National Health Act 1953 - Amendment declaration under subsections 85(2) and 85(2AA) - Amendment determination under subsection 85(2A) - drugs and medicinal preparations (No. PB 92 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 92 of 2008

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) of the National Health Act 1953

I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated  1^st SEPTEMBER 2008

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1              Commencement

This instrument commences on 1 October 2008.

2              Amendment of PB 74 of 2008

Schedule 1 amends PB 74 of 2008.

Schedule 1        Amendments

[1]       Schedule 1, item dealing with Amoxycillin

omit from “Column 3”:

tablet, chewable, 250 mg (as trihydrate),

[2]       Schedule 1, item dealing with Rosiglitazone

omit from the columns in the order indicated:

2730	Treatment of type 2 diabetes, in combination with insulin, in a patient:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of insulin is greater than 7%, despite treatment with rosiglitazone maleate and at least 1 other oral anti-diabetic agent; or
(b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of insulin shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with rosiglitazone maleate and at least 1 other oral anti-diabetic agent; and
where the HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstance, are documented in the patient's medical records, and are no more than 4 months old, at the time insulin therapy is initiated
2731	Continuation of therapy in type 2 diabetes mellitus in a patient who has previously received and been stabilised on a PBS-subsidised regimen of anti-diabetic medicines which includes both rosiglitazone maleate and insulin