DORMILAN Solution for injection for dogs and cats

Main information

  • Trade name:
  • Dormilan
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Dormilan
    Germany
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0191/001
  • Authorization date:
  • 13-02-2012
  • EU code:
  • FR/V/0191/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Dormilansolutionforinjectionfordogsandcats [FR]

Dormilan1mg/mlsolutionforinjectionfordogsandcats [DE,ES,IT,PT,UK]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Medetomidinehydrochloride............................................ 1.0mg

(equivalenttomedetomidine............................................ 0.85mg)

Excipients:

Methylparahydroxybenzoate(E218)................................ 1.0mg

Propylparahydroxybenzoate............................................ 0.2mg

Forthefulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearandcolourlesssolution.

4. CLINICALPARTICULARS

4.1. Targetspecies

Dogsandcats.

4.2. Indicationsforuse,specifyingthetargetspecies

Indogsandcats:

-Sedationinordertofacilitatetherestraintofanimalsduringclinicalexaminations.

-Premedicationpriortogeneralanaesthesia.

4.3. Contraindications

Donotuseinanimalswithseriouscardiovasculardisease,respiratorydiseaseorhepaticorrenal

disorders.

Donotuseincaseofmechanicaldisordersofgastrointestinaltract(torsionofthestomach,

imprisonment,obstructionoftheoesophagus).

Donotadministerinconjunctionwithsympathomimeticamines.

Donotuseincaseofknownhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseinanimalswithdiabetesmellitus.

Donotuseinanimalswithstateofshock,emaciationorseriousdebilitation.

Donotuseinanimalswithocularproblemswhereanincreaseinintraocularpressurewouldbe

detrimental.

SeeSection4.7.

4.4. Specialwarningsforeachtargetspecies

Itispossiblethatmedetomidinedoesnotprovideanalgesiathroughouttheentiresedationperiod.The

useofadditionalanalgesicsshouldbeconsideredduringpainfulsurgicalprocedures.

4.5. Specialprecautionsforuse

Specialprecautionsforuseinanimals

Duringitsuseinpremedication,thedosageofanaestheticwillbereducedinproportionand

establishedaccordingtothereactionoftheanimal,dependingonthevariabilityofresponsebetween

animals.Specialwarningsandcontraindicationsincludedintheliteratureoftheotherproductsshould

berespectedbeforecarryingoutanyassociation.

Medetomidinecanproducerespiratorydepression;insuchcase,manualventilationand

administrationofoxygenmaybeconducted.

Aclinicalexaminationshouldbecarriedoutinallanimalsbeforetheuseofveterinarymedicinal

productsforsedationand/orgeneralanaesthesia.

Higherdosesofmedetomidineshouldbeavoidedinlargebreeddogs.Careshouldbetakenwhen

combiningmedetomidinewithotheranaestheticsorsedativesbecauseofitsmarkedanaesthetic

sparingeffects.Animalsshouldbefasted12hoursbeforeanaesthesia.

Theanimalshouldbeplacedinacalmandquietsurroundingtoletthesedationgainitsmaximum

effect.Thistakesabout10-15minutes.Oneshouldnotstartanyprocedureorgiveothermedicines

beforemaximumsedationisreached.

Treatedanimalsshouldbekeptwarmandataconstanttemperature,bothduringtheprocedureand

recovery.

Theeyesshouldbeprotectedbyasuitablelubricant.

Nervous,aggressiveorexcitedanimalsshouldbegiventhepossibilitytocalmdownbeforeinitiationof

treatment

Sickanddebilitateddogsandcatsshouldonlybepremedicatedwithmedetomidinebeforeinduction

andmaintenanceofgeneralanaesthesiabasedonarisk-benefitassessment.

Careshouldbetakenwithuseofmedetomidineinanimalswithcardiovasculardisease,orwhichare

elderlyoringeneralpoorhealth.Liverandkidneyfunctionshouldbeevaluatedpriortouse.

Inordertoreducetherecoverytimeafteranæsthesiaorsedation,theeffectofmedetomidinecanbe

reversedbytheadministrationofanalpha-2-antagonistsuchasatipemazole.

Atipamezoledoesnotreversetheeffectofketamine.Asketaminealonecanelicitcramps,alpha-2

antagonistsshouldnotbegivenlessthan30-40min.aftertheadministrationofketamine.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Incaseofaccidentaloralintakeorself-injection,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysicianbutDONOTDRIVEassedationandchangesinblood

pressuremayoccur.

Avoidskin,eyeormucosalcontact.

Washtheexposedskinimmediatelyafterexposurewithlargeamountsofwater.

Removecontaminatedclothesthatareindirectcontactwithskin.

Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantlywithfreshwater.If

symptomsoccur,seektheadviceofaphysician.

Ifpregnantwomenhandletheproduct,specialcautionshouldbeobservednottoself-injectasuterine

contractionsanddecreasedfoetalbloodpressuremayoccurafteraccidentalsystemicexposure.

Advicetodoctors:

Medetomidineisanalpha2-adrenoreceptoragonist,symptomsafterabsorptionmayinvolveclinical

effectsincludingdose-dependentsedation,respiratorydepression,bradycardia,hypotension,adry

mouth,andhyperglycaemia.Ventriculararrhythmiashavealsobeenreported.

Respiratoryandhaemodynamicsymptomsshouldbetreatedsymptomatically.

[IT]Nationalrequirements(tobeincludedonlyintheITtext):

Tobeadministratedandsuppliedonlybyaveterinarysurgeon.

4.6. Adversereactions(frequencyandseriousness)

Thefollowingadversereactionsmayoccur:

- Cardiovasculareffects:bradycardiawithatrioventricularblock(1 st

and2 nd

degree)and

occasionalextrasystoles,vasoconstrictionofcoronaryartery,decreasedcardiacoutput.

- Increaseofbloodpressurejustaftertheadministrationofproductandthenreturntothe

normalvalueorslightlybelow.

- Somedogsandmostcatsvomit5-10minutesafterinjection.Catsmayalsovomiton

recovery.

- Sensitivitytoloudnoiseshasbeenobservedinsomeanimals.

- Anincreaseofdiuresis,hypothermia,respiratorydepression,cyanosis,apainattheinjection

siteandmuscletremorsmayalsooccur.

Thefollowingmayalsobeobserved:

- Casesofreversiblehyperglycaemiaduetoadepressionofinsulinsecretion.

- Casesofpulmonaryoedema.

Incasesofcardiovascularandrespiratorydepression,assistedventilationandadministrationof

oxygenmaybeindicated.Atropinecanincreasethecardiacrate.

Dogsweighinglessthan10kgcanpresentfrequentlywiththeabove-mentionedadversereactions.

4.7. Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyand

lactation.

Therefore,donotusethedrugduringpregnancyandlactation.

4.8. Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantadministrationofothercentralnervoussystemdepressantsshouldbeexpectedto

potentiatetheeffectofeitherproductandappropriatedoseadjustmentshouldbemade.

Medetomidinehasmarkedanaestheticsparingeffects(seesection4.5oftheSPC).

Theeffectsofmedetomidinecanbeantagonisedbytheadministrationofatipamezole.

Donotadministerconcomitantlywithsympathomimeticsorsulfamidesandtrimethoprim.

4.9. Amountstobeadministeredandadministrationroute

Dogs:intramuscularorintravenousinjection

Forsedation:

Forsedationtheproductshouldbeadministeredattherateof15-80µgofmedetomidine

hydrochlorideperkgofbodyweightI.V.,or20-100µgofmedetomidinehydrochlorideperkgofbody

weightI.M.

Usethetablebelowtodeterminethecorrectdosageonthebasisofbodyweight.

Maximaleffectisobtainedwithin15-20minutes.Clinicaleffectisdose-dependent,lasting30to180

minutes.

Dormilan dosagesinmlandcorrespondingamountofmedetomidinehydrochlorideinμg/kgbw:

body

weight

[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:

10-40µgmedetomidinehydrochlorideperkgbodyweight,correspondingto0.1-0.4mlper10kgbody

weight.Theexactdosedependsonthecombinationofdrugsusedandthedosage(s)oftheother

drug(s).Thedoseshouldfurthermorebeadjustedtothetypeofsurgery,lengthofprocedureand

patienttemperamentandweight.Premedicationwithmedetomidinewillsignificantlyreducethe

dosageoftheinductionagentrequiredandwillreducevolatileanaestheticrequirementsfor

maintenanceanaesthesia.Allanaestheticagentsusedforinductionormaintenanceofanaesthesia

shouldbeadministeredtoeffect.Beforeusinganycombinations,productliteraturefortheother

productsshouldbeobserved.Seealsosection4.5.

Cats:intramuscularinjection,intravenousinjectionandsubcutaneousinjection

Formoderate-deepsedationandrestraintofcatstheproductshouldbeadministeredatadosageof

50 –150µgmedetomidinehydrochloride/kgbw(corresp.to0.05–0.15ml/kgbw).Thespeedof

inductionisslowerwhensubcutaneousrouteofadministrationisused.

4.10. Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incasesofoverdosage,theprincipalsignsareprolongedanaesthesiaorsedation.Insomecases,

cardiorespiratoryeffectsmayoccur.Thetreatmentconsistsoftheadministrationofanalpha-2

antagonist,asatipamezole,providedthatreversalofsedationisnotdangerousfortheanimal

(atipamezoledoesnotreversetheeffectsofketamine,whichusedalonecanproduceconvulsionsin

dogsandcrampsincats).Alpha-2-antagonistsshouldnotbegivenlessthan30-40minutesafterthe

administrationofketamine.

Atipamezolehydrochlorideisadministeredbyintramuscularrouteatthefollowingdosage:5timesthe

initialdoseofmedetomidinehydrochlorideadministeredtodogs(µg/kg)and2.5timesforcats.The

volumeofatipamezolehydrochloride5mg/mlisequaltovolumeofdrugadministeredtodogs;forcats

halfofthisvolumeshouldbeused.

Ifitisimperativetoreversebradycardiabuttomaintainsedation,atropinemaybeused.

4.11. Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:sedativeandanalgesic.

ATCvetCode:QN05CM91.

5.1. Pharmacodynamicproperties

Medetomidineisasedativecomponentwhichpresentsanalgesicandmyorelaxantproperties.Itisa

selectiveagonist,specificandparticularlyeffectiveforalpha-2-adrenergicsreceptors.Theactivationof

thesereceptorsinducesadecreaseinthereleaseandturnoverofnoradrenalinincentralnervous

systemwhichisdeclaredbymeansofsedation,analgesiaandbradycardia.Atperipherallevel,

medetomidinecausesvasoconstrictionbystimulationofpost-synapticalpha-2-adrenergicreceptors,

whichproduceatransitoryhypertension.Bloodpressurereturnstonormallevels,eventoamoderate

hypotensionwithin1to2hours.Respiratoryratecanbereducedtemporarily.

Thetimeanddepthofsedationandanalgesiaaredosedependent.Whentheeffectismaximum,the

animalisrelaxedanddoesnotrespondtoexternalstimulation.Medetomidineactsinasynergic

mannerwithketamineoropiates,suchasfentanyl,resultinginabetteranaesthesia.Thenecessary

amountofvolatileanaesthesics(e.g.halothane)isreducedbymedetomidine.Inadditiontoits

sedative,analgesiaandmyorelaxantproperties,medetomidinealsoexertshypothermicandmydriatic

effects,inhibitsthesalivationanddecreasesintestinalmotility.

5.2. Pharmacokineticparticulars

Afterintramuscularinjection,medetomidineisrapidlyandalmostcompletelyabsorbedinthesiteof

injectionandpharmacokineticsisverysimilartothatobservedafterintravenousinjection.Maximum

plasmaconcentrationsarereachedwithin15to20minutes.Estimatedplasmahalf-lifeis1.2hoursfor

dogsand1.5hoursforcats.Medetomidineismainlyoxidisedintheliver,whileasmallamountis

methylatedinthekidney.Metabolitesareprimarilyexcretedinurine.

6. PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Methylparahydroxybenzoate.(E218)

Propylparahydroxybenzoate.

Sodiumchloride.

Waterforinjections.

6.2. Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3. Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4. Specialprecautionsforstorage

Donotrefrigerateorfreeze.

Protectfromlight.

Protectfromfrost.

6.5. Natureandcompositionofimmediatepackaging

TypeIclearglassvialsof10mlcapacity.Vialsarefittedwithabromobutylstopperandsealedwithan

aluminiumcap.Vialsarepackedinacardboardbox.

Packsizes:

-Boxwith1vial

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VETPHARMAANIMALHEALTH,S.L.

LesCorts,23

08028Barcelona

SPAIN

8. MARKETINGAUTHORISATIONNUMBER

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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