Romidys 1mg/ml Solution For Injection

Main information

  • Trade name:
  • Romidys 1mg/ml Solution For Injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Romidys 1mg/ml Solution For Injection
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • NERVOUS SYSTEM
  • Therapeutic area:
  • Cats Non Food, Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0146/001
  • Authorization date:
  • 25-02-2011
  • EU code:
  • UK/V/0146/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:February2011

AN:01019/2010

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Romidys1mg/mlsolutionforinjection.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

EachmlofRomidys1mg/mlsolutionforinjectioncontains:

Activeingredient

Romifidinehydrochloride 1mg

equivalentto0.876mgromifidine

Preservatives

Methylparahydroxybenzoate (E218) 1.8mg

Propylparahydroxybenzoate (E216) 0.2mg

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearalmostcolorlesssolution

4. CLINICALPARTICULARS

4.1Targetspecies

Dogsandcats.

4.2Indicationsforuse,specifyingthetargetspecies

Sedativeforuseindogsandcatsforrestraint;tofacilitatehandling,clinical

examinations,minorsurgicalinterventionsandmanipulations.Premedication

agentpriortotheinductionofgeneralanaesthesia.Forprofound

sedation/analgesiaindogsitmayalsobeusedwithanopioidanalgesic.Incats

combinationwithketamineprovidessurgicalanaesthesia.

4.3Contraindications

Donotuseinpregnantanimals.

Donotuseinanimalssufferingfromdiabetesmellitus.

4.4Specialwarningsforeachtargetspecies

Asadose-dependentincreaseinbloodureamayoccurincats,sufficientfluid

intakeshouldbeensured.

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4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Sedatedanimalsshouldberestrainedtopreventinjury.Careshouldbe

takentoensurethatanimalshavesufficientfluidintake.Animals,which

undergoprolongedsedation,shouldbepreventedfrombecoming

hypothermic.

Careshouldbetakeninanimalsinpoorhealth,orincasesof

cardiovascular,renal,hepaticorpancreaticdisease,andinanimals

sufferingfromrespiratorydistress.Theclinicalconditionofcatssuffering

frompancreatitisshouldbecloselymonitored(seeSection5.9).

ii.Specialprecautionstobetakenbythepersonadministeringthemedicinal

productstoanimals

Thisproductcontainsanα

-adrenergicagonist.

Inthecaseofaccidentaloralintakeorself-injection,seekmedicaladvice

immediatelyandshowthepackageleaflettothedoctorbutDONOT

DRIVEassedationandchangesinbloodpressuremayoccur.

Avoidskin,eyeormucosalcontact.

Immediatelyafterexposure,washtheexposedskinwithlargeamountsof

freshwater.

Removecontaminatedclothesthatareindirectcontactwithskin.

Inthecaseofaccidentalcontactoftheproductwitheyes,rinsewithlarge

amountsoffreshwater.Ifsymptomsoccur,seektheadviceofadoctor.

Ifpregnantwomenhandletheproduct,specialcautionshouldbeobserved

nottoself-injectasuterinecontractionsanddecreasedfoetalblood

pressuremayoccurafteraccidentalsystemicexposure.

Advicetodoctors:

Romifidineisanalpha2-adrenoreceptoragonist.Symptomsafter

absorptionmayinvolveclinicaleffectincludingdose-dependentsedation,

respiratorydepression,bradycardia,hypotension,adrymouth,and

hyperglycaemia.Ventriculararrhythmiashavealsobeenreported.

Respiratory and haemodynamic symptoms should be treated

symptomatically.

Revised:February2011

AN:01019/2010

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4.6Adversereactions(frequencyandseriousness)

Typicaladversereactionsofα

-agonistssuchasbradycardia,benignreversible

cardiacarrhythmiasuchastypeIortypeIIatrioventricular(AV)blocksand

hypotensionmayoccur.Thermoregulatorymechanismsmaybeinfluenced,so

thatbodytemperaturemayincreaseordecreasedependinguponthe

environmentaltemperature.

Occasionallyanimalsvomitfollowingadministration(especiallyifrecentlyfed).

Therespiratorypatternmaybecomeirregular.Catsmayvomitupto24hours

afteradministrationofromifidine.Adose-dependentriseinbloodglucosemay

accompanysedationindogsandcats.Othertypicals ideeffectsofα

-agonists

suchasmuscletwitchingandpantingandsalivationmaybeobservedindogs.

Mildandtransientinjectionsitereactionshavebeenobservedafterthe

intramuscularadministrationincats.Casesofprolongedsedationand

recurrenceofsedationafterinitialrecoveryhavebeenreported.

4.7Useduringpregnancy,lactationorlay

Theproductshouldnotbeusedinpregnantanimals

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Thesedativeeffectoftheproductmaybepotentiatedbyotherpsychoactive

compounds,suchastranquillisers,othersedativesormorphine-likeanalgesics,

thereforereducingtherequireddoseofsubsequentinjectableanaesthetic

agents.Italsopotentiatesthesedativeeffectsofanticonvulsantdrugsgivento

dogsandcatssufferingfromepilepsy.

4.9Amount(s)tobeadministeredandadministrationroute

Forintramuscular,intravenousorsubcutaneoususeindogsandforintravenous

orintramuscularuseincats.

Allanimalsshouldbestarvedforatleast12hourspriortoinjectionofthis

product.

Dosagesmayvarybetweenindividualanimalsandmaydependon

temperament.Painfulmanipulationsmayrequirethehighdoselevel.

Sedationwillbeoptimisedifanimalsareallowedtostayincalmandquiet

surroundingswithminimalenvironmentstimuli.Inordertobenefitfrom

enhancedanalgesia,itisrecommendedtoallowsufficienttime(usually15

minutes)beforeinitiatingtheprocedure.

Sedation

Dogs:

0.04-0.12mlRomidys1mg/mlSolutionforInjectionperkgbodyweight

providesadose-relatedresponse(40µg-120µgromifidineHCl/kgbody

weight).

Revised:February2011

AN:01019/2010

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Whenadministeredbyi.v.injection,80µgromifidineHCl/kgbodyweightledto

onsetofsedationwithinapproximately5minutes,theeffectlasting60-120

minutes.

Whenadministeredbys.c.injection(ori.m.),theonsetofsedationisdelayed,

withdepthofsedationlowerthanbythei.v.routeuntilapproximately30

minutesafterinjection.Thedurationofsedationmaybemoreprolonged.

Indogs,atipamezolesolution,givenbyintramuscularinjection30minutesafter

theintravenousadministrationofRomidys,willhastenrecoveryfromthe

sedativeeffectsofRomidys.Adoseof0.12mlRomidysperkgbodyweightin

dogscanbereversedwith200µgatipamezole/kg.

Cats:

0.2-0.4mlRomidys1mg/mlSolutionforInjectionperkgbodyweightprovides

adose-relatedresponse(200-400µgromifidineHCl/kgbodyweight).

Whenadministeredbyi.m.injection,200µg/kgromifidineHCl/kgbodyweight

ledtoonsetofsedationwithinapproximately10minutes,theeffectlasting

approximately60minutes.Althoughthedurationofactionissimilar,amore

rapidonsetofsedationisachievedviatheintravenousrouteofadministration

(withinapproximately5minutes).

Incats,atipamezolesolution,givenbyintramuscularinjection30minutesafter

theintramuscularadministrationofRomidys,willhastentherecoveryfromthe

sedativeeffectsofRomidys.Adoseof0.4mlRomidysperkgbodyweightin

catscanbereversedwith400µgatipamezole/kg.

Premedication

Inclinicaltrials,premedicationwithromifidinehasbeenfollowedbyanaesthesia

withpropofolorthiopentone(andmaintenancewithhalothane)indogs,andby

ketamineincats.Itshouldbenotedthatanaestheticagentsshouldbegivento

effect,dependingontheindividualresponseandthedegreeofsurgical

manipulation.

Dogs:

0.04-0.12mlRomidys1mg/mlSolutionforInjectionperkgbodyweight

providesadose-relatedresponse(40µg-120µgromifidineHCl/kgbody

weight).

