VOMEND 5 mg/ml inj. for dog and cat

Main information

  • Trade name:
  • VOMEND 5 mg/ml inj. for dog and cat
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VOMEND 5 mg/ml inj. for dog and cat
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • metoclopramide
  • Therapeutic area:
  • Cats Non Food, Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0145/001
  • Authorization date:
  • 15-11-2010
  • EU code:
  • NL/V/0145/001
  • Last update:
  • 09-08-2016

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

1/13

ANNEXIII

LABELLINGANDPACKAGELEAFLET

2/13

A.LABELLING

3/13

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

5,10,20,25,30and50ml

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VOMEND5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Austria,Germany,Italy,Luxembourg,Portugal,TheNetherlands,UnitedKingdom)

VOMENDANTI-EMETICUMsolutionforinjection

Metoclopramidehydrochloride

(France)

VOMENDANTI-EMETICUM5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Belgium,Spain)

VomendVet.5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Finland,Sweden)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1mlcontains:

Metoclopramide(ashydrochloridemonohydrate) 4.457mg

equivalenttometoclopramidehydrochloride 5mg

Benzylalcohol(E1519) 18mg

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

5,10,20,25,30and50ml

5. TARGETSPECIES

Dogs,cats

6. INDICATION(S)

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneoususe.

8. WITHDRAWALPERIOD

4/13

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP:{month/year}

Onceopened,useby___/___/___

Shelf-lifeafterfirstopening:28days.

11. SPECIALSTORAGECONDITIONS

Readthepackageleafletbeforeuse.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthBV

Handelsweg25,5531AEBladel,TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

xxxx

17. MANUFACTURER’SBATCHNUMBER

Lot:

5/13

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

5and10ml

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VOMEND5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Austria,Germany,Italy,Luxembourg,Portugal,UnitedKingdom,theNetherlands)

VOMENDANTI-EMETICUMsolutionforinjection

Metoclopramidehydrochloride

(France)

VOMENDANTI-EMETICUM5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Belgium,Spain)

VomendVet.5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Sweden,Finland)

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

1mlcontains:

Metoclopramide(ashydrochloridemonohydrate) 4.457mg

equivalenttometoclopramidehydrochloride 5mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

5,10ml

4. ROUTE(S)OFADMINISTRATION

IMorSCuse.

Readthepackageleafletbeforeuse.

5. WITHDRAWALPERIOD

6. BATCHNUMBER

Lot:{number}

7. EXPIRYDATE

EXP:{month/year}

6/13

Onceopened,useby___/___/___

Shelf-lifeafterfirstopening:28days.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

7/13

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

20,25,30and50ml

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VOMEND5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Austria,Germany,Italy,Luxembourg,Portugal,TheNetherlands,UnitedKingdom)

VOMENDANTI-EMETICUMsolutionforinjection

Metoclopramidehydrochloride

(France)

VOMENDANTI-EMETICUM5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Belgium,Spain)

VomendVet.5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Finland,Sweden)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1mlcontains:

Metoclopramide(ashydrochloridemonohydrate) 4.457mg

equivalenttometoclopramidehydrochloride 5mg

Benzylalcohol(E1519) 18mg

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

20,25,30and50ml

5. TARGETSPECIES

Dogsandcats

6. INDICATION(S)

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

IMorSCuse.

Readthepackageleafletbeforeuse.

8/13

8. WITHDRAWALPERIOD

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP:{month/year}

Onceopened,useby___/___/___

Shelf-lifeafterfirstopening:28days.

11. SPECIALSTORAGECONDITIONS

Storeintheoriginalpackage.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthBV

Handelsweg25,5531AEBladel,theNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot{number}

9/13

B.PACKAGELEAFLET

10/13

PACKAGELEAFLET

for5,10,20,25,30and50ml

VOMEND5mg/mlsolutionforinjectionfordogsandcats

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

EurovetAnimalHealthBV

Handelsweg25,5531AEBladel

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VOMEND5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Austria,Germany,Italy,Luxembourg,Portugal,TheNetherlands,UnitedKingdom)

VOMENDANTI-EMETICUMsolutionforinjection

Metoclopramidehydrochloride

(France)

VOMENDANTI-EMETICUM5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Belgium,Spain)

VomendVet.5mg/mlsolutionforinjectionfordogsandcats

Metoclopramidehydrochloride

(Finland,Sweden)

3. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENTS

Eachmlcontains:

Metoclopramide(ashydrochloridemonohydrate) 4.457mg

equivalenttometoclopramidehydrochloride 5mg

Benzylalcohol(E1519) 18mg

Clearcolourlessaqueoussolution.

4. INDICATIONS

Symptomatictreatmentofvomitingandreducedgastro-intestinalmotilityassociatedwithgastritis,

pyloricspasm,chronicnephritisanddigestiveintolerancetosomedrugs.

5. CONTRAINDICATIONS

Donotuseincasesofgastro-intestinalperforationorobstruction.

6. ADVERSEREACTIONS

11/13

Insomeveryrarecases,extrapyramidaleffects(agitation,ataxia,abnormalpositionsand/or

movements,prostration,tremorsandaggression,vocalisation)havebeenobservedaftertreatmentof

dogsandcats.Theobservedeffectsaretransientanddisappearwhentreatmentisstopped.

Inveryrarecases,allergicreactionsmayoccur.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Dogs,cats

8. DOSAGEFOREACHSPECIES,ROUTEANDMETHODOFADMINISTRATION

Intramuscularorsubcutaneoususe.

0.5mgmetoclopramidehydrochlorideperkgBW,ifnecessaryrepeatedevery6-8hours.

9. ADVICEONCORRECTADMINISTRATION

5.0mg/10kg(equivalentto1ml/10kg)

Injectionscanberepeatedevery6-8hours.

10. WITHDRAWALPERIOD

Notapplicable

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storeintheoriginalpackage.

DonotuseaftertheexpirydatestatedonthelabelandcartonafterEXP.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

12. SPECIALWARNINGS

Specialprecautionsforuseinanimals

Thedosagemustbeadaptedinanimalswithrenalorhepaticinsufficiency(duetoanincreaseinthe

riskofsideeffects).Avoidadministrationtoanimalswithepilepsy.Thedosageshouldbecarefully

observed,especiallyincatsandsmallbreeddogs.

Followingprolongedvomiting,considerationshouldbegiventofluidandelectrolytereplacement

therapy.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteradministrationtotheanimal.

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackageleafletor

thelabeltothephysician.

Incaseofaccidentalexposurebyspillageontotheskinoreyes,washimmediatelywithabundant

water.Ifadverseeffectsappear,seekmedicaladviceimmediatelyandshowthepackageleafletorthe

labeltothephysician.

Useduringpregnancy,lactationorlay

12/13

Laboratorystudiesinlaboratoryanimalshavenotproducedanyevidenceofateratogenicorfoetotoxic

effects.However,studiesonlaboratoryanimalsarelimitedandthesafetyoftheactivesubstancehas

notbeenevaluatedinthetargetspecies.Theuseoftheproductduringpregnancyandlactationmustbe

madeaccordingtothebenefit/riskassessmentcarriedoutbytheveterinarian.

Interactions

Incasesofgastritis,avoidtheco-administrationofanticholinergicdrugs(atropine)astheymay

counteracttheeffectsofmetoclopramideongastrointestinalmotility.

Incasesofsimultaneousdiarrhoea,thereisnocontra-indicationtotheuseofanticholinergicdrugs.

Concurrentuseofmetoclopramidewithneurolepticsderivatedfromphenothiazine(acepromazine)and

butyrophenones,increasestheriskofextrapyramidaleffects(seesectionAdversereactions).

Metoclopramidecanpotentiatetheactionofcentralnervoussystemdepressants.Ifusedconcurrently,

itisadvisedtousethelowestdosageofmetoclopramidetoavoidexcessivesedation.

Overdose

Mostoftheclinicalsignsreportedafteranoverdosagearewellknownextrapyramidalsideeffects

(seesectionAdversereactions).

Intheabsenceofaspecificantidote,itisrecommendedtoofferacalmenvironmenttotheanimaluntil

extrapyramidalsideeffectsdisappear.

Metoclopramidebeingrapidlymetabolisedandeliminated,sideeffectsgenerallydisappearquickly.

Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

November2010

15. OTHERINFORMATION

Packsizes:

1vialwith5,10,20,25,30and50mlsolutionforinjection.

1vialinacardboardbox.

Notallpacksizesmaybemarketed.

Pharmacodynamicproperties

Metoclopramideisanoriginalorthopramidemolecule.

Theanti-emeticactionofmetoclopramideismainlyduetoitsantagonistactivityatD2receptorsinthe

centralnervoussystem,preventingnauseaandvomitingtriggeredbymoststimuli.

Theprokineticeffectonthegastro-duodenaltransit(increaseinintensityandrhythmofstomach

contractionsandopeningofthepylorus)ismediatedbymuscarinicactivity,D2receptorantagonist

activityand5-HT

receptoragonistactivityatthegastro-intestinallevel.

Pharmacokineticparticulars

13/13

Metoclopramideisrapidlyandcompletelyabsorbedafterparenteraladministration .

Aftersubcutaneousadministrationtodogsandcats,maximumconcentrationsareobtainedafter15-30

min.

Metoclopramideisrapidlydistributedintomosttissuesandfluids,crossestheblood-brainbarrierand

entersthecentralnervoussystem.

Metoclopramideismetabolisedbytheliver.

Theeliminationofmetoclopramideisrapid,65%ofthedosebeingeliminatedwithin24hoursinthe

dog,primarilybytheurinaryroute.

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