Zitac vet 50 mg tablet for dogs

Main information

  • Trade name:
  • Zitac vet 50 mg tablet for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zitac vet 50 mg tablet for dogs
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cimetidine
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0119/001
  • Authorization date:
  • 29-04-2011
  • EU code:
  • NL/V/0119/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

I.B. SUMMARYOFPRODUCTCHARACTERISTICS,LABELANDPACKAGE

LEAFLET

I.B.1. SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Zitac vet50mgtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:cimetidine50mgpertablet.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Oblongtablets,scoredonbothsides.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Symptomatictreatmentforthereductionofvomitingassociatedwithchronicgastritisin

dogs.

4.3 Contraindications

None

4.4 Specialwarningsforeachtargetspecies

Treatmentwithcimetidineissymptomaticonlyanddoesnotresultinresolutionof

histopathologicalchangesassociatedwithgastritis.Itisrecommendedthatdogsshowing

persistentvomitingshouldundergoappropriateinvestigationstodiagnosetheunderlying

causebeforestartingtreatment.Thisisespeciallyimportantinolderanimals.Thereduction

ofgastricaciditycausedbycimetidinemaycontributetobacterialovergrowthandantigenic

stimulation.

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Incaseofrenaldysfunction,adjustmentofthedosemayberequiredastheclearanceof

cimetidinemaybedecreased.Iftheresponsetotreatmentispoorwithin15days,the

diagnosisandtreatmentplanshouldbere-evaluated.

ii) Specialprecautionstobetakenbythepersonadministeringthemedicinalproducttoanimals

None.

4.6 Adversereactions(frequencyandseriousness)

Transientandself-resolvingslightswellingofmammaryglandsmaybeobservedinfemale

dogs(gynaecomastia;anti-androgenicactivity).Areductionofprostateweightwasalso

observedinmaleratsanddogs,withnoimpactonreproductiveperformances;thiseffect

wasreversible.Nootherundesirableeffectswerereported.

4.7 Useduringpregnancyandlactation

Theuseoftheproductduringpregnancyandlactationinthetargetspecieshasnotbeen

investigated.

Therefore,useoftheveterinarymedicinalproductduringpregnancyandlactationshouldbe

basedonariskbenefit-assessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

DuetoinhibitionofcytochromeP-450activitybycimetidine,themetabolismand

eliminationofsomedrugscanbereduced.Clinicallyrelevantinteractionsmayoccurwith

compoundshavinganarrowtherapeuticindex,e.g.beta-blockers,calciumchannelblockers,

benzodiazepines,barbiturates,phenytoin,theophylline,aminophylline,warfarinand

lidocaine.Dosesofsuchdrugsmayneedtobereducedwhenadministeredconcomitantly

withcimetidine.

TheincreasedgastricpHresultingfromcimetidineadministrationmayleadtoreduced

absorptionofdrugsrequiringanacidmediumforabsorption.Itisrecommendedthatatleast

2hoursshouldelapsebetweenadministrationofcimetidineandaluminiumormagnesium

hydroxide,metoclopramide,digoxinorketoconazolewhenpossible.”

4.9 Amount(s)tobeadministeredandadministrationroute

Doseandrouteofadministration:5mgofcimetidineperkgofbodyweightadministered

threetimesdailybytheoralroute(seeindicativetablebelow).Theconcomitantuseof

appropriatedietarymeasuresisstronglyrecommended.Inclinicaltrialstheefficacyof

cimetidinehasonlybeenstudiedconcomitantlywithahypoallergenicdiet.

Table:NumberofZitacvet50mgtabletstobeadministeredthreetimesdailyaccordingto

bodyweight.

Weight(kg) NumberofZitacvet

50mgtablets

0 to 5 ½

6 to 10 1

Recommendedtreatmentscheme:reductionofvomitingisachievedinabout2weeks.

Animalsshouldhoweverbetreatedforatleast2weeksaftertheremissionofclinicalsigns,

soaminimumtreatmentdurationof28daysisusuallynecessaryandtherefore

recommended.Ifconsideredsuccessful,medicationshouldbewithdrawnfor2weeks.If

vomitingoccursagain,treatmentcanbere-initiatedwithoutriskofintolerance.

Dependingontheresponse,treatmentcanbeadaptedtotheindividualanimaluntilthe

responseisconsideredtobeadequateandcontinued.Dietarymeasuresshouldalwaysbe

maintained.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

AcuteexposuretocimetidineyieldedLD

valuesabove2600mg/kg,i.e.over170timesthe

recommendeddailydosageindogs.Atargetanimalsafetystudydemonstratedthatthe

productadministeredorallyat75mgcimetidine/kg/day(fivetimestherecommendeddaily

dose)foraperiodof91dayswaswelltoleratedbydogs.

Nosignsofoverdoseareknown.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Activeingredient:cimetidine.

Pharmacotherapeuticgroup:H

-receptorantagonists,ATCvetcode:QA02BA01.

5.1 Pharmacodynamicproperties

CimetidineisanantagonistofthehistamineH

-receptorspresentinthegastricparietalcells.

StimulationofH

-receptorsbyhistamineactivatesgastricacidsecretion.Cimetidine,viaits

antagonisticpropertiestowardhistamineH

-receptors,stronglyreducesgastricacid

secretion.Thismayresultinthediminutionofgastricirritationandsubsequentvomiting

duringchronicgastritis.Noaccompanyingimprovementintheinflammatorystatusofthe

gastricmucosawasobservedindogs.

5.2 Pharmacokineticparticulars

Afteroraladministrationoftheproductatadoserateof5mg/kgbodyweighttofasteddogs,

maximalplasmalevelsofapproximately2µg/mlarereachedafter1.5hourspost-

administration.Bioavailabilityisabout95%.Theextentofabsorptionofcimetidineindogs

isdelayedandreducedbyapproximately40%inthepresenceoffood(C

maxfasted 2.94

mcg/ml,C

maxfed 1.12mcg/ml,AUC

0-∞fasted 8.23mcg.h/mlandAUC

0-∞fed 5.43mcg.h/ml).

However,thisdoesnotaffecttheefficacyoftreatment

Theplasmahalf-lifeofcimetidineisapproximately2hoursatadosageof5mg/kg.

Cimetidineisrapidlyandalmostcompletelyexcretedintotheurine.Nodrugaccumulation

occursafterrepeatedoraltreatmentat5mg/kgthreetimesdailyover30consecutivedays.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lactosemonohydrate

Microcrystallinecellulose

Maizestarchpregelatinised

SodiumstarchglycolatetypeA

Magnesiumstearate

6.2 Incompatibilities

Notapplicable

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

6.4 Specialprecautionsforstorage

Storetheblistersintheoriginalpackagetoprotectfromlight.Remainingtablethalves

shouldbestoredintheoriginalblisterpocketinordertoprotectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Thetabletsarepackedinpush-throughblisters(whiteopaquePVC/Aluminiumfoil)inanouter

printedcartonbox.

Authorisedpacksizes:

Cartonboxcontaining30tablets(3blisterwith10tabletsperblister)

Cartonboxcontaining100tablets(10blisterwith10tabletsperblister)

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materials,derivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalBV

P.O.Box31

5830AABoxmeer

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobespecifiedlater.

9. DATEOFFIRSTAUTHORISATION

Tobecompletedlocally.

10. DATEOFREVISIONOFTHETEXT

April2011

11. PROHIBITIONOFSALE,SUPPLYAND/ORUSE

None.

I.B.2. PACKAGING,LABELLINGANDPACKAGELEAFLET

LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

CartonBoxZitacvet50mgtablets

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Zitacvet50mgtabletsfordogs

Cimetidine

2. STATEMENTOFACTIVESANDOTHERSUBSTANCES

Cimetidine50mgpertablet.

3. PHARMACEUTICALFORM

Tablet.

4. PACKAGESIZE

30tablets

100tablets

5. TARGETSPECIES

Dogs.

6. INDICATION(S)

Symptomatictreatmentforthereductionofvomitingassociatedwithchronicgastritisindogs.

7. METHODANDROUTE(S)OFADMINISTRATION

Oral,5mg/kgbodyweightthreetimesdaily.

Readpackageleafletbeforeuse

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNING(S),IFNECESSARY

Readpackageleafletbeforeuse

10. EXPIRYDATE

Exp:(Month/Year)

11. SPECIALSTORAGECONDITIONS

Storetheblistersintheoriginalpackagetoprotectfromlight.Remainingtablethalvesshouldbe

storedintheoriginalblisterpocketinordertoprotectfromlight.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”,ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly–tobesuppliedonlyonveterinaryprescriptions.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

P.O.Box31

5830AABoxmeer

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

MAnumber.

17. MANUFACTURER’SBATCHNUMBER

Batchnumber.

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

BlisterZitacvet50mgtablets

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Zitacvet50mgtabletsfordogs.

Cimetidine.

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

3. EXPIRYDATE

Exp:(Month/Year)

4. BATCHNUMBER

Batchnumber.

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly

PACKAGELEAFLETFORZitacvet50mgtabletsfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

IntervetInternationalB.V.

P.O.Box31

5830AABoxmeer

TheNetherlands

Manufacturerforthebatchrelease:

IntervetGesmbH

Siemensstrasse107

1210Vienna

Austria

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Zitacvet50mgtabletsfordogs.

