Pharmasin 100% W/W Water Soluble Granules

Main information

  • Trade name:
  • Pharmasin 100% W/W Water Soluble Granules
  • Pharmaceutical form:
  • Granules for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharmasin 100% W/W Water Soluble Granules
    Austria
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0159/001
  • Authorization date:
  • 23-02-2011
  • EU code:
  • NL/V/0159/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pharmasin100%w/wGranulesforUseinDrinkingWater

forPigs,Chickens,TurkeysandCalves.

Pharmasin1g/ggranulesforuseindrinkingwater

forpigs,chickens,turkeysandcalves”(PLandES)

Tylmasin1g/ggranulesfororalsolution

forpigs,chickens,turkeysandcalves (IT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1.1 gofgranulescontains

Activesubstance:

1goftylosin(correspondingto1.1goftylosintartrate)

Excipients:

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Granulesforuseindrinkingwater.

Whiteto off-whitecoloured granules.

4. CLINICALPARTICULARS

4.1Targetspecies

Calves, pigs,chickens, turkeys

4.2Indicationsforuse, specifying thetargetspecies

Calves:TreatmentandpreventionofpneumoniacausedbyMycoplasmasppwhenthediseasehas

beenestablished intheherd.

Pigs:TreatmentandpreventionofenzooticpneumoniacausedbyMycoplasmahyopneumoniae

andMycoplasma hyorhiniswhenthediseasehasbeenestablished intheherd.

TreatmentandpreventionofPorcineIntestinalAdenomatosis(Ileitis)associatedwithLawsonia

intracellulariswhenthediseasehasbeenestablishedintheherd.

Chickens:Treatmentandpreventionofchronicrespiratorydiseases(CRD)caused byMycoplasma

gallisepticumandMycoplasma synoviaewhenthediseasehasbeenestablished intheflock.

Treatmentand preventionofnecroticenteritiscaused byClostridiumperfringenswhenthedisease

hasbeenestablished intheflock

Turkeys:TreatmentandpreventionofinfectioussinusitiscausedbyMycoplasmagallisepticum.

whenthediseasehasbeenestablished intheflock

4.3Contraindications

Do notuseinanimalswithknownhypersensitivityto tylosinorothermacrolides.

Donotuseincasesofknownresistancetotylosinorcross-resistancetoothermacrolides(MLS-

resistance).

Donotuseinanimalsvaccinatedwithtylosin-sensitivevaccineseitheratthesametimeorwithin1

week previously.

Do notuseinanimalswithhepaticdisorders.

Do notuseinhorses.

4.4Specialwarnings<foreachtargetspecies>

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriatotylosin,bacteriological

samplingand susceptibilitytestingarerecommended.

Under-dosingand/ortreatingforaninsufficientlengthoftimeareconsidered to promotethe

developmentofresistanceinbacteriaand should beavoided.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Animalswithacuteinfectionsmayhaveareducedwaterandfeedconsumptionandshouldbe

treated withasuitableinjectableveterinarymedicinalproductfirst.

Donotleaveordisposeofwatercontainingtylosintartratewhereitmaybeaccessibletoeither

animalsnotundertreatmentorwildlife.

Specialprecautionsforthepersonadministeringtheveterinarymedicinalproductto

animals

Tylosinmayinduceirritation.Macrolides,suchastylosin,mayalsocausehypersensitivity(allergy)

followinginjection,inhalation,ingestionorcontactwithskinoreye.Hypersensitivitytotylosinmay

leadtocrossreactionstoothermacrolidesandviceversa.Allergicreactionstothesesubstances

mayoccasionallybeseriousand thereforedirectcontactshould beavoided.

Toavoidexposureduringpreparationofthemedicated drinkingwater, wearoveralls, safetyglasses,

imperviousglovesandweareitheradisposablehalfmaskrespiratorconformingtoEuropean

StandardEN149oranon-disposablerespiratortoEuropeanStandardEN140withafilterto

EN143.

Washhandsafteruse.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater. Incaseofaccidental

eyecontact, flushtheeyeswithplentyofclean, runningwater.

Do nothandletheproductifyouareallergicto ingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure, suchasskinrash, youshould seek medicaladviceand

showthephysicianthiswarning. Swellingoftheface, lipsand eyesordifficultyinbreathingaremore

serioussymptomsand requireurgentmedicalattention.

4.6Adversereactions(frequency andseriousness)

Inpigs,adversereactionshavebeenobserved,includingdiarrhea,pruritus,erythemaoftheskin,

swellingofthevulva,rectaledemaandprolapse.Thesereversiblesignsappeared 48-72 hoursafter

startoftreatment.

4.7Useduring pregnancy, lactationorlay

Laboratorystudiesinmiceandratshavenotproducedanyevidenceofteratogenic,foetotoxicor

maternotoxiceffects.Nostudieshavebeenconductedinthetargetspecies.Useonlyaccordingto

thebenefit/risk assessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Antagonismwithsubstancesofthelincosamidegroup.

4.9Amountsto beadministeredandadministrationroute

Oraladministrationthroughthedrinkingwater

Incalvestheproductcanalsobeadministeredthroughmilk ormilk replacer.

1,1gramoftheveterinarymedicinalproductcorrespondsto1gramoftylosin.Thedosagesareas

follows:

Calves:

10–20 mgtylosinperkgBW(correspondingto 11–22 mgoftheveterinarymedicinalproductper

kgBW),twicedaily(correspondingtoadailydoseof20–40mgtylosinperkgBW),for7-14

days.

Turkeys:

75–100mgtylosinperkgBWperday(correspondingto82.5–110mgoftheveterinary

medicinalproductperkgBW)for3–5 days.

Chickens:

Forthetreatmentofchronicrespiratorydisease:

75–100mgtylosinperkgBWperday(correspondingto82.5–110mgoftheveterinary

medicinalproductperkgBW)for3–5 days.

Forthetreatmentofnecroticenteritis:

20 mgtylosinperkgBWperday(correspondingto 22 mgoftheveterinarymedicinalproduct)for3

days.

Pigs:

Forthetreatmentofenzooticpneumonia:

20mgtylosinperkgBWperday(correspondingto22mgoftheveterinarymedicinalproductper

kgBW)for10 days.

ForthetreatmentofileitisorPIA:

5–10mgtylosinperkgBWperday(correspondingto5.5-11mgoftheveterinarymedicinal

productperkgBW)for7 days.

Forthepreparationofthemedicatedwater/milk/milk-replacerthebodyweightoftheanimalsto be

treatedandtheiractualdailywater/milk/milk-replacerconsumptionshouldbetakenintodue

account.Consumptionmayvarydependingonfactorslikeage,stateofhealth,breed,husbandry

system.Toprovidetherequiredamountofactivesubstanceinmgperlitredrinkingwater/milk/milk-

replacerthefollowingcalculationshould bemade:

……mgtylosinper

Averagebodyweight(kg)

kgbodyweightperday x oftheanimalsto betreated =…...mgtylosin/

Averageamountofdrinkingwaterormilk /animal(l) lofdrinkingwater

Sufficientaccesstothesystemofwatersupplyshouldbeavailablefortheanimalstobetreatedto

ensureadequatewaterconsumption.Noothersourceofdrinkingwatershouldbeavailableduring

themedicationperiod.

Shouldtherebenoclearresponsetotreatmentwithin3daysthetreatmentapproachshouldbe

reconsidered.Aftertheendofthemedicationperiodthewatersupplysystemshouldbecleaned

appropriatelyto avoid intakeofsub-therapeuticamountsoftheactivesubstancewhichmightsupport

developmentofresistance.

Medicated water, milk ormilk replacershould bereplaced every24 hours.

Ifindividualanimalsshowsignsofaseriousinfectionsuchasareduced waterorfeed intake, then

theyshould betreated individually, suchasbyinjection.

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

Thereisno evidenceoftylosintoxicityinrats, atdoseratesofup to 1000 mg/kgbytheoralroute.

Thereisno evidenceoftylosintoxicityinchickens, turkeys, pigsorcalveswhenadministered orally

atup to threetimestherecommendeddose.

4.11Withdrawalperiod(s)

Calves(meatand offal):12 days

Pigs(meatand offal):1 day

Turkeys(meatand offal):2 days

Turkey(eggs):Zerodays

Chickens(meatand offal):1 day

Chicken(eggs):Zerodays

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:macrolideantibiotic,

ATCVetCode:QJ01FA90

Pharmacodynamicproperties

TylosinisamacrolideantibioticproducedbyastrainofStreptomycesfradiae.Itexertsits

antimicrobialeffectbyinhibitingproteinsynthesisofsusceptiblemicro-organisms.

ThetylosinspectrumofactivityincludesamongstothersGram-positivebacteria,someGram–

negativestrainssuchasPasteurella, andMycoplasma spp.

Pharmacokineticparticulars

Inmostspeciespeakplasmaconcentrationshavebeenattained1to2hoursafteradministrationof

tylosin.Comparedtoplasmalevelsclearlyhighertissueconcentrationshavebeenobserved. Tylosin

wasextensivelymetabolised.

Mostoftheresiduesareexcretedinfaecespredominantlyconsistingoftylosin(factorA), relomycin

(factorD)and dihydrodesmycosin.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

None

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwith

otherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackaged forsale:3 years

Shelf-lifeafterdilutionorreconstitutionaccordingto directions:

medicated water:24 hours

medicated milk ormilk replacer:24 hours

Shelf-lifeafterfirstopeningtheimmediatepackaging:3 months

6.4.Specialprecautionsforstorage

Storeintheoriginalcontainerinorderto protectfromlight. Storebelow 30°C.

6.5Natureandcompositionofimmediatepackaging

1.1 kgresealableblock bottomzipped sachetmadeofpolyethylene/aluminium/polyethylene

terephthalatelaminate

110 ghighdensitypolyethylenepotwithpolypropylenecap

6.6Specialprecautionsforthedisposalofunusedveterinary medicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunused veterinarymedicinalproductorwastematerialsderived fromsuchveterinarymedicinal

productsshould bedisposed ofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600 Antwerpen

Belgium

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE, SUPPLYAND/ORUSE

LABELLINGANDPACKAGELEAFLET

A. LABELLING

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Resealable1.1 kgPE-Alu-PETbag

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pharmasin100%w/wGranulesforUseinDrinkingWater

forPigs,Chickens,TurkeysandCalves

Tylosin(asTylosintartrate)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1.1gofgranulescontains

1goftylosin(correspondingto1.1goftylosintartrate)

3. PHARMACEUTICALFORM

Granulesforuseindrinkingwater

4. PACKAGESIZE

1.1 kg

5. TARGETSPECIES

Pigs, chickens, turkeysand calves

6. INDICATION(S)

Read thepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Read thepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Calves(meatand offal):12days

Pigs(meatand offal):1 day

Turkeys(meatand offal):2 days

Turkey(eggs):Zerodays

Chickens(meatand offal):1 day

Chicken(eggs):Zerodays

9. SPECIALWARNING(S), IFNECESSARY

Read thepackageleafletforfullinstructionsand userwarningsbeforeuse

10.EXPIRYDATE

EXP{month/year}

Shelflifeafterdilutionorreconstitutioninwater, milk ormilk replacer:24 hours

Shelflifeafterfirstopening:3 months

Oncebroached, useby:

11.SPECIALSTORAGECODITIONS

Storeintheoriginalcontainerinorderto protectfromlight.

Storebelow30°C

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS, IFANY

Read thepackageleafletbeforeuse.

13.THEWORDS“FORANIMALTREATMENTONLY” ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE, ifapplicable

Foranimaltreatmentonly

To besupplied onlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachand sightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

16.MARKETINGAUTHORISATIONNUMBER(S)

17.MANUFACTURER’SBATCHNUMBER

Lot:

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

HDPEpotof110g

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pharmasin100%w/wGranulesforUseinDrinkingWater

forPigs,Chickens,TurkeysandCalves

Tylosin(asTylosintartrate)

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

1.1gofgranulescontains

1goftylosin(correspondingto1.1goftylosintartrate)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

110g

4. ROUTE(S)OFADMINISTRATION

Oral

5. WITHDRAWALPERIOD

Calves(meatand offal):12 days

Pigs(meatand offal):1 day

Turkeys(meatand offal):2days

Turkey(eggs):Zerodays

Chickens(meatand offal):1 day

Chicken(eggs):Zerodays

6. BATCHNUMBER

Lot:

7. EXPIRYDATE

EXP{month/year

Shelflifeafterdilutionorreconstitutioninwater, milk ormilk replacer:24 hours

Shelflifeafterfirstopening:3 months

Oncebroached, useby:

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B. PACKAGELEAFLET

PACKAGELEAFLET

Pharmasin100%w/wGranulesforUseinDrinkingWater

forPigs,Chickens,TurkeysandCalves

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDER

RESPONSIBLEFORBATCHRELEASE, IFDIFFERENT

Marketingauthorisation

HuvepharmaNV, Uitbreidingstraat 80, 2600 Antwerpen, Belgium

Manufacturer

BiovetJSC, 39 PetarRakovStr, 4550 Peshtera-Bulgaria

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pharmasin100%w/wGranulesforUseinDrinkingWater

forPigs,Chickens,TurkeysandCalves

Tylosin(asTylosintartrate)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

1.1gofgranulescontains

1goftylosin(correspondingto1.1goftylosintartrate)

4. INDICATION(S)

Calves:Treatmentand preventionofpneumoniacaused byMycoplasma sppwhenthediseasehas

beenestablished intheherd

Pigs:

-Treatment and prevention ofenzooticpneumoniacausedby Mycoplasma

hyopneumoniaeandMycoplasmahyorhiniswhenthewhenthediseasehasbeen

established intheherd.

- TreatmentandpreventionofPorcineIntestinalAdenomatosis(Ileitis)associatedwith

Lawsonia intracellulariswhenthediseasehasbeenestablished intheherd.

Chickens:

-Treatmentandpreventionofchronicrespiratorydiseases(CRD)causedbyMycoplasma

gallisepticumandMycoplasmasynoviaewhenthediseasehasbeenestablishedinthe

flock

-Treatmentandpreventionofnecroticenteritiscaused byClostridiumperfringenswhenthe

diseasehasbeenestablished intheflock

Turkeys:TreatmentandpreventionofinfectioussinusitiscausedbyMycoplasmagallisepticum.

whenthediseasehasbeenestablished intheflock.

5. CONTRAINDICATIONS

Do notuseinanimalswithknownhypersensitivityto tylosinorothermacrolides,

Do notuseincaseswithknownresistanceto tylosinorcross-resistanceto othermacrolides(MLS-

resistance).

Do notuseinanimalsvaccinated withtylosin-sensitivevaccineseitheratthesametimeorwithin1

week previously.

Do notuseinanimalswithhepaticdisorders.

Do notuseinhorses.

6. ADVERSEREACTIONS

Inpigs,adversereactionshavebeenobserved,includingdiarrhea,pruritus,erythemaoftheskin,

swellingofthevulva,rectaledemaandprolapse.Thesereversiblesignsappeared 48-72 hoursafter

startoftreatment.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Calves, pigs, chickens, turkeys

8. DOSAGEFOREACHSPECIES, ROUTE(S)ANDMETHODOF

ADMINISTRATION

Oraladministrationthroughthedrinkingwater

Incalvestheproductcanalsobeadministeredthroughmilk ormilk replacer.

1.1gramoftheveterinarymedicinalproductcorrespondsto1gramoftylosin.Thedosagesareas

follows:

Calves:

10–20 mgtylosinperkgBW(correspondingto 11–22 mgoftheveterinarymedicinalproductper

kgBW),twicedaily(correspondingtoadailydoseof20–40mgtylosinperkgBW),for7-14

days.

Turkeys:

75–100mgtylosinperkgBWperday(correspondingto82.5–110mgoftheveterinary

medicinalproductperkgBW)for3–5 days.

Chickens:

Forthetreatmentofchronicrespiratorydisease:

75–100mgtylosinperkgBWperday(correspondingto82.5–110mgoftheveterinary

medicinalproductperkgBW)for3–5 days.

Forthetreatmentofnecroticenteritis:

20 mgtylosinperkgBWperday(correspondingto 22 mgoftheveterinarymedicinalproduct)for3

days.

Pigs:

Forthetreatmentofenzooticpneumonia:

20mgtylosinperkgBWperday(correspondingto22mgoftheveterinarymedicinalproductper

kgBW)for10 days.

ForthetreatmentofileitisorPIA:

5–10mgtylosinperkgBWperday(correspondingto5.5-11mgoftheveterinarymedicinal

productperkgBW)for7 days.

Forthepreparationofthemedicatedwater/milk/milk-replacerthebodyweightoftheanimalsto be

treatedandtheiractualdailywater/milk/milk-replacerconsumptionshouldbetakenintodue

account.Consumptionmayvarydependingonfactorslikeage,stateofhealth,breed,husbandry

system.Toprovidetherequiredamountofactivesubstanceinmgperlitredrinkingwater/milk/milk-

replacerthefollowingcalculationshould bemade:

……mgtylosinper Averagebodyweight(kg)

kgbodyweightperday x oftheanimalsto betreated =…...mgtylosin/

Averageamountofdrinkingwaterormilk /animal(l) lofdrinkingwater

Ifindividualanimalsshowsignsofaseriousinfectionsuchasareduced waterorfeed intake, then

theyshould betreated individually, suchasbyinjection.

9. ADVICEONCORRECTADMINISTRATION

Sufficientaccesstothesystemofwatersupplyshouldbeavailablefortheanimalstobetreatedto

ensureadequatewaterconsumption.Noothersourceofdrinkingwatershouldbeavailableduring

themedicationperiod.

Shouldtherebenoclearresponsetotreatmentwithin3daysthetreatmentapproachshouldbe

reconsidered.Aftertheendofthemedicationperiodthewatersupplysystemshouldbecleaned

appropriatelyto avoid intakeofsub-therapeuticamountsoftheactivesubstancewhichmightsupport

developmentofresistance.

Medicated water, milk ormilk replacershould bereplaced every24 hours.

10.WITHDRAWALPERIOD

Calves(meatand offal):12 days

Pigs(meatand offal):1 day

Turkeys(meatand offal):2 days

Turkey(eggs):Zerodays

Chickens(meatand offal):1 day

Chicken(eggs):Zerodays

11.SPECIALSTORAGEPRECAUTIONS

Storeintheoriginalcontainerinorderto protectfromlight. Storebelow 30°C.

Shelf-lifeafterdilutionorreconstitutionaccordingto directions:

medicated water:24 hours

medicated milk ormilk replacer:24 hours

Shelf-lifeafterfirstopeningtheimmediatepackaging:3 months

Whenthecontainerisbroached(opened)forthefirsttime,usingthein-useshelf-lifewhichis

specifiedonthislabel,thedateonwhichanyproductremaininginthecontainershould bediscarded

should beworked out.Thisdiscard dateshould bewritteninthespaceprovided onthelabel.”

12.SPECIALWARNING(S)

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriatotylosin,bacteriological

samplingand susceptibilitytestingarerecommended.

Under-dosingand/ortreatingforaninsufficientlengthoftimeareconsidered to promotethe

developmentofresistanceinbacteriaand should beavoided.

Interactions

Antagonismwithsubstancesofthelincosamidegroup.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwith

otherveterinarymedicinalproducts.

Specialprecautionsforuseinanimals

Animalswithacuteinfectionsmayhaveareducedwaterandfeed intakeand should betreated with

asuitableinjectableveterinarymedicinalproductfirst.

Donotleaveordisposeofwatercontainingtylosintartratewhereitmaybeaccessibletoeither

animalsnotundertreatmentorwildlife.

Userwarnings

Tylosinmayinduceirritation.Macrolides,suchastylosin,mayalsocausehypersensitivity(allergy)

following injection,inhalation,ingestionorcontactwithskinoreye.Hypersensitivitytotylosinmaylead

tocrossreactionstoothermacrolidesandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeseriousandthereforedirectcontactshouldbeavoided.

ToavoidexposureduringpreparationofthemedicatedTylosinmayinduceirritation.Macrolides,such

astylosin,mayalsocausehypersensitivity(allergy)followingdrinkingwater,wearoveralls,safety

glasses,imperviousglovesandweareitheradisposablehalfmaskrespiratorconformingtoEuropean

StandardEN149oranon-disposablerespiratortoEuropeanStandardEN140withafiltertoEN143.

Washhandsafteruse.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseofaccidental

eyecontact,flushtheeyeswithplentyofclean,runningwater.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedicaladviceand

showthephysicianthiswarning.Swellingoftheface,lipsandeyesordifficultyinbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

Useduring pregnancy, lactationorlay

Laboratorystudiesinmiceandratshavenotproducedanyevidenceofteratogenic,foetotoxicor

maternotoxiceffects.Nostudieshavebeenconductedinthetargetspecies.Useonlyaccordingto

thebenefit/risk assessmentbytheresponsibleveterinarian.

Overdose

Thereisno evidenceoftylosintoxicityinrats, atdoseratesofup to 1000 mg/kgbytheoral

route.Thereisno evidenceoftylosintoxicityinchickens, turkeys, pigsorcalveswhenadministered

orallyatup to threetimestherecommended dose.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS, IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshould bedisposed ofinaccordancewithlocalrequirements.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

1.1 kgresealableblock bottomzipped sachetmadeofpolyethylene/aluminium/polyethylene

terephthalatelaminate

110 ghighdensitypolyethylenepotwithpolypropylenecap

Notallpack sizesmaybemarketed

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentative

ofthemarketingauthorisationholder.

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