Pharmasin 10% Premix

Main information

  • Trade name:
  • Pharmasin 10% Premix
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharmasin 10% Premix
    Romania
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0130/002
  • Authorization date:
  • 27-01-2009
  • EU code:
  • NL/V/0130/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN 100mg/gPremix HuvepharmaNV

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN100mg/gPremixformedicatedfeedingstuffforpigs,broilersandpullets

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Tylosin(astylosinphosphate):100mgperg.(equivalentto100000IU)

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.

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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

4.5.1 Specialprecautionsforuseinanimals

Animalswithacuteinfectionsmayhaveareducedfeedintakeandshouldbetreated

withasuitableinjectableproductfirst.Thesensitivityofbacteriatotylosinmayhave

changedovertimeorgeographically.Itissoundclinicalpracticetobasetreatment

onsusceptibilitytesting.Infarmswhichhaverecurringproblemswithswine

dysentery,farmmanagement,livestockhusbandryandhygieneshouldbeexamined

toavoidrepeatedadministrationofantimicrobialsubstances.Aneradication

procedureshouldbetakenintoaccount.

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4.5.2 Specialprecautionsforthepersonadministeringtheveterinarymedicinalproductto

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.

4.9 Amount(s)tobeadministeredandadministrationroute

Administrationthroughthefeed:forthepreparationofamedicatedfeedcontaining40-200gram

tylosinpertonoffeed,therequiredamountofPharmasin100mg/gshouldbehomogenously

mixedwithasuitablecarrierintoafeedpremixturesothatatleast5kgofthispremixturecanbe

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN 100mg/gPremix HuvepharmaNV

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addedtothefeedinordertoobtainamedicatedfeedwiththerequiredconcentration.

Forthepreparationofmedicatedfeed:

As1kgPharmasin100mg/gpremixcontains100gtylosinactivityitfollowsthat10mg

Pharmasin100mg/gpremixcorrespondsto1mgtylosinactivity.Thedosagesareasfollows:

Pigs

Forthetreatmentandpreventionofporcineintestinaladenomatosis(Ileitis):

4–5mgtylosinperkgBW(correspondingto40-50mgPharmasin100mg/gpremixperkgBW)

for3weeks.

ForthetreatmentandpreventionofdysenterycausedbyBrachyspirahyodysenteriae:

4–5mgtylosinperkgBW(correspondingto40-50mgPharmasin100mg/gpremixperkgBW)

for4-5weeks.Itmaybenecessarytocontinuetreatmentuntiltheendoftheperiodofrisk(to

avoidrelapse) .

or

8–10mgtylosinperkgBW(correspondingto80–100mgPharmasin100mg/gpremixperkg

BW)for8days,followedby4-5mgtylosinperkgBW(correspondingto40-50mgPharmasin

100mg/gpremixperkgBW)untiltheendoftheperiodofrisk(toavoidrelapse).

Broilersandpullets

Forthetreatmentandpreventionofrespiratoryinfections:

127mgtylosinperkgBW(correspondingto1270mgPharmasin100mg/gpremixperkgBW)

orthefirst5daysoflife.Itisstronglyrecommendedtorepeatthetreatmentofthebirds

attheageof3-4 weeks.

Forthetreatmentandpreventionofnecroticenteritis:

10–20mgtylosinperkgBW(correspondingto100–200mgPharmasin100mg/gpremixper

kgBW)for7days.

Forthepreparationofthemedicatedfeedthebodyweightoftheanimalstobetreatedandtheir

actualdailyfeedconsumptionshouldbetakenintodueaccount.Consumptionmayvary

dependingonfactorslikeage,breed,husbandrysystem.Toprovidetherequiredamountofactive

substanceinmgperkgmixedfeedthefollowingcalculationshouldbemade:

….mgPharmasin100mg/gpremixaveragebodyweight(kg)

/kgBW/dayxoftheanimalstobetreated=…mgPharmasin

Averagedailyamountofmixedfeedintake/kgperanimal100mg/gpremixper

kg/mixedfeed

Themixingshouldbeperformedbyan(authorised)feedingstuffmanufacturerwithadequate

apparatus.

Theuptakeofmedicatedfeeddependsontheclinicalconditionoftheanimals.Inordertoobtain

thecorrectdosagetheconcentrationoftylosinshouldbeadjustedaccordingly.

SUMMARYOFPRODUCTCHARACTERISTICS

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Shouldtherebenoclearresponsetotreatmentwithin3daysthetreatmentapproachshouldbe

reconsidered.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Tylosinhasbeenshowntoproducenoadverseeffectswhenfedtopigsat600ppminthefeed

(threetosixtimestherecommendeddoselevel)for28days.Athighlevelsdiarrhoea,apathy,

convulsionsmayoccur.Thetherapyissymptomatic.

4.11 Withdrawalperiod(s)

Meat&offal

Pig:zerodays

Broilersandpullets:1day

Donotuseinlayinghensproducingeggsforhumanconsumption.

5. PHARMACOLOGICALORIMMUNOLOGICALPROPERTIES

ATCVetCode:Pharmacotherapeuticgroup:macrolideantibiotic,ATCvetcode:QJ01FA90

5.1 Pharmacodynamicproperties

TylosinisamacrolideantibioticproducedbyastrainofStreptomycesfradiae.Itexertsits

antimicrobialeffectbyinhibitingproteinsynthesisofsusceptiblemicro-organisms.

ThetylosinspectrumofactivityincludesGram-positivebacteria,someGram–negativestrains

suchasPasteurella,andMycoplasmaspp.

5.2 Pharmacokineticproperties

Inmostspeciespeakplasmaconcentrationshavebeenattained1to2hoursafteradministrationof

tylosin.Comparedtoplasmalevelsclearlyhighertissueconcentrationshavebeenobserved.

Tylosinwasextensivelymetabolized.Mostoftheresiduesareexcretedinfaecespredominantly

consistingoftylosinA,tylosinfactorDanddihydrodesmycosin.

SUMMARYOFPRODUCTCHARACTERISTICS

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6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Wheatmeal

Dipotassiumphosphate

Pregelatinisedstarch(potato)

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelflifeafterincorporationintomealorpelletedfeed:3months.

6.4 Specialprecautionsforstorage

Storeintheoriginalcontainertoprotectfromlight.Storeinadryplace.Storebelow30°C.

Donotrefrigerateorfreeze.Protectfromfrost.

6.5 Natureandcompositionofimmediatepackaging

Low-densitypolyethylene/paper–paper-paperbagof5and20kgwithsuturedcrimp.

Notallpacksizemaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7.1 MARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

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8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Considerationshouldbegiventoofficialguidanceontheincorporationofmedicated

premixesinfinalfeed.

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMASIN 100mg/gPremix HuvepharmaNV

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LABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN

100mg/gPremixformedicatedfeedingstuffforpigs,broilersandpullets

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Tylosin(astylosinphosphate):100mgperg.(equivalentto100000IU)

3. PHARMACEUTICALFORM

Premixformedicatedfeedingstuff

4. PACKAGESIZE

5and20kgPEinanouterpaperbagwithsuturedcrimp

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.

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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

Tobesuppliedonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

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

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PACKAGELEAFLET

PHARMASIN 100mg/gPremixformedicatedfeedingstuffforpigs,broilersandpullets

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisation

HuvepharmaNV,UItbreidingstraat80,2600Antwerpen,Belgium

Manufacturer

BiovetJSC,39PetarRakovStr,4550Peshtera-Bulgaria

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pharmasin100mg/gPremixformedicatedfeedingstuffforpigs,broilersandpullets

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Tylosin(astylosinphosphate):100mgperg.

Lighttancoloured,freeflowinggranules

4. INDICATION(S)

Pigs

- Treatmentandprevention,ofPorcineIntestinalAdenomatosis(Ileitis)associatedwith

Lawsoniaintracellulariswhenthediseasehasbeendiagnosedatthegrouporherdlevel,

- TreatmentandpreventionofswinedysenterycausedbyBrachyspirahyodysenteriaewhen

thediseasehasbeendiagnosedintheherd.

Broilersandpullets:

- TreatmentandpreventionofrespiratoryinfectionscausedbyMycoplasmagallisepticumand

Mycoplasmasynoviae,whenthediseasehasbeendiagnosedintheflock.

- TreatmentandpreventionofnecroticenteritiscausedbyClostridiumperfringens,whenthe

diseasehasbeendiagnosedintheflock.

5. CONTRAINDICATIONS

SUMMARYOFPRODUCTCHARACTERISTICS

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- 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:forthepreparationofamedicatedfeedcontaining40-200gram

tylosinpertonoffeed,therequiredamountofPharmasin100mg/gshouldbehomogenouslymixed

withasuitablecarrierintoafeedpremixturesothatatleast5kgofthispremixturecanbeaddedtothe

feedinordertoobtainamedicatedfeedwiththerequiredconcentration.

Forthepreparationofmedicatedfeed:

As1kgPharmasin100mg/gpremixcontains100gtylosinactivityitfollowsthat10mgPharmasin

100mg/gpremixcorrespondsto1mgtylosinactivity.Thedosagesareasfollows:

Pigs

Forthetreatmentandpreventionofporcineintestinaladenomatosis(Ileitis):

4–5mgtylosinperkgBW(correspondingto40-50mgPharmasin100mg/gpremixperkgBW)

for3weeks.

ForthetreatmentandpreventionofdysenterycausedbyBrachyspirahyodysenteriae:

4–5mgtylosinperkgBW(correspondingto40-50mgPharmasin100mg/gpremixperkgBW)

for4-5weeks.Itmaybenecessarytocontinuetreatmentuntiltheendoftheperiodofrisk(to

avoidrelapse).

Or

8–10mgtylosinperkgBW(correspondingto80–100mgPharmasin100mg/gpremix

perkgBW)for8days,followedby4-5mgtylosinperkgBW(correspondingto40-50

mgPharmasin100mg/gpremixperkgBW)untiltheendoftheperiodofrisk(toavoid

relapse).

SUMMARYOFPRODUCTCHARACTERISTICS

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Broilersandpullets

Forthetreatmentandpreventionofrespiratoryinfections:

127mgtylosinperkgBW(correspondingto1270mgPharmasin100mg/gpremixperkgBW)

forthefirst5daysoflife.Itisstronglyrecommendedtorepeatthetreatmentofthebirds

attheageof3-4 weeks.

Forthetreatmentandpreventionofnecroticenteritis:

10–20mgtylosinperkgBW(correspondingto100–200mgPharmasin100mg/gpremixper

kgBW)for7days.

Forthepreparationofthemedicatedfeedthebodyweightoftheanimalstobetreatedandtheir

actualdailyfeedconsumptionshouldbetakenintodueaccount.Consumptionmayvary

dependingonfactorslikeage,breed,husbandrysystem.Toprovidetherequiredamountofactive

substanceinmgperkgmixedfeedthefollowingcalculationshouldbemade:

….mgPharmasin100mg/gpremixaveragebodyweight(kg)

/kgBW/dayxoftheanimalstobetreated=…mgPharmasin

Averagedailyamountofmixedfeedintake/kgperanimal100mg/gpremixper

kg/mixedfeed

Themixingshouldbeperformedbyan(authorised)feedingstuffmanufacturerwithadequate

mixingapparatus.

Theuptakeofmedicatedfeeddependsontheclinicalconditionoftheanimals.Inordertoobtain

thecorrectdosagetheconcentrationoftylosinshouldbeadjustedaccordingly.

Shouldtherebenoclearresponsetotreatmentwithin3daysthetreatmentapproachshouldbe

reconsidered.

9. ADVICEONCORRECTADMINISTRATION

Animalswithacuteinfectionsmayhaveareducedfeedintakeandshouldbetreatedwithasuitable

injectableproductfirst.Thesensitivityofbacteriatotylosinmayhavechangedovertimeor

geographically.Itissoundclinicalpracticetobasetreatmentonsusceptibilitytesting.

Infarmswhichhaverecurringproblemswithswinedysentery,farmmanagement,livestockhusbandry

andhygienicmeasuresshouldbereconsideredtoavoidrepeatedadministrationofantimicrobial

substances.Aneradicationprocedureshouldbetakenintoaccount.

10. WITHDRAWALPERIOD

Meat&offal

Pig:zerodays

Broilersandpullets:1day

Donotuseinlayinghensproducingeggsforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

SUMMARYOFPRODUCTCHARACTERISTICS

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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.

Toavoidexposureduringpreparationfothemedicatedfeed,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.Useonly

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Lincosamidesandaminoglycosideantibioticsantagonizetheactivityoftylosin.

Tylosinhasbeenshowntoproducenoadverseeffectswhenfedtopigsat600ppminthefeed(three

tosixtimestherecommendeddoselevel)for28days.Athighlevelsdiarrhoea,apathy,convulsions

mayoccur.Thetherapyissymptomatic.

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

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Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinalproductsshould

bedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

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22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

13-11-2018

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, ALEBRIJE DIST WHOLESALE has decided to voluntarily recall the specific 498 “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

FDA - U.S. Food and Drug Administration

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

20-9-2018

Vacant position at IMA's Quality Assessment Team

Vacant position at IMA's Quality Assessment Team

The Agency advertises vacancy for expert in Quality Assessment Team in Assessment Division. The Agency is looking for strong candidate who are willing to work on challenging and interesting tasks. The vacancy is a full position (100%).

IMA - Icelandic Medicines Agency

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia