TIAMVET SOLUTION

Main information

  • Trade name:
  • TIAMVET SOLUTION
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TIAMVET SOLUTION
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • tiamulin
  • Therapeutic area:
  • Chicken, Pigs, Turkeys

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0166/001
  • Authorization date:
  • 01-06-2012
  • EU code:
  • FR/V/0166/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1/5 Dokument1

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

2/5 Dokument1

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

3/5 Dokument1

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

4/5 Dokument1

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)

5/5 Dokument1

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

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29-6-2018

#FDAInnovationChallenge https://twitter.com/HHSGov/status/1012707386061012994 …

#FDAInnovationChallenge https://twitter.com/HHSGov/status/1012707386061012994 …

#FDAInnovationChallenge https://twitter.com/HHSGov/status/1012707386061012994 …

FDA - U.S. Food and Drug Administration

29-6-2018

#FDAInnovationChallenge https://twitter.com/SGottliebFDA/status/1012725536626536448 …

#FDAInnovationChallenge https://twitter.com/SGottliebFDA/status/1012725536626536448 …

#FDAInnovationChallenge https://twitter.com/SGottliebFDA/status/1012725536626536448 …

FDA - U.S. Food and Drug Administration

27-6-2018

Cubicin (Merck Sharp and Dohme Limited)

Cubicin (Merck Sharp and Dohme Limited)

Cubicin (Active substance: Daptomycin) - PSUSA - Modification - Commission Decision (2018)4101 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/PSUSA/931/201709

Europe -DG Health and Food Safety

19-6-2018

Lusduna (Merck Sharp and Dohme B.V.)

Lusduna (Merck Sharp and Dohme B.V.)

Lusduna (Active substance: insulin glargine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3918 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4101/T/6

Europe -DG Health and Food Safety

6-6-2018

Truvada (Gilead Sciences Ireland UC)

Truvada (Gilead Sciences Ireland UC)

Truvada (Active substance: emtricitabine / tenofovir disoproxil fumarate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3690 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/594/T/148

Europe -DG Health and Food Safety

6-6-2018

Stribild (Gilead Sciences Ireland UC)

Stribild (Gilead Sciences Ireland UC)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3691 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/T/93

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Tecfidera (Biogen Idec Limited)

Tecfidera (Biogen Idec Limited)

Tecfidera (Active substance: Dimethyl fumarate) - Centralised - Yearly update - Commission Decision (2018)3458 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

29-5-2018

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)3397 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/02

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety