National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 5)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 12 May 2014
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 5).
(2) This Instrument may also be cited as PB 36 of 2014.
2 Commencement
This Instrument commences on 1 June 2014.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
[1] Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Fonat Plus | AF | MP NP | C4122 C4123 C4133 |
| 4 | 5 | 4 |
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|
[2] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Cadivast 5/10 | AF | MP NP | C2449 C2450 C2451 |
| 30 | 5 | 30 |
|
|
[3] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Cadivast 5/20 | AF | MP NP | C2449 C2450 C2451 |
| 30 | 5 | 30 |
|
|
[4] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Cadivast 5/40 | AF | MP NP | C2449 C2450 C2451 |
| 30 | 5 | 30 |
|
|
[5] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Cadivast 5/80 | AF | MP NP | C2449 C2450 C2451 |
| 30 | 5 | 30 |
|
|
[6] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Cadivast 10/10 | AF | MP NP | C2449 C2450 C2451 |
| 30 | 5 | 30 |
|
|
[7] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Cadivast 10/20 | AF | MP NP | C2449 C2450 C2451 |
| 30 | 5 | 30 |
|
|
[8] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Cadivast 10/40 | AF | MP NP | C2449 C2450 C2451 |
| 30 | 5 | 30 |
|
|
[9] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Cadivast 10/80 | AF | MP NP | C2449 C2450 C2451 |
| 30 | 5 | 30 |
|
|
[10] Schedule 1, entry for Arginine with carbohydrate in each of the forms: Sachets of oral powder 4 g containing 500 mg arginine, 30 (Arginine 500); and Sachets of oral powder 4 g containing 2 g arginine, 30 (Arginine 2000)
omit from the column headed “Circumstances”: C1458 substitute: C4555
[11] Schedule 1, after entry for Arginine with carbohydrate in the form Sachets of oral powder 4 g containing 2 g arginine, 30 (Arginine 2000)
insert:
| Sachets of oral powder 7.6 g containing 5 g arginine, 30 (Arginine 5000) | Oral | Arginine 5000 | VF | MP NP | C4555 |
| 4 | 5 | 1 |
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|
[12] Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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| Chem mart Candesartan | CH | MP NP |
|
| 30 | 5 | 30 |
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(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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| Terry White Chemists Candesartan | TW | MP NP |
|
| 30 | 5 | 30 |
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|
[13] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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| Chem mart Candesartan HCTZ 16/12.5 | CH | MP NP | C4374 |
| 30 | 5 | 30 |
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|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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| Terry White Chemists Candesartan HCTZ 16/12.5 | TW | MP NP | C4374 |
| 30 | 5 | 30 |
|
|
[14] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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|
| Chem mart Candesartan HCTZ 32/12.5 | CH | MP NP | C4374 |
| 30 | 5 | 30 |
|
|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Terry White Chemists Candesartan HCTZ 32/12.5 | TW | MP NP | C4374 |
| 30 | 5 | 30 |
|
|
[15] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Chem mart Candesartan HCTZ 32/25 | CH | MP NP | C4374 |
| 30 | 5 | 30 |
|
|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Terry White Chemists Candesartan HCTZ 32/25 | TW | MP NP | C4374 |
| 30 | 5 | 30 |
|
|
[16] Schedule 1, entry for Codeine with Paracetamol [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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| Paracetamol/ Codeine GH 500/30 | GQ | MP NP PDP |
|
| 20 | 0 | 20 |
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|
[17] Schedule 1, entry for Codeine with Paracetamol [Maximum Quantity: 60 CN2064; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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|
| Paracetamol/ Codeine GH 500/30 | GQ | MP NP |
| P2064 | 60 | 0 | 20 |
|
|
[18] Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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| Diltiazem Actavis | UA | MP NP |
|
| 90 | 5 | 90 |
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|
[19] Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; and Tablet containing enalapril maleate
10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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|
| Enalapril Actavis | UA | MP NP |
|
| 30 | 5 | 30 |
|
|
[20] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL
(a) omit from the column headed “Brand”: Epirubicin Actavis 100 substitute: Epirubicin ACT
(b) omit from the column headed “Responsible Person”: TA substitute: VN
[21] Schedule 1, entry for Everolimus in each of the forms: Tablet 5 mg; and Tablet 10 mg
insert in numerical order in the column headed “Circumstances”: C4557
[22] Schedule 1, entry for Exemestane
substitute:
Exemestane | Tablet 25 mg | Oral | APO‑Exemestane | TX | MP | C1541 C2457 C4552 |
| 30 | 5 | 30 |
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|
|
|
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| NP | C1541 C2457 |
| 30 | 5 | 30 |
|
|
|
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| Aromasin | PF | MP | C1541 C2457 C4552 |
| 30 | 5 | 30 |
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|
|
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| NP | C1541 C2457 |
| 30 | 5 | 30 |
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|
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| Exaccord | RA | MP | C1541 C2457 C4552 |
| 30 | 5 | 30 |
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|
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| NP | C1541 C2457 |
| 30 | 5 | 30 |
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|
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| Exemestane‑GA | GN | MP | C1541 C2457 C4552 |
| 30 | 5 | 30 |
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|
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| NP | C1541 C2457 |
| 30 | 5 | 30 |
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| Exemestane GH | GQ | MP | C1541 C2457 C4552 |
| 30 | 5 | 30 |
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| NP | C1541 C2457 |
| 30 | 5 | 30 |
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| Exemestane Pfizer | FZ | MP | C1541 C2457 C4552 |
| 30 | 5 | 30 |
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|
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| NP | C1541 C2457 |
| 30 | 5 | 30 |
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|
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| Exemestane Sandoz | SZ | MP | C1541 C2457 C4552 |
| 30 | 5 | 30 |
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|
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| NP | C1541 C2457 |
| 30 | 5 | 30 |
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[23] Schedule 1, after entry for Fentanyl in the form Transdermal patch 16.8 mg [Brand: Fentanyl Sandoz]
insert:
Ferric carboxymaltose | Injection 500 mg (iron) in 10 mL | Injection | ferinject | VL | MP NP |
|
| 2 | 1 | 1 |
|
|
[24] Schedule 1, entry for Gemfibrozil
(a) omit:
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| Lopid | PF | MP | C1540 C3047 | P1540 | 60 | 5 | 60 |
|
|
|
|
|
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| NP | C1540 |
| 60 | 5 | 60 |
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|
(b) omit:
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| Lopid | PF | MP | C1540 C3047 | P3047 | 60 | 11 | 60 |
|
|
[25] Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (FreeStyle Optium)
insert in the columns in the order indicated:
| Test strips, 100 (GoodLife) | For external use | GoodLife | JN | MP NP |
|
| 1 | 5 | 1 |
|
|
|
|
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| MP |
| P4241 | 1 | 11 | 1 |
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|
[26] Schedule 1, entry for Lactulose
(a) omit:
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| Lac‑Dol | GN | MP NP | C1150 C1613 C3642 C3643 | P3643 | 3 | 0 | 1 |
|
|
(b) omit:
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| Lac‑Dol | GN | MP NP | C1150 C1613 C3642 C3643 | P3642 | 3 | 3 | 1 |
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|
(c) omit:
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| Lac‑Dol | GN | MP NP | C1150 C1613 C3642 C3643 | P1150 P1613 | 1 | 5 | 1 |
|
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[27] Schedule 1, entry for Lamotrigine in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Lamotrigine Aspen 50 | FM | MP NP | C1426 |
| 56 | 5 | 56 |
|
|
[28] Schedule 1, entry for Mycophenolic Acid in the form Capsule containing mycophenolate mofetil 250 mg
(a) omit:
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|
| Imulate | QA | MP | C1765 C1766 |
| 300 | 3 | 100 |
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|
(b) omit:
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| Imulate | QA | MP | C1650 C1651 C3355 C3356 |
| 600 | 5 | 100 |
| C(100) |
[29] Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg
(a) omit:
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|
| Imulate | QA | MP | C1765 C1766 |
| 150 | 3 | 50 |
|
|
(b) omit:
|
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| Imulate | QA | MP | C1650 C1651 C3355 C3356 |
| 300 | 5 | 50 |
| C(100) |
[30] Schedule 1, entry for Nandrolone Decanoate
omit from the column headed “Responsible Person”: MK substitute: AS
[31] Schedule 1, entry for Oestriol in each of the forms: Pessaries 500 micrograms, 15; and Vaginal cream 1 mg per g, 15 g
omit from the column headed “Responsible Person”: MK substitute: AS
[32] Schedule 1, after entry for Phenoxybenzamine in the form Capsule containing phenoxybenzamine hydrochloride 10 mg
insert in the columns in the order indicated:
| Capsule containing 10 mg phenoxybenzamine hydrochloride | Oral | Dibenzyline | BZ | MP NP | C1239 C1285 |
| 100 | 5 | 100 |
|
|
[33] Schedule 1, entry for Phenoxybenzamine
omit:
| Capsules containing phenoxybenzamine hydrochloride 10 mg, 100 | Oral | Dibenzyline | BZ | MP NP | C1239 C1285 |
| 1 | 5 | 1 |
|
|
[34] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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|
| Rabeprazole RBX | RA | MP NP | C1177 C1337 C1533 | P1177 | 30 | 2 | 30 |
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[35] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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|
| Rabeprazole RBX | RA | MP NP | C1177 C1337 C1533 | P1337 P1533 | 30 | 5 | 30 |
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[36] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
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|
| Risperidone Actavis 2 | UA | MP NP | C1589 C2272 C3083 | P3083 | 60 | 2 | 60 |
|
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[37] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Risperidone Actavis 2 | UA | MP NP | C1589 C2272 C3083 | P1589 P2272 | 60 | 5 | 60 |
|
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[38] Schedule 1, entry for Risperidone in the form Tablet 3 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Risperidone Actavis 3 | UA | MP NP | C1589 C2272 |
| 60 | 5 | 60 |
|
|
[39] Schedule 1, after entry for Tamoxifen in the form Tablet 20 mg (as citrate) [Brand: Tamoxifen Sandoz]
insert:
Tapentadol | Tablet (modified release) 50 mg (as hydrochloride) | Oral | Palexia SR | CS | MP NP | C4556 |
| 28 | 0 | 28 |
|
|
| Tablet (modified release) 100 mg (as hydrochloride) | Oral | Palexia SR | CS | MP NP | C4556 |
| 28 | 0 | 28 |
|
|
| Tablet (modified release) 150 mg (as hydrochloride) | Oral | Palexia SR | CS | MP NP | C4556 |
| 28 | 0 | 28 |
|
|
| Tablet (modified release) 200 mg (as hydrochloride) | Oral | Palexia SR | CS | MP NP | C4556 |
| 28 | 0 | 28 |
|
|
| Tablet (modified release) 250 mg (as hydrochloride) | Oral | Palexia SR | CS | MP NP | C4556 |
| 28 | 0 | 28 |
|
|
[40] Schedule 3, after details relevant to Responsible Person code JJ
insert:
JN | JNS Biomedical Pty Ltd | 79 163 593 833 |
[41] Schedule 3, after details relevant to Responsible Person code VI
insert:
VL | Vifor Pharma Pty Limited | 87 086 114 043 |
[42] Schedule 4, Part 1, entry for Arginine with carbohydrate
substitute:
Arginine with carbohydrate | C4555 |
|
| Urea cycle disorders |
|
[43] Schedule 4, Part 1, entry for Everolimus
insert in numerical order following existing text:
| C4557 |
|
| Metastatic (Stage IV) breast cancer The condition must be hormone receptor positive; AND Patient must be female; AND | Compliance with Authority Required procedures |
[44] Schedule 4, Part 1, entry for Exemestane
insert in numerical order following existing text:
| C4552 |
|
| Metastatic (Stage IV) breast cancer The condition must be hormone receptor positive; AND Patient must be female; AND |
|
[45] Schedule 4, Part 1, entry for Plerixafor [Circumstances Code: 4549]
omit from the column headed “Circumstances and Purposes”:
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR
substitute:
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
[46] Schedule 4, Part 1, entry for Plerixafor [Circumstances Code: 4550]
omit from the column headed “Circumstances and Purposes”:
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR
substitute:
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
[47] Schedule 4, Part 1, after entry for Tamoxifen
insert:
Tapentadol
| C4556 |
|
| Chronic severe disabling pain The condition must be unresponsive to non-narcotic analgesics |
|