Bacivet S

Main information

  • Trade name:
  • Bacivet S
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bacivet S
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Bacitracin
  • Therapeutic area:
  • Rabbit

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0187/001
  • Authorization date:
  • 27-01-2010
  • EU code:
  • FR/V/0187/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BacivetS,4200IU/g,powderforuseindrinkingwater,rabbits[BE,CZ,DE,EL,ES,FR,HU,

IT,NL]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance: Bacitracinezinc 4200IU

Excipients: QSP 1g

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Powderforuseindrinkingwater

Whitetolightyellowfreeflowingpowder

4. CLINICALPARTICULARS

4.1. Targetspecies

Rabbitsforfattening

4.2 Indicationsforuse,specifyingthetargetspecies

Rabbitsforfattening:

Attheflocklevel:reductionofclinicalsignsandmortalityduetoepizooticenterocolitis

associatedwithinfectionscausedbyClostridiumperfringens,sensitivetobacitracin.

4.3 Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstancesortoanyofexcipients.

4.4 Specialwarnings

Beforeinstallingatreatment,themanagementandsanitaryconditionsatthefarmshouldbe

evaluatedagainsttheriskofanoutbreakofthedisease.Thetreatmentshouldbeinstalledifthere

isaknownhistoryofepizooticenterocolitisatthefarmandassoonasthefirstcaseofmortality

duetoenterocolitishasbeenconfirmed.

4.5. Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromthe

animal.Ifthisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)

epidemiologicalinformationaboutsusceptibilityofthetargetbacteria

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Bacitracincanoccasionallycausehypersensitivityreactionsafterinhalationorskincontact.Do

notmanipulatethisproductincaseofknownallergytobacitracinorwhenthepersonhas

receivedtherecommendationtoavoidworkingwiththispreparation.

Avoidinhalationofdustwhenincorporatingtheproduct,andtoavoidallcontactwithit,follow

therecommendationsforuse:itisrecommendedtowearamask,securityglasses,protection

glovesandprotectionclothing.

Afterpreparationandadministrationofthesolution,washhands.Incaseofskincontact,rinse

excessivelywithclearwater.

Incaseofobservationsofsymptomssuchasskineruptionsafterexposuretotheproductora

persistenteyeirritationincaseofprojection,consultamedicaldoctorandshowhimthis

precautiontext.Swellingoftheface,lipsoreyebrowsandbreathingdifficultiesareserioussigns

andneedurgentmedicalcare.

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttobacitracine

zincandmaydecreasetheeffectivenessoftreatmentwithotherclassesofantimicrobials,dueto

thepotentialforcrossresistance.

4.6. Adversereactions(frequencyandseriousness)

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

4.7 Useduringpregnancyandlactationorlay

Studiesinlaboratoryanimals(rats)didnotshowanyteratogenicorembryotoxiceffectsofzinc

bacitracinatatherapeuticdose.ThesafetyofBacivetSinpregnantorlactatingbreedingrabbits

hasnotbeendemonstrated.TheuseofBacivetSintheseanimalsisnotrecommended.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

420IUbacitracin/kgbodyweight/day,orallyadministeredviadrinkingwaterduring14days.

Thiscorrespondsto100mgpowderperkgbodyweightor1bagper1000kgbodyweightperday.

Starttreatmentoncethefirstcaseofmortalityduetoenterocolitishasbeenconfirmed.After

evaluationofthetherapeuticresponse,thedurationoftreatmentcanbeprolongedby7daysif

necessary.

Inordertofacilitateacorrectdosingitisadvisedtodilutethepowderfirstinastocksolution.

Sincethisconcentratedstocksolutionmightnotbestableitshouldimmediatelybefurtherdiluted

tothefinalconcentration.Toensureacorrectdosage,bodyweightshouldbedeterminedas

accuratelyaspossibletoavoidunderdosing.

Forexample:inordertoobtainafinaldilutionsuitableforanimalsconsuming150mlofwater

perkgbodyweightdaily,thefollowingschedulecanbeused:aconcentratedstocksolutionwith

13,5gBacivetSperliterisprepared,andthisisthenincorporatedaratoof5%inthefinal

drinkingwaterinordertoobtainaconcentrationof670mgofpowderperliterwater.The

preparationthencontainsapproximately100mgofbacitracinzincfor150ml.Thissolutionof

drinkingwaterisgivenadlibitumtotheanimals.Theintakeofmedicatedfeedandwaterdepends

ontheclinicalconditionoftheanimals.Inordertoobtainthecorrectdosage,theconcentrationof

theantimicrobialhastobeadjustedaccordingly.Forexample:

Waterconsumption

(%ofbodyweight) QuantityofBacivetStoincorporate

perliterofdrinkingwater

10% 1000mg

15% 670mg

20% 500mg

Anewsolutionshouldbeprepareddailyduringthetreatmentperiod.

4.10 Overdose(symptoms,emergencyprocedures,antidotes)

NoundesirableeffectshavebeenobservedafteradministrationofBacivetSat5timesthe

recommendeddoselevel.

4.11 Withdrawalperiod(s)

Meatandoffal:2days

5. PHARMACOLOGICALPROPERTIES

ATCVetCode:QA07AA93

Pharmacotherapeuticgroup:Antidiarrheals,intestinalanti-inflammatoryandanti-infectiveagents

5.1. Pharmacodynamicproperties

Bacitracinisapolypeptideantibioticandisamixtureofseveralcloselyrelatedpolypeptides.It

inhibitscellwallbiosynthesisbyinhibitinglipidpyrophosphatasewhichisinvolvedin

transmembranetransportofpeptidoglycanprecursors.Thezincsaltconfersstabilitytotheactive

substanceduringstorage.Bacitracinhasbactericidalproperties.Itsspectrumincludedprimarily

Gram-positivecocciandbacilli,particularlysomespeciesofClostridiae.TheMIC

valuesare1

µg/mlforClostridiumperfringens.Bacitracinhasatime-dependentbactericidalactivitytimeon

Clostridiumperfringenswithabactericidalconcentrationof2timestheMIC

.

MICvaluesof2µg/mlorlesshavebeenproposedasverysusceptibleandMICvaluesabove16

µg/mlasresistant.Resistanceisofthechromosomaltypeandisthereforeacquiredslowlyandnot

transferable.Therearenoknowncross-resistanceandco-resistance.ResistanceofClostridium

perfringensagainstbacitracinisconsideredtoberare.

5.2 Pharmacokineticparticulars

Afteroraladministrationofbacitracinadlibituminthedrinkingwateratadoselevelof420

IU/kg/day,theconcentrationsinthecaecalcontentwereabove2µg/mlduring24hours.

Bacitracinishardlyabsorbedafteroraladministrationinrabbits.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Citricacidanhydrous

Sodiumcitrate

Colloidalsilicaanhydrous

Lactosemonohydrate

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwith

otherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelflifeafterfirstopeningtheimmediatepackaging:useimmediately

Shelflifeafterdilutionorreconstitutionaccordingtodirections:24hours

6.4 Specialprecautionsforstorage

Donotstoreabove30°C.

6.5 Natureandcompositionofimmediatepackaging

Lowdensitypolyethylene/aluminium/polyesterbag.

Boxcontaining10bagsof100g.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORIZATIONHOLDER

AlpharmaBelgiumBVBA

Laarstraat16

B-2610Antwerp

Belgium

8. MARKETINGAUTHORIZATIONNUMBERS

9. DATEOFFIRSTAUTHORIZATION/RENEWALOFAUTHORIZATION

10. DATEOFREVISIONOFTHETEXT

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

21-5-2018

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity

FDA - U.S. Food and Drug Administration

18-5-2018

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.

FDA - U.S. Food and Drug Administration

6-7-2017

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

Danish Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

5-1-2017

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

12-6-2018

EU/3/17/1956 (Sangamo Therapeutics UK LTD)

EU/3/17/1956 (Sangamo Therapeutics UK LTD)

EU/3/17/1956 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene) - Transfer of orphan designation - Commission Decision (2018)3811 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/168/17/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene) - Transfer of orphan designation - Commission Decision (2018)3810 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/167/17/T/01

Europe -DG Health and Food Safety