NELIO

Main information

  • Trade name:
  • NELIO 5
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NELIO 5
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0205/001
  • Authorization date:
  • 05-12-2010
  • EU code:
  • FR/V/0205/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

VeterinaryMedicinalproduct

NELIO5MGTABLETFORDOGS

PARTIB

Pharmaceuticalform

Tablet

VeterinaryMedicinalproduct

NELIO5MGTABLETFORDOGS

PARTIB

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmaceuticalform

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NELIO5COMPRIMEPOURCHIENS:FR

NELIO5MGTABLETFORDOGS*

NelioVet5MgTablettiKoirille:FI

NelioVet5mgtablettförhund:SE

NELIOVET:DK

*willbetranslatedinnationallanguage

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains

Activesubstance:

Benazeprilhydrochloride..............................................5mg

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.The

combinationofthisproductandotheranti-hypertensiveagents(e.g.calciumchannelblockers, 

blockersordiuretics),anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.Therefore,

concurrentuseofNSAIDsorothermedicationswithahypotensiveeffectshouldbeconsideredwith

care.Renalfunctionandsignsofhypotension(lethargy,weaknessetc)shouldbemonitoredcloselyand

treatedasnecessary.

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

2.5-5 0.25tablet 0.5tablet

>5-10 0.5tablet 1tablet

>10-15 0.75tablet 1.5tablets

>15-20 1tablet 2tablets

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

1.0),ifjudgedclinicallynecessaryandadvisedbytheveterinarysurgeon.

Incaseofuseofquartersorhalftablets:Puttheremainingquantityofthetabletbackintothe

blisterpocketanduseforthenextadministration.

Thetabletsareflavouredandmaybetakenspontaneouslybydogs,butcanalsobe

admi nistereddirectlyintothedog’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

Cardboardboxwith25blisterstripsof10tablets

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

NELIO5MGTABLETFORDOGS

PARTIB

A-LABELLING

Pharmaceuticalform

Tablet

VeterinaryMedicinalproduct

NELIO5MGTABLETFORDOGS

PARTIB

A –LABELLING–“OUTERPACKAGE”

Pharmaceuticalform

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NELIO5COMPRIMEPOURCHIENS:FR

NELIO5MGTABLETFORDOGS*

NelioVet5MgTablettiKoirille:FI

NelioVet5mgtablettförhund:SE

NELIOVET:DK

*willbetranslatedinnationallanguage

Benazepril(ashydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachtabletcontains

Benazeprilhydrochloride......................................................5mg

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

NELIO5MGTABLETFORDOGS

PARTIB

A –LABELLING–BLISTER

Pharmaceuticalform

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NELIO5COMPRIMEPOURCHIENS:FR

NELIO5MGTABLETFORDOGS*

NelioVet5MgTablettiKoirille:FI

NelioVet5mgtablettförhund:SE

NELIOVET:DK

*willbetranslatedinnationallanguage

Benazepril(ashydrochloride)

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

SOGEVAL

3. EXPIRYDATE

EXP{month/year}

4. BATCHNUMBER

Batch:

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly

VeterinaryMedicinalproduct

NELIO5MGTABLETFORDOGS

PARTIB

B –PACKAGELEAFLET

Pharmaceuticalform

Tablet

PACKAGELEAFLET

NELIO5MGTABLETFORDOGS

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

NELIO5COMPRIMEPOURCHIENS:FR

NELIO5MGTABLETFORDOGS*

NelioVet5MgTablettiKoirille:FI

NelioVet5mgtablettförhund:SE

NELIOVET:DK

*willbetranslatedinnationallanguage

Benazepril(ashydrochloride)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachtabletcontains5mgofbenazeprilhydrochloride

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

2.5-5 0.25tablet 0.5tablet

>5-10 0.5tablet 1tablet

>10-15 0.75tablet 1.5tablets

>15-20 1tablet 2tablets

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

Cardboardboxwith25blisterstripsof10tablets

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.

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

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

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

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

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

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

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

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

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

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety