ALTRESYN

Main information

  • Trade name:
  • ALTRESYN 4 mg/ml oral solution
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALTRESYN 4 mg/ml oral solution
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Altrenogest
  • Therapeutic area:
  • Pigs Females

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0198/001
  • Authorization date:
  • 23-02-2012
  • EU code:
  • FR/V/0198/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ALTRESYN4mg/mloralsolution

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains:

Activesubstance:

Altrenogest...........................................................................................4.00mg

Excipients:

Butylhydroxyanisole(E320)...................................................................0.07mg

Butylhydroxytoluène(E321)..................................................................0.07mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsolution.

Clear,paleyellow,odourlesssolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs(sexuallymaturegilts).

4.2 Indicationsforuse,specifyingthetargetspecies

Forthesynchronisationofoestrusinsexuallymaturegilts.

4.3 Contra-indications

Donotadministertoanimalssufferingfromuterineinfection.

Donotadministertomaleanimals.

Seesection4.7.

4.4 Specialwarningsforeachtargetspecies

None.

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4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Addtheveterinarymedicinalproducttothefeedimmediatelybeforefeeding.Discardanyuneaten

medicatedfeed

Touseonlyinsexuallymaturegiltswhohadalreadypresentedoneoestrus.

Partconsumedfeedmustbesafelydisposedofandnotgiventoanyotheranimal.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Directcontactwiththeskinshouldbeavoided.Personalprotectiveclothing(glovesandoveralls)mustbe

wornwhenhandlingtheproduct.

Porousglovesmayletthisproductpassthroughtotheskin.Iftheproductmakescontactwiththeskin

underneaththeglove,occlusivematerialssuchaslatexorrubberinglovesmayenhancetranscutaneous

absorptionoftheproduct.

Accidentalspillageontheskinoreyesshouldbewashedoffimmediatelywithplentyofwater.

Washhandsaftertreatmentandbeforemeals.

Pregnantwomenandwomenofchildbearingageshouldavoidcontactwiththeproductorshouldexercise

extremecautionwhenhandlingthisproduct.

Peoplesufferingfromprogesteronedependenttumours(knownorsuspected)orfromthromboembolic

disordersshouldnotusetheproduct.

Over-exposureeffects:Accidentalabsorptioncouldleadtodisruptionofthemenstrualcycle,uterineor

abdominalcramping,increasedordecreaseduterinebleeding,prolongationofpregnancyorheadache.

Directcontactwiththeskinshouldthereforebeavoided.

Incaseofover-exposure,seekmedicaladvice.

4.6 Adversereactions(frequencyandseriousness)

Ensurethecorrectdoseisadministereddailyasunder-dosingcanleadtotheformationofcysticfollicles.

4.7 Useduringpregnancy,lactationorlay

Donotuseinpregnantorlactatinganimals.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Fororaluseasatop-dressing.

20mgaltrenogest/animal,i.e.5mlperanimalonceadayfor18consecutivedays.

For540and1080mlpresentations:

TheproductshouldbeadministeredwiththeAltresyndoseronly.

Toprimethedoser:

- putthebottleinanhorizontalposition,thenozzleofthedoserdirectedup-wards

- slowlypressthetriggeruntiladroppearlsatthetipofthenozzle.

Then,thedoserdelivers5mldoseforeachcompleteactivationofthetrigger.Fortheregularadministration

holdthevialverticallyupside-down.Thedosershouldremainonthebottleforthewholeproductin-use

period,andthelocksystemshouldbeusedforanystoragebetweentreatments.

Forthe360mlpresentation:

Pressandreleasethemeteringpumptodeliverone5mldose.Donotshakebeforeusetoavoidmixingthe

solutionwiththenitrogenincludedinthepressurisedcontainer.

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Animalsshouldbesegregatedanddosedindividually.Addtheproductasatopdressingtothefeed.Addto

thesurfaceofthefeedimmediatelybeforefeeding.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noneknown.

4.11Withdrawalperiods

Meatandoffal:9days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Sexhormonesandmodulatorsofthegenitalsystem.

ATCvetcode:QG03DX90.

5.1 Pharmacodynamicproperties

Altrenogestisasyntheticprogestagenbelongingtothe19-nor-testosteronefamily.Thisprogestagenis

activebyoralroute.Altrenogestactsbydecreasingplasmaconcentrationsofendogenousgonadotrophin

hormones(LHandFSH).Lowgonadotrophinconcentrationsinducetheregressionoflargefollicles

(>5mm)anddonotallowthegrowthoffolliclesgreaterthan3mm,leadingthentoanabsenceofœstrus

andovulationduringtreatment.TheendoftreatmentisfollowedbyaregularincreaseinLHplasma

concentrationallowingfolliculargrowthandmaturation.Then,animalsreturntoheatinasynchronisedway.

5.2 Pharmacokineticparticulars

Altrenogestisrapidlyabsorbedfollowingoraladministration,withpeakplasmaconcentrationsbeing

reachedbetween1and4hoursaftertreatment.Altrenogestismainlymetabolisedintheliverandeliminated

bybiliaryexcretion.Halflifeofeliminationisestimatedtobearound14hours.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Butylhydroxyanisole(E320)

Butylhydroxytoluène(E321)

Soyabeanoil

Nitrogen

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging(for540and1080mlpresentations):2months.

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6.4.Specialprecautionsforstorage

360mlpressurizedcontainer:Protectfromsunlightanddonotexposetotemperaturesexceeding50°C.Do

notpierceorburn,evenafteruse.

540and1080ml:nospecialprecautionsforstorage.

6.5 Natureandcompositionofimmediatepackaging

Natureof360mlcontainer:

"Pressurisedaluminiumcontainerwithameteringpump."

Natureof540and1080mlcontainers:

Aluminiumcontainerclosedwithapolyethyleneplugandapolypropylenescrewcap.

Packagesize:

Cartonof1containerof360ml

Cartonof3containersof360ml

540mlcontainer

1080mlcontainer

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT