Class 4 Drug Alert (Caution in use): Aurum Pharmaceuticals Limited - Acetylcysteine 200mg/ml Injection - EL (09)A/32

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Dear Healthcare Professional,

Aurum Pharmaceuticals Limited have informed us that there is an error in the patient information/professional leaflet contained in all batches of Acetylcysteine 200mg/ml Injection 10ml currently on the market. The error concerns the dose to be given to children weighing 20kg or more and appears in the third stage of dosing which is infused over 16 hours.

The incorrect leaflet text reads:

Followed by (3):	Dose/dilution in infusion fluid	Time
	100mg in 500ml intravenously	over 16 hrs

The leaflet text should read:

Followed by (3):	Dose/dilution in infusion fluid	Time
	100mg/kg in 500ml intravenously	over 16 hrs

To avoid stock disruption, distribution of affected stock will continue. The leaflet is being amended and it is anticipated that stock containing the corrected version will be supplied to the market by April 2010. Once corrected stock is available, distribution of product containing the affected leaflet will cease.

Further information
For further enquiries, please telephone Carol Akinola, Pharmacovigilance and Medical Information Manager, Aurum Pharmaceuticals Limited on 01708 382791.

Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter.

Yours faithfully

Alison Bunce
Pharmaceutical Assessor, DMRC

MHRA Distribution (further recipients by cascade):
Regional contacts for NHS trusts and provider units
Chief pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special hospitals
Healthcare Commission for distribution to independent health care establishments
Primary care trusts (England)