SEDAXYLAN

Main information

  • Trade name:
  • Injektionsloesung fuer Tiere
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Injektionsloesung fuer Tiere
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Xylazine
  • Therapeutic area:
  • Cattle Food, Horses Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0106/001
  • Authorization date:
  • 12-02-2011
  • EU code:
  • NL/V/0106/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

PARTIB-1

SUMMARYOFPRODUCTCHARACTERISTICS

SEDAXYLAN

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Sedaxylan,20 mg/ml

Solutionforinjection,fordogs,cats,horsesandcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmillilitrecontains:

Activesubstances:

Xylazine(base) 20.0 mg

Equivalentto23.32 mgxylazinehydrochloride

Excipients: Function Amount

Methylparahydroxybenzoate(E218) preservative 1.0 mg

Propylparahydroxybenzoate(E216) preservative0.1 mg

Propyleneglycol Co solvent 8.9 mg

Forafulllistofexcipients,seesection6.1.

3 PHARMACEUTICALFORM

Solutionforinjection

Clearandcolourless.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs,cats,horsesandcattle.

4.2 Indicationforuse

Sedationofdogs,cats, horsesandcattle.

4.3 Contraindications

Donotuseinthelaterstagesofpregnancy,seesection4.7

Donotuseinanimalswithoesophagealobstruction,andtorsionofthestomach,asthemuscle

relaxantpropertiesofthedrugappeartoaccentuatetheeffectsoftheobstructionandbecauseof

possiblevomiting.

Donotuseinanimalswithrenalorhepaticimpairment,respiratorydysfunction,cardiac

abnormalities,hypotensionand/orshock.Do notuseindiabeticanimals.

Donotuseincalvesyoungerthan1 weekofage,foalsyoungerthan2 weeksorinpuppiesand

kittensyoungerthan6 weeks.Seealsosection4.7.

4.4 Specialwarningsforeachtargetspecies

Horses:

Xylazineinhibitsthenormalintestinalmotility.Therefore,itshouldonlybeusedinhorses

withcolic,thatarenotresponsiveto analgesics.Theuseofxylazineshouldbeavoidedin

horseswithcaecalmalfunction..

Aftertreatmentofhorseswithxylazine,theanimalsarereluctantto walk,so whenever

possiblethedrugshouldbeadministeredintheplacewherethetreatment/investigationis

goingtotakeplace.

Cautionshouldbetakenintheadministrationoftheproducttohorsessusceptibleto laminitis.

Horseswithairwaydiseaseormalfunctionmaydeveloplife-threateningdyspnoea.

Thedoseshouldbekeptaslowaspossible.

Catsanddogs:

Xylazineinhibitsthenormalintestinalmotility.Thismaymakexylazinesedationundesirable

foruppergastro-intestinalradiographs,becauseitpromotesfillingofthestomachwithgas

andmakesinterpretationlesscertain.

Brachycephalicdogswithairwaydiseaseormalfunctionmaydeveloplife-threatening

dyspnoea

Cattle:

Ruminantsarehighlysusceptibleto theeffectsofxylazine.Normallycattleremainstanding

atthelowerdoses, butsomeanimalsmayliedown.Atthehighestrecommendeddosesmost

animalswillliedownandsomeanimalsmayrelapseinlateralrecumbency.

Reticulo-ruminalmotorfunctionsaredepressedafterinjectionofxylazine.Thismayresults

inbloat.Itisadvisabletowithholdfeedandwaterforseveralhoursbeforeadministrationof

xylazine.

Incattletheabilitytoeructate,coughandswallowisretainedbutreducedduringtheperiod

ofsedation,thereforecattlemustbecloselywatchedduringtherecoveryperiod:theanimals

shouldbemaintainedinsternalrecumbency.

Incattlelifethreateningeffectsmayoccurafterintramusculardosesabove0.5 mg/kgbody

weight(respiratoryandcirculatoryfailure).Thereforeveryprecisedosingisrequired.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Olderandexhaustedanimalsaremoresensitiveto xylazine,whilstnervousorhighly

excitableanimalsmayrequirearelativelyhighdose.

Incaseofdehydration,xylazineshouldbeusedcautiously.

Emesisisgenerallyseenwithin3-5minutesafterxylazineadministrationincatsanddogs.It

isadvisabletofastdogsandcatsfor12 hourspriortosurgery;theymayhavefreeaccessto

drinkingwater.

Donotexceedtherecommendeddosage.

Followingadministrationanimalsshouldbeallowedto restquietlyuntilthefulleffecthas

beenreached.

Itisadvisedtocoolanimalswhentheambienttemperatureisabove25°Candto keep animals

warmatlowtemperatures..

Becausetheanalgesicpropertiesofxylazineareinsufficient,inpainfulproceduresxylazine

shouldalwaysbeusedincombinationwithalocalorgeneralanalgesic!

Xylazineproducesacertaindegreeofataxia;therefore,xylazinemustbeusedcautiouslyin

proceduresinvolvingthedistalextremitiesandinstandingcastrationsinthehorse.

Treatedanimalsshouldbemonitoreduntiltheeffecthasfadedtotally(e.g.cardiacand

respiratoryfunction,alsointhepost-operativephase).

Foruseinyounganimals,seetheagerestrictionmentionedin4.3. Iftheproductisintended

to beusedinyounganimalsbelowtheseage-limits,abenefit/riskassessmentshouldbemade

bytheveterinarian.

Specialprecautionsto betakenby thepersonadministeringtheveterinarymedicinal

producttoanimals

Inthecaseofaccidentaloralintakeorself-injection,seekmedicaladviceimmediatelyand

showthepackageinserttothephysicianbutDONOTDRIVEassedationandchangesin

bloodpressuremayoccur.

Irritation,sensitisation,contactdermatitisandsystemiceffectscannotbeexcludedafterskin

contact.

Avoidskincontactandwearimpermeablegloveswhenhandlingtheproduct.

Washtheexposedskinimmediatelyafterexposurewithlargeamountsofwater.

Inthecaseofaccidentalprojectionoftheproductintotheeyes,rinseabundantlywithfresh

water.Ifirritationpersists,seektheadviceofaphysician.

Removecontaminatedclothes.

Pregnantwomenshouldnothandletheproduct.

ADVICETODOCTORS:Xylazineisan 

-adrenoreceptoragonistwhosetoxicitymaycause

clinicaleffectsincludingsedation,respiratorydepressionandcoma,bradycardiaand

hypotensionandhyperglycaemia.Ventriculararrhythmiashavealsobeenreported.Treatment

shouldbesupportivewithappropriateintensivetherapy.

4.6 Undesirableeffects(frequencyandseriousness)

Ingeneral,sideeffects,typicalforanα2-adrenergicagonist,likebradycardia,reversible

arrhythmiaandhypotensioncanoccur.Thermoregulationcanbeinfluencedandconsequently

bodytemperaturecandecreaseorincreasedependantontheambienttemperature.Depressionof

respirationand/orrespiratoryarrestcanoccur,especiallyincats.

Catsanddogs

Catsanddogsfrequentlyvomitduringtheonsetofthexylazine-inducedsedation,especially

whentheanimalshavejustbeenfed.

Animalsmayshowprofoundsalivationfollowinganinjectionwithxylazine.

Otheradverseeffectsfordogsandcatsinclude:muscletremors,bradycardiawithAV-block,

hypotension,reducedrespiratoryrate,movementinresponsetostrongauditorystimuli,and

increasedurinationincats.

Incatsxylazinecausesuterinecontractionsanditmayinduceprematureparturition.

Indogs,adverseeffectsaregenerallymorepronouncedaftersubcutaneousadministration

comparedtointramuscularandtheeffect(efficacy)canbelesspredictable.

Cattle

Incattlexylazinemayinduceprematureparturition,anditalsoreducesimplantationofthe

ovum.

Cattle,whichhavereceivedhighdosesofxylazinesometimessufferfromloosefaecesfor24

hoursafterwards.

Otheradversereactionsincludeprofoundsalivation,ruminalatony,atonyofthetongue,

regurgitation,bloating,hypothermia,bradycardia,increasedurinationandreversibleprolapse

ofthepenis.

Incattle,adverseeffectsaregenerallymorepronouncedafterintramuscularadministration

comparedtointravenous

Horses

Horsesoftensweatastheeffectsofthesedationarewearingoff.

Severebradycardiaandreducedrespiratoryratehavebeenreportedespeciallyinhorses.

Morefrequenturinationhasbeenreported

Muscletremorsandmovementinresponsetosharpauditoryorphysicalstimuliarepossible.

Althoughrare,violentreactionshavebeenreportedinhorsesfollowingtheadministrationof

xylazine.

Ataxiaandreversibleprolapseofthepenismayoccur.

Inveryrarecasesxylazinemayinducemildcolicasthegutmotilityisdepressedtemporarily.

Asapreventivemeasurethehorseshouldreceivenofeedaftersedationuntiltheeffecthas

fadedcompletely.

4.7 Useduringpregnancyandlactation

Althoughlaboratorystudiesinratshavenotshownanyevidenceofteratogenicorfoetotoxic

effectstheuseoftheproductduringthefirsttwotrimestersofpregnancyshouldonlybemade

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Donotuseinthelaterstagesofpregnancy(particularlyincattleandcats),becausexylazine

causesuterinecontractionsanditmayinduceprematurelabour.

Donotuseincattlereceivingovumtransplantsastheincreaseduterinetonemayreducethe

chanceofimplantationoftheovum.

4.8 Interactionwithothermedicamentsandotherformsofinteractions

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

additiveCNSdepressionifusedwithxylazine.Dosagesoftheseagentsmayneedtobereduced.

Xylazineshouldthereforebeusedcautiouslyincombinationwithneurolepticsortranquillizers.

Xylazineshouldnotbeusedincombinationwithsympathomimeticdrugssuchasepinephrineas

ventriculararrhythmiamayfollow.

4.9 Amountstobeadministeredandadministrationroute

Thisproductisintendedforsingleintravenous,intramuscularorsubcutaneousinjection

dependentuponthespeciesinwhichitisto beused.Theindividualresponsetoxylazineis

somewhatvaried(aswithothersedatives),anddependspartlyonthedosage,theageofthe

patient,temperamentofthepatient,thesurroundings(stress)andgeneralcondition(diseases,fat

percentage,etc.).Dosesalsodependonthedesireddegreeofsedation.Generallytimetoonsetof

sedationandrecoverywilltakelongerafterintramuscularorsubcutaneousinjectionatthe

recommendeddosagesthanafterintravenousinjection.Firsteffectsareusuallyseenwithin2

minutesfollowingintravenousinjectionandwithin5 to 10 minutesafterintramuscularor

subcutaneousinjection.Themaximumeffectisseen10 minuteslater.Itisgenerallyseenthatan

increaseindosewillleadto anincreaseinthelevelofsedation,untilamaximumlevelis

attained.Increasingthedosagebeyondthispointwillleadtoincreaseofthedurationofthe

sedation.Recoveryincalvesmaybeprolongedafteradministrationof1.5 xtherecommended

dose.Iftherequireddepthofsedationisnotachieveditisunlikelythatrepetitionofthedosewill

provemoreeffective.Inthatcaseitisadvisabletoallowcompleterecoveryrepeatingthe

procedurewithahigherdoseafter24 hours.

Accuratelyascertainthebodyweightofananimalbeforetreatmentwithxylazine.Useasyringe

withappropriategradations.

Dogs: 1.0-2.0 mgperkgbodyweightintramuscularlyorsubcutaneously

0.5–1.0 mlinjection solution/10kgbodyweightIMorSC

0.7-1.0 mgperkgbodyweightintravenously.

0.35–0.5mlinjection solution/10kgbodyweightIV

Cats: 0.5-1.0 mgperkgbodyweightintramuscularlyorsubcutaneously.

0.125–0.25mlinjection solution/5 kgbodyweightIMorSC

Horses: 0.5-1.0 mgperkgbodyweightintravenously.

2.5–5.0 mlinjection solution/100kgbodyweightIV

Cattle: 0.05–0.20mgperkgbodyweightintramuscularlyor

0.25–1.0mlinjection solution/100kgbodyweightIM

0.03–0.10mgperkgbodyweightintravenously.

0.15–0.5mlinjection solution/100kgbodyweightIV

Theintravenousinjectionshouldbegivenslowly,especiallyinhorses.

4.10 Overdose(symptoms,emergency procedures,antidotes)

Intheeventofanaccidentaloverdose,cardiacarrhythmias,hypotension,andprofoundCNSand

respiratorydepressionmayoccur.Seizureshavealsobeenreportedafteranoverdose.Xylazine

canbeantagonizedby 

-adrenergicantagonists:atipamezolehasbeenfoundto beauseful

antidoteinsomecases.Therecommendeddosageis:0.2 mg/kgfordogsandcats,0.15 mg/kgfor

horsesand0.03 mg/kgforcattle.

Totreattherespiratorydepressanteffectsofxylazine,mechanicallyrespiratorysupportwithor

withoutrespiratorystimulants(e.g.doxapram)canberecommended.

4.11 Withdrawalperiods

Horse(meat)-Oneday.

Cattle(meat)-Oneday.

Cattle(milk)-Zerodays.

5. PHARMACOLOGICALPROPERTIES

5.1 Pharmacodynamicproperties

Pharmacologicallyxylazinehydrochlorideisclassifiedasasedativeandskeletalmusclerelaxant.

ATCVetCode:QN05CM92

Xylazinebelongsto the 

-adrenoceptoragonists.

Xylazineisa 

-adrenoceptoragonist,thatactsbystimulationofcentralandperipheral 

adrenoceptors..Throughitscentralstimulationof 

-adrenoceptors,xylazinehaspotent

antinociceptiveactivity.Inaddition 

-adrenergicactivity,xylazinehas 

-adrenergiceffects.

Xylazinealsoproducesskeletalmusclerelaxationbyinhibitionofintraneuronaltransmissionof

impulsesatthecentrallevelofthecentralnervoussystem.Theanalgesicandskeletalmuscle

relaxationpropertiesofxylazineshowconsiderableinterspeciesvariations.Sufficientanalgesia

generallywillbeattainedincombinationwithotherproductsonly.

Inmanyspecies,administrationofxylazineproducesashort-livedarterialpressoreffectfollowed

byalongerperiodofhypotensionandbradycardia.Thesecontrastingactionsuponthearterial

pressureapparentlyarerelatedto the 

-an 

-adrenergicactionsofxylazine.

Xylazinehasseveralendocrineeffects.Insulin(mediatedby 

-receptorsinpancreatic 

-cells

whichinhibitinsulinrelease),ADH(decreasedproductionofADH,causingpolyuria)andFSH

(decreased)arereportedto beinfluencedbyxylazine.

5.2 Pharmacokineticproperties

Absorption(andaction)israpidfollowingintramuscularinjection.Levelsofdrugpeak rapidly

(usuallywithin15 minutes)andthendeclineexponentially.Xylazineisahighlylipidsoluble

organicbaseanddiffusesextensivelyandrapidly(Vd1.9-2.7).Withinminutesafteran

intravenousinjection,itcanbefoundinahighconcentrationinthekidneys,theliver,theCNS,

thehypophyses,andthediaphragm.So thereisaveryrapidtransferfromthebloodvesselsto the

tissues.Intramuscularbioavailabilityisincompleteandvariablerangingfrom52-90%inthedog

to 40-48%inthehorse.Xylazineismetabolisedextensivelyandeliminatedrapidly(+70%via

theurine,whiletheentericeliminationis+30%). Therapideliminationofxylazineisprobably

relatedto anextensivemetabolismratherthantoarapidrenalexcretionofunchangedxylazine.

6. PHARMACEUTICALSPARTICULARS

6.1 Listofexcipients

Citricacidmonohydrate,

Sodiumcitrate,

Methylparahydroxybenzoate(E218),

Propylparahydroxybenzoate(E216),

Propyleneglycol,

WaterforInjections

6.2 Incompatibilities

Sedaxylanshouldnotbemixedwithothermedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:36 months

Shelf-lifeafterfirstopeningthecontainer:28 days

6.4 Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

-Vial

* volume30 mland50 ml

* contents25 mland50 ml

* glasstypeII

* ambercoloured

-Stopper

* bromobutylrubberstoppertypeI

* securedwithaluminiumcap

Notallpack sizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedmedicinalproductorwastematerials

derivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements

7. MARKETINGAUTHORIZATIONHOLDER

Name :EurovetAnimalHealthB.V.

Address :Handelsweg25, POBox179, 5530 ADBladel

Country :TheNetherlands

8. MARKETINGAUTHORIZATIONNUMBER

Notapplicable

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

February20, 2003

10. DATEOFREVISIONOFTHETEXT

April2007

PARTIB2

LABELLINGANDPACKAGELEAFLET

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

LABEL25 /50 ml

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Sedaxylan,20 mg/ml,

Solutionforinjection,fordogs,cats,horsesandcattle

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstances:

Xylazine(base)20.0 mg/ml,equivalentto 23.32 mgxylazinehydrochloride

Excipients:

Methylparahydroxybenzoate(E218)1.0 mg, Propylparahydroxybenzoate(E216)0.1 mg,

Propyleneglycol8.9 mg

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

25, 50 ml

5. TARGETSPECIES

Cattle,horse,dog,cat

6. INDICATION(S)Notmandatory

-----

7. METHODANDROUTE(S)OFADMINISTRATION

Forintravenous,intramuscularorsubcutaneousadministration.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Horse,cattle(meat)-1 day.

Cattle(milk)-0 days.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningthecontainer:28 days

11.SPECIALSTORAGECONDITIONS

---(none)

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Veterinarysurgeonuseonly

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthBV

Handelsweg25, 5531 AEBladel,theNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

{NumberallocatedbyMS}

17.MANUFACTURER’SBATCHNUMBER

Lot{number}

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

OUTERCARTON25 /50 ml

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Sedaxylan,20 mg/ml,

Solutionforinjection,fordogs,cats,horsesandcattle

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstances:

Xylazine(base)20.0 mg/ml,equivalentto 23.32 mgxylazinehydrochloride

Excipients:

Methylparahydroxybenzoate(E218)1.0 mg,Propylparahydroxybenzoate(E216)0.1 mg,

Propyleneglycol8.9 mg

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

25, 50 ml

5. TARGETSPECIES

Cattle,horse,dog,cat

6. INDICATION(S)Notmandatory

-----

7. METHODANDROUTE(S)OFADMINISTRATION

Forintravenous,intramuscularorsubcutaneousadministration.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Horse,cattle(meat)-1 day.

Cattle(milk)-0 days.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningthecontainer:28 days

11.SPECIALSTORAGECONDITIONS

---(none)

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Veterinarysurgeonuseonly

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthBV

Handelsweg25, 5531 AEBladel,theNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

{NumberallocatedbyMS}

17.MANUFACTURER’SBATCHNUMBER

Lot{number}

PACKAGELEAFLET

Sedaxylan20mg/ml,solutionforinjection,fordogs,cats,horsesandcattle

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLE

FORBATCHRELEASE,IFDIFFERENT

EurovetAnimalHealthBV

Handelsweg25, 5531 AEBladel,theNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Sedaxylan20 mg/ml,solutionforinjection,fordogs,cats,horsesandcattle

Sedaxylanvet.(Denmark)

Xylazinehydrochloride

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

1 mlsolutionforinjectioncontains:

Activesubstances:

Xylazine(base) 20.0 mg

Equivalentto23.32 mgxylazinehydrochloride

Excipients: Function Amount

Methylparahydroxybenzoate(E218) preservative 1.0 mg

Propylparahydroxybenzoate(E216) preservative0.1 mg

Propyleneglycol Co solvent 8.9 mg

Otherexcipients upto 1 ml

Clearandcolourlesssolution

4. INDICATION(S)

Sedationofdogs,cats, horsesandcattle.

5. CONTRAINDICATIONS

Donotuseinthelaterstagesofpregnancy,seesection12

Donotuseinanimalswithoesophagealobstruction,andtorsionofthestomach,asthemuscle

relaxantpropertiesofthedrugappeartoaccentuatetheeffectsoftheobstructionandbecauseof

possiblevomiting.

Donotuseinanimalswithrenalorhepaticimpairment,respiratorydysfunction,cardiac

abnormalities,hypotensionand/orshock.Do notuseindiabeticanimals.

Donotuseincalvesyoungerthan1 weekofage,foalsyoungerthan2 weeksorinpuppiesand

kittensyoungerthan6 weeks.Seealsosection12:Useduringpregnancyandlactation.

6. ADVERSEREACTIONS

Ingeneral,sideeffects,typicalforanα2-adrenergicagonist,likebradycardia,reversible

arrhythmiaandhypotensioncanoccur.Thermoregulationcanbeinfluencedandconsequently

bodytemperaturecandecreaseorincreasedependantontheambienttemperature.Depressionof

respirationand/orrespiratoryarrestcanoccur,especiallyincats.

Catsanddogs

Catsanddogsfrequentlyvomitduringtheonsetofthexylazine-inducedsedation,especially

whentheanimalshavejustbeenfed.

Animalsmayshowprofoundsalivationfollowinganinjectionwithxylazine.

Otheradverseeffectsfordogsandcatsinclude:muscletremors,bradycardiawithAV-block,

hypotension,reducedrespiratoryrate,movementinresponsetostrongauditorystimuli,and

increasedurinationincats.

Incatsxylazinecausesuterinecontractionsanditmayinduceprematureparturition.

Indogs,adverseeffectsaregenerallymorepronouncedaftersubcutaneousadministration

comparedtointramuscularandtheeffect(efficacy)canbelesspredictable.

Cattle

Incattlexylazinemayinduceprematureparturition,anditalsoreducesimplantationofthe

ovum.

Cattle,whichhavereceivedhighdosesofxylazinesometimessufferfromloosefaecesfor24

hoursafterwards.

Otheradversereactionsincludeprofoundsalivation,ruminalatony,atonyofthetongue,

regurgitation,bloating,hypothermia,bradycardia,increasedurinationandreversibleprolapse

ofthepenis.

Incattle,adverseeffectsaregenerallymorepronouncedafterintramuscularadministration

comparedtointravenous

Horses

Horsesoftensweatastheeffectsofthesedationarewearingoff.

Severebradycardiaandreducedrespiratoryratehavebeenreportedespeciallyinhorses.

Morefrequenturinationhasbeenreported

Muscletremorsandmovementinresponsetosharpauditoryorphysicalstimuliarepossible.

Althoughrare,violentreactionshavebeenreportedinhorsesfollowingtheadministrationof

xylazine.

Ataxiaandreversibleprolapseofthepenismayoccur.

Inveryrarecasesxylazinemayinducemildcolicasthegutmotilityisdepressedtemporarily.

Asapreventivemeasurethehorseshouldreceivenofeedaftersedationuntiltheeffecthas

fadedcompletely.

7. TARGETSPECIES

Dog,cat, horseandcattle

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Thisproductisintendedforsingleintravenous,intramuscularorsubcutaneousinjectiondependent

uponthespeciesinwhichitisto beused.Theindividualresponseto xylazineissomewhatvaried

(aswithothersedatives),anddependspartlyonthedosage,theageofthepatient,temperamentof

thepatient,thesurroundings(stress)andgeneralcondition(diseases,fatpercentage,etc.).Doses

alsodependonthedesireddegreeofsedation.Generallytimeto onsetofsedationandrecoverywill

takelongerafterintramuscularorsubcutaneousinjectionattherecommendeddosagesthanafter

intravenousinjection.Firsteffectsareusuallyseenwithin2 minutesfollowingintravenousinjection

andwithin5 to10 minutesafterintramuscularorsubcutaneousinjection.Themaximumeffectis

seen10 minuteslater.Itisgenerallyseenthatanincreaseindosewillleadto anincreaseinthelevel

ofsedation,untilamaximumlevelisattained.Increasingthedosagebeyondthispointwillleadto

increaseofthedurationofthesedation.Recoveryincalvesmaybeprolongedafteradministrationof

1.5 xtherecommendeddose.Iftherequireddepthofsedationisnotachieveditisunlikelythat

repetitionofthedosewillprovemoreeffective.Inthatcaseitisadvisableto allowcomplete

recoveryrepeatingtheprocedurewithahigherdoseafter24 hours.

Accuratelyascertainthebodyweightofananimalbeforetreatmentwithxylazine.Useasyringe

withappropriategradations.

Dogs:1.0-2.0 mgperkgbodyweightintramuscularlyorsubcutaneously

0.5–1.0 mlinjectionsolution/10kgbodyweightIMorSC

0.7-1.0 mgperkgbodyweightintravenously.

0.35–0.5 mlinjectionsolution/10kgbodyweightIV

Cats:0.5-1.0 mgperkgbodyweightintramuscularlyorsubcutaneously.

0.125–0.25mlinjectionsolution/5 kgbodyweightIMorSC

Horses:0.5-1.0 mgperkgbodyweightintravenously.

2.5–5.0 mlinjectionsolution/100kgbodyweightIV

Cattle:0.05–0.20 mgperkgbodyweightintramuscularlyor

0.25–1.0 mlinjectionsolution/100kgbodyweightIM

0.03–0.10 mgperkgbodyweightintravenously.

0.15–0.5 mlinjectionsolution/100kgbodyweightIV

9. ADVICEONCORRECTADMINISTRATION

Theintravenousinjectionshouldbegivenslowly,especiallyinhorses.

10.WITHDRAWALPERIOD

Horse(meat)-Oneday.

Cattle(meat)-Oneday.

Cattle(milk)-Zerodays.

11.SPECIALSTORAGEPRECAUTIONS

Keep outofthereachandsightofchildren.

DonotuseaftertheexpirydatestatedonthelabelafterEXP

Shelf-lifeafterfirstopeningthecontainer:28 days

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12.SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Horses:

Xylazineinhibitsthenormalintestinalmotility.Therefore,itshouldonlybeusedinhorses

withcolic,thatarenotresponsiveto analgesics.Theuseofxylazineshouldbeavoidedin

horseswithcaecalmalfunction..

Aftertreatmentofhorseswithxylazine,theanimalsarereluctantto walk,so whenever

possiblethedrugshouldbeadministeredintheplacewherethetreatment/investigationis

goingtotakeplace.

Cautionshouldbetakenintheadministrationoftheproducttohorsessusceptibleto laminitis.

Horseswithairwaydiseaseormalfunctionmaydeveloplife-threateningdyspnoea.

Thedoseshouldbekeptaslowaspossible.

Catsanddogs:

Xylazineinhibitsthenormalintestinalmotility.Thismaymakexylazinesedationundesirable

foruppergastro-intestinalradiographs,becauseitpromotesfillingofthestomachwithgas

andmakesinterpretationlesscertain.

Brachycephalicdogswithairwaydiseaseormalfunctionmaydeveloplife-threatening

dyspnoea

Cattle:

Ruminantsarehighlysusceptibleto theeffectsofxylazine.Normallycattleremainstanding

atthelowerdoses, butsomeanimalsmayliedown.Atthehighestrecommendeddosesmost

animalswillliedownandsomeanimalsmayrelapseinlateralrecumbency.

Reticulo-ruminalmotorfunctionsaredepressedafterinjectionofxylazine.Thismayresults

inbloat.Itisadvisabletowithholdfeedandwaterforseveralhoursbeforeadministrationof

xylazine.

Incattletheabilitytoeructate,coughandswallowisretainedbutreducedduringtheperiod

ofsedation,thereforecattlemustbecloselywatchedduringtherecoveryperiod:theanimals

shouldbemaintainedinsternalrecumbency.

Incattlelifethreateningeffectsmayoccurafterintramusculardosesabove0.5 mg/kgbody

weight(respiratoryandcirculatoryfailure).Thereforeveryprecisedosingisrequired.

Specialprecautionsforuseinanimals

Olderandexhaustedanimalsaremoresensitiveto xylazine,whilstnervousorhighly

excitableanimalsmayrequirearelativehighdose.

Incaseofdehydration,xylazineshouldbeusedcautiously.

Emesisisgenerallyseenwithin3-5minutesafterxylazineadministrationincatsanddogs.It

isadvisabletofastdogsandcatsfor12 hourspriortosurgery;theymayhavefreeaccessto

drinkingwater.

Donotexceedtherecommendeddosage.

Followingadministrationanimalsshouldbeallowedto restquietlyuntilthefulleffecthas

beenreached.

Itisadvisedtocoolanimalswhentheambienttemperatureisabove25°Candto keep animals

warmatlowtemperatures..

Becausetheanalgesicpropertiesofxylazineareinsufficient,inpainfulproceduresxylazine

shouldalwaysbeusedincombinationwithalocalorgeneralanalgesic!

Xylazineproducesacertaindegreeofataxia;therefore,xylazinemustbeusedcautiouslyin

proceduresinvolvingthedistalextremitiesandinstandingcastrationsinthehorse.

Treatedanimalsshouldbemonitoreduntiltheeffecthasfadedtotally(e.g.cardiacand

respiratoryfunction,alsointhepost-operativephase).

Foruseinyounganimals,seetheagerestrictionmentionedinsection5. Iftheproductis

intendedtobeusedinyounganimalsbelowtheseage-limits,abenefit/riskassessmentshould

bemadebytheveterinarian.

Specialprecautionsto betakenby thepersonadministeringtheveterinarymedicinal

producttoanimals

Inthecaseofaccidentaloralintakeorself-injection,seekmedicaladviceimmediatelyand

showthepackageinserttothephysicianbutDONOTDRIVEassedationandchangesin

bloodpressuremayoccur.

Irritation,sensitisation,contactdermatitisandsystemiceffectscannotbeexcludedafterskin

contact.

Avoidskincontactandwearimpermeablegloveswhenhandlingtheproduct.

Washtheexposedskinimmediatelyafterexposurewithlargeamountsofwater.

Inthecaseofaccidentalprojectionoftheproductintotheeyes,rinseabundantlywithfresh

water.Ifirritationpersists,seektheadviceofaphysician.

Removecontaminatedclothes.

Pregnantwomenshouldnothandletheproduct.

ADVICETODOCTORS:Xylazineisan 

-adrenoreceptoragonistwhosetoxicitymaycause

clinicaleffectsincludingsedation,respiratorydepressionandcoma,bradycardiaand

hypotensionandhyperglycaemia.Ventriculararrhythmiashavealsobeenreported.Treatment

shouldbesupportivewithappropriateintensivetherapy.

Useduringpregnancyandlactation

Althoughlaboratorystudiesinratshavenotshownanyevidenceofteratogenicorfoetotoxic

effectstheuseoftheproductduringthefirsttwotrimestersofpregnancyshouldonlybemade

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Donotuseinthelaterstagesofpregnancy(particularlyincattleandcats),becausexylazine

causesuterinecontractionsanditmayinduceprematurelabour.

Donotuseincattlereceivingovumtransplantsastheincreaseduterinetonemayreducethe

chanceofimplantationoftheovum.

Interactionswithothermedicinalproductsandotherformsofinteraction

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

additiveCNSdepressionifusedwithxylazine.Dosagesoftheseagentsmayneedtobereduced.

Xylazineshouldthereforebeusedcautiouslyincombinationwithneurolepticsortranquillizers.

Xylazineshouldnotbeusedincombinationwithsympathomimeticdrugssuchasepinephrineas

ventriculararrhythmiamayfollow.

Sedaxylanshouldnotbemixedwithothermedicinalproducts.

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Intheeventofanaccidentaloverdose,cardiacarrhythmias,hypotension,andprofoundCNSand

respiratorydepressionmayoccur.Seizureshavealsobeenreportedafteranoverdose.Xylazine

canbeantagonizedby 

2-adrenergicantagonists:atipamezolehasbeenfoundtobeauseful

antidoteinsomecases.Therecommendeddosageis:0.2 mg/kgfordogsandcats,0.15 mg/kgfor

horsesand0.03 mg/kgforcattle.

Totreattherespiratorydepressanteffectsofxylazine,mechanicallyrespiratorysupportwithor

withoutrespiratorystimulants(e.g.doxapram)canberecommended.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Disposaladvice

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Anyunusedveterinary

medicinalproductorwastematerialderivedfromsuchveterinarymedicinalproductshouldbe

disposedofinaccordancewithlocalrequirements.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

25-04-2007

15.OTHERINFORMATION

Pack sizes:25 or50 ml.

Notallpack sizesmaybemarketed{Nationalitem}

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

Enforcement Report for the Week of November 21, 2018

Enforcement Report for the Week of November 21, 2018

Recently Updated Records for the Week of November 21, 2018 Last Modified Date: Tuesday, November 20, 2018

FDA - U.S. Food and Drug Administration

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

9-8-2018

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

The container can separate from the blade base exposing the blades, posing a laceration hazard to consumers.

Health Canada

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

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

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the CAT meeting 18-20 April 2018

Minutes of the CAT meeting 18-20 April 2018

Europe - EMA - European Medicines Agency

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration

22-8-2018

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5632 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/T/20

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

6-8-2018

Otezla (Celgene Europe B.V.)

Otezla (Celgene Europe B.V.)

Otezla (Active substance: apremilast) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5391 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3746/T/20

Europe -DG Health and Food Safety