Nerfasin 20 mg/ml, solution for injection for cattle, horses, dogs and cats

Main information

  • Trade name:
  • Nerfasin 20 mg/ml, solution for injection for cattle, horses, dogs and cats
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Nerfasin 20 mg/ml, solution for injection for cattle, horses, dogs and cats
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Xylazine
  • Therapeutic area:
  • Cats Non Food, Cattle Food, Dogs Non Food, Horses Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0157/001
  • Authorization date:
  • 22-02-2012
  • EU code:
  • NL/V/0157/001
  • Last update:
  • 09-08-2016

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

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

CARTONBOX

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Nerfasin20 mg/ml,solutionforinjectionforcattle,horses,dogsandcats

Xylazine(ashydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Perml:

Activesubstance:

Xylazine(ashydrochloride) 20.0 mg

(equivalentto 23.31 mgxylazinehydrochloride)

Excipients:

Methylparahydroxybenzoate(E218) 1.0 mg

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

Bottle

10 ml

25 ml

50 ml

5. TARGETSPECIES

Cattle,horses,dogsandcats.

6. INDICATION(S)

7. METHODANDROUTE(S)OFADMINISTRATION

Cattle:intravenous,intramuscular.

Horses:intravenous.

Dogs:intramuscular.

Cats:intramuscular,subcutaneous.

Thestoppershouldnotbepuncturedmorethan20 times.

Numberofpunctures:.................

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Cattle:

Meatandoffal: 1 day

Milk: zerohours

Horses:

Meatandoffal: 1 day

Milk: zerohours

9. SPECIALWARNING(S),IFNECESSARY

Accidentalinjectionisdangerous–read thepackageleafletbeforeuse.

Accidentalintakeandcontactwithskin,eyesandmucousmembranesisdangerous–read the

packageleafletbeforeuse.

10.EXPIRYDATE

EXP:<month/year>

Shelflifeafterfirstopeningtheimmediatepackaging:28 days.

Oncebroached/opened,useby…..

11.SPECIALSTORAGECONDITIONS

Donotrefrigerateorfreeze.

12.SPECIFICPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposeofwastematerialinaccordancewithlocalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Administrationonlybyaveterinarysurgeon.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Wilgenweg7

3421 TVOudewater

theNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

<to becompletednationally>

17.MANUFACTURER’SBATCHNUMBER

Batch:<number>

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Bottle

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Nerfasin20 mg/ml,solutionforinjectionforcattle,horses,dogsandcats

Xylazine(ashydrochloride)

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Containsperml:

Xylazine(ashydrochloride)20.0 mg

(equivalentto 23.31 mgxylazinehydrochloride)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

10 ml

25 ml

50 ml

4. ROUTE(S)OFADMINISTRATION

Cattle:intravenous,intramuscular.

Horses:intravenous.

Dogs:intramuscular.

Cats:intramuscular,subcutaneous.

5. WITHDRAWALPERIOD

Cattle:

Meatandoffal: 1 day

Milk: zerohours

Horses:

Meatandoffal: 1 day

Milk: zerohours

6. BATCHNUMBER

Batch:<number>

7. EXPIRYDATE

EXP:<month/year>

Shelflifeafterfirstopeningtheimmediatepackaging:28 days.

Oncebroached/opened,useby…

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

9. SPECIALWARNING(S),IFNECESSARY

Seepackageleafletforuserwarnings.

B. PACKAGELEAFLET

PACKAGELEAFLET

Nerfasin20 mg/ml,solutionforinjectionforcattle,horses,dogsandcats

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLE

FORBATCHRELEASE, IFDIFFERENT

Marketingauthorisationholder

LeVetB.V.

Wilgenweg7

3421 TVOudewater

theNetherlands

Manufacturerforthebatchrelease:

ProdulabPharmaB.V.

Forellenweg16

4941 SJRaamsdonksveer

theNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Nerfasin20 mg/ml,solutionforinjectionforcattle,horses,dogsandcats

Xylazine(ashydrochloride)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENTS

perml:

Activesubstance:

Xylazine(ashydrochloride): 20.0 mg

(equivalentto 23.31 mgxylazinehydrochloride)

Excipients:

Methylparahydroxybenzoate(E218) 1.0 mg

Clear,colourlesssolution.

4. INDICATION(S)

Sedation.

Premedicationincombinationwithananaesthetic.

5. CONTRAINDICATIONS

Donotuseinanimalswithgastrointestinalobstructionasthemusclerelaxantproperties

ofthedrugappearto accentuatetheeffectsoftheobstructionandbecauseofpossible

vomiting.

Donotuseinanimalswithsevererenalorhepaticimpairment,respiratorydysfunction,

cardiacabnormalities,hypotensionand/orshock.

Donotuseindiabeticanimals.

Donotuseinanimalswithahistoryofseizures.

Donotuseincalvesyoungerthan1 weekofage,foalsyoungerthan2 weeksorin

puppiesandkittensyoungerthan6 weeks.

Donotuseduringthelaststageofpregnancy(dangerofprematurebirth),exceptat

parturition(seesection12).

6. ADVERSEREACTIONS

Ingeneral,sideeffects,typicalforanα2-adrenergicagonist,likebradycardia,reversible

arrhythmiaandhypotensioncanoccur.Thermoregulationcanbeinfluencedand

consequentlybodytemperaturecandecreaseorincreasedependantontheambient

temperature.Depressionofrespirationand/orrespiratoryarrestcanoccur,especiallyin

cats.

Catsanddogs

Catsanddogsfrequentlyvomitduringtheonsetofthexylazine-inducedsedation,

especiallywhentheanimalshavejustbeenfed.

Animalsmayshowprofoundsalivationfollowinganinjectionwithxylazine.

Otheradverseeffectsfordogsandcatsinclude:muscletremors,bradycardiawithAV-

block,hypotension,reducedrespiratoryrate,movementinresponseto strongauditory

stimuli,hyperglycaemiaandincreasedurinationincats.

Incatsxylazinecausesuterinecontractionsanditmayinduceprematureparturition.

Indogs,adverseeffectsaregenerallymorepronouncedaftersubcutaneous

administrationcomparedto intramuscularandtheeffect(efficacy)canbeless

predictable.

Insusceptibledogbreedswithalargechest(GreatDane,IrishSetter)rarecasesof

bloatinghavebeenreported.

Inanaesthetizedanimals,mainlyduringandaftertherecoveryperiod,inveryrarecases,

cardio-respiratorydisturbances(cardiacarrest,dyspnea,bradypnea,pulmonaryedema,

hypotension)andneurologicalsigns(seizures,prostration,pupillarydisorders,tremors)

wereobserved.

Cattle

Incattlexylazinemayinduceprematureparturition,anditalsoreducesimplantationof

theovum.

Cattle,whichhavereceivedhighdosesofxylazinesometimessufferfromloosefaeces

for24 hoursafterwards.

Otheradversereactionsincludesnoring,profoundsalivation,ruminalatony,atonyofthe

tongue,regurgitation,bloating,nasalstridor,hypothermia,bradycardia,increased

urinationandreversibleprolapseofthepenis.

Incattle,adverseeffectsaregenerallymorepronouncedafterintramuscular

administrationcomparedto intravenous

Horses

Horsesoftensweatastheeffectsofthesedationarewearingoff.

Severebradycardiaandreducedrespiratoryratehavebeenreportedespeciallyinhorses.

Followingadministrationtohorses,atransientrisefollowedbyafallinbloodpressure

usuallyoccurs.

Morefrequenturinationhasbeenreported

Muscletremorsandmovementinresponsetosharpauditoryorphysicalstimuliare

possible.Althoughrare,violentreactionshavebeenreportedinhorsesfollowingthe

administrationofxylazine.

Ataxiaandreversibleprolapseofthepenismayoccur.

Inveryrarecasesxylazinemayinducemildcolicasthegutmotilityisdepressed

temporarily.Asapreventivemeasurethehorseshouldreceivenofeedaftersedation

untiltheeffecthasfadedcompletely.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinform

yourveterinarysurgeon.

7. TARGETSPECIES

Cattle,horses,dogsandcats.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Cattle:intravenous,intramuscular.

Horses:intravenous.

Dogs:intramuscular.

Cats:intramuscular,subcutaneous.

*Cattle:

Dosage:

Dosageforcattle

Dosagelevel§ xylazine

(mg/kg) Nerfasin20 mg/ml

(ml/100kg) Nerfasin20 mg/ml

(ml/500kg)

A.Intramuscular

I 0.05 0.25 1.25

II 0.1 0.5 2.5

III 0.2 1 5

IV 0.3 1.5 7.5

B. Intravenous

I 0.016-0.024 0.08-0.12 0.4-0.6

II 0.034-0.05 0.17-0.25 0.85-1.25

III 0.066-0.10 0.33-0.5 1.65-2.5

§Dose1:Sedation,withaslightdecreaseofmuscletone.Theabilityto standis

maintained.

Dose2:Sedation,markeddecreaseofmuscletoneandsomeanalgesia.Theanimalusually

remainsstanding,butmayliedown.

Dose3:Deepsedation,furtherdecreaseofmuscletoneandadegreeofanalgesia.The

animalliesdown.

Dose4:Verydeepsedation,aprofounddecreaseinmuscletoneandadegreeofanalgesia.

Theanimalliesdown.

*Horses

Dosage:singledoseof0.6-1 mgxylazineperkgbodyweight.

(3-5 mlproductper100 kgbodyweight).

*Dogs

Dosage:singledoseof0.5-3 mgxylazineperkgbodyweight.

(0.025-0.15 mlproductper1 kgbodyweight).

*Cats

Dosage:singleintramuscularorsubcutaneousdoseof0.5-1mgxylazineperkgbody

weight.

(0.025-0.05 mlproductper1kgbodyweight).

Thestoppershouldnotbepuncturedmorethan20 times.

Thenumberofpuncturesshouldberecordedontheouterpackaging

9. ADVICEONCORRECTADMINISTRATION

Theintravenousinjectionshouldbegivenslowly,especiallyinhorses.

10.WITHDRAWALPERIOD

Cattle:

Meatandoffal: 1 day

Milk: zerohours

Horses:

Meatandoffal: 1 day

Milk: zerohours

11.SPECIALSTORAGEPRECAUTIONS

Keep outofthereachandsightofchildren.

Donotrefrigerateorfreeze.

DonotuseaftertheexpirydatestatedonthevialandthecartonafterEXP.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

Thestoppershouldnotbepuncturedmorethan20 times.

12.SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Horses:

Xylazineinhibitsthenormalintestinalmotility.Therefore,itshouldonlybeusedin

horseswithcolic,thatarenotresponsiveto analgesics.Theuseofxylazineshouldbe

avoidedinhorseswithcaecalmalfunction.

Aftertreatmentofhorseswithxylazine,theanimalsarereluctantto walk,so whenever

possiblethedrugshouldbeadministeredintheplacewherethetreatment/investigation

isgoingtotakeplace.

Cautionshouldbetakenintheadministrationoftheproducttohorsessusceptibleto

laminitis.

Horseswithairwaydiseaseormalfunctionmaydeveloplife-threateningdyspnoea.

Thedoseshouldbekeptaslowaspossible.

Theassociationwithotherpre-anaestheticagentsoranaestheticagentsshouldbethesubjectofa

benefit/riskassessment.Thisassessmentshouldconsiderthecompositionoftheproducts,their

doseandthenatureofthesurgery.Recommendeddosagesarelikelytovaryaccordingtothe

choiceoftheanaestheticassociation.

Catsanddogs:

Xylazineinhibitsthenormalintestinalmotility.Thismaymakexylazinesedation

undesirableforuppergastro-intestinalradiographs,becauseitpromotesfillingofthe

stomachwithgasandmakesinterpretationlesscertain.

Brachycephalicdogswithairwaydiseaseormalfunctionmaydeveloplife-threatening

dyspnoea.

Theassociationwithotherpre-anaestheticagentsoranaestheticagentsshouldbethe

subjectofabenefit/riskassessment.Thisassessmentshouldconsiderthecompositionof

theproducts,theirdoseandthenatureofthesurgery.Recommendeddosagesarelikely

to varyaccordingto thechoiceoftheanaestheticassociation.

Cattle:

Ruminantsarehighlysusceptibleto theeffectsofxylazine.Normallycattleremain

standingatthelowerdoses, butsomeanimalsmayliedown.Atthehighest

recommendeddosesmostanimalswillliedownandsomeanimalsmaylapseinlateral

recumbency.

Reticulo-ruminalmotorfunctionsaredepressedafterinjectionofxylazine.Thismay

resultsinbloat.Itisadvisabletowithholdfeedandwaterforseveralhoursbefore

administrationofxylazine.

Incattletheabilitytoeructate,coughandswallowisretainedbutreducedduringthe

periodofsedation,thereforecattlemustbecloselywatchedduringtherecoveryperiod:

theanimalsshouldbemaintainedinsternalrecumbency.

Incattlelifethreateningeffectsmayoccurafterintramusculardosesabove0.5 mg/kg

bodyweight(respiratoryandcirculatoryfailure).Thereforeveryprecisedosingis

required.

Theassociationwithotherpre-anaestheticagentsoranaestheticagentsshouldbethesubjectofa

benefit/riskassessment.Thisassessmentshouldconsiderthecompositionoftheproducts,their

doseandthenatureofthesurgery.Recommendeddosagesarelikelytovaryaccordingtothe

choiceoftheanaestheticassociation.

Specialprecautionsforuseinanimals

Keep theanimalscalm,becausetheymayrespondto externalstimuli.

Avoidintra-arterialadministration.

Tympanymayoccasionallyoccurinrecumbentcattleandcanbeavoidedbymaintaining

theanimalinsternalrecumbency.

Toavoidaspirationofsalivaorfood,lowertheanimal’sheadandneck.Fasttheanimals

beforeuseoftheproduct.

Olderandexhaustedanimalsaremoresensitiveto xylazine,whilstnervousorhighly

excitableanimalsmayrequirearelativelyhighdose.

Incaseofdehydration,xylazineshouldbeusedcautiously.

Emesisisgenerallyseenwithin3-5minutesafterxylazineadministrationincatsand

dogs.Itisadvisabletofastdogsandcatsfor12 hourspriortosurgery;theymayhave

freeaccessto drinkingwater.

Pre-medicationwithatropineincatsanddogsmayreducesalivationandbradycardia

effects

Donotexceedtherecommendeddosage.

Followingadministrationanimalsshouldbeallowedto restquietlyuntilthefulleffect

hasbeenreached.

Itisadvisedtocoolanimalswhentheambienttemperatureisabove25°Candto keep

animalswarmatlowtemperatures.

Forpainfulprocedures,xylazineshouldalwaysbeusedincombinationwithlocalor

generalanaesthesia.

Xylazineproducesacertaindegreeofataxia;therefore,xylazinemustbeusedcautiously

inproceduresinvolvingthedistalextremitiesandinstandingcastrationsinthehorse.

Treatedanimalsshouldbemonitoreduntiltheeffecthasfadedtotally(e.g.cardiacand

respiratoryfunction,alsointhepost-operativephase)andshouldbesegregatedtoavoid

bullying.

Foruseinyounganimals,seetheagerestrictionmentionedinsection5. Iftheproductis

intendedtobeusedinyounganimalsbelowtheseage-limits,abenefit/riskassessment

shouldbemadebytheveterinarian.

Specialprecautionsto betakenby thepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentaloralintakeorself-injection,seek medicaladviceimmediatelyand

showthepackageleafletto thephysicianbutDONOTDRIVEassedationandchanges

inbloodpressuremayoccur.

Avoidskin,eyeormucosalcontact.

Washtheexposedskinimmediatelyafterexposurewithlargeamountsofwater.

Removecontaminatedclothesthatareindirectcontactwithskin.

Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantlywithfresh

water.Ifsymptomsoccur,seek theadviceofaphysician.

Ifpregnantwomenhandletheproduct,specialcautionshouldbeobservednotto self-

injectasuterinecontractionsanddecreasedfoetalbloodpressuremayoccurafter

accidentalsystemicexposure.

Advicetodoctors:

Xylazineisanα2-adrenoreceptoragonist,symptomsafterabsorptionmayinvolveclinical

effectsincludingdose-dependentsedation,respiratorydepression,bradycardia,

hypotension,adrymouthandhyperglycaemia.Ventriculararrhythmiashavealsobeen

reported.Respiratoryandhaemodynamicsymptomsshouldbetreatedsymptomatically.

Useduringpregnancy,lactationorlay

Althoughlaboratorystudiesinratshavenotshownanyevidenceofteratogenicor

foetotoxiceffectstheuseoftheproductduringthefirsttwotrimestersofpregnancyshould

onlybemadeaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Donotuseinthelaterstagesofpregnancy(particularlyincattleandcats)exceptat

parturition,becausexylazinecausesuterinecontractionsanditmayinducepremature

labour.

Donotuseincattlereceivingovumtransplantsastheincreaseduterinetonemayreduce

thechanceofimplantationoftheovum.

Interactionwithothermedicinalproductsandotherformsofinteraction

OtherCNSdepressantagents(barbiturates,narcotics,anaesthetics,tranquillizers,etc.)may

causeadditiveCNSdepressionifusedwithxylazine.Dosagesoftheseagentsmayneedto

bereduced.Xylazineshouldthereforebeusedcautiouslyincombinationwithneuroleptics

ortranquillizers.

Xylazineshouldnotbeusedincombinationwithsympathomimeticdrugssuchas

epinephrineasventriculararrhythmiamayfollow.

Theconcurrentintravenoususeofpotentiatedsulphonamideswithalpha-2agonistshas

beenreportedtocausecardiacarrhythmiaswhichmaybefatal.Whilstnosucheffectshave

beenreportedwiththisproduct,itisrecommendedthatintravenousadministrationof

Trimethoprim/Sulphonamidecontainingproductsshouldnotbeundertakenwhenhorses

havebeensedatedwithxylazine.

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Intheeventofanaccidentaloverdose,cardiacarrhythmias,hypotension,andprofound

CNSandrespiratorydepressionmayoccur.Seizureshavealsobeenreportedafteran

overdose.Xylazinecanbeantagonizedbyα2-adrenergicantagonists.

Thefollowingantidotesarerecommendedinoverdose:

TargetspeciesActivesubstance Dosage

Dogs Yohimbine

Tolazoline

Atipamezole 0.125 mg/kg

5.0 mg/kg

0.2 mg/kg

Cats Yohimbine 0.1-0.4mg/kg

Cattle Atipamezole

Yohimbine

4-Aminopyridine 0.03 mg/kg

0.125 mg/kg

0.3 mg/kg

Horses Atipamezol 0.15mg/kg

Totreattherespiratorydepressanteffectsofxylazine,mechanicallyrespiratorysupport

withorwithoutrespiratorystimulants(e.g.doxapram)canberecommended.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.These

measuresshouldhelpto protecttheenvironment.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

<DDmonthYYYY>

15.OTHERINFORMATION

Bottlescontaining10 ml,25 mlor50 ml.

Notallpack sizesmaybemarketed.

Administrationonlybyaveterinarysurgeon.

MAnumber:

<to beestablishednationally.

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

There are no news related to this product.