Pathozone 250 mg Intramammary Suspension for Cattle

Main information

  • Trade name:
  • Pathozone
  • Pharmaceutical form:
  • Intramammary suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pathozone
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cefoperazone
  • Therapeutic area:
  • Cattle

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0421/001
  • Authorization date:
  • 16-11-2012
  • EU code:
  • UK/V/0421/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

ISSUED:December2012

AN:01574/2011

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pathozone250mgIntramammarySuspensionforCattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

mg/10ml

Activesubstance: Cefoperazone 250

(asthesodiumsalt) 258.9

Excipients: all-rac- α-Tocopherol(E307) 4.6

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

IntramammarySuspension.

Whitetooff-whiteoilysuspension

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle(lactatingdairycows).

4.2Indicationsforuse,specifyingthetargetspecies

Theproductisindicatedforthetreatmentofclinicalmastitisinlactatingcows.

Clinicalmastitiscausedbyawiderangeoforganismsincludingthefollowing

pathogenshavebeenshowntorespondtotreatmentwithcefoperazone.

-Streptococcusdysgalactiae

-Streptococcusuberis

-Streptococcusagalactiae

-Staphylococcusaureus(includingpenicillinaseproducingstrains)

-Escherichiacoli

-Trueperellapyogenes

-Pseudomonasaeruginosa

-Micrococcusspp.

-Klebsiellaspp.

4.3Contraindications

Donotuseincaseofhypersensitivitytocephalosporinsortoanyoftheexcipentsor

incaseofseveredisturbanceofkidneyfunction.

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4.4Specialwarningsforeachtargetspecies

Itisnotenvisagedforthisproducttobeadministratedtospeciesotherthanlactating

cattle.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingandshouldtakeinto

accountofficialandlocalantimicrobialpolicies.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmaylead

tocross-reactionstocephalosporinsandvice-versa.Allergicreactiontothese

substancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeen

advisednottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

Ifyoudevelopsymptoms,suchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarningorthepackageleaflet.Swellingoftheface,lipsoreyes

ordifficultywithbreathingaremoreserioussymptomsandmayrequireurgent

medicalattention.Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

None.

4.7Useduringpregnancy,lactationorlay

Bydefinitiontheproducthasbeendevelopedforuseinlactatingcowsandhasbeen

showntobesafeinthatregard.

Inreproductivestudiesnoadversefindingshavebeenseenwhichmightmakethe

productunsafeinpregnantanimals.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Cefoperazoneisnotcompatiblewithaminoglycosideantibioticsuchasstreptomycin,

neomycinandgentamycin.Thesimultaneousadministrationofpossiblynephrotoxic

drugsmayprolongtheeliminationofcefoperazone.

Thereisararepossibilityofcrossreactionwithotherbeta-lactamantibiotics.

4.9Amountstobeadministeredandadministrationroute

Forintramammaryuse.Singleadministration.Thecontentsofone10mlsyringe

shouldbeinjectedintotheinfectedquarterimmediatelyaftermilking.Beforeinjection

theteatshouldbethoroughlycleanedanddisinfected.

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosingisunlikelytobeaproblemasthecontentsofafullsyringehavebeen

administered.

4.11Withdrawalperiod(s)

Meatandoffal: 2days

Milk: 72hours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialforintramammaryuse,cephalosporinsand

relatedsubstances

ATCvetcode:QJ51DD12

5.1Pharmacodynamicproperties

Cefoperazoneisathirdgeneration,semi-syntheticcephalosporinantibioticwitha

broadspectrumofbactericidalactivitycoveringbothGram-positiveandGram-

negativeorganisms.Itactsbyinhibitionofbacterialcellwallsynthesis.Asathird

generationcephalosporin,cefoperazoneshowsgreaterabilitytowithstand

degradationbybeta-lactamaseenzymesthandomembersofthefirstandsecond

generationswhoseactivityinthepresenceofbeta-lactamasesisthereforeless

reliable.

5.2Pharmacokineticparticulars

Systemicdrugabsorptionofcefaperazonehasbeenfoundtobenegligibleinhealthy

animals,whereasittendstobehigherininfectedanimals,probablyduetothe

damagetoepithelialcelljunctionscausedbysubclinicalinfections.

Thedetectedurineconcentrationsindicatethatcefoperazoneisabsorbedfromthe

udderandisatleastpartlyexcretedbythekidneys.Intissueresiduestudies,no

residuesweredetectedinsamplesofmuscle,liver,kidney,fat,heartor

supramammarylymphnode.

Thehighestconcentrationsofcefoperazoneinmilkaredetectedatthefirstmilking

(12hours)afteradministration.Fromfivedaysafteradministration,cefoperazoneis

notdetectableinthemilk.Milkyielddoesnotinfluencethepercentageof

cefoperazoneexcretedinthemilk.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

all-rac- α-Tocopherol(E307)

Glycerolmonostearate

Sorbitanstearate

Arachisoil,Refined

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6.2Incompatibilities

Cefoperazoneisnotphysico-chemicallycompatiblewithdrugsoftheaminoglycoside

group.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18months.

6.4.Specialprecautionsforstorage

Donotstoreabove25

C.

Forsingleuseonly.

6.5Natureandcompositionofimmediatepackaging

10mlwhiteopaquelowdensitypolyethylenesyringefittedwithaprotectivecapofred

lowdensitypolyethylene.Cartonscontainfoursyringes.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLimited

RamsgateRoad

Sandwich

KentCT139NJ

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4438

9. DATEOFFIRSTAUTHORISATION

14December2012

10.DATEOFREVISIONOFTHETEXT

December2012

Approved: 14/12/2012