HYPERSOL

Main information

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

Documents

Localization

  • Available in:
  • HYPERSOL
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • oxytetracycline
  • Therapeutic area:
  • Pigs, Rabbit

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0251/001
  • Authorization date:
  • 21-12-2012
  • EU code:
  • FR/V/0251/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

HYPERSOL500mg/gPowderforuseinDrinkingwater

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1gofproductcontains:

Activesubstance

Oxytetracycline(ashydrochloride) 500mg

Forthefulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

- Powderforuseindrinkingwater

- Yellowpowder

4. CLINICALPARTICULARS

4.1.Targetspecies

Chickens(broilers,breedinghens)andpigs.

4.2.Indicationsforuse,specifyingthetargetspecies

Inchickens(broilers,breedinghens)andpigs

Treatmentandpreventionatthegrouplevelofsepticaemia,respiratoryandgastrointestinalinfections

causedbybacteriasensitivetooxytetracycline,wherethepresenceofdiseaseinthegrouphasbeen

confirmed.

4.3.Contraindications

Donotuseincaseofhypersensitivitytooxytetracyclineoranyothersubstancefromtetracyclines

group.

Donotuseincasesofknownoxytetracyclineresistance.

4.4.Specialwarningsforeachtargetspecies

None.

4.5.Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Thispowdershouldbedissolvedinwater,beforeuse.

Useoftheproductshouldbebasedonsusceptibilitytestingofbacteriaisolatefromtheanimal.Ifnot

possible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformationabout

susceptibilityofthetargetbacteria.

Official,nationalandregionalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductis

used.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttotheoxytetracyclineandmaydecreasetheeffectivenessoftreatmentwith

tetracyclines,duetothepotentialforcross-resistance.

Prolongedorrepeateduseshouldbeavoidedasthesepractisescanenforcedevelopmentand

spreadofthebacterialresistance.ThisisparticularlylikelyinenterobacteriaandSalmonellaspp.,

manyofwhicharealreadyresistant.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldbecombinedwith

goodmanagementpractices,e.g.goodhygiene,properventilation,nooverstocking.

Extensiveresistancetooxytetracyclinehasbeenrecognisedinporcineandpoultryisolatesofstrains

formE.Coli,Salmonellaspp.,Campylobacterspp.,andEnterococcusspp.Theproductshouldonly

beusedwherecultureandsensivitytestinghavedemonstratedthatitislikelytobeeffective.

Sickanimalsmayhaveareducedappetiteandanaltereddrinkingpatternandshould,ifnecessary,

bemedicatedparenterally.

ii)Specialprecautionstobetakenbythepersonadministeringthemedicinalproductto

animals

Peoplewithknownhypersensitivitytotetracyclinesshouldavoidcontactwiththeveterinarymedicinal

product.

Avoidinhalingdustwhenhandlingtheproductuntilcompletesolubilisationinwater.Useinawell-

ventilatedareaawayfromdraughts.

Avoidcontactwithskinandeyes.

Personalprotectiveequipmentconsistingoflatexandnitrilegloves,eyeprotectiondustmask(eithera

disposalhalf-maskrespiratorconformingtoEuropeanStandardEN149oranon-disposablerespirator

toEuropeanStandardEN140withafiltertoEN143)andsuitableprotectiveclothingshouldbeworn

whenhandlingtheveterinarymedicinalproduct.Incaseofaccidentaleyeorskincontact,rinsethe

affectedareawithlargeamountsofcleanwater.Ifirritationoccurs,seekmedicaladviceimmediately

andshowthelabeltothephysician.

Swellingoftheface,lipsoreyes,ordifficultywithbreathingaremoreserioussymptomsandrequire

urgentmedicalattention.

Washhandsandcontaminatedskinimmediatelyafterhandlingtheproduct.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

iii)Otherprecautions

None.

4.6.Adversereactions(frequencyandseriousness)

Asforallothertetracyclines,sideeffectshavebeenobservedsuchasgastro-intestinaldisorderand

lessfrequently,allergicandphotosensitivityreactions.

4.7.Useduringpregnancy,lactationorlay

Laboratorystudiesinanimalshavenotproducedanyevidenceofembryotoxicityorteratogenic

effects.

Inmammals,oxytetracyclinepasstheplacentalbarrier,resultinginstainingofteethandslowfoetal

growth.

Tetracyclinesarefoundinbreastmilk.

Useonlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8.Interactionwithothermedicinalproductsandotherformsofinteraction

Divalentortrivalentcations(Mg,Fe,Al,Ca)maychelatewithtetracyclines.Thetetracylinesshould

notbeadministeredwithantacids,gelscontainingaluminium,preparationscontainingvitaminsor

mineralsasinsolublecomplexeswillbeformed,whichdecreasestheabsorptionoftheantibiotic.

4.9.Amount(s)tobeadministeredandadministrationroute

Theuptakeofmedicateddrinkingwaterdependsontheclinicalandphysiologicalconditionsofthe

animals.Inordertoobtainthecorrectdosage,theconcentrationofoxytetracyclinemustbeadjusted

bycalculatingtherequiredmeandailywaterconsumption.

Thedurationoftreatmentis3to5days,forbothchickensandpigs.

Dosingispresentedinthefollowingtable:

Species mgof

oxytetracycline/

kgof

bodyweight/day mgofORALPOWDER

/10kgofbodyweight/

day Estimatedwater

consumption

(L/kgof

bodyweight) mgofORAL

POWDER/Lof

drinkingwater

Pigs 20mg 400mg 1L/10kg 400mg

Chickens 20mg 400mg 1L/5 200mg

Basedontherecommendeddose,andthenumberandweightoftheanimalstobetreated,theexact

dailyamountofoxytetracyclineshouldbecalculatedaccordingtothefollowingformula:

mgoxytetracycline

/kgbodyweight/day

x Meanbodyweight

(kg)ofanimalstobe

treated

=mgoxytetracyclineperlitre

drinkingwater

Meandailywaterconsumption(L)peranimal

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.

Theuseofsuitabilitycalibratedweighingequipmentisrecommendedifpartpacksareused.Thedaily

amountistobeaddedtothedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.

Medicateddrinkingwatershouldbefreshlypreparedevery24hours.

Forfulladvantagesofsolubilityqualities,itisrecommendedtoprepareaconcentratedpre-solution –

approximately400gramsproductperlitredrinkingwater –andtodilutethisfurthertotherapeutic

concentrationsifrequired.Alternatively,theconcentratedsolutioncanbeusedinaproportionalwater

medicator.

4.10.Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noneknown

4.11.Withdrawalperiod

Meatandoffal:7days

Eggs: donotuseinlayingbirdsproducingeggsintendedforhumanconsumption

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,tetracycline

ATCvetcode:QJ01AA06.

5.1.Pharmacodynamicproperties

Theoxytetracyclinelinksreversiblytotheribosomalsubunit30Sreceptors,thisleadingtoablockage

oftheunionbetweenaminoacyl-tRNAtothesitecorrespondingtothemRNA-ribosomecomplex

messenger.

Itresultsinaninhibitionoftheproteinsynthesisandinhibitsbacterialgrowth.Themainlybacteriostatic

activityofoxytetracyclineinvolvesuptakeofthesubstanceintothebacterialcellwhichoccursbyboth

passiveandactivediffusions.Themainmechanismofresistanceisduetothepossiblepresenceofa

Rfactorresponsibleforadecreaseintheactivetransportofoxytetracycline.

Oxytetracyclineisabroad-spectrumantibiotic.ItismainlyactiveagainstGram-positiveandGram

negativebacteria,aerobicandanaerobic,aswellasagainstmycoplasma,theChlamydiaand

Rickettsiae.

Acquiredresistancetooxytetracyclinehasbeenreported.Thisresistanceisusuallyofplasmidorigin.

Cross-resistancetoothertetracyclinesispossible.Theprolongedorrepeateduseofoxytetracycline

aswellascontinuoustreatmentwithlowdosesofoxytetracyclinemayalsocauseincreased

resistancetootherantibioticsduetopotentialco-resistancewithotherantimicrobials

Fourresistancemechanismsacquiredbymicroorganismsagainsttetracyclinesingeneralhavebeen

reported:decreasedaccumulationoftetracyclines(decreasedpermeabilityofthebacterialcellwall

andactiveefflux),proteinprotectionofthebacterialribosome,enzymaticinactivationoftheantibiotic

andrRNAmutations(preventingthetetracyclinebindingribosome).

Rateofresistancetotetracycline(74%)onantibioticresistantSalmonellaentericaisolatesofanimal

originsourcedfromtheCzechRepublicwasobserved. (1)

(1)Havlickovaetal(2009)

5.2.Pharmacokineticparticulars

Theoralabsorptionofoxytetracyclineislow.Themeanvaluesoforalabsorptionofoxytetrayclineare

3-5%inpigsandca48%inturkeys.

Thisbioavailabilitycanbereducedinthepresenceoffoodinthestomachasoxytetracyclineleadsto

theformationofinsolublechelateswithdivalentortrivalentcations(Mg,Fe,Al,Ca).

Inpigs,theinfluenceoffoodisnegligibleonthebioavailabilityofoxytetracyclinewhichislessthan

5%.

Theoxytetracyclinebindsvariablytoplasmaproteinsaccordingtothespecies(75%)(Itsdistributionis

large.Theoxytetracyclinediffusesthroughoutthebody,thehighestconcentrationshavebeenfoundin

thekidneys,liver,spleenandlungs.Theoxytetracyclinecrossestheplacentalbarrier.

Oxytetracyclineisexcretedunchangedmainlyviaurine.Itisalsoexcretedviabilebutahigh

proportionofoxytetracyclineisreabsorbedbythesmallintestine(enterohepaticcycle).

6. PHARMACEUTICALPARTICULARS

6.1.Listofexcipients

Citricacid,anhydrous.

6.2.Incompatibilities

Inabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3.Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelflifeafterfirstopening:6months.

Shelflifeafterdissolutionindrinkingwater:24hours

6.4.Specialprecautionsforstorage

For5kgand10kgbags:Donotstoreabove25°C

For1kgjarand5kgbucket:Nospecialstorageconditionsarerequired.

6.5.Natureandcompositionofimmediatepackaging

- 1kgjar:Jarmadeofhighdensitypolyethylene(incontactwiththeveterinarymedicinal

product)withascrewcapmadeoflowdensitypolyethylene/aluminium/cardboard

operculum/polypropylene

- 5kgbucket:internalbagmadeoflowdensitypolyethylene(incontactwiththeveterinary

medicinalproduct)inabucketmadeofpolypropylene –covermadeofpolypropylene

- 5kgand10kgbags:Bagmadeoflowdensitypolyethylene(incontactwiththeveterinary

medicinalproduct)/paper/paper

Notallpacksizesmaybemarketed.

6.6.Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

QALIAN

34RUEJEANMONNET

ZONEINDUSTRIELLED'ETRICHE

49500SEGRE

FRANCE

8. MARKETINGAUTHORISATIONNUMBER(S)

FR/V/76274673/2010

1kgjar

Bucketofa5kgbag

5kbag

10kgbag

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

21/12/2012

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