NELIO 5

Main information

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

Documents

Localization

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

Therapeutic information

  • Therapeutic group:
  • benazepril
  • Therapeutic area:
  • Cats

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0178/001
  • Authorization date:
  • 05-12-2010
  • EU code:
  • FR/V/0178/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

VeterinaryMedicinalproduct

NELIO5mgTABLETFORCATS

PARTIB

Pharmaceuticalform

Tablet

VeterinaryMedicinalproduct

NELIO5mgTABLETFORCATS

PARTIB

SUMMARYOFPRODUCTCHARACTERISTICS

Pharmaceuticalform

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NELIO5mgTABLETFORCATS

FR:NELIO5TABLETFORCATS

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains

Activesubstance:

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

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Clovershapedscoredbeigetablet,divisibleintohalvesorquarters.

4. CLINICALPARTICULARS

4.1Targetspecies

Cats.

4.2Indicationsforuse,specifyingthetargetspecies

Cats:

Reductionofproteinuriaassociatedwithchronickidneydisease.

4.3Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseincasesofhypotension,hypovolaemia,hyponatraemiaoracuterenalfailure.

Donotuseincasesofcardiacoutputfailureduetoaorticorpulmonarystenosis.

Donotuseduringpregnancyorlactation(section4.7).

4.4Specialwarningsforeachtargetspecies

None

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Efficacyandsafetyofbenazeprilhavenotbeenestablishedincatsofweightlessthan2.5kg

Noevidenceofrenaltoxicitytotheveterinarymedicinalproducthasbeenobservedincats

duringclinicaltrials, however,asisroutineincasesofchronickidneydisease,itis

recommendedtomonitorplasmacreatinine,ureaanderythrocytecountsduringtherapy

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladviceimmediatelyandshowthelabelor

thepackageleaflettothephysician.

Pregnantwomenshouldtakespecialcaretoavoidaccidentaloralexposure,because

angiotensinconvertingenzyme(ACE)inhibitorshavebeenfoundtoaffecttheunbornchild

duringpregnancyinhumans.

4.6Adversereactions(frequencyandseriousness)

Incatswithchronickidneydisease,theproductmayincreaseplasmacreatinine

concentrationsatthestartoftherapy.Amoderateincreaseinplasmacreatinine

concentrationsfollowingadministrationofACEinhibitorsiscompatiblewiththereductionin

glomerularhypertensioninducedbytheseagents,andthereforeisnotnecessarilyareason

tostoptherapyintheabsenceofothersigns.

Theproductmayincreasefoodconsumptionandbodyweight.

Emesis,anorexia,dehydration,lethargyanddiarrhoeahavebeenreportedinrareoccasions.

4.7Useduringpregnancy,lactationorlay

Donotuseduringpregnancyorlactation.Thesafetyoftheproducthasnotbeenestablished

inbreeding,pregnantorlactatingcatsBenazeprilreducedovary/oviductweightsincats

whenadministereddailyat10mg/kgfor52weeks.Embryotoxiceffects(foetalurinarytract

malformation)wereseenintrialswithlaboratoryanimals(rats)atmaternallynontoxicdoses..

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Inhumans,thecombinationofACEinhibitorsandNon-SteroidalAnti-InflammatoryDrugs

(NSAIDs)canleadtoreducedanti-hypertensiveefficacyorimpairedrenalfunction.The

combinationoftheproductandotheranti-hypertensiveagents(e.g.calciumchannelblockers,

-blockersordiuretics),anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.

Therefore,concurrentuseofNSAIDsorothermedicationswithahypotensiveeffectshould

beconsideredwithcare.Renalfunctionandsignsofhypotension(lethargy,weaknessetc)

shouldbemonitoredcloselyandtreatedasnecessary..Interactionswithpotassium

preservingdiureticslikespironolactone,triamtereneoramiloridecannotberuledout.Itis

recommendedtomonitorplasmapotassiumlevelswhenusingtheproductincombination

withapotassiumsparingdiureticbecauseoftheriskofhyperkalaemia.

4.9Amountstobeadministeredandadministrationroute

Theproductshouldbegivenorallyoncedaily,withorwithoutfood.Thedurationoftreatment

isunlimited.

Theproducttabletsareflavouredandaretakenvoluntarilybymostcats.

Cats:

Theproductshouldbeadministeredorallyataminimumdoseof0.5mg(range0.5-1.0)

benazeprilhydrochloride/kgbodyweightoncedailyaccordingtothefollowingtable:

Catweight(kg) Numberoftablets

2.5 –5.0 0.5

>5. –10.0 1

Incaseofuseofhalftablets:Puttheremaininghalfofthetabletbackintotheblisterpocket

anduseforthenextadministration.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theproductreducederythrocytecountsinnormalcatswhendosedat10mg/kgbodyweight

oncedailyfor12monthsbutthiseffectwasnotobservedattherecommendeddoseduring

clinicaltrialsincats.

Transientreversiblehypotensionmayoccurincasesofaccidentaloverdose.Therapyshould

consistofintravenousinfusionwithwarmisotonicsaline.

I

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Cardiovascularsystem,ACEInhibitor,plain,Benazepril.

ATCvetcode:QC09AA07

5.1Pharmacodynamicproperties

Benazeprilhydrochlorideisaprodrughydrolysedinvivotoitsactivemetabolite,benazeprilat.

BenazeprilatisahighlypotentandselectiveinhibitorofACE,thuspreventingtheconversion

ofinactiveangiotensinItoactiveangiotensinIIandtherebyalsoreducingsynthesisof

aldosterone.Therefore,itblockseffectsmediatedbyangiotensinIIandaldosterone,including

vasoconstrictionofbotharteriesandveins,retentionofsodiumandwaterbythekidneyand

remodellingeffects(includingpathologicalcardiachypertrophyanddegenerativerenal

changes).

Theproductcauseslong-lastinginhibitionofplasmaACEactivityincats,withmorethan95%

inhibitionatpeakeffectandsignificantactivity(>90%)persisting24hoursafterdosing.

Incatswithexperimentalrenalinsufficiency,Theproductnormalizedtheelevatedglomerular

capillarypressureandreducedthesystemicbloodpressure.

Reductioninglomerularhypertensionmayretardtheprogressionofkidneydiseaseby

inhibitionoffurtherdamagetothekidneys.Placebocontrolledclinicalfieldstudiesincatswith

chronickidneydisease(CKD)havedemonstratedthattheproductsignificantlyreducedlevels

ofurineproteinandurineproteintocreatinineratio(UPC);thiseffectisprobablymediatedvia

reducedglomerularhypertensionandbeneficialeffectsontheglomerularbasement

membrane.

NoeffectoftheproductonsurvivalincatswithCKDhasbeenshown,buttheproduct

increasedtheappetiteofthecats,particularlyinmoreadvancedcases.

5.2Pharmacokineticparticulars

Afteroraladministrationofbenazeprilhydrochloride,peaklevelsofbenazeprilareattained

rapidly(Tmax2hours)anddeclinequicklyastheactivesubstanceispartiallymetabolisedby

liverenzymestobenazeprilat.Thesystemicbioavailabilityisincompleteduetoincomplete

absorption(<30%)andfirstpassmetabolism.

Peakbenazeprilatconcentrations(Cmaxof110.0ng/mlafteradoseof0.65mg/kgbenazepril

hydrochloride)areachievedwithaTmaxof1hourandhalf.

Benazeprilatconcentrationsdeclinebiphasically:theinitialfastphase(t1/2=2.4hours)

representseliminationoffreedrug,whiletheterminalphase(1/2=29hours)reflectsthe

releaseofbenazeprilatthatwasboundtoACE,mainlyinthetissues.

Benazeprilandbenazeprilatareextensivelyboundtoplasmaproteins(85-90%),andin

tissuesarefoundmainlyintheliverandkidney.

Repeatedadministrationoftheproductleadstoslightbioaccumulationofbenazeprilat

(R=1.36with0.5mg/kg),steadystatebeingachievedwithinafewdays.

Benazeprilatisexcreted85%viathebiliaryand15%viatheurinaryroute.Theclearanceof

benazeprilatisnotaffectedincatswithimpairedrenalfunctionandthereforenoadjustmentof

theproductdoseisrequiredincasesofrenalinsufficiency.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Pigliverflavour

Yeast

Lactosemonohydrate

Croscarmellosesodium

Anhydrouscolloidalsilica

Hydrogenatedcastoroil

Microcrystallinecellulose

6.2Incompatibilities

Notknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:21months.

Shelf-lifeofdivisionsofthetablets:72hours

6.4.Specialprecautionsforstorage

Donotstoreabove30

C

Storeinoriginalpackage.

Anypart-usedtabletshouldbereturnedtotheopenedblisterandusedwithin24hours

6.5Natureandcompositionofimmediatepackaging

Aluminium/Aluminiumheat-sealedblisterpack10tabletsperstrip.

Boxwith1stripof10tablets

Boxwith2stripsof10tablets

Boxwith3stripsof10tablets

Boxwith5stripsof10tablets

Boxwith10stripsof10tablets

Boxwith20stripsof10tablets

Boxwith50stripsof10tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

SOGEVAL

200avenuedeMayenne

Zoneindustrielledestouches

53000LAVAL

France

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletedinaccordancewithnationalrequirements.

VeterinaryMedicinalproduct

NELIO5mgTABLETFORCATS

PARTIB

A-LABELLING

Pharmaceuticalform

Tablet

VeterinaryMedicinalproduct

NELIO5mgTABLETFORCATS

PARTIB

A –LABELLING–“OUTERPACKAGE”

Pharmaceuticalform

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NELIO5mgTABLETFORCATS

Benazeprilhydrochloride

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

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

3. PHARMACEUTICALFORM

Tablet

Clovershapedscoredbeigetablet,divisibleintohalvesorquarters.

4. PACKAGESIZE

Boxwith1stripof10tablets

Boxwith2stripsof10tablets

Boxwith3stripsof10tablets

Boxwith5stripsof10tablets

Boxwith10stripsof10tablets

Boxwith20stripsof10tablets

Boxwith50stripsof10tablets

5. TARGETSPECIES

Cats.

6. INDICATION(S)

Forreductionofproteinuriaassociatedwithchronickidneydiseaseincats

7. METHODANDROUTE(S)OFADMINISTRATION

Oraluse.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP:{month/year}

11.SPECIALSTORAGECONDITIONS

Donotstoreabove30

C

Storeinoriginalpackage.

Anypart-usedtabletshouldbereturnedtotheopenedblisterandusedwithin72hours

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

NELIO5mgTABLETFORCATS

PARTIB

A –LABELLING–BLISTER

Pharmaceuticalform

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NELIO5mgTABLETFORCATS

Benazeprilhydrochloride

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

SOGEVAL

3. EXPIRYDATE

EXP{month/year}

4. BATCHNUMBER

Batch:

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

VeterinaryMedicinalproduct

NELIO5mgTABLETFORCATS

PARTIB

B –PACKAGELEAFLET

Pharmaceuticalform

Tablet

PACKAGELEAFLET

NELIO5mgTABLETFORCATS

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

NELIO5mgTABLETFORCATS

Benazeprilhydrochloride

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachtabletcontains5mgofbenazeprilhydrochloride

4. INDICATION(S)

TheproductbelongstoagroupofmedicinescalledAngiotensinConvertingEnzyme(ACE)

inhibitors.Itisprescribedbytheveterinarysurgeonforreductionofproteinuriaassociated

withchronickidneydiseaseincats.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstancebenazeprilhydrochlorideorto

anyingredientofthetablets.

Donotuseincasesofhypotension(lowbloodpressure),hypovolemia(lowbloodvolume)or

acuterenalfailure.

Donotuseincasesofcardiacoutputfailureduetoaorticorpulmonarystenosis.

Donotuseinpregnantorlactatingcatsbecausethesafetyofbenazeprilhydrochloridehas

notbeenestablishedduringpregnancyorlactationinthisspecies.

6. ADVERSEREACTIONS

Incatswithchronickidneydiseasetheremaybeamoderateincreaseinlevelsofcreatinine,

anindicatorofkidneyfunction,intheblood.Thisislikelyduetotheeffectofthemedicationin

reducingthebloodpressurewithinthekidneyandisthereforenotnecessarilyareasonfor

treatmenttobestopped,unlesstheanimalisshowingotheradversereactions.

Theproductmayincreasefoodconsumptionandbodyweightincats.

Vomiting,poorappetite,dehydration,lethargyanddiarrhoeahavebeenreportedonrare

occasionsincats.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinform

yourveterinarysurgeon.

7. TARGETSPECIES

Cats.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Theproductshouldbegivenorallyoncedaily,withorwithoutfood.Thedurationoftreatment

isunlimited.

Theproducttabletsareflavouredandaretakenvoluntarilybymostcats.

Incatstheproductshouldbeadministeredorallyataminimumdoseof0.5mg(range0.5-

1.0)benazeprilhydrochloride/kgbodyweightoncedailyaccordingtothefollowingtable:

Catweight(kg) Numberoftablets

2.5 –5.0 0.5

>5.0 –10.0

1

9. ADVICEONCORRECTADMINISTRATION

Thetabletsareflavouredandmaybetakenspontaneouslybycats,butcanalsobe

administereddirectlyintothecat'smouthorbegivenwithfoodifnecessary.

Incaseofuseofhalftablets:Puttheremaininghalfofthetabletbackintotheblisterpocket

anduseforthenextadministration.

10.WITHDRAWALPERIOD

Notapplicable.

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove30

C

Storeinoriginalpackage.

Anypart-usedtabletshouldbereturnedtotheopenedblisterandusedwithin72hours.

Donotusetheveterinarymedicinalproductaftertheexpirydatestatedontheblisterand

outercarton.

12.SPECIALWARNING(S)

Specialwarningsfordogsandcats

Theefficacyandsafetyoftheproducthasnotbeenestablishedincatsbelow2.5kgbody

weight.

Specialprecautionsforuseinanimals

Incasesofchronickidneydisease,yourveterinarianwillcheckthehydrationstatusofyour

petbeforestartingtherapy,andmayrecommendthatregularbloodtestsarecarriedout

duringtherapyinordertomonitorplasmacreatinineconcentrationsandblooderythrocyte

counts.

.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals.

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladviceimmediatelyandshowthelabelor

thepackageleaflettothephysician.

PregnantwomenshouldtakespecialcaretoavoidaccidentaloralexposurebecauseACE

inhibitorshavebeenfoundtoaffecttheunbornchildduringpregnancyinhumans.

Useduringpregnancyandlactation

Donotuseduringpregnancyorlactation.Thesafetyoftheproducthasnotbeenestablished

inbreeding,pregnantorlactatingcats.

Interactionwithothermedicinalproductsandotherformsofinteraction

Informtheveterinarysurgeoniftheanimalistaking,orhasrecentlytaken,anyother

medicines.

Inhumans,thecombinationofACEinhibitorsandNSAIDs(Non-SteroidalAnti-Inflammatory

Drugs)canleadtoreducedanti-hypertensiveefficacyorimpairedkidneyfunction.The

combinationoftheproductandotheranti-hypertensiveagents(e.g.calciumchannelblockers,

-blockersordiuretics),anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.

Therefore,concurrentuseofNSAIDsorothermedicationswithahypotensiveeffectshould

beconsideredwithcare.

Yourveterinarysurgeonmayrecommendtocloselymonitorkidneyfunctionandforsignsof

hypotension(lethargy,weaknessetc)andtreattheseifnecessary.

Interactionswithpotassium-preservingdiureticslikespironolactone,triamtereneoramiloride

cannotberuledout.Yourveterinarysurgeonmayrecommendtomonitorplasmapotassium

concentrationswhenusingtheproductincombinationwithapotassium-sparingdiuretic

becauseoftheriskofhyperkalaemia(highbloodpotassium).

Overdose

Transientreversiblehypotension(lowbloodpressure)mayoccurincaseofaccidental

overdose.Therapyshouldconsistofintravenousinfusionofwarmisotonicsaline.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

Packsizes:

Boxwith1stripof10tablets

Boxwith2stripsof10tablets

Boxwith3stripsof10tablets

Boxwith5stripsof10tablets

Boxwith10stripsof10tablets

Boxwith20stripsof10tablets

Boxwith50stripsof10tablets

Notallpacksizesmaybemarketed.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocal

representativeofthemarketingauthorisationholder.

Localrepresentative:

Pharmacodynamicproperties

Benazeprilhydrochlorideisaprodrughydrolysedinvivotoitsactivemetabolite,benazeprilat.

Benazeprilatisahighlypotentandselectiveinhibitoroftheangiotensinconvertingenzyme

(ACE),thuspreventingtheconversionofinactiveangiotensinItoactiveangiotensinIIand

therebyalsoreducingsynthesisofaldosterone.Therefore,itblockseffectsmediatedby

angiotensinIIandaldosterone,includingvasoconstrictionofbotharteriesandveins,retention

ofsodiumandwaterbythekidneyandremodellingeffects(includingpathologicalcardiac

hypertrophyanddegenerativerenalchanges).

Theproductcauseslong-lastinginhibitionofplasmaACEactivityincats,withmorethan95%

inhibitionatpeakeffectandsignificantactivity(>90%)persisting24hoursafterdosing.

Incatswithexperimentalrenalinsufficiency,theproductnormalizedtheelevatedglomerular

capillarypressureandreducedthesystemicbloodpressure.Reductioninglomerular

hypertensionmayretardtheprogressionofkidneydiseasebyinhibitionoffurtherdamageto

thekidneys.

Inaclinicaltrialincatswithchronickidneydisease,theproductsignificantlyreducedprotein

lossintheurine;thiseffectisprobablymediatedviareducedglomerularhypertensionand

beneficialeffectsontheglomerularbasementmembrane.Theproductalsoincreasedthe

appetiteofthecats,particularlyinmoreadvancedcases.

IncontrastwithotherACEinhibitors,benazeprilatisexcreted85%viathebiliaryand15%via

theurinaryroute,andthereforenoadjustmentofthedoseoftheproductisnecessaryinthe

treatmentofcaseswithrenalinsufficiency.

28-11-2018

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4-6-2018

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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

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FDA - U.S. Food and Drug Administration

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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