Narcostart 1 mg/ml solution for injection for cats and dogs

Main information

  • Trade name:
  • Narcostart 1 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:
  • Narcostart 1 mg/ml solution for injection for cats and dogs
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0138/001
  • Authorization date:
  • 30-03-2011
  • EU code:
  • NL/V/0138/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

PartIB Summaryofproductcharacteristics,labelandpackageinsert

SummaryofProductCharacteristics

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Narcostart1 mg/ml–SolutionforInjectionforCatsandDogs

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

Sedastart1 mg/ml–SolutionforInjectionforCatsandDogs

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

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1 mlsolutionforinjectioncontains:

Activesubstance: Medetomidine(ashydrochloride) 0.85 mg

(equivalentto 1.0 mgmedetomidinehydrochloride)

Excipients: Methylparahydroxybenzoate(E218) 1.0 mg

Propylparahydroxybenzoate(E216) 0.2 mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Aclearcolourless,sterileaqueoussolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

DogandCat

4.2 Indicationsforuse, specifyingthetargetspecies

In dogsand cats:

Sedationto facilitatehandling.Premedicationpriortogeneralanaesthesia.

In cats:

Incombinationwithketamineforgeneralanaesthesiaforminorsurgicalproceduresof

shortduration.

4.3 Contraindications

Donotuseinanimalswith:

- severecardiovasculardiseaseorrespiratorydiseasesorimpairedliveror

kidneyfunction.

- mechanicaldisturbancesofthegastrointestinaltract(torsioventriculi,

incarcerations,oesophagalobstructions).

- pregnancy.

- diabetesmellitus.

- stateofshock,emaciationorseriousdebilitation.

Donotuseconcomitantlywithsympathomimeticamines.

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyother

excipients.

Donotuseinanimalswithocularproblemswhereanincreaseinintraocularpressure

wouldbedetrimental.

4.4 Specialwarningsforeachtargetspecies

Medetomidinemaynotprovideanalgesiathroughouttheentireperiodofsedation,

thereforeconsiderationshouldbegiventoprovidingadditionalanalgesiaforpainful

procedures.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Aclinicalexaminationshouldbecarriedoutinallanimalsbeforetheuseofveterinary

medicinalproductsforsedationand/orgeneralanaesthesia.

Higherdosesofmedetomidineshouldbeavoidedinlargebreeddogs.Careshouldbe

takenwhencombiningmedetomidinewithotheranaestheticsorsedativesbecauseof

itsmarkedanaestheticsparingeffects.Thedoseoftheanaestheticshouldbereduced

accordinglyandtitratedtoresponseduetoconsiderablevariabilityinrequirements

betweenpatients.Beforeusinganycombinations,thewarningsandcontra-indications

intheproductliteraturefortheotherproductsshouldbeobserved.

Animalsshouldbefasted12 hoursbeforeanaesthesia.

Theanimalshouldbeplacedinacalmandquietsurroundingtoletthesedationgain

itsmaximumeffect.Thistakesabout10-15minutes.Oneshouldnotstartany

procedureorgiveothermedicinesbeforemaximumsedationisreached.

Treatedanimalsshouldbekeptwarmandataconstanttemperature,bothduringthe

procedureandrecovery.

Theeyesshouldbeprotectedbyasuitablelubricant.

Nervous,aggressiveorexcitedanimalsshouldbegiventhepossibilitytocalmdown

beforeinitiationoftreatment.

Sickanddebilitateddogsandcatsshouldonlybepremedicatedwithmedetomidine

beforeinductionandmaintenanceofgeneralanaesthesiabasedonarisk-benefit

assessment.

Careshouldbetakenwithuseofmedetomidineinanimalswithcardiovascular

disease,orwhichareelderlyoringeneralpoorhealth.Liverandkidneyfunction

shouldbeevaluatedpriortouse.

Asketaminealonecanelicitcramps,alpha-2antagonistsshouldbeadministerednot

before30-40 min.afterketamine.

Medetomidinemaycauserespiratorydepressionandunderthesecircumstances,

manualventilationandoxygenmaybeadministered.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproductto animals

1.Inthecaseofaccidentaloralintakeorself-injection,seekmedicaladvice

immediatelyandshowthepackageinserttothephysicianbutDONOTDRIVEas

sedationandchangesinbloodpressuremayoccur.

2.Avoidskin,eyeormucosalcontact.

3.Washtheexposedskinimmediatelyafterexposurewithlargeamountsofwater.

4.Removecontaminatedclothesthatareindirectcontactwithskin.

5.Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantlywith

freshwater.Ifsymptomsoccur,seek theadviceofaphysician.

6.Ifpregnantwomenhandletheproduct,specialcautionshouldbeobservednotto

self-injectasuterinecontractionsanddecreasedfoetalbloodpressuremayoccur

afteraccidentalsystemicexposure.

7.Advicetodoctors:

Medetomidineisanalpha2-adrenoreceptoragonist,symptomsafterabsorption

mayinvolveclinicaleffectsincludingdose-dependentsedation,respiratory

depression,bradycardia,hypotension,adrymouth,andhyperglycaemia.

Ventriculararrhythmiashavealsobeenreported.Respiratoryandhaemodynamic

symptomsshouldbetreatedsymptomatically.

4.6 Adversereactions(frequencyandseriousness)

Bradycardiawithatrioventricularblock(1 st

and2 nd

degree)andoccasionally

extrasystolia.Vasoconstrictionofcoronaryartery.Decreasedcardiacoutput.Blood

pressurewillincreaseinitiallyafteradministrationandthenreturntonormal,or

slightlybelownormal.Somedogsandmostcatswillvomitwithin5-10minutesof

injection.Catsmayalsovomitonrecovery.Sensitivitytoloudnoisesisobservedin

someindividuals.

Increaseddiuresis.Hypothermia.Respiratorydepression,cyanosis,painatinjection

siteandmuscletremormaybeseen.Inindividualcasesreversiblehyperglycaemiadue

to depressionofinsulinsecretion.

Incirculatoryandrespiratorydepressionmanualventilationandanoxygen

supplementmaybeindicated.Atropinemayincreasethecardiacrate.Dogswitha

bodyweightoflessthan10kgmayshowtheundesirableeffectsmentionedabove

moreoften.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasnotbeenestablishedduringpregnancyandlactation.

Thereforeitshouldnotbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantadministrationofothercentralnervoussystemdepressantsshouldbe

expectedtopotentiatetheeffectofeitheractivesubstance.Appropriatedose

adjustmentshouldbemade.

Medetomidinehasmarkedanaestheticsparingeffects.Seealsosection4.5.

Theeffectsofmedetomidinemaybeantagonizedbyadministrationofatipamezoleor

yohimbine.

4.9 Amountto beadministeredandadministrationroute

Narcostartisintendedfor:

Dogs:Intramuscularorintravenousinjection.

Cats:Intramuscularinjection.

Useofanappropriatelygraduatedsyringeisrecommendedtoensureaccuratedosing

whenadministeringsmallvolumes

Dogs:

ForsedationNarcostartshouldbeadministeredattherateof750μgmedetomidine

hydrochloridei.v.or1000μgmedetomidinehydrochloridei.m.persquaremeterof

bodysurface.Usethetablebelowtodeterminethecorrectdosageonthebasisofbody

weight:

Maximaleffectisobtainedwithin15-20minutes.Clinicaleffectisdose-dependent,

lastingfrom30-180 minutes.

Narcostartdosagesinmlandcorrespondingamountofmedetomidinehydrochloride

inμg/kgbw):

Bodyweight

[kg] i.v.–Injection

[ml] corresp.to

[μg/kgbw] i.m.–Injection

[ml] corresp.to

[μg/kgbw]

1 0.08 80.0 0.10 100.0

2 0.12 60.0 0.16 80.0

3 0.16 53.3 0.21 70.0

4 0.19 47.5 0.25 62.5

5 0.22 44.0 0.30 60.0

6 0.25 41.7 0.33 55.0

7 0.28 40.0 0.37 52.9

8 0.30 37.5 0.40 50.0

9 0.33 36.7 0.44 48.9

10 0.35 35.0 0.47 47.0

12 0.40 33.3 0.53 44.2

14 0.44 31.4 0.59 42.1

16 0.48 30.0 0.64 40.0

18 0.52 28.9 0.69 38.3

20 0.56 28.0 0.74 37.0

25 0.65 26.0 0.86 34.4

30 0.73 24.3 0.98 32.7

35 0.81 23.1 1.08 30.9

40 0.89 22.2 1.18 29.5

50 1.03 20.6 1.37 27.4

60 1.16 19.3 1.55 25.8

70 1.29 18.4 1.72 24.6

80 1.41 17.6 1.88 23.5

90 1.52 16.9 2.03 22.6

100 1.63 16.3 2.18 21.8

Forpremedication,Narcostartshouldbeadministeredatadosageof10-40µg

medetomidinehydrochlorideperkgbodyweight,correspondingto0.1–0.4ml

Narcostartper10kgbodyweight.Theexactdosedependsonthecombinationof

drugsusedandthedosage(s)oftheotherdrug(s).Thedoseshouldfurthermorebe

adjustedtothetypeofsurgery,lengthofprocedureandpatienttemperamentand

weight.Premedicationwithmedetomidinewillsignificantlyreducethedosageofthe

inductionagentrequiredandwillreducevolatileanaestheticrequirementsfor

maintenanceanaesthesia.Allanaestheticagentsusedforinductionormaintenanceof

anaesthesiashouldbeadministeredtoeffect.Beforeusinganycombinations,product

literaturefortheotherproductsshouldbeobserved.Seealsosection4.5.

Cats:

Formoderate-deepsedationandrestraintofcatsNarcostartshouldbeadministeredat

adosageof50–150μgmedetomidinehydrochloride/kgbw(corresp.to0.05–0.15

mlNarcostart/kgbw).

ForanaesthesiaNarcostartshouldbeadministeredatadosageof80μg

medetomidinehydrochloride/kgbw(corresp.to0.08mlNarcostart/kgbw)and2.5

to7.5mgketamine/kgbw.Usingthisdosageanaesthesiaoccurswithin3–4minutes

andisapparentfor20–50minutes.Forlongerlastingproceduresadministrationhas

toberepeatedbyusing½oftheinitialdose(i.e.40μgmedetomidinehydrochloride

(corresp.to0.04mlNarcostart/kgbw)and2.5–3.75mgketamine/kgbw)or3.0

mgketamine/kgbwalone.Alternatively,forlongerlastingproceduresanaesthesia

maybeextendedbyuseoftheinhalationagentsisofluraneorhalothane,withoxygen

oroxygen/nitrousoxide.Seesection4.5

4.10 Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Inthecaseofoverdosethemainsignsareprolongedanaesthesiaorsedation.Insome

casescardio-respiratoryeffectsmayoccur.Fortreatmentofthesecardio-respiratory

effectsofanoverdoseitisrecommendedtoadministeranalpha-2antagoniste.g.

atipamezoleoryohimbine,providedthatreversalofsedationisnotdangeroustothe

patient(atipamezoledoesnotreversetheeffectsofketaminewhichmaycause

seizuresindogsandelicitcrampsincatswhenusedalone).Useatipamezole

hydrochloride5mg/mlintramuscularlyinthedoginthesamevolumeasNarcostart,

inthecatusehalfthevolume.Therequireddoseofatipamezolehydrochloride

correspondsindogstothe5-folddoseofthemedetomidinehydrochloridedoseinmg

administeredbeforeandincatstothe2.5-folddose.Alpha-2antagonistsshouldbe

administerednotbefore30-40 min.afterketamine.

Ifitisimperativeto reversebradycardiabutmaintainsedation,atropinemaybeused.

4.11 Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Sedative/Analgesic

ATCvetcode: QN05CM91

5.1 Pharmacodynamicproperties

TheactiveingredientofNarcostartis(R,S)-4-[1-(2,3-dimethylphenyl)-ethyl)]-

imidazole-hydrochloride(INN:Medetomidine),asedativecompoundwithanalgesic

andmyorelaxingproperties.Medetomidineisaselective,specificandhighly

efficaciousalpha-2-receptoragonist.Theactivationofalpha-2receptorsleadstoa

decreaseinreleaseandturnoverofnorepinephrineinthecentralnervoussystem,

leadingtosedation,analgesiaandbradycardia.Intheperipherymedetomidinecauses

vasoconstrictionviastimulationofpostsynapticalpha-2adrenoceptors,leadingtoa

transientarterialhypertension.Within1–2hoursarterialbloodpressurefallsbackto

normotensionorslighthypotension.Therespiratoryratemaybetransientlydecreased.

Depthanddurationofsedationandanalgesiaaredoserelated.Profoundsedationand

recumbency,withreducedsensitivitytoenvironmentalstimuli(sounds,etc.),areseen

withmedetomidine.Medetomidineactssynergisticallywithketamineandopiates,

suchasfentanyl,leadingtobetteranaesthesia.Theamountofvolatileanaesthetics,

suchashalothane,willbereducedbymedetomidine.Besideitssedative,analgesicand

myo-relaxingproperties,medetomidinealsoexertshypothermicandmydriaticeffects,

inhibitssalivationanddecreasesintestinalmotility.

5.2 Pharmacokineticparticulars

Afterintramuscularadministrationmedetomidineisrapidlyandnearlycompletely

absorbedfromtheinjectionsiteandpharmacokineticsisverysimilartointravenous

administration.Maximalplasmaconcentrationsarereachedwithin15and20minutes.

Plasmahalf-lifeisconsideredtobe1.2hoursinthedogand1.5hoursinthecat.

Medetomidineismainlyoxidisedintheliver,asmalleramountundergoesmethylation

inthekidneys.Metaboliteswillbeexcretedmainlyviaurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Sodiumchloride

Hydrochloricacid(forpH-adjustment)

Sodiumhydroxide(forpH-adjustment)

WaterforInjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale: 3 years.

Shelf-lifeafterfirstopeningtheimmediatepackaging: 28 days

6.4 Specialprecautionsforstorage

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Glass(typeI)vialsclosedwithbromobutylrubberclosuressecuredwithaluminium

crimpcaps.

1 x1 glassvialwith10 ml.

5 x1 glassvialswith10 ml.

Notallpack sizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

NL-3421 GWOudewater.

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

9. DATEOFFIRSTAUTHORISATION

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Carton

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Narcostart1 mg/ml-SolutionforInjectionforCatsandDogs

Medetomidinehydrochloride

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1 mlsolutionforinjectioncontains:

Activesubstance:

Medetomidine(ashydrochloride) 0.85mg

(equivalentto1.00mgmedetomidinehydrochloride)

Excipients:

Methylparahydroxybenzoate(E218)1.0 mg

Propylparahydroxybenzoate(E216)0.2 mg

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

1 vialwith10 mlsolutionforinjection.

5 vialswith10 mlsolutionforinjectioneach.

5. TARGETSPECIES

DogsandCats.

6. INDICATIONS

In dogsand cats:

Sedationto facilitatehandling.Premedicationpriortogeneralanaesthesia.

In cats:

Incombinationwithketamineforgeneralanaesthesiaforminorsurgicalproceduresof

shortduration.

7. METHODANDROUTE(S)OFADMINISTRATION

Theproductisintendedfor:

Dogs: Intramuscularorintravenousinjection.

Cats: Intramuscularinjection.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP:

Shelflifeafterfirstbroachingthevial:28 days.

Oncebroached,useby……………………….

11.SPECIALSTORAGECONDITIONS

Donotfreeze.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithlocal

requirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421 GWOudewater

TheNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot:

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Vial

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Narcostart1 mg/ml-SolutionforInjectionforCatsandDogs

Medetomidinehydrochloride

2. QUANTITYOFTHEACTIVESUBSTANCE

1 mlsolutionforinjectioncontains:

Activesubstance:

Medetomidine(ashydrochloride) 0.85mg

(equivalentto1.0mgmedetomidinehydrochloride)

Excipients:

Methylparahydroxybenzoate(E218) 1.0 mg

Propylparahydroxybenzoate(E216) 0.2 mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

1 vialwith10 mlsolutionforinjection.

4. ROUTE(S)OFADMINISTRATION

Dogs: Intramuscularorintravenousinjection.

Cats: Intramuscularinjection.

5. WITHDRAWALPERIOD

Notapplicable.

6. BATCHNUMBER

Batch:

7. EXPIRYDATE

EXP:

Onceopened,useby28 days.

Keep outofthereachandsightofchildren.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

PACKAGELEAFLET

Narcostart1 mg/ml-SolutionforInjectionforCatsandDogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AND OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

LeVetB.V.

Willeskop212

3421 GWOudewater

TheNetherlands

Manufacturerforthebatchrelease:

ProdulabPharmaB.V.

Forellenweg16

4941 SJRaamsdonksveer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Narcostart1 mg/ml-SolutionforInjectionforCatsandDogs

Activesubstance:Medetomidinehydrochloride

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

INGREDIENT(S)

Narcostartisaclearcolourless,sterileaqueoussolutionforinjectioncontaining:

Activesubstance:

Medetomidine(ashydrochloride) 0.85mg/ml

(equivalentto1.0mg/mlmedetomidinehydrochloride)

Excipients:

Methylparahydroxybenzoate(E218) 1.0 mg/ml

Propylparahydroxybenzoate(E216) 0.2 mg/ml

4. INDICATION(S)

In dogsand cats:

Sedationto facilitatehandling.Premedicationpriortogeneralanaesthesia.

In cats:

Incombinationwithketamineforgeneralanaesthesiaforminorsurgicalproceduresof

shortduration.

5. CONTRAINDICATIONS

Donotuseinanimalswith:

- severecardiovasculardiseaseorrespiratorydiseasesorimpairedliveror

kidneyfunction.

- mechanicaldisturbancesofthegastrointestinaltract(torsioventriculi,

incarcerations,oesophagalobstructions).

- pregnancy.

- diabetesmellitus.

- stateofshock,emaciationorseriousdebilitation.

Donotuseconcomitantlywithsympathomimeticamines.

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyother

excipients.

Donotuseinanimalswithocularproblemswhereanincreaseinintraocularpressurewould

bedetrimental.

6. ADVERSEREACTIONS

Bradycardiawithatrioventricularblock(1 st and2 nd degree)andoccasionallyextrasystolia.

Vasoconstrictionofcoronaryartery.Decreasedcardiacoutput.Bloodpressurewillincrease

initiallyafteradministrationandthenreturntonormal,orslightlybelownormal.Somedogs

andmostcatswillvomitwithin5-10minutesofinjection.Catsmayalsovomitonrecovery.

Sensitivitytoloudnoisesisobservedinsomeindividuals.

Increaseddiuresis.Hypothermia.Respiratorydepression,cyanosis,painatinjectionsiteand

muscletremormaybeseen.Inindividualcasesreversiblehyperglycaemiaduetodepression

ofinsulinsecretion

Incirculatoryandrespiratorydepressionmanualventilationandoxygensupplementmaybe

indicated.Atropinemayincreasethecardiacrate.Dogswithabodyweightoflessthan10kg

mayshowtheundesirableeffectsmentionedabovemoreoften.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthispackageleaflet,please

informyourveterinarysurgeon

7. TARGETSPECIES

Dogandcat.

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

ADMINISTRATION

Narcostartisintendedfor:

Dogs:Intramuscularorintravenousinjection.

Cats:Intramuscularinjection.

Useofanappropriatelygraduatedsyringeisrecommendedtoensureaccuratedosingwhen

administeringsmallvolumes

Dogs:

ForsedationNarcostartshouldbeadministeredattherateof750μgmedetomidine

hydrochloridei.v.or1000μgmedetomidinehydrochloridei.m.persquaremeterofbody

surface.Usethetablebelowto determinethecorrectdosageonthebasisofbodyweight:

Maximaleffectisobtainedwithin15-20minutes.Clinicaleffectisdose-dependent,lasting

from30-180 minutes.

Narcostartdosagesinmlandcorrespondingamountofmedetomidinehydrochlorideinμg/kg

bw):

Bodyweight

[kg] i.v.–Injection

[ml] corresp.to

[μg/kgbw] i.m.–Injection

[ml] corresp.to

[μg/kgbw]

1 0.08 80.0 0.10 100.0

2 0.12 60.0 0.16 80.0

3 0.16 53.3 0.21 70.0

4 0.19 47.5 0.25 62.5

5 0.22 44.0 0.30 60.0

6 0.25 41.7 0.33 55.0

7 0.28 40.0 0.37 52.9

8 0.30 37.5 0.40 50.0

9 0.33 36.7 0.44 48.9

10 0.35 35.0 0.47 47.0

12 0.40 33.3 0.53 44.2

14 0.44 31.4 0.59 42.1

16 0.48 30.0 0.64 40.0

18 0.52 28.9 0.69 38.3

20 0.56 28.0 0.74 37.0

25 0.65 26.0 0.86 34.4

30 0.73 24.3 0.98 32.7

35 0.81 23.1 1.08 30.9

40 0.89 22.2 1.18 29.5

50 1.03 20.6 1.37 27.4

60 1.16 19.3 1.55 25.8

70 1.29 18.4 1.72 24.6

80 1.41 17.6 1.88 23.5

90 1.52 16.9 2.03 22.6

100 1.63 16.3 2.18 21.8

Forpremedication,Narcostartshouldbeadministeredatadosageof10-40µgmedetomidine

hydrochlorideperkgbodyweight,correspondingto0.1–0.4mlNarcostartper10kgbody

weight.Theexactdosedependsonthecombinationofdrugsusedandthedosage(s)ofthe

otherdrug(s).Thedoseshouldfurthermorebeadjustedtothetypeofsurgery,lengthof

procedureandpatienttemperamentandweight.Premedicationwithmedetomidinewill

significantlyreducethedosageoftheinductionagentrequiredandwillreducevolatile

anaestheticrequirementsformaintenanceanaesthesia.Allanaestheticagentsusedfor

inductionormaintenanceofanaesthesiashouldbeadministeredtoeffect.Beforeusingany

combinations,productliteraturefortheotherproductsshouldbeobserved.Seealsosection

4.5.

Cats:

Formoderate-deepsedationandrestraintofcatsNarcostartshouldbeadministeredata

dosageof50–150μgmedetomidinehydrochloride/kgbw(corresp.to0.05–0.15ml

Narcostart/kgbw).

ForanaesthesiaNarcostartshouldbeadministeredatadosageof80μgmedetomidine

hydrochloride/kgbw(corresp.to0.08mlNarcostart/kgbw)and2.5to7.5mgketamine/

kgbw.Usingthisdosageanaesthesiaoccurswithin3–4minutesandisapparentfor20–50

minutes.Forlongerlastingproceduresadministrationhastoberepeatedbyusing½ofthe

initialdose(i.e.40μgmedetomidinehydrochloride(corresp.to0.04mlNarcostart/kgbw)

and2.5–3.75mgketamine/kgbw)or3.0mgketamine/kgbwalone.Alternatively,for

longerlastingproceduresanaesthesiamaybeextendedbyuseoftheinhalationagents

isofluraneorhalothane,withoxygenoroxygen/nitrousoxide.

9. ADVICEONCORRECTADMINISTRATION

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

10. WITHDRAWALPERIOD

Notapplicable

11. SPECIALSTORAGEPRECAUTIONS

Keep outofthereachandsightofchildren.

Donotfreeze.

Donotuseaftertheexpirydatestatedonthelabelandonthecarton.

Shelf-lifeafterfirstopeningthecontainer:28 days

12. SPECIALWARNING(S)

Medetomidinemaynotprovideanalgesiathroughouttheentireperiodofsedation,therefore

considerationshouldbegivento providingadditionalanalgesiaforpainfulprocedures.

Specialprecautionsforuseinanimals

Aclinicalexaminationshouldbecarriedoutinallanimalsbeforetheuseofveterinary

medicinalproductsforsedationand/orgeneralanaesthesia.

Higherdosesofmedetomidineshouldbeavoidedinlargebreeddogs.Careshouldbetaken

whencombiningmedetomidinewithotheranaestheticsorsedativesbecauseofitsmarked

anaestheticsparingeffects.Thedoseoftheanaestheticshouldbereducedaccordinglyand

titratedtoresponseduetoconsiderablevariabilityinrequirementsbetweenpatients.Before

usinganycombinations,thewarningsandcontra-indicationsintheproductliteratureforthe

otherproductsshouldbeobserved.

Animalsshouldbefasted12 hoursbeforeanaesthesia.

Theanimalshouldbeplacedinacalmandquietsurroundingtoletthesedationgainits

maximumeffect.Thistakesabout10-15minutes.Oneshouldnotstartanyprocedureorgive

othermedicinesbeforemaximumsedationisreached.

Treatedanimalsshouldbekeptwarmandataconstanttemperature,bothduringthe

procedureandrecovery.

Theeyesshouldbeprotectedbyasuitablelubricant.

Nervous,aggressiveorexcitedanimalsshouldbegiventhepossibilitytocalmdownbefore

initiationoftreatment

Sickanddebilitateddogsandcatsshouldonlybepremedicatedwithmedetomidinebefore

inductionandmaintenanceofgeneralanaesthesiabased onarisk-benefitassessment.

Careshouldbetakenwithuseofmedetomidineinanimalswithcardiovasculardisease,or

whichareelderlyoringeneralpoorhealth.Liverandkidneyfunctionshouldbeevaluated

priortouse.

Asketaminealonecanelicitcramps,alpha-2antagonistsshouldbeadministerednotbefore

30-40 min.afterketamine.

Medetomidinemaycauserespiratorydepressionandunderthesecircumstances,manual

ventilationandoxygenmaybeadministered.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

1. Inthecaseofaccidentaloralintakeorself-injection,seekmedicaladviceimmediately

andshowthepackageinserttothephysicianbutDONOTDRIVEassedationand

changesinbloodpressuremayoccur.

2. Avoidskin,eyeormucosalcontact.

3. Washtheexposedskinimmediatelyafterexposurewithlargeamountsofwater.

4. Removecontaminatedclothesthatareindirectcontactwithskin.

5. Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantlywithfresh

water.Ifsymptomsoccur,seek theadviceofaphysician.

6. Ifpregnantwomenhandletheproduct,specialcautionshouldbeobservednottoself-

injectasuterinecontractionsanddecreasedfoetalbloodpressuremayoccurafter

accidentalsystemicexposure.

7. Advicetodoctors:

Medetomidineisanalpha2-adrenoreceptoragonist,symptomsafterabsorptionmay

involveclinicaleffectsincludingdose-dependentsedation,respiratorydepression,

bradycardia,hypotension,adrymouth,andhyperglycaemia.Ventriculararrhythmias

havealsobeenreported.Respiratoryandhaemodynamicsymptomsshouldbetreated

symptomatically.

Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasnotbeenestablishedduringpregnancyandlactation.Therefore

itshouldnotbeusedduringpregnancyandlactation.

Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantadministrationofothercentralnervoussystemdepressantsshouldbe

expectedtopotentiatetheeffectofeitheractivesubstance.Appropriatedoseadjustment

shouldbemade.

Medetomidinehasmarkedanaestheticsparingeffects.

Theeffectsofmedetomidinemaybeantagonizedbyadministrationofatipamezoleor

yohimbine.

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Inthecaseofoverdosethemainsignsareprolongedanaesthesiaorsedation.Insomecases

cardio-respiratoryeffectsmayoccur.Fortreatmentofthesecardio-respiratoryeffectsofan

overdoseitisrecommendedtoadministeranalpha-2antagoniste.g.atipamezoleor

yohimbine,providedthatreversalofsedationisnotdangeroustothepatient(atipamezole

doesnotreversetheeffectsofketaminewhichmaycauseseizuresindogsandelicitcrampsin

catswhenusedalone).Useatipamezolehydrochloride5mg/mlintramuscularlyinthedogin

thesamevolumeasNarcostart,inthecatusehalfthevolume.Therequireddoseof

atipamezolehydrochloridecorrespondsindogstothe5-folddoseofthemedetomidine

hydrochloridedoseinmgadministeredbeforeandincatstothe2.5-folddose.Alpha-2

antagonistsshouldbeadministerednotbefore30-40 min.afterketamine.

Ifitisimperativeto reversebradycardiabutmaintainsedation,atropinemaybeused.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

<MM/YYYY>

15. OTHERINFORMATION

1 x1 glassvialwith10 ml.

5 x1 glassvialswith10 ml.

Notallpack sizesmaybemarketed.

5-12-2018

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible <em>Listeria monocytogenes</em> Health Risk

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible <em>Listeria monocytogenes</em> Health Risk

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily recalling 933 packages of Cow Pie fresh frozen meats for dogs and cats, produced in August 2017, because it has the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

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

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

7-6-2018

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Heartworm disease can be fatal to pets, but it is also preventable. Learn more about the dangers of heartworm disease and the importance of year-round prevention.

FDA - U.S. Food and Drug Administration

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

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

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

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

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

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