Zipyran Plus

Main information

  • Trade name:
  • ZIPYRAN P Tabletten für Hunde
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZIPYRAN P Tabletten für Hunde
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ANTHELMINTICS
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0224/001
  • Authorization date:
  • 10-12-2011
  • EU code:
  • FR/V/0224/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ZIPYRANTABLETSFORDOGS

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances:

Praziquantel.........................................................................................50mg

Pyrantel(aspyrantelembonate)......................................................50mg

Febantel.............................................................................................150mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Yellowishroundscoredtablet,divisibleintoequalquarters.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Treatmentofmixedinfectionsbyadultcestodesandnematodesofthefollowing

species:

Nematodes:

Hookworms:Ancylostomacaninum

UncinariaStenocephala

Ascarids:Toxocaracanis

Toxascarisleonina

Cestodes:

Tapeworms:Taeniaspp

Dipylidiumcaninum

4.3Contraindications

Seesection4.7.

Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyofthe

excipients

4.4Specialwarningsforeachtargetspecies

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowing

frequent,repeateduseofananthelminticofthatclass.

Fleasserveasintermediatehostsandsourceofinfectionforonecommontypeof

tapeworm –Dipylidiumcaninum.

Tapeworminfestationmayreoccurunlesscontrolofintermediatehostsaswellasthe

environmentisundertakenconcurrentlytothetreatment.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Indebilitatedorheavilyinfestedanimals,theproductshouldbeusedonlyafter

evaluationoftherisk/benefitbytheveterinarian

Digestivehaemorrhages(diarrhoea,bloodystoolsandevendeaths)provokedby

wormlysismayresultfromanthelminthictreatmentincasesofheavyinfestations.

Indogslessthan6weeksold,tapeworminfectionsarehighlyuncommon.Treatment

ofanimalslessthan6weeksoldwithafixedcombinationproductagainstcestodes

andnematodesmay,therefore,notbenecessary.

Theactivesubstancesarenotknowntocauseparticularadverseeffectsinyoung

animals.Neverthelessthesafetyoftheformulationhasnotbeenestablishedindogs

lessthan5monthsofage.

Roundwormandhookworminfections:Insomeanimals,Ancylostomacaninumand

Toxocaracanismaynotbeeradicatedbythetreatment,resultinginacontinuedrisk

ofeggsheddingintotheenvironment.Follow-upexaminationsofthefaecesare

advisableandaccordingtotheresultsoftheseexaminations,treatmentwitha

nematocidalproductmaybecarriedout,ifnecessary.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Incaseofaccidentalingestion,seekmedicaladviceandshowthepackageleaflettothe

physician.

Incaseofaccidentalcontactwashhandsthoroughly

Peoplewithknownhypersensitivitytoanyoftheingredientsshouldavoidcontactwith

theveterinarymedicinalproduct

4.6Adversereactions(frequencyandseriousness)

Noneknown.

4.7Useduringpregnancy,lactationorlay

Donotuseinpregnantbitchesduringthefirstfourweeksofgestation.

Theproductmaybeusedduringlactation

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithpiperazine,astheanthelminticeffectsofpyranteland

piperazinemaybeantagonized.

Plasmaconcentrationsofpraziquantelmaybedecreasedbyconcomitant

administrationwithdrugsthatincreasetheactivityofcytochromeP-450enzymes

(e.g.dexamethasone,phenobarbital).

Concurrentusewithothercholinergiccompoundscanleadtotoxicity.

4.9Amountstobeadministeredandadministrationroute

Forsingleoraltreatmentonly.

Therecommendeddoseis5mgofPraziquantel,5mgofPyrantel(asembonate)and

15mgofFebantelperkgofbodyweight(equivalenttoonetablet/10kgbw)in

accordancewiththefollowingtable:

AnimalBodyweight

(kg) Nºoftablets

2.5 –5 ½

5 –10 1

10 –15 1½

15 –20

2

20-25 2½

25-30 3

Thetabletsareadministeredbyplacingwholeand/ordividedtabletsatthebackof

thetongueforforcedswallowing.

Tofurtherimproveaccuracyofdosing,tabletsmaybequartered.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible.

Incasesofconfirmedsingleinfestationbycestodesornematodes,amonovalent

productcontainingacestocideoranematocidealoneshouldbeused.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Doseshigherthan3timestherecommendeddosecancausedigestivedisorders

(vomitinganddiarrhea)

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anthelmintics,quinolinederivativesandrelated

substances,praziquantelcombinations.

ATCvetcode:QP52AA51

5.1Pharmacodynamicproperties

Inthisfixedcombinationpyrantelandfebantelactagainstnematodes(ascarids,

hookworms)indogs.InparticulartheactivityspectrumcoversToxocaracanis,

Toxascarisleonina,UncinariastenocephalaandAncylostomacaninum.This

combinationshowssynergisticactivityinthecaseofhookworms.

Praziquanteliseffectiveagainstanumberofcestodes.Activityofpraziquantel

againstadultandimmatureformsoftheseparasiteshasbeendescribedinliterature.

Praziquantelis veryrapidlyabsorbedthroughtheparasite’ssurfaceanddistributed

throughouttheparasite.Bothinvitroandinvivostudieshaveshownthat

praziquantelcausesseveredamagetotheparasiteintegument,resultinginthe

contractionandparalysisoftheparasites.Thereisanalmostinstantaneoustetanic

contractionoftheparasitemusculatureandarapidvacuolisationofthesyncytial

tegument.Thisrapidcontractionhasbeenexplainedbychangesindivalentcation

fluxes,especiallycalcium.

Pyrantelactsasacholinergicagonist.Itsmodeofactionistostimulatenicotinic

cholinergicreceptorsoftheparasite,inducespasticparalysisofthenematodesand

therebyallowremovalfromthegastro-intestinal(GI)systembyperistalsis.

Withinthemammaliansystemfebantelundergoesringclosureformingfenbendazole

andoxfendazole.Itisthesechemicalentitieswhichexerttheanthelminticeffectby

inhibitionoftubulinpolymerisation.Formationofmicrotubulesistherebyprevented,

resultingindisruptionofstructuresvitaltothenormalfunctioningofthehelminth.

Glucoseuptake,inparticularisaffected,leadingtoadepletionincellATP.The

parasitediesuponexhaustionofitsenergyreserves,whichoccurs2-3dayslater

5.2Pharmacokineticparticulars

Aftertheoraladministrationpraziquantelisnearlycompletelyabsorbedinthe

digestivetract.Themaximumconcentrationisreachedapproximately60minutes

aftertheadministration.

Praziquanteliswidelymetabolizedintheliver.Praziquantelisfoundintheurineas

metabolites(40%after8hours).

Afteroraladministration,themaximumplasmaticconcentrationsofFebantelare

reachedapproximatelyafter3hours.FebantelismetabolizedasFenbendazoleand

itsderivatesoxidesandhydroxides.Febanteltracesarefoundinfaecesandas

metabolitesintheurine.

TheembonatesaltofPyrantelhaslowaqueoussolubilityandispoorlyabsorbed

fromtheintestinaltractindogs.Itisfoundasactivesubstanceinthefaeces(50to

60%).Followingabsorption,pyrantelembonateisquicklyandalmostcompletely

metabolizedintoinactivecomponentswhicharerapidlyexcretedintheurine.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Povidone

Cellulose,microcrystalline

Silica,colloidalanhydrous

Sodiumlaurilsulfate

Crospovidone

Saccharinsodium

Magnesiumstearate

Maizestarch

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Anydividedtabletportionshouldbediscardedandnotstored

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions

6.5Natureandcompositionofimmediatepackaging

BlistersofPVCandaluminium

Packsizes:

Cardboardboxcontaining1blisterof2tablets

Cardboardboxcontaining1blisterof10tablets.

Cardboardboxcontaining25blistersof10tablets

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements

7. MARKETINGAUTHORISATIONHOLDER

LABORATORIOSCALIER,S.A.

C/.Barcelonès,26(PlàdelRamassà)

LESFRANQUESESDELVALLES,(Barcelona)SPAIN

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

03/04/2013

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

19-11-2018

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

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Europe - EFSA - European Food Safety Authority EFSA Journal

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration