Narcostop

Main information

  • Trade name:
  • Narcostop 5 mg/ml, solution for injection for cats and dogs
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Narcostop 5 mg/ml, solution for injection for cats and dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • atipamezole
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0139/001
  • Authorization date:
  • 30-03-2011
  • EU code:
  • NL/V/0139/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

PartIB Summaryofproductcharacteristics,labelandpackageinsert

SummaryofProductCharacteristics

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Narcostop5mg/ml–SolutionforInjectionforCatsandDogs

(NL,AT,BE,CZ,EL,FR,HU,IS,IE,LU,PL,SK)

Sedastop5mg/ml–SolutionforInjectionforCatsandDogs

(SE,NO,DK,ES,PT,IT,UK,FI)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlsolutionforinjectioncontains:

Activesubstance:

Atipamezole(ashydrochloride)4.27mg

Equivalentto5.0mgofatipamezolehydrochloride

Excipients:

Methylparahydroxybenzoate(E218)1.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Aclearcolourless,sterileaqueoussolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsandcats

4.2 Indicationsforuse,specifyingthetargetspecies

Atipamezolehydrochlorideisindicatedforreversalofthesedativeeffectsand

cardiovascular effects oncirculation afteruseofalpha-2-agonistslikemedetomidine

anddexmedetomidineindogsandcats.

4.3 Contraindications

Theproductshouldnotbeusedin:

-Breedinganimals

-Animalssufferingfromliver-orrenaldiseases

Seealsosection4.7

4.4 Specialwarningsforeachtargetspecies

Makesuretheanimalhasregained anormalswallowingreflexbeforeanyfoodor

drinkisoffered.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Afteradministrationoftheproduct,theanimalsshouldbeallowedtorestinaquiet

place.Duringrecoverytimeanimalsshouldnotbeleftunattended.

Duetodifferentdosingrecommendationscautionshouldbetakenifusingtheproduct

off-labelinanimalsotherthanthetargetspecies.

Ifothersedativesthanmedetomidinearegiven itmustbekeptinmindthattheeffects

ofthoseotheragentsmaypersistafterreversalof(dex)medetomidine.

Atipamezoledoesnotreversetheeffectofketamine,whichmaycauseseizuresin

dogsandelicitcrampsincatswhenusedalone.Donotuseatipamezoleearlierthan

30-40minutesafterconcomitantadministrationofketamine.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Duetothepotentpharmacologicalactivityofatipamezole,skin-,eye-andmucous

membrane-contactwiththisproductshouldbeavoided.Incaseofaccidentalspillage

washtheaffectedareaimmediatelywithcleanrunning water.Seekmedicalattentionif

irritationpersists.Removecontaminatedclothesthatareindirectcontactwiththe

skin.

Careshouldbetakentoavoidaccidentalingestionorself-injection.Ifaccidental

ingestion orself-injectionoccurs,seekmedicalattentionimmediately,showingacopy

ofthepackageleaflet.

4.6 Adversereactions(frequencyandseriousness)

Atransienthypotensiveeffecthasbeenobservedduringthefirst10minutespost-

injectionofatipamezolehydrochloride.Inrarecaseshyperactivity,tachycardia,

salivation,atypicalvocalization,muscletremor,vomiting,increasedrespiratoryrate,

uncontrolledurinationanduncontrolleddefecationmayoccur.

Invery rarecasesrecurrenceofsedationmayoccurortherecoverytimemaynotbe

shortenedafteradministrationofatipamezole.

Incats,whenusinglowdosestopartiallyreversetheeffectsofmedetomidineor

dexmedetomidine,thepossibility ofhypothermia(evenwhenarousedfromsedation)

shouldbeguardedagainst.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation.

Theproductshouldnotbeadministeredtopregnantandlactatingbitchesandqueens

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Asimultaneousadministrationofatipamezolewithothercentrallyactingmedicinal

productsasdiazepam,acepromazineoropiatesisnotrecommended.

4.9 Amounttobeadministeredandadministrationroute

Forsingleintramuscularinjection.

Atipamezolehydrochlorideisadministered15-60minaftermedetomidineor

dexmedetomidinehydrochlorideadministration.

Dogs:theintramuscularatipamezolehydrochloridedose[inµg]isfivetimesthatof

thepreviousmedetomidinehydrochloridedoseortentimesthatofthe

dexmedetomidinehydrochloridedose.Duetothe5-foldhigherconcentrationofthe

activeingredient(atipamezolehydrochloride)inthisproductcomparedtothatof

preparationscontaining1mgmedetomidinehydrochloridepermlandthe10-fold

higherconcentrationcomparedtothatofpreparationscontaining0.5mg

dexmedetomidinehydrochloride,anequalvolumeofeachpreparationisrequired.

DosageexampleDogs:

Medetomidine1mg/mlsolution

forinjectiondosage Narcostop5mg/mlsolutionfor

injectionfordogsdosage

0.04ml/kgbodyweight(bw),

i.e.40µg/kgbw 0.04ml/kgbw,

i.e.200µg/kgbw

Dexmedetomidine0.5mg/ml

solutionforinjectiondosage Narcostop5mg/mlsolutionfor

injectionfordogsdosage

0.04ml/kgbodyweight(bw),

i.e.20µg/kgbw 0,04ml/kgbw,

i.e.200µg/kgbw

Cats:theintramuscularatipamezolehydrochloridedose[in µg]istwo-and-a-halftimes

thatofthepreviousmedetomidinehydrochloridedoseorfivetimesthatofthe

dexmedetomidinehydrochloridedose.Duetothe5-foldhigherconcentrationofthe

activeingredient(atipamezolehydrochloride)inthisproductcomparedtothatof

preparationscontaining1mgmedetomidinehydrochloridepermlandthe10-fold

higherconcentrationcomparedtothatofpreparationscontaining0.5mg

dexmedetomidinehydrochloride,halfthevolumeoftheproducttothatofthe

previouslyadministeredmedetomidineordexmedetomidineshouldbegiven.

DosageexampleCats:

Medetomidine1mg/mlsolution

forinjectiondosage Narcostop5mg/mlsolutionfor

injectionforcatsdosage

0.08ml/kgbodyweight(bw),

i.e.80µg/kgbw 0.04ml/kgbw,

i.e.200µg/kgbw

Dexmedetomidine0.5mg/ml

solutionforinjectiondosage Narcostop5mg/mlsolutionfor

injectionforcatsdosage

0.08ml/kgbodyweight(bw),

i.e.40µg/kgbw 0,04ml/kgbw,

i.e.200µg/kgbw

Therecoverytimeisshortenedtoapproximately5minutes.Theanimalbecomes

mobileafterapproximately10minutesafteradministrationoftheproduct.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdoseofatipamezolehydrochloridemayresultintransienttachycardiaandover-

alertness(hyperactivity,muscletremor).Ifnecessary,thesesymptomsmaybe

reversedbya(dex)medetomidinehydrochloridedosewhichislowerthantheusually

usedclinicaldose.

Ifatipamezolehydrochlorideisinadvertently administeredtoananimalnotpreviously

treatedwith(dex)medetomidinehydrochloride,hyperactivityandmuscletremormay

occur.Theseeffectsmaypersistforabout15minutes.Over-alertnessinthecatisbest

handledbyminimizingexternalstimuli.

4.11Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode: QV03AB90

Pharmacotherapeuticgroup: 

2-receptorantagonist(Antidote)

5.1 Pharmacodynamicproperties

Atipamezoleisapotentandselectiveα2-receptorblockingagent(α2-antagonist),

whichpromotesthereleaseoftheneurotransmitternoradrenalinein thecentralaswell

asintheperipheralnervoussystems.Thisleadstoactivationofthecentralnervous

systemduetosympatheticactivation.Otherpharmacodynamiceffectsasforexample

influenceofthecardiovascularsystemareonlymild–butatransientdecreaseof

bloodpressuremaybeseenwiththefirst10minutesafterinjectionofatipamezole

hydrochloride.

Asaα2-antagonist,atipamezoleiscapableofeliminating(orinhibiting)theeffectsof

theα2-receptoragonist,medetomidineordexmedetomidine.Thusatipamezole

reversesthesedativeeffectsof(dex)medetomidinehydrochlorideindogsandcatsto

normalandmayleadtoatransientincreaseinheartrate.

5.2 Pharmacokineticparticulars

Atipamezolehydrochlorideisrapidlyabsorbedafterintramuscularinjection.The

maximalconcentrationinthecentralnervoussystemisreachedin10-15minutes.

Volumeofdistribution(V

)isabout1–2.5l/kg.Thehalf-lifeofatipamezole

hydrochlorideisreportedtobeapproximately1hour.Atipamezolehydrochloride

israpidlyandcompletelymetabolized.Themetabolitesaremainlyexcretedinurine

andinasmallamountinfaeces.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Methylparahydroxybenzoate(E218)

Sodiumchloride

Hydrochloricacid(forpH-adjustment)

Sodiumhydroxide(forpH-adjustment)

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelflifeafterfirstopeningtheimmediatepackaging:28days.

6.4 Specialprecautionsforstorage

Keepthevialintheoutercartoninordertoprotectfromlight.

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Clearglass(typeI)vialwithbromobutylrubberstopper(typeI)containing10ml

solutionforinjection.

Cardboardboxwith1vialcontaining10ml.

Cardboardboxwith5vialscontaining10ml.

Cardboardboxwith10vialscontaining10ml.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

NL-3421GWOudewater.

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

9. DATEOFFIRSTAUTHORISATION

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Carton

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NarcostopSedastop5mg/ml-SolutionforInjectionforCatsandDogs

Atipamezolehydrochloride

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1mlsolutionforinjectioncontains:

Activesubstance:

Atipamezole(ashydrochloride) 4.27mg

Equivalentto5.0mgofatipamezolehydrochloride

Excipients:

Methylparahydroxybenzoate(E218) 1.0mg

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

10ml,5x10ml,10x10ml

5. TARGETSPECIES

Fordogsandcats.

6. INDICATIONS

Atipamezolehydrochlorideisindicated forreversalofthesedativeeffectsand cardiovascular

effects oncirculation afteruseofalpha-2-agonistslikemedetomidineand

dexmedetomidineindogsandcats.7.METHOD AND ROUTE(S) OF

ADMINISTRATION

Forsingleintramuscularuse.Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable

9. SPECIALWARNING(S),IFNECESSARY

Accidentalinjectionisdangerous.Readpackageleafletbeforeuse.

10.EXPIRYDATE

EXP:

Shelflifeafterfirstopeningthecontainer:28days.

Oncebroached,useby………….

Batch:

Thisveterinarymedicinalproductmustnotbemixed withotherveterinarymedicinalproducts

11.SPECIALSTORAGECONDITIONS

Keepthevialintheoutercartoninordertoprotectfromlight.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421GWOudewater

TheNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

Formatiert:Einzug:ErsteZeile:0cm

Lot:

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Vial

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NarcostopSedastop5mg/ml-SolutionforInjectionforCatsandDogs

Atipamezolehydrochloride

2. QUANTITYOFTHEACTIVESUBSTANCE

1mlsolutionforinjectioncontains:

Activesubstance:

Atipamezole(ashydrochloride 4.27mg

Equivalentto5.0mgofatipamezolehydrochloride

Excipients:

Methylparahydroxybenzoate(E218) 1.0mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

10ml

4. ROUTE(S)OFADMINISTRATION

Forsingleintramuscularuse.

5. WITHDRAWALPERIOD

Notapplicable.

6. BATCHNUMBER

Batch:

7. EXPIRYDATE

EXP:

Onceopened,useby28days.

Keepthevialintheoutercartoninordertoprotectfromlight.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

PACKAGELEAFLET

NarcostopSedastop5mg/ml-SolutionforInjectionforCatsandDogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AND OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

LeVetB.V.

Willeskop212

3421GWOudewater

TheNetherlands

Manufacturerforthebatchrelease:

ProdulabPharmaB.V.

Forellenweg16

4941SJRaamsdonksveer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NarcostopSedastop5mg/ml-SolutionforInjectionforCatsandDogs

Activesubstance:Atipamezolehydrochloride

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER

INGREDIENT(S)

Narcostopisanaqueoussolutionforinjectioncontaining:

Activesubstance:

Atipamezole(ashydrochloride 4.27mg/ml

Equivalentto5.0mgofatipamezolehydrochloride

Excipients:

Methylparahydroxybenzoate(E218) 1.0mg/ml

4. INDICATION(S)

DogsandCats:

Atipamezolehydrochlorideisindicated forreversalofthesedativeeffectsand cardiovascular

effects oncirculation afteruseofalpha-2-agonistslikemedetomidineanddexmedetomidine

indogsandcats.

5. CONTRAINDICATIONS

Theproductshouldnotbeusedin:

-Breedinganimals

-Animalssufferingfromliver-orrenaldiseases

6. ADVERSEREACTIONS

Atransienthypotensiveeffecthasbeenobservedduring thefirst10minutespost-injectionof

atipamezolehydrochloride.Inrarecaseshyperactivity,tachycardia,salivation,atypical

vocalization,muscletremor,vomiting,increasedrespiratoryrate,uncontrolledurinationand

uncontrolleddefecationmayoccur.

Invery rarecasesrecurrenceofsedationmayoccurortherecoverytimemaynotbeshortened

afteradministrationofatipamezole.

Incats,whenusinglowdosestopartiallyreversetheeffectsofmedetomidineor

dexmedetomidine,thepossibility ofhypothermia(evenwhenarousedfromsedation)should

beguardedagainst.

Ifyounoticeanyseriouseffectsoranyothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.”

7. TARGETSPECIES

DogsandCats

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF

ADMINISTRATION

Forsingleintramuscularinjection.

Atipamezolehydrochlorideisadministered15-60minaftermedetomidineor

dexmedetomidinehydrochlorideadministration.

Dogs:theintramuscularatipamezolehydrochloridedose[inµg]isfivetimesthatofthe

previousmedetomidinehydrochloridedoseortentimesthatofthedexmedetomidine

hydrochloridedose.Duetothe5-foldhigherconcentrationoftheactive ingredient

(atipamezolehydrochloride)inthisproductcomparedtothatofpreparationscontaining1

mgmedetomidinehydrochloridepermland the10-foldhigherconcentrationcomparedtothat

ofpreparationscontaining0.5mgdexmedetomidinehydrochloride,anequalvolumeofeach

preparationisrequired.

DosageexampleDogs:

Medetomidine1mg/mlsolution

forinjectiondosage Narcostop5mg/mlsolutionfor

injectionfordogsdosage

0.04ml/kgbodyweight(bw),

i.e.40µg/kgbw 0.04ml/kgbw,

i.e.200µg/kgbw

Dexmedetomidine0.5mg/ml

solutionforinjectiondosage Narcostop5mg/mlsolutionfor

injectionfordogsdosage

0.04ml/kgbodyweight(bw), 0,04ml/kgbw,

i.e.20µg/kgbw i.e.200µg/kgbw

Cats:theintramuscularatipamezolehydrochloridedose[in µg]istwo-and-a-halftimesthat

ofthepreviousmedetomidinehydrochloridedoseorfivetimesthatofthedexmedetomidine

hydrochloridedose.Duetothe5-foldhigherconcentrationoftheactive ingredient

(atipamezolehydrochloride)inthisproductcomparedtothatofpreparationscontaining1

mgmedetomidinehydrochloridepermland the10-foldhigherconcentrationcomparedtothat

ofpreparationscontaining0.5mgdexmedetomidinehydrochloride,halfthevolumeofthe

producttothatofthepreviouslyadministeredmedetomidineordexmedetomidineshouldbe

given.

DosageexampleCats:

Medetomidine1mg/mlsolution

forinjectiondosage Narcostop5mg/mlsolutionfor

injectionforcatsdosage

0.08ml/kgbodyweight(bw),

i.e.80µg/kgbw 0.04ml/kgbw,

i.e.200µg/kgbw

Dexmedetomidine0.5mg/ml

solutionforinjectiondosage Narcostop5mg/mlsolutionfor

injectionforcatsdosage

0.08ml/kgbodyweight(bw),

i.e.40µg/kgbw 0,04ml/kgbw,

i.e.200µg/kgbw

Therecoverytimeisshortenedtoapproximately5 minutes.Theanimalbecomesmobileafter

approximately10minutesafteradministrationoftheproduct.

9. ADVICEONCORRECTADMINISTRATION

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

10. WITHDRAWALPERIOD

Notapplicable

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Keepthevialintheoutercartoninordertoprotectfromlight.Donotfreeze

Donotuseaftertheexpirydatestatedonthelabelandonthecarton.

Shelf-lifeafterfirstopeningtheimmediatepackaging: 28days.

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Afteradministrationoftheproduct,theanimalsshouldbeallowedtorestinaquietplace.

Duringrecoverytimeanimalsshouldnotbeleftunattended.

Makesuretheanimalhasregained anormalswallowingreflexbeforeanyfoodordrinkis

offered.

Duetodifferentdosingrecommendationscautionshouldbetakenifusingtheproductoff-

labelinanimalsotherthanthetargetspecies.

Ifothersedativesthanmedetomidinearegivenitmustbekeptinmindthattheeffectsof

thoseotheragentsmaypersistafterreversalof(dex)medetomidine.

Atipamezoledoesnotreversetheeffectofketamine,whichmaycauseseizuresindogsand

elicitcrampsincatswhenusedalone.Donotuseatipamezoleearlierthan30-40 minutesafter

concomitantadministrationofketamine.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Duetothepotentpharmacologicalactivityofatipamezole,skin-,eye-andmucous

membrane-contactwiththisproductshouldbeavoided.Incaseofaccidentalspillagewash

theaffectedareaimmediatelywithcleanrunningwater.Seekmedicalattentionifirritation

persists.Removecontaminatedclothesthatareindirectcontactwiththeskin.

Careshould betaken toavoidaccidentalingestionorself-injectionIfaccidentalingestionor

self-injectionoccurs,seekmedicalattentionimmediately,showingacopyofthepackage

leaflet.

Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeen establishedduringpregnancyand

lactation.

Theproductshouldnotbeadministeredtopregnantandlactatingbitchesandqueens

Interactionwithothermedicinalproductsandotherformsofinteraction

Asimultaneousadministrationofatipamezolewithothercentrallyactingmedicinalproducts

asdiazepam,acepromazineoropiatesisnotrecommended.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdoseofatipamezolehydrochloridemayresultin transienttachycardiaandover-alertness

(hyperactivity,muscletremor).Ifnecessary,thesesymptomsmaybereversedbya

(dex)medetomidinehydrochloridedosewhichislowerthantheusuallyusedclinicaldose.

Ifatipamezolehydrochlorideisinadvertently administeredtoan animalnotpreviouslytreated

with(dex)medetomidinehydrochloride,hyperactivityandmuscletremormayoccur.These

effectsmaypersistforabout15minutes.Over-alertnessinthecatisbesthandledby

minimizingexternalstimuli.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

<MM/YYYY>

15. OTHERINFORMATION

1x1glassvialwith10ml.

5x1glassvialswith10ml.

10x1glassvialwith10ml.

Notallpacksizesmaybemarketed.

Tobesuppliedonlyonveterinaryprescription.

28-11-2018

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

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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.

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Europe -DG Health and Food Safety

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EU/3/13/1219 (Zogenix GmbH)

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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

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