Z-Itch 40 mg/ml Pour-on Solution

Main information

  • Trade name:
  • Z-Itch 40 mg/ml Pour-on Solution
  • Pharmaceutical form:
  • Pour-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Z-Itch 40 mg/ml Pour-on Solution
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • permethrin
  • Therapeutic area:
  • Horses Non Food, Horses Other

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0477/001
  • Authorization date:
  • 20-03-2013
  • EU code:
  • UK/V/0477/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:August2013

AN:00620/2012

Page1of4

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Z-Itch

40mg/mlPour-onSolution

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Permethrin(80:20)technical 40.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Pour-onsolution.

Aclear,colourlesstopaleyellow,non-aqueoussolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Horsesanddonkeys.

4.2 Indicationsforuse,specifyingthetargetspecies

ForthecontrolofthebitinginsectCulicoidesspp.Thisproductmaybeusedasanaidin

thecontrolofsweetitch

4.3 Contraindications

Donotadministertohorsesanddonkeysintendedforhumanconsumption.

Donottreatthesaddlearea.

4.4 Specialwarnings

Sweetitchisbelievedtobecausedbyhypersensitivitytothebitesofflyinginsectse.g.

Culicoidesspecies.Inadditiontotreatment,othermeasuresshouldbetakentoreduce

exposuretosuchinsectswherepracticable.Itmaybeappropriateforownerstoseek

veterinaryadviceonmanagementofhorseswithsweetitch.Itisalsorecommendedthat

ownersseekveterinaryadviceinseverecasesofsweetitchandincasesofsweetitch

whichdonotrespondtotreatment.

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Forexternaluseonly.

Theproductmustnotbeappliedforwardoftheears.

Revised:August2013

AN:00620/2012

Page2of4

Takecaretoavoideyecontact.

Incaseofaccidentalsplashingintothehorse'seye,theaffectedeyeshouldbewashed

thoroughlyandimmediatelywithcopiousquantitiesofcleanwaterandveterinaryattention

sought.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Wearprotectiveclothing,bootsandchemicallyresistantglovessuchasrubber,PVCor

nitrilewhenapplyingtheproduct.Washsplashesfromskinandeyesimmediately.

Whenusingtheproductdonoteat,drinkorsmoke.

Washhandsandexposedskinbeforeeating,drinkingorsmokingandafterwork.

Useinawellventilatedarea.

Keepawayfromfood,drinkandanimalfeedingstuffs.

4.6Adversereactions(frequencyandseriousness)

Afewhorses,particularlythoseofthefine-skinnedArabtype,mayreactadverselyto

treatmentwiththeproduct.Insuchindividualsasmallpatchtestatthebaseoftheneckis

recommended.Ifadversereactionsshouldoccur,treatmentshouldbestopped

immediately.Anyresultingskinirritationisshortlived.

Procedureforpatchtesting

Usingprotectiveglovesapplyasmallquantityoftheproduct(about1ml)toanidentifiable

areaatthebaseoftheanimal’sneckandrubontotheskinwithaswab.Wraptheused

swabintheglovesanddisposeofsafely.At24and48hoursafterapplication,examine

theareatowhichtheproductwasappliedandobservetheskinforsignsofreaction

(redness,swelling,flakingorexudation).Ifareactionoccurs,donotusetheproducton

theanimal.

4.7Useduringpregnancy,lactationorlay

Nospecialprecautionsrequired.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Careshouldbetakenwhenapplyingtheproductasitmayhaveanadverseeffecton

certainplastics.

4.9 Amountstobeadministeredandadministrationroute

Horsesanddonkeys:4mg/kgbodyweight,equivalentto1.0mlper10kgbodyweightto

amaximumof40ml.

Dosageguidelines

Bodyweight(kg) 100 200 250 300 >400

Dosevolume(ml) 10 20 25 30 40

Revised:August2013

AN:00620/2012

Page3of4

Applythemeasureddoseinapproximatelyequalproportionstothemaneandrump

avoidingthesaddlearea.Treatmentshouldbestartedatthebeginningofthesweetitch

seasonandrepeatedasnecessary-treatmentonceweeklyshouldbesufficientformost

horses.

Ifhorsesanddonkeysaretobegroomed,applytheproductaftergrooming.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Toxicsignsinmammalsaretremors,hyperexcitability,salivation,choreoathetosisand

paralysis.Thesignsdisappearrapidlyandtheanimalsrecover,generallywithinaweek.

Thereisnospecificantidotebutsymptomatictherapycanbegivenifconsidered

necessary.

4.11Withdrawalperiod(s)

Nottobeusedinhorsesintendedforhumanconsumption.

Treatedhorsesmayneverbeslaughteredforhumanconsumption.

Thehorsemusthavebeendeclaredasnotintendedforhumanconsumptionunderthe

nationalhorsepassportlegislation.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticide.

ATCvetcode:QP53AC04.

5.1 Pharmacodynamicproperties

Permethrinisaneurotoxinaffectingtheaxonsintheinsectperipheralandcentralnervous

systembyinteractionwithsodiumchannels.

5.2 Pharmacokineticparticulars

Theproductisindicatedforcutaneousadministration.Followingtopicalapplicationtothe

animal,thesolutionisdistributedovertheskin.

Syntheticpyrethroidsaregenerallymetabolisedinmammalsthroughesterhydrolysis,

oxidationandconjugationandthereisnotendencyfortissueaccumulation.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Butyldioxitol.

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Revised:August2013

AN:00620/2012

Page4of4

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintightlyclosedoriginalcontainerinadryplace.

Protectfromlight.

6.5Natureandcompositionofimmediatepackaging

Containersize: 250ml.

Container

material: Natural,highdensitypolyethylene.

Closure: White,polypropylenescrewfitcapwithinductionseal.

Dosingdevice: Integralgraduateddispensingchamber.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Dangeroustofishandotheraquaticlife.Donotcontaminateponds,waterwaysorditches

withtheproductorusedcontainer.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

FlorisVeterinaireProduktenBV

Kempenlandstraat33/35

5262GKVught

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm36057/4000

9. DATEOFFIRSTAUTHORISATION

27January2011

10. DATEOFREVISIONOFTHETEXT

August2013

Approved: 21/08/2013

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FDA - U.S. Food and Drug Administration

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

29-8-2018

Vectra 3D (Ceva SantE Animale)

Vectra 3D (Ceva SantE Animale)

Vectra 3D (Active substance: dinotefuran, pyriproxyfen, permethrin) - Centralised - Renewal - Commission Decision (2018)5783 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2555/R/9

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

21-8-2018

Always use contact lens solution, not water, to clean and store your lenses!  #OnePairTakeCare  https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89  pic.twitter.com/Jm50z0UFVu

FDA - U.S. Food and Drug Administration

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

27-7-2018

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)5047 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/03

Europe -DG Health and Food Safety

19-7-2018

HES (hydroxyethyl starch)

HES (hydroxyethyl starch)

HES (hydroxyethyl starch) (Active substance: hydroxyethyl starch (HES), solutions for infusion) - Community Referrals - Art 107i - Commission Decision (2018)4832 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-107i/1457

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

20-6-2018

Blincyto (Amgen Europe B.V.)

Blincyto (Amgen Europe B.V.)

Blincyto (Active substance: blinatumomab) - Centralised - Authorisation - Switch to non-conditional - Commission Decision (2018)3953 of Wed, 20 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3731/II/9

Europe -DG Health and Food Safety

11-6-2018

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Active substance: idelalisib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3765 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3843/T/40

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

29-5-2018

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)3397 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/02

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety

2-5-2018

Agenda:  Agenda - Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges

Agenda: Agenda - Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges

Big data workshop: regulatory solutions for big data challenges

Europe - EMA - European Medicines Agency