Vetmulin

Main information

  • Trade name:
  • Vetmulin 125 mg/ml Concentrate for Oral Solution
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Vetmulin 125 mg/ml Concentrate for Oral Solution
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Tiamulin
  • Therapeutic area:
  • Chicken, Pigs, Turkeys

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0202/001
  • Authorization date:
  • 25-11-2009
  • EU code:
  • FR/V/0202/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Vetmulin125mg/mlOralSolutionforuseindrinkingwaterforpigs(BE,BG,CZ,

EL,HU,IE,NL,PL,RO,UK,ES,IT,AT,DE,PT)

VetmulinVet,OralSolutionforuseindrinkingwaterforpigs(DK)

Vetmulin101.2mg/mlOralSolutionforuseindrinkingwaterforpigs(FR)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance125mgTiamulinhydrogenfumarate(equivalentto101.2mg

tiamulin

Excipients

Methylparahydroxybenzoate(E218):0.90mg

Propylparahydroxybenzoate(E216):0.10mg

Forafulllistofexcipients:seesection6.1

3. PHARMACEUTICALFORM

Oralsolutionforuseindrinkingwater

Clearcolourlesstoslightlyyellowliquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs

4.2 Indicationsforuse(specifyingthetargetspecies)

Forthetreatmentofswinedysenterycausedbyorfurthercomplicatedbytiamulin-

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

susceptibleBrachyspirahyodysenteriae.

Treatmentofenzooticpneumoniaandthereductionoflesionscausedbytiamulin-

susceptibleMycoplasmahyopneumoniae

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytotheactiveingredient.

Donotadministerproductscontainingmonensin,salinomycin,narasin,

maduramycinorotherionophoresduringorforatleastsevendaysbeforeorafter

treatmentwiththeproduct.Seealsosection5.1.and4.8.

4.4 Specialwarnings(foreachtargetspecies)

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.

Incaseofinsufficientuptakeofwater,animalsshouldbetreatedparenterally.

4.5 Specialprecautionsforuse

4.5.1Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies

Strategictreatmentshouldbelimitedtoanimalswheretiamulinsusceptible

agentshavebeenisolatedintheherd.Longtermorrepeateduseshouldbe

avoidedbyimprovingmanagementpracticeandthoroughcleansingand

disinfection

Severegrowthdepressionordeathmayresultifanimalsreceiveproducts

containingmonensin,salinomycin,narasin,maduramycinorother

ionophoresduringorforatleastsevendaysbeforeoraftertreatmentwith

theproduct.Seealsosection4.3and4.8.

4.5.2Specialprecautionsforthepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivitytotheactivesubstancemustnot

administertheveterinarymedicinalproduct.

Whenmixing,directcontactwiththeskinandmucousmembranesshouldbe

avoided.Accidentalingestionshouldbeavoided.Wearoveralls,safety

glasses,maskandimperviousgloveswhenhandlingormixingtheproduct.

Contaminatedclothingshouldberemovedandanysplashesontotheskin

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

shouldbewashedoffimmediately.Ifaccidentaleyecontactoccurs,

immediatelyrinsethoroughlywithwater.Seekmedicaladviceifirritation

persists.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

Inrarecases,hypersensitivitytotiamulinfollowingoraladministrationisreportedin

termsofcutaneousandgenitalerythemaandpruritus.Theadversereactionsare

oftenmildandtransientbutinveryrarecasesmaybeserious.Ifthesetypicalside

effectsoccur,stoptreatmentimmediatelyandcleananimalsandpenswithwater.

Normally,theanimalsrecoverfastthereafter.Symptomatictreatmentsuchas

electrolytetherapyandananti-inflammatorytherapymaybeuseful.

4.7 Useduringpregnancy,lactationorlay

Theproductcanbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Animalsshouldnotreceiveproductscontainingmonensin,salinomycin,narasin,

maduramycinorotherionophoresduringorforatleastsevendaysbeforeorafter

treatmentwiththeproduct.Severegrowthdepression,paralysisordeathmayresult.

Tiamulinmaylessentheantibacterialactivityofß-lactamantibioticswhoseactionis

dependentonbacterialgrowth.

Crossresistancemayoccurbetweenothermembersofmacrolidesorlincosamide

antibiotics.Resistancetotheactivesubstanceandcrossresistanceshouldbe

consideredbeforetheproductisused.

Seealsosection4.3and4.5.1.

4.9 Amount(s)tobeadministeredandadministrationroute

Fororaladministrationthroughthedrinkingwater

Swinedysentery

8.8mgtiamulinhydrogenfumarateperkgbodyweightperday(equivalentto

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

7mlproductper100kgbodyweightperday)for5consecutivedays.

Enzooticpneumonia

15-20mgtiamulinhydrogenfumarateperkgbodyweightperday(equivalentto12 –

16mlproductper100kgbodyweightperday)for5days.

Administration:

Theuptakeofmedicatedwaterdependsontheactualbodyweight,thewater

consumption,theclinicalconditionoftheanimals,theenvironment,theageandthe

kindoffeedprovided.Inordertoobtainthecorrectdosage,theconcentrationof

tiamulinshouldbecalculated,asfollows:

.....mlVetmulin125mg/ml

oralsolutionforusein

drinkingwaterperkgbody

weightandday

x Averagebody

weight(kg)

=....mlVetmulin125mg/ml

oralsolutionforusein

drinkingwaterperlitreof

drinkingwater

Averagedailywaterintake(l/animal)

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Therequireddosesshouldbemeasuredbysuitablycalibratedmeasuring

equipment.Medicatedwatershouldberefreshedevery24hours.Theuptakeof

consistentamountsofdrinkingwatershouldbeensuredbysufficientdrinking

facilities.

Toavoidformationofresistancebyconsumptionoftiamulininsubtherapeutic

doses,thewateringequipmenthastobecleanedadequatelyattheendof

treatment.

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Asingleoraldoseof100mg/kgBWcausedhyperpnoeaandabdominalcomplaints

inpigs.Atadoseof150mg/kgtheonlyeffectsonthecentralnervoussystemwas

lethargy.Adoseof55mg/kgduring14dayscausedincreasedsalivationandamild

irritationofthestomach.Tiamulinhydrogenfumaratehasarelativelyhigh

therapeuticindexinpigs.Theminimumlethaldosehasnotbeenestablishedinpigs.

Ifsignsofpoisoningareobserved,withdrawrapidlythemedicatedwaterand

replaceitwithfreshwater.Appropriatesymptomatictreatmentshouldbeinitiated.

4.11 Withdrawalperiod(s)

Meatandoffal

5days

5. PHARMACOLOGICALORIMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Pleuromutilins.

ATCVetCodeQJ01XQ01

5.1 Pharmacodynamicproperties

Tiamulinhydrogenfumarateisasemi-syntheticderivativeofthediterpeneantibiotic

pleuromutilin,producedbyPleurotusmutilis.

Tiamulinisbacteriostaticandinhibitsproteinsynthesis.Theproducthasastrong

affinityfortheribosome,causinganinhibitionofpeptidyltransferases.Asaresult

proteinsynthesisisstopped.

Invitroresearchhasshownthatresistantbacterialmutantscanbecreatedthrough

multistepresistance.Inpractice,resistanceinmycoplasmashasbeenreported

rarely.ResistanceagainstB.hyodysenteriaehasbeenseen,howeverthisspirochete

remainsverysensitivetotiamulin.

Ifresponsetotreatmentofdysenterywiththeproductispoor,thenthepossibilityof

resistancemustbeconsidered.Crossresistancebetweentiamulinandtylosinhas

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

beenreported.

5.2 Pharmacokineticproperties

Followingoraladministration,tiamulinhydrogenfumarateisrapidlyabsorbedfrom

thegastrointestinaltractofpigs(85-90%)andappearsinthebloodwithin30

minutes.2-4hours(t

)aftertheoraladministrationof10mgtiamulin/kgBWinthe

formofanoralsolution,aC

of1µg/mlwasmeasured;anoraladministrationof

25mg/kggaveaC

of1.82µg/ml.

Thereisverygooddistributioninthetissueswithaccumulationinlungsandinthe

colon.30-50%oftiamulinisboundtoserumproteins.

Tiamulinisrapidlymetabolisedintheliver(hydroxylation,de-alkalysation,

hydrolysis).Atleast16biologicallyinactivemetaboliteshavebeenidentified.The

excretionoftiamulinanditsmetabolitesisthroughthebileandfaeces(70-85%).

Theremainderisexcretedthroughtheurine(15-30%).

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Disodiumphosphate,anhydrous

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Ethanol96%

Purifiedwater

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale

30months

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months

Shelf-lifeafterdilutionaccordingtodirections:24hours

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

6.4 Specialprecautionsforstorage

Donotstoreabove25°C.

6.5 Natureandcompositionofimmediatepackaging

Vetmulin125mg/mlispresentedina1litrewhitehighdensitypolyethylenebottle

withwhitepolypropylenetamper-evidentclosuresealedwithwhitefoameddisk.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7.1 MARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinaryprescription

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

LABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Vetmulin125mg/mlOralSolutionforuseindrinkingwaterforpigs(BE,BG,CZ,EL,HU,IE,

NL,PL,RO,UK,ES,IT,AT,DE,PT)

VetmulinVet,OralSolutionforuseindrinkingwaterforpigs(DK)

Vetmulin101.2mg/mlOralSolutionforuseindrinkingwaterforpigs(FR)

Tiamulinhydrogenfumarate.

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance

Eachmlcontains:125mgTiamulinhydrogenfumarate(equivalentto101.2mgtiamulin)

Excipients

Methylparahydroxybenzoate(e218)

Propylparahydroxybenzoate(e216)

3. PHARMACEUTICALFORM

Oralsolutionforuseindrinkingwater.Clearcolourlesstoslightlyyellowliquid.

4. PACKAGESIZE

1litre

5. TARGETSPECIES

Pigs

6. INDICATION(S)

Seepackageleaflet

7. METHODANDROUTE(S)OFADMINISTRATION

Indrinkingwater

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meat&Offal:5days

9. SPECIALWARNING(S),IFNECESSARY

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeintoaccountofficialand

localantimicrobialpolicies

Strategictreatmentshouldbelimitedtoanimalswheretiamulinsusceptibleagentshave

beenisolatedintheherd.Longtermorrepeateduseshouldbeavoidedbyimproving

managementpracticeandthoroughcleansinganddisinfection

Severegrowthdepressionordeathmayresultifanimalsreceiveproductscontaining

monensin,salinomycin,narasin,maduramycinorotherionophoresduringorforatleast

sevendaysbeforeoraftertreatmentwiththeproduct

Usersafetywarnings:

Peoplewithknownhypersensitivitytotheactivesubstancemustnotadministerthe

veterinarymedicinalproduct

Whenmixing,directcontactwiththeskinandmucousmembranesshouldbeavoided.

Accidentalingestionshouldbeavoided.Wearoveralls,safetyglasses,maskandimpervious

gloveswhenhandlingormixingtheproduct.Contaminatedclothingshouldberemovedand

anysplashesontotheskinshouldbewashedoffimmediately.Ifaccidentaleyecontact

occurs,immediatelyrinsethoroughlywithwater.Seekmedicaladviceifirritationpersists.

Washhandsafteruse.

.

10.EXPIRYDATE

<EXP{month/year}>

Onceopened,usewithin3months

Oncediluted,usewithin24hours

Onceopeneduseby:

11.SPECIALSTORAGECONDITIONS

Storebelow25°C.

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithnationalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription

14.THEWORDS “KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

manufacturerresponsibleforbatchreleaseintheEEA.

BiovetJSC,

39PetarRakovStr,

4550Peshtera –Bulgaria

16.MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

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

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

PACKAGELEAFLET

Vetmulin125mg/mlOralSolutionforuseindrinkingwaterforpigs(BE,BG,CZ,EL,HU,IE,

NL,PL,RO,UK,ES,IT,AT,DE,PT)

VetmulinVet,OralSolutionforuseindrinkingwaterforpigs(DK)

Vetmulin101.2mg/mlOralSolutionforuseindrinkingwaterforpigs(FR)

Tiamulinhydrogenfumarate

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisation

HuvepharmaNV,Uitbreidingstraat80,2600Antwerpen,Belgium

Manufacturer

BiovetJSC,39PetarRakovStr,4550Peshtera-Bulgaria

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Vetmulin125mg/mlOralsolutionforuseindrinkingwaterforpigs

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activesubstance

Eachmlcontains:125mgTiamulinhydrogenfumarate(equivalentto101.2mgtiamulin

Clearcolourlesstoslightlyyellowliquid.

Excipients

Methylparahydroxybenzoate(E218): 0.90mg

Propylparahydroxybenzoate(E216): 0.10mg

4. INDICATION(S)

Forthetreatmentofswinedysenterycausedbyorfurthercomplicatedbytiamulin-

susceptibleBrachyspirahyodysenteriae.

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

Treatmentofenzooticpneumoniaandthereductionoflesionscausedbytiamulin-

susceptibleMycoplasmahyopneumoniae.

5. CONTRAINDICATIONS

Donotuseinanimalswithknownhypersensitivitytotheactiveingredient.

Donotadministerproductscontainingmonensin,salinomycin,narasin,maduramycinor

otherionophoresduringorforatleastsevendaysbeforeoraftertreatmentwiththeproduct.

6. ADVERSEREACTIONS

Inrarecases,hypersensitivitytotiamulinfollowingoraladministrationisreportedintermsof

cutaneousandgenitalerythemaandpruritus.Theadversereactionsareoftenmildand

transientbutinveryrarecasesmaybeserious.Ifthesetypicalsideeffectsoccur,stop

treatmentimmediatelyandcleananimalsandpenswithwater.Normally,theanimalsrecover

fastthereafter.Symptomatictreatmentsuchaselectrolytetherapyandananti-inflammatory

therapymaybeuseful.Ifyounoticeanyseriousorothereffectsnotmentionedinthisleaflet,

pleaseinformyourveterinarysurgeon

7. TARGETSPECIES

Pigs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Swinedysentery

8.8mgtiamulinhydrogenfumarateperkgbodyweightperday(equivalentto7mlproduct

per100kgbodyweightperday)for5consecutivedays.

Enzooticpneumonia

15-20mgtiamulinhydrogenfumarateperkgbodyweightperday(equivalentto12 –

16mlproductper100kgbodyweightperday)for5days.

Administration:

Theuptakeofmedicatedwaterdependsontheactualbodyweight,thewaterconsumption,

theclinicalconditionoftheanimals,theenvironment,theageandthekindoffeedprovided.

Inordertoobtainthecorrectdosage,theconcentrationoftiamulinshouldbecalculated,as

follows:

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

.....mlVetmulin125mg/ml

oralsolutionforusein

drinkingwaterperkgbody

weightandday

x Averagebody

weight(kg)

=....mlVetmulin125mg/mloral

solutionforuseindrinkingwater

perlitreofdrinkingwater

Averagedailywaterintake(l/animal)

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibleto

avoidunderdosing.Therequireddosesshouldbemeasuredbysuitablycalibrated

measuringequipment.

Medicatedwatershouldberefreshedevery24hours.Theuptakeofconsistentamountsof

drinkingwatershouldbeensuredbysufficientdrinkingfacilities.

Toavoidformationofresistancebyconsumptionoftiamulininsubtherapeuticdoses,the

wateringequipmenthastobecleanedadequatelyattheendoftreatment.

9. ADVICEONCORRECTADMINISTRATION

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.

Incaseofinsufficientuptakeofwater,animalsshouldbetreatedparenterally’

10.WITHDRAWALPERIOD

Meatandoffal

5days

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storebelow25°C.

Shelf-lifeafterdilutionaccordingtodirections:24hours

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months

Donotuseaftertheexpirydatestatedonthelabel

12.SPECIALWARNING(S)

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.

Incaseofinsufficientuptakeofwater,animalsshouldbetreatedparenterally.

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeintoaccountofficialand

localantimicrobialpoliciesStrategictreatmentshouldbelimitedtoanimalswheretiamulin

susceptibleagentshavebeenisolatedintheherd.Longtermorrepeateduseshouldbe

avoidedbyimprovingmanagementpracticeandthoroughcleansinganddisinfection

Severegrowthdepressionordeathmayresultifanimalsreceiveproductscontaining

monensin,salinomycin,narasin,maduramysinorotherionophoresduringorforatleast

sevendaysbeforeoraftertreatmentwiththeproduct.

Theproductcanbeusedduringpregnancyandlactation.

Tiamulinmaylessentheantibacterialactivityofß-lactamantibioticswhoseactionis

dependantonbacterialgrowth

Asingleoraldoseof100mg/kgBWcausedhyperpnoeaandabdominalcomplaintsinpigs.

Atadoseof150mg/kgtheonlyeffectsonthecentralnervoussystemwaslethargy.Adose

of55mg/kgduring14dayscausedincreasedsalivationandamildirritationofthestomach.

Tiamulinhydrogenfumaratehasarelativelyhightherapeuticindexinpigs.Theminimum

lethaldosehasnotbeenestablishedinpigs.

Ifsignsofpoisoningareobserved,withdrawrapidlythemedicatedwaterandreplaceitwith

freshwater.Appropriatesymptomatictreatmentshouldbeinitiated

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

Donotstoreabove25°C.

Usersafetywarnings:

Peoplewithknownhypersensitivitytotheactivesubstancemustnotadministerthe

veterinarymedicinalproduct

Whenmixing,directcontactwiththeskinandmucousmembranesshouldbeavoided.

Accidentalingestionshouldbeavoided.Wearoveralls,safetyglasses,maskandimpervious

gloveswhenhandlingormixingtheproduct.Contaminatedclothingshouldberemovedand

anysplashesontotheskinshouldbewashedoffimmediately.Ifaccidentaleyecontact

occurs,immediatelyrinsethoroughlywithwater.Seekmedicaladviceifirritationpersists.

Washhandsafteruse.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinaryproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithnationalrequirements.

SUMMARYOFPRODUCTCHARACTERISTICS

Vetmulin125mg/mlSolution HuvepharmaNV

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocal

representativeofthemarketingauthorisationholder.

Vetmulin125mg/mlispresentedina1litrewhitehighdensitypolyethylenebottlewithwhite

polypropylenetamper-evidentclosuresealedwithwhitefoameddisk.

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Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal...

FDA - U.S. Food and Drug Administration

26-11-2018

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Active substance: efavirenz / emtricitabine / tenofovir disoproxil fumarate) - Centralised - 2-Monthly update - Commission Decision (2018)7982 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/797/II/130

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

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

Europe -DG Health and Food Safety

7-8-2018

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5419 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5420 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety

25-7-2018

Viread (Gilead Sciences Ireland UC)

Viread (Gilead Sciences Ireland UC)

Viread (Active substance: tenofovir disoproxil fumarate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4980 of Wed, 25 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/419/T/187

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

6-6-2018

Truvada (Gilead Sciences Ireland UC)

Truvada (Gilead Sciences Ireland UC)

Truvada (Active substance: emtricitabine / tenofovir disoproxil fumarate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3690 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/594/T/148

Europe -DG Health and Food Safety

6-6-2018

Stribild (Gilead Sciences Ireland UC)

Stribild (Gilead Sciences Ireland UC)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3691 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/T/93

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Tecfidera (Biogen Idec Limited)

Tecfidera (Biogen Idec Limited)

Tecfidera (Active substance: Dimethyl fumarate) - Centralised - Yearly update - Commission Decision (2018)3458 of Wed, 30 May 2018

Europe -DG Health and Food Safety

28-5-2018

Seresto and its associated name Foresto

Seresto and its associated name Foresto

Seresto and its associated name Foresto (Active substance: imidacloprid/flumethrin) - Community Referrals - Art 13 - Commission Decision (2018)3404 of Mon, 28 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/A/125

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

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/3/14/1383 (IQVIA RDS Ireland Limited)

EU/3/14/1383 (IQVIA RDS Ireland Limited)

EU/3/14/1383 (Active substance: Single-chain urokinase plasminogen activator) - Transfer of orphan designation - Commission Decision (2018)3150 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/14/T/01

Europe -DG Health and Food Safety

26-3-2018

EU/3/18/1990 (PharmaBio Consulting)

EU/3/18/1990 (PharmaBio Consulting)

EU/3/18/1990 (Active substance: Dimethyl fumarate) - Orphan designation - Commission Decision (2018)1879 of Mon, 26 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/219/17

Europe -DG Health and Food Safety