Instrument number PB 74 of 2007
Amendment special arrangements under subsection 100(1) of the National Health Act 1953
I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.
Dated 6 Sept 2007
STEPHEN DELLAR
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment Special Arrangements — Chemotherapy Pharmaceuticals Access Program
1 Commencement
This instrument commences on 1 October 2007.
2 Amendment of PB 54 of 2007
Schedule 1 amends PB 54 of 2007.
Schedule 1 Amendments
(section 2)
[1] Schedule 1, omit item dealing with Calcium Folinate
[2] Schedule 1, omit item dealing with Cetuximab
and substitute:
Cetuximab | In compliance with authority procedures set out in paragraph 14: Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration-approved Product Information Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated |
[3] Schedule 1, after item dealing with Fluorouracil
insert in the columns in the order indicated:
Folinic acid | In respect of the tablet containing calcium folinate equivalent to 15 mg folinic acid: Antidote to folic acid antagonists In respect of the injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL, injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL and injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL: — |
[4] Schedule 2, omit items dealing with Calcium Folinate
[5] Schedule 2, after item dealing with Fluorouracil
insert in the columns in the order indicated:
Folinic acid | Tablet containing calcium folinate equivalent to 15 mg folinic acid | Oral | 10 | .. | Leucovorin Calcium (Mayne Pharma Pty Ltd) |
Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL | Injection | 5 | 5 | Calcium Folinate Ebewe Leucovorin Calcium (Mayne Pharma Pty Ltd) Leucovorin Calcium (Pfizer Pty Limited) | |
Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL | Injection | 10 | 1 | Calcium Folinate Ebewe Leucovorin Calcium (Pfizer Pty Limited) | |
Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL | Injection | 4 | 1 | Leucovorin Calcium (Mayne Pharma Pty Ltd) |
[6] Schedule 2, after item dealing with Oxaliplatin in the form Powder for I.V. infusion 100 mg
insert in the columns in the order indicated:
| Solution concentrate for I.V. infusion 200 mg in 40 mL | Injection | 1 | 2 | Eloxatin |
[7] Schedule 4, omit item dealing with Calcium Folinate
and substitute:
Folinic acid | Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL | Leucovorin Calcium (Mayne Pharma Pty Ltd) | 1
| 25.59 | 25.60 |
Leucovorin Calcium (Pfizer Pty Limited) | 10 | 205.31 | 205.51 | ||
Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL | Calcium Folinate Ebewe | 1 | 23.62 | 23.63 |