Pharmasin 25% Premix

Main information

  • Trade name:
  • Pharmasin 25% Premix
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharmasin 25% Premix
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • tylosin
  • Therapeutic area:
  • Chicken Broilers, Chicken Young, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0130/003
  • Authorization date:
  • 20-01-2012
  • EU code:
  • NL/V/0130/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pharmasin250mg/gPremixformedicatedfeedingstuffforpigs,broilersandpullets

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Tylosine(astylosinphosphate):250mgperg.(equivalentto250000IU)

Forafulllistofexcipientsseesection6.1

3. PHARMACEUTICALFORM

Premixformedicatedfeedingstuff.

Lighttancoloured,freeflowinggranules.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs,broilersandpullets.

4.2 Indicationsforuse(specifyingthetargetspecies)

Pigs

- TreatmentandpreventionofPorcineIntestinalAdenomatosis(Ileitis)associated

withLawsoniaintracellulariswhenthediseasehasbeendiagnosedatthegroup

orherdlevel,

- TreatmentandpreventionofswinedysenterycausedbyBrachyspira

hyodysenteriaewhenthediseasehasbeendiagnosedintheherd.

Broilersandpullets:

- TreatmentandpreventionofrespiratoryinfectionscausedbyMycoplasma

gallisepticumandMycoplasmasynoviae,whenthediseasehasbeendiagnosedin

theflock.

- TreatmentandpreventionofnecroticenteritiscausedbyClostridium

perfringens,whenthediseasehasbeendiagnosedintheflock.

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

4.3 Contraindications

- Donotuseinanimalswithknownsensitivitytotheactivesubstanceand/ortoanyofthe

excipientsoftheveterinarymedicinalproduct,

- Donotuseinanimalswithknownhypersensitivitytotylosinandothermacrolides,

- Donotusewherecross-resistancetoothermacrolides(MLS-resistance)issuspected,

- Donotuseinanimalsvaccinatedwithtylosin-sensitivevaccineseitheratthesametime

orwithin1weekpreviously.

Donotuseinanimalswithhepaticdisorders.

Donotuseinhorses.

4.4 Specialwarnings(foreachtargetspecies)

None.

4.5 Specialprecautionsforuse

4.5.1Specialprecautionsforuseinanimals

Animalswithacuteinfectionsmayhaveareducedfeedintakeandshouldbetreated

withasuitableinjectableproductfirst.Thesensitivityofbacteriatotylosinmayhave

changedovertimeorgeographically.Itissoundclinicalpracticetobasetreatment

onsusceptibilitytesting.

Infarmswhichhaverecurringproblemswithswinedysentery,farmmanagement,

livestockhusbandryandhygieneshouldbeexaminedtoavoidrepeated

administrationofantimicrobialsubstances.Aneradicationprocedureshouldbetaken

intoaccount.

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

4.5.2Specialprecautionsforthepersonadministeringtheveterinarymedicinalproductto

animals

Tylosinmayinduceirritation.Macrolides,suchatylosin,mayalsocause

hypersensitivity(allergy)followinginjection,inhalation,ingestionorcontactwith

skinoreye.Hypersensitivitytotylosinmayleadtocrossreactionstoother

macrolidesandviceversa.Allergicreactionstothesesubstancesmayoccasionally

beseriousandthereforedirectcontactshouldbeavoided.

Toavoidexposureduringpreparationofthemedicatedfeed,wearoveralls,safety

glasses,imperviousgloves,andweareitheradisposablehalfmaskrespirator

conformingtoEuropeanStandardEN149oranon-disposablerespiratortoEuropean

StandardEN140withafiltertoEN143.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

Laboratorystudiesinmiceandratshavenotproducedanyevidenceofteratogenic,

foetotoxicormaternotoxiceffects.Nostudieshavebeenconductedinthetargetspecies

population.Useonlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Lincosamidesandaminoglycosideantibioticsantagonizetheactivityoftylosin.

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

4.9 Amount(s)tobeadministeredandadministrationroute

Administrationthroughthefeed:forthepreparationofamedicatedfeedcontaining40-1100

gramtylosinepertonoffeed,therequiredamountofPharmasin250mg/gPremixshouldbe

homogenouslymixedwithasuitablecarrierintoafeedpremixturesothatatleast5kgofthis

premixturecanbeaddedtothefeedinordertoobtainamedicatedfeedwiththerequired

concentration.

Forthepreparationofmedicatedfeed:

As1kgPharmasin250mg/gpremixcontains250gtylosinactivityitfollowsthat4mg

Pharmasin250mg/gpremixcorrespondsto1mgtylosinactivity.Thedosagesareas

follows:

Pigs

Forthetreatmentandpreventionofporcineintestinaladenomatosis(PIA):

4–5mgtylosinperkgBW(correspondingto16-20mgPharmasin250mg/gpremixper

kgBW)for3weeks.

ForthetreatmentandpreventionofdysenterycausedbyBrachyspirahyodysenteriae:

4–5mgtylosinperkgBW(correspondingto16-20mgPharmasin250mg/gpremixper

kgBW)for4-5weeks.Itmaybenecessarytocontinuetreatmentuntiltheendoftheperiod

ofrisk(toavoidrelapse).

or

8–10mgtylosinperkgBW(correspondingto32–40mgPharmasin250mg/gpremixper

kgBW)for8days,followedby4-5mgtylosinperkgBW(correspondingto16-20mg

Pharmasin250mg/gpremixperkgBW)untiltheendoftheperiodofrisk.

Broilersandpullets:

Forthetreatmentandpreventionofrespiratoryinfections:

127mgtylosinperkgBW(correspondingto508mgPharmasin250mg/gpremixperkg

BW) forthefirst5daysoflife.Itisstronglyrecommendedtorepeatthetreatmentof

thebirdsattheageof3-4 weeks.

Forthetreatmentandpreventionofnecroticenteritis:

10–20mgtylosinperkgBW(correspondingto40–80mgPharmasin250mg/gpremixper

kgBW)for7days.

Forthepreparationofthemedicatedfeedthebodyweightoftheanimalstobetreatedand

theiractualdailyfeedconsumptionshouldbetakenintodueaccount.Consumptionmayvary

dependingonfactorslikeage,breed,husbandrysystem.Toprovidetherequiredamountof

activesubstanceinmgperkgmixedfeedthefollowingcalculationshouldbemade:

….mgPharmasin250mg/gpremixaveragebodyweight(kg)

/kgBW/dayxoftheanimalstobetreated=…mgPharmasin

Averagedailyamountofmixedfeedintake/kgperanimal250mg/gpremixper

kg/mixedfeed

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

Themixingshouldbeperformedbyan(authorised)feedingstuffmanufacturerwithadequate

mixingapparatus.

Theuptakeofmedicatedfeeddependsontheclinicalconditionoftheanimals.Inorderto

obtainthecorrectdosagetheconcentrationoftylosinshouldbeadjustedaccordingly.

Shouldtherebenoclearresponsetotreatmentwithin3daysthetreatmentapproachshould

bereconsidered.

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Tylosinhasbeenshowntoproducenoadverseeffectswhenfedtopigsat600ppminthe

feed(threetosixtimestherecommendeddoselevel)for28days.Athighlevelsdiarrhoea,

apathy,convulsionsmayoccur.Thetherapyissymptomatic.

4.11 Withdrawalperiod(s)

Meatandoffal

Pig:Zerodays

Broilersandpullets:1day

Donotuseinlayinghensproducingeggsforhumanconsumption.

5. PHARMACOLOGICALORIMMUNOLOGICALPROPERTIES

ATCVetCode:

Pharmacotherapeuticgroup:macrolideantibiotic,ATCvetcode:QJ01FA90

5.1 Pharmacodynamicproperties

TylosinisamacrolideantibioticproducedbyastrainofStreptomycesfradiae.Itexertsits

antimicrobialeffectbyinhibitingproteinsynthesisofsusceptiblemicro-organisms.

ThetylosinspectrumofactivityincludesGram-positivebacteria,someGram–negative

strainssuchasPasteurella,andMycoplasmaspp.atconcentrationsof16µg/mlorless.

5.2 Pharmacokineticproperties

Inmostspeciespeakplasmaconcentrationshavebeenattained1to2hoursafter

administrationoftylosin.Comparedtoplasmalevelsclearlyhighertissueconcentrations

havebeenobserved.Tylosinwasextensivelymetabolized.Mostoftheresiduesareexcreted

infaecespredominantlyconsistingoftylosinA,tylosinfactorDanddihydrodesmycosin.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Wheatmeal

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

Dipotassiumphosphate

Pregelatinisedstarch(potato)

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelflifeafterincorporationintomealorpelletedfeed:3months.

6.4 Specialprecautionsforstorage

Storeintheoriginalcontainer toprotectfromlight. Storeinadryplace.Storebelow30°C.

Donotrefrigerateorfreeze.Protectfromfrost.

6.5 Natureandcompositionofimmediatepackaging

Low-densitypolyethylene/paper–paper-paperbagof5and20kgwithsuturedcrimp.

1kgPE/Alu/PETbag

Notallpacksmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7.1 MARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

8. MARKETINGAUTHORISATIONNUMBER(S)

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Considerationshouldbegiventoofficialguidanceontheincorporationofmedicated

premixesinfinalfeed.

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

LABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pharmasin250mg/gPremixformedicatedfeedingstuffforpigs,broilersandpullets

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Tylosinactivity(astylosinphosphate):250gperkg(equivalentto250000IU).

3. PHARMACEUTICALFORM

Premixformedicatedfeedingstuff

4. PACKAGESIZE

5and20kgPEinanouterpaperbagwithsuturedcrimp

1kgPE/Alu/PET

5. TARGETSPECIES

Pigs,broilersandpullets

6. INDICATION(S)

Seepackageleaflet

7. METHODANDROUTE(S)OFADMINISTRATION

Tobeadministeredthroughthemedicatedfeed

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal

Pigs:Zerodays

Broilersandpullets:1day

Donotuseinlayinghensproducingeggsforhumanconsumption.

9. SPECIALWARNING(S),IFNECESSARY

UserWarnings

Tylosinmayinduceirritation.Macrolides,suchatylosin,mayalsocausehypersensitivity(allergy)

followinginjection,inhalation,ingestionorcontactwithskinoreye.Hypersensitivitytotylosinmay

leadtocrossreactionstoothermacrolidesandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeseriousandthereforedirectcontactshouldbeavoided.

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

Toavoidexposureduringpreparationofthemedicatedfeed,wearoveralls,safetyglasses,impervious

gloves,andweareitheradisposablehalfmaskrespiratorconformingtoEuropeanStandardEN149or

anon-disposablerespiratortoEuropeanStandardEN140withafiltertoEN143.Washhandsafteruse.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseofaccidentaleye

contact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedicaladviceand

showthephysicianthiswarning.Swellingoftheface,lipsandeyesordifficultyinbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

10. EXPIRYDATE

<EXP{month/year}>

Shelflifeafterincorporationintomealorpelletedfeed:3months

11. SPECIALSTORAGECONDITIONS

Storeintheoriginalcontainertoprotectfromlight.Storeinadryplace.Storebelow30°C.Donot

refrigerateorfreeze.Protectfromfrost.

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)

17. MANUFACTURER’SBATCHNUMBER

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

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

PACKAGELEAFLET

Pharmasin250mg/gPremixformedicatedfeedingstuffforpigs,broilersandpullets

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisation

HuvepharmaNV,Uitbreidingstraat80,2600Antwerpen,Belgium

Manufacturer

BiovetJSC,39PetarRakovStr,4550Peshtera-Bulgaria

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pharmasin250mg/gPremixformedicatedfeedingstuffforpigs,broilersandpullets

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Tylosine(astylosinphosphate):250mgperg.

Lighttancoloured,freeflowinggranules.

4. INDICATION(S)

Pigs

- TreatmentandpreventionofPorcineIntestinalAdenomatosis(PIA)associatedwith

Lawsoniaintracellulariswhenthediseasehasbeendiagnosedatthegrouporherdlevel,

- TreatmentandpreventionofswinedysenterycausedbyBrachyspirahyodysenteriaewhen

thediseasehasbeendiagnosedintheherd.

Broilersandpullets:

- TreatmentandpreventionofrespiratoryinfectionscausedbyMycoplasmagallisepticumand

Mycoplasmasynoviae,whenthediseasehasbeendiagnosedintheflock.

- TreatmentandpreventionofnecroticenteritiscausedbyClostridiumperfringens,whenthe

diseasehasbeendiagnosedintheflock.

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

5. CONTRAINDICATIONS

- Donotuseinanimalswithknownsensitivitytotheactivesubstanceand/ortoanyofthe

excipientsoftheveterinarymedicinalproduct,

- Donotuseinanimalswithknownhypersensitivitytotylosinandothermacrolides,

- Donotusewherecross-resistancetoothermacrolides(MLS-resistance)issuspected.

Donotuseinanimalsvaccinatedwithtylosin-sensitivevaccineseitheratthesametimeorwithin1

weekpreviously.

Donotuseinanimalswithhepaticdisorders.

Donotuseinhorses.

6. ADVERSEREACTIONS

Inpigs,adversereactionshavebeenobserved,includingdiarrhoea,pruritus,erythema,rectaloedema

andprolapse.

7. TARGETSPECIES

Pigs,broilersandpullets.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Administrationthroughthefeed:forthepreparationofamedicatedfeedcontaining40-1100gram

tylosinepertonoffeed,therequiredamountofPharmasin250mg/gPremixshouldbehomogenously

mixedwithasuitablecarrierintoafeedpremixturesothatatleast5kgofthispremixturecanbe

addedtothefeedinordertoobtainamedicatedfeedwiththerequiredconcentration.

Forthepreparationofmedicatedfeed:

As1kgPharmasin250mg/gpremixcontains250gtylosinactivityitfollowsthat4mgPharmasin

250mg/gpremixcorrespondsto1mgtylosinactivity.Thedosagesareasfollows:

Pigs

Forthetreatmentandpreventionofporcineintestinaladenomatosis(PIA):

4–5mgtylosinperkgBW(correspondingto16-20mgPharmasin250mg/gpremixperkgBW)

for3weeks.

ForthetreatmentandpreventionofdysenterycausedbyBrachyspirahyodysenteriae:

4–5mgtylosinperkgBW(correspondingto16-20mgPharmasin250mg/gpremixperkgBW)for

4-5weeks.Itmaybenecessarytocontinuetreatmentuntiltheendoftheperiodofrisk(toavoid

relapse).

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

or

8–10mgtylosinperkgBW(correspondingto32–40mgPharmasin250mg/gpremixperkgBW)

for8days,followedby4-5mgtylosinperkgBW(correspondingto16-20mgPharmasin250mg/g

premixperkgBW)untiltheendoftheperiodofrisk(toavoidrelapse).

Broilersandpullets

Forthetreatmentandpreventionofrespiratoryinfections:

127mgtylosinperkgBW(correspondingto508mgPharmasin250mg/gpremixperkgBW) for

thefirst5daysoflife.Itisstronglyrecommendedtorepeatthetreatmentofthebirdsatthe

ageof3-4 weeks.

Forthetreatmentandpreventionofnecroticenteritis:

10–20mgtylosinperkgBW(correspondingto40–80mgPharmasin250mg/gpremixperkgBW)

for7days.

Forthepreparationofthemedicatedfeedthebodyweightoftheanimalstobetreatedandtheiractual

dailyfeedconsumptionshouldbetakenintodueaccount.Consumptionmayvarydependingon

factorslikeage,breed,husbandrysystem.Toprovidetherequiredamountofactivesubstanceinmg

perkgmixedfeedthefollowingcalculationshouldbemade:

….mgPharmasin250mg/g averagebodyweight(kg)

premix/kgBW/day xoftheanimalstobetreated=…mgPharmasin

Averagedailyamountofmixedfeedintake/kgperanimal250mg/gpremixper

kg/mixedfeed

Themixingshouldbeperformedbyan(authorised)feedingstuffmanufacturerwithadequatemixing

apparatus.

Theuptakeofmedicatedfeeddependsontheclinicalconditionoftheanimals.Inordertoobtainthe

correctdosagetheconcentrationoftylosinshouldbeadjustedaccordingly.

Shouldtherebenoclearresponsetotreatmentwithin3daysthetreatmentapproachshouldbe

reconsidered.

9. ADVICEONCORRECTADMINISTRATION

Animalswithacuteinfectionsmayhaveareducedfeedintakeandshouldbetreatedwithasuitable

injectableproductfirst.Thesensitivityofbacteriatotylosinmayhavechangedovertimeor

geographically.Itissoundclinicalpracticetobasetreatmentonsusceptibilitytesting.Infarmswhich

haverecurringproblemswithswinedysentery,farmmanagement,livestockhusbandryandhygienic

measuresshouldbereconsideredtoavoidrepeatedadministrationofantimicrobialsubstances.An

eradicationprocedureshouldbetakenintoaccount.

10. WITHDRAWALPERIOD

Meatandoffal

Pig:Zerodays

Broilersandpullets:1day

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

Donotuseinlayinghensproducingeggsforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storeintheoriginalcontainertoprotectfromlight. Storeinadryplace.Storebelow30°C.Donot

refrigerateorfreeze.Protectfromfrost.

DonotuseaftertheexpirydatewhichisstatedonthelabelafterEXP.

Shelflifeafterincorporationintomealorpelletedfeed:3months.

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Animalswithacuteinfectionsmayhaveareducedfeedintakeandshouldbetreatedwithasuitable

injectableproductfirst.Thesensitivityofbacteriatotylosinmayhavechangedovertimeor

geographically.Itissoundclinicalpracticetobasetreatmentonsusceptibilitytesting.Infarmswhich

haverecurringproblemswithswinedysentery,farmmanagement,livestockhusbandryandhygiene

shouldbeexaminedtoavoidrepeatedadministrationofantimicrobialsubstances.Aneradication

procedureshouldbetakenintoaccount.

Specialprecautionsforthepersonadministeringtheveterinarymedicinalproducttoanimals

Tylosinmayinduceirritation.Macrolides,suchatylosin,mayalsocausehypersensitivity(allergy)

followinginjection,inhalation,ingestionorcontactwithskinoreye.Hypersensitivitytotylosinmay

leadtocrossreactionstoothermacrolidesandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeseriousandthereforedirectcontactshouldbeavoided.

Toavoidexposureduringpreparationofthemedicatedfeed,wearoveralls,safetyglasses,impervious

gloves,andweareitheradisposablehalfmaskrespiratorconformingtoEuropeanStandardEN149or

anon-disposablerespiratortoEuropeanStandardEN140withafiltertoEN143.Washhandsafteruse.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseofaccidentaleye

contact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedicaladviceand

showthephysicianthiswarning.Swellingoftheface,lipsandeyesordifficultyinbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

Laboratorystudiesinmiceandratshavenotproducedanyevidenceofteratogenic,foetotoxicor

maternotoxiceffects.Nostudieshavebeenconductedinthetargetspeciespopulation.Use

onlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Lincosamidesandaminoglycosideantibioticsantagonizetheactivityoftylosin.

Tylosinhasbeenshowntoproducenoadverseeffectswhenfedtopigsat600ppminthefeed(three

tosixtimestherecommendeddoselevel)for28days.Athighlevelsdiarrhoea,apathy,convulsions

mayoccur.Thetherapyissymptomatic.

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmasin250mg/gPremix HuvepharmaNV

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinalproductsshould

bedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

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4-5-2018

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk

Badger Botanicals, LLC of Springville, Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements sold directly to consumers via the company website from January 1st, 2018 to April l 12th, 2018 in pouches of 250g, because it has the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

15-1-2014

Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS

Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS

On 20 December 2013 and on 10 January 2014, the Danish Health and Medicines Authority decided to revoke the section 39 authorisations for wholesale distribution and manufacturing of medicinal products with the authorisation IDs 25081 and 25082 granted to Singad Pharma ApS (company number 255894).

Danish Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

29-10-2018

Replagal (Shire Human Genetic Therapies AB)

Replagal (Shire Human Genetic Therapies AB)

Replagal (Active substance: Agalsidase alfa) - Centralised - Yearly update - Commission Decision (2018)7250 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

1-8-2018

Champix (Pfizer Europe MA EEIG)

Champix (Pfizer Europe MA EEIG)

Champix (Active substance: varenicline tartrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5197 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/699/T/71

Europe -DG Health and Food Safety

3-7-2018

Samsca (Otsuka Pharmaceutical Europe Ltd)

Samsca (Otsuka Pharmaceutical Europe Ltd)

Samsca (Active substance: tolvaptan) - Centralised - 2-Monthly update - Commission Decision (2018) 4250 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/II/31

Europe -DG Health and Food Safety

6-6-2018

Stocrin (Merck Sharp and Dohme B.V.)

Stocrin (Merck Sharp and Dohme B.V.)

Stocrin (Active substance: efavirenz) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3689 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/250/T/113

Europe -DG Health and Food Safety

4-6-2018

Champix (Pfizer Limited)

Champix (Pfizer Limited)

Champix (Active substance: varenicline tartrate) - Centralised - Yearly update - Commission Decision (2018)3620 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

28-5-2018

Procysbi (Chiesi Farmaceutici S.p.A.)

Procysbi (Chiesi Farmaceutici S.p.A.)

Procysbi (Active substance: mercaptamine (cysteamine bitartrate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3337 of Mon, 28 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2465/T/21

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1306 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1306 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1306 (Active substance: Cysteamine bitartrate) - Transfer of orphan designation - Commission Decision (2018)3151 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/070/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1252 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1252 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1252 (Active substance: Cysteamine bitartrate) - Transfer of orphan designation - Commission Decision (2018)3133 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/164/13/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Active substance: Cysteamine bitartrate (gastroresistant)) - Transfer of orphan designation - Commission Decision (2018)3137 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/034/10/T/01

Europe -DG Health and Food Safety

23-4-2018

Mylotarg (Pfizer Limited)

Mylotarg (Pfizer Limited)

Mylotarg (Active substance: gemtuzumab ozogamicin) - New authorisation - Commission Decision (2018)2504 of Mon, 23 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4204

Europe -DG Health and Food Safety