BUSCOPAN 20 MG/ML, solution for injection for horses and calves

Main information

  • Trade name:
  • BUSCOPAN 20 MG/ML, solution for injection for horses and calves
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BUSCOPAN 20 MG/ML, solution for injection for horses and calves
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • butylscopolamine
  • Therapeutic area:
  • Cattle Young, Horses Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0107/001
  • Authorization date:
  • 19-02-2012
  • EU code:
  • NL/V/0107/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

SUMMARYOFPRODUCTCHARACTERISTICS

Page2of17

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Buscopan20mg/mlsolutionforinjectionforhorsesandcalves

Buscopanvet20mg/mlsolutionforinjection(Ireland)

Buscopanvet(Italy)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance

Hyoscinebutylbromide 20mg

(Equivalentto16.32mgbutylhyoscine)

Excipients

Methylparahydroxybenzoate(E218) 1.8mg

Propylparahydroxybenzoate(E216) 0.2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Colourlesssolutionforinjection

4. CLINICALPARTICULARS

4.1 Targetspecies

Horsesandcalves

4.2 Indicationsforuse,specifyingthetargetspecies

Horse: [Theproduct]isindicatedforantispasmodictreatmentincaseofequinecolic.

Calf: [Theproduct]isindicatedforitsantispasmodiceffect,asanaidtothesymptomatic

treatmentofcalfscour.Oralre-hydrationandotherappropriatetherapymustalsobe

administeredasrequired.

4.3 Contraindications

Donotuseinhorsessufferingfromparalyticileus.

Donotuseinhorseslessthan6weeksofage.

Seealsosection4.11Withdrawalperiodsandsection4.7foruseduringpregnancy.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

Page3of17

Incaseofnoclinicalresponsethenecessityforsurgicalinterventionshouldbetakenintoconsideration.

Seealsosection4.11Withdrawalperiods.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Horsesshouldbemonitoredcarefullyfollowingtreatment.Iftheresponsetotreatmentwith[the

product]ispoor,carefulre-evaluationofthediagnosisshouldbemadeandthepossibilityofsurgical

interventionshouldbeconsidered,as[theproduct]doesnotmasksymptomsofsurgicalcases.

Incasesofmechanicalobstructionofthegut,concomitanttherapywithpolyionicfluids,laxativesand

analgeticsshouldbeconsidered.

Inanimalswithcardiacdysfunctiontheproductshouldbeadministeredaftermakingarisk/benefit

assessment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivitytohyoscinebutylbromideormethyl-,orpropyl

parahydroxybenzoateshouldavoidcontactwiththeproduct.Wearimpermeablegloves.Inthecaseof

accidentalspillageontotheskinoreyes,washoffsplashesfromskinandeyeswithcleanrunning

water.

4.6 Adversereactions(frequencyandseriousness)

Aslighttransientincreaseinheartratemaybeobservedduetotheparasympatholyticactivityof

hyoscinebutylbromide.

4.7 Useduringpregnancy,lactationorlay

Theuseisnotrecommendedduringpregnancy.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Theeffectsofhyoscinebutylbromidemaybepotentiatedbytheconcomitantuseofother

anticholinergicdrugs.Donotuseincombinationwithotherdrugsthatactonthe(para)sympathic

system.Concomitanttherapyshouldtakeinconsiderationthepharmacokineticpropertiesofhyoscine

butylbromide.ConcurrentuseofNon-Steroidal-Anti-InflammatoryDrugs(NSAIDS),orotherproducts

withanalgesicpropertiesmaymasksignsofclinicalconditionsrequiringfurtherdiagnosisand

treatment.

4.9 Amountstobeadministeredandadministrationroute

Horse: [Theproduct]shouldbeadministeredatadosageof0.3mghyoscinebutylbromideperkg

bodyweight,byasingleintravenousinjection.

Thiscorrespondsto1.5mlof[theproduct]/100kgbodyweighti.v.

Calf: [Theproduct]shouldbeadministeredatadosageof0.4mghyoscinebutylbromideperkg

bodyweight,byasingleintramuscularinjection.

Thiscorrespondsto2mlof[theproduct]/100kgbodyweighti.m.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inatolerancestudyinhorses,usingupto5–foldtherecommendeddosageof0.3mg/kg,theproduct

causednosevereadversereactions.

Page4of17

Afive-foldoverdoseoccasionallyproducedsignsofatransient,slightdecreaseindefecation

frequency.Aten-foldoverdosageinhorsesproducedatransitoryabsenceofpupillarylightreflex,a

transitoryincreaseofheartrateandlowerintestinalmotility.Signsofcolicduetoenteroparalysis

appear6-8hoursafteradministration.Adversereactionsafteroverdosageshoulddisappearwithout

anyfurthertreatmentwithin6hours.

Intramuscularinjectionoftheproductincalvesatupto3-foldoftherecommendeddoseof0.4mg/kg

causednosystemicnorlocaladversereactions.

Incaseofoverdoseparasympatholyticsymptomatologymaybepresent.

4.11Withdrawalperiod(s)

Horse: Meatandoffal:1day

Calf: Meatandoffal:2days

Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Hyoscinebutylbromideisaquaternaryammoniumderivativeofscopolamine.

Therapeuticsubgroup:Syntheticantispasmodicandanticholinergicagents.

ATCvetcode:QA03BB01butylscopolamine(hyoscinebutylbromide).

5.1 Pharmacodynamicproperties

Likeotherbelladonnaalkaloidderivatives,thiscompoundantagonisestheactionsofacetylcholineatthe

muscarinicreceptorandalsopossessesslightadditionalactivityatnicotinicreceptors.Its

pharmacologicalprofileisqualitativelysimilartotheprincipalmemberofthisclass,atropine.Incontrast

toatropinehyoscinebutylbromidedoesnotcrosstheblood-brainbarrierandexhibitslessimpactonthe

cardiovascularsystemaswellaslessinhibitionofsalivaryandlacrimalsecretion.Incomparisonto

atropinethedurationofeffectisshorteranddisappearswithoutanyantidote.Theantispasmodiceffect

ofhyoscinebutylbromideresultsinrelaxationofsmoothmusculaturelastingforapproximately20-45

minutes.Adosedependentincreaseinheartrateaswellasinhibitionofsalivationandlacrimationcan

beobserved

5.2 Pharmacokineticparticulars

Thequaternaryammoniumstructureoftheactivesubstancepreventspenetrationintothecentral

nervoussystemafterparenteraladministration.Theeliminationhalf-lifefromplasmainthetarget

speciesis1-2hours.Hyoscinebutylbromideisveryrapidlyeliminatedfromtheblood.Twohours

aftertheintravenousadministrationof[theproduct],serumlevelsofhyoscinebutylbromidefallbelow

thelowerlimitofdetectionof100ng/ml.Afterparenteraladministrationinhorses,hyoscine

butylbromideiseliminatedmainlyviaurine,mainlyasunchangedsubstance.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumchloride

Methylparahydroxybenzoate(E218)

Page5of17

Propylparahydroxybenzoate(E216)

Waterforinjections

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale: 3years

Shelflifeafterfirstopeningtheimmediatepackaging: 28days

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Colourlessinjectionglassvials(typeI)withsiliconizedandTeflon-facedstoppersmadeofbromobutyl

rubberandcrimp-onaluminiumcaps.Eachvialcontains50mlandispackedintoacollapsiblecarton.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

tobecompletedbytheOperativeUnit

8. MARKETINGAUTHORISATIONNUMBER(S)

tobecompletedbytheOperativeUnit

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: tobecompletedbytheOperativeUnit

Dateofrenewaloftheauthorisation:tobecompletedbytheOperativeUnitafterRenewal

10 DATEOFREVISIONOFTHETEXT

tobecompletedbytheOperativeUnitafterRenewal

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable

Page6of17

LABELLINGANDPACKAGELEAFLET

Page7of17

A.LABELLING

Page8of17

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Buscopan20mg/mlsolutionforinjectionforhorsesandcalves

Hyoscinebutylbromide

Buscopanvet20mg/mlsolutionforinjection(Ireland)

Buscopanvet

(Italy)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Hyoscinebutylbromide20mg/ml

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

50ml

5. TARGETSPECIES

Horsesandcalves

6. INDICATION(S)

Horse: [Theproduct]isindicatedforantispasmodictreatmentincaseofequinecolic.

Calf: [Theproduct]isindicatedforitsantispasmodiceffect,asanaidtothesymptomatic

treatmentofcalfscour.Oralre-hydrationandotherappropriatetherapymustalsobe

administeredasrequired.

7. METHODANDROUTE(S)OFADMINISTRATION

Horse: [Theproduct]shouldbeadministeredatadosageof0.3mghyoscinebutylbromideperkg

bodyweight,byasingleintravenousinjection.

Thiscorrespondsto1.5mlof[theproduct]/100kgbodyweighti.v.

Calf: [Theproduct]shouldbeadministeredatadosageof0.4mghyoscinebutylbromideperkg

bodyweight,byasingleintramuscularinjection.

Thiscorrespondsto2mlof[theproduct]/100kgbodyweighti.m.

Page9of17

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Horse: Meatandoffal:1day

Calf: Meatandoffal:2days

Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

9. EXPIRYDATE

<EXP{month/year}>

Shelf-lifeofbroachedvial:28days

10. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposeofwastematerialinaccordancewithlocalrequirements.

11. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

12. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

13. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

tobecompletedbytheOperativeUnit

14. MARKETINGAUTHORISATIONNUMBER(S)

tobecompletedbytheOperativeUnit

15. MANUFACTURER’SBATCHNUMBER

Lot{number}

Page10of17

Page11of17

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Buscopan20mg/mlsolutionforinjectionforhorsesandcalves

Hyoscinebutylbromide

Buscopanvet20mg/mlsolutionforinjection(Ireland)

Buscopanvet (Italy)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Hyoscinebutylbromide20mg/ml

3. PACKAGESIZE

50ml

4. TARGETSPECIES

Horsesandcalves

5. METHODANDROUTE(S)OFADMINISTRATION

Horse: Singlei.v.injectionof1.5ml/100kgb.w.

Calf: Singlei.m.injectionof2ml/100kgb.w.

Readthepackageleafletbeforeuse.

6. WITHDRAWALPERIOD

Horse: Meatandoffal:1day

Calf: Meatandoffal:2days

Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

7. EXPIRYDATE

<EXP{month/year}>

Shelf-lifeofbroachedvial:28days

Page12of17

8. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

9. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

10. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

tobecompletedbytheOperativeUnit

11. MARKETINGAUTHORISATIONNUMBER(S)

tobecompletedbytheOperativeUnit

12. MANUFACTURER’SBATCHNUMBER

Lot{number}

Page13of17

B.PACKAGELEAFLET

Page14of17

PACKAGELEAFLET

Buscopan20mg/mlsolutionforinjectionforhorsesandcalves

Buscopanvet20mg/mlsolutionforinjection(Ireland)

Buscopanvet (Italy)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder Manufacturerforbatchrelease

tobecompletedbytheOperativeUnit

BoehringerIngelheimVetmedicaGmbH

BingerStrasse173

55218IngelheimamRhein

Germany

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Buscopan20mg/mlsolutionforinjectionforhorsesandcalves

Buscopanvet

(ItalyandIreland)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlcontains:

Hyoscinebutylbromide 20mg

Methylparahydroxybenzoate(E218)1.8mg

Propylparahydroxybenzoate(E216)0.2mg

4. INDICATION(S)

Horse: [Theproduct]isindicatedforantispasmodictreatmentincaseofequinecolic.

Calf: [Theproduct]isindicatedforitsantispasmodiceffect,asanaidtothesymptomatic

treatmentofcalfscour.Oralre-hydrationandotherappropriatetherapymustalsobe

administeredasrequired.

5. CONTRAINDICATIONS

Donotuseinhorsessufferingfromparalyticileus.

Donotuseinhorseslessthan6weeksofage.

Seealsosection“Withdrawalperiods”andsection“Specialwarnings”foruseduringpregnancy.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Page15of17

6. ADVERSEREACTIONS

Aslighttransientincreaseinheartratemaybeobservedduetotheparasympatholyticactivityof

hyoscinebutylbromide.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Horsesandcalves

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Horse: [Theproduct]shouldbeadministeredatadosageof0.3mghyoscinebutylbromideperkg

bodyweight,byasingleintravenousinjection.

Thiscorrespondsto1.5mlof[theproduct]/100kgbodyweighti.v.

Calf: [Theproduct]shouldbeadministeredatadosageof0.4mghyoscinebutylbromideperkg

bodyweight,byasingleintramuscularinjection.

Thiscorrespondsto2mlof[theproduct]/100kgbodyweighti.m.

9. ADVICEONCORRECTADMINISTRATION

Seesection8.

10. WITHDRAWALPERIOD

Horse: Meatandoffal:1day

Calf: Meatandoffal:2days

Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Donotuseaftertheexpirydate(EXP)statedonthecartonandvial.

Shelflifeafterfirstopeningthecontainer:28days

12. SPECIALWARNING(S)

Page16of17

Incaseofnoclinicalresponsethenecessityforsurgicalinterventionshouldbetakenintoconsideration.

Seealsosection“Withdrawalperiod.”

Theuseisnotrecommendedduringpregnancy.

Specialprecautionsforuseinanimals

Horsesshouldbemonitoredcarefullyfollowingtreatment.Iftheresponsetotreatmentwith[the

product]ispoor,carefulre-evaluationofthediagnosisshouldbemadeandthepossibilityofsurgical

interventionshouldbeconsidered,as[theproduct]doesnotmasksymptomsofsurgicalcases.

Incasesofmechanicalobstructionofthegut,concomitanttherapywithpolyionicfluids,laxativesand

analgeticsshouldbeconsidered.

Inanimalswithcardiacdysfunctiontheproductshouldbeadministeredaftermakingarisk/benefit

assessment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivitytohyoscinebutylbromideormethyl-,orpropyl

parahydroxybenzoateshouldavoidcontactwiththeproduct.Wearimpermeablegloves.Inthecaseof

accidentalspillageontotheskinoreyes,washoffsplashesfromskinandeyeswithcleanrunning

water.

Interactions

Theeffectsofhyoscinebutylbromidemaybepotentiatedbytheconcomitantuseofother

anticholinergicdrugs.Donotuseincombinationwithotherdrugsthatactonthe(para)sympathic

system.Concomitanttherapyshouldtakeinconsiderationthepharmacokineticpropertiesofhyoscine

butylbromide.ConcurrentuseofNon-Steroidal-Anti-InflammatoryDrugs(NSAIDS),orotherproducts

withanalgesicpropertiesmaymasksignsofclinicalconditionsrequiringfurtherdiagnosisand

treatment.

Overdose

Inatolerancestudyinhorses,usingupto5–foldtherecommendeddosageof0.3mg/kg,theproduct

causednosevereadversereactions.

Afive-foldoverdoseoccasionallyproducedsignsofatransient,slightdecreaseindefecation

frequency.Aten-foldoverdosageinhorsesproducedatransitoryabsenceofpupillarylightreflex,a

transitoryincreaseofheartrateandlowerintestinalmotility.Signsofcolicduetoenteroparalysis

appear6-8hoursafteradministration.Adversereactionsafteroverdosageshoulddisappearwithout

anyfurthertreatmentwithin6hours.

Intramuscularinjectionoftheproductincalvesatupto3-foldoftherecommendeddoseof0.4mg/kg

causednosystemicnorlocaladversereactions.

Incaseofoverdoseparasympatholyticsymptomatologymaybepresent.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Disposeofanyunusedproductandemptycontainersinaccordancewithguidancefromyourlocal

wasteregulationauthority.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

tobecompletedbytheOperativeUnitafterrenewal

Page17of17

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50mlinjectionvial.

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