaneouslytocattle,maximumplasmalevelsof2.87µg/mLare

reachedat4hoursafteradministration.Theterminaleliminationhalf-life(t½)ofdesfuroylceftiofurin

cattleis10.0hours.Noaccumulationwasobservedafteradailytreatmentover5days.Eliminationoccurs

mainlyviatheurineandpartlyinthefaeces.

Ceftiofuriscompletelybioavailablefollowingsubcutaneousadministration.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Hydrogenatedsoyalecithin

Sorbitanoleate

Cottonseedoil

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:100and250ml:3years;50ml:18months.

Shelf-lifeafterfirstbroachingofthecontainer:28days.

6.4.Specialprecautionsforstorage

Donotrefrigerateorfreeze.Protectfromfrost.

6.5 Natureandcompositionofimmediatepackaging

Cartonboxcontainingoneglassvial,typeII50ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining15glassvials,typeII50ml,sealedwithabromobutylrubberstopperand

aluminiumoverseal.

Cartonboxcontainingoneglassvial,typeII100ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining12glassvials,typeII100ml,sealedwithabromobutylrubberstopperand

aluminiumoverseal.

Cartonboxcontainingoneglassvial,typeII250ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining6glassvials,typeII250ml,sealedwithbromobutylrubberstopperandaluminium

overseal.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithnationlocalrequirements

7. MARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9

3449JAWoerden

TheNetherlands

Tel.:++31348416945

Fax:++31348483676

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION

23-02-2011

10 DATEOFREVISIONOFTHETEXT

31august2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobesuppliedonlyonveterinaryprescription.

ANNEXII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Polystyrenebox

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

Ceftiofur(asceftiofurhydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:Ceftiofur(ashydrochloride)50.0mg

3. PHARMACEUTICALFORM

Suspensionforinjection.

Whitetooffwhitecolouredsuspension.

4. PACKAGESIZE

15x50ml

12x100ml

6x250ml

5. TARGETSPECIES

Pigsweighingupto125kg.

Cattle.

6. INDICATION(S)

Pigs,Cattle:

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Pigs:intramuscularinjection

Cattle:subcutaneousinjection

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Pigs:

Meatandoffal:8days.

Cattle:

Meatandoffal:8days.

Milk:zerohours.

9. SPECIALWARNING(S),IFNECESSARY

Penicillinsandcephalosporinsmayoccasionallycausesevereallergicreactions.Seepackageleafletfor

userwarnings.

10. EXPIRYDATE

EXP:MM/YY

Oncebroached,useby….

Shelflifeafterfirstopeningtheimmediatepackaging:28days

11. SPECIALSTORAGECONDITIONS

Donotrefrigerateorfreeze.Protectfromfrost.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithnationlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9

3449JAWoerden

TheNetherlands

Tel.:++31348416945

Fax:++31348483676

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Cartonbox

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

Ceftiofur(asceftiofurhydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:Ceftiofur(ashydrochloride)50.0mg

3. PHARMACEUTICALFORM

Suspensionforinjection.

Whitetooffwhitecolouredsuspension.

4. PACKAGESIZE

50ml

100ml

250ml

5. TARGETSPECIES

Pigsweighingupto125kg.

Cattle.

6. INDICATION(S)

Pigs,Cattle:

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Pigs:intramuscularinjection

Cattle:subcutaneousinjection

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Pigs:

Meatandoffal:8days.

Cattle:

Meatandoffal:8days.

Milk:zerohours.

9. SPECIALWARNING(S),IFNECESSARY

Penicillinsandcephalosporinsmayoccasionallycausesevereallergicreactions.Seepackageleafletfor

userwarnings.

10. EXPIRYDATE

EXP:MM/YY

Oncebroached,useby….

Shelflifeafterfirstopeningtheimmediatepackaging:28days

11. SPECIALSTORAGECONDITIONS

Donotrefrigerateorfreeze.Protectfromfrost.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithnationlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9

3449JAWoerden

TheNetherlands

Tel.:++31348416945

Fax:++31348483676

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

VialstypeII

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

Ceftiofur(asceftiofurhydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:Ceftiofur(ashydrochloride)50.0mg

3. PHARMACEUTICALFORM

Suspensionforinjection.

