National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 64 of 2009) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 64 of 2009

Amendment determination under section 84AF of the National Health Act 1953

I, LINDA JACKSON, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under section 84AF of the National Health Act 1953.

Dated 6 July 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 August 2009.

2              Amendment of PB 115 of 2008

Schedule 1 amends PB 115 of 2008.

Schedule 1        Amendments

[1]Schedule 1, after item dealing with Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL (Clamoxyl)

insert in the columns in the order indicated:

Amoxycillin with Clavulanic Acid Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL Oral Curam Sandoz Pty Ltd 60 075 449 553

[2]Schedule 1, after item dealing with Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL (Clamoxyl Duo 400)

insert in the columns in the order indicated:

Amoxycillin with Clavulanic Acid Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with
57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL 		Oral Curam Duo Sandoz Pty Ltd 60 075 449 553
Amoxycillin with Clavulanic Acid Tablet containing
500 mg amoxycillin (as trihydrate) with
125 mg clavulanic acid (as potassium clavulanate) 		Oral APO-Amoxycillin/
Clavulanic Acid 500/125 		Apotex Pty Ltd 52 096 916 148

[3]Schedule 1, item dealing with Ampicillin in the form Powder for injection 1 g (as sodium) (Ibimicyn)

omit from the columns in the order indicated:

Genepharm Pty Ltd 68 118 734 795

and substitute:

Specialised Therapeutics Australia Pty Ltd 73 124 031 241

[4]Schedule 1, item dealing with Ampicillin in the form Powder for injection 500 mg (as sodium) (Ibimicyn)

omit from the columns in the order indicated:

Genepharm Pty Ltd 68 118 734 795

and substitute:

Specialised Therapeutics Australia Pty Ltd 73 124 031 241

[5]Schedule 1, after items dealing with Aripiprazole

insert in the columns in the order indicated:

Arsenic Injection concentrate containing arsenic trioxide 10 mg in
10 mL 		Injection Phenasen Virgo Unit Trust 77 695 661 635

[6]Schedule 1, after item dealing with Azithromycin in the form Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL

insert in the columns in the order indicated:

Azithromycin Tablet 500 mg (as dihydrate) Oral Azithromycin Sandoz Sandoz Pty Ltd 60 075 449 553

[7]Schedule 1, after item dealing with Bimatoprost

insert in the columns in the order indicated:

Bimatoprost with timolol Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL Application to the eye Ganfort 0.3/5 Allergan Australia Pty Limited 85 000 612 831

[8]Schedule 1, items dealing with Bisacodyl

omit from the columns in the order indicated:

Bisacodyl Suppositories 10 mg, 12 Rectal Fleet Laxative Suppositories C.B. Fleet Co. (Aust.) Pty Ltd 67 004 098 266

[9]Schedule 1, after item dealing with Bisoprolol in the form Tablet containing bisoprolol fumarate 10 mg

insert in the columns in the order indicated:

Bisoprolol Tablet containing bisoprolol fumarate
10 mg 		Oral Bisoprolol Sandoz Sandoz Pty Ltd 60 075 449 553
Bisoprolol Tablet containing bisoprolol fumarate
10 mg 		Oral Bispro 10 Alphapharm Pty Ltd 93 002 359 739

  1. Schedule 1, after item dealing with Bisoprolol in the form Tablet containing bisoprolol fumarate 2.5 mg

insert in the columns in the order indicated:

Bisoprolol Tablet containing bisoprolol fumarate
2.5 mg 		Oral Bisoprolol Sandoz Sandoz Pty Ltd 60 075 449 553
Bisoprolol Tablet containing bisoprolol fumarate
2.5 mg 		Oral Bispro 2.5 Alphapharm Pty Ltd 93 002 359 739

  1. Schedule 1, after item dealing with Bisoprolol in the form Tablet containing bisoprolol fumarate 5 mg

insert in the columns in the order indicated:

Bisoprolol Tablet containing bisoprolol fumarate
5 mg 		Oral Bisoprolol Sandoz Sandoz Pty Ltd 60 075 449 553
Bisoprolol Tablet containing bisoprolol fumarate
5 mg 		Oral Bispro 5 Alphapharm Pty Ltd 93 002 359 739

  1. Schedule 1, after item dealing with Busulfan

insert in the columns in the order indicated:

Cabergoline Tablet 1 mg Oral Bergoline 1 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, after item dealing with Cabergoline in the form Tablet
    1 mg (Cabaser)

insert in the columns in the order indicated:

Cabergoline Tablet 2 mg Oral Bergoline 2 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, after item dealing with Cabergoline in the form Tablet
    500 micrograms

insert in the columns in the order indicated:

Cabergoline Tablet 500 micrograms Oral Tinexa Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 12.5 mg (Dilasig 12.5) 

omit from the columns in the order indicated:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

and substitute:

Fawns and McAllan Proprietary Limited 16 004 296 066

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 12.5 mg (Vedilol 12.5) 

omit from the columns in the order indicated:

Spirit Pharmaceuticals Pty Ltd 67 109 225 747

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 25 mg (Dilasig 25) 

omit from the columns in the order indicated:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

and substitute:

Fawns and McAllan Proprietary Limited 16 004 296 066

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 25 mg (Vedilol 25) 

omit from the columns in the order indicated:

Spirit Pharmaceuticals Pty Ltd 67 109 225 747

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 3.125 mg (Dilasig 3.125) 

omit from the columns in the order indicated:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

and substitute:

Fawns and McAllan Proprietary Limited 16 004 296 066

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 3.125 mg (Vedilol 3.125) 

omit from the columns in the order indicated:

Spirit Pharmaceuticals Pty Ltd 67 109 225 747

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 6.25 mg (Dilasig 6.25) 

omit from the columns in the order indicated:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

and substitute:

Fawns and McAllan Proprietary Limited 16 004 296 066

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 6.25mg (Vedilol 6.25) 

omit from the columns in the order indicated:

Spirit Pharmaceuticals Pty Ltd 67 109 225 747

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, omit item dealing with Chorionic Gonadotrophin in the form Injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL

  1. Schedule 1, after item dealing with Citalopram in the form Tablet
    10 mg (as hydrobromide)

insert in the columns in the order indicated:

Citalopram Tablet 20 mg (as hydrobromide) Oral APO-Citalopram Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Clarithromycin in the form Powder for oral liquid 250 mg per 5 mL, 50 mL

insert in the columns in the order indicated:

Clarithromycin Tablet 250 mg Oral APO-Clarithromycin Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Codeine

insert in the columns in the order indicated:

Codeine with Paracetamol Tablet containing codeine phosphate
30 mg with paracetamol 500 mg 		Oral APO-Paracetamol/
Codeine 500/30 		Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Escitalopram in the form Tablet
    10 mg (as oxalate) (Esitalo)

insert in the columns in the order indicated:

Escitalopram Tablet 10 mg (as oxalate) Oral Lexam 10 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, after item dealing with Escitalopram in the form Tablet
    20 mg (as oxalate) (Esitalo)

insert in the columns in the order indicated:

Escitalopram Tablet 20 mg (as oxalate) Oral Lexam 20 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, after item dealing with Essential amino acids formula with vitamins and minerals

insert in the columns in the order indicated:

Etanercept Injection 50 mg in
1 mL single use injection pen, 4 		Injection Enbrel Wyeth Australia Pty Limited 16 000 296 211

  1. Schedule 1, item dealing with Flucloxacillin in the form Powder for injection 1 g (as sodium) (Flubiclox)

omit from the columns in the order indicated:

Genepharm Pty Ltd 68 118 734 795

and substitute:

Specialised Therapeutics Australia Pty Ltd 73 124 031 241

  1. Schedule 1, item dealing with Flucloxacillin in the form Powder for injection 500 mg (as sodium) (Flubiclox)

omit from the columns in the order indicated:

Genepharm Pty Ltd 68 118 734 795

and substitute:

Specialised Therapeutics Australia Pty Ltd 73 124 031 241

  1. Schedule 1, after item dealing with Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL

insert in the columns in the order indicated:

Gemcitabine Solution concentrate for I.V. infusion
500 mg (as hydrochloride) in
50 mL 		Injection Gemcitabine Ebewe InterPharma Pty Ltd 19 099 877 899

  1. Schedule 1, after item dealing with Glucagon

insert in the columns in the order indicated:

Glucose I.V. infusion
139 mmol (anhydrous) per 500 mL, 500 mL 		Injection B.Braun Australia Pty Ltd B.Braun Australia Pty Ltd 56 002 945 155
Glucose I.V. infusion
139 mmol (anhydrous) per 500 mL, 500 mL 		Injection Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited 39 109 383 593
Glucose I.V. infusion
278 mmol (anhydrous) per 500 mL, 500 mL 		Injection Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited 39 109 383 593
Glucose I.V. infusion
278 mmol (anhydrous) per L, 1 L 		Injection B.Braun Australia Pty Ltd B.Braun Australia Pty Ltd 56 002 945 155

  1. Schedule 1, after item dealing with Glucose in the form I.V. infusion 278 mmol (anhydrous) per L, 1 L (Baxter Healthcare Pty Ltd)

insert in the columns in the order indicated:

Glucose I.V. infusion
69.5 mmol (anhydrous) per
250 mL, 250 mL 		Injection B.Braun Australia Pty Ltd B.Braun Australia Pty Ltd 56 002 945 155

  1. Schedule 1, items dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Glucose Indicator—Blood Electrode strips, 100 (TrueSense) For external use TrueSense Abbott Australasia Pty Ltd 95 000 180 389

  1. Schedule 1, after item dealing with Glucose Indicator—Blood in the form Electrode strips, 50 (MWD Pen Sensor Strips)

insert in the columns in the order indicated:

Glucose Indicator—Blood Electrode strips, 50 (MyGlucoHealth) For external use MyGlucoHealth Entra Health Systems Pty Ltd 14 135 973 303

  1. Schedule 1, after item dealing with Hexamine

insert in the columns in the order indicated:

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate Oral powder 300 g (KetoCal) Oral KetoCal Nutricia Australia Pty Limited 99 076 246 752

  1. Schedule 1, after item dealing with Hypromellose in the form Eye drops 5 mg per mL, 15 mL

insert in the columns in the order indicated:

Hypromellose Oral gel 20 mg per g, 100 g Oral application Aquae Gel Hamilton Pharmaceutical Pty Ltd 93 008 204 635

  1. Schedule 1, item dealing with Insulin Lispro in the form Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 (Humalog Pen)

omit from the column headed “Brand”:

Humalog Pen

and substitute:

Humalog KwikPen

  1. Schedule 1, item dealing with Insulin Lispro with Insulin Lispro Protamine Suspension in the form Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5 (Humalog Mix25 Pen)

omit from the column headed “Brand”:

Humalog Mix25 Pen

and substitute:

Humalog Mix25 KwikPen

  1. Schedule 1, item dealing with Insulin Lispro with Insulin Lispro Protamine Suspension in the form Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5 (Humalog Mix50 Pen)

omit from the column headed “Brand”:

Humalog Mix50 Pen

and substitute:

Humalog Mix50 KwikPen

  1. Schedule 1, after item dealing with Lisinopril in the form Tablet 20 mg (Lisinopril Ranbaxy)

insert in the columns in the order indicated:

Lisinopril Tablet 20 mg Oral Lisinopril Sandoz Sandoz Pty Ltd 60 075 449 553

  1. Schedule 1, after item dealing with Morphine in the form Tablet containing morphine sulfate 10 mg

insert in the columns in the order indicated:

Morphine Tablet containing morphine sulfate
10 mg (controlled release) 		Oral Momex SR 10 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, after item dealing with Morphine in the form Tablet containing morphine sulfate 10 mg (controlled release) (MS Contin)

insert in the columns in the order indicated:

Morphine Tablet containing morphine sulfate
100 mg (controlled release) 		Oral Momex SR 100 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, after item dealing with Morphine in the form Tablet containing morphine sulfate 30 mg

insert in the columns in the order indicated:

Morphine Tablet containing morphine sulfate
30 mg (controlled release) 		Oral Momex SR 30 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, after item dealing with Morphine in the form Tablet containing morphine sulfate 5 mg (controlled release)

insert in the columns in the order indicated:

Morphine Tablet containing morphine sulfate
60 mg (controlled release) 		Oral Momex SR 60 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, after item dealing with Nifedipine in the form Tablet 30 mg (controlled release) (Adefin XL 30)

insert in the columns in the order indicated:

Nifedipine Tablet 30 mg (controlled release) Oral APO-Nifedipine XR Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Nifedipine in the form Tablet 60 mg (controlled release) (Adefin XL 60)

insert in the columns in the order indicated:

Nifedipine Tablet 60 mg (controlled release) Oral APO-Nifedipine XR Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Oxybutynin in the form Tablet containing oxybutynin hydrochloride 5 mg (Oxybutynin Winthrop)

insert in the columns in the order indicated:

Oxybutynin Transdermal patches 36 mg, 8 Transdermal Oxytrol Hospira Pty Limited 13 107 058 328

  1. Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL (Baxter Paclitaxel)

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion
100 mg in 16.7 mL 		Injection Paclitaxel Actavis Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL (Anzatax)

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion
150 mg in 25 mL 		Injection Paclitaxel Actavis Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL (Baxter Paclitaxel)

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion 30 mg in 5 mL Injection Paclitaxel Actavis Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL (Baxter Paclitaxel)

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion 300 mg in 50 mL Injection Paclitaxel Actavis Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after item dealing with Paracetamol in the form Suppositories 500 mg, 24

insert in the columns in the order indicated:

Paracetamol Tablet 500 mg Oral APO-Paracetamol Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, items dealing with Paracetamol

omit from the columns in the order indicated:

Paracetamol Tablet 500 mg Oral Parmol Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

  1. Schedule 1, after item dealing with Paroxetine in the form Tablet
    20 mg (as hydrochloride) (Paroxetine-DP)

insert in the columns in the order indicated:

Paroxetine Tablet 20 mg (as hydrochloride) Oral Paroxetine-GA Ascent Pharmahealth Ltd 52 107 340 367

  1. Schedule 1, after items dealing with Pravastatin

insert in the columns in the order indicated:

Praziquantel Tablet 600 mg Oral Biltricide Bayer Australia Ltd 22 000 138 714

  1. Schedule 1, after item dealing with Ramipril in the form Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg

insert in the columns in the order indicated:

Ramipril Tablet 1.25 mg Oral APO-Ramipril Apotex Pty Ltd 52 096 916 148
Ramipril Tablet 1.25 mg Oral Chem mart Ramipril Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Ramipril in the form Tablet 1.25 mg (Ramipril Winthrop)

insert in the columns in the order indicated:

Ramipril Tablet 1.25 mg Oral Terry White Chemists Ramipril Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Ramipril in the form Tablet 1.25 mg (Tryzan Tabs 1.25)

insert in the columns in the order indicated:

Ramipril Tablet 10 mg Oral APO-Ramipril Apotex Pty Ltd 52 096 916 148
Ramipril Tablet 10 mg Oral Chem mart Ramipril Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Ramipril in the form Tablet 10 mg (Ramipril Sandoz)

insert in the columns in the order indicated:

Ramipril Tablet 10 mg Oral Terry White Chemists Ramipril Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Ramipril in the form Tablet 10 mg (Tryzan Tabs 10)

insert in the columns in the order indicated:

Ramipril Tablet 2.5 mg Oral APO-Ramipril Apotex Pty Ltd 52 096 916 148
Ramipril Tablet 2.5 mg Oral Chem mart Ramipril Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Ramipril in the form Tablet 2.5 mg (Ramipril Winthrop)

insert in the columns in the order indicated:

Ramipril Tablet 2.5 mg Oral Terry White Chemists Ramipril Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Ramipril in the form Tablet 2.5 mg (Tryzan Tabs 2.5)

insert in the columns in the order indicated:

Ramipril Tablet 5 mg Oral APO-Ramipril Apotex Pty Ltd 52 096 916 148
Ramipril Tablet 5 mg Oral Chem mart Ramipril Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Ramipril in the form Tablet 5 mg (Ramipril Winthrop)

insert in the columns in the order indicated:

Ramipril Tablet 5 mg Oral Terry White Chemists Ramipril Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after items dealing with Rituximab

insert in the columns in the order indicated:

Rivaroxaban Tablet 10 mg Oral Xarelto Bayer Australia Ltd 22 000 138 714
Rivaroxaban Tablet 10 mg, 15 Oral Xarelto Bayer Australia Ltd 22 000 138 714
Rivaroxaban Tablet 10 mg, 30 Oral Xarelto Bayer Australia Ltd 22 000 138 714

  1. Schedule 1, after items dealing with Sitagliptin

insert in the columns in the order indicated:

Sitagliptin with metformin Tablet containing
50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride 		Oral Janumet Merck Sharp & Dohme (Australia) Pty Ltd 14 000 173 508
Sitagliptin with metformin Tablet containing
50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride 		Oral Janumet Merck Sharp & Dohme (Australia) Pty Ltd 14 000 173 508
Sitagliptin with metformin Tablet containing
50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride 		Oral Janumet Merck Sharp & Dohme (Australia) Pty Ltd 14 000 173 508

  1. Schedule 1, after item dealing with Sodium Acid Phosphate

insert in the columns in the order indicated:

Sodium Chloride I.V. infusion
154 mmol per L, 1 L 		Injection B.Braun Australia Pty Ltd B.Braun Australia Pty Ltd 56 002 945 155

  1. Schedule 1, after item dealing with Sodium Chloride in the form I.V. infusion 154 mmol per L, 1 L (Baxter Healthcare Pty Ltd)

insert in the columns in the order indicated:

Sodium Chloride I.V. infusion
38.5 mmol per
250 mL, 250 mL 		Injection B.Braun Australia Pty Ltd B.Braun Australia Pty Ltd 56 002 945 155

  1. Schedule 1, after item dealing with Sodium Chloride in the form I.V. infusion 513 mmol per L, 1 L

insert in the columns in the order indicated:

Sodium Chloride I.V. infusion 77 mmol per 500 mL, 500 mL Injection B.Braun Australia Pty Ltd B.Braun Australia Pty Ltd 56 002 945 155
Sodium Chloride I.V. infusion 77 mmol per 500 mL, 500 mL Injection Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited 39 109 383 593

  1. Schedule 1, after item dealing with Sodium Chloride with Glucose in the form I.V. infusion 39 mmol-69 mmol (anhydrous) per 500 mL,
    500 mL

insert in the columns in the order indicated:

Sodium Lactate Compound I.V. infusion containing approximately
131 mmol sodium (as lactate and chloride),
5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and
111 mmol chloride per L, 1 L 		Injection B.Braun Australia Pty Ltd B.Braun Australia Pty Ltd 56 002 945 155

  1. Schedule 1, after item dealing with Sodium Lactate Compound in the form I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride), 0.9 mmol calcium (as chloride), 14 mmol bicarbonate (as lactate) and 56 mmol chloride per 500 mL, 500 mL

insert in the columns in the order indicated:

Sodium Lactate Compound I.V. infusion containing approximately
65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride),
0.9 mmol calcium (as chloride), 14 mmol bicarbonate (as lactate) and 56 mmol chloride per 500 mL, 500 mL 		Injection Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited 39 109 383 593

  1. Schedule 1, after items dealing with Sotalol

insert in the columns in the order indicated:

Soy lecithin Eye spray 10 mg per mL, 10 mL Application tearsagain Bio Revive Pty Ltd 58 097 360 417

  1. Schedule 1, after items dealing with Telmisartan with Hydrochlorothiazide

insert in the columns in the order indicated:

Temazepam Tablet 10 mg Oral APO-Temazepam Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, item dealing with Teriparatide

omit from the column headed “Form”:

3 mL

and substitute:

2.4 mL

  1. Schedule 1, after items dealing with Vinorelbine

insert in the columns in the order indicated:

Voriconazole Powder for oral suspension 40 mg per mL, 70 mL Oral Vfend Pfizer Australia Pty Ltd 50 008 422 348
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