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 14 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 14 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 2^nd January 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 February 2008.

2              Amendment of PB 88 of 2007

Schedule 1 amends PB 88 of 2007.

Schedule 1        Amendments

[1]       Schedule 1, item dealing with Influenza Vaccine

omit from “Column 3”:

In respect of the injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H₁N₁)-like strain 7.5 micrograms haemagglutinin; A/Wisconsin/67/2005 (H₃N₂)-like strain 7.5 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe:

Children up to 35 months of age at increased risk of adverse consequences from infections of the lower respiratory tract

In respect of the injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H₁N₁)-like strain 15 micrograms haemagglutinin; A/Wisconsin/67/2005 (H₃N₂)-like strain 15 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe:

Persons at special risk of adverse consequences from infections of the lower respiratory tract

and substitute:

In respect of the injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/Solomon Islands/3/2006 (H₁N₁)-like strain 7.5 micrograms haemagglutinin; A/Brisbane/10/2007 (H₃N₂)-like strain 7.5 micrograms haemagglutinin; B/Florida/4/2006-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe:

Children up to 35 months of age at increased risk of adverse consequences from infections of the lower respiratory tract

In respect of the injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/Solomon Islands/3/2006 (H₁N₁)-like strain 15 micrograms haemagglutinin; A/Brisbane/10/2007 (H₃N₂)-like strain 15 micrograms haemagglutinin; B/Florida/4/2006-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe:

Persons at special risk of adverse consequences from infections of the lower respiratory tract

[2]       Schedule 1, item dealing with Metoprolol

omit from the columns in the order indicated:

Metoprolol

In respect of the pack containing 15 tablets metoprolol succinate 23.75 mg (controlled release), 15 tablets metoprolol succinate 47.5 mg (controlled release) and 15 tablets metoprolol succinate 95 mg (controlled release), tablet containing metoprolol succinate 23.75 mg (controlled release), tablet containing metoprolol succinate 47.5 mg (controlled release), tablet containing metoprolol succinate 95 mg (controlled release) and tablet containing metoprolol succinate 190 mg (controlled release):

In compliance with authority procedures set out in subparagraph 14 (d):

1734

 Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated

In respect of the tablet containing metoprolol tartrate 50 mg and tablet containing metoprolol tartrate 100 mg:

—

and substitute:

Metoprolol	—
Metoprolol succinate	In compliance with authority procedures set out in subparagraph 14 (d):
1734	Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated

[3]       Schedule 1, item dealing with Pemetrexed

omit from “Column 3” the words:

Pleural mesothelioma

and substitute

Mesothelioma

[4]       Schedule 1, item dealing with Pioglitazone

insert in the columns in the order indicated, immediately after the existing circumstances:

2648	Treatment of type 2 diabetes, in combination with metformin hydrochloride and a sulfonylurea, in a patient:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a thiazolidinedione (glitazone) is greater than 7%, despite treatment with maximally tolerated doses of metformin hydrochloride and a sulfonylurea; 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 a thiazolidinedione (glitazone) shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with maximally tolerated doses of metformin hydrochloride and a sulfonylurea; 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 glitazone treatment is initiated

[5]       Schedule 2A, after item dealing with Sulfacetamide

insert:

Tamarindus indica seed polysaccharide

In compliance with authority procedures set out in subparagraph 14 (d):

Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops