VETERELIN

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
    Ireland
  • 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.

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EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

29-5-2018

Osurnia (Elanco Europe Ltd)

Osurnia (Elanco Europe Ltd)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Yearly update - Commission Decision (2018)3406 of Tue, 29 May 2018

Europe -DG Health and Food Safety

17-4-2018

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Active substance: Ornithine phenylacetate) - Transfer of orphan designation - Commission Decision (2018)2355 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/105/11/T/03

Europe -DG Health and Food Safety