MENBUTIL 100 mg/ml Solution for Injection for Cattle, Pigs, Horses, Sheep and Goats

Main information

  • Trade name:
  • MENBUTIL 100 mg/ml Solution for Injection for Cattle, Pigs, Horses, Sheep and Goats
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MENBUTIL 100 mg/ml Solution for Injection for Cattle, Pigs, Horses, Sheep and Goats
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • menbutone
  • Therapeutic area:
  • Cattle, Goats, Horses, Pigs, Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0200/001
  • Authorization date:
  • 03-11-2011
  • EU code:
  • FR/V/0200/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Menbutil100mg/mlSolutionforInjectionforCattle,Pigs,Horses,SheepandGoats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Menbutone 100.0mg

Excipient(s):

Chlorocresol 2.0mg

Sodiummetabisulphite(E223) 2.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,slightlyyellowsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle,Pigs,Horses,SheepandGoats.

4.2 Indicationsforuse,specifyingthetargetspecies

Incattle,pigs,horses,sheepandgoats:

-Stimulationofhepato-digestiveactivityincaseofdigestivedisordersandhepaticinsufficiency.

4.3 Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseinanimalswithcardiacdiseaseorinthelatestagesofpregnancy.

4.4 Specialwarningsforeachtargetspecies

Onlyslowintravenousadministrationisadvisedforhorses.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theintravenousadministrationshouldbedoneslowly(notlessthan1minute)toavoidthesideeffects

describedbelowinsection4.6.

Itisrecommendednottoinjectintramuscularlymorethan20mlononeapplicationsite.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Donoteat,drinkorsmokewhilehandlingtheproduct.

Incaseofaccidentalself-injection,seekmedicaladviseimmediatelyandshowthepackageleafletor

thelabeltothephysician..

4.6 Adversereactions(frequencyandseriousness)

Afterintravenousadministration,salivation,lachrymosity,tremors,spontaneousurinationand

defecationmayoccur.

Afterintramuscularadministration,reactionattheinjectionsite(oedema,haemorrhage,necrosis)may

occur.

4.7 Useduringpregnancy,lactationorlay

Donotuseduringthelastthirdofpregnancy.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Calves(upto6months),sheep,goatsandpigs:

10mgmenbutoneperkgbodyweightappliedeitherdeeplyi.m.orslowlyi.v.administration,

equivalentto1mlofsolutionforinjectionper10kgbodyweight.

Cattle:

5-7.5mgmenbutoneperkgbodyweightviaintravenousadministration,equivalentto1mLof

solutionforinjectionper15-20kgbodyweight.

Horses:

2.5-5mgperkgbodyweightviaslowintravenousadministration,equivalentto1mLofsolutionfor

injectionper20-40kgbodyweight.

Theproductadministrationmayberepeatedonceifnecessaryafter24hours

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Therecommendeddosageshavetobestrictlyconsidered,sincethesafetyfactorsofMenbutoneare

notknown.Cardiovasculardrugsshouldbeusedincaseofaheartblock.

4.11Withdrawalperiod(s)

MeatandOffal:Zerodays

Milk:Zerodays

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:drugforbiletherapy

ATCvetcode:QA05AX90

5.1 Pharmacodynamicproperties

Menbutone,orgenabilicacid,isaderivativeofoxybutyricacidwhichactsasacholereticstimulating

secretion,atrypsinogenandapepsinogen.Afterinjectionintothebody,itincreasesbiliary,

pancreaticandpepticsecretionby2to5timescomparedwiththenormallevelsofthese.

Thus,itpromotestransitandassimilationoffood,andactsasahepaticdetoxifyingagent.

5.2 Pharmacokineticparticulars

Incowsonehourafterintravenousinjection,20mg/LofMenbutoneweremeasuredinplasma.After8

hours,theplasmaconcentrationswerelowerthan1mg/L.40.4%oftheoraldoseand12%ofthe

intravenousdosewereexcretedintheurinewithin24hours.Inmilk,amaximumconcentrationof0.7

to0.8mg/Lwasreportedataboutfivehoursafterinjection.Atorbefore14hours,Menbutone

concentrationshadfallento0.1mg/Lorless.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Edeticacid(E385)

Sodiummetabisufit(E233)

Chlorocresol

Ethanolamine

Waterforinjections

6.2 Incompatibilities

Nottoadministertogetherwithsolutionswhichcontain:

- Calcium

- ProcainPenicillin

- VitaminBcomplex

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale: 18 months

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Donotstoreabove25°C

6.5 Natureandcompositionofimmediatepackaging

MultidosecleartypeIglassvialof100mlwithbromobutylrubberstopperandaluminiumcrimpcaps.

Boxwith1x100mlor12x100ml.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

aniMedicaGmbH

ImSüdfeld9

D-48308Senden-Bösensell

Germany

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobesuppliedonlyonveterinaryprescription.

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