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Gazette APVMA 2, 7 February 2006 page 20
NOTICEEmodepside, Praziquantel
in the products: PROFENDER ALLWORMER SPOT-ON FOR CATS; PROFENDER ALLWORMER FOR SMALL CATS AND KITTENS 0.5 TO 2.5 KG; PROFENDER ALLWORMER FOR CATS 2.5 TO 5 KG; PROFENDER ALLWORMER FOR LARGE CATS 5 TO 8 KG
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Bayer Australia Ltd for registration of four new products containing the active constituents Emodepside and Praziquantel. The products are PROFENDER ALLWORMER SPOT- ON FOR CATS; PROFENDER ALLWORMER FOR SMALL CATS AND KITTENS 0.5 TO 2.5 KG; PROFENDER ALLWORMER FOR CATS 2.5 TO 5 KG; PROFENDER ALLWORMER FOR LARGE CATS 5 TO 8 KG. The products are for the treatment and control of intestinal parasites in cats.
In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the applications for registration should be granted. Submissions should state the grounds on which they are based. Such grounds should relate only to matters outlined below that the APVMA is required to take into account in deciding whether to grant the application. Comments must be received by the APVMA within 28 days of the date of this notice.
Particulars of Application
Proposed products’ names:
PROFENDER ALLWORMER SPOT-ON FOR CATS;
PROFENDER ALLWORMER FOR SMALL CATS AND KITTENS 0.5 TO 2.5 KG;
PROFENDER ALLWORMER FOR CATS 2.5 TO 5 KG;
PROFENDER ALLWORMER FOR LARGE CATS 5 TO 8 KG
Applicant company: Bayer Australia Ltd
Name of active constituents: Emodepside, Praziquantel
Signal heading: Schedule 5
Statement of claims: For the control of intestinal parasites in cats
Pack sizes:
| Pipette size | Number of pipettes |
| 0.3 mL | 2, 4, 20, 40, 80 |
| 0.7 mL | 2, 4, 20, 40, 80 |
| 1.12 mL | 2, 4, 20, 40, 80 |
| 14 mL | 1 |
Withholding period not applicable
Summary of the APVMA’s evaluation of PROFENDER ALLWORMER SPOT- ON FOR CATS PROFENDER ALLWORMER FOR SMALL CATS AND KITTENS 0.5 TO 2.5 KG; PROFENDER ALLWORMER FOR CATS 2.5 TO 5 KG; PROFENDER ALLWORMER FOR LARGE CATS 5 TO 8 KG in accordance with Section 14(3)(e) and (f) of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994
The APVMA has evaluated the application and in its assessment in relation to human and environmental safety under section 14(3)(e) of the Agvet Code, it proposes to determine that:
(i) The APVMA is satisfied that the proposed use of PROFENDER ALLWORMER SPOT-ON FOR CATS; PROFENDER ALLWORMER FOR SMALL CATS AND KITTENS 0.5 TO 2.5 KG; PROFENDER ALLWORMER FOR CATS 2.5 TO 5 KG; PROFENDER ALLWORMER FOR LARGE CATS 5 TO 8 KG would not be an undue hazard to the safety of people exposed to them during their handling and use.
The Office of Chemical Safety (OCS) in the Australian Government Department of Health and Aging assessed the human toxicological aspects of these applications.
The products will be formulated overseas and repackaging will not be required in Australia. The products are applied externally but the handling of cats recently treated with the product does not raise any human health concerns. The products are of sufficiently low toxicity that accidental poisoning is considered unlikely. Nevertheless first aid and safety directions have been recommended to be included on the label.
The APVMA accepts the findings and recommendations of its advisers on this criterion.
(ii) The APVMA is satisfied that the proposed use of PROFENDER ALLWORMER SPOT-ON FOR CATS; PROFENDER ALLWORMER FOR SMALL CATS AND KITTENS 0.5 TO 2.5 KG; PROFENDER ALLWORMER FOR CATS 2.5 TO 5 KG; PROFENDER ALLWORMER FOR LARGE CATS 5 TO 8 KG will not be an undue hazard to the safety of people using anything containing their residues. There are no residues concerns because the products are used only on cats. Cats are not food-producing animals in Australia.
(iii) The APVMA is satisfied that the proposed use of PROFENDER ALLWORMER SPOT-ON FOR CATS; PROFENDER ALLWORMER FOR SMALL CATS AND KITTENS 0.5 TO 2.5 KG; PROFENDER ALLWORMER FOR CATS 2.5 TO 5 KG; PROFENDER ALLWORMER FOR LARGE CATS 5 TO 8 KG is not likely to be harmful to human beings if used according to the product label directions.
The active constituents have been evaluated by OCS and the product is scheduled as S5. The appropriate Signal Heading is on the label. First Aid and Safety Directions for Emodepside and Praziquantel have been recommended by OCS and have been included on the label. The determination of an Acceptable Daily Intake (ADI) and an Acute Reference Dose (ARfD) was unnecessary because emodepside is for use in cats and is unlikely to enter the human food chain.
The APVMA accepts the findings and recommendations of its advisers on this criterion.
(iv) The APVMA is satisfied that the proposed use of PROFENDER ALLWORMER SPOT-ON FOR CATS; PROFENDER ALLWORMER FOR SMALL CATS AND KITTENS 0.5 TO 2.5 KG; PROFENDER ALLWORMER FOR CATS 2.5 TO 5 KG; PROFENDER ALLWORMER FOR LARGE CATS 5 TO 8 KG on cats is not likely to have an unintended effect that is harmful to animals, plants or the environment.
The Department of the Environment and Heritage (DEH) has assessed the available data. Potential environmental risks were considered likely to be acceptable taking into account the use is confined to individual companion animals.
Data supplied supported the safety of the products in cats when used as directed according to the label instructions
The APVMA accepts the findings and recommendations of its advisers on this criterion.
(v) The APVMA is satisfied that the proposed use of PROFENDER ALLWORMER SPOT-ON FOR CATS; PROFENDER ALLWORMER FOR SMALL CATS AND KITTENS 0.5 TO 2.5 KG; PROFENDER ALLWORMER FOR CATS 2.5 TO 5 KG; PROFENDER ALLWORMER FOR LARGE CATS 5 TO 8 KG would not adversely affect trade between Australia and places outside Australia because the products are for use in cats. Cats are not used for human consumption in Australia nor are they exported from Australia for such purposes.
In relation to its assessment of efficacy under section 14(3)(f), the APVMA proposes to determine that:
(i) The APVMA is satisfied the data from trials supporting the efficacy of PROFENDER ALLWORMER SPOT-ON FOR CATS; PROFENDER ALLWORMER FOR SMALL CATS AND KITTENS 0.5 TO 2.5 KG; PROFENDER ALLWORMER FOR CATS 2.5 TO 5 KG; PROFENDER ALLWORMER FOR LARGE CATS 5 TO 8 KG adequately demonstrate that under local conditions these products are effective for the proposed uses.
Written submissions on the APVMA’s proposal to grant the application for registration should be addressed to:
Dr Judith Platt
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6272 3776
Fax: (02) 6272 5249
Email: judith.platt@apvma.gov.au