ALFAGLANDIN C 0.250 mg/ml solution for injection for cattle

Main information

  • Trade name:
  • ALFAGLANDIN C 0.250 mg/ml solution for injection for cattle
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALFAGLANDIN C 0.250 mg/ml solution for injection for cattle
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cloprostenol
  • Therapeutic area:
  • Cattle Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0146/001
  • Authorization date:
  • 24-03-2010
  • EU code:
  • NL/V/0146/001
  • Last update:
  • 09-08-2016

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

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ALFAGLANDINC0.250mg/mlsolutionforinjectionforcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perml:

Activesubstance:

Eachmlsolutioncontains0.250mgcloprostenol(ascloprostenolsodium)

Excipient(s):

Chlorocresol1mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle.

4.2 Indicationsforuse,specifyingthetargetspecies

Pyometra

Suboestrus

Oestrussynchronisation

Terminationofabnormalpregnancyincattleuptoday150ofthepregnancy(forabnormal

pregnancy)

Ovarianlutealcysts

Inductionofparturition

4.3 Contraindications

Donotadministertopregnantanimalsunlesstheobjectiveistoterminategestationortoinduce

parturition.

4.4 Specialwarningsforeachtargetspecies

Arefractoryperiodof4to5daysafterovulatinghastobetakenintoaccountduringwhichcattlewill

notbesensitivetotheluteolyticeffectsofprostaglandins.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Administerbyintramuscularinjectionobservingtheusualasepticprecautions.

Careshouldbetakentoavoidinjectionthroughwetordirtyareasofskin.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

- ProstaglandinsoftheF

2α typecanbeabsorbedthroughtheskinandmaycausebronchospasm

ormiscarriage.

- Directcontactwiththeskinoreyesmaycauseirritationandallergicreactions.

- Theproductshouldnotbeadministeredbypregnantwomenorwomenwhoareintendingto

becomepregnant.

- Peoplewithaknownhypersensitivitytocloprostenolorchlorocresolshouldavoidcontact

withtheveterinarymedicinalproduct.

- Thisproductcanbeabsorbedthroughtheskinandthereforecareshouldbetakenwhen

handlingtheproduct,especiallybywomenofchild-bearingpotential,asthmaticsandpeople

withbronchialandotherrespiratoryproblems.

- Avoiddirectcontactwiththeskinandeyes.

- Avoidaccidentalself-injection

- Weargloves.

- Accidentalspillageontheskinorintotheeyesshouldbewashedoffimmediatelywithplenty

ofwater.

- Incaseofaccidentalself-injectionorrespiratoryproblems,seekmedicaladviceimmediately

andshowthepackageleafletorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Localisedpost-injectionbacterialinfections,whichmaybecomegeneralised,areoccasionallyreported.

4.7 Useduringpregnancy,lactationorlay

Donotadministerduringpregnancy,iftheobjectiveisnottoinduceterminationofanabnormal

gestationortoinduceparturition.

Theproducthasnonegativeinfluenceonfertility.Nonegativeeffectsonoffspringhavebeen

reportedafterinseminationornaturalserviceaftertreatmentwithcloprostenol.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Simultaneoususeofoxytocinandcloprostenolincreasestheeffectoncontractilityofthemusculature

oftheuterus.

4.9 Amountstobeadministeredandadministrationroute

Byintramuscularinjection:0.5mg(2ml)cloprostenolperanimal.

Oestrussynchronisation:twoinjectionswith11daysinterval.

Terminationofabnormalpregnancy:betweenday5and150afterinsemination.

Inductionofparturition:within10daysbeforetheexpecteddateofparturition.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theproducthasawidesafetymargin.Thereisnoantidoteavailable.

4.11 Withdrawalperiod(s)

Milk:0days.

Meat:1day.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Prostaglandins

ATCvetcode:QG02AD90

5.1 Pharmacodynamicproperties

CloprostenolisasyntheticprostaglandinanaloguestructurallyrelatedtoProstaglandinF2α.

Itisapotentluteolyticagentforuseincattle.Cloprostenolcausesfunctionalandmorphological

regressionofthecorpusluteum(luteolysis)followedbyreturntooestrusandnormalovulation.

5.2 Pharmacokineticparticulars

Afterintramuscularinjectionsoftheproductincowsthefollowingpharmacokineticparameterswere

found:aCmaxat16min.andaT1/2of44min.Theseparametersindicatearapidabsorptionfromthe

injectionsiteandalsoarapidelimination.Afterintramuscularadministrationof0.5mgand10mg

(C14)cloprostenoltocowstheexcretionbyurinewas58%and56%ofthedosesrespectively.

Unchangedcloprostenolandtetranoracidwerethemainmetabolitesfoundintheurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumchloride

Sodiumcitrate

Citricacid

Chlorocresol

Sodiumhydroxide(forpHadjustment)

Waterforinjections

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

Incompatiblewithstrongacidic/alkalineproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4. Specialprecautionsforstorage

Protectfromlight.Donotfreeze.Protectfromfrost.

Storeinarefrigerator(2

C–8

C)afterfirstopeningtheimmediatepackaging.

6.4 Natureandcompositionofimmediatepackaging

Amberglass,20ml,typeIIvialwithbromobutylrubberstopperandaluminiumclosure.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

P.O.Box78

3440ABWoerden

TheNetherlands

Tel.:0031-348416945

Fax0031-348483676

e-mail:a lfasan@wxs.nl

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

LABELLINGANDPACKAGELEAFLET

A.LABELLING

>

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

POLYSTYRENEBOX

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ALFAGLANDINC0.250mg/mlsolutionforinjectionforcattle.

Cloprostenolsodium

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlsolutioncontains0.250mgcloprostenol(ascloprostenolsodium)

Excipient(s):chlorocresol1mg/ml

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

28vialsx20ml.

5. TARGETSPECIES

Cattle.

6. INDICATION(S)

Pyometra

Suboestrus

Oestrussynchronisation

Terminationofabnormalpregnancyincattleuptoday150ofthepregnancy(forabnormal

pregnancy)

Ovarianlutealcysts

Inductionofparturition

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscular.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Milk:0days.

Meat:1day.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

Administerbyintramuscularinjectionobservingtheusualasepticprecautions.

Careshouldbetakentoavoidinjectionthroughwetordirtyareasofskin.

UserWarnings

-ProstaglandinsoftheF

2α typecanbeabsorbedthroughtheskinandmaycausebronchospasmor

miscarriage.

-Directcontactwiththeskinoreyesmaycauseirritationandallergicreactions.

-Theproductshouldnotbeadministeredbypregnantwomenorwomenwhoareintendingtobecome

pregnant.

-Peoplewithaknownhypersensitivitytocloprostenolorchlorocresolshouldavoidcontactwiththe

veterinarymedicinalproduct.

-Thisproductcanbeabsorbedthroughtheskinandthereforecareshouldbetakenwhenhandlingthe

product,especiallybywomenofchild-bearingpotential,asthmaticsandpeoplewithbronchialand

otherrespiratoryproblems.

-Avoiddirectcontactwiththeskinandeyes.

-Avoidaccidentalself-injection

-Weargloves.

-Accidentalspillageontheskinorintotheeyesshouldbewashedoffimmediatelywithplentyof

water.

-Incaseofaccidentalself-injectionorrespiratoryproblems,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.

10. EXPIRYDATE

EXP{month/year}Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

11. SPECIALSTORAGECONDITIONS

Protectfromlight.Donotfreeze.Protectfromfrost.

Storeinarefrigerator(2

C–8

C)afterfirstopeningtheimmediatepackaging.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithnationalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription-

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

P.O.Box78

3440ABWoerden

TheNetherlands

Tel.:0031-348416945

Fax0031-348483676

e-mail: Alfasan@wxs.nl

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGINGUNITS

GLASSVIAL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ALFAGLANDINC0.250mg/mlsolutionforinjectionforcattle

Cloprostenolsodium

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Eachmlsolutioncontains0.250mgcloprostenol(ascloprostenolsodium)

Excipient(s):Chlorocresol1mg/ml

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

20mlsolutionforinjection

4. ROUTE(S)OFADMINISTRATION

Intramuscular.

5. WITHDRAWALPERIOD

Milk:0days.

Meat:1day.

6. BATCHNUMBER

Batch:

7. EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B.PACKAGELEAFLET

PACKAGELEAFLET

AlfaglandinC0.250mg/ml,solutionforinjectionforcattle

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE

Marketingauthorisationholderandmanufacturer

AlfasanNederlandBV

P.O.Box78

3440ABWoerden

TheNetherlands

Tel.:0031-348416945

Fax0031-348483676

e-mail: alfasan@wxs.nl

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AlfaglandinC0.250mg/ml,solutionforinjectionforcattle

Cloprostenolsodium

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlsolutioncontains0.250mgcloprostenol(ascloprostenolsodium).

Excipient(s):Chlorocresol1mg/ml

4. INDICATION(S)

Pyometra

Suboestrus

Oestrussynchronisation

Terminationofabnormalpregnancyincattleuptoday150ofthepregnancy(forabnormal

pregnancy)

Ovarianlutealcysts

Inductionofparturition

5. CONTRAINDICATIONS

Donotadministertopregnantanimalsunlesstheobjectiveistoterminateanabnormalgestationorto

induceparturition.

6. ADVERSEREACTIONS

Localisedpost-injectionbacterialinfections,whichmaybecomegeneralised,areoccasionallyreported.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cattle.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Byintramuscularinjection:0.5mg(2ml)cloprostenolperanimal.

Oestrussynchronisation:twoinjectionswith11daysinterval.

Terminationofabnormalpregnancy:betweenday5and150afterinsemination.

Inductionofparturition:within10daysbeforetheexpecteddateofparturition.

9. ADVICEONCORRECTADMINISTRATION

Weargloves.

10. WITHDRAWALPERIOD

Milk:0days.

Meat:1day.

11. SPECIALSTORAGEPRECAUTIONS

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Protectfromlight.Donotfreeze.Protectfromfrost.

Storeinarefrigerator(2

C–8

C)afterfirstopeningtheimmediatepackaging.

Donotuseaftertheexpirydatestatedonthelabel/carton.

Keepoutofthereachandsightofchildren.

12. SPECIALWARNING(S)

Donotmixwithanyotherveterinarymedicinalproduct.

Incompatiblewithstrongacidic/alkalineproducts.

Arefractoryperiodof4to5daysafterovulatinghastobetakenintoaccountduringwhichcattlewill

notbesensitivetotheluteolyticeffectsofprostaglandins.

Simultaneoususeofoxytocinandcloprostenolincreasestheeffectsoncontractilityofthemusculature

oftheuterus.

Donotadministertopregnantanimalsunlesstheobjectiveistoterminateanabnormalgestationorto

induceparturition.

Administerbyintramuscularinjectionobservingtheusualasepticprecautions.

Careshouldbetakentoavoidinjectionthroughwetordirtyareasofskin.

UserWarnings

-ProstaglandinsoftheF

2α typecanbeabsorbedthroughtheskinandmaycausebronchospasmor

miscarriage.

-Directcontactwiththeskinoreyesmaycauseirritationandallergicreactions.

-Theproductshouldnotbeadministeredbypregnantwomenorwomenwhoareintendingtobecome

pregnant.

-Peoplewithaknownhypersensitivitytocloprostenolorchlorocresolshouldavoidcontactwiththe

veterinarymedicinalproduct.

-Thisproductcanbeabsorbedthroughtheskinandthereforecareshouldbetakenwhenhandlingthe

product,especiallybywomenofchild-bearingpotential,asthmaticsandpeoplewithbronchialand

otherrespiratoryproblems.

-Avoiddirectcontactwiththeskinandeyes.

-Avoidaccidentalself-injection

-Weargloves.

-Accidentalspillageontheskinorintotheeyesshouldbewashedoffimmediatelywithplentyof

water.

-Incaseofaccidentalself-injectionorrespiratoryproblems,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithnationalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Packaging:polystyreneboxcontaining28x20mlvials.