SPIRAMYCINE CEVA

Main information

  • Trade name:
  • SPIRAMYCINE CEVA
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SPIRAMYCINE CEVA
    Slovenia
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0244/001
  • Authorization date:
  • 27-06-2012
  • EU code:
  • FR/V/0244/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SPIROVET600000IU/mlsolutionforinjectionforcattleandpigs[BG,CZ,EE,HU,IE,LT,LV,PL,

PT,SI,SK,UK]

SPIRAMYCINECEVA600000IU/ml,solutionforinjectionforcattleandpigs[FR]

SPIROCIN600000IU/ml,solutionforinjectionforcattleandpigs[DK]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Spiramycin..................................................600000IU

Excipient:

Benzylalcohol(E1519)...............................41.6mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Clear,yellowsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattleandpigs(sows).

4.2 Indicationsforuse,specifyingthetargetspecies

Diseasescausedbyspiramycinsusceptiblebacteria.

Cattle(adults):

Treatmentof:

-Respiratorydiseases,

-Mastitis,

-Metritis,

-Interdigitalnecrobacillosis(foulinthefoot).

Sows:

Treatmentofmastitis.

4.3 Contraindications

Donotuseinanimalsknownfortheirhypersensitivitytospiramycinortoanyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

None.

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4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Incattle,donotadministermorethan15mlperinjectionsite.

Insows,donotadministermorethan7mlperinjectionsite.

Duetothelikelyvariability(time,geographical)intheoccurrenceofresistanceofbacteriafor

spiramycin,bacteriologicalsamplingandsusceptibilitytestingarerecommended.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Careshouldbetakenwhenhandlingtheproducttoavoidself-injection.Incaseofaccidentalself-

injection,seekmedicaladvice,andshowthepackageleaflet.

Peoplewithknownhypersensitivitytospiramycinand/ortoothermacrolidesortothecomponentsof

theformulationshouldavoidcontactwiththeproduct.

Washhandsafterhandlingtheproduct.

Incaseofaccidentaleyeexposure,washwithplentyofwater.

Incaseofaccidentalcontactwithskin,rinseimmediatelywithwater.

4.6 Adversereactions(frequencyandseriousness)

Macroscopiclesionsattheinjectionsitemayoccurafterthetreatmentincattle.Theselesionsmaystill

bepresent42daysafterinjection.

Hypersalivationmayoccur3hoursafterthetreatmentincattle.

4.7 Useduringpregnancy,lactationorlay

Noteratogenicityhasbeenreportedinmice.Embryotoxicitywasobservedinrabbitsatmaternotoxic

oraldoses.Thesafetyoftheproducthasnotbeenassessedincowsandpigsduringpregnancyand

lactation.However,theuseoftheproductduringpregnancyandlactationshouldnotraisetoxicological

concerns.

Laboratorystudiesindogsandratshaveshownevidenceofeffectsonspermatogenesis atveryhighdosages

2050000IU/kgbody-weightperdayfor56days.

Thesafetyoftheproducthasnotbeenestablishedinmalebreedinganimals.Useintheseanimalsonly

accordinglytothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Intramuscularuse.

Bodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunderdosing.

Forbothcattleandsowswhenmorethanoneinjectionisnecessaryonthesamedaybecauseofthe

restrictionofmaximumdosevolume,alltheinjectionsshouldbeadministeredonthesamesideofthe

neck15cmapart.Ifitisnecessarytorepeattheinjectionafter24hoursalltheinjectionsshouldbe

givenontheothersideoftheneckagain15cmapart.Thisprocedureisnecessarysothatindividual

injectionsitesarekeptapart.Failuretofollowtheseinstructionsmayresultinresiduesviolations.

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Cattle:

30000IUofspiramycinperkgbodyweight,i.e.5mlofproductper100kgbodyweight.

Theinjectionmayberepeatedonceafter24hours.

Donotadministermorethan15mlperinjectionsite.

Sows:

75000IUofspiramycinperkgbodyweight,i.e.5mlofproductper40kgbodyweight.

Theinjectionmayberepeatedonceafter24hours.

Donotadministermorethan7mlperinjectionsite.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thespiramycintoxicityisverylowandanoverdosagedoesnotinducetoxiceffects.

4.11Withdrawalperiod(s)

Meatandoffal:

Cattle:52days.

Pigs:35days.

Milk:10days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialforsystemicuse,macrolide

ATCvetcode:QJ01FA02

5.1 Pharmacodynamicproperties

Spiramycinactsonbacterialproteinsynthesisbybindingtothe50Sribosomalsubunits,inhibitingthe

translocationstep.

Spiramycinisanantibioticexertingbacteriostaticactionagainstmycoplasma,Gramnegativeand

Grampositivebacteria.

Spiramycinisactiveagainstthefollowingpathogenicbacteria:

Staphylococcusaureus,Staphylococcusepidermitis,Streptococcusuberis,Streptococcus

agalactiae,Streptococcusdysgalactiae,Mannheimiahaemolytica,Pasteurellamultocida,

Mycoplasmabovis,Fusobacteriumnecrophorum,Bacteroidesspp,Arcanobacterumpyogenes,

Streptococcussuis.

5.2 Pharmacokineticparticulars

Incattle,themaximalplasmaticconcentration(Cmax)ofspiramycinisabout0.7mg/landisreachedin

2.7hours(Tmax).

Inpigs,Cmax(2.4mg/l)isreachedmorerapidly,1.4hours.

Spiramycinhasawidedistributioninalltissues.

Spriramycinismetabolisedtoneospirmaycin.

Spiramyciniseliminatedviathebile.

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6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol(E1519)

Dimethylacetamide

Waterforinjection.

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

None.

6.5 Natureandcompositionofimmediatepackaging

Natureofcontainer

-ColourlessTypeIglassvial

-Translucentmulti-layerplasticvial-polypropylene/ethylenevinylalcohol(EVOH)/polypropylene

vial

-Chlorobutylrubberstopper

-Aluminumandplasticflipoffcapsule

Packsizes:

Boxcontaining1glassvialof50ml

Boxcontaining1glassvialof100ml

Boxcontaining1glassvialof250ml

Boxcontaining1plasticvialof50ml

Boxcontaining1plasticvialof100ml

Boxcontaining1plasticvialof250ml

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

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8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

29-8-2018

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