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COMMONWEALTH OF AUSTRALIA Instrument number PB 68 of 2007 Amendment declaration under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953 I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, make this instrument under subsections 85 (2), 85(2A) and 85(2AA) of the National Health Act 1953. Dated 6 Sept 2007 STEPHEN DELLAR Assistant Secretary Pharmaceutical Evaluation Branch Department of Health and Ageing Amendment declaration — drugs and medicinal preparations 1 Commencement This instrument commences on 1 October 2007. 2 Amendment of PB 48 of 2007 Schedule 1 amends PB 48 of 2007. 1 Schedule 1 Amendments (section 2) [1] Schedule 1, omit item dealing with “Alfaré” [2] Schedule 1, after item dealing with Alendronic acid with colecalciferol insert in the columns in the order indicated: Alginic acid with calcium carbonate and sodium bicarbonate [3] — Schedule 1, after item dealing with Amiloride insert in the columns in the order indicated: Amino acid formula without methionine, threonine and valine and low in isoleucine Methylmalonic acidaemia Amino acid formula without phenylalanine Phenylketonuria Amino acid formula without phenylalanine, tyrosine and methionine Tyrosinaemia Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine Phenylketonuria Amino acid formula with vitamins and minerals without lysine and low in tryptophan In respect of the oral powder 400 g (XLYS, LOW TRY Analog): Propionic acidaemia An infant or young child with proven glutaric aciduria type 1 In respect of the oral powder 500 g (XLYS, LOW TRY Maxamaid): A child aged less than 7 years with proven glutaric aciduria type 1 Amino acid formula with vitamins and minerals without methionine In respect of the oral powder 400 g (XMET Analog): For infants and very young children with pyridoxine non-responsive homocystinuria In respect of the sachets containing oral powder 20 g, 30 (HCU gel), sachets containing oral powder 25 g, 30 (HCU express), oral powder 500 g (XMET Maxamaid) and oral powder 500 g (XMET Maxamum): Pyridoxine non-responsive homocystinuria Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine Methylmalonic acidaemia Amino acid formula with vitamins and minerals without phenylalanine Phenylketonuria Amino acid formula with vitamins and minerals without phenylalanine and tyrosine Tyrosinaemia Amino acid formula with vitamins and minerals without valine, leucine and isoleucine Maple syrup urine disease Propionic acidaemia 2 Amino acids — synthetic, formula In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition [4] Schedule 1, omit item dealing with Calcium Folinate [5] Schedule 1, omit item dealing with “Caprilon” [6] Schedule 1, after item dealing with Carbimazole insert in the columns in the order indicated: Carbohydrate, fat, vitamins, minerals and trace elements [7] Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae Schedule 1, omit item dealing with “Carbohydrate Free Mixture” 3 [8] Schedule 1, omit item dealing with “Dialamine” [9] Schedule 1, omit item dealing with “Digestelact” [10] Schedule 1, after item dealing with Diphenoxylate with Atropine insert in the columns in the order indicated: Diphtheria and tetanus vaccine, adsorbed — Diphtheria and tetanus vaccine, adsorbed, diluted for adult use — [11] Schedule 1, omit item dealing with Diphtheria and Tetanus Vaccine – Adsorbed [12] Schedule 1, omit item dealing with Diphtheria and Tetanus Vaccine – Adsorbed (Diluted) [13] Schedule 1, omit item dealing with “Duocal” [14] Schedule 1, omit item dealing with “Easiphen” [15] Schedule 1, omit item dealing with “EleCare” [16] Schedule 1, omit item dealing with “Energivit” [17] Schedule 1, after item dealing with Esomeprazole and Clarithromycin and Amoxycillin insert in the columns in the order indicated: Essential amino acids formula with minerals and vitamin C Gyrate atrophy of the choroid and retina Urea cycle disorders 4 [18] Schedule 1, after item dealing with Folic Acid insert in the columns in the order indicated: Folinic acid In respect of the tablet containing calcium folinate equivalent to 15 mg folinic acid: Antidote to folic acid antagonists In respect of the injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL, injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL and injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL: — [19] Schedule 1, item dealing with Glucose Indicator—Blood omit from the column headed “Circumstances”: electrode strips, 50 (GlucoMen Sensor), [20] Schedule 1, omit item dealing with “HCU express” [21] Schedule 1, omit item dealing with “HCU gel” [22] Schedule 1, omit item dealing with “Karicare De-Lact” [23] Schedule 1, omit item dealing with “Ketonex-1” [24] Schedule 1, omit item dealing with “Ketonex-2” [25] Schedule 1, omit item dealing with “Kindergen” [26] Schedule 1, omit item dealing with “Locasol” [27] Schedule 1, omit item dealing with “Lophlex’ [28] Schedule 1, omit item dealing with “Lophlex LQ” [29] Schedule 1, omit item dealing with Lumiracoxib [30] Schedule 1, omit item dealing with “Mapleflex” [31] Schedule 1, omit item dealing with “Metabolic Mineral Mixture” 5 [32] Schedule 1, after item dealing with Miconazole insert in the columns in the order indicated: Milk powder — lactose free formula In compliance with authority procedures set out in subparagraph 14 (d): Acute lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet Milk powder — lactose modified In compliance with authority procedures set out in subparagraph 14 (d): Acute lactose intolerance in children aged 1 year and over, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet Milk powder — synthetic In compliance with authority procedures set out in subparagraph 14 (d): Hypercalcaemia in children under the age of 4 years Milk protein and fat formula with vitamins and minerals — carbohydrate free Patients with intractable seizures requiring treatment with a ketogenic diet Glucose transport protein defects Pyruvate dehydrogenase deficiency Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance Mineral mixture Metabolic disorders [33] Schedule 1, omit item dealing with “Minaphlex” [34] Schedule 1, omit item dealing with “Monogen” [35] Schedule 1, omit item dealing with “MSUD AID III” [36] Schedule 1, omit item dealing with “MSUD Analog” [37] Schedule 1, omit item dealing with “MSUD Express” [38] Schedule 1, omit item dealing with “MSUD Express Cooler” [39] Schedule 1, omit item dealing with “MSUD-gel” 6 [40] Schedule 1, omit item dealing with “MSUD Maxamaid” [41] Schedule 1, omit item dealing with “MSUD Maxamum” [42] Schedule 1, omit item dealing with “Neocate” [43] Schedule 1, omit item dealing with “Neocate Advance” [44] Schedule 1, omit item dealing with “Neocate Advance Tropical Flavour” [45] Schedule 1, omit item dealing with “Neocate LCP” [46] Schedule 1, omit item dealing with “Pepti-Junior” [47] Schedule 1, omit item dealing with “Phenex-2” [48] Schedule 1, omit item dealing with “Phlexy-10” [49] Schedule 1, omit item dealing with “Phlexy-10 Drink Mix” [50] Schedule 1, omit item dealing with “PK AID II” [51] Schedule 1, omit item dealing with “PKU Cooler 10” [52] Schedule 1, omit item dealing with “PKU Cooler 15” [53] Schedule 1, omit item dealing with “PKU Cooler 20” [54] Schedule 1, omit item dealing with “PKU-Express” [55] Schedule 1, omit item dealing with “PKU-gel” [56] Schedule 1, omit item dealing with “Pro-Phree” 7 [57] Schedule 1, after item dealing with Propylthiouracil insert in the columns in the order indicated: Protein hydrolysate formula with medium chain triglycerides In respect of the oral powder 400 g (Alfaré): In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment, for up to 3 months, for intolerance (not infant colic) to cows' milk protein in a child aged less than 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet, and where the date of birth of the patient is included in the authority application Continuing treatment for intolerance (not infant colic) to cows' milk protein in a child aged less than 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application Continuing treatment for intolerance (not infant colic) to cows' milk protein in a child aged 2 years or over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application Biliary atresia Chronic liver failure with fat malabsorption Chylous ascites Chylothorax Cystic fibrosis Enterokinase deficiency Proven fat malabsorption Severe diarrhoea of greater than 2 weeks' duration in an infant aged less than 4 months, where the date of birth of the patient is included in the authority application Severe intestinal malabsorption including short bowel syndrome In respect of the oral powder 450 g (Pepti-Junior): In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment, for up to 3 months, for intolerance (not infant colic) to cows' milk protein in a child aged less than 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet, and where the date of birth of the patient is included in the authority application Continuing treatment for intolerance (not infant colic) to cows' milk protein in a child aged less than 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application Continuing treatment for intolerance (not infant colic) to cows' milk protein in a child aged 2 years or over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application Biliary atresia Chronic liver failure with fat malabsorption Chylous ascites Cystic fibrosis Enterokinase deficiency Proven fat malabsorption Severe diarrhoea of greater than 2 weeks' duration in an infant aged less than 4 months, where the date of birth of the patient is included in the authority application Severe intestinal malabsorption including short bowel syndrome [58] Schedule 1, omit item dealing with “RCF” 8 [59] Schedule 1, item dealing with Riluzole omit the following words from the third line in the column headed “Circumstances”: 2 years and substitute: 5 years [60] Schedule 1, item dealing with Rosiglitazone omit from the columns in the order indicated: 2638 Treatment of type 2 diabetes, in combination with insulin, in a patient: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a thiazolidinedione (glitazone) is greater than 7%, despite treatment with insulin and oral anti-diabetic agents, or with insulin alone where metformin hydrochloride is contraindicated; or (b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a thiazolidinedione (glitazone) shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with insulin and oral antidiabetic agents, or with insulin alone where metformin hydrochloride is contraindicated; and where the HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstance, are documented in the patient's medical records, and are no more than 4 months old, at the time glitazone treatment is initiated and substitute: 2730 Treatment of type 2 diabetes, in combination with insulin, in a patient: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of insulin is greater than 7%, despite treatment with rosiglitazone maleate and at least 1 other oral anti-diabetic agent; or (b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of insulin shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with rosiglitazone maleate and at least 1 other oral antidiabetic agent; and where the HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstance, are documented in the patient's medical records, and are no more than 4 months old, at the time insulin therapy is initiated 2731 [61] Continuation of therapy in type 2 diabetes mellitus in a patient who has previously received and been stabilised on a PBS-subsidised regimen of antidiabetic medicines which includes both rosiglitazone maleate and insulin Schedule 1, omit item dealing with “S-26 LF” 9 [62] Schedule 1, omit item dealing with Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate [63] Schedule 1, after item dealing with Sotalol insert in the columns in the order indicated: Soy protein and fat formula with vitamins and minerals — carbohydrate free Patients with intractable seizures requiring treatment with a ketogenic diet Glucose transport protein defects Pyruvate dehydrogenase deficiency Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance [64] Schedule 1, after item dealing with Trifluoperazine insert in the columns in the order indicated: Triglycerides, medium chain In compliance with authority procedures set out in subparagraph 14 (d): Chylous ascites Chylothorax Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders Hyperlipoproteinaemia type 1 Intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect, requiring a ketogenic diet Long chain fatty acid oxidation disorders Triglycerides, medium chain and long chain with glucose polymer Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae Triglycerides — medium chain, formula In respect of the oral powder 400 g (Monogen): Chylous ascites Chylothorax Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders Hyperlipoproteinaemia type 1 Long chain fatty acid oxidation disorders In respect of the oral powder 420 g (Caprilon): Chylous ascites Chylothorax Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders [65] Schedule 1, omit item dealing with Triglycerides Oil – Medium Chain [66] Schedule 1, omit item dealing with “TYR Express” [67] Schedule 1, omit item dealing with “TYR gel” 10 [68] Schedule 1, after item dealing with Warfarin insert in the columns in the order indicated: Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose In compliance with authority procedures set out in subparagraph 14 (d): Infants and young children with chronic renal failure requiring treatment with a low protein and a low phosphorus diet, or a low protein, a low phosphorus and a low potassium diet [69] Schedule 1, omit item dealing with “XLYS, LOW TRY Analog” [70] Schedule 1, omit item dealing with “XLYS, LOW TRY Maxamaid” [71] Schedule 1, omit item dealing with “XMET Analog” [72] Schedule 1, omit item dealing with “XMET Maxamaid” [73] Schedule 1, omit item dealing with “XMET Maxamum” [74] Schedule 1, omit item dealing with “XMTVI Analog” [75] Schedule 1, omit item dealing with “XMTVI Asadon” [76] Schedule 1, omit item dealing with “XMTVI Maxamaid” [77] Schedule 1, omit item dealing with “XMTVI Maxamum” [78] Schedule 1, omit item dealing with “XP Analog” [79] Schedule 1, omit item dealing with “XP Analog LCP” [80] Schedule 1, omit item dealing with “XPhen, Tyr Analog” [81] Schedule 1, omit item dealing with “XPhen, Tyr Maxamaid” [82] Schedule 1, omit item dealing with “XPhen, Tyr Maxamum” [83] Schedule 1, omit item dealing with “XP Maxamaid” 11 [84] Schedule 1, omit item dealing with “XP Maxamum” [85] Schedule 1, omit item dealing with “XPTM Tyrosidon” [86] Schedule 3, after item dealing with Alendronic Acid insert in the columns in the order indicated: Alginic acid [87] Alginic acid with calcium carbonate and sodium bicarbonate Schedule 3, item dealing with Calcium Carbonate omit from the column headed “Allowable Compounds”: Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate and substitute: Alginic acid with calcium carbonate and sodium bicarbonate [88] Schedule 3, omit item dealing with Sodium Alginate [89] Schedule 3, item dealing with Sodium Bicarbonate omit from the column headed “Allowable Compounds”: Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate and substitute: Alginic acid with calcium carbonate and sodium bicarbonate [90] Schedule 6, omit item dealing with Charcoal — Activated 12