AustLII Tasmanian Numbered Regulations

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POISONS LIST AMENDMENT ORDER (NO. 2) 2004 (S.R. 2004, NO. 75) - REG 4

Schedule 2 amended (Medicinal Poisons)

Schedule 2 to the Principal Order is amended as follows:
(a) by omitting item 2019 and substituting the following:

2019. 

Brompheniramine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(b) in a day-night pack containing brompheniramine in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.

(b) by omitting item 2026 and substituting the following:

2026. 

Chlorpheniramine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(b) in a day-night pack containing chlorpheniramine in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.

(c) by omitting item 2031 and substituting the following:

2031. 

Codeine when –

 

(a) compounded –

 

(i) with a single non-opiate analgesic substance in tablets or capsules each containing 10mg or less of codeine when –

 

(A)  packed in blister or strip packaging or in a container with a child-resistant closure; and

 

(B)  in a primary pack containing 25 or less dosage units; or

 

(ii) with a single non-opiate analgesic substance in individually wrapped powders each containing 10mg or less of codeine when in a primary pack containing 25 or less dosage units; or

 

(iii) with one or more other therapeutically active substances –

 

(A)  in divided preparations each containing 10mg or less of codeine; or

 

(B)  in undivided preparations containing 0.25% or less of codeine; and

 

(b) labelled with a recommended daily dose not exceeding 60mg of codeine.

(d) by omitting item 2035 and substituting the following:

2035. 

Dexchlorpheniramine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(b) in a day-night pack containing dexchlorpheniramine in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.

(e) by omitting items 2041 , 2042 and 2043 and substituting the following:

2041. 

Diphenhydramine –

 

(a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness; or

 

(b) when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(ii) in a day-night pack containing diphenhydramine in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.

2042. 

Diphenylpyraline when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(b) in a day-night pack containing diphenylpyraline in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.

2043. 

Doxylamine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(b) in a day-night pack containing doxylamine in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.

(f) by omitting item 2054 and substituting the following:

2054. 

Fluorides for human use (except in preparations containing 15mg/kg or 15mg/L or less of fluoride ion) –

 

(a) as sodium fluoride, in preparations for ingestion containing 2.2mg or less of sodium fluoride per dosage unit; or

 

(b) in preparations for topical use containing 2.5% or less of fluoride ion except –

 

(i) pastes, powders or gels for the cleaning of teeth, included in Schedule 3 ; or

 

(ii) pastes, powders or gels for the cleaning of teeth, containing 1 000mg/kg or less of fluoride ion; or

 

(iii) other dental hygiene products containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure and labelled with warnings to the following effect:

 

(A)  Do not swallow;

 

(B)  Do not use [this product / name of product] in children 6 years of age or less.

(g) by omitting items 2067 and 2068 and substituting the following:

2067. 

Hyoscyamus niger for oral use –

 

(a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or

 

(b) in divided preparations containing 0.03mg of total solanaceous alkaloids or less per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids –

 

except in a pack containing 0.03mg or less of total solanaceous alkaloids.

2068. 

Ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1 200mg or less of ibuprofen –

 

(a) in liquid preparations when sold in the manufacturer's original pack containing 4 grams or less of ibuprofen; or

 

(b) in divided preparations, each containing 200mg or less of ibuprofen, in packs of 100 or less dosage units except when –

 

(i) as the only therapeutically active constituent other than an effervescent agent; and

 

(ii) packed in blister or strip packaging or in a container with a child-resistant closure; and

 

(iii) in a primary pack of 25 or less dosage units; and

 

(iv) the primary pack is labelled with one of the following warning statements:

 

WARNING – This medication may be dangerous when used in large amounts or for a long time;

 

CAUTION – This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful;

 

CAUTION – This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged or excessive use without medical supervision could be harmful; and

 

(v) the primary pack is labelled with warning statements to the following effect:

 

Do not use [this product / name of the product]:

 

If you have a stomach ulcer;

 

In the last 3 months of pregnancy [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea] ;

 

If you are allergic to ibuprofen or other anti-inflammatory medicines.

 

Unless a doctor has told you to, don't use [this product / name of the product]:

 

For more than a few days at a time;

 

With other medicines containing ibuprofen or other anti-inflammatory medicines or other medicines that you are taking regularly;

 

If you have asthma;

 

In children 6 years of age or less;

 

If you are aged 65 years or over;

 

If you are pregnant [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea] .

(h) by omitting item 2094R and substituting the following:

2094R. 

Mometasone in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

(i) by omitting item 2098 and substituting the following:

2098. 

Nicotine for use as an aid in withdrawal from tobacco smoking in preparations for inhalation.

(j) by omitting item 2109 and substituting the following:

2109. 

Pheniramine –

 

(a) in eye drops; or

 

(b) when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(ii) in a day-night pack containing pheniramine in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.

(k) by omitting item 2120 and substituting the following:

2120. 

Promethazine –

 

(a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness; or

 

(b) when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(ii) in a day-night pack containing promethazine in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.

(l) by omitting item 2136 and substituting the following:

2136. 

Thenyldiamine –

 

(a) in nasal preparations for topical use; or

 

(b) when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(ii) in a day-night pack containing thenyldiamine in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.

(m) by inserting after item 2139 the following:

2139M. 

Triamcinolone in aqueous nasal sprays delivering 50 micrograms or less of triamcinolone per actuation when the maximum recommended daily dose is no greater than 200 micrograms and when packed in a primary pack containing 120 actuations or less, for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

(n) by omitting items 2140 and 2141 and substituting the following:

2140. 

Trimeprazine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(b) in a day-night pack containing trimeprazine in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.

2141. 

Triprolidine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –

 

(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 

(b) in a day-night pack containing triprolidine in the bed-time dose –

 

except in preparations for the treatment of children 2 years of age or less.



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