Gazette APVMA 1, 4 January 2005 page 16

NOTICE Sevoflurane

[in the product: SEVOFLO INHALATION ANAESTHETIC]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Abbott Australasia Pty Ltd, Lord Street, BOTANY NSW Australia for registration of a new product containing the active constituent sevoflurane. The product is SEVOFLO INHALATION ANAESTHETIC. The product is for use in dogs.

In accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application 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 product name: SEVOFLO INHALATION ANAESTHETIC
Applicant company: Abbott Australasia Pty Ltd
Name of active constituent: Sevoflurane
Signal heading: Schedule 4
Statement of claims: Inhalation anaesthetic for use in dogs.
Pack sizes: 250mL amber glass or amber polyethylene napthenate bottles with either a roll on pilfer proof aluminium cap with a polyethylene lining or a patented closure known as a Quik-Fil which incorporates a polyethylene lining and a spring/plunger assembly.

Summary of the APVMA’s evaluation of SEVOFLO INHALATION ANAESTHETIC 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 SEVOFLO INHALATION ANAESTHETIC would not be an undue hazard to the safety of people exposed to it during its handling and use.

The Office of Chemical Safety in the Commonwealth Department of Health and Ageing assessed the human toxicological aspects of this application. The product is to be used to anaesthetise individual dogs under veterinary care and any significant toxicity concerns for the user of the product are addressed adequately on the label. The active constituent sevoflurane is listed in Schedule 4 of the Standard for the Uniform Scheduling of Drugs (SUSDP).

The product will be formulated in the United Kingdom and repackaging will not be required in Australia.

The APVMA accepts the findings and recommendations of its advisers on this criterion.

(ii) The APVMA is satisfied that the proposed use of SEVOFLO INHALATION ANAESTHETIC will not be an undue hazard to the safety of people using anything containing its residues. There are no residues concerns with products used in dogs because dogs are not food producing animals in Australia.

The APVMA accepts the findings and recommendations of its advisers on this criterion.

(iii) The APVMA is satisfied that the proposed use of sevoflurane in SEVOFLO INHALATION ANAESTHETIC is not likely to be harmful to human beings if used according to the product label directions.

A Notice inviting submissions on the APVMA’s proposal to grant approval for the active constituent sevoflurane was published in the Gazette on 2 November 2004. Approval of the active constituent was granted on 1 December 2004 with approval number APVMA 58174. The product is scheduled as S4. The appropriate Signal Heading is on the label. Safety Directions: “May irritate eyes and skin. Avoid contact with eyes and skin. Ensure adequate ventilation during use.” have been recommended by the Office of Chemical Safety and have been included on the label. No Occupational Health and Safety statements were considered necessary because the use pattern limited any potentially significant hazards. The establishment of an Acceptable Daily Intake (ADI) or Acute Reference Dose (ARfD) was unnecessary because the active constituent is not likely 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 SEVOFLO INHALATION ANAESTHETIC is not likely to have an unintended effect that is harmful to animals, plants or the environment.

Data supplied supported the safety of SEVOFLO INHALATION ANAESTHETIC for dogs when used as directed according to the label.

The Department of the Environment and Heritage (DEH) did not need to assess this product because it is used in individual animals under veterinary direction for inhalation anaesthesia. It is already scheduled and used in humans.

The APVMA accepts the findings and recommendations of its advisers on this criterion.

(v) The APVMA is satisfied that the proposed use of sevoflurane in SEVOFLO INHALATION ANAESTHETIC would not adversely affect trade between Australia and places outside Australia because the product is used under prescription on dogs. Dogs are not used for human consumption.

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 SEVOFLO INHALATION ANAESTHETIC adequately demonstrate that under Australian conditions this product is effective for the proposed uses.

Written submissions on the APVMA’s proposal to grant the application for registration should be addressed in writing to:

Dr Roger Meischke
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 5859
Fax: (02) 6272 5249
email: roger.meischke@apvma.gov.au