Ketamine ampoules – labelling alert NZ

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The ANZCA New Zealand National Committee has been advised that the labelling on newly supplied ampoules of ketamine (from Claris) is potentially misleading in that it does not state the total dose or volume of the drug in the ampoule. The label refers to 100mg/mL while the ampoule contains a total of 2mL = 200mg. 
 

Medsafe has advised ANZCA that: “As a result of a complaint, the NZ sponsor has submitted a changed medicine notification to the pre-market assessment team at Medsafe to have the labelling changed so that the strength is expressed as 200mg/2mL as per the previously supplied product. Once the sponsor has advised the date stock with the new labelling will be available in NZ, we will get back to you.” Note: the pre-filled syringes of ketamine remain unchanged.

 

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