Intra Hoof-Fit Gel for dairy cattle

Main information

  • Trade name:
  • INTRA PASTA (temporary name)
  • Pharmaceutical form:
  • Gel
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • INTRA PASTA (temporary name)
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • PREPARATIONS FOR TREATMENT OF WOUNDS AND ULCERS
  • Therapeutic area:
  • Cattle Other

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0173/001
  • Authorization date:
  • 20-02-2013
  • EU code:
  • NL/V/0173/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

IntraHoof-FitGel40mg/g+40mg/ggelfordairycattle DK,EE,LT,LU,LV,NL,UK

IntraPasta40mg/g+40mg/ggelfordairycattle FR

Pecoprovet40mg/g+40mg/ggelfordairycattle SE

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Pergram

Activesubstances:

Copper 40mg

(Correspondingwith244.1mgcopperdiammoniumEDTA)

Zinc 40mg

(Correspondingwith238.4mgzincdiammoniumEDTA)

Excipients:

Forthefulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Gel.

Greenwater-basedviscousgel.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dairycattle.

4.2 Indicationsforuse,specifyingthetargetspecies

Foruseaspartofatreatmentprogrammeofdigitaldermatitis.

4.3 Contraindications

Noneknown.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

None.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Theproductmaycauseeyeirritation.

Avoidcontactwitheyes.

Incaseofcontactwitheyes,rinseimmediatelywithplentyofwater.

Theproductmaybeharmfulafterswallowing.

Avoidhand-to-mouthcontact.

Donoteat,drinkorsmokeduringtreatment.

Washhandsaftertreatment.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyand

lactation.Systemicabsorptionofactivesbeinglow,itisunlikelyforteratogenic,foetotoxicor

maternotoxiceffectstooccurattherecommendeddosage.

Useonlyaccordinglytotherisk-benefitassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Incasethelesionisdirty,cleanitwithadisposableclothtoenabledirectcontactwiththegel.

Administertheproducttothelesionwithacleanbrush.Thelesioniscompletelycoveredwiththegel

duringtreatmentcontainingsteps:

Day0: Administerthegeltothelesionandcoverwithbandage.

Day3: Removethebandageandadministerthegelagain,withoutbandage.

Day7: Incaseofinsufficientrecovery,againadministerthegelwithoutbandage.

Contactaveterinarysurgeonincaseofnorecoveryonday10.

Foreverycontainerwithgelabrushissupplied.Thebandageisnotsuppliedwiththeproduct.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noinformationisavailable.

4.11Withdrawalperiod(s)

Meatandoffal: zerodays.

Milk: zerohours.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Dermatologicals,preparationsfortreatmentofwounds&ulcers.

ATCvetcode:QD03

5.1 Pharmacodynamicproperties

Copperhasantimicrobialpropertiesandapositiveeffectonwoundhealing.

Zincstimulateswoundhealingandhasamildantimicrobialeffectagainstgrampositivebacteria.

5.2 Pharmacokineticparticulars

Theproductisadministereddermally,directlyonthelesion.

Possibleabsorbedamountsofcopperareboundbyweakbondstoalbumininbloodplasmaandstored

intheliver.Excessofcopperisexcretedviabile,asmallpercentageviaurineandpartlyviamilk.

Possibleabsorbedamountsofzincaremainlyexcretedviabile(80%),partlyviaurineandpartlyvia

milk.

5.3 Environmentalproperties

Aftertreatmentwiththegel,themajoritywilldisappearintothemanureonthebarnfloorsandwillbe

removedwiththeslurrytothepastureofthefarmer.Theamountsofcopperandzincexposedtothe

environmentarenegligibleandwillnotformanecotoxicologicalrisk.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Tartrazine(E102).

Carmellosesodium.

SodiumStarchGlycolatetypeC.

IsopropylAlcohol.

Glycerol.

PurifiedWater.

6.2 Incompatibilities

Donotmixwithotherveterinarypharmaceuticals.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:1month.

6.4.Specialprecautionsforstorage

Donotrefrigerateorfreeze.Donotstoreabove25°C.

6.5 Natureandcompositionofimmediatepackaging

Polypropylene(PP)containerwithahighdensitypolyethylene(HDPE)screwlockcap.

Polypropylene(PP)brushwithstainlesssteelspacerandpolyesterbristle.

Cartonboxwith6containersof430gofgeland6brushes.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

IntracareBV

Voltaweg4

5466AZVeghel

+31(0)413354105

+31(0)413362324

info@intracare.nl

8. MARKETINGAUTHORISATIONNUMBER(S)

REGNL109438(TheNetherlands).

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

February2012.

10 DATEOFREVISIONOFTHETEXT

05February2013.

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGEANDIMMEDIATEPACKAGE

Theimmediatepackageisapolypropylenecontainerandtheouterpackageisacartonbox.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

IntraHoof-FitGel40mg/g+40mg/ggelfordairycattle DK,EE,LT,LU,LV,NL,UK

IntraPasta40mg/g+40mg/ggelfordairycattle FR

Pecoprovet40mg/g+40mg/ggelfordairycattle SE

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstances:

Copper: 40mg/g.

Zinc: 40mg/g.

Othersubstances:

Tartrazine(E102).

Glycerol.

CarmelloseSodium.

SodiumStarchGlycolatetypeC.

IsopropylAlcohol.

PurifiedWater.

3. PHARMACEUTICALFORM

Gel.Greenwater-basedviscousgel.

4. PACKAGESIZE

Immediatepackaging:Contentof430gram.

Outerpackaging: Contentof6x430gram.

5. TARGETSPECIES

Dairycattle.

6. INDICATION(S)

Foruseaspartofatreatmentprogrammeofdigitaldermatitis.

7. METHODANDROUTE(S)OFADMINISTRATION

Incasethelesionisdirty,cleanitwithadisposableclothtoenabledirectcontactwiththegel.

Administertheproducttothelesionwithacleanbrush.Thelesioniscompletelycoveredwiththegel

duringtreatmentcontainingsteps:

Day0: Administerthegeltothelesionandcoverwithbandage.

Day3: Removethebandageandadministerthegelagain,withoutbandage.

Day7: Incaseofinsufficientrecovery,againadministerthegelwithoutbandage.

Contactaveterinarysurgeonincaseofnorecoveryonday10.

Foreverycontainerwithgelabrushissupplied.Thebandageisnotsuppliedwiththeproduct.

8. WITHDRAWALPERIOD

Meatandoffal: zerodays.

Milk: zerohours.

9. SPECIALWARNING(S),IFNECESSARY

Donotmixwithotherveterinarypharmaceuticals.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyand

lactation.Systemicabsorptionofactivesbeinglow,itisunlikelyforteratogenic,foetotoxicor

maternotoxiceffectstooccurattherecommendeddosage.

Useonlyaccordinglytotherisk-benefitassessmentbytheresponsibleveterinarian.

Userwarnings:

Theproductmaycauseeyeirritation.

Avoidcontactwitheyes.

Incaseofcontactwitheyes,rinseimmediatelywithplentyofwater.

Theproductmaybeharmfulafterswallowing.

Avoidhand-to-mouthcontact.

Donoteat,drinkorsmokeduringtreatment.

Washhandsaftertreatment.

10. EXPIRYDATE

EXP.

Shelflifeafterfirstopeningthecontainer:1month.

11. SPECIALSTORAGECONDITIONS

Donotrefrigerateorfreeze.Donotstoreabove25°C.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Marketingauthorisationholder:

IntracareBV

Voltaweg4

5466AZVeghel

Manufacturerresponsibleforrelease:

Femigin

Rijksweg28/a

7975RTUffelte

16. MARKETINGAUTHORISATIONNUMBER(S)

REGNL109438.

17. MANUFACTURER’SBATCHNUMBER

Lot.:

B.PACKAGELEAFLET

(Allinformationisprovidedonthelabel/packaging)