Maree Zinzley, Manager Approvals, of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”) that the following variation application has been made to a registered trade name product under section 9(2) of the Act:

Trade Name: NV GENTAMAX 100

Reference: A009478

Active Ingredients and Concentrations:

100mg/mL GENTAMICIN (as Sulfate)

Formulation Type: Aqueous Solution

Current Claims:

For the treatment of infections due to such gram-negative organisms as Actinobacillus sp., Klebsiella sp., Bordetella bronchiseptica, Enterobacter sp., Pseudomonas sp., and E. coli in horses, cats and dogs.

Current Dosage and Administration:

Horses: 1.5mg/kg every 8 hours.
Cats and Dogs: 4.0mg/kg twice on the first day then once daily.
Mares: Intrauterine infusion: 2.5g diluted in 400ml sterile normal saline, once daily for 3–5 days during oestrus.

Proposed Dosage and Administration: (Changes in Bold)

Horses: 6.6 mg/kg once daily, administer by slow intravenous injection only.
Foals (<14 days): 8.8mg/kg once daily, administer by slow intravenous injection only.
Mares: Intrauterine infusion: 2.5g diluted in 400ml sterile normal saline, once daily for 3–5 days during oestrus.
Cats and Dogs: 4.0 mg/kg twice on the first day then once daily, administer by subcutaneous, intramuscular or intravenous injection.

Any person may make a written submission to the director-general concerning this application.

Under sections 16 and 17 of the Act, a written submission:

1. must state in full the reasons for making the submission;
2. may state any decision sought on that application; and
3. must be received by the director-general no later than 30 working days after the date of notification in the New Zealand Gazette.

Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.

The following address is:

1. where submissions on this application are to be sent;
2. where requests for copies of the public information relating to the application can be sent;
3. where public information relating to the application can be viewed; and
4. the director-general’s address for service:

ACVM Group, Ministry for Primary Industries, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

Ceva Animal Health (NZ) Limited, Level 26, PWC Tower, 188 Quay Street, Auckland 1010. Postal Address: PO Box 90098, Victoria Street West, Auckland 1142.

Dated at Wellington this 1st day of October 2021.

MAREE ZINZLEY, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).