Clavubactin 250/62.5 mg tablet

Main information

  • Trade name:
  • Clavubactin 250/62.5 mg tablet
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Clavubactin 250/62.5 mg tablet
    Portugal
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0110/002
  • Authorization date:
  • 30-03-2011
  • EU code:
  • NL/V/0110/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLAVUBACTIN®250/62.5MGtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances: quantity

Amoxicillin

(asamoxicillintrihydrate) 250mg

Clavulanicacid

(aspotassiumclavulanate) 62.5mg

Excipient(s):

Saccharinsodium 3.50mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Yellowish-whitetolightyellowoblongtabletwithbreakmarkonbothsides.

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

CLAVUBACTIN250/62,5mgtabletsfordogs.

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstances:

Amoxicillin(asamoxicillintrihydrate) 250mg

Clavulanicacid(aspotassiumclavulanate) 62.5mg

Adjuvant(s):

Saccharinsodium 3.5mg

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

CLAVUBACTIN250/62,5mgtabletvet.

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

3. EXPIRYDATE

EXP{month/year}………

4. BATCHNUMBER

LOT…….

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B.PACKAGELEAFLET

PACKAGELEAFLET

CLAVUBACTIN250/62,5 mg tabletsfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

Name: LeVetB.V.

Address: Wilgenweg7

3421TVOudewater

TheNetherlands

Manufacturerforthebatchrelease:

Name: LosanPharmaGmb

Address: OttoHahnstrasse13

79395Neuenberg

Germany

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLAVUBACTIN250/62,5mgtabletsfordogs.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activesubstancespertablet:

Amoxicillin(asamoxicillintrihydrate)250mg

Clavulanicacid(aspotassiumclavulanate) 62.5mg

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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Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

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