CEFTIOMAX 50 mg/ml ceftiofur suspension for injection for swine and cattle

Main information

  • Trade name:
  • CEFTIOMAX 50 mg/ml ceftiofur suspension for injection for swine and cattle
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEFTIOMAX 50 mg/ml ceftiofur suspension for injection for swine and cattle
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • PT/V/0101/001
  • Authorization date:
  • 02-04-2011
  • EU code:
  • PT/V/0101/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PACKAGELEAFLET

CEFTIOMAX50mg/mlsuspensionforinjectionforswineandcattle[BG,CZ,EE,ES,

HU,IT,LT,LV,PL,PT,RO,SK]

READYCEF50mg/mlsuspensionforinjectionforswineandcattle[AT,BE,DE,EL,

FR,NL,UK]

1.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturer

LaboratoriosCalier,S.A.

Barcelonès,26(PladelRamassà)

LesFranquesesdelVallès(Barcelona)

SPAIN

2.NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEFTIOMAX50mg/mlsuspensionforinjectionforswineandcattle[BG,CZ,EE,ES,

HU,IT,LT,LV,PL,PT,RO,SK]

READYCEF50mg/mlsuspensionforinjectionforswineandcattle[AT,BE,DE,EL,

FR,NL,UK]

Ceftiofur(asceftiofurhydrochloride)

3.STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlcontains:

Activesubstance:

Ceftiofur(asceftiofurhydrochloride)...50mg

4.INDICATION(S)

Swine:

TreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocida,

ActinobacilluspleuropneumoniaeandStreptococcussuissensitivetoceftiofur

hydrochloride.

Cattle:

ForthetreatmentofbacterialrespiratorydiseaseassociatedwithMannheimia

haemolytica(formerPasteurellahaemolytica),PasteurellamultocidaandHistophilus

somni(formerHaemophilussomnus)sensitivetoceftiofurhydrochloride.

Forthetreatmentofacuteinterdigitalnecrobacillosis(panaritium,footrot),associated

withFusobacteriumnecrophorumandBacteroidesmelaninogenicus(Porphyromonas

asaccharolytica)sensitivetoceftiofurhydrochloride.

Forthetreatmentofthebacterialcomponentofacutepost-partum(puerperal)metritis

within10daysaftercalvingassociatedwithEscherichiacoli,Arcanobacterium

pyogenesandFusobacteriumnecrophorumsensitivetoceftiofurhydrochloride.The

indicationisrestrictedtocaseswheretreatmentwithanotherantimicrobialhasfailed.

Formatiert:Englisch(USA)

5. CONTRAINDICATIONS

Donotadministertoananimalpreviouslyfoundtobehypersensitivetoceftiofurand

otherß-lactamantibioticsortoanyoftheexcipients.

Donotuseincaseofknownresistancetotheactivesubstanceortootherbeta-lactam

antibiotics.

Donotinjectintravenously.

Donotuseinpoultry(includingeggs)duetoriskofspreadofantimicrobialresistance

tohumans.

6. ADVERSEREACTIONS

Inswine,mildreactionsattheinjectionsite,suchasdiscolorationofthefasciaorfat,

havebeenobservedinsomeanimalsforupto20daysafterinjection.

Incattle,mildinflammatoryreactionsattheinjectionsite,suchastissueoedemaand

discolorationofthesubcutaneoustissueand/orfascialsurfaceofthemusclemaybe

observed.Clinicalresolutionisreachedinmostanimalsby10daysafterinjection

althoughslighttissuediscolorationmaypersistfor28daysormore.

Hypersensitivityreactionsunrelatedtodosecanoccur.Allergicreactions(e.g.skin

reactions,anaphylaxia)mayoccasionallyoccur.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

7.TARGETSPECIES

Swineandcattle

8.DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Swine:

3mgceftiofur/kgbw/dayfor3daysbyintramuscularinjection,i.e.1mlofthe

veterinarymedicinalproduct/16kgbw/day.

Cattle:

Treatmentofrespiratorydisease:1mgceftiofur/kgbw/dayfor3to5daysby

subcutaneousinjection,i.e.1mloftheveterinarymedicinalproduct/50kgbw/day.

Treatmentofacuteinterdigitalnecrobacillosis:1mgceftiofur/kgbw/dayfor3daysby

subcutaneousinjection,i.e.1mloftheveterinarymedicinalproduct/50kgbw/day.

Acutepost-partummetritiswithin10daysaftercalving:1mgceftiofur/kgbw/dayfor

5consecutivedaysbysubcutaneousinjection,i.e.1mloftheveterinarymedicinal

product/50kgbw/day.

Subsequentinjectionsmustbegivenatdifferentsites.

Incaseofacutepost-partummetritis,additionalsupportivetherapymightberequiredin

somecases.

Beforeuseshakethebottleforaminuteoruntiltheproductappearsadequately

resuspended.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

100mlvialscanonlybebroachedamaximumof20times.250mlvialscanonlybe

broachedamaximumof50timesThestoppershouldnotbepuncturedmorethan20

times.

9.ADVICEONCORRECTADMINISTRATION

None

10.WITHDRAWALPERIOD

Swine:Meatandoffal:5days.

Cattle:Meatandoffal:8days.

Milk:zerodays.

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25°C.

Donotuseaftertheexpirydatestatedonthecarton.

Shelf-lifeafterfirstbroachingofthecontainer:28days.

Protectfromlight

Donotrefrigerateorfreeze

Keepthecontainerintheoutercarton

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Cautionshouldbeexercisedinanimalsthathavepreviouslyshownhypersensitivity

reactionstoceftiofur,othercephalosporins,penicillins,orotherdrugs.Ifanallergic

reactionoccurs,nofurtheradministrationsofceftiofurshouldbeadministeredand

appropriatetherapyforbeta-lactamhypersensitivityshouldbeinstituted.

Theproductmayconstitutearisktopublichealthduetospreadofantimicrobial

resistance.

Theproductshouldbereservedforthetreatmentofclinicalconditionswhichhave

respondedpoorly,orareexpectedtorespondpoorlytofirstlinetreatment.Official,

nationalandregionalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.Increaseduse,includinguseoftheproductdeviatingfromthe

instructionsgivenintheSPC,mayincreasetheprevalenceofresistance.Theproduct

shouldonlybeusedbasedonsusceptibilitytesting.

Theproductisintendedfortreatmentofindividualanimals.Donotusefordisease

preventionorasapartofheardhealthprogrammes.Treatmentofgroupsofanimals

shouldbestrictlyrestrictedtoongoingdiseaseoutbreaksaccordingtotheapproved

conditionsofuse.

Donotuseasprophylaxisincaseofretainedplacenta.

UserWarnings

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross

reactionstocephalosporinsandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeserious.

Incaseofhypersensitivityorifyouhavebeenwarnednottousetheseproductsany

contactwiththeproductshouldbeavoided.

Takecaretoavoidaccidentalselfinjection.

Inthecaseofself-injectionorfollowingexposureanddevelopmentofsymptomssuch

asskinrash,seekmedicaladviceimmediatelyandshowthepackageleaflettothe

physician.

Swellingoftheface,lipsoreyesordifficultywithbreathingaremoreserioussymptoms

andrequireurgentmedicalattention.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thelowtoxicityofceftiofurhasbeendemonstratedinswineusingceftiofursodiumat

dosesinexcessof8timestherecommendeddailydoseofceftiofurintramuscularly

administeredfor15consecutivedays.

Incattle,nosignsofsystemictoxicityhavebeenobservedfollowingsubstantial

parenteraloverdosages.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisproductmustnotbemixedwithother

veterinarymedicinalproducts.

Useduringpregnancyandlactation

Studiesinlaboratoryspecieshavenotproducedanyevidenceofteratogenic,

foetotoxicormaternotoxiceffectsorofabortion.Safetyhasnotbeenestablishedinthe

targetspeciesduringpregnancy.Useonlyaccordingtothebenefit/riskassessmentby

theresponsibleveterinarian.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDVETERINARY

MEDICINALPRODUCTORWASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductsorwastematerialderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Boxwith1 clearglass vialof100ml.

Boxwith1clearglassvialof250ml.

“Whenthecontainerisbroached(opened)forthefirsttime,usingthein-useshelf-life

whichisspecifiedonthispackageinsert,thedateonwhichanyproductremainingin

thecontainershouldbediscardedshouldbeworkedout.Thisdiscarddateshouldbe

writte ninthespaceprovidedonthelabel.”

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

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