Nerfasin

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
    Ireland
  • 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.

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1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Enforcement Report for the Week of October 31, 2018

Enforcement Report for the Week of October 31, 2018

Recently Updated Records for the Week of October 31, 2018 Last Modified Date: Monday, October 29, 2018

FDA - U.S. Food and Drug Administration

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

October 23, 2018 For immediate release

Health Canada

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

6-9-2018

August 31, 2018: Former Home Health Nurse Pleads Guilty to Tampering with Patients' Drugs

August 31, 2018: Former Home Health Nurse Pleads Guilty to Tampering with Patients' Drugs

August 31, 2018: Former Home Health Nurse Pleads Guilty to Tampering with Patients' Drugs

FDA - U.S. Food and Drug Administration

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 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 evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

31-8-2018

Danish Medicines Agency launches new concept for National Scientific Advice

Danish Medicines Agency launches new concept for National Scientific Advice

Today, 31 August 2018, the Danish Medicines Agency is launching a new concept for National Scientific Advice for companies, hospitals and others who request advice on the requirements applicable to clinical investigation and marketing authorisations.

Danish Medicines Agency

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

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

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

23-11-2018

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Active substance: Nitisinone) - PSUSA - Modification - Commission Decision (2018)7890 of Fri, 23 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2169/201802

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

20-11-2018

Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration

Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration

Philips has agreed to notify any actual or anticipated shortages of accessories, repair parts and consumables of the HeartStart MRx in Australia until 31 December 2022

Therapeutic Goods Administration - Australia

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

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

Therapeutic goods advertising: Update 31 October 2018

Therapeutic goods advertising: Update 31 October 2018

The 2018 Code No.2 made today replaces the code that was made on 29 June 2018, and will take effect on 1 January 2019

Therapeutic Goods Administration - Australia

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

31-10-2018

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Active substance: adalimumab) - Centralised - Yearly update - Commission Decision (2018)7341 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

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

31-10-2018

Eporatio (ratiopharm GmbH)

Eporatio (ratiopharm GmbH)

Eporatio (Active substance: epoetin theta) - Centralised - Yearly update - Commission Decision (2018)7336 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Viramune (Boehringer Ingelheim International GmbH)

Viramune (Boehringer Ingelheim International GmbH)

Viramune (Active substance: nevirapine) - Centralised - Yearly update - Commission Decision (2018)7337 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

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

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

Fortacin (Recordati Ireland Ltd)

Fortacin (Recordati Ireland Ltd)

Fortacin (Active substance: lidocaine / prilocaine) - Centralised - Renewal - Commission Decision (2018)6103 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2693/R/23

Europe -DG Health and Food Safety

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

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

30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

29-8-2018

Lojuxta (Amryt Pharmaceuticals DAC)

Lojuxta (Amryt Pharmaceuticals DAC)

Lojuxta (Active substance: Lomitapide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5762 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2578/T/31

Europe -DG Health and Food Safety