Acticarp 50 mg/ml solution for injection for dogs and cats

Main information

  • Trade name:
  • Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen
  • Pharmaceutical form:
  • solution for injection or infusion
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • carprofen
  • Therapeutic area:
  • Cats Non Food, Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0170/001
  • Authorization date:
  • 17-08-2012
  • EU code:
  • NL/V/0170/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

PART1 B1 SUMMARYOFPRODUCTCHARACTERISTICS(SPC)

SPCfor‘ActicarpSA50mg/mlSolutionforinjectionfordogsandcats’presentedin

subsequentpages,

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AT:ActicarpSA50 mg/mlInjektionslösungfürHundeundKatzen

BE:ActicarpSA50 mg/mlOplossingvoorinjectievoorhondenenkatten

CZ:ActicarpSA50 mg/mlInjekčníroztokpropsyakočky

DE:ActicarpSA50 mg/mlInjektionslösungfürHundeundKatzen

LU:ActicarpSA50 mg/mlSolutioninjectablepourchiensetchats

NL:ActicarpSA50 mg/mlOplossingvoorinjectievoorhondenenkatten

PT:ActicarpSA50mg/mlSoluçãoinjectávelparacãesegatos

SK:ActicarpSA50 mg/mlInjekĉnýroztokprepsovamačky

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Carprofen 50mg

Excipients:

Benzylalcohol 10 mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Aclearpaleyellowto yellowishsolutionforinjection.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogsandcats(catsasfromtheageof5months).

4.2Indicationsforuse, specifyingthetargetspecies

Dogs: Forthereductionofpost-operativepainandinflammationfollowing

orthopaedicandsofttissue(includingintra-ocular)surgery.

Cats: Forthecontrolofpost-operativepainaftersmallsurgicalprocedures

4.3Contraindications

Donotuseinanimalssufferingfromcardiac,hepaticorrenaldiseaseorgastrointestinal

problems,wherethereisapossibilityofgastrointestinalulcerationorbleeding,or

hypersensitivitytocarprofenoranyotherNSAIDsoranyexcipientsofthisproduct.As

withotherNSAIDsthereisariskofrarerenaloridiosyncratichepaticadverseevents.

Donotadministerbyintramuscularinjection.

Donotuseaftersurgerywhichwasassociatedwithconsiderablebloodloss.

Donotuseincatsonrepeatedoccasions.

Donotuseincatslessthan5 monthsofage.

Donotuseindogslessthan10 weeksofage.

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Donotexceedtherecommendeddoseordurationoftreatment.

Useinageddogsandcats,mayinvolveadditionalrisk.Ifsuchusecannotbeavoided,

suchanimalsmayrequireareduceddosageandcarefulclinicalmanagement.

Avoiduseindehydrated,hypovolaemicorhypotensiveanimals,asthereisapotential

riskofincreasedrenaltoxicity.Concurrentadministrationofpotentiallynephrotoxic

drugsshouldbeavoided.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatmentof

inflammatoryconditionsassociatedwithbacterialinfection,appropriateconcurrent

antimicrobialtherapyshouldbeinstigated.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproductto animals

Carprofen,incommonwithotherNSAIDs,hasbeenshowntoexhibitphotosensitising

potentialinlaboratorystudies.Avoidskincontactwiththeproduct.Shouldthisoccur,

washtheaffectedareasimmediately.

Careshouldbetakentoavoidaccidentalself-injection.Incaseofaccidentalinjection,

seek medicaladviceimmediatelyandshowthepackageleafletto thephysician.

4.6Adversereactions(frequencyandseriousness)

TypicalundesirableeffectsassociatedwithNSAIDssuchasvomiting,soft

faeces/diarrhoea,faecaloccultblood,lossofappetiteandlethargyhavebeenreported.

Theseadversereactionsoccurgenerallywithinthefirsttreatmentweekandareinmost

casestransientanddisappearfollowingterminationofthetreatmentbutinveryrare

casesmaybeseriousorfatal.

Ifadversereactionsoccur,useoftheproductshouldbestoppedandtheadviceofa

veterinarianshouldbesought.

AswithotherNSAIDsthereisariskofrarerenaloridiosyncratichepaticadverse

events.

Occasionallyreactionsattheinjectionsitemaybeobservedfollowingsubcutaneous

injection.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinlaboratoryanimals(rat,rabbit)haveshownevidenceoffoetotoxic

effectsofcarprofenatdosesclosetothetherapeuticdose.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation.Do notuseindogsorcatsduringpregnancyorlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Carprofenshouldnotbeadministeredconcurrently,orwithin24hoursofanother

NSAID,orinconjunctionwithglucocorticosteroids.SomeNSAIDshighlybindto

plasmaproteinsandarecompetitivetoothersubstanceswhichbindthesameproteins.

Thelattermayresultintoxiceffects.Hence,concurrentadministrationwithpotentially

nephrotoxicsubstancesshouldbeavoided.

4.9Amountstobeadministeredandadministrationroute

Dogs:Therecommendeddosageis4mg/kgbodyweight(1ml/12.5kgbodyweight)by

intravenousorsubcutaneousinjection,bestgivenpre-operatively,eitheratthetimeof

premedicationorinductionofanaesthesia.

Cats:Therecommendeddosageis4mg/kgbodyweight(0.08ml/kgbodyweight)by

intravenousorsubcutaneousinjection,bestgivenpre-operatively,eitheratthetimeof

premedicationorinductionofanaesthesia.

Duetothelongerhalflifeincatsandnarrowertherapeuticindexparticularcareshould

betakennottoexceedtherecommendeddoseandnottorepeattheadministration.The

useofa1 mlgraduatedsyringeisrecommendedtomeasurethedoseaccurately.

Thestoppercanbepuncturedsafelyupto 24 times.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdose,nootheradversereactionsthanthosementionedinsection4.6are

expected.

Thereisnospecificantidoteforcarprofenoverdosagebutgeneralsupportivetherapy,as

appliedtoclinicaloverdosagewithNSAID’s,shouldbeapplied.

4.11Withdrawalperiod(s)

Notapplicable

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiflammatoryandantirheumaticproducts,nonsteroids,

propionicacidderivates

ATCvetcode:QM01AE91

5.1Pharmacodynamicproperties

Carprofenisamemberofthe2-arylpropionicacidgroupofnon-steroidalanti-

inflammatorydrugs(NSAIDs),andpossessesanti-inflammatory,analgesicand

antipyreticactivity.

Carprofen,likemostotherNSAIDsisaninhibitoroftheenzymecyclo-oxygenaseof

thearachidonicacidcascade.However,theinhibitionofprostaglandinsynthesisby

carprofenisslightinrelationtoitsanti-inflammatoryandanalgesicpotency.At

therapeuticdosesinthedogandcat,inhibitionoftheproductsofcyclo-oxygenase

(prostaglandinsandthromboxanes)orlipoxygenase(leucotrienes)hasbeenabsentor

slight.

5.2Pharmacokineticparticulars

Theabsorptionisrapidandcomplete.

Followingasinglesubcutaneousdoseof4mgcarprofen/kgthemaximumplasma

concentration(Cmax)of16μg/mlwasreachedafter(Tmax)approximately4.5hoursin

dogsand26μg/mlafterapproximately3.4 hoursincats.

Thevolumeofdistributionissmall.Carprofenishighlyproteinbound.

Thebioavailabilityis85%indogsandmorethan90%incats.

Carprofenhasaplasmaeliminationhalf-lifeof10 hoursindogsand20 hoursincats.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

L-Arginine

Glycocholicacid

Soyphosphtidylcholine(Lecithin)

Benzylalcohol

Sodiumhydroxide

Hydrochloricacid

WaterforInjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2 years

Shelf-lifeafterfirstopeningoftheimmediatepackaging:28 days

6.4.Specialprecautionsforstorage

Storeinarefrigerator(2to 8 °C). Donotfreeze.

Oncebroached,theproductisstableattemperaturesupto25 °Cfor28 days.

6.5Natureandcompositionofimmediatepackaging

20mlTypeImoldedamberglassvialclosedwithFluorotecPlusrubberstopperand

aluminiumflipoffyellowseal,packed inacardboardbox.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal/national

requirements.

7. MARKETINGAUTHORISATIONHOLDER

EcupharNV

Legeweg157-i

8020 Oostkamp

Belgium

8. MARKETINGAUTHORISATIONNUMBER

9. DATEOFTHEFIRSTAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

Proposalforlabelling

Englishlabelling

-Enclosed-

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

CardboardBox

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AT:ActicarpSA50 mg/mlInjektionslösungfürHundeundKatzen

BE:ActicarpSA50 mg/mlOplossingvoorinjectievoorhondenenkatten

CZ:ActicarpSA50 mg/mlInjekčníroztokpropsyakočky

DE:ActicarpSA50 mg/mlInjektionslösungfürHundeundKatzen

LU:ActicarpSA50 mg/mlSolutioninjectablepourchiensetchats

NL:ActicarpSA50 mg/mlOplossingvoorinjectievoorhondenenkatten

PT:ActicarpSA50 mg/mlSoluçãoinjectávelparacãesegatos

SK:ActicarpSA50 mg/mlInjekĉnýroztokprepsovamačky

Carprofen

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1 mlsolutionforinjectioncontains50 mgCarprofenandBenzylalcohol

3. PHARMACEUTICALFORM

SolutionforInjection

4. PACKAGESIZE

1 vialof20 ml

5. TARGETSPECIES

Dogsandcats(catsasfromtheageof5 months)

6. INDICATION(S)

Dogs: Forthereductionofpost-operativepainandinflammationfollowingorthopaedic

andsofttissue(includingintra-ocular)surgery.

