Tilmicosol 250 mg/ml concentrate for oral solution

Main information

  • Trade name:
  • Tilmicosol 250 mg/ml concentrate for oral solution
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Tilmicosol 250 mg/ml concentrate for oral solution
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • tilmicosin
  • Therapeutic area:
  • Cattle Young, Chicken, Pigs, Turkeys

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • HU/V/0112/001
  • Authorization date:
  • 24-11-2010
  • EU code:
  • HU/V/0112/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS(SPC)

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Tilmicosol

(inCyprus, Czech Republic,Greece, Hungary,Spain,Lithuania, Portugaland United Kingdom)

Tilmic

(inDenmark)

TylmiScan

(inPoland)

250 mg/mlConcentrateforOralSolutionforUseinDrinkingWaterorMilkReplacer

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Tilmicosin(asphosphate)250mg/ml

Excipients:

Propylgallate(E310)0.2 mg/ml

Disodiumedetate 2.0 mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Concentratefororalsolutionforuseindrinkingwaterormilkreplacer.

Clearyellowtoambercolouredsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Chickens(excepthensproducingeggsforhumancomsumption),

Turkeys,

Pigs,

Calves(nonruminant)

4.2Indicationsforuse,specifyingthetargetspecies

Pigs:Forthetreatmentandpreventionofrespiratorydiseaseinpigherds,associatedwith

Mycoplasmahyopneumoniae,Pasteurellamultocida,Actinobacilluspleuropneumoniaeandother

organismssusceptibleto tilmicosin.

Chickens:Forthetreatmentandpreventionofrespiratorydiseaseinchickenflocks,associated

withMycoplasmagallisepticumandM. synoviae.

Turkeys:Forthetreatmentandpreventionofrespiratorydiseaseinturkeylocks,associatedwith

MycoplasmagallisepticumandM.synoviae.

Calves:Forthetreatmentandpreventionofbovinerespiratorydisease,associatedwith

Mannheimiahaemolytica,Pasteurellamultocida,Mycoplasmabovis,M.disparandother

organismssusceptibleto tilmicosin.

4.3Contraindications

Donotallowhorsesandotherequinesaccesstodrinkingwatercontainingtilmicosin.

Donotuseincaseofhypersensitivityto tilmicosinorto anyoftheexcipients.

Donotadministerto ruminatinganimalswithactiverumenfunction.

4.4Specialwarningsforeachtargetspecies

Important:Mustbedilutedbeforeadministrationtoanimals

Pigs,chickensandturkeys:Waterconsumptionshouldbemonitoredinordertoguarantee

adequatedosing.Incasewaterconsumptiondoesnotmatchquantitiesforwhichrecommended

concentrationswerecalculated,theconcentrationofTilmicosolhastobeadaptedinawaythatthe

recommenddosagewillbetakenupbytheanimalsordifferentmedicationshouldbeconsidered.

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Fororaluseonly.Containsdisodiumedetate;do notinject

Severelyillindividualstendtodrinklessandmayneedsimultaneoustreatment,preferablyby

parenteralmedication.

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttotilmicosinand

maydecreasetheeffectivenessoftreatmentwithtilmicosin-relatedsubstances.Theuseofthe

productshouldbebased onsusceptibilitytests.

Medicateddrinkingwaterormilkreplacershouldbepreparedfreshevery24 hours.

Official,nationalandregionalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Tilmicosinmayinduceirritation.Macrolides,suchastilmicosin,mayalsocausehypersensitivity

(allergy)followinginjection,inhalation,ingestionorcontactwithskinoreye.Hypersensitivityto

tilmicosinmayleadtocrossreactionstoothermacrolidesandviceversa.Allergicreactionsto

thesesubstancesmayoccasionallybeseriousandthereforedirectcontactshouldbeavoided.

Toavoidexposureduringpreparationofthemedicateddrinkingwater,wearoveralls,safety

glasses,andimperviousgloves.Donoteat,drinkorsmokewhenhandlingthisproduct.Wash

handsafteruse.

