Safety Information

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Provive MCT - LCT 1% Emulsion for Injection (10mg/mL) and Provive 1% Emulsion for Injection (10mg/mL) - investigation of infection in Australia

5 May 2014

On 2 May the Australian Therapeutic Goods Administration (TGA) announced a quarantine of two batches of Provive MCT - LCT 1% Emulsion for Injection (10mg/mL) in Australia because of a suspected link with three cases of infection associated with the organism Ralstonia Pickettii. These batches had only been distributed in Australia. Subsequently the TGA issued a further precautionary notice advising healthcare professionals in Australia to avoid using, if possible, a wider range of propofol injection products made at the same manufacturing site.

Ralstonia Pickettii is a common organism in the environment and is not normally harmful unless a patient is immunocompromised.

Medsafe is currently investigating whether there are any implications for product available within New Zealand. Currently there have been no reports of infection recorded in New Zealand and the affected batches are not available here.

Products Affected

Provive MCT - LCT 1% Emulsion for Injection (10mg/mL) and Provive 1% Emulsion for Injection (10mg/mL) - all sizes

Product name	Sponsor
Provive MCT - LCT	AFT
Provive	AFT

Additional Information

Regulator Actions

Medsafe is actively involved in investigating this issue and will update this notice should further information become available.

Reporting

Healthcare professionals are advised to report any adverse events associated with the use of propofol to the Centre for Adverse Reactions monitoring (CARM), as soon as possible. As a precaution, Ralstonia Pickettii should be considered as a potential causative organism should pyrexia of unknown origin be observed in patients who have recently received propofol.

How to report a problem