Cimetidine

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENTS

Cimetidine50mgpertablet.

4. INDICATION(S)

Symptomatictreatmentforthereductionofvomitingassociatedwithchronicgastritisindogs.

5. CONTRAINDICATION(S)

None.

6. ADVERSEREACTIONS

Transientandself-resolvingslightswellingofmammaryglandsmaybeobservedinfemaledogs

(gynaecomastia;anti-androgenicactivity).Areductionofprostateweightwasalsoobservedin

maleratsanddogs,withnoimpactonreproductiveperformances;thiseffectwasreversible.No

otherundesirableeffectswerereported.Ifyounoticeanyseriouseffectsorothereffectsnot

mentionedinthisleaflet,pleaseinformyourveterinarysurgeon.

7. TARGETSPECIES

Dogs.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF

ADMINISTRATION

Doseandrouteofadministration:5mgofcimetidineperkgofbodyweightadministeredthree

timesdailybytheoralroute.Theconcomitantuseofappropriatedietarymeasuresisstrongly

recommended.Inclinicaltrialstheefficacyofcimetidinehasonlybeenstudiedconcomitantlywith

ahypoallergenicdiet.

Table:NumberofZitacvet50mgtabletstobeadministeredthreetimesdailyaccordingtobody

weight.

Weight(kg) NumberofZitacvet

50mgtablets

0 to 5 ½

6 to 10 1

Recommendedtreatmentscheme:reductionofvomitingisachievedinabout2weeks.Animals

shouldhoweverbetreatedforatleast2weeksaftertheremissionofclinicalsigns,soaminimum

treatmentdurationof28daysisusuallynecessaryandthereforerecommended.Ifconsidered

successful,medicationshouldbewithdrawnfor2weeks.Ifvomitingoccursagain,treatmentcan

bere-initiatedwithoutriskofintolerance.

Dependingontheresponse,treatmentcanbeadaptedtotheindividualanimaluntiltheresponseis

consideredtobeadequateandcontinued.Dietarymeasuresshouldalwaysbemaintained.

9. ADVICEONCORRECTADMINISTRATION

None.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storetheblistersintheoriginalpackagetoprotectfromlight.Remainingtablethalvesshouldbe

storedintheoriginalblisterpocketinordertoprotectfromlight.

Donotuseafterexpirydatewhichisstatedonthecarton

12. SPECIALWARNINGS

Treatmentwithcimetidineissymptomaticonlyanddoesnotresultinresolutionof

histopathologicalchangesassociatedwithgastritis.Itisrecommendedthatdogsshowingpersistent

vomitingshouldundergoappropriateinvestigationstodiagnosetheunderlyingcausebefore

startingtreatment.Thisisespeciallyimportantinolderanimals.Thereductionofgastricacidity

causedbycimetidinemaycontributetobacterialovergrowthandantigenicstimulation.

Iftheresponsetotreatmentispoorwithin15days,thediagnosisandtreatmentplanshouldbere-

evaluated.

Incaseofrenaldysfunction,adjustmentofthedosemayberequiredastheclearanceofcimetidine

maybedecreased.

Theuseoftheproductduringpregnancyandlactationinthetargetspecieshasnotbeen

investigated.Therefore,useoftheveterinarymedicinalproductduringpregnancyandlactation

shouldbebasedonarisk-benefit-assessmentbytheresponsibleveterinarian.

DuetoinhibitionofcytochromeP-450activitybycimetidine,themetabolismandeliminationof

somedrugscanbereduced.Clinicallyrelevantinteractionsmayoccurwithcompoundshavinga

narrowtherapeuticindex,e.g.beta-blockers,calciumchannelblockers,benzodiazepines,

barbiturates,phenytoin,theophylline,aminophylline,warfarinandlidocaine.Dosesofsuchdrugs

mayneedtobereducedwhenadministeredconcomitantlywithcimetidine.

TheincreasedgastricpHresultingfromcimetidineadministrationmayleadtoreducedabsorption

ofdrugsrequiringanacidmediumforabsorption.Itisrecommendedthatatleast2hoursshould

elapsebetweenadministrationofcimetidineandaluminiumormagnesiumhydroxide,

metoclopramide,digoxinorketoconazolewhenpossible.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

April2011

15. OTHERINFORMATION

Presentations:

Cartonboxcontaining30tablets(3blisterwith10tabletsperblister)

Cartonboxcontaining100tablets(10blisterwith10tabletsperblister)

Notallpacksizesmaybemarketed

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentative

ofthemarketingauthorisationholder.

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

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

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

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

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

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

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