Anaesthesiashouldbeinducedapproximately10minutesafterintravenousand

10-15minutesaftersubcutaneousandintramuscularadministrationofRomidys

1mg/mlsolutionforinjection.

Cats:

0.2mlRomidys1mg/mlSolutionforInjectionperkgbodyweightbyi.m.

injection,10-15minutespriortoi.m.injectionofketamine(10mg/kg

bodyweight)providessurgicalanaesthesiaforupto30minutes.

IncreasingthedoseofRomidysto0.4mlperkgbodyweightpriortoketamine,

willextendtheperiodofsurgicalanaesthesia.

Incats,itwasshownthata"top-updose"of50%oftheinitialdosesof

romifidineandketaminecouldbeusedtoprolonganaesthesia.

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Dosagestwicetherecommendeddosecausedtransientsideeffectstypicalof

-agonistssuchasbradycardia,benignheartarrhythmiasuchastypeIortype

IIatrioventricular(AV)blocks,hypotension,decreaseinbodytemperature,

hyperglycaemiaandincreaseinbloodureaconcentration.

Dogshavebeenadministered1.0mg/kgromifidineHClintravenously(10x

recommendeddose)dailyforfourweekswithoutseriousadverseeffects.Cats

havebeenadministered600µgasasingleintramusculardosewithoutserious

adverseeffects.Undesirableadverseeffects(seeSection5.4)aregenerally

dosedependentanddisappearby24hoursaftertreatment.Inanexperimental

study,pancreatitiswasobservedincatsafterrepeatedintramuscular

administrationofthemaximumtherapeuticdoseandofoverdosesgivenat2

dayintervalsoveraperiodof6days.

Intheeventofanaestheticemergency,theeffectsofthisproductcanbe

reversedusinganα

-antagonist,suchasatipamezolesolution(suggesteddose

rate:cats-400µg/kgbodyweight,dogs-200µg/kgbodyweight).

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCvetcode:QN05CM93

Romifidineisanaα

-agonistoftheimino-imidazolidineclass.

Romifidineexertssedativeandanalgesiceffects.Itssedativeeffectisinduced

bystimulationofα

-receptorsinthecentralnervoussystem.Thesubstance

possessesastrongspecificaffinityforthesereceptors.

5.2Pharmacokineticparticulars

Themeanabsolutebioavailabilityoftheinjectablesolutionfollowing

intramuscularadministrationis86%indogsand95%incats.Itis92%following

subcutaneousadministrationindogs.

Maximalplasmaconcentrationsaftersubcutaneousandintramuscular

administrationareobtainedwithinapproximately50minutesindogsand

approximately25minutesfollowingintramuscularinjectionincats,respectively.

Romifidineisrapidlydistributedinthebodywithavolumeofdistributionof

approximately3l/kgbodyweightfordogsand6l/kgbodyweightforcats,

respectivelyfollowingintravenousadministration.

Revised:February2011

AN:01019/2010

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Romifidineismetabolisedintheliver.Themeanplasmaeliminationhalf-lifeis

approximately2hoursindogsand6hoursincats.Approximately80%ofthe

administereddoseiseliminatedviaurineandtheremainderviafaecesindogs.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylhydroxybenzoate(E218)

Propylhydroxybenzoate(E216)

Sodiumchloride

Waterforinjection

6.2Incompatibilities

Noneknown.

6.3Shelf-life

Unopenedvial: 3years

Broachedvial: 28days

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Donotfreeze.

6.5Natureandcompositionofimmediatepackaging

Colourlessglassinjectionvialof20ml,closedwitharubberstopperandsealed

withanaluminiumcap.

-Boxcontaining1or12vialsof20ml

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VIRBACS.A.

ère avenue-2065m-L.I.D.

06516CARROS

FRANCE

Revised:February2011

AN:01019/2010

Page7of7

8. MARKETINGAUTHORISATIONNUMBER

Vm 05653/4126

9. DATEOFFIRSTAUTHORISATION

Date:10February1999

10.DATEOFREVISIONOFTHETEXT

Date:February2011

Prohibitionofsale,supplyand/oruse:

Veterinarymedicinalproductsubjecttoprescription.

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