EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 69 OF 2007
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATIONS UNDER SECTIONS 85, 85A and 88
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
Subsection 85(3) authorises the Minister by legislative instrument to determine by reference to strength, type of unit, size of unit, or otherwise, the form or forms of a listed drug.
Subsection 85(5) authorises the Minister by legislative instrument to determine the manner of administration of a form of a listed drug where the form has been determined under subsection 85(3).
Subsection 85(6) authorises the Minister by legislative instrument to determine a brand of a pharmaceutical item. A “brand” is defined in subsection 84(1) to mean the trade name which the person who is or will be the “responsible person” supplies the pharmaceutical item, or if there is no tradename, the name of the responsible person. The responsible person for a brand of a pharmaceutical item is determined by the Minister by legislative instrument under section 84AF.
Subsection 85A(2) authorises the Minister to determine various matters with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit. Paragraph 85A(2)(a) authorises the determination of the maximum quantity or number of units that may in one prescription be directed to be supplied for all purposes or for a particular purpose. Paragraph 85A(2)(b) authorises the determination of the maximum number of occasions in which the supply may in one prescription be directed to be repeated for all purposes or a particular purpose. Paragraph 85A(2)(c) authorises the determination of the manner of administration that may in a prescription be directed to be used.
Section 88 provides for various matters relating to the prescribing of pharmaceutical benefits. Subsection 88(1A) authorises the Minister to determine the pharmaceutical benefits for the supply of which a dental practitioner is authorised to write a prescription.
This instrument determines matters under subsections 85(3), 85(5), 85(6), 85A(2), and 88(1A).
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends determinations under sections 85, 85A and 88 made by legislative instrument number PB 49 of 2007 which came into effect on 1 August 2007. The amendments are set out in the items of Schedule 1 to the instrument.
This instrument contains a number of changes in terminology to accord with amendments of the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 which came into effect on 1 August 2007.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 October 2007, was made on 6 September 2007.
Consultations
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.
The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 October 2007.
Paragraph 2: provides that Schedule 1 amends PB 49 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1 – PART 1
Form Added
Irbesartan with Tablet 300 mg-25 mg
Hydrochlorothiazide
Oxaliplatin Solution concentrate for I.V. infusion 200 mg in 40 mL
Brands Added
Amisulpride Tablet 100 g (Amisulpride Sandoz)
Tablet 200 g (Amisulpride Sandoz)
Tablet 400 g (Amisulpride Sandoz)
Fluconazole Capsule 100 mg (Fluconazole Winthrop)
Capsule 200 mg (Fluconazole Winthrop)
Insulin Glulisine Injections (human analogue), cartridges, 100 units per mL,
3 mL, 5 (Apidra SoloStar)
Ramipril Capsule 10 mg (Tryzan 10)
Item Deleted
Lumiracoxib Tablet 100 mg
Forms Deleted
Glucose Indicator—Blood Electrode strips, 50 (GlucoMen Sensor)
Insulin Neutral with Injection (human) 50 units-50 units per mL, 10 mL
Insulin Isophane Injections (human), cartridges, 20 units-80 units per mL, 3 mL, 5
Brands Deleted
Insulin Glulisine Injections (human analogue), cartridges, 100 units per mL,
3 mL, 5 (Apidra)
Insulin Neutral with Injection (human) 30 units-70 units per mL, 10 mL (Mixtard 30/70)
Insulin Isophane
Simvastatin Tablet 5 mg (Lipex 5)
Listed Drug Name and Form Alteration
From: |
| |
“Alfaré” | Oral powder 400 g | |
To: |
| |
Protein hydrolysate formula with medium chain triglycerides
| Oral powder 400 g (Alfaré) | |
From: |
| |
Calcium Folinate | Injection equivalent to 50 mg folinic acid in 5 mL | |
To: |
| |
Folinic acid | Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL
| |
From: |
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Calcium Folinate | Injection equivalent to 100 mg folinic acid in 10 mL | |
To: |
| |
Folinic acid | Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL
| |
From: |
| |
Calcium Folinate | Injection equivalent to 300 mg folinic acid in 30 mL | |
To: |
| |
Folinic acid | Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL
| |
From: |
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Calcium Folinate | Tablet equivalent to 15 mg folinic acid | |
To: |
| |
Folinic acid | Tablet containing calcium folinate equivalent to 15 mg folinic acid
| |
From: |
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“Caprilon” | Oral powder 420 g | |
To: |
| |
Triglycerides — medium chain, formula
| Oral powder 420 g (Caprilon) | |
From: |
| |
“Carbohydrate Free Mixture” | Oral powder 225 g | |
To: |
| |
Milk protein and fat formula with vitamins and minerals — carbohydrate free
| Oral powder 225 g (Carbohydrate Free Mixture) | |
From: |
| |
“Dialamine” | Oral powder 200 g | |
To: |
| |
Essential amino acids formula with minerals and vitamin C
| Oral powder 200 g (Dialamine) | |
From: |
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“Digestelact” | Oral powder 900 g | |
To: |
| |
Milk powder — lactose modified
| Oral powder 900 g (Digestelact) | |
From: |
| |
Diphtheria and Tetanus Vaccine — Adsorbed | Injection 0.5 mL ampoule | |
To: |
| |
Diphtheria and tetanus vaccine, adsorbed | Injection 0.5 mL
| |
From: |
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Diphtheria and Tetanus Vaccine — Adsorbed (Diluted) | Injection 0.5 mL in pre-filled syringe | |
To: |
| |
Diphtheria and tetanus vaccine, adsorbed, diluted for adult use
| Injection 0.5 mL in pre-filled syringe
| |
From: |
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“Duocal” | Oral powder 400 g | |
To: |
| |
Triglycerides, medium chain and long chain with glucose polymer
| Oral powder 400 g (Duocal) | |
From: |
| |
“Easiphen” | Oral liquid 250 mL | |
To: |
| |
Amino acid formula with vitamins and minerals without phenylalanine | Oral liquid 250 mL (Easiphen)
| |
From: |
| |
“EleCare” | Oral powder 400 g | |
To: |
| |
Amino acids — synthetic, formula | Oral powder 400 g (EleCare)
| |
From: |
| |
“Energivit” | Oral powder 400 g | |
To: |
| |
Carbohydrate, fat, vitamins, minerals and trace elements
| Oral powder 400 g (Energivit) | |
From: |
| |
“HCU gel” | Sachets containing oral powder 20 g, 30 | |
To: |
| |
Amino acid formula with vitamins and minerals without methionine
| Sachets containing oral powder 20 g, 30 (HCU gel) | |
From: |
| |
“HCU express” | Sachets containing oral powder 25 g, 30 | |
To: |
| |
Amino acid formula with vitamins and minerals without methionine
| Sachets containing oral powder 25 g, 30 (HCU express) | |
From: |
| |
“Karicare De-Lact” | Oral powder 900 g | |
To: |
| |
Milk powder — lactose free formula
| Oral powder 900 g (Karicare De-Lact) | |
From: |
| |
“Ketonex-1” | Oral powder 350 g | |
To: |
| |
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
| Oral powder 350 g (Ketonex-1) | |
From: |
| |
“Ketonex-2” | Oral powder 325 g | |
To: |
| |
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
| Oral powder 325 g (Ketonex-2) | |
From: |
| |
“Kindergen” | Oral powder 400 g | |
To: |
| |
Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
| Oral powder 400 g (Kindergen) | |
From: |
| |
“Locasol” | Low calcium compound powder 400 g | |
To: |
| |
Milk powder — synthetic
| Low calcium oral powder 400 g (Locasol) | |
From: |
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“Lophlex” | Sachets containing oral powder 27.8 g, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Sachets containing oral powder 27.8 g, 30 (Lophlex) |
From: |
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“Lophlex LQ” | Oral liquid 125 mL, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Oral liquid 125 mL, 30 (Lophlex LQ) |
From: |
|
“Mapleflex” | Sachets containing oral powder 29 g, 30 |
To: |
|
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
| Sachets containing oral powder 29 g, 30 (Mapleflex) |
From: |
|
“Metabolic Mineral Mixture” | Oral powder 250 g |
To: |
|
Mineral mixture
| Oral powder 250 g (Metabolic Mineral Mixture) |
From: |
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“Minaphlex” | Sachets containing oral powder 29 g, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Sachets containing oral powder 29 g, 30 (Minaphlex) |
From: |
|
“Monogen” | Oral powder 400 g |
To: |
|
Triglycerides — medium chain, formula
| Oral powder 400 g (Monogen) |
From: |
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“MSUD AID III” | Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
| Oral powder 500 g (MSUD AID III) |
From: |
|
“MSUD Analog” | Oral powder 400 g |
To: |
|
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
| Oral powder 400 g (MSUD Analog) |
From: |
|
“MSUD Express” | Sachets containing oral powder 25 g, 30 |
To: |
|
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
| Sachets containing oral powder 25 g, 30 (MSUD Express) |
From: |
|
“MSUD Express Cooler” | Oral liquid 130 mL, 30 |
To: |
|
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
| Oral liquid 130 mL, 30 (MSUD Express Cooler) |
From: |
|
“MSUD-gel” | Sachets containing oral powder 20 g, 30 |
To: |
|
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
| Sachets containing oral powder 20 g, 30 (MSUD-gel) |
From: |
|
“MSUD Maxamaid” | Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
| Oral powder 500 g (MSUD Maxamaid) |
From: |
|
“MSUD Maxamum” | Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
| Oral powder 500 g (MSUD Maxamum) |
From: |
|
“Neocate” | Oral powder 400 g |
To: |
|
Amino acids — synthetic, formula | Oral powder 400 g (Neocate) |
From: |
|
“Neocate Advance” | Oral powder 400 g |
To: |
|
Amino acids — synthetic, formula
| Oral powder 400 g (Neocate Advance) |
From: |
|
“Neocate Advance Tropical Flavour” | Oral powder 400 g |
To: |
|
Amino acids — synthetic, formula
| Oral powder 400 g (Neocate Advance Tropical Flavour) |
From: |
|
“Neocate LCP” | Oral powder 400 g |
To: |
|
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
| Oral powder 400 g (Neocate LCP) |
From: |
|
“Pepti-Junior” | Oral powder 450 g |
To: |
|
Protein hydrolysate formula with medium chain triglycerides
| Oral powder 450 g (Pepti-Junior) |
From: |
|
“Phenex-2” | Oral powder 325 g |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Oral powder 325 g (Phenex-2) |
From: |
|
“Phenex-2” | Oral powder 400 g |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Oral powder 400 g (Phenex-2) |
From: |
|
“Phlexy-10” | Capsules 500 mg, 200 |
To: |
|
Amino acid formula without phenylalanine
| Capsules 500 mg, 200 (Phlexy-10) |
From: |
|
“Phlexy-10” | Tablets 1 g, 75 |
To: |
|
Amino acid formula without phenylalanine
| Tablets 1 g, 75 (Phlexy-10) |
From: |
|
“Phlexy-10” | Bars 42 g, 20 |
To: |
|
Amino acid formula without phenylalanine
| Bars 42 g, 20 (Phlexy-10) |
From: |
|
“Phlexy-10 Drink Mix” | Sachets containing oral powder 20 g, 30 |
To: |
|
Amino acid formula without phenylalanine
| Sachets containing oral powder 20 g, 30 (Phlexy-10 Drink Mix) |
From: |
|
“PK AID II” | Oral powder 250 g |
To: |
|
Amino acid formula without phenylalanine
| Oral powder 250 g (PK AID II) |
From: |
|
“PKU Cooler 10” | Oral liquid 87 mL, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Oral liquid 87 mL, 30 (PKU Cooler 10) |
From: |
|
“PKU Cooler 15” | Oral liquid 130 mL, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Oral liquid 130 mL, 30 (PKU Cooler 15) |
From: |
|
“PKU Cooler 20” | Oral liquid 174 mL, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Oral liquid 174 mL, 30 (PKU Cooler 20) |
From: |
|
“PKU-Express” | Sachets containing oral powder 25 g, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Sachets containing oral powder 25 g, 30 (PKU-Express) |
From: |
|
“PKU-gel” | Sachets containing oral powder 20 g, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Sachets containing oral powder 20 g, 30 (PKU-gel) |
From: |
|
“Pro-Phree” | Oral powder 400 g |
To: |
|
Carbohydrate, fat, vitamins, minerals and trace elements
| Oral powder 400 g (Pro-Phree) |
From: |
|
“RCF” | Oral liquid 384 mL |
To: |
|
Soy protein and fat formula with vitamins and minerals — carbohydrate free
| Oral liquid 384 mL (RCF) |
From: |
|
“S-26 LF” | Infant formula powder 900 g |
To: |
|
Milk powder — lactose free formula
| Oral powder 900 g (S-26 LF) |
From: |
|
Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate | Oral liquid 1 g-320 mg-534 mg in 20 mL, 500 mL |
To: |
|
Alginic acid with calcium carbonate and sodium bicarbonate | Oral liquid containing alginic acid as sodium alginate 1 g, calcium carbonate 320 mg and sodium bicarbonate 534 mg in 20 mL, 500 mL |
From: |
|
Triglycerides Oil — Medium Chain | 500 mL |
To: |
|
Triglycerides, medium chain | Oil 500 mL (MCT Oil)
|
From: |
|
“TYR gel” | Sachets containing oral powder 20 g, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
| Sachets containing oral powder 20 g, 30 (TYR gel) |
From: |
|
“TYR Express” | Sachets containing oral powder 25 g, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
| Sachets containing oral powder 25 g, 30 (TYR Express) |
From: |
|
“XLYS, LOW TRY Analog”
| Oral powder 400 g |
To: |
|
Amino acid formula with vitamins and minerals without lysine and low in tryptophan
| Oral powder 400 g (XLYS, LOW TRY Analog) |
From: |
|
“XLYS, LOW TRY Maxamaid”
| Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without lysine and low in tryptophan
| Oral powder 500 g (XLYS, LOW TRY Maxamaid) |
From: |
|
“XMET Analog” | Oral powder 400 g |
To: |
|
Amino acid formula with vitamins and minerals without methionine
| Oral powder 400 g (XMET Analog) |
From: |
|
“XMET Maxamaid” | Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without methionine
| Oral powder 500 g (XMET Maxamaid) |
From: |
|
“XMET Maxamum” | Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without methionine
| Oral powder 500 g (XMET Maxamum) |
From: |
|
“XMTVI Analog” | Oral powder 400 g |
To: |
|
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine
| Oral powder 400 g (XMTVI Analog) |
From: |
|
“XMTVI Asadon” | Oral powder 200 g |
To: |
|
Amino acid formula without methionine, threonine and valine and low in isoleucine
| Oral powder 200 g (XMTVI Asadon) |
From: |
|
“XMTVI Maxamaid” | Oral powder 500 g |
To: |
|
From: |
|
“XMTVI Maxamum” | Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine
| Oral powder 500 g (XMTVI Maxamum) |
From: |
|
“XP Analog” | Oral powder 400 g |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Oral powder 400 g (XP Analog) |
From: |
|
“XP Analog LCP” | Oral powder 400 g |
To: |
|
Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine
| Oral powder 400 g (XP Analog LCP) |
From: |
|
“XPhen, Tyr Analog” | Oral powder 400 g |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
| Oral powder 400 g (XPhen, Tyr Analog) |
From: |
|
“XPhen, Tyr Maxamaid” | Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
| Oral powder 500 g (XPhen, Tyr Maxamaid) |
From: |
|
“XPhen, Tyr Maxamum” | Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
| Oral powder 500 g (XPhen, Tyr Maxamum) |
From: |
|
“XP Maxamaid” | Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Oral powder 500 g (XP Maxamaid) |
From: |
|
“XP Maxamum” | Oral powder 500 g |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Oral powder 500 g (XP Maxamum) |
From: |
|
“XP Maxamum” | Sachets containing oral powder 50 g, 30 |
To: |
|
Amino acid formula with vitamins and minerals without phenylalanine
| Sachets containing oral powder 50 g, 30 (XP Maxamum) |
From: |
|
“XPTM Tyrosidon” | Oral powder 500 g |
To: |
|
Amino acid formula without phenylalanine, tyrosine and methionine
| Oral powder 500 g (XPTM Tyrosidon) |
Alteration of Form
From: |
|
Prochlorperazine | Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5 |
To: |
|
Prochlorperazine | Suppositories containing prochlorperazine equivalent to |
From: |
|
Prochlorperazine | Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5 |
To: |
|
Prochlorperazine | Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5 |
SCHEDULE 1 – PART 2
Listed Drug Name and Form Alteration
From: |
|
“Digestelact” | Oral powder 900 g |
To: |
|
Milk powder — lactose modified
| Oral powder 900 g (Digestelact) |
From: |
|
“EleCare” | Oral powder 400 g |
To: |
|
Amino acids — synthetic, formula | Oral powder 400 g (EleCare)
|
From: |
|
“Karicare De-Lact” | Oral powder 900 g |
To: |
|
Milk powder — lactose free formula
| Oral powder 900 g (Karicare De-Lact) |
From: |
|
“Neocate” | Oral powder 400 g |
To: |
|
Amino acids — synthetic, formula
| Oral powder 400 g (Neocate) |
From: |
|
“Neocate Advance” | Oral powder 400 g |
To: |
|
Amino acids — synthetic, formula
| Oral powder 400 g (Neocate Advance) |
From: |
|
“Neocate Advance Tropical Flavour” | Oral powder 400 g |
To: |
|
Amino acids — synthetic, formula
| Oral powder 400 g (Neocate Advance Tropical Flavour) |
From: |
|
“Neocate LCP” | Oral powder 400 g |
To: |
|
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
| Oral powder 400 g (Neocate LCP) |
From: |
|
“S-26 LF” | Infant formula powder 900 g |
To: |
|
Milk powder — lactose free formula
| Oral powder 900 g (S-26 LF) |
SCHEDULE 3 – PART 1
Alteration of Form
From: |
|
Prochlorperazine | Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5 |
To: |
|
Prochlorperazine | Suppositories containing prochlorperazine equivalent to |
From: |
|
Prochlorperazine | Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5 |
To: |
|
Prochlorperazine | Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5 |