Pharmasin 250 mg/g Oral Granules

Main information

  • Trade name:
  • Pharmasin 250 mg/g Oral Granules
  • Pharmaceutical form:
  • Granules
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharmasin 250 mg/g Oral Granules
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • tylosin
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0129/002
  • Authorization date:
  • 12-03-2009
  • EU code:
  • NL/V/0129/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN 250mg/gOralGranulesforpigs(BE,CZ,DE,IT,PL,NL)

TYLMASINGranulat(DK)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgcontains:

Activesubstance:

Tylosin(astylosinphosphate):250mgperg(equivalentto250000IU)

Excipients:

Forafulllistofexcipientsseesection6.1

3. PHARMACEUTICALFORM

Oralgranules

Lighttancoloured,freeflowinggranules.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs.

4.2 Indicationsforuse(specifyingthetargetspecies)

Pigs:Treatmentandpreventionofclinicalsignsofporcineproliferativeenteritis(porcine

intestinaladenomatosis,proliferativehemorrhagicenteropathy,ileitis)associatedwith

Lawsoniaintracellulariswhenthediseasehasbeendiagnosedatthegrouplevel.

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceand/ortoanyof

theexcipientsoftheproduct.

Donotuseinanimalswithknownhypersensitivitytotylosinandothermacrolides.

Donotusewherecross-resistancetoothermacrolides(MLSresistance)issuspected.

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

Donotuseinanimalsvaccinatedwithtylosin-sensitivevaccineseitheratthesametimeor

within1weekpreviously.

Donotuseinanimalswithhepaticdisorders.

Donotuseinhorses–dangerofinflammationofthececum.

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

4.4 Specialwarnings(foreachtargetspecies)

None.

4.5 Specialprecautionsforuse

4.5.1 Specialprecautionsforuseinanimals

Thisproductisonlyforadministrationinsmallquantitiesoffeedforimmediate

consumption,toindividualanimals.Animalswithacuteinfectionsmayhavea

reducedfeedintakeandshouldbetreatedwithasuitableinjectableproductfirst.The

sensitivityofbacteriatotylosinmayhavechangedovertimeorgeographically.Itis

soundclinicalpracticetobasetreatmentonsusceptibilitytesting.

4.5.2 Specialprecautionsforthepersonadministeringtheveterinarymedicinalproductto

animals

Tylosinmayinduceirritation.Macrolides,suchatylosin,mayalsocause

hypersensitivity(allergy)followinginjection,inhalation,ingestionorcontactwith

skinoreye.Hypersensitivitytotylosinmayleadtocrossreactionstoother

macrolidesandviceversa.Allergicreactionstothesesubstancesmayoccasionally

beseriousandthereforedirectcontactshouldbeavoided.

Toavoidexposureduringmixingandhandlingoftheveterinarymedicinalproduct

wearsafetyglasses,imperviousgloves,andweareitheradisposablehalfmask

respiratorconformingtoEuropeanStandardEN149oranon-disposablerespiratorto

EuropeanStandardEN140withafiltertoEN143.Washhandsafteruse.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incase

ofaccidentaleyecontact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseek

medicaladviceandshowthephysicianthiswarning.Swellingoftheface,lipsand

eyesordifficultyinbreathingaremoreserioussymptomsandrequireurgentmedical

attention.

4.6 Adversereactions(frequencyandseriousness)

Inpigs,adversereactionshavebeenobserved,includingdiarrhoea,pruritus,erythema,rectal

oedemaandprolapse.

4.7 Useduringpregnancy,lactationorlay

Noadverseeffectstotylosinhavebeenseeninfertility,multi-generationteratologystudies.

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

Useonlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Lincosamidesandaminoglycosideantibioticsantagonizetheactivityoftylosin.

4.9 Amount(s)tobeadministeredandadministrationroute

Foruseinindividualpigsonfarmswhereonlyasmallnumberofpigsaretoreceivethe

medicine.Largergroupsshouldbetreatedwithmedicatedfeedingstuffcontainingthe

premix.

Individualpigsshouldreceive5mgtylosinperkgbodyweight,correspondingto20mg

Pharmasin250mg/gOralGranules/kgbodyweight,onceadayfor3weeks.Thisisachieved

bythoroughlymixingtheproductintothedailyrationforeachindividualpig.Therequired

amountofproductshouldbeaddedtotheestimatedquantityofdailyrationforeachpigina

bucketorsimilarreceptacleandthoroughlymixed.Theproductshouldonlybeaddedtodry

non-pelletedfeed.

Thepigtobetreatedshouldbeweighedtopreventunderdosing.

Shouldtherebenoclearresponsetotreatmentwithin3daysthetreatmentapproachshould

bereconsidered.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theproducthasbeenshowntoproducenoadverseeffectswhenfedtopigsat600ppmin

thefeed(threetosixtimestherecommendeddoselevel)for28days.Athighlevels

diarrhoea,apathy,convulsionsmayoccur.Thetherapyissymptomatic

4.11 Withdrawalperiod(s)

Pigs(meat)–0days

5. PHARMACOLOGICALORIMMUNOLOGICALPROPERTIES

ATCVetCode:

Pharmacotherapeuticgroup:macrolideantibiotic,ATCvetcode:QJ01FA90

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

5.1 Pharmacodynamicproperties

TylosinisamacrolideantibioticproducedbyastrainofStreptomycesfradiae.Itexertsits

antimicrobialeffectbyinhibitingproteinsynthesisofsusceptiblemicro-organisms.

ThetylosinspectrumofactivityincludesGram-positivebacteria,someGram–negative

strainssuchasPasteurella,andMycoplasmaspp.

5.2 Pharmacokineticproperties

Absorption:tylosinreachesmaximalbloodlevelsbetween1and3hoursafteranoraldose.

Distribution:afteroraldosesweregiventopigs,tylosinwasfoundinalltissuesbetween30

minutesand2hoursafteradministration,exceptforthebrainandspinalcord.Comparedto

plasmalevelsclearlyhighertissueconcentrationshavebeenobserved.

Metabolismandexcretion:mostofthematerialexcretedthroughthefaecesconsistsof

tylosin(factorA),relomycine(factorD)anddihydrodesmycosin.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Wheatmeal

Dipotassiumphosphate

Pregelatinisedstarch(potato)

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:24months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

6.4 Specialprecautionsforstorage

Storeinadryplace.Storebelow30°C.Donotrefrigerateorfreeze.Protectfromfrost.Store

intheoriginalcontainerinordertoprotectfromlight.

6.5 Natureandcompositionofimmediatepackaging

5kgLDPEbaginouter3-plypaperbagwithsuturedcrimp.

1kgPE/Alu/PETbag.

Notallpacksizemaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

7.1 MARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

LABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN250mg/gOralGranulesforpigs(BE,CZ,DE,IT,PL,NL)

TYLMASINGranulat(DK)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Tylosin(astylosinphosphate):250mgperg.(equivalentto250000IU)

3. PHARMACEUTICALFORM

Oralgranules

4. PACKAGESIZE

5kgLDPEbaginanouter3-plypaperbagwithsuturedcrimp.

1kgPE/Alu/PETbag.

5. TARGETSPECIES

Pigs.

6. INDICATION(S)

Seepackageleaflet.

7. METHODANDROUTE(S)OFADMINISTRATION

Oraladministrationtotheindividualpig.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Pigs(meat):0days

9. SPECIALWARNING(S),IFNECESSARY

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

UserWarnings:

Tylosinmayinduceirritation.Macrolides,suchatylosin,mayalsocausehypersensitivity(allergy)

followinginjection,inhalation,ingestionorcontactwithskinoreye.Hypersensitivitytotylosinmay

leadtocrossreactionstoothermacrolidesandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeseriousandthereforedirectcontactshouldbeavoided.

Toavoidexposureduringmixingandhandlingoftheveterinarymedicinalproductwearsafety

glasses,imperviousgloves,andweareitheradisposablehalfmaskrespiratorconformingtoEuropean

StandardEN149oranon-disposablerespiratortoEuropeanStandardEN140withafiltertoEN143.

Washhandsafteruse.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseofaccidentaleye

contact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedicaladviceand

showthephysicianthiswarning.Swellingoftheface,lipsandeyesordifficultyinbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

10. EXPIRYDATE

<EXP{month/year}>

11. SPECIALSTORAGECONDITIONS

Storeinadryplace.Storebelow30°C.Donotrefrigerateorfreeze.Protectfromfrost.Storeinthe

originalcontainerinordertoprotectfromlight.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

16. MARKETINGAUTHORISATIONNUMBER(S)

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

17. MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

PACKAGELEAFLET

PHARMASIN 250mg/gOralGranulesforpigs(BE,CZ,DE,IT,PL,NL)

TYLMASINGranulat(DK)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisation

HuvepharmaNV,Uitbreidingstraat80,2600Antwerpen,Belgium

Manufacturer

BiovetJSC,39PetarRakovStr,4550Peshtera-Bulgaria

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN 250mg/gOralGranulesforpigs

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachgcontains

Activesubstance:

Tylosin(astylosinphosphate):250mgperg(equivalentto250000IU).

Lighttancoloured,freeflowinggranules.

4. INDICATION(S)

Pigs:Treatmentandpreventionofclinicalsignsofporcineproliferativeenteritis(porcineintestinal

adenomatosis,proliferativehemorrhagicenteropathy,ileitis)associatedwithLawsoniaintracellularis

whenthediseasehasbeendiagnosedatthegrouplevel

5. CONTRAINDICATIONS

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceand/ortoanyofthe

excipientsoftheproduct.

Donotuseinanimalswithknownhypersensitivitytotylosinandothermacrolides.

Donotusewherecross-resistancetoothermacrolides(MLSresistance)issuspected.

Donotuseinanimalsvaccinatedwithtylosin-sensitivevaccineseitheratthesametimeorwithin1

weekpreviously.

Donotuseinanimalswithhepaticdisorders.

Donotuseinhorses–dangerofinflammationofthececum.

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

6. ADVERSEREACTIONS

Inpigs,adversereactionshavebeenobserved,includingdiarrhoea,pruritus,erythema,rectaloedema

andprolapse.Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

7. TARGETSPECIES

Pigs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Foruseinindividualpigsonfarmswhereonlyasmallnumberofpigsaretoreceivethemedicine.

Largergroupsshouldbetreatedwithmedicatedfeedingstuffcontainingthepremix.

Individualpigsshouldreceive5mgtylosinperkgbodyweight,correspondingto20mgPharmasin

250mg/gOralGranules/kgbodyweight,onceadayfor3weeks.Thisisachievedbythoroughly

mixingtheproductintothedailyrationforeachindividualpig.Therequiredamountofproduct

shouldbeaddedtotheestimatedquantityofdailyrationforeachpiginabucketorsimilarreceptacle

andthoroughlymixed.Theproductshouldonlybeaddedtodrynon-pelletedfeed.

Thepigtobetreatedshouldbeweighedtopreventunderdosing.

Shouldtherebenoclearresponsetotreatmentwithin3daysthetreatmentapproachshouldbe

reconsidered.

9. ADVICEONCORRECTADMINISTRATION

Thisproductisonlyforadministrationinsmallquantitiesoffeedforimmediateconsumption,to

individualanimals.

Animalswithacuteinfectionsmayhaveareducedfeedintakeandshouldbetreatedwithasuitable

injectableproductfirst.Thesensitivityofbacteriatotylosinmayhavechangedovertimeor

geographically.Itissoundclinicalpracticetobasetreatmentonsusceptibilitytesting.

10. WITHDRAWALPERIOD

Pigs(meat):0days

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storeinadryplacebelow30°C.Donotrefrigerateorfreeze.Protectfromfrost.Storeintheoriginal

containerinordertoprotectfromlight.Shelf-lifeafterfirstopeningtheimmediatepackaging:3

months

DonotuseaftertheexpirydatewhichisstatedonthelabelafterEXP

12. SPECIALWARNING(S)

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN250mg/gOralGranules HuvepharmaNV

Tylosinmayinduceirritation.Macrolides,suchastylosin,mayalsocausehypersensitivity(allergy)

followinginjection,inhalation,ingestionorcontactwithskinoreye.Hypersensitivitytotylosinmay

leadtocrossreactionstoothermacrolidesandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeseriousandthereforedirectcontactshouldbeavoided.

Toavoidexposureduringmixingandhandlingoftheveterinarymedicinalproductwearsafety

glasses,imperviousgloves,andweareitheradisposablehalfmaskrespiratorconformingtoEuropean

StandardEN149oranon-disposablerespiratortoEuropeanStandardEN140withafiltertoEN143.

Washhandsafteruse.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseofaccidentaleye

contact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedicaladviceand

showthephysicianthiswarning.Swellingoftheface,lipsandeyesordifficultyinbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

Noadverseeffectstotylosinhavebeenseeninfertility,multi-generationteratologystudies.Useonly

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian

Lincosamidesandaminoglycosideantibioticsantagonizetheactivityoftylosin

Theproducthasbeenshowntoproducenoadverseeffectswhenfedtopigsat600ppminthefeed

(threetosixtimestherecommendeddoselevel)for28days.Athighlevelsdiarrhoea,apathy,

convulsionsmayoccur.Thetherapyissymptomatic.

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinalproductsshould

bedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

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