Inthecaseofaccidentalingestion,washoutmouthimmediatelywithwaterandseekmedical

advice.Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseof

accidentaleyecontact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedicaladvice

andshowthephysicianthiswarning.Swellingoftheface,lipsandeyesordifficultyinbreathing

aremoreserioussymptomsandrequireurgentmedicalattention.

iii)Specialprecautionsfortheenvironment

Manurefromtreatedanimalsshouldnotbedepositedonthesamefieldinsuccessiveyears.

4.6Adversereactions(frequencyandseriousness)

Inveryrarecases, adecreaseinwaterintakehasbeenobserved.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftilmicosinhasnotbeenestablishedinanimalsusedforbreedingpurposes.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Pigs:Tobeincludedinthedrinkingwatertoprovideadailydoseof15-20mgtilmicosinperkg

bodyweightfor5days,whichmaybeachievedbytheinclusionof200mgtilmicosinperlitre

(80mlTilmicosolper100litres).

Chickensandturkeys(excepthensproducingeggsforhumanconsumption):Tobeincludedinthe

drinkingwateratadailydoseof15-20mg/kgbodyweightinchickensand10-27mg/kg

bodyweightinturkeysfor3days,whichmayachievedbytheinclusionof75mgtilmicosinper

litre(30 mlTilmicosolper100 litres).

Calves:Tobeincludedinmilkreplaceronly,atadoseof12.5mg/kgbodyweightandgiventwice

dailyfor3-5consecutivedays,whichmaybeachievedbytheinclusionof1mlofproductevery

20 kgbodyweight

Theuptakeofmedicatedwater/milkreplacerdependsontheclinicalconditionoftheanimals.In

orderto obtainthecorrectdosage,theconcentrationofTilmicosolshouldbeadjustedaccordingly.

4.10Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Whenpigsareoffereddrinkingwatercontaining300or400mgtilmicosin/litre(equivalentto

22.5-40mg/kgbodyweightor1.5-2timestherecommendedconcentration)commonlyanimals

exhibitareducedwaterintake.Althoughthishasaself-limitingeffectontilmicosinintake,it

could,inextremecircumstances,resultindehydration.Thiscanbecorrectedbytheremovalofthe

medicateddrinkingwaterandreplacementwithfreshunmedicatedwater.

Nosymptomsofoverdosehavebeenseeninchickensgivendrinkingwatercontaininglevelsof

tilmicosinupto375mg/litre(equivalentto75-100mg/kgbodyweightor5timestherecommended

dose)for5days,dailytreatmentwith75mg/litre(equivalenttothemaximumrecommendeddose)

for10daysresultedinadecreaseinfaecalconsistency.

Nosymptomsofoverdosehavebeenseeninturkeysgivendrinkingwatercontaininglevelsof

tilmicosinupto375mg/litre(equivalentto50-135mg/kgbodyweightor5timestherecommended

dose)for3days,dailytreatmentwith75mg/litre(equivalenttothemaximumrecommendeddose)

for6 daysalsoproducednosymptomsofoverdose.

Nosymptomsofoverdose,withexceptionofaslightdecreaseinthemilkconsumption,havebeen

seenincalvesgiventwicedailydoses5timesthemaximumrecommendeddoseorfortwicethe

maximumrecommendeddurationoftreatment.

4.11Withdrawalperiod(s)

Meatandoffalof:

Pigs-14 days

Chickens-12 days

Turkeys-19 days

Calves-42 days

Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.Donotusewithin

14 daysofonsetofthelaying.

Notauthorisedforuseinlactatinganimalsproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

PharmacotherapeuticGroup:Antibacterialsforsystemicuse,macrolides

ATCVetcode:QJ01FA91

5.1 Pharmacodynamicproperties

Tilmicosinisasemi-syntheticantibioticofthemacrolidegroup,andisbelievedtoaffectprotein

synthesis.Ithasbacteriostaticactionbutathighconcentrationsitmaybebactericidal.

ThisantibacterialactivityispredominantlyagainstGram-positivemicroorganismwithactivity

againstcertaingram-negativeonesandMycoplasmaofabovine,porcine,ovineandavianorigin.

Inparticular,itsactivityhasbeendemonstratedagainstthefollowingmicroorganism:

Pigs: Mycoplasma hyopneumoniae, Pasteurella multocida and Actinobacillus

pleuropneumoniae

Chickensandturkeys:Mycoplasmagallisepticumand Mycoplasmasynoviae

Calves:Mannheimiahaemolytica, Pasteurellamultocida, Mycoplasmabovis, M. dispar

Scientificevidencesuggeststhatmacrolidesactsynergisticallywiththehostimmunesystem.

Macrolidesappeartoenhancephagocytekillingofbacteria.Tilmicosinhasbeenshowntoinhibit

invitrothereplicationofthePorcineReproductiveandRespiratorySyndromevirusinalveolar

macrophagesinadosedependentfashion.

Cross-resistancebetweentilmicosinandothermacrolidesandlincomycinhasbeenobserved.

5.2 Pharmacokineticparticulars

Whilstbloodconcentrationsoftilmicosinarelow,thereispH-dependentmacrophage

accumulationoftilmicosinininflamedtissue.

Pigs:Afteroraladministrationof200mgtilmicosin/litredrinkingwater,theaverageactive

substanceconcentrationsdetectedinlungtissue,alveolarmacrophagesandbronchialepithelium5

daysafterthestartoftreatmentwerereported1.44 μg/ml,3.8 μg/mland7.4 μg/grespectively.

Poultry:Asearlyas6hoursafteroraladministrationof75mgtilmicosin/litredrinkingwater,the

averageactivesubstanceconcentrationsdetectedinlungandalveolartissuewere0.63μg/gand

0.30μg/grespectively.48hoursafterthestartofthetreatment,thetilmicosinconcentrationsin

lungandalveolartissuewere2.3 μg/gand3.29 μg/grespectively.

Calves:Asearlyas6hoursafteroraladministrationof25mgtilmicosin/kgbodyweight/dayin

milkreplacer,anaverageactivesubstanceconcentrationof3.1μg/gwasdetectedinlungtissue.78

hoursafterthestartoftreatment,thetilmicosinconcentrationinlungtissuewas42.7μg/g.

Therapeuticallyeffectiveconcentrationsoftilmicosinweremeasuredupto60hoursafter

treatment.

Turkeys:Afteroraladministrationof75mgtilmicosin/litredrinkingwater,theaverageactive

substanceconcentrationsdetectedinlungtissue,airsactissueandplasma5daysafterthestartof

treatmentwere1.89μg/ml,3.71μg/mland0.02μg/grespectively.Thehighestmeantilmicosin

concentrationdetectedforlungtissueswas2.19μg/gat6days;forairsactissueitwas4.18μg/g

at2 daysandintheplasmaitwas0.172 μg/gat3 days.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Disodiumedetate

Propylgallate,E310

Phosphoricacid,concentrated(forpHadjustment)

Purifiedwater

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2 years

Shelf-lifeafterfirstopeningtheimmediatepackaging:3 months

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24 hours

6.4. Specialprecautionsforstorage

Donotstoreabove25°C. Storeintheoriginalcontainerinorderto protectfromlight.Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

250 mlinwhitehighdensitypolyethylenebottlewithpolypropylenescrewcap

1000mlinwhitehighdensitypolyethylenebottlewithpolypropylenescrewcapandcalibrated

polypropylenemeasuringcup

Notallpack sizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

LavetPharmaceuticalsLtd.

H-1161 Budapest,Ottóu.14.

Hungary

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

1.B.2LABELLING

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

250 mlpolyethylenebottlewithpolypropylenescrewcap.

1000 mlpolyethylenebottlewithpolypropylenescrewcap.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Tilmicosol250 mg/mlConcentrateforOralSolutionforUseinDrinkingWaterorMilkReplacer

Tilmicosin(asphosphate)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance: Tilmicosin(asphosphate) 250 mg/ml

3. PHARMACEUTICALFORM

Concentratefororalsolutionforuseindrinkingwaterormilkreplacer

4. PACKAGESIZE

250 ml

1000 ml

5. TARGETSPECIES

Chickens,(excepthensproducingeggsforhumanconsumption),turkeys,pigs,calves(non

ruminant).

6. INDICATION(S)

Pigs:Forthetreatmentandpreventionofrespiratorydiseaseinpigherds,associatedwith

Mycoplasmahyopneumoniae,Pasteurellamultocida,Actinobacilluspleuropneumoniaeandother

organismssusceptibleto tilmicosin.

Chickens:Forthetreatmentandpreventionofrespiratorydiseaseinchickenflocks,associated

withMycoplasmagallisepticumandM. synoviae.

Turkeys:Forthetreatmentandpreventionofrespiratorydiseaseinturkeylocks,associatedwith

MycoplasmagallisepticumandM.synoviae.

Calves:Forthetreatmentandpreventionofbovinerespiratorydisease,associatedwith

Mannheimiahaemolytica,Pasteurellamultocida,Mycoplasmabovis,M.disparandother

organismssusceptibleto tilmicosin.

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletonreverseofthelabelbeforeuse.

Fororaluseindrinkingwaterormilkreplacer.

8. WITHDRAWALPERIOD

Meatandoffalof:

Pigs:14 days

Chickens:12 days

Turkeys:19 days

Calves:42 days

Notforuseinlayingbirdsproducingeggsforhumanconsumption.Donotusewithin14daysof

onsetofthelaying.Notauthorisedforuseinlactatinganimalsproducingmilkforhuman

consumption.

9. SPECIALWARNING(S),IFNECESSARY

Important:Mustbedilutedbeforeadministrationtoanimals.

Fororaluseonly.Do notinject.

Donotallowhorsesandotherequinesaccesstodrinkingwatercontainingtilmicosin.

Donotadministerto ruminatinganimalswithactiverumenfunction.

UserWarnings:

Peoplewithknownhypersensitivityto tilmicosinshouldavoidcontactwiththeproduct.

Whenmixingtheveterinarymedicinalproductdirectcontactwitheyes,skinandmucous

membranesshouldbeavoided.Personalprotectiveequipmentshouldbeworn.

Incaseofaccidentalingestionseekmedicaladviceimmediatelyandshowthelabeltothe

physician.Seepackageleafletforfulluserwarnings.

10.EXPIRYDATE

EXP{month/year}

Afterfirstopeningofcontainer:3 months

Afterdilutionorreconstitutionaccordingtodirections:24 hours.

11.SPECIALSTORAGECONDITIONS

Donotstoreabove25°C.

Storeintheoriginalcontainerinordertoprotectfromlight.Do notfreeze.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

Manurefromtreatedanimalsshouldnotbedepositedonthesamefieldinsuccessiveyears.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-to besuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LavetPharmaceuticalLtd.

1161 Budapest

Ottó u.14.

Hungary

16.MARKETINGAUTHORISATIONNUMBER(S)

17.MANUFACTURER’SBATCHNUMBER

Batch:{number}

1.B.3 PRODUCTINFORMATION

PACKAGELEAFLET

Tilmicosol250 mg/mlconcentratefororalsolution

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

LavetPharmaceuticalsLtd.,1161 Budapest,Ottóu.14., Hungary

Manufacturerforthebatchrelease:

LavetPharmaceuticalsLtd.,2143 Kistarcsa,Batthyányu.4/b., Hungary

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Tilmicosol250 mg/mlConcentrateforOralSolutionforUseinDrinkingWaterorMilkReplacer

Tilmicosin(asphosphate)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activesubstance: Tilmicosin(asphosphate) 250 mg/ml

4. INDICATION(S)

Pigs:Forthetreatmentandpreventionofrespiratorydiseaseinpigherds,associatedwith

Mycoplasmahyopneumoniae,Pasteurellamultocida,Actinobacilluspleuropneumoniaeandother

organismssusceptibleto tilmicosin.

Chickens:Forthetreatmentandpreventionofrespiratorydiseaseinchickenflocks,associated

withMycoplasmagallisepticumandM. synoviae.

Turkeys:Forthetreatmentandpreventionofrespiratorydiseaseinturkeylocks,associatedwith

MycoplasmagallisepticumandM.synoviae.

Calves:Forthetreatmentandpreventionofbovinerespiratorydisease,associatedwith

Mannheimiahaemolytica,Pasteurellamultocida,Mycoplasmabovis,M.disparandother

organismssusceptibleto tilmicosin.

5. CONTRAINDICATIONS

Donotallowhorsesandotherequinesaccesstodrinkingwatercontainingtilmicosin.

Donotuseincaseofhypersensitivityto tilmicosinorto anyoftheexcipients.

Donotadministerto ruminatinganimalswithactiverumenfunction.

6. ADVERSEREACTIONS

Inveryrarecases, adecreaseinwaterintakehasbeenobserved.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Chickens(excepthensproducingeggsforhumanconsumption),turkeys,pigs,calves(non

ruminant).

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF

ADMINISTRATION

Tobeadministeredorallyindrinkingwaterorinmilkreplacer.

Pigs:Tobeincludedinthedrinkingwatertoprovideadailydoseof15-20mgtilmicosinperkg

bodyweightfor5days,whichmaybeachievedbytheinclusionof200mgtilmicosinperlitre(80

mlTilmicosolper100 litres).

Chickensandturkeys(excepthensproducingeggsforhumanconsumption):Tobeincludedinthe

drinkingwateratadailydoseof15-20mg/kgbodyweightinchickensand10-27mg/kg

bodyweightinturkeysfor3days,whichmayachievedbytheinclusionof75mgtilmicosinper

litre(30 mlTilmicosolper100 litres).

Calves:Tobeincludedinmilkreplaceronly,atadoseof12.5mg/kgbodyweightandgiventwice

dailyfor3-5consecutivedays,whichmaybeachievedbytheinclusionof1mlofproductevery

20 kgbodyweight

9. ADVICEONCORRECTADMINISTRATION

Theproposeddoseto beadministeredmaybeachievedasfollows.

Pigs:200 mgtilmicosinperlitre(80 mlTilmicosolper100 litres).

Chickensandturkeys:75 mgtilmicosinperlitre(30 mlTilmicosolPer100 litres)

Calves:1 mlTilmicosolevery20 kgbodyweightadministeredinmilkreplaceronly.

10.WITHDRAWALPERIOD

Meatandoffalof:

Pigs-14 days

Chickens-12 days

Turkeys-19 days

Calves-42 days

Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.Donotusewithin

14 daysofonsetofthelaying.

Notauthorisedforuseinlactatinganimalsproducingmilkforhumanconsumption.

11.SPECIALSTORAGEPRECAUTIONS

Keep outofthereachandsightofchildren.

Donotstoreabove25

C.

Storeintheoriginalcontainerinordertoprotectfromlight.Do notfreeze.

Donotuseaftertheexpirydatestatedonthelabel.

Shelf-lifeafterfirstopeningthecontainer:3 months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24 hours.

12. SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Important:Mustbedilutedbeforeadministrationtoanimals

Pigs,chickensandturkeys:Waterconsumptionshouldbemonitoredinordertoguarantee

adequatedosing.Incasewaterconsumptiondoesnotmatchquantitiesforwhichrecommended

concentrationswerecalculated,theconcentrationofTilmicosolhastobeadaptedinawaythatthe

recommenddosagewillbetakenupbytheanimalsordifferentmedicationshouldbeconsidered.

SpecialPrecautionsforUseinAnimals

Fororaluseonly.Containsdisodiumedetate;do notinject

Severelyillindividualstendtodrinklessandmayneedsimultaneoustreatment,preferablyby

parenteralmedication.

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttotilmicosinamd

maydecreasetheeffectivenessoftreatmentwithtilmicosin-relatedsubstances.Theuseofthe

productshouldbebased onsusceptibilitytests.

Medicateddrinkingwaterormilkreplacershouldbepreparedfreshevery24 hours.

Official,nationalandregionalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Whenpigsareoffereddrinkingwatercontaining300 or400 mgtilmicosin/litre(equivalent to

22.5-40mg/kgbodyweightor1.5-2timestherecommendedconcentration)commonlyanimals

exhibitareducedwaterintake.Althoughthishasaself-limitingeffectontilmicosinintake,it

could,inextremecircumstances,resultindehydration.Thiscanbecorrectedbytheremovalofthe

medicateddrinkingwaterandreplacementwithfreshunmedicatedwater.

Nosymptomsofoverdosehavebeenseeninchickensgivendrinkingwatercontaininglevelsof

tilmicosinupto375mg/litre(equivalentto75-100mg/kgbodyweightor5timestherecommended

dose)for5days,dailytreatmentwith75mg/litre(equivalenttothemaximumrecommendeddose)

for10daysresultedinareductioninfaecalconsistency.

Nosymptomsofoverdosehavebeenseeninturkeysgivendrinkingwatercontaininglevelsof

tilmicosinupto375mg/litre(equivalentto50-135mg/kgbodyweightor5timestherecommended

dose)for5days,dailytreatmentwith75mg/litre(equivalenttothemaximumrecommendeddose)

for6 daysalsoproducednosymptomsofoverdose.

Nosymptomsofoverdose,withexceptionofaslightdecreaseinthemilkconsumption,havebeen

seenincalvesgiventwicedailydoses5timesthemaximumrecommendeddoseorfortwicethe

maximumrecommendeddurationoftreatment.

UserWarnings

Tilmicosinmayinduceirritation.Macrolides,suchastilmicosin,mayalsocausehypersensitivity

(allergy)followinginjection,inhalation,ingestionorcontactwithskinoreye.Hypersensitivityto

tilmicosinmayleadtocrossreactionstoothermacrolidesandviceversa.Allergicreactionsto

thesesubstancesmayoccasionallybeseriousandthereforedirectcontactshouldbeavoided.

Toavoidexposureduringpreparationofthemedicateddrinkingwater,wearoveralls,safety

glasses,andimperviousgloves.Donoteat,drinkorsmokewhenhandlingthisproduct.Wash

handsafteruse.

Inthecaseofaccidentalingestion,washoutmouthimmediatelywithwaterandseekmedical

advice.Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseof

accidentaleyecontact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedicaladvice

andshowthephysicianthiswarning.Swellingoftheface,lipsandeyesordifficultyinbreathing

aremoreserioussymptomsandrequireurgentmedicalattention.

UseDuringPregnancyandLactation

Thesafetyoftilmicosinhasnotbeenestablishedinanimalsusedforbreedingpurposes.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithnationalrequirements.

Manurefromtreatedanimalsshouldnotbedepositedonthesamefieldinsuccessiveyears.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Pack sizes:

250 mlinwhitehighdensitypolyethylenebottlewithpolypropylenescrewcap.

1000mlinwhitehighdensitypolyethylenebottlewithpolypropylenescrewcapandcalibrated

polypropylenemeasuringcup.

Notallpack sizesmaybemarketed.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentative

ofthemarketingauthorisationholder.

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INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

31-7-2018

Public Notification: Black Rhino 25000 contains hidden drug ingredient

Public Notification: Black Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Krazzy Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Gold Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Platinum Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

10-7-2018

Preventieve HIV-remmers (PrEP) worden verstrekt voor een periode van vijf jaar

Preventieve HIV-remmers (PrEP) worden verstrekt voor een periode van vijf jaar

PrEP wordt binnen een onderzoekssetting voor een periode van vijf jaar verstrekt aan de hoogrisicogroep van mannen die seks hebben met mannen (MSM). Dat heeft minister Bruno Bruins (Medische Zorg) vandaag bekend gemaakt. Op basis van schattingen van het RIVM zullen ongeveer 6500 mannen hiervan gebruik gaan maken en kunnen hiermee  250 hiv-infecties per jaar worden voorkomen. Voor gebruikers gaat een eigen bijdrage gelden van maximaal 25%, dat komt overeen met ongeveer 12 euro per maand. Ook wordt hen gev...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

25-6-2018

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.

FDA - U.S. Food and Drug Administration

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

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

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

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

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