Detogesic

Main information

  • Trade name:
  • Detogesic 10mg/ml Solution for Injection for Horses
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Detogesic 10mg/ml Solution for Injection for Horses
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Detomidine
  • Therapeutic area:
  • Horses

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0226/001
  • Authorization date:
  • 16-02-2012
  • EU code:
  • UK/V/0226/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:August2013

AN:00202/2012

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DETOGESIC10mg/mlSolutionforInjectionfor

Horses BE,BG,CY,CZ,DE,

EL,ES,FR,IE,IT,LU,

NL,PL,PT,RO,SI,

SK,UK

EQUISEDANvet10mg/mlSolutionforInjectionfor

Horses FI,NO,SE

EQUISEDAN10mg/mlSolutionforInjectionfor

Horses DK,LT.LV

EQUIDOR10mg/mlSolutionforInjectionforHorses AT,HU

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Detomidinehydrochloride10mg/ml(Detomidine8.36mg/ml)

Excipient(s):

Preservative

Methylparahydroxybenzoate(E218) 1mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

SolutionforInjection.

Clear,almostcolourlesssolutionforintravenousinjection.

4. CLINICALPARTICULARS

4.1Targetspecies

Horse

4.2Indicationsforuse,specifyingthetargetspecies

Forthesedationandslightanalgesiaofhorses,tofacilitatephysical

examinationsandtreatments,suchasminorsurgicalinterventions.

Theproductcanbeusedfor:

Medicalexaminations (e.g.endoscopic,rectalandgynaecological

examinations,X-rays).

Minorsurgicalprocedures(e.g.treatmentofwounds,dentaltreatment,

tendontreatment,excisionofskintumours,teattreatment).

Beforetreatmentandmedication(e.g.stomachtube,horseshoeing).

Forpre-medicationpriortoadministrationofinjectionorinhalationanaesthetics.

Seesection4.5beforeuse.

Revised:August2013

AN:00202/2012

Page2of7

4.3Contraindications

Donotuseinanimalswithcardiacabnormalitiesorrespiratorydisease.

Donotuseinanimalswithliverinsufficiencyorrenalfailure.

Donotuseinanimalswithgeneralhealthproblems(e.g.dehydratedanimals).

Donotuseinthelast3monthsofpregnancy.

Donotuseincombinationwithbutorphanolinhorsessufferingfromcolic.

Donotuseincombinationwithbutorphanolinpregnantmares.

SeealsoSections4.7and4.8.

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Assedationbegins,horsesmaystarttoswayandlowertheheadrapidlywhile

theyremainstanding.Topreventinjuriesinhorseandpeoplewhiletreating

horses,thelocationfortreatmentshouldbechosencarefully.Usual

precautionarymeasuresshouldbetakentopreventself-injury.

Animalssufferingfromshockorliverorkidneydiseaseshouldonlybetreated

accordingtothebenefit/riskassessmentbytheresponsibleveterinarysurgeon.

Theproductshouldnotbeusedinanimalssufferingfromcardiacdiseases

(withpre-existingbradycardiaandriskofatrioventricularblock),respiratory,

liverorrenalinsufficienciesoranyotherextraordinarystressconditions.

Itisrecommendedthatfeedshouldbewithheldforatleast12hourspriorto

anaesthesia.

Waterorfoodshouldnotbeofferedtotreatedanimalsuntilthedrugeffecthas

passed.

Inpainfulproceduresdetomidineshouldbeusedonlyincombinationwithan

analgesicoralocalanaesthetic.

Whilewaitingfortheonsetofsedation,animalsshouldremainincalm

surroundings.

Detomidine/butorphanolcombinationsshouldnotbeusedinhorseswitha

historyofliverdiseaseorcardiacirregularities.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductshouldbeadministeredwithcaution,andcaretakentoavoid

accidentalself-injection.

Revised:August2013

AN:00202/2012

Page3of7

Inthecaseofaccidentaloralintakeorself-injectionseekmedicaladvice

immediatelyandshowthepackageleaflettothedoctorbutDONOT

DRIVEassedationandchangesinbloodpressuremayoccur.

Avoidskin,eyeormucosalcontact.

Washtheexposedskinimmediatelyafterexposurewithlargeamountsof

freshwater.

Removecontaminatedclothesthatareindirectcontactwithskin.

Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantly

withfreshwater.Ifsymptomsoccur,seektheadviceofadoctor.

Ifpregnantwomenhandletheproduct,specialcautionshouldbeobserved

nottoself-injectasuterinecontractionsanddecreasedfoetalblood

pressuremayoccurafteraccidentalsystemicexposure.

Advicetodoctors:

Detomidineisanalpha-2-adrenoreceptoragonist.Symptoms afterabsorption

mayinvolveclinicaleffectsincludingdose-dependentsedation,respiratory

depression,bradycardia,hypotension,adrymouth,andhyperglycaemia.

Ventriculararrhythmiashavealsobeenreported.Respiratoryand

haemodynamicsymptomsshouldbetreatedsymptomatically.

4.6Adversereactions(frequencyandseriousness)

Injectionofdetomidinemaycausethefollowingsideeffects:

- Bradycardia.

- Transienthypo-orhypertension.

- Respiratorydepression,rarelyhyperventilation.

- Increaseinbloodglucose.

- Aswithothersedatives,inrarecasesparadoxicalreactions(excitations)

candevelop.

- Ataxia.

-Cardiacarrhythmia,atrioventricularandsino-atrialblock.

-Uterinecontractions.

Atdosesabove40mcg/kgbodyweight,thefollowingsymptomscanalsobe

observed:sweating,pilo-erectionandtremorofmuscles,transientpenis

prolapseinstallionsandgeldings.

Inveryrarecaseshorsesmayshowmildsymptomsofcolicfollowing

administrationofalpha-2sympathomimeticsbecausesubstancesofthisclass

transientlyinhibitthemotilityoftheintestines.Theproductshouldbe

prescribedwithcautioninhorseswhichpresentwithsignsofcolicor

impaction.

Adiureticeffectisusuallyobservedwithin45to60minutesaftertreatment.

4.7Useduringpregnancy,lactationorlay

Donotusetheproductinmaresinthelast3monthsofpregnancy.During

theremainingmonthsuseonlyaccordingtoarisk/benefitanalysisbythe

responsibleveterinarysurgeon.

Useduringlactationshouldalsobethesubjectofrisk/benefitanalysisbythe

responsibleveterinarysurgeon.

Revised:August2013

AN:00202/2012

Page4of7

Donotuseincombinationwithbutorphanolinpregnantmares.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofothersedativesshouldproceedonlyafterconsultationof

thewarningsandprecautionsfortheproduct(s)concerned.

Detomidineshouldnotbeusedincombinationwithsympathomimeticamines

suchasadrenaline,dobutamineandephedrine,exceptasrequiredin

anaestheticemergencies.

Theconcurrentuseofcertainpotentiatedsulphonamidesmaycausecardiac

arrhythmiawithfataloutcome.Donotuseincombinationwith

sulphonamides.

Detomidineincombinationwithothersedativesandanaestheticsshouldbe

usedcarefullybecauseadditive/synergisticeffectsmaybepossible.Where

anaesthesiaisinducedwithacombinationofdetomidineandketamine,prior

tomaintenancewithhalothane,theeffectsofhalothanemaybedelayedand

caremustbetakentoavoidoverdosage.Whendetomidineisusedasapre-

medicantpriortogeneralanaesthesia,itmaydelaytheonsetofinduction.

4.9 Amountstobeadministeredandadministrationroute

Administrationroute

Forintravenous(IV)useonly.Theproductshouldbeinjectedslowly.Onset

ofeffectismorerapidfollowingintravenoususe.

Amount(s)tobeadministered

Usealoneforsedation:dosagetable

Dosage

inmcg/kg Dosage

inml/100kg Levelof

sedation Commencement

ofeffect(min) Durationof

effect

(hrs)

10-20 0.1-0.2 Light 3-5 0.5-1

20-40 0.2-0.4 Moderate 3-5 0.5-1

Whenprolongedsedationandanalgesiaisrequired,dosesof40to80mcg/kg

canbeused.Thedurationofeffectisupto3hours.Itisrecommendedto

wait15minutesafterdetomidineadministrationbeforestartingtheplanned

procedure.

Forcombinationwithotherproductstointensifysedationorforpremedication

priortogeneralanaesthesia,dosesof10to30mcg/kgcanbeused.Priorto

useincombinationwithotherproductssuchasbutorphanolorketamine,

consulttheappropriateproductdetailsfordoseratesAllow5minutesafterthe

administrationofdetomidineforthehorsetobecomedeeplysedatedbefore

anysubsequenttreatment.

Thebodyweightoftheanimaltobetreatedshouldbedeterminedas

accuratelyaspossibletoavoidoverdosing.

Revised:August2013

AN:00202/2012

Page5of7

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Intheeventofanaccidentaloverdose,cardiacarrhythmias,hypotension,

delayedrecoveryandprofoundCNSandrespiratorydepressionmayoccur.

Shouldtheeffectsofdetomidinebecomelife-threatening,administrationofan

alpha-2-adrenergicantagonistisrecommended

4.11Withdrawalperiod(s)

Meatandoffal:2days

Milk:12hours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Sedativeandanalgesic

ATCvetcode: QN05CM90

5.1 Pharmacodynamicproperties

Theactiveingredientoftheproductis4-(2,3-dimethylbenzyl)-imidazole-

hydrochloride(INN:detomidine).Detomidineleadstosedationoftreated

animalsandrelievespain,withdurationandintensityofeffectbeingdose

related.Detomidineactsasanagonistatalpha-2adrenoceptors,and

observedanalgesiceffectsareduetoinhibitionoftransmissionofthepain

impulsewithintheCNS.

Detomidineactsonperipheralalpha-adrenoceptors,thereforeanincreasein

bloodglucoselevelandathigherdosagespiloerection,sweatinganddiuresis

mayoccur.Aninitialincreaseinmeanbloodpressureisobserved,which

returnstonormalorslightlybelowandheartratedecreases.TheECGshows

anenlargedPR-interval,andmildatrio-ventricularblocksmaybeobserved.

Thesechangesaretransient.Respiratoryresponseincludesaninitial

decreaseinrespirationrate,increasingtonormalorslightlyhighervalues

withinafewminutes.

5.2 Pharmacokineticparticulars

Detomidineisabsorbedrapidlyafterintramuscularinjection,withaT

of15-

30minutes.Bioavailabilityafterintramuscularadministrationis66-85%.

Afterrapiddistributionofdetomidineintothetissues,withahalf-lifeof0.15

hourspostintravenousinjection,detomidineisalmostcompletely

metabolized,mainlyintheliver-t

is1to2hours.Thevolumeofdistribution

rangesfrom0.75to1.89l/kg,andproteinbindingis75-85%.Theelimination

half-lifeinthehorsewas1.19hours,withlessthan1%parentcompound

presentinurine.Metabolitesaremainlyexcretedviaurineandfaeces.

Revised:August2013

AN:00202/2012

Page6of7

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylparahydroxybenzoate(E218)

Sodiumchloride

Sodiumhydroxide(forpHadjustment)

WaterforInjections

6.2Incompatibilities

Thisveterinarymedicinalproductmustnotbemixedwithotherveterinary

medicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinal

productaspackagedforsale:

3years

Shelf-lifeafterfirstopeningimmediatepackaging: 28days.

6.4. Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalcartoninordertoprotectfromlight.

Storeinadryplace.

6.5Natureandcompositionofimmediatepackaging

Multi-dose,clear,Type1glassvial,withpierceablebromobutylrubberstopper

andanaluminiumcollar,containing10ml.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

VetcareLimited

Peltotuentie5

25130Muurla

Finland

Revised:August2013

AN:00202/2012

Page7of7

8. MARKETINGAUTHORISATIONNUMBER

Vm03379/4000

9. DATEOFFIRSTAUTHORISATION

Date:07April2008

10. DATEOFREVISIONOFTHETEXT

Date:August2013

Approved:21/08/2013

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Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

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

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

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

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia