VETERELIN 0.004 mg/ml solution for injection for cattle, horses, pigs, and rabbits

Main information

  • Trade name:
  • VETERELIN 0.004 mg/ml solution for injection for cattle, horses, pigs, and rabbits
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VETERELIN 0.004 mg/ml solution for injection for cattle, horses, pigs, and rabbits
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • buserelin
  • Therapeutic area:
  • Cattle, Horses, Pigs, Rabbit

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • PT/V/0104/001
  • Authorization date:
  • 23-11-2011
  • EU code:
  • PT/V/0104/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT:

VETERELIN0.004mg/mlsolutionforinjectionforcattle,horses,pigs,andrabbits

VETERELIN4mikrog/mlsolutionforinjectionforcattle,horses,pigs,andrabbits(FI)

2.QUALITATIVEANDQUANTITATIVECOMPOSITION:

Eachmlofsolutionforinjectioncontains:

Activesubstance:

Buserelin.....................................................................0.004mg

(equivalentto0.0042mgBuserelinacetate)

Excipient

Benzylalcohol...................................................................10mg

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM:

Solutionforinjection.

Clearandcolourlesssolution.

4.CLINICALPARTICULARS:

4.1Targetspecies:

Cattle(cows),horses(mares),rabbits(does)andpigs(gilts).

4.2Indicationsforuse,specifyingtargetspecies:

ForCows

-Ovulationinductionordelayedovulation

-Treatmentofanoestrus

-Treatmentoffollicularcystswithorwithoutsymptomsofnymphomania

-Improvementofconceptionrateinartificialinseminationprocedures,alsoafter

synchronisationofoestruswithaPGF2αanalogue.Resultsmayhowevervarydependingon

breedingconditions

ForMares

-Ovulationinductionandtherebytosynchroniseovulationmorecloselywithmatinginmares.

-Treatmentoffollicularcysts–withorwithoutsymptomsofnymphomania

ForRabbits

Improvementofconceptionrateandovulationinductionatpostpartuminsemination.

ForPigs(Nulliparouscyclinggilts):

Ovulationinductionafteroestrussynchronizationwithananalogueofprogestagen(altrenogest)

inordertoperformasingleartificialinsemination.

4.3Contraindications:

Donotuseinanimalswithknownhypersensitivitytotheactiveingredientortotheexcipients.

4.4Specialwarningsforeachtargetspecies

TreatmentwithaGnRHanalogueisonlysymptomatic;thecausesunderlyingafertilitydisorder

arenoteliminatedbythistreatment.

4.5Specialprecautionsforuse

4.5.iSpecialprecautionsforuseinanimals

Gilts

Useoftheproductcontrarytotherecommendedprotocolsmayresultintheformationof

follicularcystswhichmaydetrimentallyaffectfertilityandprolificacy.

4.5.iiSpecialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Avoideyeandskincontactwiththesolutionforinjection.Incaseofaccidentalcontact,rinse

thoroughlywithwater.Shouldskincontactwiththeproductoccur,washtheexposedarea

immediatelywithsoapandwater,asGnRHanaloguesmaybeabsorbedthroughtheskin.

Pregnantwomenshouldnotadministertheproduct,asbuserelinhasbeenshowntobe

foetotoxicinlaboratoryanimals.

Womenofchild-bearingageshouldadministertheproductwithcaution.

Whenadministeringtheproduct,careshouldbetakentoavoidaccidentalself-injectionby

ensuringthatanimalsaresuitablyrestrainedandtheapplicationneedleisshieldeduntilthe

momentofinjection.

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackage

leafletorthelabeltothephysician.Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

None.

4.7Useduringpregnancyandlactation

Theuseisnotrecommendedduringpregnancyorlactation.

4.8Interactionwithothermedicamentsandotherformsofinteraction:

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Incattle,horsesandrabbits,thepreferredrouteofadministrationisintramuscularinjection

(i.m.),butitmayalsobeinjectedintravenously(i.v.)orsubcutaneously(s.c.).

Inpigs,thepreferredrouteofadministrationisintramuscularly(i.m.),butitmayalsobe

injectedintravenously(i.v.).

Species Indication µg

Buserelin

peranimal ml Veterelin

4µg/ml per

animal

Cows Treatmentofanoestrus 20 5

Ovulationinduction 20 5

Delayedovulation 10 2.5

Improvementofconceptionrateinartificial

inseminationprocedures,alsoaftersynchronisation

ofoestruswithaPGF2αanalogue.Resultsmay

howevervarydependingonbreedingconditions.

Foroestrussynchronisationincowsaccordingtoa

10dayfixedtimeinseminationregime,buserelin

shouldbeadministeredatday0followedby

PGF2alphatreatmentatday7,andasecondbuserelin

treatmentatday9accordingtothementioned

posology 10 2.5

Follicularcystswithorwithoutsymptomsof

nymphomania 20 5

Mares Treatmentoffollicularcysts-withorwithout

symptomsofnymphomania 40 10

Ovulationinductionandtherebytosynchronize

ovulationmorecloselywithmatinginmares. 40 10

Gilts

Nulparous

cyclinggilts Ovulationinductionafteroestrussynchronization

withananalogueofprogestagen(altrenogest)in

ordertoperformasingleartificialinsemination.

Administrationshouldbedone115-120hoursafter

theendofsynchronizationwithaprogestagen.A

singleartificialinseminationshouldbeperformed

30-33hoursafterVETERELINadministration. 10 2.5

Rabbits Improvementofconceptionrate 0.8 0.2

Ovulationinductionatpost-partuminsemination 0.8 0.2

Theproductshouldbeadministeredonce.

Thevialcanonlybebroachedamaximumof20times.

4.10Overdose(symptoms,emergencyprocedures,antidotes):

Inthecaseofrepeatedadministrationsofadosecorrespondingto3.5mlofproduct,reduced

foodconsumptionmaybeobservedingiltsafterthe2 nd injection.Thiseffectistransientandno

specifictreatmentisrequired.

4.11Withdrawalperiod:

Meatandoffal:zerodays

Milk:zerohours

5 PHARMACOLOGICALPROPERTIES

ATCVetCode:QH01CA90

Pharmacotherapeuticgroup:Gonadotropin-releasinghormones

5.1Pharmacodynamicproperties

Buserelinisapeptidehormonewhichischemicallyanalogoustothereleasinghormone(RH)of

theluteinisinghormone(LH)andfolliclestimulatinghormone(FSH)thusagonadotrophin

releasinghormone(GnRH)analogue.

Themodeofactionoftheveterinarymedicinalproductcorrespondstothephysiologic-

endocrinologicalactionofthenaturallyoccurringgonadotrophinreleasinghormone.

GnRHleavesthehypothalamusviathehypophysealportalvesselsandenterstheanteriorlobe

ofthehypophysis.HereitinducesthesecretionofthetwogonadotrophinsFSHandLHintothe

peripheralbloodstream.Thesecanactphysiologicallytocausematurationofovarianfollicles,

ovulationandlutenizationintheovary.

5.2.Pharmacokineticproperties

Afterintravenousadministration,buserelinisdegradedrapidly:itshalf-lifeis3to4.5minutes

inratand12minutesinguineapigs.Buserelinisaccumulatedinthepituitarygland,liverand

kidneyswherethesubstanceisdegradedbyenzymesintosmallpeptidesfragmentswith

negligiblebiologicactivity.Themainexcretionrouteisintheurine.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol

Sodiumchloride

Sodiumdihydrogenphosphatemonohydrate

Sodiumhydroxide

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

6.3Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:24months

Shelf-lifeafterfirstopeningtheimmediatepackaging:8hours

6.4Specialprecautionsforstorage:

Donotstoreabove25 o C.

Keeptheproductintheoutercontainerinordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging:

Colourlessglassvialsof10(or20)ml,withbromobutylrubberclosureandaluminiumcapsules

withFlip-offopeningringinPPofbluecolour.

Boxcontaining:

1x10mlvial

1x20mlvial

5x10mlvial

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

LABORATORIOSCALIER,S.A.

C/Barcelonès,26(PladelRamassà)

LESFRANQUESESDELVALLÈS,(Barcelona)

SPAIN

8.MARKETINGAUTHORISATIONNUMBER(S)

9.DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Underveterinaryprescription.

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

CARDBOARDCARTON

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Veterelin0.004mg/mlsolutionforinjectionforcattle,pigs,horsesandrabbits

Buserelin(asbuserelinacetate)

Veterelin4mikrog/mlsolutionforinjectionforcattle,pigs,horsesandrabbits(FI)

Buserelin(asbuserelinacetate)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance:

Buserelin.................................................................0.004mg/ml

(equivalentto0.0042mgofBuserelinacetate)

Excipient

Benzylalcohol...............................................................10mg/ml

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

10ml

20ml

5. TARGETSPECIES

Cattle(cows),horses(mares),rabbits(does)andpigs(gilts).

6. INDICATION(S)

Forcows:

-Ovulationinductionordelayedovulation

-Treatmentofanoestrus

-Treatmentoffollicularcystswithorwithoutsymptomsofnymphomania

-Improvementofconceptionrateinartificialinseminationprocedures,alsoafter

synchronisationofoestruswithaPGF2αanalogue.Resultsmayhowevervarydependingon

breedingconditions

Formares:

-Ovulationinductionandtherebytosynchroniseovulationmorecloselywithmatinginmares.

-Treatmentoffollicularcysts–withorwithoutsymptomsofnymphomania

Forrabbits:

Improvementofconceptionrateandovulationinductionatpostpartuminsemination.

Forpigs(Nulliparouscyclinggilts):

Ovulationinductionafteroestrussynchronizationwithananalogueofprogestagen(altrenogest)

inordertoperformasingleartificialinsemination.

7. METHODANDROUTE(S)OFADMINISTRATION

Preferablybyi.m.,buti.v.mayalsobeused.

Forcattle,horsesandrabbitss.c.mayalsobeused.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:zerodays

Milk:zerohours

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXPmonth/year

Oncebroached,/openedusewithin8hours.

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25

C.

Keeptheproductintheoutercontainerinordertoprotectfromlight.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LABORATORIOSCALIER,S.A.

C/Barcelonès,26(PladelRamassà)

LESFRANQUESESDELVALLÈS,(Barcelona)

SPAIN

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

VIAADHESIVELABELONBOTTLE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Veterelin4µg/mlsolutionforinjectionforcattle,pigs,horsesandrabbits

Buserelin(asbuserelinacetate)

Veterelin4mikrog/mlsolutionforinjectionforcattle,pigs,horsesandrabbits(FI)

Buserelin(asbuserelinacetate)

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Buserelin.................................................................0.004mg/ml

(equivalentto0.0042mgofBuserelinacetate)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

10ml

20ml

4. ROUTE(S)OFADMINISTRATION

Preferablybyi.m.,buti.v.mayalsobeused.

Forcattle,horsesandrabbitss.c.mayalsobeused.

Readthepackageleafletbeforeuse.

5. WITHDRAWALPERIOD

Meatandoffal:zerodays

Milk:zerohours

6. BATCHNUMBER

Batch

7. EXPIRYDATE

EXPmonth/year

Oncebroached,/opened,usewithin8hours.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B.PACKAGELEAFLET

PACKAGELEAFLET

Veterelin0.004mg/mlsolutionforinjectionforcattle,pigs,horsesandrabbits

Veterelin4mikrog/mlsolutionforinjectionforcattle,pigs,horsesandrabbits(FI)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturer:

LABORATORIOSCALIER,S.A.

C/Barcelonès,26(PladelRamassà)

LESFRANQUESESDELVALLÈS,(Barcelona)

SPAIN

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Veterelin0.004mg/mlsolutionforinjectionforcattle,pigs,horsesandrabbits

Buserelin(asbuserelinacetate)

Veterelin4mikrog/mlsolutionforinjectionforcattle,pigs,horsesandrabbits(FI)

Buserelin(asbuserelinacetate)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHER

INGREDIENT(S)

Eachmlofsolutionsforinjectioncontains:

Activesubstance:

Buserelinacetate...........................................................0.004mg

(equivalentto0.0042mgofBuserelinacetate)

Excipient

Benzylalcohol...................................................................10mg

4. INDICATION(S)

Forcows:

-Ovulationinductionordelayedovulation

-Treatmentofanoestrus

-Treatmentoffollicularcystswithorwithoutsymptomsofnymphomania

-Improvementofconceptionrateinartificialinseminationprocedures,alsoafter

synchronisationofoestruswithaPGF2αanalogue.Resultsmayhowevervarydependingon

breedingconditions

Formares:

-Ovulationinductionandtherebytosynchroniseovulationmorecloselywithmatinginmares.

-Treatmentoffollicularcysts–withorwithoutsymptomsofnymphomania

Forrabbits:

Improvementofconceptionrateandovulationinductionatpostpartuminsemination.

Forpigs(Nulliparouscyclinggilts):

Ovulationinductionafteroestrussynchronizationwithananalogueofprogestagen(altrenogest)

inordertoperformasingleartificialinsemination.

5. CONTRAINDICATIONS

Donotuseinanimalswithknownhypersensitivitytotheactiveingredientortotheexcipients.

6. ADVERSEREACTIONS

None.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cattle(cows),horses(mares),rabbits(does)andpigs(gilts).

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

ADMINISTRATION

Incattle,horsesandrabbits,thepreferredrouteofadministrationisintramuscularinjection

(i.m.),butitmayalsobeinjectedintravenously(i.v.)orsubcutaneously(s.c.).

Inpigs,thepreferredrouteofadministrationisintramuscularly(i.m.),butitmayalsobe

injectedintravenously(i.v.).

Species Indication µg

Buserelin

peranimal ml

Veterelin

4µg/mlper

animal

Cows Treatmentofanoestrus 20 5

Ovulationinduction 20 5

delayedovulation 10 2.5

Improvementofconceptionrateinartificial

inseminationprocedures,alsoaftersynchronisation

ofoestruswithaPGF2αanalogue.Resultsmay

howevervarydependingonbreedingconditions.

Foroestrussynchronisationincowsaccordingtoa10

dayfixedtimeinseminationregime,thebuserelin

shouldbeadministeredatday0followedby

PGF2alphatreatmentatday7,andasecondbuserelin

treatmentatday9accordingtothementioned

posology 10 2.5

Follicularcystswithorwithoutsymptomsof

nymphomania 20 5

Mares Treatmentoffollicularcysts-withorwithout

symptomsofnymphomania. 40 10

Ovulationinductionandtherebytosynchronize

ovulationmorecloselywithmatinginmares. 40 10

Gilts

Nulparous

cycling

gilts Ovulationinductionafteroestrussynchronization

withananalogueofprogestagen(altrenogest)in

ordertoperformasingleartificialinsemination.

Administrationshouldbedone115-120hoursafter

theendofsynchronizationwithaprogestagen.A

singleartificialinseminationshouldbeperformed30-

33hoursafterVETERELINadministration 10 2.5

Rabbits Improvementofconceptionrate 0.8 0.2

Ovulationinductionatpost-partuminsemination 0.8 0.2

Theproductshouldbeadministeredonce.

Thevialcanonlybebroachedamaximumof20times.

9. ADVICEONCORRECTADMINISTRATION

None.

10. WITHDRAWALPERIOD

Meatandoffal:zerodays

Milk:zerohours

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25ºC.

Keeptheproductintheoutercontainerinordertoprotectfromlight.

Donotuseaftertheexpirydatestatedonthelabel.

Oncebroached,usewithin8hours.

12. SPECIALWARNING(S)

Contraindications:

Donotuseinanimalswithknownhypersensitivitytotheactiveingredientortotheexcipients.

Specialprecautionsforuseinanimals

Gilts

Useoftheproductcontrarytotherecommendedprotocolsmayresultintheformationof

follicularcystswhichmaydetrimentallyaffectfertilityandprolificacy.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Avoideyeandskincontactwiththesolutionforinjection.Incaseofaccidentalcontact,rinse

thoroughlywithwater.Shouldskincontactwiththeproductoccur,washtheexposedarea

immediatelywithsoapandwater,asGnRHanaloguesmaybeabsorbedthroughtheskin.

Pregnantwomenshouldnotadministertheproduct,asbuserelinhasbeenshowntobe

foetotoxicinlaboratoryanimals.

Womenofchild-bearingageshouldadministertheproductwithcaution.

Whenadministeringtheproduct,careshouldbetakentoavoidaccidentalself-injectionby

ensuringthatanimalsaresuitablyrestrainedandtheapplicationneedleisshieldeduntilthe

momentofinjection.

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackage

leafletorthelabeltothephysician.Washhandsafteruse.

Useduringpregnancyandlactation

Theuseisnotrecommendedduringpregnancyorlactation.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Underveterinaryprescription.

Boxcontaining:

1x10mlvial

1x20mlvial

5x10mlvial

Notallpacksizesmaybemarketed.

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

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