Cats:Forthecontrolofpost-operativepainaftersmallsurgicalprocedures

7. METHODANDROUTE(S)OFADMINISTRATION

Dogs:4mg/kgbodyweight(1 ml/12.5kg)

Cats:4 mg/kgbodyweight(0.08 ml/kg)

Forintravenousorsubcutaneousinjection,preferablygivenpre-operatively,eitheratthetime

ofpremedicationorinductionofanaesthesia.

8. WITHDRAWALPERIOD

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP

Oncebroached,usewithin28 days.

11.SPECIALSTORAGECONDITIONS

Storeinarefrigerator(2to 8 °C). Donotfreeze.

Oncebroached,theproductisstableattemperaturesupto25 °Cfor28 days.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocal/nationalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EcupharNV

Legeweg157-i

8020 Oostkamp

Belgium

16.MARKETINGAUTHORISATIONNUMBER(S)

17.MANUFACTURER’SBATCHNUMBER

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

VialLabel

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AT:ActicarpSA50 mg/mlInjektionslösungfürHundeundKatzen

BE:ActicarpSA50 mg/mlOplossingvoorinjectievoorhondenenkatten

CZ:ActicarpSA50 mg/mlInjekčníroztokpropsyakočky

DE:ActicarpSA50 mg/mlInjektionslösungfürHundeundKatzen

LU:ActicarpSA50 mg/mlSolutioninjectablepourchiensetchats

NL:ActicarpSA50 mg/mlOplossingvoorinjectievoorhondenenkatten

PT:ActicarpSA50 mg/mlSoluçãoinjectávelparacãesegatos

SK:ActicarpSA50 mg/mlInjekĉnýroztokprepsovamačky

Carprofen

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Carprofen:50 mg/ml

Benzylalcohol

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

20 ml

4. ROUTE(S)OFADMINISTRATION

Dogs/cats:4mg/kgIVorSC

5. WITHDRAWALPERIOD

6. BATCHNUMBER

Lot:

7. EXPIRYDATE

EXP

Oncebroached,usewithin28 days

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

Proposalforpackageinsert

EnglishPIL

-Enclosed–

PACKAGELEAFLET

AT:ActicarpSA50 mg/mlInjektionslösungfürHundeundKatzen

BE:ActicarpSA50 mg/mlOplossingvoorinjectievoorhondenenkatten

CZ:ActicarpSA50 mg/mlInjekčníroztokpropsyakočky

DE:ActicarpSA50 mg/mlInjektionslösungfürHundeundKatzen

LU:ActicarpSA50 mg/mlSolutioninjectablepourchiensetchats

NL:ActicarpSA50 mg/mlOplossingvoorinjectievoorhondenenkatten

PT:ActicarpSA50 mg/mlSoluçãoinjectávelparacãesegatos

SK:ActicarpSA50 mg/mlInjekĉnýroztokprepsovamačky

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

MarketingAuthorizationHolder:

EcupharNV

Legeweg157-i

8020 Oostkamp

Belgium

Manufacturingauthorizationholderresponsibleforbatchrelease:

EcupharNV

Legeweg157-i

8020 Oostkamp

Belgium

or

AccordHealthcareLimited

SageHouse

319, PinnerRoad

NorthHarrow

MiddlesexHA14HF

UnitedKingdom

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AT:ActicarpSA50 mg/mlInjektionslösungfürHundeundKatzen

BE:ActicarpSA50 mg/mlOplossingvoorinjectievoorhondenenkatten

CZ:ActicarpSA50 mg/mlInjekčníroztokpropsyakočky

DE:ActicarpSA50 mg/mlInjektionslösungfürHundeundKatzen

LU:ActicarpSA50 mg/mlSolutioninjectablepourchiensetchats

NL:ActicarpSA50 mg/mlOplossingvoorinjectievoorhondenenkatten

PT:ActicarpSA50 mg/mlSoluçãoinjectávelparacãesegatos

SK:ActicarpSA50 mg/mlInjekĉnýroztokprepsovamačky

Carprofen

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHER

INGREDIENT(S)

Permlsolutionforinjection:

Activesubstance:

Carprofen 50 mg

Excipients:

Benzylalcohol

4. INDICATION(S)

Dogs: Forthereductionofpost-operativepainandinflammationfollowingorthopaedic

andsofttissue(includingintra-ocular)surgery.

Cats: Forthecontrolofpost-operativepainaftersmallsurgicalprocedures.

5. CONTRAINDICATIONS

Donotuseinanimalssufferingfromcardiac,hepaticorrenaldiseaseorgastrointestinal

problems,wherethereisapossibilityofgastrointestinalulcerationorbleeding,or

hypersensitivitytocarprofenoranyotherNSAIDsoranyexcipientsofthisproduct.Aswith

otherNSAIDsthereisariskofrarerenaloridiosyncratichepaticadverseevents.

Donotadministerbyintramuscularinjection.

Donotuseaftersurgerywhichwasassociatedwithconsiderablebloodloss.

Donotuseincatsonrepeatedoccasions.

Donotuseincatslessthan5 monthsofage.

Donotuseindogslessthan10 weeksofage.

6. ADVERSEREACTIONS

TypicalundesirableeffectsassociatedwithNSAIDssuchasvomiting,softfaeces/diarrhoea,

faecaloccultblood,lossofappetiteandlethargyhavebeenreported.Theseadversereactions

occurgenerallywithinthefirsttreatmentweekandareinmostcasestransientanddisappear

followingterminationofthetreatmentbutinveryrarecasesmaybeseriousorfatal.

Ifadversereactionsoccur,useoftheproductshouldbestoppedandtheadviceofa

veterinarianshouldbesought.

AswithotherNSAIDsthereisariskofrarerenaloridiosyncratichepaticadverseevents.

Occasionallyreactionsattheinjectionsitemaybeobservedfollowingsubcutaneousinjection.

7. TARGETSPECIES

Dogsandcats(catsasfromtheageof5months).

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Theproductshouldbegivenasasinglesubcutaneousorintravenousinjection.

Dosage:

Dogs:4 mg/kgbodyweight(1 ml/12.5kgbodyweight)

Cats:4 mg/kgbodyweight(0.08ml/kgbodyweight)

Duetothelongerhalflifeincatsandnarrowertherapeuticindexparticularcareshouldbe

takennottoexceedtherecommendeddoseandnottorepeattheadministration.

9. ADVICEONCORRECTADMINISTRATION

Theproductshouldbestbegivenpre-operatively,eitheratthetimeofpremedicationor

inductionofanaesthesia.

Theuseofa1 mlgraduatedsyringeisrecommendedtomeasurethedoseaccurately.

Thestoppercanbepuncturedsafelyupto 24 times.

10.WITHDRAWALPERIOD

Notapplicable.

11.SPECIALSTORAGEPRECAUTIONS

Storeinarefrigerator(2to 8 °C). Donotfreeze.

Oncebroached,theproductisstableattemperaturesupto25 °Cfor28 days.

Keep outofreachandsightofchildren.

Donotuseaftertheexpirydatestatedontheoutercartonandimmediatelabel.

12.SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Donotexceedtherecommendeddoseordurationoftreatment.

Useinageddogsandcats,mayinvolveadditionalrisk.Ifsuchusecannotbeavoided,such

animalsmayrequireareduceddosageandcarefulclinicalmanagement.

Avoiduseindehydrated,hypovolaemicorhypotensiveanimals,asthereisapotentialriskof

increasedrenaltoxicity.Concurrentadministrationofpotentiallynephrotoxicdrugsshouldbe

avoided.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatmentofinflammatory

conditionsassociatedwithbacterialinfection,appropriateconcurrentantimicrobialtherapy

shouldbeinstigated.

Interactionwithothermedicinalproductsandotherformsofinteraction

Carprofenshouldnotbeadministeredconcurrently,orwithin24hoursofanotherNSAID,or

inconjunctionwithglucocorticosteroids.SomeNSAIDshighlybindtoplasmaproteinsand

arecompetitivetoothersubstanceswhichbindthesameproteins.Thelattermayresultin

toxiceffects.Hence,concurrentadministrationwithpotentiallynephrotoxicsubstancesshould

beavoided.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

Overdose

Incaseofoverdose,nootheradversereactionsthanthosementionedinsection6are

expected.

Thereisnospecificantidoteforcarprofenoverdosagebutgeneralsupportivetherapy,as

appliedtoclinicaloverdosagewithNSAID’s,shouldbeapplied.

Useduringpregnancy,lactationorlay

Laboratorystudiesinlaboratoryanimals(rat,rabbit)haveshownevidenceoffoetotoxic

effectsofcarprofenatdosesclosetothetherapeuticdose.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyand

lactation.Donotuseindogsorcatsduringpregnancyorlactation.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Carprofen,incommonwithotherNSAIDs,hasbeenshowntoexhibitphotosensitising

potentialinlaboratorystudies.Avoidskincontactwiththeproduct.Shouldthisoccur,wash

theaffectedareasimmediately.

Careshouldbetakentoavoidaccidentalself-injection.Incaseofaccidentalinjection,seek

medicaladviceimmediatelyandshowthepackageleaflettothephysician.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocal/nationalrequirements.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

Tobesuppliedonlyonveterinaryprescription.

Foranimaltreatmentonly.

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Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration