Fentadon 50 microgram/ml, solution for injection for dogs

Main information

  • Trade name:
  • Fentadon 50 microgram/ml, solution for injection for dogs
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fentadon 50 microgram/ml, solution for injection for dogs
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • fentanyl
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0155/001
  • Authorization date:
  • 20-01-2012
  • EU code:
  • NL/V/0155/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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LABELLINGANDPACKAGELEAFLET

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A.LABELLING

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<PARTICULARSTOAPPEARONTHEOUTERPACKAGE>

<PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE>

{OUTERCARTON/5/10/20/25/30/50/100ml}

{LABEL/100ml}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fentadon50microgram/ml,solutionforinjectionfordogs

SE,DK:FentadonVet.50microgram/ml,solutionforinjectionfordogs

NO:Fentadonvet50microgram/ml,solutionforinjectionfordogs

Fentanyl

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:

Activesubstance:

Fentanyl50microgram(equivalenttofentanylcitrate78.5microgram)

Excipient(s):

Methylparahydroxybenzoate(E218)1.6mg

Propylparahydroxybenzoate(E216)0.2mg

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,colourless

4. PACKAGESIZE

5/10/20/25/30/50/100ml

5. TARGETSPECIES

Dogs

6. INDICATION(S)

---

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable

9. SPECIALWARNING(S),IFNECESSARY

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Accidentalinjectionisdangerous.Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year}

Oncebroached,useby..

11. SPECIALSTORAGECONDITIONS

Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Controlleddrug.Administrationonlybyaveterinarysurgeon.Veterinary

productonrestrictedprescription.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25

5531AEBladel,theNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

-------

17. MANUFACTURER’SBATCHNUMBER

Batch{number}

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MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGINGUNITS

{LABEL/5/10/20/25/30/50ml}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fentadon50microgram/ml,solutionforinjectionfordogs

SE,DK:FentadonVet.50microgram/ml,solutionforinjectionfordogs

NO:Fentadonvet50microgram/ml,solutionforinjectionfordogs

Fentanyl

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Eachmlcontains:

Activesubstance:

Fentanyl50microgram(equivalenttofentanylcitrate78.5microgram)

Excipient(s):

Methylparahydroxybenzoate(E218)1.6mg

Propylparahydroxybenzoate(E216)0.2mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

5/10/20/25/30/50ml

4. ROUTE(S)OFADMINISTRATION

Accidentalinjectionisdangerous.Readthepackageleafletbeforeuse.

5. WITHDRAWALPERIOD

Notapplicable

6. BATCHNUMBER

Batch{number}

7. EXPIRYDATE

EXP{month/year}

Oncebroached,/opened,useby…

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

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B.PACKAGELEAFLET

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PACKAGELEAFLET

Fentadon50microgram/ml,solutionforinjectionfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

EurovetAnimalHealthB.V.

Handelsweg25

5531AEBladel,theNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fentadon50microgram/ml,solutionforinjectionfordogs

SE,DK:FentadonVet.50microgram/ml,solutionforinjectionfordogs

NO:Fentadonvet50microgram/ml,solutionforinjectionfordogs

Fentanyl

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlcontains:

Activesubstance:

Fentanyl50microgram(equivalenttofentanylcitrate78.5microgram)

Excipient(s):

Methylparahydroxybenzoate(E218)1.6mg

Propylparahydroxybenzoate(E216)0.2mg

4. INDICATION(S)

Forintraand/orpost-operativeanalgesiaduringsurgicalproceduressuchassofttissue-and

orthopaedicsurgery.

Forthecontrolofpost-operativepainassociatedwithmajororthopaedicandsofttissuesurgeryin

dogs.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstance,ortoanyoftheexcipients.

Donotuseindogswithcardiacfailure,hypotension,hypovolaemia,obstructiveairwaydisease,

respiratorydepression,hypertensionorwithahistoryofepilepsy.

Donotuseinanimalswithsevereliverandrenaldysfunction.

Refertosection12

6. ADVERSEREACTIONS

Incommonwithothernarcoticanalgesics,themostcommonseriousadversereactionswithfentanyl

arerespiratorydepressionandbradycardia.Bradycardiamayoccurduetoincreasedcardiacvagal

stimulation.Therespiratorydepressanteffectscanbeoflongdurationandmayexhibitabiphasic

pattern.Atransientfallinbloodpressuremayoccurfollowingintravenousadministrationoffentanyl

citrateinjectionevenatdosesof2.5–5µg/kg.Hypothermiamayoccur.Lowerednociceptive

thresholdindogswhentheeffectsofdrugdissipatehavebeendescribed.

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Duringstudieswiththeproductthefollowingreactionshavebeenobserved:

Rapidbreathing,panting,urination,defecation,vocalisation,tongueprotruding,over-activity,

irritability,bodytremors,vomiting,scratchingandsedation.

7. TARGETSPECIES

Dogs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Forintravenousadministration.Onsetofactionisseenwithin5minutes.Thedurationoftheanalgesic

effectis20(lowestrecommendeddose)to40minutes(highestrecommendeddose).

Fentanylcanbeadministeredaccordingtothefollowingdosageregimen:

AnalgesiabyContinuousRateInfusion(CRI)

5–10µg/kg(0.1-0.2ml/kg)IVasabolusfollowedby12–24µg/kg/hr(0.24–0.48ml/kg/hr)

IVforintra-operativeanalgesiaasCRI.

6–10µg/kg/hr(0.12–0.2ml/kg/hr)IVforsubsequentpost-operativeanalgesiaasCRIinsedated

animals.Duringpost-operativeCRIadministrationoffentanyl,animalsshouldbemonitored

carefully.

Chemical-physicalcompatibilityhasonlybeendemonstratedfordilutions1:5withthefollowing

solutionsforinfusion:sodiumchloride0.9%,Ringersolution,andglucose5%.

Thisveterinarymedicinalproducthasanarrowmarginofsafetyanditisimportanttomeasurethe

doseaccuratelytoavoidover-dosing.

9. ADVICEONCORRECTADMINISTRATION

10. WITHDRAWALPERIOD

Notapplicable

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotfreeze

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

Chemicalandphysicalstabilityofthedilutionshasbeendemonstratedfor4hoursat25°C.From

microbiologicalpointofviewthedilutionsshouldbeusedimmediately.

12. SPECIALWARNING(S)

Theuseofthemedicinemustbeprecededbyathoroughclinicalexamination.Atropinemaybeused

toblockthevagaleffects.

Specialprecautionsforuseinanimals

Thisveterinarymedicinalproductshouldbeindividuallytitratedtoaneffectivedosethatprovides

adequateanalgesiaandminimisesundesirableeffects.Animalsshouldbecarefullymonitoreduntilan

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effectivedoseisreached.Duetoindividualdifferencesinpainsensitivity,theeffectsoffentanylmay

bevariable.Olderanimalsmaytendtotitratetoalowereffectivedosethanyoungeranimals.

Itisimportantwhenestimatingtherequireddoseforintra-operativeanalgesiatoassessthelikely

degreeofsurgicalstimulation,theeffectofpremedicationdrugs,possibilityofsupportivecarelike

endotrachealintubationandventilatorysupportandthedurationoftheprocedure.

IfothernarcoticorCNS-depressantdrugs(e.g.propofol,isoflurane,sevoflurane)areused

concurrentlywithfentanylthedosagesoftheseagentsmayneedtobereduced.Whenestimatingthe

requireddoseforpost-operativeanalgesiathedegreeoftissuedamagehastobeassessed.Asaclass,

opioids,includingthisveterinarymedicinalproduct,mayresultinhypothermiawithdurationrelated

todose,bradypnea,hypotensionandbradycardia.Therefore,animalsshouldbecontinuously

monitoredforrectaltemperature,pulserate,respiratoryrateandheartrhythmduringsurgical

anaesthesia.Incaseofrenal,cardiacorhepaticdysfunction,orhypovolaemiaorshock,theremaybe

greaterriskassociatedwiththeuseoftheproduct.Itisdesirabletoreducedosageincaseof

hypothyroidismandincaseofchronichepaticorrenaldisease.Aswithallnarcoticanalgesics,care

shouldbetakenwhenadministeringfentanyltoanimalswithmyastheniagravis.

Facilitiesforthemaintenanceofapatentairway,intermittentpositivepressureventilation(IPPV)and

oxygensupplementationshouldbeavailable.Whenrespiratorydepressionoccurscontrolled

ventilationshouldbeinstalled.Aswithallpotentopioids,profoundanalgesiaisaccompaniedby

respiratorydepression,whichmaypersistintoorrecurintheearlypost-operativeperiod.The

respiratorydepressanteffectsmaybemoreproblematicinanimalswithpre-existingrespiratory

diseaseorincreasedintracranialpressure.Theeffectofanopioidonheadinjuryisdependentonthe

typeandseverityoftheinjuryandtherespiratorysupportsupplied.Itisimperativetoensurethat

adequatespontaneousbreathinghasbeenestablishedandmaintainedbeforedischargefromthe

recoveryareawheneverlargedosesofinfusionsoffentanylhavebeenadministered.Thebenefit:risk

ratioforusingtheproductshouldbemadebytheattendingvet.Thepharmacologicaleffectsof

fentanylcitratecanbereversedbynaloxone.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Fentanyl,anopioid,maycauseadverseeffectsafterinternalexposure,includingrespiratory

depressionorapnoea,sedation,hypotensionandcoma.Theproductmaycausehypersensitivity

reactions.

Avoidcontactwiththeskinandeyes.Wearprotectivegloveswhenhandlingtheproduct.Washhands

afteruse.Washanysplashesfromskinandeyesimmediatelywithlargeamountsofwater.Remove

contaminatedclothes.

Careshouldbetakentoavoidaccidentalself-injection.Incaseofaccidentalself-injection,seek

medicaladviceimmediatelyandshowthepackageleaflettothedoctorbutDONOTDRIVEas

sedationmayoccur.

- Adverseeffectsonthefoetuscannotbeexcluded.Pregnantwomenshouldavoidhandlingthe

product.Incaseofbreastfeedingwomenbeingaccidentallyexposed,breastfeedingisdiscouragedfor

24hours,asfentanylmaytransfertobreastmilk.

ADVICETODOCTORS:

Fentanylisanopioidwhosetoxicitymaycauseclinicaleffectsincludingrespiratorydepressionor

apnoea,sedation,hypotensionandcoma.Whenrespiratorydepressionoccurscontrolledventilation

shouldbeinstalled.Administrationoftheopioidantagonistnaloxonetoreversethesymptomsis

recommended.

Interactions:

Fentanylisapotentanaestheticsparingsubstance.Toavoidanaestheticoverdoseindogstreatedwith

theveterinarymedicinalproduct,anaestheticagentsshouldbeadministereduntilthedesiredeffectis

produced.

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Theveterinarymedicinalproductshouldbeusedwithcautioninconjunctionwithmorphineorother

opioidtypeanalgesicsastheeffectshavenotbeenstudied.

Theeffectsoftheconcomitantuseoftheveterinarymedicinalproductandα-adrenergicagonistshave

notbeenstudied.Therefore,α2-adrenergicagonistsshouldbeusedwithcautioninanimalsdosedwith

theveterinarymedicinalproductduetopotentiallyadditiveorsynergisticeffects.

Incompatibilities:

Donotmixwithanyotherveterinarymedicinalproductexcepttheinfusionsolutionsindicatedin

section8.

Theproductisincompatiblewithinjectionfluidscontainingmeloxicamoranyothernonaqueous

solution.

Useduringpregnancyandlactation:

Laboratorystudiesinratshavenotproducedanyevidenceofateratogenic,foetotoxic,mutagenic

effects.Placentaltransferoffentanyloccurs.Administrationduringparturitionmaycauserespiratory

depressioninthefoetus.

Thesafetyoftheveterinarymedicinalproductinthetargetspecieshasnotbeenestablishedduring

pregnancyandlactation.Theuseoftheproductisnotrecommendedduringpregnancy.

Overdose:

A2foldoverdoseasabolusinjectionresultedintheeffectsmentionedunder6.Intheeventthatany

ofthefollowingobservationsaremadefollowingtheapplication/overdoseoftheproduct,reversal

shouldbeinitiated:severesedation,unconsciousness,seizures,labouredorabdominalbreathingor

severehypotension.Thespecificnarcoticantagonistnaloxonehydrochloridecanbeusedtocounteract

respiratorydepression.Adoseof0.01to0.04mg/kgisgivenintravenouslyandmayberepeatedat

intervalsof2to3minutesifnecessary.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

January2012

15. OTHERINFORMATION

5/10/20/25/30/50/100ml

Notallpacksizesmaybemarketed.