Ketosol 100 mg/ ml Solution for Injection for Horses, Cattle and Pigs

Main information

  • Trade name:
  • Ketosol 100 mg/ ml Solution for Injection for Horses, Cattle and Pigs
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ketosol 100 mg/ml Solution for Injection for Horses, Cattle and Pigs
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ketoprofen
  • Therapeutic area:
  • Cattle, Horses, Pigs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0382/001
  • Authorization date:
  • 25-04-2012
  • EU code:
  • UK/V/0382/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:October2012

AN:00043/2011

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ketosol100mg/mlsolutionforinjectionforhorses,cattleandpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perml:

Activesubstance:

Ketoprofen 100mg

Excipients:

Benzylalcohol(E1519) 10mg

Forfulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,lightyellowsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Horses,cattle,pigs.

4.2 Indicationsforuse,specifyingthetargetspecies

Horses:

- thealleviationofinflammationandpainassociatedwithmusculoskeletal

disorders

- thealleviationofvisceralpainassociatedwithcolic.

Cattle:

- thesupportivetreatmentofparturientparesisassociatedwithcalving

- reducingthepyrexiaanddistressassociatedwithbacterialrespiratorydisease

whenusedinconjunctionwithanantimicrobialtherapyasappropriate

- improvingtherecoveryrateinacuteclinicalmastitis,includingacuteendotoxin

mastitis,causedbygramnegativemicroorganisms,inconjunctionwith

antimicrobialtherapy

- reducingoedemaoftheudderassociatedwithcalving.

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Pigs:

- reducingthepyrexiaandrespiratoryrateassociatedwithbacterialorviral

respiratorydiseasewhenusedinconjunctionwithantimicrobialtherapyas

appropriate

- thesupportivetreatmentofMastitisMetritisAgalactiaSyndromeinsows,in

conjunctionwithantimicrobialtherapyasappropriate.

4.3 Contraindications

Donotuseinhorses,cattleorpigsthathavepreviouslyshownahypersensitivityto

ketoprofen.

Donotadministerothernon-steroidalanti-inflammatorydrugs(NSAIDs)concurrently

orwithin24hoursofeachother.

Donotuseinanimalssufferingfromcardiac,hepaticorrenaldisease,wherethereis

thepossibilityofgastrointestinalulcerationorbleeding,wherethereisevidenceofa

blooddyscrasiaorhypersensitivitytothemedicinalproduct.

4.4 Specialwarningsforeachtargetspecies

None

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useinanyanimallessthan6weeksofageorinagedanimalsmayinvolve

additionalrisk.Ifsuchusecannotbeavoidedanimalsmayrequireareduceddosage

andcarefulmanagement.

Donotuseinfoalsundertheageof15days.

Avoiduseinanydehydrated,hypovolemicorhypotensiveanimalsasthereisa

potentialriskofincreasedrenaltoxicity.

Avoidintra-arterialinjection.

Donotexceedthestateddoseordurationoftreatment.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttotheanimals

Incaseofaccidentalself-injectionseekmedicaladviceandshowthepackageleaflet

orthelabeltothephysician.

Peoplewithknownhypersensitivitytotheactivesubstanceand/orbenzylalcohol

shouldavoidcontactwiththeproduct.

Avoidsplashesontheskinandeyes.Washtheaffectedareathoroughlywithwater

shouldthisoccur.Ifirritationpersistsseekmedicaladvice.

Washhandsafteruse.

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4.6 Adversereactions(frequencyandseriousness)

IncommonwithallNSAIDs,duetotheiractionofinhibitionofprostaglandin

synthesis,therecanbeapossibilityincertainindividualsofgastricorrenal

intolerance.

Allergicreactionsmayoccurveryrarely,inthiscasethetreatmentshouldbe

stopped.

Followingintramuscularinjection,localirritationattheinjectionsitecanbeseen.

4.7 Useduringpregnancy,lactationorlay

Thesafetyofketoprofenhasbeeninvestigatedinpregnantanimals(rats,rabbits)

andcattle.Ketoprofenshowednoteratogenicorembryotoxiceffects.However,in

theabsenceofspecificdatainpregnantmaresandsows,theuseoftheproductin

theseanimalsshouldbesubjecttoabenefit/riskassessmentbytheresponsible

veterinarian.

Itisindicatedforuseinlactatingsows.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

SomeNSAIDsmaybehighlyboundtoplasmaproteinsandcompetewithother

highlybounddrugswhichcanleadtotoxiceffects.

Concurrentadministrationwithnephrotoxicdrugsshouldbeavoided.

Concurrentadministrationofothersteroidalornon-steroidalanti-inflammatorydrugs,

diureticsoranticoagulantagentsmayleadtopotentiatingadverseeffects.A

treatmentfreeperiod,dependentontheproductadministered,shouldbeobserved

betweensuchtreatments.

4.9 Amountstobeadministeredandadministrationroute

Horse:intravenoususe

Foruseinmusculoskeletalconditions,therecommendeddosageis2.2mg

ketoprofen/kgofbodyweight,i.e.1mloftheproduct/45kgofbodyweight,

administeredbyintravenousinjectiononcedailyforupto3to5days.

Foruseinequinecolic,therecommendeddosageis2.2mgketoprofen/kgofbody

weight,i.e.1mloftheproduct/45kgofbodyweight,givenbyintravenousinjection

forimmediateeffect.

Onlyafterathoroughre-examinationasecondinjectionmaybegivenifcolicrecurs.

Cattle:intravenoususe,intramuscularuse

Therecommendeddosageis3mgketoprofen/kgofbodyweight,i.e.1mlofthe

product/33kgofbodyweight,administeredbyintravenousordeepintramuscular

injectiononcedailyforupto3days.

Pig:intramuscularuse

Therecommendeddosageis3mgketoprofen/kgofbodyweight,i.e.1mlofthe

product/33kgofbodyweight,administeredoncebydeepintramuscularinjection.

Donotadministermorethan10mlateachinjectionsite.

Thestoppercannotbepuncturedmorethan20times.

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noclinicalsignswereobservedwhenketoprofenwasadministeredtohorsesat5

timestherecommendeddosefor15days,tocattleat5timestherecommended

dosefor5days,ortopigsat3timestherecommendeddosefor3days.

4.11Withdrawalperiod(s)

Horses,cattleandpigsmustnotbeslaughteredforhumanconsumptionduring

treatment.Animalsmaybeslaughteredforhumanconsumptiononlyafterthe

followingperiodsfromthelasttreatment:

Cattle

meatandoffal:followingintravenousadministration-1day

followingintramuscularadministration-4days

milk:zerohours

Pigs(meatandoffal):4days

Horses(meatandoffal):1day

Nottobeusedinmaresproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

ATCVetcode:QM01AE03

Group:Antiinflammatoryandantirheumaticproducts,nonsteroidsofthegroupof

propionicacidderivatives

5.1 Pharmacodynamicproperties

Ketoprofenisaderivativeofphenylpropionicacid,andbelongstothenon-steroidal

anti-inflammatorygroupofdrugs.Likeallsuchsubstances,itsprincipal

pharmacologicalactionsareanti-inflammatory,analgesicandantipyretic.The

mechanismofactionisrelatedtotheabilityofketoprofentointerferewiththe

synthesisofprostaglandinsfromprecursorssuchasarachidonicacid.

Ketoprofeninhibitsthe biosynthesisofPGE2andPGF2αwithoutinfluencingthe

relationshipbetweenPGE2/PGF2αandthromboxanes.Eventhoughketoprofen

inhibitscyclooxygenase,thelysosomescellmembranesarestabilizedand

bradykinineffectantagonized.

5.2 Pharmacokineticparticulars

Ketoprofenisrapidlyabsorbedafterintramuscularadministration.Maximumplasma

concentrationisreachedwithin30to60minutes.Absolutebioavailabilityafter

intramuscularadministrationincattleandpigsis90-100%,inthehorse70%.The

volumeofdistributionandclearanceareapproximately0.17L/kgand0.3L/kg

respectively.Linearkineticsprevails.

Theplasmahalf-lifeafterintramuscularadministrationis2to3hours.Ketoprofen

binds95%toplasmaproteinsandismetabolisedbyreductiontothesecondary

alcohol.Itisexcretedrapidly;mainlyviatheurinei.e.80%ofthedoseadministered

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areeliminatedwithin12hours.Thereducedketoprofenmetaboliteprevailsincattle,

theglucuronidatedconjugateinhorses.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol(E1519)

L-arginine

Citricacidmonohydrate(forpHadjustment)

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:30months.

Shelflifeafterfirstopeningthevial:28days.

6.4. Specialprecautionsforstorage

Keepthevialintheoutercartoninordertoprotectfromlight.

6.5 Natureandcompositionofimmediatepackaging

50mland100mlamberglassvials(TypeII)withredchlorobutylrubberstopper,

coveredwithanaluminumcap.Thevialsarepackagedsinglyincarboardcartons.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

CP-PharmaGmbH

Ostlandring13

31303Burgdorf

Germany

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8. MARKETINGAUTHORISATIONNUMBER

Vm20916/4012

9. DATEOFFIRSTAUTHORISATION

24October2012

10. DATEOFREVISIONOFTHETEXT

October2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Administrationbyaveterinarysurgeonorundertheirdirectresponsibility.

Tobesuppliedonlyonveterinaryprescription.