Vitofyllin 50 mg Film-coated Tablets for Dogs

Main information

  • Trade name:
  • Vitofyllin 50 mg Film-coated Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Vitofyllin 50 mg Film-coated Tablets for Dogs
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • PERIPHERAL VASODILATORS
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0392/001
  • Authorization date:
  • 22-02-2012
  • EU code:
  • UK/V/0392/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:May2012

AN:02114/2010

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Vitofyllin50mgfilm-coatedtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Propentofylline 50.00mg/tablet

Excipients:

FerricOxide,yellow,(E172) 0.075mg/tablet

TitaniumDioxide,(E171) 0.215mg/tablet

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Film-coatedtablets.

Yellow,round,convextabletswithcross-snaptabononeandimpr inting“50”ontheother

side.

Thetabletcanbedividedintoequalhalvesandquarters.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs.

4.2Indicationsforuse,specifyingthetargetspecies

Fortheimprovementofperipheralandcerebralvascularbloodcirculation.For

improvementindullness,lethargyandoveralldemeanourindogs.

4.3Contraindications

Refertosection4.7

Donotuseindogsweighinglessthan2.5kg.

Donotuseincasesofhypersensitivitytotheactivesubstanceand/ortoanyoftheother

ingredientsoftheproduct.

4.4Specialwarnings

None.

Issued:May2012

AN:02114/2010

Page2of5

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Specificdiseases(e.g.kidneydisease)shouldbetreatedaccordingly.

Considerationshouldbegiventorationalisingthemedicationofdogsalreadyreceiving

treatmentforcongestiveheartfailureorbronchialdisease.

Inthecaseofrenalfailure,thedoseshouldbereduced.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Careshouldbetakentoavoidaccidentalingestion.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Onrareoccasions,allergicskinreactions,vomitingandcardiacdisturbanceshave

beenreported.Inthesecases,thetreatmentshouldbestopped.

4.7Useduringpregnancy,lactationorlay

Donotuseinpregnantorlactatingbitchesorbreedinganimalsastheproducthasnot

beenevaluatedintheseanimals.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Thebasicdosageis6-10mgpropentofylline/kgbodyweight,dividedintotwo3-5mg/kg

dosesasfollows:

Bodyweight

(kg) Tablets Daily

total

tablets Dailytotal

dose

(mg/kg) am pm

2.5-4kg ¼ ¼ ½ 6.3-10.0

5-7kg ½ ½ 1 7.1-10.0

8 –9kg ¾ ¾ 1½ 8.3-9.4

10-15kg 1 1 2 6.7 –10.0

16-25kg 1½ 1½ 3 6.0 –9.4

26-33kg 2 2 4 6.1-7.7

Dogsofmorethan20kgcanbegivenVitofyllin100mgfilm-coatedtabletsfordogs.

Issued:May2012

AN:02114/2010

Page3of5

Thetabletscanbeadministereddirectlyontothebackofthedog'stongueorcanbe

mixedinasmallballoffoodandshouldbeadministeredatleast30minutesbefore

feeding.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Excitationtachycardia,hypotension,reddeningofmucousmembranesandvomiting.

Thewithdrawalofthetreatmentleadstoaspontaneousremissionofthesesigns.

4.11Withdrawalperiod(s)

(notapplicable)

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:peripheralvasodilator;purinederivatives;propentofylline

ATCvetcode:QC04AD90

5.1Pharmacodynamicproperties

Propentofyllinehasbeenshowntoincreasebloodflow,particularlyoftheheartand

skeletalmuscle.Italsoincreasesthebloodflowofthebrainandthereforeitsoxygen

supply,withoutincreasingthebrain'sglucosedemand.Ithasamodestpositive

chronotropiceffectandamarkedpositiveionotropiceffect.Inaddition,ithasbeen

showntohaveananti-arrhythmiceffectindogswithmyocardialischemiaanda

bronchodilatoractionequivalenttothatofaminofylline.

Propentofyllineinhibitsplateletaggregationandimprovestheflowpropertiesof

erythrocytes.

Ithasadirecteffectontheheartandreducesperipheralvascularresistancethereby

loweringcardiacload.

Propentofyllinemayincreasewillingnesstoexerciseandexercisetolerance,particularly

inolderdogs.

5.2Pharmacokineticparticulars

Afteroraladministrationpropentofyllineisfastandcompletelyabsorbedandquickly

distributedinthetissues.Givenorallytodogs,maximumplasmalevelsarereached

alreadyafter15minutes.

Thehalf-timeisabout30minutesandthebioavailabilityforthemothersubstance

amountstoabout30%.Thereareanumberofeffectivemetabolitesandthe

biotransformationtakesplacemainlyintheliver.Propentofyllineisexcretedinformofits

metabolitesin80-90%viathekidneys.Therestiseliminatedwiththefaeces.Thereis

noaccumulation.

Issued:May2012

AN:02114/2010

Page4of5

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

MaizeStarch

Crospovidone

Talc

Silica,ColloidalAnhydrous

MagnesiumStearate

FilmCoating:

TitaniumDioxide,E171

FerricOxide,yellow,E172

Hypromellose

Macrogol6000

Talc

6.2Incompatibilities

Notapplicable.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Unuseddividedtabletsshouldbereturnedtotheblisterpackandanydividedtablet

portionsremainingafter72hoursshouldbediscarded.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackage(blister)andkeeptheblisterpacksintheoutercartonand

storeinadryplace.Dividedtabletsshouldbestoredintheblisterpack.

6.5Natureandcompositionofimmediatepackaging

Polyvinylchloride –PolyVinylidenedichloride/Aluminiumblisterwith14tablets,ina

cardboardboxcontaining4blisters(56tablets).

Polyvinylchloride –PolyVinylidenedichloride/Aluminiumblisterwith14tablets,ina

cardboardboxcontaining10blisters(140tablets).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Issued:May2012

AN:02114/2010

Page5of5

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

AnimalcareLimited

CommonRoad

Dunnington

York

YO195RU

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm10347/4032

9. DATEOFFIRSTAUTHORISATION

2May2012

10.DATEOFREVISIONOFTHETEXT

May2012