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National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 2) (No. PB 17 of 2011)

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PB 17 of 2011
National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 2)
 
National Health Act 1953
___________________________________________________________________________
 
I, FELICITY MCNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 24 February 2011
 
 
 
 
 
 
 
 
 
 
 
FELICITY MCNEILL
Acting First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
___________________________________________________________________
 
 
 
 
 
1              Name of Instrument
 
(1)                This Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No.2).
 
(2)                This Instrument may also be cited as PB 17 of 2011.
 
2                Commencement
                            This Instrument commences on 1 March 2011.
3              Amendments to PB 117 of 2010
                            Schedule 1 amends PB 117 of 2010.
 
Schedule 1                   Amendments
[1]   Schedule 1, entry for “BCG Immunotherapeutic” (Baccillis Calmette- Guérin/ Connaught strain)
omit from the column headed ‘Form’:
Single dose set comprising 1 vial powder for intravesical administration containing 6.6 to 19.2 x 10 8 CFU and 1 vial diluent 3 mL
substitute:
Powder for intravesical administration containing 6.6 to 19.2 x 10 8 CFU
 
[2]   Schedule 1, entry for Bleomycin  
 omit:
 
 
 
Blenoxane
BQ
EMP
C1139
C1198
 
10
0
 
 
[3]   Schedule 1, after entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL:
insert in the columns in the order indicated:

 
Solution concentrate for I.V. infusion 20 mg in 2 mL
Injection
DBL Docetaxel Concentrated Injection
HH
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P3051
1
0
 

 
 
 
Docetaxel Ebewe
IT
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P3051
1
0
 

 
 
 
DBL Docetaxel Concentrated Injection
HH
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P1194 P1742 P2416 P2439 P2732 P3292 P3428
2
0
 

 
 
 
Docetaxel Ebewe
IT
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P1194 P1742 P2416 P2439 P2732 P3292 P3428
2
0
 

 
[4]   Schedule 1, after entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL:
Insert in the columns in the order indicated:

 
Solution concentrate for I.V. infusion 80 mg in 8 mL
Injection
DBL Docetaxel Concentrated Injection
HH
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
 
1
0
 

 
 
 
Docetaxel Ebewe
IT
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
 
1
0
 

 
[5]   Schedule 1, entry for Ondansetron
substitute:

Ondansetron
Tablet (orally disintegrating) 4 mg
Oral
Ondansetron ODT-DRLA
RZ
EMP
C3050
 
4
0
 

 
Tablet (orally disintegrating) 8 mg
Oral
Ondansetron ODT-DRLA
RZ
EMP
C3050
 
4
0
 

 
Tablet 4 mg (as hydrochloride dihydrate)
Oral
APO-Ondansetron
TX
EMP
C3050
 
4
0
 

 
 
 
Ondansetron-DRLA
RZ
EMP
C3050
 
4
0
 

 
 
 
Ondaz
SZ
EMP
C3050
 
4
0
 

 
 
 
Onsetron 4
ZP
EMP
C3050
 
4
0
 

 
 
 
Zofran
GK
EMP
C3050
 
4
0
 

 
Tablet 8 mg (as hydrochloride dihydrate)
Oral
APO-Ondansetron
TX
EMP
C3050
 
4
0
 

 
 
 
Ondansetron-DRLA
RZ
EMP
C3050
 
4
0
 

 
 
 
Ondaz
SZ
EMP
C3050
 
4
0
 

 
 
 
Onsetron 8
ZP
EMP
C3050
 
4
0
 

 
 
 
Zofran
GK
EMP
C3050
 
4
0
 

 
Wafer 4 mg
Oral
Ondaz Zydis
SZ
EMP
C3050
 
4
0
 

 
 
 
Zofran Zydis
GK
EMP
C3050
 
4
0
 

 
Wafer 8 mg
Oral
Ondaz Zydis
SZ
EMP
C3050
 
4
0
 

 
 
 
Zofran Zydis
GK
EMP
C3050
 
4
0
 

 
Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL
Oral
Zofran syrup 50 mL
GK
EMP
C3050
 
1
0
 

 
I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL
Injection
Ondansetron-Claris
AE
EMP
C3050
 
1
0
 

 
 
 
Ondaz
SZ
EMP
C3050
 
1
0
 

 
 
 
Onsetron
ZP
EMP
C3050
 
1
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
C3050
 
1
0
 

 
 
 
Zofran
GK
EMP
C3050
 
1
0
 

 
I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
Injection
Ondansetron-Claris
AE
EMP
C3050
 
1
0
 

 
 
 
Ondaz
SZ
EMP
C3050
 
1
0
 

 
 
 
Onsetron
ZP
EMP
C3050
 
1
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
C3050
 
1
0
 

 
 
 
Zofran
GK
EMP
C3050
 
1
0
 

 
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 
See http://www.frli.gov.au.