SELGIAN

Main information

  • Trade name:
  • SELGIAN 8 KG
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SELGIAN 8 KG
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • selegiline
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0103/001
  • Authorization date:
  • 13-02-2012
  • EU code:
  • FR/V/0103/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Syncrostim500IUlyophilisateandsolventforsolutionforinjectionforcattleandsheep

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Lyophilisatevialscontains:

Activesubstance:

EquineserumGonadotrophin(eCG,formerlyknownasPMSG)...............500IU

Solventvialcontains:

Benzylalcohol.......................................................................................16.5mg/ml

Reconstitutedsolutionfor1doseof2mlcontains:

Activesubstances

EquineserumGonadotrophin(eCG,formerlyknownasPMSG) 500IU

Excipients

Benzylalcohol 33.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Lyophilisateandsolventforsolutionforinjection

Lyophilisate:freeze-driedproductintheformofpowderagglomeratedincotton-likepellets.

Solvent:clearcolourlesssolution.

Reconstitutedsolution:clearcolourlesssolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle,Sheep.

4.2 Indicationsforuse,specifyingthetargetspecies

Innoncyclingcattle(cowsandheifers)andinewesandewe-lambs:

Inductionandsynchronizationofoestrusandovulation.Tobeusedincombinationwithaprogestagen.

4.3 Contraindications

Seesection4.7.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

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Incaseofanaphylacticshock,symptomatic treatment(e.g.adrenalineorcorticosteroids)shouldbe

administered.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Careshouldbetakenwhenhandlingtheproducttoavoidself-injection.Incaseofaccidentalself-

injection,seekmedicaladvice,andshowthepackageleaflet.

Washhandsafterhandlingtheproduct.

StudiesinlaboratoryanimalsexhibitedteratogeniceffectsaftertheadministrationofeCG.Pregnant

women,thoseintendingtobecomepregnant,orwhosepregnancystatusisunknown,shouldnotusethe

product.

Accidentalspillageontheskinshouldbewashedoffimmediatelywithsoapandwater.

4.6 Adversereactions(frequencyandseriousness)

eCGisanexogenousproteinforspeciesotherthanequine.Therefore,antigen-antibodyreactionsmay

result.Inveryrarecases,repeatedadministrationsofeCGcanprovokeanaphylacticshock(see

section4.5).

4.7 Useduringpregnancy,lactationorlay

StudiesinlaboratoryanimalshaveshownteratogeniceffectsafteradministrationofeCG.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyandlactation.

Donotuseduringpregnancy

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Intramuscularuse.

500IUofEquineserumgonadotrophin(eCG)peranimalinoneadministrationcorrespondingto2mlof

thereconstitutedsolution.

Dissolvethelyophilisatewith2mlofsolvent.Mixuntilcompletelydissolvedtoobtainahomogenous

solution.

Thereconstitutedsolutionshouldbeusedimmediately.

Theproductshouldbeadministeredatthetimeoftheprogestagendevicewithdrawal.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Administrationofhigherdosesthanrecommendeddosesmayincreasetheriskoftwinsincattleand

tripletsinsheep.

4.11Withdrawalperiod(s)

Meatandoffal:zerodays

Milk:zerodays

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5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:gonadotropins

ATCvetcode:QG03GA03

5.1 Pharmacodynamicproperties

EquineSerumGonadotrophin(eCG,inthepastcalledPMSG)isalargeglycoproteinsecretedduring

pregnancyinthemareanditsstructureissimilartotheendogenousgonadotrophinhormones:FSHand

LH.

eCGexertsitseffectsonFSHandLHreceptorsoftargetcellsdistributedinthegonads:infemales,

eCGsupportstheovarianfollicularmaturationbystimulatingthegrowthanddevelopmentofantral

follicles.Inovineandinnon-cyclingbovinefemale,itsuseisrecommendedafteratreatmentforthe

synchronizationofœstruswithaprogestagen:eCGimprovesfolliclematurationandovulationrateand

allowssynchronizationofovulation.

5.2 Pharmacokineticparticulars

Inplasma,eCGdeclinesbiphasicallywithspeciesterminalhalf-livesof22-64hoursand118-220hours

asmeasuredinsheep(i.v.,i.m.)andcows(i.v.,i.m.)respectively.

eCGismainlydegradedinliverandkidneyandeliminatedintheurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lyophilisate:Mannitol.

Solvent:

Benzylalcohol.

Sodiumchloride.

Waterforinjections.

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:30months

Solvent:shelf-lifeafterfirstopeningthevial:28days.

Shelflifeafterreconstitutionaccordingtodirections:useimmediately.

6.4.Specialprecautionsforstorage

Lyophilisate:protectfromlight.

Storeinarefrigerator(2

C-8

C)

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6.5 Natureandcompositionofimmediatepackaging

Primarypackaging:

Lyophilisate:

ColourlessglassvialtypeIclosedwithachlorobutylstopperandaluminiumcapsule.

Solvent:

ColourlessglassvialtypeIIclosedwithachlorobutylstopperandaluminiumcapsule.

Packsizes:

Cardboardboxcontaining5vialsoflyophilisateandonevialof10mlsolvent

Cardboardboxcontaining10vialsoflyophilisateand2vialsof10mlsolvent

Cardboardboxcontaining25vialsoflyophilisateandonevialof50mlsolvent

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

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Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

3-7-2014

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Danish Medicines Agency

28-5-2014

More than 10,000 websites shut down in global operation

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Jakavi (Active substance: ruxolitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3272 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2464/T/35

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Perjeta (Roche Registration GmbH)

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EU/3/17/1876 (FGK Representative Service GmbH)

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EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

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