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Variation of registered chemical product Rilexine Palatable

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					                                                                  ADVICE SUMMARY
                             APPLICATION FOR VARIATION OF A REGISTERED CHEMICAL PRODUCT

Product name:               RILEXINE 75 PALATABLE LIVER FLAVOURED CEPHALEXIN ANTIBIOTIC TABLETS FOR CATS AND DOGS
Applicant:                  VIRBAC (AUSTRALIA) PTY LTD
Product number:             54343
Application number:         42465

Purpose of Application and Description of Use:       Variation of label approval to include an additional dose rate and a new dose rate for refactory pyoderma.

Active Constituent:         CEPHALEXIN AS CEPHALEXIN MONOHYDRATE



Regulatory Decision:
To grant the application subject to the following conditions:

Standard Conditions of Label Approval


For full conditions, refer to http://www.apvma.gov.au/advice_summaries/adv_summaries.shtml.




42465                                                                      Page 1 of 3                                              KP25S_F40 Version: 2 Issued: 10/08/2007
ADVICE

External Efficacy Reviewer
The test product claims to be equally an effective treatment of respiratory, digestive and urinary infections and soft cutaneous tissue infections caused by
cephalexin-susceptible bacteria when administered to cats and dogs at either 15 mg/kg bw twice daily or 30 mg/kg bw once daily (single dose). Virbac
Australia Pty Ltd provided data from clinical trials and pharmacokinetic studies. Two studies, which investigated clinical efficacy of cephalexin against lower
urinary tract infections in dogs and cats, showed no significant difference (p=0.05) in efficacy between a single dose of cephalexin paste (15 mg/kg) and twice
daily dosing by tablet (30 mg/kg). In pharmacokinetic studies conducted in cats and dogs, Cmax and Tmax of both doses in either species were similar, while
AUC at the single dose was substantially higher. These results therefore supported that the single dose is likely to be as efficacious as claimed. The reviewer
cautioned that the benefit may be equivocal since more frequent dosing is generally advantageous to enhance the efficacy of β-lactams. The data also supported
that refractory cases of canine pyoderma may need a longer duration of treatment with higher doses of cephalexin, but safety using a 60 mg/kg once daily dose
for prolonged periods was not demonstrated.

Data relied on to provide the advice
                                                                                                                                                                                      Inherited
Data    Data             Author(s)                               Title                                Date         Data Type           Data Sub-type              Authorising        Application
No      Source*                                                                                                                                                     Party                No.
14274   S         Anon, Virbac            Clinical Field Trial : Therapeutic Efficacy of            1998     Efficacy and Safety   Efficacy                    Applicant
                                          646.03 against infections of lower urinary tract
                                          in dogs
14275   S         Anon, Virbac            Clinical Field Trial : Therapeutic Efficacy of            1998     Efficacy and Safety   Efficacy                    Applicant
                                          646.03 against infections of lower urinary tract
                                          in cats
14267   S         Dr. John Thornton       Bioequivalence Study of Cephalexin in Cats                1996     Efficacy and Safety   Pharmacological             Applicant
                  Department of                                                                                                    Data/Studies
                  Companion Animal
                  Medicine and Surgery
                  (The University of
                  Queensland)
14276   S         Anon, Virbac            Study of pharmacokinetics in plasma and urine             1995     Efficacy and Safety   Pharmacological             Applicant
                                          after single dosing by intravenous and oral                                              Data/Studies
                                          (tablets) routes in beagle dogs
14263   S         Odenholt-Tornqvist I.   Pharmacodynamic effects of subinhibitory                  1991     Efficacy and Safety   Pharmacological             Public
                  et al                   concentrations of 13-lactam antibiotics in vitro                                         Data/Studies
14268   S         Anon, Virbac            Preliminary pharmacokinetic study after a single          2005     Efficacy and Safety   Pharmacological             Applicant




42465                                                                                 Page 2 of 3                                                      KP25S_F40 Version: 2 Issued: 10/08/2007
                                        administration of cephalexin at 15 and 30 mg/kg                                        Data/Studies
                                        in dogs
14270   S       Anon, Virbac            Study of pharmacokinetics in plasma and urine             1997   Efficacy and Safety   Pharmacological           Applicant
                                        after single dosing by intravenous and oral                                            Data/Studies
                                        (paste formulation) routes in cats
14269   S       Anon, Virbac            Study of pharmacokinetics in plasma, urine and            1997   Efficacy and Safety   Pharmacological           Applicant
                                        skin after a single dosing by intravenous and                                          Data/Studies
                                        oral (paste formulation) routes in beagle dogs
14262   S       Bousquet E., Ganiere    Post Antibiotic effect of cephalexin against              1999   Efficacy and Safety   Pharmacological           Public
                J.P., Ruvoen N.,        isolates of Staphyloccocus intermedius obtained                                        Data/Studies
                Larrat M.               from cases of canine pyoderma
14258   S       Wackowiez, G.,          Pharmacokinetics of cefalexin in plasma and               1997   Efficacy and Safety   Pharmacological           Public
                Richard J.J.,           urine after single intravenous and oral (tablets)                                      Data/Studies
                Fabreguettes, G.        adminstration in dogs
18476   S       Boothe. D,M.            Small animal clinical pharmacology and                    2001   Efficacy and Safety   Efficacy                  Public
                                        therapeutics.
18477   S       Chandler, E.A.,                                                                   1991   Efficacy and Safety   Efficacy                  Public
                Thompson, D.J
                Sutton, J.B Price,C.J
18516   S       Crosse, R. and Burt,    Antibiotic concentration in the serum of dogs             1984   Efficacy and Safety   Efficacy                  Public
                D.G                     and cats following a single oral dose of
                                        cephalexin
18517   S       Grant, D.I                                                                        1991   Efficacy and Safety   Efficacy                  Public
18518   S       Keitzmann, M., Nolte,   Tolerance and pharmacokinetics of cephalexin              1992   Efficacy and Safety   Efficacy                  Public
                I., Stothmann-          in cats after oral administration.
                Leurssen, A., Grunau,
                B., Scharer, V.
18519   S       Oten, H., Plempel,      Antiobiotica-Fibel.                                       1975   Efficacy and Safety   Efficacy                  Public
                M.,Siegenthaler, W.
18520   S       Riviere, J.E                                                                      1989   Efficacy and Safety   Efficacy                  Public
18521   S       Thornton, J.R and       Pharmacokineticsof cephalexin in cats after oral          1997   Efficacy and Safety   Efficacy                  Public
                Martin, P.J             administration of antibiotic in table and paste
                                        form.

* S = Data submitted with the application




42465                                                                               Page 3 of 3                                                  KP25S_F40 Version: 2 Issued: 10/08/2007

				
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