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 86 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 86 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 1st AUGUST 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 September 2008.

2              Amendment of PB 74 of 2008

Schedule 1 amends PB 74 of 2008.

Schedule 1        Amendments

[1]       Schedule 1, item dealing with Cinacalcet

insert in “Column 3” after existing text:

Maintenance therapy, following initiation and stabilisation of treatment with cinacalcet, of a patient with chronic kidney disease on dialysis who has intact parathyroid hormone (iPTH) greater than 15 pmol per L and an (adjusted) serum calcium concentration of less than 2.6 mmol per L after 6 months treatment

[2]       Schedule 1, item dealing with Clarithromycin

omit from “Column 3”:

—

and substitute:

In respect of the tablet 250 mg:

—

In respect of the powder for oral liquid 250 mg per 5 mL, 50 mL:

Bordetella pertussis

Atypical mycobacterial infections

[3]       Schedule 1, omit item dealing with Dipivefrine

[4]       Schedule 1, item dealing with Glucose Indicator―Blood

insert in “Column 3” after “In respect of the” (first occurring):

electrode strips, 25 (On-Call Plus),

[5]       Schedule 1, item dealing with Sevelamer

(a) insert in “Column 3” after “greater than 1.6 mmol per L”:

at the commencement of therapy

(b) insert in “Column 3” after “greater than 4.0”:

at the commencement of therapy

[6]       Schedule 3, after item dealing with Chlorhexidine

insert in the columns in the order indicated:

Clarithromycin Clarithromycin with Water – Purified BP

[7]       Schedule 3, item dealing with Water – Purified BP

insert in “Column 2” after “Cephalexin with Water – Purified BP”:

Clarithromycin with Water – Purified BP