NELIO 20

Main information

  • Trade name:
  • NELIO 20
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NELIO 20
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • benazepril
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0205/002
  • Authorization date:
  • 05-12-2010
  • EU code:
  • FR/V/0205/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

VeterinaryMedicinalproduct

NELIO20MGTABLETFORDOGS

PARTIB

Pharmaceuticalform

Tablet

VeterinaryMedicinalproduct

NELIO20MGTABLETFORDOGS

PARTIB

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmaceuticalform

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NELIO20COMPRIMEPOURCHIENS:FR

NELIO20MGTABLETFORDOGS*

NelioVet20MgTablettiKoirille:FI

NelioVet20mgtablettförhund:SE

NELIOVET:DK

*willbetranslatedinnationallanguage

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains

Activesubstance:

Benazeprilhydrochloride............................................20mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Clovershapedscoredbeigetablet,divisibleintohalvesorquarters.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Dogs:

-Treatmentofcongestiveheartfailure

4.3Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseincasesofhypotension,hypovolaemia,hyponatraemiaoracuterenalfailure.

Donotuseincasesofcardiacoutputfailureduetoaorticorpulmonarystenosis.

Donotuseduringpregnancyorlactation(section4.7).

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Noevidenceofrenaltoxicityoftheveterinarymedicinalproducthasbeenobservedduring

clinicaltrials,.however,asisroutineincasesofchronickidneydisease,itisrecommendedto

monitorplasmacreatinine,ureaanderythrocytecountsduringtherapy..

Thesafetyandefficacyoftheproducthasnotbeenexaminedindogsweighinglessthan2.5

kg

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladviceimmediatelyandshowthelabelor

thepackageleaflettothephysician.

Pregnantwomenshouldtakespecialcaretoavoidaccidentaloralexposure,because

angiotensinconvertingenzyme(ACE)inhibitorshavebeenfoundtoaffecttheunbornchildduring

pregnancyinhumans.

4.6Adversereactions(frequencyandseriousness)

Indouble-blindclinicaltrialsindogswithcongestiveheartfailure,theproductwaswelltoleratedwith

anincidenceofadversereactionslowerthanobservedinplacebo-treateddogs.

Asmallnumberofdogsmayexhibittransientvomiting,incoordinationorsignsoffatigue.

Indogswithchronickidneydisease,theproductmayincreaseplasmacreatinineconcentrationsatthe

startoftherapy.Amoderateincreaseinplasmacreatinineconcentrationsfollowingadministrationof

ACEinhibitorsiscompatiblewiththereductioninglomerularhypertensioninducedbytheseagents,and

isthereforenotnecessarilyareasontostoptherapyintheabsenceofothersigns..

4.7 Useduringpregnancy,lactationorlay

Donotuseduringpregnancyorlactation.Thesafetyoftheproducthasnotbeenestablished

inbreeding,pregnantorlactatingdogs.Incatsbenazeprilreducedtheweightoftheovariesandthe

ovarianductswhengivenatadailydoseof10mg/kgfor52weeks.Embryotoxiceffects(foetal

urinarytractmalformation)wereseenintrialswithlaboratoryanimals(rats)atmaternallynontoxic

doses.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Indogswithcongestiveheartfailure,thisproducthasbeengivenincombinationwithdigoxin,

diuretics,pimobendanandanti-arrhythmicveterinarymedicinalproductswithoutdemonstrable

adverseinteractions.

Inhumans,theassociationofACEinhibitorsandNon-SteroidalAnti-InflammatoryDrugs(NSAIDs)

canleadtoreducedanti-hypertensiveefficacyorimpairedrenalfunction.Thecombinationofthis

productandotheranti-hypertensiveagents(e.g.calciumchannelblockers,β-blockersordiuretics),

anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.Therefore,concurrentuseof

NSAIDsorothermedicationswithahypotensiveeffectshouldbeconsideredwithcare.Renalfunction

andsignsofhypotension(lethargy,weaknessetc)shouldbemonitoredcloselyandtreatedas

necessary.

Interactionswithpotassiumpreservingdiureticslikespironolactone,triamtereneoramiloridecannotbe

ruledout.Itisrecommendedtomonitorplasmapotassiumlevelswhenusingthisproductincombination

withapotassiumsparingdiureticbecauseoftheriskofhyperkalaemia.

4.9Amountstobeadministeredandadministrationroute

Theproductshouldbegivenorallyoncedaily,withorwithoutfood.Thedurationoftreatmentis

unlimited.

Dogs:

Theproductshouldbeadministeredorallyataminimumdoseof0.25mg(range0.25-0.5)benazepril

hydrochloride/kgbodyweightoncedaily,accordingtothefollowingtable:

Weightofdog(kg) Standarddose Doubledose

>20-40 0.5tablet 1tablet

>40-60 0.75tablet 1½tablets

>60-80 1tablet 2tablet

Thedosemaybedoubled,stilladministeredoncedaily,toaminimumdoseof0.5mg/kg(range0.5-

1.0),ifjudgedclinicallynecessaryandadvisedbytheveterinarysurgeon.

Incaseofuseofquartersorhalftablets:Puttheremainingquantityofthetabletbackintothe

blisterpocketanduseforthenextadministration.

Thetabletsareflavouredandmaybetakenspontaneouslybydogs,butcanalsobe

administereddirectlyintothedo g’smouthorbegivenwithfoodifnecessary.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theproductreducederythrocytecountsinnormaldogswhendosedat150mg/kgbodyweightonce

dailyfor12months,butthiseffectwasnotobservedattherecommendeddoseduringclinicaltrialsin

dogs.

Transientreversiblehypotensionmayoccurincaseofaccidentaloverdose.Therapyshould

consistofintravenousinfusionwithwarmisotonicsaline.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Cardiovascularsystem,ACEInhibitor,plain,Benazepril.

ATCvetcode:QC09AA07

5.1Pharmacodynamicproperties

Benazeprilhydrochlorideisaprodrughydrolysedinvivotoitsactivemetabolite,benazeprilat.

BenazeprilatisahighlypotentandselectiveinhibitorofACE,thuspreventingtheconversionofinactive

angiotensinItoactiveangiotensinIIandtherebyalsoreducingsynthesisofaldosterone.Therefore,it

blockseffectsmediatedbyangiotensinIIandaldosterone,includingvasoconstrictionofbotharteries

andveins,retentionofsodiumandwaterbythekidneyandremodellingeffects(includingpathological

cardiachypertrophyanddegenerativerenalchanges).

Theproductcauseslong-lastinginhibitionofplasmaACEactivityindogs,withmorethan95%

inhibitionatpeakeffectandsignificantactivity(>80%)persisting24hoursafterdosing.

Theproductreducesthebloodpressureandvolumeloadontheheartindogswithcongestiveheart

failure.

5.2Pharmacokineticparticulars

Afteroraladministrationofbenazeprilhydrochloride,peaklevelsofbenazeprilareattained

rapidly(Tmax0.5hour)anddeclinequicklyastheactivesubstanceispartiallymetabolisedby

liverenzymestobenazeprilat.Thesystemicbioavailabilityisincomplete(~13%)dueto

incompleteabsorption(38%)andfirstpassmetabolism.

Peakbenazeprilatconcentrations(Cmaxof30ng/mlafteradoseof0.5mg/kgbenazepril

hydrochloride)areachievedwithaTmaxof1.5hours.

Benazeprilatconcentrationsdeclinebiphasically:theinitialfastphase(t1/2=1.7hours)

representseliminationoffreedrug,whiletheterminalphase(t1/2=19hours)reflectsthe

releaseofbenazeprilatthatwasboundtoACE,mainlyinthetissues.

Benazeprilandbenazeprilatareextensivelyboundtoplasmaproteins(85-90%),andin

tissuesarefoundmainlyintheliverandkidney.

Thereisnosignificantdifferenceinthepharmacokineticsofbenazeprilatwhenbenazepril

hydrochlorideisadministeredtofedorfasteddogs.Repeatedadministrationoftheproduct

leadstoslightbioaccumulationofbenazeprilat(R=1.47with0.5mg/kg),steadystatebeing

achievedwithinafewdays(4days).

Benazeprilatisexcreted54%viathebiliaryand46%viatheurinaryroute.Theclearanceof

benazeprilatisnotaffectedindogswithimpairedrenalfunctionandthereforenoadjustment

oftheproductdoseisrequiredincasesofrenalinsufficiency.

5.3Environmentalproperties

Notapplicable

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Pigliverflavour

Yeast

Lactosemonohydrate

Croscarmellosesodium

Anhydrouscolloidalsilica

Hydrogenatedcastoroil

Microcrystallinecellulose

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:21months.

Shelf-lifeofdivisionsofthetablets:72hours

6.4.Specialprecautionsforstorage

Donotstoreabove30

C

Storeinoriginalpackageinordertoprotectfrommoisture.

Anypart-usedtabletshouldbereturnedtotheopenedblisterandusedwithin3days

6.5Natureandcompositionofimmediatepackaging

[PA-Al-PVC]/Aluminiumheatsealedblisterstripof10tablets

Cardboardboxwith1blisterstripof10tablets

Cardboardboxwith5blisterstripsof10tablets

Cardboardboxwith10blisterstripsof10tablets

Cardboardboxwith14blisterstripsof10tablets

Cardboardboxwith18blisterstripsof10tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

SOGEVALLaboratories

200avenuedeMayenne,BP2227

53022LAVALCedex9

France

Tel:33243495151

Fax:33243539700

E-mail:sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletedinaccordancewithnationalrequirements.

VeterinaryMedicinalproduct

NELIO20MGTABLETFORDOGS

PARTIB

A-LABELLING

Pharmaceuticalform

Tablet

VeterinaryMedicinalproduct

NELIO20MGTABLETFORDOGS

PARTIB

A –LABELLING–“OUTERPACKAGE”

Pharmaceuticalform

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NELIO20COMPRIMEPOURCHIENS:FR

NELIO20MGTABLETFORDOGS*

NelioVet20MgTablettiKoirille:FI

NelioVet20mgtablettförhund:SE

NELIOVET:DK

*willbetranslatedinnationallanguage

Benazepril(ashydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachtabletcontains

Benazeprilhydrochloride......................................................20mg

3. PHARMACEUTICALFORM

Tablet

Clovershapedscoredbeigetablet,divisibleintohalvesorquarters.

4. PACKAGESIZE

Cardboardboxwith1blisterstripof10tablets

Cardboardboxwith5blisterstripsof10tablets

Cardboardboxwith10blisterstripsof10tablets

Cardboardboxwith25blisterstripsof10tablets

5. TARGETSPECIES

Dogs

6. INDICATION(S)

Fortreatmentofcongestiveheartfailureindogs

7. METHODANDROUTE(S)OFADMINISTRATION

Oraluse

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year}

11.SPECIALSTORAGECONDITIONS

Donotstoreabove30

C

Storeinoriginalpackageinordertoprotectfrommoisture.

Anypart-usedtabletshouldbereturnedtotheopenedblisterandusedwithin3days

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

M.A.H:

SOGEVAL

200avenuedeMayenne,

ZoneIndustrielledestouches

53000LAVAL

France

Tel:33243495151

Fax:33243539700

E-mail:sogeval@sogeval.fr

16.MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

VeterinaryMedicinalproduct

NELIO20MGTABLETFORDOGS

PARTIB

A –LABELLING–BLISTER

Pharmaceuticalform

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NELIO20COMPRIMEPOURCHIENS:FR

NELIO20MGTABLETFORDOGS*

NelioVet20MgTablettiKoirille:FI

NelioVet20mgtablettförhund:SE

NELIOVET:DK

*willbetranslatedinnationallanguage

Benazepril(ashydrochloride)

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

SOGEVAL

3. EXPIRYDATE

EXP{month/year}

4. BATCHNUMBER

Batch:

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly

VeterinaryMedicinalproduct

NELIO20MGTABLETFORDOGS

PARTIB

B –PACKAGELEAFLET

Pharmaceuticalform

Tablet

PACKAGELEAFLET

NELIO20MGTABLETFORDOGS

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisationholder:

SOGEVAL

200avenuedeMayenne

Zoneindustrielledestouches

53000LAVAL

France

Tel:33243495151

Fax:33243539700

E-mail:sogeval@sogeval.fr

Manufacturerforthebatchrelease:

SOGEVAL

200AvenuedeMayenne –Zone

IndustrielledesTouches

53000LAVAL

FRANCE

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NELIO20COMPRIMEPOURCHIENS:FR

NELIO20MGTABLETFORDOGS*

NelioVet20MgTablettiKoirille:FI

NelioVet20mgtablettförhund:SE

NELIOVET:DK

*willbetranslatedinnationallanguage

Benazepril(ashydrochloride)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachtabletcontains20mgofbenazeprilhydrochloride

Clovershapedscoredbeigetablet,divisibleintohalvesorquarters.

4. INDICATION(S)

TheproductbelongstoagroupofmedicinescalledAngiotensinConvertingEnzyme(ACE)inhibitors.

Itisprescribedbytheveterinarysurgeonforthetreatmentof

congestiveheartfailureindogs

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseincasesofhypotension(lowbloodpressure),hypovolaemia(lowbloodvolume),

hyponatraemiaoracuterenalfailure

Donotuseincasesofcardiacoutputfailureduetoaorticorpulmonarystenosis

Donotuseinpregnantorlactatingdogsbecausethesafetyofbenazeprilhydrochloridehasnotbeen

establishedduringpregnancyorlactation.

6. ADVERSEREACTIONS

Somedogswithcongestiveheartfailuremayexhibitvomitingorfatigueduringtreatment.

Indogswithchronickidneydiseasetheremaybeamoderateincreaseinlevelsofcreatinine,an

indicatorofkidneyfunction,intheblood.Thisislikelyduetotheeffectofthemedicationinreducing

thebloodpressurewithinthekidneyandisthereforenotnecessarilyareasonfortreatmenttobe

stopped,unlesstheanimalisshowingotheradversereactions

.Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinform

yourveterinarysurgeon.

7. TARGETSPECIES

Dogs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Theproductshouldbegivenorallyoncedaily,withorwithoutfood.Thedurationoftreatmentis

unlimited.

Theproducttabletsareflavouredandaretakenvoluntarilybymostdogs.

Dogs:

Theproductshouldbeadministeredorallyataminimumdoseof0.25mg(range0.25-0.5)benazepril

hydrochloride/kgbodyweightoncedaily,accordingtothefollowingtable:

Weightofdog(kg) Standarddose Doubledose

>20-40 0.5tablet 1tablet

>40-60 0.75tablet 1½tablets

>60-80 1tablet 2tablet

Indogswithcongestiveheartfailure,thedosemaybedoubled,stilladministeredoncedaily,toa

minimumdoseof0.5mg/kg(range0.5-1.0),ifjudgedclinicallynecessaryandadvisedbytheveterinary

surgeon.Alwaysfollowthedosinginstructionsgivenbytheveterinarysurgeon.

9. ADVICEONCORRECTADMINISTRATION

Thetabletsareflavouredandmaybetakenspontaneouslybydogs,butcanalsobe

administereddirectlyintothedog’smouthorbegivenwithfoodifnecessary.

Incaseofuseofquartersorhalftablets:Puttheremainingquantityofthetabletbackintothe

blisterpocketanduseforthenextadministration.

10.WITHDRAWALPERIOD

Notapplicable

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove30

C

Storeinoriginalpackageinordertoprotectfrommoisture.

Anypart-usedtabletshouldbereturnedtotheopenedblisterandusedwithin3days

Donotusetheveterinarymedicinalproductaftertheexpirydatestatedontheblisterand

outercarton.

12.SPECIALWARNING(S)

Specialwarningsfordogs

Theefficacyandsafetyofthisproducthasnotbeenestablishedindogsbelow2.5kgbodyweight.

Specialprecautionsforuseinanimals

Incasesofchronickidneydisease,yourveterinarianwillcheckthehydrationstatusofyour

petbeforestartingtherapy,andmayrecommendthatregularbloodtestsarecarriedout

duringtherapyinordertomonitorplasmacreatinineconcentrationsandblooderythrocyte

counts.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladviceimmediatelyandshowthelabelorthe

packageleaflettothephysician.

PregnantwomenshouldtakespecialcaretoavoidaccidentaloralexposurebecauseACEinhibitors

havebeenfoundtoaffecttheunbornchildduringpregnancyinhumans.

Useduringpregnancy,lactationorlay

Donotuseduringpregnancyorlactation.Thesafetyoftheproducthasnotbeenestablishedin

breeding,pregnantorlactatingdogs.

Interactionwithothermedicinalproductsandotherformsofinteraction

Informtheveterinarysurgeoniftheanimalistaking,orhasrecentlytaken,anyothermedicines.

Indogswithcongestiveheartfailure,thisproducthasbeengivenincombinationwithdigoxin,diuretics,

pimobendanandanti-arrhythmicproductswithoutevidenceofassociatedadversereactions.

Inhumans,thecombinationofACEinhibitorsandNSAIDs(Non-SteroidalAnti-InflammatoryDrugs)

canleadtoreducedanti-hypertensiveefficacyorimpairedkidneyfunction.Thecombinationofthis

productandotheranti-hypertensiveagents(e.g.calciumchannelblockers, 

-blockersordiuretics),

anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.Therefore,concurrentuseof

NSAIDsorothermedicationswithahypotensiveeffectshouldbeconsideredwithcare.

Yourveterinarysurgeonmayrecommendtocloselymonitorkidneyfunctionandforsignsof

hypotension(lethargy,weaknessetc)andtreattheseifnecessary.

Interactionswithpotassium-preservingdiureticslikespironolactone,triamtereneoramiloridecannotbe

ruledout.Yourveterinarysurgeonmayrecommendtomonitorplasmapotassiumconcentrationswhen

usingthisproductincombinationwithapotassium-sparingdiureticbecauseoftheriskof

hyperkalaemia(highbloodpotassium).

.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Transientreversiblehypotension(lowbloodpressure)mayoccurincasesofaccidentaloverdose.

Therapyshouldconsistofintravenousinfusionofwarmisotonicsaline.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

Packsizes:

Cardboardboxwith1blisterstripof10tablets

Cardboardboxwith5blisterstripsof10tablets

Cardboardboxwith10blisterstripsof10tablets

Cardboardboxwith14blisterstripsof10tablets

Cardboardboxwith18blisterstripsof10tablets

Notallpacksizesmaybemarketed.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocal

representativeofthemarketingauthorisationholder.

Localrepresentative:

Pharmacodynamicproperties

Benazeprilhydrochlorideisaprodrughydrolysedinvivotoitsactivemetabolite,benazeprilat.

Benazeprilatisahighlypotentandselectiveinhibitoroftheangiotensinconvertingenzyme

(ACE),thuspreventingtheconversionofinactiveangiotensinItoactiveangiotensinIIand

therebyalsoreducingsynthesisofaldosterone.Therefore,itblockseffectsmediatedby

angiotensinIIandaldosterone,includingvasoconstrictionofbotharteriesandveins,retention

ofsodiumandwaterbythekidneyandremodellingeffects(includingpathologicalcardiac

hypertrophyanddegenerativerenalchanges).

Thisproductcauseslong-lastinginhibitionofplasmaACEactivityindogs,withmorethan

95%inhibitionatpeakeffectandsignificantactivity(>80%)persisting24hoursafterdosing.

Thisproductreducesthebloodpressureandvolumeloadontheheartindogswith

congestiveheartfailure.

IncontrastwithotherACEinhibitors,benazeprilatisexcretedequallybybothbiliaryand

urinaryroutesindogs,andthereforenoadjustmentofthedoseofthisproductisnecessaryin

thetreatmentofcaseswithrenalinsufficiency.

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Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the CAT meeting 18-20 April 2018

Minutes of the CAT meeting 18-20 April 2018

Europe - EMA - European Medicines Agency

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration