Alizin

Main information

  • Trade name:
  • Alizin
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Alizin
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Dogs Females

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0187/001
  • Authorization date:
  • 18-05-2011
  • EU code:
  • UK/V/0187/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Page1of6

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Alizin30mg/mlSolutionforInjection

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlcontains:

-activesubstance

aglepristone………………………………….. 30 mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearyellowoilysolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs(bitches).

4.2 Indicationforuse,specifyingthetargetspecies

Pregnantbitches:inductionofabortionupto45daysaftermating.

4.3 Contra-indications

Donotuseindogswithimpairedhepaticorrenalfunction,indiabeticanimalsorin

dogsinpoorhealth.

Donotuseindogswitheithermanifestorlatenthypoadrenocorticism

(Addison’sdisease)orindogswithageneticpredispositionto

hypoadrenocorticism.

Donotuseindogswithknownhypersensitivitytoaglepristoneortheveterinary

medicinalproductexcipient.

4.4 Specialwarningsforeachtargetspecies

Rarecasesoflackofefficacy(>0.01%to<0.1%)havebeenreportedaspartofthe

pharmacovigilancesurvey.Toreducethepossibilityoflackofexpectedefficacy,

avoidtheuseofAlizinuntilaftertheendofoestrusandavoidnewmatingbeforethe

endofoestrus.

Inbitchesconfirmedpregnant,apartialabortionwasobservedin5%ofcasesin

fieldtrials.Athoroughclinicalexaminationisalwaysrecommendedinorderto

confirmthattheuteruscontentisfullyevacuated.Ideally,theexaminationshouldbe

Page2of6

conductedusingultrasound.Thisexaminationshouldbeperformed10daysafter

treatmentandatleast30daysaftermating.

Incaseofpartialabortionornoabortion,repeattreatmentmayberecommended

10daysaftertreatment,betweenday30andday45aftermating.Surgeryshould

alsobeconsidered.

4.5 Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Intheabsenceofavailabledata,theveterinarymedicinalproductshouldbeused

withcautionindogswithchronicobstructive-airwaydiseaseand/orcardiovascular

disease,particularlybacterialendocarditis.

Fatalitieshavebeenreportedsubsequenttooff-labeluseinseriouslyillbitcheswith

uterineinfections.Acausalassociationisdifficulttodeterminebutisunlikely.

Inupto50%ofbitches,matingmaynotbefollowedbypregnancy.Thepossibility

thatabitchmaythereforebetreatedunnecessarilyshouldbetakenintoaccountin

evaluatingtheproductrisk-benefitratio.

Bitchesthatremainpregnantdespitetreatmentshouldbemonitored,asviabililtyof

thepuppiesmaybecompromised.

Possiblelong-termeffectsoftreatmenthavenotbeenstudied.

Ownersshouldbeadvisedtoconsulttheirveterinarysurgeoniftheirdogshowsthe

followingsignsaftertreatmentwiththeveterinarymedicinalproduct:

- purulentorhaemorragicvaginaldischarge

- prolongedvaginaldischargelastingover3weeks.

(ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Nor-steroidsareusedinhumanstoinduceabortion.Accidentalinjectionmaybea

particularhazardtowomenwhoarepregnant,intendingtobecomepregnantor

whosepregnancystatusisunknown.Careshouldbetakenbytheveterinarysurgeon

whenhandlingtheproductandthepersonrestrainingthedogtoavoidaccidental

injection.Pregnantwomenshouldadministertheproductwithcaution.Thisisanoil-

basedproductthatmaycauseprolongedlocalreactionsatthesiteofinjection.In

caseofaccidentalinjection,seekurgentmedicaladviceandshowthedoctorthis

warning.

Womenofchild-bearingageshouldavoidcontactwiththeveterinarymedicinal

productorweardisposableplasticgloveswhenadministeringtheveterinary

medicinalproduct.

Page3of6

4.6 Adversereactions(frequencyandseriousness)

Inbitchestreatedafter20daysofgestation,abortionisaccompaniedbythe

physiologicalsignsofparturition:fetalexpulsion,vaginaldischarge,reducedappetite,

restlessnessandmammarycongestion.Infieldtrials,3.4%ofdogssufferedfrom

uterineinfections.Afterinducedabortionwiththeveterinarymedicinalproduct,an

earlyreturntooestrusisfrequentlyobserved(oestrus-oestrusintervalshortenedby

1to3months).

Sideeffectssuchasanorexia(25%),excitation(23%),depression(21%),vomiting

(2%)anddiarrhoea(13%)havebeenreportedfromfieldtrials.

Infieldtrials,theadministrationoftheveterinarymedicinalproductproducedpain

duringandshortlyafterinjectionin17%ofdogsandalocalinflammatoryreactionat

theinjectionsitein23%ofdogs.Thesizeandintensityofthisreactiondependedon

thevolumeoftheveterinarymedicinalproductwhichwasadministered.Oedema,

skinthickening,locallymph-nodeenlargementandulcerationmayoccur.Alllocal

reactionsarereversibleandwillusuallydisappearwithin28daysafterinjection.

Infieldtrials,administrationoftheveterinarymedicinalproductinduced

haematological/biochemicalchangesin4.5%ofdogs.Thesechangeswerealways

transientandreversible.Themodifiedhaematologicalparameterswereasfollows:

neutrophilia,neutropaenia,thrombocytosis,haematocritvariation,lymphocytosis,

lymphopaenia.

Themodified(elevated)biochemicalparameterswereasfollows:urea,creatinine,

chloride,potassium,sodium,ALT,ALP,AST.

Inrarecases(frequency>1/10000and<1/1000),ahypersensitivityreactionhas

been/canbeobserved.

4.7Useduringpregnancy,lactationorlay

Donotadministertopregnantbitchesunlessitisdesirabletoterminatethe

pregnancy.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Intheabsenceofavailabledata,ariskofdruginteractionbetweenaglepristoneand

ketoconazole,itraconazoleanderythromycinmayexist.

Asaglepristoneisananti-glucocorticoid,itmightreducetheeffectofglucocorticoid

treatment.

Possibleinteractionswithothermedicamentshavenotbeenstudied.

Page4of6

4.9 Amountstobeadministeredandadministrationroute

Administer10mgperkgofbodyweightofaglepristone,equivalentto0.33mlof

veterinarymedicinalproductperkgofbodyweight,twice,24hoursapart.

Weightofbitch3kg 6kg 9kg 12kg 24kg 30kg 42kg

Volumeof

product 1ml 2ml 3ml 4ml 8ml 10ml 14ml

Injectsubcutaneously(only).Severelocalreactionscanbeavoidediftheveterinary

medicinalproductisadministeredintothescruffoftheneck.Alightmassageofthe

injectionsiteisrecommended.

Inlargebitches,itisrecommendedthatamaximumof5mlisinjectedatanyone

site.

Thisproductdoesnotcontainanantimicrobialpreservative.Swabtheseptumbefore

removingeachdose.Useadry,sterileneedleandsyringe.

Followingadministrationoftheveterinarymedicinalproducttodogs,abortion(or

resorption)occurswithin7days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theadministrationof30mg/kg,i.e.3timestherecommendeddose,inbitches

showednoadverseeffects,exceptlocalinflammatoryreactions,relatedtothelarger

volumesinjected.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antiprogestogen.

ATCvetcode:QG03XB90.

Page5of6

5.1 Pharmacodynamicproperties

Aglepristoneisasyntheticsteroidcounteractingtheeffectofprogesteroneby

competingwiththishormoneattheleveloftheuterinereceptors,resultingin

abortion(orresorption)within7daysafteradministration.

Aglepristonedoesnotmodifyprogesterone,prostaglandins,oxytocinorcortisol

plasmaconcentrationwithin24hoursafteritsadministrationbutitinducesa

dischargeofprolactinwithin12hours.

Invitro,theaffinityofaglepristonefortheprogesteronereceptorsintheuterusofthe

dogis3timeshigherthanthatofprogesterone.

Therelativebindingaffinityofaglepristonetoglucocorticoidreceptorsissimilarto

thatofdexamethasonebutaglepristonehasantagonisticproperties.

5.2 Pharmacokineticparticulars

After2injectionsof10mg/kg/dayata24-hourinterval,themaximalconcentration

(about280ng/ml)isreachedafter2.5days.Themeanresidencetimeisaround

6days:thisperiodincludesthemeanabsorptiontimefromtheinjectionsite.

Afteradministrationofa10mg/kgradio-labelleddose,theexcretionofradioactivityis

veryslow.Only60%oftheadministereddoseisexcretedduringthefirst10days

andaround80%over24days.

Excretionisessentiallyviathefaeces(around90%).

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

- Anhydrousethanol

- Refinedarachisoil.

6.2Incompatibilities

Noneknown.

Donotmixwithotherveterinarymedicalproducts.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelflifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Keepthevialintheoutercartoninordertoprotectfromlight.

Shouldanyapparentgrowthordiscolorationoccur,theproductshouldbediscarded.

Page6of6

6.5Natureandcompositionofimmediatepackaging

Vials(glass,typeII)of5ml,10mlor30mlforinjectablepreparationswith

bromobutylstoppersandaluminiumcaps.

Presentations:

- boxof1vialof5ml,10ml,30ml

- boxof10vialsof10ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETING-AUTHORISATIONHOLDER

VirbacS.A.

ère avenue –2065m-L.I.D.–

06516CarrosCedex

France

8. MARKETING-AUTHORISATIONNUMBER

Vm05653/4108

9. RENEWALOFTHEAUTHORISATION

26/11/2008

10 DATEOFREVISIONOFTHETEXT

14/12/2009

14-11-2018

“Vita-X Revitalizing Capsules” for men may pose serious health risks

“Vita-X Revitalizing Capsules” for men may pose serious health risks

Health Canada is advising Canadians that two versions of “Vita-X Revitalizing Capsules” by Lanlay Healthmetic Inc., promoted for “long lasting vital energy for men,” may pose serious health risks. One version contains seven capsules and has “NPN 80053009,” a Natural Product Number (NPN) indicating Health Canada authorization, on the label. The second version contains one capsule, has no NPN on the label and is not authorized by Health Canada.

Health Canada

There are no news related to this product.