Animeloxan 20 mg/ml solution for injection for cattle, pigs and horses

Main information

  • Trade name:
  • Animeloxan 20 mg/ml solution for injection for cattle, pigs and horses
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Animeloxan 20 mg/ml solution for injection for cattle, pigs and horses
    Austria
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0377/002
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0377/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:March2012

AN:00649/2010

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Animeloxan,20mg/ml,solutionforinjectionforcattle,pigsandhorses

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlsolutionforinjectioncontains:

Activesubstance:

Meloxicam 20mg

Excipients:

Ethanol,anhydrous 158.00mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

SolutionforInjection

Clear,yellowsolution

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle,pigandhorse

4.2Indicationsforuse,specifyingthetargetspecies

Cattle:

Foruseinacuterespiratoryinfectionwithappropriateantibiotictherapytoreduce

clinicalsignsincattle.

Foruseindiarrhoeaincombinationwithoralre-hydrationtherapytoreduceclinical

signsincalvesofoveroneweekofageandyoung,non-lactatingcattle.

Foradjunctivetherapyinthetreatmentofacutemastitis,incombinationwithantibiotic

therapy.

Pigs:

Foruseinnon-infectiouslocomotordisorderstoreducethesymptomsoflamenessand

inflammation.

Foradjunctivetherapyinthetreatmentofpuerperalsepticaemiaandtoxaemia(mastitis-

metritis-agalactiasyndrome)withappropriateantibiotictherapy

Horses:

Foruseinthealleviationofinflammationandreliefofpaininbothacuteandchronic

musculo-skeletaldisorders.

Forthereliefofpainassociatedwithequinecolic.

4.3Contraindications

Seealsosection4.7.

Donotuseinhorseslessthan6weeksofage.

Donotuseinanimalssufferingfromimpairedhepatic,cardiacorrenalfunctionand

haemorrhagicdisorders,orwherethereisevidenceofulcerogenicgastrointestinal

lesions.

Issued:March2012

AN:00649/2010

Page2of5

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Forthetreatmentofdiarrhoeaincattle,donotuseinanimalsoflessthanoneweekof

age.

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifadversereactionsoccur,treatmentshouldbediscontinuedandtheadviceofa

veterinarianshouldbesought.

Avoiduseinveryseverelydehydrated,hypovolaemicorhypotensiveanimalswhich

requireparenteralrehydration,astheremaybeapotentialriskofrenaltoxicity.

Incaseofinadequatereliefofpainwhenusedinthetreatmentofequinecolic,careful

re-evaluationofthediagnosisshouldbemadeasthiscouldindicatetheneedfor

surgicalintervention.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Accidentalself-injectionmaygiverisetopain.Peoplewithknownhypersensitivityto

NSAIDsshouldavoidcontactwiththeveterinarymedicinalproduct.

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

Ifaccidentalskincontactoccurs,washtheaffectedareathoroughly.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Incattle,asinglesubcutaneousinjectioncancauseanon-painfulswellingthatlastsupto

23days.Intravenousinjectionisgenerallywell-tolerated.

Inpigs,twoconsecutiveintramuscularinjectionshavealocalirritanteffectthatcanlast

upto9days.

Inhorses,atransientswellingattheinjectionsitecanoccurbutresolveswithout

intervention.

Inveryrarecasesanaphylactoidreactionsmayoccurandshouldbetreated

symptomatically.

4.7Useduringpregnancy,lactationorlay

Cattleandpigs:

Canbeusedduringpregnancyandlactation.

Horses:

Donotuseinpregnantorlactatingmares.

Donotuseinhorsesproducingmilkforhumanconsumption.

Seealsosection4.3.

Issued:March2012

AN:00649/2010

Page3of5

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotadministerconcurrentlywithglucocorticosteroids,othernon-steroidalanti-

inflammatorydrugsorwithanti-coagulantagents.

4.9Amountstobeadministeredandadministrationroute

Cattle:

Singlesubcutaneousorintravenousinjectionatadosageof0.5mgmeloxicam/kgbody

weight(i.e.2.5ml/100kgbodyweight)incombinationwithantibiotictherapyorwithoral

re-hydrationtherapy,asappropriate.

Pigs:

Singleintramuscularinjectionatadosageof0.4mgmeloxicam/kgbodyweight(i.e.2.0

ml/100kgbodyweight)incombinationwithantibiotictherapy,asappropriate.If

required,asecondadministrationofmeloxicamcanbegivenafter24hours.

Horses:

Singleintravenousinjectionatadosageof0.6mgmeloxicam/kgbodyweight(i.e.3.0

ml/100kgbodyweight).

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inthecaseofoverdosagesymptomatictreatmentshouldbeinitiated.

4.11Withdrawalperiod(s)

Cattle:

Meatandoffal: 15days

Milk: 5days

Pigs:

Meatandoffal: 8days

Horses:

Meatandoffal: 5days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinflammatoryandantirheumaticproducts,non-steroids

(oxicams)

ATCvetcode: QM01AC06

5.1Pharmacodynamicproperties

Meloxicamisanon-steroidalanti-inflammatorydrug(NSAID)oftheoxicamclasswhich

actsbyinhibitionofprostaglandinsynthesis,therebyexertinganti-inflammatory,

analgesic,anti-exudativeandantipyreticeffects.Itreducesleukocyteinfiltrationintothe

inflamedtissue.Toaminorextentitalsoinhibitscollagen-inducedthrombocyte

aggregation.Meloxicamalsohasanti-endotoxicpropertiesbecauseithasbeenshown

toinhibitproductionofthromboxaneB

inducedbyE.coliendotoxinadministrationin

calves,lactatingcowsandpigs.

Issued:March2012

AN:00649/2010

Page4of5

5.2Pharmacokineticparticulars

Absorption

Inpigs,maximumplasmaconcentrationsofmeloxicamwerereachedat1.0hpost

administrationof singleintramuscularadministrationof Animeloxan20mg/ml atadose

of0.4mgmeloxicam/kgbodyweight.

Incattle,maximumplasmaconcentrationsofmeloxicamwerereachedat6.8hpost

singlesubcutaneousadministrationofAnimeloxan20mg/mlatadoseof0.5mg

meloxicam/kgbodyweight.

Distribution

Morethan98%ofmeloxicamisboundtoplasmaproteins.Thehighestmeloxicam

concentrationsaretobefoundinliverandkidney.Comparativelylowconcentrationsare

detectableinskeletalmuscleandfat.

Metabolism

Meloxicamispredominantlyfoundinplasma.Incattle,meloxicamisalsoamajor

excretionproductinmilkandbilewhereasurinecontainsonlytracesoftheparent

compound.Inpigs,bileandurinecontainonlytracesoftheparentcompound.

Meloxicamismetabolisedtoanalcohol,anacidderivativeandtoseveralpolar

metabolites.Allmajormetaboliteshavebeenshowntobepharmacologicallyinactive.

Themetabolisminhorseshasnotbeeninvestigated.

Elimination

Inpigs, themeanterminalhalf-lifewascalculatedtobeapproximately3.2hfor

meloxicamfollowingintramuscularadministration.

Incattle,themeanterminalhalf-lifefollowingsubcutaneousadministrationwas

calculatedtobeapproximately14.0hformeloxicam.

Inhorses,afterintravenousinjectionmeloxicamiseliminatedwithaterminalhalf-lifeof

8.5hours.

Approximately50%oftheadministereddoseiseliminatedviaurineandtheremainder

viafaeces.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

N-Methyl2-Pyrrolidone

Ethanol,anhydrous

Sodiumhydroxide

Hydrochloricacid,dilute

Waterforinjection

6.2Incompatibilities

Noneknown.

Issued:March2012

AN:00649/2010

Page5of5

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging: 28days.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialtemperaturestorage

conditions.

6.5Natureandcompositionofimmediatepackaging

Clearglass(typeI)bottlesof50mland100ml,eachclosedwithbromobutylrubber

stoppersandfixedwithAluminium/PPflipcaps.

Availableincardboardboxescontaining:

1x50mlor12x50ml

1x100mlor12x100ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

aniMedicaGmbH

ImSuedfeld9

48308Senden-Boesensell

Germany

8. MARKETINGAUTHORISATIONNUMBER

Vm24745/4015

9. DATEOFFIRSTAUTHORISATION

28March2012

10.DATEOFREVISIONOFTHETEXT

March2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

22-6-2018

June 20, 2018: Fitchburg Woman and Saugus Man Sentenced for Roles in Counterfeit Steroid Conspiracy

June 20, 2018: Fitchburg Woman and Saugus Man Sentenced for Roles in Counterfeit Steroid Conspiracy

June 20, 2018: Fitchburg Woman and Saugus Man Sentenced for Roles in Counterfeit Steroid Conspiracy

FDA - U.S. Food and Drug Administration

2-5-2018

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

FDA - U.S. Food and Drug Administration

9-11-2011

Danish Pharmacovigilance Update, 20 October 2011

Danish Pharmacovigilance Update, 20 October 2011

In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.

Danish Medicines Agency

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration

20-7-2018

Agenda:  Agenda - CAT agenda of the 18-20 July 2018 meeting

Agenda: Agenda - CAT agenda of the 18-20 July 2018 meeting

Committee for Advanced Therapies (CAT) agenda for the meeting on 18-20 July 2018

Europe - EMA - European Medicines Agency

29-6-2018

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit  https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFriday pic.twitter.com/JWK672XtdI

FDA - U.S. Food and Drug Administration

20-6-2018

Rhiniseng (Laboratorios Hipra, S.A.)

Rhiniseng (Laboratorios Hipra, S.A.)

Rhiniseng (Active substance: inactivated vaccine against atrophic rhinitis in pigs) - Centralised - Yearly update - Commission Decision (2018)3952 of Wed, 20 Jun 2018

Europe -DG Health and Food Safety