Benazepril hydrochloride Le Vet 20 mg tablets for dogs

Main information

  • Trade name:
  • Benazepril hydrochloride Le Vet 20 mg tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Benazepril hydrochloride Le Vet 20 mg tablets for dogs
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • benazepril
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0126/003
  • Authorization date:
  • 07-07-2011
  • EU code:
  • NL/V/0126/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

PartIB1Summaryofproductcharacteristics

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

NL:BenazeprilhydrochlorideLeVet20mgtablettenvoorhonden

AT:Benakor20mg,TablettenfürHunde

BE:BenakorF20mgtablettenvoorhonden

CZ:BenakorF20mg,tabletypropsy

EE:BenakorF20mgtabletidkoertele

ES:Benakor20mgcomprimidosparaperros

FI:Benakorvet20mgtabletti

FR:BenakorF20compriméspourchiens

IE:Benakor20mgtabletsfordogs

IT:Benakor20mgcompressepercani

LU:BenakorF20mgcompriméspourchiens

NO:Benakorvet.20mgtablettertilhund

PL:BenakorF20mgtabletkidlapsów

PT:Benakor20mgcomprimidosparacães

SK:BenakorF20mgtabletyprepsov

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Benazeprilhydrochloride 20mg

Excipient(s):

Colourant:Ironoxides(E172)8mg

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Tablets

Orangeoblongdivisibletablets,withabreakmarkononeside.

4.CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Dogs:

Treatmentofcongestiveheartfailure.

4.3Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseincasesofhypotension,hypovolaemia,hyponatraemiaoracuterenalfailure.

Donotuseincasesofcardiacoutputfailureduetoaorticorpulmonarystenosis.

Donotuseinpregnancyorlactation(section4.7).

4.4Specialwarningsforeachtargetspecies

None

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Noevidenceofrenaltoxicitytotheproducthasbeenobservedindogsduringclinicaltrials,however,asis

routineincasesofchronickidneydisease,itisrecommendedtomonitorplasmacreatinine,ureaand

erythrocytecountsduringtherapy.

Specialprecautionstobetakenbythepersonadministeringthemedicinalproductto

animals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladviceimmediatelyandshowthelabelorthepackage

leaflettothephysician.

Pregnantwomenshouldtakespecialcaretoavoidaccidentaloralexposurebecauseangiotensin

convertingenzyme(ACE)inhibitorshavebeenfoundtoaffecttheunbornchildduringpregnancyin

humans.

4.6Adversereactions(frequencyandseriousness)

Indouble-blindclinicaltrialsindogswithcongestiveheartfailure,benazeprilhydrochloridewaswell

toleratedwithanincidenceofadversereactionslowerthanobservedinplacebo-treateddogs.

Asmallnumberofdogsmayexhibittransientvomiting,incoordinationorsignsoffatigue.

Indogswithchronickidneydisease,theproductmayincreaseplasmacreatinineconcentrationsatthestart

oftherapy.AmoderateincreaseinplasmacreatinineconcentrationsfollowingadministrationofACE

inhibitorsiscompatiblewiththereductioninglomerularhypertensioninducedbytheseagents,andis

thereforenotnecessarilyareasontostoptherapyintheabsenceofothersigns.

4.7Useduringpregnancyorlactation

Donotuseduringpregnancyorlactation.Thesafetyoftheproducthasnotbeenestablishedinbreeding,

pregnantorlactatingdogs.Embryotoxiceffects(foetalurinarytractmalformation)wereseenintrialswith

laboratoryanimals(rats)atmaternallynontoxicdoses.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Indogswithcongestiveheartfailure,benazeprilhydrochloridehasbeengivenincombinationwith

digoxin,diuretics,pimobendanandanti-arrhythmicveterinarymedicinalproductswithoutdemonstrable

adverseinteractions.

Inhumans,thecombinationofACEinhibitorsandNon-SteroidalAnti-inflammatoryDrugs(NSAIDs)can

leadtoreducedantihypertensiveefficacyorimpairedrenalfunction.Thecombinationofbenazepril

hydrochlorideandotherantihypertensiveagents(e.g.calciumchannelblockers,β-blockersordiuretics),

anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.Therefore,concurrentuseofNSAIDs

orothermedicationswithahypotensiveeffectshouldbeconsideredwithcare.Renalfunctionandsignsof

hypotension(lethargy,weaknessetc.)shouldbemonitoredcloselyandtreatedasnecessary.

Interactionswithpotassiumpreservingdiureticslikespironolactone,triamtereneoramiloridecannotbe

ruledout.Itisrecommendedtomonitorplasmapotassiumlevelswhenusingbenazeprilhydrochloridein

combinationwithapotassiumsparingdiureticbecauseoftheriskofhyperkalaemia.

4.9Amountstobeadministeredandadministrationroute

Theproductshouldbegivenorallyoncedaily,withorwithoutfood.Thedurationoftreatmentis

unlimited.

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

hydrochloride/kgbodyweightoncedaily,accordingtothefollowingtable:

Weightofdog(kg) Benakor20mg

Standarddose Doubledose

>20-40 0.5tablet 1tablet

>40-80 1tablet 2tablets

Thedosemaybedoubled,stilladministeredoncedaily,toaminimumdoseof0.5mg/kg(range0.5-1.0),

ifjudgedclinicallynecessaryandadvisedbytheveterinarysurgeon.

Incaseofusinghalvedtablets:Puttheremaininghalfofadividedtabletbackintheblisterpocketand

storeitinadryplacebelow25ºC.Usetheremainingtablethalfforthenextadministration.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Benazeprilhydrochloridereducederythrocytecountsinnormaldogswhendosedat150mg/kgbody

weightoncedailyfor12months,butthiseffectwasnotobservedattherecommendeddoseduringclinical

trialsindogs.

Transientreversiblehypotensionmayoccurincasesofaccidentaloverdose.Therapyshouldconsistof

intravenousinfusionofwarmisotonicsaline.

4.11Withdrawalperiod(s)

Notapplicable.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ACEinhibitors,plain

ATCvetcode:QC09AA07

5.1Pharmacodynamicproperties

Benazeprilhydrochlorideisapro-drughydrolysedinvivotoitsactivemetabolite,benazeprilat.

BenazeprilatisahighlypotentandselectiveinhibitorofACE,thuspreventingtheconversionofinactive

angiotensinItoactiveangiotensinIIandtherebyalsoreducingsynthesisofaldosterone.Therefore,it

blockseffectsmediatedbyangiotensinIIandaldosterone,includingvasoconstrictionofbotharteriesand

veins,retentionofsodiumandwaterbythekidneyandremodellingeffects(includingpathologicalcardiac

hypertrophyanddegenerativerenalchanges).

Theproductcauseslong-lastinginhibitionofplasmaACEactivityindogs,withmorethan95%inhibition

atpeakeffectandsignificantactivity(>80%indogs)persisting24hoursafterdosing.

Theproductreducesthebloodpressureandvolumeloadontheheartindogswithcongestiveheartfailure.

5.2Pharmacokineticparticulars

Afteroraladministrationofbenazeprilhydrochloride,peaklevelsofbenazeprilareattainedrapidly(T

1.1hoursindogs)anddeclinequicklyastheactivesubstanceispartiallymetabolisedbyliverenzymesto

benazeprilat.Thesystemicbioavailabilityisincomplete(~13%indogs)duetoincompleteabsorption

(38%indogs)andfirstpassmetabolism.Indogs,peakbenazeprilatconcentrations(C

of384.16ng/ml

afteradoseof1.6mg/kgbenazeprilhydrochloride)areachievedwithaT

of1.1hours.

Benazeprilatconcentrationsdeclinebiphasically:theinitialfastphase(t1/2=1.7hoursindogs)represents

eliminationoffreedrug,whiletheterminalphase(t1/2=19hoursindogs)reflectsthereleaseof

benazeprilatthatwasboundtoACE,mainlyinthetissues.

Benazeprilandbenazeprilatareextensivelyboundtoplasmaproteins(85-90%),andintissuesarefound

mainlyintheliverandkidney.

Thereisnosignificantdifferenceinthepharmacokineticsofbenazeprilatwhenbenazeprilhydrochloride

isadministeredtofedorfasteddogs.Repeatedadministrationofbenazeprilhydrochlorideleadstoslight

accumulationofbenazeprilat(R=1.47indogswith0.5mg/kg),steadystatebeingachievedwithinafew

days(4daysindogs).

Benazeprilatisexcreted54%viathebiliaryand46%viatheurinaryrouteindogs.Theclearanceof

benazeprilatisnotaffectedindogswithimpairedrenalfunctionandthereforenoadjustmentofbenazepril

hydrochloridedoseisrequiredincasesofrenalinsufficiency.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Silicacolloidalanhydrous(E551)

Microcrystallinecellulose(E460)

Lactosemonohydrate

ColorconPigmentOrange23069(Ironoxides,E172)

Sodiumcyclamate(E952)

SodiumstarchglycolateTypeA

Magnesiumstearate(E470b).

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

PVC/PE/PVDC-Aluminiumblister:15months.

Aluminium/Aluminiumblister:18months.

Tablethalvesshouldbeusedwithinoneday.

6.4.Specialprecautionsforstorage

Donotstoreabove25ºC.

Storeintheoriginalpackage.

Storetablethalvesintheoriginalblisterintheoriginalpackage.

6.5Natureandcompositionofimmediatepackaging

1cartoncontains:

1,2,3,4,5,6or7PVC/PE/PVDC/Alu-foilblistersof14tabletseach

or

1,2,3,4,5,6,7Alu/Alu-foilblistersof14tabletseach.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Wilgenweg7

3421TVOudewater

TheNetherlands

8.MARKETINGAUTHORISATIONNUMBER

<localrequirement>

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<localrequirement>

10DATEOFREVISIONOFTHETEXT

<localrequirement>

PartIB2 Proposalforpackaging,labellingandpackageinsert

1.Labelling

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Cardboardbox

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Benakor20mgtabletsfordogs

Benazeprilhydrochloride

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Benazeprilhydrochloride 20mg

Colourant:Ironoxides(E172)8mg

3. PHARMACEUTICALFORM

Tablets

4. PACKAGESIZE

14,28,42,56,70,84or98tablets

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

Donotstoreabove25ºC.

Storeintheoriginalpackage.

Tablethalvesshouldbeusedwithinoneday.

Storetablethalvesintheoriginalblisterintheoriginalpackage.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Wilgenweg7

3421TVOudewater

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch{number}

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

Blister

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Benakor20mgtabletsfordogs

Benazeprilhydrochloride

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

LeVet

3. EXPIRYDATE

EXP{month/year}

4. BATCHNUMBER

Batch{number}

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly

2.Packageinsert

PACKAGELEAFLET

Benakor20mgtabletsfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisationholder:

LeVetB.V.

Wilgenweg7

3421TVOudewater

TheNetherlands

Manufacturerforthebatchrelease:

ProdulabPharmaB.V.

Forellenweg16

4841SJRaamsdonksveer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Benakor20mgtabletsfordogs

Benazeprilhydrochloride

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachtabletcontains20mgbenazeprilhydrochloride

Colourant:Ironoxides(E172)8mg

Orangeoblongdivisibletablets,withabreakmarkononeside.

4. INDICATION(S)

TheproductbelongstoagroupofmedicinescalledAngiotensinConvertingEnzyme(ACE)inhibitors.It

isprescribedbytheveterinarysurgeonforthetreatmentofcongestiveheartfailureindogs.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstancebenazeprilhydrochlorideortoanyingredient

ofthetablets.

Donotuseincasesofhypotension(lowbloodpressure),hypovolemia(lowbloodvolume)oracuterenal

failure.

Donotuseincasesofcardiacoutputfailureduetoaorticorpulmonarystenosis.

Donotuseinpregnantorlactatingdogsbecausethesafetyofbenazeprilhydrochloridehasnotbeen

establishedduringpregnancyorlactationinthisspecies.

6. ADVERSEREACTIONS

Somedogswithcongestiveheartfailuremayexhibitvomitingorfatigueduringtreatment.

Indogswithchronickidneydiseasetheremaybeamoderateincreaseinlevelsofcreatinine,anindicator

ofkidneyfunction,intheblood.Thisislikelyduetotheeffectofthemedicationinreducingtheblood

pressurewithinthekidneyandisthereforenotnecessarilyareasonfortreatmenttobestopped,unlessthe

animalisshowingotheradversereactions.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Dogs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Theproductshouldbegivenorallyoncedaily,withorwithoutfood.Thedurationoftreatmentis

unlimited.

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

hydrochloride/kgbodyweightoncedaily,accordingtothefollowingtable:

Weightofdog(kg) Benakor20mg

Standarddose Doubledose

>20-40 0.5tablet 1tablet

>40-80 1tablet 2tablets

Indogswithcongestiveheartfailure,thedosemaybedoubled,stilladministeredoncedaily,toa

minimumdoseof0.5mg(range0.5-1.0)benazeprilhydrochloride/kgbodyweightifjudgednecessaryand

advisedbytheveterinarysurgeon.Alwaysfollowthedosinginstructionsgivenbytheveterinarysurgeon.

Incaseofusinghalvedtablets:Puttheremaininghalfofadividedtabletbackintheblisterpocketand

storeitinadryplacebelow25ºC.Usetheremainingtablethalfforthenextadministration.

9. ADVICEONCORRECTADMINISTRATION

Foranimaltreatmentonly.Fororaluseonly.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25ºC.

Storeintheoriginalpackage.

DonotuseaftertheexpirydatestatedonthecartonafterEXP.

Tablethalvesshouldbeusedwithinoneday.

Storetablethalvesintheoriginalblisterintheoriginalpackage.

12. SPECIALWARNING(S)

Specialwarningsfordogs

Theefficacyandsafetyoftheproducthasnotbeenestablishedindogsbelow2.5kgbodyweight.

Specialprecautionsforuseinanimals

Incasesofchronickidneydisease,yourveterinarianwillcheckthehydrationstatusofyourpetbefore

startingtherapy,andmayrecommendthatregularbloodtestsarecarriedoutduringtherapyinorderto

monitorplasmacreatinineconcentrationsandblooderythrocytecounts.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladviceimmediatelyandshowthelabelorthepackage

leaflettothephysician.

PregnantwomenshouldtakespecialcaretoavoidaccidentaloralexposurebecauseACEinhibitorshave

beenfoundtoaffecttheunbornchildduringpregnancyinhumans.

Useduringpregnancy,lactation

Donotuseduringpregnancyorlactation.Thesafetyoftheproducthasnotbeenestablishedinbreeding,

pregnantorlactatingdogs.

Interactions

Informtheveterinarysurgeoniftheanimalistaking,orhasrecentlytaken,anyothermedicines.

Indogswithcongestiveheartfailure,benazeprilhydrochloridehasbeengivenincombinationwith

digoxin,diuretics,pimobendanandanti-arrhythmicproductswithoutevidenceofassociatedadverse

reactions.

Inhumans,thecombinationofACEinhibitorsandNSAIDs(Non-SteroidalAnti-InflammatoryDrugs)can

leadtoreducedanti-hypertensiveefficacyorimpairedkidneyfunction.Thecombinationoftheproduct

andotheranti-hypertensiveagents(e.g.calciumchannelblockers,β-blockersordiuretics),anaestheticsor

sedativesmayleadtoadditivehypotensiveeffects.Therefore,concurrentuseofNSAIDsorother

medicationswithahypotensiveeffectshouldbeconsideredwithcare.

Yourveterinarysurgeonmayrecommendtocloselymonitorkidneyfunctionandforsignsofhypotension

(lethargy,weaknessetc)andtreattheseifnecessary.

Interactionswithpotassium-preservingdiureticslikespironolactone,triamtereneoramiloridecannotbe

ruledout.Yourveterinarysurgeonmayrecommendtomonitorplasmapotassiumconcentrationswhen

usingtheproductincombinationwithapotassium-sparingdiureticbecauseoftheriskofhyperkalaemia

(highbloodpotassium).

Overdose

Transientreversiblehypotension(lowbloodpressure)mayoccurincasesofaccidentaloverdose.Therapy

shouldconsistofintravenousinfusionofwarmisotonicsaline.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

<localrequirement>

15. OTHERINFORMATION

Pharmacodynamicproperties

Benazeprilhydrochlorideisapro-drughydrolysedinvivotoitsactivemetabolite,benazeprilat.

Benazeprilatisahighlypotentandselectiveinhibitoroftheangiotensinconvertingenzyme(ACE),thus

preventingtheconversionofinactiveangiotensinItoactiveangiotensinIIandtherebyalsoreducing

synthesisofaldosterone.Therefore,itblockseffectsmediatedbyangiotensinIIandaldosterone,including

vasoconstrictionofbotharteriesandveins,retentionofsodiumandwaterbythekidneyandremodelling

effects(includingpathologicalcardiachypertrophyanddegenerativerenalchanges).

Benazeprilhydrochloridecauseslong-lastinginhibitionofplasmaACEactivityindogs,withmorethan95%

inhibitionatpeakeffectandsignificantactivity(>80%in)persisting24hoursafterdosing.

Benazeprilhydrochloridereducesthebloodpressureandvolumeloadontheheartindogswithcongestive

heartfailure.

IncontrastwithotherACEinhibitors,benazeprilatisexcretedequallybybothbiliaryandurinaryroutesin

dogs,andthereforenoadjustmentofthedoseoftheproductisnecessaryinthetreatmentofcaseswithrenal

insufficiency.

1cartoncontains:

1,2,3,4,5,6or7PVC/PE/PVDC/Alu-foilblistersof14tabletseach

or

1,2,3,4,5,6,7Alu/Alu-foilblistersof14tabletseach.

Notallpacksizesmaybemarketed.

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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

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

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

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

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

20-7-2018

Agenda:  Agenda - CAT agenda of the 18-20 July 2018 meeting

Agenda: Agenda - CAT agenda of the 18-20 July 2018 meeting

Committee for Advanced Therapies (CAT) agenda for the meeting on 18-20 July 2018

Europe - EMA - European Medicines Agency

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

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit  https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFriday pic.twitter.com/JWK672XtdI

FDA - U.S. Food and Drug Administration

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

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety