DRUG ALERT: Hameln Pharmaceuticals atropine sulphate
injection (25 August 2005)
Hameln Pharmaceuticals says that there is an error on the patient information
leaflet of the following batches of its atropine sulphate injection BP
600µg/ml in 1ml ampoules.
|
Batch number
|
Expiry date
|
Pack size
|
First distributed |
433009
|
August 2007
|
10 x 1ml
|
October 2004 |
444001
|
October 2007
|
10 x 1ml
|
March
2005 |
505001
|
January 2008
|
10 x 1ml
|
May 2005 |
|
The leaflet incorrectly states that the dosage for preoperative medication
in children over one year may, as an alternative, be calculated as 10–20mg
per kg body weight. This should read 10–20µg per kg body
weight. The information in the drug’s summary of product characteristics
is correct.
No recall is planned but distribution of stock has ceased until the leaflet is
replaced with one containing the correct details. For further information contact
Hameln Pharmaceuticals customer care on 01452 522255.
|
