COMMONWEALTH OF AUSTRALIA
Instrument number PB 129 of 2009
Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953
I, ROGER BUSCH, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.
Dated 21 December 2009
 
 
 
ROGER BUSCH
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
 
Amendment determination — pharmaceutical benefits
1              Commencement
                This instrument commences on 1 February 2010.
2              Amendment of PB 114 of 2008
                Schedule 1 amends PB 114 of 2008.
Schedule 1            Amendments
 
[1]                 Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins and minerals without phenylalanine
omit from the columns in the order indicated:
 
Sachets containing oral powder 29 g, 30 (Minaphlex)
Oral
4
5
Minaphlex
and substitute:
 
Sachets containing oral powder 29 g, 30 (PKU Anamix Junior)
Oral
4
5
PKU Anamix Junior
[2]                 Part 1 of Schedule 1, item dealing with Baclofen in the forms Tablet 10 mg and Tablet 25 mg
omit from the column headed “Brand”: Baclo
[3]                 Part 1 of Schedule 1, omit item dealing with Bifonazole
[4]                 Part 1 of Schedule 1, item dealing with Calcium
omit from the columns in the order indicated:
 
Tablet 250 mg (as citrate)
Oral
240
1
Citracal
[5]                 Part 1 of Schedule 1, item dealing with Captopril in the form Tablet 12.5 mg
omit from the column headed “Brand”: Genepharm Pty Ltd
[6]                 Part 1 of Schedule 1, item dealing with Captopril in the form Tablet 25 mg
omit from the column headed “Brand”: Captohexal        and substitute:    Captopril Sandoz
[7]                 Part 1 of Schedule 1, item dealing with Carvedilol in the forms Tablet 6.25 mg, Tablet 12.5 mg and Tablet 25 mg
insert in alphabetical order in the column headed “Brand”: Carvedilol generichealth
[8]                 Part 1 of Schedule 1, item dealing with Cephalexin in the form Capsule 250 mg (anhydrous)
insert in alphabetical order in the column headed “Brand”: Cephalexin generichealth
[9]                 Part 1 of Schedule 1, item dealing with Ciprofloxacin in the forms Tablet 500 mg (as hydrochloride) and Tablet 750 mg (as hydrochloride)
omit from the column headed “Brand”: Proquin
[10]             Part 1 of Schedule 1, item dealing with Citalopram in the form Tablet 40 mg (as hydrobromide)
(a)    insert in alphabetical order in the column headed “Brand”: APO-Citalopram
(b)    insert in alphabetical order in the column headed “Brand”: Citalopram Sandoz
(c)  omit from the column headed “Brand”: Talohexal
 
 
[11]             Part 1 of Schedule 1, item dealing with Diazepam in the form Tablet 5 mg
insert in alphabetical order in the column headed “Brand”: Diazepam-GA
[12]             Part 1 of Schedule 1, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg
omit from the column headed “Brand”: Dinac
[13]             Part 1 of Schedule 1, item dealing with Essential amino acids formula with minerals and vitamin C
omit from the columns in the order indicated:
 
Oral powder 200 g (Dialamine)
Oral
10
5
Dialamine
[14]             Part 1 of Schedule 1, item dealing with Fluconazole in the form Capsule 50 mg
omit from the column headed “Brand”: Fluconazole Hexal         and substitute:    Fluconazole Sandoz
[15]             Part 1 of Schedule 1, item dealing with Fluoxetine in the form Capsule 20 mg (as hydrochloride)
insert in alphabetical order in the column headed “Brand”: Fluoxetine-GA
[16]             Part 1 of Schedule 1, item dealing with Gemcitabine in the forms Powder for I.V. infusion 200 mg (as hydrochloride) and Powder for I.V. infusion 1 g (as hydrochloride)
insert in alphabetical order in the column headed “Brand”: Gemcitabine Ebewe
[17]             Part 1 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 50 (Betachek G5)
insert in the columns in the order indicated:
 
 
Test strips, 50 (Bionime Rightest)
For external use
2
5
Bionime Rightest
[18]             Part 1 of Schedule 1, after item dealing with Hydromorphone in the form Tablet containing hydromorphone hydrochloride 8 mg
insert in the columns in the order indicated:
 
Tablet (modified release) containing hydromorphone hydrochloride 4 mg
Oral
10
..
Jurnista
[19]             Part 1 of Schedule 1, omit item dealing with Influenza Vaccine
and substitute in the columns in the order indicated:

Influenza Vaccine
Injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/California/7/2009 (H1N1)-like strain 7.5 micrograms haemagglutinin; A/Perth/16/2009 (H3N2)-like strain 7.5 micrograms haemagglutinin; B/Brisbane/60/2008-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe
Injection
1
..
Fluvax Junior
Vaxigrip Junior

 
Injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/California/7/2009 (H1N1)-like strain 15 micrograms haemagglutinin; A/Perth/16/2009 (H3N2)-like strain 15 micrograms haemagglutinin; B/Brisbane/60/2008-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe
Injection
1
..
Fluvax
Influvac
Vaxigrip

[20]             Part 1 of Schedule 1, items dealing with Insect Allergen Extract—Honey Bee Venom, Insect Allergen Extract—Paper Wasp Venom and
Insect Allergen Extract—Yellow Jacket Venom
omit from the column headed “Form (strength, type, size, etc.)”:
vial with 9 mL vial solvent and 3 vials diluent 1.8 mL
[21]             Part 1 of Schedule 1, item dealing with Ipratropium in the form Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30
omit from the column headed “Brand”: Apoven 250
[22]             Part 1 of Schedule 1, item dealing with Ipratropium in the form Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30
omit from the column headed “Brand”: Apoven 500
[23]             Part 1 of Schedule 1, item dealing with Irinotecan in the forms I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL,
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL, I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL and I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
insert in alphabetical order in the column headed “Brand”: Irinotecan Ebewe
[24]             Part 1 of Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg
omit from the column headed “Brand”: Glucomet 500 mg
[25]             Part 1 of Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit from the column headed “Brand”: Glucomet 850 mg
[26]             Part 1 of Schedule 1, item dealing with Metoprolol in the forms Tablet containing metoprolol tartrate 50 mg and Tablet containing
metoprolol tartrate 100 mg
omit from the column headed “Brand”: Metolol
[27]             Part 1 of Schedule 1, item dealing with Mitozantrone in the form Injection 10 mg (as hydrochloride) in 5 mL
omit from the column headed “Brand”: Mitozantrone Ebewe
[28]             Part 1 of Schedule 1, item dealing with Naltrexone
insert in alphabetical order in the column headed “Brand”: Naltrexone QP
[29]             Part 1 of Schedule 1, item dealing with Nifedipine in the form Tablet 20 mg
omit from the column headed “Brand”: Nyefax 20 mg
[30]             Part 1 of Schedule 1, item dealing with Pravastatin in the forms Tablet containing pravastatin sodium 10 mg, Tablet containing pravastatin sodium 20 mg and Tablet containing pravastatin sodium 40 mg
omit from the column headed “Brand”: Pravastatin-DP
[31]             Part 1 of Schedule 1, item dealing with Ranitidine in the form Tablet 300 mg (as hydrochloride)
omit from the column headed “Brand”: Ranoxyl
[32]             Part 1 of Schedule 1, omit item dealing with Silver Sulfadiazine with Chlorhexidine
[33]             Part 1 of Schedule 1, item dealing with Sotalol in the form Tablet containing sotalol hydrochloride 160 mg
omit from the column headed “Brand”: Sotab
[34]             Part 1 of Schedule 1, item dealing with Tamoxifen in the form Tablet 10 mg (as citrate)
omit from the column headed “Brand”: Tamoxen 10 mg
[35]             Part 2 of Schedule 1, item dealing with Diazepam in the form Tablet 5 mg
insert in alphabetical order in the column headed “Brand”: Diazepam-GA
[36]             Part 2 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 50 (Betachek G5)
insert in the columns in the order indicated:
 
 
Test strips, 50 (Bionime Rightest)
 
For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements
For external use
2
11
Bionime Rightest
[37]             Part 2 of Schedule 1, after item dealing with Hydromorphone in the form Tablet containing hydromorphone hydrochloride 8 mg
insert in the columns in the order indicated:

 
Tablet (modified release) containing hydromorphone hydrochloride 4 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
20
..
Jurnista

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

[38]             Part 2 of Schedule 1, item dealing with Pravastatin in the forms Tablet containing pravastatin sodium 10 mg, Tablet containing pravastatin sodium 20 mg and Tablet containing pravastatin sodium 40 mg
omit from the column headed “Brand”: Pravastatin-DP
[39]             Part 1 of Schedule 2, item dealing with Diazepam in the form Tablet 5 mg
insert in alphabetical order in the column headed “Brand”: Diazepam-GA
[40]             Part 1 of Schedule 2, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg
omit from the column headed “Brand”: Dinac
[41]             Part 2 of Schedule 2, item dealing with Diazepam in the form Tablet 5 mg
insert in alphabetical order in the column headed “Brand”: Diazepam-GA
[42]             Part 2 of Schedule 2, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg
omit from the column headed “Brand”: Dinac
[43]             Part 1 of Schedule 3, item dealing with Cephalexin in the form Capsule 250 mg (anhydrous)
insert in alphabetical order in the column headed “Brand”: Cephalexin generichealth
[44]             Part 1 of Schedule 3, item dealing with Diazepam in the form Tablet 5 mg
insert in alphabetical order in the column headed “Brand”: Diazepam-GA
[45]             Part 1 of Schedule 3, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg
omit from the column headed “Brand”: Dinac
[46]             Part 1 of Schedule 3, after item dealing with Hydromorphone in the form Tablet containing hydromorphone hydrochloride 8 mg
insert in the columns in the order indicated:
 
Tablet (modified release) containing hydromorphone hydrochloride 4 mg
Oral
10
..
Jurnista