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: Mastiplan

Reference: A011329

Active Ingredients and Concentrations:

Each single dose 8g syringe contains 300mg cephapirin (as sodium salt) and 20mg prednisolone

Formulation Type: Oily Suspension

Current Claims:

Broad spectrum treatment of clinical mastitis in lactating cows caused by Gram-positive bacteria and Gram-negative bacteria sensitive to cephapirin. Prednisolone assists in the reduction in local signs of inflammation and fever induced by clinical mastitis and rapid recovery in milk production.

Current Use Pattern – Cows on Twice Daily Milking:

The entire contents of one syringe should be infused into the teat canal of each infected quarter immediately following each of four successive milking’s i.e. every 12 hours.

Proposed New Use Patterns – Cows on Once a Day Milking:

1. The entire contents of one syringe should be infused into the teat canal of each infected quarter immediately following each of three successive milking’s i.e. every 24 hours.

2. The entire contents of one syringe should be infused into the teat canal of each infected quarter immediately following each of six successive milking’s i.e. every 24 hours.

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:

Schering-Plough Animal Health Limited, 33 Whakatiki Street Upper Hutt 5018. Postal Address: Private Bag 908, Upper Hutt 5140.

Dated at Wellington this 7th day of January 2021.

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