Clavubactin 500/125 mg tablet

Main information

  • Trade name:
  • Clavubactin 500/125 mg tablet
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Clavubactin 500/125 mg tablet
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ampicillin and enzyme inhibitor
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0110/003
  • Authorization date:
  • 30-03-2011
  • EU code:
  • NL/V/0110/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLAVUBACTIN®500/125MGtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances: quantity

Amoxicillin

(asamoxicillintrihydrate) 500mg

Clavulanicacid

(aspotassiumclavulanate) 125mg

Excipient(s):

Saccharinsodium 7.00mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Yellowish-whitetolightyellowoblong-formedtabletwithroundedgesandembossement625onone

side.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofinfectionsindogscausedbybacteriasensitivetoamoxicillinincombinationwith

clavulanicacid,particularly:

- Skininfections(includingsuperficialanddeeppyodermas)associatedwithStaphylococci(including

beta-lactamaseproducingstrains)andStreptococci.

- UrinarytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducingstrains),

Streptococci,Escherichiacoli(includingbeta-lactamaseproducingstrains),Fusobacterium

necrophorumandProteusspp.

- RespiratorytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducing

strains),StreptococciandPasteurellae.

- EnteritisassociatedwithEscherichiacoli(includingbeta-lactamaseproducingstrains)and

Proteusspp.

- Infectionsoftheoralcavity(mucousmembrane)associatedwithClostridia,Corynebacteria,

Staphylococci(includingbeta-lactamaseproducingstrains),Streptococci,Bacteroidesspp

(includingbeta-lactamaseproducingstrains),FusobacteriumnecrophorumandPasteurellae.

4.3 Contraindications

Donotuseinanimalswithknownhypersensivitytopenicillinorothersubstancesofthebeta-lactam

group.

Donotuseinseriousdysfunctionofthekidneysaccompaniedbyanuriaandoliguria.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

4.4 Specialwarningsforeachtargetspecies

Noneknown.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Nationalveterinaryguidelinesandpracticeswithrespecttotheuseofbroad-spectrumantibiotics

shouldbetakenintoaccount.

Donotuseincaseofbacteriasensitivetosmallspectrumpenicillinsortoamoxicillinassingle

substance.

Itisadvisedthatuponinitiatingtherapyappropriatesensitivitytestingisperformedandthattherapyis

continuedonlyaftersusceptibilitytothecombinationhasbeenestablished.

Inappropriateuseoftheproductmayincreasetheprevalenceofresistantbacteriaandmaydecrease

itseffectiveness.

Inanimalswithhepaticandrenalfailure,thedosingregimenshouldbecarefullyevaluated.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivityreactions(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross-reactionsto

cephalosporinsandviceversa.

Allergicreactionstothesesubstancesmayoccasionallybeserious.

- Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

- Whilehandlingtheproduct,avoidcontactwiththeskinandeyes.

- Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladvise

andshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

- Washhandsafteruse.

4..6Adversereactions(frequencyandseriousness)

Mildgastrointestinalsymptoms(diarrhea,nauseaandvomiting)mayoccurafteradministrationofthe

product.

Allergicreactions(skinreactions,anaphylaxia)mayoccasionallyoccur.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehavenotproducedanyevidenceofteratogenicorfetotoxiceffects.

Nostudieshavebeenconductedinthepregnantandlactatingdogs.Useonlyaccordingtothe

benefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Chloramphenicol,macrolides,sulfonamides,andtetracyclinesmayinhibittheantibacterialeffectsof

penicillins.

4.9 Amountstobeadministeredandadministrationroute

Posology

Fororaladministrationindogsandcats.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.

Dosage

Therecommendeddoseis12.5mgofcombinedactivesubstance(=10mgamoxicillinand2.5mg

clavulanicacid)perkgbodyweight,twicedaily.

Animalweight Dosage

Upto2.5kg 1

tabletClavubactin®50/12.5

2.5-5kg 1tabletClavubactin®50/12.5

5-7.5kg 1 1

tabletClavubactin®50/12.5

7.5-10kg 2tabletsClavubactin®50/12.5

10-12.5kg 1

tabletClavubactin®250/62.5or2 1

tabletsofClavubactin®50/12.5

12.5-25kg 1tabletClavubactin®250/62.5

25-37.5kg 1 1 /

tabletClavubactin®250/62.5

37.5-50kg 1tabletClavubactin®500/125or2tabletsofClavubactin®250/62.5

Inrefractorycasesofskininfections,adoubledoseisrecommended(25mgperkgbodyweight,twice

daily).

Durationoftherapy

- Themajorityofroutinecasesrespondto5–10daysoftherapy.

- Inchroniccases,,alongercaseoftherapyisrecommendedasfollows:

Chronicskininfections 10-30daysorlongerinclinicalrefractorycasesorindeep

bacterialpyoderma(upto6-8weeks)dependingonclinical

response

Chroniccystitis 10-28days

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Mildgastrointestinalsymptoms(diarrhea,nauseaandvomiting)mayoccurmorefrequentlyafter

overdoseoftheproduct.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

5.1 Pharmacodynamicproperties

ATCvetcode:QJ01CR02

Amoxicillinisasemi-syntheticpenicillinwithbactericidalaction,belongingtothebetalactamantibiotic

group.Clavulanicacidisabeta-lactamaseinhibitorwithasimilarstructuretothepenicillinnucleus.

Resistancetoantibioticsfromthepenicillingroupisoftencausedbybeta-lactamaseenzymes.These

enzymesdestroytheantibioticbeforeitcanactonthebacteriathemselves.

Clavulanicacidbreaksthroughthisbacterialdefencemechanismbyinactivatingthebetalactamase.

Bacteriaproducingextra-chromosomalbeta-lactamases,whichareconsequentlyresistantto

amoxicillin,demonstrateinvitrosusceptibilityinthepresenceofclavulanicacid.Inveterinarypractice,

goodclinicalefficacyhasbeendemonstratedwitharatioof1partclavulanicacidto4partsamoxicillin.

Invitrothecombinationamoxicillin+clavulanicacidisactiveagainstawiderangeofclinically

importantaerobicandanaerobicbacteria.Goodsusceptibilityisshownwithseveralgram-positive

bacteriaincludingStaphylococci(includingbeta-lactamaseproducingstrains,MIC900.6

g/ml),

Clostridia(MIC900.5

g/ml),CorynebacteriaandStreptococci,andgram-negativebacteriaincluding

Bacteroidesspp(includingbetalactamaseproducingstrains,MIC900.5

g/ml),Pasteurellae(MIC90

0.12

g/ml),Escherichiacoli(includingbeta-lactamaseproducingstrains,MIC908

g/ml)and

Proteusspp(MIC900.5

g/ml).VariablesusceptibilityisfoundinsomeE.coliandKlebsiellaspp.

SusceptibilitytestsonbacterialpathogensfromcanineandfelineoriginrevealedthefollowingMIC50

valuesforafixedcombinationofamoxicillinandclavulanicacid(2:1):Proteusspp0.5

g/ml,

Staphylococcusintermedius0.094µg/ml,andBordetellabronchiseptica4µg/ml.

BacteriawithaMIC90of<2µg/mlareconsideredbeingsusceptibleandthosewithaMIC90of>8

µg/mlbeingresistant.ResistanceisshownamongEnterobacterspp,Pseudomonasaeruginosaand

methicillin-resistantStaphylococcusaureus.AtrendinresistanceofE.coliisreported.

5.2 Pharmacokineticparticulars

Thepharmacokineticbehaviourofclavulanicacidisroughlycomparablewiththatofamoxicillin.

Amoxicilliniswellabsorbedafteroraladministration.Indogs,thesystemicbioavailabilityis60-70%.

Amoxicillin(pKa2.8)hasarelativelysmallapparentdistributionvolume,lowplasma-proteinbinding

(34%indogs)andashorteliminationhalf-lifeperiodduetoactivetubularexcretionbythekidneys.

Afterabsorption,highestconcentrationsarefoundinthekidneys(urine)andbile,followedbytheliver,

lungs,heartandspleen.

Distributionofamoxicillinintocerebrospinalfluidislowunlessthemeningesareinflamed.

Clavulanicacid(pKa2.7)isalsowellabsorbedafteroraladministration.Penetrationintocerebrospinal

fluidispoor.Plasma-proteinbindingisabout25%andtheeliminationhalflifevalueisshort.Clavulanic

acidislargelyeliminatedbyrenalexcretion(unchangedintheurine).

ThepharmacokineticparametersofClavubactin®tabletsindogsandcatsafteroraladministrationofa

doseof25mgactivematerial(=20mgamoxicillin+5mgclavulanicacid)perkgbodyweightare

summarizedinthefollowingtable.

Cmax tmax t1/2 AUC∞

(µg/ml) (hour) (hour) h.µg/ml

Dog

Amoxicillin 11.41±2.74 1.38±0.41 1.52±0.19 36.57±7.31

Clavulanicacid 2.06±1.05 0.95±0.33 0.71±0.23 3.14±1.21

Thereisevidencethatabsorptionofamoxicillinisanactiveprocessbothinanimalspeciesandinman

whichissaturableathigherdosesandisinfluencedbythepresenceofclavulanicacidwhichmay

competeforthesamedipeptidecarrier-mediatedsystem.Thismayalsoexplaintheobservedvariability

ofclavulanicacidabsorptionintargetspecies.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

microcrystallinecellulose,hypromellose,crospovidone,povidone,macrogol6000,stearicacid,saccharin

sodium,vanillaflavour,quinolineyellowlacquer(E104),titaniumdioxide(E171),colloidalanhydrous

silicaandmagnesiumstearate.

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

2years.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalcontainer.

Storeoutofthereachofchildren.

Duringtherapytablethalvesshouldbestoredinadryplace(preferablyinthealuminium/aluminium

strip);nonusedhalvesaftertreatmentshouldbedisposed.

6.5 Natureandcompositionofimmediatepackaging

Aluminium/aluminiumstripswith2tablets,inacardboardboxcontaining5strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining5strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining25strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining50strips.

Aluminium/aluminiumstripswith10tablets,inacardboardboxcontaining10strips.

Aluminium/aluminiumstripswith10tablets,inacardboardboxcontaining25strips.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Wilgenweg7

NL-3421TVOudewater

theNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobeestablishednationally.

9. DATEOFRENEWALOFTHEAUTHORISATION

24April2007

10 DATEOFREVISIONOFTHETEXT

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Cardboardbox

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLAVUBACTIN500/125mgtabletsfordogs.

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstances:

Amoxicillin(asamoxicillintrihydrate) 500mg

Clavulanicacid(aspotassiumclavulanate) 125mg

Adjuvant(s):

Saccharinsodium 7.0mg

3. PHARMACEUTICALFORM

Tablet.

4. PACKAGESIZE

Aluminium/aluminiumstripswith2tablets,inacardboardboxcontaining5strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining5strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining25strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining50strips.

Aluminium/aluminiumstripswith10tablets,inacardboardboxcontaining10strips.

Aluminium/aluminiumstripswith10tablets,inacardboardboxcontaining25strips.

Notallpacksizesmaybemarketed.

5. TARGETSPECIES

Dog.

6. INDICATION(S)

Treatmentofinfectionsindogscausedbybacteriasensitivetoamoxicillinincombinationwith

clavulanicacid,particularly:

- Skininfections(includingsuperficialanddeeppyodermas)associatedwithStaphylococci(including

beta-lactamaseproducingstrains)andStreptococci.

- UrinarytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducingstrains),

Streptococci,Escherichiacoli(includingbeta-lactamaseproducingstrains),Fusobacterium

necrophorumandProteusspp.

- RespiratorytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducing

strains),StreptococciandPasteurellae.

- EnteritisassociatedwithEscherichiacoli(includingbeta-lactamaseproducingstrains)and

Proteusspp.

- Infectionsoftheoralcavity(mucousmembrane)associatedwithClostridia,Corynebacteria,

Staphylococci(includingbeta-lactamaseproducingstrains),Streptococci,Bacteroidesspp

(includingbeta-lactamaseproducingstrains),FusobacteriumnecrophorumandPasteurellae.

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

<EXP{month/year}>

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25°C.

Storeintheoriginalpackage.

Duringtherapytablethalvesshouldbestoredinadryplace(preferablyinthealuminium/aluminium

strip);nonusedhalvesaftertreatmentshouldbedisposed.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasureswillhelp

toprotecttheenvironment.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Name:LeVetB.V.

Address:Wilgenweg7

3421TVOudewater

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

Tobeestablishednationally.

17. MANUFACTURER’SBATCHNUMBER

BatchLot{number}

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

(Aluminium/aluminiumstrip)

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLAVUBACTIN500/125mgtabletvet.

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

3. EXPIRYDATE

EXP{month/year}………

4. BATCHNUMBER

LOT…….

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B.PACKAGELEAFLET

PACKAGELEAFLET

CLAVUBACTIN500/125 mg tabletsfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

Name: LeVetB.V.

Address: Wilgenweg7

3421TVOudewater

TheNetherlands

Manufacturerforthebatchrelease:

Name: LosanPharmaGmb

Address: OttoHahnstrasse13

79395Neuenberg

Germany

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLAVUBACTIN500/125mgtabletsfordogs.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activesubstancespertablet:

Amoxicillin(asamoxicillintrihydrate)500mg

Clavulanicacid(aspotassiumclavulanate) 125mg

Otheringredients

Microcrystallinecellulose,hypromellose,crospovidone,povidone,macrogol6000,stearicacid,

saccharinsodium,vanillaflavour,quinolineyellowlacquer(E104),titaniumdioxide(E171),

colloidalanhydroussilicaandmagnesiumstearate.

4. INDICATION(S)

Treatmentofinfectionsindogscausedbybacteriasensitivetoamoxicillinincombination

withclavulanicacid,particularly:

- Skininfections(includingsuperficialanddeeppyodermas)associatedwithStaphylococci(including

beta-lactamaseproducingstrains)andStreptococci.

- UrinarytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducingstrains),

Streptococci,Escherichiacoli(includingbeta-lactamaseproducingstrains),Fusobacterium

necrophorumandProteusspp.

- RespiratorytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducing

strains),StreptococciandPasteurellae.

- EnteritisassociatedwithEscherichiacoli(includingbeta-lactamaseproducingstrains)and

Proteusspp.

- Infectionsoftheoralcavity(mucousmembrane)associatedwithClostridia,Corynebacteria,

Staphylococci(includingbeta-lactamaseproducingstrains),Streptococci,Bacteroidesspp

(includingbeta-lactamaseproducingstrains),FusobacteriumnecrophorumandPasteurellae.

5. CONTRAINDICATIONS

Donotuseinanimalswithknownhypersensivitytopenicillinorothersubstancesofthebetalactam

group.

Donotuseinseriousdysfunctionofthekidneysaccompaniedbyanuriaandoliguria.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

6. ADVERSEREACTIONS

Mildgastrointestinalsymptoms(diarrhea,nauseaandvomiting)mayoccurafteradministrationofthe

product.Allergicreactions(skinreactions,anaphylaxia)mayoccasionallyoccur.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Dogs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Posology

Fororaladministrationonly.

Dosage

Therecommendeddoseis12.5mgofcombinedactivesubstance(=10mgamoxicillinand2.5mg

clavulanicacid)perkgbodyweight,twicedaily.

Animalweight Dosage

Upto2.5kg 1

tabletClavubactin®50/12.5

2.5-5kg 1tabletClavubactin®50/12.5

5-7.5kg 1 1 /

tabletClavubactin®50/12.5

7.5-10kg 2tabletsClavubactin®50/12.5

10-12.5kg 1

tabletClavubactin®250/62.5or

tabletsofClavubactin®50/12.5

12.5-25kg 1tabletClavubactin®250/62.5

25-37.5kg 1 1 /

tabletClavubactin®250/62.5

37.5-50kg 1tabletClavubactin®500/125or

2tabletsofClavubactin®250/62.5

Inrefractorycasesofskininfections,adoubledoseisrecommended(25mgperkg

bodyweight,twicedaily).

Durationoftherapy

- Themajorityofroutinecasesrespondto5–10daysoftherapy.

- Inchroniccases,,alongercaseoftherapyisrecommendedasfollows:

Chronicskininfections 10-30daysorlongerinclinicalrefractorycasesorindeep

bacterialpyoderma(upto6-8weeks)dependingonclinical

response

Chroniccystitis 10-28days

9. ADVICEONCORRECTADMINISTRATION

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Donotstoreabove25°C.

Storeintheoriginalpackage.

Keepoutofthereachandsightofchildren.

Duringtherapytablethalvesshouldbestoredinadryplace(preferablyinthealuminium/aluminium

strip);nonusedhalvesaftertreatmentshouldbedisposed.

DonotuseaftertheexpirydatestatedonthecartonafterEXP.

12. SPECIALWARNING(S)

Specialprecautionsforuse

Nationalveterinaryguidelinesandpracticeswithrespecttotheuseofbroad-spectrumantibiotics

shouldbetakenintoaccount.

Donotuseincaseofbacteriasensitivetosmallspectrumpenicillinsortoamoxicillinassingle

substance.

Itisadvisedthatuponinitiatingtherapyappropriatesensitivitytestingisperformedandthattherapyis

continuedonlyaftersusceptibilitytothecombinationhasbeenestablished.

Inappropriateuseoftheproductmayincreasetheprevalenceofresistantbacteriaandmaydecrease

itseffectiveness.

Inanimalswithhepaticandrenalfailure,thedosingregimenshouldbecarefullyevaluated.

Specialprecautionsforuseinanimals

None.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivityreactions(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross-reactionsto

cephalosporinsandviceversa.

Allergicreactionstothesesubstancesmayoccasionallybeserious.

- Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

- Whilehandlingtheproduct,avoidcontactwiththeskinandeyes.

- Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladvise

andshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

- Washhandsafteruse.

Useduringpregnancyandlactation

Laboratorystudiesinratsandmicehavenotproducedanyevidenceofteratogenicorfetotoxiceffects.

Nostudieshavebeenconductedinthepregnantandlactatingdogsandcats.Useonlyaccordingtothe

benefit/riskassessmentbytheresponsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Chloramphenicol,macrolides,sulfonamides,andtetracyclinesmayinhibittheantibacterialeffectsof

penicillins.

Overdose(symptoms,emergencyprocedures,antidotes)

Mildgastrointestinalsymptoms(diarrhea,nauseaandvomiting)mayoccurmorefrequentlyafter

overdoseoftheproduct.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshould

helptoprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

24April2007

15. OTHERINFORMATION

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

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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

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, 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: 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

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

26-6-2018

Huish Outdoors recalls Oceanic and Hollis Scuba Diving Regulators

Huish Outdoors recalls Oceanic and Hollis Scuba Diving Regulators

The scuba diving regulators can restrict airflow at low tank pressures (below 500 psi), posing a drowning hazard to divers.

Health Canada

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

21-6-2018

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may b...

FDA - U.S. Food and Drug Administration

20-6-2018

Public Notification: Black Stallion 35000 contains hidden drug ingredient

Public Notification: Black Stallion 35000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Stallion 35000, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Mini Cookies with Caramel Flavor”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Liubitelskie Cookies”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

18-4-2018

ViaGro 500mg Male Enhancement capsules

ViaGro 500mg Male Enhancement capsules

Safety advisory

Therapeutic Goods Administration - Australia

14-4-2018

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Extreme 50000, a product promoted and sold for sexual enhancement on various websites, including www.bonanza.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

14-12-2017

Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil

Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil

Orange, CA, Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil.

FDA - U.S. Food and Drug Administration

25-9-2017

Global operation against illegal medicines

Global operation against illegal medicines

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

Danish Medicines Agency

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration

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

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

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