Poison amendments
December 19, 2012
THE Poisons Standard
Amendment No. 5 of 2012 has
been registered on the Federal
Register of Legislative Instruments
this week.
Changes in the Standard include
an amendment to ibuprofen,
placing it in Schedule 2 when in
preparations for oral use when
labelled with a recommended daily
dose of 1200 mg or less of
ibuprofen: in liquid preparations
when sold in the manufacturer’s
original pack containing 8 grams or
less of ibuprofen; or in divided
preparations, each containing 200mg
or less of ibuprofen, in packs of not
more than 100 dosage units except
when: as the only therapeutically
active constituent (other than
phenylephrine or when combined
with an effervescent agent); packed
in blister or strip packaging or in a
container with a child-resistant
closure; in a primary pack containing
not more than 25 dosage units;
compliant with the requirements of
the Required Advisory Statements
for Medicine Labels; not labelled
for the treatment of children 6
years of age or less; and not
labelled for the treatment of
children under 12 years of age
when combined with phenylephrine.
Moreover the amended schedule
also sees five new entries to
Schedule 4: abiraterone acetate,
boceprevir, fidaxomicin,
ridaforolimus, and telaprevir.
Penflufen and
aminocyclopyrachlor have also
been added to Schedule 5, with the
amendments effective from 01 Jan.
To view the amendments
CLICK HERE.
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