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Alfaxan ® Anaesthetic Injection Alfaxan ® at a glance Repeatable. Reliable. Relax. Repeatable. Reliable. Relax.
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Page 1: References - Jurox Animal Health · Alfaxan® at a glance References 1. Muir, W., et al., Cardiorespiratoryand anesthetic effects of clinical and supraclinicaldosesof alfaxalonein

Alfaxan® Anaesthetic Injection

Alfaxan® at a glance

References1. Muir,W.,etal.,Cardiorespiratoryandanestheticeffectsofclinical

andsupraclinicaldosesofalfaxaloneindogs.VeterinaryAnaesthesiaandAnalgesia,2008.35(6):p.451-462.

2. Muir, W., et al., The cardiorespiratory and anesthetic effects ofclinical and supraclinical doses of alfaxalone in cats. VeterinaryAnaesthesiaandAnalgesia,2009.36(1):p.42-54.

3. Whittem, T. and Pasloske, P., RD9604.03 – H005. Eight day targetanimal safety study of intravenous Alfaxan® CD RTU in dogsadministeredeveryotherday.2004,JuroxPty.Ltd.

4. Pasloske, K. and Whittem, T., JX9604.07-H004. A target animalsafety study in cats after administration of Alfaxan® CD RTU assingle,repeatedinjectionsondays0,2and5atdosesof5,15or25mg/kg.2004,0nfileatJuroxPtyLtd.

5. O’HaganB.,etal.,Clinicalevaluationofalfaxaloneasananaestheticinduction agent in dogs less than 12 weeks of age. AustralianVeterinaryJournal,2012:p.n/a

6. O’HaganB.,etal.,Clinicalevaluationofalfaxaloneasananaestheticinduction agent in cats less than 12 weeks of age. AustralianVeterinaryJournal,2012:p.n/a

7. Pasloske,K.,etal.,Plasmapharmacokineticsofalfaxalone inbothpremedicated and un-premedicated Greyhound dogs after single,intravenousadministrationofAlfaxan®ataclinicaldose.JournalofVeterinaryPharmacologyandTherapeutics,2009.32:p.510-513.

8. Metcalfe,S.,etal.,Amulti-centreclinicaltrialevaluatingtheefficacyand safety of Alfaxan® administered to bitches for induction ofanaesthesiaprior tocaesareansection. In33rdWorldsmallAnimalCongress.2008.Dublin,Ireland:WSAVA/FECAVA.

9. Baron Strategic Services. Anaesthesia Market Research. Juroxvet survey report Oct 11. On file at Jurox Pty. Ltd., Rutherford,NSW.Australia.

10. Child, K.J. et al., Metabolism and excretion of CT1341 in the rat.InSteroidAnaesthesia,1972.RoyalCollegeofPhysicians,London.

11. Muir, W., et al., The cardiorespiratory and anesthetic effects ofclinical and supraclinical doses of alfaxalone in cats. VeterinaryAnaesthesiaandAnalgesia,2009.36(1):p.42-54.

12. Muir,W.,etal.,Cardiorespiratoryandanestheticeffectsofclinicalandsupraclinicaldosesofalfaxaloneindogs.VeterinaryAnaesthesiaandAnalgesia,2008.35(6):p.451-462.

13. Pasloske,K.,etal.,AmulticentreclinicaltrialevaluatingtheefficacyandsafetyofAlfaxan®-CDRTUadministered todogs for inductionandmaintenanceofanaesthesia.InBritishSmallAnimalVeterinaryAssociationCongress.2005.Birmingham,UK.

14. Pasloske,K.,etal.,Amulticentreclinicaltrialevaluatingtheefficacyand safety of Alfaxan®-CD RTU administered to cats for inductionandmaintenanceofanaesthesia.InBritishSmallAnimalVeterinaryAssociationCongress.2007.Birmingham,UK.

15. Ambros, B., et al., Comparison of the anesthetic efficacy andcardiopulmonaryeffectsof continuous rate infusionsofalfaxalonein2-hydroxypropyl--cyclodextrinandpropofol indogs.Am.J.vet.Res.,2008.69(11):p.1391-8.

16. Heit,M.C.,etal.,CardiovascularandrespiratorysafetyofAlfaxan®CD RTU in cats premedicated with acepromazine, medetomidine,midazolamorbutorphanol.InACVIM.2004.

17. Amengual,M.,etal.,Anevaluationofanaestheticinductioninhealthydogs using rapid intravenous injection of propofol or alfaxalone.VeterinaryAnaesthesiaandAnalgesia,2012:p.n/a.

18. Herbert, G.L., et al., Alfaxalone for total intravenous anaesthesiain dogs undergoing ovariohysterectomy: a comparison ofpremedication with acepromazine or dexmedetomidine. VeterinaryAnaesthesiaandAnalgesia,2012:p.n/a.

19. Jansen, K.S. and J.J. Uilenreel, A comparison between alfaxaloneand propofol continuous rate infusions in a total intravenousanaesthesia protocol for canine surgical patients. 2009, Faculty ofVeterinaryMedicine–UniversityofUtrecht.

20. Jimenez, C.P., et al., Evaluation of the quality of recovery afteradministrationofpropofoloralfaxaloneforinductionofanaesthesiain dogs anaesthetized for magnetic resonance imaging. VeterinaryAnaesthesiaandAnalgesia,2012.39(2):p.151-159.

21. Maddern, K., et al., Alfaxalone induction dose followingadministration of medetomidine and butorphanol in the dog.VeterinaryAnaesthesiaandAnalgesia,2010.37(1):p.7-13.

22. Taboada, M. F. and Murison, P.J., Induction of anaesthesia withalfaxalone or propofol before isoflurane maintenance in cats.VeterinaryRecord,2010.167(3):p.85-89.

23. Mathis,A.,etal.,Comparisonofqualityofrecoveryfromanaesthesiaincatsinducedwithpropofoloralfaxalone.VeterinaryAnaesthesiaandAnalgesia,2012.39(3):p.282-290.

24. Murison,P.J.andTaboada.,Effectofpropofolandalfaxaloneonpainafterovariohysterectomyincats.VeterinaryRecord,2010.166(11):p.334-335.

25. Psatha, E., et al., Clinical efficacy and cardiorespiratory effects ofalfaxalone, or diazepam/fentanyl for induction of anaesthesia indogs that are a poor anaesthetic risk. Veterinary Anaesthesia andAnalgesia,2011.38:p.24-36.

26. Zaki,S.,etal.,ClinicalevaluationofAlfaxan-CD®asanintravenousanaestheticinyoungcats.AustralianVeterinaryJournal,2009.87(3):p.82-87.

Repeatable. Reliable. Relax.

For more information contact:

Jurox Pty Limited

85GardinerStreet

Rutherford

NSW,2320

Australia

Enquiries+61(0)249318200

[email protected]

®RegisteredTrademarkofJuroxPtyLimited

Jurox New Zealand Limited

8KordelPlace

EastTamaki

Auckland,2013

NewZealand

Enquiries0800587696

[email protected]

®RegisteredTrademarkofJuroxPtyLimited

Repeatable. Reliable. Relax.

Page 2: References - Jurox Animal Health · Alfaxan® at a glance References 1. Muir, W., et al., Cardiorespiratoryand anesthetic effects of clinical and supraclinicaldosesof alfaxalonein

Tolerance

Alfaxan®isuniqueasananaestheticagent,exhibitingawidemarginbetweentheeffectivedoseandthatwhichmayadverselyaffectthepatient.

A. Over-dosage

InacutetolerancetrialsdogswereadministeredAlfaxan®upto10 timestherecommendeddoseof2mg/kgandcatsupto5 timestherecommendeddoseof5mg/kgwithonlyventilationwithroomairbeingrequiredforanimalsatthemaximumdosagestoallowrecoverytonormal.[1,2]

Inrepeatedover-dosagetrialsdogswereadministeredAlfaxan®upto5 timestherecommendeddoseof2mg/kgandcatswereadministeredAlfaxan®upto5 timestherecommendedrateof5mg/kgrespectivelyon3occasionsovera7dayperiodwithnoadverseeffects.[3,4]

B. Age

Alfaxan®hasbeenadministeredtopuppiesandkittensfrom6weeksofagewithnoadverseeffects.[5,6]

C. Sighthounds

Alfaxan®hasbeenusedinGreyhoundswithnoadverseeffects.[7]

D. Caesarean section

Alfaxan®hasbeenusedasaninductionagentforCaesareansectionindogswithnoadverseeffects.[8]

Efficacy

Alfaxan®hasnowbeenroutinelyusedinmillionsofsurgicalproceduresinAustraliaandothercountriesacrosstheglobe,includingNewZealand,Canada,UK,GermanyandFrance.Thesurgerieshaveincluded(butarenotlimitedto)castration,ovariohysterectomy,dentistry,cancerremoval,eyeandearsurgery,orthopaedicproceduresandarangeofclinicaltaskswhereanaesthesiaisdeemedappropriate–MRI,radiology,abscesscleaningandwounddebridement.Infact,inanysituationwhereanaesthesiaisrequiredAlfaxan®hasbeenusedsafelyandeffectively.

InasurveyofveterinaryanaesthesiainAustralia,whereitwasfirstmarketedintheearly2000s,responsesshowedthatAlfaxan®iscurrentlyusedforover50%ofallinductionsindogsandover75%ofallinductionsincats.[9]

Pharmacokinetics, pharmacodynamics and cardiorespiratory profile

FollowingasingledoseofAlfaxan®,alfaxalone,theactiveingredient,israpidlymetabolisedbytheliverandeliminatedinthebileandurine,withthedrugbeingcompletelyclearedfromthebodywithinafewhours.[10]

AfteradministrationofAlfaxan®thedurationofunconsciousnesswillvaryduetoarangeoffactors.Asageneralguide,atrecommendeddosesandwithoutpremedication,catswillremainanaesthetisedforapproximately25minutesanddogsforapproximately10minutes.[11,12]ConcomitantuseofsedativeandanalgesicmedicationscanbeexpectedtodecreasethedoserequirementsforAlfaxan®andalterthedurationoftheresultinganaesthesia.

Alfaxan®: essential factsActive ingredient and mode of action

Alfaxan®isregisteredfortheinductionand/ormaintenanceofanaesthesiaindogsandcats.Theactiveingredientisalfaxalone,aneuroactivesteroid.Itproducesanaestheticeffectsbyaugmentingtheinhibitoryeffectsofgamma-aminobutyricacid(GABA)ontheGABAAreceptor,resultingindecreasedimpulsetransmissionduetonervecellhyperpolarisation.

PatientsinducedwithAlfaxan®maintainclinicallyacceptablebloodpressureparameters,breathespontaneouslyandmaintainclinicallyacceptablerespiratoryrates.[13,14]

Compatibility

Alfaxan®hasbeenproventobesafewhenusedwithawiderangeofpremedicantclassesofdrugs,includingphenothiazines(acepromazine),anticholinergics(atropine),benzodiazepines(diazepam,midazolam),-2-adrenoreceptoragonists(xylazine,medetomidine,dexmedetomidine),opiates(methadone,morphine,butorphanol,buprenorphine,hydromorphone)andNSAIDS(carprofen,meloxicam)aswellasthenormalgaseousmaintenanceagents.[5-7,13-26]

Dose rates

NOTE: Theproductshouldbeadministeredslowly(¼ofthecalculateddosegivenat15secondintervals)andtheeffectmonitoredbycheckingcardinalsignsandstandardreflexesuntiltheappropriatelevelofanaesthesiaisachieved.UseofsedativesandpremedicantswillreducetherequireddoseofAlfaxan®andalterthedurationoftheresultantanaesthesia.Ifgaseousanaesthesiaisusedformaintenance,thepatientshouldbeplacedontheanaestheticmachineimmediatelyafterintubation.

Therecommendeddoseratesare:

DOGS: 2mg/kgofthe1%(10mg/mL)solution.

Bodyweight (kg) Dose volume (mL)

1 0.2

5 1

10 2

15 3

20 4

25 5

Above25kg 1mLper5kg,toeffect

CATS: 5mg/kgofthe1%(10mg/mL)solution.

Bodyweight (kg) Dose volume (mL)

0.5 0.25

1 0.5

2 1

5 2.5

Above5kg 0.5mLperkg,toeffect

NOTE:ForfurtherinformationpleasechecktheAlfaxan®websitewww.alfaxan.comorcontacttheTechnicalManagerforJuroxPty.Ltd.

Page 3: References - Jurox Animal Health · Alfaxan® at a glance References 1. Muir, W., et al., Cardiorespiratoryand anesthetic effects of clinical and supraclinicaldosesof alfaxalonein

Tolerance

Alfaxan®isuniqueasananaestheticagent,exhibitingawidemarginbetweentheeffectivedoseandthatwhichmayadverselyaffectthepatient.

A. Over-dosage

InacutetolerancetrialsdogswereadministeredAlfaxan®upto10 timestherecommendeddoseof2mg/kgandcatsupto5 timestherecommendeddoseof5mg/kgwithonlyventilationwithroomairbeingrequiredforanimalsatthemaximumdosagestoallowrecoverytonormal.[1,2]

Inrepeatedover-dosagetrialsdogswereadministeredAlfaxan®upto5 timestherecommendeddoseof2mg/kgandcatswereadministeredAlfaxan®upto5 timestherecommendedrateof5mg/kgrespectivelyon3occasionsovera7dayperiodwithnoadverseeffects.[3,4]

B. Age

Alfaxan®hasbeenadministeredtopuppiesandkittensfrom6weeksofagewithnoadverseeffects.[5,6]

C. Sighthounds

Alfaxan®hasbeenusedinGreyhoundswithnoadverseeffects.[7]

D. Caesarean section

Alfaxan®hasbeenusedasaninductionagentforCaesareansectionindogswithnoadverseeffects.[8]

Efficacy

Alfaxan®hasnowbeenroutinelyusedinmillionsofsurgicalproceduresinAustraliaandothercountriesacrosstheglobe,includingNewZealand,Canada,UK,GermanyandFrance.Thesurgerieshaveincluded(butarenotlimitedto)castration,ovariohysterectomy,dentistry,cancerremoval,eyeandearsurgery,orthopaedicproceduresandarangeofclinicaltaskswhereanaesthesiaisdeemedappropriate–MRI,radiology,abscesscleaningandwounddebridement.Infact,inanysituationwhereanaesthesiaisrequiredAlfaxan®hasbeenusedsafelyandeffectively.

InasurveyofveterinaryanaesthesiainAustralia,whereitwasfirstmarketedintheearly2000s,responsesshowedthatAlfaxan®iscurrentlyusedforover50%ofallinductionsindogsandover75%ofallinductionsincats.[9]

Pharmacokinetics, pharmacodynamics and cardiorespiratory profile

FollowingasingledoseofAlfaxan®,alfaxalone,theactiveingredient,israpidlymetabolisedbytheliverandeliminatedinthebileandurine,withthedrugbeingcompletelyclearedfromthebodywithinafewhours.[10]

AfteradministrationofAlfaxan®thedurationofunconsciousnesswillvaryduetoarangeoffactors.Asageneralguide,atrecommendeddosesandwithoutpremedication,catswillremainanaesthetisedforapproximately25minutesanddogsforapproximately10minutes.[11,12]ConcomitantuseofsedativeandanalgesicmedicationscanbeexpectedtodecreasethedoserequirementsforAlfaxan®andalterthedurationoftheresultinganaesthesia.

Alfaxan®: essential factsActive ingredient and mode of action

Alfaxan®isregisteredfortheinductionand/ormaintenanceofanaesthesiaindogsandcats.Theactiveingredientisalfaxalone,aneuroactivesteroid.Itproducesanaestheticeffectsbyaugmentingtheinhibitoryeffectsofgamma-aminobutyricacid(GABA)ontheGABAAreceptor,resultingindecreasedimpulsetransmissionduetonervecellhyperpolarisation.

PatientsinducedwithAlfaxan®maintainclinicallyacceptablebloodpressureparameters,breathespontaneouslyandmaintainclinicallyacceptablerespiratoryrates.[13,14]

Compatibility

Alfaxan®hasbeenproventobesafewhenusedwithawiderangeofpremedicantclassesofdrugs,includingphenothiazines(acepromazine),anticholinergics(atropine),benzodiazepines(diazepam,midazolam),-2-adrenoreceptoragonists(xylazine,medetomidine,dexmedetomidine),opiates(methadone,morphine,butorphanol,buprenorphine,hydromorphone)andNSAIDS(carprofen,meloxicam)aswellasthenormalgaseousmaintenanceagents.[5-7,13-26]

Dose rates

NOTE: Theproductshouldbeadministeredslowly(¼ofthecalculateddosegivenat15secondintervals)andtheeffectmonitoredbycheckingcardinalsignsandstandardreflexesuntiltheappropriatelevelofanaesthesiaisachieved.UseofsedativesandpremedicantswillreducetherequireddoseofAlfaxan®andalterthedurationoftheresultantanaesthesia.Ifgaseousanaesthesiaisusedformaintenance,thepatientshouldbeplacedontheanaestheticmachineimmediatelyafterintubation.

Therecommendeddoseratesare:

DOGS: 2mg/kgofthe1%(10mg/mL)solution.

Bodyweight (kg) Dose volume (mL)

1 0.2

5 1

10 2

15 3

20 4

25 5

Above25kg 1mLper5kg,toeffect

CATS: 5mg/kgofthe1%(10mg/mL)solution.

Bodyweight (kg) Dose volume (mL)

0.5 0.25

1 0.5

2 1

5 2.5

Above5kg 0.5mLperkg,toeffect

NOTE:ForfurtherinformationpleasechecktheAlfaxan®websitewww.alfaxan.comorcontacttheTechnicalManagerforJuroxPty.Ltd.

Page 4: References - Jurox Animal Health · Alfaxan® at a glance References 1. Muir, W., et al., Cardiorespiratoryand anesthetic effects of clinical and supraclinicaldosesof alfaxalonein

Alfaxan® Anaesthetic Injection

Alfaxan® at a glance

References1. Muir,W.,etal.,Cardiorespiratoryandanestheticeffectsofclinical

andsupraclinicaldosesofalfaxaloneindogs.VeterinaryAnaesthesiaandAnalgesia,2008.35(6):p.451-462.

2. Muir, W., et al., The cardiorespiratory and anesthetic effects ofclinical and supraclinical doses of alfaxalone in cats. VeterinaryAnaesthesiaandAnalgesia,2009.36(1):p.42-54.

3. Whittem, T. and Pasloske, P., RD9604.03 – H005. Eight day targetanimal safety study of intravenous Alfaxan® CD RTU in dogsadministeredeveryotherday.2004,JuroxPty.Ltd.

4. Pasloske, K. and Whittem, T., JX9604.07-H004. A target animalsafety study in cats after administration of Alfaxan® CD RTU assingle,repeatedinjectionsondays0,2and5atdosesof5,15or25mg/kg.2004,0nfileatJuroxPtyLtd.

5. O’HaganB.,etal.,Clinicalevaluationofalfaxaloneasananaestheticinduction agent in dogs less than 12 weeks of age. AustralianVeterinaryJournal,2012:p.n/a

6. O’HaganB.,etal.,Clinicalevaluationofalfaxaloneasananaestheticinduction agent in cats less than 12 weeks of age. AustralianVeterinaryJournal,2012:p.n/a

7. Pasloske,K.,etal.,Plasmapharmacokineticsofalfaxalone inbothpremedicated and un-premedicated Greyhound dogs after single,intravenousadministrationofAlfaxan®ataclinicaldose.JournalofVeterinaryPharmacologyandTherapeutics,2009.32:p.510-513.

8. Metcalfe,S.,etal.,Amulti-centreclinicaltrialevaluatingtheefficacyand safety of Alfaxan® administered to bitches for induction ofanaesthesiaprior tocaesareansection. In33rdWorldsmallAnimalCongress.2008.Dublin,Ireland:WSAVA/FECAVA.

9. Baron Strategic Services. Anaesthesia Market Research. Juroxvet survey report Oct 11. On file at Jurox Pty. Ltd., Rutherford,NSW.Australia.

10. Child, K.J. et al., Metabolism and excretion of CT1341 in the rat.InSteroidAnaesthesia,1972.RoyalCollegeofPhysicians,London.

11. Muir, W., et al., The cardiorespiratory and anesthetic effects ofclinical and supraclinical doses of alfaxalone in cats. VeterinaryAnaesthesiaandAnalgesia,2009.36(1):p.42-54.

12. Muir,W.,etal.,Cardiorespiratoryandanestheticeffectsofclinicalandsupraclinicaldosesofalfaxaloneindogs.VeterinaryAnaesthesiaandAnalgesia,2008.35(6):p.451-462.

13. Pasloske,K.,etal.,AmulticentreclinicaltrialevaluatingtheefficacyandsafetyofAlfaxan®-CDRTUadministered todogs for inductionandmaintenanceofanaesthesia.InBritishSmallAnimalVeterinaryAssociationCongress.2005.Birmingham,UK.

14. Pasloske,K.,etal.,Amulticentreclinicaltrialevaluatingtheefficacyand safety of Alfaxan®-CD RTU administered to cats for inductionandmaintenanceofanaesthesia.InBritishSmallAnimalVeterinaryAssociationCongress.2007.Birmingham,UK.

15. Ambros, B., et al., Comparison of the anesthetic efficacy andcardiopulmonaryeffectsof continuous rate infusionsofalfaxalonein2-hydroxypropyl--cyclodextrinandpropofol indogs.Am.J.vet.Res.,2008.69(11):p.1391-8.

16. Heit,M.C.,etal.,CardiovascularandrespiratorysafetyofAlfaxan®CD RTU in cats premedicated with acepromazine, medetomidine,midazolamorbutorphanol.InACVIM.2004.

17. Amengual,M.,etal.,Anevaluationofanaestheticinductioninhealthydogs using rapid intravenous injection of propofol or alfaxalone.VeterinaryAnaesthesiaandAnalgesia,2012:p.n/a.

18. Herbert, G.L., et al., Alfaxalone for total intravenous anaesthesiain dogs undergoing ovariohysterectomy: a comparison ofpremedication with acepromazine or dexmedetomidine. VeterinaryAnaesthesiaandAnalgesia,2012:p.n/a.

19. Jansen, K.S. and J.J. Uilenreel, A comparison between alfaxaloneand propofol continuous rate infusions in a total intravenousanaesthesia protocol for canine surgical patients. 2009, Faculty ofVeterinaryMedicine–UniversityofUtrecht.

20. Jimenez, C.P., et al., Evaluation of the quality of recovery afteradministrationofpropofoloralfaxaloneforinductionofanaesthesiain dogs anaesthetized for magnetic resonance imaging. VeterinaryAnaesthesiaandAnalgesia,2012.39(2):p.151-159.

21. Maddern, K., et al., Alfaxalone induction dose followingadministration of medetomidine and butorphanol in the dog.VeterinaryAnaesthesiaandAnalgesia,2010.37(1):p.7-13.

22. Taboada, M. F. and Murison, P.J., Induction of anaesthesia withalfaxalone or propofol before isoflurane maintenance in cats.VeterinaryRecord,2010.167(3):p.85-89.

23. Mathis,A.,etal.,Comparisonofqualityofrecoveryfromanaesthesiaincatsinducedwithpropofoloralfaxalone.VeterinaryAnaesthesiaandAnalgesia,2012.39(3):p.282-290.

24. Murison,P.J.andTaboada.,Effectofpropofolandalfaxaloneonpainafterovariohysterectomyincats.VeterinaryRecord,2010.166(11):p.334-335.

25. Psatha, E., et al., Clinical efficacy and cardiorespiratory effects ofalfaxalone, or diazepam/fentanyl for induction of anaesthesia indogs that are a poor anaesthetic risk. Veterinary Anaesthesia andAnalgesia,2011.38:p.24-36.

26. Zaki,S.,etal.,ClinicalevaluationofAlfaxan-CD®asanintravenousanaestheticinyoungcats.AustralianVeterinaryJournal,2009.87(3):p.82-87.

Repeatable. Reliable. Relax.

For more information contact:

Jurox Pty Limited

85GardinerStreet

Rutherford

NSW,2320

Australia

Enquiries+61(0)249318200

[email protected]

®RegisteredTrademarkofJuroxPtyLimited

Jurox New Zealand Limited

8KordelPlace

EastTamaki

Auckland,2013

NewZealand

Enquiries0800587696

[email protected]

®RegisteredTrademarkofJuroxPtyLimited

Repeatable. Reliable. Relax.


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