Download Amendment Determination 2007

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