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Atropine Sulfate 3mg/10ml solution for injection alert

Patient Information Leaflet (PIL) error

February 19th 2019

Tagged: MHRA alert

By MHRA

Laboratoire Aguettant has advised of an error in the Patient Information Leaflet (PIL) for the following batches of atropine sulfate 3mg/10ml solution for injection in pre-filled syringe.

In affected leaflets, the equivalent content of atropine base is expressed incorrectly as 0.17mg per ml and 0.83mg in10ml.

The affected batches are numbered:

  • 6501622*A: 1 x pre-filled syringe
  • 6502640: 10 x pre-filled syringes
  • 6502785: 10 x pre-filled syringes
  • 9901362: 10 x pre-filled syringes

The corrected PIL will state the following:

  • Each ml of solution for injection contains 0.3mg atropine sulfate monohydrate equivalent to 0.25mg atropine
  • Each 10ml syringe contains atropine sulfate monohydrate equivalent to 2.5mg atropine

In addition to this, minor errors on the Summary of Product Characteristics (SPC) and the carton are also being corrected. In the current versions of both, the equivalent content of atropine base is expressed as 0.26mg per ml and 2.49mg in10ml. This is being corrected to give equivalent contents of 0.25mg per ml and 2.5mg in 10ml

Steps have already been taken to correct the PIL, the SPC and the carton. Distribution of the above batches will cease once corrected stock is available. It is anticipated that new batches will be available in June 2019.

 

 

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