4. PACKAGESIZE

50ml

100ml

250ml

5. TARGETSPECIES

Pigsweighingupto125kg.

Cattle.

6. INDICATION(S)

Pigs,Cattle:

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Pigs:intramuscularinjection

Cattle:subcutaneousinjection

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Pigs:

Meatandoffal:8days.

Cattle:

Meatandoffal:8days.

Milk:zerohours.

9. SPECIALWARNING(S),IFNECESSARY

Penicillinsandcephalosporinsmayoccasionallycausesevereallergicreactions.Seepackageleafletfor

userwarnings.

10. EXPIRYDATE

EXP:MM/YY

Oncebroached,useby….

Shelflifeafterfirstopeningtheimmediatepackaging:28days

11. SPECIALSTORAGECONDITIONS

Donotrefrigerateorfreeze.Protectfromfrost.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithnationlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9

3449JAWoerden

TheNetherlands

Tel.:++31348416945

Fax:++31348483676

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

B.PACKAGELEAFLET

PACKAGELEAFLET

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

ceftiofur(asceftiofurhydrochloride)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE(EUbatchrelease)

AlfasanNederlandBV

Kuipersweg9

3449JAWoerden

TheNetherlands

Tel.:++31348416945

Fax:++31348483676

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

Ceftiofur(asceftiofurhydrochloride)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlwhitetooffwhitecolouredsuspensioncontains:

Ceftiofur(ashydrochloride)50.0mg

4. INDICATION(S)

Infectionsassociatedwithbacteriasensitivetoceftiofur:

Inpigs:

-TreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocida,Actinobacillus

pleuropneumoniaeandStreptococcussuis.

Thisproductisnottobeusedinpigswithabodyweightmorethan125kg.

Incattle:

-TreatmentofbacterialrespiratorydiseaseassociatedwithMannheimiahaemolytica,Pasteurella

multocidaandHaemophilussomnus.

-Treatmentofacuteinterdigitalnecrobacillosis(panaritium,foulinthefoot),associatedwith

FusobacteriumnecrophorumandBacteroidesmelaninogenicus(Porphyromonasasaccharolytica).

-Treatmentofthebacterialcomponentofacutepost-partum(puerperal)metritiswithin10daysafter

calvingassociatedwithEscherichiacoli,ArcanobacteriumpyogenesandFusobacterium

necrophorum,sensitivetoceftiofur.Theindicationisrestrictedtocaseswheretreatmentwithanother

antimicrobialhasfailed

5. CONTRAINDICATIONS

Donotinjectintravenously.

Donotadministertoananimalpreviouslyfoundtobehypersensitivetoceftiofurandotherb-lactam

antibioticsortoanyoftheexcipients.

Donotuseinpoultry(includingeggs)duetoriskofspreadofantimicrobialresistancetohumans.

6. ADVERSEREACTIONS

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

Hypersensitivityreactionsunrelatedtodosecanoccur.Allergicreactions(e.g.skinreactions,anaphylaxia)

mayoccasionallyoccur.Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

Inpigs,mildreactionsattheinjectionsite,suchasdiscolorationofthefasciaorfat,havebeenobservedin

someanimalsforupto20daysafterinjection.

Incattle,mildinflammatoryreactionsattheinjectionsite,suchastissueoedemaanddiscolorationofthe

subcutaneoustissueand/orfascialsurfaceofthemusclemaybeobserved.Clinicalresolutionisreachedin

mostanimalsby10daysafterinjectionalthoughslighttissuediscolorationmaypersistfor28daysormore.

7. TARGETSPECIES

Pigsweighingupto125kg.

Cattle.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Pigs:

Bacterialrespiratorydisease:3mgceftiofur/kgbw/dayfor3daysviaintramuscularroute,i.e.1ml/16kg

bwateachinjection.

Themaximuminjectionvolumemustnotexceed4mlperinjectionsite.Eachinjectionmustbegivenat

separatesites,withnooverlapofsubsequentinjections.Thisproductisnottobeusedinpigswitha

bodyweightmorethan125kg.

Cattle:

Bacterialrespiratorydisease:1mgceftiofur/kgbw/dayfor3to5daysbysubcutaneousinjection,i.e.1

ml/50kgbwateachinjection.

Acuteinterdigitalnecrobacillosis:1mg/kgbw/dayfor3daysbysubcutaneousinjection,i.e.1ml/50kgbw

ateachinjection.

Acutepost-partummetritiswithin10daysaftercalving:1mg/kgbw/dayfor5consecutivedaysby

subcutaneousinjection,i.e.1ml/50kgbwateachinjection.

Incaseofacutepost-partummetritis,additionalsupportivetherapymightberequiredinsomecases.

Eachinjectionmustbegivenatseparatesites,withnooverlapofsubsequentinjections.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Asthevialcannotbebroachedmorethan40times,theusershouldchoosethemoreappropriatevialsize.

9. ADVICEONCORRECTADMINISTRATION

Shakebeforeusetobringproductbackintosuspension.

10. WITHDRAWALPERIOD

Pigs:

Meatandoffal:8days.

Cattle:

Meatandoffal:8days.

Milk:zerohours.

11. SPECIALSTORAGEPRECAUTIONS

Donotrefrigerateorfreeze.Protectfromfrost.

Shelf-lifeafterfirstbroachingofthecontainer:28days.

Donotuseaftertheexpirydatestatedonthelabel/cartonafterEXP:

Keepoutofthereachandsightofchildren.

12. SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Donotuseincaseofknownresistancetotheactivesubstance.

Crossresistancetootherlactamantibioticscanbepresent.Donotuseincasessuchcross-resistanceis

known.

Specialprecautionsforuse

Shakethebottlewellbeforeusetobringtheproductbackintosuspension.

Specialprecautionsforuseinanimals

Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

Ceftiosanisintendedfortreatmentofindividualanimals.Donotusefordiseasepreventionorasapartof

heardhealthprogrammes.Treatmentofgroupsofanimalsshouldbestrictlyrestrictedtoongoingdisease

outbreaksaccordingtotheapprovedconditionsofuse.

Donotuseasprophylaxisincaseofretainedplacenta.

UseofCeftiosanmayconstitutearisktopublichealthduetospreadofantimicrobial

resistance.

Ceftiosanshouldbereservedforthetreatmentofclinicalconditionswhichhaveresponded

poorly,orareexpectedtorespondpoorly(referstoveryacutecaseswhentreatmentmustbe

initiatedwithoutbacteriologicaldiagnosis)tofirstlinetreatment.Official,nationaland

regionalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.

Increaseduse,includinguseoftheproductdeviatingfromtheinstructionsgiven,may

increasetheprevalenceofresistance.Wheneverpossible,Ceftiosanshouldonlybeused

basedonsusceptibilitytesting.

Userwarnings

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross

reactionstocephalosporinsandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeserious.Donothandlethisproductifyouknowyouaresensitised,orif

youhavebeenadvisednottoworkwithsuchpreparations.Handlethisproductwith

greatcaretoavoidexposure,takingallrecommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathing,aremore

serioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

Useduringpregnancy,lactationorlay

Laboratorystudieshavenotproducedanyevidenceofateratogenic,foetotoxicormaternotoxiceffects.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinthetargetspeciesduring

pregnancyandlactation.

Useonlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarian.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

Interactionwithothermedicinalproductsandotherformsofinteraction.

Thebactericidalpropertiesofcephalosporinsareantagonizedbysimultaneoususeofbacteriostatic

antibiotics(macrolides,sulfonamidesandtetracyclines).

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thelowtoxicityofceftiofurhasbeendemonstratedinpigsusingceftiofursodiumatdosesinexcessof8

timestherecommendeddailydoseofceftiofuradministeredintramuscularly.for15consecutivedays.

Incattle,nosignsofsystemictoxicityhavebeenobservedfollowingsubstantialparenteraloverdosages.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithnationlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

31August2012

15. OTHERINFORMATION

Cartonboxcontainingoneglassvial,typeII50ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining15glassvials,typeII50ml,sealedwithabromobutylrubberstopperand

aluminiumoverseal.

Cartonboxcontainingoneglassvial,typeII100ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining12glassvials,typeII100ml,sealedwithabromobutylrubberstopperand

aluminiumoverseal.

Cartonboxcontainingoneglassvial,typeII250ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining6glassvials,typeII250ml,sealedwithbromobutylrubberstopperandaluminium

overseal.

Notallpacksizesmaybemarketed.

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

19-11-2018

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA 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 a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration